TESTOVIRON DEPOT

Nazione: Israele

Lingua: inglese

Fonte: Ministry of Health

Principio attivo:

TESTOSTERONE ENANTATE

Commercializzato da:

BAYER ISRAEL LTD

Codice ATC:

G03BA03

Forma farmaceutica:

OILY SOLUTION FOR INJECTION

Composizione:

TESTOSTERONE ENANTATE 250 MG/ML

Via di somministrazione:

I.M

Tipo di ricetta:

Required

Prodotto da:

BAYER AG, GERMANY

Gruppo terapeutico:

TESTOSTERONE

Area terapeutica:

TESTOSTERONE

Indicazioni terapeutiche:

Testosterone replacement therapy for male hypogonadism, when testosterone deficiency has been confirmed by clinical features and biochemical tests .Puberty induction in boys with delayed puberty (pubertas tarda).

Data dell'autorizzazione:

2020-08-31

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Scheda tecnica

1.
NAME OF THE MEDICINAL PRODUCT
Testoviron
®
Depot
250 mg/mL Oily solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 mL solution for injection contains 250 mg testosterone enantate,
equivalent to 180 mg testosterone
in oily solution.
For the full list of excipients, see section 6.1
.
3.
PHARMACEUTICAL FORM
Oily 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 (see section 4.4
“Special warnings and
precautions for use”).
-
Puberty induction in boys with delayed puberty (
_pubertas tarda_
).
_ _
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Serum testosterone levels must be measured before the start and during
initiation of therapy. Serum
levels below the normal range would indicate that the injection
interval must be shortened. If serum
levels are excessive, prolongation of the injection interval can be
considered.
To achieve low dose levels, corresponding aliquots (0.2 mL equivalent
to 50 mg testosterone enantate,
0.4 mL equivalent to 100 mg testosterone enantate, etc.) must be
removed from the 250 mg testosterone
enantate ampoule using a 1 mL injection syringe with 0.01 mL
graduations.
The injections must be administered very slowly (see sections 4.4 and
4.8). Care should be taken to
inject Testoviron Depot deeply into the gluteal muscle, while
observing the usual precautions for
intramuscular injections. Special care must be given to avoid
intravascular injections.
The intramuscular injection must be conducted immediately after
opening the ampoule or pre-filled
syringe.
Posology
_Male hypogonadism _
For long-term replacement in hypogonadism, 1 mL Testoviron Depot
(equivalent to 250 mg testosterone
enantate) is recommended every 2–3 weeks as a guide. Individual
dosage can be modified depending
on the clinical picture and serum testosterone levels measured.
In cases of rare, persistent an