Land: Canada
Språk: engelsk
Kilde: Health Canada
METHACHOLINE CHLORIDE
METHAPHARM INC
V04CX
OTHER DIAGNOSTIC AGENTS
160MG
POWDER FOR SOLUTION
METHACHOLINE CHLORIDE 160MG
INHALATION
20 ML
Prescription
OTHER DIAGNOSTIC AGENTS
Active ingredient group (AIG) number: 0136042004; AHFS:
APPROVED
2002-09-26
_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 ................................................................ Les hele dokumentet