Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Vitamin A; Ergocalciferol; Choline chloride; Cyanocobalamin
Waymade Healthcare Plc
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
FRONT BACK KetLiq-PL-UK-IE-2 KetLiq-PL-UK-IE-2 Patient Information Leaflet Ketovite Liquid Oral Liquid Read all of this leaflet carefully before you start taking this medicine. It contains important information for you. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • This medicine is available without prescription. However, you still need to take Ketovite Liquid carefully to get the best results from it. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. • You must contact a doctor if your symptoms worsen or do not improve. • There are usually no undesirable effects after taking Ketovite Liquid. If you do notice any unexpected effects, stop taking it and tell your doctor or pharmacist. In this leaflet: 1. What Ketovite Liquid is and what it is used for 2. Before you take Ketovite Liquid 3. How to take Ketovite Liquid 4. Possible side effects 5. How to store Ketovite Liquid 6. Further 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 amino acids) • in other disorders of starch, sugar or amino acid metabolism • in patients who are on restricted, specialised or synthetic diets Ketovite Liquid is a multivitamin preparation, intended for use at the same time as Ketovite Tablets. 2. BEFORE YOU TAKE KETOVITE LIQUID Do not take Ketovite Liquid if you • are allergic (hypersensitive) to any of the ingredients of the liquid (see list in section 6 “Further information”) • have hypercalcaemia (high blood calcium level) • are taking other vitamin preparations, especially those containing Vitamins A and D, such as cod-liver oil. Take special ca Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ketovite Liquid. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Vitamin A as palmitate (1.7 x 10 6 units/g) HSE 2500 units Vitamin D 2 (ergocalciferol) BP 400 units Cyanocobalamin BP 12.5 microgram Choline chloride HSE 150.0 mg 3 PHARMACEUTICAL FORM Oral emulsion. 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 For adults, children and the elderly: 5 ml daily, by oral administration. 4.3 CONTRAINDICATIONS Hypersensitivity to the product. 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 Liquid except under medical supervision. The methyl parahydroxybenzoate (E218) in Ketovite Liquid may cause allergic reactions which can be delayed. Warning: do not exceed the stated dose. 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-dopa. Serum B 12 concentrations may be decreased by concurrent administration of oral contraceptives. 4.6 FERTILITY, PREGNANCY AND LACTATION Caution should be used in pregnancy as excessive doses of Vitamin A may be teratogenic, especially when taken in the first trimester. Large doses of V Read the complete document