KETOROLAC TROMETHAMINE INJECTION, USP SOLUTION

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

Wirkstoff:

KETOROLAC TROMETHAMINE

Verfügbar ab:

AURO 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

Therapiebereich:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Produktbesonderheiten:

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

Berechtigungsstatus:

APPROVED

Berechtigungsdatum:

2021-10-22

Fachinformation

PRODUCT MONOGRAPH
PR
KETOROLAC TROMETHAMINE INJECTION, USP
(KETOROLAC TROMETHAMINE)
STERILE SOLUTION
30 MG / ML
NON-STEROIDAL ANTI-INFLAMMATORY DRUG (NSAID)
Auro Pharma Inc. Date of Preparation:
3700 Steeles Avenue West, Suite # 402 October 20, 2021.
Woodbridge, Ontario, L4L 8K8,
Canada
Submission
Control No: 239985
Page 2 of 40
_ _
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
..........................................................................................................
28
RE