国: アルメニア
言語: 英語
ソース: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
calcium (calcium carbonate), colecalciferol
Takeda AS
առկա չէ (A12AX)
calcium (calcium carbonate), colecalciferol
500mg+ 10mcg(400IU)
tablets chewable with lemon flavour
(30), (60), (120) in plastic container
OTC
Registered
2017-08-30
SUMMARY OF THE PRODUCT CHARACTERISTICS 1 N AME OF THE M EDICINAL P RODUCT Calcium D3 Nycomed Forte 500 mg/400 IU chewable tablets 2 Q UALITATIVE AND Q UANTITATIVE C OMPOSITION One tablet contains: Calcium carbonate equivalent to 500 mg calcium_ _ Cholecalciferol concentrate (powder form) equivalent to 400 IU (10 microgram) cholecalciferol (vitamin D 3 ) Excipients: with known effect: One tablet contains 44.3 mg isomalt (E953) (contained in the flavour), 0.7 mg sucrose For a full list of excipients, see section 6.1 3 P HARMACEUTICAL F ORM Chewable tablets with lemon flavour. Round, white, uncoated and convex tablets of 14 mm. May have small specks. 4 C LINICAL P ARTICULARS 4.1 THERAPEUTIC INDICATIONS Prevention and treatment of vitamin D and calcium deficiency in the elderly. 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 _ One tablet twice daily. _ _ SPECIAL PATIENT POPULATIONS _ _ _PAEDIATRIC POPULATION: _ Calcium D3 Nycomed Forte 500 mg/400 IU are not intended for use in children. _IMPAIRED RENAL FUNCTION: _ Calcium D3 Nycomed Forte 500 mg/400 IU should not be used in patients with severe renal impairment (see section 4.3). _ _ _IMPAIRED HEPATIC FUNCTION _ No dose adjustment is required. METHOD OF ADMINISTRATION Oral. The tablets should be chewed or sucked. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substances or to any of the excipients listed in section 6.1 Severe renal impairment (glomerular filtration rate < 30 ml/min/1.73m 2 ) Diseases and/or conditions resulting in hypercalcaemia and/or hypercalciuria Renal calculi (nephrolithiasis) Hypervitaminosis D 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE During long-term treatment, serum calcium levels should be followed and renal function should be monitored through measurements of serum creatinine. Monitoring is especially important in elderly patients on conco 完全なドキュメントを読む