DECA DURABOLIN INJ 100MG/ML SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

NANDROLONE DECANOATE

Available from:

SCHERING-PLOUGH CANADA INC

ATC code:

A14AB01

INN (International Name):

NANDROLONE

Dosage:

100MG

Pharmaceutical form:

SOLUTION

Composition:

NANDROLONE DECANOATE 100MG

Administration route:

INTRAMUSCULAR

Units in package:

2ML

Prescription type:

Schedule G (CDSA IV)

Therapeutic area:

ANDROGENS

Product summary:

Active ingredient group (AIG) number: 0106422002; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2010-07-26

Summary of Product characteristics

1 PRODUCT MONOGRAPH
DECA-DURABOLIN7
(nandrolone decanoate injection)
U.S.P.
ANDROGEN - ANABOLIC
Schering Plough Canada Inc.
Date of Preparation:
16750 TransCanada Highway
December 15, 2008
Kirkland, QC H9H 4M7
Control#: 126649
2
PRODUCT MONOGRAPH
DECA-DURABOLIN
7
(nandrolone decanoate injection)
U.S.P.
Androgen-Anabolic
ACTIONS AND CLINICAL PHARMACOLOGY
Anabolic steroids are synthetic derivatives of testosterone.
DECA-DURABOLIN
7
(nandrolone decanoate injection) is primarily used for its protein
anabolic
effect and its catabolic inhibiting effect on tissue. Nitrogen balance
is improved with anabolic
agents but only when there is sufficient intake of calories and
protein. Whether this positive
nitrogen balance is of primary benefit in the utilization of
protein-building dietary substances has not
been established.
Increases in hemoglobin levels have occurred in some cases of aplastic
anemia receiving anabolic
steroids.
Certain clinical effects and adverse reactions demonstrate the
androgenic properties of this class of
drugs. Complete dissociation of anabolic and androgenic effects has
not been achieved. The actions
of anabolic steroids are therefore similar to those of male sex
hormones with the possibility of
causing serious disturbances of growth and sexual development if given
to young children. They
suppress the gonadotropic functions of the pituitary and may exert a
direct effect upon the testes.
Human growth hormone is preferred treatment of pituitary dwarfism.
If human growth hormone is not available, anabolic agents may be used
to treat this condition.
3
PHARMACOKINETICS
DECA-DURABOLIN
7
(nandrolone decanoate injection) is slowly released from the injection
site
into the blood with a half-life of 6 days. In the blood, the ester is
rapidly hydrolysed to nandrolone
with a half-life of one hour or less. The half-life for the combined
process nandrolone decanoate and
of the distribution and elimination of nandrolone is 4.3 hours.
Nandrolone is metabolised by the
liver. 19-Norandrosterone, 19-noretiocholanolon