Страна: Канада
Език: английски
Източник: Health Canada
ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE
AA PHARMA INC
C09BA02
ENALAPRIL AND DIURETICS
5MG; 12.5MG
TABLET
ENALAPRIL MALEATE 5MG; HYDROCHLOROTHIAZIDE 12.5MG
ORAL
100
Prescription
ANGIOTENSIN-CONVERTING ENZYME INHIBITORS
Active ingredient group (AIG) number: 0217290002; AHFS:
APPROVED
2010-06-11
_ENALAPRIL MALEATE / HCTZ_ _(enalapril maleate and hydrochlorothiazide tablets) _ _Page 1 of 61_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR ENALAPRIL MALEATE / HCTZ (Enalapril Maleate and Hydrochlorothiazide Tablets) Tablets 5 mg /12.5 mg and 10 mg /25 mg, oral USP Angiotensin Converting Enzyme Inhibitor / Diuretic AA PHARMA INC. 1165 Creditstone Road, Unit#1 Vaughan, Ontario L4K 4N7 Date of Initial Authorization: DEC 28, 2017 Date of Revision: MAY 10, 2023 Submission Control Number: 270203 _ENALAPRIL MALEATE / HCTZ_ _(enalapril maleate and hydrochlorothiazide tablets) _ _Page 1 of 61_ RECENT MAJOR LABEL CHANGES 1 INDICATIONS, 1.1 Pediatrics 05/2023 1 INDICATIONS, 1.2 Geriatrics 05/2023 2 CONTRAINDICATIONS 05/ 2023 4 DOSAGE AND ADMINISTRATION, 4.4 Administration 05/2023 4 DOSAGE AND ADMINISTRATION, 4.5 Missed dose 05/2023 7 WARNINGS AND PRECAUTIONS 05/2023 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 .......... Прочетете целия документ