Страна: Тайвань
мова: китайська
Джерело: 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)
SOMATROPIN (r-hGH)
台灣默克股份有限公司 台北市內湖區堤頂大道2段89號6樓 (23526610)
H01AC01
凍晶乾燥注射劑
SOMATROPIN (r-hGH) (6828001040) IU (I
小瓶裝附等瓶數瓶裝溶劑;;盒裝
菌 疫
限由醫師使用
MERCK SERONO S.P.A. VIA DELLE MAGNOLIE 15, ZONA INDUSTRIALE DI MODUGNO, 70026 MODUGNO, ITALY IT
somatropin
腦下垂體生長激素分泌不足、其他GONADOL DYSGENESIS(TURNER’S SYNDROME)所導致之生長遲滯、青春期前因慢性腎臟衰竭導致之生長遲滯。成人生長激素嚴重分泌不足之補充療法。低出生體重兒(Small for Gestational Age;SGA)逾四歲者之生長障礙。
註銷日期: 2022/06/21; 註銷理由: 許可證已逾有效期; 有效日期: 2020/09/20; 英文品名: SAIZEN 8MG CLICK EASY
已註銷
2000-09-20
BASED ON SOMATROPIN (SAIZEN) POWDER 8 MG CCDS SOMATROPIN (V3) 15 NOV 2016 1 NAME OF THE MEDICINAL PRODUCT Saizen 8 mg click.easy , powder and solvent for solution for injection QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial of Saizen 8 mg click.easy contains Somatropin * (recombinant human growth hormone) * produced by recombinant DNA technology in mammalian cells Reconstitution with the contents of the bacteriostatic solvent cartridge gives a concentration of 5.83 mg per ml. PHARMACEUTICAL FORM Powder and solvent for solution for injection. EXCIPIENTS: Powder: Sucrose, Phosphoric acid (for pH-adjustment), Sodium Hydroxide (for pH-adjustment) Solvent: Metacresol (as preservative 0.3% w/v) solution in water for injection CLINICAL PARTICULARS THERAPEUTIC INDICATIONS Saizen is indicated in the treatment of: • growth failure in children caused by decreased or absent secretion of endogenous growth hormone. • growth failure in girls with gonadal dysgenesis (Turner Syndrome), confirmed by chromosomal analysis. • growth failure in prepubertal children due to chronic renal failure (CRF). • growth disturbance (current height SDS <-2.5 and parental adjusted height SDS <-1) in short children born small for gestational age (SGA) with a birth weight and/or length below -2 SD, who failed to show catch-up growth (HV SDS <0 during the last year) by 4 years of age or later. • replacement therapy in adults with pronounced growth hormone deficiency as diagnosed by a single dynamic test for growth hormone deficiency. Patients must also fulfil the following criteria: _Childhood Onset: _ Patients who were diagnosed as growth hormone deficient during childhood, must be retested and their growth hormone deficiency confirmed before replacement therapy with Saizen is started. _Adult Onset: _ Patients must have growth hormone deficiency as a result of hypothalamic or pituitary disease and at least one other hormone deficiency diagnosed (except for prolactin) and adequate replacement therapy instituted, Прочитайте повний документ