SIVEXTRO TABLET

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

TEDIZOLID PHOSPHATE

Dostupné s:

MERCK CANADA INC

ATC kód:

J01XX11

INN (Mezinárodní Name):

TEDIZOLID

Dávkování:

200MG

Léková forma:

TABLET

Složení:

TEDIZOLID PHOSPHATE 200MG

Podání:

ORAL

Jednotky v balení:

6/30

Druh předpisu:

Prescription

Terapeutické oblasti:

OXAZOLIDINONES

Přehled produktů:

Active ingredient group (AIG) number: 0156690001; AHFS:

Stav Autorizace:

CANCELLED PRE MARKET

Datum autorizace:

2023-12-15

Charakteristika produktu

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_SIVEXTRO (tedizolid phosphate) Product Monograph _
_Page 1 of 33_
PRODUCT MONOGRAPH
PR
SIVEXTRO™
tedizolid phosphate tablets
200 mg
tedizolid phosphate for injection
200 mg/vial
Antibacterial Agent
MERCK CANADA INC.
16750 route Transcanadienne
Kirkland, QC H9H 4M7
www.merck.ca
Date of Preparation:
September 29, 2015
Submission Control No: 187248
_ _
_SIVEXTRO (tedizolid phosphate) Product Monograph _
_Page 2 of 33_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................6
DRUG INTERACTIONS
..................................................................................................10
DOSAGE AND ADMINISTRATION
..............................................................................11
OVERDOSAGE
................................................................................................................14
ACTION AND CLINICAL PHARMACOLOGY
............................................................14
STORAGE AND STABILITY
..........................................................................................17
SPECIAL HANDLING INSTRUCTIONS
.......................................................................18
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................18
PART II: SCIENTIFIC INFORMATION
...............................................................................19
PHARMACEUTICAL INFORMATION
..................................................