Active substanceNystatinNystatin
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  • Nystatin
    suppositories the vagina. 
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  • Dosage form: & nbspVaginal capsules
    Composition:

    1 suppository contains:

    Active substances: nifuratel 500.00 mg + nystatin 200,000, 00 ME Excipients: dimethylpolysiloxane AK1000 (Dimethicone) 960.0 mg Shell composition: gelatin 351.0 mg, glycerol (glycerol) 171.0 mg,

    ethylparahydroxybenzoate sodium 1.8 mg, sodium propyl parahydroxybenzoate 1.0 mg, titanium dioxide 0.4 mg, iron oxide yellow 2.4 mg

    Description:soft gelatinous egg-shaped suppositories of yellow color with a brown tinge, containing a yellow oily suspension.
    Pharmacotherapeutic group:antimicrobial combination agent (antimicrobial and antiprotozoal agent + antifungal agent)
    ATX: & nbsp

    G.01.A.A   Antibiotics

    G.01.A.A.01   Nystatin

    Pharmacodynamics:

    antimicrobial preparation for topical use. Has antiprotozoal, antifungal and antibacterial action.

    Nifuratel, a derivative of nitrofuran. Highly active against a number of bacteria, fungi and protozoa (incl. Trichomonas vaginalis).

    Nystatin is an antifungal antibiotic of the polyene group. By binding to sterols in the cell membrane of fungi, it breaks its permeability, which leads to cell death. Highly active in relation to Candida albicans.

    The combination of nifuratel and nystatin allows to achieve more pronounced antifungal action and significantly expand the spectrum of antimicrobial actions.

    High efficacy and low toxicity of the components of the drug cause a wide range of its clinical applications in the treatment of mixed etiologies of vaginitis, in particular, the use for the prevention of fungal infections caused by specific treatment of trichomoniasis.

    Macmirror The complex does not violate the physiological flora, which allows to avoid the development of dysbacteriosis and quickly restore the normocenosis of the vagina.
    Pharmacokinetics:

    the conducted researches confirm,that at vaginal application at animals (rabbits and dogs) with repeated introduction of a daily dose that in 30 times exceeded a therapeutic dose, the substances entering into structure of a preparation do not render systemic action.

    The conducted studies of the pharmacokinetics of the drug in humans also confirm that, with intravaginal application, the drug is not practically absorbed from the surface of the vaginal mucosa and does not have a systemic effect.

    The concentration of nifuratel in the blood plasma is below the limit of quantitation. The maximum concentration (Smak) is 4.54 ng / ml; time to reach the maximum concentration (Tmax) 8.0 h; the integral area under the pharmacokinetic curve "concentration-time" (AUC) 10.27 ng ml-1 h.

    Nystatin is not absorbed through the skin and mucous membranes during topical application.
    Indications:

    Vulvovaginal infections caused by drug-susceptible pathogens, including: bacterial vaginitis, vaginal trichomoniasis; vaginitis caused by fungi of the genus Candida, mixed vaginitis.

    Contraindications:

    Hypersensitivity to nifuratel, nystatin or any auxiliary substance of the drug.

    Childhood.

    Carefully:
    Pregnancy and lactation:

    The use of the drug during pregnancy is possible if the potential benefit to the mother exceeds the risk to the fetus or child.

    Possible use in the period of breastfeeding, since the drug is not practically absorbed through the mucous membranes, so it does not penetrate breast milk.
    Dosing and Administration:

    Intravaginal: 1 vaginal suppository is administered daily at night before bedtime for 8 days or as recommended by the doctor. If necessary, treatment can be repeated after menstruation.

    For maximum effect, insert the suppository deep into the vagina.

    Side effects:

    Allergic reactions are possible in the form of skin rashes or itching. With the development of allergic reactions, the drug should be discontinued.

    Overdose:No cases of overdose have been reported.
    Interaction:

    No clinically significant interaction of the McMiore Complex with other drugs has been established.

    Special instructions:

    It is necessary to conduct simultaneous treatment of the sexual partner because of the danger of re-infection. During the treatment with the drug, sexual intercourse should be avoided.

    Suppositories are not used for treatment in childhood, when it is necessary to use the drug in this category of patients, it is recommended to apply the preparation Macmiore Complex in the form of a cream vaginal cream complete with an applicator (graduated syringe). The presence of a special nozzle allows you to enter the cream without damaging the hymen.

    Effect on the ability to drive transp. cf. and fur:Influence on ability to drive vehicles, mechanisms The use of the drug does not affect the ability to drive vehicles, and other activities requiring increased attention.
    Form release / dosage:

    Vaginal suppositories: the blister contains 8 or 12 vaginal suppositories;

    1 blister with instructions for use are placed in a cardboard box.

    Packaging:(12) - packings, cellular planimetric (1) - packs cardboard
    (8) - packings, cellular, planimetric (1) - packs, cardboard
    Storage conditions:

    In a dry place at a temperature of no higher than 25 ° C.

    Keep out of the reach of children!

    Shelf life:

    3 years. Do not use after expiry date.

    Terms of leave from pharmacies:On prescription
    Registration number:П N012638 / 01
    Date of registration:07.08.2008
    The owner of the registration certificate:Polikem Sr.L.Polikem Sr.L. Italy
    Manufacturer: & nbsp
    Representation: & nbspSIESC LTD, ZAOSIESC LTD, ZAO
    Information update date: & nbsp18.08.2015
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