CEFTRIAXONE SODIUM FOR INJECTION BP POWDER FOR SOLUTION

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

CEFTRIAXONE (CEFTRIAXONE SODIUM)

Tersedia dari:

SANDOZ CANADA INCORPORATED

Kode ATC:

J01DD04

INN (Nama Internasional):

CEFTRIAXONE

Dosis:

2G

Bentuk farmasi:

POWDER FOR SOLUTION

Komposisi:

CEFTRIAXONE (CEFTRIAXONE SODIUM) 2G

Rute administrasi :

INTRAMUSCULAR

Unit dalam paket:

5.6ML/8ML(IM)-20.5ML(IV)

Jenis Resep:

Prescription

Area terapi:

THIRD GENERATION CEPHALOSPORINS

Ringkasan produk:

Active ingredient group (AIG) number: 0117292006; AHFS:

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2018-03-15

Karakteristik produk

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
.....................................................................................