Krajina: Singapur
Jazyk: angličtina
Zdroj: HSA (Health Sciences Authority)
ISOCONAZOLE NITRATE
BAYER (SOUTH EAST ASIA) PTE LTD
G01AF07
600 mg
SUPPOSITORY
ISOCONAZOLE NITRATE 600 mg
VAGINAL
Pharmacy Only
BAYER DE MEXICO, S.A. DE C.V.
ACTIVE
1989-05-26
GYNO-TRAVOGEN OVULE QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ovule contains 600 mg isoconazole nitrate INDICATIONS Fungal infections of the vagina including mixed infections with gram-positive bacteria. DOSAGE AND METHOD OF ADMINISTRATION Dosage 1-day treatment: 1 vaginal suppository (containing 600 mg isoconzole) is used as one single dose. Method of administration The ovulum must be inserted deep into the vagina. This is best done in the lying position in the evening before going to sleep. The enclosed finger stalls should be used to assist insertion. The treatment is not to be carried out during menstruation. CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients. SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE For treatment of the external genital region or for simultaneous prophylactic treatment of the partner it is recommended to use Travogen cream. During treatment and in the following week vaginal douching should be avoided. To avoid renewed infection, personal linen (face-cloth, towels, underwear – preferably of cotton) should be changed daily and boiled. DRUG INTERACTIONS None so far known. PREGNANY AND LACTATION The experience with the use of isoconazole-containing preparations during pregnancy does not indicate a teratogenic risk in humans. Because of the only slight absorption (less than 10% of the dose administered) and the short duration of the therapy, damage to the baby from isoconazole nitrate transferred with the breast milk can be ruled out. UNDESIRABLE EFFECTS Local concomitant symptoms such as smarting, burning and itching occur occasionally. Local symptoms such as erythema or vesiculation may occur in isolated cases under treatment with Gyno-Travogen. Gynotravogen PI_SG_CCT Version 4.0_12 May 09 In rare cases allergic reactions of the skin or of the mucosa may occur. PHARMACOLOGICAL PROPERTIES PHARMACODYNAMIC PROPERTIES Gyno Prečítajte si celý dokument
1.4.3_Clean Gyno-Travogen Ovule PI_CCT 04_09 Mar 2023 RESTRICTED GYNO-TRAVOGEN OVULE QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ovule contains 600 mg isoconazole nitrate INDICATIONS Gyno-Travogen suppository is indicated in fungal infections of the vagina including mixed infections with gram-positive bacteria. DOSAGE AND METHOD OF ADMINISTRATION Dosage 1-day treatment: 1 vaginal suppository (containing 600 mg isoconazole) is used as one single dose. Method of administration The ovulum must be inserted deep into the vagina. This is best done in the lying position in the evening before going to sleep. The enclosed finger stalls should be used to assist insertion. The treatment is not to be carried out during menstruation. CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients. SPECIAL WARNINGS AND PRECAUTIONS FOR USE For treatment of the external genital region or for simultaneous prophylactic treatment of the partner it is recommended to use Travogen cream. During treatment and in the following week vaginal douching should be avoided. To avoid renewed infection, personal linen (face-cloth, towels, underwear – preferably of cotton) should be changed daily and boiled. Some of the excipients in Gyno-Travogen suppository may reduce the effectiveness of latex products such as condoms and diaphragms. INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION No interaction studies have been performed. Concomitant treatment with intra-vaginal isoconazole nitrate and coumarin type anticoagulants (e.g., warfarin) might lead to increased plasma levels of the anticoagulant. FERTILITY, PREGNANCY AND LACTATION PREGNANCY The experience with the use of isoconazole-containing preparations during pregnancy does not indicate a teratogenic risk in humans. 1.4.3_Clean Gyno-Travogen Ovule PI_CCT 04_09 Mar 2023 RESTRICTED LACTATION It is unknown whether isoconazole/isoconazole nitrate is excreted in human milk. A risk of exposure to the suckling child cannot be excluded. FERTILITY Preclin Prečítajte si celý dokument