Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
LEUPRORELIN ACETATE
Mercury Pharmaceuticals Ltd
L02AE; L02AE02
LEUPRORELIN ACETATE
3.75 milligram(s)
Powder and solvent for suspension for injection
intramuscular route
One (1) type I glass vial containing 3.75 mg
Product subject to prescription which may not be renewed (A)
GP-Pharm S.A.
Endocrine therapy. Hormones and related agents. Gonadotropin-releasing hormones analogues
Gonadotropin releasing hormone analogues; leuprorelin
It is indicated for palliative treatment of locally advanced or metastatic prostate cancer
Not marketed
2015-07-17
Health Products Regulatory Authority 16 April 2019 CRN008YR9 Page 1 of 11 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Lutrate 1 month Depot 3.75 mg powder and solvent for prolonged-release suspension for injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 3.75 mg of leuprorelin acetate (equivalent to 3.57 mg leuprorelin free base). 1 ml of reconstituted suspension contains 1.875 mg of leuprorelin acetate. Excipients with known effect: Each vial contains from 1.3 to 2.2 mg (<1 mmol) of sodium (as carmellose sodium). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder and solvent for prolonged-release suspension for injection. Powder: white to off-white powder. Solvent: clear transparent solution (pH 5.0 – 7.0). 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS (i) Metastatic prostate cancer. (ii) Locally advanced prostate cancer, as an alternative to surgical castration. (iii) As an adjuvant treatment to radiotherapy in patients with high-risk localised or locally advanced prostate cancer. (iv) As an adjuvant treatment to radical prostatectomy in patients with locally advanced prostate cancer at high risk of disease progression. (v) As neo-adjuvant treatment prior to radiotherapy in patients with high-risk localised or locally advanced prostate cancer. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The usual recommended dose of Lutrate 1 month Depot is 3.75 mg presented as a one month depot injection and administered as a single intramuscular injection every month. Lutrate 1 month Depot must be administered under the supervision of a physician or a qualified health practitioner. The dose of Lutrate 1 month Depot allowing the continuous release of leuprorelin acetate during one month is incorporated in a depot formulation. The lyophilized powder should be reconstituted and administered as a single intramuscular injection at monthly intervals. Intra-arterial or intravenous administration must be avoided. The vial of Lutrate 1 month Depot mi Read the complete document