APO-ALLOPURINOL TABLET

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

ALLOPURINOL

Διαθέσιμο από:

APOTEX INC

Φαρμακολογική κατηγορία (ATC):

M04AA01

INN (Διεθνής Όνομα):

ALLOPURINOL

Δοσολογία:

100MG

Φαρμακοτεχνική μορφή:

TABLET

Σύνθεση:

ALLOPURINOL 100MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

100/1000

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

ANTIGOUT AGENTS

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2013-03-18

Αρχείο Π.Χ.Π.

_APO-ALLOPURINOL (Allopurinol) Tablets – Product Monograph_
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_Page 1 of 26 _
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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
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4
1
INDICATIONS
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4
1.1
Pediatrics
.............................................................................................................................
4
1.2
Geriatrics
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4
2
CONTRAINDICATIONS
..........................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
......................................................................
5
4
DOSAGE AND ADMINISTRATION
..........................................................................................
5
4.2
Recom