Country: New Zealand
Bahasa: Inggeris
Sumber: Medsafe (Medicines Safety Authority)
Leuprorelin acetate 22.5mg (includes 28.2mg leuprorelin acetate to deliver 22.5mg leuprorelin); ; ; Leuprorelin acetate 22.5mg (includes 29.2mg leuprorelin acetate to deliver 22.5mg leuprorelin)
Mundipharma New Zealand Ltd
Leuprorelin acetate 22.5 mg (includes 28.2mg leuprorelin acetate to deliver 22.5mg leuprorelin)
22.5 mg
Injection with diluent
Active: Leuprorelin acetate 22.5mg (includes 28.2mg leuprorelin acetate to deliver 22.5mg leuprorelin) Excipient: N-Methyl-2-pyrrolidone Polyglactin Active: Leuprorelin acetate 22.5mg (includes 29.2mg leuprorelin acetate to deliver 22.5mg leuprorelin) Excipient: N-Methyl-2-pyrrolidone Polyglactin
Syringe, Kit (Syringe A & B, replacement plunger+needle), 1 dose unit
Prescription
Prescription
Hemmo Pharmaceuticals Pvt. Ltd.
indicated for the palliative treatment of advanced prostate cancer.
Package - Contents - Shelf Life: Syringe, Kit (Syringe A & B, replacement plunger+needle) - 1 dose units - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 8 weeks not refrigerated stored at or below 25°C 30 minutes reconstituted stored at or below 25°C - Syringe, PP Syringe A - 1 dose units - - Syringe, PP Syringe B - 1 dose units -
2003-10-22
Data Sheet Version 9.0 1 ELIGARD ® NAME OF THE MEDICINE Leuprorelin acetate CAS: 74381-53-6 DESCRIPTION Eligard ® is a sterile polymeric matrix formulation of leuprorelin acetate for subcutaneous injection. It is designed to deliver leuprorelin acetate at a controlled rate over a therapeutic period. Leuprorelin acetate is a synthetic nonapeptide analogue of naturally occurring gonadotropin releasing hormone (GnRH or LH-RH) that, when given continuously, inhibits pituitary gonadotropin secretion and suppresses testicular steroidogenesis. The analogue possesses greater potency than the natural hormone. The chemical name is 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-leucyl- L-leucyl-L-arginyl-N-ethyl-L-prolinamide acetate (salt). COMPOSITION Eligard ® is available in a single use kit. The kit consists of a two-syringe mixing system, a 20-gauge 5/8 inch needle (for Eligard ® 1 month and Eligard ® 3 month and Eligard® 4 month) or a or a 18-gauge 5/8-inch needle (for Eligard ® 6 month), a silicone desiccant pouch to control moisture uptake, and package insert for constitution and administration procedures. Each syringe is individually packaged. One contains the Atrigel ® Delivery System and the other contains leuprorelin acetate. Eligard ® is prefilled and supplied in two separate, sterile syringes whose contents are mixed immediately prior to administration. The two syringes are joined and the single dose product is mixed until it is homogenous. Eligard ® is administered subcutaneously where it forms a solid drug delivery depot. The Atrigel ® Delivery System is a polymeric (non-gelatin containing) delivery system consisting of a biodegradable polyglactin. The polymer is dissolved in a biocompatible solvent, _N_ -methyl-2- pyrrolidone. The polyglactin mixture and volume differ with each presentation of Eligard ® . Data Sheet Version 9.0 2 Eligard ® contains no anti-microbial agent Eligard ® does not contain: lactose, sucrose, gluten, tartrazine, or any other azo dyes. Eligard ® 1 month co Baca dokumen lengkap