Prolia® is supplied as a sterile, preservative-free, clear, colourless to slightly yellow solution for injection at pH 5.2. The solution should not be used if cloudy or discoloured. The solution may contain trace amounts of translucent to white proteinaceous particles. Each 1 mL single-use pre-filled syringe or vial contains 60 mg of denosumab in 1 mL (60 mg/mL). Product is for single-use in one patient only. Dispose of any medicinal product remaining in the pre-filled syringe or vial. It is recommended to store pre-filled syringes and vials in a refrigerator at 2° to 8°C in the original carton. Do not freeze. Protect from direct light. Do not excessively shake the pre-filled syringe or vial. Do not expose to temperatures above 25°C. If removed from the refrigerator, Prolia® should be kept at room temperature (up to 25°C) in the original container and must be used within 30 days. Pre-filled syringe with automatic needle guard; Pre-filled syringe*: Pack size of one, presented in blistered (pre-filled syringe with or without an automatic needle guard) or unblistered packaging (pre-filled syringe only). The needle cover of the pre-filled syringe contains dry natural rubber (a derivative of latex), which may cause allergic reactions. * Not available in Australia. Vial*: Pack size of one. A 27 gauge needle is recommended for the administration of Prolia®. Do not re-enter the vial. * Not available in Australia. NAME AND ADDRESS OF THE SPONSOR Amgen Australia Pty Ltd ABN 31 051 057 428 Level 7, NSW 2113 Medical Information: 1800 646 998 POISON SCHEDULE OF THE MEDICINE S4 Prescription Medicine DATE OF APPROVAL
Prolia® is supplied as a sterile, preservative-free, clear, colourless to slightly yellow solution for injection at pH 5.2. The solution should not be used if cloudy or discoloured. The solution may contain trace amounts of translucent to white proteinaceous particles. Each 1 mL single-use pre-filled syringe or vial contains 60 mg of denosumab in 1 mL (60 mg/mL). Product is for single-use in one patient only. Dispose of any medicinal product remaining in the pre-filled syringe or vial. It is recommended to store pre-filled syringes and vials in a refrigerator at 2° to 8°C in the original carton. Do not freeze. Protect from direct light. Do not excessively shake the pre-filled syringe or vial. Do not expose to temperatures above 25°C. If removed from the refrigerator, Prolia® should be kept at room temperature (up to 25°C) in the original container and must be used within 30 days. Pre-filled syringe with automatic needle guard; Pre-filled syringe*: Pack size of one, presented in blistered (pre-filled syringe with or without an automatic needle guard) or unblistered packaging (pre-filled syringe only). The needle cover of the pre-filled syringe contains dry natural rubber (a derivative of latex), which may cause allergic reactions. * Not available in Australia. Vial*: Pack size of one. A 27 gauge needle is recommended for the administration of Prolia®. Do not re-enter the vial. * Not available in Australia. NAME AND ADDRESS OF THE SPONSOR Amgen Australia Pty Ltd ABN 31 051 057 428 Level 7, NSW 2113 Medical Information: 1800 646 998 POISON SCHEDULE OF THE MEDICINE S4 Prescription Medicine DATE OF APPROVAL
auspar-denosumab-140128-pi.docx