KETOROLAC TROMETHAMINE INJECTION, USP SOLUTION

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

Wirkstoff:

KETOROLAC TROMETHAMINE

Verfügbar ab:

EUGIA PHARMA INC.

ATC-Code:

M01AB15

INN (Internationale Bezeichnung):

KETOROLAC

Dosierung:

30MG

Darreichungsform:

SOLUTION

Zusammensetzung:

KETOROLAC TROMETHAMINE 30MG

Verabreichungsweg:

INTRAMUSCULAR

Einheiten im Paket:

100

Verschreibungstyp:

Prescription

Produktbesonderheiten:

Active ingredient group (AIG) number: 0121995002; AHFS:

Berechtigungsstatus:

APPROVED

Berechtigungsdatum:

2022-11-25

Fachinformation

PRODUCT MONOGRAPH
PR
KETOROLAC TROMETHAMINE INJECTION, USP
(KETOROLAC TROMETHAMINE)
STERILE SOLUTION
30 MG / ML
NON-STEROIDAL ANTI-INFLAMMATORY DRUG (NSAID)
Eugia Pharma Inc. Date of Preparation:
3700 Steeles Avenue West, Suite # 402 NOV 22, 2022
Woodbridge, Ontario
L4L 8K8 Canada
Submission Control No.: 268616
Page 2 of 40
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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
..................................................................................................
14
DRUG INTERACTIONS
..................................................................................................17
DOSAGE AND ADMINISTRATION
..............................................................................19
OVERDOSAGE
................................................................................................................20
ACTION AND CLINICAL PHARMACOLOGY
.............................................................21
STORAGE AND STABILITY
..........................................................................................24
DOSAGE FORMS, COMPOSITION AND PACKAGING
..............................................24
PART II: SCIENTIFIC INFORMATION
...............................................................................
25
PHARMACEUTICAL INFORMATION
..........................................................................25
DETAILED PHARMACOLOGY
.....................................................................................26
TOXICOLOGY
...............................................