Country: Belanda
Bahasa: Belanda
Sumber: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
CHOLECALCIFEROL ; SAMENSTELLING overeenkomend met CHOLECALCIFEROL
CHOLECALCIFEROL ; COMPOSITION equivalent to CHOLECALCIFEROL
Capsule, zacht
BUTYLHYDROXYTOLUEEN (E 321) ; GELATINE (E 441) ; GLYCEROL (E 422) ; IJZEROXIDE ROOD (E 172) ; TITAANDIOXIDE (E 171) ; TRIGLYCERIDEN MIDDELLANGE KETEN ; WATER, GEZUIVERD
Oraal gebruik
2022-10-05
Sandoz B.V. Page 1/7 Colecalciferol Sandoz 20.000 IE, zachte capsules RVG 129688 1313-v1 1.3.1.3 Bijsluiter September 2022 BIJSLUITER: INFORMATIE VOOR DE GEBRUIKER Colecalciferol Sandoz 20.000 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 for the starting treatment of clinically relevant vitamin D deficiency (serum level < 25 nmol/L (<10 ng/mL)) in adults. {[Nationally completed name]} is indicated in adults. 2 . WHAT YOU NEED TO KNOW BEFORE YOU TAKE {[NATIONALLY COMPLETED NAME]} DO NOT TAKE {[NATIONALLY COMPLETED NAME]}: Sandoz B.V. Page 2/7 Colecalciferol Sandoz 20.000 IE, zachte capsules RVG 129688 1313-v1 1.3.1.3 Bijsluiter September 2022 - if you are allergic to cholecalciferol or any of the other ingredients of this medicine (listed in section 6) - if you have high levels of calcium in your blood (hypercalcaemia) or urine (hypercalciuria) - if you have severe kidney problems (severe renal impairment) - if you have high levels of vitamin D i Baca dokumen lengkap
Sandoz B.V. Page 1/9 Colecalciferol Sandoz 20.000 IE, zachte capsules RVG 129688 1311-v1 1.3.1.1 Samenvatting van de Productkenmerken September 2022 1. NAAM VAN HET GENEESMIDDEL Colecalciferol Sandoz 20.000 IE, zachte capsules _ _ 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each soft capsule contains 0.5 mg colecalciferol (Vitamin D3), equivalent to 20,000 IU. For the full list of excipients, see section 6.1. _ _ 3. PHARMACEUTICAL FORM Soft capsule. {[Nationally completed name] 20,000 IU soft capsules} are pink opaque, size 3, oval soft capsules. Capsule length is approximately 11.2 mm and width is approximately 6.4 mm. _ _ 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Initial treatment of clinically relevant vitamin D deficiency (serum level < 25 nmol/L (<10 ng/mL)) in adults. {[Nationally completed name]} 20,0000IU IU soft capsules are indicated in adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION 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 carefully evaluated and artificially added vitamin D content of certain food types should be taken into consideration. _The initial loading dose of in total 100,000 IU can be achieved by 1 capsule of 20,000IU /week for up _ _to 4-5 weeks _ Sandoz B.V. Page 2/9 Colecalciferol Sandoz 20.000 IE, zachte capsules RVG 129688 1311-v1 1.3.1.1 Samenvatting van de Productkenmerken September 2022 After completion of this loading dose, a lower maintenance dose should be considered, dependent upon desirable serum levels of 25-hydroxycolecalciferol (25(OH)D), the severity of the disease and the patient’s response to treatment. Alternatively, national posology recommendations in treatment of vitamin D deficiency can be followed. _Special populations _ _Hepatic impairment _ No dose Baca dokumen lengkap