ROCURONIUM BROMIDE INJECTION SOLUTION

Krajina: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktívna zložka:

ROCURONIUM BROMIDE

Dostupné z:

JAMP PHARMA CORPORATION

ATC kód:

M03AC09

INN (Medzinárodný Name):

ROCURONIUM BROMIDE

Dávkovanie:

10MG

Forma lieku:

SOLUTION

Zloženie:

ROCURONIUM BROMIDE 10MG

Spôsob podávania:

INTRAVENOUS

Počet v balení:

15G/50G

Typ predpisu:

Prescription

Prehľad produktov:

Active ingredient group (AIG) number: 0126317001; AHFS:

Stav Autorizácia:

APPROVED

Dátum Autorizácia:

2022-08-17

Súhrn charakteristických

_Rocuronium Bromide Injection _
_–_
_ Product Monograph_ _Page 1 of 36_
PRODUCT MONOGRAPH
PR
ROCURONIUM BROMIDE INJECTION
10 mg/mL, Solution for Injection, 5 mL vial
Sterile and Preservative Free
Non-depolarizing Skeletal Neuromuscular Blocking Agent
JAMP Pharma Corporation
1310 rue Nobel
Boucherville, Quebec
J4B 5H3, Canada
Submission Control No.: 257208
Date of Preparation:
August 16, 2022
_Rocuronium Bromide Injection _
_–_
_ Product Monograph_ _Page 2 of 36_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..................................................... 3
SUMMARY PRODUCT INFORMATION
....................................................................3
INDICATIONS AND CLINICAL
USE..........................................................................3
CONTRAINDICATIONS..............................................................................................3
WARNINGS AND PRECAUTIONS
.............................................................................4
ADVERSE REACTIONS
..............................................................................................8
DRUG INTERACTIONS
............................................................................................
11
DOSAGE AND
ADMINISTRATION..........................................................................
12
OVERDOSAGE..........................................................................................................
18
ACTION AND CLINICAL PHARMACOLOGY
......................................................... 18
STORAGE AND
STABILITY.....................................................................................
26
SPECIAL HANDLING INSTRUCTIONS
................................................................... 26
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................... 26
PART II: SCIENTIFIC
INFORMATION..........................................................................
28
PHARMACEUTICAL INFORMATION
.................................................................