Deca-Durabolin 50mg/1ml solution for injection ampoules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Nandrolone decanoate

Available from:

Aspen Pharma Trading Ltd

ATC code:

A14AB01

INN (International Name):

Nandrolone decanoate

Dosage:

50mg/1ml

Pharmaceutical form:

Solution for injection

Administration route:

Intramuscular

Class:

Schedule 4 (CD Anab)

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 06040300; GTIN: 5013257001183

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DECA-DURABOLIN 50 MG/ML SOLUTION FOR
INJECTION (NANDROLONE DECANOATE)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE THIS MEDICINE IS
ADMINISTERED BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or your pharmacist.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may
harm
them, even if their signs of illness are the same as yours.
•
If you get any side effects talk to your doctor or pharmacist or
nurse. This includes any
possible side
effects not listed in this leaflet.
WHAT IS IN THIS LEAFLET:
1.
WHAT DECA-DURABOLIN IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE DECA-DURABOLIN IS GIVEN TO YOU
3.
HOW DECA-DURABOLIN IS GIVEN TO YOU
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE DECA-DURABOLIN
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT DECA-DURABOLIN IS AND WHAT IT IS USED FOR
Deca-Durabolin is a clear yellow oily solution for injection
containing 50 mg/ml of the active
ingredient nandrolone decanoate.
The active substance, nandrolone decanoate belongs to the group of
medicines known as
anabolic steroids that help to prevent bone loss.
Deca-Durabolin is used in osteoporosis, when bones thin and become
brittle, after the
menopause.
2.
WHAT YOU NEED TO KNOW BEFORE DECA-DURABOLIN IS GIVEN TO YOU
DO NOT RECEIVE DECA-DURABOLIN:
•
If you are pregnant or think you may be pregnant (see section 2
“pregnancy,
breast- feeding and fertility”).
•
If you are allergic (hypersensitive) to nandrolone decanoate or any of
the ingredients
of this medicine (listed in section 6 “What Deca-Durabolin
contains”).
•
In children under the age of 3 years.
•
If you have porphyria (an inherited blood disorder)
If you are allergic to peanuts or soya (see section 2 "Important
information about some of
the ingredients of Deca-Durabolin").
TAKE SPECIAL CARE WITH DECA-DURABOLIN:
If you notice any signs of masculinization (for insta

Summary of Product characteristics

OBJECT 1
DECA-DURABOLIN 50 MG/ML SOLUTION FOR INJECTION
Summary of Product Characteristics Updated 16-Jun-2016 | Aspen
1. Name of the medicinal product
Deca-Durabolin 50mg/ml
2. Qualitative and quantitative composition
Each ampoule contains 1 ml of 50 mg/ml nandrolone decanoate For the
full list of excipients, see section
6.1.
3. Pharmaceutical form
Solution for injection
Clear, yellow, oily solution
4. Clinical particulars
4.1 Therapeutic indications
For use in osteoporosis in post-menopausal women
Established osteoporosis should have been diagnosed by the following
parameters:
i) crush or wedge fractures of the vertebrae
ii) other osteoporotic fractures
iii) established reduction in bone mineral content as measured by
accepted BMC measurements.
4.2 Posology and method of administration
Posology:
_Post-menopausal women_
50mg every three weeks
The duration of treatment depends on the clinical response and the
possible occurrence of side-effects.
We would recommend that the effectiveness of therapy be monitored with
the appropriate methods for
osteoporosis on a 6-12 monthly basis.
Method of administration:
Deca-Durabolin should be administered by deep intramuscular injection
4.3 Contraindications
Pregnancy (see section 4.6).
Breast-feeding
Porphyria
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:
• Hematocrit and hemoglobin to exclude polycythemia.
Conditions that need supervision:
Patients, especially the elderly, with the following conditions should
be monitored for:
• TUMOURS - Mammary carcinoma, hypernephroma, bronchial carcinoma
and skeletal metastases. In
these patients hypercalcaemia or hypercalc