ISOFLURANE USP LIQUID
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
23-05-2018
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Active ingredient:
ISOFLURANE
Available from:
FRESENIUS KABI CANADA LTD
ATC code:
N01AB06
INN (International Name):
ISOFLURANE
Dosage:
99.9%
Pharmaceutical form:
LIQUID
Composition:
ISOFLURANE 99.9%
Administration route:
INHALATION
Units in package:
100/250ML
Prescription type:
Prescription
Therapeutic area:
INHALATION ANESTHETICS
Product summary:
Active ingredient group (AIG) number: 0114368001; AHFS:
Authorization status:
APPROVED
Authorization date:
2006-10-05
Summary of Product characteristics
PRODUCT
MONOGRAPH
PR
ISOFLURANE USP
(Isoflurane, 99.9%)
Inhalation Anesthetic
FRESENIUS KABI CANADA LTD.
165 Galaxy Blvd, Suite 100
Toronto, ON M9W 0C8
Date of Revision:
May 23, 2018
Control No.: 215732
Isoflurane USP - Product Monograph_ _
Page 2 of 26
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
......................................................................................
13
OVERDOSAGE
.........................................................................................................................
15
STORAGE AND STABILITY
..................................................................................................
17
DOSAGE FORMS, COMPOSITION AND PACKAGING
..................................................... 17
PART II: SCIENTIFIC INFORMATION
...............................................................................18
PHARMACEUTICAL INFORMATION
..................................................................................
18
DETAILED PHARMACOLOGY
.............................................................................................
19
TOXICOLOGY
.................................................................................................................
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