Posology : מינונים

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 and painful erection (priapism), the dose must be reduced or the therapy temporarily discontinued.

Paediatric population
The safety and efficacy of Testoviron Depot in children aged up to 12 years have not been established.

Puberty induction in boys with delayed puberty (pubertas tarda)
Puberty induction with testosterone enantate should be performed only by a physician experienced in paediatric endocrinology. (see section 4.4). The dosing schedule is predicated on the underlying pathological picture and should be guided by the relevant recommendations by professional associations.

Various dosage regimens have been used. Some with lower dosages initially with gradual increases as puberty progresses, with or without a decrease to maintenance levels. Other regimens use higher dosage to induce pubertal changes and lower dosage for maintenance after puberty. The chronological and skeletal ages must be taken into consideration, both in determining the initial dose and in adjusting the dose. Dosage is within the range of 50 to 200 mg every 2 to 4 weeks within 4 to 6 months.

Method of administration

Solution for injection for intramuscular use.
Special groups

Elderly patients
Limited data indicate that dose adjustment is not necessary in elderly patients (see section 4.4).

Patients with hepatic damage
No formal studies have been conducted in patients with impaired hepatic function. The use of Testoviron Depot is contraindicated in males with past or existing liver tumours (see section 4.3).

Patients with renal damage
No formal studies have been conducted in patients with impaired renal function.