WAYMADE-KETOROLAC TROMETHAMINE TABLET

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

KETOROLAC TROMETHAMINE

Dostupné s:

WAYMADE PLC

ATC kód:

M01AB15

INN (Mezinárodní Name):

KETOROLAC

Dávkování:

10MG

Léková forma:

TABLET

Složení:

KETOROLAC TROMETHAMINE 10MG

Podání:

ORAL

Jednotky v balení:

100

Druh předpisu:

Prescription

Terapeutické oblasti:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Přehled produktů:

Active ingredient group (AIG) number: 0121995001; AHFS:

Stav Autorizace:

APPROVED

Datum autorizace:

2017-04-03

Charakteristika produktu

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_Page 1 of 42_
PRODUCT MONOGRAPH
PR
WAYMADE-KETOROLAC TROMETHAMINE
ketorolac tromethamine
10 mg tablets
Non-Steroidal Anti-Inflammatory Drug (NSAID)
Waymade PLC
Sovereign House, Miles Gray Road
Basildon, Essex SS14 3FR
United Kingdom
Imported and distributed by:
Ignite Pharma Inc.
King City, Ontario L7B 1C2
DATE OF PREPARATION:
APRIL 3, 2017 SUBMISSION CONTROL NO: 202019
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_Page 2 of 42_
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
..................................................................................................15
DRUG INTERACTIONS
..................................................................................................18
DOSAGE AND ADMINISTRATION
..............................................................................20
OVERDOSAGE
................................................................................................................21
ACTION AND CLINICAL PHARMACOLOGY
............................................................22
STORAGE AND STABILITY
..........................................................................................25
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................25
PART II: SCIENTIFIC INFORMATION
...............................................................................26
PHARMACEUTICAL INFORMATION
..........................................................................26
DETAILED PHARMACOLOGY
.............................................................................