Valsts: Kanāda
Valoda: angļu
Klimata pārmaiņas: Health Canada
LINEZOLID
SANDOZ CANADA INCORPORATED
J01XX08
LINEZOLID
2MG
SOLUTION
LINEZOLID 2MG
INTRAVENOUS
100
Prescription
OXAZOLIDINONES
Active ingredient group (AIG) number: 0143501003; AHFS:
CANCELLED PRE MARKET
2019-08-01
_ _ _Linezolid Injection _ _Page 1 of 41_ PRODUCT MONOGRAPH PR LINEZOLID INJECTION Linezolid Injection 2 mg/mL, 300 mL bag Antibacterial Agent Sandoz Canada Inc. 145 Jules-Léger Boucherville, QC, Canada J4B 7K8 Date of Preparation: May 16, 2018 Submission Control No: 215585 _ _ _Linezolid Injection _ _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 ................................................................................. 5 ADVERSE REACTIONS ................................................................................................... 9 DRUG INTERACTIONS ................................................................................................. 15 DOSAGE AND ADMINISTRATION ............................................................................. 16 OVERDOSAGE ................................................................................................................ 18 ACTION AND CLINICAL PHARMACOLOGY ............................................................ 18 STORAGE AND STABILITY ......................................................................................... 23 DOSAGE FORMS, COMPOSITION AND PACKAGING ............................................. 23 PART II: SCIENTIFIC INFORMATION .............................................................................. 24 PHARMACEUTICAL INFORMATION ......................................................................... 24 CLINICAL TRIALS ......................................................................................................... 25 DETAILED PHARMACOLOGY ................................. Izlasiet visu dokumentu