Pajjiż: Olanda
Lingwa: Olandiż
Sors: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
CINACALCETHYDROCHLORIDE 99 mg/stuk SAMENSTELLING overeenkomend met ; CINACALCET 90 mg/stuk
Aristo Pharma GmbH Wallenroder Strasse 8-10 13435 BERLIJN (DUITSLAND)
H05BX01
CINACALCETHYDROCHLORIDE 99 mg/stuk SAMENSTELLING overeenkomend met ; CINACALCET 90 mg/stuk
Filmomhulde tablet
CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSPOVIDON (E 1202) ; GLYCEROLTRIACETAAT (E 1518) ; HYPROMELLOSE (E 464) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; LACTOSE 1-WATER ; MACROGOL 6000 ; MAÏSZETMEEL, GEPREGELATINEERD ; NATRIUMSTEARYLFUMARAAT ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSPOVIDON (E 1202) ; GLYCEROLTRIACETAAT (E 1518) ; HYPROMELLOSE (E 464) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; LACTOSE 1-WATER ; MACROGOL 6000 ; MAÏSZETMEEL, GEPREGELATINEERD ; NATRIUMSTEARYLFUMARAAT ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171)
Oraal gebruik
Cinacalcet
1900-01-01
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT CINACALCET ARISTO 30 MG, FILMOMHULDE TABLETTEN CINACALCET ARISTO 60 MG, FILMOMHULDE TABLETTEN CINACALCET ARISTO 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 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. What [product name] is and what it is used for 2. What you need to know before you take [product name] 3. How to take [product name] 4. Possible side effects 5. How to store [product name] 6. Contents of the pack and other information 1. WHAT [PRODUCT NAME] IS AND WHAT IT IS USED FOR [Product name] 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). [Product name] 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. In primary and secondary hyperparathyroidism too much PTH is produced by the parathyroid glands. “Primary” means that the hyperparathyroidism is not caused by any other condition and “secondary” means that the hyperparathyroidism is caused by anoth Aqra d-dokument sħiħ
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Cinacalcet Aristo 30 mg, filmomhulde tabletten Cinacalcet Aristo 60 mg, filmomhulde tabletten Cinacalcet Aristo 90 mg, filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains cinacalcet hydrochloride equivalent to 30 mg, 60 mg or 90 mg cinacalcet. Excipient with known effect _[product name] 30 mg film-coated tablets _ Each 30 mg tablet contains approximately 2mg of lactose. Each 30 mg tablet contains approximately 0.05mg of sodium. _[product name] 60 mg film-coated tablets _ Each 60 mg tablet contains approximately 5 mg of lactose. Each 60 mg tablet contains approximately 0.1mg of sodium. _[product name] 90 mg film-coated tablets _ Each 90 mg tablet contains approximately 7 mg of lactose. Each 90 mg tablet contains approximately 0.2mg of sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). _[product name] 30 mg film-coated tablets _ White to off-white, oval shaped film-coated tablets debossed with ‘30’ on one side, with a length of approximately 10.0 mm and a width of approximately 6.3 mm. _[product name] 60 mg film-coated tablets _ White to off-white, oval shaped film-coated tablets debossed with ‘60’ on one side, with a length of approximately. 12.5 mm and a width of approximately 7.9 mm. _[product name] 90 mg film-coated tablets _ White to off-white, oval shaped film-coated tablets debossed with ‘90’ on one side, with a length of approximately. 14.3 mm and a width of approximately 9.0 mm. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _ _ _Secondary hyperparathyroidism in adults _ Adults Treatment of secondary hyperparathyroidism (HPT) in adult patients with end-stage renal disease (ESRD) on maintenance dialysis therapy. [product name] 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 adult Aqra d-dokument sħiħ