AURO-AMOXICILLIN POWDER FOR SUSPENSION

দেশ: কানাডা

ভাষা: ইংরেজি

সূত্র: Health Canada

সক্রিয় উপাদান:

AMOXICILLIN (AMOXICILLIN TRIHYDRATE)

থেকে পাওয়া:

AURO PHARMA INC

এটিসি কোড:

J01CA04

INN (আন্তর্জাতিক নাম):

AMOXICILLIN

ডোজ:

250MG

ফার্মাসিউটিকাল ফর্ম:

POWDER FOR SUSPENSION

রচনা:

AMOXICILLIN (AMOXICILLIN TRIHYDRATE) 250MG

প্রশাসন রুট:

ORAL

প্যাকেজ ইউনিট:

100ML/150ML

প্রেসক্রিপশন টাইপ:

Prescription

থেরাপিউটিক এলাকা:

AMINOPENICILLINS

পণ্য সারাংশ:

Active ingredient group (AIG) number: 0131314003; AHFS:

অনুমোদন অবস্থা:

APPROVED

অনুমোদন তারিখ:

2016-11-03

পণ্য বৈশিষ্ট্য

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