KETOPROFEN-E TABLET (ENTERIC-COATED)

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

KETOPROFEN

MAH:

AA PHARMA INC

ATC_code:

M01AE03

INN:

KETOPROFEN

dosage:

100MG

pharmaceutical_form:

TABLET (ENTERIC-COATED)

composition:

KETOPROFEN 100MG

administration_route:

ORAL

units_in_package:

100/500/1000

prescription_type:

Prescription

therapeutic_area:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

leaflet_short:

Active ingredient group (AIG) number: 0110497002; AHFS:

authorization_status:

APPROVED

authorization_date:

2011-02-16

SPC

_Pr_
_KETOPROFEN, _
_Pr_
_KETOPROFEN-E and _
_Pr_
_KETOPROFEN SR (Ketoprofen)_
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_Page 1 of 49_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
KETOPROFEN
Ketoprofen Capsules BP
Capsule, 50 mg, for oral use
Pr
KETOPROFEN-E
Ketoprofen Enteric-coated Tablets
Tablet, 50 mg and 100 mg, for oral use
Pr
KETOPROFEN SR
Ketoprofen Sustained-release Tablets
Tablet, 200 mg, for oral use
Non-Steroidal Anti-inflammatory Drug (NSAID)
AA PHARMA INC.
1165 Creditstone Road, Unit #1
Vaughan, Ontario
L4K 4N7
Date of Initial Authorization:
DEC 31, 1989
Date of Revision:
MAY 10, 2022
Submission Control Number: 258038
_ _
_Pr_
_KETOPROFEN, _
_Pr_
_KETOPROFEN-E and _
_Pr_
_KETOPROFEN SR (Ketoprofen)_
_ _
_Page 2 of 49_
RECENT MAJOR LABEL CHANGES
1 Indications
05/2022
2 Contraindications
05/2022
3 Serious Warnings and Precautions Box
05/2022
4 Dosage and Administration, 4.1 Dosing Considerations
05/2022
4 Dosage and Administration, 4.2 Recommended Dose and
Dosage Adjustment
05/2022
4 Dosage and Administration, 4.4 Administration
05/2022
7 Warnings and Precautions
05/2022
7 Warnings and Precautions, 7.1.1 Pregnant Women
05/2022
7 Warnings and Precautions, 7.1.2 Breast-feeding
05/2022
7 Warnings and Precautions, 7.1.4 Geriatrics
05/2022
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........................................................