欣得泰凍晶注射劑3毫克

Country: Թայվան

language: չինարեն

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

active_ingredient:

CETRORELIX ACETATE

MAH:

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_code:

H01CC02

pharmaceutical_form:

凍晶注射劑

composition:

CETRORELIX ACETATE (9200042810) (3.12-3.24 MG)MG

units_in_package:

小瓶;;注射針筒

class:

製　劑

prescription_type:

須由醫師處方使用

manufactured_by:

ABBOTT BIOLOGICALS B.V. VEERWEG 12,8121 AA OLST,THE NETHERLAND NL

therapeutic_area:

cetrorelix

therapeutic_indication:

預防接受卵巢強效刺激排卵治療的患者，早發性的排出不成熟的卵。

leaflet_short:

註銷日期: 2017/04/14; 註銷理由: 許可證已逾有效期; 有效日期: 2016/08/01; 英文品名: CETROTIDE 3MG

authorization_status:

已註銷

authorization_date:

2001-08-01

PIL

3 mg
powder and solvent for solution for injection
Active substance: Cetrorelix acetate
Composition
One vial with 167.7 mg powder containing as active substance 3.12 -
3.24 mg cetrorelix acetate equivalent to 3 mg cetrorelix.
Additionally, the
powder contains mannitol as excipient.
One pre-filled syringe containing 3 ml water for injections.
1028702
5662-0130
Pharmaceutical form
Cetrotide
®
3 mg is a powder for solution for injection.
Pharmacotherapeutic group
Cetrotide
®
3 mg inhibits the effects of a natural hormone, called luteinising
hormone releasing hormone (LHRH). LHRH regulates the secret ion of
another hormone, called luteinising hormone (LH), which induces
ovulation during the menstrual cycle. Cetrotide
®
3 mg inhibits premature ovulation
which is undesirable during hormone treatment for ovarian stimulation
as only mature egg cells are suitable for fertilisation.
Indications
Prevention of premature ovulation in patients undergoing a controlled
ovarian stimulation, followed by oocyte pick-up and assisted
reproductive
techniques.
In clinical trials Cetrotide
®
3 mg was used with human menopausal gonadotropin (HMG), however,
limited experience with recombinant FSH suggested
similar efficacy.
Contra-indications
•
Hypersensitivity to cetrorelix acetate, extrinsic peptide hormones or
mannitol.
•
Pregnancy and lactation.
•
Postmenopausal women.
•
Patients with moderate and severe renal and hepatic impairment.
Pregnancy and lactation
Cetrotide
®
3 mg is not intended to be used during pregnancy and lactation (see
section ”Contra-indications”).
Studies in animals have indicated that cetrorelix exerts a dose
related influence on fertility, reproductive performance and
pregnancy. No teratogenic
effects occurred when the drug was administered during the sensitive
phase of gestation.
Special warnings and special precautions for use
During or following ovarian stimulation an ovarian hyperstimulation
syndrome can occur. This event must be considered as an intrinsic risk
of the
stimulation procedure wit