Land: Ierland
Taal: Engels
Bron: HPRA (Health Products Regulatory Authority)
RETINOL PALMITATE COLECALCIFEROL FERRIC AMMONIUM CITRATE POTASSIUM GLYCEROPHOSPHATE CALCIUM GLYCEROPHOSPHATE MANGANESE SULFATE COPPER SULFATE PENTAHYDRATE
Seven Seas Ltd
RETINOL PALMITATE COLECALCIFEROL FERRIC AMMONIUM CITRATE POTASSIUM GLYCEROPHOSPHATE CALCIUM GLYCEROPHOSPHATE MANGANESE SULF
10 Millilitre
Oral Emulsion
Product not subject to medical prescription
Authorised
0000-00-00
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Minadex Tonic Oral Emulsion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Excipients: each 5ml also contains: For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Oral emulsion. Yellowish to green translucent oral emulsion with an odour and taste of orange. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS As a treatment for vitamin and mineral deficiency and as an appetite stimulant during and after illness. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION 4.3 CONTRAINDICATIONS Use in patients hypersensitive to any of the constituents Each 5ml contains: Vitamin A (Retinol) 0.433 mg (650 I.U.) Colecalciferol 0.065 mg (65 I.U.) Iron (as Green Ferric Ammonium Citrate) 12.000 mg Potassium Glycerophosphate solution 2.250 mg Calcium glycerophosphate 11.250 mg Manganese Sulphate. 0.380 mg Copper Sulphate, pentahydrate 0.500 mg Glucose 0.655 g Sucrose 2.8417 g Soya Bean Oil 36.5 mg Sodium Methyl Parahydroxybenzoate 10.0 mg Sodium Metasulphite 10.0 mg 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 IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 09/11/2012_ _CRN 2123980_ _page number: 1_ 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE 1. Minadex contains ferric ammonium citrate which may stain teeth 2. The stated dose should not be exceeded 3. No other medicine containing iron or vitamins A and D should be taken without prior medical consultation 4. This product contains glucose. Patients with rare glucose-galactose malabsorption should Lees het volledige document