البلد: السويد
اللغة: السويدية
المصدر: Läkemedelsverket (Medical Products Agency)
kolekalciferol
Renapharma AB
A11CC05
cholecalciferol
2000 IE
Kapsel, mjuk
sorbitol Hjälpämne; glycerol Hjälpämne; kolekalciferol 50 mikrog Aktiv substans
Receptbelagt
Förpacknings: Burk, 90 kapslar; Burk, 250 kapslar
Godkänd
2023-01-17
PACKAGE LEAFLET: INFORMATION FOR THE USER DETREMIN, 2000 I.U. SOFT CAPSULE 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET : 1. What Detremin is and what it is used for 2. What you need to know before you take Detremin 3. How to take Detremin 4. Possible side effects 5. How to store Detremin 6. Contents of the pack and other information 1. WHAT DETREMIN IS AND WHAT IT IS USED FOR Detremin soft capsule contains cholecalciferol (vitamin D 3 ). Detremin is used to treat vitamin D deficiency, in adults and adolescents (children over 12 years). Detremin is also used as prophylaxis and treatment of vitamin D deficiency in malabsorption. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DETREMIN DO NOT TAKE DETREMIN -if you are allergic to vitamin D 3 or any of the other ingredients of this medicine (listed in section 6) -if you have hypercalcemia (too high levels of calcium in the blood) -if you have hypervitaminosis D (too high levels of vitamin D in the blood) Do not take this medicine together with calcium if you have severely impaired renal function. WARNINGS AND PRECAUTIONS Do not take more Detremin than your doctor has prescribed, since over dosage may occur. Do not combine Detremin with other vitamin D containing products other than the one your doctor has prescribed. Talk to your doctor, pharmacist or nurse before taking Detremin: -if you have impaired renal function -if you have or have had kidney stones if you have renal calcification (calcification of the kidney) -if you h اقرأ الوثيقة كاملة
1 SUMMARY OF PRODUCT CHARACTERISTICS 1 . NAME OF THE MEDICINAL PRODUCT Detremin, 2000 IU soft capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each soft capsule contains cholecalciferol (vitamin D3) 2000 IU (equivalent to 50 microgram vitamin D3). Excipient(s) with known effect: Each capsule contains 8 mg of sorbitol (E420). For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Soft capsule. The soft capsule is clear, slightly yellow, in oval shape. Capsule dimensions are 12 mm x 7 mm. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS • Treatment of vitamin D deficiency, in adults and adolescents (children ≥12 years). • Prophylaxis and treatment of vitamin D deficiency in malabsorption 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY Recommended dose _Recommended dose for vitamin D deficiency:_ VITAMIN D STATUS 25(OH)D NMOL/L* DAILY DOSE Deficiency <25 1-2 CAPSULES 2000-4 000 IU *Serum 25-hydroxycholecalciferol The dose should be adjusted dependent upon serum levels of 25-hydroxycholecalciferol, the severity of the disease, and the patient´s response to treatment. Measurement of 25(OH)D, serum phosphate, and serum calcium is recommended 1-3 months after treatment initiation. When relevant, 2 measurements should also include serum albumin, serum ALP (alkaline phosphatase), and serum creatinine. A regular daily dose of 2000 IU (one capsule) raises serum 25-hydroxycholecalciferol (25(OH)D) in average by approximately 50 nmol/l within 4-5 months in adults. The dose in adults and adolescents should not exceed 4000 IU (2 capsules) per day. After initial correction of the vitamin D deficit for 3 - 6 months, the dose should be adjusted to a lower maintenance dose. The dose, treatment duration and the necessity of further monitoring shall be individualized, guided by the diagnosis, the severity of the disease and the patient’s response to treatment. _Treatment of vitamin D deficiency in malabsorption:_ 1 capsule per day. The dose may be adjusted up to 5 capsules per day under monitoring. اقرأ الوثيقة كاملة