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BC CANCER CHEMOTHERAPY PREPARATION AND STABILITY …

BC CANCER CHEMOTHERAPY PREPARATION and STABILITY Chart version 1/49 Activation Date: 2 March 2006 Revised Date: 15 August 2018 BC CANCER CHEMOTHERAPY PREPARATION AND STABILITY CHART DRUG & STRENGTH (Storage Prior to Use, Manufacturer, Preservative Status) Reconstitute With: To Give: Vial STABILITY Product Product STABILITY Special Precautions/Notes Aldesleukin 22 million units ( mg) (Novartis) (F)(PFL) no preservative1 mL SWI1,2 direct diluent against side of vial during reconstitution1 do NOT shake1 18 million unit /mL ( mg/mL)1,2 48 h F1 50 mL D5W1 30 70 mcg/mL1 Less than 30 mcg/mL: dilute in D5W containing human albumin 48 h F1 - do not use in-line filter1,2 - avoid bacteriostatic water for injection or NS due to increased aggregation1 SC syringe3,4 14 d F4 **(PFL) Alemtuzumab 30 mg/mL (Genzyme/Bayer)5 (F)(PFL) do not shake no preservative6 N/A filter NOT required6 30 mg/mL6 discard unused portion6 SC syringe7 discard at the end of the day F or RT - do NOT shake8 100 mL NS, D5W6 8 h F or RT6 **(PFL)8 Amifostine 500 mg (MedImmune) (RT) no preservative9 mL NS only9 50 mg/mL9 24 h F, 5 h RT9 25 50 mL* NS only9 5 40 mg/mL: 24 h F, 5 h RT9 - discard cloudy solution10 BC CANCER CHEMOTHERAPY PREPARATION and STABILITY Chart version 2/49 Activation Date: 2 March 2006 Revised Date: 15 August 2018 BC CANCER CHEMOTHERAPY PREPARATION AND STABILITY CHART DRUG & STRENGTH (Storage Prior to Us)

18 million unit/mL (1.1 mg/mL)4,5 48 h F4 50 mL D5W4 30-70 mcg/mL4 Less than 30 mcg/mL: dilute in D5W containing human albumin 0.1%5 48 h F4 - do not use in-line filter4,5 - avoid bacteriostatic water for injection or NS due to increased aggregation4 SC syringe6,7 14 d F7 **(PFL)

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Transcription of BC CANCER CHEMOTHERAPY PREPARATION AND STABILITY …

1 BC CANCER CHEMOTHERAPY PREPARATION and STABILITY Chart version 1/49 Activation Date: 2 March 2006 Revised Date: 15 August 2018 BC CANCER CHEMOTHERAPY PREPARATION AND STABILITY CHART DRUG & STRENGTH (Storage Prior to Use, Manufacturer, Preservative Status) Reconstitute With: To Give: Vial STABILITY Product Product STABILITY Special Precautions/Notes Aldesleukin 22 million units ( mg) (Novartis) (F)(PFL) no preservative1 mL SWI1,2 direct diluent against side of vial during reconstitution1 do NOT shake1 18 million unit /mL ( mg/mL)1,2 48 h F1 50 mL D5W1 30 70 mcg/mL1 Less than 30 mcg/mL: dilute in D5W containing human albumin 48 h F1 - do not use in-line filter1,2 - avoid bacteriostatic water for injection or NS due to increased aggregation1 SC syringe3,4 14 d F4 **(PFL) Alemtuzumab 30 mg/mL (Genzyme/Bayer)5 (F)(PFL) do not shake no preservative6 N/A filter NOT required6 30 mg/mL6 discard unused portion6 SC syringe7 discard at the end of the day F or RT - do NOT shake8 100 mL NS, D5W6 8 h F or RT6 **(PFL)8 Amifostine 500 mg (MedImmune) (RT) no preservative9 mL NS only9 50 mg/mL9 24 h F, 5 h RT9 25 50 mL* NS only9 5 40 mg/mL: 24 h F, 5 h RT9 - discard cloudy solution10 BC CANCER CHEMOTHERAPY PREPARATION and STABILITY Chart version 2/49 Activation Date: 2 March 2006 Revised Date: 15 August 2018 BC CANCER CHEMOTHERAPY PREPARATION AND STABILITY CHART DRUG & STRENGTH (Storage Prior to Use, Manufacturer, Preservative Status) Reconstitute With: To Give.

2 Vial STABILITY Product Product STABILITY Special Precautions/Notes Amsacrine 75 mL (Erfa Canada) (RT) no preservative11 glass syringes preferred during reconstitution; max. time in plastic syringe11: 15 min mL supplied diluent (L-lactic acid)1 transfer from ampoule into the diluent vial11 5 mg/mL11 24 h RT11 (**PFL)11 500 mL D5W11 (plastic or glass container)11 7 d F, 48 h RT11-13 - contains DMA** Arsenic 10 mg/10 mL (Lundbeck/Teva) (RT) no preservative14 N/A 1 mg/mL14 (use filter needle to withdraw from ampoule) discard unused portion14 100-250 mL NS, D5W14 24 h RT, 48 h F14 Asparaginase (asparaginase E. coli) 10,000 units (CGF/EUSA) (F) no preservative15 4 mL SWI15 do NOT shake; rotate gently15 2500 units/mL 3 h RT or 72 h F15 syringe complete administration within 3 h RT or 72 h F15 50-250 mL NS or D5W16 complete administration within 3 h RT15,17 BC CANCER CHEMOTHERAPY PREPARATION and STABILITY Chart version 3/49 Activation Date: 2 March 2006 Revised Date: 15 August 2018 BC CANCER CHEMOTHERAPY PREPARATION AND STABILITY CHART DRUG & STRENGTH (Storage Prior to Use, Manufacturer, Preservative Status) Reconstitute With: To Give: Vial STABILITY Product Product STABILITY Special Precautions/Notes Erwinia asparaginase (asparaginase Erwinia chrysanthemi) 10,000 units (CGF/EUSA) (F) no preservative18 1-2 mL NS18 do NOT shake.

3 Mix gently to minimize bubbles and contact with stopper18 10 000-5000 units/mL (use 5 micron filter needle to withdraw from vial)19 15 min RT18 glass or polypropylene syringe18 4 h RT18 - contact with the rubber stopper may denature the reconstituted drug, creating filaments of insoluble material18 - discard if particulate matter is present19 - do not use sterile water for reconstitution as the resulting product is not isotonic18 PEG-asparaginase - see pegaspargase in L-Z chart (pegylated asparaginase E. coli) Atezolizumab 1200 mg/20 mL (Hoffman-La Roche) (F)(PFL) do not shake no preservative20 N/A 60 mg/mL20 discard unused portion20 250 mL NS only21 mix by slow inversion21 complete administration within 8 h RT, 24 h F20 - discard vial if cloudy, discoloured (should be clear to pale yellow), or visible particles21 - do NOT shake21 BC CANCER CHEMOTHERAPY PREPARATION and STABILITY Chart version 4/49 Activation Date: 2 March 2006 Revised Date: 15 August 2018 BC CANCER CHEMOTHERAPY PREPARATION AND STABILITY CHART DRUG & STRENGTH (Storage Prior to Use, Manufacturer, Preservative Status) Reconstitute With: To Give.

4 Vial STABILITY Product Product STABILITY Special Precautions/Notes Avelumab 200 mg/10 mL (EMD) (F)(PFL) no preservative22 N/A 20 mg/mL22 discard unused portion17 if refrigerated, bring vial to RT prior to use22 250 mL NS, sodium chloride22 mix by gentle inversion22 complete administration within 8 h RT, 24 h F22 if refrigerated, bring bag to RT prior to administration22 - do NOT shake22 - use micron in-line filter to administer22 BC CANCER CHEMOTHERAPY PREPARATION and STABILITY Chart version 5/49 Activation Date: 2 March 2006 Revised Date: 15 August 2018 BC CANCER CHEMOTHERAPY PREPARATION AND STABILITY CHART DRUG & STRENGTH (Storage Prior to Use, Manufacturer, Preservative Status) Reconstitute With: To Give: Vial STABILITY Product Product STABILITY Special Precautions/Notes azaCITIDine 100 mg (Celgene) (RT) no preservative23 4 mL SWI23 shake vigorously23 record time of reconstitution 25 mg/mL23 45 min RT, 8 h F23 SC syringe23 45 min RT (including PREPARATION time), 8 h F23 refrigerate syringe immediately after PREPARATION if not to be used within 45 minutes of reconstitution24 - discard if contains large particles23 - re-suspend syringe contents before injection by vigorously rolling syringe between palms23 -if cold diluent reconstitution is used to extend STABILITY , minimize exposure to RT.

5 Ensure proper refrigeration of diluent, reconstituted vial, and final product cold diluent reconstitution: 4 mL SWI at 2-8 C25,26 25 mg/mL23 22 h F25,26 22 h F25,26 Refrigerated syringes23: 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 6/49 Activation Date: 2 March 2006 Revised Date: 15 August 2018 BC CANCER CHEMOTHERAPY PREPARATION AND STABILITY CHART DRUG & STRENGTH (Storage Prior to Use, Manufacturer, Preservative Status) Reconstitute With: To Give: Vial STABILITY Product Product STABILITY Special Precautions/Notes azaCITIDine 100 mg (Dr. Reddy s) (RT) no preservative27 4 mL SWI27 shake vigorously27 25 mg/mL27 45 min RT, 8 h F27 SC syringe27 45 min RT (including PREPARATION time), 8 h F27 refrigerate syringe immediately after PREPARATION if not to be used within 45 minutes of reconstitution27 Refrigerated syringes27: allow up to 30 min prior to administration to reach a temperature of approximately 20-25 C discard syringe if time elapsed at RT is greater than 30 min - do not filter27 - discard if contains large particles27 - re-suspend syringe contents before injection by vigorously rolling syringe between palms27 BC CANCER CHEMOTHERAPY PREPARATION and STABILITY Chart version 7/49 Activation Date: 2 March 2006 Revised Date: 15 August 2018 BC CANCER CHEMOTHERAPY PREPARATION AND STABILITY CHART DRUG & STRENGTH (Storage Prior to Use, Manufacturer, Preservative Status) Reconstitute With: To Give.

6 Vial STABILITY Product Product STABILITY Special Precautions/Notes BCG intravesical 81 mg (Sanofi Pasteur) (F)(PFL) preservative28 do NOT shake; roll to reconstitute28 3 mL supplied diluent28 record time of reconstitution 108 CFU/vial (Connaught strain)28 2 h F, RT28 50 mL NS28 2 h F or RT after reconstitution28 **(PFL)28 - auxiliary label: biohazard17 BCG (Tice substrain) intravesical 50 mg = 1 to 8 x 108 CFU (Hospira/Organon) (F)(PFL) no preservative29 1 mL preservative free NS for injection29 use reconstitution device provided allow to stand for a few minutes, then gently swirl to suspend29 1 to 8 108 CFU/vial29 2 h F (PFL)29 transfer from vial to 60 mL syringe, rinse vial with another 1 mL NS. Add rinse to same 60 mL syringe. qs to 50 mL with NS29 2 h F29 - auxiliary label: biohazard17 - overfill unknown - protect from light29 - do not filter29 Belinostat 500 mg (Spectrum) (RT) no preservative30 9 mL SWI30 50 mg/mL30 12 h RT30 250 mL NS30 complete administration within 36 h RT30 - use micron inline filter to administer30 BC CANCER CHEMOTHERAPY PREPARATION and STABILITY Chart version 8/49 Activation Date: 2 March 2006 Revised Date: 15 August 2018 BC CANCER CHEMOTHERAPY PREPARATION AND STABILITY CHART DRUG & STRENGTH (Storage Prior to Use, Manufacturer, Preservative Status) Reconstitute With: To Give: Vial STABILITY Product Product STABILITY Special Precautions/Notes Bendamustine 25 mg 100 mg (Lundbeck/Teva) (RT)(PFL) no preservative31 25 mg vial: add 5 mL SWI31 100 mg vial: add 20 mL SWI31 shake well.

7 Dissolves completely in 5 minutes31 5 mg/mL31 30 minutes31 500 mL NS31 mg/mL31 complete administration within 24 h F, 3 h RT31 Bevacizumab 100 mg/4 mL 400 mg/16 mL (Roche) (F)(PFL) do not shake no preservative32 N/A 25 mg/mL32 discard unused portion32 mg/mL33 100-250 mL NS only32,33 48 h F, RT32-34 - do NOT shake32 Bleomycin 15 units (NB: dose in units only) (Bristol) (F) no preservative35 6 mL* NS35 units/mL 48 h F35 50 mL* NS35 24 h RT35 - no overfill36 BC CANCER CHEMOTHERAPY PREPARATION and STABILITY Chart version 9/49 Activation Date: 2 March 2006 Revised Date: 15 August 2018 BC CANCER CHEMOTHERAPY PREPARATION AND STABILITY CHART DRUG & STRENGTH (Storage Prior to Use, Manufacturer, Preservative Status) Reconstitute With: To Give: Vial STABILITY Product Product STABILITY Special Precautions/Notes Bleomycin 15 units (NB: dose in units only) (Hospira) (F)(PFL) no preservative37 6 mL* NS, SWI37 units/mL37 48 h F, 24 h RT37 50 mL* NS, SWI37 24 h RT38 - no overfill39 Bleomycin 15 units (NB: dose in units only) (Fresenius Kabi) (F)(PFL) no preservative40 6 mL NS40 units/mL40 48 h F40 50 mL NS40 24 h RT40 Blinatumomab mcg (Amgen) (F)(PFL) do not shake no preservative41 3 mL SWI41 do NOT use supplied IV solution stabilizer to reconstitute vials41 direct diluent against side of vial during reconstitution41 gently swirl to avoid excess foaming41 mcg/mL41 4 h RT, 24 h F41 250 mL NS41 add supplied IV solution stabilizer to NS bag and gently mix to avoid foaming41 add reconstituted drug to bag following addition of IV solution stabilizer41 complete administration within 96 h RT, 10 d F41 - use non-DEHP bag and IV administration set41 - use or micron in-line filter41 - prime lines with blinatumomab solution.

8 Do NOT use NS BC CANCER CHEMOTHERAPY PREPARATION and STABILITY Chart version 10/49 Activation Date: 2 March 2006 Revised Date: 15 August 2018 BC CANCER CHEMOTHERAPY PREPARATION AND STABILITY CHART DRUG & STRENGTH (Storage Prior to Use, Manufacturer, Preservative Status) Reconstitute With: To Give: Vial STABILITY Product Product STABILITY Special Precautions/Notes Bortezomib SC injection mg (Actavis) (RT)(PFL) no preservative42 mL NS42 mg/mL42 8 h RT42 SC syringe42 8 h RT42 - auxiliary info: WARNING: SUBCUTANEOUS use only. Fatal if given by other routes. Bortezomib mg (Actavis) (RT)(PFL) no preservative42 mL NS42 1 mg/mL42 8 h RT42 IV syringe42 8 h RT42 - auxiliary info: WARNING: INTRAVENOUS use only. Fatal if given by other routes. Bortezomib SC injection mg (Janssen) (RT)(PFL) no preservative43 mL NS43 mg/mL43 2 d RT, F17,44 SC syringe43 48 h RT, 14 d F17,44 - auxiliary info: WARNING: SUBCUTANEOUS use only. Fatal if given by other routes.

9 Bortezomib mg (Janssen) (RT)(PFL) no preservative43 mL NS43 1 mg/mL43 2 d RT, F17,45 IV syringe43 8 h RT43 - auxiliary info: WARNING: INTRAVENOUS use only. Fatal if given by other routes. BC CANCER CHEMOTHERAPY PREPARATION and STABILITY Chart version 11/49 Activation Date: 2 March 2006 Revised Date: 15 August 2018 BC CANCER CHEMOTHERAPY PREPARATION AND STABILITY CHART DRUG & STRENGTH (Storage Prior to Use, Manufacturer, Preservative Status) Reconstitute With: To Give: Vial STABILITY Product Product STABILITY Special Precautions/Notes Bortezomib SC injection mg (Teva) (RT)(PFL) no preservative46 mL NS46 mg/mL46 2 d RT, F17,47 SC syringe46 48 h RT, 14 d F17,47 - auxiliary info: WARNING: SUBCUTANEOUS use only. Fatal if given by other routes. Bortezomib mg (Teva) (RT)(PFL) no preservative46 mL NS46 1 mg/mL46 2 d RT, F46 IV syringe46 48 h RT, 14 d F17,47 - auxiliary info: WARNING: INTRAVENOUS use only. Fatal if given by other routes.

10 Brentuximab vedotin 50 mg (GMD/Seattle Genetics) (F)(PFL) no preservative48 mL SWI48 direct diluent against side of vial during reconstitution48 do NOT shake48 5 mg/mL48 24 h F48 mg/mL in NS, D5W, Lactated Ringer s 100-250 mL48 24 h F48 - solution should be clear to slightly opalescent, colorless, and free of visible particulates48 BC CANCER CHEMOTHERAPY PREPARATION and STABILITY Chart version 12/49 Activation Date: 2 March 2006 Revised Date: 15 August 2018 BC CANCER CHEMOTHERAPY PREPARATION AND STABILITY CHART DRUG & STRENGTH (Storage Prior to Use, Manufacturer, Preservative Status) Reconstitute With: To Give: Vial STABILITY Product Product STABILITY Special Precautions/Notes Busulfan 60 mg/10 mL (SteriMax) (F) no preservative49 N/A 6 mg/mL49 discard unused portion17,49 NS, D5W (dilute to volume 10 times drug volume to achieve final concentration of ~ mg/mL)49 in NS: complete administration within 8 h RT, 12 h F49 in D5W: complete administration within 8 h RT49 - contains DMA** - always add busulfan to diluent to mix.


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