Valsts: Tanzānija
Valoda: angļu
Klimata pārmaiņas: Tanzania Medicinces & Medical Devices Authority
ferrous sulphate , folic acid ,zinc sulphate monoh
Shelys Pharmaceuticals Limited, TANZANIA
Haematinics iron and all combinations
ferrous sulphate + folic acid +zinc sulphate monoh
180.75 mg
Capsules
Beta Healthcare International Limited, KENYA
Physical description: Body -Deep Red Coloured with yellow “HEMOVIT” print; Cap -Deep Red Coloured with white “Shelys” print; Local technical representative: Shelys Pharmaceuticals Limited (9387)
Registered/Compliant
2022-04-11
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Hemovit Capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains: Ferrous Fumarate (Equivalent to Elemental Iron) 100 mg, Ascorbic Acid (Vitamin C) 75 mg, Folic Acid 0.75 mg, Cyanocobalamin (Vitamin B 12 ) 5 mcg and Zinc Sulphate 5 mg. _For full list of excipients, see section 6.1 _ 3. PHARMACEUTICAL FORM Capsule Body – Deep Red Coloured with yellow “HEMOVIT” print; Cap – Deep Red Coloured with white _“SHELYS”_ Print capsules. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hemovit Capsules are indicated in case of iron deficiency as in nutritional microcytic anaemia, iron deficiency anaemia, for prophylaxis of anaemia in pregnant and lactating women growing children, anaemia following blood loss, tropical disease, worm infestation, bacterial or protozoal infection or following surgery, as nutritional supplement during old age, adolescence or covalescence. 4.2 POSOLOGY AND ROUTE OF ADMINISTRATION _DOSAGE _ Capsules – Children: 1 Capsule daily - Adult: 1-2 Capsule daily _ADMINISTRATIVE ROUTE _ Oral Administration only 4.3 CONTRAINDICATIONS Hemovit Capsules should not be given to patients who are receiving repeated blood transfusions or in patients with anaemia not produced by iron deficiency. 4.4 SPECIAL WARNING AND PRECAUTIONS FOR USE Hemovit Capsules should not be given together with antibiotics like tetracycline or antacid since they reduce the iron absorption. It should be given with care to patients with hyperoxpaluria because of ascorbic acid. Hemovit Capsules should be used with caution in patients with sideroblastic anaemia not due to iron deficiency. History of peptic ulcer. Keep the medicine out of reach of children. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTIONS If you use other drugs or over the counter products at the same time, the effects of Hemovit Capsules may change. This may increase your risk for side-effects or cause your drug not to work properly. Tell your do Izlasiet visu dokumentu