Quốc gia: Canada
Ngôn ngữ: Tiếng Anh
Nguồn: Health Canada
AMANTADINE HYDROCHLORIDE
PENDOPHARM DIVISION OF PHARMASCIENCE INC
N04BB01
AMANTADINE
100MG
CAPSULE
AMANTADINE HYDROCHLORIDE 100MG
ORAL
100
Prescription
ADAMANTANES
Active ingredient group (AIG) number: 0109101001; AHFS:
APPROVED
2017-03-13
_ _ pdp-AMANTADINE HYDROCHLORIDE _ _ _Page 1 of 42 _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR PDP-AMANTADINE HYDROCHLORIDE CAPSULES amantadine hydrochloride capsules 100 mg House Standard PR PDP-AMANTADINE HYDROCHLORIDE SYRUP amantadine hydrochloride oral solution 10 mg/mL USP Antiparkinsonian Agent Antiviral Agent PENDOPHARM, Division of Pharmascience Inc. 6111 Royalmount Avenue, Suite 100 Montréal, QC, Canada H4P 2T4 Date of Initial Authorization: Jun 27, 1992 Date of Revision: Jun 13, 2022 Submission Control Number: 261229 _ _ _ _ _pdp-AMANTADINE HYDROCHLORIDE_ _ _ _Page 2 of 42 _ RECENT MAJOR LABEL CHANGES 1 Indications 12/2021 2 Contraindications 06/2022 4 Dosage and Administration 12/2021 4.2 Recommended Dose and Dosage Adjustment 06/2022 7 Warnings and Precautions 12/2021 7 Warnings and Precautions, Cardiovascular 06/2022 7 Warnings and Precautions, Neurologic 06/2022 7 Warnings and Precautions, Ophthalmologic 06/2022 7 Warnings and Precautions, Psychiatric 06/2022 7 Warnings and Precautions, Renal 06/2022 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........................................................................................................... 5 2 CONTRAINDICATIONS ................................................................................................. 5 4 DOSAGE AND ADMINISTRATION Đọc toàn bộ tài liệu