Modell Libera®
Teva
1451 Items
2019-09-19
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Clinical Pharmacology
Model Liber - combined oral estrogen-progestin contraceptive drug for continuous long-term use for 91 days. The contraceptive effect of the drug is due to the complementary mechanisms of active substances, the most important of which include suppression of ovulation, an increase in the viscosity of the cervical secretions, which makes it difficult for sperm to enter the uterus, and changes in the endometrium that prevent implantation of a fertilized egg.
When using the drug Modelle Libera, the number of menstrual bleeding is reduced to four per year. In the last 7 days of a long-term administration of the drug (days 85-91) with the use of 10 μg of ethinyl estradiol instead of placebo, there is an increase in the suppression of the ovarian follicular apparatus and a reduction in the risk of ovulation skipping. Menstrual-like bleeding associated with drug withdrawal occurs because there is no progestin effect on the endometrium, but in women there is a residual suppression of the hypothalamo-pituitary system due to the small dose of ethinyl estradiol to control the functional activity of the ovaries.
Indications
Oral contraception.
Composition
1 tablet of levonorgestrel and ethinyl estradiol contains: active ingredients: levonorgestrel 0.10 mg, ethinyl estradiol 0.02 mg
1 tablet of ethinyl estradiol contains: active ingredient: ethinyl estradiol 0.01 mg
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Dosage and Administration
The drug Modelle Libera is ingested continuously for 91 days, 1 tablet per day at the same time in the order indicated on the package (blister).
To achieve the greatest contraceptive effect of the drug should be taken in accordance with the recommendations and at intervals not exceeding 24 hours.
- thrombosis (venous and arterial) and thromboembolism at present or in history (including deep venous thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular disorders);
- the conditions preceding thrombosis (including transient ischemic attacks, angina pectoris) at present or in history;
- multiple or severe risk factors for venous or arterial thrombosis
- hereditary or acquired susceptibility to venous or arterial thrombosis: resistance to activated protein C, hyperhomocysteinemia, antithrombin III deficiency, protein C deficiency, protein S deficiency, antibodies to phospholipids (antibodies to cardiolipin, lupus anticoagulant);
- migraine with focal neurological symptoms now or in history;
- uncontrolled arterial hypertension;
- diabetes mellitus with diabetic angiopathy;
- pancreatitis with severe hypertriglyceridemia now or in history;
- liver failure and severe liver disease (until normalization of liver function tests);
- liver tumors (benign or malignant) now or in history;
- severe dyslipoproteinemia;
- identified hormone-dependent malignant diseases (including genitals or mammary glands) or suspicion of them;
- bleeding from the vagina of unknown origin;
- pregnancy or suspicion of it;
- breastfeeding period;
- age up to 18 years (due to the lack of data on the efficacy and safety of the drug in adolescent girls under 18 years of age);
- simultaneous use with Hypericum perforatum preparations;
- hypersensitivity to any of the components of the drug;
- galactose intolerance, lactase deficiency or glucose-galactose malabsorption, because the drug contains lactose;
- postmenopausal period.
Overdosage
No serious side effects from overdose were reported. Based on the experience of using COC, the symptoms that may occur during an overdose are identified: nausea, vomiting, "bloody" spotting from the vagina or metrorrhagia.
Treatment: conduct symptomatic therapy. There is no specific antidote.
- Brand name: Modell Libera®
- Active ingredient: Levonorgestrel, Ethinyl Estradiol; Ethinyl Estradiol [set]
- Dosage form: A set of pills, film-coated, 0.1 mg + 0.02 mg and 0.01 mg.
- Manufacturer: Teva
- Country of Origin: Israel
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