Země: Kanada
Jazyk: angličtina
Zdroj: Health Canada
IPRATROPIUM BROMIDE
RATIOPHARM INC DIVISION OF TEVA CANADA LIMITED
R03BB01
IPRATROPIUM BROMIDE
250MCG
SOLUTION
IPRATROPIUM BROMIDE 250MCG
INHALATION
20 ML
Prescription
ANTIMUSCARINICS ANTISPASMODICS
Active ingredient group (AIG) number: 0115643001; AHFS:
CANCELLED POST MARKET
2009-07-17
PRODUCT MONOGRAPH PR RATIO-IPRATROPIUM UDV (Ipratropium Bromide) 1 mL and 2 mL inhalation solution unit dose vials Each plastic unit dose vial (UDV) contains: 250 mcg of ipratropium bromide in 1 mL 250 mcg of ipratropium bromide in 2 mL 500 mcg of ipratropium bromide in 2 mL BRONCHODILATOR RATIOPHARM INC. 17 800, Lapointe Mirabel, Quebec Canada, J7J 1P3 Date of Preparation: April 18, 2002 Date of Revision: October 22, 2009 Submission Control No: 133622 _ _ _Product Monograph – ratio-IPRATROPIUM _ _Page 2 of 29 _ 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....................................................................................................5 DRUG INTERACTIONS ....................................................................................................9 DOSAGE AND ADMINISTRATION................................................................................9 OVERDOSAGE ................................................................................................................10 ACTION AND CLINICAL PHARMACOLOGY ............................................................10 STORAGE AND STABILITY..........................................................................................13 SPECIAL HANDLING INSTRUCTIONS .......................................................................13 DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................14 PART II: SCIENTIFIC INFORMATION ..................................................................... Přečtěte si celý dokument