SUPREFACT DEPOT 2 MONTHS IMPLANT

Country: Kanada

Tungumál: enska

Heimild: Health Canada

Virkt innihaldsefni:

BUSERELIN (BUSERELIN ACETATE)

Fáanlegur frá:

CHEPLAPHARM ARZNEIMITTEL GMBH

ATC númer:

L02AE01

INN (Alþjóðlegt nafn):

BUSERELIN

Skammtar:

6.3MG

Lyfjaform:

IMPLANT

Samsetning:

BUSERELIN (BUSERELIN ACETATE) 6.3MG

Stjórnsýsluleið:

SUBCUTANEOUS

Einingar í pakka:

2 IMPLANTS

Gerð lyfseðils:

Prescription

Lækningarsvæði:

ANTINEOPLASTIC AGENTS

Vörulýsing:

Active ingredient group (AIG) number: 0117891002; AHFS:

Leyfisstaða:

APPROVED

Leyfisdagur:

2020-06-04

Vara einkenni

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