Ülke: Yeni Zelanda
Dil: İngilizce
Kaynak: Medsafe (Medicines Safety Authority)
Cinacalcet hydrochloride 66.12mg equivalent to cinacalcet 60 mg
Devatis Limited
60 mg
Film coated tablet
Active: Cinacalcet hydrochloride 66.12mg equivalent to cinacalcet 60 mg Excipient: Colloidal silicon dioxide Crospovidone Magnesium stearate Microcrystalline cellulose Opadry Clear OY-29020 Purified water Sheffcoat green L TN 1264G49 Starch
Prescription
May be used to treat the biochemical manifestations of secondary hyperparathyroidism in adult patients with end stage renal disease, receiving dialysis. Cinacalcet hydrochloride should be used as an adjunctive therapy.
Package - Contents - Shelf Life: Blister pack, PVC/PCTFE/Al blisters - 28 tablets - 60 months from date of manufacture, no storage statement needed
2017-08-14
CINACALCET Devatis 30 mg/60 mg/90 mg Film Coated Tablets MODULE 1.3.2 CONSUMER MEDICINE INFORMATION (CMI) DEVATIS LIMITED Property-Strictly confidential Page 1 / 6 Version: V03/December 2021 CINACALCET DEVATIS 30 MG, 60 MG & 90 MG FILM COATED TABLETS _Cinacalcet hydrochloride _ _ _ CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET Please read this leaflet carefully before you start using CINACALCET Devatis Film Coated Tablets. This leaflet answers some common questions about CINACALCET Devatis Film Coated Tablets. 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 CINACALCET Devatis Film Coated Tablets against the benefits he/she expects it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING CINACALCET DEVATIS FILM COATED TABLETS, ASK YOUR DOCTOR, NURSE OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE . You may need to read it again. WHAT CINACALCET DEVATIS FILM COATED TABLETS IS USED FOR CINACALCET is used to treat: a condition called secondary hyperparathyroidism (high-per-pear-a-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, PTH keeps your calcium and phosphorus levels normal by moving the right amounts of calcium and phosph Belgenin tamamını okuyun
CINACALCET Devatis 30 mg/60 mg/90 mg Film Coated Tablets MODULE 1.3.1 NEW ZEALAND DATA SHEET DEVATIS LIMITED Property-Strictly confidential Page 1 / 15 Version: V04/December 2021 NEW ZEALAND DATA SHEET 1. PRODUCT NAME CINACALCET Devatis 30 mg, 60 mg & 90 mg Film-Coated Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE: Each 30 mg tablet contains 33.06 mg of cinacalcet hydrochloride (equivalent to 30 mg cinacalcet). Each 60 mg tablet contains 66.12 mg of cinacalcet hydrochloride (equivalent to 60 mg cinacalcet). Each 90 mg tablet contains 99.18 mg of cinacalcet hydrochloride (equivalent to 90 mg cinacalcet). EXCIPIENT WITH KNOWN EFFECT: Each 30 mg tablet contains 0.3 mg of lactose Each 60 mg tablet contains 0.6 mg of lactose Each 90 mg tablet contains 0.9 mg of lactose For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Light green, oval film-coated tablets, marked with “30”, “60” or “90” on one side respectively. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS CINACALCET Devatis may be used to treat the biochemical manifestations of secondary hyperparathyroidism in patients with end stage renal disease, receiving dialysis. CINACALCET Devatis should be used as adjunctive therapy. CINACALCET Devatis is indicated for the treatment of hypercalcemia in patients with parathyroid carcinoma. CINACALCET Devatis 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 _DOSE _ PATIENTS WITH END STAGE RENAL DISEASE RECEIVING DIALYSIS_ _ CINACALCET Devatis reduces PTH while simultaneously lowering Ca×P, calcium and phosphorus levels in patients receiving dialysis. _ _ The recommended starting dose for adults is 30 mg once per day. _ _ CINACALCET Devatis should be titrated every 2 to 4 weeks to a maximum dose of 180 mg once daily to achieve a target PTH between 15.9 and 31.8 pmol/L (150-300 pg/mL). _ _ In chronic kidney dis Belgenin tamamını okuyun