国家: 马来西亚
语言: 英文
来源: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
CALCITONIN SALMON
ZUELLIG PHARMA SDN BHD
CALCITONIN SALMON
5 Ampoules
Solupharm Pharmazeutische Erzeugnisse GmbH
NT Pharma SmPC_Malaysia _Reference: Malaysia Package Insert Sept-15 (Swiss-26-Mar-15) Author: Rghuram A, Kappel J, Zhang S, Tracking No. 2014-_ _PSB/G>C-0696-s, Date of Release: 03-Jun 2014 _ 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 strengths 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 acute 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. Treatment of hypercalcaemia of malignancy. DOSAGE AND ADMINISTRATION Due to the association between long-term calcitonin use and the onset of malignancies (see "Warnings and Precautions"), 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: NT Pharma SmPC_Malaysia _Reference: Malaysia Package Insert Sept-15 (Swiss-26-Mar-15) Author: Rghuram A, Kappel J, Zhang S, Tracking No. 2014-_ _PSB/G>C-0696-s, Date of Release: 03-Jun 2014 _ The standard maintenance dose i 阅读完整的文件