País: Irlanda
Idioma: anglès
Font: HPRA (Health Products Regulatory Authority)
FERRIC HYDROXIDE POLYMALTOSE COMPLEX
Vifor France
B03AB04
FERRIC HYDROXIDE POLYMALTOSE COMPLEX
50 MG/5ml
Oral Drops Solution
Product subject to prescription which may be renewed (B)
Iron trivalent, oral preparations
Authorised
2005-09-16
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ferrum Hausmann Syrup 50mg / 5ml oral solution. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5 ml dose of oral solution contains: Iron 50 mg as Iron (III)-ydroxide polymaltose complex Excipients: Each 5ml of oral solution contains 1g sucrose, 2.0g sorbitol 70% (non-crystallising), 2.915mg methyl parahydroxybenzoate, 0.835mg propyl parahyroxybenzoate and 16.25mg ethanol. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oral solution Dark brown, flavoured oral solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS In the treatment of anaemia due to iron deficiency. Treatment and prophylactic therapy of iron deficiency during pregnancy. This product should only be used in pregnancy after the first thirteen weeks. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults: 100 to 200mg (10 ml to 20ml) Iron daily. Children aged 1-12 years: 50 to 100mg (5 to 10ml) Iron daily. Depending on the severity of the anaemia. The supplied measuring cup is used for an exact administration of the dosage. Ferrum Hausmann syrup can be mixed with fruit and vegetable juices or with bottle-feed. The slight colouration does not affect either the taste or the efficacy. Medical advice should be sought if symptoms do not improve after four weeks of use of this product as these symptoms may reflect an underlying disease process. ROUTE OF ADMINISTRATION: Oral. HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 09/06/2016_ _CRN 2178377_ _page number: 1_ 4.3 CONTRAINDICATIONS 1. Use in patients with iron storage or assimilation diseases. 2. Use in patients with a known hypersensitivity to the active ingredient. 3. Use in indi Llegiu el document complet