Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
LEVOFLOXACIN HEMIHYDRATE
Farmaprojects S.A.
LEVOFLOXACIN HEMIHYDRATE
5 Mg/Ml
Solution for Infusion
Product subject to prescription which may not be renewed (A)
Authorised
0000-00-00
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) Read the complete document
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 _______________________________ Read the complete document