Land: Canada
Sprog: engelsk
Kilde: Health Canada
MANNITOL; MANNITOL; MANNITOL; MANNITOL
PHARMAXIS LTD
V04CX
OTHER DIAGNOSTIC AGENTS
5MG; 10MG; 20MG; 40MG
KIT
MANNITOL 5MG; MANNITOL 10MG; MANNITOL 20MG; MANNITOL 40MG
INHALATION
15G/50G
Prescription Recommended
DIAGNOSTIC AGENTS
Active ingredient group (AIG) number: 0461510001; AHFS:
APPROVED
2019-06-13
_Pr_ _Aridol_ ® _ Product Monograph _ _Page 1 of 29_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR ARIDOL ® Mannitol Inhalation Powder Inhalation Powder, Capsules of 0 mg, 5 mg, 10 mg, 20 mg or 40 mg, Oral Inhalation Diagnostic Agent to Assess Bronchial Hyperresponsiveness ATC Code: V04CX Pharmaxis Ltd 20 Rodborough Rd Frenchs Forest ,2086 Australia Imported and Distributed by: Methapharm Inc 81 Sinclair Boulevard Brantford, ON N3S 7X6 Canada Date of Initial Approval: June 12, 2019 Submission Control No: 217446 _Pr_ _Aridol_ ® _ Product Monograph _ _Page 2 of 29_ TABLE OF CONTENTS PR ARIDOL ® ................................................................................................................................ 1 PART I: HEALTH PROFESSIONAL INFORMATION ........................................................... 4 1 INDICATIONS ............................................................................................................... 4 1.1 Pediatrics ................................................................................................................ 4 1.2 Geriatrics ................................................................................................................ 4 2 CONTRAINDICATIONS ................................................................................................ 4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ...................................................... 4 4 DOSAGE AND ADMINISTRATION ............................................................................... 5 4.1 Dosing Considerations ............................................................................................ 5 4.2 Recommended Dose and Dosage Adjustment ........................................................ 5 4.3 Administration ......................................................................................................... 5 5 OVERDOSAGE ........................................................................................................... 13 6 DOSAGE Læs hele dokumentet