PRO-AMOX-250 POWDER FOR SUSPENSION

Ország: Kanada

Nyelv: angol

Forrás: Health Canada

Aktív összetevők:

AMOXICILLIN (AMOXICILLIN TRIHYDRATE)

Beszerezhető a:

PRO DOC LIMITEE

ATC-kód:

J01CA04

INN (nemzetközi neve):

AMOXICILLIN

Adagolás:

250MG

Gyógyszerészeti forma:

POWDER FOR SUSPENSION

Összetétel:

AMOXICILLIN (AMOXICILLIN TRIHYDRATE) 250MG

Az alkalmazás módja:

ORAL

db csomag:

15G/50G

Recept típusa:

Prescription

Terápiás terület:

AMINOPENICILLINS

Termék összefoglaló:

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

Engedélyezési státusz:

APPROVED

Engedély dátuma:

2019-10-24

Termékjellemzők

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
.......................................