LEVOFLOXACIN 5 Mg/Ml Solution for Infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

LEVOFLOXACIN HEMIHYDRATE

Available from:

Farmaprojects S.A.

INN (International Name):

LEVOFLOXACIN HEMIHYDRATE

Dosage:

5 Mg/Ml

Pharmaceutical form:

Solution for Infusion

Prescription type:

Product subject to prescription which may not be renewed (A)

Authorization status:

Authorised

Authorization date:

0000-00-00

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER 

LEVOFLOXACIN 5 MG/ML SOLUTION FOR INFUSION 
LEVOFLOXACIN 

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. 
•  This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if 
their symptoms are the same as yours. 
•  If any of the side effects gets serious or if you notice any
side effects not listed in this leaflet, 
please tell your doctor or pharmacist. 

IN THIS LEAFLET 
1. 
WHAT LEVOFLOXACIN 5 MG/ML IS AND WHAT IT IS USED FOR 
2. 
BEFORE YOU ARE GIVEN LEVOFLOXACIN 5 MG/ML 
3. 
HOW LEVOFLOXACIN 5 MG/ML IS GIVEN 
4. 
POSSIBLE SIDE EFFECTS  
5. 
STORING LEVOFLOXACIN 5 MG/ML 
6. FURTHER 
INFORMATION 

1. 
WHAT LEVOFLOXACIN 5 MG/ML IS AND WHAT IT IS USED FOR  
Levofloxacin belongs to a group of antibiotics called
fluorquinolones. It works by stopping the 
growth of bacteria that cause infections.  

Levofloxacin is used to treat the following bacterial infections:  

•  pneumonia, 
•  complicated (difficult to treat) urinary tract infections
including infection of the kidney 
(pyelonephritis), 
•  infections of the skin and underneath the skin, including
muscles.  This is sometimes called 
“soft tissue infections”.  
•  infection of the prostate. 

2. 
BEFORE YOU USE LEVOFLOXACIN 5 MG/ML 

DO NOT USE Levofloxacin 5mg/ml and TELL YOUR DOCTOR: 

•  if your are allergic (hypersensitive) to levofloxacin or any of
the ingredients of Levofloxacin 5 
mg/ml solution for infusion, or if you have ever had an allergic
reaction to any other quinolone 
antibiotic.  See section 6 of this leaflet for a list
of ingredients.  

•  if you suffer from epilepsy, because your risk of getting
“fits” (convulsions) is increased. 

•  if you have ever had tendon problems (e.g. tendinitis)

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Levofloxacin 5 mg/ml. Solution for Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution for infusion contains 5 mg of levofloxacin (as levofloxacin hemihydrate).
Each 100 ml of solution for infusion contains 500 mg of levofloxacin (as levofloxacin hemihydrate)
Each 50 ml of solution for infusion contains 250 mg of levofloxacin (as levofloxacin hemihydrate).
Excipients:
Each ml of solution for infusion contains 0.15 mmol (3.5 mg) sodium (as chloride)
50 ml of solution for infusion contain 7.7 mmol (177.1 mg) sodium (as chloride)
100 ml of solution for infusion contain 15.4 mmol (354.2 mg) sodium (as chloride)
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for infusion.
A clear greenish-yellow solution free from particles.
The pH of the solution for infusion is approximately 4.8
The osmolality of the solution for infusion is approximately 300 mOsm/kg
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In adults for whom intravenous therapy is considered to be appropriate, Levofloxacin 5 mg/ml solution for infusion is
indicated for the treatment of the following infections when due to levofloxacin-susceptible microorganisms (see
sections 4.4 and 5.1):
• Community-acquired pneumonia (when it is considered inappropriate to use antibacterial agents that are commonly
recommended for the initial treatment of this infection).
• Complicated urinary tract infections including pyelonephritis.
• Chronic bacterial prostatitis.
• Skin and soft tissue infections.
Before prescribing Levofloxacin 5 mg/ml solution for infusion, consideration should be given to national and/or local
guidance on the appropriate use of fluoroquinolones.
IRISH MEDICINES BOARD
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