DECA-DURABOLIN ORGAJECT 50mg/1mL injection ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

nandrolone decanoate, Quantity: 50 mg/mL

Available from:

Aspen Pharmacare Australia Pty Ltd

INN (International Name):

Nandrolone decanoate

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: Arachis Oil; benzyl alcohol

Administration route:

Intramuscular

Units in package:

1 ampoule

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

INDICATIONS AS AT 16 APRIL 1997. Acute renal failure, chronic renal insufficiency and anaemia of chronic renal failure. For the palliative treatment of inoperable mammary carcinoma. Osteoporosis (where oestrogen therapy is contraindicated). Aplastic anaemia. Patients on long-term treatment with corticosteriods.

Product summary:

Visual Identification: Clear oily liquid; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2017-03-08

Summary of Product characteristics

-1-
PRODUCT INFORMATION
DECA-DURABOLIN
®
_(nandrolone decanoate)_
NAME OF THE MEDICINE
DECA-DURABOLIN
®
50 MG/ML (Solution for injection of nandrolone decanoate)
_Molecular Formula: C_
_28_
_H_
_44_
_O_
_3 _
_Molecular mass: 428.7 Cas. No: 360-70-3_
_Chemical Name: _
_3-oxo-estr-4-en-17_
β
_-yl _
_decanoate_
Deca-Durabolin is an androgenic oily preparation for intramuscular
administration.
DESCRIPTION
Nandrolone decanoate is a white to creamy white, crystalline powder.
It is practically insoluble in water
but is freely soluble in chloroform, ethanol, ether, fixed oils and
esters.
Deca-Durabolin comes in glass ampoules containing 1 mL of light yellow
oily liquid. Each
ampoule contains 1 ml of 50 mg/mL nandrolone decanoate.
COMPOSITION
Each ml of Deca-Durabolin contains 50 mg of the active ingredient
nandrolone decanoate.
The
product
also contains the inactive ingredients benzyl alcohol (0.1 mL) and
arachis (peanut) oil making
up the volume.
PHARMACOLOGY
PHARMACODYNAMIC PROPERTIES
Deca-Durabolin is an injectable anabolic preparation. The
pharmacologically active substance is
nandrolone. The decanoate ester gives the preparation a duration of
action of about three weeks after
injection.
Nandrolone is chemically related to the male hormone. Compared to
testosterone, it has an enhanced
anabolic and a reduced androgenic activity. This has been demonstrated
in animal bioassays and
explained by receptor binding studies. The low androgenicity of
nandrolone is confirmed in clinical
use. In the human, Deca-Durabolin has been shown to positively
influence calcium metabolism and to
increase bone mass in osteoporosis. In women with disseminated mammary
carcinoma, Deca-
Durabolin has been reported to produce objective regressions for many
months. Furthermore, Deca-
Durabolin has a nitrogen-saving action. This effect on protein
metabolism has been established by
-2-
metabolic studies and is utilised therapeutically in conditions where
a protein deficiency exists such as
during chronic debilitating diseases and after major sur