ROCURONIUM BROMIDE INJECTION SOLUTION

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

ROCURONIUM BROMIDE

Tersedia dari:

EUGIA PHARMA INC.

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:

2022-07-08

Karakteristik produk

Page 1 of 35
PRODUCT MONOGRAPH
PR ROCURONIUM BROMIDE INJECTION
10 mg/mL Solution for Injection
(50 mg/5 mL and 100 mg/10 mL)
Sterile Solution
Non-depolarizing Skeletal Neuromuscular Blocking Agent
EUGIA PHARMA INC.
3700 Steeles Avenue West, Suite # 402
Woodbridge, Ontario
L4L 8K8, Canada
Submission Control No.: 264657
Date of Preparation:
July 7, 2022
Page 2 of 35
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
................................................................ 3
SUMMARY PRODUCT INFORMATION
......................................................................................
3
INDICATIONS AND CLINICAL USE
............................................................................................
3
CONTRAINDICATIONS
.................................................................................................................
4
WARNINGS AND PRECAUTIONS
................................................................................................
4
ADVERSE REACTIONS
..................................................................................................................
8
DRUG INTERACTIONS
................................................................................................................
11
DOSAGE AND ADMINISTRATION
............................................................................................
12
OVERDOSAGE
..............................................................................................................................
18
ACTION AND CLINICAL
PHARMACOLOGY...........................................................................
18
STORAGE AND STABILITY
........................................................................................................
25
SPECIAL HANDLING INSTRUCTIONS
.....................................................................................
26
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................................... 26
PART II: SCIENTIFIC INFORMATION
..............................