Maa: Kanada
Kieli: englanti
Lähde: Health Canada
IPRATROPIUM BROMIDE
APOTEX INC
R03BB01
IPRATROPIUM BROMIDE
250MCG
SOLUTION
IPRATROPIUM BROMIDE 250MCG
INHALATION
2ML
Prescription
ANTIMUSCARINICS ANTISPASMODICS
Active ingredient group (AIG) number: 0115643001; AHFS:
APPROVED
1997-06-23
Page 1 of 34 PRODUCT MONOGRAPH APO-IPRAVENT LPRATROPIUM BROMIDE NEBULIZER SOLUTION 250 MCG/ML (0.025%) IN 20 ML BOTTLES AND 2 ML STERULES 125 MCG/ML (0.0125%) IN 2 ML STERULES BRONCHODILATOR APOTEX INC. 150 SIGNET DRIVE TORONTO, ONTARIO M9L 1T9 DATE OF REVISION: FEBRUARY 07, 2017 CONTROL NO: 190543 Page 2 of 34 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 ......................................................................................................... 6 DRUG INTERACTIONS ....................................................................................................... 10 DOSAGE AND ADMINISTRATION ...................................................................................... 10 OVERDOSAGE .................................................................................................................... 11 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 .................................................... Lue koko asiakirja