PLAQUENIL TABLET

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

HYDROXYCHLOROQUINE SULFATE

Mevcut itibaren:

SANOFI-AVENTIS CANADA INC

ATC kodu:

P01BA02

INN (International Adı):

HYDROXYCHLOROQUINE

Doz:

200MG

Farmasötik formu:

TABLET

Kompozisyon:

HYDROXYCHLOROQUINE SULFATE 200MG

Uygulama yolu:

ORAL

Paketteki üniteler:

100

Reçete türü:

Prescription

Terapötik alanı:

ANTIMALARIALS

Ürün özeti:

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

Yetkilendirme durumu:

APPROVED

Yetkilendirme tarihi:

2006-05-05

Ürün özellikleri

_PLAQUENIL (hydroxychloroquine sulfate tablets) _
_Page 1 of 48_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
PLAQUENIL
®
Hydroxychloroquine Sulfate Tablets
Tablets, 200 mg, Oral
USP
Anti-Inflammatory – Antimalarial – Aminoquinolines
sanofi-aventis Canada Inc.
2905 Place Louis R.-Renaud
Laval, Quebec H7V 0A3
Date of Initial Authorization:
DEC 31, 1957
Date of Revision:
DEC 04, 2023
Submission Control No.: 277166
_ _
_PLAQUENIL (hydroxychloroquine sulfate tablets) _
_Page 2 of 48_
RECENT MAJOR LABEL CHANGES
7 Warning and Precautions, Skin
06/2022
7 Warning and Precautions, Cardiovascular
07/2023
7 Warning and Precautions, Hepatic/Biliary/Pancreatic
07/2023
7 Warning and Precautions, Musculoskeletal
12/2023
7 Warning and Precautions, Renal
07/2023
7 Warnings and Precautions, 7.1.1 Pregnant Women
07/2023
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
.................................................................................................
4
4
DOSAGE AND ADMINISTRATION
.................................................................................
5
4.1
Dosing Considerations
..........................................................................................