CEFTRIAXONE SODIUM FOR INJECTION BP POWDER FOR SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

CEFTRIAXONE (CEFTRIAXONE SODIUM)

Available from:

STERIMAX INC

ATC code:

J01DD04

INN (International Name):

CEFTRIAXONE

Dosage:

10G

Pharmaceutical form:

POWDER FOR SOLUTION

Composition:

CEFTRIAXONE (CEFTRIAXONE SODIUM) 10G

Administration route:

INTRAVENOUS

Units in package:

15G/50G

Prescription type:

Prescription

Therapeutic area:

THIRD GENERATION CEPHALOSPORINS

Product summary:

Active ingredient group (AIG) number: 0117292008; AHFS:

Authorization status:

APPROVED

Authorization date:

2010-11-10

Summary of Product characteristics

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
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4 DOSAGE AND ADMINISTRATION, 4.3 RECONSTITUTION
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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
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TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL
INFORMATION...............................................................
4
1
INDICATIONS..............................................................................................................
4
1.1
Pediatrics
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5
1.2
Geriatrics............................................................................................................
5
2
CONTRAINDICATIONS
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5
4
DOSAGE AND ADMINISTRATION
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