Testogel

Land: New Zealand

Språk: engelsk

Kilde: Medsafe (Medicines Safety Authority)

Aktiv ingrediens:

Testosterone 16.2 mg/g;  

Tilgjengelig fra:

Pharmaco (NZ) Ltd

Dosering :

16.2 mg/g

Legemiddelform:

Transdermal gel

Sammensetning:

Active: Testosterone 16.2 mg/g   Excipient: Carbomer 980 Ethanol Isopropyl myristate Purified water Sodium hydroxide

Resept typen:

Prescription

Indikasjoner:

Indicated in adults as testosterone replacement therapy for male hypogonadism when testosterone deficiency has been confirmed by clinical features and biochemical tests

Produkt oppsummering:

Package - Contents - Shelf Life: Bottle, plastic, PP canister with a metered-dose pump and PP cap - 1 dose units - 36 months from date of manufacture stored at or below 30°C

Autorisasjon dato:

2022-06-08

Informasjon til brukeren

1
TESTOGEL
®
_16.2MG/G TESTOSTERONE _
_ _
_Transdermal gel _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
Please read this leaflet
carefully before you start
using TESTOGEL.
This leaflet answers some
common questions about
TESTOGEL. 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 TESTOGEL 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 with the
medicine. You may need to
read it again.
WHAT TESTOGEL IS
USED FOR
This medicine contains
testosterone, a male hormone
produced naturally in the
body.
This medicine 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
Your doctor may have
prescribed TESTOGEL for
another reason.
Ask your doctor if you have
any questions about why
TESTOGEL has been
prescribed for you.
This medicine is available
only with a doctor's
prescription.
BEFORE YOU USE
TESTOGEL
_ _
_WHEN YOU MUST NOT USE IT _
Do not use TESTOGEL if:
-
you have or are
suspected of having
prostate cancer
-
you have or are
suspected of having
breast cancer
-
you are allergic to
testosterone or any of the
other ingredients of this
medicine
-
Children and young men
under the age of 18 years
should not use this
medicine.
-
This medicine should not
be used by females of
any age.
-
Do not allow women
(especially women that
are pregnant or breast-
feeding) or children to
come into contact with
TESTOGEL gel or the
areas of skin where
TESTOGEL has been
applied.
If you are not sure whether
you should start using
TESTOGEL, talk to your
doctor.
_

Preparatomtale

NEW ZEALAND DATA SHEET
TESTOGEL-001
Nov 2023
Page 1 of 12
TESTOGEL
testosterone
1 NAME OF MEDICINE
Testogel 16.2 mg/g transdermal gel
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One gram of gel contains 16.2 mg testosterone. One pump actuation
delivers 1.25 g of gel containing
20.25 mg of testosterone.
Excipients with known effect: This medicine contains 0.9 g alcohol
(ethanol) in each dose of 1.25 g
gel.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Transdermal gel
Transparent or slightly opalescent, colourless gel.
4 CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
This medicine is indicated in adults as testosterone replacement
therapy for male hypogonadism
when testosterone deficiency has been confirmed by clinical features
and biochemical tests (see 4.4
Special warnings and precautions for use).
4.2
DOSE AND METHOD OF ADMINISTRATION
Posology
_Adult and elderly men _
The recommended dose is two pump actuations of gel (_i.e._ 40.5 mg of
testosterone) applied once
daily at about the same time, preferably in the morning. The daily
dose should be adjusted by the
physician depending on the clinical or laboratory response in
individual patients, not exceeding four
pump actuations or 81 mg testosterone per day. The adjustment of
posology should be achieved by
increments of one pump actuation of gel.
The dose should be titrated based on the pre-dose morning testosterone
blood levels. Steady state
blood testosterone levels are reached usually by the second day of
treatment with this medicine. In
NEW ZEALAND DATA SHEET
TESTOGEL-001
Nov 2023
Page 2 of 12
order to evaluate the need to adjust the testosterone dosage, blood
testosterone levels should be
measured in the morning before application of the product, after the
steady state is reached.
Testosterone blood levels should be assessed periodically. The dose
may be reduced if the
testosterone blood levels are raised above the desired level. If the
levels are low, the dosage may be
increased stepwise, up to a daily administration of 81 mg of
test