Uzix

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

AMIKACIN

Available from:

Rafarm S.A. 12, Korinthou Str., 15451 Neo Psihiko, Athens, Greece

ATC code:

J01GB06

INN (International Name):

AMIKACIN 250 mg/ml

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

AMIKACIN 250 mg/ml

Prescription type:

POM

Therapeutic area:

ANTIBACTERIALS FOR SYSTEMIC USE

Authorization status:

Authorised

Authorization date:

2006-08-09

Patient Information leaflet

UZIX 
AMIKACIN SULFATE 
Injection solution, 500mg/2ml 

 READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.  
• Keep this leaflet. You may need to read it again.  
• If you have any further questions, ask your doctor
or pharmacist.  
• If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet, 
please tell your doctor.  

IN THIS LEAFLET:  
1. What UZIX is and what it is used for  
2. Before you use UZIX  
3. How to use UZIX  
4. Possible side effects  
5. How to store UZIX  
6. Further information  

1. WHAT UZIX IS AND WHAT IT IS USED FOR  
UZIX is one of a group of antibiotic medicines called
‘aminoglycosides’.  
UZIX is used in the treatment of serious infections
caused by bacteria sensitive to amikacin.  

2. BEFORE YOU USE UZIX  

DO NOT USE UZIX  
• if you have shown signs of hypersensitivity (severe allergy)
to amikacin, or any of the other 
ingredients listed in section 6, in the past  
• if you suffer from a disorder called myasthenia gravis
(severe weakness of certain muscles of 
the body)  

Tell your doctor if any of the above applies to you before this
medicine is used.  

TAKE SPECIAL CARE WITH UZIX  
• if you have kidney problems  
• if you have hearing difficulties or tinnitus (ringing or
buzzing in the ears)  
• if you have shown signs of allergy to any of the antibiotics
related to amikacin 
(aminoglycosides) in the past  
• If you have a known allergy to sulphites  

UZIX should be used with caution in premature and neonatal
infants.  
Tell your doctor if any of the above applies to you before this
medicine is used. 

TAKING/USING OTHER MEDICINES  
Special care is needed if you are taking/using other medicines,
as some could interact with 
UZIX for example:  
• diuretics (water tablets) such as
furosemide

Summary of Product characteristics

Page 1 of 7 

1. 
NAME OF THE MEDICINAL PRODUCT 

UZIX 

2. 
QUALITATIVE  AND  QUANTITATIVE  COMPOSITION 

1 ml of solution for injection contains 250 mg of amikacin
(as sulphate). 
  1 vial of 2 ml of solution for injection
contains 500 mg of amikacin (as sulphate). 
 Excipients:  Sodium  metabisulfite, Sodium citrate,  Sulfuric  acid,  Water for injection 

3. 
PHARMACEUTICAL  FORM 

Solution for injection. 

4. 
CLINICAL  PARTICULARS 

4.1 
THERAPEUTIC  INDICATIONS 

UZIX  is  a  semi-synthetic,  aminoglycoside  antibiotic  which  is  active  against  a  broad  spectrum  of 
Gram-negative organisms, including pseudomonas and some
Gram-positive organisms. 

Sensitive  Gram-negative  organisms  include;  Pseudomonas  aeruginosa,  Escherichia  coli.,  indole-
positive and indole-negative Proteus spp., Klebsiella, Enterobacter and Serratia spp., Minea-Herralae, 
Citrobacter freundii, Salmonella, Shigella,
Acinetobacter and Providencia spp. 

Many  strains  of  these  Gram-negative  organisms  resistant  to  gentamicin  and  tobramycin  show 
sensitivity to amikacin in vitro. 

The principal Gram-positive organism sensitive to amikacin
is Staphylococcus aureus, including some 
methicillin-resistant strains. UZIX has some activity against other Gram-positive organisms including 
certain strains of Streptococcus pyogenes, Enterococci and Diplococcus pneumoniae.  

UZIX is indicated in the short-term treatment of serious infections due to susceptible strains of Gram-
negative  bacteria,  including  Pseudomonas  species.  Although  amikacin  is  not  the  drug  of  choice  for 
infections due to staphylococci, at times it may be indicated for the treatment of known or suspected 
staphylococcal  disease. These situations