DECA-DURABOLIN INJECTION 25 mgml

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

NANDROLONE DECANOATE

Available from:

DCH AURIGA SINGAPORE

ATC code:

A14AB01

Dosage:

25 mg/ml

Pharmaceutical form:

INJECTION

Composition:

NANDROLONE DECANOATE 25 mg/ml

Administration route:

INTRAMUSCULAR

Prescription type:

Prescription Only

Manufactured by:

Ever Pharma Jena GmbH (bulk and primary packager)

Authorization status:

ACTIVE

Authorization date:

1990-04-20

Patient Information leaflet

423214-A01.pdf Page 1
Lydia Kim
29/04/2014 9:13 AM
Page 1
_BY GRACE LAM AT 8:35 AM, APR 29, 2014_
423214-A01.pdf Page 2
Lydia Kim
29/04/2014 9:13 AM
Page 2

Summary of Product characteristics

NANDROLONE DECANOATE 25 mg/ml
CCDS v3 and v5
1.
NAME OF THE MEDICINAL PRODUCT
Deca-Durabolin® 25 mg/ml solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ampoule contains 1 ml of 25 mg/ml nandrolone decanoate
For the full list of excipients, see 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear, yellow, oily solution
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
•
Treatment of osteoporosis
•
For the palliative treatment of selected cases of disseminated mammary
carcinoma in
women.
•
As an adjunct to specific therapies and dietary measures in pathologic
conditions
characterized by a negative nitrogen balance
4.2
Posology and method of administration
Deca-Durabolin should be administered by deep intramuscular injection.
For treatment of osteoporosis: 50 mg once every 3 weeks
For the palliative treatment of selected cases of disseminated mammary
carcinoma in women:
50mg every 2 – 3 weeks
As an adjunct to specific therapies and dietary measures in pathologic
conditions characterized
by a negative nitrogen balance: 25-50 mg every 3 weeks.
N.B. For an optimal therapeutic effect it is necessary to administer
adequate amounts of
vitamins, minerals and protein in a calorie-rich diet.
Safety and efficacy have not been adequately determined in children
and adolescents (see
section 4.4).
4.3
Contraindications
•
Pregnancy (see Section 4.6)
•
Known or suspected carcinoma of the prostate or breast in the male
(see section 4.4)
•
Hypersensitivity to the active substance or to any of the excipients,
including arachis oil.
Deca-Durabolin is therefore contraindicated in patients allergic to
peanuts or soya (see
section 4.4)
4.4
Special warnings and precautions for use
Medical examination:
Physicians should consider monitoring patients receiving
Deca-Durabolin before the start
of treatment, at quarterly intervals for the first 12 months and
yearly thereafter for the
following parameters:
•
Digital rectal examination (DRE) of the prostate and PSA to exclude
benign
prostate hyperplas