Страна: Канада
мова: англійська
Джерело: Health Canada
OLMESARTAN MEDOXOMIL; HYDROCHLOROTHIAZIDE
PHARMARIS CANADA INC
C09DA08
OLMESARTAN MEDOXOMIL AND DIURETICS
40MG; 25MG
TABLET
OLMESARTAN MEDOXOMIL 40MG; HYDROCHLOROTHIAZIDE 25MG
ORAL
15G/50G
Prescription
Active ingredient group (AIG) number: 0252502003; AHFS:
APPROVED
2022-04-08
Page 1 of 40 PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR PRZ-OLMESARTAN/HCTZ Olmesartan Medoxomil and Hydrochlorothiazide Tablets Tablets, 20 mg / 12.5 mg, 40 mg / 12.5 mg,and 40 mg / 25 mg, Oral Angiotensin II AT 1 Receptor Blocker – Diuretic PHARMARIS CANADA INC. 8310-130 Street, Suite 102, Surrey, British Columbia, Canada V3W 8J9 Date of Initial Authorization: April 06, 2022 Submission Control No: 228559 Page 2 of 40 RECENT MAJOR LABEL CHANGES None at the time of authorization. TABLE OF CONTENTS 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.................................................... 4 4 DOSAGE AND ADMINISTRATION ............................................................................ 5 4.1 Dosing Considerations..................................................................................... 5 4.2 Recommended Dose and Dosage Adjustment Replacement Therapy ............. 5 4.3 Reconstitution .................................................................................................. 7 4.4 Administration .................................................................................................. 7 4.5 Missed Dose .................................................................................................... 7 5 OVERDOSAGE ........................................................................................................... 7 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ..... Прочитайте повний документ