AG-ALLOPURINOL TABLET

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

ALLOPURINOL

Διαθέσιμο από:

ANGITA PHARMA INC.

Φαρμακολογική κατηγορία (ATC):

M04AA01

INN (Διεθνής Όνομα):

ALLOPURINOL

Δοσολογία:

200MG

Φαρμακοτεχνική μορφή:

TABLET

Σύνθεση:

ALLOPURINOL 200MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

30

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

ANTIGOUT AGENTS

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2018-10-29

Αρχείο Π.Χ.Π.

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
...........................................................