Cezidin 1g/vial

Riik: Malta

keel: inglise

Allikas: Medicines Authority

Toimeaine:

CEFTAZIDIME

Saadav alates:

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

ATC kood:

J01DD02

INN (Rahvusvaheline Nimetus):

CEFTAZIDIME 1 g

Ravimvorm:

POWDER FOR SOLUTION FOR INJECTION

Koostis:

CEFTAZIDIME 1 g

Retsepti tüüp:

POM

Terapeutiline ala:

ANTIBACTERIALS FOR SYSTEMIC USE

Volitamisolek:

Withdrawn

Loa andmise kuupäev:

2007-04-05

Infovoldik

CEZIDIN 1G 
CEFTAZIDIME PENTAHYDRATE 

  1. DESCRIPTION OF THE MEDICINAL PRODUCT 
1.1 NAME: 
Cezidin 
1.2 COMPOSITION: DRUG SUBSTANCE: 
Ceftazidime pentahydrate  
      EXCIPIENTS: 
Sodium Carbonate  
1.3 PHARMACEUTICAL FORM: 
Powder for solution for Injection 
1.4 CONTENT IN DRUG SUBSTANCE:
 1g/vial Ceftazidime 
1.5 DESCRIPTION-PACKAGE: 
Cezidin is a white to off-white powder supplied in glass vials and
packed in carton boxes.  
1.6 PHARMACOTHERAPEUTIC CATEGORY: 
β-lactam antibiotic 
1.7 MARKETING AUTHORIZATION HOLDER-MANUFACTURER: 
DEMO S.A., Pharmaceutical Industry, 21
st
 Km National Road Athens-Lamia, 145 68 Athens, Greece. 
  2. WHAT SHOULD YOU KNOW FOR THE
MEDICINE YOUR DOCTOR PRESCRIBED  
2.1 GENERAL INFORMATION:
 Ceftazidime is a β-lactamic
semisynthetic, wide spectrum antibiotic (3rd generation
cephalosporin) for parenteral use. In vitro studies have 
proved that Ceftazidime has bactericidal activity, as it inhibits the
enzymes responsible for the biosynthesis of the
cell wall. Ceftazidime is active in vitro against a wide 
spectrum of Gram-negative microorganisms,
including strains resistant
to gentamycin and other aminoglucosides. Ceftazidime
has proved to be active against Gram-
positive microorganisms, as well. Ceftazidime remains unaffected
by most clinically essential 
β-lactamases, plasmidic or chromosomal, that are
produced by Gram-
positive or Gram-negative microorganisms and it is therefore
active against many strains that are
resistant to ampicillin and other cephalosporins.
Ceftazidime has 
proven to be active against the following microorganisms, _in
vitro _as well as in clinical infections:  
GRAM NEGATIVE: 
Pseudomonas spp (including _Pseudomonas aeruginosa_), Klebsiella spp
(including _Klebsiella pneumoniae_),  _Proteus
mirabilis_,  _Proteus vulgaris_, 
_Escherichia Coli_
,  _Enterobacter spp_ (including _Enterobacter
cloacae_ and _Enterobacter aer

Toote omadused

SUMMARY OF PRODUCT CHARACTERISTICS 

1.  NAME OF THE MEDICINAL PRODUCT 
CEZIDIN 1g/vial 

2.  QUALITATIVE & QUANTITATIVE COMPOSITION 
 Each vial contains Ceftazidime for injection equivalent to 1g of
Ceftazidime_. _

3.  PHARMACEUTICAL FORM  
Powder for Solution for Injection. 

4.  CLINICAL PARTICULARS 
4.1 THERAPEUTIC 
INDICATIONS 
Ceftazidime is indicated for treatment of infections caused by
strains resistant to cephalosporins of 
1st and 2nd generation, as well as aminoglucosides. 

 ●  Severe infections, such as: septicaemia, bacillemia,
peritonitis, meninghitis, infections in 
immunosuppressed patients and infections in patients in
intenive care, such as infected burns.  
●   Infections of respiratory, including pulmonal infections in
patients with cystic fibrosis.  
●   Oto-rhinal-laryngological infections.  
●   Urinary tract infections.  
●   Infections of skin and soft tissues.  
●   Gastrointestinal infections, billiary infections and
abdominal infections.  
●   Infections of bones and joints.  
●  Infections associated with haemodialysis, peritoneal dialysis
and continuous ambulatory 
peritoneal dialysis (CAPD).  

Suitable tests should be performed in order to identify the pathogens
that cause the infection and 
verify their sensitivity to Ceftazidime. However, treatment
with Ceftazidime may initiate before 
verification of the sensitivity of the pathogens and then treatment
can be adjusted with reference to 
the test results. Ceftazidime may be used as monotherapy in cases of
diagnosed or protential 
septicaemia. Ceftazidime may also be administered in combination
with other antibiotics such as 
aminoglycosides, vancomycin, clindamycin, for the treatment of severe
and life-threatening 
infections, as well as to immunosuppressed patients. When such a
combined treatment is required, 
administration instructions of other antibiotics must be followed.
Dosage depends on  severity of  
in