MODELL® 911 (MODELLE® 911)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceLevonorgestrelLevonorgestrel
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    • Dosage form: & nbsppills
    Composition:

    1 tablet contains: active substance: levonorgestrel 1.5 mg; Excipients: cellulose microcrystalline 44.4 mg, lactose monohydrate 43.3 mg, poloxamer 188 1.8 mg, croscarmellose sodium 5.0 mg, magnesium stearate 0.5 mg.

    Description:Round biconvex tablets of white color with engraving "C" on one side and "1" on the other side.
    Pharmacotherapeutic group:Gestagen
    ATX: & nbsp

    G.03.A.D   Preparations for emergency contraception

    G.03.A.D.01   Levonorgestrel

    Pharmacodynamics:

    Levonorgestrel is a synthetic gestagen. which has a contraceptive effect. It is used as a means of emergency contraception due to pronounced gestagenic and anti-estrogenic effects. With the recommended dosing regimen levonorgestrel suppresses ovulation and fertilization, if sexual intercourse occurs in the pre-evolutionary phase of the menstrual cycle.It can also cause changes in the endometrium that prevent the implantation of a fertilized egg, and increases the viscosity of the secretion of the cervix, which prevents the progress of spermatozoa. Levonorgestrel Ineffective in the case when the implantation has already occurred.

    Subject to the recommended dosing regimen levonorgestrel does not significantly affect the factors of blood coagulability, the exchange of fats and carbohydrates.

    When one 1.5-mg levonorgestrel tablet is used once during 72 hours after unprotected intercourse, the expected pregnancy can be prevented in 84% of cases (compared to 79% with 2 levonorgestrel tablets taken with a 12-hour interval).

    Pharmacokinetics:

    Suction. Ingestion levonorgestrel quickly and almost completely absorbed. Absolute bioavailability is about 100% of the dose. After taking levonorgestrel at a dose of 1.5 mg, the maximum concentration in the blood plasma (CmOh), equal to 18.5 ng / ml, is achieved after 2 hours.

    Distribution. Levonorgestrel binds to serum albumin and with sex hormone binding globulin (SHBG).Only 1.5% of the dose received in the body is in free form, and 65% is associated with SHGG. Penetrates into breast milk.

    Metabolism. Metabolism of levonorgestrel corresponds to the metabolism of steroids. Metabolized in the liver by hydroxylation, metabolites are excreted in the form of conjugated glucuronides. Pharmacologically active metabolites of levonorgestrel are unknown.

    Excretion. Levonorgestrel is excreted approximately equally by the kidneys and through the intestine, exclusively in the form of metabolites. The half-life (T1/2) is about 26 hours.

    Indications:Emergency (postcoital) contraception within 72 hours (after unprotected sex or unreliability of the contraceptive method used).
    Contraindications:

    Hypersensitivity to levonorgestrel or any other component of the drug; children's age till 16 years; severe hepatic impairment; pregnancy; lactose intolerance, lactase deficiency or glucose-galactose malabsorption.

    Carefully:Diseases of the liver and biliary tract, jaundice (including in the anamnesis), Crohn's disease.
    Pregnancy and lactation:

    The MODEL® 911 is contraindicated in pregnancy.Based on the available data, in the case of pregnancy when an emergency method of contraception is used, the adverse effect of the drug on the fetus is not revealed.

    Levonorgestrel penetrates into breast milk. After taking the drug, breastfeeding should be stopped for 24 hours.

    Dosing and Administration:

    One tablet should be taken orally as soon as possible, preferably within 12 hours, but no later than 72 hours after unprotected intercourse. If vomiting occurs within 3 hours after taking MODEL® 911, you should take another tablet of MODEL® 911.

    The MODEL® 911 can be used on any day of the menstrual cycle. In the case of an irregular menstrual cycle, you must first exclude pregnancy.

    After taking an emergency contraceptive before the next menstrual period, barrier methods of contraception should be used (for example, a condom, a vaginal diaphragm, a cervical cap).

    Side effects:

    The frequency of side effects is classified according to the recommendations of the World Health Organization: very often - not less than 10%; often - not less than 1%,but less than 10%; infrequently - not less than 0,1%, but less than 1%; rarely - not less than 0.01%, but less than 0.1%; very rarely (including isolated cases) - less than 0.01%.

    From the nervous system: very often - headache; often - dizziness.

    From the gastrointestinal tract: very often - nausea, pain in epigastrium; often - vomiting, diarrhea.

    From the genitals and the breast: very often acyclic spotting (bleeding), pain in the lower abdomen; often - soreness of the mammary glands, menstruation delay more than 5-7 days; very rarely - dysmenorrhea.

    From the skin and subcutaneous tissues: very rarely - hives, skin rashes, skin itching, face swelling.

    Other: very often - a feeling of fatigue.

    Overdose:

    Symptoms: nausea, vomiting, bleeding "cancellation."

    Treatment: there is no specific antidote. Conduct symptomatic therapy.
    Interaction:

    With simultaneous use with inductors of microsomal enzymes of the liver, there is an acceleration of the metabolism of levonorgestrel.

    The following drugs may decrease the effectiveness of levonorgestrel: amprenavir, lansoprazole, nevirapine, oxcarbazepine, tacrolimus, topiramate, tretinoin, barbiturates (including primidon), phenytoin and carbamazepine; preparations containing St. John's wort

    perforated (Hypericum perforatum); and rifampicin, ritonavir, ampicillin, tetracycline, rifabutin, griseofulvin.

    Levonorgestrel reduces the effectiveness of hypoglycemic and anticoagulant (coumarin derivatives, fenindion) of medicinal products. Increases plasma concentrations of glucocorticosteroids. Women who take these drugs should consult a doctor for advice.

    Preparations containing levonorgestrel, can increase the risk of toxicity of cyclosporine due to the suppression of its metabolism.

    Special instructions:

    The MODEL® 911 should be used exclusively for emergency contraception. The effectiveness of emergency contraception with delayed use of the MODEL® 911 drug is reduced.

    The drug does not replace the use of permanent methods of contraception.

    The repeated use of MODEL® 911 during one menstrual cycle is not recommended because of the increased frequency of acyclic bleeding / bleeding.

    In most cases, MODEL® 911 does not affect the character of the menstrual cycle.However, acyclic bleeding may occur and menstruation may be delayed for several days. If you delay menstruation for more than 5-7 days and change its nature (meager or abundant discharge), you must exclude pregnancy. The appearance of pain in the lower abdomen, fainting can indicate ectopic (ectopic) pregnancy.

    The use of levonorgestrel is not recommended in women with a high risk of developing an ectopic pregnancy (with the presence of salpingo-oophoritis or an ectopic pregnancy in an anamnesis).

    In children under 16 years experience with levonorgestrel, 1.5 mg tablets is limited. The use of the MODEL® 911 preparation is possible only in exceptional cases (including rape) and only after consultation of the gynecologist. After an emergency contraception, a second consultation with a gynecologist is recommended. Emergency contraception does not protect against sexually transmitted diseases. In case of violations of the function of the gastrointestinal tract (for example, with Crohn's disease), the effectiveness of the drug may be reduced.

    Effect on the ability to drive transp. cf. and fur:

    The effect of the drug on the ability to drive vehicles and mechanisms has not been investigated. If dizziness develops with the drug MODEL® 911 should be careful when performing actions that require increased concentration of attention and speed of psychomotor reactions.

    Form release / dosage:Tablets of 1.5 mg.
    Packaging:

    1 tablet in PVC-PVDC / Aluminum blister. 1 blister with instructions for use in a cardboard box.

    Storage conditions:

    Store at a temperature not exceeding 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    3 years. Do not use after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:LP-004190
    Date of registration:15.03.2017
    Expiration Date:15.03.2022
    The owner of the registration certificate:Teva Pharmaceutical Enterprises Co., Ltd.Teva Pharmaceutical Enterprises Co., Ltd. Israel
    Manufacturer: & nbsp
    Representation: & nbspTeva Teva Israel
    Information update date: & nbsp03.04.2017
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