SANDOZ AMOXI-CLAV TABLET

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

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

Saatavilla:

SANDOZ CANADA INCORPORATED

ATC-koodi:

J01CR02

INN (Kansainvälinen yleisnimi):

AMOXICILLIN AND BETA-LACTAMASE INHIBITOR

Annos:

500MG; 125MG

Lääkemuoto:

TABLET

Koostumus:

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

Antoreitti:

ORAL

Kpl paketissa:

20/100

Prescription tyyppi:

Prescription

Terapeuttinen alue:

AMINOPENICILLINS

Tuoteyhteenveto:

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

Valtuutuksen tilan:

APPROVED

Valtuutus päivämäärä:

2018-11-08

Valmisteyhteenveto

_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
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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