AURO-AMOXICILLIN CAPSULE

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

AMOXICILLIN (AMOXICILLIN TRIHYDRATE)

Dostępny od:

AURO PHARMA INC

Kod ATC:

J01CA04

INN (International Nazwa):

AMOXICILLIN

Dawkowanie:

500MG

Forma farmaceutyczna:

CAPSULE

Skład:

AMOXICILLIN (AMOXICILLIN TRIHYDRATE) 500MG

Droga podania:

ORAL

Sztuk w opakowaniu:

30/100/500

Typ recepty:

Prescription

Dziedzina terapeutyczna:

AMINOPENICILLINS

Podsumowanie produktu:

Active ingredient group (AIG) number: 0131314006; AHFS:

Status autoryzacji:

APPROVED

Data autoryzacji:

2012-06-27

Charakterystyka produktu

Auro-Amoxicillin Product Monograph
Page 1 of 28
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
Auro-Amoxicillin
Amoxicillin Capsules
Capsules, 250 mg and 500 mg amoxicillin (as amoxicillin trihydrate),
Oral
BP
Antibiotic
AURO PHARMA INC.
3700 Steeles Avenue West, Suite #
402 Woodbridge, Ontario, L4L 8K8
Canada
Date of Initial Authorization:
JUN 27, 2012
Date of Revision:
NOV 02, 2023
Submission Control Number: 276668
Auro-Amoxicillin Product Monograph
Page 2 of 28
RECENT MAJOR LABEL CHANGES
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
10/2023
7 WARNINGS AND PRECAUTIONS
10/2023
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 Usual Dosage
............................................... 5
4.4 Administration
.......................................................................................................................
7
4.5 Missed Dose
..........................................................................................................................
7
5 OVERDOSAGE
....