AURO-AMOXICILLIN POWDER FOR SUSPENSION
Land: Kanada
Språk: engelska
Källa: Health Canada
Produktens egenskaper
(SPC)
05-12-2023
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Aktiva substanser:
AMOXICILLIN (AMOXICILLIN TRIHYDRATE)
Tillgänglig från:
AURO PHARMA INC
ATC-kod:
J01CA04
INN (International namn):
AMOXICILLIN
Dos:
125MG
Läkemedelsform:
POWDER FOR SUSPENSION
Sammansättning:
AMOXICILLIN (AMOXICILLIN TRIHYDRATE) 125MG
Administreringssätt:
ORAL
Enheter i paketet:
100ML/150ML
Receptbelagda typ:
Prescription
Terapiområde:
AMINOPENICILLINS
Produktsammanfattning:
Active ingredient group (AIG) number: 0131314002; AHFS:
Bemyndigande status:
APPROVED
Tillstånd datum:
2016-11-03
Produktens egenskaper
Auro-Amoxicillin Product Monograph
Page 1 of 29
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
AURO-AMOXICILLIN
AMOXICILLIN FOR ORAL SUSPENSION
Powder for Suspension, 125 mg / 5 mL and 250 mg/5 ml amoxicillin (as
amoxicillin
trihydrate) after reconstitution, Oral
USP
Antibiotic
AURO PHARMA INC.
3700 Steeles Avenue West, Suite #
402 Woodbridge, Ontario, L4L 8K8
Canada
Date of Initial Authorization:
NOV 03, 2016
Date of Revision:
December 05, 2023
Submission Control Number: 276656
Auro-Amoxicillin Product Monograph
Page 2 of 29
RECENT MAJOR LABEL CHANGES
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
12/2023
7 WARNINGS AND PRECAUTIONS, Cardiovascular
12/2023
7 WARNINGS AND PRECAUTIONS 7.1.4 Geriatrics
12/2023
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
.....................................................................................................................
7
4.4 Administratio
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