Երկիր: Մալայզիա
Լեզու: անգլերեն
Աղբյուրը: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
BUSERELIN ACETATE
SANOFI-AVENTIS (MALAYSIA) SDN. BHD.
BUSERELIN ACETATE
2Units Units; 1 Units Units
Sanofi-Aventis Deutschland GmbH
Suprefact Inj_PI (May 2011) 1 This package insert is continually updated: please read carefully before using a new pack. SUPREFACT ® Buséréline /Buserelin Solution injectable / Solution for injection Composition Active substance: buserelin. Solution for injection Each ml of the solution for injection contains 1.05 mg buserelin acetate equivalent to 1 mg buserelin. Excipients: Benzyl alcohol (preservative), sodium dihydrogen phosphate, sodium chloride, sodium hydroxide, water for injections. Contains sodium, but less than 1 mmol (23 mg) sodium per ml. As this preparation contains benzyl alcohol, it's use should be avoided in children under 2 years of age. Not to be used in neonates Pharmacodynamic Properties Pharmacotherapeutic group: Gonadotropin releasing hormone analogue ATC code: L02A E01 Buserelin is a highly active analogue of the natural gonadotropin-releasing hormone (gonadorelin; GnRH, LHRH). The initial pharmacological effect of buserelin is to stimulate gonadotropin release and testosterone secretion. This is followed by a progressive decrease in testosterone into the castrate range. While gonadotropin release is inhibited during continued treatment with buserelin, the secretion of the other pituitary hormones (growth hormone, prolactin, ACTH, TSH) is not directly influenced. The secretion of adrenal steroids remains unchanged. In terms of removing testosterone stimulation of tumour tissue, buserelin is as effective as orchiectomy in the treatment of prostatic carcinoma. Pharmacokinetic properties Buserelin is water-soluble. When administered by subcutaneous injection, it is reliably absorbed. Buserelin circulates in serum predominantly in intact, active form. Protein binding is about 15%. According to preclinical data, buserelin preferentially accumulates in the liver and kidneys as well as in the anterior pituitary – the biological target organ. The elimination half-life after intravenous administration is about 50 to 80 minutes, 80 minutes after subcutaneous administration. Buserelin and its ina Կարդացեք ամբողջական փաստաթուղթը