The instruction for medical use of Gaynomaks Torgovoye medicine a name of Gaynomaks the International unlicensed name Is not present the Dosage form Suppositories vaginal Structure 1 suppository contains active agents: tiokonazol 100.00 mg, Tinidazolum of 150.00 mg, excipient – vitepsol S55. The description Smooth, oval suppositories from white till yellowish color. Pharmacotherapeutic group Drugs for treatment of diseases of urogenital bodies and sex hormones. Antiseptic agents and antimicrobial drugs for treatment of gynecologic diseases. Antiseptic agents and antimicrobial drugs for treatment of gynecologic diseases imidazole Derivatives. Imidazole of derivatives combination. ATH G01AF20 code the Pharmacological Pharmacokinetics Later properties of single introduction of a tiokonazol of 100 mg in the form of a vaginal suppository at patients with vaginal candidiasis, average concentration of drug in plasma made 18.0 ng/ml. During clinical trials it is established that single dosing (100 mg) of a tiokonazol allows to keep antifunginalny effect within 2-3 days. At single intravaginalny introduction only 10% of Tinidazolum were exposed to system absorption. Tinidazolum T1/2 – 14.0 – 14.7 h. At intravaginalny use as tiokonazol, and Tinidazolum, are absorbed slightly. Thus, absorption of two active agents in a combination has to be low. The pharmacodynamics the Drug Gaynomaks, suppositories vaginal represents a combination of a tiokonazol and Tinidazolum. Tiokonazol – synthetic antifungal means with high activity concerning yeast-like and other mushrooms (dermatophytes). He is effective also concerning bacterial activators: Trichomonas vaginalis, Gardnerella vaginalis, Bacteroides spp., some gram-positive bacteria (including Staphylococcus and Sreptococcus spp.). The mechanism of action of a tiokonazol consists in increase in permeability of a cellular membrane of a mushroom by means of inhibition of synthesis of ergosterol, its main component. Increase in permeability of a cellular membrane breaks intracellular ionic balance that leads of cells to death. Tinidazolum is effective in the relation as protozoan activators (Trichomonas vaginalis, Entamoeba histolytica and Giardia lamblia), and the majority of anaerobic bacteria (Trichomonas vaginalis, Gardnerella vaginalis, Bacteroides fragilis, Bacteroides melaninogenicus, Bacteroides spp., Clostridium spp., Eubacterium spp., Peptostreptococcus spp. and Veillonella spp.). The mechanism of effect of Tinidazolum is up to the end not studied. Recovery of nitrogroup is mediated by a ferredoksinovy system and the low oxidation-reduction potential developed only by anaerobic bacteria. This fact can serve as the reason that absorption of Tinidazolum happens more actively at anaerobe bacterias, than at aerobes though Tinidazolum gets through cellular membranes of both those, and others. At recovery reaction, active intermediate agents are formed and the diffusion gradient accrues that strengthens Tinidazolum absorption. In spite of the fact that the cross resistance, as a rule, is characteristic of group 5 of nitroimidazoles, 65-70% of strains of Trichomonas vaginalis high-resistant to metronidazole have hypersensitivity to Tinidazolum. The efficiency of a combination of a tiokonazol with Tinidazolum at intravaginalny introduction is 90-100%, at the same time recovery by microbiological criterion is 85%. Indications – the candidosis vulvovaginitis caused by the Candida albicans activator – the bacterial vaginosis caused by Gardnerella vaginalis activators or anaerobic bacteria – the mecotic vaginitis caused by Trichomonas vaginalis – the vaginita caused with multi-infection. Route of administration and Intravaginalno’s doses. Not to use without consultation of the doctor. Drug is appointed on 1 vaginal suppository to night within 7 days. The alternative scheme – it is possible to apply on 1 vaginal suppository 2 times a day within 3 days. Vaginal suppositories should be entered deeply into a vagina. Patients of advanced age When prescribing drug the change of the mode of dosing is not required to patients of advanced age (65 years are more senior). Side effects For assessment of frequency of the undesirable phenomena are used the following criteria: very often (≥ 1/10), it is frequent (≥ 1/100, but & lt, 1/10), is not frequent (≥ 1/1000, but & lt, 1/100), is rare (≥ 1/10,000, but & lt, 1/1000), is very rare (& lt, 1/10,000), it is not known (it is not established on the available data). Gaynomaks it is well transferred at intravaginalny use. System side effects arise very seldom as at vaginal absorption Tinidazolum level in blood plasma very low. Often: – weakness, fatigue, an indisposition, a headache, dizziness, – nausea, anorexia, loss of appetite, a meteorism, dyspepsia, spasms in a stomach, discomfort in epigastric area, vomiting, a constipation – urine darkening. It is not known (it is not established on the available data): – a leukopenia (passing), a neutropenia, allergic reactions – an ataxy, a coma (seldom), the confused consciousness (rarely), a depression (seldom), a somnolence, drowsiness, insomnia, a sleep disorder, a peripheral neuropathy, spasms, convulsions, overexcitation, a disorientation – a stomach ache, diarrhea, a coated tongue (seldom), stomatitis, decolouration of language, dryness in a mouth, pseudomembranous colitis – an itching, urticaria, a Quincke’s disease, skin rashes – local burning, burning in an urethra, hypostasis, irritation mucous vaginas, a local itching, discharges from a vagina, a disparenuriya, a nocturia, vaginal pains. Contraindications – hypersensitivity to active components or their derivatives, other components of drug – organic diseases of nervous system – disturbance of a hematopoiesis now or in the anamnesis – children’s and teenage age up to 18 years – pregnancy the I trimester, the lactation period. Medicinal interactions Because of absorption of Tinidazolum when using with the medicines given below can arise the following interactions. Atsenokumarol, Anizindion, Dikumarol, Fenindionum, Fenprokumon, Varfarin: increase in risk of bleedings. Holestiramin: decrease in efficiency of Tinidazolum. Cimetidinum: increase in concentration of Tinidazolum in blood plasma. Cyclosporine: increase in level of cyclosporine in blood plasma. Disulfiramum: impact on the central nervous system (for example, psychotic reactions). Fluorouratsil: increase in level of a ftoruratsil in blood plasma and symptoms of potential ftoruratsilovy intoxication (granulocytopenia, anemia, thrombocytopenia, stomatitis, vomiting). Fosfenitoin: increase in toxicity of a fosfenitoin and/or decrease in concentration of Tinidazolum in blood plasma. Ketokonazol: increase in concentration of Tinidazolum in blood plasma. Lithium: increase in concentration of lithium in plasma of blood and symptoms of intoxication lithium (weakness, a shiver, a polydipsia, confusion of consciousness). Phenobarbital: reduction of concentration of Tinidazolum in blood plasma. Phenytoinum: increase in potential intoxication Phenytoinum and/or decrease in concentration of Tinidazolum in blood plasma. Rifampinum: decrease in concentration of Tinidazolum in blood plasma. Takrolimus: increase in level of a takrolimus. CYP3A4 inductors/inhibitors: decrease in efficiency of Tinidazolum or increase in risk of adverse reactions (such CYP3A4 inhibitors as Cimetidinum and ketokonazol, can prolong a half-life period both slow down clearance of Tinidazolum and increase concentration of Tinidazolum in blood plasma). Because of absorption of a tiokonazol when using with the medicines given below the following interaction can develop. Oxycodone: increase in concentration of oxycodone in blood plasma and delay of clearance of oxycodone. Special instructions not to swallow and not to apply in a different way except intravaginalny! In spite of the fact that steady hematologic disturbances against the background of drug use were not revealed. Gaynomaks it is impossible to accept at patients with disturbance of a hematopoiesis now or in the anamnesis as development of a passing leukopenia and neutropenia is possible. It is necessary to avoid alcohol intake during treatment and, at least, within 3 days after the termination of a course in view of possible disulfiramopodobny reactions. Use of Gaynomaks in the period of periods since the efficiency of drug decreases is not recommended or there are difficulties at its use. Gaynomaks it should not be used at the young girls who did not reach puberty. It is necessary to avoid simultaneous use of suppositories with contraceptive diaphragms and condoms in view of their possible interaction with a basis of suppositories. Other products for intimate hygiene (tampons, means for a shower, spermitsida) should not be used during treatment. Patients with the diagnosis “mecotic vaginitis” need to recommend simultaneous treatment of their sexual partner. In a renal failure At reduced function of kidneys the elimination half-life of drug does not change therefore the dose decline is not required. But at serious violation of function of kidneys where carrying out a hemodialysis is required, dose adjustment has to be made. In an abnormal liver function patients have no data on Tinidazolum pharmacokinetics with a liver failure. To such patients the recommended dose of Tinidazolum has to be entered with care. Children Safety and efficiency at children is not established. Therefore drug is contraindicated at children’s and teenage age up to 18 years. Pregnancy and a lactation In the II-III trimester of pregnancy drug can be used under control of the doctor and only in cases when the expected advantage for mother exceeds potential risk for a fruit. For treatment it is necessary to stop breastfeeding as Tinidazolum gets into breast milk. Feeding by a breast can be resumed in 72 hours after the termination of a course of treatment. Features of influence of medicine on ability of control of vehicles and mechanisms Considering possible side effects it is necessary to be careful during the driving and works with potentially dangerous mechanisms. Overdose Side/undesirable effects at overdose are not known. As the speed of system absorption of a tiokonazol is very low, the overdose at local use is impossible. Treatment: at accidental intake of a large amount of drug carry out gastric lavage. Specific antidote does not exist, carry out symptomatic therapy. A form of release and packing On 7 suppositories in blister strip packaging from polyvinylchloride / polyethylene. On 1 blister strip packaging together with the instruction for medical use in the state and Russian languages place in a cardboard pack. To Store storage conditions at a temperature not above 25 °C. Not to freeze. To store out of children’s reach! 3 years not to apply a period of storage after an expiration date. Prescription status According to the prescription the Producer Ekseltis Ilach Sang. To Va Thicke. A.Sh., Tekirdag, Turkey Owner of the registration certificate Ekseltis Ilach Sang. To Va Thicke. A.Sh., Istanbul, Turkey the Name, the address and a contact information of the organization in the territory of the Republic of Kazakhstan, the accepting claim (offer) on quality of medicines from consumers and responsible for post-registration observation of safety of medicine Representative office with limited liability ‘EKSELTIS S.L. Helskear.’ To the Republic of Kazakhstan 050059, Almaty, Al-Farabi Ave. 7, body 5A, office 177 Ph. 8 727 3115201 The name, the address and a contact information of the organization in the territory of the Republic of Kazakhstan responsible for post-registration observation of safety of medicine of ConsultAsia LLP 050061, Almaty, Shevchenko St. of 165 B ph./fax: +727-379-42-58 e-mail:
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