Država: Singapur
Jezik: engleski
Izvor: HSA (Health Sciences Authority)
Leuprorelin 20.87 mg eqv to Leuprorelin Acetate
DCH AURIGA SINGAPORE
L02AE02
22.5 mg
INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION,EXTENDED RELEASE
Leuprorelin 20.87 mg eqv to Leuprorelin Acetate 22.5 mg
SUBCUTANEOUS
Prescription Only
Tolmar Inc. (Powder and Solvent)
ACTIVE
2014-02-25
ELIGARD 7.5 MG ELIGARD 22.5 MG ELIGARD 45 MG 1. NAME OF THE MEDICINAL PRODUCT ELIGARD 7.5 mg powder and solvent for solution for injection ELIGARD 22.5 mg powder and solvent for solution for injection ELIGARD 45 mg powder and solvent for solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ELIGARD 7.5 mg One prefilled syringe with powder for solution for injection contains 7.5 mg leuprorelin acetate, equivalent to 6.96 mg leuprorelin. ELIGARD 22.5 mg One prefilled syringe with powder for solution for injection contains 22.5 mg leuprorelin acetate, equivalent to 20.87 mg leuprorelin. ELIGARD 45 mg One prefilled syringe with powder for solution for injection contains 45 mg leuprorelin acetate, equivalent to 41.7 mg leuprorelin. For _a full list of_ excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder and solvent for solution for injection, Powder (Syringe B): Pre-filled syringe with a white to off-white powder. Solvent (Syringe A): Pre-filled syringe with a clear, colourless to pale yellow solution 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ELIGARD is indicated for the palliative treatment of hormone dependent advanced prostate cancer. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Dosage for Adult Males ELIGARD should be administered under the direction of a healthcare professional having available the appropriate expertise for monitoring the response to treatment. ELIGARD 7.5 mg is administered as a single subcutaneous injection every month. The injected solution forms a solid medicinal product delivery depot and provides continuous release of leuprorelin acetate for one month. ELIGARD 22.5 mg is administered as a single subcutaneous injection every three months. The injected solution forms a solid medicinal product delivery depot and provides continuous release of Pročitajte cijeli dokument
1. NAME OF THE MEDICINAL PRODUCT ELIGARD 7.5 mg powder and solvent for solution for injection ELIGARD 22.5 mg powder and solvent for solution for injection ELIGARD 45 mg powder and solvent for solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Powder and solvent for solution for injection Powder (Syringe B): Pre-filled syringe with a white to off-white powder. Solvent (Syringe A): ELIGARD 7.5 mg One prefilled syringe with powder for solution for injection contains 7.5 mg leuprorelin acetate, equivalent to 6.96 mg leuprorelin. ELIGARD 22.5 mg One prefilled syringe with powder for solution for injection contains 22.5 mg leuprorelin acetate, equivalent to 20.87 mg leuprorelin. ELIGARD 45 mg One prefilled syringe with powder for solution for injection contains 45 mg leuprorelin acetate, equivalent to 41.7 mg leuprorelin. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder and solvent for solution for injection_._ Powder (Syringe B): Pre-filled syringe with a white to off-white powder. Solvent (Syringe A): ELIGARD 7.5mg: Pre-filled syringe with a clear, colourless to pale yellow/brown solution ELIGARD 22.5mg & 45mg: Pre-filled syringe with a clear, colourless to pale yellow solution _ _ 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ELIGARD is indicated for the palliative treatment of hormone dependent advanced prostate cancer._ _ 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adult Males _ ELIGARD should be administered under the direction of a healthcare professional having available the appropriate expertise for monitoring the response to treatment. ELIGARD 7.5 mg is administered as a single subcutaneous injection every month. The injected solution forms a solid medicinal product delivery depot and provides continuous release of leuprorelin acetate for one month. ELIGARD 22.5 mg is administered as a single subcutaneous injection every three months. The injected solution forms a solid medicinal product delivery depot and provides continuous release of leuprorelin Pročitajte cijeli dokument