INJECTABLE ROCURONIUM BROMIDE SOLUTION

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

ROCURONIUM BROMIDE

Tersedia dari:

OMEGA LABORATORIES LIMITED

Kode ATC:

M03AC09

INN (Nama Internasional):

ROCURONIUM BROMIDE

Dosis:

10MG

Bentuk farmasi:

SOLUTION

Komposisi:

ROCURONIUM BROMIDE 10MG

Rute administrasi :

INTRAVENOUS

Unit dalam paket:

100

Jenis Resep:

Prescription

Ringkasan produk:

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

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2023-07-10

Karakteristik produk

_PRODUCT MONOGRAPH: Injectable Rocuronium Bromide _
Page 1 of 33
PRODUCT MONOGRAPH
Pr
INJECTABLE ROCURONIUM BROMIDE
Rocuronium Bromide Injection
10 mg / mL, Solution for Injection, 5 mL vial
Sterile and Preservative Free
Non-depolarizing Skeletal Neuromuscular Blocking Agent
Omega Laboratories Limited
11177 Hamon
Montreal, Canada
H3M 3E4
Date of Preparation:
JUL 10, 2023
Submission Control No.: 276019
_PRODUCT MONOGRAPH: Injectable Rocuronium Bromide _
Page 2 of 33
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
................................................................................................................
17
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 17
STORAGE AND STABILITY
.........................................................................................
24
SPECIAL HANDLING INSTRUCTIONS
......................................................................
25
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 25
PART II: SCIENTIFIC INFORMATION
..............................................................................
26
PHARMACEUTICAL INFORMATION
....