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

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Levofloxacino Kabi 5mg/ml infusion solution EFG

Levofloxacin

Read all of this leaflet carefully before you start using 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, ask your doctor, nurse or pharmacist.
If you experience any side effects, talk to your doctor, nurse or pharmacist, even if it is a side effect not listed in this leaflet. See section 4.

Contents of the leaflet:

What Levofloxacino Kabi is and what it is used for
What you need to know before using Levofloxacino Kabi
How to use Levofloxacino Kabi
Possible side effects
Storage of Levofloxacino Kabi
Contents of the pack and other information

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

The name of this medicine is Levofloxacino Kabi. Levofloxacino Kabi contains an active substance called levofloxacin, which belongs to a group of medicines known as antibiotics. Levofloxacin is an antibiotic of the quinolone type and 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.

It is important that you follow your doctor's instructions regarding dosage, dosing interval, and duration of treatment.

Do not store or reuse this medication. If you have leftover antibiotics after completing treatment, return them to the pharmacy for proper disposal. Medicines must not be disposed of via wastewater or household waste.

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 beneath the skin, including muscles. This is sometimes referred to as "soft tissues".

In certain special situations, Levofloxacino Kabi can be used to reduce the chance of acquiring a lung infection called anthrax or to prevent worsening of this disease after exposure to the bacteria that cause anthrax.

2. What you need to know before using 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 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 previously suffered from epilepsy.
You have ever had tendon problems, such as tendinitis, related to taking quinolone-type medicines. Tendons are the tissues connecting your muscles to the skeleton.
You are a child or adolescent undergoing growth.
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, 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 of age or older.
You are taking corticosteroids, sometimes called steroids (see section "Use of Levofloxacino Kabi with other medicines").
You have ever had a seizure (convulsions).
You have suffered brain damage due to 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 serious blood problems while taking this medicine.
You have ever had mental health problems.
You have ever had heart problems: you should be cautious when taking this medicine if you have a family history of prolonged QT interval or were born with prolonged QT interval (seen on an electrocardiogram), if you have a very slow heart rate (called bradycardia), if you have a weak heart (heart failure), history of heart attacks (myocardial infarction), if you are female or elderly, or if you 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 enlargement or a "bulge" in a large blood vessel (aortic aneurysm or peripheral large vessel aneurysm)
- If you have previously experienced aortic dissection (tear in the wall of the aorta)
- If you have been diagnosed with heart valve insufficiency (regurgitation of heart valves)
- If you have a family history of aortic aneurysm or aortic dissection, congenital heart valve disease, or other risk factors or predisposing disorders (e.g., connective tissue disorders such as Marfan syndrome or 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, known atherosclerosis, rheumatoid arthritis (a joint disease), or endocarditis (a heart infection))
You are diabetic.
You have ever had liver problems.
You suffer from myasthenia gravis.
You suffer from nerve problems (peripheral neuropathy).
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. Sores may also appear 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 may progress to widespread skin peeling and life-threatening or fatal complications.
DRESS initially presents with flu-like symptoms and a rash on the face, followed by a more widespread rash, fever, elevated liver enzymes in blood tests, increased 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.

You should not take antibacterial medicines containing fluoroquinolones or quinolones, including Levofloxacino Kabi, 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, nurse, or pharmacist while taking fluoroquinolones if:

You experience sudden, severe pain in the abdomen, chest, or back, which may be symptoms of aortic dissection or aneurysm—seek emergency medical help immediately. The risk may increase if you are receiving systemic corticosteroid treatment.
You begin to experience sudden onset of shortness of breath, especially when lying down, or notice swelling in your ankles, feet, or abdomen, or develop palpitations (sensation of rapid or irregular heartbeat)—inform your doctor immediately.
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 experience nausea, general discomfort, severe discomfort or persistent or worsening stomach pain, 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 had an organ transplant, have kidney problems, or are taking corticosteroids. Tendon inflammation and rupture may occur within the first 48 hours of treatment or even several months after stopping Levofloxacino Kabi. At the first sign of tendon pain or inflammation (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking Levofloxacino Kabi, contact your doctor, and rest the affected area. Avoid unnecessary physical activity, as this may 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 Levofloxacino Kabi 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 containing fluoroquinolones or quinolones, including Levofloxacino Kabi, have been associated with very rare but serious adverse effects, some of which are 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 loss, severe fatigue, and serious 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 treatment, possibly considering the use of an antibiotic from another class.

Inform your doctor or pharmacist before taking Levofloxacino Kabi if you are unsure whether any of the above conditions apply to you.

Use of Levofloxacino Kabi with other medicines

Inform your doctor or pharmacist if you are currently taking, have recently taken, or might need to take any other medicines. This is because Levofloxacino Kabi may affect the action of other medicines. Additionally, some medicines may affect the action of Levofloxacino Kabi.

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 Kabi:

Corticosteroids, sometimes called steroids—used for inflammation. You may have an increased risk of tendon inflammation and/or rupture.
Warfarin—used to thin the blood. You may have an increased risk of bleeding. Your doctor may need periodic blood tests to monitor blood clotting.
Theophylline—used for respiratory problems. You may have an increased risk of seizures when taken with Levofloxacino Kabi.
Non-steroidal anti-inflammatory drugs (NSAIDs)—used for pain and inflammation, such as acetylsalicylic acid, ibuprofen, fenbufen, ketoprofen, indomethacin. You may have an increased risk of seizures when taken with Levofloxacino Kabi.
Cyclosporine—used after organ transplants. You may have an increased risk of cyclosporine adverse effects.
Medicines known to affect heart rhythm. These include medicines used for abnormal heart rhythms (antiarrhythmics such as quinidine, hydroquinidine, disopyramide, sotalol, dofetilide, ibutilide, and amiodarone), for depression (tricyclic antidepressants such as amitriptiline 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). Special caution is needed when taking these medicines with Levofloxacino Kabi. If you have kidney problems, your doctor may prescribe a lower dose.

Opiate testing in urine

Urine tests may show "false positive" results for strong painkillers known as "opiates" in patients taking Levofloxacino Kabi. Inform your doctor that you are taking Levofloxacino Kabi 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

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 using machines

Some adverse effects such as dizziness, drowsiness, loss of balance (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 Kabi contains sodium.

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

3. How to use Levofloxacino Kabi

How to use Levofloxacino Kabi

Levofloxacino Kabi is a hospital-use medicine.
It will be administered by your doctor or nurse as an injection into one of your veins over a period of time (this is called intravenous infusion).
For Levofloxacino Kabi 250 mg solution for infusion, the infusion time will be 30 minutes or longer.
For Levofloxacino Kabi 500 mg solution for infusion, the infusion time will be 60 minutes or longer.
Your heart rate and blood pressure will be monitored frequently. This is because an unusually rapid heartbeat and a temporary drop in blood pressure are possible adverse 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 Kabi is administered

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

Your doctor will decide the appropriate dose of Levofloxacino Kabi 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 underlying tissue infection, 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 when cloudy) during treatment with this medicine and for two days after stopping it, as your skin may become much more sensitive to sunlight and could burn, sting, or even blister if you do not take the following precautions:

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

If you use more Levofloxacino Kabi than you should

It is unlikely that your doctor or nurse will administer 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 Kabi than needed, the following effects may occur: epileptic seizures (convulsions), confusion, dizziness, decreased consciousness, tremors, heart disorders that may cause irregular heartbeat, and gastrointestinal discomfort (nausea).

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at 91 562 04 20 (indicating the medicine and the amount ingested).

If you forget to use Levofloxacino Kabi

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 Kabi

Your doctor or nurse will continue administering Levofloxacino Kabi even if you feel better. Stopping treatment too early may cause your condition to worsen or lead to bacterial resistance 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 the treatment.

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

4. Possible adverse effects

Like all medicines, Levofloxacino Kabi can cause adverse effects, although not everyone will experience them. Usually, these effects are mild to moderate and tend to disappear quickly.

Stop treatment with Levofloxacino Kabi and contact a doctor or nurse or go to a hospital immediately if you notice 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 Kabi and contact a doctor or nurse immediately if you notice the following serious adverse effects, as you may require urgent medical treatment:

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

Watery diarrhoea that may contain blood, possibly with stomach cramps and fever. These could be signs of a serious bowel problem
Pain and inflammation in tendons or ligaments, which could lead to rupture. The Achilles tendon is most commonly affected
Seizures (convulsions)
Seeing or hearing things that are not real (hallucinations, paranoia)
Depression, mental disorders, feeling restless (agitation), abnormal dreams or nightmares
Severe disturbance of mental function causing confusion in thinking and reduced awareness of surroundings (delirium)
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 disturbances in water elimination 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”

Frequency not known (cannot be estimated from available data)

Severe skin rashes including Stevens-Johnson syndrome and toxic epidermal necrolysis. These may appear on the trunk as reddish macules in target-like shapes or circular spots, often with blisters in the centre, skin peeling, mouth, throat, nose, genital or eye ulcers, and may be preceded by flu-like symptoms. See also section 2
Loss of appetite, yellowing of skin and eyes, dark urine, burning sensation or painful abdomen. These may be signs of liver problems which may include fulminant liver failure
Changes in thoughts and thinking (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 experience 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, limb pain, difficulty walking, abnormal sensations such as pricking, tingling, pins and needles, burning, numbness or pain (neuropathy), fatigue, reduced memory and concentration, effects on mental health (which may include sleep disorders, anxiety, panic attacks, depression and suicidal thoughts), reduced hearing, vision, taste and smell, in some cases regardless of the presence of pre-existing risk factors.

Cases of enlargement and weakening or tearing of the aortic wall (aneurysms and dissections), which could lead to rupture and potentially be fatal, and heart valve insufficiency have been reported in patients who have received 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
Discomfort (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 caused by a fungus called Candida, which may require treatment
Changes in the number of white blood cells in your blood test results (leucopenia, eosinophilia)
Stress (anxiety), confusion, nervousness, drowsiness, tremors, sensation of dizziness (vertigo)
Difficulty breathing (dyspnoea)
Changes in taste, loss of appetite, stomach disorders or indigestion (dyspepsia), pain in the stomach area, bloating sensation (flatulence) or constipation
Itching and skin rash, intense itching or hives (urticaria), excessive sweating (hyperhidrosis)
Joint pain or muscle pain
Abnormal values in your blood tests due to liver problems (increased bilirubin) or kidney problems (increased creatinine)
Generalised 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 the number of white blood cells in the blood (neutropenia)
Exaggerated immune response (hypersensitivity)
Decrease in blood sugar levels (hypoglycaemia). This is important for diabetic patients
Tingling sensation in hands and feet (paraesthesia)
Disorders of the ear (tinnitus) or vision (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 disorder)
Changes in kidney function and occasionally, kidney failure which may result from an allergic-type kidney reaction called interstitial nephritis
Fever
Clearly defined erythematous spots with or without blisters appearing within hours of levofloxacin administration and healing with post-inflammatory residual hyperpigmentation; usually recurring at the same skin or mucosal site after subsequent exposure to levofloxacin
Memory impairment

Frequency not known (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 tiredness, 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) or decreased blood sugar levels that may lead to coma (hypoglycaemic coma). This is important for 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
Hearing problems or loss
Abnormally fast 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 type of adverse effect, consult your doctor or nurse, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Levofloxacino Kabi

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

Do not use this medicine after the expiry date stated on the vial and carton after EXP. The expiry date refers to the last day of the month indicated.

KabiPac vials:

Store the medicine in its outer packaging to protect it from light. Do not refrigerate or freeze.

Freeflex® bags:

Do not store above 25°C.

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

Protection from light is not required during infusion.

Levofloxacino Kabi should only be used if it is a clear, yellowish-green solution free from particles. Discard any remaining solution.

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

6. Contents of the container and other information

Composition of Levofloxacino Kabi

The active substance 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 injections.

Appearance of the product and contents of the container

Levofloxacino Kabi is an infusion solution (to be administered via an infusion set). The solution is clear 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 pack).
Freeflex® polyethylene bags of 100 ml filled with 50 ml or 100 ml (10 or 20 bags per pack).

Only certain pack 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 Płynów 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:

Austria Levofloxacin Kabi 5 mg/ml Infusionslösung
Belgium Levofloxacine Fresenius Kabi 5mg/ml oplossing voor infusie
Bulgaria ????????????? ???? 5 mg/ml ?????????? ???????
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 EFG.

This summary of product characteristics was approved in February 2025

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

This information is intended for healthcare professionals only:

Administration

Levofloxacin Kabi is administered by slow intravenous infusion.
Inspect the vial/bag before use. The solution should only be administered if it is clear, yellowish-green, and practically free from particles.

Infusion time

The recommended infusion duration is at least 30 minutes for 250 mg or 60 minutes for 500 mg of Levofloxacino Kabi.
The solution does not need to be protected from light during infusion.
Infusions of ofloxacin (a related compound to levofloxacin) are known to cause tachycardia (abnormally fast heart rate) and decreased blood pressure, and in rare cases, collapse.
If a marked drop in blood pressure is observed during levofloxacin infusion, the infusion must be stopped immediately.

Dosage in patients with normal renal function (creatinine clearance > 50 ml/min)

The dose 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)

	Dosing regimen
250 mg/24 h	500 mg/24 h	500 mg/12 h
Creatinine clearance	initial dose: 250 mg	initial dose: 500 mg	initial dose: 500 mg
50 - 20 ml/min	then: 125 mg/24 h	then: 250 mg/24 h	then: 250 mg/12 h
19-10 ml/min	then: 125 mg/48 h	then: 125 mg/24 h	then: 125 mg/12 h
< 10 ml/min (including hemodialysis and CAPD) 1	then: 125 mg/48 h	then: 125 mg/24 h	then: 125 mg/24 h

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 parenteral nutrition solutions (amino acids, carbohydrates, electrolytes).

Incompatibilities

Must not be mixed with heparin or alkaline solutions (e.g. sodium hydrogen carbonate).

Storage

Keep the medicine 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.