Страна: Канада
мова: англійська
Джерело: Health Canada
TRIAZOLAM
AA PHARMA INC
N05CD05
TRIAZOLAM
0.25MG
TABLET
TRIAZOLAM 0.25MG
ORAL
7
Targeted (CDSA IV)
BENZODIAZEPINES
Active ingredient group (AIG) number: 0112970002; AHFS:
APPROVED
2010-06-02
_TRIAZOLAM (triazolam) _ _Page 1 of 31_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION TRIAZOLAM Triazolam Tablets, 0.25 mg and Oral USP ATC code: N05CD05 Hypnotic AA PHARMA INC. Vaughan, Ontario L4K 4N7 www.aapharma.ca Date of Initial Authorization: DEC 31, 1989 Date of Revision: DEC 16, 2021 Submission Control Number: 253167 _ _ _TRIAZOLAM (triazolam) _ _Page 2 of 31_ RECENT MAJOR LABEL CHANGES 1 Indications, 1.2 Geriatrics 12/2021 2 Contraindications 12/2021 3 Serious Warnings and Precautions Box 12/2021 4 Dosage and Administration, 4.1 Dosing considerations 12/2021 4 Dosage and Administration, 4.2 Recommended Dose and Dosage Adjustment 12/2021 7 Warnings and Precautions 12/2021 7 Warnings and Precautions, 7.1.4 Geriatrics 12/2021 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 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................ 5 4 DOSAGE AND ADMINISTRATION ................................................................................. 5 4.1 Dosing Considerations ................................................................. Прочитайте повний документ