Testosterone enantate 250mg/1ml solution for injection ampoules

国家: 英国

语言: 英文

来源: MHRA (Medicines & Healthcare Products Regulatory Agency)

有效成分:

Testosterone enantate

可用日期:

Alliance Pharmaceuticals Ltd

ATC代码:

G03BA03

INN（国际名称）:

Testosterone enantate

剂量:

250mg/1ml

药物剂型:

Solution for injection

给药途径:

Intramuscular

类:

Schedule 4 (CD Anab)

处方类型:

Valid as a prescribable product

產品總結:

BNF: 06040200; GTIN: 5024403000233

资料单张

Testosterone PIL UK 007
PATIENT INFORMATION LEAFLET
TESTOSTERONE ENANTATE 250MG/ ML SOLUTION FOR INJECTION
Testosterone Enantate
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 any further questions, ask your doctor or 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. See
section
4.
WHAT IS IN THIS LEAFLET
1.
What Testosterone Enantate is and what it is used for
2. What you need to know before you use Testosterone Enantate
3. How to use Testosterone Enantate
4. Possible side effects
5.
How to store Testosterone Enantate
6.
Contents of the pack and other information
1. WHAT TESTOSTERONE ENANTATE IS AND WHAT IT IS USED FOR
Testosterone Enantate is a manufactured version of the naturally
occurring
male sex hormone, testosterone.
It 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
•
Bone loss caused by low hormone levels.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE TESTOSTERONE ENANTATE
Testosterone PIL UK 007
DO NOT USE TESTOSTERONE ENANTATE:
•
if you are allergic to Testosterone Enantate or any of the other
ingredients of this medicine (listed in section 6)
•
if you suffer from androgen (steroid hormone) dependent prostate
cancer or breast cancer
•
if you have high calcium levels in your blood
•
if you have or have had tumours of the liver
•
if you have kidney disease (nephrosis)
WARNINGS AND PRECAUTIONS
TALK TO YOUR DOCTOR BEFORE USING

产品特点

OBJECT 1
TESTOSTERONE ENANTATE AMPOULES
Summary of Product Characteristics Updated 02-Dec-2016 | Alliance
Pharmaceuticals
1. Name of the medicinal product
Testosterone Enantate 250 mg/ ml Solution for Injection.
2. Qualitative and quantitative composition
Each 1ml ampoule contains 250mg Testosterone Enantate (the equivalent
of about 180 mg testosterone)
in oily solution.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for injection.
Clear, yellowish oily 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.
4.2 Posology and method of administration
METHOD OF ADMINISTRATION
Solution for intramuscular injection.
The injection must be administered extremely slowly (see 4.4 Special
warnings and precautions for use
and 4.8 Undesirable effects). The oily solution is injected
immediately after its drawing up into the
syringe.
POSOLOGY
To stimulate development of underdeveloped androgen-dependent organs
and for initial treatment of
deficiency symptoms, 250mg Testosterone Enantate intramuscularly every
two to three weeks.
For maintenance treatment: 250mg Testosterone Enantate intramuscularly
every three to six weeks,
according to individual requirement.
Serum testosterone levels should be measured before start of treatment
and occasionally during the
treatment at the end of an injection interval. Serum levels below
normal range would indicate the need for
a shorter injection interval. In case of high serum levels an
extension of the injection interval may be
considered.
SPECIAL POPULATIONS
PAEDIATRIC POPULATION
Testosterone Enantate is not indicated for use in children and
adolescents (see 4.4 Special warnings and
precautions for use).
Safety and efficacy have not been adequately determined in children
and adolescents.
ELDERLY PATIENTS
Limited data do not suggest the need for a dosage adjustment in
elderly patients (see 4.4 Special war