Pays: Pays-Bas
Langue: néerlandais
Source: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
CHOLECALCIFEROL CONCENTRAAT, POEDERVORM 5 mg/stuk SAMENSTELLING overeenkomend met ; CHOLECALCIFEROL 12,5 µg/stuk
Mibe GmbH Arzneimittel Münchener Strasse 15 06796 BREHNA (DUITSLAND)
A11CC05
CHOLECALCIFEROL CONCENTRAAT, POEDERVORM 5 mg/stuk SAMENSTELLING overeenkomend met ; CHOLECALCIFEROL 12,5 µg/stuk
Tablet
CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL ; MAÏSZETMEEL, GEMODIFICEERD (MODIFICATIE ONBEKEND ; NATRIUMASCORBAAT (E 301) ; NATRIUMZETMEELGLYCOLAAT ; SACCHAROSE ; SILICIUMDIOXIDE (E 551) ; TOCOFEROL, DL-ALFA (E 307) ; TRIGLYCERIDEN MIDDELLANGE KETEN, CELLULOSE, MICROKRISTALLIJN (E 460) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL ; MAÏSZETMEEL, GEMODIFICEERD (MODIFICATIE ONBEKEND, (E 1450) ; NATRIUMASCORBAAT (E 301) ; NATRIUMZETMEELGLYCOLAAT ; SACCHAROSE ; SILICIUMDIOXIDE (E 551) ; TOCOFEROL, DL-ALFA (E 307) ; TRIGLYCERIDEN MIDDELLANGE KETEN, CELLULOSE, MICROKRISTALLIJN (E 460) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL ; MAÏSZETMEEL, GEMODIFICEERD (MODIFICATIE ONBEKEND, (E 1450) ; NATRIUMASCORBAAT (E 301) ; NATRIUMZETMEELGLYCOLAAT (E468) ; SACCHAROSE ; SILICIUMDIOXIDE (E 551) ; TOCOFEROL, DL-ALFA (E 307) ; TRIGLYCERIDEN MIDDELLANGE KETEN,
Oraal gebruik
Colecalciferol
Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); LACTOSE 1-WATER; MAGNESIUMSTEARAAT (E 470b); MAÏSZETMEEL; MAÏSZETMEEL, GEMODIFICEERD (MODIFICATIE ONBEKEND, (E 1450); NATRIUMASCORBAAT (E 301); NATRIUMZETMEELGLYCOLAAT (E468); SACCHAROSE; SILICIUMDIOXIDE (E 551); TOCOFEROL, DL-ALFA (E 307); TRIGLYCERIDEN MIDDELLANGE KETEN;
1900-01-01
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT CHOLECALCIFEROL MIBE 500 IE, TABLETTEN Cholecalciferol (vitamin D 3 ) For use in infants, children, adolescents and adults READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. - Keep this leaflet. You may need to read it again. - Ask your pharmacist if you need more information or advice. - 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. - You must talk to a doctor if you do not feel better or if you feel worse. WHAT IS IN THIS LEAFLET 1. What Cholecalciferol mibe 500 IE, tabletten is and what it is used for 2. What you need to know before you take Cholecalciferol mibe 500 IE, tabletten 3. How to take Cholecalciferol mibe 500 IE, tabletten 4. Possible side effects 5. How to store Cholecalciferol mibe 500 IE, tabletten 6. Contents of the pack and other information 1. WHAT CHOLECALCIFEROL MIBE 500 IE, TABLETTEN IS AND WHAT IT IS USED FOR Cholecalciferol mibe 500 IE, tabletten contains vitamin D 3 (equivalent to cholecalciferol) for the regulation of the absorption and metabolism of calcium and for the integration of calcium into bone tissue. Cholecalciferol mibe 500 IE, tabletten is used - for prophylaxis of rickets (impaired bone hardening during the growth phase) and osteomalacia (softening of bones) in children, adolescents and adults. - for prophylaxis of vitamin D deficiency in children, adolescents and adults with an identified risk. - for the supportive treatment of osteoporosis (thinning of bone tissue) in adults. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CHOLECALCIFEROL MIBE 500 IE, TABLETTEN DO NOT TAKE CHOLECALCIFEROL MIBE 500 IE, TABLETTEN - if you are allergic to cholecalciferol or any of the other ingredients of this medicine (listed in section 6) - if you suffer from hypercalcaemia Lire le document complet
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Cholecalciferol mibe 500 IE, tabletten Cholecalciferol mibe 1000 IE, tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Cholecalciferol mibe 500 IE, tabletten: Each tablet contains 12.5 microgram of cholecalciferol (equivalent to 500 IU vitamin D 3 ), as cholecalciferol concentrate, powder form. Cholecalciferol mibe 1000 IE, tabletten: Each tablet contains 25 microgram of cholecalciferol (equivalent to 1000 IU vitamin D 3 ), as cholecalciferol concentrate, powder form. Excipients with known effect: One tablet Cholecalciferol mibe 500 IE, tabletten contains 34.47 mg lactose monohydrate and 0.87 mg sucrose. One tablet Cholecalciferol mibe 1000 IE, tabletten contains 68.94 mg lactose monohydrate and 1.73 mg sucrose. Cholecalciferol mibe 500 IE, tabletten / 1000 IE, tabletten contains less than 1 mmol sodium (23 mg) per tablet. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. Cholecalciferol mibe 500 IE, tabletten are round, biconvex, white to yellowish tablets. Cholecalciferol mibe 1000 IE, tabletten are oblong, biconvex, white to yellowish tablets with score line. The tablet can be divided into equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS - Prophylaxis of rickets and osteomalacia in children, adolescents and adults - Prophylaxis of vitamin D deficiency in children, adolescents and adults with an identified risk - As an adjunct to specific therapy of osteoporosis in adults 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Prophylaxis of rickets and osteomalacia in children, adolescents and adults _ _ _ 1 tablet Cholecalciferol mibe 500 IE, tabletten or ½ tablet Cholecalciferol mibe 1000 IE, tabletten daily (equivalent to 0.0125 mg or 500 IU vitamin D 3 ) (see section 4.4). 2 The dosage should be established by the treating physician. Generally, for the prophylaxis of rickets in preterm newborn infants, - with a birth weight > 1500 g: 1 tablet Cholecalciferol mibe 500 IE, tabletten or ½ tab Lire le document complet