WAYMADE-KETOROLAC TROMETHAMINE TABLET

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

KETOROLAC TROMETHAMINE

Disponible depuis:

WAYMADE PLC

Code ATC:

M01AB15

DCI (Dénomination commune internationale):

KETOROLAC

Dosage:

10MG

forme pharmaceutique:

TABLET

Composition:

KETOROLAC TROMETHAMINE 10MG

Mode d'administration:

ORAL

Unités en paquet:

100

Type d'ordonnance:

Prescription

Domaine thérapeutique:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Descriptif du produit:

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

Statut de autorisation:

APPROVED

Date de l'autorisation:

2017-04-03

Résumé des caractéristiques du produit

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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
.............................................................................