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  • Nebido
    / Bayer


    Active Ingredient

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Vial

    4 ml X 250 mg/ml

    full basket chart 62423 14570

    Dosage

    Posology: One vial (corresponding to 1000 mg testosterone undecanoate) is administered as injections every 10 to 14 weeks to maintain sufficient testosterone levels without accumulation in the body. R Start of treatment Serum testosterone levels should be measured before start and during initiation of treatment. Depending on serum testosterone levels and clinical symptoms, the first injection interval may be reduced to a minimum of 6 weeks as compared to the recommended range of 10 to 14 weeks for maintenance. Starting the treatment this way will help to quickly attain steady-state drug levels.
    R Maintenance and individualization of treatment The injection interval should remain within the recommended range of 10 to 14 weeks. Careful monitoring of serum testosterone levels is required during maintenance of treatment. It is advisable to measure serum testosterone levels regularly. Measurements should be performed at the end of an injection interval and clinical symptoms considered. These serum levels should be within the lower third of the normal range. Serum levels below normal range would indicate the need for a shorter injection interval. In case of high serum levels an extension of the injection interval may be considered.
    Pediatric population: This drug is not indicated for use in children and adolescents and it has not been evaluated clinically in males under 18 years of age.
    Special populations: Geriatric patients: Limited data do not suggest the need for a dosage adjustment in elderly patients.
    Patients with hepatic impairment: No formal studies have been performed in patients with hepatic impairment. The use is contraindicated in men with past or present liver tumors.
    Patients with renal impairment: No formal studies have been performed in patients with renal impairment.
    Method of administration: The injections must be administered very slowly.This drug  is strictly for intramuscular injection. Care should be taken to inject deeply into the gluteal muscle following the usual precautions for intramuscular administration. Special care must be taken to avoid intravasal injection. The contents of a vial are to be injected intramuscular immediately after opening the vial.
    For full details see prescribing information.


    Indications

    Testosterone replacement therapy in primary and secondary male hypogonadism.


    Contra-Indications

    Androgen-dependent carcinoma of the prostate or the male mammary gland. Hypercalcemia associated with a malignant tumor. Past or present liver tumor. Hypersensitivity to the active substance or any of the excipients. Use in women, children and adolescents. It has not been evaluated clinically in males under 18 years of age.


    Special Precautions

    Should be used only if hypogonadism (hyper- and hypogonadotrophic) has been demonstrated and if other etiology, responsible for the symptoms, has been excluded before treatment is started. Testosterone insufficiency should be clearly demonstrated by clinical features and confirmed by two separate blood testosterone measurements. There is limited experience of the use in elderly patients over 65 years of age. It should be taken in account that physiologically testosterone serum levels are lower with increasing age. Therapy might result in a positive finding in doping tests. Prior to testosterone initiation, all patients must undergo a detailed examination in order to exclude a risk of pre-existing prostatic cancer. Careful and regular monitoring of the prostate and breast must be performed. Hemoglobin and hematocrit levels should be checked periodically in patients on long-term androgen therapy to detect cases of polycythemia. The possibility of a hepatic tumor should be considered in the differential diagnosis if a treated patient has severe abdominal pain, liver enlargement, or signs of intra-abdominal hemorrhage. Should be used with caution in cancer patients at risk of hypercalcaemia (and associated hypercalcuria), due to bone metastases. Regular monitoring of serum calcium concentrations is recommended in these patients. Caution should be exercised in patients predisposed to edema. Caution must be taken in patients who have elevated blood pressure, disturbance in renal function, epilepsy or migraine. The product may elevate blood pressure. The product is not recommended for patients with cardiac insufficiency. Use of the product may aggravate pre-existing sleep apnea. Improved insulin sensitivity may occur in patients treated with androgens who achieve normal testosterone plasma concentrations following replacement therapy. Certain clinical signs: irritability, nervousness, weight gain, prolonged or frequent erections may indicate excessive androgen exposure requiring dosage adjustment. Should be permanently withdrawn if symptoms of excessive androgen exposure persist or reappear during treatment with the recommended dosage regimen. Androgens are not suitable for enhancing muscular development in healthy individuals or for increasing physical ability. There are limitations on using intramuscular injections in patients with acquired or inherited blood clotting irregularities and these limitations have to be observed. There are limitations on using I.M. injections in patients with acquired or inherited blood clotting irregularities and these limitations have to be observed.
    For full details see prescribing information.


    Side Effects

    Acne, polycythemia, increased weight, hot flush, increased prostate specific antigen, abnormal porstate examination, benign prostate hyperplasia, various kinds of injection site reactions.
    For full details see prescribing information.


    Drug interactions

    May enhance the blood sugar reducing effects of insulin. Drugs that induce microsomal enzymes (e.g., barbiturates). Has been found to increase the effect of oral anticoagulants. Concurrent administration with ACTH or corticosteroids may enhance edema formation, particularly with cardiac or hepatic disease or in patients predisposed to edema. May decrease levels of thyroxine-binding globulin, resulting in decreased total T4 serum levels and increased resin uptake of T3 and T4.


    Pregnancy and Lactation

    Nebido is not indicated for use in women and must not be used in pregnant or breast-feeding women.


    Overdose

    Overdose does not require any special therapeutic measures apart from termination of therapy or dose reduction which is usually sufficient.


    Manufacturer
    Bayer Schering Pharma AG
    Licence holder
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