TESTAVAN testosterone 2% w/w gel in a metered-dose dispenser with a cap applicator

Ország: Ausztrália

Nyelv: angol

Forrás: Department of Health (Therapeutic Goods Administration)

Aktív összetevők:

testosterone, Quantity: 1.71 g

Beszerezhető a:

Clinect Pty Ltd

INN (nemzetközi neve):

Testosterone

Gyógyszerészeti forma:

Gel

Összetétel:

Excipient Ingredients: ethanol; purified water; propylene glycol; diethylene glycol monoethyl ether; carbomer 980; trolamine; disodium edetate

Az alkalmazás módja:

Transdermal

db csomag:

1 x 85.5 g. 56 doses only.

Recept típusa:

(S4) Prescription Only Medicine

Terápiás javallatok:

TESTAVAN is indicated for use as testosterone replacement therapy for adult male hypogonadism when testosterone deficiency has been confirmed by clinical features and biochemical tests.

Termék összefoglaló:

Visual Identification: Translucent to slightly opalescent gel; Container Type: Bottle, with integral pump - manual actuated; Container Material: PP; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Engedélyezési státusz:

Licence status A

Engedély dátuma:

2017-05-26

Betegtájékoztató

TESTAVAN
®
T
E
S
T
A
V
A
N
®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING TESTAVAN?
TESTAVAN contains the active ingredient testosterone. TESTAVAN is used
only in adult men, to replace the body's natural
hormone, testosterone, when not enough is made by the body.
For more information, see Section 1. Why am I using TESTAVAN? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE TESTAVAN?
Do not use if you have ever had an allergic reaction to testosterone,
propylene glycol or any of the ingredients listed at the end of
the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
TESTAVAN? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with TESTAVAN and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE TESTAVAN?
•
The usual starting dose is 23 mg testosterone (one pump actuation) per
day.
•
Read the package leaflet before use.
More instructions can be found in Section 4. How do I use TESTAVAN? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING TESTAVAN?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
TESTAVAN.
•
Keep all of your doctor's appointments.
THINGS YOU
SHOULD NOT DO
•
Do not stop using TESTAVAN or lower the dosage without first checking
with your doctor.
DRIVING
OR USING
MACHINES
•
This medicine is not expected to affect your ability to drive a car or
operate machinery.
LOOKING AFTER
YOUR MEDICINE
•
Keep TESTAVAN in a cool dry place where the temperature stays below
25°C.
•
Store TESTAVAN in the original container.
•
Store TESTAVAN away from moisture, heat or sunlight
For more information, see Section 5. What s

Termékjellemzők

13
AUSTRALIAN PRODUCT INFORMATION –
TESTAVAN® (TESTOSTERONE) GEL
NAME OF THE MEDICINE
Testosterone
QUALITATIVE AND QUANTITATIVE COMPOSITION
TESTAVAN contains 20 mg (2 % w/w) testosterone in one gram of gel. It
is presented in a metered-dose
pump. One pump actuation delivers 1.15 g (in 1.25 mL) of gel,
equivalent to 23 mg of testosterone. Each
pump contains 85.5 g of gel capable of dispensing 56 metered
individual doses.
Excipient with known effect: propylene glycol.
For the full list of excipients, see Section 6.1 List of excipients.
PHARMACEUTICAL FORM
Gel
TESTAVAN is a translucent to slightly opalescent, hydroalcoholic
transdermal gel.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
TESTAVAN is indicated for use as testosterone replacement therapy for
adult male hypogonadism when
testosterone deficiency has been confirmed by clinical features and
biochemical tests.
4.2
DOSE AND METHOD OF ADMINISTRATION DOSAGE
_DOSAGE _
ADULT MEN
The recommended starting dose is 23 mg testosterone (one pump
actuation) applied once daily,
preferably in the morning. To ensure proper dosing, serum testosterone
levels should be periodically
measured and dose titrated to maintain serum testosterone levels.
The serum testosterone level should be measured 2 to 4 hours after
dosing approximately 14 days and
35 days after starting treatment or after a dose adjustment. If the
serum testosterone concentration is
below 17.3 nmol/L (500 ng/dL), the daily TESTAVAN dose may be
increased by 1 pump actuation. If the
serum testosterone concentration exceeds 36.4 nmol/L (1050 ng/dL), the
daily dose may be decreased
by 1 pump actuation.
Dose titration should be based on both serum testosterone levels and
the existence of clinical signs and
symptoms related to testosterone deficiency.
Patients switching from another testosterone product to TESTAVAN
should have their dosage titrated
according to serum testosterone levels and clinical signs and symptoms
following the instructions in the
dosage and administration section.
_MAXIMUM RECOMMENDED DOSE