Sustanon 250mg/1ml solution for injection ampoules

Country: Միացյալ Թագավորություն

language: անգլերեն

source: MHRA (Medicines & Healthcare Products Regulatory Agency)

active_ingredient:

Testosterone propionate; Testosterone phenylpropionate; Testosterone decanoate; Testosterone isocaproate

MAH:

Aspen Pharma Trading Ltd

ATC_code:

G03BA03

INN:

Testosterone propionate; Testosterone phenylpropionate; Testosterone decanoate; Testosterone isocaproate

dosage:

30mg/1ml ; 60mg/1ml ; 100mg/1ml ; 60mg/1ml

pharmaceutical_form:

Solution for injection

administration_route:

Intramuscular

class:

Schedule 4 (CD Anab)

prescription_type:

Never Valid To Prescribe As A VMP

leaflet_short:

BNF: 06040200; GTIN: 5013257001671 5013945300536

PIL

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SUSTANON 250, 250 MG/ML, SOLUTION FOR INJECTION
(testosterone esters)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please 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. This
includes any possible side
effects not listed in this leaflet.
WHAT IS IN THIS LEAFLET:
1. WHAT SUSTANON 250 IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE SUSTANON 250 IS ADMINISTERED
3. HOW SUSTANON 250 IS ADMINISTERED
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE SUSTANON 250
6. CONTENTS OF THE PACK AND OTHER INFORMATION
1. WHAT SUSTANON 250 IS AND WHAT IT IS USED FOR
Sustanon 250 is a clear pale yellow solution for injection containing
the active ingredient
testosterone in 4 (250 mg/ml) separate forms. The active substances of
Sustanon 250 (see
section 6 “What Sustanon 250 contains” are turned into
testosterone by your body. Testosterone
is a natural male hormone known as an androgen.
In men, testosterone is produced by the testicles. It is necessary for
the normal growth,
development and function of the male sex organs and for secondary male
sex characteristics. It is
necessary for the growth of body hair, the development of bones and
muscles, and it stimulates
the production of red blood cells. It also makes men’s voices
deepen.
Sustanon 250 is used in adult men for testosterone replacement to
treat various health problems
caused by a lack of testosterone (male hypogonadism). This should be
confirmed by two
separate blood testosterone measurements and also include clinical
symptoms such as
impotence, infertility, low sex drive, tiredness, depressive moods and
bone loss caused by low
hormone levels.
Sustanon 250 may

SPC

OBJECT 1
SUSTANON 250, 250MG/ML SOLUTION FOR INJECTION
Summary of Product Characteristics Updated 03-Jan-2017 | Aspen
1. Name of the medicinal product
Sustanon 250, 250mg/ml solution for injection
2. Qualitative and quantitative composition
Sustanon 250 is a solution in oil. Each ampoule contains 1 ml arachis
oil containing the following active
substances:
- 30 mg Testosterone propionate
- 60 mg Testosterone phenylpropionate
- 60 mg Testosterone isocaproate
- 100 mg Testosterone decanoate
All four components are esters of the natural hormone testosterone.
The total amount of testosterone per
ml is 176 mg.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for injection
A clear, pale yellow solution
4. Clinical particulars
4.1 Therapeutic indications
Testosterone replacement therapy for male hypogonadism, when
testosterone deficiency has been
confirmed by clinical features and biochemical tests.
Testosterone administration may also be used as supportive therapy for
female-to-male transsexuals.
4.2 Posology and method of administration
POSOLOGY
In general, the dose should be adjusted to the response of the
individual patient.
_Adults (incl. elderly):_
Usually, one injection of 1ml per 3 weeks is adequate.
_Paediatric population:_
Safety and efficacy have not been adequately determined in children
and adolescents. Pre-pubertal
children treated with Sustanon 250 should be treated with caution (see
section 4.4).
_Female-to-male transsexuals:_
Different specialist centres have used doses varying from one
injection of 1ml every two weeks to one
injection of 1ml every four weeks.
Method of administration
Sustanon 250 should be administered by deep intramuscular injection.
4.3 Contraindications
• Pregnancy (see section 4.6).
• Known or suspected carcinoma of the prostate or breast (see
section 4.4.).
• Breast-feeding.
• Hypersensitivity to the active substance or to any of the
excipients listed in section 6.1, including
arachis oil. Sustanon 250 is therefore contraindicated in patien