NOVAMOXIN TABLET (CHEWABLE)

Land: Canada

Taal: Engels

Bron: Health Canada

Werkstoffen:

AMOXICILLIN (AMOXICILLIN TRIHYDRATE)

Beschikbaar vanaf:

TEVA CANADA LIMITED

ATC-code:

J01CA04

INN (Algemene Internationale Benaming):

AMOXICILLIN

Dosering:

250MG

farmaceutische vorm:

TABLET (CHEWABLE)

Samenstelling:

AMOXICILLIN (AMOXICILLIN TRIHYDRATE) 250MG

Toedieningsweg:

ORAL

Eenheden in pakket:

100/500

Prescription-type:

Prescription

Therapeutisch gebied:

AMINOPENICILLINS

Product samenvatting:

Active ingredient group (AIG) number: 0131314001; AHFS:

Autorisatie-status:

APPROVED

Autorisatie datum:

2013-06-03

Productkenmerken

NOVAMOXIN
1
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR NOVAMOXIN
AMOXICILLIN CAPSULES, USP
Capsules, 250 mg and 500 mg amoxicillin (as amoxicillin trihydrate),
Oral
AMOXICILLIN CHEWABLE TABLETS, USP
Tablets, 250 mg amoxicillin (as amoxicillin trihydrate), Oral
AMOXICILLIN GRANULES FOR ORAL SUSPENSION, USP
Suspension, 250 mg/5 ml amoxicillin (as amoxicillin trihydrate) after
reconstitution, Oral
AMOXICILLIN SUGAR-REDUCED GRANULES FOR ORAL SUSPENSION, Teva Standard
Suspension, 250 mg/5 ml amoxicillin (as amoxicillin trihydrate) after
reconstitution, Oral
Antibiotic
Teva Canada Limited
Date of Initial Authorization:
30 Novopharm Court February 9, 1979
Toronto, ON
M1B 2K9 Date of Revision:
Canada May 16, 2023
www.tevacanada.com
Submission Control Number: 268379
NOVAMOXIN
2
RECENT MAJOR LABEL CHANGES
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
05/2023
7 WARNINGS AND PRECAUTIONS
05/2023
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.....................................................................
4
1
INDICATIONS
..................................................................................................................
4
1.1
Pediatrics
......................................................................................................................
4
1.2
Geriatrics
.......................................................................................................................
4
2
CONTRAINDICATIONS
.....................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
................................................................ 5
4
DOSAGE AND ADMINISTRATION
.....................................................................................
5
4.1
Dosing Considerations
..................................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
.............................................................. 5
4.3
Reconstitution
......