País: Canadá
Língua: inglês
Origem: Health Canada
PIPERACILLIN (PIPERACILLIN SODIUM); TAZOBACTAM (TAZOBACTAM SODIUM)
AURO PHARMA INC
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
2013-03-06
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _PAGE 1 OF 42 _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR PIPERACILLIN AND TAZOBACTAM FOR INJECTION Lyophilized Powder for Injection 2 g piperacillin (as piperacillin sodium) and 0.25 g tazobactam (as tazobactam sodium) per vial 3 g piperacillin (as piperacillin sodium) and 0.375 g tazobactam (as tazobactam sodium) per vial 4 g piperacillin (as piperacillin sodium) and 0.5 g tazobactam (as tazobactam sodium) per vial For Intravenous Use Only Manufacturer's Standard Antibiotic/β-lactamase Inhibitor AURO PHARMA INC. DATE OF REVISION: 3700 Steeles Avenue West, Suite # 402 December 22, 2021 Woodbridge, Ontario, L4L 8K8 CANADA Submission Control No.: 254902 _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _PAGE 2 OF 42 _ 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 ............................................................................................8 DRUG INTERACTIONS ..........................................................................................12 DOSAGE AND ADMINISTRATION .....................................................................14 OVERDOSAGE .........................................................................................................18 ACTION AND CLINICAL PHARMACOLOGY ..................................................19 STORAGE AND STABILITY..................................................................................21 SPECIAL HANDLING INSTRUCTIONS ..............................................................22 DOSAGE FORMS, CO Leia o documento completo