Levofloxacin Kabi

Leaflet accompanying the packaging: information for the user

Levofloxacin Kabi, 5 mg/mL, solution for infusion

Levofloxacin

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• In case of any doubts, you should consult a doctor, pharmacist, or nurse.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Levofloxacin Kabi and what is it used for
• 2. Important information before using Levofloxacin Kabi
• 3. How to use Levofloxacin Kabi
• 4. Possible side effects
• 5. How to store Levofloxacin Kabi
• 6. Contents of the packaging and other information

1. What is Levofloxacin Kabi and what is it used for

The name of this medicine is Levofloxacin Kabi. Levofloxacin Kabi contains the active substance levofloxacin, which belongs to a group of medicines called antibiotics. Levofloxacin is a "quinolone" antibiotic. It works bactericidally on bacteria that cause infections in the body.

Levofloxacin Kabi can be used to treat bacterial infections:

• of the lungs, in patients with pneumonia;
• of the urinary system, including the kidneys or bladder;
• of the prostate gland, in cases of chronic infection;
• of the skin and subcutaneous tissue, including muscles. This is sometimes referred to as "soft tissue" infections.

In some cases, Levofloxacin Kabi may be used to prevent a lung disease called anthrax, which can occur after contact with bacteria that cause anthrax, or to treat this disease.

2. Important information before using Levofloxacin Kabi

When not to use Levofloxacin Kabi and consult a doctor

• If the patient is allergic to levofloxacin, any other quinolone antibiotic, e.g., moxifloxacin, ciprofloxacin, or ofloxacin, or any of the other ingredients of this medicine (listed in section 6).
• Symptoms of an allergic reaction include: rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue.
• If the patient has ever had epilepsy in the past.
• If the patient has ever had tendon problems, e.g., tendonitis, related to treatment with quinolone antibiotics. Tendons connect muscles to bones.
• If the medicine has been prescribed for a child or adolescent during growth.
• If the patient is pregnant, may become pregnant, or suspects that they are pregnant.
• If the patient is breastfeeding.

This medicine should not be used if any of the above statements apply to the patient. In case of doubts, before starting to use Levofloxacin Kabi, the patient should talk to their doctor, nurse, or pharmacist.

Warnings and precautions

Before using this medicine, the patient should consult a doctor, nurse, or pharmacist if they:

• are 60 years old or older;
• use corticosteroids, sometimes called steroids (see "Levofloxacin Kabi and other medicines");
• have had seizures (seizure) in the past;
• have had brain damage caused by a stroke or other brain injury;
• have kidney problems;
• have a condition called "glucose-6-phosphate dehydrogenase deficiency"; the patient may be more prone to developing serious blood disorders while using this medicine;
• have had mental health problems in the past;
• have had heart problems: caution should be exercised when using this medicine if the patient has a congenital prolongation of the QT interval (visible in an ECG, i.e., an electrical activity test of the heart), has electrolyte disturbances in the blood (especially low potassium or magnesium levels in the blood), has a slow heart rate (bradycardia), has impaired heart function (heart failure), has had a heart attack (myocardial infarction) in the past, is a woman or an elderly person, or is taking other medicines that cause abnormal changes in the ECG (see "Levofloxacin Kabi and other medicines");
• have an enlarged major blood vessel (aortic or large peripheral artery aneurysm);
• have had an aortic dissection (tear in the aortic wall);
• have been diagnosed with heart valve problems;
• have had a family history of aortic aneurysm or aortic dissection, or congenital heart valve disease, or other risk factors or conditions (e.g., Marfan syndrome or Ehlers-Danlos syndrome, Turner syndrome, Sjögren's syndrome [an autoimmune inflammatory disease] or vascular diseases, such as Takayasu arteritis, giant cell arteritis, Behcet's disease, hypertension, or confirmed atherosclerosis, rheumatoid arthritis [joint disease] or endocarditis [heart infection]);
• suffer from diabetes;
• have had liver problems in the past;
• suffer from myasthenia gravis;
• have nerve damage (peripheral neuropathy);
• have had a severe skin rash or skin peeling and blistering and (or) ulcers in the mouth after using levofloxacin.

Severe skin reactions

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

• SJS or TEN may initially appear on the torso as red, target-like, or circular patches, often with blisters in the center. They can also occur as ulcers in the mouth, throat, nose, genitals, and eyes (red and swollen eyes). These severe skin rashes are often preceded by fever and (or) flu-like symptoms. These rashes can lead to widespread skin peeling, can be life-threatening, or cause death.
• In DRESS syndrome, flu-like symptoms and a rash on the face initially occur, followed by a widespread rash with a high body temperature, elevated liver enzymes, eosinophilia, and swollen lymph nodes. If a severe rash or any of these skin symptoms occur, the patient should stop taking levofloxacin and consult a doctor or seek immediate medical attention.

This medicine should not be used if the patient has ever had a severe side effect while taking a quinolone or fluoroquinolone antibiotic. In such a case, the patient should inform their doctor as soon as possible.

The patient should consult a doctor, nurse, or pharmacist if they are taking fluoroquinolones:

• In case of sudden severe abdominal, back, or chest pain, which may be a sign of an aortic aneurysm or dissection, the patient should immediately go to the emergency department. The risk of these changes may be higher in patients being treated with systemic corticosteroids.
• In case of sudden shortness of breath, especially when lying down, or swelling of the ankles, feet, or abdomen, or palpitations (feeling of rapid or irregular heartbeat), the patient should immediately consult a doctor.
• If the patient experiences sudden, involuntary muscle twitches, muscle tremors, or muscle spasms, they should immediately consult a doctor, as these may be symptoms of myoclonus. The doctor may decide to discontinue levofloxacin and initiate appropriate treatment.
• In case of nausea, general malaise, discomfort, or severe and persistent pain or worsening pain in the abdominal area or vomiting, the patient should immediately consult a doctor, as these may be symptoms of pancreatitis (acute pancreatitis). See section 2.
• If the patient experiences fatigue, pallor, bruising, uncontrolled bleeding, fever, sore throat, and significant deterioration of their condition or feeling of decreased resistance to infections, they should immediately consult a doctor, as these may be symptoms of blood disorders. The doctor should monitor the patient's blood count through a blood morphology test. If abnormalities are found in the blood morphology, the doctor may decide to discontinue treatment.
• Rarely, pain and swelling of the joints and tendon inflammation or rupture may occur. The risk is increased in elderly patients (over 60 years old), after organ transplantation, in cases of kidney problems, or during corticosteroid treatment. Tendon inflammation and rupture can occur within the first 48 hours of treatment and even several months after discontinuing Levofloxacin Kabi. After the first symptoms of pain or tendon inflammation appear (e.g., in the ankle, wrist, elbow, shoulder, or knee), the patient should discontinue Levofloxacin Kabi, consult a doctor, and rest the affected area. The patient should avoid excessive exertion, as this may increase the risk of tendon rupture.
• The patient may rarely experience symptoms of nerve damage (neuropathy), such as pain, burning, tingling, numbness, and (or) weakness, especially in the feet and legs and hands and arms. In such a case, the patient should discontinue Levofloxacin Kabi and immediately inform their doctor to prevent the development of potentially irreversible disease.

Long-term, disabling, and potentially irreversible severe side effects

Fluoroquinolone and quinolone antibacterial medicines, including Levofloxacin Kabi, have been associated with very rare but severe side effects. Some of these have been long-term (lasting for months or years), disabling, or potentially irreversible. These include: tendon pain, muscle pain, and joint pain in the upper and lower limbs, walking difficulties, abnormal sensations, such as tingling, burning, prickling, numbness, or itching (paresthesia), sensory disturbances, including vision, taste, and smell and hearing disturbances, depression, memory disturbances, severe fatigue, and severe sleep disturbances. If the patient experiences any of these side effects after taking Levofloxacin Kabi, they should immediately consult their doctor before continuing treatment. The patient and doctor will decide whether to continue treatment, also considering antibiotics from another group. If the patient is unsure whether any of the above statements apply to them, they should consult their doctor, pharmacist, or nurse before starting to use Levofloxacin Kabi.

Levofloxacin Kabi and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. This is because Levofloxacin Kabi may affect the action of other medicines. Other medicines may also affect the action of Levofloxacin Kabi.

In particular, the patient should inform their doctor if they are taking any of the following medicines, as the risk of side effects may increase when used with Levofloxacin Kabi.

Below.

• Corticosteroids, sometimes called steroids, used in inflammatory conditions. The patient may be more prone to developing tendonitis and (or) tendon rupture.
• Warfarin, used to thin the blood. The patient may be more prone to bleeding. The doctor may order regular blood tests to check blood clotting.
• Theophylline, used in breathing problems. The patient may be more prone to developing seizures (seizure) if they take Levofloxacin Kabi.
• Non-steroidal anti-inflammatory drugs (NSAIDs), used in pain and inflammatory conditions, e.g., acetylsalicylic acid, ibuprofen, fenbufen, ketoprofen, indomethacin. The patient may be more prone to developing seizures (seizure) if they take Levofloxacin Kabi.
• Cyclosporine, used after organ transplantation. The patient may be more prone to developing side effects of cyclosporine.
• Medicines that affect heart rhythm. This includes medicines used in irregular heart rhythm (anti-arrhythmic medicines, e.g., quinidine, hydroquinidine, disopyramide, sotalol, dofetilide, ibutilide, and amiodarone), in depression (tricyclic antidepressants, e.g., amitriptyline and imipramine), in mental disorders (antipsychotic medicines), and in bacterial infections (macrolide antibiotics, e.g., erythromycin, azithromycin, and clarithromycin).
• Probenecid, used in gout and cimetidine, used in the treatment of stomach ulcers and heartburn. Particular caution should be exercised when using any of these medicines with Levofloxacin Kabi. If the patient has kidney problems, the doctor may recommend a lower dose.

Tests for detecting opioids in urine

The results of tests for detecting strong painkillers, called opioids, in the urine may be falsely positive in patients taking Levofloxacin Kabi. If the doctor has prescribed a urine test, the patient should inform the doctor that they are taking Levofloxacin Kabi.

Tuberculosis tests

This medicine may give false negative results in some tests used by laboratories to detect the bacteria that cause tuberculosis.

Pregnancy and breastfeeding

This medicine should not be used if the patient:

• is pregnant, may become pregnant, or suspects that they may be pregnant;
• is breastfeeding or plans to breastfeed.

Driving and using machines

After using this medicine, the patient may experience side effects, including dizziness, drowsiness, feeling of spinning (dizziness), or vision disturbances. Some of these side effects may impair the patient's ability to concentrate and react quickly. In such a case, the patient should not drive vehicles or perform any work that requires attention.

Levofloxacin Kabi contains sodium

This medicine contains 177 mg of sodium (the main component of table salt) in 50 mL. This corresponds to 8.85% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to use Levofloxacin Kabi

How Levofloxacin Kabi is administered

• Levofloxacin Kabi is used in hospitals.
• The medicine will be administered to the patient by a doctor or nurse in the form of an injection. The injection will be given into one of the patient's veins and will take some time (this is called intravenous infusion).
• Levofloxacin Kabi in a dose of 250 mg is administered over 30 minutes or longer.
• Levofloxacin Kabi in a dose of 500 mg is administered over 60 minutes or longer.
• The doctor will carefully monitor the patient's pulse and blood pressure. This is because very rapid heartbeat and temporary drops in blood pressure are possible side effects that have been observed during the infusion of similar antibiotics. If the patient's blood pressure drops significantly during the infusion, the infusion should be stopped immediately.

What dose of Levofloxacin Kabi is administered

If the patient is unsure why they are receiving Levofloxacin Kabi or has any questions about the dose of Levofloxacin Kabi they are taking, they should talk to their doctor, nurse, or pharmacist.

• The doctor will decide what dose of Levofloxacin Kabi the patient should receive.
• The dose depends on the type and location of the infection.
• The duration of treatment depends on the severity of the infection.

Adult patients and elderly patients

• Pneumonia: 500 mg once or twice a day.
• Urinary system infections, including kidney or bladder infections: 500 mg once a day.
• Prostate gland infections: 500 mg once a day.
• Skin and subcutaneous tissue infections, including muscle infections: 500 mg once or twice a day.

Adult patients and elderly patients with impaired renal function

The doctor may recommend a lower dose.

Children and adolescents

This medicine should not be used in children and adolescents.

Protecting the skin from sunlight

During and for 2 days after using this medicine, the patient should avoid direct sunlight. This is because the patient's skin will become more sensitive to the sun, which can lead to sunburn, tingling, and the formation of large blisters on the skin if the patient does not take the following precautions:

• use UV filters with a high sun protection factor;
• always wear headgear and clothing that covers the arms and legs;
• avoid sunbathing.

Using a higher than recommended dose of Levofloxacin Kabi

It is unlikely that the doctor or nurse will administer too high a dose of the medicine. The doctor or nurse will monitor the patient's progress and check what medicine the patient is receiving. If the patient is unsure why they are receiving a dose of the medicine, they should always ask. If the patient receives too high a dose of Levofloxacin Kabi, the following symptoms may occur: seizures (seizure), confusion, dizziness, vision disturbances, muscle tremors, and heart disturbances leading to irregular heartbeat, as well as nausea.

Missing a dose of Levofloxacin Kabi

The doctor or nurse will know the recommendations for the timing and method of administering the medicine to the patient. It is unlikely that the patient will receive the medicine in any way other than as prescribed. If the patient thinks that a dose of the medicine has been missed, they should tell their doctor or nurse.

Stopping the use of Levofloxacin Kabi

The doctor or nurse will continue to administer the medicine, even if the patient feels better. If the treatment is stopped too early, the patient's condition may worsen or the bacteria may become resistant to the medicine. After a few days of treatment with the intravenous solution, the doctor may decide to change the form of the medicine to tablets to complete the prescribed treatment course. In case of any further doubts about the use of this medicine, the patient should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. They are usually mild or moderate and often disappear after a short time.

If the patient experiences any of the following side effects, they should stop using Levofloxacin Kabi and immediately consult their doctor or nurse.

Very rare(occurring in less than 1 in 10,000 patients)

• Allergic reaction. Symptoms may include: rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue.

If the patient experiences any of the following severe side effects, they should stop using Levofloxacin Kabi and immediately consult their doctor or nurse, as they may require immediate treatment.

Rare(occurring in less than 1 in 1,000 patients)

• Watery diarrhea, which may contain blood, sometimes with stomach cramps and high fever. These may be symptoms of serious intestinal problems.
• Pain and inflammation of tendons or ligaments, which can lead to rupture. This most often affects the Achilles tendon.
• Seizures (seizures).
• Seeing or hearing things that do not exist (hallucinations, paranoia).
• Feeling depressed, mentally disturbed, anxious (agitation), having unusual dreams or nightmares.
• Severe mental disturbances causing chaotic thinking and reduced awareness of the surroundings (delirium).
• Widespread rash, high body temperature, elevated liver enzymes, blood disorders (eosinophilia), swollen lymph nodes, and other body organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS). See also section 2.
• Syndrome associated with abnormal water excretion and low sodium levels (SIADH).
• Drop in blood sugar levels (hypoglycemia) or drop in blood sugar levels leading to coma (hypoglycemic coma). This is important in patients with diabetes.

Very rare(occurring in less than 1 in 10,000 patients)

• Burning, tingling, pain, or numbness. These may be symptoms of neuropathy.

Frequency not known(cannot be estimated from the available data)

• Severe skin rashes, including Stevens-Johnson syndrome and toxic epidermal necrolysis. These can occur as red, target-like, or circular patches, often with central blisters on the torso, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes, and may be preceded by fever and flu-like symptoms. See also section 2.
• Loss of appetite, yellowing of the skin and eyes, dark urine, itching, liver tenderness (abdominal pain). These may be symptoms of liver function disorders, which can include fatal liver damage.
• Changes in smell, loss of smell or taste (olfactory hallucinations, anosmia, ageusia).
• Feeling strongly excited, agitated, or enthusiastic (mania).
• Problems with movement and walking (dyskinesia, extrapyramidal disorders).
• Transient loss of consciousness or fainting (syncope).
• Transient loss of vision.
• Disturbances or loss of hearing.
• Abnormal, rapid heart rhythm, life-threatening irregular heartbeat, including cardiac arrest, change in heart rhythm (so-called "QT interval prolongation" visible in an ECG, i.e., an electrical activity test of the heart).
• Difficulty breathing or wheezing (bronchospasm).
• Allergic reactions in the lungs.
• Pancreatitis.
• Hepatitis.
• Increased sensitivity of the skin to sunlight and ultraviolet radiation (photosensitivity), discoloration (skin hyperpigmentation).
• Vasculitis (inflammation of blood vessels) due to an allergic reaction.
• Stomatitis (inflammation of the mucous membrane of the mouth).
• Muscle rupture (rhabdomyolysis).
• Redness and swelling of the joints (arthritis).
• Pain, including back pain, chest pain, and limb pain.
• Sudden, involuntary muscle twitches, muscle tremors, and muscle spasms (myoclonus).
• Porphyria attacks in patients with porphyria (a very rare metabolic disorder).
• Persistent headache with or without blurred vision (benign intracranial hypertension).

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of this medicine.

5. How to store Levofloxacin Kabi

The medicine should be stored out of the sight and reach of children. This medicine should not be used after the expiry date stated on the carton and container/vial after EXP. The expiry date refers to the last day of the month stated.

KabiPac container

Store the container in the outer packaging to protect it from light. Do not store in a refrigerator or freeze. FreeflexbagDo not store above 25°C. Store the bag in the outer packaging to protect it from light. Do not store in a refrigerator or freeze. Protection from light during infusion is not necessary. Levofloxacin Kabi should only be used if the solution is clear, greenish-yellow, and free from visible particles. Any unused solution should be discarded. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Levofloxacin Kabi contains

• The active substance of the medicine is levofloxacin.
• One mL of the solution contains 5 mg of levofloxacin.
• 50 mL of the solution for infusion contains 250 mg of levofloxacin.
• 100 mL of the solution for infusion contains 500 mg of levofloxacin.
• The other ingredients are: sodium chloride, sodium hydroxide, hydrochloric acid, and water for injections.

What Levofloxacin Kabi looks like and contents of the packaging

Levofloxacin Kabi is available as a solution for infusion (given in a drip). The solution is clear, greenish-yellow in color. It is supplied in:

• a polyethylene container (KabiPac) with a capacity of 100 mL, containing 50 mL or 100 mL of solution (1, 10, 20, or 25 containers in a cardboard box);
• a polyolefin bag of the freeflextype with a capacity of 100 mL, containing 50 mL or 100 mL of solution (10 or 20 bags in a cardboard box).

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Fresenius Kabi Polska Sp. z o.o., Al. Jerozolimskie 134, 02-305 Warsaw

Manufacturer

KabiPac containers

Fresenius Kabi Polska Sp. z o.o., Infusion Fluids Factory, ul. Sienkiewicza 25, 99-300 Kutno

Freeflexbags

HP Halden Pharma AS, Svinesundsveien 80, 1788 Halden, Norway

For more detailed information, the patient should contact the marketing authorization holder: Fresenius Kabi Polska Sp. z o.o., Al. Jerozolimskie 134, 02-305 Warsaw, tel.: +48 22 345 67 89

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

Austria

Levofloxacin Kabi 5 mg/ml Infusionslösung

Belgium

Levofloxacine Fresenius Kabi 5mg/ml oplossing voor infusie

Bulgaria

Левофлоксацин Каби 5 mg/ml инфузионен разтвор

Cyprus

Levofloxacin Kabi 5 mg/ml διάλυμα για έγχυση

Czech Republic

Levofloxacin Kabi

Germany

Levofloxacin Kabi 5 mg/ml Infusionslösung

Finland

Levofloxacin Fresenius Kabi 5 mg/ml infuusioneste, liuos

Hungary

Levofloxacin Kabi 5 mg/ml oldatos infúzió

Ireland

Levofloxacin 5 mg/ml solution for infusion

Italy

Levofloxacina Kabi

Luxembourg

Levofloxacin Kabi 5 mg/ml Infusionslösung

Malta

Levofloxacin 5 mg/ml solution for infusion

Netherlands

Levofloxacine Fresenius Kabi 5mg/ml oplossing voor infusie

Poland

Levofloxacin Kabi

Portugal

Levofloxacina Kabi

Romania

Levofloxacin Kabi 5 mg/ml solutie perfuzabila

Slovakia

Levofloxacin Kabi 5mg/ml infúzny roztok

Slovenia

Levofloksacin Kabi 5 mg/ml raztopina za infundiranje

Spain

Levofloxacino Kabi 5 mg/ml solución para perfusión

Date of last revision of the leaflet:21.02.2025

Information intended for healthcare professionals only:

Administration

• Levofloxacin Kabi is administered as a slow intravenous infusion.
• The container/bag should be inspected before use. The medicine can only be used if the solution is clear, greenish-yellow, and free from visible particles.

Infusion time

• The recommended infusion time for Levofloxacin Kabi is at least 30 minutes for a dose of 250 mg or 60 minutes for a dose of 500 mg.
• Protection from light during infusion is not necessary.
• It is known that during intravenous infusion of ofloxacin (an isomer of levofloxacin), tachycardia (abnormal rapid heartbeat) and hypotension (low blood pressure) may occur, and in rare cases, circulatory collapse may occur.
• If a significant drop in blood pressure occurs during the infusion of levofloxacin, the infusion should be stopped immediately.

Dosing in patients with normal renal function (creatinine clearance above 50 mL/min.)

• Dosing in patients with normal renal function, depending on the indication, is described in section 3, "How to use Levofloxacin Kabi".

Dosing in patients with impaired renal function (creatinine clearance ≤50 mL/min.)

No additional doses are needed after hemodialysis or continuous ambulatory peritoneal dialysis (CAPD).

Compatible solutions

Mixing with other infusion solutions.

Levofloxacin Kabi, solution for infusion, is compatible with the following infusion fluids:

• 50 mg/mL (5%) glucose solution;
• 25 mg/mL (2.5%) glucose solution in Ringer's solution;
• 9 mg/mL (0.9%) sodium chloride solution;
• combined solutions for parenteral nutrition (amino acids, carbohydrates, electrolytes).

Incompatibilities

• Levofloxacin Kabi should not be mixed with heparin or alkaline solutions (e.g., sodium bicarbonate).

Storage conditions

• Store the medicine in the outer packaging to protect it from light.
• Do not store in a refrigerator or freeze.
• Levofloxacin Kabi should be used immediately (within 3 hours) after opening to prevent bacterial contamination.