Land: Kanada
Språk: engelska
Källa: Health Canada
METHACHOLINE CHLORIDE
OMEGA LABORATORIES LIMITED
V04CX
OTHER DIAGNOSTIC AGENTS
100MG
POWDER FOR SOLUTION
METHACHOLINE CHLORIDE 100MG
INHALATION
30ML VIAL
Prescription
OTHER DIAGNOSTIC AGENTS
Active ingredient group (AIG) number: 0136042001; AHFS:
APPROVED
2005-01-28
_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 ..................................................... Läs hela dokumentet