Страна: Канада
Язык: английский
Источник: Health Canada
DEXMEDETOMIDINE (DEXMEDETOMIDINE HYDROCHLORIDE)
OMEGA LABORATORIES LIMITED
N05CM18
DEXMEDETOMIDINE
100MCG
SOLUTION
DEXMEDETOMIDINE (DEXMEDETOMIDINE HYDROCHLORIDE) 100MCG
INTRAVENOUS
100
Prescription
Active ingredient group (AIG) number: 0152679003; AHFS:
APPROVED
2023-06-28
dexmedeTOMidine Hydrochloride for Injection, USP _ _ _Page 1 of 33 _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR DEXMEDETOMIDINE HYDROCHLORIDE FOR INJECTION, USP Solution, 100 mcg/mL dexmedetomidine (as dexmedetomidine hydrochloride) intravenous infusion (Concentrate, 2 mL vial) Preservative free. The stopper is not made with natural rubber latex Alpha 2 -adrenergic agonist Omega Laboratories Limited 11177 Hamon Montreal, Canada H3M 3E4 Submission Control Number: 277599 Date of Initial Authorization: June 28, 2023 Date of Revision: August 21, 2023 dexmedeTOMidine Hydrochloride for Injection, USP _ _ _Page 2 of 33 _ RECENT MAJOR LABEL CHANGES 4.1 Dosing Considerations 08/2023 7.0 Warnings and Precautions 08/2023 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 .................................................................................................. 4 4 DOSAGE AND ADMINISTRATION .................................................................................. 4 4.1 Dosing Considerations ................................................................................................ 4 4.2 Recommended Dose and Dosage Adjustment ............................... Прочитать полный документ