Active substanceBenzalkonium chlorideBenzalkonium chloride
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  • Dosage form: & nbspVaginal cream 1.2%.
    Composition:
    Ingredients per 100 g of cream
    Active substance:
    Benzalkonium chloride 50% aqueous solution .......... 2.4 g,
    which corresponds to benzalkonium chloride .......... 1.2 g
    Excipients:
    citric acid .......... 0.002 grams
    disodium hydrogen phosphate dodecahydrate .............. to pH 3.5-5.5
    macrogol and ethylene glycol palmitostearate (Tefoz® 63) ..... 24.0 g
    lavender oil ......................... 0.05 g
    purified water .................... up to 100 g
    Description:

    White homogeneous cream with the smell of lavender.

    Pharmacotherapeutic group:Contraceptive agent for topical application.
    ATX: & nbsp

    D.08.A.J.01   Benzalkonium chloride

    G.02.B.B   Intravaginal contraceptives

    Pharmacodynamics:

    Spermicidal action is due to the ability of the active substance to destroy the membranes of spermatozoa (first flagella, then the heads), which leads to the impossibility of fertilization of the egg cell with damaged sperm. The effect develops immediately after insertion into the vagina.

    In vitro active with respect to Neisseria gonorrhoeae., Chlamydia spp., Trichomonas vaginalis., Herpes simplex a type 2, Staphylococcus aureus. He has an impact on Mycoplasma spp. and has little effect on Gardnerella vaginalis, Candida albicans, Haemophilus ducreyi and Treponema pallidum.

    He affects the normal microflora of the vagina (including the Dodderlein wand) and the hormonal cycle.
    Pharmacokinetics:

    Benzalkonium chloride is not absorbed by the mucous membrane of the vagina, it is removed by simple washing with water and with normal physiological excretions.

    Indications:

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

    As an additional local contraception when using a vaginal diaphragm or an intrauterine device.
    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. When pregnancy comes on the background of contraception benzalkoniya chloride, no effect on the course of pregnancy. It is not excreted in breast milk, it can be used during lactation.
    Dosing and Administration:

    For vaginal application.

    Connect the dispenser to the tuba instead of the lid. Gently squeeze the contents of the tube before filling the dispenser (until the piston stop) so that air bubbles do not form. Disconnect the dispenser from the tube. Close the tube with a lid.

    Lying on your back, insert the cream deep into the vagina with the help of the dispenser, slowly pressing the piston. The duration of the action is 10 hours. Be sure to enter a new dose of cream before every second sexual intercourse.

    One dose (5 grams of cream) is designed for one sexual act.

    Side effects:

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

    If they occur, discontinue use of Pharmatex.

    If any of the side effects listed in the manual are aggravated, or if you notice any other side effects not listed in the instructions, tell your doctor.

    Overdose:Cases of overdose are not marked.
    Interaction:

    It is not recommended simultaneous use with drugs used vaginally. Any drug injected into the vagina can inactivate the local spermicidal effect of Pharmatex.

    Pharmatex is destroyed by soap. Do not do irrigation of the vagina before and after sexual contact, because soap, even its traces, destroys the active substance.
    Special instructions:

    The effectiveness of contraception depends on the correct use of the drug.

    - It is forbidden to use soap for the toilet of the genitals 2 hours before and after sexual intercourse, tk. soap destroys the active substance Pharmatex.

    - After sexual intercourse, the toilet of the external genital organs can only be clean water. Vaginal irrigation is used 2 hours after sexual intercourse.

    - With Pharmatex, introduced into the vagina, because of the danger of reducing the subsequent contraceptive effect, you can not take baths and swim in the sea, the pool and the reservoirs.

    - It is necessary to temporarily stop the use of Pharmatex for diseases of the vagina before the end of treatment with vaginal drugs.

    Effect on the ability to drive transp. cf. and fur:There is no evidence of a negative effect of the drug on the ability to drive vehicles and other mechanisms.
    Form release / dosage:

    Vaginal cream 1.2%.

    Packaging:For 72 grams of cream in an aluminum tube with a membrane and a screw cap of high-density polyethylene with a perforator for piercing the membrane. The tube inside is covered with protective epoxy-phenolic varnish. One tube with instructions for use and a dispenser made of low-density polyethylene in a cardboard bundle.
    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 expiry date.
    Terms of leave from pharmacies:Without recipe
    Registration number:П N011489 / 02
    Date of registration:26.05.2009
    The owner of the registration certificate:Laboratory Innotech InternationalLaboratory Innotech International France
    Manufacturer: & nbsp
    Representation: & nbspLaboratory Innotech International Laboratory Innotech International France
    Information update date: & nbsp12.08.2013
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