ACH-HYDROXYCHLOROQUINE SULFATE TABLET

Country: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

HYDROXYCHLOROQUINE SULFATE

Доступно од:

ACCORD HEALTHCARE INC

АТЦ код:

P01BA02

INN (Међународно име):

HYDROXYCHLOROQUINE

Дозирање:

200MG

Фармацеутски облик:

TABLET

Састав:

HYDROXYCHLOROQUINE SULFATE 200MG

Пут администрације:

ORAL

Јединице у пакету:

100

Тип рецептора:

Prescription

Терапеутска област:

ANTIMALARIALS

Резиме производа:

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

Статус ауторизације:

APPROVED

Датум одобрења:

2020-10-19

Карактеристике производа

_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
...........................................................................................
2
TABLE OF CONTENTS
.............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.....................................................................
4
1
INDICATIONS
..............................................................................................................
4
1.1
Pediatrics
...................................................................................................................
4
1.2
Geriatrics
...................................................................................................................
4
2
CONTRAINDICATIONS
.................................................................................................
5
4
DOSAGE AND ADMINISTRATION
........................