País: Canadà
Idioma: anglès
Font: Health Canada
CEFTOLOZANE (CEFTOLOZANE SULFATE); TAZOBACTAM (TAZOBACTAM SODIUM)
MERCK CANADA INC
J01DI54
CEFTOLOZANE AND BETA-LACTAMASE INHIBITOR
1G; 0.5G
POWDER FOR SOLUTION
CEFTOLOZANE (CEFTOLOZANE SULFATE) 1G; TAZOBACTAM (TAZOBACTAM SODIUM) 0.5G
INTRAVENOUS
11.4ML (RECONST.) (1.5G)
Prescription
THIRD GENERATION CEPHALOSPORINS
Active ingredient group (AIG) number: 0257450001; AHFS:
APPROVED
2015-09-30
_ZERBAXA_ _®_ _ (ceftolozane and tazobactam) _ _Page 1 of 41_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION ZERBAXA ® Ceftolozane and Tazobactam powder for injection 1.5 gram (g) per vial Containing ceftolozane 1 g (as ceftolozane sulfate) and tazobactam 0.5 g (as tazobactam sodium) Cephalosporin and Beta-lactamase Inhibitor antibacterial for systemic use MERCK CANADA INC. DATE OF PREPARATION: 16750 route Transcanadienne October 7, 2020 Kirkland, QC Canada H9H 4M7 www.merck.ca SUBMISSION CONTROL NO: 238477 _ _ _ZERBAXA_ ® _ (ceftolozane and tazobactam) _ _Page 2 of 41_ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION .........................................................3 SUMMARY PRODUCT INFORMATION ........................................................................3 INDICATIONS AND CLINICAL USE ..............................................................................3 CONTRAINDICATIONS ...................................................................................................4 WARNINGS AND PRECAUTIONS ..................................................................................4 ADVERSE REACTIONS ....................................................................................................7 DRUG INTERACTIONS ..................................................................................................10 DOSAGE AND ADMINISTRATION ..............................................................................11 OVERDOSAGE ................................................................................................................14 ACTION AND CLINICAL PHARMACOLOGY ............................................................14 STORAGE AND STABILITY ..........................................................................................19 DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................19 PART II: SCIENTIFIC INFORMATION ...............................................................................20 PHARMACEUTICAL Llegiu el document complet