DEXMEDETOMIDINE HYDROCHLORIDE FOR INJECTION SOLUTION

Ország: Kanada

Nyelv: angol

Forrás: Health Canada

Aktív összetevők:

DEXMEDETOMIDINE (DEXMEDETOMIDINE HYDROCHLORIDE)

Beszerezhető a:

SANDOZ CANADA INCORPORATED

ATC-kód:

N05CM18

INN (nemzetközi neve):

DEXMEDETOMIDINE

Adagolás:

100MCG

Gyógyszerészeti forma:

SOLUTION

Összetétel:

DEXMEDETOMIDINE (DEXMEDETOMIDINE HYDROCHLORIDE) 100MCG

Az alkalmazás módja:

INTRAVENOUS

db csomag:

100

Recept típusa:

Prescription

Terápiás terület:

MISCELLANEOUS ANXIOLYTICS SEDATIVES AND HYPNOTICS

Termék összefoglaló:

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

Engedélyezési státusz:

CANCELLED PRE MARKET

Engedély dátuma:

2023-04-04

Termékjellemzők

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_Dexmedetomidine Hydrochloride for Injection _
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_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...