Country: Canada
Language: English
Source: Health Canada
IPRATROPIUM BROMIDE (IPRATROPIUM BROMIDE MONOHYDRATE); SALBUTAMOL (SALBUTAMOL SULFATE)
APOTEX INC
R03AL02
SALBUTAMOL AND IPRATROPIUM BROMIDE
0.5MG; 2.5MG
SOLUTION
IPRATROPIUM BROMIDE (IPRATROPIUM BROMIDE MONOHYDRATE) 0.5MG; SALBUTAMOL (SALBUTAMOL SULFATE) 2.5MG
INHALATION
20X2.5ML
Prescription
ANTIMUSCARINICS ANTISPASMODICS
Active ingredient group (AIG) number: 0232902001; AHFS:
APPROVED
2005-03-31
Page 1 of 40 PRODUCT MONOGRAPH PR APO-SALVENT IPRAVENT STERULES Salbutamol Sulfate and Ipratropium Bromide Inhalation Solution Each sterule contains 3 mg salbutamol sulfate [2.5 mg salbutamol base] and 0.5 mg of ipratropium bromide anhydrous [as monohydrate] in 2.5 mL of saline BRONCHODILATOR APOTEX INC. DATE OF REVISION: 150 Signet Drive June 22, 2018 Toronto, Ontario M9L 1T9 Control No. 215519 Page 2 of 40 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 ......................................................................................................... 13 DOSAGE AND ADMINISTRATION ..................................................................................... 14 OVERDOSAGE ....................................................................................................................... 15 ACTION AND CLINICAL PHARMACOLOGY ................................................................... 16 STORAGE AND STABILITY ................................................................................................. 22 DOSAGE FORMS, COMPOSITION AND PACKAGING .................................................... 22 PART II: SCIENTIFIC INFORMATION ........................................................................... 23 PHARMACEUTICAL INFORMATION ................................................................................. 23 C Read the complete document