CEFTRIAXONE SODIUM FOR INJECTION BP POWDER FOR SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

CEFTRIAXONE (CEFTRIAXONE SODIUM)

Available from:

PFIZER CANADA ULC

ATC code:

J01DD04

INN (International Name):

CEFTRIAXONE

Dosage:

250MG

Pharmaceutical form:

POWDER FOR SOLUTION

Composition:

CEFTRIAXONE (CEFTRIAXONE SODIUM) 250MG

Administration route:

INTRAMUSCULAR

Units in package:

10X10ML VIAL

Prescription type:

Prescription

Therapeutic area:

THIRD GENERATION CEPHALOSPORINS

Product summary:

Active ingredient group (AIG) number: 0117292001; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2023-07-17

Summary of Product characteristics

_Product Monograph - _
_Pr_
_Ceftriaxone Sodium for Injection BP _
_Page 1 of 63 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
CEFTRIAXONE SODIUM FOR INJECTION BP
Sterile Powder for Solution, 250 mg, 500 mg, and 1 g ceftriaxone (as
ceftriaxone sodium) per vial,
Pharmacy Bulk Vials 10 g ceftriaxone (as ceftriaxone sodium) per vial
Intravenous or Intramuscular
BP
Antibiotic
Pfizer Canada ULC
17300 Trans-Canada Highway
Kirkland, Québec
H9J 2M5
Date of Initial Authorization:
September 20, 2006
Date of Revision:
March 09, 2022
Submission Control Number: 256934
_Product Monograph - _
_Pr_
_Ceftriaxone Sodium for Injection BP _
_Page 2 of 63 _
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, General, Severe Cutaneous
Adverse Reactions
03/2022
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
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
1
INDICATIONS................................................................................................................
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
4.1
Dosing Considerations
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5
4.2
Recommended Dose and Dosage Adjustment
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