JAMP HYDROXYCHLOROQUINE SULFATE TABLET

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

HYDROXYCHLOROQUINE SULFATE

Sẵn có từ:

JAMP PHARMA CORPORATION

Mã ATC:

P01BA02

INN (Tên quốc tế):

HYDROXYCHLOROQUINE

Liều dùng:

200MG

Dạng dược phẩm:

TABLET

Thành phần:

HYDROXYCHLOROQUINE SULFATE 200MG

Tuyến hành chính:

ORAL

Các đơn vị trong gói:

15G/50G

Loại thuốc theo toa:

Prescription

Khu trị liệu:

ANTIMALARIALS

Tóm tắt sản phẩm:

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

Tình trạng ủy quyền:

APPROVED

Ngày ủy quyền:

2019-08-09

Đặc tính sản phẩm

_JAMP Hydroxychloroquine Sulfate (hydroxychloroquine sulfate tablets)_
Page 1 of 43_ _
_ _
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
........................................................