Страна: Индонезия
Язык: индонезийский
Источник: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
DUS, 5 STRIP @ 6 TABLET SALUT SELAPUT
2023-01-25
RESTRICTED ELEVIT 1. NAME OF THE MEDICINAL PRODUCT Elevit. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Qualitative composition in terms of the active ingredient(s) (INN): Elevit is a preparation containing multivitamins in combination with minerals and trace elements. Quantitative composition in terms of the active ingredient(s) per dosage form: VITAMINS: Vitamin B1 (Thiamine as Thiamine nitrate) 1.4 mg Vitamin B2 (Riboflavin) 1.4 mg Vitamin B3 (Nicotinamide) 18 mg Vitamin B5 (Pantothenic acid as Calcium pantothenate) 6 mg Vitamin B6 (Pyridoxine as Pyridoxine hydrochloride) 1.9 mg Vitamin B7 (Biotin) 0.03 mg Vitamin B9 (Folate as - folic acid and L-methylfolate calcium) 800 mcg Vitamin B12 (Cyanocobalamin) 2.6 mcg Vitamin C (Ascorbic acid) 85 mg Vitamin D3 (Colecalciferol) 1000 IU Vitamin E (dl-alpha-tocopherol as 15 mg dl-alpha-tocopheryl acetate) MINERALS AND TRACE ELEMENTS: Calcium (as Calcium hydrogen phosphate, 125 mg Calcium pantothenate and L-methylfolate calcium) Copper (as Cupric sulfate anhydrous) 1 mg Iodine (as Potassium iodide) 220 mcg Iron (as Ferrous bisglycinate) 27 mg Magnesium (as Magnesium oxide, heavy) 100 mg Manganese (as Manganese sulfate monohydrate) 2 mg Selenium (as Sodium selenite) 50 mcg Zinc (as Zinc citrate trihydrate) 11 mg For the full list of excipient(s) see section ’List of excipients’. 3. PHARMACEUTICAL FORM Film coated tablet. Elevit is a white to slightly greyish oval and biconvex film coated tablet. DISETUJUI OLEH BPOM: 16 JANUARI 2023 ID: EREG10036612100088 RESTRICTED 4. CLINICAL PARTICULARS 4.1. Indication(s) Multivitamin/ multimineral preparation for the prevention and correction of vitamin and mineral deficiencies in preparation for pregnancy as doctor recommendation, during pregnancy and lactation. 4.2. Dosage and method of administration 4.2.1. Method of administration For oral use. 4.2.2. Dosage regimen One tablet daily to be taken as a whole with a glass of water preferably with a meal. In case of morning sickness, it is recommended that the tablet is taken at noo Прочитать полный документ