Land: Holland
Sprog: hollandsk
Kilde: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
CHOLECALCIFEROL 80 µg/stuk ; SAMENSTELLING overeenkomend met CHOLECALCIFEROL 3200 IE/stuk
CHOLECALCIFEROL 80 µg/stuk ; SAMENSTELLING overeenkomend met CHOLECALCIFEROL 3200 IE/stuk
Capsule, zacht
BUTYLHYDROXYTOLUEEN (E 321) ; GELATINE (E 441) ; GLYCEROL (E 422) ; IJZEROXIDE GEEL (E 172) ; TITAANDIOXIDE (E 171) ; TRIGLYCERIDEN MIDDELLANGE KETEN ; WATER, GEZUIVERD
Oraal gebruik
1900-01-01
Sandoz B.V. Page 1/7 Colecalciferol 1A Pharma 800 IE/ 3200 IE, zachte capsules RVG 128772-3 1313-v1 1.3.1.3 Bijsluiter September 2022 BIJSLUITER: INFORMATIE VOOR DE GEBRUIKER Colecalciferol 1A Pharma 800 IE, zachte capsules Colecalciferol 1A Pharma 3200 IE, zachte capsules colecalciferol (Vitamin D3) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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. - 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. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1 . What {[Nationally completed name]} is and what it is used for 2 . What you need to know before you take {[Nationally completed name]} 3 . How to take {[Nationally completed name]} 4 . Possible side effects 5 . How to store {[Nationally completed name]} 6 . Contents of the pack and other information 1 . WHAT {[NATIONALLY COMPLETED NAME]} IS AND WHAT IT IS USED FOR {[Nationally completed name]} contains colecalciferol (vitamin D). Vitamin D helps the body to absorb calcium and enhances bone formation. This medicine is recommended in the following cases: 800 IU soft capsules • Treatment of vitamin D deficiency (serum level < 25 nmol/L (<10 ng/mL)) in adults and adolescents. • Prevention of vitamin D deficiency (serum level < 25 nmol/L (<10 ng/mL)) in adults with an identified risk. 3,200 IU soft capsules Treatment of vitamin D deficiency (serum level < 25 nmol/L (<10 ng/mL)) in adults and adolescents. Sandoz B.V. Page 2/7 Colecalciferol 1A Pharma 800 IE/ 3200 IE, zachte capsules RVG 128772-3 1313-v1 1.3.1.3 Bijsluiter September 2022 2 . WHAT YOU NEED TO KNOW BEFORE YOU TAKE {[NATIONALLY COMPLETED NAME]} DO NOT TAKE {[NATIONALLY COMPLETED NAME]}: - if you are allergic t Læs hele dokumentet
Sandoz B.V. Page 1/10 Colecalciferol 1A Pharma 800 IE, 3200 IE, zachte capsules RVG 128772-3 1311-v1b 1.3.1.1 Samenvatting van de Productkenmerken Oktober 2022 1. NAAM VAN HET GENEESMIDDEL Colecalciferol 1A Pharma 800 IE, zachte capsules Colecalciferol 1A Pharma 3200 IE, zachte capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each soft capsule contains 20 micrograms colecalciferol (Vitamin D3), equivalent to 800 IU. Each soft capsule contains 80 micrograms colecalciferol (Vitamin D3), equivalent to 3,200 IU. For the full list of excipients, see section 6.1. _ _ 3. PHARMACEUTICAL FORM Soft capsule. {[Nationally completed name] 800 IU soft capsules} are light yellow opaque, size 2, oval soft capsules. Capsule length is approximately 9.5 mm and width is approximately 5.9 mm. {[Nationally completed name] 3,200 IU soft capsules} are yellow opaque, size 6, oval soft capsules. Capsule length is approximately 13.6 mm and width is approximately 8.4 mm. _ _ 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 800IU soft capsules • Treatment of vitamin D deficiency (serum level < 25 nmol/L (<10 ng/mL)) in adults and adolescents. • Prevention of vitamin D deficiency (serum level < 25 nmol/L (<10 ng/mL)) in adults with an identified risk. 3,200IU soft capsules • Treatment of vitamin D deficiency (serum level < 25 nmol/L (<10 ng/mL)) in adults and adolescents. {[Nationally completed name]} 800IU, 1,000IU and 3,200IU soft capsules are indicated in adolescents and adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Sandoz B.V. Page 2/10 Colecalciferol 1A Pharma 800 IE, 3200 IE, zachte capsules RVG 128772-3 1311-v1b 1.3.1.1 Samenvatting van de Productkenmerken Oktober 2022 Posology The dosage must be determined individually by the treating doctor depending on the extent of the necessary vitamin D supplementation. The dose should be adjusted dependent upon desirable serum levels of 25-hydroxycolecalciferol (25(OH)D), severity of the disease and patients response to treatment. The patient’s dietary habits should be careful Læs hele dokumentet