CEFTRIAXONE SODIUM FOR INJECTION BP POWDER FOR SOLUTION

País: Canadá

Língua: inglês

Origem: Health Canada

Ingredientes ativos:

CEFTRIAXONE (CEFTRIAXONE SODIUM)

Disponível em:

PFIZER CANADA ULC

Código ATC:

J01DD04

DCI (Denominação Comum Internacional):

CEFTRIAXONE

Dosagem:

250MG

Forma farmacêutica:

POWDER FOR SOLUTION

Composição:

CEFTRIAXONE (CEFTRIAXONE SODIUM) 250MG

Via de administração:

INTRAMUSCULAR

Unidades em pacote:

10X10ML VIAL

Tipo de prescrição:

Prescription

Área terapêutica:

THIRD GENERATION CEPHALOSPORINS

Resumo do produto:

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

Status de autorização:

CANCELLED POST MARKET

Data de autorização:

2023-07-17

Características técnicas

_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
...............................................................................................................
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
..................................................................................
5
4.1
Dosing Considerations
.........................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
......................