TORADOL IM SOLUTION

国家: 加拿大

语言: 英文

来源: Health Canada

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03-04-2023

有效成分:

KETOROLAC TROMETHAMINE

可用日期:

ATNAHS PHARMA UK LIMITED

ATC代码:

M01AB15

INN(国际名称):

KETOROLAC

剂量:

10MG

药物剂型:

SOLUTION

组成:

KETOROLAC TROMETHAMINE 10MG

给药途径:

INTRAMUSCULAR

每包单位数:

1 ML

处方类型:

Prescription

治疗领域:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

產品總結:

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

授权状态:

APPROVED

授权日期:

2015-11-10

产品特点

                                _Product Monograph _
_ _
TORADOL IM
(ketorolac tromethamine injection)
_Page 1 of 56_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TORADOL
® IM
ketorolac tromethamine injection
Solution, 10 mg/mL, intramuscular
Non-Steroidal Anti-Inflammatory Drug (NSAID)
Atnahs Pharma UK Limited
Sovereign House, Miles Gray Road
Basildon, Essex SS14 3FR
United Kingdom
Date of Initial Authorization:
November 3, 2015
Date of Revision:
April 3, 2023
Distributed by:
Methapharm Inc.
Brantford, Ontario N3S 7X6
Canada
Submission Control Number: 267937
TORADOL
®
is a registered trademark of Atnahs Pharma UK Limited, used under
license.
_ _
_Product Monograph _
_ _
TORADOL IM
(ketorolac tromethamine injection)
_Page 2 of 56_
RECENT MAJOR LABEL CHANGES
3 SERIOUS WARNING AND PRECAUTIONS BOX
[03/2022]
7 WARNINGS AND PRECAUTIONS, Monitoring and Laboratory Tests
[03/2022]
7 WARNINGS AND PRECAUTIONS, Skin
[03/2022]
7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women
[03/2022]
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
1
INDICATIONS
..............................................................................................................
4
1.1 Pediatrics
..................................................................................................................
4
1.2 Geriatrics
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4
2
CONTRAINDICATIONS
................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
........................................................... 6
4
DOSAGE AND ADMINISTRATION
........................................................................
                                
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