LINEZOLID INJECTION SOLUTION
Land: Canada
Sprog: engelsk
Kilde: Health Canada
Produktets egenskaber
(SPC)
16-05-2018
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Aktiv bestanddel:
LINEZOLID
Tilgængelig fra:
SANDOZ CANADA INCORPORATED
ATC-kode:
J01XX08
INN (International Name):
LINEZOLID
Dosering:
2MG
Lægemiddelform:
SOLUTION
Sammensætning:
LINEZOLID 2MG
Indgivelsesvej:
INTRAVENOUS
Enheder i pakken:
100
Recept type:
Prescription
Terapeutisk område:
OXAZOLIDINONES
Produkt oversigt:
Active ingredient group (AIG) number: 0143501003; AHFS:
Autorisation status:
CANCELLED PRE MARKET
Autorisation dato:
2019-08-01
Produktets egenskaber
_ _
_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
.................................
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