METHACHOLINE OMEGA POWDER FOR SOLUTION

Land: Kanada

Språk: engelska

Källa: Health Canada

Aktiva substanser:

METHACHOLINE CHLORIDE

Tillgänglig från:

OMEGA LABORATORIES LIMITED

ATC-kod:

V04CX

INN (International namn):

OTHER DIAGNOSTIC AGENTS

Dos:

480MG

Läkemedelsform:

POWDER FOR SOLUTION

Sammansättning:

METHACHOLINE CHLORIDE 480MG

Administreringssätt:

INHALATION

Enheter i paketet:

30ML VIAL

Receptbelagda typ:

Prescription

Terapiområde:

OTHER DIAGNOSTIC AGENTS

Produktsammanfattning:

Active ingredient group (AIG) number: 0136042006; AHFS:

Bemyndigande status:

APPROVED

Tillstånd datum:

2005-01-28

Produktens egenskaper

_METHACHOLINE OMEGA (Methacholine chloride powder for inhalation
solution) Page 1 of 23 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
METHACHOLINE OMEGA
Methacholine chloride powder for inhalation solution
Powder for Solution, 100 mg / vial, 480 mg / vial and 1600 mg / vial,
Inhalation
Cholinergic / Diagnostic Aid (Bronchial Airway Hyperresponsiveness)
Omega Laboratories Limited
11 177 Hamon
Montreal, Quebec
H3M 3E4
Date of Initial Authorization:
January 26, 2005
Date of Revision:
April 20, 2023
Submission Control Number: 270530
_METHACHOLINE OMEGA (Methacholine chloride powder for inhalation
solution) Page 2 of 23 _
_ _
RECENT MAJOR LABEL CHANGES
1. INDICATIONS
[04/2023]
2. CONTRAINDICATIONS
[04/2023]
3. SERIOUS WARNINGS AND PRECAUTIONS BOX
[04/2023]
4. DOSAGE AND ADMINISTRATION
[04/2023]
7. WARNINGS AND PRECAUTIONS
[04/2023]
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
..........................................................................................
2
TABLE OF CONTENTS
................................................................................................................
2
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
........................................................... 5
4.
DOSAGE AND ADMINISTRATION
.....................................................