Kraj: Kanada
Język: angielski
Źródło: Health Canada
AMOXICILLIN (AMOXICILLIN TRIHYDRATE); CLAVULANIC ACID (CLAVULANATE POTASSIUM)
SANIS HEALTH INC
J01CR02
AMOXICILLIN AND BETA-LACTAMASE INHIBITOR
875MG; 125MG
TABLET
AMOXICILLIN (AMOXICILLIN TRIHYDRATE) 875MG; CLAVULANIC ACID (CLAVULANATE POTASSIUM) 125MG
ORAL
15G/50G
Prescription
Active ingredient group (AIG) number: 0234720005; AHFS:
APPROVED
2023-03-10
_AMOXICILLIN/CLAV Product Monograph _ _ _ _Page 1 of 37_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR AMOXICILLIN/CLAV Amoxicillin and Clavulanate Potassium Tablets AMOXICILLIN/CLAV – 500 mg tablets 500 mg amoxicillin (as trihydrate) and 125 mg clavulanic acid (as clavulanate potassium), Oral AMOXICILLIN/CLAV – 875 mg tablets 875 mg amoxicillin (as trihydrate) and 125 mg clavulanic acid (as clavulanate potassium), Oral USP Standard Combinations of penicillins, including beta-lactamase inhibitors Sanis Health Inc. 1 President's Choice Circle Brampton, Ontario L6Y 5S5 Date of Initial Authorization: March 10, 2023 Date of Revision: October 06, 2023 Submission Control Number: 279154 _AMOXICILLIN/CLAV Product Monograph _ _ _ _Page 2 of 37_ RECENT MAJOR LABEL CHANGES 7 Warnings and Precautions, Immune 10/2023 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 ....................................................................................................... 5 4 DOSAGE AND ADMINISTRATION ....................................................................................... 5 4.2 Recommended Dose and Dosage Adjustment .................................. Przeczytaj cały dokument