Primoteston Depot 250mg/1mL Injection Syringe

Χώρα: Αυστραλία

Γλώσσα: Αγγλικά

Πηγή: Department of Health (Therapeutic Goods Administration)

Δραστική ουσία:

testosterone enantate, Quantity: 250 mg/mL (Equivalent: testosterone, Qty 180 mg/mL)

Διαθέσιμο από:

Bayer Australia Ltd

Φαρμακοτεχνική μορφή:

Injection

Σύνθεση:

Excipient Ingredients: benzyl benzoate; Castor Oil

Οδός χορήγησης:

Intramuscular

Μονάδες σε πακέτο:

3 x 1mL

Kατηγορία:

Medicine Registered

Τρόπος διάθεσης:

(S4) Prescription Only Medicine

Θεραπευτικές ενδείξεις:

INDICATIONS AS AT 15 FEB 1996 : Androgen replacement therapy for confirmed testosterone deficiency in males.

Περίληψη προϊόντος:

Visual Identification: Clear colourless to faintly yellowish liquid; Container Type: Syringe; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Καθεστώς αδειοδότησης:

Registered

Ημερομηνία της άδειας:

1991-08-19

Φύλλο οδηγιών χρήσης

PRIMOTESTON® DEPOT CMI VX1
1
PRIMOTESTON
®
DEPOT
(PREE·MO·TEST·ON)
_testosterone enantate _
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some common
questions about Primoteston Depot.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using Primoteston
Depot against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT PRIMOTESTON
DEPOT IS USED FOR
Primoteston Depot is used to
replace the body’s natural hormone
testosterone when not enough is
made by the body.
Testosterone is a natural hormone,
known as an androgen, which
controls normal sexual
development and function in men.
Testosterone is essential for the
development and maintenance of
the male reproductive organs as
well as other male characteristics,
such as facial and body hair
growth, deep voice, sexual drive,
muscle mass and body fat
distribution.
The depot effect of testosterone
enantate permits long intervals
between injections. An injection of
Primoteston Depot can maintain its
effect for 2-4 weeks, depending on
your initial hormonal status.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED FOR
YOU.
Your doctor may have prescribed it
for another reason.
BEFORE YOU ARE
GIVEN PRIMOTESTON
DEPOT
_WHEN YOU MUST NOT BE _
_GIVEN IT _
DO NOT USE PRIMOTESTON DEPOT IF
YOU HAVE AN ALLERGY TO:
•
testosterone enantate, the active
ingredient in Primoteston Depot
•
any of the ingredients listed at the
end of this leaflet.
Some of the symptoms of an
allergic reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
rash, itching or hives on the skin
DO NOT USE PRIMOTESTON DEPOT IF
YOU HAVE:
•
prostate cancer
•
breas

Αρχείο Π.Χ.Π.

AUSTRALIAN PRODUCT INFORMATION
PRIMOTESTON® DEPOT
Primoteston® depot PI VX1; CCDS 9
Page 1 of 7
1 NAME OF THE MEDICINE
Testosterone enantate
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 mL Primoteston Depot contains 250 mg testosterone enantate
(equivalent to approximately
180 mg testosterone).
Primoteston Depot contains: benzyl benzoate
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3 PHARMACEUTICAL FORM
Solution for injection
In clear, yellowish oily solution
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Androgen replacement therapy for confirmed testosterone deficiency in
males.
4.2 DOSE AND METHOD OF ADMINISTRATION
Like all oily solutions, Primoteston Depot must be injected
intramuscularly, immediately after
drawing up into the syringe, and extremely slowly (see 4.4 Special
warnings and precautions for
use).
For the development and stimulation of still underdeveloped
androgen-dependent target organs
and for the initial treatment of deficiency symptoms: 1 prefilled
syringe i.m. every 2-3 weeks.
To maintain an adequate androgenic effect, 1 prefilled syringe i.m.
every 3-4 weeks. Shorter
injection intervals may be necessary depending on the individual
requirement for hormone, but
longer intervals of up to 6 weeks are also sufficient in many cases.
Serum testosterone levels should be measured before start of treatment
and periodically during
the treatment as recommended by current treatment guidelines.
The product should be inspected visually for particles prior to
administration. Only clear solution
free from particles should be used.
4.3 CONTRAINDICATIONS
Prostatic carcinoma, mammary carcinoma in males. Hypercalcaemia
accompanying malignant
tumours. Previous or existing liver tumours.
Hypersensitivity to any of the ingredients.
Primoteston® depot PI VX1; CCDS 9
Page 2 of 7
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
The general aim of androgen replacement therapy for confirmed
testosterone deficiency in males
is to keep serum testosterone levels within the reference range for
the