ACH-HYDROXYCHLOROQUINE SULFATE TABLET

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

HYDROXYCHLOROQUINE SULFATE

Disponible depuis:

ACCORD HEALTHCARE INC

Code ATC:

P01BA02

DCI (Dénomination commune internationale):

HYDROXYCHLOROQUINE

Dosage:

200MG

forme pharmaceutique:

TABLET

Composition:

HYDROXYCHLOROQUINE SULFATE 200MG

Mode d'administration:

ORAL

Unités en paquet:

100

Type d'ordonnance:

Prescription

Domaine thérapeutique:

ANTIMALARIALS

Descriptif du produit:

Active ingredient group (AIG) number: 0107403001; AHFS:

Statut de autorisation:

APPROVED

Date de l'autorisation:

2020-10-19

Résumé des caractéristiques du produit

_ACH-HYDROXYCHLOROQUINE SULFATE (Hydroxychloroquine sulfate tablets) _
_Page 1 of 42 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
ACH-HYDROXYCHLOROQUINE SULFATE
Hydroxychloroquine Sulfate Tablets
Tablets, 200 mg, Oral
USP
ATC Code: P01BA02
Anti-Inflammatory – Antimalarial – Aminoquinolines
Accord Healthcare Inc.
Date of Initial Authorization:
3535 boul. St. Charles, Suite 704
October 19, 2020
Kirkland, QC, H9H 5B9
Canada
Date of Revision:
January 6, 2023
Submission Control Number: 270069
_ACH-HYDROXYCHLOROQUINE SULFATE (Hydroxychloroquine sulfate tablets) _
_Page 2 of 42 _
RECENT MAJOR LABEL CHANGES
4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and Dosage
Adjustment
01/2022
7 WARNINGS AND PRECAUTIONS, Hematologic
01/2022
7 WARNINGS AND PRECAUTIONS, Musculoskeletal
01/2022
7 WARNINGS AND PRECAUTIONS, Psychiatric
01/2022
7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women
01/2022
7 WARNINGS AND PRECAUTIONS, 7.1.4 Geriatrics
01/2022
7 WARNINGS AND PRECAUTIONS, Skin
01/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
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2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
.....................................................................
4
1
INDICATIONS
..............................................................................................................
4
1.1
Pediatrics
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4
1.2
Geriatrics
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4
2
CONTRAINDICATIONS
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5
4
DOSAGE AND ADMINISTRATION
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