JAMP-ALLOPURINOL TABLET

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

ALLOPURINOL

Disponibil de la:

JAMP PHARMA CORPORATION

Codul ATC:

M04AA01

INN (nume internaţional):

ALLOPURINOL

Dozare:

100MG

Forma farmaceutică:

TABLET

Compoziție:

ALLOPURINOL 100MG

Calea de administrare:

ORAL

Unități în pachet:

100/1000

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

ANTIGOUT AGENTS

Rezumat produs:

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

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2014-03-06

Caracteristicilor produsului

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_JAMP-Allopurinol PM_
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_Page 1 of 26_
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PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION PR
JAMP-ALLOPURINOL
Allopurinol Tablets, USP
Tablets, 100, 200 and 300 mg, oral
USP
Xanthine Oxidase Inhibitor
JAMP Pharma Corporation
1310 rue Nobel
Boucherville, Quebec
J4B 5H3, Canada
Submission Control Number: 266368
Date
of
Initial
Authorization:
March 6, 2014
Date
of
Revision:
August 24, 2022
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_JAMP-Allopurinol PM_
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_ _
_Page 2 of 26_
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RECENT MAJOR LABEL CHANGES
3 Serious Warnings and Precautions Box
08/2022
4 Dosage and Administration, 4.2 Recommended Dose and Dosage
Adjustment
08/2022
7 Warnings and Precautions
08/2022
7 Warnings and Precautions, 7.1.4 Geriatrics
08/2022
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
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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
.........