TESTOMAX 50 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

TESTOSTERONE

Available from:

PADAGIS ISRAEL PHARMACEUTICALS LTD, ISRAEL

ATC code:

G03EA02

Pharmaceutical form:

GEL

Composition:

TESTOSTERONE 50 MG/DOSE

Administration route:

TRANSDERMAL

Prescription type:

Required

Manufactured by:

PADAGIS ISRAEL PHARMACEUTICALS LTD, ISRAEL

Therapeutic group:

TESTOSTERONE AND ESTROGEN

Therapeutic area:

TESTOSTERONE AND ESTROGEN

Therapeutic indications:

Testosterone replacement therapy for males hypogonadism when testosterone deficiency has been confirmed by clinical features and biochemical tests.

Authorization date:

2022-02-28

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT:
TESTOMAX 50 mg
TESTOMAX 25 mg
2. QUALITATIVE AND QUANTITATIVE COMPOSITION:
TESTOMAX 50 mg: Testosterone 0.05 g per 5 g sachet
TESTOMAX 25 mg: Testosterone 0.025 g per 2.5 g sachet
For excipients, see 6.1.
3. PHARMACEUTICAL FORM: Gel
Clear, transparent colorless gel
.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Testosterone replacement therapy for males hypogonadism when
testosterone
deficiency has been confirmed by clinical features and biochemical
tests.
4.2 POSOLOGY AND ADMINISTRATION ROUTE
Cutaneous use
_Adults and elderly _
The recommended dose is 5 g of gel (i.e. 50 mg of testosterone)
applied once daily,
at about the same time, preferably in the morning. The daily dose
should be adjusted
by the doctor depending on the clinical or laboratory response in
individual patients,
not exceeding 10 g of gel per day. The adjustment of posology should
be achieved
by 2.5 g of gel steps.
The application should be administered by the patient himself, onto
clean, dry,
healthy skin over the shoulders, or both arms or abdomen.
After opening the sachet, the total content must be extracted from the
sachet and
applied immediately onto the skin. The gel has just to be simply
spread on the skin
gently as a thin layer. It is not necessary to rub it on the skin.
Allow drying for at least
3-5 minutes before dressing. Wash hands with soap and water after
applications.
Do not apply to the genital areas as the high alcohol content may
cause local
irritation.
Steady state plasma testosterone concentrations are reached
approximately on the
2
nd
day of treatment with Testomax. In order to adjust the testosterone
dose, serum
testosterone concentrations must be measured in the morning before
application
from the 3
rd
day on after starting treatment (one week seems reasonable). The dose
may be reduced if the plasma testosterone concentrations are raised
above the
desired level. If the concentrations are low, the dosage may be
increased, not
exceeding 1