Country: Ireland
Bahasa: Inggeris
Sumber: HPRA (Health Products Regulatory Authority)
Cinacalcet hydrochloride; TALC PH.EUR.
Teva B.V.
H05B
Cinacalcet hydrochloride; TALC PH.EUR.
30 milligram(s)
Film-coated tablet
Product subject to prescription which may be renewed (B)
ANTI-PARATHYROID AGENTS
Marketed
2016-02-05
Adobe InDesign CC JB V 10.InD Cutterguide Black PMS Green Cinacalcet Teva 30mg, 60mg, 90mg FC Tabs All TEI KS V2 58950 Leaflet 190x380mm NA Univers Body Size 9pt AM 21-03-19 5.0 YA 15-6-20 CINACALCET TEVA 30 MG FILM-COATED TABLETS CINACALCET TEVA 60 MG FILM-COATED TABLETS CINACALCET TEVA 90 MG FILM-COATED TABLETS CINACALCET PACKAGE LEAFLET: INFORMATION FOR THE PATIENT 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 TEVA IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CINACALCET TEVA 3. HOW TO TAKE CINACALCET TEVA 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE CINACALCET TEVA 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1 WHAT CINACALCET TEVA IS AND WHAT IT IS USED FOR Cinacalcet Teva 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 Teva 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 Teva is used in children aged 3 years t Baca dokumen lengkap
Health Products Regulatory Authority 12 March 2024 CRN00F595 Page 1 of 13 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cinacalcet Teva 30 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 30 mg cinacalcet (as hydrochloride). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet (tablet). Light green to green, film-coated, oval shaped tablet (10 mm X 6 mm), debossed with C30 on one side of the tablet and plain 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 Teva 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 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. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Secondary hyperparathyroidism_ _Adults and elderly (> 65 years) _ The recommended starting dose for adults is 30 mg once per day. Cinacalcet Teva should be titrated every 2 to 4 weeks to a maximum dose of 180 mg once daily to achieve a target parathyroid hormone (PTH) in dialysis patients of between 150-300 pg/mL (15.9-31.8 pmol/L) in the intact PTH (iPTH) assay. PTH levels should be assessed at least 12 hours after dosing with Cinacalcet Te Baca dokumen lengkap