AMOXICILLIN SODIUM AND POTASSIUM CLAVULANATE FOR INJECTION POWDER FOR SOLUTION

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

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

Dostupno od:

SANDOZ CANADA INCORPORATED

ATC koda:

J01CR02

INN (International ime):

AMOXICILLIN AND BETA-LACTAMASE INHIBITOR

Doziranje:

200MG; 2000MG

Farmaceutski oblik:

POWDER FOR SOLUTION

Sastav:

CLAVULANIC ACID (CLAVULANATE POTASSIUM) 200MG; AMOXICILLIN (AMOXICILLIN SODIUM) 2000MG

Administracija rute:

INTRAVENOUS

Jedinice u paketu:

15G/50G

Tip recepta:

Prescription

Područje terapije:

AMINOPENICILLINS

Proizvod sažetak:

Active ingredient group (AIG) number: 0234720014; AHFS:

Status autorizacije:

APPROVED

Datum autorizacije:

2020-01-28

Svojstava lijeka

_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
.