Veracol 500mg IM, Powder & solvent for solution for injection

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CEFTRIAXONE

Available from:

DEMO S.A. Pharmaceutical Industry 21st km National Road Athens - Lamia 14568 Krioneri, Greece

ATC code:

J01DD04

INN (International Name):

CEFTRIAXONE 500 mg

Pharmaceutical form:

POWDER AND SOLVENT FOR SOLUTION FOR INJECTION

Composition:

CEFTRIAXONE 500 mg

Prescription type:

POM

Therapeutic area:

ANTIBACTERIALS FOR SYSTEMIC USE

Authorization status:

Withdrawn

Authorization date:

2007-08-02

Patient Information leaflet

VERACOL

CEFTRIAXONE INJECTION 

COMPOSITION: 
Active ingredient:

Ceftriaxone Sodium Trisesquihydrate, Excipients: None 

PHARMACOTECHNICAL FORM:

Powder for Solution for injection 

CONTENT IN ACTIVE INGREDIENT:
 Each vial of VERACOL 1g (IV or IM) contains Ceftriaxone sodium
trisesquihydrate equivalent to 1000 
mg of Ceftriaxone. Each vial of VERACOL 500mg IM contains
Ceftriaxone sodium trisequihydrate equivalent to 500 mg of
Ceftriaxone. 
Each vial of VERACOL 250mg IM contains Ceftriaxone sodium
trisesquihydrate equivalent to 250 mg of Ceftriaxone. 

DESCRIPTION-PACKAGING: 
VERACOL is packed in glass vials and in carton boxes with 1 solvent
ampoule. 
VERACOL 1g IV                  1 vial + 1 ampoule of 10ml
solvent (water for injections) 
VERACOL 1g IM                 1 vial + 1 ampoule of 3.5ml
solvent (lidocaine hydrochloride 1%) 
VERACOL 500 mg IM         1 vial + 1 ampoule of 2ml solvent
(lidocaine hydrochloride 1%) 
VERACOL 250 mg IM         1 vial + 1 ampoule of 2ml solvent
(lidocaine hydrochloride 1%) 

PHARMACOTHERAPEUTIC CLASS: 
Antimicrobial chemotherapeutic agent. 

GENERAL INFORMATION:
 _Microbiology:_ Ceftriaxone is a long acting, wide spectrum
antibiotic for parenteral use, which belongs to the third 
generation of cephalosporines. Antibacterial action of
Ceftriaxone is a result of its ability to inhibit the bacterial
cell wall synthesis. _In _
_vitro_, Ceftriaxone acts against a wide spectrum of Gram-negative
and Gram-positive microorganisms. Ceftriaxone is very stable in
the 
presence of β-lactamases, penicillinases and cephalosporinases and
both gram-positive and gram negative bacteria. Ceftriaxone is 
usually active against the following microbes _in vitro_ and in
clinical infections (See Clinical Indications) 
_Gram-positive anaerobes:_ _Staphylococcus aureus_ (sensitive to
methycillin), _Staphylococci coagulase-negative_, _Streptococcus
pyogenes_ 
(β-haemolytic, gro

Summary of Product characteristics

Page 1 of 10 
SUMMARY OF PRODUCT CHARACTERISTICS 

1. 
NAME OF THE MEDICINAL PRODUCT 
VERACOL 1g IV, Powder & solvent for solution for injection 
VERACOL 1g IM, Powder & solvent for solution for injection 
VERACOL 500mg IM, Powder & solvent for solution for injection 
2. 
QUALITATIVE & QUANTITATIVE COMPOSITION 
2.1  COMPOSITION OF VERACOL 1G IV OR IM 
_COMPOSITION PER VIAL _

_Active ingredients: _
_Quantities: _
Ceftriaxone sodium trisesquihydrate 1193.00 
mg 
equivalent to Ceftriaxone 
1000.00 mg 
_Excipients:  _
None  

2.2  COMPOSITION OF VERACOL 500MG IM 
_Active ingredients: _
_Quantities: _
Ceftriaxone sodium trisesquihydrate 596.50 
mg 
equivalent to Ceftriaxone 
500.00 mg 
_Excipients:  _
None  

3. 
PHARMACEUTICAL FORM 
Powder and solvent for solution for injection. 

4. 
CLINICAL PARTICULARS 
4.1  THERAPEUTIC INDICATIONS 
Ceftriaxone is indicated for the treatment of the following
infections when caused by susceptible 
to Ceftriaxone organisms: 
-  Septicaemia  
-  Meningitis  
-  LYME disease: proved cases of serious assault of the CNS, heart
and joints 
-  Abdominal infections (peritonitis, biliary infections and
infections of the gastrointestinal tube) 
-  Infection of the bones, the joints, the soft molecules of the
skin and of wounds 
Page 2 of 10 
-  Infections in patients with a reduced response from the immune
system (immunosuppressed) in 
combination with other groups of antibiotics such as aminoglycosides 
-  Infections of the kidneys and the urinary ducts 
-  Infections of the respiratory tract, especially the lungs, as
well as Ear-Nose and Throat (ENT) 
infections 
-  Infections of the genitalia including gonorrhea 
-  Preoperative protection, in case that strain resistance to first
and second generation 
cephalosporins have been proved by clinical tests. 

4.2  POSOLOGY AND METHOD OF ADMINISTRATION 
USUAL DOSAGE:  
_Adults and children over 12 years old:_ The customary