LINEZOLID INJECTION SOLUTION
Land: Kanada
Tungumál: enska
Heimild: Health Canada
Vara einkenni
(SPC)
28-12-2017
Sum skjöl fyrir þessa vöru eru ekki tiltæk eins og er, þú getur sent beiðni til þjónustu við viðskiptavini okkar og við munum láta þig vita um leið og við getum fengið þau.
Senda beiðni.
Senda beiðni.
Virkt innihaldsefni:
LINEZOLID
Fáanlegur frá:
TEVA CANADA LIMITED
ATC númer:
J01XX08
INN (Alþjóðlegt nafn):
LINEZOLID
Skammtar:
2MG
Lyfjaform:
SOLUTION
Samsetning:
LINEZOLID 2MG
Stjórnsýsluleið:
INTRAVENOUS
Einingar í pakka:
300ML
Gerð lyfseðils:
Prescription
Lækningarsvæði:
OXAZOLIDINONES
Vörulýsing:
Active ingredient group (AIG) number: 0143501003; AHFS:
Leyfisstaða:
CANCELLED POST MARKET
Leyfisdagur:
2018-05-17
Vara einkenni
PRODUCT MONOGRAPH
PR
LINEZOLID INJECTION
Linezolid Injection
2 mg/mL
Antibacterial Agent
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario,
Canada, M1B 2K9
Date of Revision: December 28, 2017
Submission Control Number:
211371
2
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
.........................................................................................
17
OVERDOSAGE
...........................................................................................................................
18
ACTION AND CLINICAL PHARMACOLOGY
.......................................................................
19
STORAGE AND STABILITY
.....................................................................................................
23
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................................ 23
PART II: SCIENTIFIC INFORMATION
...............................................................................
24
PHARMACEUTICAL INFORMATION
.....................................................................................
24
CLINICAL TRIALS
...........................................................................................................
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