PMS-IPRATROPIUM SOLUTION
Land: Canada
Sprog: engelsk
Kilde: Health Canada
Produktets egenskaber
(SPC)
13-05-2017
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Aktiv bestanddel:
IPRATROPIUM BROMIDE
Tilgængelig fra:
PHARMASCIENCE INC
ATC-kode:
R03BB01
INN (International Name):
IPRATROPIUM BROMIDE
Dosering:
250MCG
Lægemiddelform:
SOLUTION
Sammensætning:
IPRATROPIUM BROMIDE 250MCG
Indgivelsesvej:
INHALATION
Enheder i pakken:
20ML
Recept type:
Prescription
Terapeutisk område:
ANTIMUSCARINICS ANTISPASMODICS
Produkt oversigt:
Active ingredient group (AIG) number: 0115643001; AHFS:
Autorisation status:
APPROVED
Autorisation dato:
2014-01-20
Produktets egenskaber
PRODUCT MONOGRAPH
PMS-IPRATROPIUM
Ipratropium Bromide Nebulizer Solution
250 mcg/mL (0.025%) in 20 mL Bottles
BRONCHODILATOR
PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montreal, Quebec
H4P 2T4
www.pharmascience.com
DATE OF REVISION:
May 11, 2017
CONTROL NO.: 204492
_pms-IPRATROPIUM Product Monograph Page 2 of 28_
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
......................................................................................................
7
DRUG INTERACTIONS
....................................................................................................
10
DOSAGE AND ADMINISTRATION
................................................................................
10
OVERDOSAGE
...................................................................................................................
11
ACTION AND CLINICAL
PHARMACOLOGY...............................................................
11
STORAGE AND STABILITY
............................................................................................
14
SPECIAL HANDLING INSTRUCTIONS
.........................................................................
15
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................... 15
PART II: SCIENTIFIC INFORMATION
..........................................................................
16
PHARMACEUTICAL INFORMATION
............................................................................
16
CLINICAL TRIALS
...........................
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