LINEZOLID INJECTION SOLUTION

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

LINEZOLID

Commercializzato da:

SANDOZ CANADA INCORPORATED

Codice ATC:

J01XX08

INN (Nome Internazionale):

LINEZOLID

Dosaggio:

2MG

Forma farmaceutica:

SOLUTION

Composizione:

LINEZOLID 2MG

Via di somministrazione:

INTRAVENOUS

Confezione:

100

Tipo di ricetta:

Prescription

Area terapeutica:

OXAZOLIDINONES

Dettagli prodotto:

Active ingredient group (AIG) number: 0143501003; AHFS:

Stato dell'autorizzazione:

CANCELLED PRE MARKET

Data dell'autorizzazione:

2019-08-01

Scheda tecnica

_ _
_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
.................................