Country: ইন্দোনেশিয়া
ভাষা: ইন্দোনেশীয়
সূত্র: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
CALCITONIN, SALMON
PYRIDAM FARMA TBK - Indonesia
CALCITONIN, SALMON
50 IU
INJEKSI
DUS, 5 AMPUL @ 1 ML
SOLUPHARM PHARMAZEUTISCHE ERZEUGNISSE GMBH - Federal Republic of Germany
2022-01-28
MIACALCIC® Ampoules Description and composition Pharmaceutical form Ampoules (1 mL) contains 50 and 100 IU of synthetic salmon calcitonin. Active substance Active ingredients: Synthetic salmon calcitonin One International Unit (=IU) corresponds to about 0.2 micrograms of the drug substance. Active moiety Salmon calcitonin. Excipients Glacial acetic acid, sodium acetate trihydrate, sodium chloride, water for Injection. Indications Miacalcic solution for injection is indicated for the treatment of: Osteoporosis in patients for whom alternative treatments are not suitable Primary osteoporosis, e.g. early and advanced stages of postmenopausal osteoporosis and senile osteoporosis in women and men. Bone pain associated with osteolysis and/or osteopenia PAGET’s disease of bone (osteitis deformans) only in patients who do not respond to alternative treatments or for whom such treatments are not suitable Hypercalcaemia and hypercalcaemic crisis due to • Tumoral osteolysis secondary to breast, lung or kidney carcinoma, myeloma and other malignancies. • Hyperparathyroidism, immobilization or vitamin D intoxication For both the acute treatment of emergencies and the prolonged treatment of chronic states, until specific therapy of the underlying condition proves effective. Neurodystropic disorders (synonymus with algodystrophy or SUDECK’S DISEASE) Due to various aetiological factors such as post-traumatic painful osteoporosis, reflex dystrophy, shoulder-arm syndrome, causalgia, drug-induced neurotrophic disorders. Dosage and administration Dosage All indications Patients should receive precise instruction in the self-administration of subcutaneous injections from the physician or the nurse. DISETUJUI OLEH BPOM : 21/01/2022 EREG100193VR12100050 - 51 Due to the association between occurrence of malignancies and long term calcitonin use (see section Special warnings and precautions for use), the treatment duration in all indications should be limited to the shortest period of time possible and using the lowest effective সম্পূর্ণ নথি পড়ুন