MYLAN-IPRATROPIUM SOLUTION
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
29-12-2010
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Active ingredient:
IPRATROPIUM BROMIDE
Available from:
MYLAN PHARMACEUTICALS ULC
ATC code:
R03BB01
INN (International Name):
IPRATROPIUM BROMIDE
Dosage:
250MCG
Pharmaceutical form:
SOLUTION
Composition:
IPRATROPIUM BROMIDE 250MCG
Administration route:
INHALATION
Units in package:
20ML
Prescription type:
Prescription
Therapeutic area:
ANTIMUSCARINICS ANTISPASMODICS
Product summary:
Active ingredient group (AIG) number: 0115643001; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2018-07-12
Summary of Product characteristics
PAGE 1 OF 34
PRODUCT MONOGRAPH
PR
MYLAN-IPRATROPIUM STERINEBS
AND
PR
MYLAN-IPRATROPIUM SOLUTION
(Ipratropium Bromide Inhalation Solution)
0.025% (250
μ
g/mL)
BRONCHODILATOR
Mylan Pharmaceuticals ULC
37 Advance Road
Etobicoke, Ontario
DATE OF REVISION:
Canada M8Z 2S6
December 15, 2010
Control number: 142044
PAGE 2 OF 34
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION........................................................ 3
SUMMARY
PRODUCT
INFORMATION................................................................................
3
INDICATIONS
AND
CLINICAL
USES
...................................................................................
3
CONTRAINDICATIONS
..........................................................................................................
4
WARNINGS
AND
PRECAUTIONS
.........................................................................................
4
ADVERSE
REACTIONS...........................................................................................................
6
DRUG
INTERACTIONS
...........................................................................................................
9
DOSAGE
AND
ADMINISTRATION
.......................................................................................
9
OVERDOSAGE
.......................................................................................................................
10
ACTION
AND
CLINICAL
PHARMACOLOGY....................................................................
11
STORAGE
AND
STABILITY
.................................................................................................
14
SPECIAL
HANDLING
INSTRUCTIONS...............................................................................
14
DOSAGE
FORMS,
COMPOSITION
AND
PACKAGING ..................................................... 15
PART II: SCIENTIFIC INFORMATION
..............................................................................
16
PHARMACEUTICAL
INFORMATION...........................................................
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