DEXMEDETOMIDINE HYDROCHLORIDE FOR INJECTION SOLUTION

Nchi: Kanada

Lugha: Kiingereza

Chanzo: Health Canada

Viambatanisho vya kazi:

DEXMEDETOMIDINE (DEXMEDETOMIDINE HYDROCHLORIDE)

Inapatikana kutoka:

AURO PHARMA INC

ATC kanuni:

N05CM18

INN (Jina la Kimataifa):

DEXMEDETOMIDINE

Kipimo:

100MCG

Dawa fomu:

SOLUTION

Tungo:

DEXMEDETOMIDINE (DEXMEDETOMIDINE HYDROCHLORIDE) 100MCG

Njia ya uendeshaji:

INTRAVENOUS

Vitengo katika mfuko:

25X2ML

Dawa ya aina:

Prescription

Eneo la matibabu:

MISCELLANEOUS ANXIOLYTICS SEDATIVES AND HYPNOTICS

Bidhaa muhtasari:

Active ingredient group (AIG) number: 0152679003; AHFS:

Idhini hali ya:

APPROVED

Idhini ya tarehe:

2019-01-03

Tabia za bidhaa

DEXMEDETOMIDINE HYDROCHLORIDE FOR INJECTION
PRODUCT MONOGRAPH
PAGE 1 OF 40
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR DEXMEDETOMIDINE HYDROCHLORIDE FOR INJECTION
Solution, 100 mcg / mL dexmedetomidine (as dexmedetomidine
hydrochloride), intravenous
infusion
(Concentrate, 2 mL vial)
Alpha2-adrenergic agonist
AURO PHARMA INC.
3700 Steeles Avenue West, Suite # 402
Woodbridge, ON, L4L 8K8,
CANADA
Date of Initial Authorization:
JAN 03, 2019
Date of Revision:
NOV 27, 2023
Submission Control Number: 276148
DEXMEDETOMIDINE HYDROCHLORIDE FOR INJECTION
PRODUCT MONOGRAPH
PAGE 2 OF 40
RECENT MAJOR LABEL CHANGES
4.1 Dosing Considerations
05/2023
7.0 Warnings and Precautions
11/2023
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.
..........................................................................................
5
4.1 DOSING CONSIDERATIONS
....................................................................................................
5
4.2 RECOMMENDED DOSE AND DOSAGE ADJUSTMENT
...................................