Riik: Holland
keel: hollandi
Allikas: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
CHOLECALCIFEROL 500 µg/stuk ; SAMENSTELLING overeenkomend met CHOLECALCIFEROL 20000 IE/stuk
CHOLECALCIFEROL 500 µg/stuk ; SAMENSTELLING overeenkomend met CHOLECALCIFEROL 20000 IE/stuk
Capsule, zacht
GELATINE (E 441) ; GLYCEROL (E 422) ; PATENTBLAUW V (E 131) ; TOCOFEROL, DL-ALFA ACETAAT ; TRIGLYCERIDEN MIDDELLANGE KETEN ; WATER, GEZUIVERD, GELATINE (E 441) ; GLYCEROL (E 422) ; PATENTBLAUW V (E131) ; TOCOFEROL, DL-ALFA ACETAAT ; TRIGLYCERIDEN MIDDELLANGE KETEN ; WATER, GEZUIVERD
Oraal gebruik
2022-12-01
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT CHOLECALCIFEROL ACURE 20.000 IE ZACHTE CAPSULES CHOLECALCIFEROL ACURE 25.000 IE ZACHTE CAPSULES cholecalciferol (vitamin D 3 ) 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 or pharmacist. - 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. Whatis and what it is used for 2. What you need to know before you take Lugege kogu dokumenti3. How to take 4. Possible side effects 5. How to store 6. Contents of the pack and other information 1. WHAT IS AND WHAT IT IS USED FOR contains cholecalciferol (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 in adults. is indicated in adults. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DO NOT TAKE - 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 in your blood (hypervitaminosis D) if you have calcium kidney stones (calcium nephrolithiasis) or calcium deposits in your kidneys (nephrocalcinosis) WARNINGS AND PRECAUTIONS Do not take more than your doctor has prescribed, since overdosage may occur. Do not at the same time take other vitamin D containing products (e.g., medicinal products,
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAAM VAN HET GENEESMIDDEL Cholecalciferol Acure 20.000 IE zachte capsules Cholecalciferol Acure 25.000 IE zachte capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 500 micrograms of cholecalciferol (vitamin D 3 , equivalent to 20 000 IU). Each capsule contains 625 micrograms of cholecalciferol (vitamin D 3 , equivalent to 25 000 IU). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM 20 000 IU capsule, soft Transparent, blue, round with 7.2 mm of diameter, soft capsules with a seam in the middle, filled with light yellow viscous liquid. 25 000 IU capsule, soft White to almost white, oval with 12 mm of length and 6.7 mm of thickness, soft capsules with a seam in the middle, filled with light yellow viscous liquid. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Initial treatment of clinically relevant vitamin D deficiency (serum levels < 25 nmol/l or < 10 ng/ml) in adults.20 000 IU and 25 000 IU soft capsules are indicated in adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Dose should be established on an individual basis depending on the extent of the necessary vitamin D supplementation. The dosage must be determined individually by the treating doctor depending on the extent of the necessary vitamin D supplementation. The patient’s dietary habits should be carefully evaluated and artificially added vitamin D content of certain food types should be taken into consideration. _ _ _Initial treatment of clinically relevant vitamin D deficiency (serum levels < 25 nmol/l or < 10 ng/ml) _ _in adults: _ 1 capsule of 20 000 IU /week for up to 4-5 weeks 1 capsule of 25 000 IU /week for up to 4 weeks After first month, 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 2 fo Lugege kogu dokumenti