PROVOCHOLINE POWDER FOR SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

METHACHOLINE CHLORIDE

Available from:

METHAPHARM INC

ATC code:

V04CX

INN (International Name):

OTHER DIAGNOSTIC AGENTS

Dosage:

160MG

Pharmaceutical form:

POWDER FOR SOLUTION

Composition:

METHACHOLINE CHLORIDE 160MG

Administration route:

INHALATION

Units in package:

20 ML

Prescription type:

Prescription

Therapeutic area:

OTHER DIAGNOSTIC AGENTS

Product summary:

Active ingredient group (AIG) number: 0136042004; AHFS:

Authorization status:

APPROVED

Authorization date:

2002-09-26

Summary of Product characteristics

_Product Monograph _
_ _
_PROVOCHOLINE (Methacholine Chloride) _
_Page 1 of 28_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
PROVOCHOLINE
®
Methacholine Chloride (powder)
USP
100 mg, 160 mg, 320 mg, 1280 mg and 1600 mg
PR
PROVOCHOLINE
®
INHALATION SOLUTION (STERILE)
Methacholine Chloride Inhalation Solution
0 mg / mL, 0.0625 mg / mL, 0.25 mg / mL, 1 mg / mL, 4 mg / mL and 16
mg / mL
Cholinergic/Diagnostic Aid (Bronchial Airway Hyperresponsiveness)
Methapharm Inc.
81 Sinclair Boulevard
Brantford, Ontario
N3S 7X6
Date of Initial Authorization:

Date of Revision:
< Oct. 28, 2022>
Submission Control No: 249113
_ _
_Product Monograph _
_ _
_PROVOCHOLINE (Methacholine Chloride) _
_Page 2 of 28_
RECENT MAJOR LABEL CHANGES
1 Indications
[11/2021]
2 Contraindications
[11/2021]
3 Serious Warnings and Precautions Box
[11/2021]
4 Dosage and Administration
[11/2021]
7 Warnings and Precautions
[11/2021]
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 ................................................................