JAMP-AMOXICILLIN CAPSULE

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

AMOXICILLIN (AMOXICILLIN TRIHYDRATE)

제공처:

JAMP PHARMA CORPORATION

ATC 코드:

J01CA04

INN (국제 이름):

AMOXICILLIN

복용량:

500MG

약제 형태:

CAPSULE

구성:

AMOXICILLIN (AMOXICILLIN TRIHYDRATE) 500MG

관리 경로:

ORAL

패키지 단위:

10/100/500

처방전 유형:

Prescription

치료 영역:

AMINOPENICILLINS

제품 요약:

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

승인 상태:

APPROVED

승인 날짜:

2014-10-23

제품 특성 요약

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