JAMP-AMOXICILLIN CAPSULE

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

AMOXICILLIN (AMOXICILLIN TRIHYDRATE)

Dostupné s:

JAMP PHARMA CORPORATION

ATC kód:

J01CA04

INN (Mezinárodní Name):

AMOXICILLIN

Dávkování:

250MG

Léková forma:

CAPSULE

Složení:

AMOXICILLIN (AMOXICILLIN TRIHYDRATE) 250MG

Podání:

ORAL

Jednotky v balení:

20/100/1000

Druh předpisu:

Prescription

Terapeutické oblasti:

AMINOPENICILLINS

Přehled produktů:

Active ingredient group (AIG) number: 0131314001; AHFS:

Stav Autorizace:

APPROVED

Datum autorizace:

2014-10-23

Charakteristika produktu

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
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4
1.2
Geriatrics
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4
2
CONTRAINDICATIONS
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4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
................................................................ 5
4
DOSAGE AND ADMINISTRATION
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5
4.1
Dosing Considerations
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5
4.2
Recommended Dose and Dosage Adjustment Usual Dosage
……………………………….…. 7
4.3
Reconstitution
...................................................................................................