Riik: Kanada
keel: inglise
Allikas: Health Canada
VERAPAMIL HYDROCHLORIDE
APOTEX INC
C08DA01
VERAPAMIL
80MG
TABLET
VERAPAMIL HYDROCHLORIDE 80MG
ORAL
100/500
Prescription
MISCELLANEOUS CALCIUM-CHANNEL BLOCKING AGENTS
Active ingredient group (AIG) number: 0113846002; AHFS:
MARKETED
1989-12-31
PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION Pr APO-VERAP Verapamil Hydrochloride Tablets, 80 mg and 120 mg, oral BP Antianginal / Antiarrhythmic / Antihypertensive Agent APOTEX INC. 150 Signet Drive, Weston, Ontario M9L 1T9. Date of Initial Authorization: JUN 30, 1989 Date of Revision: MAY 12, 2022 www.apotex.ca/products Submission Control Number: 258995 _ _ _VERAPAMIL HYDROCHLORIDE TABLETS (verapamil hydrochloride) _ _Page 2 of 48_ RECENT MAJOR LABEL CHANGES 1 Indications, 1.1 Pediatrics 05/2022 1 Indications, 1.2 Geriatrics 05/2022 2 Contraindications 05/2022 4 Dosage and Administration, 4.2 Recommended Dose and Dosage Adjustment 05/2022 7 Warnings and Precautions, Cardiovascular 05/2022 7 Warnings and Precautions, Hepatic/Biliary/Pancreatic 05/2022 7 Warnings and Precautions, Monitoring and Laboratory tests 05/2022 7 Warnings and Precautions, Neurologic 05/2022 7 Warnings and Precautions, 7.1.1 Pregnant Women 05/2022 7 Warnings and Precautions, 7.1.3 Pediatrics 05/2022 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 .......................................................................5 1 INDICATIONS ................................................................................................................5 1.1 Pediatrics ............................................................................................................5 1.2 Geriatrics.............................................................................................................5 2 CONTRAINDICATIONS ...................................................................................................5 4 DOSAGE AND ADMINISTRATION.......................................... Lugege kogu dokumenti