Krajina: Spojené kráľovstvo
Jazyk: angličtina
Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)
Dexpanthenol; Pyridoxine hydrochloride; Nicotinamide; Riboflavin sodium phosphate; Thiamine hydrochloride; Vitamin A; Ergocalciferol; Ascorbic acid; Sodium ascorbate
Wallace Manufacturing Chemists Ltd
Dexpanthenol; Pyridoxine hydrochloride; Nicotinamide; Riboflavin sodium phosphate; Thiamine hydrochloride; Vitamin A; Ergocalciferol; Ascorbic acid; Sodium ascorbate
4mg/1ml ; 2mg/1ml ; 25mg/1ml ; 2mg/1ml ; 4mg/1ml ; 10000unit/1ml ; 1000unit/1ml ; 38.7mg/1ml ; 68.88mg/1ml
Oral drops
Oral
No Controlled Drug Status
Never Valid To Prescribe As A VMP
BNF: 09100000; GTIN: 05034593017706
Concavit Drops Each 0.5ml contains: - Vitamin A BP 5000.00 iu Calciferol BP 500.00 iu Vitamin C 50mg _(as Ascorbic Acid BP _ _19.35mg and _ _ Sodium Ascorbate USP _ _34.44mg)_ Thiamine Hydrochloride 2.00 mg Riboflavine 1.0 mg _(as Riboflavine Sodium Phosphate BP _ _1.37 mg) _ Pyridoxine Hydrochloride BP 1.00 mg Nicotinamide BP 12.50 mg Panthenol 2.0mg In addition the drops also contain Sodium Edetate, Glycerin, Polysorbate 80, Propylene Glycol, Hydroxybenzoates (Methyl, Ethyl, Propyl and Butyl), Propyl Gallate, Flavouring (Orange Essence & Morella Cherry Essence), Sodium Saccharin, Sorbitol Solution and Water. Concavit drops is available in packs of 15ml. Concavit is an oral vitamin supplement. The product licence holder is Wallace Manufacturing Chemists Ltd., Wallace House, 51-53 Stert Street, Abingdon, Oxfordshire OX14 3JF, United Kingdom and the drops are manufactured by Thorpe Laboratories Ltd., Enterprise Road, Mablethorpe, LincolnshireLN12 1LH, England. Product Licence number: PL 00400/5010R Concavit is intended as a multiple vitamin supplement in situations of special dietary need. It is not intended for the correction of specific vitamin deficiencies. BEFORE YOU USE CONCAVIT Do not use Concavit to treat vitamin deficiencies caused by inability to absorb the vitamin(s) orally. Do not use Concavit if: You are hypersensitive to any of the ingredients You have a history of high levels of Vitamins A or D You have bone tumours You have elevated blood calcium levels. You have abnormal metabolic sensitivity to vitamin D Do not take Vitamin A supplements if you are pregnant or likely to become pregnant except on the advice of your doctor or antenatal clinic. PRECAUTIONS FOR THE USE OF CONCAVIT Do not exceed the stated dose. INTERACTIONS WITH OTHER MEDICINE Concavit may react with other medicines you are taking. If you are taking any of the medicines listed then consult your pharmacist or doctor. Contraceptive pills may increase levels of Vitamin A. Agents such as Bile Acid Resins e.g. C Prečítajte si celý dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Concavit Drops 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _Each 0.5 ml contains: - _ Vitamin A BP 5000.00 in Calciferol BP 500.00 iu Ascorbic Acid BP 19.35 mg Sodium Ascorbate USP 34.44 mg Thiamine Hydrochloride BP 2.00 mg Ribofiavine 1.00 mg (as Ribofiavine Sodium Phosphate BP) (1.37 mg) Pyridoxine Hydrochloride BP 1.00 mg Nicotinamide BP 12.50 mg d-Panthenol 2.00 mg 3. PHARMACEUTICAL FORM Oral Liquid, Drops 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS As a supplement of multiple vitamins in situations of special dietary need. Not suitable for the correction of specific vitamin deficiencies. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Oral administration Adults, and children -0.5 ml per day. The Elderly – no specific dose recommendation. 4.3 CONTRA-INDICATIONS • Oral administration in the treatment of deficiency state in malabsorption syndromes. • Hypersensitivity to any of the ingredients. • History of hypervitaminoses A or D. • Sarcoidosis • Hypercalcaemia • Abnormal metabolic sensitivity to Vitamin D. Do not take vitamin A supplements if you are pregnant or likely to become pregnant except on the advice of a doctor or antenatal clinic. 4.4 SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE There are serious risks of developing hypercalcaemia when calcium salts or thiazides are co-administered. Serum calcium, phosphate, alkaline phosphatase, liver function tests and magnesium should be monitored when indicated. Absorption of Vitamin A is reduced in cystic fibrosis, hepatic diseases, pancreatic dysfunction and in patients with intestinal infections. The use of Vitamin A in renal diseases requires extreme caution. Do not exceed the stated dose. 4.5 INTERACTIONS WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION • Contraceptive pills raise plasma levels of Vitamin A. • Agents such as bile acid resins, e.g. cholestyramine and colestipol impair the absorption of fats including the Vitamins A and D. • As both Vitamin Prečítajte si celý dokument