JAMP-AMOXICILLIN POWDER FOR SUSPENSION

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

AMOXICILLIN (AMOXICILLIN TRIHYDRATE)

Pieejams no:

JAMP PHARMA CORPORATION

ATĶ kods:

J01CA04

SNN (starptautisko nepatentēto nosaukumu):

AMOXICILLIN

Deva:

125MG

Zāļu forma:

POWDER FOR SUSPENSION

Kompozīcija:

AMOXICILLIN (AMOXICILLIN TRIHYDRATE) 125MG

Ievadīšanas:

ORAL

Vienības iepakojumā:

15G/50G

Receptes veids:

Prescription

Produktu pārskats:

Active ingredient group (AIG) number: 0131314002; AHFS:

Autorizācija statuss:

APPROVED

Autorizācija datums:

2023-03-02

Produkta apraksts

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