Land: Nederland
Taal: Nederlands
Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
CINACALCETHYDROCHLORIDE 33,1 mg/stuk SAMENSTELLING overeenkomend met ; CINACALCET 30 mg/stuk
Rafarm S.A. 12 Korinthou street, N. Psihico 154 51 ATHENE (GRIEKENLAND)
H05BX01
CINACALCETHYDROCHLORIDE 33,1 mg/stuk SAMENSTELLING overeenkomend met ; CINACALCET 30 mg/stuk
Filmomhulde tablet
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) ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171) ; ZETMEEL, GEPREGELATINEERD, CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSPOVIDON (E 1202) ; GLYCEROLTRIACETAAT (E 1518) ; HYPROMELLOSE (E 464) ; 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) ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171) ; ZETMEEL, GEPREGELATINEERD
Oraal gebruik
Cinacalcet
2019-02-26
December 2020 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT CINACALCET RAFARM 30 MG FILMOMHULDE TABLETTEN CINACALCET RAFARM 60 MG FILMOMHULDE TABLETTEN CINACALCET RAFARM 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. Whatis and what it is used for 2. What you need to know before you take Lees het volledige document3. How to take 4. Possible side effects 5. How to store 6. Contents of the pack and other information 1. WHAT IS AND WHAT IT IS USED FOR 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). is used in adults: • to treat secondary hyperparathyroidism in patients 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. 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 products, whose condition is not
1. NAME OF THE MEDICINAL PRODUCT Cinacalcet Rafarm 30 mg film-coated tablets. Cinacalcet Rafarm 60 mg film-coated tablets. Cinacalcet Rafarm 90 mg film-coated tablets. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains cinacalcet hydrochloride corresponding to 30 mg of cinacalcet. Each tablet contains cinacalcet hydrochloride corresponding to 60 mg of cinacalcet. Each tablet contains cinacalcet hydrochloride corresponding to 90 mg of cinacalcet. Excipient with known effect: Each 30 mg tablet contains 0.3 mg of lactose. Each 60 mg tablet contains 0.6 mg of lactose. Each 90 mg tablet contains 0.9 mg of lactose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet).is a light green film-coated tablet. They are oval-shaped and have “30” marked on one side. (Width: 4.4 to 4.7 mm; Length: 6.9 to 7.2 mm) Lees het volledige documentis a light green film-coated tablet. They are oval-shaped and have “60” marked on one side. (Width: 5.5 to 5.7 mm; Length: 8.7 to 8.9 mm) is a light green film-coated tablet. They are oval-shaped and have “90” marked on one side. (Width: 6.5 to 6.7 mm; Length: 9.9 to 10.2 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). 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 Reduction of hypercalcaemia in adult patients with: • parathyroid carcinoma. • primary HPT for whom parathyroidectomy would be