AG-ALLOPURINOL TABLET

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

ALLOPURINOL

Saatavilla:

ANGITA PHARMA INC.

ATC-koodi:

M04AA01

INN (Kansainvälinen yleisnimi):

ALLOPURINOL

Annos:

200MG

Lääkemuoto:

TABLET

Koostumus:

ALLOPURINOL 200MG

Antoreitti:

ORAL

Kpl paketissa:

30

Prescription tyyppi:

Prescription

Terapeuttinen alue:

ANTIGOUT AGENTS

Tuoteyhteenveto:

Active ingredient group (AIG) number: 0103654002; AHFS:

Valtuutuksen tilan:

APPROVED

Valtuutus päivämäärä:

2018-10-29

Valmisteyhteenveto

AG-Allopurinol PM
Page 1 of 26
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
AG-Allopurinol
Allopurinol Tablets, USP
Tablets, 100, 200 and 300 mg, oral
USP
Xanthine Oxidase Inhibitor
Angita Pharma Inc.
1310, rue Nobel
Boucherville, Quebec
J4B 5H3, Canada
Submission Control Number: 266474
Date
of
Initial
Authorization:
October 29, 2018
Date of Revision:
SEPT 1, 2022
AG-Allopurinol PM
Page 2 of 26
RECENT MAJOR LABEL CHANGES
3 Serious Warnings and Precautions Box
09/2022
4 Dosage and Administration, 4.2 Recommended Dose and Dosage
Adjustment
09/2022
7 Warnings and Precautions
09/2022
7 Warnings and Precautions, 7.1.4 Geriatrics
09/2022
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
Recommended Dose and Dosage Adjustment
.......................................................... 5
4.5
Missed Dose
...........................................................