PROVOCHOLINE POWDER FOR SOLUTION

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

METHACHOLINE CHLORIDE

Sẵn có từ:

METHAPHARM INC

Mã ATC:

V04CX

INN (Tên quốc tế):

OTHER DIAGNOSTIC AGENTS

Liều dùng:

160MG

Dạng dược phẩm:

POWDER FOR SOLUTION

Thành phần:

METHACHOLINE CHLORIDE 160MG

Tuyến hành chính:

INHALATION

Các đơn vị trong gói:

20 ML

Loại thuốc theo toa:

Prescription

Khu trị liệu:

OTHER DIAGNOSTIC AGENTS

Tóm tắt sản phẩm:

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

Tình trạng ủy quyền:

APPROVED

Ngày ủy quyền:

2002-09-26

Đặc tính sản phẩm

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