Powder and solvent for suspension for injection, sustained release formulation.

Therapeutic indications

• treatment of patients with locally advanced non-metastatic prostate cancer as an alternative to surgical castration (see section 5.1)
• Treatment of metastatic prostate cancer.
• As adjuvant treatment to radiotherapy in patients with high-risk localised or locally advanced prostate cancer.
• As neoadjuvant treatment prior to radiotherapy in patients with high-risk localised or locally advanced prostate cancer.
• As adjuvant treatment to radical prostatectomy in patients with locally advanced prostate cancer at high risk of disease progression.
• Treatment of endometriosis.
• Treatment of precocious puberty (onset before 8 years in girls and 10 years in boys).

Features

• Nature and contents of container
• A type I, 4mL capacity glass vial with an elastomer stopper and an aluminium cap containing the powder.
• A type I, 3mL capacity glass ampoule containing 2mL of the suspension vehicle.
• Box containing 1 vial and 1 ampoule with 1 syringe and 2 needles.
• Special precautions for storage
• Do not store above 25°C. Keep container in the outer carton.

Shelf life

• The product should be used immediately after reconstitution.