TORADOL TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

KETOROLAC TROMETHAMINE

Tersedia dari:

AA PHARMA INC

Kode ATC:

M01AB15

INN (Nama Internasional):

KETOROLAC

Dosis:

10MG

Bentuk farmasi:

TABLET

Komposisi:

KETOROLAC TROMETHAMINE 10MG

Rute administrasi :

ORAL

Unit dalam paket:

100

Jenis Resep:

Prescription

Area terapi:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Ringkasan produk:

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

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2015-11-10

Karakteristik produk

_ _
_TORADOL_
_® _
_(Ketorolac Tromethamine Tablets) _
_Page 1 of 56_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
TORADOL
®
Ketorolac Tromethamine Tablets
Tablets, 10 mg, For Oral Use
House Standard
Non-Steroidal Anti-Inflammatory Drug (NSAID)
AA Pharma Inc.
1165 Creditstone Road, Unit#1
Vaughan, Ontario
L4K 4N7
Date of Initial Authorization:
JUN 16, 2017
Date of Revision:
APRIL 4, 2023
Submission Control Number: 267475
TORADOL

is a registered trademark used under license by AA Pharma Inc.
_ _
_TORADOL_
_® _
_(Ketorolac Tromethamine Tablets) _
_Page 2 of 56_
RECENT MAJOR LABEL CHANGES
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
04/2023
7 WARNINGS AND PRECAUTIONS, Monitoring and Laboratory Tests
04/2023
7 WARNINGS AND PRECAUTIONS, Skin
04/2023
7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant women
04/2023
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
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
1
INDICATIONS
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4
1.1
Pediatrics
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4
1.2
Geriatrics
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4
2
CONTRAINDICATIONS
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4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................. 6
4
DOSAGE AND ADMINISTRATION
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7
4.1
Dosing Con