LEVOFLOXACIN KERN PHARMA 5 mg/ml SOLUTION FOR INFUSION

Introduction

Package Leaflet: Information for the User

Levofloxacino Kern Pharma 5 mg/ml solution for infusion EFG

levofloxacino

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, pharmacist or nurse.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

The name of this medicine is Levofloxacino Kern Pharma 5 mg/ml solution for infusion.In the rest of this leaflet, the name of the medicine appears as Levofloxacino Kern Pharma

Contents of the pack

1. What is Levofloxacino Kern Pharma and what is it used for
2. What you need to know before you are given Levofloxacino Kern Pharma
3. How to take Levofloxacino Kern Pharma
4. Possible side effects
5. How to store Levofloxacino Kern Pharma
6. Contents of the pack and other information

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

The name of this medicine is Levofloxacino Kern Pharma.

Levofloxacino Kern Pharma contains the active substance levofloxacino, which belongs to a group of medicines called antibiotics. Levofloxacino is a type of antibiotic known as a quinolone, and it works by killing the bacteria that cause infections in your body.

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

It is important that you follow the instructions regarding dosage, administration interval, and treatment duration indicated by your doctor.

Do not store or reuse this medicine. If you have any leftover antibiotic after completing treatment, return it to the pharmacy for proper disposal. Do not throw medicines down the drain or in the trash.

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 under the skin, including muscles. This is sometimes referred to as "soft tissue".

In some special situations, Levofloxacino Kern Pharma may be used to reduce the risk of acquiring a lung infection called anthrax or worsening of this disease after being exposed to the bacteria that causes anthrax.

2. What you need to know before you are given Levofloxacino Kern Pharma

Do not use this medicine if:

• You are allergic to levofloxacino, to other antibiotics of the quinolone type such as moxifloxacino, ciprofloxacino or ofloxacino, or to any of the other components of this medicine (listed in section 6).

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

• You have or have had epilepsy.
• You have ever had tendon problems, such as tendinitis, related to the use of quinolone-type medications. The tendon is the tissue that connects your muscle to your skeleton.
• You are a child or adolescent in the growth phase.
• You are pregnant, may be pregnant, or think you may be pregnant.
• You are breastfeeding.

Do not use this medicine if any of the above cases 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 old or older.
• You are taking corticosteroids, sometimes called steroids (see section "Use of Levofloxacino Kern Pharma with other medicines").
• You have received a transplant.
• You have had a seizure (convulsions) in the past.
• You have had brain damage due to a stroke or other brain injury.
• You have kidney problems.
• You have what is known as "glucose-6-phosphate dehydrogenase deficiency", as you may be prone to having serious blood problems when taking this medicine.
• You have had mental health problems in the past.
• You have ever had heart problems: caution should be exercised when using this type of medicine if you were born with, or have a family history of, prolonged QT interval (seen on an electrocardiogram (ECG), a graphical representation of the electrical activity of the heart), have an imbalance in blood salt levels (especially low potassium or magnesium levels in the blood), have a slow heart rate (called "bradycardia"), have a weak heart (heart failure), have a history of heart attack (myocardial infarction), if you are a woman or an elderly person or 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 have myasthenia gravis.
• You have peripheral nerve disorder (peripheral neuropathy).
• If you have been diagnosed with an aneurysm of a large blood vessel (aortic aneurysm or large peripheral vessel aneurysm).
• If you have had a previous episode of aortic dissection (tear in the aortic wall).
• If you have been diagnosed with heart valve insufficiency (regurgitation of the heart valves).
• If you have a family history of aortic dissection or aneurysm, congenital heart valve disease, or other risk factors or predisposing conditions (e.g., connective tissue disorders such as Marfan syndrome, Ehlers-Danlos vascular syndrome, Turner syndrome, or Sjögren's syndrome (an autoimmune inflammatory disease) or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behçet's disease, hypertension, atherosclerosis, rheumatoid arthritis (a joint disease) or endocarditis (a heart infection)).
• If you have ever developed a severe skin rash or peeling of the skin, blisters, and/or sores in the mouth after taking levofloxacino.

Severe skin reactions

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

• SJS/TEN may initially appear on the trunk as red, target-like spots or circular patches, often with blisters in the center. They can also appear as ulcers 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 can progress to widespread skin peeling and life-threatening or fatal complications.
• DRESS is initially manifested by flu-like symptoms and a rash on the face, followed by a more widespread rash with elevated body temperature, elevated liver enzymes observed in blood tests, and an increase in a type of white blood cell (eosinophilia) and swollen lymph nodes.

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

Do not take antibacterial medicines that contain fluoroquinolones or quinolones, including levofloxacino, if you have experienced a severe adverse reaction in the past when taking a quinolone or fluoroquinolone. If this is the case, inform your doctor as soon as possible.

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

• You may experience psychiatric reactions when taking Levofloxacino, even when taking it for the first time. In very rare cases, psychosis can evolve into suicidal thoughts or attempts. If this happens, stop taking Levofloxacino and contact your doctor immediately.
• If you feel a sudden, severe, and intense pain in the chest, abdomen, or back, which can be symptoms of aortic dissection or aneurysm, go to the emergency room immediately. The risk may increase if you are receiving systemic corticosteroid treatment.
• If you start experiencing sudden shortness of breath, especially when lying down, or if you notice swelling in the ankles, feet, or abdomen, or the appearance of heart palpitations (feeling of rapid or irregular heartbeat), inform your doctor immediately.
• If you start experiencing sudden, involuntary jerks, muscle spasms, or muscle contractions, consult a doctor immediately, as these could be signs of myoclonus. Your doctor may need to interrupt treatment with levofloxacino and initiate appropriate treatment.
• If you have nausea, general discomfort, have intense or persistent pain in the stomach area, or vomit, consult a doctor immediately, as this could be a sign of pancreatitis (inflammation of the pancreas).
• If you experience fatigue, pale skin, bruising, uncontrolled bleeding, fever, sore throat, and a severe deterioration of your general condition, or a feeling that your resistance to infections may be decreased, consult a doctor immediately, as these could be signs of blood disorders. Your doctor should monitor your blood with blood counts. In case of abnormal blood counts, your doctor may need to interrupt treatment.

In rare cases, pain and swelling in the joints and inflammation or rupture of the tendons may occur. The risk is higher if you are an elderly person (over 60 years old), have received an organ transplant, have kidney problems, or are being treated with corticosteroids. Tendon inflammation and rupture can occur within the first 48 hours of treatment and even several months after stopping treatment with levofloxacino. At the first sign of pain or inflammation of a tendon (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking levofloxacino, contact your doctor, and rest the affected area. Avoid any unnecessary exercise, as this may increase the risk of tendon rupture.

In rare cases, 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 happens, stop taking levofloxacino and inform your doctor immediately to prevent the development of a potentially irreversible disorder.

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

Antibacterial medicines that contain 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. This includes pain in the tendons, muscles, and joints of the upper and lower limbs, difficulty walking, abnormal sensations such as pins and needles, tingling, prickling, numbness, or burning (paresthesia), sensory disorders such as decreased vision, taste, smell, or hearing, depression, decreased memory, intense fatigue, and severe sleep disorders.

If you experience any of these adverse effects after taking levofloxacino, contact your doctor immediately before continuing treatment. You and your doctor will decide whether to continue or not, also considering the use of an antibiotic from another class.

Use of Levofloxacino Kern Pharma with other medicines

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

In particular, inform your doctor if you are taking any of the following medicines, as this may increase the risk of adverse effects when taking them 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 make the blood more liquid. You may be more likely to experience bleeding. Your doctor may need to perform periodic blood tests to check if your blood is clotting properly.
• Theophylline - used for respiratory problems. You may be more likely to experience a seizure (convulsions) if you take 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 (convulsions) when taking them with Levofloxacino Kern Pharma.
• Cyclosporin - used after organ transplants. You may be more likely to experience the adverse effects of cyclosporin.
• Medicines that 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 give you a lower dose.
• Cimetidine (used for ulcers and heartburn). If you have kidney problems, your doctor may want to give you a lower dose.

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

Determination of opiates in urine

Urine tests may show "false positive" results for the presence of strong painkillers called "opiates" in patients using Levofloxacino Kern Pharma. Inform your doctor that you are using Levofloxacino Kern Pharma if you have been prescribed a urine test.

Tuberculosis test

This medicine may cause a "false negative" result in some laboratory tests used to detect the bacteria that causes 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, may be pregnant, or think you may be pregnant
• you are breastfeeding or plan to breastfeed

Driving and using machines

Some adverse effects such as dizziness, drowsiness, balance disturbance (vertigo), or visual disturbances may occur. Some of these adverse effects may affect your ability to concentrate or slow down your reaction time. If this happens, do not drive or perform any work that requires a high level of attention.

Levofloxacino Kern Pharma contains sodium

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

3. How to take Levofloxacino Kern Pharma

How Levofloxacino Kern Pharma is administered

• Levofloxacino Kern Pharma is a medication for hospital use.
• It will be administered by your doctor or nurse via an injection. The injection will be administered into one of your veins and over a period of time (this is called intravenous infusion).
• For Levofloxacino Kern Pharma 250 mg, the infusion time will be 30 minutes or more.
• For Levofloxacino Kern Pharma 500 mg, the infusion time will be 60 minutes or more.
• Your heart rate and blood pressure will be frequently monitored. This is because an unusual rapid heartbeat and a temporary decrease in blood pressure are possible adverse effects that have been seen during the infusion of a similar antibiotic. If your blood pressure drops significantly while you are receiving the infusion, it will be immediately interrupted.

How much Levofloxacino Kern Pharma is administered

If you are not sure why you are being given levofloxacino or have any questions about how much levofloxacino you are being given, ask your doctor, nurse, or pharmacist.

• Your doctor will decide how much levofloxacino you should be given.
• The dose will depend on the type of infection you have and where it is located 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 a day.
• Urinary tract infection, including kidneys or bladder: 500 mg once a day.
• Prostate infection: 500 mg once a day.
• Skin and subcutaneous tissue infections, including muscles: 500 mg once or twice a day.

Adults and elderly patients with kidney problems

Your doctor may give you a lower dose.

Children and adolescents

This medication should not be given to children or adolescents.

Protect your skin from sunlight

Do not expose your skin directly to the sun (even if it's cloudy) while you are being given this medication and for two days after stopping it, as your skin will become much more sensitive to the sun and may burn, sting, or even blister if you don't take the following precautions:

• Make sure to use high-factor sun creams.
• Always wear a hat and clothing that covers your arms and legs.
• Avoid UVA lamps.

If you are given more Levofloxacino Kern Pharma than you should

It is unlikely that your doctor or nurse will give you more medication than you need. Your doctor and nurse will monitor your progress and check the medication that has been given to you. Always ask if you are not sure why you are being given this medication.

If you are given more Levofloxacino Kern Pharma than you need, the following effects may appear: epileptic seizures (convulsions), confusion, dizziness, decreased consciousness, tremors, heart disorders that can cause irregular heartbeats as well as discomfort (nausea).

If you miss a dose of Levofloxacino Kern Pharma

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

If you stop treatment with Levofloxacino Kern Pharma

Your doctor or nurse will continue to give you Levofloxacino Kern Pharma, even if you feel better. If treatment is stopped too soon, the infection may return, you may get worse, or the bacteria may become resistant to the medication. After a few days of treatment with the infusion solution, your doctor may decide to switch you to the tablet form of this medication to complete the treatment.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them. They are usually mild to moderate and tend to disappear soon.

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

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

• If you have an allergic reaction. The 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 notice the following serious side effects, as you may need urgent medical treatment:

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

• Watery diarrhea that may contain blood, possibly with stomach cramps and fever. These could be signs of a serious intestinal problem.
• Pain and inflammation in the tendons or ligaments, which could lead to rupture. The Achilles tendon is the one most frequently affected.
• Epileptic seizures (convulsions).
• Seeing or hearing things that are not real (hallucinations, paranoia).
• Depression, mental disorders, feeling of restlessness (agitation), abnormal dreams or nightmares.
• • Widespread rash, high body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes, and other organs involved (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome). See also section 2.
  • Syndrome associated with alterations in water elimination and low sodium levels (SIADH)
  • Decreased blood sugar levels (hypoglycemia) or decreased blood sugar levels that can lead to coma (hypoglycemic coma). This is important for diabetic patients.

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

• Burning, tingling, pain, or numbness. These can be signs of what is called "neuropathy".

Unknown(frequency cannot be estimated from available data)

• Severe skin rashes, including Stevens-Johnson syndrome and toxic epidermal necrolysis. These can appear on the trunk as reddish spots in a target shape or circular patches, often with blisters in the center, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes, and can be preceded by fever and flu-like symptoms. See section 2.
• Lack of appetite, yellowing of skin and eyes, dark urine, itching, or painful stomach (abdomen). These can be signs of liver problems, which can include liver failure.
• Changes in opinion and thoughts (psychotic reactions) with a risk of having suicidal thoughts or actions
• Nausea, general discomfort, stomach upset, or vomiting. These could be signs of an inflamed pancreas (acute pancreatitis). See section 2.

Consult an eye specialist immediately if your vision deteriorates or you have any other eye problems while taking Levofloxacino Kern Pharma.

The 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 pinching, tingling, burning, numbness, or pain (neuropathy), depression, fatigue, sleep disorders, decreased memory, and decreased hearing, vision, taste, and smell, in some cases regardless of the presence of pre-existing risk factors.

There have been reports of increased size and weakening or tearing of the aortic wall (aneurysms and dissections), which could lead to rupture and be fatal, and cardiac valve insufficiency in patients who have received fluoroquinolones. See also section 2.

Tell your doctorif any of the following side effects worsen or last more than a few days:

Common(may affect up to 1 in 10 people)

• Sleep problems.
• Headache, dizziness.
• Discomfort (nausea, vomiting) and diarrhea.
• Increased levels of some liver enzymes in the blood.
• Reactions at the infusion site.
• Vein inflammation.

Uncommon(may affect up to 1 in 100 people)

• Changes in the number of other bacteria or fungi, infection by a fungus called Candida, which may require treatment.
• Changes in the number of white blood cells in your blood test results (leukopenia, eosinophilia).
• Stress (anxiety), confusion, nervousness, drowsiness, tremors, feeling of dizziness (vertigo).
• Difficulty breathing (dyspnea).
• Changes in taste, loss of appetite, stomach upset, or indigestion (dyspepsia), stomach pain, feeling of bloating (flatulence), or constipation.
• Itching and skin rash, intense itching, or hives (urticaria), excessive sweating (hyperhidrosis).
• Joint or muscle pain.
• Abnormal blood test results due to liver (increased bilirubin) or kidney (increased creatinine) problems.
• General weakness.

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

• Appearance of bruises and easy bleeding due to a decrease in the number of platelets in the blood (thrombocytopenia).

• Decrease in the number of white blood cells in the blood (neutropenia).
• Exaggerated immune response (hypersensitivity).
• Feeling of tingling in hands and feet (paresthesia).
• Ear disorders (tinnitus) or vision disorders (blurred vision).
• Abnormally fast heartbeat (tachycardia) or decreased blood pressure (hypotension).
• Muscle weakness. This is important in people with myasthenia gravis (a rare nervous system disease).
• Changes in kidney function and occasional kidney failure, which can be a consequence of an allergic reaction in the kidney called interstitial nephritis.
• Fever.
• • Clearly defined erythematous patches with or without blisters that develop a few hours after administration of levofloxacino and heal with residual post-inflammatory hyperpigmentation; usually, they recur in the same area of the skin or mucous membrane after subsequent exposure to levofloxacino.
  • Memory impairment.

Unknown(frequency cannot be estimated from available data)

• Decrease in red blood cells (anemia): this can cause the skin to become pale or yellowish due to damage to red blood cells; decrease in the number of all types of blood cells (pancytopenia).
• The bone marrow stops producing new blood cells, which can cause fatigue, decreased ability to fight infections, and uncontrolled bleeding (bone marrow failure).
• Fever, sore throat, and persistent general discomfort. This can be due to a decrease in the number of white blood cells (agranulocytosis).
• Circulatory collapse (anaphylactic shock).
• Increased blood sugar levels (hyperglycemia). This is important in people with diabetes.
• Changes in smell, loss of smell or taste (parosmia, anosmia, ageusia).
• Feeling very 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 loss of hearing.
• Abnormally fast heartbeat, irregular heartbeat with risk of life, including cardiac arrest, alteration of heart rhythm (called "prolongation of the QT interval", observed in the ECG, a graphical representation of the heart's electrical activity).
• Difficulty breathing or wheezing (bronchospasm).
• Pulmonary allergic reactions.
• Pancreatitis (inflammation of the pancreas).
• Hepatitis (inflammation of the liver).
• Increased skin sensitivity to sunlight and ultraviolet light (photosensitivity), darker skin areas (hyperpigmentation).
• Inflammation of the blood vessels that carry blood throughout the body due to an allergic reaction (vasculitis).
• Inflammation of the tissue inside the mouth (stomatitis).
• Muscle rupture and destruction (rhabdomyolysis).
• Red and swollen joints (arthritis).
• Pain, including back, chest, and limb pain.
• Sudden, involuntary jerks, muscle spasms, or muscle contractions (myoclonus).
• Porphyria crisis in patients with porphyria (a very rare metabolic disease).
• Persistent headache with or without blurred vision (benign intracranial hypertension).

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a side effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Levofloxacino Kern Pharma

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the bag, vial, and outer carton after "EXP". The expiration date is the last day of the month indicated.

Bottles with wrapping:Keep the bottle in the outer bag to protect it from light.

Use immediately after removing the bottle from the bag.

Bottles without wrapping:They should be kept in the case to protect them from light. Use immediately after removing the bottle from the case (see section 6.3).

No need to protect from light during infusion.

Once the bottle is opened for infusion (puncture of the rubber stopper), the solution should be used immediately to prevent any bacterial contamination.

Do not use this medication if you notice that the solution is not transparent and/or contains particles.

Medicines should not be disposed of through wastewater or household waste. Ask your nurse or pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package contents and additional information

Composition of Levofloxacino Kern Pharma

• The active ingredient is levofloxacino.

Levofloxacino Kern Pharma is available in a 100 mL polypropylene bottle containing 500 mg of levofloxacino in the form of levofloxacino hemihydrate. One mL of infusion solution contains 5 mg of levofloxacino.

• The other ingredients are: sodium chloride, sodium hydroxide, hydrochloric acid, and water for injectable preparations.

Appearance of the product and package contents

Levofloxacino Kern Pharma is a clear, yellowish-green solution without particles. It is presented in a plastic bottle made of polypropylene, with a molded plastic cap, rubber gasket (type II), and a ring pull or a double-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. Boxes of 10 bottles are available.

Alternatively:

The 100 mL bottles are inside the box.

The 100 mL bottles are presented in boxes of 1 or 10 bottles.

Not all 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 medication 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 solución para perfusión EFG

Cyprus: Levofloxacin Noridem 5 mg/ml Δι?λυμα για ?γχυση

Austria: Levofloxacin Noridem 5 mg/ml Infusionlösung

Germany: Levofloxacin 5 mg/ml Infusionslösung

Date of last revision of this leaflet: July 2024

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/