Gynecology
Our Female Health Care portfolio includes both in-house products and in-licensed products. This business direction is developed in order to provide high quality and commercially successful products.
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Endocrinology
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Gynecology
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Infections
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Transplantation
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Oncology
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Gastrointestinal tract
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Central nervous system
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Cardiovascular system
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Inflammatory diseases
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Anti-gouty drugs
Zhenale
Composition
Active substance: mifepristone - 10.0 mg.
Presentation
Tablets 10 mg.
1 tablet in a blister of polyvinyl chloride film and aluminum printed and glazed foil. 1 or 2 blisters with instructions for use are placed in a carton pack.
1 or 2 tablets in an amber glass bottle. 1 bottle with instructions for use are placed in a carton pack.
Therapeutic indications
Emergency (postcoital) contraception within 72 hours after sexual intercourse without prior use of contraceptive drugs or methods or in case of failure of practicing contraception (incl. an error in applying the rhythm method, unsuccessful interruption of sexual intercourse, condom break or slipped).
Route of administration
Orally, one tablet of Zhenale® 10mg within 72 hours after an unprotected sexual intercourse 2 hours before or in 2 hours after meal regardless of the phase of the menstrual cycle.
In case of irregular menstrual cycle, pregnancy must first be excluded. After administration of the emergency contraception drug barrier contraceptives (such as a condom) should be used until the next menstruation. Usage of the product in case of a repeated unprotected sexual intercourse during one menstrual cycle is not recommended due to increased risk of acyclic bleeding/spotting.
Mifegyne
Composition
Micronized mifepristone 200 mg (manufacturer's monograph)
Presentation
Tablets 200 mg. 3 tablets in a blister of PVC/aluminum foil. One blister and instructions for use in a carton pack.
Therapeutic indications
Medical termination of intra-uterine pregnancy in early stages (up to 42 days amenorrhea). Preparation for and induction of labor in full-term pregnancy.
Route of administration
The product should be used only in medical institutions under medical supervision.
Medical termination of pregnancy: Mifepristone is taken as a single 600 mg (3 tablets of 200 mg each) oral dose in the presence of a doctor. The patient should remain under medical supervision for at least 2 hours after administration. An ultrasound control must take place in 36-48 hours after Mifegyne® administration. In 8-14 days, a follow-up clinical examination, ultrasound control and beta-chorionic hormone test are carried out in order to check for complete expulsion. Failure of the method on day 14 (incomplete abortion or ongoing pregnancy) leads to vacuum aspiration followed by histological examination of the aspirate.
Preparation and induction of labor: mifepristone single 200mg (1 tablet) oral daily dose in the presence of a doctor. In 24 hours the second 200 mg dose is administered. In 48-72 hours, the condition of the birth canal is assessed, and, if necessary, prostaglandins or oxytocin are prescribed.
Mifepristone
Composition
Each tablet contains:
Active substance: mifepristone - 200.0 mg.
Presentation
Tablets 200 mg. 1 or 3 tablet in a blister of polyvinyl chloride film and aluminum foil. 1 or 3 blisters with instructions for medical use are placed in a carton pack.
Therapeutic indications
Medical termination of developing intra-uterine pregnancy in early stages (up to 42 days amenorrhea) administered together with the prostaglandin analogue.
Preparation for and induction of labor in full-term pregnancy.
Route of administration
Medical termination of pregnancy: Mifepristone is taken as a single 600 mg (3 tablets of 200 mg each) or 200 mg (1 tablets) oral dose in the presence of a doctor, taken with
100 ml of water (in 1-1.5 hours after light morning meal) The patient should remain under medical supervision for at least 3 hours after mifepristone administration. In 36-48 hours after mifepristone administration, the synthetic prostaglandin analogue misoprostol is administered as a 400 mcg oral dose. The patient should remain under medical supervision for at least 3 hours after misoprostol administration.
For the preparation and induction of labor in a full-term pregnancy: mifepristone 200 mg (1 tablet) single oral dose in the presence of a doctor. In 24 hours the second mifepristone 200 mg dose is administered. In 48-72 hours, the condition of the birth canal is assessed, and, if necessary, prostaglandins or oxytocin are administered.
