AMOXICILLIN SODIUM AND POTASSIUM CLAVULANATE FOR INJECTION POWDER FOR SOLUTION

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Kup teraz

Składnik aktywny:

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

Dostępny od:

SANDOZ CANADA INCORPORATED

Kod ATC:

J01CR02

INN (International Nazwa):

AMOXICILLIN AND BETA-LACTAMASE INHIBITOR

Dawkowanie:

100MG; 500MG

Forma farmaceutyczna:

POWDER FOR SOLUTION

Skład:

CLAVULANIC ACID (CLAVULANATE POTASSIUM) 100MG; AMOXICILLIN (AMOXICILLIN SODIUM) 500MG

Droga podania:

INTRAVENOUS

Sztuk w opakowaniu:

15G/50G

Typ recepty:

Prescription

Dziedzina terapeutyczna:

AMINOPENICILLINS

Podsumowanie produktu:

Active ingredient group (AIG) number: 0234720015; AHFS:

Status autoryzacji:

APPROVED

Data autoryzacji:

2020-01-28

Charakterystyka produktu

                                _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
.
                                
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