NuvaRing

NuvaRing – the combined hormonal contraceptive for intravaginalny use.

Form of release and structure

Dosage form – a ring vaginal: transparent, smooth, almost colourless or colourless, without visible considerable damages, in a junction – transparent or almost transparent area (on 1 piece in tight packages from aluminum foil, in a cardboard pack 1 or 3 packages).

Content of active agents is 1 ring:

• Etonogestrel – 11,7 mg;
• Ethinylestradiol – 2,7 mg.

Auxiliary components: ethylene and vinyl acetate copolymer (28% of vinyl acetate), magnesium stearate, ethylene and vinyl acetate copolymer (9% of vinyl acetate).

Indications to use

Use of the NuvaRing is shown for intravaginalny contraception.

Contraindications

• Multiple or heavy risk factors of arterial or venous thromboses: genetic predisposition (existence at the immediate family at young age of thromboses, disturbances of cerebral circulation or a myocardial infarction), defeats of the valve device of heart, arterial hypertension, fibrillation of auricles, obesity (an index of body weight more than 30 kg on 1 ^sq.m), an extensive injury and/or an operative measure, smoking is aged more senior than 35 years, a long immobilization;
• Arterial and venous thromboses, thrombembolia, including a thromboembolism of a pulmonary artery, a deep vein thrombosis, cerebrovascular disturbances, a myocardial infarction (including in the anamnesis);
• Tendency to development of arterial or venous thrombosis, including such hereditary diseases as deficit of antithrombin III, resistance to the activated protein of C, deficit of a protein of C, deficit of a protein of S, anti-phospholipidic antibodies (lupoid anticoagulant, antibodies to cardiolipin) and a gipergomotsisteinemiya;
• The Tranzitorny ischemic attacks, stenocardia and other pathologies preceding thrombosis (including in the anamnesis);
• Migraine with focal neurologic symptomatology (including the anamnesis);
• Pancreatitis (including the anamnesis) with the accompanying expressed gipertriglitseridemiya;
• High-quality or malignant new growths of a liver (including the anamnesis);
• The expressed liver pathologies;
• Diabetes mellitus with defeat of vessels;
• The assumed or diagnosed malignant hormonedependent tumors (including generative organs, mammary glands);
• The period of pregnancy or suspicion on it;
• Vaginal bleedings of an unspecified etiology;
• Breastfeeding period;
• Hypersensitivity to drug substances.

Efficiency and safety of use of the NuvaRing by patients aged up to 18 years are not established.

At emergence of symptoms of any of the states stated above use of drug should be stopped immediately.

Purpose of drug should be made with extra care (after careful assessment of a ratio of advantage and risk of contraception): with the risk factors of development of a thromboembolism and thrombosis including disturbances of a cordial rhythm, arterial hypertension, diseases of valves of heart, genetic predisposition (existence of thromboses, a myocardial infarction or disturbance of cerebral circulation at the immediate family at young age), obesity, smoking, a dislipoproteinemiya, migraine without focal neurologic symptomatology, serious surgical interventions, a long immobilization; to patients with a dislipoproteinemiya, thrombophlebitis of superficial veins, controlled arterial hypertension, defect of valves of heart, a diabetes mellitus without vascular complications, a zhelchekamenny disease, acute or chronic abnormal liver functions, a porphyria, a gemolitiko-uraemic syndrome, a system lupus erythematosus, a hearing loss against the background of an otosclerosis, a hysterical chorea (Sydenham's chorea), Quincke's (hereditary) disease, drepanocytic anemia, chronic inflammatory pathologies of intestines (ulcer colitis, a disease Krone), hloazmy; at the pathologies complicating use of a vaginal ring (a cystocele and/or a rectum, loss of a neck of uterus, chronic heavy locks), at a skin itch and/or jaundice against the background of a cholestasia.

In case of an emergence/aggravation of any of the specified states or deterioration in health it is necessary to see a doctor.

Route of administration and dosage

The contraceptive ring is applied by introduction to a vagina. The procedure is made 1 time in 4 weeks, in a prone position, standing (having raised the leg bent in a knee) or squating. Having squeezed a ring, it is entered into a vagina and placed in a comfortable position, the accuracy of location does not influence efficiency of contraception.

In the absence of hormonal contraception in the previous menstrual cycle the ring is entered in the first day of menstrual bleeding. 3 weeks later, in a day of the week and approximately at the same time when the ring was established, it is taken. In the period of lack of a ring there passes menstrualnopodobny bleeding which comes in 2-3 days after removal. The new ring is entered in one week of a break into the established day of the week even if bleeding of cancellation did not end.

If use of the NuvaRing is begun from the second to the fifth day of a menstrual cycle, during the first 7 days it is necessary to use barrier contraceptives in addition.

Upon transition from the combined oral contraceptives the ring is recommended to be entered in the last day of a break between cycles of use or in any day of a cycle, but on condition of regular reception of the previous combined hormonal means and full confidence in lack of pregnancy.

It is impossible to exceed the period of the recommended break in use of hormonal contraceptive means.

Upon transition from progestagenny contraceptives the contraceptive ring can be entered in day of removal of an implant or gormonosoderzhashchy intrauterine system, the next injection or in any day after use mini-saw. In each of the listed cases during the first 7 days of use use of additional barrier methods of contraception is required.

After abortion in the I trimester of pregnancy the ring can be entered right after operation without resorting to additional contraceptive resources.

Introduction of a ring is recommended within the fourth week after abortion in the II trimester of pregnancy or childbirth (in the absence of breastfeeding). At later period of the beginning of use additional use of condoms at sexual contact during the first 7 days of hormonal contraception is recommended.

If after the delivery or abortion the woman had a sexual contact, then before introduction of a ring it is necessary to confirm lack of pregnancy or to enter a ring at the beginning of a menstrual cycle.

After introduction the ring within 3 weeks has to reside in a vagina. During accidental removal not to break contraceptive effect, it should be washed out warm water and to place in a vagina within the next few 3 hours.

If the period of lack of a ring in the established place exceeds 3 hours on the first or second week of use, then it is recommended after introduction it in a vagina during the next 7 days to use additional barrier contraceptives.

If accidental removal happened on the third week of use and the ring was absent more than 3 hours, then the risk of disturbance of contraceptive effect is very high. In this case the dropped-out ring should be thrown out and chosen one of the following actions.

It is possible to enter at once a new ring which it is necessary to carry the next 3 weeks. Menstrualnopodobny bleeding can not come, the risk of emergence of the smearing bloody allocations or breakthrough bleedings in the middle of a new cycle increases.

The following option can be chosen only in case of lack of disturbances in the mode of use of a ring within the first 2 weeks. He assumes to wait for bleeding of cancellation and to enter a new ring not later than in 1 week after removal of the previous ring.

If in the period of a week break the woman had a sexual contact, then before introduction of a new ring it is necessary to exclude pregnancy. In the absence of pregnancy and after introduction of a ring it is necessary to use additional barrier contraceptives during the first 7 days.

Contraceptive property of a ring lasting use up to 4 weeks remains sufficient. If the ring is not taken out by more than 4 weeks, then there is a risk of pregnancy as the contraceptive effect is exhausted. Therefore it is necessary to be convinced of lack of pregnancy before the following introduction of the NuvaRing.

For a cancellation bleeding delay the following ring should be entered in the first day of an estimated break and to use it within 3 weeks. During this period emergence of the smearing allocations and breakthrough bleedings is possible. Then it is necessary to observe the usual mode of regular use of a ring.

That to move the beginning of bleeding of cancellation the next day weeks, the ring should be removed not in the established day of the week, and later, having reduced having rummaged in use. It is necessary to consider at the same time that the break is less, the risk of absence of menstrualnopodobny bleeding and emergence of bloody allocations in the following cycle of use of a ring is more.

At detection of damage (gap) of a ring, it should be replaced new.

It is regularly recommended to check existence of a ring in a vagina as its loss, for example at women with chronic locks is possible, at the wrong introduction, after sexual contact.

To remove a ring it it is necessary to hook an index finger and to extend from a vagina, then to throw out, previously having placed in a package.

Side effects

• Generative organs and mammary glands: often – an itch of external genitals, painful bleedings of cancellation, allocation from a vagina, pain in a small pelvis, morbidity and a nagrubaniye of mammary glands; infrequently – absence of menstrualnopodobny bleedings, increase in mammary glands, unpleasant feelings in mammary glands and/or in the field of a basin, consolidation in mammary glands, bloody allocations (bleedings) during sexual intercourse, morbidity of sexual intercourse, polyps of a neck of uterus, ectropion of a neck of uterus, acyclic bleedings, plentiful bleedings of cancellation, a fibrous and cystous mastopathy, a burning sensation and/or morbidities in a vagina, a predmenstrualnopodobny syndrome, a smell from a vagina, dryness and discomfort of a vulva and mucous membrane of a vagina; frequency is unknown – a galactorrhoea, local reactions at the partner from a penis, such as pain, bruise, hyperemia, grazes;
• Immune system: frequency is unknown – hypersensitivity;
• Infections and invasions: often – a vaginal infection; infrequently – cystitis, a cervicitis, infections of urinary tract;
• Metabolism: often – increase in body weight; infrequently – increase in appetite;
• Alimentary system: often – nausea, an abdominal pain; infrequently – vomiting, abdominal distention, a lock, diarrhea;
• Mental disorders: often – decrease in a libido, a depression; infrequently – change of mood;
• Organ of sight: infrequently – a vision disorder;
• Nervous system: often – a headache, migraine; infrequently – a hypesthesia, dizziness;
• Cardiovascular system: infrequently – inflows, increase in the arterial pressure (AP); seldom – a venous thromboembolism;
• Integument: often – an acne; infrequently – a skin itch, an alopecia, rash, eczema; frequency is unknown – a small tortoiseshell;
• Urinary system: infrequently – a pollakiuria, a dysuria, imperative desires to an urination;
• Musculoskeletal system: infrequently – muscular spasms, pain in a back and/or in extremities;
• Febriculas: infrequently – irritability, fatigue, disease state, hypostases;
• Others: often – discomfort during use of a vaginal ring, loss of a vaginal ring; infrequently – difficulties in use, damage (gap) of a ring, feeling of a foreign body.

Besides, against the background of use of the NuvaRing development of cholecystitis, pancreatitis, cerebrovascular disturbances, hloazma, benign and malignant tumors of a liver, insulin resistance change is possible.

At hereditary forms of a Quincke's disease the combined hormonal contraceptives can cause or aggravate symptoms of a Quincke's disease.

Special instructions

Purpose of the NuvaRing is shown only after an exception of pregnancy and full gynecologic inspection (including mammary glands, bodies of a small pelvis, a cytologic research of smears of a neck of uterus), measurements of the ABP, carrying out some laboratory researches excluding contraindications. During use of a contraceptive ring the woman has to undergo medical examination at least once a half-year.

At an aggravation or emergence of symptoms of diseases, deterioration in health the woman should see a doctor behind consultation.

Use of the NuvaRing can cause disturbance of blood circulation and, as a result, to become the reason of development of a deep vein thrombosis, a pulmonary embolism, arterial thrombosis and connected with the specified pathologies of complications, sometimes with risk of a lethal outcome.

In exclusively exceptional cases the women accepting complex hormonal contraceptives have a vein thrombosis and arteries of a liver, mezenterialny vessels, vessels of a brain, a retina, kidneys and other blood vessels though connection with administration of drug is definitely not established.

Manifestation of symptoms of arterial or venous thrombosis can become: a strong sudden stethalgia with possible return in the left hand, long and intensive headaches, a fit of coughing or asthmas, an acute abdomen, unexpected weakness or the expressed numbness of one party or any part of a body, motive disturbances, doubling in eyes, sudden loss of sight (partial or full), aphasia, dizziness, emergence in the lower extremity of unilateral hypostasis and/or pain, local temperature increase, discoloration of skin or a hyperemia, a collapse with a focal epileptic seizure or without it.

The risk factors capable to cause venous fibrinferments and embolisms, can be: age, existence of thromboses in the family anamnesis, obesity (an index of body weight more than 30 kg on 1 ^sq.m), a long immobilization, extensive operative measures, any operations standing, serious injuries, perhaps, a varicosity and thrombophlebitis of superficial veins.

Use of drug needs to be stopped in 4 weeks prior to carrying out planned operation and to renew only at a complete recovery of a physical activity 2 weeks later.

Except age, obesity and heredity factors of possible emergence of complications of arterial thromboembolisms can become: intensive smoking (especially at women is after 35 years), a dislipoproteinemiya, migraine, fibrillation of auricles, arterial hypertension, defect of valves of heart.

If in the family anamnesis (close relatives have patients: parents in youth, brothers, sisters) are predisposition to fibrinferments, it is impossible to begin use of any hormonal contraceptives without consultation of the specialist.

Undesirable disturbances of blood circulation can arise at biochemical factors of predisposition to venous or arterial thrombosis (a gipergomotsisteinemiya, resistance to the activated protein of C, deficit of a protein of C, deficit of antithrombin III, an antibody to phospholipids, deficit of a protein of S), at a diabetes mellitus, a gemolitiko-uraemic syndrome, a system lupus erythematosus, chronic inflammatory diseases of intestines, drepanocytic anemia, in a puerperal period.

Increase in frequency or expressiveness of migraine against the background of reception of hormonal contraceptives can become the reason of their cancellation.

According to epidemiological researches the risk of development of tumors at prolonged use of hormonal oral contraceptives increases. As far as it is connected using the NuvaRing, not established as diagnosis of a tumor at this category of patients can be connected with carrying out more frequent observations at the doctor.

Against the background of use of drug development of benign or malignant tumors of a liver which can cause life-threatening bleedings in an abdominal cavity is possible. Therefore at differential diagnosis of diseases at the women accepting hormonal contraceptives it is necessary to consider a possibility of existence of a tumor of a liver at the available symptoms of intra belly bleeding, acute pain in an upper part of a stomach or increase in a liver.

Use of drug can cause slight increase of the ABP, at the expressed constancy of this pathology it is necessary to consider a question of expediency of further hormonal contraception.

In case of a recurrence of the cholestatic jaundice which for the first time arose during pregnancy or earlier accepted sexual steroids, development of acute or chronic abnormal liver functions cancellation of the NuvaRing is required.

In the presence at the woman of a diabetes mellitus constant observation of the doctor, especially in the first cycles of use of drug is necessary.

The available pathologies can become the reason of the wrong introduction or frequent loss of a ring: cystocele and/or rectum, loss of a neck of uterus, severe form of chronic locks.

In case of unexpected emergence of symptoms of cystitis it is necessary to check correctness of introduction of a ring.

Efficiency of the NuvaRing can go down at disturbance of the mode of use or simultaneous use of other medicines.

When developing acyclic bleedings during use of a ring it is necessary to address the gynecologist for an exception of pregnancy or organic pathology.

In the absence of cancellation bleeding after removal of a ring two cycles in a row it is necessary to see a doctor.

When carrying out laboratory researches it is necessary to inform the medic on use of contraceptive hormonal drugs.

The contraceptive ring does not protect from diseases, sexually transmitted, including HIV infection (AIDS).

Influence of the NuvaRing on ability to control of vehicles and mechanisms is not established.

Medicinal interaction

In need of the accompanying therapy against the background of use of a contraceptive ring it is necessary to get advice of the doctor to avoid development of undesirable side reactions.

Terms and storage conditions

To store at a temperature of 2-8 °C. To protect from children.

Period of validity – 3 years.