Asporelix 0.25 (Cetrorelix 0.25mg Powder and Solvent for Solution for Injection)

Quốc gia: Malaysia

Ngôn ngữ: Tiếng Anh

Nguồn: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Thành phần hoạt chất:

CETRORELIX

Sẵn có từ:

BSV BIOSCIENCE MALAYSIA SDN. BHD.

INN (Tên quốc tế):

CETRORELIX

Các đơn vị trong gói:

1 Vials; 1mL x 1 Ampoules

Sản xuất bởi:

Bharat Serums and Vaccines Limited

Đặc tính sản phẩm

For Subcutaneous use only
For Single use only
SIZE: 200 X 200 MM
IN90305E1MY
For the use of a Registered Medical Practitioner or a Hospital or a
Laboratory only.
BLACK COLOUR
Paper : 40 gsm, ITC Print Paper
Outline & Cutting marks not to print
Artwork Code No. : IN90305E1MY
Back to Back Printing
1 Vertical & 3 Horizontal Folds
DOSAGE FORM:
Powder and Solvent for Solution for Injection.
COMPOSITION:
Each vial contains:
Cetrorelix (as acetate) ……........ 0.25 mg
(Lyophilized)
Excipients: Mannitol BP
DESCRIPTION:
Asporelix 0.25 (Cetrorelix 0.25mg Powder): A white to off white
lyophilized cake or powder
Sterile Water for Injection 1mL (Diluent): A clear colourless liquid,
odourless.
After reconstitution: The solid dissolves completely, leaving no
visible residue as un-dissolved matter. The
constituted solution should not significantly less clear than equal
volume of water for injection contained in a
similar vessel and examined similarly. The pH of reconstituted
solution is between 4.0 to 6.0
PHARMACODYNAMICS:
Pharmacotherapeutic group: anti-gonadotropin-releasing hormones, ATC
code: H01CC02.
Mechanism of Action
Cetrorelix is a luteinising hormone releasing hormone (LHRH)
antagonist. LHRH binds to membrane
receptors on pituitary cells. Cetrorelix competes with the binding of
endogenous LHRH to these receptors.
Due to this mode of action, cetrorelix controls the secretion of
gonadotropins (LH and FSH).
Cetrorelix dose-dependently inhibits the secretion of LH and FSH from
the pituitary gland. The onset of
suppression is virtually immediate and is maintained by continuous
treatment, without initial stimulatory
effect.
Clinical efficacy and safety
In females, cetrorelix delays the LH surge and consequently ovulation.
In women undergoing ovarian
stimulation the duration of action of cetrorelix is dose dependent. At
a dose of 0.25 mg per injection repeated
injections every 24 hours will maintain the effect of cetrorelix.
The antagonistic hormonal effects of cetrorelix is fully reversible
after termination of treatment.