AMOXICILLIN SODIUM AND POTASSIUM CLAVULANATE FOR INJECTION POWDER FOR SOLUTION

国: カナダ

言語: 英語

ソース: Health Canada

有効成分:

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

から入手可能:

SANDOZ CANADA INCORPORATED

ATCコード:

J01CR02

INN（国際名）:

AMOXICILLIN AND BETA-LACTAMASE INHIBITOR

投薬量:

200MG; 2000MG

医薬品形態:

POWDER FOR SOLUTION

構図:

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

投与経路:

INTRAVENOUS

パッケージ内のユニット:

15G/50G

処方タイプ:

Prescription

治療領域:

AMINOPENICILLINS

製品概要:

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

認証ステータス:

APPROVED

承認日:

2020-01-28

製品の特徴

_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
.