מדינה: האיחוד האירופי
שפה: אנגלית
מקור: EMA (European Medicines Agency)
cinacalcet
Dompé Biotec S.p.A.
H05BX01
cinacalcet
Calcium homeostasis
Hypercalcemia; Parathyroid Neoplasms; Hyperparathyroidism
Treatment of secondary hyperparathyroidism (HPT) in patients with end-stage renal disease (ESRD) on maintenance dialysis therapy.Mimpara may be used as part of a therapeutic regimen including phosphate binders and/or Vitamin D sterols, as appropriate (see section 5.1).Reduction of hypercalcaemia in patients with:-parathyroid carcinoma.- primary HPT for whom parathyroidectomy would be indicated on the basis of serum calciumlevels (as defined by relevant treatment guidelines), but in whom parathyroidectomy is not clinically appropriate or is contraindicated.
Revision: 6
Withdrawn
2004-10-22
B. PACKAGE LEAFLET 57 Medicinal product no longer authorised PACKAGE LEAFLET : INFORMATION FOR THE USER PARAREG 30 MG FILM-COATED TABLETS PARAREG 60 MG FILM-COATED TABLETS PARAREG 90 MG FILM-COATED TABLETS Cinacalcet READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. Keep this leaflet. You may need to read it again. If you have further questions, please ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It m ay harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET 1. What Parareg is and what it is used for 2. Before you take Parareg 3. How to take Parareg 4. Possible side effects 5 How to store Parareg 6. Further information 1. WHAT PARAREG IS AND WHAT IT IS USED FOR Parareg works by controlling the levels of parathy roid 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). Parareg is used: • to treat secondary hyperparathyroidism in patients with kidney disease on dialysis. • to reduce high levels of calcium in the blood (hypercalcaemia) in patients with parathyroid cancer • to reduce high levels of calcium in the blood (hypercalcaemia) in patients with primary hyperparathyroidism who still have high calcium levels after removal of the parathyroid gland or when removal of the gland is not possible. In primary and secondary hyperparathyroidism too much PTH is produced by the parathyroids. This can cause the loss of calcium in the bones, which can lead to bone pain and fractures, problems with blood and heart vessels, kidney stones, mental illness and coma. 2. BEFORE YOU TAKE PARAREG DO NOT TAKE PARAREG: • DO NOT take Parareg if y ou are ALLERGIC (hypersensitive) to cinacalcet or any of the oth קרא את המסמך השלם
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 Medicinal product no longer authorised 1. NAME OF THE MEDICINAL PRODUCT Parareg 30 mg film-coated tablets. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 30 mg cinacalcet (as hydrochloride). For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). 30 mg: Light green, oval, film-coated tablets marked “AMGEN” on one side and “30” on the other. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of secondary hyperparathyroidism (HPT) in patients with end-stage renal disease (ESRD) on m aintenance dialysis therapy. Parareg may be used as part of a therapeutic regim en including phosphate binders and/or Vitamin D sterols, as appropriate (see section 5.1). Reduction of hypercalcaemia in patients with: • parathyroid carcinoma. • prim ary 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 For oral use. It is recommended that Parareg be taken with food or shortly after a meal, as studies have shown that bioavailability of cinacalcet is increased when taken with food (see section 5.2). Tablets should be taken whole and not divided. Hepatic impairment No change in starting dose is necessary. Parareg should be used with caution in _ _ patients with m oderate to severe hepatic impairment and treatment should be closely monitored during dose titration and continued treatment (see sections 4.4 and 5.2). SECONDARY HYPERPARATHYROIDISM Adults and elderly (> 65 years) The recommended starting dose for adults is 30 mg once per day . Parareg 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 קרא את המסמך השלם