CEFTRIAXONE SODIUM FOR INJECTION BP POWDER FOR SOLUTION

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

CEFTRIAXONE (CEFTRIAXONE SODIUM)

Mevcut itibaren:

STERIMAX INC

ATC kodu:

J01DD04

INN (International Adı):

CEFTRIAXONE

Doz:

1G

Farmasötik formu:

POWDER FOR SOLUTION

Kompozisyon:

CEFTRIAXONE (CEFTRIAXONE SODIUM) 1G

Uygulama yolu:

INTRAMUSCULAR

Paketteki üniteler:

10X1G

Reçete türü:

Prescription

Terapötik alanı:

THIRD GENERATION CEPHALOSPORINS

Ürün özeti:

Active ingredient group (AIG) number: 0117292007; AHFS:

Yetkilendirme durumu:

APPROVED

Yetkilendirme tarihi:

2010-11-10

Ürün özellikleri

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
CEFTRIAXONE SODIUM FOR INJECTION BP
Sterile Powder for Solution, 250 mg, 500 mg, 1 g, 2 g and 10 g
ceftriaxone (as ceftriaxone
sodium) per vial,
Intravenous or Intramuscular
BP
Antibiotic
SteriMax Inc.
2770 Portland Drive,
Oakville, ON
L6H 6R4
Control No. 259108
Date of Initial Authorization:
November 19, 2010
Date of Revision:
July 6, 2022
Page 2 of 55
RECENT MAJOR LABEL CHANGES
1 INDICATIONS, 1.1 PEDIATRICS
12/2021
1 INDICATIONS, 1.2 GERIATRICS
12/2021
4 DOSAGE AND ADMINISTRATION, 4.1 DOSING CONSIDERATIONS
12/2021
4 DOSAGE AND ADMINISTRATION, 4.2 RECOMMENDED DOSE
AND DOSAGE ADJUSTMENT
12/2021
4 DOSAGE AND ADMINISTRATION, 4.3 RECONSTITUTION
12/2021
4 DOSAGE AND ADMINISTRATION, 4.4 ADMINISTRATION
12/2021
7 WARNINGS AND PRECAUTIONS, 7.1.1 PREGNANT WOMEN
12/2021
7 WARNINGS AND PRECAUTIONS, 7.1.2 BREAST-FEEDING
12/2021
7 WARNINGS AND PRECAUTIONS, 7.1.3 PEDIATRICS
12/2021
7 WARNINGS AND PRECAUTIONS, 7.1.4 GERIATRICS
12/2021
TABLE OF CONTENTS
SECTION 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...............................................................
4
1
INDICATIONS..............................................................................................................
4
1.1
Pediatrics
...........................................................................................................
5
1.2
Geriatrics............................................................................................................
5
2
CONTRAINDICATIONS
...............................................................................................
5
4
DOSAGE AND ADMINISTRATION
.........................................................................