APO-CEFUROXIME TABLET

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

CEFUROXIME (CEFUROXIME AXETIL)

제공처:

APOTEX INC

ATC 코드:

J01DC02

INN (국제 이름):

CEFUROXIME

복용량:

250MG

약제 형태:

TABLET

구성:

CEFUROXIME (CEFUROXIME AXETIL) 250MG

관리 경로:

ORAL

패키지 단위:

100

처방전 유형:

Prescription

치료 영역:

SECOND GENERATION CEPHALOSPORINS

제품 요약:

Active ingredient group (AIG) number: 0122448001; AHFS:

승인 상태:

APPROVED

승인 날짜:

2001-08-24

제품 특성 요약

_APO-CEFUROXIME (Cefuroxime axetil tablets) _
_Page 1 of 33_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-CEFUROXIME
Cefuroxime Axetil Tablets, USP
Tablets, 250 mg and 500 mg, Oral
ANTIBIOTIC
APOTEX INC
150 Signet Drive
Toronto, Ontario
M9L 1T9
Date of Initial Authorization:
AUG 29, 2001
Date of Revision:
MAY 11, 2023
Submission Control Number: 270017
_APO-CEFUROXIME (Cefuroxime axetil tablets) _
_Page 2 of 33_
RECENT MAJOR LABEL CHANGES
3 Serious Warnings and Precautions Box
05/2023
4 Dosage and Administration, 4.1 Dosing Considerations
05/2023
7 Warnings and Precautions, 7.1.4 Geriatrics
05/2023
7 Warnings and Precautions, Neurologic
05/2023
7 Warnings and Precautions, Renal
05/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
.............................................................................................
2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
1
INDICATIONS
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4
1.1 Pediatrics
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4
1.2 Geriatrics
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4
2
CONTRAINDICATIONS
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5
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
.............................................................. 5
4
DOSAGE AND ADMINISTRATION
..................................................................................
5
4.1 Dosing Considerations
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