CEFAZOLIN FOR INJECTION POWDER FOR SOLUTION

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

şimdi satın al

Indir Ürün özellikleri (SPC)
21-06-2023

Aktif bileşen:

CEFAZOLIN (CEFAZOLIN SODIUM)

Mevcut itibaren:

HIKMA CANADA LIMITED

ATC kodu:

J01DB04

INN (International Adı):

CEFAZOLIN

Doz:

500MG

Farmasötik formu:

POWDER FOR SOLUTION

Kompozisyon:

CEFAZOLIN (CEFAZOLIN SODIUM) 500MG

Uygulama yolu:

INTRAMUSCULAR

Paketteki üniteler:

15G/50G

Reçete türü:

Prescription

Terapötik alanı:

FIRST GENERATION CEPHALOSPORINS

Ürün özeti:

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

Yetkilendirme durumu:

APPROVED

Yetkilendirme tarihi:

2015-02-04

Ürün özellikleri

                                PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
CEFAZOLIN FOR INJECTION
Powder for Solution, 500 mg, 1 gram and 10 grams cefazolin (as
cefazolin sodium) per vial,
Intravenous, Intramuscular
Manufacturer’s Standard
Antibiotic
Hikma Canada Limited
5995 Avebury Road, Suite 804
Mississauga, Ontario
L5R 3P9
Date of Initial Authorization:
JUN 21, 2023
Submission Control Number: 276118
Page 2 of 23
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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8
4.4
Administration
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9
5
OVERDOSAGE......................................................
                                
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