NOVAMOXIN TABLET (CHEWABLE)

Pajjiż: Kanada

Lingwa: Ingliż

Sors: Health Canada

Ingredjent attiv:

AMOXICILLIN (AMOXICILLIN TRIHYDRATE)

Disponibbli minn:

TEVA CANADA LIMITED

Kodiċi ATC:

J01CA04

INN (Isem Internazzjonali):

AMOXICILLIN

Dożaġġ:

250MG

Għamla farmaċewtika:

TABLET (CHEWABLE)

Kompożizzjoni:

AMOXICILLIN (AMOXICILLIN TRIHYDRATE) 250MG

Rotta amministrattiva:

ORAL

Unitajiet fil-pakkett:

100/500

Tip ta 'preskrizzjoni:

Prescription

Żona terapewtika:

AMINOPENICILLINS

Sommarju tal-prodott:

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

L-istatus ta 'awtorizzazzjoni:

APPROVED

Data ta 'l-awtorizzazzjoni:

2013-06-03

Karatteristiċi tal-prodott

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
......