Šalis: Tanzanija
kalba: anglų
Šaltinis: Tanzania Medicinces & Medical Devices Authority
Lansoprazole, Clarithromycin , Tinidazole
Zota HealthCare Ltd, INDIA
Drugs for peptic ulcer and gastro-oesophageal refl
Lansoprazole, Clarithromycin and Tinidazole
267/250/500
Tablets/Capsules
ZOTA HEALTHCARE LIMITED , INDIA
Physical description: Lansoprazole Capsules: Pink/clear transparent size “2” hard gelatine capsule containing white to off white colour pallets Tinidazole Tablets: Orange color, Capsule shaped, film coated tablet with break line on one side and plain on other side Clarithromycin Tablets: White colour, round shaped coated tablets plain on both side; Local technical representative: Moraf Pharmaceuticals Limited (5668)
Registered/Compliant
2022-12-05
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT GASTRO KIT (Lansoprazole, Clarithromycin and Tinidazole Combi kit ) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION COMPOSITION: EACH COMBI KIT CONTAINS: A. Two Lansoprazole Delayed Release Capsules USP 30 mg: Each Hard Gelatin Capsule Contains: Lansoprazole USP…...30 mg (As enteric coated pellets) Excipients …………q.s Approved Colour is used in empty capsule shells B. Two Clarithromycin Tablets USP 250 mg Each Film Coated Tablets Contains Clarithromycin USP…250 mg Excipients ………….q.s Colour: Titanium Dioxide C. Two Tinidazole Tablets 500 mg Each Film-Coated Tablet Contains: Tinidazole USP….500 mg Excipients …...q.s Colour: Sunset Yellow EXCIPIENTS SUGAR As lansoprazole contains sugar, patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. 7% Sugar concentration is used in the formulation of pellets. SODIUM METHYL HYDROXYBENZOATE Sodium Methyl Hydroxybenzoate has no teratogenic, carcinogenic, mutagenic or embryotoxic toxicity in the amounts at which it is used as 0.1%. SODIUM PROPYL HYDROXYBENZOATE Sodium Propyl Hydroxybenzoate has no teratogenic, carcinogenic, mutagenic or embryotoxic toxicity in the amounts at which it is used as 0.1%. SUNSET YELLOW: The acceptable daily intake (ADI) is 0–4 mg/kg under both EU and WHO/FAO guidelines. Sunset Yellow FCF has no carcinogenicity, genotoxicity, or developmental toxicity in the amounts at which it is used. 3. PHARMACEUTICAL FORM A. Lansoprazole Delayed Release Capsules USP 30 mg Hard Gelatin Capsule Pink / Clear transparent size '2' hard gelatin capsules containing white to off white colour pellets. B. Clarithromycin Tablets USP 250 mg Film coated tablets White Colour , round shaped coated tablets plain on both side. C. Tinidazole Tablets 500 mg Film coated tablets Orange color, Capsule shaped, film coated tablet with break line on one side and plain on other side. THE SCORE Perskaitykite visą dokumentą