Zetagal Powder for solution for injection 750MG/vialv

Country: Malta

Lingwa: Ingliż

Sors: Medicines Authority

Ingredjent attiv:

CEFUROXIME

Disponibbli minn:

Elpen Pharmaceutical Co. Inc. 95 Marathonos Ave., 190 09 Pikermi, Attica, Greece

Kodiċi ATC:

J01DC02

INN (Isem Internazzjonali):

CEFUROXIME 750 mg

Għamla farmaċewtika:

POWDER FOR SOLUTION FOR INJECTION

Kompożizzjoni:

CEFUROXIME 750 mg

Tip ta 'preskrizzjoni:

POM

Żona terapewtika:

ANTIBACTERIALS FOR SYSTEMIC USE

L-istatus ta 'awtorizzazzjoni:

Withdrawn

Data ta 'l-awtorizzazzjoni:

2006-11-14

Fuljett ta 'informazzjoni

 
1
        PACKAGE INSERT LEAFLET 
ZETAGAL
®

Cefuroxime – Second generation cephalosporin 

1. CHARACTERISTICS OF THE PHARMACEUTICAL PRODUCT 

1.1 NAME   
ZETAGAL
®

1.2 COMPOSITION 
ACTIVE INGREDIENT: Cefuroxime Sodium. 
EXCIPIENTS: Not applicable. 

1.3 PHARMACEUTICAL 
FORM  
Powder for solution for injection. 

1.4  CONTENT IN ACTIVE INGREDIENT  
ZETAGAL® pd. inj. sol. 250 mg/vial: 
Cefuroxime Sodium equivalent to 250 mg of Cefuroxime base. 
ZETAGAL® pd. inj. sol. 750 mg/vial: 
Cefuroxime Sodium equivalent to 750 mg of Cefuroxime base. 
ZETAGAL® pd. inj. sol. 1500 mg/vial: 
Cefuroxime Sodium equivalent to 1500 mg of Cefuroxime base. 

1.5  DESCRIPTION- PACKAGE  
Each carton contains one vial with powder for solution for
injection. 

1.6. PHARMACOTHERAPEUTIC CLASS 
Antibiotic (Cephalosporin).  

1.7 LICENCE 
HOLDER  
ELPEN PHARMACEUTICAL Co., Inc.  
95, Marathonos Ave., Pikermi, Attika 19009, Greece 
Tel: [phone]   Fax: [phone] 

1.8 MANUFACTURER  
ELPEN PHARMACEUTICAL Co., Inc.  
95, Marathonos Ave., Pikermi, Attika 19009, Greece 
Tel: [phone]   Fax: [phone] 

2. INFORMATION YOU SHOULD KNOW ABOUT THE MEDICINE THAT 
YOUR DOCTOR PRESCRIBED FOR YOU 

2.1 GENERAL 
INFORMATION 
ZETAGAL®  is a second generation semi-synthetic cephalosporin
antibiotic. It presents 
bactericidal activity against a broad range of common
pathogens, including beta-
lactamase producing strains, and therefore it is effective
against a range of strains 
resistant to ampicillin and amoxycillin. Its bactericidal
activity is based on the inhibition of 
the bacterial cell wall synthesis, by binding its basic proteins. 

2.2 INDICATIONS 
ZETAGAL®  is indicated in the treatment of infections
caused by susceptible strains as 
follows: 
i. 
Infections (not meningitis) caused by haemophilus influenza resistant
to ampicillin. 
ii. 
Gonococcal infections due to gonococcus resista

Karatteristiċi tal-prodott

Page 1 of 7 
SUMMARY OF PRODUCT CHARACTERISTICS 

1.  TRADE NAME OF THE MEDICINAL PRODUCT 

ZETAGAL
®   
Powder for solution for injection  750MG/vialv 

2.  QUALITATIVE AND QUANTITATIVE COMPOSITION  

2.1 ACTIVE 
INGREDIENT 

Cefuroxime Sodium- Second generation cephalosporin 

2.2    DESCRIPTION- PACKAGE  
Each carton contains one vial with powder for solution for
injection: 
ZETAGAL® pd. inj. sol. 750 mg/vial: 
Cefuroxime Sodium equivalent to 750 mg of Cefuroxime base. 

3.  PHARMACEUTICAL FORM 

Sterile Powder for solution for injection 
. 
4.  CLINICAL PARTICULARS 

 PHARMACOTHERAPEUTIC CLASS 
 Antibiotic (Cephalosporin). 

4.1. 
 THERAPEUTIC INDICATIONS 

GENERAL INFORMATION 
ZETAGAL®  is a second generation
semi-synthetic cephalosporin antibiotic. It presents bactericidal 
activity against a broad range of common pathogens,
including beta-lactamase producing strains, 
and therefore it is effective against a range of strains
resistant to ampicillin and amoxycillin. Its 
bactericidal activity is based on the inhibition of the bacterial
cell wall synthesis, by binding its 
basic proteins. 

INDICATIONS 
ZETAGAL® is indicated in the treatment of infections
caused by susceptible strains as follows: 
i. 
Infections (not meningitis) caused by haemophilus influenza resistant
to ampicillin. 
ii.  Gonococcal infections due to gonococcus resistant to
penicillin. 
iii.  Nosocomial infections due to strains resistant to 1st
generation cephalosporins.  
(i.e. coccobacter sp, klebsiella sp, proteus sp, enterobacter
sp, providencia sp and 
citrobacter sp.) 

ZETAGAL® IS INDICATED IN: 

1.  RESPIRATORY TRACT INFECTIONS such as acute and
chronic bronchitis, inflamed bronchectasis, 
bacterial pneumonia, pulmonary
apostema and postoperative pulmonary infections_._ 
2.  EAR, NOSE AND THROAT INFECTIONS such
as sinusitis, tonsillitis, pharyngitis