Gainomax (Gaynomax)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceTinidazole + ThioconazoleTinidazole + Thioconazole
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  • Gainomax
    suppositories the vagina. 
    Exeltys Khelskea S.L.     Spain
    • Dosage form: & nbspVaginal suppositories
    Composition:

    Each suppository contains:

    Active substances: tioconazole - 100.00 mg tinidazole - 150.0 mg;

    Excipients: Witepsol 2250.0 mg.

    Description:

    A yellowish suppository with a flat body in the form of a truncated ellipse with a rounded end and a rounded depression on the truncated side.

    Pharmacotherapeutic group:Antimicrobial agent combined (antimicrobial and antiprotozoal agent + antifungal agent)
    ATX: & nbsp

    G.01.A.F.20   Combinations of imidazole derivatives

    Pharmacodynamics:

    The drug Gainomax is a combination of thioconazole and Tinidazole.

    Thioconazole combines an antifungal action against dermatophytes Trichophyton spp., Microsporum spp., Epidermophyton spp., yeast and yeast-like fungi of the genus Candida with antibacterial action against gram-positive bacteria Staphylococcus spp. and Streptococcus spp. Active against pathogens Trichomonas vaginalis, Ciardnerella vaginalis, Bacteroides spp. The mechanism of action is to suppress the synthesis of ergosterol cell membrane of fungi. It is fungicidal and bactericidal.

    Tinidazole is an antiprotozoal drug with an antimicrobial effect. Active with respect to Trichomonas vaginalis, Entamoeba histolytica, Giardia lamblia (Giardia intestinal is). Has a bactericidal effect against the following anaerobic microorganisms: Bacteroides spp., Clostridium spp., Eubacterium spp., Fusobacterium spp., Peptococcus spp., Peptostreptococcus spp., Veillonella spp. The mechanism of action is due to the inhibition of synthesis and damage to the DNA structure of pathogens.

    Pharmacokinetics:

    With intravaginal application, systemic absorption of active components is negligible.

    Indications:

    Treatment of vaginitis caused by pathogens of labor Candida, Trichomonas and Gardnerella (vaginal candidiasis, trichomonas vulvovaginitis, gardnerellevic vaginitis, nonspecific vaginitis), as well as mixed infection.

    Contraindications:

    - Hypersensitivity to tinidazole, thioconazole and other components of the drug;

    - aboutOrganic diseases of the nervous system at present or in the anamnesis;

    - leukoz, violation of hemopoiesis;

    - Pin pregnancy in the first trimester;

    - gOre feeding.

    - dUp to 18 years of age.

    Pregnancy and lactation:

    The effect of the drug on reproductive function and development of the fetus in the experiment was not found. The clinical experience of using the drug in pregnant women is very limited. The drug Gainomax is contraindicated for use in the first trimester of pregnancy. In II and III trimester of pregnancy, the use of the drug is possible if the potential benefit to the mother exceeds the possible risk to the fetus.

    Determined that tinidazole can penetrate into breast milk. During the treatment with the drug Gainomax should stop breastfeeding.

    Dosing and Administration:

    Intravaginal.

    The drug is used for 1 vaginal suppository at night for 7 days.

    Alternative scheme of application: 1 vaginal suppository 2 times a day (morning and night) for 3 days.

    Vaginal suppositories should be administered in a lying position deep in the vagina. Wash hands thoroughly before and after applying the product.

    If there is no improvement after treatment or new symptoms appear, it is necessary to consult a doctor.

    Older patients

    When using the drug elderly patients (over 65 years of age) do not need to change the dosage regimen.

    Side effects:

    Classification of incidence of adverse reactions: very often (≥ 1/10); often (≥ 1/100 and <1/10); infrequently (≥ 1/1000 and <1/100); rarely (≥ 1/10 000 and <1/1000); very rarely (<1/10 000).

    When using the drug Gainomax for intravaginal use, adverse reactions occur rarely and in most cases are mild.

    Local reactions: rarely - edema, irritation of the mucous membrane of the vagina, burning sensation, itching of the vagina.

    From the nervous system: rarely - headache, fatigue.

    From the side of the kidneys and urinary tract: rarely - darkening of urine.

    Allergic reactions: rarely - skin rash, hives, very rarely - angioedema.

    If side effects develop, discontinue use and consult a doctor.

    Although no cases of transient leukopenia were observed with the intravaginal application of the Gainomax preparation, cases of this symptom associated with neurological or gastrointestinal symptoms associated with systemic administration of tinidazole were described.

    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:

    No cases of overdose have been reported.

    At casual reception of a preparation inside wash out of a stomach spend, if necessary spend symptomatic therapy.

    Interaction:

    The drug interaction of the drug Gainomax in vaginal application has not been studied.

    Despite the fact that the active component tinidazole, which is part of the vaginal suppositories is absorbed insignificantly, it is impossible to exclude such side effects as intestinal colic, nausea, vomiting, reddening of the skin with simultaneous application with alcohol.

    Special instructions:

    Despite the fact that in clinical studies there were no changes on the part of the blood system during treatment with the drug Gainomax, it can not be used for patients with diseases of the hematopoiesis system (leukemia, hemopoiesis disorders) now or in the anamnesis.

    The use of suppositories can reduce the reliability of mechanical contraception (latex containing condoms, vaginal diaphragms). During treatment it is recommended to select reliable methods of contraception.

    Alcohol intake should be excluded during treatment with the drug, and also within 3 days after the application of the last dose.

    Do not use the drug in the therapy of virgins and young girls (girls) who have not reached puberty.

    If there is an allergic reaction, irritation treatment should be discontinued. If necessary, the drug can be removed by washing the vagina with boiled water.

    To prevent re-infection, hygiene rules should be followed. If there is an infection in the sexual partner, he should also be prescribed appropriate treatment.

    The drug should not be stored in the refrigerator.

    Read the instructions carefully before using the product. Keep the manual, it may be needed again.

    If you have any questions, contact your doctor. The medicinal product that you are treated is intended for you personally, and it should not be passed on to others, as it can harm them even if you have the same symptoms as you.

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

    The drug does not affect the ability to drive vehicles or engage in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

    Form release / dosage:

    Vaginal suppositories, 150 mg + 100 mg.

    Packaging:

    For 7 suppositories in a PVC / LDPE strip.

    1 strip with instructions for use 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 the expiration date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:LP-000007
    Date of registration:20.10.2010 / 27.12.2016
    Expiration Date:Unlimited
    The owner of the registration certificate:Exeltys Khelskea S.L.Exeltys Khelskea S.L. Spain
    Manufacturer: & nbsp
    Representation: & nbspExeltys Khelskea S.L.Exeltys Khelskea S.L.Spain
    Information update date: & nbsp03.04.2017
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