Prostap SR DCS (F)

PROSTAP SR Powder: Each single-dose syringe contains 3.75 mg leuprorelin acetate (equivalent to 3.57 mg base)

Prostap SR DCS 3.75mg Powder and Solvent for Prolonged-release Suspension for Injection in Pre-filled Syringe is indicated in:

• 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 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.
• Endometrial preparation prior to intrauterine surgical procedures including endometrial ablation or resection.
• Preoperative management of uterine fibroids to reduce their size and associated bleeding.
• Preservation of ovarian function in pre-menopausal women with neoplastic disease undergoing chemotherapy treatment that can cause premature ovarian insufficiency. PROSTAP SR is not a replacement for standard fertility-preservation methods. Treatment with a GnRH analogue should be proposed after careful evaluation, in each case, of the benefit/risk profile.
• As treatment in pre- and perimenopausal women with advanced breast cancer suitable for hormonal manipulation.
• As 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.

Available on request.

Available on request.