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Nebido 1000 mg/4ml solution for injection
Category
ETC
Indication(s)·Usage
  • Testosterone replacement therapy for male hypogonadism, when testosterone deficiency has been confirmed
Effective components
Testosterone undecanoate 250 mg/mL (corresponding to 157.9 mg testosterone)

Active ingredient(s) and Contents

  • Effective components

    • Testosterone undecanoate 250 mg/mL (corresponding to 157.9 mg testosterone)
  • Other

    • Benzyl benzoate, Refined castor oil

Dosage and administration

  • One ampoule / vial of Nebido (corresponding to 1000 mg testosterone undecanoate) is injected every 10 to 14 weeks. Injections with this frequency are capable of maintaining sufficient testosterone levels and do not lead to accumulation.

    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. With this loading dose, sufficient steady state testosterone levels may be achieved more rapidly.

    Maintenance and individualisation of treatment :
    The injection interval should be 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 testosterone serum 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.

Storage and handling

  • At cold storage temperatures the properties of this oil-based solution might temporarily change (e.g. higher viscosity, cloudiness). If stored at cold temperature, the product should be brought to room or body temperature before use.