ARIDOL KIT
Země: Kanada
Jazyk: angličtina
Zdroj: Health Canada
Charakteristika produktu
(SPC)
12-06-2019
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Aktivní složka:
MANNITOL; MANNITOL; MANNITOL; MANNITOL
Dostupné s:
PHARMAXIS LTD
ATC kód:
V04CX
INN (Mezinárodní Name):
OTHER DIAGNOSTIC AGENTS
Dávkování:
5MG; 10MG; 20MG; 40MG
Léková forma:
KIT
Složení:
MANNITOL 5MG; MANNITOL 10MG; MANNITOL 20MG; MANNITOL 40MG
Podání:
INHALATION
Jednotky v balení:
15G/50G
Druh předpisu:
Prescription Recommended
Terapeutické oblasti:
DIAGNOSTIC AGENTS
Přehled produktů:
Active ingredient group (AIG) number: 0461510001; AHFS:
Stav Autorizace:
APPROVED
Datum autorizace:
2019-06-13
Charakteristika produktu
_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
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