KETOROLAC TROMETHAMINE INJECTION, USP LIQUID

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

KETOROLAC TROMETHAMINE

Disponibil de la:

FRESENIUS KABI CANADA LTD

Codul ATC:

M01AB15

INN (nume internaţional):

KETOROLAC

Dozare:

30MG

Forma farmaceutică:

LIQUID

Compoziție:

KETOROLAC TROMETHAMINE 30MG

Calea de administrare:

INTRAMUSCULAR

Unități în pachet:

24X1ML PFS

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Rezumat produs:

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

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2018-09-25

Caracteristicilor produsului

_KETOROLAC TROMETHAMINE INJECTION, USP (Ketorolac Tromethamine
Injection) _
_Page 1 of 49_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
KETOROLAC TROMETHAMINE INJECTION, USP
Ketorolac Tromethamine Injection
Liquid, 30 mg / mL per Vial, Intramuscular
Liquid, 30 mg / mL per Simplist® Prefilled Syringe, Intramuscular
Non-Steroidal Anti-Inflammatory Drug (NSAID)
Fresenius Kabi Canada Ltd.
165 Galaxy Blvd, Suite 100
Toronto, ON M9W 0C8
Date of Initial Authorization:
NOV 30, 2001
Date of Revision:
DEC 02, 2022
Submission Control Number: 265131
_KETOROLAC TROMETHAMINE INJECTION, USP (Ketorolac Tromethamine
Injection) _
_Page 2 of 49_
RECENT MAJOR LABEL CHANGES
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
12/2022
7 WARNINGS AND PRECAUTIONS, Monitoring and Laboratory Tests
12/2022
7 WARNINGS AND PRECAUTIONS, Skin
12/2022
7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women
12/2022
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
..................................................................................................2
TABLE OF CONTENTS
..................................................................................................................2
PART I: HEALTH PROFESSIONAL INFORMATION
.............................................................................4
1
INDICATIONS
..................................................................................................................4
1.1
Pediatrics.............................................................................................................
4
1.2
Geriatrics
.............................................................................................................
4
2
CONTRAINDICATIONS......................................................................................................4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
....................................................................6
4
DOSAGE AND ADMINISTRATION
.....................