מדינה: קנדה
שפה: אנגלית
מקור: Health Canada
HYDROXYCHLOROQUINE SULFATE
JAMP PHARMA CORPORATION
P01BA02
HYDROXYCHLOROQUINE
200MG
TABLET
HYDROXYCHLOROQUINE SULFATE 200MG
ORAL
100/1000
Prescription
ANTIMALARIALS
Active ingredient group (AIG) number: 0107403001; AHFS:
APPROVED
2019-08-09
_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 ........................................................ קרא את המסמך השלם