APO-ALLOPURINOL TABLET

Land: Kanada

Tungumál: enska

Heimild: Health Canada

Virkt innihaldsefni:

ALLOPURINOL

Fáanlegur frá:

APOTEX INC

ATC númer:

M04AA01

INN (Alþjóðlegt nafn):

ALLOPURINOL

Skammtar:

300MG

Lyfjaform:

TABLET

Samsetning:

ALLOPURINOL 300MG

Stjórnsýsluleið:

ORAL

Einingar í pakka:

100/500

Gerð lyfseðils:

Prescription

Lækningarsvæði:

ANTIGOUT AGENTS

Vörulýsing:

Active ingredient group (AIG) number: 0103654003; AHFS:

Leyfisstaða:

APPROVED

Leyfisdagur:

2013-03-18

Vara einkenni

_APO-ALLOPURINOL (Allopurinol) Tablets – Product Monograph_
_ _
_Page 1 of 26 _
_ _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-ALLOPURINOL
Allopurinol Tablets
Tablets, 100, 200 and 300 mg, oral
USP
ATC Code: M04AA01
Xanthine Oxidase Inhibitor
APOTEX INC.
150 Signet Drive
Toronto, Ontario
M9L 1T9
Date of initial authorization
March 18, 2013
Date of Revision:
July 7, 2022
Submission Control Number: 264690
_APO-ALLOPURINOL (Allopurinol) Tablets – Product Monograph_
_ _
_Page 2 of 26 _
_ _
RECENT MAJOR LABEL CHANGES
3 Serious Warnings and Precautions Box
07/2022
4 Dosage and Administration, 4.2 Recommended Dose and Dosage
Adjustment
07/2022
7 Warnings and Precautions
07/2022
7 Warnings and Precautions, 7.1.4 Geriatrics
07/2022
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
......................................................................
5
4
DOSAGE AND ADMINISTRATION
..........................................................................................
5
4.2
Recom