Страна: Ірландія
мова: англійська
Джерело: HPRA (Health Products Regulatory Authority)
LEUPRORELIN ACETATE
Mercury Pharmaceuticals Ltd
L02AE; L02AE02
LEUPRORELIN ACETATE
22.5 milligram(s)
Powder and solvent for suspension for injection
intravenous route
One (1) type I glass vial containing 22.5 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 t is indicated for palliative treatment of hormone dependent advanced prostate cancer
Not marketed
2015-07-17
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Lutrate 3 month Depot 22.5mg Powder and Solvent for Prolonged-Release Suspension for Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 22.5 mg of leuprorelin acetate (equivalent to 21.42 mg leuprorelin free base). 1 mL of reconstituted suspension contains 11.25 mg of leuprorelin acetate. _Excipients with known effect:_ Each vial contains from 1.6 to 2.7 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, colorless and particle free 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 3 month Depot is 22.5 mg presented as a three months depot injection and administered as a single intramuscular injection every three months. Lutrate 3 month Depot must be administered under direction of healthcare professional having the appropriate expertise for monitoring the response to treatment. The dose of Lutrate 3 month Depot allowing the continuous release of leuprorelin acetate over a three month period is incorporated in a depot formulation. The lyophilized powder should be reconstituted and administered as a single intramuscular injection every three months. Intraarterial or intravenous administration must be avoided. The vial of Lutrate 3 month De Прочитайте повний документ