JAMP-AMOXICILLIN CAPSULE

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

AMOXICILLIN (AMOXICILLIN TRIHYDRATE)

MAH:

JAMP PHARMA CORPORATION

ATC_code:

J01CA04

INN:

AMOXICILLIN

dosage:

500MG

pharmaceutical_form:

CAPSULE

composition:

AMOXICILLIN (AMOXICILLIN TRIHYDRATE) 500MG

administration_route:

ORAL

units_in_package:

10/100/500

prescription_type:

Prescription

therapeutic_area:

AMINOPENICILLINS

leaflet_short:

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

authorization_status:

APPROVED

authorization_date:

2014-10-23

SPC

JAMP-Amoxicillin Product Monograph Page 1 of 28
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
JAMP-AMOXICILLIN
Amoxicillin Powder for Oral Suspension
Suspension, 250 mg / 5 mL amoxicillin (as amoxicillin trihydrate)
after reconstitution, Oral
House Standard
Antibiotic
JAMP Pharma Corporation
1310 rue Nobel
Boucherville, Quebec
J4B 5H3, Canada
Date of Initial Authorization:
March 10, 2023
Date of Revision:
MAR 15, 2024
Submission Control Number: 279419
JAMP-Amoxicillin Product Monograph Page 2 of 28
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
RECENT MAJOR LABEL CHANGES
……………………………………………………………………………………….
2
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
……………………………….…. 7
4.3
Reconstitution
...................................................................................................