Država: Irska
Jezik: angleščina
Source: HPRA (Health Products Regulatory Authority)
Levofloxacin
Fresenius Kabi Deutschland GmbH
J01MA; J01MA12
Levofloxacin
5 milligram(s)/millilitre
Solution for infusion
Product subject to prescription which may not be renewed (A)
Fluoroquinolones; levofloxacin
Marketed
2009-07-24
UK-IE PIL Levofloxacin 5mg/ml V010 1 PACKAGE LEAFLET: INFORMATION FOR THE USER LEVOFLOXACIN 5MG/ML SOLUTION FOR INFUSION. Levofloxacin READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor, nurse or pharmacist. • If you get any side effects, talk to your doctor nurse or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Levofloxacin is and what it is used for 2. What you need to know before you are given Levofloxacin 3. How to use Levofloxacin 4. Possible side effects 5. How to store Levofloxacin 6. Contents of the pack and other information 1. WHAT LEVOFLOXACIN IS AND WHAT IT IS USED FOR The name of your medicine is Levofloxacine. Levofloxacin contains a medicine called levofloxacin. This belongs to a group of medicines called antibiotics. Levofloxacin is a ’quinolone’ antibiotic. It works by killing the bacteria that cause infections in your body. LEVOFLOXACIN CAN BE USED TO TREAT INFECTIONS OF THE: • Lungs, in people with pneumonia • Urinary tract, including your kidneys or bladder • Prostate gland, where you have a long lasting infection • Skin and underneath the skin, including muscles. This is sometimes called ‘soft tissue’ In some special situations, Levofloxacin may be used to lessen the chances of getting a pulmonary disease named anthrax or worsening of the disease after you are exposed to the bacteria causing anthrax. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN LEVOFLOXACIN DO NOT HAVE THIS MEDICINE AND TELL YOUR DOCTOR IF: • You are allergic to levofloxacin, any other quinolone antibiotic such as moxifloxacin, ciprofloxacin or ofloxacin or any of the other ingredients of this medicine (listed in section 6) • Signs of an allergic reactivon include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or ton Preberite celoten dokument
Health Products Regulatory Authority 14 September 2023 CRN00DMMY Page 1 of 14 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Levofloxacin 5mg/ml solution for infusion, LDPE bottles 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 50 ML FILLED IN 100 ML BOTTLE/BAGS: Each ml of solution for infusion contains 5 mg levofloxacin (as levofloxacin hemihydrate). 50 ml of solution for infusion contains 250 mg of levofloxacin as active substance. 100 ML FILLED IN 100 ML BOTTLE/BAGS: Each ml of solution for infusion contains 5 mg levofloxacin (as levofloxacin hemihydrate). 100 ml of solution for infusion contains 500 mg of levofloxacin as active substance. Excipient(s) with known effect: The medicinal product contains 3.54 mg of sodium per ml _For the full list of excipients, see section 6.1_ 3 PHARMACEUTICAL FORM Solution for infusion. Yellow to greenish yellow solution 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Levofloxacin solution for infusion is indicated in adults for the treatment of the following infections (see sections 4.4 and 5.1): Acute pyelonephritis and complicated urinary tract infections (see section 4.4) Chronic bacterial prostatitis Inhalation Anthrax: postexposure prophylaxis and curative treatment (see section 4.4). In the below-mentioned infections Levofloxacin should be used only when it is considered inappropriate to use other antibacterial agents that are commonly recommended for the treatment of these infections. Community-acquired pneumonia Complicated skin and soft tissue infections Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Levofloxacin solution for infusion is administered by slow intravenous infusion once or twice daily. The dosage depends on the type and severity of the infection and the susceptibility of the presumed causative pathogen. Treatment with Levofloxacin after initial use of the intravenous preparation may be completed with an appropriate oral p Preberite celoten dokument