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BC CANCER CHEMOTHERAPY PREPARATION AND STABILITY CHART DRUG & STRENGTH Reconstitute To Give: Vial Product Product Stability Special (Storage Prior to Use, With: Stability (for IV bag size selection, Precautions/Notes Manufacturer, Preservative see Notes†) Status) AGS-16C3F 30 mg 5.1 mL SWI1 6 mg/mL1 discard unused ≥ 0.3 mg/mL1 complete - unopened vials (Astellas) portion1 administration within may be kept at RT (F)(PFL) swirl gently; do NOT 100 mL D5W2,3 6 h RT of for up to 4h prior to do not shake shake1 **(PFL)1 reconstitution1 use if protected no preservative1 mix by gentle from light1 allow foam to clear inversion1 **(PFL) before proceeding1 record time of reconstitution Aldesleukin 22 million units 1.2 mL SWI4 18 million unit/mL 48 h F, RT4 30-70 mcg/mL4 48 h F, RT4 - do NOT use in- (1.3 mg) (1.1 mg/mL)4 line filter4 (SteriMax) direct diluent against 50 mL D5W4 - avoid (F)(PFL) side of vial during bacteriostatic water no preservative4 reconstitution4 <30 mcg/mL: for injection or NS dilute in D5W due to increased do NOT shake4 containing human aggregation4 albumin 0.1%5 - bring to room temperature prior to infusion4 SC syringe6,7 14 d F7 **(PFL) BC Cancer Chemotherapy Preparation and Stability Chart© version 2.00. All rights reserved. 1/60 This document may not be reproduced in any form without the express written permission of BC Cancer Provincial Pharmacy. Activation Date: 2 March 2006 Revised Date: 1 September 2021 BC CANCER CHEMOTHERAPY PREPARATION AND STABILITY CHART DRUG & STRENGTH Reconstitute To Give: Vial Product Product Stability Special (Storage Prior to Use, With: Stability (for IV bag size selection, Precautions/Notes Manufacturer, Preservative see Notes†) Status) Aldesleukin intralesional 1.2 mL SWI4 18 million unit/mL 48 h F, RT4 add 3.2 mL D5W syringe: - avoid 22 million units (1.1 mg/mL)4 to reconstituted vial 48 h F8 bacteriostatic water (1.3 mg) direct diluent against to give (discard any remaining for injection or NS (SteriMax) side of vial during 5 million units/mL8,9 unused syringes due to increased (F)(PFL) reconstitution4 following procedure) aggregation4 no preservative4 withdraw entire do NOT shake4 contents of vial into syringes for administration8,10 Alemtuzumab 30 mg/mL N/A filter NOT discard unused SC syringe13 discard at the end of - do NOT shake14 (Genzyme/Bayer)11 required12 portion12 the day F, RT (F)(PFL) 12 do not shake 30 mg/mL 12 no preservative 100 mL 8 h F, RT12 12 NS, D5W **(PFL)14 BC Cancer Chemotherapy Preparation and Stability Chart© version 2.00. All rights reserved. 2/60 This document may not be reproduced in any form without the express written permission of BC Cancer Provincial Pharmacy. Activation Date: 2 March 2006 Revised Date: 1 September 2021 BC CANCER CHEMOTHERAPY PREPARATION AND STABILITY CHART DRUG & STRENGTH Reconstitute To Give: Vial Product Product Stability Special (Storage Prior to Use, With: Stability (for IV bag size selection, Precautions/Notes Manufacturer, Preservative see Notes†) Status) Amivantamab 350 mg N/A 50 mg/mL discard unused 250 mL NS, D5W15 complete - do NOT shake15 (Janssen) portion15 administration within - discard if (F)(PFL) dilute to final volume 10 h RT15 discolouration or no preservative15 by withdrawing visible particles are volume from bag present15 equal to volume of drug to be added15 mix by gentle inversion15 Amsacrine 75 mg/1.5 mL glass syringes 5 mg/mL16 24 h RT16 500 mL D5W16 7 d F, 48 h RT16-18 - contains DMA*** (Erfa Canada) preferred during (RT) reconstitution; **(PFL)16 (plastic or glass no preservative16 max. time in plastic container)16 syringe16: 15 min 13.5 mL supplied diluent (L-lactic acid)1 transfer 1.5mL from ampoule into the diluent vial16 BC Cancer Chemotherapy Preparation and Stability Chart© version 2.00. All rights reserved. 3/60 This document may not be reproduced in any form without the express written permission of BC Cancer Provincial Pharmacy. Activation Date: 2 March 2006 Revised Date: 1 September 2021 BC CANCER CHEMOTHERAPY PREPARATION AND STABILITY CHART DRUG & STRENGTH Reconstitute To Give: Vial Product Product Stability Special (Storage Prior to Use, With: Stability (for IV bag size selection, Precautions/Notes Manufacturer, Preservative see Notes†) Status) Arsenic trioxide 12 mg/6 mL N/A 2 mg/mL19 discard unused 100-250 mL 72 h F, 24 h RT19 (Teva) portion19 NS, D5W19 (RT) no preservative19 Erwinia asparaginase (asparaginase Erwinia 1-2 mL NS20 10,000-5000 15 min RT20 syringe20 4 h RT20 - contact with the chrysanthemi) units/mL rubber stopper may 10,000 units do not shake; mix denature the (CGF/Jazz) gently to minimize reconstituted drug, (F) bubbles and contact creating filaments no preservative20 with stopper20 of insoluble material; if present, administer with 5 micron filter20 - do not use sterile water for reconstitution as the resulting product is not isotonic20 PEG-asparaginase - see pegaspargase in L-Z chart (pegylated asparaginase E. coli) BC Cancer Chemotherapy Preparation and Stability Chart© version 2.00. All rights reserved. 4/60 This document may not be reproduced in any form without the express written permission of BC Cancer Provincial Pharmacy. Activation Date: 2 March 2006 Revised Date: 1 September 2021 BC CANCER CHEMOTHERAPY PREPARATION AND STABILITY CHART DRUG & STRENGTH Reconstitute To Give: Vial Product Product Stability Special (Storage Prior to Use, With: Stability (for IV bag size selection, Precautions/Notes Manufacturer, Preservative see Notes†) Status) Atezolizumab 840 mg/14 mL N/A 60 mg/mL21 discard unused 250 mL NS21 24 h F, 8 h RT21 - do NOT shake21 1200 mg/20 mL portion21 (Hoffman-La Roche) mix by gentle (F)(PFL) inversion21 do not shake no preservative21 Avelumab 200 mg/10 mL N/A 20 mg/mL22 discard unused 250 mL complete - do NOT shake22 (EMD) portion23 NS, ½-NS22 administration within - administer with (F)(PFL) 24 h F, 8 h RT22 0.2 micron in-line no preservative22 if refrigerated, mix by gentle filter22 bring vial to RT inversion22 if refrigerated, bring prior to use22 bag to RT prior to administration22 BC Cancer Chemotherapy Preparation and Stability Chart© version 2.00. All rights reserved. 5/60 This document may not be reproduced in any form without the express written permission of BC Cancer Provincial Pharmacy. Activation Date: 2 March 2006 Revised Date: 1 September 2021 BC CANCER CHEMOTHERAPY PREPARATION AND STABILITY CHART DRUG & STRENGTH Reconstitute To Give: Vial Product Product Stability Special (Storage Prior to Use, With: Stability (for IV bag size selection, Precautions/Notes Manufacturer, Preservative see Notes†) Status) azaCITIDine 100 mg 4 mL SWI24 25 mg/mL24 45 min RT, SC syringe24 45 min RT (including - discard if contains (Celgene) 8 h F24 preparation time), large particles24 (RT) shake vigorously24 8 h F24 - re-suspend no preservative24 syringe contents record time of refrigerate syringe before injection by reconstitution immediately after vigorously rolling preparation if not to be syringe between used within 45 min of palms24 reconstitution25 -if cold diluent reconstitution is Refrigerated used to extend syringes24: stability, minimize allow up to 30 min exposure to RT; prior to administration ensure proper to reach a refrigeration of temperature of diluent, ~20-25°C reconstituted vial, discard syringe if and final product time elapsed at RT is greater than 30 min cold diluent 25 mg/mL24 22 h F26,27 22 h F26,27 reconstitution: 4 mL SWI at 2- 8°C26,27 BC Cancer Chemotherapy Preparation and Stability Chart© version 2.00. All rights reserved. 6/60 This document may not be reproduced in any form without the express written permission of BC Cancer Provincial Pharmacy. Activation Date: 2 March 2006 Revised Date: 1 September 2021 BC CANCER CHEMOTHERAPY PREPARATION AND STABILITY CHART DRUG & STRENGTH Reconstitute To Give: Vial Product Product Stability Special (Storage Prior to Use, With: Stability (for IV bag size selection, Precautions/Notes Manufacturer, Preservative see Notes†) Status) azaCITIDine 100 mg 4 mL SWI28 25 mg/mL28 45 min RT, SC syringe28 45 min RT (including - do not filter28 (Dr. Reddy‘s) 8 h F28 preparation time), - discard if contains (RT) shake vigorously28 8 h F28 large particles28 no preservative28 - re-suspend refrigerate syringe syringe contents immediately after before injection by preparation if not to be vigorously rolling used within 45 min of syringe between reconstitution28 palms28 Refrigerated syringes28: allow up to 30 min prior to administration to reach a temperature of ~20-25°C discard syringe if time elapsed at RT is greater than 30 min BC Cancer Chemotherapy Preparation and Stability Chart© version 2.00. All rights reserved. 7/60 This document may not be reproduced in any form without the express written permission of BC Cancer Provincial Pharmacy. Activation Date: 2 March 2006 Revised Date: 1 September 2021 BC CANCER CHEMOTHERAPY PREPARATION AND STABILITY CHART DRUG & STRENGTH Reconstitute To Give: Vial Product Product Stability Special (Storage Prior to Use, With: Stability (for IV bag size selection, Precautions/Notes Manufacturer, Preservative see Notes†) Status) BCG (Tice substrain) 1 mL preservative- 1 to 8×108 2 h F29 transfer from vial to use within 2 h F of - auxiliary info: intravesical free NS29 CFU/vial29 60 mL syringe, rinse reconstitution29,30 biohazard30 50 mg = 1 to 8 x 108 **(PFL)29 vial with another 1 mL - do NOT filter29 CFU allow to stand for a NS; add rinse to **(PFL)29 - do NOT shake29 (Merck Canada) few minutes, then same 60 mL syringe (F)(PFL) gently swirl to and qs to 50 mL with no preservative29 suspend29 NS29 record time of if a closed system reconstitution transfer device is used: transfer from vial to 60 mL syringe and qs to 50 mL with NS; do NOT rinse vial29 BCG (Tice substrain) 1 mL preservative 1 to 8×108 2 h F31 transfer from vial to use within 2 h F of - auxiliary info: intravesical free NS31 CFU/vial31 60 mL syringe and qs reconstitution30,31 biohazard30 50 mg = 1 to 8 x 108 **(PFL31 to 50 mL with NS31 - do NOT filter31 CFU allow to stand for a **(PFL)31 - do NOT shake31 (Merck USA) few minutes, then (F)(PFL) gently swirl to no preservative31 suspend31 record time of reconstitution BC Cancer Chemotherapy Preparation and Stability Chart© version 2.00.
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  • Australian Public Assessment Report for Aminolevulinic Acid Hcl

    Australian Public Assessment Report for Aminolevulinic Acid Hcl

    Australian Public Assessment Report for Aminolevulinic acid HCl Proprietary Product Name: Gliolan Sponsor: Specialised Therapeutics Australia Pty Ltd March 2014 Therapeutic Goods Administration About the Therapeutic Goods Administration (TGA) · The Therapeutic Goods Administration (TGA) is part of the Australian Government Department of Health, and is responsible for regulating medicines and medical devices. · The TGA administers the Therapeutic Goods Act 1989 (the Act), applying a risk management approach designed to ensure therapeutic goods supplied in Australia meet acceptable standards of quality, safety and efficacy (performance), when necessary. · The work of the TGA is based on applying scientific and clinical expertise to decision- making, to ensure that the benefits to consumers outweigh any risks associated with the use of medicines and medical devices. · The TGA relies on the public, healthcare professionals and industry to report problems with medicines or medical devices. TGA investigates reports received by it to determine any necessary regulatory action. · To report a problem with a medicine or medical device, please see the information on the TGA website < http://www.tga.gov.au>. About AusPARs · An Australian Public Assessment Record (AusPAR) provides information about the evaluation of a prescription medicine and the considerations that led the TGA to approve or not approve a prescription medicine submission. · AusPARs are prepared and published by the TGA. · An AusPAR is prepared for submissions that relate to new chemical entities, generic medicines, major variations, and extensions of indications. · An AusPAR is a static document, in that it will provide information that relates to a submission at a particular point in time. · A new AusPAR will be developed to reflect changes to indications and/or major variations to a prescription medicine subject to evaluation by the TGA.