Active substanceBenzalkonium chlorideBenzalkonium chloride
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  • Dosage form: & nbspFROMvaginal suppositories.
    Composition:For one suppository:

    Active ingredient: benzalkonium chloride 18.9 mg;

    Auxiliary component: glycerides of semi-synthesis.

    Description:

    Suppositories white or light yellow, one end pointed, the other - has a funnel-shaped depression, uniform in the longitudinal section.

    Pharmacotherapeutic group:contraceptive for topical use
    ATX: & nbsp

    D.08.A.J.01   Benzalkonium chloride

    G.02.B.B   Intravaginal contraceptives

    Pharmacodynamics:

    Spermatocidal effect is due to the ability to damage the membranes of spermatozoa (at the beginning of the flagella, then the head), which makes it impossible to fertilize the damaged sperm. The effect develops 5 minutes after the introduction into the vagina.

    In vitro is active with respect to Neisseria gonorrhoeae, Chlamydia spp., Trichomonas vaginalis, Herpes simplex type 2, Staphylococcus aureus.

    He does not act on Mycoplasma spp. and has little effect on Gardnerella vaginalis, Candida albicans, Haemophilus ducreyi and Treponema pallidum.

    It does not affect the normal microflora of the vagina (including Doderylein's stick) and the hormonal cycle.

    Pharmacokinetics:Virtually not absorbed with intravaginal injection, removed by simple washing with water and with normal physiological secretions.
    Indications:

    Local contraception for women of reproductive age (including if there are contraindications to the use of oral contraceptives or intrauterine contraception, in the postpartum period,lactation; after termination of pregnancy; perimenopause; irregular sexual intercourse; miss or late in the reception of ever-used oral contraceptives).

    Contraindications:

    Hypersensitivity to the components of the drug, vaginitis, ulceration and irritation of the mucous membrane of the vagina and cervix.

    Pregnancy and lactation:

    The drug is a contraceptive, during pregnancy is not used. At the onset of pregnancy against the background of contraception benzalkoniya chloride influence on the course of pregnancy is not found.

    It is not excreted in breast milk, it can be used during lactation.

    Dosing and Administration:

    Intravaginal.

    Lying on the back, the suppository is injected deep into the vagina 5 minutes before the sexual intercourse; the duration of the action is 4 hours. It is obligatory to introduce a new suppository with each repeated intercourse.

    Side effects:

    Allergic reactions, contact dermatitis, itching and burning in the vagina and / or penis partner, painful urination.

    Interaction:

    Any medicinal product, as well as soap and solutions containing it, administered intravaginally, can reduce the spermicidal effect of the drug.

    Iodine solutions (including 0.1% iodonate solution) inactivate the drug.

    Special instructions:

    To increase the efficiency, careful compliance with the method of application of the preparation is necessary.

    Possible application in conjunction with a vaginal diaphragm or intrauterine contraceptives.

    Avoid washing or watering the vagina with soapy water, as soap destroys the active substance of the drug (outdoor toilet is possible only with clean water).

    Form release / dosage:

    Vaginal suppositories, 18.9 mg.

    Packaging:

    Suppositories of 5 pieces are placed in a contour mesh package.

    For 1, 2 contour mesh packages along with the instruction for use are placed in a pack of cardboard.

    Storage conditions:

    Store at a temperature not exceeding 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    2 years.

    Do not use after expiry date.

    Terms of leave from pharmacies:Without recipe
    Registration number:LSR-007630/09
    Date of registration:29.09.2009
    Expiration Date:Unlimited
    The owner of the registration certificate:K.O. Ромфарм Компани С.Р.Л.K.O. Ромфарм Компани С.Р.Л. Romania
    Manufacturer: & nbsp
    Information update date: & nbsp06.01.2017
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