CEFTRIAXONE SODIUM FOR INJECTION BP POWDER FOR SOLUTION

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

CEFTRIAXONE (CEFTRIAXONE SODIUM)

Dostupno od:

SANDOZ CANADA INCORPORATED

ATC koda:

J01DD04

INN (International ime):

CEFTRIAXONE

Doziranje:

250MG

Farmaceutski oblik:

POWDER FOR SOLUTION

Sastav:

CEFTRIAXONE (CEFTRIAXONE SODIUM) 250MG

Administracija rute:

INTRAMUSCULAR

Jedinice u paketu:

1ML(IM)-2.5ML(IV)

Tip recepta:

Prescription

Područje terapije:

THIRD GENERATION CEPHALOSPORINS

Proizvod sažetak:

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

Status autorizacije:

APPROVED

Datum autorizacije:

2018-03-15

Svojstava lijeka

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR CEFTRIAXONE SODIUM FOR INJECTION BP
Sterile Powder for Solution, 250 mg, 1 g, 2 g and 10 g ceftriaxone per
vial
Intravenous or Intramuscular
BP
Antibiotic
Sandoz Canada Inc.
110 Rue de Lauzon
Boucherville, (Québec), Canada
J4B 1K6
Date of Initial Authorization:
August 17, 2006
Date of Revision:
January 6, 2022
Submission Control Number: 255080
Ceftriaxone Sodium for Injection BP
Page 2 of 58
RECENT MAJOR LABEL CHANGES
7 Warnings and Precautions
01/2022
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
TABLE OF CONTENTS
.................................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
............................................................................
4
1
INDICATIONS.....................................................................................................................
4
1.1
P
EDIATRICS
.........................................................................................................................
5
1.2
G
ERIATRICS
.........................................................................................................................
5
2
CONTRAINDICATIONS
........................................................................................................
5
4
DOSAGE AND
ADMINISTRATION..........................................................................................
5
4.1
D
OSING
C
ONSIDERATI ONS
.......................................................................................................
5
4.2
R
ECOMMENDED
D
OSE AND
D
OSAGE
A
DJUSTMENT
...........................................................................
6
4.3
R
ECONSTI TUTI ON
..................................................................................................................
7
4.4
A
DMINISTRATION
.....................................................................................