CEFTRIAXONE SODIUM FOR INJECTION BP POWDER FOR SOLUTION

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

CEFTRIAXONE (CEFTRIAXONE SODIUM)

Disponible des:

PFIZER CANADA ULC

Codi ATC:

J01DD04

Designació comuna internacional (DCI):

CEFTRIAXONE

Dosis:

500MG

formulario farmacéutico:

POWDER FOR SOLUTION

Composición:

CEFTRIAXONE (CEFTRIAXONE SODIUM) 500MG

Vía de administración:

INTRAMUSCULAR

Unidades en paquete:

10X10 ML VIALS

tipo de receta:

Prescription

Área terapéutica:

THIRD GENERATION CEPHALOSPORINS

Resumen del producto:

Active ingredient group (AIG) number: 0117292005; AHFS:

Estat d'Autorització:

CANCELLED PRE MARKET

Data d'autorització:

2023-07-17

Fitxa tècnica

_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
......................