PATIENT INFORMATION LEAFLET

Levofloxacino Kabi 5mg/ml infusion solution EFG

Levofloxacino

Read 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 they appear in this leaflet. See section 4.

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

2.What you need to know before using Levofloxacino Kabi

3.How to use Levofloxacino Kabi

4.Possible side effects

5Storage of Levofloxacino Kabi

6.Contents of the pack and additional information

This medication is called Levofloxacino Kabi. Levofloxacino Kabi contains an active ingredient called levofloxacino, which belongs to a group of medications known as antibiotics. Levofloxacino is a type of antibiotic called 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 tissues".

In certain special situations, Levofloxacino Kabi may be used to reduce the likelihood of acquiring a type of lung infection called anthrax or a worsening of the disease after exposure to the bacteria that causes anthrax.

Do not use this medicine and consult your doctor if:

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

-You experience signs of an allergic reaction, including: skin rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue.

-You have or have had epilepsy.

-You have ever had problems with tendons, such as tendinitis, that were related to taking quinolone-type medicines. The tendon is the tissue that connects your muscle to your skeleton.

-You are a child or adolescent in the growth period.

-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. In case of 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 ever had a seizure (convulsion).

-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 severe blood problems when taking this medicine.

-You have ever had mental health problems.

-You have ever had heart problems: you must 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 on an electrocardiogram of the heart), if you have a very slow heart rate (called bradycardia), if you have a weak heart (heart failure), a history of heart attack (myocardial infarction), if you are a woman or elderly, or if you are taking other medicines that can cause abnormal changes in the electrocardiogram (see section "Use of Levofloxacino Kabi with other medicines").

-You have been diagnosed with an aneurysm of a large artery (aortic aneurysm or aneurysm of a large peripheral artery).

• •If you have had a previous episode of 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 conditions (e.g., 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, known 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 ever developed a severe skin rash or peeling of the skin, blisters, and/or mouth sores after taking levofloxacino.

Severe skin reactions

Severe skin reactions, including Stevens-Johnson syndrome, 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 red, ring-shaped spots or circular patches often with blisters in the center. They may also appear as ulcers in the mouth, throat, nose, genitals, and eyes (red, swollen eyes). These severe skin eruptions often precede fever and/or flu-like symptoms. The eruptions may progress to generalized skin peeling and potentially life-threatening or fatal complications.

•DRESS initially presents 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 increased eosinophils and enlarged lymph nodes.

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

You should not take fluoroquinolone or quinolone antibiotics, including Levofloxacino Kabi, if you have had a severe reaction to a quinolone or fluoroquinolone in the past. If this is the case, inform your doctor as soon as possible.

Consult your doctor, nurse, or pharmacist while taking fluoroquinolones if:

•You experience sudden, intense pain in the abdomen, chest, or back, which may be symptoms of aortic dissection or aneurysm, seek immediate emergency care. The risk may be increased if you are receiving systemic corticosteroid treatment.

•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 palpitations (sensation of rapid or irregular heartbeat), inform your doctor immediately.

•You start experiencing sudden, involuntary muscle contractions, muscle spasms, or muscle contractions - consult a doctor immediately, as these may be signs of myoclonia. Your doctor may need to interrupt levofloxacin treatment and initiate appropriate treatment.

• •If you experience nausea, general discomfort, have intense or persistent pain, or worsening pain in the abdominal area or vomiting - consult a doctor immediately, as this may be a sign of acute pancreatitis.
• •If you experience fatigue, pale skin, hematoma, 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 may 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, you may experience pain and swelling in the joints and inflammation or rupture of tendons. The risk is higher if you are an elderly person (over 60 years old), have received an organ transplant, have kidney problems, or are taking corticosteroids. Tendon inflammation and rupture can occur within the first 48 hours of treatment and even several months after stopping Levofloxacino Kabi treatment. 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 keep the affected area at rest. 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 Kabi and inform your doctor immediately to prevent the development of a potentially irreversible condition.

Severe, prolonged, and potentially irreversible effects

Fluoroquinolone or quinolone antibiotics, including Levofloxacino Kabi, have been associated with rare but severe, prolonged (lasting months or years), incapacitating, or potentially irreversible effects. This includes tendon pain, muscle pain, and joint pain in the upper and lower extremities, difficulty walking, abnormal sensations such as pinpricks, numbness, tingling, 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 effects after taking Levofloxacino Kabi, contact your doctor immediately before continuing treatment. You and your doctor will decide whether to continue or not the treatment, considering also the use of an antibiotic of another class.

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

Use of Levofloxacino Kabi with other medicines

Inform your doctor or pharmacist that you are using, have used recently, or may need to take any other medicine. This is because Levofloxacino Kabi may affect the functioning of other medicines. Additionally, some medicines may affect the functioning of Levofloxacino Kabi.

Inform your doctor in particular if you are taking any of the following medicines, as it 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 inflammation and/or tendon rupture.

-Warfarin - used to make blood thinner. You may have a higher probability of experiencing bleeding. Your doctor may need to perform periodic blood tests to check if your blood clots properly.

-Teophylline - used for respiratory problems. You have a higher probability of experiencing seizures (convulsions) if taken with Levofloxacino Kabi.

-Nonsteroidal anti-inflammatory drugs (NSAIDs) - used for pain and inflammation such as aspirin, ibuprofen, phenbufen, ketoprofen, indomethacin. You have a higher probability of experiencing seizures (convulsions) when taking them with Levofloxacino Kabi.

-Ciclosporin - used after organ transplants. You may have a higher probability of experiencing ciclosporin side effects.

-Medicines with known effects on 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) and cimetidine (used for ulcers and heartburn). You should be especially 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 "opioids" in patients taking Levofloxacino Kabi. Inform your doctor that you are using Levofloxacino Kabi if they have prescribed a urine test.

Tuberculosis test

This medicine may cause a "false negative" result in some laboratory tests used to search for the bacteria that causes 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 be.

Driving and operating machines

You may experience some side effects such as dizziness, drowsiness, balance disturbances (vertigo), or visual disturbances. Some of these side effects may affect your ability to concentrate or decrease 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 (main component of table salt / for cooking) in 50 ml. This is equivalent to 8.85% of the maximum daily recommended sodium intake for an adult.

How to use Levofloxacino Kabi

• Levofloxacino Kabi is a medication for hospital use
• It will be administered by your doctor or nurse through 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 Kabi 250 mg infusion solution, the infusion time will be 30 minutes or more
• For Levofloxacino Kabi 500 mg infusion solution, the infusion time will be 60 minutes or more
• Your heart rate and blood pressure will be monitored frequently. This is because a rapid heartbeat and a temporary decrease in blood pressure are possible side 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 stopped immediately.

How much Levofloxacino Kabi is administered

If you are unsure why you are being administered Levofloxacino Kabi or have any questions about how much Levofloxacino Kabi you are receiving, consult your doctor, nurse, or pharmacist.

• Your doctor will decide how much Levofloxacino Kabi you should receive
• 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 infection, including muscles: 500 mg once or twice a day

Adults and elderly patients with kidney problems

Your doctor may administer a lower dose.

Children and adolescents

This medication should not be administered to children or adolescents.

Protect your skin from the sun

Do not expose your skin directly to the sun (even on cloudy days) while you are receiving this medication and for two days after stopping it, as your skin will become much more sensitive to the sun and may burn, itch, 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

It is unlikely that your doctor or nurse will administer more medication than you need. Your doctor and nurse will monitor your progress and control the medication they have administered. Always ask if you are unsure why you are receiving this medication.

If you are given more Levofloxacino Kabi than you need, the following effects may occur: seizures (convulsions), confusion, dizziness, decreased consciousness, tremors, heart rhythm disturbances that may cause irregular heartbeat, and 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 receive 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, even if you feel better. If treatment is interrupted too soon, 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 treatment.

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

Like all medicines, Levofloxacino Kabi may cause side effects, although not everyone will experience them. Normally, they are mild to moderate and usually disappear quickly.

Stop taking 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. Symptoms may include: skin rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue

Stop taking 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)

• Diarrhea that may contain blood, possibly with stomach cramps and fever. These may be signs of a serious intestinal problem
• Pain and inflammation in tendons or ligaments, which may lead to rupture. The Achilles tendon is most frequently affected
• Seizures (convulsions)
• Seeing or hearing things that are not real (hallucinations, paranoia)
• Depression, mental disorders, feeling restless (agitation), abnormal dreams or nightmares
• Severe alteration of mental abilities that causes confusion in thoughts and decreased awareness of the environment (delirium)
• Generalized rash, high body temperature, elevated liver enzymes, abnormal blood tests (eosinophilia), swollen lymph nodes, and other organs involved (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome). See 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 may 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 may be signs of what is called "neuropathy"

Frequency not known(cannot be estimated from available data)

• Severe skin eruptions, including Stevens-Johnson syndrome and toxic epidermal necrolysis. These may appear on the trunk as red target-shaped macules or circular patches often with blisters in the center, skin peeling, mouth ulcers, throat, nose, genital, and eye ulcers, and may be preceded by flu-like symptoms. See section 2
• Loss of appetite, yellow skin and eyes, dark urine, burning or stomach pain. These may be signs of liver problems that may include fulminant liver failure
• Changes in opinion and thoughts (psychotic reactions) with a risk of having suicidal thoughts or actions
• Abdominal pain, nausea, general discomfort, or vomiting. These may be signs of an inflamed pancreas (acute pancreatitis). See section 2.

Consult a specialist eye doctor immediately if your vision worsens 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 or permanent adverse reactions (even months or years) or permanent, 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, memory impairment, and hearing, vision, taste, and smell impairment, in some cases regardless of the presence of pre-existing risk factors

Cases 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 insufficiency in patients who have received fluoroquinolones have been reported. See section 2.

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

Frequent(may affect up to 1 in 10 people)

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

Rare(may affect up to 1 in 100 people)

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

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

• Bleeding or bruising easily 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)
• Decreased blood sugar levels (hypoglycemia). This is important for diabetic patients
• Feeling of tingling in hands and feet (paresthesias)
• Ear or vision disorders (tinnitus, blurred vision)
• Abnormally fast heartbeat (tachycardia) or decreased blood pressure (hypotension)
• Muscle weakness. This is important in people with myasthenia gravis (rare nervous system disease)
• Changes in kidney function and, occasionally, kidney insufficiency that may be a result of an allergic reaction in the kidneys called interstitial nephritis
• Fever
• Clearly defined red patches with or without blisters that develop a few hours after levofloxacin administration and heal with residual post-inflammatory hyperpigmentation; usually, they repeat in the same skin or mucous membrane site after subsequent exposure to levofloxacin
• Memory deterioration

Frequency not known(cannot be estimated from available data)

• Decreased red blood cells in the blood (anemia): this may cause pale or yellowish skin 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 may cause fatigue, reduced ability to fight infections, and uncontrolled bleeding (bone marrow insufficiency)
• Fever, sore throat, and persistent general discomfort. This may 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 may lead to coma (hypoglycemic coma). This is important for diabetic patients
• Changes in the sense of smell, loss of smell or taste (parosmia, anosmia, ageusia)
• Feeling extremely excited, euphoric, agitated, or enthusiastic (mania)
• Movement and gait disorders (dyskinesia, extrapyramidal disorders)
• Temporary loss of consciousness or posture (syncope)
• Temporary loss of vision
• Ear or hearing problems
• Abnormally fast heartbeat, irregular heartbeat with life-threatening risk including heart stoppage, alteration of heart rhythm (denominated "prolongation of the QT interval", observed in the ECG, graphical representation of heart electrical activity)
• Difficulty breathing or wheezing (bronchospasm)
• Respiratory allergic reactions
• Pancreatitis (inflammation of the pancreas)
• Heptatitis (inflammation of the liver)
• Increased skin sensitivity to the sun and ultraviolet light (photosensitivity), darker skin patches (hyperpigmentation)
• Inflammation of the blood vessels due to an allergic reaction (vasculitis)
• Inflammation of the mucous membrane inside the mouth (stomatitis)
• Muscle rupture and muscle destruction (rhabdomyolysis)
• Red and swollen joints (arthritis)
• Pain, including back, chest, and limb pain
• Sudden, involuntary muscle contractions or muscle spasms (myoclonia)
• Porphyria crisis in patients with porphyria (rare metabolic disease)
• Persistent headache with or without blurred vision (benign intracranial hypertension)

Reporting of adverse reactions:

If you experience any type of adverse reaction, consult your doctor or nurse, even if it is a possible adverse reaction that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting adverse reactions, you can contribute to providing more information on the safety of this medicine.

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

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

KabiPac Bottles:

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.

No protection from light is required during infusion.

Only use Levofloxacino Kabi if it is a transparent, yellow-green solution free of particles. Discard any remaining solution.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of containers and medications that you no longer need. This will help protect the environment.

Composition of Levofloxacino Kabi

-The active ingredient is levofloxacino.

-Each ml of solution contains 5 mg of levofloxacino.

-50 ml of solution for infusion contains 250 mg of levofloxacino.

-100 ml of solution for infusion contains 500 mg of levofloxacino.

-The other components are sodium chloride, sodium hydroxide, hydrochloric acid, and water for injection preparations.

Aspect of the product and content of the package

Levofloxacino Kabi is a solution for infusion (to be administered with a syringe). The solution is transparent and yellow-green.

It is supplied in:

-KabiPac polyethylene bottles of 100 ml filled with 50 ml or 100 ml (1, 10, 20 or 25 bottles per package).

-Freeflex polyethylene bags of 100 ml filled with 50 ml or 100 ml (10 or 20 bags per package).

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing Holder of the marketing authorization

Fresenius Kabi España, S.A

Marina, 16-18

08005 Barcelona (Spain)

Responsible for manufacturing

Bottles:

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??????????????

Czech RepublicLevofloxacin Kabi 5mg/ml infuzní roztok

GermanyLevofloxacin Kabi 5 mg/ml InfusionslösungFinlandLevofloxacin Fresenius Kabi 5 mg/ml infuusioneste, liuos

HungaryLevofloxacin Kabi 5 mg/ml oldatos infúzió

IrelandLevofloxacin 5 mg/ml solution for infusion

ItalyLevofloxacina Kabi 5mg/ml soluzione per infusione

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 August 2024.

“Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)

http://www.aemps.gob.es

http://www.aemps.gob.es”

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This information is intended solely for medical professionals or healthcare professionals:

Administration

-Levofloxacin Kabi is administered by intravenous infusion.

-Inspect the bottle/bag before use. It should only be administered if the solution is

transparent, yellow-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 Levofloxacin Kabi.

-During infusion, the solution does not need to be protected from light.

-It is known that infusions of ofloxacin (a related compound to levofloxacin)

can cause tachycardia (abnormal rapid heartbeat) and a decrease in blood pressure,

and in rare cases, collapse.

-If a clear drop in blood pressure is observed during infusion with levofloxacin, the

infusion should be stopped immediately.

Dose in patients with normal renal function(creatinine clearance greater than 50 ml/min)

-The dose in patients with normal renal function depends on the indication, as described in the

section 3 “How to use Levofloxacin Kabi”.

Dose in patients with impaired renal function(creatinine clearance ≤ 50 ml/min)

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

Compatibilities

Compatibility with other infusion solutions:

Levofloxacin 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

-Do not mix 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.