AMOXICILLIN SODIUM AND POTASSIUM CLAVULANATE FOR INJECTION POWDER FOR SOLUTION

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

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

Sẵn có từ:

SANDOZ CANADA INCORPORATED

Mã ATC:

J01CR02

INN (Tên quốc tế):

AMOXICILLIN AND BETA-LACTAMASE INHIBITOR

Liều dùng:

200MG; 1000MG

Dạng dược phẩm:

POWDER FOR SOLUTION

Thành phần:

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

Tuyến hành chính:

INTRAVENOUS

Các đơn vị trong gói:

15G/50G

Loại thuốc theo toa:

Prescription

Khu trị liệu:

AMINOPENICILLINS

Tóm tắt sản phẩm:

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

Tình trạng ủy quyền:

APPROVED

Ngày ủy quyền:

2020-01-28

Đặc tính sản phẩm

_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
.