국가: 아일랜드
언어: 영어
출처: HPRA (Health Products Regulatory Authority)
CALCIUM CARBONATE CHOLECALCIFEROL CONCENTRATE (POWDER FORM 100,000 IU/G)
Hermes Arzneimittel GmbH
1000/880
Tablets Chewable
2012-02-17
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Calcium Vitamin D 3 Hermes 1000mg/880 IU Chewable Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each chewable tablet contains: 2,500 mg of calcium carbonate (equivalent to 1,000 mg of calcium). 8.8 mg of colecalciferol concentrate (powder form) (equivalent to 22 micrograms of colecalciferol = 880 IU of vitamin D 3 ). Excipients: Each chewable tablet contains 1.00 mg of aspartame (E951), 119.32 mg of sorbitol (E420), 370.00 mg of isomalt (E953) and 1.694 mg of sucrose. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Chewable tablet. Round, white tablet with faultless surface and a breakmark. The tablet can be divided into equal halves. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Calcium Vitamin D 3 Hermes 1000mg/880 IU Chewable Tablets is indicated: - for the prevention and treatment of vitamin D and calcium deficiency in the elderly - as vitamin D and calcium supplement as an adjunct to specific osteoporosis treatment of patients who are at risk of vitamin D and calcium deficiency 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults and elderly_ 1 chewable tablet daily (corresponding to 1,000 mg of calcium and 880 IU of vitamin D 3 ). _Dosage in hepatic impairment_ No dose adjustment is required _Dosage in renal impairment_ Calcium Vitamin D 3 Hermes 1000mg/880 IU Chewable Tablets should not be used in patients with severe renal impairment (see section 4.3). _Dosage during pregnancy_ During pregnancy the daily intake should not exceed 1,500 mg of calcium and 600 I.U. of vitamin D 3 . Therefore, the daily dose must not exceed half a tablet (see section 4.6). IRISH MEDICINES BOARD ______________________________________________________________________________________________________________ 전체 문서 읽기