BRIDION SOLUTION

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

SUGAMMADEX (SUGAMMADEX SODIUM)

זמין מ:

MERCK CANADA INC

קוד ATC:

V03AB35

INN (שם בינלאומי):

SUGAMMADEX

כמות:

100MG

טופס פרצבטיות:

SOLUTION

הרכב:

SUGAMMADEX (SUGAMMADEX SODIUM) 100MG

מסלול נתינה (של תרופות):

INTRAVENOUS

יחידות באריזה:

10X2ML/ 10X5ML

סוג מרשם:

Prescription

איזור תרפויטי:

ANTIDOTES

leaflet_short:

Active ingredient group (AIG) number: 0157810001; AHFS:

מצב אישור:

APPROVED

תאריך אישור:

2016-02-05

מאפייני מוצר

_BRIDION_
_® _
_(sugammadex sodium)_
_ _
_Page 1 of 45_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
BRIDION
®
sugammadex (as sugammadex sodium)
100 mg/mL solution for intravenous injection
Selective Relaxant Binding Agent
MERCK CANADA INC.
16750 route Transcanadienne
Kirkland, QC H9H 4M7
www.merck.ca
Date of Initial Authorization:
FEB 04, 2016
Date of Revision:
OCT 18, 2021
Submission Control Number: 234372
_ _
_BRIDION_
_® _
_(sugammadex sodium)_
_ _
_Page 2 of 45_
RECENT MAJOR LABEL CHANGES
4 Dosage and Administration, 4.2 Recommended Dose and
Dosage Adjustment, Obese Patients
02/2021
1 Indications, 1.1 Pediatrics
10/2021
4 Dosage and Administration, 4.2 Recommended Dose and
Dosage Adjustment, Pediatrics
10/2021
4 Dosage and Administration, 4.4 Administration
10/2021
7 Warnings and Precautions, 7.1.3 Pediatric
10/2021
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
.....................................................................
5
1
INDICATIONS
..............................................................................................................
5
1.1
Pediatrics
.........................................................................................................
5
1.2
Geriatrics...........................................................................................................
5
2
CONTRAINDICATIONS
.................................................................................................
5
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................ 6
4
DOSAGE AND
ADMINISTRATION.................................................................................
6
4.1
Dosing Consi