Kraj: Kanada
Język: angielski
Źródło: Health Canada
RAMIPRIL; HYDROCHLOROTHIAZIDE
PHARMASCIENCE INC
C09BA05
RAMIPRIL AND DIURETICS
10.0MG; 25.0MG
TABLET
RAMIPRIL 10.0MG; HYDROCHLOROTHIAZIDE 25.0MG
ORAL
30/100
Prescription
ANGIOTENSIN-CONVERTING ENZYME INHIBITORS
Active ingredient group (AIG) number: 0251649005; AHFS:
APPROVED
2010-02-02
_pms-RAMIPRIL-HCTZ (ramipril/hydrochlorothiazide) _ _Page 1 of 67_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR PMS-RAMIPRIL-HCTZ Ramipril and Hydrochlorothiazide Tablets Tablets, 10/12.5 mg, 10/25 mg, Oral Angiotensin Converting Enzyme Inhibitor Plus Diuretic PHARMASCIENCE INC. 6111 Royalmount Ave., Suite 100 Montréal, Québec H4P 2T4 www.pharmascience.com Submission Control Number: 273262 Date of Initial Approval: January 21, 2010 Date of Revision: June 20, 2023 _pms-RAMIPRIL-HCTZ (ramipril/hydrochlorothiazide) _ _Page 2 of 67_ RECENT MAJOR LABEL CHANGES 7 WARNING AND PRECAUTIONS, Ophthalmologic 10/2021 7 WARNING AND PRECAUTIONS, Respiratory 06/2023 TABLE OF CONTENTS SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF AUTHORIZATION ARE NOT LISTED. TABLE OF CONTENTS RECENT MAJOR LABEL CHANGES ............................................................................................... 2 TABLE OF CONTENTS ................................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION ......................................................................... 4 1 INDICATIONS ....................................................................................................................... 4 2 CONTRAINDICATIONS .......................................................................................................... 4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ..................................................................... 5 4 DOSAGE AND ADMINISTRATION .......................................................................................... 5 4.1 Dosing Considerations ...................................................................................................... 5 4.2 Recommended Dose and Dosage Adjustment ................................................................. 6 4.4 Administration ............................................................................................................ Przeczytaj cały dokument