Active substanceProgesteroneProgesterone
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    Serono Limited     United Kingdom
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  • Dosage form: & nbspgel, vaginal
    Composition:

    1 applicator contains:

    active substance: progesterone 90.00 mg;

    auxiliary substancesa: glycerol 145.10 mg, paraffin liquid 47.25 mg, palm oils of hydrogenated glyceride 11,25 mg, carbomer 974Р 11,25 mg, sorbic acid 0,90 mg, polycarbophil 22,50 mg, sodium hydroxide q. s., water q. s.

    Description:

    Homogeneous gel is white or almost white with a specific smell.

    Pharmacotherapeutic group:Gestagen
    ATX: & nbsp

    G.03.D.A   Derivative derivatives

    G.03.D.A.04   Progesterone

    Pharmacodynamics:

    Progesterone is a hormone of the yellow body. Causes mucosal transition The uterus from the proliferation phase caused by follicle-stimulating hormone (FSH), at secretory phase. Reduces excitability and contractility of the musculature of the uterus and fallopian tubes.

    Progesterone inhibits the secretion of hypothalamic release factors FSH and luteinizing hormone, inhibits the formation of hypophysis gonadotropic hormones and inhibits ovulation.

    In the preparation of Krainon® progesterone in the form of a vaginal gel is included in the polymer delivery system, which binds to the vaginal mucosa and guarantees a constant release of the drug for at least 3 days.

    Pharmacokinetics:

    Suction

    When using a vaginal gel in a dose containing 90 mg of progesterone, the time to reach the maximum concentration of the drug in the blood (11 ng / ml) is about 6 hours.

    The elimination half-life is 34-48 hours.

    Metabolism

    Progesterone is metabolized predominantly in the liver. Vaginal application significantly reduces the effect of "first passage" through the liver.

    The main metabolite, 3α, 5β-pregnanediol, is excreted in the urine.

    Indications:

    - Maintenance of the luteal phase in the process of using auxiliary methods of reproduction;

    - secondary amenorrhea, dysfunctional uterine bleeding,caused by a deficiency of progesterone;

    - replacement hormone therapy in postmenopause (in combination with estrogenic drugs).

    Contraindications:

    - Hypersensitivity to progesterone or to other components of the drug;

    - vaginal bleeding of unclear etiology;

    - acute porphyria;

    - malignant tumors of genital organs or mammary glands or suspicion of their presence;

    - acute thrombosis or thrombophlebitis, thromboembolic disease, acute impairment of cerebral circulation (including in history);

    - incomplete abortion;

    - the period of breastfeeding.

    Carefully:

    With arterial hypertension, chronic renal failure, cardiovascular insufficiency, diabetes mellitus, bronchial asthma, epilepsy, migraine, depression, hyperlipoproteinemia.

    Pregnancy and lactation:

    Krajnon® can be used in the first trimester of pregnancy if the function of the yellow body is insufficient.

    The use of the drug Kraynon ® in the later period of pregnancy is not recommended.

    Krajnon® can not be used during breastfeeding.

    Dosing and Administration:

    Maintenance of the luteal phase in the use of assisted methods of reproduction

    Starting from the day of embryo transfer, the gel in the amount of 1.125 g (90 mg of progesterone -1 applicator) is administered daily intravaginally. At the onset of pregnancy, therapy is continued up to 12 weeks or for 10-12 weeks from the date of confirmed pregnancy.

    Secondary amenorrhea, dysfunctional uterine bleeding due to progesterone deficiency

    1,125 g (90 mg progesterone) of the gel are administered intravaginally every other day from the 15th day to the 25th day of the cycle. If necessary, the dose may be decreased or increased.

    Replacement hormone therapy in postmenopause (in combination with estrogen preparations)

    90 mg of progesterone (1 applicator) 2 times a week.

    Yingpatient formation for self-administration

    Precisely follow the doctor's advice when using Kraynon®.

    Krainon® contains a yellow body hormone identical to natural hormone progesterone.

    Krajnon® is introduced into the vagina. For hygienic reasons and for the convenience of the drug, Krainon® is packaged in a disposable applicator, which is discarded after use.

    1 - Air container

    2 - Flat end

    3 - Upper end

    4 - Bottom end

    5 - Snap-off cap

    Carry out the appliance according to this instruction:

    A) Take the applicator, tightly grasping its upper end with a large and index fingers. Shake the applicator like a medical thermometer so that the gel moves to the lower end of the applicator.

    B) While holding the applicator by the upper flat end of the air container, remove the breakout cap from the opposite end by turning. Do not apply pressure to the air container.

    C) The applicator can be inserted both in the sitting position and in the prone position with slightly bent knees. Carefully insert the lower end of the applicator into the vagina.

    D) Strongly squeeze the air container so that the gel from the applicator gets into the vagina. Despite the fact that some amount of gel remains in the applicator, you will receive the required dose completely. Now you can discard the applicator with the rest of the gel in it. Krainon® covers the vaginal mucosa, providing a prolonged release of progesterone.

    Side effects:

    Headache, drowsiness, abdominal pain, tenderness of the mammary glands,intermenstrual bleeding, irritation of the vaginal mucosa and other local moderate reactions in the field of application; hypersensitivity reactions are also possible, usually manifested as a skin rash.

    Overdose:

    No cases of an overdose of Kraynon® were reported.

    Interaction:

    There is no data on the interaction of Krainon® with other drugs.

    The use of the drug together with other intravaginal agents is not recommended.

    Special instructions:

    The attending physician should pay special attention to the possible appearance of early symptoms of thrombotic disorders (thrombophlebitis, cerebral circulatory disorders, pulmonary embolism and retinal thrombosis). If a symptom is found that indicates these disorders, or even suggests that they are present, the drug should be immediately withdrawn.

    Patients with any risk factors for thrombotic disorders should be closely monitored.

    In the process of long-term treatment, regular gynecological examinations are necessary in order to exclude the possibility of developing endometrial hyperplasia.

    A physical examination before the start of therapy should include an assessment of the condition and development of the mammary glands and pelvic organs, as well as a cervical smear (Papanicolaou test).

    In order to prevent the possibility of incomplete abortion in the use of Kraynon®, the level of chorionic gonadotropin should be determined or ultrasound should be performed.

    Use with caution in case of liver dysfunction.

    In cases of bleeding, such as in all cases of irregular vaginal bleeding, organic pathology should be ruled out.

    In the case of vaginal bleeding of unclear etiology, an appropriate examination should be carried out.

    Since progestogens have the ability to retain fluid in the body, patients with diseases such as epilepsy, migraine, bronchial asthma, cardiovascular failure, impaired renal function, should be closely monitored.

    It is necessary to closely monitor patients who have a history of depression and interrupt treatment if depression worsens.

    A small number of patients receiving estrogen-progestagen therapy may experience a decrease in glucose tolerance. The mechanism of this violation is not known.In this regard, patients suffering from diabetes, in the process of treatment with progesterone should be under close supervision.

    The preparation Krainon ® includes sorbic acid, which can cause a local skin reaction (contact dermatitis).

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

    Krainon® has a weak or moderate effect on the ability to drive and work with machinery. Since with the application of the drug Kraynon®, you may experience a feeling of fatigue or drowsiness, care must be taken when driving a car and other mechanisms. The use of alcohol can enhance this effect.

    Form release / dosage:

    Vaginal gel, 8%.

    Packaging:

    By 1.125 g of gel in polypropylene applicators of white color with a detachable cap.

    One applicator in packages of laminated foil.

    For 6 or 15 packs together with instructions for medical use in the pack cardboard.

    Storage conditions:

    At a temperature of no higher than 25 ° C. Do not freeze.

    Keep out of the reach of children.

    Shelf life:

    3 years.

    Do not use after the expiration date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:LS-000427
    Date of registration:01.06.2010 / 22.12.2015
    Expiration Date:Unlimited
    The owner of the registration certificate:Serono LimitedSerono Limited United Kingdom
    Manufacturer: & nbsp
    Representation: & nbspMERK CERONO division of Merck KGaA MERK CERONO division of Merck KGaA Germany
    Information update date: & nbsp22.01.2018
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