PRO-AMOX-250 POWDER FOR SUSPENSION

国: カナダ

言語: 英語

ソース: Health Canada

有効成分:

AMOXICILLIN (AMOXICILLIN TRIHYDRATE)

から入手可能:

PRO DOC LIMITEE

ATCコード:

J01CA04

INN（国際名）:

AMOXICILLIN

投薬量:

250MG

医薬品形態:

POWDER FOR SUSPENSION

構図:

AMOXICILLIN (AMOXICILLIN TRIHYDRATE) 250MG

投与経路:

ORAL

パッケージ内のユニット:

15G/50G

処方タイプ:

Prescription

治療領域:

AMINOPENICILLINS

製品概要:

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

認証ステータス:

APPROVED

承認日:

2019-10-24

製品の特徴

PRO-AMOX Product Monograph
Page 1 of 29
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
PRO-AMOX-125
PR
PRO-AMOX-250
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
PRO DOC LTÉE
2925, boul. Industriel
Laval, Québec
H7L 3W9
Date
of
Initial
Authorization:
OCT 24, 2019
Date
of
Revision:
FEB 23,
2024
Submission
Control
Number: 283608
PRO-AMOX Product Monograph
Page 2 of 29
RECENT MAJOR LABEL CHANGES
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
02/2024
7 WARNINGS AND PRECAUTIONS, Cardiovascular
02/2024
7 WARNINGS AND PRECAUTIONS 7.1.4 Geriatrics
02/2024
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 Administration
.......................................