البلد: المملكة المتحدة
اللغة: الإنجليزية
المصدر: MHRA (Medicines & Healthcare Products Regulatory Agency)
Vitamin A; Ergocalciferol; Choline chloride; Cyanocobalamin
Rosemont Pharmaceuticals Ltd
A11JA
Vitamin A; Ergocalciferol; Choline chloride; Cyanocobalamin
500unit/1ml ; 80unit/1ml ; 30mg/1ml ; 2.5microgram/1ml
Oral emulsion
Oral
No Controlled Drug Status
Never Valid To Prescribe As A VMP
BNF: 09060700; GTIN: 5015001128153
Ketovite Liquid JOB INFORMATION COLOURS Product Name: Print Colours: 18pt 9pt Font Size: 4 ARTWORK VERSION: Pharmacode: N/A N/A 1 EAN Code: No. of Colours: 1 of 1 Page Number: Tabbed: Keyline Ref: 180 x 240mm UKL508 N/A N/A Dimensions: Folded Size: W3UD1RBJ1 New Item Code: N/A Previous Item Code: N/A Supplier Code: 150 ml Pack Size: 150 ml Bottle Size: N/A Strength: N/A CR-00118 Design Icon: Change Control No.: HELVETICA BOLD Helvetica Regular Font Type: JOB SPECIFICATION MAIN BODY TEXT Non-print Colours: BLACK BLACK 877 PANTONE 485 KEYLINE BRAILLE SUBSTRATE 100 90 80 70 60 50 40 30 20 10 0 02/03/22 Date: Steve Operator: - PRINT VERSION: - Date: - Operator: THIRD PARTY APPROVAL Name: Sign: APPROVALS Date: REGULATORY APPROVAL Name: Sign: Date: FRONT BACK Package leaflet: Information for the user Ketovite Liquid READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. - Keep this leaflet. You may need to read it again. - Ask your pharmacist if you need more information or advice. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. - You must talk to a doctor if you do not feel better or if you feel worse. WHAT IS IN THIS LEAFLET 1. What Ketovite Liquid is and what it is used for 2. What you need to know before you take Ketovite Liquid 3. How to take Ketovite Liquid 4. Possible side effects 5. How to store Ketovite Liquid 6. Contents of the pack and other information 1. WHAT KETOVITE LIQUID IS, AND WHAT IT IS USED FOR Ketovite Liquid is a sugar-free therapeutic supplement for the prevention of vitamin deficiency. It is used in conditions such as: • galactosemia (a disorder of milk sugar digestion) • disaccharide intolerance (a reaction to sugars such as sucrose, lactose and maltose) • phenylketonuria (an inability to digest one of the essential ami اقرأ الوثيقة كاملة
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ketovite Liquid 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5 ml contains: Vitamin A (as palmitate) 2,500 IU Ergocalciferol (Vitamin D 2) 400 IU Cyanocobalamin 12.5 micrograms Choline chloride 150 mg Excipient(s) with known effect 5 ml solution contains 7.5 mg methyl parahydroxybenzoate (E218). For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oral solution (oral liquid). A pale pink to yellow liquid. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS As a sugar-free therapeutic supplement for the prevention of vitamin deficiency in conditions such as galactosaemia, disaccharide intolerance, phenylketonuria and other disorders of carbohydrate or amino acid metabolism, as well as in patients who are on restricted, specialised or synthetic diets. In order to achieve complete vitamin supplementation Ketovite Liquid should be used in conjunction with Ketovite Tablets. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology For adults, children and the elderly: 5 ml daily. Method of administration For oral use. 4.3 CONTRAINDICATIONS • Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. • Hypercalcaemia. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE The recommended dose should not be exceeded without medical advice. No other vitamin supplement containing Vitamins A and D should be taken with Ketovite except under medical supervision. Warning: do not exceed the stated dose. Methyl parahydroxybenzoate This medicinal product contains methyl parahydroxybenzoate (E218). May cause allergic reactions (possibly delayed). 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION Absorption of some vitamins in this preparation may be reduced in conditions of fat malabsorption or with the concurrent use of neomycin, colestyramine, liquid paraffin, aminoglycosides, aminosalicylic acid, anticonvulsants, biguanides, chloramphenicol, cimetidine, colchicine, potassium salts and methyl-dop اقرأ الوثيقة كاملة