ROCURONIUM BROMIDE INJECTION SOLUTION

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

ROCURONIUM BROMIDE

Mevcut itibaren:

PFIZER CANADA ULC

ATC kodu:

M03AC09

INN (International Adı):

ROCURONIUM BROMIDE

Doz:

10MG

Farmasötik formu:

SOLUTION

Kompozisyon:

ROCURONIUM BROMIDE 10MG

Uygulama yolu:

INTRAVENOUS

Paketteki üniteler:

5ML

Reçete türü:

Prescription

Terapötik alanı:

NEUROMUSCULAR BLOCKING AGENTS

Ürün özeti:

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

Yetkilendirme durumu:

APPROVED

Yetkilendirme tarihi:

2018-01-04

Ürün özellikleri

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
Pfizer Canada ULC
17300 Trans-Canada Highway
Kirkland, Québec
H9J 2M5
Submission Control No.: 225871
Date of Revision:
May 31, 2019
_Product Monograph - _
_Pr_
_Rocuronium Bromide Injection _
_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
..........................................................................28
CLINICAL TR