JAMP HYDROXYCHLOROQUINE SULFATE TABLET

Krajina: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktívna zložka:

HYDROXYCHLOROQUINE SULFATE

Dostupné z:

JAMP PHARMA CORPORATION

ATC kód:

P01BA02

INN (Medzinárodný Name):

HYDROXYCHLOROQUINE

Dávkovanie:

200MG

Forma lieku:

TABLET

Zloženie:

HYDROXYCHLOROQUINE SULFATE 200MG

Spôsob podávania:

ORAL

Počet v balení:

15G/50G

Typ predpisu:

Prescription

Terapeutické oblasti:

ANTIMALARIALS

Prehľad produktov:

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

Stav Autorizácia:

APPROVED

Dátum Autorizácia:

2019-08-09

Súhrn charakteristických

_JAMP Hydroxychloroquine Sulfate (hydroxychloroquine sulfate tablets)_
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PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
JAMP HYDROXYCHLOROQUINE SULFATE
Hydroxychloroquine Sulfate Tablets
Tablets, 200 mg, Oral
USP
Anti-Inflammatory – Antimalarial – Aminoquinolines
JAMP Pharma Corporation
1310 rue Nobel
Boucherville, Quebec
J4B 5H3, Canada
Date of Initial Authorization:
August 09, 2019
Date of Revision:
June 22, 2023
Submission Control No.: 274020
_JAMP Hydroxychloroquine Sulfate (hydroxychloroquine sulfate tablets)_
Page 2 of 43_ _
_ _
RECENT MAJOR LABEL CHANGES
2 Contraindications
06/2023
7 Warnings and Precautions, Hematologic
06/2023
7 Warnings and Precautions, Musculoskeletal
06/2023
7 Warnings and Precautions, Psychiatric
06/2023
7 Warnings and Precautions, 7.1.4 Geriatrics
06/2023
7 Warnings and Precautions, 7.1.1 Pregnant Women
06/2023
7 Warning and Precautions, Skin
06/2023
7 Warning and Precautions, Cardiovascular
06/2023
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
........................................................