NovaRing

Prevention of pregnancy (contraception).

A woman can inject NovaRing® into the vagina herself . The doctor must inform the woman how to administer and remove NovaRing®. To introduce the ring, a woman must choose a pose that is convenient for her, for example, stand with one leg raised, sit down or lie down. NovaRing® must be compressed and inserted into the vagina so that the ring fits comfortably. The exact placement of the NovaRing® preparation in the vagina is not critical for ring contraception.

From the moment of administration of the drug NovaRing®, the ring should remain in the vagina continuously for 3 weeks. A woman should constantly check for the presence of a ring in the vagina (for example, before and after intercourse).

NovaRing® must be removed after three weeks on the same day of the week when it was introduced. After a week-long break, you must enter a new ring (for example, if the ring was introduced on Wednesday at 22 hours, it must be removed on Wednesday after three weeks at 22 hours. The new ring should be entered on the next Wednesday). NovaRing® can be removed by hooking it with the index finger or holding the ring between the index and middle fingers. The used ring should be put in a bag (stored in a place inaccessible to children and pets) and thrown away with ordinary household waste so as to avoid accidental contact of the ring with other people. NovaRing® should not be flushed to the toilet. Bleeding associated with the cessation of the drug usually begins 2-3 days after the removal of the drug NovaRing® and may not end until the day the next ring is introduced.

Combined hormonal contraceptives (CCGs) cannot be used in the presence of any of the following conditions.

Presence or risk of venous thromboembolism (VTE).

• Venous thromboembolism - the presence of VTE now (undergoing treatment with anticoagulants) or in history (such as deep vein thrombosis (DVT) or pulmonary embolism (ELS).
• Known or acquired hereditary risk factors for venous thromboembolism, such as resistance to activated protein C (including Leiden's factor V), deficiency of antithrombin III, deficiency of protein C, deficiency of protein S.
• Extensive surgery with prolonged immobilization.
• High risk of venous thromboembolism due to the presence of multiple risk factors.

Presence or risk of arterial thromboembolism (ATE)

• Arterial thromboembolism - the presence of arterial thromboembolism now or in history (eg myocardial infarction) or prodromal state (eg angina).
• Cerebrovascular disease is the presence of a stroke, a history of a stroke or prodromal condition (eg transient ischemic cerebral circulation).
• Known hereditary or acquired tendency to develop arterial thromboembolism, such as hyperhomocysteinemia and antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant).
• Migraine history with focal neurological symptoms.
• High risk of developing arterial thromboembolism due to the presence of multiple risk factors or one serious risk factor:

1. Diabetes with vascular complications.
2. Severe arterial hypertension.
3. Severe dyslipoproteinemia.

• A history of pancreatitis or pancreatitis, which is accompanied by high hypertriglyceridemia.
• Severe liver disease (until liver function test returns to normal).
•  Presence of benign or malignant liver tumors at present or in history.
• Hormone-dependent malignant tumors of the genital or mammary glands have been identified or suspected.
• Vaginal bleeding of unknown etiology.
• Hypersensitivity to the active substances or to any component of NovaRing®.

NovaRing® is contraindicated for use with a combination regimen for hepatitis C virus, which includes ombitasvir/paritravel/ritonavir with or without dasabuvir.

Active ingredients: 1 ring contains 11.7 mg of ethonogestrel and 2.7 mg of ethinyl estradiol.

Excipients: ethylene vinyl acetate copolymer (28% vinyl acetate), ethylene vinyl acetate copolymer (9% vinyl acetate), magnesium stearate.

The vaginal ring.

Basic physical and chemical properties: smooth, transparent ring without large visible damage with a transparent to almost transparent area, colorless or almost colorless.

1 NovaRing vaginal ring in sachet; 1 sachet in a cardboard box.

Store in the original package at 2–80 °С, out of the reach of children.

N.V. Organon, Netherlands.

In the presence of any of the following conditions / risk factors, the benefits and risks of each woman should be weighed separately before using NovaRing® and discussed with the patient before she decides to use the drug. In case of exacerbation, aggravation or occurrence of any of these conditions for the first time, the woman should consult a doctor. Your doctor determines whether you should stop taking NovaRing®.

• Circulatory disorders.
• The risk of venous thromboembolism (VTE).
• The use of any KGC increases the risk of venous thromboembolism (compared to the risk of not using the KGC). Drugs containing levonogestrel, norgestimate or norethisterone are associated with a minimal risk of developing VTE. Other drugs, such as NovaRing®, can increase the risk by 2-fold. The decision to use any contraceptive that is not a drug with the lowest risk of developing VTE can only be made after discussing with the woman and informing her about the risks of developing VTE when using the drug NovaRing®, how her individual risk factors will affect this risk. , and that the risk of developing VTE is maximal during the first year of use of the drug. The risk is also increased when resuming use of the KGC if the break is 4 weeks or longer.
• Among women who do not use the CCG and are not pregnant, two out of 10,000 will develop VTE within one year. However, for each individual woman, the risk may be much higher, depending on the main risk factors.
• It is estimated that out of 10,000 women who use low-dose GCG containing levonogestrel, VTE will occur in 61 women within 1 year. Contradictory results were reported regarding the occurrence of VTE when using NovaRing® compared with those of CCG containing levonogestrel (relative risk of occurrence is estimated as no increase in risk, BP = 0.96 to increase risk 2 times, BP = 1.90), fixed data 6 to 12 cases of VTE per year for 10,000 women using NovaRing®.
• In both of the above cases, the number of VTE cases per year is less than the expected number during pregnancy and in the postpartum period.
• VTE can be lethal in 1-2% of cases.

№1655 dated 07/22/2019