Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
cinacalcet hydrochloride
Mylan Pharmaceuticals Limited
H05BX01
cinacalcet
Calcium homeostasis
Hyperparathyroidism, Secondary; Hypercalcemia
Treatment of secondary hyperparathyroidism (HPT) in patients with end-stage renal disease (ESRD) on maintenance dialysis therapy.Cinacalcet Mylan may be used as part of a therapeutic regimen including phosphate binders and/or vitamin D sterols, as appropriate.Reduction of hypercalcaemia in patients with:parathyroid carcinomaprimary HPT for whom parathyroidectomywould be indicated on the basis of serum calcium levels (as defined by relevant treatment guidelines), but in whom parathyroidectomy is not clinically appropriate or is contraindicated.
Revision: 15
Authorised
2015-11-19
38 B. PACKAGE LEAFLET 39 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT CINACALCET MYLAN 30 MG FILM-COATED TABLETS CINACALCET MYLAN 60 MG FILM-COATED TABLETS CINACALCET MYLAN 90 MG FILM-COATED TABLETS 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 Mylan is and what it is used for 2. What you need to know before you take Cinacalcet Mylan 3. How to take Cinacalcet Mylan 4. Possible side effects 5. How to store Cinacalcet Mylan 6. Contents of the pack and other information 1. WHAT CINACALCET MYLAN IS AND WHAT IT IS USED FOR Cinacalcet Mylan contains the active ingredient cinacalcet, which 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 Mylan 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 parathyroid gland is not possible. Cinacalcet Mylan is used in children aged 3 years to less than 18 years of age: to treat secondary hyperparathyroidism in patients with serious kidn Przeczytaj cały dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Cinacalcet Mylan 30 mg film-coated tablets. Cinacalcet Mylan 60 mg film-coated tablets. Cinacalcet Mylan 90 mg film-coated tablets. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Cinacalcet Mylan 30 mg film-coated tablets Each film-coated tablet contains 30 mg of cinacalcet (as hydrochloride). Cinacalcet Mylan 60 mg film-coated tablets Each film-coated tablet contains 60 mg of cinacalcet (as hydrochloride). Cinacalcet Mylan 90 mg film-coated tablets Each film-coated tablet contains 90 mg of cinacalcet (as hydrochloride). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Cinacalcet Mylan 30 mg film-coated tablets 10.0 mm x 6.4 mm, green, film-coated, oval, biconvex, bevelled edge tablet debossed with M on one side of the tablet and CI30 on the other side. Cinacalcet Mylan 60 mg film-coated tablets 12.5 mm x 8.0 mm, green, film-coated, oval, biconvex, bevelled edge tablet debossed with M on one side of the tablet and CI60 on the other side. Cinacalcet Mylan 90 mg film-coated tablets 14.3 mm x 9.0 mm, green, film-coated, oval, biconvex, bevelled edge tablet debossed with M on one side of the tablet and CI90 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. 3 _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 Mylan 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: • parathyroi Przeczytaj cały dokument