Maa: Israel
Kieli: englanti
Lähde: Ministry of Health
TESTOSTERONE ENANTATE
BAYER ISRAEL LTD
G03BA03
OILY SOLUTION FOR INJECTION
TESTOSTERONE ENANTATE 250 MG/ML
I.M
Required
BAYER AG, GERMANY
TESTOSTERONE
TESTOSTERONE
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).
2020-08-31
[לוגו מדינת ישראל] [http://www.gov.il/] [http://www.gov.il/] [לוגו משרד הבריאות] [לוגו משרד הבריאות] [*5400] [http://www.health.gov.il/PniyotHazibur/Pages/CallCenter.aspx] [http://www.health.gov.il/PniyotHazibur/Pages/CallCenter.aspx] הציבור הרחב עסקים ומוסדות עובדים בבריאות חפש מידע תפריט * [סגירה] סגור * דף הבית [http://www.health.gov.il/] * אודות * אודות המשרד [http://www.health.gov.il/About/Pages/about_us.aspx] * תוכנית עבודה [http://www.health.gov.il/About/Pages/Agenda.aspx] * תקציב המשרד [http://www.health.gov.il/About/Pages/budget.aspx] * תרשים מבנה ארגוני [http://www.health.gov.il/About/Pages/OrganizationalStructureDiagram.aspx] * בעלי תפקידים [http://www.health.gov.il/About/Phonebook/Pages/PhoneBook.aspx] * יחידות המשרד [http://www.health.gov.il/UnitsOffice/Pages/UnitsList.aspx] * לשכות הבריאות [http://www.health.gov.il/About/Phonebook/Pages/PhoneBook.aspx?tab=3] * אמנת שירות [http://www.health.gov.il/About/sla/Pages/default.aspx] * אותות ופרסים [http://www.health.gov.il/About/Awards/Pages/mifal.aspx] * פרוייקטים תשתיתיים [http://www.health.gov.il/About/projects/shared_medical_info/Pages/default.aspx] * דרושים [http://www.health.gov.il/About/Careers/Pages/default.aspx] * מנכ"לי משרד הבריאות לדורותיהם [http://www.health.gov.il/About/Pages/GeneralManegerHistory.aspx] * יחידות המשרד * יחידות המשרד [http://www.health.gov.il/UnitsOffice/Pages/UnitsList.aspx] * לשכות הבריאות [http://www.health.gov.il/UnitsOffice/LB/Pages/default.aspx] * וועדות ומועצות [http://www.health.gov.il/Services/Committee/Pages/CommitteeList.aspx] * נושאים * בריאות הנפש [http://www.health.gov.il/Subjects/mental_health/Pages/default.aspx] * בריאות הסביבה [http://www.health.gov.il/Subjects/Environmental_Health/ Lue koko asiakirja
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 Lue koko asiakirja