SUPREFACT DEPOT 3 MONTHS IMPLANT

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

BUSERELIN (BUSERELIN ACETATE)

제공처:

CHEPLAPHARM ARZNEIMITTEL GMBH

ATC 코드:

L02AE01

INN (International Name):

BUSERELIN

복용량:

9.45MG

약제 형태:

IMPLANT

구성:

BUSERELIN (BUSERELIN ACETATE) 9.45MG

관리 경로:

SUBCUTANEOUS

패키지 단위:

3 IMPLANTS

처방전 유형:

Prescription

치료 영역:

ANTINEOPLASTIC AGENTS

제품 요약:

Active ingredient group (AIG) number: 0117891003; AHFS:

승인 상태:

APPROVED

승인 날짜:

1999-09-02

제품 특성 요약

1
PRODUCT MONOGRAPH
PR
SUPREFACT
® DEPOT 2 MONTHS
Buserelin acetate implant
buserelin base 6.3 mg
and
PR
SUPREFACT
® DEPOT 3 MONTHS
Buserelin acetate implant
buserelin base 9.45 mg
Luteinizing Hormone-Releasing Hormone (LH-RH) Analogue
CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 24
17489 Greifswald
Germany
Date of Revision: June 3, 2020
Distributed by
Xediton Pharmaceuticals Inc.
2000 Argentia Rd, Mississauga
Ontario L5N 1W1
Tel: 1-888-XEDITON
Submission Control No.: 237855
PRODUCT MONOGRAPH
2
PR
SUPREFACT
® DEPOT 2 MONTHS
Buserelin acetate implant
buserelin base 6.3 mg
and
PR
SUPREFACT
® DEPOT 3 MONTHS
Buserelin acetate implant
buserelin base 9.45 mg
PHARMACOLOGIC CLASSIFICATION
Luteinizing Hormone-Releasing Hormone (LH-RH) Analogue
ACTION AND CLINICAL PHARMACOLOGY
Buserelin acetate is a synthetic peptide analogue of the natural
gonadotropin releasing hormone
(GnRH/LH-RH). The substitution of glycine in position 6 by D-serine,
and that of glycinamide in
position 10 by ethylamide, leads to a nonapeptide with a greatly
enhanced LH-RH effect. The
effects of buserelin on follicle stimulating hormone (FSH) and
luteinizing hormone (LH) release
are 20 to 170 times greater than those of LH-RH. Buserelin also has a
longer duration of action
than natural LH-RH.
Investigations in healthy adult males and females have demonstrated
that the increase in plasma
LH and FSH levels persists for at least 7 hours and that a return to
basal values requires about 24
hours.
Clinical inhibition of gonadotropin release, and subsequent reduction
of serum testosterone or
estradiol to castration level, was found when large pharmacologic
doses (50-500 mcg SC/day or
300-1200 mcg IN/day) were administered for periods greater than 1 to 3
months. Chronic
administration of such doses of buserelin results in sustained
inhibition of gonadotropin
production, suppression of ovarian and testicular steroidogenesis and,
ultimately, reduced
circulating levels of gonadotropin and gonadal steroids. These effects
form the basis for buserelin
use in patients