SANDOZ AMOXI-CLAV TABLET

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

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

Sẵn có từ:

SANDOZ CANADA INCORPORATED

Mã ATC:

J01CR02

INN (Tên quốc tế):

AMOXICILLIN AND BETA-LACTAMASE INHIBITOR

Liều dùng:

500MG; 125MG

Dạng dược phẩm:

TABLET

Thành phần:

AMOXICILLIN (AMOXICILLIN TRIHYDRATE) 500MG; CLAVULANIC ACID (CLAVULANATE POTASSIUM) 125MG

Tuyến hành chính:

ORAL

Các đơn vị trong gói:

20/100

Loại thuốc theo toa:

Prescription

Khu trị liệu:

AMINOPENICILLINS

Tóm tắt sản phẩm:

Active ingredient group (AIG) number: 0234720009; AHFS:

Tình trạng ủy quyền:

APPROVED

Ngày ủy quyền:

2018-11-08

Đặc tính sản phẩm

_Sandoz Amoxi-Clav Tablet Product Monograph _
_ _
_Page 1 of 36_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR SANDOZ® AMOXI-CLAV TABLET
Amoxicillin and Clavulanate Potassium Tablets
Sandoz® Amoxi-Clav Tablet
– 500 mg tablets
500 mg amoxicillin (as trihydrate) and 125 mg clavulanic acid (as
clavulanate potassium), Oral
Sandoz® Amoxi-Clav Tablet
– 875 mg tablets
875 mg amoxicillin (as trihydrate) and 125 mg clavulanic acid (as
clavulanate potassium), Oral
USP Standard
Combinations of penicillins, including beta-lactamase inhibitors
Sandoz Canada Inc.
110 rue de Lauzon
Boucherville
Québec Canada
J4B 1E6
Date of Initial Authorization:
November 8, 2018
Date of Revision:
June 12, 2023
Submission Control Number: 271576
_Sandoz Amoxi-Clav Tablet Product Monograph _
_ _
_Page 2 of 36_
RECENT MAJOR LABEL CHANGES
7 Warnings and Precautions, Immune
06/2023
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
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2
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................................
4
1
INDICATIONS
...................................................................................................................
4
1.1
Pediatrics
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4
1.2
Geriatrics
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4
2
CONTRAINDICATIONS
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5
4
DOSAGE AND ADMINISTRATION
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5
4.2
Recommended Dose and Dosage