Levofloxacin Kern Pharma 5 mg/ml solution for infusion EFG: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Levofloxacino Kern Pharma 5 mg/ml infusion solution EFG

levofloxacin

Read the entire leaflet carefully before you are given this medicine, because it contains important information for you.

Keep this leaflet, as you may need to read it again.
If you have any questions, consult your doctor, pharmacist or nurse.
If you experience any adverse reactions, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

The name of this medicine is Levofloxacino Kern Pharma 5 mg/ml infusion solution. Throughout the rest of the leaflet, the medicine will be referred to as Levofloxacino Kern Pharma.

Contents of the leaflet

What Levofloxacino Kern Pharma is and what it is used for
What you need to know before being given Levofloxacino Kern Pharma
How Levofloxacino Kern Pharma is given
Possible side effects
How to store Levofloxacino Kern Pharma
Contents of the pack and other information

1. What Levofloxacino Kern Pharma is and what it is used for

The name of this medicine is Levofloxacino Kern Pharma.

Levofloxacino Kern Pharma contains an active substance called levofloxacin, which belongs to a group of medicines known as antibiotics. Levofloxacin is a quinolone-type antibiotic that works by killing the bacteria causing infections in your body.

Antibiotics are used to treat bacterial infections and are not effective against viral infections such as flu or the common cold.

It is important that you follow the instructions regarding dose, dosing interval, and duration of treatment as indicated by your doctor.

Do not store or reuse this medicine. If you have any antibiotic left over after completing your treatment, return it to the pharmacy for proper disposal. Medicines should not be disposed of via wastewater or household waste.

Levofloxacino Kern Pharma can be used to treat infections in:

the lungs, in patients with pneumonia
the urinary tract, including the kidneys or bladder
the prostate, when the infection is persistent
the skin and beneath the skin, including muscles. This is sometimes referred to as "soft tissues."

In certain special situations, Levofloxacino Kern Pharma may be used to reduce the risk of developing or worsening a lung infection called anthrax after exposure to the bacterium that causes anthrax.

2. What you need to know before starting to take Levofloxacino Kern Pharma

Do not use this medicine if:

You are allergic to levofloxacin, to other antibiotics of the quinolone type such as moxifloxacin, ciprofloxacin or ofloxacin, or to any of the other ingredients of this medicine (listed in section 6).

Signs of an allergic reaction include: skin rash, difficulty swallowing or breathing, swelling of lips, face, throat or tongue.

You suffer from or have suffered from epilepsy.
You have ever experienced tendon problems, such as tendinitis, related to taking quinolone-type medicines. Tendons are the tissues that connect your muscles to the skeleton.
You are a child or adolescent during the growth period.
You are pregnant, could become pregnant, or think you might be pregnant.
You are breastfeeding.

Do not use this medicine if any of the above apply to you. If in doubt, consult your doctor, pharmacist, or nurse before using Levofloxacino Kern Pharma.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before taking this medicine if:

You are 60 years of age or older.
You are taking corticosteroids, sometimes called steroids (see section “Use of Levofloxacino Kern Pharma with other medicines”).
You have received an organ transplant.
You have ever had a seizure (epileptic fit).
You have suffered brain damage due to stroke or other brain injury.
You have kidney problems.
You have a condition known as “glucose-6-phosphate dehydrogenase deficiency”, as you may be prone to serious blood problems while taking this medicine.
You have ever had mental health problems.
You have ever had heart problems: caution is advised when using this type of medicine if you were born with, or have a family history of, prolonged QT interval (seen on electrocardiogram (ECG), a graphical representation of the heart's electrical activity), if you have an imbalance in blood electrolyte levels (especially low potassium or magnesium levels), if you have a slow heart rate (called “bradycardia”), if you have a weak heart (heart failure), if you have a history of heart attack (myocardial infarction), if you are female or elderly, or if you are taking other medicines that may cause abnormal changes in the ECG (see section “Use of Levofloxacino Kern Pharma with other medicines”).
You are diabetic.
You have ever had liver problems.
You suffer from myasthenia gravis.
You have peripheral nerve disorder (peripheral neuropathy).
You have been diagnosed with an enlargement or “bulge” in a large blood vessel (aortic aneurysm or peripheral large vessel aneurysm).
You have previously experienced aortic dissection (tearing of the aortic wall).
You have been diagnosed with heart valve insufficiency (regurgitation of heart valves).
You have a family history of aortic dissection or aortic aneurysm, congenital heart valve disease, or other risk factors or predisposing conditions (e.g., connective tissue disorders such as Marfan syndrome, vascular Ehlers-Danlos syndrome, Turner syndrome, or Sjögren's syndrome (an inflammatory autoimmune disease), or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behçet's disease, hypertension, known atherosclerosis, rheumatoid arthritis (a joint disease), or endocarditis (a heart infection)).
You have previously developed a severe skin rash, skin peeling, blisters, and/or mouth sores after taking levofloxacin.

Serious skin reactions

Serious skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with the use of levofloxacin.

SJS/TEN may initially appear on the trunk as reddish, target-like spots or circular lesions, often with blisters in the center. Ulcers may also develop in the mouth, throat, nose, genitals, and eyes (red, swollen eyes). These severe skin rashes are often preceded by fever and/or flu-like symptoms. The rashes may progress to widespread skin peeling and life-threatening or fatal complications.
DRESS initially presents with flu-like symptoms and a facial rash, followed by a more widespread rash, elevated body temperature, increased liver enzymes in blood tests, elevated levels of a type of white blood cell (eosinophilia), and enlarged lymph nodes.

If you develop a severe rash or any of these skin symptoms, stop taking levofloxacin and contact your doctor or seek immediate medical attention.

Do not take antibacterial medicines containing fluoroquinolones or quinolones, including levofloxacin, if you have previously experienced a serious adverse reaction to a quinolone or fluoroquinolone. If this applies to you, inform your doctor as soon as possible.

Consult your doctor, pharmacist, or nurse during treatment with this medicine:

You may experience psychiatric reactions while taking Levofloxacino, even with first-time use. In very rare cases, psychosis may progress to suicidal thoughts or suicide attempts. If this occurs, stop taking Levofloxacino and contact your doctor immediately.
If you experience sudden, severe, and intense pain in the chest, abdomen, chest, or back, which may be symptoms of aortic dissection or aneurysm, go immediately to an emergency department. The risk may increase if you are receiving systemic corticosteroid treatment.
If you develop sudden onset of shortness of breath, especially when lying down, or notice swelling in your ankles, feet, or abdomen, or experience palpitations (sensation of rapid or irregular heartbeat), inform your doctor immediately.
If you begin to experience sudden involuntary jerks, muscle spasms, or muscle contractions—consult a doctor immediately, as these could be signs of myoclonus. Your doctor may need to discontinue levofloxacin treatment and initiate appropriate therapy.
If you have nausea, general discomfort, severe or persistent stomach pain, worsening pain in the stomach area, or vomiting—consult a doctor immediately, as this could be a sign of pancreas inflammation (acute pancreatitis).
If you experience fatigue, paleness of the skin, bruising, uncontrolled bleeding, fever, sore throat, a significant worsening of your general condition, or a feeling that your resistance to infections may be reduced—consult a doctor immediately, as these could be signs of blood disorders. Your doctor should monitor your blood with blood counts. If blood counts are abnormal, your doctor may need to discontinue treatment.

Rarely, joint pain and swelling, or tendon inflammation or rupture, may occur. The risk is higher if you are elderly (over 60 years), have received an organ transplant, have kidney problems, or are taking corticosteroids. Tendon inflammation and rupture may occur within the first 48 hours of treatment and even several months after stopping levofloxacin. At the first sign of tendon pain or inflammation (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking levofloxacin, contact your doctor, and rest the affected area. Avoid unnecessary physical activity, as this could increase the risk of tendon rupture.

Rarely, you may experience symptoms of nerve damage (neuropathy), such as pain, burning, tingling, numbness, and/or weakness, especially in the feet and legs or hands and arms. If this occurs, stop taking levofloxacin and inform your doctor immediately to prevent the development of a potentially irreversible disorder.

Serious, disabling, long-lasting, and potentially irreversible adverse effects

Antibacterial medicines containing fluoroquinolones or quinolones, including Levofloxacino Kern Pharma, have been associated with very rare but serious adverse effects, some of which were long-lasting (persisting for months or years), disabling, or potentially irreversible. These include tendon, muscle, and joint pain in the upper and lower limbs, difficulty walking, abnormal sensations such as pricking, tingling, pins and needles, numbness, or burning (paresthesia), sensory disturbances such as decreased vision, taste, smell, or hearing, depression, memory decline, severe fatigue, and serious sleep disorders. (See section 4)

If you experience any of these adverse effects after taking levofloxacin, contact your doctor immediately before continuing treatment. You and your doctor will decide whether to continue treatment, possibly considering the use of an antibiotic from another class.

Use of Levofloxacino Kern Pharma with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This is because Levofloxacino Kern Pharma may affect how other medicines work. Additionally, some medicines may affect how Levofloxacino Kern Pharma works.

In particular, inform your doctor if you are taking any of the following medicines, as they may increase the risk of adverse effects when taken with Levofloxacino Kern Pharma:

Corticosteroids, sometimes called steroids—used for inflammation. You may be more likely to experience tendon inflammation and/or rupture.
Warfarin—used to thin the blood. You may be more likely to experience bleeding. Your doctor may need periodic blood tests to monitor your blood’s clotting ability.
Theophylline—used for respiratory problems. You may be more likely to experience a seizure (epileptic fit) when taking it with Levofloxacino Kern Pharma.
Non-steroidal anti-inflammatory drugs (NSAIDs)—used for pain and inflammation, such as acetylsalicylic acid, ibuprofen, fenbufen, ketoprofen, indomethacin. You may be more likely to experience a seizure (epileptic fit) when taken with Levofloxacino Kern Pharma.
Cyclosporine—used after organ transplants. You may be more likely to experience adverse effects from cyclosporine.
Medicines known to affect heart rhythm. This includes medicines used for abnormal heart rhythm (antiarrhythmics such as quinidine, hydroquinidine, disopyramide, sotalol, dofetilide, ibutilide, and amiodarone), for depression (tricyclic antidepressants such as amitriptyline and imipramine), for psychiatric disorders (antipsychotics), and for bacterial infections (macrolide antibiotics such as erythromycin, azithromycin, and clarithromycin).
Probenecid (used for gout). If you have kidney problems, your doctor may want to prescribe a lower dose.
Cimetidine (used for ulcers and heartburn). If you have kidney problems, your doctor may want to prescribe a lower dose.

Inform your doctor or nurse if any of the above apply to you.

Opiate testing in urine

Urine tests may show “false positive” results for strong painkillers called “opioids” in patients taking Levofloxacino Kern Pharma. Inform your doctor that you are taking Levofloxacino Kern Pharma if you are prescribed a urine test.

Tuberculosis testing

This medicine may cause a “false negative” result in certain laboratory tests used to detect the bacteria causing tuberculosis.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medicine.

Do not use this medicine if:

you are pregnant, could become pregnant, or think you might be pregnant
you are breastfeeding or plan to breastfeed

Driving and use of machines

Some adverse effects such as dizziness, drowsiness, balance disturbances (vertigo), or visual disturbances may occur. Some of these adverse effects may affect your ability to concentrate or reduce your reaction speed. If this occurs, do not drive or perform any work requiring a high level of attention.

Levofloxacino Kern Pharma contains sodium

This medicine contains 177.1 mg of sodium (the main component of table/cooking salt) in each 250 mg tablet. This corresponds to 8.85% of the maximum daily sodium intake recommended for an adult.

3. How to take Levofloxacino Kern Pharma

How Levofloxacino Kern Pharma is administered

Levofloxacino Kern Pharma is a hospital-use medicine.
It will be administered by your doctor or nurse as an injection into one of your veins, given over a period of time (this is called intravenous infusion).
For Levofloxacino Kern Pharma 250 mg, the infusion time will be 30 minutes or longer.
For Levofloxacino Kern Pharma 500 mg, the infusion time will be 60 minutes or longer.
Your heart rate and blood pressure will be monitored frequently. This is because an unusually fast heartbeat and a temporary drop in blood pressure are possible side effects that have been observed during infusion of a similar antibiotic. If your blood pressure drops significantly during the infusion, it will be stopped immediately.

How much Levofloxacino Kern Pharma is administered

If you are unsure why you are receiving levofloxacin or have any questions about the dose you are receiving, consult your doctor, nurse, or pharmacist.

Your doctor will decide the appropriate dose of levofloxacin for you.
The dose will depend on the type of infection you have and its location in your body.
The duration of treatment will depend on the severity of your infection.

Adults and elderly patients

Pneumonia: 500 mg once or twice daily.
Urinary tract infection, including kidneys or bladder: 500 mg once daily.
Prostate infection: 500 mg once daily.
Skin and soft tissue infections, including muscles: 500 mg once or twice daily.

Adults and elderly patients with kidney problems

Your doctor may administer a lower dose.

Children and adolescents

This medicine must not be given to children or adolescents.

Protect your skin from sunlight

Do not expose your skin directly to sunlight (even on cloudy days) while receiving this medicine and for two days after stopping it, as your skin may become much more sensitive to sunlight and may burn, sting, or even blister if you do not take the following precautions:

Be sure to use sunscreen creams with a high protection factor.
Always wear a hat and clothing covering your arms and legs.
Avoid ultraviolet (UV) lamps.

If you are given more Levofloxacino Kern Pharma than you should

It is unlikely that your doctor or nurse will give you more medicine than you need. Your doctor and nurse will monitor your condition and the medicine you have been given. Always ask if you are unsure why you are receiving this medicine.

If you are given more Levofloxacino Kern Pharma than required, the following effects may occur: epileptic seizures (convulsions), confusion, dizziness, decreased consciousness, tremors, heart disorders that may cause irregular heartbeat, and discomfort (nausea).

If you miss a dose of Levofloxacino Kern Pharma

Your doctor or nurse will have instructions on when to administer this medicine. It is unlikely that the medicine will not be given as prescribed. However, if you think a dose has been missed, inform your doctor or nurse.

If you stop treatment with Levofloxacino Kern Pharma

Your doctor or nurse will continue administering Levofloxacino Kern Pharma even if you feel better. Stopping treatment too early may cause the infection to return, worsen your condition, or lead to bacteria becoming resistant to the medicine. After a few days of treatment with the infusion solution, your doctor may decide to switch you to the tablet form of this medicine to complete your treatment.

If you have any further questions about using this product, ask your doctor, nurse, or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them. Usually, these are mild to moderate in intensity and tend to disappear in a short time.

Stop treatment with Levofloxacino Kern Pharma and contact a doctor or nurse or go to a hospital immediately if you experience the following adverse effects:

Very rare (may affect up to 1 in 10,000 people)

If you have an allergic reaction. Signs may include: skin rash, difficulty swallowing or breathing, swelling of lips, face, throat, or tongue.

Stop treatment with Levofloxacino Kern Pharma and contact a doctor or nurse immediately if you experience the following serious adverse effects, as you may require urgent medical treatment:

Rare (may affect up to 1 in 1,000 people)

Watery diarrhoea, possibly containing blood, possibly with stomach cramps and fever. These could be signs of a serious intestinal problem.
Pain and inflammation in tendons or ligaments, which could lead to rupture. The Achilles tendon is most frequently affected.
Seizures (convulsions).
Seeing or hearing things that are not real (hallucinations, paranoia).
Depression, mental disorders, feeling restless (agitation), abnormal dreams or nightmares.
- Widespread rash, high body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), enlarged lymph nodes and involvement of other body organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome). See also section 2.
- Syndrome associated with impaired water excretion and low sodium levels (SIADH).
- Decreased blood sugar levels (hypoglycaemia) or decreased blood sugar levels that may lead to coma (hypoglycaemic coma). This is important for diabetic patients.

Very rare (may affect up to 1 in 10,000 people)

Burning, tingling, pain, or numbness. These may be signs of what is known as “neuropathy”.

Not known (frequency cannot be estimated from available data)

Severe skin rashes including Stevens-Johnson syndrome and toxic epidermal necrolysis. These may appear on the trunk as red macules in target-like shapes or circular spots, often with blisters in the center, skin peeling, mouth, throat, nose, genital, and eye ulcers, and may be preceded by fever and flu-like symptoms. See section 2.
Loss of appetite, yellowing of the skin and eyes, dark urine, burning sensation or painful abdomen on palpation. These may be signs of liver problems, which may include fulminant liver failure.
Changes in thinking and thoughts (psychotic reactions) with risk of suicidal thoughts or actions.
Nausea, general malaise, discomfort or pain in the stomach area, or vomiting. These could be signs of an inflamed pancreas (acute pancreatitis). See section 2.

Seek immediate advice from an eye specialist if your vision deteriorates or you develop any other eye problems while taking Levofloxacino Kern Pharma.

Administration of antibiotics containing quinolones and fluoroquinolones has been associated with very rare cases of long-lasting (even months or years) or permanent adverse reactions, such as tendon inflammation, tendon rupture, joint pain, limb pain, difficulty walking, abnormal sensations such as pricking, tingling, pins and needles, burning, numbness or pain (neuropathy), fatigue, memory and concentration impairment, effects on mental health (which may include sleep disorders, anxiety, panic attacks, depression, and suicidal ideation), as well as hearing, vision, taste, and smell impairment, in some cases regardless of the presence of pre-existing risk factors. See section 2.

Cases of enlargement and weakening or tearing of the aortic wall (aneurysms and dissections), which could lead to rupture and potentially be fatal, and cardiac valve insufficiency have been reported in patients receiving fluoroquinolones. See also section 2.

Inform your doctor if any of the following adverse effects worsen or last longer than a few days:

Frequent (may affect up to 1 in 10 people)

Sleep disturbances.
Headache, dizziness.
Malaise (nausea, vomiting) and diarrhoea.
Increase in levels of certain liver enzymes in the blood.
Reactions at the infusion site.
Inflammation of the vein.

Uncommon (may affect up to 1 in 100 people)

Changes in the number of other bacteria or fungi, fungal infection known as Candida, which may require treatment.
Changes in white blood cell count in blood test results (leucopenia, eosinophilia).
Stress (anxiety), confusion, nervousness, drowsiness, tremors, dizziness (vertigo).
Difficulty breathing (dyspnoea).
Changes in taste, loss of appetite, stomach disorders or indigestion (dyspepsia), stomach area pain, bloating (flatulence) or constipation.
Itching and skin rash, intense pruritus or hives (urticaria), excessive sweating (hyperhidrosis).
Joint pain or muscle pain.
Abnormal blood test values due to liver problems (increased bilirubin) or kidney problems (increased creatinine).
Generalized weakness.

Rare (may affect up to 1 in 1,000 people)

Appearance of bruises and easy bleeding due to decreased number of blood platelets (thrombocytopenia).
Decrease in white blood cells in blood (neutropenia).
Exaggerated immune response (hypersensitivity).
Tingling sensation in hands and feet (paraesthesia).
Disorders of the ear (tinnitus) or vision (blurred vision).
Abnormally rapid heartbeat (tachycardia) or decreased blood pressure (hypotension).
Muscle weakness. This is important in people with myasthenia gravis (a rare nervous system disorder).
Changes in kidney function and, occasionally, kidney failure that may result from an allergic-type kidney reaction called interstitial nephritis.
Fever.
- Clearly demarcated erythematous spots with or without blisters appearing a few hours after administration of levofloxacin and healing with post-inflammatory hyperpigmentation; usually recurring at the same skin or mucosal site after subsequent exposure to levofloxacin.
- Memory impairment.

Not known (frequency cannot be estimated from available data)

Decrease in red blood cells (anaemia): this may cause the skin to become pale or yellowish due to damage to red blood cells; decrease in all types of blood cells (pancytopenia).
Bone marrow stops producing new blood cells, which may cause fatigue, reduced ability to fight infections, and uncontrolled bleeding (bone marrow failure).
Fever, sore throat, and persistent general malaise. This may be due to a decrease in white blood cells (agranulocytosis).
Circulatory collapse (anaphylactic-type shock).
Increased blood sugar levels (hyperglycaemia). This is important in people with diabetes.
Changes in smell, loss of smell or taste (parosmia, anosmia, ageusia).
Feeling highly excited, euphoric, agitated, or enthusiastic (mania).
Movement and gait disorders (dyskinesia, extrapyramidal disorders).
Temporary loss of consciousness or posture (syncope).
Temporary loss of vision, eye inflammation.
Hearing problems or hearing loss.
Abnormally rapid heartbeat, irregular heartbeat with life-threatening risk including cardiac arrest, disturbance in heart rhythm (known as “prolongation of the QT interval”, observed on ECG, a graphical representation of the heart's electrical activity).
Difficulty breathing or wheezing (bronchospasm).
Pulmonary allergic reactions.
Inflammation of the pancreas (pancreatitis).
Inflammation of the liver (hepatitis).
Increased sensitivity of the skin to sunlight and ultraviolet light (photosensitivity), darker areas of skin (hyperpigmentation).
Inflammation of blood vessels throughout the body due to an allergic reaction (vasculitis).
Inflammation of the tissue inside the mouth (stomatitis).
Muscle rupture and destruction of muscle (rhabdomyolysis).
Red and swollen joints (arthritis).
Pain, including back, chest, and limb pain.
Sudden, involuntary jerks, muscle spasms, or muscle contractions (myoclonus).
Acute attacks of porphyria in patients with porphyria (a very rare metabolic disorder).
Persistent headache with or without blurred vision (benign intracranial hypertension).

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Levofloxacin Kern Pharma

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the bag, bottle, and outer carton after "EXP". The expiry date refers to the last day of the month indicated.

Bottles with packaging: Store the bottle in the outer bag to protect it from light.

Use immediately after removing the bottle from the bag.

Bottles without packaging: Must be kept in the carton to protect them from light. Use immediately after removing the bottle from the carton (see section 6.3).

Protection from light is not required during infusion.

Once the infusion bottle has been opened (piercing the rubber stopper), the solution should be used immediately to prevent any bacterial contamination.

Do not use this medicine if the solution is not clear and/or contains particles.

Medicines should not be disposed of via wastewater or household waste. Ask your nurse or pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Levofloxacino Kern Pharma

The active substance is levofloxacin.

Levofloxacino Kern Pharma is available in 100 mL polypropylene bottles containing 500 mg of levofloxacin as levofloxacin hemihydrate. One mL of infusion solution contains 5 mg of levofloxacin.

The other components are: sodium chloride, sodium hydroxide, hydrochloric acid and water for injections.

Appearance of the product and contents of the container

Levofloxacino Kern Pharma is a clear, yellowish-green solution free from particles. It is supplied in plastic bottles made of polypropylene, with a moulded plastic cap, rubber seal (type II), ring pull or a dual-port closure cap, which includes a rubber gasket (type II) inside and two ring pulls on the outside.

Each 100 mL bottle is placed in a metallized plastic bag. Cartons containing 10 bottles are available.

Alternatively:

The 100 mL bottles are contained within the carton.

The 100 mL bottles are available in cartons of 1 or 10 bottles.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Manufacturer

DEMO S.A., Pharmaceutical Industry

21st km National Road Athens-Lamia,

14568 Krioneri, Athens, Greece.

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Ireland: Levofloxacin 5 mg/mL Solution for Infusion

Spain: Levofloxacino Kern Pharma 5 mg/mL infusion solution EFG

Cyprus: Levofloxacin Noridem 5 mg/mL Διάλυμα για έγχυση

Austria: Levofloxacin Noridem 5 mg/mL Infusionlösung

Germany: Levofloxacin 5 mg/mL Infusionlösung

Date of the most recent revision of this leaflet: August 2025

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/