Hospira Ceftriaxone Sodium Powder for Injection

Pajjiż: Awstralja

Lingwa: Ingliż

Sors: Department of Health (Therapeutic Goods Administration)

Ixtrih issa

Ingredjent attiv:

Ceftriaxone sodium

Disponibbli minn:

Hospira Pty Limited

Klassi:

Medicine Registered

Karatteristiċi tal-prodott

                                Product Information - Australia 
 
Version 1.0 
Page 1 of 11
 
HOSPIRA™ CEFTRIAXONE SODIUM POWDER FOR INJECTION 
 
 
NAME OF THE MEDICINE  
Ceftriaxone sodium  
 
N
S
NH
2
O
N
H
N
OMe
N
S
COONa
S
N
N
N
O
ONa
Me
H
H
O
3.5 H
2
O
 
 
 
 
 
DESCRIPTION  
Hospira™ Ceftriaxone Sodium Powder for Injection is a sterile,
semisynthetic, broad spectrum 
cephalosporin antibiotic for intravenous or intramuscular
administration.  
 
Ceftriaxone sodium is
Disodium (6R,7R)-7-[[(2Z)-(2-aminothiazol-4-yl)(methoxyimino)acetyl]amino]-3-
[[(2-methyl-6-oxido-5-oxo-2,5-dihydro-1,2,4-triazin-3-yl)sulphanyl]methyl]-8-oxo-5-thia-1-
azabicyclo[4.2.0]oct-2-ene-2-carboxylate 3.5 hydrate. 
. 
 
The chemical formula of ceftriaxone sodium is C
18
H
16
N
8
Na
2
O
7
S
3
  3
½H
2
O.  It has a calculated molecular 
weight of 661.59 (CAS registry number: 104376-79-6).   
 
Ceftriaxone sodium is a white or yellowish crystalline powder which
is very soluble in water, sparingly 
soluble in methanol and very slightly soluble in ethanol.  The pH
of a 5% aqueous solution is 
approximately 6 to 8.  Ceftriaxone sodium solutions may be
light yellow to amber coloured in colour.  
 
Hospira™ Ceftriaxone Sodium Powder for Injection contains
approximately 83 mg (3.6 mEq) of sodium 
per gram of ceftriaxone activity.  
 
 
PHARMACOLOGY
  
 
PHARMACOKINETICS 
Ceftriaxone is absorbed poorly from the gastrointestinal tract.
 Average plasma concentrations of 
ceftriaxone following a single 30 minute intravenous (IV) infusion of
a 0.5, 1 or 2 g dose and intramuscular 
(IM) administration of a single 0.5 or 1 g dose in healthy subjects
are presented in Table 1.  
 
 
 
 
 
 
 
 
Product Information - Australia 
 
Version 1.0 
Page 2 of 11
 
 
 TABLE 1 
 AVERAGE CEFTRIAXONE PLASMA CONCENTRATIONS AFTER SINGLE DOSE
ADMINISTRATION. 
 
DOSE/ 
ROUTE 
AVERAGE PLASMA CONCENTRATIONS (MICROGRAMS/ML) 
(TIME FORM END OF ADMINISTRATION) 
0.5 hour 
1 hour 
2 hour
                                
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