Quốc gia: Úc
Ngôn ngữ: Tiếng Anh
Nguồn: Department of Health (Therapeutic Goods Administration)
cinacalcet hydrochloride, Quantity: 99.191 mg
Alphapharm Pty Ltd
Tablet
Excipient Ingredients: microcrystalline cellulose; crospovidone; magnesium stearate; colloidal anhydrous silica; povidone; titanium dioxide; hypromellose; triacetin; iron oxide yellow; indigo carmine aluminium lake
Oral
28
(S4) Prescription Only Medicine
Cinacalcet Viatris (cinacalcet hydrochloride tablets) may be used to treat the biochemical manifestations of secondary hyperparathyroidism in patients with end stage renal disease, receiving dialysis (see CLINICAL TRIALS). Cinacalcet Viatris (cinacalcet hydrochloride tablets) should be used as adjunctive therapy.,Cinacalcet Viatris (cinacalcet hydrochloride tablets) is indicated for the treatment of hypercalcaemia in patients with parathyroid carcinoma.,Cinacalcet Viatris (cinacalcet hydrochloride tablets) may be used to treat the biochemical manifestations of primary hyperparathyroidism in patients for whom parathyroidectomy is not a treatment option.
Visual Identification: A Green, film-coated, oval, biconvex, beveled edge tablet debossed with M on one side of the tablet and CI90 on the other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2020-11-03
CINACALCET MYLAN _Cinacalcet hydrochloride_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about this medicine. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking this medicine against the benefits he/she expects it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, TALK TO YOUR DOCTOR OR PHARMACIST. READ THIS LEAFLET CAREFULLY BEFORE YOU START CINACALCET MYLAN AND KEEP IT WITH THE MEDICINE. YOU MAY NEED TO READ IT AGAIN. WHAT CINACALCET MYLAN IS USED FOR CINACALCET MYLAN is used to treat: • a condition called secondary hyperparathyroidism (high- perpara-THIGH-royd-izm) in people with kidney disease who require dialysis treatment. • a condition called primary hyperparathyroidism when surgical removal of the parathyroid gland is not a treatment option. • high blood calcium levels in people with cancer of the parathyroid gland. _SECONDARY_ _HYPERPARATHYROIDISM_ Kidney disease can cause a condition called secondary hyperparathyroidism, which can have a big impact on your health. Four small glands located behind the thyroid gland in your neck are called parathyroid glands. They make a hormone called parathyroid hormone (PTH). Normally, PTH makes sure you have just enough calcium and phosphorus in your blood to keep your bones, heart, muscles, nerves and blood vessels working well. When your kidneys are working properly, PTH keeps your calcium and phosphorus levels normal by moving the right amounts of calcium and phosphorus in and out of your bones. When your kidneys aren't working properly, the calcium and phosphorus balance in your body is upset, and your parathyroid glands send out too much PTH to your body. This condition is called secondary hyperparathyroidism, and it can cause bone disease and also may be a risk factor for heart disease and abnormal calcium deposits in blood vessels Đọc toàn bộ tài liệu
AUSTRALIAN PRODUCT INFORMATION CINACALCET MYLAN _(cinacalcet hydrochloride) film-coated tablet _ 1 NAME OF THE MEDICINE Cinacalcet hydrochloride 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet of CINACALCET MYLAN contains either 30 mg, 60 mg or 90 mg of cinacalcet as the free base equivalent (corresponding to 33 mg, 66 mg and 99 mg as the hydrochloride salt, respectively). Excipients with known effect: sulfites For the full list of excipients, see Section 6.1 List of Excipients. 3 PHARMACEUTICAL FORM CINACALCET MYLAN 30 mg film-coated tablet: green, film-coated, oval, biconvex, bevelled edge tablet debossed with M on one side of the tablet and C130 on the other side. CINACALCET MYLAN 60 mg film-coated tablet: green, film-coated, oval, biconvex, bevelled edge tablet debossed with M on one side of the tablet and C160 on the other side. CINACALCET MYLAN 90 mg film-coated tablet: green, film-coated, oval, biconvex, bevelled edge tablet debossed with M on one side of the tablet and C190 on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS CINACALCET MYLAN may be used to treat the biochemical manifestations of secondary hyperparathyroidism in patients with end stage renal disease, receiving dialysis (see Section 5.1 Pharmacodynamic Properties - Clinical Trials). CINACALCET MYLAN should be used as adjunctive therapy. CINACALCET MYLAN is indicated for the treatment of hypercalcaemia in patients with parathyroid carcinoma. CINACALCET MYLAN may be used to treat the biochemical manifestations of primary hyperparathyroidism in patients for whom parathyroidectomy is not a treatment option. 4.2 DOSE AND METHOD OF ADMINISTRATION _DOSAGE _ Patients with end stage renal disease receiving dialysis CINACALCET MYLAN reduces parathyroid hormone (PTH) while simultaneously lowering Ca x P, calcium and phosphorus levels in patients receiving dialysis. The recommended starting dose for adults is 30 mg once per day. CINACALCET MYLAN should be titrated every 2 to 4 weeks to a maximum dose of 180 mg once daily to ach Đọc toàn bộ tài liệu