Pays: Royaume-Uni
Langue: anglais
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Colecalciferol
Galen Ltd
A11CC05
Colecalciferol
10000unit/1ml
Oral drops
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 09060400; GTIN: 5016298407310
1 PATIENT INFORMATION LEAFLET 2 PACKAGE LEAFLET: INFORMATION FOR THE USER THORENS 10 000 I.U. /ML ORAL DROPS, SOLUTION CHOLECALCIFEROL (VITAMIN D 3 ) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE, BECAUSE 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, or nurse. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor, or pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4 WHAT IS IN THIS LEAFLET 1. What THORENS is and what it is used for 2. What you need to know before you use THORENS 3. How to use THORENS 4. Possible side effects 5. How to store THORENS 6. Contents of the pack and other information 1. WHAT THORENS IS AND WHAT IT IS USED FOR THORENS oral drops contains cholecalciferol (vitamin D 3 ). Vitamin D 3 , can be found in some foods and is also produced by the body when skin is exposed to sunlight. Vitamin D 3 helps the kidneys and intestine absorb calcium and it helps build bones. Vitamin D 3 deficiency is the predominant cause of rickets (defective mineralization of bones in children) and osteomalacia (inadequate mineralization of bones in adults). THORENS oral drops are used: • to prevent rickets in children (defective mineralization of bones predominantly due to vitamin D 3 deficiency) and osteomalacia in adults (inadequate mineralization of bones predominantly due to vitamin D 3 deficiency). • to prevent rickets in preterm newborns. • to prevent vitamin D 3 deficiency in children and adults when a risk of deficiency is identified. • to prevent vitamin D 3 deficiency in children and adults with problems in absorbing food (malabsorption) defined by doctor. • to treat rickets in children and osteomalacia in adults. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE THOR Lire le document complet
OBJECT 1 THORENS 10 000 I.U. /ML ORAL DROPS, SOLUTION Summary of Product Characteristics Updated 02-Sep-2015 | Galen Limited 1. Name of the medicinal product THORENS 10 000 I.U. /ml oral drops, solution 2. Qualitative and quantitative composition 1 ml oral solution (50 drops) contains 10 000 I.U. cholecalciferol (vitamin D 3 ), equivalent to 0.25 mg. 1 drop contains 200 I.U. cholecalciferol (vitamin D 3 ) For the full list of excipients, see section 6.1. 3. Pharmaceutical form Oral drops, solution. Clear and colorless to greenish-yellow oily solution without visible solid particles and/or precipitate 4. Clinical particulars 4.1 Therapeutic indications • Prophylaxis of rickets and osteomalacia in children and adults • Prophylaxis of rickets in preterm newborns • Prophylaxis of vitamin D deficiency in children and adults with an identified risk • Prophylaxis of vitamin D deficiency in children and adults with malabsorption • Treatment of rickets and osteomalacia in children and adults 4.2 Posology and method of administration 1 drop contains 200 IU vitamin D 3 . • Paediatric posology - prevention of deficiency 0-1 years 400 IU/day (2 drops) - prevention of deficiency 1-18 years 600 IU/day (3 drops) - doses of up to 1000 IU/day (5 drops) may be required to prevent deficiency in some children - treatment of deficiency 0-18 years 2000 IU/day (10 drops) for 6 weeks, followed by maintenance therapy of 400-1000 IU/day (2 5 drops). • Pregnancy and breast-feeding posology - prevention of deficiency 400 IU/day (2 drops) - doses of up to 2000 IU/day (10 drops) may be required to prevent deficiency in some women (see below) - even higher doses may be required during breast-feeding if women choose not to give the infant a vitamin D 3 supplement • Adult posology - prevention of vitamin D 3 deficiency 600 800 IU/day (3 4 drops). Higher doses may be required in certain situations, see below. - as an adjunct to specific therapy for osteoporosis: 800 IU/day (4 drops) • Certain populations are at high risk Lire le document complet