Χώρα: Μαλαισία
Γλώσσα: Αγγλικά
Πηγή: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
SALCATONIN/CALCITONIN SALMON
ZUELLIG PHARMA SDN BHD
SALCATONIN/CALCITONIN SALMON
5Units Units
NOVARTIS PHARMA STEIN AG
Novartis Page 1 Malaysian Package Leaflet 01 Jul 2014 Miacalcic Ampoules Miacalcic Ampoules Regulator of calcium homeostasis DESCRIPTION AND COMPOSITION Pharmaceutical forms Miacalcic ® is available as a solution for injection or infusion in: • ampoules (1 mL) containing 50 IU/mL or 100 IU/mL. Active substance The active substance is synthetic salmon calcitonin (INN name Calcitonin). One millilitre contains 50 IU or 100 IU of synthetic salmon calcitonin. One International Unit (= IU) corresponds to about 0.2 micrograms of synthetic salmon calcitonin. Certain dosage strengt hs may not be available in all countries. Active moiety Salmon calcitonin. Excipients Acetic acid, sodium acetate trihydrate, sodium chloride, water for injections. INDICATIONS Miacalcic solution for injection or infusion is indicated for: Prevention of ac ute bone loss due to sudden immobilization such as in patients with recent osteoporotic fractures. The duration of treatment should not be more than 4 weeks. For the treatment of Paget’s disease, only in patients who do not respond to alternative treatments or for whom such treatments are not suitable, for example those with severe renal impairment. The duration of treatment is limited to 3 months. Treatement of hypercalcaemia of malignancy. DOSAGE AND ADMINISTRATION Due to the association between long- term calcitonin use and the onset of malignancies (see "Warnings and P recautions"), treatment with calcitonin in all indications should be limited to the shortest period of time possible and using the lowest effective dose. Prevention of Osteoporosis The lowest effective dose is not yet precisely known. The following dosage is currently recommended: Διαβάστε το πλήρες έγγραφο