AMOXICILLIN/CLAV TABLET

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

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

Disponibil de la:

SANIS HEALTH INC

Codul ATC:

J01CR02

INN (nume internaţional):

AMOXICILLIN AND BETA-LACTAMASE INHIBITOR

Dozare:

875MG; 125MG

Forma farmaceutică:

TABLET

Compoziție:

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

Calea de administrare:

ORAL

Unități în pachet:

15G/50G

Tip de prescriptie medicala:

Prescription

Rezumat produs:

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

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2023-03-10

Caracteristicilor produsului

_AMOXICILLIN/CLAV Product Monograph _
_ _
_Page 1 of 37_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR AMOXICILLIN/CLAV
Amoxicillin and Clavulanate Potassium Tablets
AMOXICILLIN/CLAV
– 500 mg tablets
500 mg amoxicillin (as trihydrate) and 125 mg clavulanic acid (as
clavulanate potassium), Oral
AMOXICILLIN/CLAV
– 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
Sanis Health Inc.
1 President's Choice Circle
Brampton, Ontario
L6Y 5S5
Date of
Initial Authorization:
March 10, 2023
Date of Revision:
October 06,
2023
Submission
Control
Number:
279154
_AMOXICILLIN/CLAV Product Monograph _
_ _
_Page 2 of 37_
RECENT MAJOR LABEL CHANGES
7 Warnings and Precautions, Immune
10/2023
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 Adjustment
..................................