Pays: Canada
Langue: anglais
Source: Health Canada
BENZYDAMINE HYDROCHLORIDE
ODAN LABORATORIES LTD
A01AD02
BENZYDAMINE
0.15%
MOUTHWASH/GARGLE
BENZYDAMINE HYDROCHLORIDE 0.15%
BUCCAL
250ML
Prescription
MOUTHWASHES AND GARGLES
Active ingredient group (AIG) number: 0113801001; AHFS:
APPROVED
2017-04-13
_Product Monograph –ODAN-BENZYDAMINE_ _Page 1 of 13_ PRODUCT MONOGRAPH PR ODAN-BENZYDAMINE Benzydamine Mouthwash, BP benzydamine hydrochloride 1.5 mg/mL (0.15% w/v) LOCAL ANALGESIC Odan Laboratories Limited 325 Stillview Avenue Pointe-Claire, QC, Canada, H9R 2Y6 Date of Preparation: April 13, 2017 Submission Control No: 189026 _Product Monograph –ODAN-BENZYDAMINE_ _Page 2 of 13_ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION.........................................................3 SUMMARY PRODUCT INFORMATION ........................................................................3 INDICATIONS AND CLINICAL USE ..............................................................................3 CONTRAINDICATIONS ...................................................................................................3 WARNINGS AND PRECAUTIONS ..................................................................................3 DOSAGE AND ADMINISTRATION ................................................................................4 OVERDOSAGE ..................................................................................................................4 ACTION AND CLINICAL PHARMACOLOGY ..............................................................5 STORAGE AND STABILITY ............................................................................................5 DOSAGE FORMS, COMPOSITION AND PACKAGING ...............................................5 PART II: SCIENTIFIC INFORMATION .................................................................................6 PHARMACEUTICAL INFORMATION............................................................................6 CLINICAL TRIALS ............................................................................................................7 DETAILED PHARMACOLOGY .......................................................................................7 TOXICOLOGY ....................................................................................................... Lire le document complet