Country: Armenia
Bahasa: Inggeris
Sumber: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
metronidazole
Hankook Korus Pharm Co.
P01AB01
metronidazole
500mg
tablets
(30/3x10/) and (100/10x10/), in blister
Prescription
Registered
2015-10-28
Summary of Product Characteristics insert company logo 1. NAME OF THE MEDICINAL PRODUCT Metronidazole-Asteria Tab. 500mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active ingredient No. Chemical Name Quantity/g Use 1 Metronidazole 500mg Active ingredient Excipient(s) No. Chemical Name Quantity/Tab. Use 1 Magnesium stearate 5.0mg Lubricant 2 Sodium carboxylmethylstarch 5.0mg Disintegrant 3 20% starch dextrin 36mg Adherent 4 Pregelatinized starch 20 mg Diluent/Dinste grant 3. PHARMACEUTICAL FORM Tablets 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Symptomatic Trichomoniasis: Metronidazole is indicated for the treatment of symptomatic trichomoniasis in females and males when the presence of the trichomonad has been confirmed by appropriate laboratory procedures (wet smears and/or cultures). Summary of Product Characteristics insert company logo Asymptomatic Trichomoniasis: Metronidazole is indicated in the treatment of asymptomatic females when the organism is associated with endocervicitis, cervicitis, or cervical erosion. Since there is evidence that presence of the trichomonad can interfere with accurate assessment of abnormal cytological smears, additional smears should be performed after eradication of the parasite. Treatment of Asymptomatic Consorts: T. vaginalis infection is a venereal disease. Therefore, asymptomatic sexual partners of treated patients should be treated simultaneously if the organism has been found to be present, in the order to prevent reinfection of the partner. The decision as to whether to treat an asymptomatic male partner who has a negative culture or one for whom no culture has been attempted is an individual one. In making this decision, it should be noted that there is evidence that a woman may become reinfected if her consort is not treated. Also, since there can be considerable difficulty in isolating the organism from the asymptomatic male carrier, negative smears and cultures cannot be relied upon in this regard. In any event, the consort should be treated with Metronida Baca dokumen lengkap