Nchi: Kanada
Lugha: Kiingereza
Chanzo: Health Canada
DEXMEDETOMIDINE (DEXMEDETOMIDINE HYDROCHLORIDE)
SANDOZ CANADA INCORPORATED
N05CM18
DEXMEDETOMIDINE
100MCG
SOLUTION
DEXMEDETOMIDINE (DEXMEDETOMIDINE HYDROCHLORIDE) 100MCG
INTRAVENOUS
100
Prescription
MISCELLANEOUS ANXIOLYTICS SEDATIVES AND HYPNOTICS
Active ingredient group (AIG) number: 0152679003; AHFS:
CANCELLED PRE MARKET
2023-04-04
_ _ _Dexmedetomidine Hydrochloride for Injection _ _ _ _Page 1 of 35 _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR DEXMEDETOMIDINE HYDROCHLORIDE FOR INJECTION Dexmedetomidine Hydrochloride for Injection Solution, 100 mcg / mL dexmedetomidine (as dexmedetomidine hydrochloride), intravenous infusion (Concentrate, 2 mL vial) Mfr. Std. Alpha 2 -adrenergic agonist Sandoz Canada Inc. 110 Rue de Lauzon Boucherville Quebec J4B 1E6 Date of Initial Authorization: October 21, 2019 Date of Revision: November 30, 2022 Submission Control Number: 265106 _ _ _Dexmedetomidine Hydrochloride for Injection _ _ _ _Page 2 of 35 _ RECENT MAJOR LABEL CHANGES 4.1 Dosing Considerations 11/2022 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 ............................................................................................................... 4 2 CONTRAINDICATIONS...................................................................................................... 5 4 DOSAGE AND ADMINISTRATION ..................................................................................... 5 4.1 Dosing Considerations ............................................................................................ 5 4.2 Recommended Dose and Dosage Adjustment ......................................................... 5 4.3 Reconstitution... Soma hati kamili