{"effective_time":"20170130","health_care_provider_letter":["Temporary Importation of Canadian Piperacillin and Tazobactam for Injection to Address Drug Shortage January 16, 2017 Dear Healthcare Professional: Due to the current critical shortage of Piperacillin and Tazobactam for Injection products in the United States (U.S.) market, SteriMax Inc. (SteriMax) is coordinating with the U.S. Food and Drug Administration (FDA) to increase the availability of the drug. SteriMax has initiated temporary importation of non-FDA approved Piperacillin and Tazobactam for Injection (3.375 g/vial, 4.5 g/vial, and 40.5 g/vial) into the U.S. market. The Piperacillin and Tazobactam for Injection from SteriMax is marketed in Canada and is manufactured at an FDA-inspected facility that is in compliance with current good manufacturing practice requirements. X-Gen Pharmaceuticals will distribute SteriMax's Piperacillin and Tazobactam for Injection to address the critical shortage. At this time, no other entity except SteriMax or its distributor X-Gen Pharmaceuticals is authorized by the FDA to import or distribute SteriMax's Piperacillin and Tazobactam for Injection in the United States. Effective immediately, X-Gen Pharmaceuticals will distribute the following presentations of SteriMax's Piperacillin and Tazobactam for Injection: SteriMax Piperacillin and Tazobactam for Injection 3.375 g/vial (equivalent to 3 g of piperacillin and 0.375 g of tazobactam) DIN: 02362627 (Canada) 4.5 g/vial (equivalent to 4 g of piperacillin and 0.5 g of tazobactam) DIN: 02362635 (Canada) 40.5 g/vial (equivalent to 36 g of piperacillin and 4.5 g of tazobactam) DIN: 02439131 (Canada) Note: DIN refers to Drug Identification Number for products marketed in Canada. The barcode may not register accurately on the U.S. scanning systems. The barcode used for SteriMax’s non-U.S. approved Piperacillin and Tazobactam for Injection is an international pharmaceutical manufacturing code and may not be appropriately recognized by scanning systems used in the U.S. Institutions should confirm the barcode systems do not provide incorrect information when the product is scanned. Alternative procedures should be followed to assure that the correct drug product is being used and administered to individual patients. The vial and carton labels will display the text used and approved for marketing the products in Canada with both English and French translations. At the end of this letter, you will find a product comparison table and a comparison of the carton and vial labels with the U.S. FDA reference listed drug (RLD). It is important to note that there are differences in the format and content of the labeling between the RLD and SteriMax’s Piperacillin and Tazobactam for Injection. In particular, for the U.S. market, we would like to highlight the following instructions: Please reconstitute the SteriMax product with only the following Compatible Reconstitution Diluents: 0.9% Sodium Chloride Injection, Sterile Water for Injection, Dextrose 5% Injection. Please dilute the reconstituted product with the following Compatible Intravenous Solutions: 0.9% Sodium Chloride Injection, Sterile Water for Injection, 5% Dextrose Injection, 6% Dextran in Saline. We also recommend the following for the use of SteriMax’s Piperacillin and Tazobactam for Injection as temporary supply in the U.S.: Store original vials at controlled room temperature (20-25°C [68°F to 77°F]) prior to reconstitution. Due to unique regulatory requirements in the U.S., this formulation of Piperacillin and Tazobactam for Injection is considered NOT compatible with Lactated Ringer’s Solution (LRS), so LRS should not be used as a diluent. Please discard unused portions of reconstituted as well as further diluted product including product stored in I.V. bags after storage for 24 hours at room temperature (20°C to 25°C [68°F to 77°F]), or 48 hours when refrigerated (2°C to 8°C [36°F to 46°F]). Single dose or pharmacy vials should not be frozen after reconstitution. Please note that SteriMax Piperacillin and Tazobactam for Injection and aminoglycosides are recommended for separate administration. SteriMax Piperacillin and Tazobactam for Injection is not compatible with Tobramycin for simultaneous co-administration via Y-site infusion. Compatibility of SteriMax Piperacillin and Tazobactam for Injection with other aminoglycosides has not been established. Piperacillin and Tazobactam for Injection is available only by prescription in the U.S. Finally, please ensure that your staff and others in your institution who may be involved in the administration of Piperacillin and Tazobactam receive a copy of this letter and review the information. If you have any questions about the information contained in this letter or the use of SteriMax’s Piperacillin and Tazobactam for Injection, please contact SteriMax Quality Assurance or Regulatory Affairs at 1-800-881-3550 (Monday – Friday, 9AM to 5PM, Eastern Standard Time). To place an order , please contact X-Gen Pharmaceuticals Customer Service/Order Entry at 1-866-390-4411 (Monday – Friday, 9AM to 5PM, Eastern Standard Time). We encourage healthcare providers to report any adverse events and medication errors that occur while using this product, as for any other drug. To report adverse events or quality problems associated with the use of this product, please call SteriMax Quality Assurance at 1-800-881-3550. Adverse events or quality problems experienced with the use of this product may also be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, or regular mail, or by fax: Complete and submit the report Online: www.fda.gov/medwatch/report.htm Regular mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178. We remain at your disposal to answer any questions you may have about our product; and provide more information if needed. Sincerely, Ritesh Acharya, Director of Medical Affairs SteriMax Inc."],"health_care_provider_letter_table":["
SteriMax Piperacillin and Tazobactam for Injection
3.375 g/vial (equivalent to 3 g of piperacillin and 0.375 g of tazobactam) DIN: 02362627 (Canada)
4.5 g/vial (equivalent to 4 g of piperacillin and 0.5 g of tazobactam) DIN: 02362635 (Canada)
40.5 g/vial (equivalent to 36 g of piperacillin and 4.5 g of tazobactam) DIN: 02439131 (Canada)
"],"how_supplied":["16 HOW SUPPLIED/ STORAGE AND HANDLING Piperacillin and Tazobactam for Injection are supplied as pharmacy bulk vials in the following size: Each Piperacillin and Tazobactam for Injection 40.5 g pharmacy bulk vial provides Piperacillin Sodium equivalent to 36 grams of Piperacillin and Tazobactam Sodium equivalent to 4.5 g of Tazobactam. Supplied 1 per box."],"id":"bc57f260-0e8d-4ef9-b6e5-1898d5339023","openfda":{},"package_label_principal_display_panel":["PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 40.5 grams Vial Label Sterile/ DIN 02439131 Piperacillin and Tazobactam for Injection, Mfr. Std. 36 g piperacillin/4.5 g tazobactam Powder for Injection Antibiotic/ β-lactamase Inhibitor For Intravenous Infusion PHARMACY BULK VIAL –NOT FOR DIRECT INFUSION Single Puncture – Multiple Dispensing Latex Free Stopper Preservative Free For use in pharmacy (hospital) admixture program only. Single use vial. Reconstitute and dilute before use. Each vial contains sterile piperacillin sodium and tazobactam sodium powder equivalent to 36 g piperacillin/ 4.5 g tazobactam. Reconstitution: Tap vial gently to loosen powder prior to reconstitution. Reconstitute with 152 mL recommended diluent per vial to yield a concentration of 0.200 g/mL of piperacillin and 0.025 g/mL of tazobactam. Shake well. Should be further diluted – see package insert. Use reconstituted solution within 24 hours at room temperature or 48 hours if refrigerated. Discard unused portion. Store powder at 15°-25°C. Product monograph available upon request. Sterimax Inc. Oakville, ON L6H 6R4 LLAJ511.01 1","PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 40.5 grams Carton Sterile/ DIN 02439131 1 X 40.5 Vial Piperacillin and Tazobactam for Injection, Mfr. Std. 36 g piperacillin/4.5 g tazobactam Sterile piperacillin sodium / tazobactam sodium lyophilized powder for injection Antibiotic/ β-lactamase Inhibitor For Intravenous Infusion PHARMACY BULK VIAL –NOT FOR DIRECT INFUSION Single Puncture – Multiple Dispensing Latex Free Stopper Preservative Free For use in pharmacy (hospital) admixture program only. Single use vial. Reconstitute and dilute before use. Each vial contains sterile piperacillin sodium and tazobactam sodium powder equivalent to 36 g piperacillin/ 4.5 g tazobactam. Usual Adult Total Daily Dose: 12 g/1.5 g, given as 3 g/0.375 g every 6 hours. 4 g/0.5 g every 8 hours for intra-abdominal infections. Not recommended for children under 12 years. Reconstitution: Tap vial gently to loosen powder prior to reconstitution. Reconstitute with 152 mL recommended diluent per vial to yield a concentration of 0.200 g/mL of piperacillin and 0.025 g/mL of tazobactam. Shake well. Should be further diluted – see package insert. Use reconstituted solution within 24 hours at room temperature or 48 hours if refrigerated. Discard unused portion. Store powder at 15°-25°C. Product monograph available upon request. Sterimax Inc. Oakville, ON L6H 6R4 CCAJ511.01 2"],"set_id":"35dc55e5-7910-4556-9756-eaf5fa2dd8d2","spl_product_data_elements":["Piperacillin, Tazobactam Piperacillin, Tazobactam Piperacillin Sodium Piperacillin Anhydrous Tazobactam Sodium Tazobactam"],"spl_unclassified_section":["Comparison Table 1 Product Comparison Table SteriMax Piperacillin and Tazobactam for Injection Zosyn® Composition Each gram of piperacillin contains 2.36 mEq (54.28 mg) of Na+ (sodium) Each gram of piperacillin contains 2.84 mEq (65 mg) of Na+ (sodium) 3.375 g/vial Each vial: piperacillin sodium equivalent to 3 grams of piperacillin and tazobactam sodium equivalent to 0.375 gram of tazobactam. Each vial: piperacillin sodium equivalent to 3 grams of piperacillin and tazobactam sodium equivalent to 0.375 gram of tazobactam. 0.75 mg of EDTA. 4.5 g/vial Each vial: piperacillin sodium equivalent to 4 grams of piperacillin and tazobactam sodium equivalent to 0.5 gram of tazobactam. Each vial: piperacillin sodium equivalent to 4 grams of piperacillin and tazobactam sodium equivalent to 0.5 gram of tazobactam. 1 mg of EDTA. 40.5 g/vial Each vial: piperacillin sodium equivalent to 36 grams of piperacillin and tazobactam sodium equivalent to 4.5 grams of tazobactam. Each vial: piperacillin sodium equivalent to 36 grams of piperacillin and tazobactam sodium equivalent to 4.5 grams of tazobactam. 9 mg of EDTA. Active Ingredient Piperacillin and tazobactam Piperacillin and tazobactam Strength 3.375 g/vial, 4.5 g/vial, 40.5 g/vial 3.375 g/vial, 4.5 g/vial, 40.5 g/vial Inactive Ingredients N/A 3.375 g/vial: 0.75 mg EDTA 4.5 g/vial: 1 mg EDTA 40.5 g/vial: 9 mg EDTA Physiochemical Parameters White to off white sterile powder Highly water soluble Information not available. pH 5.0 – 7.0 Information not available. Description White to off-white sterile powder White to off-white sterile powder How Supplied 3.375 g/vial: single dose glass vial 4.5 g/vial: single dose glass vial 40.5 g/vial: pharmacy bulk glass vial 3.375 g/vial: single dose glass vials 4.5 g/vial: single dose glass vial 40.5 g/vial: pharmacy bulk glass vial Country-Specific Information Canada: Drug Identification Numbers (DINs) 3.375 g/vial: DIN 02362627 4.5 g/vial: DIN 02362635 40.5 g/vial: DIN 02439131 USA: Special Import Permit issued by FDA Drug Status Prescription Authorization Holder SteriMax Inc. 2770 Portland Drive Oakville, ON L6H 6R4","Comparison Table 2 Comparison Table of Canadian Product to Zosyn (RLD) / Strength: 40.5 g/vial Item Zosyn ® (piperacillin and tazobactam for injection, USP) (Approved RLD Carton and Vial Label Information Amerinet Choice) Pr Piperacillin and Tazobactam for Injection Mfr. Std. (Proposed Carton and Vial Label Information SteriMax Inc.) Carton Label - Principal Display Principal Display Panel NDC 0206-8859-10 Rx only Zosyn® (Piperacillin and Tazobactam for Injection, USP) 40.5 gram vial PHARMACY BULK PACKAGE Not for Direct Infusion RECONSTITUTED STOCK SOLUTION MUST BE TRANSFERRED AND FURTHER DILUTED FOR I.V. INFUSION Pfizer Injectables Principal Display Panel 1 x 40.5 g vial Sterile DIN 02439131 Pr Piperacillin and Tazobactam for Injection – Mfr. Std. 36 g piperacillin/4.5 g tazobactam Sterile piperacillin sodium / tazobactam sodium lyophilized powder for injection For intravenous infusion PHARMACY BULK VIAL – NOT FOR DIRECT INFUSION Single Puncture – Multiple Dispensing LATEX FREE STOPPER PRESERVATIVE FREE STERIMAX Carton Label - Side Panel 1 Side Panel 1 Does not contain preservatives. Reconstitute with exactly 152 mL of a suitable diluent to achieve a concentration of 200 mg/mL of piperacillin and 25 mg/mL tazobactam. Discard any unused portion after 24 hours of stored at room temperature or after 48 hours if refrigerated. See package insert for complete directions for use. Prior to Reconstitution: Store at controlled room temperature 20° to 25°C (68° to 77°F). After Reconstitution: DO NOT FREEZE RECONSTITUTED SOLUTION. See package insert for stability of reconstituted solution. Contains piperacillin and tazobactam cryodessicated powders for injection equivalent to 36 grams of piperacillin and 4.5 grams of tazobactam and 100.4 mEq (2,304 mg) of sodium. Contains 9 mg of edetate disodium dihydrate. Distributed by: Wyeth Pharmaceuticals Inc A subsidiary of Pfizer Inc Philadelphia, PA 19101 Side Panel 1 DIN 02439131 Pr Piperacillin and Tazobactam for Injection 36 g piperacillin/4.5 g tazobactam Antibiotic / β-lactamase Inhibitor For use in pharmacy (hospital) admixture program only. Single use vial. Reconstitute and dilute before use. Each vial contains sterile piperacillin sodium and tazobactam sodium powder equivalent to 36 g piperacillin/4.5 g tazobactam. Usual Adult Total Daily Dose: 12 g/1.5 g, given as 3 g/0.375 g every 6 hours. 4 g/0.5 g every 8 hours for intra-abdominal infections. Not recommended for children under 12 years. Tap vial gently to loose powder prior to reconstitution. Reconstitute with 152 mL recommended diluent per vial to yield 0.200 g/mL piperacillin and 0.025 g/ml tazobactam. Shake well. Should be further diluted - see package insert. Use reconstituted solution within 24 hours at room temperature or 48 hours if refrigerated. Discard unused portion. Store powder at 15°-25°C. Product monograph available upon request. Sterimax Inc., Oakville, ON L6H 6R4 Carton Label - Side Panel 2 Side Panel 2 Zosyn® (Piperacillin and Tazobactam for Injection, USP) 40.5 gram vial PHARMACY BULK PACKAG Not for Direct Infusion RECONSTITUTED STOCK SOLUTION MUST BE TRANSFERRED AND FURTHER DILUTED FOR I.V. INFUSION Pfizer Injectables Side Panel 2 (FRENCH) 1 fiole de 40,5 g Stérile DIN 02439131 Pipéracilline et Tazobactam pour inection – Norme fabricant 36 g de pipéracilline/4.5 g tazobactam. Poudre stérile lyophilisée pour injection de pipéracilline sodique / de tazobactam sodique Antibiotiqe/Inhibiteur de β-lactamase Pour perfusion intraveineuse FIOLE GRAND FORMAT POUR PHARMACIES – NON DESTINÉE À L’INFUSION DIRECTE Ponction unique – doses multiples BOUCHON SANS LATEX SANS AGENT DE CONSERVATION STERIMAX Carton Label -Side Panel 3 Side Panel 3 Zosyn® (Piperacillin and Tazobactam for Injection, USP) 40.5 gram vial PHARMACY BULK PACKAGE Not for Direct Infusion RECONSTITUTED STOCK SOLUTION MUST BE TRANSFERRED AND FURTHER DILUTED FOR I.V. INFUSION Control No. Exp. Date Side Panel 3 (FRENCH) Antibiotique / inhibiteur de β-lactamases À utiliser en pharmacie (hôpital) dans un programme de préparation de perfusions intraveineuses seulement. Fioles à usage unique. Reconstituer et diluer avant utilisation. Chaque fiole contient de la poudre stérile de pipéracilline sodique et de tazobactam sodique, équivalant à 36 g de pipéracilline / 4,5 g de tazobactam. Posologie quotidienne habituelle totale pour adultes : 12 g/1,5 g, en doses de 3 g/0,375 g toutes les 6 heures. Pour les infections intra-abdominales, 4 g/0,5 g toutes les 8 heures. Usage déconseillé chez les enfants de moins de 12 ans. Reconstitution: tapoter doucement sur la fiole pour détacher la poudre avant reconstitution. Reconstituer dans 152 mL par fiole de diluant recommandé pour obtenir 0,200 g/mL de pipéracilline et 0,025 g/mL de tazobactam. Bien agiter. La solution doit être diluée davantage. Voir la notice d’accompagnement du produit. Utiliser la solution reconstituée dans un délai de 24 heures si elle est conserve à température ambiante ou de 48 heures si la solution est réfrigérée. Jeter toute portion non utilisée. Conserver la poudre entre 15 et 25 °C. La monographie du produit est disponible sur demande. SteriMax Inc., Oakville, ON L6H 6R4 Vial Label Pfizer Injectables NDC 0206-8859-10 Zosyn® Rx only (Piperacillin and Tazobactam for Injection, USP) 40.5 gram vial PHARMACY BULK PACKAGE Not for Direct Infusion Distributed by Wyeth Pharmaceuticals Inc A subsidiary of Pfizer Inc, Philadelphia, PA 19101 Contains piperacillin and tazobactam cryodesiccated powders for injection equivalent to 36 grams of piperacillin, 4.5 grams of tazobactam and 100.4 mEq (2,304 mg) of sodium. Reconstitute with exactly 152 mL of a suitable diluent to achieve concentration of 200 mg/mL of piperacillin and 25 mg/mL of tazobactam. Discard any unused portion after 24 hours if stored at room temperature or after 48 hours if refrigerated. See package insert for complete directions for use. Prior to Reconstitution: Store at controlled room temperature 20° to 25°C (68°C to 77°F). After Reconstitution: DO NOT FREEZE RECONSTITUTED SOLUTION. See package insert for stability of reconstituted solution. RECONSTITUTED STOCK SOLUTION MUST BE TRANSFERRED AND FURTHER DILUTED FOR I.V. INFUSION Does not contain preservatives. Contains 9 mg of edetate disodium dihydrate. Barcode 8920111 RA Control No./Exp. Date DIN 02439131 Pr Piperacillin and Tazobactam for Injection – Mfr. Std. 36 g piperacillin/4.5 g tazobactam Powder for Injection Antibiotic / β-lactamase Inhibitor For Intravenous Infusion PHARMACY BULK VIAL – NOT FOR DIRECT INFUSION Single Puncture – Multiple Dispensing LATEX FREE STOPPER BOUCHON SANS LATEX PRESERVATIVE FREE SteriMax For use in pharmacy (hospital) admixture program only. Single use vial. Reconstitute and dilute before use. Each vial contains sterile piperacillin sodium and tazobactam sodium powder equivalent to 36 g piperacillin/4.5 g tazobactam. Reconstitution: tap vial gently to loose powder prior to reconstitution. Reconstitute with 152 mL recommended diluent per vial to yield 0.200 g/mL of piperacillin and 0.025 g/mL of tazobactam. Shake well. Should be further diluted - see package insert. Use reconstituted solution within 24 hours at room temperature or 48 hours if refrigerated. Discard unused portion. Store powder at 15°-25°C . Product monograph available upon request. À utiliser en pharmacie (hôpital) dans un programme de préparation de perfusions intraveineuses seulement. Fioles à usage unique. Ponction unique – doses multiples. Reconstituer et diluer avant utilisation. Chaque fiole contient de la poudre stérile de pipéracilline sodique et de tazobactam sodique, équivalant à 36 g de pipéracilline / 4,5 g de tazobactam. Reconstitution: tapoter doucement sur la fiole pour détacher la poudre avant reconstitution. Reconstituer dans 152 mL par fiole de diluant recommandé pour obtenir 0,200 g/mL de pipéracilline et de 0,025 g/mL de tazobactam. Bien agiter. La solution doit être diluée davantage. Voir la notice d’accompagnement du produit. Utiliser la solution reconstituée dans un délai de 24 heures si elle est conserve à température ambiante ou de 48 heures si la solution est réfrigérée. Jeter toute portion non utilisée. Conserver la poudre entre 15 et 25 C . La monographie du produit est disponible sur demande. Barcode Sterimax Inc.,Oakville, ON L6H 6R4 Lot : EXP. : See next Table for images of the labels.","Comparison Table 3 Comparison Table of Canadian Product to Zosyn (RLD) / Strength: 40.5 g/vial Item Zosyn ® (piperacillin and tazobactam for injection, USP) (Approved RLD Carton and Vial Label Information Amerinet Choice) Pr Piperacillin and Tazobactam for Injection Mfr. Std. (Proposed Carton and Vial Label Information SteriMax Inc.) Carton Label Principal Display Principal Display Panel Principal Display Panel Carton Label Side Panel 1 Side Panel 1 Side Panel 1 Carton Label Side Panel 2 Side Panel 2 Side Panel 2 Carton Label Side Panel 3 Side Panel 3 Side Panel 3 Vial Label 3 4 5 7 8 9 10 11 12 6"],"spl_unclassified_section_table":["
Product Comparison Table
SteriMax Piperacillin and Tazobactam for Injection Zosyn®
Composition Each gram of piperacillin contains 2.36 mEq (54.28 mg) of Na+ (sodium) Each gram of piperacillin contains 2.84 mEq (65 mg) of Na+ (sodium)
3.375 g/vial Each vial: piperacillin sodium equivalent to 3 grams of piperacillin and tazobactam sodium equivalent to 0.375 gram of tazobactam. Each vial: piperacillin sodium equivalent to 3 grams of piperacillin and tazobactam sodium equivalent to 0.375 gram of tazobactam. 0.75 mg of EDTA.
4.5 g/vial Each vial: piperacillin sodium equivalent to 4 grams of piperacillin and tazobactam sodium equivalent to 0.5 gram of tazobactam. Each vial: piperacillin sodium equivalent to 4 grams of piperacillin and tazobactam sodium equivalent to 0.5 gram of tazobactam. 1 mg of EDTA.
40.5 g/vial Each vial: piperacillin sodium equivalent to 36 grams of piperacillin and tazobactam sodium equivalent to4.5 grams of tazobactam. Each vial: piperacillin sodium equivalent to 36 grams of piperacillin and tazobactam sodium equivalent to 4.5 grams of tazobactam. 9 mg of EDTA.
Active Ingredient Piperacillin and tazobactam Piperacillin and tazobactam
Strength 3.375 g/vial, 4.5 g/vial, 40.5 g/vial 3.375 g/vial, 4.5 g/vial, 40.5 g/vial
Inactive Ingredients N/A 3.375 g/vial: 0.75 mg EDTA 4.5 g/vial: 1 mg EDTA 40.5 g/vial: 9 mg EDTA
Physiochemical Parameters White to off white sterile powder Highly water soluble Information not available.
pH 5.0 – 7.0 Information not available.
Description White to off-white sterile powder White to off-white sterile powder
How Supplied 3.375 g/vial: single dose glass vial 4.5 g/vial: single dose glass vial40.5 g/vial: pharmacy bulk glass vial 3.375 g/vial: single dose glass vials 4.5 g/vial: single dose glass vial40.5 g/vial: pharmacy bulk glass vial
Country-Specific Information Canada: Drug Identification Numbers (DINs) 3.375 g/vial: DIN 02362627 4.5 g/vial: DIN 02362635 40.5 g/vial: DIN 02439131 USA: Special Import Permit issued by FDA
Drug Status Prescription
Authorization Holder SteriMax Inc. 2770 Portland Drive Oakville, ON L6H 6R4
","
Comparison Table of Canadian Product to Zosyn (RLD) / Strength: 40.5 g/vial
Item Zosyn® (piperacillin and tazobactam for injection, USP) (Approved RLD Carton and Vial Label Information Amerinet Choice) PrPiperacillin and Tazobactam for Injection Mfr. Std. (Proposed Carton and Vial Label Information SteriMax Inc.)
Carton Label - Principal Display Principal Display Panel NDC 0206-8859-10 Rx only Zosyn® (Piperacillin and Tazobactam for Injection, USP) 40.5 gram vial PHARMACY BULK PACKAGE Not for Direct Infusion RECONSTITUTED STOCK SOLUTION MUST BE TRANSFERRED AND FURTHER DILUTED FOR I.V. INFUSION Pfizer Injectables Principal Display Panel 1 x 40.5 g vial Sterile DIN 02439131 PrPiperacillin and Tazobactam for Injection – Mfr. Std. 36 g piperacillin/4.5 g tazobactam Sterile piperacillin sodium / tazobactam sodium lyophilized powder for injection For intravenous infusion PHARMACY BULK VIAL – NOT FOR DIRECT INFUSION Single Puncture – Multiple Dispensing LATEX FREE STOPPER PRESERVATIVE FREE STERIMAX
Carton Label - Side Panel 1 Side Panel 1 Does not contain preservatives. Reconstitute with exactly 152 mL of a suitable diluent to achieve a concentration of 200 mg/mL of piperacillin and 25 mg/mL tazobactam. Discard any unused portion after 24 hours of stored at room temperature or after 48 hours if refrigerated. See package insert for complete directions for use. Prior to Reconstitution: Store at controlled room temperature 20° to 25°C (68° to 77°F). After Reconstitution: DO NOT FREEZE RECONSTITUTED SOLUTION. See package insert for stability of reconstituted solution. Contains piperacillin and tazobactam cryodessicated powders for injection equivalent to 36 grams of piperacillin and 4.5 grams of tazobactam and 100.4 mEq (2,304 mg) of sodium. Contains 9 mg of edetate disodium dihydrate. Distributed by: Wyeth Pharmaceuticals Inc A subsidiary of Pfizer Inc Philadelphia, PA 19101 Side Panel 1 DIN 02439131 PrPiperacillin and Tazobactam for Injection 36 g piperacillin/4.5 g tazobactam Antibiotic / β-lactamase Inhibitor For use in pharmacy (hospital) admixture program only. Single use vial. Reconstitute and dilute before use. Each vial contains sterile piperacillin sodium and tazobactam sodium powder equivalent to 36 g piperacillin/4.5 g tazobactam. Usual Adult Total Daily Dose: 12 g/1.5 g, given as 3 g/0.375 g every 6 hours. 4 g/0.5 g every 8 hours for intra-abdominal infections. Not recommended for children under 12 years. Tap vial gently to loose powder prior to reconstitution. Reconstitute with 152 mL recommended diluent per vial to yield 0.200 g/mL piperacillin and 0.025 g/ml tazobactam. Shake well. Should be further diluted - see package insert. Use reconstituted solution within 24 hours at room temperature or 48 hours if refrigerated. Discard unused portion. Store powder at 15°-25°C. Product monograph available upon request. Sterimax Inc., Oakville, ON L6H 6R4
Carton Label - Side Panel 2 Side Panel 2 Zosyn® (Piperacillin and Tazobactam for Injection, USP) 40.5 gram vial PHARMACY BULK PACKAG Not for Direct Infusion RECONSTITUTED STOCK SOLUTION MUST BE TRANSFERRED AND FURTHER DILUTED FOR I.V. INFUSION Pfizer Injectables Side Panel 2 (FRENCH) 1 fiole de 40,5 g Stérile DIN 02439131 Pipéracilline et Tazobactam pour inection – Norme fabricant 36 g de pipéracilline/4.5 g tazobactam. Poudre stérile lyophilisée pour injection de pipéracilline sodique / de tazobactam sodique Antibiotiqe/Inhibiteur de β-lactamase Pour perfusion intraveineuse FIOLE GRAND FORMAT POUR PHARMACIES – NON DESTINÉE À L’INFUSION DIRECTE Ponction unique – doses multiples BOUCHON SANS LATEX SANS AGENT DE CONSERVATION STERIMAX
Carton Label -Side Panel 3 Side Panel 3 Zosyn® (Piperacillin and Tazobactam for Injection, USP) 40.5 gram vial PHARMACY BULK PACKAGE Not for Direct Infusion RECONSTITUTED STOCK SOLUTION MUST BE TRANSFERRED AND FURTHER DILUTED FOR I.V. INFUSION Control No. Exp. Date Side Panel 3 (FRENCH) Antibiotique / inhibiteur de β-lactamases À utiliser en pharmacie (hôpital) dans un programme de préparation de perfusions intraveineuses seulement. Fioles à usage unique. Reconstituer et diluer avant utilisation. Chaque fiole contient de la poudre stérile de pipéracilline sodique et de tazobactam sodique, équivalant à 36 g de pipéracilline / 4,5 g de tazobactam. Posologie quotidienne habituelle totale pour adultes : 12 g/1,5 g, en doses de 3 g/0,375 g toutes les 6 heures. Pour les infections intra-abdominales, 4 g/0,5 g toutes les 8 heures. Usage déconseillé chez les enfants de moins de 12 ans. Reconstitution: tapoter doucement sur la fiole pour détacher la poudre avant reconstitution. Reconstituer dans 152 mL par fiole de diluant recommandé pour obtenir 0,200 g/mL de pipéracilline et 0,025 g/mL de tazobactam. Bien agiter. La solution doit être diluée davantage. Voir la notice d’accompagnement du produit. Utiliser la solution reconstituée dans un délai de 24 heures si elle est conserve à température ambiante ou de 48 heures si la solution est réfrigérée. Jeter toute portion non utilisée. Conserver la poudre entre 15 et 25 °C. La monographie du produit est disponible sur demande. SteriMax Inc., Oakville, ON L6H 6R4
Vial Label Pfizer Injectables NDC 0206-8859-10 Zosyn® Rx only (Piperacillin and Tazobactam for Injection, USP) 40.5 gram vial PHARMACY BULK PACKAGE Not for Direct Infusion Distributed by Wyeth Pharmaceuticals Inc A subsidiary of Pfizer Inc, Philadelphia, PA 19101 Contains piperacillin and tazobactam cryodesiccated powders for injection equivalent to 36 grams of piperacillin, 4.5 grams of tazobactam and 100.4 mEq (2,304 mg) of sodium. Reconstitute with exactly 152 mL of a suitable diluent to achieve concentration of 200 mg/mL of piperacillin and 25 mg/mL of tazobactam. Discard any unused portion after 24 hours if stored at room temperature or after 48 hours if refrigerated. See package insert for complete directions for use. Prior to Reconstitution: Store at controlled room temperature 20° to 25°C (68°C to 77°F). After Reconstitution: DO NOT FREEZE RECONSTITUTED SOLUTION. See package insert for stability of reconstituted solution. RECONSTITUTED STOCK SOLUTION MUST BE TRANSFERRED AND FURTHER DILUTED FOR I.V. INFUSION Does not contain preservatives. Contains 9 mg of edetate disodium dihydrate. Barcode 8920111 RA Control No./Exp. Date DIN 02439131 PrPiperacillin and Tazobactam for Injection – Mfr. Std. 36 g piperacillin/4.5 g tazobactam Powder for Injection Antibiotic / β-lactamase Inhibitor For Intravenous Infusion PHARMACY BULK VIAL – NOT FOR DIRECT INFUSION Single Puncture – Multiple Dispensing LATEX FREE STOPPER BOUCHON SANS LATEX PRESERVATIVE FREE SteriMax For use in pharmacy (hospital) admixture program only. Single use vial. Reconstitute and dilute before use. Each vial contains sterile piperacillin sodium and tazobactam sodium powder equivalent to 36 g piperacillin/4.5 g tazobactam. Reconstitution: tap vial gently to loose powder prior to reconstitution. Reconstitute with 152 mL recommended diluent per vial to yield 0.200 g/mL of piperacillin and 0.025 g/mL of tazobactam. Shake well. Should be further diluted - see package insert. Use reconstituted solution within 24 hours at room temperature or 48 hours if refrigerated. Discard unused portion. Store powder at 15°-25°C. Product monograph available upon request. À utiliser en pharmacie (hôpital) dans un programme de préparation de perfusions intraveineuses seulement. Fioles à usage unique. Ponction unique – doses multiples. Reconstituer et diluer avant utilisation. Chaque fiole contient de la poudre stérile de pipéracilline sodique et de tazobactam sodique, équivalant à 36 g de pipéracilline / 4,5 g de tazobactam. Reconstitution: tapoter doucement sur la fiole pour détacher la poudre avant reconstitution. Reconstituer dans 152 mL par fiole de diluant recommandé pour obtenir 0,200 g/mL de pipéracilline et de 0,025 g/mL de tazobactam. Bien agiter. La solution doit être diluée davantage. Voir la notice d’accompagnement du produit. Utiliser la solution reconstituée dans un délai de 24 heures si elle est conserve à température ambiante ou de 48 heures si la solution est réfrigérée. Jeter toute portion non utilisée. Conserver la poudre entre 15 et 25 C. La monographie du produit est disponible sur demande. Barcode Sterimax Inc.,Oakville, ON L6H 6R4 Lot : EXP. :
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Comparison Table of Canadian Product to Zosyn (RLD) / Strength: 40.5 g/vial
Item Zosyn® (piperacillin and tazobactam for injection, USP) (Approved RLD Carton and Vial Label Information Amerinet Choice) PrPiperacillin and Tazobactam for Injection Mfr. Std. (Proposed Carton and Vial Label Information SteriMax Inc.)
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