PROVOCHOLINE INHALATION SOLUTION

Држава: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

METHACHOLINE CHLORIDE; METHACHOLINE CHLORIDE; METHACHOLINE CHLORIDE; METHACHOLINE CHLORIDE; METHACHOLINE CHLORIDE

Доступно од:

METHAPHARM INC

АТЦ код:

V04CX

INN (Међународно име):

OTHER DIAGNOSTIC AGENTS

Дозирање:

0.0625MG; 0.25MG; 1MG; 16MG; 4MG

Фармацеутски облик:

SOLUTION

Састав:

METHACHOLINE CHLORIDE 0.0625MG; METHACHOLINE CHLORIDE 0.25MG; METHACHOLINE CHLORIDE 1MG; METHACHOLINE CHLORIDE 16MG; METHACHOLINE CHLORIDE 4MG

Пут администрације:

INHALATION

Јединице у пакету:

100

Тип рецептора:

Prescription

Терапеутска област:

OTHER DIAGNOSTIC AGENTS

Резиме производа:

Active ingredient group (AIG) number: 0551578001; AHFS:

Статус ауторизације:

APPROVED

Датум одобрења:

2021-11-12

Карактеристике производа

_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 ................................................................