APO-ALLOPURINOL TABLET

Pajjiż: Kanada

Lingwa: Ingliż

Sors: Health Canada

Ingredjent attiv:

ALLOPURINOL

Disponibbli minn:

APOTEX INC

Kodiċi ATC:

M04AA01

INN (Isem Internazzjonali):

ALLOPURINOL

Dożaġġ:

100MG

Għamla farmaċewtika:

TABLET

Kompożizzjoni:

ALLOPURINOL 100MG

Rotta amministrattiva:

ORAL

Unitajiet fil-pakkett:

100/1000

Tip ta 'preskrizzjoni:

Prescription

Żona terapewtika:

ANTIGOUT AGENTS

Sommarju tal-prodott:

Active ingredient group (AIG) number: 0103654001; AHFS:

L-istatus ta 'awtorizzazzjoni:

APPROVED

Data ta 'l-awtorizzazzjoni:

2013-03-18

Karatteristiċi tal-prodott

_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