Ethinylestradiol (ethinylestradiol)
- etonogestrel (etonogestrel)

Composition and form of release of the drug

vaginal ring smooth, transparent, colorless or almost colorless, without much visible damage, with a transparent or almost transparent area at the junction.

Excipients: ethylene and vinyl acetate copolymer (28% vinyl acetate) - 1677 mg, ethylene and vinyl acetate copolymer (9% vinyl acetate) - 197 mg, magnesium stearate - 1.7 mg.

1 PC. - aluminum foil waterproof bags (1) - cardboard packs.
1 PC. - aluminum foil waterproof bags (3) - cardboard packs.

pharmachologic effect

Combined hormonal contraceptive drug containing etonogestrel and ethinyl estradiol.

Etonogestrel is a progestogen (a derivative of 19-nortestosterone) that binds with high affinity to receptors in target organs. Ethinylestradiol is an estrogen and is widely used in the manufacture of contraceptives.

The contraceptive effect is due to a combination of various factors, the most important of which is the suppression of ovulation.

In clinical studies, it was found that the Pearl Index (an indicator reflecting the frequency of pregnancy in 100 women during 1 year of contraception) in women aged 18 to 40 years was 0.96 (95% CI: 0.64-1.39) and 0.64 (95% CI: 0.35-1.07) in the statistical analysis of all randomized participants (ITT analysis) and the analysis of participants in studies that completed them according to the protocol (PP analysis), respectively. These values ​​were similar to the values ​​of the Pearl indices obtained in comparative studies of combined oral contraceptives(CHC) containing levonorgestrel / ethinylestradiol (0.150 / 0.030 mg) or drospirenone / ethinylestradiol (3 / 0.30 mg).

Against the background of the use of the drug, the cycle becomes more regular, the pain and intensity of menstrual-like bleeding decreases, which helps to reduce the incidence of iron deficiency. There is evidence of a reduced risk of endometrial and ovarian cancer with the use of drugs containing this combination.

Pharmacokinetics

Ethinylestradiol

According to the results of measurements of the concentrations of ethinylestradiol in the cervical region and inside the uterus in women using and women using oral contraceptives containing 0.150 mg of desogestrel and 0.020 mg of ethinylestradiol, the observed values ​​of ethinylestradiol concentrations were comparable.

Ethinylestradiol binds to serum. The apparent V d is about 15 l/kg.

Ethinylestradiol is metabolized by aromatic hydroxylation. During its biotransformation, a large number of hydroxylated and methylated metabolites are formed, which circulate both in the free state and in the form of glucuronide and sulfate conjugates. The apparent clearance is approximately 3.5 l / h.

The concentration of ethinylestradiol in the blood decreases in two phases. T 1/2 in the terminal phase varies widely; the median is about 34 hours. Ethinylestradiol is not excreted unchanged; its metabolites are excreted by the kidneys and through the intestines in a ratio of 1.3:1. T 1/2 of metabolites is about 1.5 days.

Etonogestrel

According to the results of measuring the concentrations of etonogestrel in the cervical region and inside the uterus in women using the drug, and women using oral contraceptives containing 0.150 mg of desogestrel and 0.020 mg of ethinylestradiol, the observed values ​​of etonogestrel concentrations were comparable. Etonogestrel binds to serum albumin and sex hormone-binding globulin (SHBG). The apparent V d of etonogestrel is 2.3 l / kg. Biotransformation of etonogestrel occurs by known pathways of sex hormone metabolism. The apparent plasma clearance is about 3.5 l/h. The plasma concentration of etonogestrel decreases in two phases. In the terminal phase, T 1/2 is about 29 hours. Etonogestrel and its metabolites are excreted by the kidneys and through the intestines with bile in a ratio of 1.7:1. T 1/2 metabolites is approximately 6 days.

In patients with impaired liver function, the metabolism of sex hormones may be impaired.

Indications

Contraception.

Contraindications

Thrombosis (arterial or venous) and thromboembolism at present or in history (including deep vein thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular disorders); conditions preceding thrombosis (including transient ischemic attacks, angina pectoris) at present or in history; predisposition to the development of venous or arterial thrombosis, including hereditary diseases: resistance to activated protein C, antithrombin III deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinemia and antiphospholipid antibodies (antibodies to cardiolipin, lupus); migraine with focal neurological symptoms at present or in history; diabetes mellitus with vascular damage; pronounced or multiple risk factors for venous or arterial thrombosis: hereditary predisposition to thrombosis (thrombosis, myocardial infarction or cerebrovascular accident at a young age in one of the closest relatives), arterial hypertension, lesions of the valvular apparatus of the heart, atrial fibrillation, extended surgery, prolonged immobilization, extensive trauma, obesity (BMI> 30 kg / m 2), smoking in women over 35 years of age; pancreatitis (including history) in combination with severe hypertriglyceridemia; severe liver disease; liver tumors, malignant or benign (including history); established or suspected hormone-dependent malignant tumors (for example, genital or breast); vaginal bleeding of unknown etiology; pregnancy (including intended); period breastfeeding; hypersensitivity to any of the active or excipients.

Carefully

The presence of risk factors for the development of thrombosis and thromboembolism: hereditary predisposition to thrombosis (thrombosis, myocardial infarction or cerebrovascular accident at a young age in one of the immediate relatives), smoking, obesity, dyslipoproteinemia, arterial hypertension, migraine without focal neurological symptoms, valve disease heart, rhythm disturbances, prolonged immobilization, major surgical interventions; thrombophlebitis of superficial veins; dyslipoproteinemia; heart valve disease; adequately controlled arterial hypertension; diabetes mellitus without vascular complications; acute or chronic liver dysfunction; jaundice and/or itching caused by cholestasis; cholelithiasis; porphyria; systemic lupus erythematosus; hemolytic-uremic syndrome; chorea of ​​Sydenham (small chorea); hearing loss due to otosclerosis; angioedema (hereditary) edema; chronic inflammatory bowel disease (Crohn's disease and ulcerative colitis); sickle cell anemia; chloasma; conditions that make it difficult to use the vaginal ring: cervical prolapse, hernia Bladder, rectal hernia, severe chronic constipation.

Dosage

This combination is used as part of a special dosage form for topical use.

Side effects

From the immune system: hypersensitivity.

From the side of metabolism and nutrition: increased appetite, weight gain.

From the nervous system: headache, migraine, dizziness, hypesthesia, depression, decreased libido, mood changes, fatigue, irritability.

From the urinary system: cervicitis, cystitis, urinary tract infections, dysuria, urge to urinate, pollakiuria-izuria, urge to urinate, pollakiuria.

From the digestive system: abdominal pain, nausea, bloating, diarrhea, vomiting, constipation.

From the reproductive system: vaginal infection, breast engorgement and tenderness, genital itching in women, painful menstrual bleeding, pelvic pain, vaginal discharge, no menstrual bleeding, breast discomfort, breast enlargement, breast lumps, cervical polyps uterus, contact (during intercourse) spotting (bleeding), pain during intercourse, ectropion of the cervix, fibrocystic mastopathy, heavy menstrual-like bleeding, acyclic bleeding, discomfort in the pelvic area, premenstrual-like syndrome, burning sensation in the vagina, vaginal odor, soreness in the vagina, discomfort and dryness of the vulva and vaginal mucosa.

From the musculoskeletal system: back pain, muscle spasms, pain in the extremities.

From the side of the skin and skin: acne, alopecia, eczema, pruritus, rash, urticaria.

From the side of the organ of vision: visual impairment.

From the side of the cardiovascular system: external thromboembolism, hot flashes, increased blood pressure.

Others: discomfort when using the vaginal ring, prolapse of the vaginal ring, malaise, swelling, sensation of a foreign body, difficulty in using a contraceptive, rupture (damage) of the ring.

drug interaction

Interaction between hormonal contraceptives and other drugs can lead to the development of acyclic bleeding and / or contraceptive failure.

Possible drug interactions inducing microsomal liver enzymes, which can lead to an increase in the clearance of sex hormones. Interaction with the following drugs has been established: phenytoin, barbiturates, primidone, rifampicin, and possibly oxcarbazepine, topiramate, felbamate, ritonavir, griseofulvin, and preparations containing St. John's wort.

When treating with any of the listed drugs, you should temporarily use a barrier method of contraception (condom) or choose another method of contraception. During concomitant use of drugs that cause induction of microsomal liver enzymes, and within 28 days after their cancellation, barrier methods of contraception should be used.

A decrease in the effectiveness of oral contraceptives containing ethinyl estradiol has been observed with concomitant use antibiotics such as ampicillin and tetracyclines. The mechanism of this effect has not been studied. In a pharmacokinetic interaction study, oral administration amoxicillin (875 mg 2 times / day) or doxycycline (200 mg / day, then 100 mg / day) within 10 days during the use of the drug had little effect on the pharmacokinetics of etonogestrel and ethinyl estradiol. When applied antibiotics (excluding amoxicillin and doxycycline) You should use a barrier method of contraception (condom) during treatment and for 7 days after stopping antibiotics. If concomitant therapy is to be continued after 3 weeks of ring use, then the next ring must be administered immediately without the usual interval.

Hormonal contraceptives can cause a violation of the metabolism of other drugs. Accordingly, their concentrations in plasma and tissues may increase. (eg, cyclosporine) or decrease (eg, lamotrigine).

special instructions

If any of the diseases, conditions or risk factors listed below are present, the benefits and possible risks for each individual woman should be assessed before she starts using medicinal product. In the event of an exacerbation of diseases, a deterioration in the condition, or the occurrence of any of the conditions listed below for the first time, a woman should consult a doctor.

The use of hormonal contraceptives may be associated with the development of venous thrombosis (deep vein thrombosis and pulmonary embolism) and arterial thrombosis, as well as associated complications, sometimes with a fatal outcome.

The use of any COC increases the risk of developing venous thromboembolism (VTE) compared with the risk of developing VTE in patients who do not use COCs. The greatest risk of developing VTE occurs in the first year of COC use. Data from a large prospective cohort study on the safety of various COCs suggest that the greatest increase in risk, compared with the level of risk in women who do not use COCs, occurs in the first 6 months after starting the use of COCs or resuming their use after a break (4 weeks or more) . In non-pregnant women not using oral contraceptives, the risk of developing VTE is 1 to 5 cases per 10,000 woman-years (WY). In women using oral contraceptives, the risk of developing VTE is from 3 to 9 cases per 10,000 VL. However, the risk increases to a lesser extent than during pregnancy, when it is 5-20 cases per 10,000 YL (pregnancy data are based on the actual duration of pregnancy in standard studies; when converted to a pregnancy of 9 months, the risk is from 7 to 27 cases per 10,000 YL). In women in the postpartum period, the risk of developing VTE is 40 to 65 cases per 10,000 VL. VTE is fatal in 1-2% of cases.

Women using COCs should be advised to consult a doctor if symptoms of thrombosis appear. If thrombosis is suspected or confirmed, COC use should be discontinued. In this case, it is necessary to use effective means contraception, since anticoagulants (coumarins) have a teratogenic effect.

The most important risk factor for developing cervical cancer is infection with the human papillomavirus (HPV). Epidemiological studies have shown that long-term COC use leads to an additional increase in this risk, but it remains unclear how much this is due to other factors such as more frequent cervical smears and differences in sexual behavior, incl. use of barrier contraceptives.

Breast cancer diagnosed in women using COCs is clinically less pronounced than cancer detected in women who have never used COCs. The increased risk of developing breast cancer may be due to both the fact that in women taking COCs, the diagnosis of breast cancer is established earlier, and the biological effects of COCs, or a combination of both of these factors.

In rare cases, women who took COCs have experienced cases of benign, and even more rarely, malignant liver tumors. In some cases, these tumors have led to the development of life-threatening bleeding into the abdominal cavity. The physician should consider the possibility of a liver tumor in the differential diagnosis of diseases in a woman if the symptoms include acute pain in the upper abdomen, an enlarged liver, or signs of intra-abdominal bleeding.

Women with hypertriglyceridemia or a family history of hypertriglyceridemia have an increased risk of developing pancreatitis when taking hormonal contraceptives.

Many women taking hormonal contraceptives have a slight increase in blood pressure, but a clinically significant increase in blood pressure is rare. A direct relationship between the use of hormonal contraceptives and the development of arterial hypertension has not been established. If a persistent increase in blood pressure is noted during use, it is necessary to contact your doctor to decide whether it is necessary to remove the vaginal ring and prescribe antihypertensive therapy. With adequate control of blood pressure with the help, it is possible to resume the use of the drug.

During pregnancy and during the use of COCs, the development or worsening of the following conditions was noted, although their relationship with the use of contraceptives has not been fully established: jaundice and / or itching caused by cholestasis, formation of gallstones, porphyria, systemic lupus erythematosus, hemolytic-uremic syndrome, Sydenham's chorea (chorea minor), herpes of pregnancy, hearing loss due to otosclerosis, angioedema (hereditary) edema.

Acute or chronic liver dysfunction may warrant withdrawal until normalization of liver function tests. Recurrence of cholestatic jaundice, observed earlier during pregnancy or when using sex steroid preparations, requires discontinuation of the drug.

Women with diabetes should be under constant medical supervision, especially in the first months of contraception.

There is evidence of worsening of the course of Crohn's disease and ulcerative colitis with the use of hormonal contraceptives.

In rare cases, pigmentation of the skin of the face (chloasma) may occur, especially if it occurred earlier during pregnancy. Women who are prone to developing chloasma should avoid exposure to sunlight and ultraviolet radiation.

During use, acyclic bleeding (spotting or sudden bleeding) may occur. If such bleeding is observed after regular cycles against the background of proper use, you should contact your gynecologist for the necessary diagnostic tests, incl. to exclude organic pathology or pregnancy. Diagnostic curettage may be required.

The use of contraceptive hormonal drugs may affect the results of certain laboratory tests, including biochemical parameters of liver function, thyroid gland, adrenal and renal, plasma concentrations of transport proteins (eg, corticosteroid-binding globulin and sex hormone-binding globulin), lipid/lipoprotein fractions, measures of carbohydrate metabolism, and measures of coagulation and fibrinolysis. Indicators, as a rule, change within normal values.

Pregnancy and lactation

Contraindicated during pregnancy and lactation (breastfeeding).

For impaired liver function

Contraindicated in severe liver diseases (before the normalization of function indicators).

Latin name: NovaRing
ATX code: G02BB01
Active substance: Ethinylestradiol
and etonogestrel
Manufacturer: Organon, Netherlands
Pharmacy leave condition: On prescription

Nuvaring - a new high-performance contraceptive drug the latest generation, intended for intravaginal use.

Indications for use

The contraceptive ring Novaring is prescribed for contraceptive purposes.

Composition

The active ingredients of the vaginal ring are ethinyl estradiol together with etonogestrel, the dosages of the active ingredients are 2.7 mg and 11.7 mg, respectively.

Additional components include:

• Magnesium stearate
• Ethylene and vinyl acetate copolymer.

Medicinal properties

Price from 989 to 3897 rubles.

Synthetic hormones released by the ring during vaginal use have a contraceptive effect by blocking the onset of ovulation. Each of the hormones entering the body affects the functioning of the ovaries, preventing the maturation of the follicles. Etonogestrel is the progestogen component of the ring, which binds to specific progesterone receptors in the so-called target organs.

Ethinylestradiol is an estrogen component, the action of this drug is associated with the occurrence of various processes that are mainly aimed at inhibiting ovulation.

The hormonal drug exhibits not only contraceptive properties, normalizes the menstrual cycle, reduces pain during the first days of menstrual discharge, reducing blood loss. Due to this influence, the risk of iron deficiency and the development of anemia is reduced.

When using Nuvaring, the likelihood is significantly reduced ectopic pregnancy, the development of cancer of the ovaries and the endometrial layer of the uterus. At the same time, cystic formations in the ovaries, inflammatory processes in the pelvic organs, and benign neoplasms in the mammary glands are less often diagnosed.

Etonogestrel penetrates the walls of the vagina, its highest concentration is observed after 7 days, exactly when it begins to act as a contraceptive. At the same time, its bioavailability is 100%, which is significantly higher than when taking oral contraceptives. Metabolic processes take place in the liver cells, excretion is carried out by the intestines and the renal system. The half-life of metabolic products is about 6 days.

Ethinylestradiol is characterized by fairly high absorption rates. The highest level of the hormone is observed after 3 days. since the installation of the hormonal ring. The bioavailability index is 56%, which practically coincides with the oral use of hormones. Metabolism occurs in the intestines and kidneys, metabolites are excreted in 36 hours.

Release form

The surface of the hormonal ring is smooth, transparent and completely colorless. There is a small transparent area in the connection area. Inside the moisture-resistant package is 1 hormonal ring NovaRing. A pack may contain 1 or 3 bags (with 3 rings - Nuvaring 3) along with instructions.

Nuvaring: instructions for use

It is necessary to insert the ring into the vagina for 21 days. After this period, it must be removed on the day of the week on which it was installed. After a week break (7 days), a new contraceptive is introduced. It is worth noting that after 2-3 days. after removing the Nuvaring ring, menstrual-like bleeding usually begins, it ends after the next intravaginal installation of the contraceptive. If this contraceptive is used for the first time, then you should pay attention to some features of its use:

• A hormonal contraceptive has not been used before - the introduction of the Nuvaring ring is carried out in the first days of the cycle (best on the 1st day). If the installation occurred after 1 day. cycle, it is recommended to use additional methods of contraception for the next seven days.
• If hormonal contraceptives have been previously used, the ring should be inserted in the interval between taking COCs (the seven-day withdrawal period). With the correct use of COCs and confirmation that the woman is not pregnant, the introduction of the Nuvaring ring can be performed on any day of the MC. You can go from Yarina in the same way.
• After taking mini-pills, single-component progestin contraceptive pills, using hormonal intrauterine systems, injectable contraceptives, and implants, the ring is inserted according to certain rules. After progestogen tablets (mini-pills), you can insert a contraceptive drug on any day, regardless of when the last pill was taken, the cycle after childbirth was adjusted or not. After removing the spiral, you will need to insert a contraceptive ring on the same day (according to the instructions). In the case of using a previously injectable contraceptive, you will need to start installing the ring on the day when the hormone administration procedure is to be performed. During the seven-day use of the ring, it is necessary to apply a barrier method of protection against unwanted pregnancy.

Instructions for use after an abortion

When carrying out an abortion before 4 months of pregnancy, it will be necessary to insert the rings immediately after the implementation of this procedure or wait for the first menstruation (in this case, a contraceptive is administered on the 1st day of the cycle).

After an abortion during the second trimester or after delivery, the vaginal ring can be installed no earlier than a month (4 weeks) after natural childbirth (breastfeeding is stopped) or an abortion.
If the use of a hormonal drug passes with deviations from standard scheme, the following guidelines should be followed:

• A break in the use of the hormonal ring exceeds 7 days. in the presence of unprotected sexual contacts: pregnancy is first excluded and a contraceptive is immediately introduced, the next 7 days. it is preferable to use barrier methods of protection against unwanted pregnancy.
• Temporary removal of the hormonal ring: its stay outside the vagina is less than three hours, then the level of protection against pregnancy is not reduced. If the period of absence of a hormonal drug in the vagina was more than 3 hours in the first weeks of using this contraceptive, the ring should be inserted as soon as possible. In this case, the contraceptive effect may be reduced, there is a need for additional measures to prevent pregnancy. If the ring was removed for more than 3 hours in the third week, it is necessary to stop using this drug and insert a new one. The break in use should not last more than 7 days. You can also wait for menstruation, on the first day when menstruation began, you can enter an intravaginal contraceptive. Use of condoms for the next 7 days. is mandatory.
• The use of a vaginal contraceptive for more than 4 weeks. requires further exclusion of pregnancy due to the fact that the contraceptive effect of drugs has decreased significantly. After pregnancy is excluded, you can use the drug according to the standard scheme.

How to delay your period

To postpone menstruation (offensive spotting) for a day or several days, it is possible to introduce a hormonal ring without a standard seven day break. In this case, the possibility of bleeding should not be ruled out.

How to insert a ring into the vagina

Before inserting the ring, it is necessary to squeeze it with the help of the index and thumb and gently place inside the vagina.

In case of accidental loss of the ring when using tampons, it is recommended to rinse the contraceptive under running warm water, then insert it again. If necessary, you can check with the doctor: “What should I do if I pull out the tampon along with the ring?” It is worth noting that with a tampon a woman will not feel any discomfort. When using tampons, you need to be careful not to let the ring fall out of the vagina.

To remove the ring, you should pick it up with your index finger, squeeze it slightly, then pull it towards you. The used hormonal preparation, which the woman pulled out of the vagina after 21 days, should be disposed of.

If the woman did not correctly insert the ring, it was accidentally placed in the urethra, the likelihood of developing cystitis increases, and frequent urination may occur. In this case, a woman can become pregnant. Before you fight cystitis, you should find out the true cause of its appearance. You will need to remove the ring as soon as possible. As a result of the subsequent correct introduction, it must be securely fixed, frequent inflammatory processes of the genitourinary system, and in particular cystitis, after Nuvaring they will no longer bother, the pain during urination will disappear.

The use of the ring for myoma

The presence of fibroids is not a contraindication to the use of this contraceptive, you can use the ring without harm to your own health. It should be noted that the fibroid does not grow during the use of the ring, as evidenced by ultrasound. Patients with fibroids are advised to consult a doctor about the advisability of using the ring. If necessary, you can switch from Nuvaring to tablets. Whether it is possible to treat fibroids in this way and which contraceptives to give preference to, check with the attending gynecologist. Cancellation of Nuvaring should be agreed with a specialist. Restoration of the cycle after hormone therapy will come after six months.

Treatment of endometriosis

With endometriosis, the use of a hormonal ring can be indicated, when switching from other COCs (for example, if Yarina was previously prescribed), a significant improvement in the course of the disease is observed, during menstruation a woman loses less blood. During the first month of use, the severity of pain decreases, which contributes to the gradual restoration of the endometrial layer of the uterus. After the woman has switched to using the ring, menstruation is painless. The drug acts gently, without disturbing the work of other organs and systems. Each of the active ingredients has a local therapeutic effect.

Use during pregnancy and breastfeeding

Such contraceptives are not prescribed for this group of patients. Nuvaring is contraindicated during lactation and pregnancy.

Contraindications

• Tendency to develop thrombosis and thromboembolism
• Conditions that indicate the development of thrombosis
• Severe migraine-like headaches with severe focal neurological symptoms now or earlier
• Diabetes mellitus complicated by vascular lesions
• Pancreatitis with hypertriglyceridemia
• Serious disorders of the liver (including benign and malignant tumor process)
• The presence of hormone-dependent neoplasms
• Bloody discharge from the internal genital organs of unknown origin
• Pregnancy, GV
• Excessive susceptibility to Nuva Ring (main components).

Precautionary measures

If you have not previously used contraceptives of this type, you should undergo a medical examination to identify diseases that are a contraindication to the use of a hormonal ring. Control visits to the gynecologist should take place every 6 months.

It must be remembered that this contraceptive does not protect against AIDS and other infectious diseases that are sexually transmitted. During the use of a contraceptive, the risk of thrombosis increases significantly.

Possible symptoms include:

• feeling of heat in lower limbs pain or severe swelling
• Hyperemia of individual areas of the skin
• Cough syndrome, developing shortness of breath with characteristic seizures
• Violation of the clarity of vision
• Intense and prolonged headaches
• Slurring of speech
• Collapse
• Movement disorder
• Lethargy, decreased sensation in some part of the body
• Syndrome of "acute" abdomen.

If a possible blockage of blood vessels by blood clots is not excluded, it is necessary to immediately cancel the drug, seek medical help.

During contraceptive therapy (women used pills), the development of a tumor process in the liver tissues was diagnosed. The use of a vaginal ring does not exclude the development of such a pathology, as well as on tablets.

During hormone therapy, the risk of pancreatitis is rapidly increasing.

If you are prone to chloasma, you should avoid prolonged exposure to direct sunlight.

Exacerbation of the course of ulcerative colitis, as well as Crohn's disease, is not excluded.

Persons with diabetes need to be under strict medical supervision during the first months of hormone therapy.

If menstruation stops and the woman becomes pregnant, the use of the contraceptive should be stopped immediately.

Cross-drug interactions

It is necessary to read the instructions for drugs such as oxcarbazepine, carbamazepine, topiramate, phenytoin, felbamate, rifampicin, as well as barbiturates and preparations based on St. John's wort. This is due to the fact that the combined use increases the risk of acyclic spotting. It is necessary to use additional means of protection during treatment with such drugs for a month.

The use of antibiotics (for example, tetracycline or ampicillin) reduces the contraceptive effect of the hormonal agent. It is recommended to use a condom during antibiotic treatment. What antibiotics to use and what are the consequences of taking them, it is better to ask a gynecologist.

With the intravaginal use of antifungal suppositories, the risk of damage to the hormonal ring or its rupture increases.

During hormone therapy, a change in the metabolism of other drugs can be observed, these include cyclosporine, as well as lamotrigine.

Side effects

At long-term use hormonal drugs, it is worth studying the instructions for the drugs, as multiple side effects, in particular, Nuvaring does not exclude:

• Oversensitivity
• Increased appetite and weight gain
• Decreased libido
• Sudden mood swings, depression
• migraine-like pain
• Violation of visual acuity
• Deterioration of the cardiovascular system, which is characterized by thromboembolism, changes in blood pressure, the occurrence of so-called hot flashes
• Gastrointestinal disorders
• Rash, acne, and severe itching
• Pain in the muscles, spine and limbs
• Dysuria, urinary frequency, cystitis
• Lethargy, edema
• Reproductive system: breast engorgement, the appearance of a genital node, the development of dysmenorrhea, heavy periods or their absence, bleeding of unknown etiology, discharge with blood impurities during sexual contact, local burning sensation, pain inside the vagina.

Overdose

The presence of serious consequences of an overdose was not detected.

Bleeding, indigestion are not excluded.

Please note that there is a special hotline that helps women deal with various problems with the use of the vaginal ring. With the development of side symptoms against the background of an overdose, you should call the hotline (the number is indicated on the official page of the Novaring drug in Russia). The hotline operators will consult and give recommendations on how to act in a given situation.

Storage conditions and shelf life

The storage of the hormonal ring must be strictly observed. temperature regime(2-8 C) for 3 years.

Analogues

Bayer, Germany

Price from 759 to 3295 rubles.

Yarina refers to combined hormonal drugs, the intake is designed for one month. Tablets act in a complex way, showing a contraceptive effect and an antiandrogenic effect. Inside the package can be placed 21 or 28 tab.

Pros:

• Eliminate the appearance of acne
• Normalize MC
• Easy to switch from other COCs.

Minuses:

• Produced by a foreign manufacturer, which is displayed on the price
• Has a negative effect on the functioning of the liver
• Against the background of hormone therapy, adverse reactions appear.

A drug.

Etonogestrel - this progestogen binding in target organs to progesterone receptors.

Ethinylestradiol — estrogen . The effect of the drug is provided by a combination of various mechanisms, the most significant of which is the suppression of ovulation.

The use of the drug is regulated menstrual cycle , reducing pain during menstrual bleeding and their intensity. This reduces the likelihood of developing iron deficiency anemia .

The use of the drug reduces the risk ovarian cancer and endometrium, development, inflammation of the organs of the female reproductive system and benign pathologies of the mammary glands.

Pharmacodynamics and pharmacokinetics

Etonogestrel is absorbed through the vaginal mucosa and its maximum concentration is reached after about 7 days. Bioavailability is about 100%, which is higher than with oral etonogestrel. The substance is metabolized in the liver and excreted in the urine and bile. The half-life of metabolites is 6 days.

Ethinylestradiol also penetrates through the vaginal mucosa into the blood. The maximum concentration is reached after 3 days. Bioavailability is approximately 56% and is comparable to oral administration. Metabolized in urine and bile, elimination half-life is about 36 hours.

Indications for use

Contraception.

Contraindications

• arterial and venous, thromboembolism and predisposition to them;
• heart defects with complications in the form of thrombosis;
• with vascular changes;
• severe liver disease;
• malignant and benign liver tumors;
• hormone-dependent malignant tumors (breast and reproductive system);
• vaginal bleeding unknown origin;
• hypersensitivity to any of the substances of the drug (active or auxiliary).

If any of these conditions occur, stop taking the drug immediately.

Prescribe the drug with caution in such cases:

• a family history of venous or arterial thrombosis ;
• major surgical interventions and interventions on the lower extremities, prolonged immobilization;
• with a body mass index over 30;
• smoking (especially women over 35);
• lipid metabolism disorder;
• heart defects ;
• diabetes;
• violations of the liver;
• chorea ;
• otosclerosis with hearing loss;
• ulcerative colitis and Crohn's disease ;
• sickle cell anemia ;
• porphyria ;
• chloasma ;
• cases of difficult use of the vaginal ring: severe chronic, hernia of the bladder and rectum, prolapse of the cervix.

With an exacerbation of diseases and a deterioration in the condition, or with a condition that has arisen for the first time from the above, the further question of taking the drug should be decided with the doctor.

Side effects

When applied, the following side effects of Novaring may occur, occurring with varying frequency.

• Infections: vaginal infections and urinary tract.
• The immune system: hypersensitivity.
• Metabolism: increased appetite and weight gain.
• Mental disorders: decreased sexual desire, mood changes,.
• Nervous system: headache, dizziness , migraine .
• Organs of vision: visual impairment.
• Cardiovascular system: increased blood pressure, thromboembolism , sensation of "tides".
• Digestive system: nausea, bloating, abdominal pain, diarrhea, constipation, vomiting.
• Skin: , pruritus , rash .
• Musculoskeletal system: pain in the limbs and back, muscle spasms.
• Urinary system: dysuria , frequent urination.
• On the part of the reproductive system and mammary glands, the side effects of the ring can be manifested by: genital itching, vaginal discharge, bloody discharge during intercourse, heavy menstruation, uterine bleeding, premenstrual syndrome, burning in the vagina, pain and discomfort in the vagina.
• General condition of the body: fatigue, swelling.

There may also be discomfort and discomfort in the vagina.

Instructions for use Nuvaring rings (Method and dosage)

The ring is inserted once every 4 weeks into the vagina, where it stays for 21 days, and then removed. A new ring is introduced after a break of 7 days.

On the 2-3rd day after the removal of the ring, bleeding begins, which is associated with the termination of the drug.

If the previous menstrual cycle was not applied hormonal contraceptives , the Novaring contraceptive ring is administered on the first day of menstruation. It is possible to install up to the 5th day of the cycle, however, in this case, it is recommended to use a condom for the first week of using the drug.

When switching from combined oral contraceptives, the ring is administered on the last day of the interval between taking hormonal contraceptives. With the correct and regular use of the combined hormonal contraceptive and confidence in the absence of pregnancy, you can insert the vaginal ring on any day of the cycle.

Terms of sale

On prescription.

Storage conditions

Keep out of the reach of children and at a temperature not lower than 2°C and not higher than 8°C.

Best before date

special instructions

The use of hormonal contraceptives may be associated with the development venous And arterial thrombosis .

Possible symptoms of thrombosis are:

• pain and swelling in one leg;
• sudden onset of intense chest pain;
• dyspnea or cough paroxysmal nature;
• dizziness , intense headaches;
• sudden loss of vision or double vision;
• speech disorders;
• sudden weakness or numbness of one side of the body or any part of the body;
• movement disorders.

If there are signs of thrombosis, stop taking hormonal contraceptives immediately and consult a doctor.

The reason for stopping the use of hormonal contraceptives should be an increase in the severity of migraine and the frequency of attacks.

In women with hypertriglyceridemia increased risk of developing pancreatitis.

With a tendency to develop chloasma avoid exposure to ultraviolet radiation and the sun during the application of the ring.

The use of the drug can cause acyclic bleeding in the form of spotting or bleeding that occurs suddenly.

Use during pregnancy is contraindicated. When it occurs, remove the ring.

Pregnancy after the abolition of Nuvaring occurs when the natural cycle and normal ovulation are restored.

The use of the drug during breastfeeding is contraindicated.

The NovaRing contraceptive ring is a reliable method of contraception for women. It is popular all over the world. However, not all girls know how to use it correctly so as not to harm their health and be 100% sure of their protection.

NuvaRing has an annular elastic shape. The ring is perfectly smooth to the touch and colorless. It is inserted into the vagina for 21 days. After that, it must be removed. Inside the vagina, the contraceptive ring changes shape and adapts to the female anatomy. Therefore, the woman does not feel it at all.

During the period of wearing the ring, you do not need to limit yourself to physical activity - you can do any sport. During the entire sexual intercourse, NovaRing is not felt and does not cause inconvenience.

The vaginal ring is produced in the Netherlands in a single pharmacological form. Therefore, you will not find this contraceptive anywhere, for example, in pills or candles.

The contraceptive ring has the same dimensions: diameter - 5.4 cm, thickness - 4 cm. The ring is suitable for any woman, regardless of age, height and body weight, as it is ideally located inside.

The composition and principle of action of the contraceptive NovaRing

NovaRing is a hormonal contraceptive. The main substances that are included in the composition are Etonogestrel, Ethinylestradiol and other excipients.

The principle of action of the contraceptive is manifested in the inhibition and blocking of the process of ovulation in a woman. That is why the follicle does not mature and pregnancy does not occur.

The Pearl Index, which indicates the frequency of fertilization, is 0.96.

When using a contraceptive in women, the profusion is reduced menstrual cycle, the intensity of pain decreases before and during menstruation. NuvaRing also helps reduce the risk of developing ovarian and endometrial cancer.

Release form

Vaginal ring NovaRing No. 1 and No. 3. The numbers indicate the number of products in one package.

Advantages and disadvantages of using a ring

Any drug has both advantages and disadvantages. The NuvaRing vaginal ring is no exception. It is important here to understand what is important to you. And on the basis of their thoughts and feelings, make their choice in favor of the ring or in favor of another contraceptive.

Advantages

The positive aspects of NuvaRing include:

• high reliability of contraceptive action;
• the minimum dosage of the hormone in the preparation does not have a high effect on the body;
• need to be changed once every 21 days;
• hormonal contraceptive has only local effects;
• the use of the drug does not affect the fluctuations in the woman's weight;
• in case of violation, a regular menstrual cycle is established;
• menstruation becomes less abundant and painless;
• the drug does not complicate the work of the liver, stomach and liver;
• with regular use of the ring, the risk of ovarian cancer is reduced;
• NuvaRing does not affect sensitivity during intercourse;
• the vaginal ring is not felt inside, allows you to lead an active lifestyle and engage in any kind of sports;
• after stopping the use of a contraceptive, the childbearing function is quickly restored - within 4-5 weeks;
• the sexual partner does not feel the ring during intercourse, so its use can be kept secret.

disadvantages

Disadvantages of the NovaRing vaginal ring:

• a high range of contraindications (read the instructions initially);
• the ring does not guarantee protection against sexually transmitted diseases (HIV and AIDS);
• the use of a contraceptive is psychologically unusual for many women.

As you can see, the disadvantages are much less. Therefore, if you have a permanent one partner, and there are no contraindications, then use the vaginal ring as a contraceptive.

Side effects of the drug

Some women may feel side effects from using NuvaRing. But usually they appear at the very beginning and after a few days they go away on their own. Side effects of the vaginal ring are:

• CNS - headache, anxiety, slight dizziness, sudden mood swings;
• Digestion - diarrhea, bouts of vomiting, nausea;
• Endocrine system - weight loss or gain, breast enlargement, slight decrease in libido, menstrual cycle disorder;
• Female genital organs - inflammation of the vaginal mucosa, white discharge from the vagina;
• Genitourinary system - cystitis and other similar diseases;
• Local reaction - a foreign body inside the vagina, the prolapse of the ring is premature.

Very rarely, side effects occur and last for a long time. In this case, consult a doctor and remove the ring from the vagina.

Contraindications

The NovaRing vaginal ring has some contraindications. Be sure to read them or take note.

1. Thrombosis of arteries and veins.
2. If a woman suffers from neurological diseases, then a migraine may occur.
3. Pregnancy and lactation.
4. Internal vaginal bleeding.
5. Diseases of the pancreas - pancreatitis.
6. Liver diseases in a chronic form.
7. Cancer and other inflammatory processes.
8. Hypertension of various degrees.
9. Epilepsy.
10. Chronic constipation.
11. Overweight - obesity.
12. Heart defects.

Remember: any use of a contraceptive drug begins with a full consultation with a gynecologist. Before using NuvaRing, you need to undergo an examination and pass tests.

User manual

The vaginal ring is used once a month. It is administered for 3 weeks. It is very important to remember the day of the week when you inject the contraceptive. It is on this day, in three weeks, that he must be pulled out.

For example, you put NuvaRing on Saturday at 19:00, then after 21 days the ring must be removed on Saturday at 19:00.

After the ring is removed, the woman begins bleeding within two to three days. In some cases, the bleeding continues until a new vaginal ring is inserted.

How to insert a NuvaRing?

You can enter a contraceptive yourself. Instructions for the introduction of the ring.

1. Take a comfortable position: lying down, squatting, standing.
2. Wash your hands with an antibacterial agent.
3. Reduce the diameter of the ring by compressing it.
4. Insert the ring deep into the vagina.
5. The ring should slide through without obstacles.
6. If you feel any discomfort, adjust the vaginal ring with your hand.
7. An indicator of the correct introduction of a contraceptive will be the absence of discomfort.
8. If the ring accidentally falls out, rinse it thoroughly under running warm water and put it back in.
9. After 21 days, remove the ring: hook it with your index finger and pull.

The insertion instructions are very simple. But if you have any doubts, then consult a doctor.

Ring use and menstruation

NuvaRing is inserted into the vagina on the first day of the cycle. It is acceptable to introduce a contraceptive on the 2nd and 3rd day of menstruation.

Remember that in the first week of using the drug, you need to additionally protect yourself.

Switching from oral contraceptives to the vaginal ring

If the woman regularly took hormonal pills and not pregnant, the vaginal ring can be inserted on any day of the cycle.

Switching from progestogen contraception

Progestin contraception includes injectable contraception, mini-pills, or an implant.

If you have previously used similar methods of contraception, then you can enter the vaginal ring absolutely any day. But, during the first 7 days of use, it is necessary to use other barrier agents.

Using the ring after an abortion in the first trimester

You can use the vaginal ring immediately after an abortion. In the first and subsequent weeks of wearing the ring, you do not need to additionally protect yourself.

Use of the ring after childbirth and abortion in the second trimester

Temporary removal of the NuvaRing

If for some reason you pulled out the ring, put it back within three hours. During this time, the contraceptive will not lose its properties.

In the case when the vaginal ring was outside the vagina for 3 hours, the effects of contraception are significantly reduced. Insert it as soon as possible.

Within a week after the introduction, it is necessary to additionally use other contraception.

If you wear the ring for more than 3 weeks, then the chances of getting pregnant increase significantly. Since the effects will be reduced, it is recommended to quickly remove the contraceptive.

Ring damage

Sometimes there were cases of rupture and superficial damage to the ring. When the contraceptive breaks, it falls out of the vagina. In case of breakage, the product should be replaced with a new one.

Special instructions for the use of the drug

Before resuming the use of NuvaRing, it is necessary to undergo a complete medical examination: anamnesis analysis and 100% exclusion of the possibility of conception, monitor the behavior of blood pressure, do a breast examination, study vaginal smears from the uterine cervix, and conduct other examinations to identify contraindications and side effects.

A complete examination should be carried out at least once every six months. It is very important to follow the recommendations for the use of the drug and follow the instructions clearly.

Women over 40 years old, smokers and suffering from cervical neoplasia need additional consultation with a gynecologist before using the drug.

vaginal ring cost

NuvaRing is sold in pharmacies in large cities. The estimated cost of one product varies from 700 to 1000 rubles.

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Catad_pgroup Local contraceptives

Indications for use
- Contraception
- Idiopathic menorrhagia
- Prevention of endometrial hyperplasia during HRT

INFORMATION IS PROVIDED STRICTLY
FOR HEALTHCARE PROFESSIONALS

NuvaRing - official * instructions for use

*registered by the Ministry of Health of the Russian Federation (according to grls.rosminzdrav.ru)

INSTRUCTIONS
on the use of a medicinal product for medical use

Registration number:

Tradename:

NuvaRing ® (NuvaRing ®)

International non-proprietary name or grouping name:

ethinylestradiol + etonogestrel

Dosage form:

vaginal rings

Composition

1 vaginal ring contains:
active substances: etonogestrel - 11.7 mg, ethinylestradiol - 2.7 mg;
Excipients: ethylene and vinyl acetate copolymer - 1677 mg, ethylene and vinyl acetate copolymer - 197 mg, magnesium stearate - 1.7 mg.

Description

Smooth, transparent, colorless or almost colorless ring without much visible damage with a transparent or almost transparent area at the junction.

Pharmacotherapeutic group:

combined contraceptive (estrogen + gestagen)

ATX code: G02BB01

Pharmacological properties

Pharmacodynamics

Mechanism of action
NuvaRing ® is a hormonal combined contraceptive containing etonogestrel and ethinyl estradiol. Etonogestrel is a progestogen (a derivative of 19-nortestosterone) that binds with high affinity to progesterone receptors in target organs. Ethinylestradiol is an estrogen and is widely used in the manufacture of contraceptives.
The contraceptive effect of NovaRing ® is due to a combination of various factors, the most important of which is the suppression of ovulation.

Efficiency
In clinical studies, it was found that the Pearl Index (an indicator that reflects the frequency of pregnancy in 100 women during 1 year of contraception) in women aged 18 to 40 years for the drug NuvaRing ® was 0.96 (95% CI: 0.64 -1.39) and 0.64 (95% CI: 0.35-1.07) in the statistical analysis of all randomized participants (ITT analysis) and the analysis of participants in studies that completed them according to the protocol (PP analysis), respectively. These values ​​were similar to Pearl Index values ​​obtained from comparative studies of combined oral contraceptives (COCs) containing levonorgestrel/ethinylestradiol (0.150/0.030 mg) or drospirenone/ethinylestradiol (3/0.30 mg).
Against the background of the use of the drug NovaRing ®, the cycle becomes more regular, the pain and intensity of menstrual bleeding decreases, which helps to reduce the incidence of iron deficiency. There is evidence of a reduced risk of endometrial and ovarian cancer with the use of the drug.

The nature of bleeding
Comparison of bleeding patterns over one year in 1000 women who used NovaRing ® and COCs containing levonorgestrel / ethinyl estradiol (0.150 / 0.030 mg) showed a significant reduction in the frequency of breakthrough bleeding or spotting when using NovaRing ® compared with COOK. In addition, the frequency of cases when bleeding occurred only during a break in the use of the drug was significantly higher among women who used NovaRing®.

Effect on bone mineral density
Comparative two-year study of the effect of NovaRing ® (n=76) and non-hormonal intrauterine device(n=31) showed no effect on bone mineral density in women.

Children
The safety and efficacy of NovaRing ® for adolescent girls under the age of 18 has not been studied.

Pharmacokinetics

Etonogestrel

Suction
Etonogestrel, released from the NovaRing ® vaginal ring, is rapidly absorbed through the vaginal mucosa. The maximum concentration of etonogestrel in blood plasma, which is about 1700 pg / ml, is reached approximately 1 week after the introduction of the ring. Plasma concentrations change within a small range and slowly decrease to about 1600 pg/ml after 1 week, 1500 pg/ml after 2 weeks and 1400 pg/ml after 3 weeks of use. Absolute bioavailability is about 100%, which exceeds the oral bioavailability of etonogestrel. According to the results of measuring the concentrations of etonogestrel in the cervix and inside the uterus in women using the drug NovaRing ®, and women using oral contraceptives containing 0.150 mg of desogestrel and 0.020 mg of ethinyl estradiol, the observed values ​​of etonogestrel concentrations were comparable.

Distribution
Etonogestrel binds to plasma albumin and sex hormone-binding globulin (SHBG). The apparent volume of distribution of etonogestrel is 2.3 L/kg.

Metabolism
Biotransformation of etonogestrel occurs by known pathways of sex hormone metabolism. The apparent plasma clearance is about 3.5 l/h. Direct interaction with ethinyl estradiol, taken simultaneously, has not been identified.

breeding
Plasma concentrations of etonogestrel decrease in two phases. In the terminal phase, the half-life is approximately 29 hours. Etonogestrel and its metabolites are excreted by the kidneys and through the intestines with bile in a ratio of about 1.7:1. The half-life of metabolites is approximately 6 days.

Ethinylestradiol

Suction
Ethinyl estradiol, released from the NovaRing ® vaginal ring, is rapidly absorbed through the vaginal mucosa. The maximum plasma concentration of about 35 pg / ml is reached 3 days after the introduction of the ring and decreases to 19 pg / ml after 1 week, to 18 pg / ml after 2 weeks and 18 pg / ml after 3 weeks of use. Absolute bioavailability is approximately 56% and is comparable to that of oral administration of ethinyl estradiol. According to the results of measuring the concentrations of ethinylestradiol in the cervical region and inside the uterus in women using the drug NovaRing ®, and women using oral contraceptives containing 0.150 mg of desogestrel and 0.020 mg of ethinylestradiol, the observed values ​​of ethinylestradiol concentrations were comparable.
The concentration of ethinylestradiol was studied in a comparative randomized study of the drug NovaRing ® (daily release of ethinylestradiol in the vagina 0.015 mg), transdermal patch (norelgestromin / ethinylestradiol; daily release of ethinylestradiol 0.020 mg) and COC (levonorgestrel / ethinylestradiol; daily release of ethinylestradiol) cycle in healthy women. The systemic exposure of ethinylestradiol within a month (AUC0-?) for NovaRing ® was statistically significantly lower than that of the patch and COC, and amounted to 10.9, 37.4 and 22.5 ng h / ml, respectively.

Distribution
Ethinylestradiol binds nonspecifically to plasma albumin. The apparent volume of distribution is about 15 l/kg.

Metabolism
Ethinylestradiol is metabolized by aromatic hydroxylation. During its biotransformation, a large number of hydroxylated and methylated metabolites are formed. They circulate in free form or as sulfate and glucuronide conjugates. The apparent clearance is approximately 35 l / h.

breeding
Plasma ethinylestradiol concentrations decrease in two phases. The half-life in the terminal phase varies widely; the median is about 34 hours. Ethinylestradiol is not excreted unchanged. Metabolites of ethinylestradiol are excreted by the kidneys and through the intestines with bile in a ratio of 1.3:1. The half-life of metabolites is about 1.5 days.

Special patient groups

Children
The pharmacokinetics of NovaRing ® in healthy adolescent girls under the age of 18 years who have already begun menstruation has not been studied.

Impaired kidney function
The effect of kidney disease on the pharmacokinetics of NovaRing® has not been studied.

Impaired liver function
The effect of liver disease on the pharmacokinetics of NovaRing® has not been studied. However, in patients with impaired liver function, the metabolism of sex hormones may be impaired.

ethnic groups
The pharmacokinetics of the drug in representatives of ethnic groups has not been specifically studied.

Indications for use

Contraception.

Contraindications

NovaRing ® is contraindicated in the presence of any of the conditions listed below. If any of these conditions occur during the period of use of the drug NovaRing ®, the use of the drug should be stopped immediately.

• Thrombosis (arterial or venous) and thromboembolism at present or in history (including deep vein thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular disorders).
• Conditions preceding thrombosis (including transient ischemic attacks, angina pectoris) at present or in history.
• Predisposition to the development of venous or arterial thrombosis, including hereditary diseases: resistance to activated protein C, antithrombin III deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinemia and antiphospholipid antibodies (cardiolipin antibodies, lupus anticoagulant).
• Migraine with focal neurological symptoms at present or in history.
• Diabetes mellitus with vascular damage.
• Pronounced or multiple risk factors for venous or arterial thrombosis: hereditary predisposition to thrombosis (thrombosis, myocardial infarction or cerebrovascular accident at a young age in one of the closest relatives), hypertension, valvular heart disease, atrial fibrillation, extended surgery, prolonged immobilization, extensive trauma, obesity (body weight> 30 kg / m²), smoking in women over 35 years of age (see section "Special Instructions").
• Pancreatitis with severe hypertriglyceridemia, current or history.
• Severe liver disease.
• Tumors of the liver (malignant or benign), including a history.
• Known or suspected hormone-dependent malignant tumors (for example, genital or breast cancers).
• Bleeding from the vagina of unknown etiology.
• Pregnancy, including intended.
• Hypersensitivity to any of the active or excipients of NovaRing®.

Carefully

In the presence of any of the diseases, conditions or risk factors listed below, the benefits of using NovaRing ® and the possible risks for each individual woman should be evaluated before she starts using NovaRing ® (see section "Special Instructions"). In the event of an exacerbation of diseases, a deterioration in the condition, or the appearance of any of the conditions listed below for the first time, a woman should consult a doctor to decide on the possibility of further use of the drug NovaRing ®.

With caution, the drug NovaRing ® should be used in the following cases:

• risk factors for the development of thrombosis and thromboembolism: hereditary predisposition to thrombosis (thrombosis, myocardial infarction or cerebrovascular accident at a young age in one of the closest relatives), smoking, obesity, dyslipoproteinemia, arterial hypertension, migraine without focal neurological symptoms, heart valve disease , cardiac arrhythmias, prolonged immobilization, major surgical interventions;
• thrombophlebitis of superficial veins;
• dyslipoproteinemia;
• heart valve disease;
• adequately controlled arterial hypertension;
• diabetes mellitus without vascular complications;
• acute or chronic liver disease;
• jaundice and/or itching caused by cholestasis;
• cholelithiasis;
• porphyria;
• systemic lupus erythematosus;
• hemolytic-uremic syndrome;
• Sydenham's chorea (small chorea);
• hearing loss due to otosclerosis;
• (hereditary) angioedema;
• chronic inflammatory bowel disease (Crohn's disease and ulcerative colitis);
• sickle cell anemia;
• chloasma;
• conditions that may make it difficult to use the vaginal ring: cervical prolapse, bladder hernia, rectal hernia, severe chronic constipation.

Use during pregnancy and during breastfeeding

NovaRing ® is intended to prevent pregnancy. If a woman wants to stop using the drug in order to become pregnant, it is recommended to wait for the restoration of the natural cycle to conceive, as this will help to correctly calculate the date of conception and delivery.

Pregnancy

The use of NovaRing ® during pregnancy is contraindicated. If pregnancy occurs, the ring should be removed. Extensive epidemiological studies have not found an increased risk of developing birth defects in children born to women who took COCs before pregnancy, as well as teratogenic effects in cases where women took COCs for early dates pregnancy without knowing about it. Although this applies to all COCs, it is not known if this also applies to NovaRing®. A clinical study in a small group of women showed that, despite the fact that NovaRing ® is administered into the vagina, the concentrations of contraceptive sex hormones inside the uterus when using NovaRing ® are similar to those when using COCs. Pregnancy outcomes in women who used the drug NovaRing ® during a clinical study are not described.

breastfeeding period

The use of the drug NovaRing ® during breastfeeding is not indicated. The composition of the drug can affect lactation, reduce the amount and change the composition of breast milk. Small amounts of contraceptive sex hormones and/or their metabolites may be excreted in milk, but evidence for them negative influence on the health of children is not received.

Dosage and administration

To achieve a contraceptive effect, NovaRing ® must be used according to the instructions.

A woman can independently insert the NovaRing ® vaginal ring into the vagina.

The doctor should inform the woman how to insert and remove the NovaRing ® vaginal ring. To introduce the ring, the woman should choose a comfortable position, for example, standing, raising one leg, squatting or lying down. The NovaRing ® vaginal ring should be compressed and inserted into the vagina until the ring is in a comfortable position. The exact position of the ring in the vagina is not critical for the contraceptive effect (Fig. 1-4).

After insertion (see subsection "How to start using NovaRing ®"), the ring should be constantly in the vagina for 3 weeks. It is advisable for a woman to regularly check whether it remains in the vagina. If the ring has been accidentally removed, then the instructions in the subsection “What to do if the ring has been temporarily removed from the vagina” must be followed.

The NovaRing ® vaginal ring should be removed after 3 weeks on the same day of the week when the ring was inserted into the vagina. After a week break, a new ring is inserted (for example, if the NovaRing ® vaginal ring was installed on Wednesday at about 22.00, then it should be removed on Wednesday after 3 weeks at about 22.00. A new ring is inserted on the next Wednesday). To remove the ring, it must be picked up with the index finger or squeezed with the index and middle fingers and pulled out of the vagina (Fig. 5). The used ring should be placed in a bag (keep out of the reach of children and pets) and discarded. Bleeding associated with the termination of the action of the drug NovaRing ® usually begins 2-3 days after removal of the NovaRing ® vaginal ring and may not completely stop until a new ring is installed.

How to start using NovaRing ® ?

• In the previous cycle, hormonal contraceptives were not used
  NovaRing ® should be administered on the first day of the cycle (i.e. on the first day of menstruation). It is allowed to install the ring on the 2-5th day of the cycle, however, in the first cycle, in the first 7 days of using NovaRing ®, additional use of barrier methods of contraception is recommended.
• Switching from combined hormonal contraceptives
  A woman should enter the NovaRing ® vaginal ring on the last day of the usual interval between cycles in taking combined hormonal contraceptives (tablets or patch).
  If a woman has been taking the combined hormonal contraceptive correctly and regularly and is sure that she is not pregnant, she can switch to the use of the vaginal ring on any day of the cycle.
  In no case should the recommended hormone-free interval of the previous method be exceeded.
• Switching from progestogen-only products (mini-pill, progestin-only oral contraceptives, implants, injectables, or hormone-containing intrauterine systems - IUDs)
  A woman taking mini-pills or progestin oral contraceptives can switch to NovaRing ® on any day. The ring is inserted on the day the implant or IUD is removed. If the woman received injections, then the use of the drug NovaRing ® begins on the day when the next injection should have been made. In all these cases, the woman must use a barrier method of contraception during the first 7 days after the introduction of the ring.
• After an abortion in the first trimester
  A woman can insert the ring immediately after an abortion. In this case, she does not need additional contraceptives. If the use of the drug NovaRing ® immediately after an abortion is undesirable, it is necessary to follow the recommendations given in the subsection "In the previous cycle, hormonal contraceptives were not used." At interval, the woman is recommended an alternative method of contraception.
• After childbirth or after an abortion in the second trimester
  A woman is recommended to enter the ring no earlier than 4 weeks after childbirth (if she is not breastfeeding) or abortion in the second trimester. If the ring is set to more than late dates, then the use of an additional barrier method is recommended for the first 7 days. However, if sexual intercourse has already taken place, then before using the drug NovaRing ®, it is necessary to exclude pregnancy or wait for the first menstruation.

The contraceptive effect and cycle control may be impaired if the woman does not follow the recommended regimen. To avoid a decrease in the contraceptive effect, the following recommendations should be followed.

• What to do in case of lengthening the break in the use of the ring?
  If during the break in the use of the ring there were sexual intercourse, pregnancy should be excluded. The longer the break, the higher the chance of pregnancy. If pregnancy is excluded, a woman should insert a new ring into the vagina as soon as possible. An additional barrier method of contraception, such as a condom, must be used for the next 7 days.
• What if the ring was temporarily removed from the vagina?
  The ring must be constantly in the vagina for 3 weeks. If the ring has been accidentally removed, it should be rinsed with cold or lukewarm (not hot) water and inserted into the vagina immediately.
  • If the ring was left outside the vagina for less than 3 hours, then its contraceptive effect is not reduced. A woman should insert the ring into the vagina as soon as possible (no later than 3 hours later).
  • If the ring was outside the vagina for more than 3 hours during the first or second week of use, the contraceptive effect may decrease. The woman should insert the ring into the vagina as soon as possible. For the next 7 days, you must use a barrier method of contraception, such as a condom. The longer the ring has been out of the vagina and the closer this period is to the 7-day break in the use of the ring, the higher the likelihood of pregnancy.
  • If the ring was outside the vagina for more than 3 hours in the third week of use, then the contraceptive effect may decrease. The woman should discard this ring and choose one of the two following methods.
    1. Immediately install a new ring.
       Note: a new ring can be used for the next 3 weeks. In this case, there may be no bleeding associated with the termination of the drug. However, spotting or bleeding in the middle of the cycle is possible.
    2. Wait for the bleeding associated with the termination of the drug, and introduce a new ring no later than 7 days after the removal of the previous ring.
       Note: this option should be chosen only if the regimen of the ring was not violated during the first two weeks.
• What to do in case of prolonged use of the ring?
  If the drug NovaRing ® was used for no more than a maximum period of 4 weeks, then the contraceptive effect remains sufficient. A woman can take a week off from using the ring and then insert a new ring.
  If the NovaRing ® vaginal ring has remained in the vagina for more than 4 weeks, then the contraceptive effect may worsen, so pregnancy must be excluded before the introduction of a new ring.
  If a woman does not adhere to the recommended regimen of application and bleeding does not occur after a week's break in the use of the ring, then pregnancy should be excluded before the introduction of a new ring.
• How to move or delay the onset of menstrual bleeding?
  To delay menstrual-like withdrawal bleeding, a woman can insert a new ring without a week's break. The next ring must be applied within 3 weeks. This may cause spotting or bleeding. Further, after the usual week-long break, the woman returns to the regular use of the drug NovaRing ®.
  To move the onset of bleeding to another day of the week, the woman may be advised to take a shorter break from the ring (for as many days as needed). The shorter the break in the use of the ring, the higher the likelihood of no bleeding that occurs after the removal of the ring, and the occurrence of bleeding or spotting during the period of application of the next ring.

Children

The safety and efficacy of NovaRing® in adolescent girls under 18 years of age have not been studied.

Side effect

When using the drug, there may be side effects that occur with different frequencies: often (? 1/100), infrequently (<1/100, ?1/1 000), редко (<1/1 000, ?1/10 000).

Serious consequences of an overdose of hormonal contraceptives are not described. Possible symptoms include nausea, vomiting, and slight bleeding from the vagina in young girls. There are no antidotes. Treatment is symptomatic.

Interaction with other medicinal products and other forms of interaction

Interaction with other drugs

Interactions between hormonal contraceptives and other drugs may lead to the development of acyclic bleeding and / or contraceptive failure.

The following interactions with combined oral contraceptives are described in the literature in general.

Hepatic metabolism: there may be interactions with drugs that induce microsomal liver enzymes, which can lead to an increase in the clearance of sex hormones. Interactions have been established, for example, with phenytoin, barbiturates, primidone, carbamazepine, rifampicin, and possibly also with oxcarbazepine, topiramate, felbamate, ritonavir, griseofulvin and preparations containing St. John's wort (Hypericum perforatum).

When treating with any of the listed drugs, you should temporarily use a barrier method of contraception (condom) in combination with the use of the drug NovaRing ® or choose another method of contraception. During the concomitant use of drugs that induce microsomal enzymes, and within 28 days after their withdrawal, barrier methods of contraception should be used.

If concomitant therapy is to be continued after 3 weeks of ring use, then the next ring must be administered immediately without the usual interval.

Antibiotics: a decrease in the effectiveness of oral contraceptives containing ethinyl estradiol has been observed with the concomitant use of antibiotics such as ampicillin and tetracyclines. The mechanism of this effect has not been studied. In a pharmacokinetic interaction study, ingestion of amoxicillin (875 mg, 2 times a day) or doxycycline (200 mg per day, and then 100 mg per day) for 10 days during the use of the drug NovaRing ® did not significantly affect the pharmacokinetics of etonogestrel and ethinyl estradiol. When using antibiotics (excluding amoxicillin and doxycycline), you should use a barrier method of contraception (condom) during treatment and for 7 days after stopping antibiotics. If concomitant therapy is to be continued after 3 weeks of ring use, then the next ring must be administered immediately without the usual interval.

Pharmacokinetic studies have not revealed the effect of the simultaneous use of antifungal agents and spermicides on the contraceptive efficacy and safety of NovaRing®. With the combined use of suppositories with antifungal drugs, the risk of ring rupture slightly increases.

Hormonal contraceptives may interfere with the metabolism of other drugs. Accordingly, their plasma and tissue concentrations may increase (eg, cyclosporine) or decrease (eg, lamotrigine).

To exclude possible interaction, it is necessary to read the instructions for use of other drugs.

Laboratory research

The use of hormonal contraceptives may affect the results of certain laboratory tests, including biochemical parameters of liver, thyroid, adrenal and kidney function; on the plasma concentration of transport proteins, for example, corticosteroid-binding globulin (CBG) and SHBG; on lipid/lipoprotein fractions; on indicators of carbohydrate metabolism; as well as on indicators of blood clotting and fibrinolysis. Indicators, as a rule, change within normal values.

Combined use with tampons

Pharmacokinetic data show that the use of tampons does not affect the absorption of hormones released from the NovaRing ® vaginal ring. In rare cases, the ring may be accidentally removed when removing the tampon (see subsection "What to do if the ring was temporarily removed from the vagina" in the section "Method of application and doses").

special instructions

If any of the diseases, conditions or risk factors listed below are present, the benefits of using NovaRing ® and the possible risks for each individual woman should be evaluated before she starts using NovaRing ®. In the event of an exacerbation of diseases, a deterioration in the condition, or the appearance of any of the conditions listed below for the first time, a woman should consult a doctor to decide on the possibility of further use of the drug NovaRing ®.

Circulatory disorders

The use of hormonal contraceptives may be associated with the development of venous thrombosis (deep vein thrombosis and pulmonary embolism) and arterial thrombosis, as well as associated complications, sometimes with a fatal outcome.

The use of any COC increases the risk of developing venous thromboembolism (VTE) compared with the risk of developing VTE in patients not using COCs. The greatest risk of developing VTE occurs in the first year of COC use. Data from a large prospective cohort study on the safety of various COCs suggest that the greatest increase in risk, compared with the level of risk in women who do not use COCs, occurs in the first 6 months after starting COC use or resuming their use after a break (4 weeks or more) . In non-pregnant women not using oral contraceptives, the risk of developing VTE is 1 to 5 cases per 10,000 woman-years (WY). In women using oral contraceptives, the risk of developing VTE is from 3 to 9 cases per 10,000 VL. The increased risk is less than in pregnancy, where the risk is 5-20 per 10,000 YL (pregnancy data are based on actual length of pregnancy in standard studies; based on a 9-month pregnancy, the risk is 7 to 27 cases per 10,000 YL). In women in the postpartum period, the risk of developing VTE is 40 to 65 cases per 10,000 VL. VTE is fatal in 1-2% of cases.

According to the results of studies, the increased risk of developing VTE in women using NovaRing ® is similar to that in women using COCs (adjusted risk ratio, see the table below). The large prospective observational study TASC (Transatlantic Active Study on the Cardiovascular Safety of NovaRing ®) assessed the risk of VTE in women who started using NovaRing ® or COCs, switched to NovaRing ® or COCs from other contraceptives or resumed the use of NovaRing ® or COC in a population of typical users. The women were followed up for 24-48 months. The results showed a similar level of risk of developing VTE in women using NovaRing ® (frequency 8.3 cases per 10,000 LL) and in women using COCs (frequency 9.2 cases per 10,000 LL). For women using COCs other than those containing desogestrel, gestodene and drospirenone, the incidence of VTE was 8.5 cases per 10,000 VL.

A retrospective cohort study initiated by the FDA (US Food and Drug Administration) showed that the incidence of VTE in women who started using NovaRing ® is 11.4 cases per 10,000 YL, while in women women who started using COCs containing levonorgestrel, the incidence of VTE is 9.2 cases per 10,000 VL.

Assessment of the risk (risk ratio) of developing VTE in women using NovaRing ®, compared with the risk of developing VTE in women using COCs

Epidemiological study, population	Comparator(s)	Risk ratio (RR) (95% CI)
TASC (Dinger, 2012) Women who started using the drug (including again after a break) and switched from other contraceptives.	All available COCs during the study 1 .	RR 2: 0.8 (0.5-1.5)
	Available COCs other than those containing desogestrel, gestodene, drospirenone.	RR 2: 0.9 (0.4-2.0)
"FDA Initiated Study" (Sydney, 2011) Women who started using combined hormonal contraceptives (CHCs) for the first time during the study period.	COCs available during the study period 3 .	RR 4: 1.09 (0.55-2.16)
	Levonorgestrel / 0.03 mg ethinyl estradiol.	RR 4: 0.96 (0.47-1.95)

1 Including low-dose COCs containing the following progestins: chlormadinone acetate, cyproterone acetate, desogestrel, dienogest, drospirenone, etinodiol diacetate, gestodene, levonorgestrel, norethindrone, norgestimate, or norgestrel.
2 Based on age, BMI, duration of use, history of VTE.
3 Including low-dose COCs containing the following progestins: norgestimate, norethindrone, or levonorgestrel.
4 Taking into account age, place and year of inclusion in the study.

Extremely rare cases of thrombosis of other blood vessels (for example, arteries and veins of the liver, mesenteric vessels, kidneys, brain and retina) are known with the use of COCs. It is not known whether these cases are associated with the use of COCs.

Possible symptoms of venous or arterial thrombosis may include unilateral edema and/or pain in the lower extremity, localized fever in the lower extremity, redness or discoloration of the skin on the lower extremity; sudden severe chest pain, possibly radiating to the left arm; an attack of shortness of breath, cough; any unusual, severe, prolonged headaches; sudden partial or complete loss of vision; double vision; slurred speech or aphasia; dizziness; collapse, with or without focal epileptic seizure; sudden weakness or severe numbness on one side of the body or any part of the body; movement disorders; "sharp" abdomen.

Risk factors for the development of venous thrombosis and embolism:

• age;
• the presence of diseases in the family history (venous thrombosis and embolism in brothers / sisters at any age or in parents at a young age). If a hereditary predisposition is suspected, a woman should be referred to a specialist for advice before starting any hormonal contraceptive;
• prolonged immobilization, major surgery, any surgery to the lower extremities, or major trauma. In such situations, it is recommended to stop using the drug (in the case of a planned operation, at least 4 weeks in advance) with subsequent resumption of use no earlier than 2 weeks after the full restoration of motor activity;
• possibly thrombophlebitis of superficial veins with varicose veins.

There is no consensus on the possible role of these conditions in the etiology of venous thrombosis.

Risk factors for the development of complications of arterial thromboembolism:

• age;
• smoking (with heavy smoking and with age, the risk increases even more, especially in women over 35 years old);
• dyslipoproteinemia;
• obesity (body mass index over 30 kg/m²);
• increased blood pressure;
• migraine;
• heart valve disease;
• atrial fibrillation;
• the presence of diseases in a family history (arterial thrombosis in brothers / sisters at any age or in parents at a relatively early age). If a hereditary predisposition is suspected, a woman should be referred to a specialist for advice before starting the use of any hormonal contraceptives.

Biochemical factors that may indicate a hereditary or acquired predisposition to venous or arterial thrombosis include resistance to activated protein C, hyperhomocysteinemia, antithrombin III deficiency, protein C deficiency, protein S deficiency, antibodies to phospholipids (cardiolipin antibodies, lupus anticoagulant).

Other conditions that can lead to unwanted circulatory disorders include diabetes mellitus, systemic lupus erythematosus, hemolytic uremic syndrome and chronic inflammatory bowel disease (eg Crohn's disease or ulcerative colitis), as well as sickle cell anemia.

It is necessary to take into account the increased risk of thromboembolism in the postpartum period.

An increase in the frequency or severity of migraine (which may be a prodromal symptom of cerebrovascular accident) during the use of hormonal contraceptives may prompt immediate discontinuation of hormonal contraceptive use.

Women using CHCs should be advised to contact their doctor if symptoms of thrombosis appear. If thrombosis is suspected or confirmed, CHC use should be discontinued. In this case, it is necessary to use effective contraceptives, since anticoagulants (coumarins) have a teratogenic effect.

The risk of developing tumors

The most important risk factor for developing cervical cancer is infection with the human papillomavirus (HPV). Epidemiological studies have shown that long-term use of COCs leads to an additional increase in this risk, but it remains unclear how much this is due to other factors, such as more frequent cervical smears and differences in sexual behavior, including the use of barrier contraceptives. It remains unclear how this effect is associated with the use of NovaRing®.

A meta-analysis of the results of 54 epidemiological studies revealed a small increase (1.24) in the relative risk of developing breast cancer in women taking combined hormonal oral contraceptives. The risk gradually decreases over 10 years after stopping the drugs. Breast cancer rarely develops in women under the age of 40, so the additional incidence of breast cancer in women who take or have taken COCs is small compared to the overall risk of developing breast cancer. Breast cancer diagnosed in women using COCs is clinically less pronounced than cancer detected in women who have never used COCs. An increased risk of developing breast cancer may be due to both the fact that in women taking COCs, the diagnosis of breast cancer is established earlier, and the biological effects of COCs, or a combination of both of these factors.

In rare cases, women who took COCs have experienced cases of benign, and even more rarely, malignant liver tumors. In some cases, these tumors have led to the development of life-threatening bleeding into the abdominal cavity. The doctor should consider the possibility of a liver tumor in the differential diagnosis of diseases in a woman taking NovaRing ® if the symptoms include acute pain in the upper abdomen, liver enlargement, or signs of intra-abdominal bleeding.

Other states

• Women with hypertriglyceridemia or a family history of hypertriglyceridemia have an increased risk of developing pancreatitis when taking hormonal contraceptives.
• Many women taking hormonal contraceptives experience a slight increase in blood pressure, but a clinically significant increase in blood pressure is rare. A direct relationship between the use of hormonal contraceptives and the development of arterial hypertension has not been established. If during the use of the drug NovaRing ® there is a constant increase in blood pressure, you should contact your doctor to decide whether it is necessary to remove the vaginal ring and prescribe antihypertensive therapy. With adequate control of blood pressure with antihypertensive drugs, it is possible to resume the use of the drug NovaRing ®.
• During pregnancy and during the use of combined oral contraceptives, the development or worsening of the following conditions was noted, although their relationship with the use of contraceptives has not been fully established: jaundice and / or itching caused by cholestasis, formation of gallstones, porphyria, systemic lupus erythematosus, hemolytic - uremic syndrome, Sydenham's chorea (chorea minor), herpes of pregnancy, hearing loss due to otosclerosis, (hereditary) angioedema.
• Acute or chronic liver diseases may serve as a basis for discontinuation of the drug NovaRing ® until the normalization of liver function parameters. Recurrence of cholestatic jaundice, observed earlier during pregnancy or when using sex hormone preparations, requires discontinuation of the drug NovaRing ®.
• Although estrogens and progestogens may affect peripheral insulin resistance and tissue glucose tolerance, there is no evidence to support the need to change hypoglycemic therapy during the use of hormonal contraceptives. However, women with diabetes should be under constant medical supervision when using NovaRing®, especially in the first months of contraception.
• There is evidence of worsening of the course of Crohn's disease and ulcerative colitis with the use of hormonal contraceptives.
• In rare cases, pigmentation of the skin of the face (chloasma) may occur, especially if it occurred earlier during pregnancy. Women who are predisposed to the development of chloasma should avoid exposure to sunlight and ultraviolet radiation while using NovaRing ®.
• The following conditions may prevent proper insertion of the ring or cause it to fall out: cervical prolapse, bladder and/or rectal hernia, severe chronic constipation.
• In very rare cases, women have inadvertently inserted the NovaRing ® vaginal ring into the urethra and possibly into the bladder. When symptoms of cystitis appear, the possibility of incorrect insertion of the ring must be considered.
• Cases of vaginitis during the use of the drug NovaRing ® are described. There is no evidence that the treatment of vaginitis affects the effectiveness of the use of the drug NovaRing ®, as well as evidence of the effect of the use of the drug NovaRing ® on the effectiveness of the treatment of vaginitis.
• Very rare cases of difficult removal of the ring have been described, requiring its removal by a healthcare professional.

Medical examination / consultation

Before prescribing NovaRing ® or resuming its use, you should carefully review the medical history (including family history) of the woman and conduct a gynecological examination to exclude pregnancy. It is necessary to measure blood pressure, conduct an examination of the mammary glands, pelvic organs, including a cytological examination of cervical smears and some laboratory tests, to exclude contraindications and reduce the risk of possible side effects of the drug. The frequency and nature of medical examinations depend on the individual characteristics of each patient, but medical examinations are carried out at least once every 6 months. A woman should read the instructions for use and follow all recommendations. The woman should be informed that NovaRing ® does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

Reduced efficiency

The effectiveness of the drug NovaRing ® may decrease if the regimen is not followed or if concomitant therapy is carried out.

Reduced cycle control

During the use of the drug NovaRing ®, acyclic bleeding (spotting or sudden bleeding) may occur. If such bleeding is observed after regular cycles against the background of the correct use of the drug NovaRing ®, you should contact your gynecologist for the necessary diagnostic tests, including to rule out organic pathology or pregnancy. Diagnostic curettage may be required.

Some women do not bleed after the ring is removed. If the drug NuvaRing ® was used in accordance with the instructions, it is unlikely that the woman is pregnant. If the recommendations of the instructions are not followed and there is no bleeding after the removal of the ring, as well as in the absence of bleeding for two cycles in a row, pregnancy must be excluded.

Effects of ethinylestradiol and etonogestrel on the sexual partner

The possible pharmacological effects and degree of exposure of ethinyl estradiol and etonogestrel to male sexual partners (due to absorption through the tissues of the penis) have not been studied.

Ring damage

In rare cases, when using the drug NovaRing ®, a rupture of the ring was observed. The core of NovaRing ® is solid, so its contents remain intact, and the release of hormones does not change significantly. If the ring breaks, it usually falls out of the vagina (see the recommendations in the subsection "What to do if the ring was temporarily removed from the vagina" in the section "Method of application and doses"). If the ring breaks, a new ring must be inserted.

Ring drop

Sometimes there was a prolapse of the NovaRing ® vaginal ring from the vagina, for example, when it was inserted incorrectly, when a tampon was removed, during intercourse, or against the background of severe or chronic constipation. In this regard, it is advisable for a woman to regularly check the presence of the NovaRing ® vaginal ring in the vagina. In case of loss of the NovaRing ® vaginal ring from the vagina, it is necessary to follow the recommendations of the subsection “What to do if the ring was temporarily removed from the vagina” in the section “Method of application and doses”.

Influence on the ability to drive vehicles and work with mechanisms

Based on information about the pharmacodynamic properties of the drug NovaRing ®, it can be expected that it does not affect the ability to drive vehicles and work with mechanisms.

Release form

Vaginal rings 0.015 mg + 0.120 mg / day. 1 ring is packed in a waterproof aluminum foil bag, coated on the inside with a layer of low density polyethylene, on the outside with a layer of polyethylene terephthalate (PET). 1 or 3 bags in a cardboard box with instructions for use.

Storage conditions

Store at a temperature of 2 to 8 °C.
Keep out of the reach of children.

Best before date

3 years.
Do not use after the expiry date stated on the packaging.

Holiday conditions

On prescription.

Legal entity in whose name the registration certificate is issued

N.V. Organon, Netherlands

Manufacturer

Produced:
N.V. Organon, Netherlands

Issuing quality control:
N.V. Organon, Netherlands
N.V. Organon, Kloosterstraat 6, 5349 AB, Oss, the Netherlands
or
Organon (Ireland) Ltd., Ireland
Organon (Ireland) Ltd., P.O. Box 2857, Drynam Road, Swords, Co. Dublin, Ireland

Consumer claims should be sent to:
LLC "MSD Pharmaceuticals"
st. Pavlovskaya, d. 7, building 1
Moscow, Russia, 115093