国家: 荷兰
语言: 荷兰文
来源: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
CINACALCETHYDROCHLORIDE 66,1 mg/stuk SAMENSTELLING overeenkomend met ; CINACALCET 60 mg/stuk
Devatis GmbH Spitalstrasse 22 795 39 LORRACH (DUITSLAND)
H05BX01
CINACALCETHYDROCHLORIDE 66,1 mg/stuk SAMENSTELLING overeenkomend met ; CINACALCET 60 mg/stuk
Filmomhulde tablet
CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSPOVIDON (E 1202) ; GLYCEROLTRIACETAAT (E 1518) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; INDIGOKARMIJN ALUMINIUMLAK (E 132) ; LACTOSE 1-WATER ; MACROGOL 400 ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL, GEPREGELATINEERD ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSPOVIDON (E 1202) ; GLYCEROLTRIACETAAT (E 1518) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; INDIGOKARMIJN ALUMINIUMLAK (E 132) ; LACTOSE 1-WATER ; MACROGOL 400 ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL, GEPREGELATINEERD ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171),
Oraal gebruik
Cinacalcet
Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); CROSPOVIDON (E 1202); GLYCEROLTRIACETAAT (E 1518); HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); IJZEROXIDE GEEL (E 172); INDIGOKARMIJN ALUMINIUMLAK (E 132); LACTOSE 1-WATER; MACROGOL 400; MAGNESIUMSTEARAAT (E 470b); MAÏSZETMEEL, GEPREGELATINEERD; SILICIUMDIOXIDE (E 551); TITAANDIOXIDE (E 171);
2015-11-19
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT CINACALCET DEVATIS 30 MG FILMOMHULDE TABLETTEN CINACALCET DEVATIS 60 MG FILMOMHULDE TABLETTEN CINACALCET DEVATIS 90 MG FILMOMHULDE TABLETTEN Cinacalcet 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, pharmacist or nurse. - 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 Cinacalcet Devatis is and what it is used for 2. What you need to know before you take Cinacalcet Devatis 3. How to take Cinacalcet Devatis 4. Possible side effects 5. How to store Cinacalcet Devatis 6. Contents of the pack and other information 1. WHAT CINACALCET DEVATIS IS AND WHAT IT IS USED FOR Cinacalcet Devatis works by controlling the levels of parathyroid hormone (PTH), calcium and phosphorous in your body. It is used to treat problems with organs called parathyroid glands. The parathyroids are four small glands in the neck, near the thyroid gland, that produce parathyroid hormone (PTH). Cinacalcet Devatis is used in adults: - to treat secondary hyperparathyroidism in adults with serious kidney disease who need dialysis to clear their blood of waste products. - to reduce high levels of calcium in the blood (hypercalcaemia) in adult patients with parathyroid cancer. - to reduce high levels of calcium in the blood (hypercalcaemia) in adult patients with primary hyperparathyroidism when removal of the gland is not possible. Cinacalcet Devatis is used in children aged 3 years to less than 18 years of age: - to treat secondary hyperparathyroidism in patients with serious kidney disease who need dialysis to clear their blood of waste pro 阅读完整的文件
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Cinacalcet Devatis 30 mg filmomhulde tabletten Cinacalcet Devatis 60 mg filmomhulde tabletten Cinacalcet Devatis 90 mg filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 30 mg cinacalcet (as hydrochloride) Each tablet contains 60 mg cinacalcet (as hydrochloride) Each tablet contains 90 mg cinacalcet (as hydrochloride) Excipient with known effect: Each 30 mg tablet contains 0.285 mg of lactose Each 60 mg tablet contains 0.57 mg of lactose Each 90 mg tablet contains 0.855 mg of lactose For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet 30 mg tablets: Light green, oval film-coated tablets, marked with “30” on one side and the dimensions 7.1 mm x 4.6 mm. 60 mg tablets: Light green, oval film-coated tablets, marked with “60” on one side and the dimensions 8.8 mm x 5.6 mm. 90 mg tablets Light green, oval film-coated tablets, marked with “90” on one side and the dimensions 10.1 mm x 6.6 mm. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Secondary hyperparathyroidism _Adults _ Treatment of secondary hyperparathyroidism (HPT) in adult patients with end-stage renal disease (ESRD) on maintenance dialysis therapy. _Paediatric population _ Treatment of secondary hyperparathyroidism (HPT) in children aged 3 years and older with end-stage renal disease (ESRD) on maintenance dialysis therapy in whom secondary HPT is not adequately controlled with standard of care therapy (see section 4.4). Cinacalcet may be used as part of a therapeutic regimen including phosphate binders and/or Vitamin D sterols, as appropriate (see section 5.1). Parathyroid carcinoma and primary hyperparathyroidism in adults 2 Reduction of hypercalcaemia in adult patients with: • parathyroid carcinoma. • primary HPT for whom parathyroidectomy would be indicated on the basis of serum calcium levels (as defined by relevant treatment guidelines), but in whom parathyroidectomy is not clinically appr 阅读完整的文件