AMOXICILLIN SODIUM AND POTASSIUM CLAVULANATE FOR INJECTION POWDER FOR SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

CLAVULANIC ACID (CLAVULANATE POTASSIUM); AMOXICILLIN (AMOXICILLIN SODIUM)

Available from:

SANDOZ CANADA INCORPORATED

ATC code:

J01CR02

INN (International Name):

AMOXICILLIN AND BETA-LACTAMASE INHIBITOR

Dosage:

200MG; 1000MG

Pharmaceutical form:

POWDER FOR SOLUTION

Composition:

CLAVULANIC ACID (CLAVULANATE POTASSIUM) 200MG; AMOXICILLIN (AMOXICILLIN SODIUM) 1000MG

Administration route:

INTRAVENOUS

Units in package:

15G/50G

Prescription type:

Prescription

Therapeutic area:

AMINOPENICILLINS

Product summary:

Active ingredient group (AIG) number: 0234720013; AHFS:

Authorization status:

APPROVED

Authorization date:

2020-01-28

Summary of Product characteristics

_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
.