Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Colecalciferol
Galen Ltd
A11CC05
Colecalciferol
10000unit/1ml
Oral solution
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 09060400; GTIN: 5016298417326 5016298427332
1 PATIENT INFORMATION LEAFLET 2 PACKAGE LEAFLET: INFORMATION FOR THE USER THORENS 25 000 I.U. /2.5 ML ORAL 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 solution 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 solution is 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 THO Read the complete document
OBJECT 1 THORENS 25 000 I.U. /2.5 ML ORAL SOLUTION Summary of Product Characteristics Updated 01-Sep-2015 | Galen Limited 1. Name of the medicinal product THORENS 25 000 I.U. /2.5 ml oral solution 2. Qualitative and quantitative composition A single-dose bottle of 2.5 ml oral solution contains: 25 000 I.U. cholecalciferol (vitamin D 3 ), equivalent to 0.625 mg. 1 ml oral solution contains 10 000 I.U. cholecalciferol (vitamin D 3 ), equivalent to 0.25 mg For the full list of excipients, see section 6.1. 3. Pharmaceutical form Oral Solution in single dose container Clear and colourless 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 Posology • Paediatric posology - prevention of deficiency 0-1 years 25000 IU (1 bottle) every 8 weeks - prevention of deficiency 1-18 years 25000 IU (1 bottle) every 6 weeks - treatment of deficiency 0-18 years 25000 IU (1 bottle) once every 2 weeks for 6 weeks (followed by maintenance therapy of 400-1000 IU/day) • Pregnancy and breastfeeding - The high strength formulation is not recommended • Adult - prevention of vitamin D 3 deficiency 25000 IU/month (1 bottle), higher doses may be required in certain situations, see below - as an adjunct to specific therapy for osteoporosis: 25000 IU/month (1 bottle) - treatment of vitamin D 3 deficiency (<25 ng/ml) 50000 IU/week (2 bottles) for 6-8 weeks, followed by maintenance therapy (1400-2000 IU/day may be required; follow-up 25(OH)D measurements should be made approximately three to four months after initiating maintenance therapy to confirm that the target level has Read the complete document