国: オーストラリア
言語: 英語
ソース: Department of Health (Therapeutic Goods Administration)
cinacalcet hydrochloride, Quantity: 33 mg (Equivalent: cinacalcet, Qty 30 mg)
Pharmacor Pty Ltd
Tablet, film coated
Excipient Ingredients: lactose monohydrate; crospovidone; microcrystalline cellulose; hyprolose; magnesium stearate; titanium dioxide; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350; indigo carmine aluminium lake
Oral
28, 10
(S4) Prescription Only Medicine
Cinacalcet may be used to treat the biochemical manifestations of secondary hyperparathyroidism in patients with end stage renal disease, receiving dialysis. Cinacalcet should be used as adjunctive therapy. ,Cinacalcet is indicated for the treatment of hypercalcaemia in patients with parathyroid carcinoma. ,Cinacalcet may be used to treat the biochemical manifestations of primary hyperparathyroidism in patients for whom parathyroidectomy is not a treatment option.
Visual Identification: Light green colored, oval shaped, film coated tablets debossed with "A33" on one side and "30" on other side.; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius
Registered
2019-01-08
Pharmacor Cinacalcet Ver: 03 1 PHARMACOR CINACALCET TABLETS _Cinacalcet hydrochloride _ _ _ Pharmacor Cinacalcet 30 mg Tablets Pharmacor Cinacalcet 60 mg Tablets Pharmacor Cinacalcet 90 mg Tablets CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Pharmacor Cinacalcet. 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 Pharmacor Cinacalcet against the benefits he/she expects it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING PHARMACOR CINACALCET, ASK YOUR DOCTOR, NURSE OR PHARMACIST. READ THIS LEAFLET CAREFULLY BEFORE YOU START PHARMACOR CINACALCET AND KEEP IT WITH THE MEDICINE. YOU MAY NEED TO READ IT AGAIN. WHAT PHARMACOR CINACALCET IS USED FOR Pharmacor Cinacalcet 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 完全なドキュメントを読む
Pharmacor Cinacalcet Ver: 03 1 AUSTRALIAN PRODUCT INFORMATION PHARMACOR CINACALCET (CINACALCET HYDROCHLORIDE) FILM-COATED TABLETS 1. NAME OF THE MEDICINE Cinacalcet hydrochloride. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Pharmacor Cinacalcet 30 mg tablets: Each film-coated tablet contains Cinacalcet hydrochloride 33 mg equivalent to Cinacalcet 30 mg. Pharmacor Cinacalcet 60 mg tablets: Each film-coated tablet contains Cinacalcet hydrochloride 66 mg equivalent to Cinacalcet 60 mg. Pharmacor Cinacalcet 90 mg tablets: Each film-coated tablet contains Cinacalcet hydrochloride 99 mg equivalent to Cinacalcet 90 mg. List of excipients with known effect: Sugars (as lactose monhydrate) For the full list of excipients, see Section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Film-coated Tablets Pharmacor Cinacalcet 30 mg tablets: Light green colored, oval shaped, film coated tablets debossed with 'A33' on one side and '30' on other side. Pharmacor Cinacalcet 60 mg tablets: Light green colored, oval shaped, film coated tablets debossed with 'A34' on one side and '60' on other side. Pharmacor Cinacalcet Ver: 03 2 Pharmacor Cinacalcet 90 mg tablets: Light green colored, oval shaped, film coated tablets debossed with 'A35' on one side and ‘90’ on other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Cinacalcet 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). Cinacalcet should be used as adjunctive therapy. Cinacalcet is indicated for the treatment of hypercalcaemia in patients with parathyroid carcinoma. Cinacalcet 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 (DOSE AND INTERVAL) PATIENTS WITH END STAGE RENAL DISEASE RECEIVING DIALYSIS Pharmacor Cinacalcet reduces parathyroid hormone (PTH) while simu 完全なドキュメントを読む