Ország: Tanzánia
Nyelv: angol
Forrás: Tanzania Medicinces & Medical Devices Authority
Ferric Ammonium , Folic Acid , Pyridoxine , Thiamine , Nicotinamide
CORE PHARMA LIMITED, TANZANIA
Haematinics iron and all combinations
Ferric Ammonium + Folic Acid + Pyridoxine + Thiamine + Nicotinamide
200,0.5,(50mcg),1.5,2.33 mg
Suspension, Oral
SANPRAS HEALTHCARE PRIVATE LIMITED, INDIA
Physical description: Brown coloured syrup liquid; Local technical representative: CORE PHARMA LIMITED (1120)
Registered/Compliant
2022-12-05
SUMMARY OF PRODUCT CHARACTERISTIC 1. NAME OF THE MEDICINAL PRODUCT VITACORE 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5ml contains: Ferric Ammonium Citrate USP….200 mg Cyanocobalamin (Vit. B12) BP… 50 mcg Pyridoxine Hydrochloride (Vitamin B6) BP….0.5 mg Folic acid BP 1.5 mg .................................... Zinc Sulphate BP 2.33 mg ............................ In a flavored Syrup Base Approved color used. _Excipient of safety concern _ Sucrose…2000 mcg as Sweetener Liquid Glucose….1500 mcg as Sweetener Sorbitol……500 mcg as Sweetener Sodium Methyl Paraben…10 mcg as Preservative Sodium Propyl Paraben….1 mcg as Preservative Sodium benzoate….10 mcg as Preservative Disodium EDTA….0.0025 mcg as Preservative 3. PHARMACEUTICAL FORM Oral Liquid. Brown Colour Syrupy Liquid 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS It is used as a treatment for vitamin and mineral deficiency and as an appetite stimulant during and after illness. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Method of administration: Oral Dosage: Children 6 months to 3 years: 5 ml (1 teaspoonful) twice daily Children 3 years to 12 years: 5 ml (1 teaspoonful) three times daily Adults: 10 ml (2 teaspoonsful) three times daily Elderly Patients: 10 ml (2 teaspoonsful) three times daily. Iron is best absorbed on an empty stomach (usually if taken 1 hour before or 2 hours after meals). 4.3. CONTRAINDICATIONS Use in patients hypersensitive to any of the constituents. Avoid taking antacids, dairy products, tea, or coffee within 2 hours before or after this medication because they will decrease its effectiveness. 4.4. SPECIAL WARNINGS AND PRECAUTIONS FOR USE 1. Vitacore contains ferric ammonium citrate which may stain teeth 2. The stated dose should not be exceeded 3. No other medicine containing iron or vitamins B6 should be taken without prior medical consultation 4. This product contains glucose. Patients with rare glucose-galactose malabsorption should not take this medicine. 5. This product also contains sucrose. Patients Olvassa el a teljes dokumentumot