帥健注射劑8公絲

Nchi: Taiwani

Lugha: Kichina

Chanzo: 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)

Viambatanisho vya kazi:

SOMATROPIN (r-hGH)

Inapatikana kutoka:

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)

ATC kanuni:

H01AC01

Dawa fomu:

凍晶乾燥注射劑

Tungo:

SOMATROPIN (r-hGH) (6828001040) IU (I

Vitengo katika mfuko:

小瓶裝附等瓶數瓶裝溶劑;;盒裝

Darasa:

菌　疫

Dawa ya aina:

限由醫師使用

Viwandani na:

MERCK SERONO S.P.A. VIA DELLE MAGNOLIE 15, ZONA INDUSTRIALE DI MODUGNO, 70026 MODUGNO, ITALY IT

Eneo la matibabu:

somatropin

Matibabu dalili:

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。

Bidhaa muhtasari:

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

Idhini hali ya:

已註銷

Idhini ya tarehe:

2000-09-20

Taarifa za kipeperushi

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,