Nchi: Kanada
Lugha: Kiingereza
Chanzo: Health Canada
CLAVULANIC ACID (CLAVULANATE POTASSIUM); AMOXICILLIN (AMOXICILLIN SODIUM)
SANDOZ CANADA INCORPORATED
J01CR02
AMOXICILLIN AND BETA-LACTAMASE INHIBITOR
100MG; 500MG
POWDER FOR SOLUTION
CLAVULANIC ACID (CLAVULANATE POTASSIUM) 100MG; AMOXICILLIN (AMOXICILLIN SODIUM) 500MG
INTRAVENOUS
15G/50G
Prescription
AMINOPENICILLINS
Active ingredient group (AIG) number: 0234720015; AHFS:
APPROVED
2020-01-28
_Amoxicillin Sodium and Potassium Clavulanate for Injection_ _ _ _Page 1 of 39_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION Pr AMOXICILLIN SODIUM AND POTASSIUM CLAVULANATE FOR INJECTION Co-Amoxiclav for injection Powder for Solution 500 mg amoxicillin (as amoxicillin sodium) and 100 mg clavulanic acid (as clavulanate potassium) per vial 1000 mg amoxicillin (as amoxicillin sodium) and 200 mg clavulanic acid (as clavulanate potassium) per vial 2000 mg amoxicillin (as amoxicillin sodium) and 200 mg clavulanic acid (as clavulanate potassium) per vial Injection House Standard Antibiotic & β-Lactamase inhibitor Sandoz Canada Inc. 110 rue de Lauzon Boucherville, Quebec, Canada J4B 1E6 Date of Initial Authorization: January 27, 2020 Date of Revision: January 26, 2023 Submission Control Number: 261365 _ _ _Amoxicillin Sodium and Potassium Clavulanate for Injection_ _ _ _Page 2 of 39_ RECENT MAJOR LABEL CHANGES 4 Dosage and Administration, 4.3 Reconstitution 01/2023 7 Warnings and Precautions, Immune 01/2023 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 .............................................................................................................5 2 CONTRAINDICATIONS ...................................................................................................5 3 SERIOUS WARNINGS AND PRECAUTIONS BOX . Soma hati kamili