CEFAZOLIN SODIUM FOR INJECTION BP POWDER FOR SOLUTION

국가: 캐나다

언어: 영어

출처: Health Canada

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Download 제품 특성 요약 (SPC)
14-09-2022

유효 성분:

CEFAZOLIN (CEFAZOLIN SODIUM)

제공처:

STERIMAX INC

ATC 코드:

J01DB04

INN (국제 이름):

CEFAZOLIN

복용량:

1G

약제 형태:

POWDER FOR SOLUTION

구성:

CEFAZOLIN (CEFAZOLIN SODIUM) 1G

관리 경로:

INTRAMUSCULAR

패키지 단위:

15G/50G

처방전 유형:

Prescription

치료 영역:

FIRST GENERATION CEPHALOSPORINS

제품 요약:

Active ingredient group (AIG) number: 0109442005; AHFS:

승인 상태:

APPROVED

승인 날짜:

2022-02-11

제품 특성 요약

                                PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
CEFAZOLIN SODIUM FOR INJECTION BP
Powder for Solution, 1 gram, 2 grams and 10 grams Cefazolin (as
cefazolin sodium) per vial
Intravenous, Intramuscular
BP
Antibiotic
SteriMax Inc.
Date of Initial Authorization: JUN 24, 2020
2770 Portland Drive
Oakville, ON
Date of Revision: SEP 14, 2022
L6H 6R4
Control No: 263261
Pr
CEFAZOLIN SODIUM FOR INJECTION BP Page 2 of 21
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, SKIN
01/2021
7 WARNINGS AND PRECAUTIONS, RENAL
09/2022
TABLE OF CONTENTS
Sections or subsections that are not applicable at the time of
authorization are not listed.
RECENT MAJOR LABEL CHANGES
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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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5
1.2
Geriatrics
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5
2
CONTRAINDICATIONS
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5
4
DOSAGE AND ADMINISTRATION
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5
4.2
Recommended Dose and Dosage Adjustment
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4.3
Reconstitution
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7
4.4
Administration
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