LEVOFLOXACIN KABI 5 mg/mL SOLUTION FOR INFUSION

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Levofloxacino Kabi 5mg/ml solution for infusion EFG

Levofloxacino

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Keep this leaflet, you may need to read it again.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information:

1. What is Levofloxacino Kabi and what is it used for
2. What you need to know before you use Levofloxacino Kabi
3. How to use Levofloxacino Kabi
4. Possible side effects

5 Conservation of Levofloxacino Kabi

1. Contents of the pack and additional information

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

The name of this medicine is Levofloxacino Kabi. Levofloxacino Kabi contains the active substance levofloxacin, which belongs to a group of medicines called antibiotics. Levofloxacin is a type of antibiotic known as a quinolone, and it works by killing the bacteria that cause infections in your body.

Levofloxacino Kabi 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 Kabi can be used to reduce the possibility of acquiring a lung infection called anthrax or worsening of this disease after being exposed to the bacteria that cause anthrax.

2. What you need to know before you use Levofloxacino Kabi

Do not use this medicine and consult your doctor 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 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 become 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, nurse, or pharmacist before using Levofloxacino Kabi.

Warnings and precautions

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

• You are 60 years old or older
• You are taking corticosteroids, sometimes called steroids (see section "Use of Levofloxacino Kabi with other medicines")

• You have had a seizure (convulsions)
• 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 problems
• You have ever had heart problems: you should be careful when taking this medicine if you have a family history of prolonged QT interval or if you were born with a prolonged QT interval (observed in a heart electrocardiogram), if you have a very slow heart rate (called bradycardia), if you have a weak heart (heart failure), a history of heart attacks (myocardial infarction), if you are a woman or of advanced age or are taking other medicines that may cause abnormal changes in the electrocardiogram (see section "Use of Levofloxacino Kabi with other medicines")
• If you have been diagnosed with an aneurysm of a large blood vessel (aortic aneurysm or peripheral large 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 aneurysmor aortic dissection, congenital heart valve disease, or other risk factors or predisposing disorders (e.g., connective tissue disorders such as Marfan syndrome or 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)

• You are diabetic
• You have ever had liver problems
• You have myasthenia gravis
• You have nerve problems (peripheral neuropathy)
• You have developed a severe skin rash or skin peeling, blisters, and/or sores in the mouth after taking levofloxacin

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 levofloxacin.

• SJS/TEN may initially appear on the trunk as reddish targets or circular patches, often with blisters in the center. They can also appear 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. The rashes can progress to widespread skin peeling and life-threatening or fatal complications.
• DRESS is initially manifested with 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 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 that contain fluoroquinolones or quinolones, including Levofloxacino Kabi, if you have experienced any 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, nurse, or pharmacist while taking fluoroquinolones if

• If you feel a sudden and severe pain in the abdomen, chest, 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 onset of 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 and involuntary jerks, muscle spasms, or contractions - consult a doctor immediately, as these could be signs of myoclonus. Your doctor may need to interrupt treatment with levofloxacin and initiate appropriate treatment.
  • If you have nausea, general discomfort, have intense discomfort or continuous pain, or worsening pain in the stomach area, or if you vomit - consult a doctor immediately, as this could be a sign of pancreatitis (acute pancreatitis).
  • 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 can 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 Kabi. At the first sign of pain or inflammation of a tendon (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking Levofloxacino Kabi, contact your doctor, and rest the affected area. Avoid any unnecessary exercise, as this could 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 Kabi and inform your doctor immediately to prevent the development of a potentially irreversible disorder.

Severe, long-lasting, and potentially irreversible adverse effects

Antibacterial medicines that contain fluoroquinolones or quinolones, including Levofloxacino Kabi, have been associated with very rare but severe adverse effects, some of which were long-lasting (persistent 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, and hearing, depression, decreased memory, intense fatigue, and severe sleep disorders.

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

Inform your doctor or pharmacist before taking Levofloxacino Kabi if you are not sure if any of the above cases apply to you.

Use of Levofloxacino Kabi with other medicines

Tell your doctor or pharmacist that you are using, have recently used, or might use any other medicine. This is because Levofloxacino Kabi can affect the functioning of other medicines. Additionally, some medicines can affect the functioning of Levofloxacino Kabi.

In particular, inform your doctor if you are taking any of the following medicines, as this increases the likelihood of experiencing adverse effects when taking them with Levofloxacino Kabi:

• Corticosteroids, sometimes called steroids - used for inflammation. You may have a higher probability of experiencing tendon inflammation and/or rupture
• Warfarin - used to make the blood more liquid. You may have a higher probability of experiencing bleeding. Your doctor may need to perform periodic blood tests to check if your blood is clotting correctly
• Theophylline - used for respiratory problems. You have a higher probability of experiencing a seizure (convulsions) if you take it with Levofloxacino Kabi
• Non-steroidal anti-inflammatory drugs (NSAIDs) - used for pain and inflammation, such as acetylsalicylic acid, ibuprofen, fenbufen, ketoprofen, indomethacin. You have a higher probability of experiencing a seizure (convulsions) when taking them with Levofloxacino Kabi
• Cyclosporin - used after organ transplants. You may have a higher probability of experiencing the adverse effects of cyclosporin
• Medicines with a known effect on your heartbeats. 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) and cimetidine (used for ulcers and heartburn). You should be particularly careful when taking these medicines with Levofloxacino Kabi. If you have kidney problems, your doctor may want to give you a lower dose.

Determination of opiates in urine

Urine tests may show "false positive" results for the presence of strong painkillers called "opiates" in patients using Levofloxacino Kabi. Inform your doctor that you are using Levofloxacino Kabi 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 cause tuberculosis.

Pregnancy and breastfeeding

Do not use this medicine if:

• you are pregnant, may become 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 can affect your ability to concentrate or reduce your reaction time. If this happens, do not drive or perform any work that requires a high level of attention.

Levofloxacino Kabi contains sodium.

This medicine contains 177 mg of sodium (the main component of table salt / cooking salt) in 50 ml. This is equivalent to 8.85% of the maximum recommended daily intake of sodium for an adult.

3. How to use Levofloxacino Kabi

How to use Levofloxacino Kabi

• Levofloxacino Kabi is a medication for hospital use
• For Levofloxacino Kabi 250 mg solution for infusion, the infusion time will be 30 minutes or more
• For Levofloxacino Kabi 500 mg solution for infusion, 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 being administered the infusion, it will be interrupted immediately.

How much Levofloxacino Kabi is administered

If you are not sure why you are being administered Levofloxacino Kabi or have any questions about how much Levofloxacino Kabi you are being administered, consult your doctor, nurse, or pharmacist.

• Your doctor will decide how much Levofloxacino Kabi you should be administered
• 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 soft tissue infections, including muscles: 500 mg once or twice a day

Adults and elderly patients with kidney problems

Your doctor may administer a lower dose to you.

Children and adolescents

This medication should not be administered to children or adolescents.

Protect your skin from sunlight

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

• Make sure to use high-protection sunscreens
• Always wear a hat and clothing that covers your arms and legs
• Avoid ultraviolet lamps

If you use more Levofloxacino Kabi than you should

If you are administered more Levofloxacino Kabi 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).

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicology Information Service, phone 91 562 04 20 (indicating the medication and the amount ingested)

If you forget to use Levofloxacino Kabi

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

If you interrupt treatment with Levofloxacino Kabi

Your doctor or nurse will continue to administer Levofloxacino Kabi to you, even if you feel better. If treatment is interrupted too early, you may worsen 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, Levofloxacino Kabi can cause side effects, although not everyone will experience them. They are usually mild to moderate and tend to disappear in a short time.

Stop treatment with Levofloxacino Kabi 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 Kabi 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
• Severe alteration of mental abilities that causes confusion in thoughts and decreased awareness of the environment (delirium)
• Widespread rash, high body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes, and other body 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)
• Decrease in blood sugar levels (hypoglycemia) or decrease in 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"

Frequency not known(cannot be estimated from the 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 flu-like symptoms. See also section 2
• Lack of appetite, yellowing of skin and eyes, dark urine, itching, or painful stomach (abdomen). These can be signs of liver problems that can include fulminant 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 Kabi.

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, pain in the extremities, difficulty walking, abnormal sensations such as pinching, tingling, burning, numbness, or pain (neuropathy), fatigue, decreased memory and concentration, effects on mental health (which can include sleep disorders, anxiety, panic attacks, depression, and suicidal ideas), 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 heart valve problems in patients who have received fluoroquinolones. See also section 2.

Tell your doctor if 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)
• Decrease in blood sugar levels (hypoglycemia). This is important for diabetic patients
• Feeling of tingling in hands and feet (paresthesia)
• Ear (tinnitus) or vision (blurred vision) disorders
• 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
• Red, clearly defined patches with or without blisters that develop a few hours after administration of levofloxacin and heal with residual post-inflammatory hyperpigmentation; usually, they recur in the same area of the skin or mucous membrane after subsequent exposure to levofloxacin
• Memory impairment

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

• Decrease in red blood cells (anemia): this can cause the skin to become pale or yellow 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) or decreased blood sugar levels that can lead to coma (hypoglycemic coma). 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
• Hearing or vision problems
• Abnormally fast heartbeat, irregular heartbeat with life-threatening risk, including cardiac arrest, alteration of heart rhythm (called "prolongation of the QT interval", observed in the ECG, graphical representation of the heart's electrical activity)
• Difficulty breathing or wheezing (bronchospasm)
• Pulmonary allergic reactions
• Pancreas inflammation (pancreatitis)
• Liver inflammation (hepatitis)
• 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 nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Levofloxacino Kabi

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date that appears on the vial and box after CAD. The expiration date is the last day of the month indicated.

KabiPac vials:

Keep the medication in the outer packaging to protect it from light. Do not refrigerate or freeze.

Freeflex bags:

Do not store at a temperature above 25°C

Keep the container in the outer packaging to protect it from light. Do not refrigerate or freeze.

It does not need to be protected from light during infusion.

Levofloxacino Kabi should only be used if it is a clear, yellow-green solution and free of particles. Discard the leftover solution.

Medications should not be thrown down the drain or into the trash. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Container Content and Additional Information

Composition of Levofloxacino Kabi

• The active ingredient is levofloxacin.
• Each ml of solution contains 5 mg of levofloxacin.
• 50 ml of infusion solution contain 250 mg of levofloxacin.
• 100 ml of infusion solution contain 500 mg of levofloxacin.
• The other components are sodium chloride, sodium hydroxide, hydrochloric acid, and water for injectable preparations.

Appearance of the Product and Container Content

Levofloxacino Kabi is an infusion solution (to be administered with a dropper). The solution is transparent and yellowish-green.

It is supplied in:

• KabiPac polyethylene vials of 100 ml filled with 50 ml or 100 ml (1, 10, 20 or 25 vials per package).
• Freeflex polyethylene bag systems of 100 ml filled with 50 ml or 100 ml (10 or 20 bags per package).

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer Marketing Authorization Holder

Fresenius Kabi España, S.A.U

Marina, 16-18

08005 Barcelona (Spain)

Manufacturer

Vials:

Fresenius Kabi Polska Sp. Z o.o.

Wytwórnia Plynów Infuzyjnych

99-300 Kutno, Sienkiewicza 25 (Poland)

Freeflex® Bags:

HP Halden Pharma AS

Svinesundsveien 80

1788 Halden

Norway

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

AustriaLevofloxacin Kabi 5 mg/ml Infusionslösung

BelgiumLevofloxacine Fresenius Kabi 5mg/ml oplossing voor infusie

Bulgaria????????????? ???? 5 mg/ml ?????????? ???????

CyprusLevofloxacin Kabi 5 mg/ml δι?λυμα για ?γχυση

Czech RepublicLevofloxacin Kabi

GermanyLevofloxacin Kabi 5 mg/ml Infusionslösung

FinlandLevofloxacin Fresenius Kabi 5 mg/ml infuusioneste, liuos

HungaryLevofloxacin Kabi 5 mg/ml oldatos infúzió

IrelandLevofloxacin 5 mg/ml solution for infusion

ItalyLevofloxacina Kabi

LuxembourgLevofloxacin Kabi 5 mg/ml Infusionslösung

MaltaLevofloxacin 5 mg/ml solution for infusion

NetherlandsLevofloxacine Fresenius Kabi 5mg/ml oplossing voor infusie

PolandLevofloxacin Kabi

PortugalLevofloxacina Kabi

RomaniaLevofloxacin Kabi 5 mg/ml solutie perfuzabila

SlovakiaLevofloxacin Kabi 5mg/ml infúzny roztok

SloveniaLevofloksacin Kabi 5 mg/ml raztopina za infundiranje

SpainLevofloxacino Kabi 5 mg/ml solución para perfusión EFG.

This leaflet was approved in February 2025

“Detailed and updated information on this medicinal product is available on the website

of the Spanish Agency for Medicines and Health Products (AEMPS)

http://www.aemps.gob.es”

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This information is intended only for healthcare professionals:

Administration

• Levofloxacin Kabi is administered by slow intravenous infusion.
• Inspect the vial/bag before use. It should only be administered if the solution is

transparent, yellowish-green, and practically free of particles.

Infusion Time

• The recommended infusion time is at least 30 minutes for 250 mg or 60 minutes for 500

mg of Levofloxacino Kabi.

• During infusion, it is not necessary to protect the solution from light.
• It is known that ofloxacin (a component related to levofloxacin) infusions can cause

tachycardia (abnormal rapid heartbeat) and decreased blood pressure, and in rare cases, collapse.

• If a significant drop in blood pressure is observed during infusion with levofloxacin, the

infusion should be interrupted immediately.

Dosage in Patients with Normal Renal Function (Creatinine Clearance > 50 ml/min)

• The dosage in patients with normal renal function depends on the indication, as described in

section 3 “How to use Levofloxacino Kabi”.

Dosage in Patients with Impaired Renal Function (Creatinine Clearance ≤ 50 ml/min)

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

Compatibilities

Mixing with other infusion solutions:

Levofloxacino Kabi is compatible with the following infusion solutions:

• Glucose 50 mg/ml (5%).
• Glucose-Ringer 25 mg/ml (2.5%).
• Sodium chloride 9 mg/ml (0.9%).
• Combined solutions for parenteral nutrition (amino acids, carbohydrates, electrolytes).

Incompatibilities

• It should not be mixed with heparin or alkaline solutions (e.g., sodium hydrogen carbonate).

Storage

Keep the medicinal product in the outer packaging to protect it from light.

Do not refrigerate or freeze.

Levofloxacin should be used immediately (within 3 hours) after opening to prevent

bacterial contamination.