Land: Kanada
Tungumál: enska
Heimild: Health Canada
CEFEPIME (CEFEPIME HYDROCHLORIDE)
APOTEX INC
J01DE01
CEFEPIME
1G
POWDER FOR SOLUTION
CEFEPIME (CEFEPIME HYDROCHLORIDE) 1G
INTRAMUSCULAR
IM:2.4ML/ IV:10ML/ IV INF:SEE PM.
Prescription
FOURTH GENERATION CEPHALOSPORINS
Active ingredient group (AIG) number: 0150504004; AHFS:
APPROVED
2009-02-16
PRODUCT MONOGRAPH Cefepime for Injection (cefepime hydrochloride) 1 g and 2 g cefepime per vial Orchid Standard Antibiotic _Manufactured by: _ ORCHID HEALTHCARE (A Division of Orchid Chemicals & Pharmaceuticals Ltd.) Plot No: B3-B6 & B11-B14, SIPCOT Industrial Park, Irungattukottai- 602 105, Sriperumbudur P.O., Kancheepuram District, INDIA. _Manufactured for: _ APOTEX INC. 150 Signet Drive Weston, ON, M9L 1T9 DATE OF PREPARATION April 20, 2020 Control #: 234594 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 ....................................................................................................... 10 DOSAGE AND ADMINISTRATION ................................................................................... 10 OVERDOSAGE ..................................................................................................................... 15 ACTION AND CLINICAL PHARMACOLOGY ................................................................. 15 STORAGE AND STABILITY .............................................................................................. 19 SPECIAL HANDLING INSTRUCTIONS ............................................................................ 19 DOSAGE FORMS, COMPOSITION AND PACKAGING .................................................. 19 PART II: SCIENTIFIC INFORMATION ......................................................... Lestu allt skjalið