Страна: Австралия
Език: английски
Източник: Department of Health (Therapeutic Goods Administration)
cinacalcet hydrochloride, Quantity: 66.12 mg (Equivalent: cinacalcet, Qty 60 mg)
Amgen Australia Pty Ltd
Tablet, film coated
Excipient Ingredients: colloidal anhydrous silica; Carnauba Wax; magnesium stearate; microcrystalline cellulose; crospovidone; povidone; pregelatinised maize starch; titanium dioxide; lactose monohydrate; hypromellose; indigo carmine; triacetin; iron oxide yellow; macrogol 400
Oral
28 tablets
(S4) Prescription Only Medicine
SENSIPAR may be used to treat the biochemical manifestations of secondary hyperparathyroidism in patients with end stage renal disease, receiving dialysis (see CLINICAL TRIALS). SENSIPAR should be used as adjunctive therapy. SENSIPAR is indicated for the treatment of hypercalcemia in patients with parathyroid carcinoma. SENSIPAR may be used to treat the biochemical manifestations of primary hyperparathryoidism in patients for whom parathryoidectomy is not a treatment option.
Visual Identification: Light green, film-coated, oval shaped tablets marked with "AMG" on one side and "60" on the opposite side.; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 4 Years; Container Temperature: Store below 30 degrees Celsius
Registered
SENSIPAR ® _Cinacalcet hydrochloride_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Sensipar. It does not contain all the available information. It does not take the place of talking to your doctor, nurse or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking Sensipar against the benefits he/she expects it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING SENSIPAR, ASK YOUR DOCTOR, NURSE OR PHARMACIST. READ THIS LEAFLET CAREFULLY BEFORE YOU START SENSIPAR AND KEEP IT WITH THE MEDICINE. YOU MAY NEED TO READ IT AGAIN. WHAT SENSIPAR IS USED FOR Sensipar is used to treat: • a condition called secondary hyperparathyroidism (high-per- para-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 and other parts of the body. Sensipar Прочетете целия документ
PRODUCT INFORMATION – SENSIPAR SENSIPAR AU PI CDS V26 PAGE 1 OF 24 AUSTRALIAN PRODUCT INFORMATION – SENSIPAR ® (CINACALCET HYDROCHLORIDE) FILM COATED TABLETS 1. NAME OF THE MEDICINE Cinacalcet hydrochloride 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet 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). For the full list of excipients, see section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Film-coated tablet Sensipar 30 mg tablets: light green, film-coated, oval-shaped tablets marked with “AMG” on one side and “30” on the opposite side. Sensipar 60 mg tablets: light green, film-coated, oval-shaped tablets marked with “AMG” on one side and “60” on the opposite side. Sensipar 90 mg tablets: light green, film-coated, oval-shaped tablets marked with “AMG” on one side and “90” on the opposite side, packaged in blister packs of 28 tablets. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Sensipar may be used to treat the biochemical manifestations of secondary hyperparathyroidism (HPT) in patients with end stage renal disease, receiving dialysis (see section 5.1 Pharmacodynamic properties, Clinical trials). Sensipar should be used as adjunctive therapy. Sensipar is indicated for the treatment of hypercalcaemia in patients with parathyroid carcinoma. Sensipar may be used to treat the biochemical manifestations of primary HPT in patients for whom parathyroidectomy is not a treatment option. PRODUCT INFORMATION – SENSIPAR SENSIPAR AU PI CDS V26 PAGE 2 OF 24 4.2 DOSE AND METHOD OF ADMINISTRATION Dosage (dose and interval) _Patients with end stage renal disease receiving dialysis _ Sensipar 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. Sensipar should be titrated every 2 to 4 weeks to a maximum dose of 180 mg once dail Прочетете целия документ