Šalis: Nyderlandai
kalba: olandų
Šaltinis: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
CINACALCETHYDROCHLORIDE SAMENSTELLING overeenkomend met ; CINACALCET
Apotex Europe B.V. Darwinweg 20 2333 CR LEIDEN
H05BX01
CINACALCETHYDROCHLORIDE COMPOSITION corresponding to ; CINACALCET
Filmomhulde tablet
BRILJANTBLAUW FCF ALUMINIUMLAK (E133) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ZWART (E 172) ; MACROGOL 8000 ; MAGNESIUMSTEARAAT (E 470b) ; MANNITOL (D-) (E 421) ; NATRIUMZETMEELGLYCOLAAT ; POLYVINYLALCOHOL (E1203) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171), BRILJANTBLAUW FCF ALUMINIUMLAK (E133) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ZWART (E 172) ; MACROGOL 8000 ; MAGNESIUMSTEARAAT (E 470b) ; MANNITOL (D-) (E 421) ; NATRIUMZETMEELGLYCOLAAT (E468) ; POLYVINYLALCOHOL (E1203) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),
Oraal gebruik
Cinacalcet
Hulpstoffen: BRILJANTBLAUW FCF ALUMINIUMLAK (E133); CELLULOSE, MICROKRISTALLIJN (E 460); CROSCARMELLOSE NATRIUM (E 468); IJZEROXIDE GEEL (E 172); IJZEROXIDE ZWART (E 172); MACROGOL 8000; MAGNESIUMSTEARAAT (E 470b); MANNITOL (D-) (E 421); NATRIUMZETMEELGLYCOLAAT (E468); POLYVINYLALCOHOL (E1203); SILICIUMDIOXIDE (E 551); TALK (E 553 B); TITAANDIOXIDE (E 171);
2017-09-27
CINACALCET APOTEX 30 MG, 60 MG AND 90 MG, FILMOMHULDE TABLETTEN – RVG 118364-5-6 MODULE 1.3 Product Information Version: 2019-10-11 MODULE 1.3.1 Package Leaflet Replaces: 2018-05-17 1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT _ _ Cinacalcet Apotex 30 mg, filmomhulde tabletten Cinacalcet Apotex 60 mg, filmomhulde tabletten Cinacalcet Apotex 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 Apotex is and what it is used for 2. What you need to know before you take Cinacalcet Apotex 3. How to take Cinacalcet Apotex 4. Possible side effects 5. How to store Cinacalcet Apotex 6. Contents of the pack and other information 1. WHAT CINACALCET APOTEX IS AND WHAT IT IS USED FOR Cinacalcet Apotex 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 Apotex 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 Apotex is used Perskaitykite visą dokumentą
CINACALCET APOTEX 30 MG, 60 MG AND 90 MG, FILMOMHULDE TABLETTEN – RVG 118364-5-6 MODULE 1.3 Product Information Version: 2018-05-17 MODULE 1.3.1 Summary of Product Characteristics Replaces: 2017-09-27 1 1. NAME OF THE MEDICINAL PRODUCT Cinacalcet Apotex 30 mg, filmomhulde tabletten Cinacalcet Apotex 60 mg, filmomhulde tabletten Cinacalcet Apotex 90 mg, filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 30 mg tablet contains 30 mg of cinacalcet (as hydrochloride) Each 60 mg tablet contains 60 mg of cinacalcet (as hydrochloride) Each 90 mg tablet contains 90 mg of cinacalcet (as hydrochloride) For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet) Light green colored, oval shaped (9.525 x 5.95 mm), biconvex film-coated tablets, engraved “APO” on one side and “C30” on the other side Light green colored, oval shaped ( 11.90 x 7.50 mm) , biconvex film-coated tablets, engraved “APO” on one side and “C60” on the other side Light green colored, oval shaped ( 13.493 x 8.35 mm) , biconvex film-coated tablets, engraved “APO” on one side and “C90” on the other side 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 Apotex 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. CINACALCET APOTEX 30 MG, 60 MG AND 90 MG, FILMOMHULDE TABLETTEN – RVG 118364-5-6 MODU Perskaitykite visą dokumentą