Страна: Вірменія
мова: англійська
Джерело: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
nifuratel, nystatin
Doppel Farmaceutici S.r.l.
G01AA51
nifuratel, nystatin
500mg+ 200 000IU
capsules vaginal soft
(8/1x8/) in blister
Prescription
Registered
2020-12-31
_ _ SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF MEDICINAL PRODUCT Macmiror Complex 500 mg / 200,000 I.U. soft vaginal capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vaginal capsule contains: _Active substances_: nifuratel 500 mg, nystatin 200,000 I.U. Excipients with known effect: Sodium ethyl parahydroxybenzoate, sodium propyl parahydroxybenzoate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Soft vaginal capsules. Description of product: soft gelatine oval capsules of mustard colour containing slightly yellow oily suspension. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Multi-purpose treatment for vulvo-vaginal conditions caused by pathogenic microorganisms: Candida, Trichomonas and bacteria. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology One vaginal capsule per day in the evening before bedtime during 8 days, or according to the medical prescription. Method of administration To achieve the best results, the capsule must be inserted as high as possible into the vagina. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substances or to any one of the excipients listed in section 6.1. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Use of this medicinal product, particularly where prolonged, can lead to sensitisation phenomena. If any hypersensitivity reactions arise then administration of the medicinal product must be stopped. During the treatment sexual intercourse must be abstained from. This medicine contains the excipients sodium ethyl p-hydroxybenzoate and sodium propyl p-hydroxybenzoate thatmay cause allergic reactions (even delayed). _ _ 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION No pharmacological interactions with the ingredients of Macmiror Complex have been described. 4.6 FERTILITY, PREGNANCY AND LACTATION Pregnancy There are no or limited amount of data from the use of Nifuratel-Nystatin association in pregnant women. During pregnancy, the product should only be administered when absolutely necessary and under close Прочитайте повний документ