AURO-AMOXICILLIN CAPSULE

국가: 캐나다

언어: 영어

출처: Health Canada

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Download 제품 특성 요약 (SPC)
02-11-2023

유효 성분:

AMOXICILLIN (AMOXICILLIN TRIHYDRATE)

제공처:

AURO PHARMA INC

ATC 코드:

J01CA04

INN (International Name):

AMOXICILLIN

복용량:

500MG

약제 형태:

CAPSULE

구성:

AMOXICILLIN (AMOXICILLIN TRIHYDRATE) 500MG

관리 경로:

ORAL

패키지 단위:

30/100/500

처방전 유형:

Prescription

치료 영역:

AMINOPENICILLINS

제품 요약:

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

승인 상태:

APPROVED

승인 날짜:

2012-06-27

제품 특성 요약

                                Auro-Amoxicillin Product Monograph
Page 1 of 28
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
Auro-Amoxicillin
Amoxicillin Capsules
Capsules, 250 mg and 500 mg amoxicillin (as amoxicillin trihydrate),
Oral
BP
Antibiotic
AURO PHARMA INC.
3700 Steeles Avenue West, Suite #
402 Woodbridge, Ontario, L4L 8K8
Canada
Date of Initial Authorization:
JUN 27, 2012
Date of Revision:
NOV 02, 2023
Submission Control Number: 276668
Auro-Amoxicillin Product Monograph
Page 2 of 28
RECENT MAJOR LABEL CHANGES
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
10/2023
7 WARNINGS AND PRECAUTIONS
10/2023
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 Usual Dosage
............................................... 5
4.4 Administration
.......................................................................................................................
7
4.5 Missed Dose
..........................................................................................................................
7
5 OVERDOSAGE
....
                                
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