CEFAZOLIN FOR INJECTION USP POWDER FOR SOLUTION

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

CEFAZOLIN (CEFAZOLIN SODIUM)

제공처:

SANDOZ CANADA INCORPORATED

ATC 코드:

J01DB04

INN (International Name):

CEFAZOLIN

복용량:

500MG

약제 형태:

POWDER FOR SOLUTION

구성:

CEFAZOLIN (CEFAZOLIN SODIUM) 500MG

관리 경로:

INTRAMUSCULAR

패키지 단위:

10X500MG

처방전 유형:

Prescription

치료 영역:

FIRST GENERATION CEPHALOSPORINS

제품 요약:

Active ingredient group (AIG) number: 0109442002; AHFS:

승인 상태:

APPROVED

승인 날짜:

2008-04-18

제품 특성 요약

_Cefazolin for Injection USP _
_Page 1 of 23_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR CEFAZOLIN FOR INJECTION USP
Cefazolin for Injection
Powder for Injection, 500 mg, 1 g & 10 g cefazolin (as cefazolin
sodium) per vial, Intravenous,
Intramuscular
USP
Antibiotic
Sandoz Canada Inc.
110 rue de Lauzon
Boucherville, Quebec
J4B 1E6
Date of Initial Authorization:
April 18, 2008
Date of Revision:
September 7, 2022
Submission Control Number: 263209
_Cefazolin for Injection USP _
_Page 2 of 23_
RECENT MAJOR LABEL CHANGES
7 Warnings and Precautions, Skin
11/2020
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
.................................................................................................
2
TABLE OF CONTENTS
...................................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
...........................................................................
3
1
INDICATIONS
.......................................................................................................................
4
1.1 PEDIATRICS
...................................................................................................................
5
1.2 GERIATRICS
....................................................................................................................
5
2
CONTRAINDICATIONS
..........................................................................................................
5
4 DOSAGE AND ADMINISTRATION
..........................................................................................
5
4.2 RECOMMENDED DOSE AND DOSAGE ADJUSTMENT
............................................................. 5
4.3 RECONSTITUTIONS
..........................................................................................................
8
4.4 ADMINISTRATION
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