País: Países Bajos
Idioma: neerlandés
Fuente: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
CINACALCETHYDROCHLORIDE 66,1 mg/stuk SAMENSTELLING overeenkomend met ; CINACALCET 60 mg/stuk
Genepharm S.A. 18th km Marathonos Avenue 153 51 PALLINI (GRIEKENLAND)
H05BX01
CINACALCETHYDROCHLORIDE 66,1 mg/stuk SAMENSTELLING overeenkomend met ; CINACALCET 60 mg/stuk
Filmomhulde tablet
CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSCARMELLOSE NATRIUM (E 468) ; GLYCEROLTRIACETAAT (E 1518) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; INDIGOKARMIJN ALUMINIUMLAK (E 132) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL, GEPREGELATINEERD ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; GLYCEROLTRIACETAAT (E 1518) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; INDIGOKARMIJN ALUMINIUMLAK (E 132) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL, GEPREGELATINEERD ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171),
Oraal gebruik
Cinacalcet
Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); CROSCARMELLOSE NATRIUM (E 468); GLYCEROLTRIACETAAT (E 1518); HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); IJZEROXIDE GEEL (E 172); INDIGOKARMIJN ALUMINIUMLAK (E 132); LACTOSE 1-WATER; MAGNESIUMSTEARAAT (E 470b); MAÏSZETMEEL, GEPREGELATINEERD; SILICIUMDIOXIDE (E 551); TITAANDIOXIDE (E 171);
1900-01-01
PACKAGE LEAFLET: INFORMATION FOR THE USER CINACALCET GENEPHARM 30 MG FILMOMHULDE TABLETTEN CINACALCET GENEPHARM 60 MG FILMOMHULDE TABLETTEN CINACALCET GENEPHARM 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 Genepharm is and what it is used for 2. What you need to know before you take Cinacalcet Genepharm 3. How to take Cinacalcet Genepharm 4. Possible side effects 5. How to store Cinacalcet Genepharm 6. Contents of the pack and other information 1. WHAT CINACALCET GENEPHARM IS AND WHAT IT IS USED FOR Cinacalcet Genepharm 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 Genepharm 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 par- athyroid cancer. • to reduce high levels of calcium in the blood (hypercalcaemia) in adult patients with pri- mary hyperparathyroidism when removal of the gland is not possible. Cinacalcet Genepharm 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 Leer el documento completo
1 _ _ SUMMARY OF PRODUCT CHARACTERISTICS 2 _ _ 1. NAME OF THE MEDICINAL PRODUCT Cinacalcet Genepharm 30 mg filmomhulde tabletten Cinacalcet Genepharm 60 mg filmomhulde tabletten Cinacalcet Genepharm 90 mg filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Cinacalcet Genepharm 30 mg: Each Cinacalcet Genepharm film-coated tablet contains 30 mg cinacalcet (as hydrochloride). Cinacalcet Genepharm 60 mg: Each Cinacalcet Genepharm film-coated tablet contains 60 mg cinacalcet (as hydrochloride). Cinacalcet Genepharm 90 mg: Each Cinacalcet Genepharm film-coated tablet contains 90 mg cinacalcet (as hydrochloride). Excipient(s) with known effect: Each 30 mg tablet contains 2.24 mg of lactose monohydrate Each 60 mg tablet contains 4.48 mg of lactose monohydrate Each 90 mg tablet contains 6.72 mg of lactose monohydrate For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Cinacalcet Genepharm 30 mg: green, oblong, biconvex film-coated tablets, engraved with ‘30’on one side and plain on the other side, with a length of 9.8 mm (±0.2 mm) and a width of 6.2 mm (±0.2 mm). Cinacalcet Genepharm 60 mg: green, oblong, biconvex film-coated tablets, engraved with ‘60’ on one side and plain on the other side, with a length of 12.4 mm (±0.2 mm) and a width of 7.8 mm (±0.2 mm). Cinacalcet Genepharm 90 mg: green, oblong, biconvex film-coated tablets, engraved with ‘90’on one side and plain on the other side, with a length of 14.2 mm (±0.2 mm) and a width of 8.9 mm (±0.2 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 Leer el documento completo