ROCURONIUM BROMIDE INJECTION SOLUTION

Nchi: Kanada

Lugha: Kiingereza

Chanzo: Health Canada

Viambatanisho vya kazi:

ROCURONIUM BROMIDE

Inapatikana kutoka:

JAMP PHARMA CORPORATION

ATC kanuni:

M03AC09

INN (Jina la Kimataifa):

ROCURONIUM BROMIDE

Kipimo:

10MG

Dawa fomu:

SOLUTION

Tungo:

ROCURONIUM BROMIDE 10MG

Njia ya uendeshaji:

INTRAVENOUS

Vitengo katika mfuko:

15G/50G

Dawa ya aina:

Prescription

Bidhaa muhtasari:

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

Idhini hali ya:

APPROVED

Idhini ya tarehe:

2022-08-17

Tabia za bidhaa

_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
.................................................................