SANDOZ AMOXI-CLAV TABLET

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

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

Mevcut itibaren:

SANDOZ CANADA INCORPORATED

ATC kodu:

J01CR02

INN (International Adı):

AMOXICILLIN AND BETA-LACTAMASE INHIBITOR

Doz:

875MG; 125MG

Farmasötik formu:

TABLET

Kompozisyon:

AMOXICILLIN (AMOXICILLIN TRIHYDRATE) 875MG; CLAVULANIC ACID (CLAVULANATE POTASSIUM) 125MG

Uygulama yolu:

ORAL

Paketteki üniteler:

20/100

Reçete türü:

Prescription

Terapötik alanı:

AMINOPENICILLINS

Ürün özeti:

Active ingredient group (AIG) number: 0234720005; AHFS:

Yetkilendirme durumu:

APPROVED

Yetkilendirme tarihi:

2018-11-08

Ürün özellikleri

_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
...............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................................
4
1
INDICATIONS
...................................................................................................................
4
1.1
Pediatrics
.........................................................................................................................
4
1.2
Geriatrics
..........................................................................................................................
4
2
CONTRAINDICATIONS
.......................................................................................................
5
4
DOSAGE AND ADMINISTRATION
.......................................................................................
5
4.2
Recommended Dose and Dosage