Country: Kanada
Lingwa: Ingliż
Sors: Health Canada
PIPERACILLIN (PIPERACILLIN SODIUM); TAZOBACTAM (TAZOBACTAM SODIUM)
SANDOZ CANADA INCORPORATED
J01CR05
PIPERACILLIN AND BETA-LACTAMASE INHIBITOR
4G; 0.5G
POWDER FOR SOLUTION
PIPERACILLIN (PIPERACILLIN SODIUM) 4G; TAZOBACTAM (TAZOBACTAM SODIUM) 0.5G
INTRAVENOUS
10X4.5G
Prescription
EXTENDED-SPECTRUM PENICILLINS
Active ingredient group (AIG) number: 0225919006; AHFS:
APPROVED
2021-10-22
_Piperacillin and Tazobactam for Injection _ _Page 1 of 47 _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION Pr PIPERACILLIN AND TAZOBACTAM FOR INJECTION piperacillin sodium/tazobactam sodium Lyophilized Powder for Injection For Intravenous Use Only 2 g / 0.25 g, 3 g / 0.375 g, 4 g / 0.5 g, 12 g / 1.5 g, 36 g / 4.5 g per vial (as piperacillin sodium and as tazobactam sodium) Manufacturer’s Standard Antibiotic / ß-lactamase Inhibitor Sandoz Canada Inc. 110 Rue de Lauzon Date of Revision: October 18, 2021 Boucherville, QC, Canada J4B 1E6 Submission Control No: 248976 _Piperacillin and Tazobactam for Injection _ _Page 2 of 47 _ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION............................................................3 SUMMARY PRODUCT INFORMATION .................................................................................3 INDICATIONS AND CLINICAL USE.......................................................................................3 CONTRAINDICATIONS ...........................................................................................................5 WARNINGS AND PRECAUTIONS ..........................................................................................5 ADVERSE REACTIONS ...........................................................................................................9 DRUG INTERACTIONS.......................................................................................................... 12 DOSAGE AND ADMINISTRATION....................................................................................... 14 OVERDOSAGE ....................................................................................................................... 19 ACTION AND CLINICAL PHARMACOLOGY ...................................................................... 20 STORAGE AND STABILITY.................................................................................................. 22 SPECIAL HANDLING INSTRUCTIONS .............................................. Aqra d-dokument sħiħ