Prostap 3 (Leuprorelin Acetate) DCS 11.25mg Syringe POM x1

Powder and solvent for suspension for injection in pre-filled syringe.

Product Description

Contains active ingredient leuprorelin acetate.

• Prostap® 3 is a synthetic hormone which can be used to reduce the levels of testosterone and oestrogen circulating in the body.
• It is used to treat prostate cancer in men and endometriosis in women.

Features

Therapeutic indications:

• Metastatic prostate cancer.
• Locally advanced prostate cancer, as an alternative to surgical castration.
• As an adjuvant treatment to radiotherapy in patients with high-risk localised or locally advanced prostate cancer.
• As an adjuvant treatment to radical prostatectomy in patients with locally advanced prostate cancer at high risk of disease progression.
• As a neo-adjuvant treatment prior to radiotherapy in patients with high-risk localised or locally advanced prostate cancer.
• Management of endometriosis, including pain relief and reduction of endometriotic lesions.
• As treatment in pre- and perimenopausal women with advanced breast cancer suitable for hormonal manipulation.
• As an adjuvant treatment in combination with tamoxifen or an aromatase inhibitor, of endocrine-responsive early-stage breast cancer in pre- and perimenopausal women at higher risk of disease recurrence (young age, high-grade tumour, lymph node involvement). In women who have received chemotherapy, premenopausal status must be confirmed after completion of chemotherapy.
• In children - treatment of central precocious puberty (girls under 9 years of age, boys under 10 years of age).

Nature and contents of container

• One dual-chamber pre-filled syringe containing 11.25 mg leuprorelin acetate powder in the front chamber and 1 ml of sterile solvent in the rear chamber.
• 1 x 23-gauge syringe needle fitted with safety device.
• 1 x syringe plunger.

Special precautions for storage

• Do not store above 25°C.
• Do not refrigerate or freeze.
• Store in the original container in order to protect from light.

Shelf life

• Once reconstituted with sterile solvent, the suspension should be administered immediately.

Technical information

• Pack measurements: 33mm x 187mm x 89mm
• Weight: 52g

Product Information Leaflet

Prostap® 3 DCS Patient Information Leaflet (PIL)