SUPREFACT INJECTION SOLUTION

Land: Malaysia

Språk: engelska

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

Aktiva substanser:

BUSERELIN ACETATE

Tillgänglig från:

SANOFI-AVENTIS (MALAYSIA) SDN. BHD.

INN (International namn):

BUSERELIN ACETATE

Enheter i paketet:

2Units Units; 1 Units Units

Tillverkad av:

Sanofi-Aventis Deutschland GmbH

Produktens egenskaper

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