Levofloxacin kabi

Package leaflet: Information for the user

Levofloxacin Kabi, 5 mg/mL, solution for infusion
Levofloxacinum
Please read all of this leaflet carefully before 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 further questions, ask your doctor, pharmacist, or nurse.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

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

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

The name of this medicine is Levofloxacin Kabi. Levofloxacin Kabi contains the active substance
levofloxacin, which belongs to a group of medicines called antibiotics. Levofloxacin is a
"quinolone" antibiotic. It acts by killing bacteria that cause infections in the body.
Levofloxacin Kabi may be used to treat bacterial infections of:

• the lungs, in patients with pneumonia;
• the urinary tract, including the kidneys or bladder;
• the prostate gland, in cases of long-term infection;
• the skin and underlying tissues, including muscles. This is sometimes referred to as "soft tissues."

In certain situations, Levofloxacin Kabi may be used to prevent a lung disease called anthrax, which may occur following exposure to the bacteria causing anthrax, or to treat this disease.

2. Important information before using Levofloxacin Kabi

When not to use Levofloxacin Kabi and to contact a doctor

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

Do not use this medicine if any of the above statements apply to the patient.
In case of doubt, before starting treatment with Levofloxacin Kabi, consult
a doctor, nurse or pharmacist.
Warnings and precautions
Before using this medicine, consult a doctor, nurse or
pharmacist if the patient:

• is 60 years of age or older;
• is taking glucocorticosteroids, sometimes called steroids (see section "Levofloxacin Kabi and other medicines");
• has ever had seizures (epileptic fit);
• has ever had brain damage caused by stroke or other brain injury;
• has kidney problems;
• has a condition called "glucose-6-phosphate dehydrogenase deficiency"; the patient may then be more susceptible to serious blood disorders during treatment with this medicine;
• has ever had mental health problems;
• has ever had heart problems: caution is required during treatment with this medicine if the patient has congenital or family history of QT interval prolongation (seen on ECG, i.e. examination of electrical activity of the heart), if the patient has electrolyte imbalances in the blood (especially low potassium or magnesium levels), if the patient has a slow heart rate (called "bradycardia"), if the patient's heart function is impaired (heart failure), if the patient has previously had a heart attack (myocardial infarction), if the patient is female or elderly, or if the patient is taking other medicines causing atypical changes in ECG (see section "Levofloxacin Kabi and other medicines");
• has been diagnosed with aneurysm of a large blood vessel (aortic aneurysm or large peripheral artery);
• has previously experienced aortic dissection (tearing of the aortic wall);
• has been diagnosed with heart valve regurgitation;
• has family history of aortic aneurysm or aortic dissection, or congenital heart valve disease, or other risk factors or predisposing conditions (e.g. connective tissue disorders such as Marfan syndrome or Ehlers-Danlos syndrome, Turner syndrome, Sjögren's syndrome [an autoimmune inflammatory disease], or vascular diseases such as Takayasu arteritis, giant cell arteritis, Behçet's disease, hypertension, confirmed atherosclerosis, rheumatoid arthritis [joint disease] or endocarditis [heart infection]);
• has diabetes;
• has ever had liver problems;
• has myasthenia gravis;
• has nerve damage (peripheral neuropathy);
• has ever had severe skin rash or skin peeling, blistering and (or) oral ulcers after taking levofloxacin.

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

• SJS or TEN may initially appear on the trunk as reddish, target-like or round spots, often with blisters in the center. Oral ulcers, throat, nose, genital organs and eyes (red and swollen eyes) may also occur. These severe skin rashes are often preceded by fever and (or) flu-like symptoms. These rashes may lead to extensive skin peeling and can be life-threatening or fatal.
• In DRESS syndrome, flu-like symptoms and facial rash appear initially, followed by widespread rash with high fever, increased liver enzyme activity and elevated white blood cell count (eosinophilia) in blood tests, and enlarged lymph nodes. If a severe rash or any of these skin symptoms occur, stop taking levofloxacin immediately and contact a doctor or seek urgent medical help.

Do not use antibacterial medicines containing fluoroquinolones or quinolones, including
Levofloxacin Kabi, if the patient has previously experienced any severe adverse reaction during treatment with a quinolone or fluoroquinolone. In such a case, inform the doctor immediately.
Consult a doctor, nurse or pharmacist if the patient is taking
fluoroquinolones:

• If sudden severe abdominal, back or chest pain occurs, which may indicate an aortic aneurysm or dissection, go immediately to the emergency department. The risk of these events may be higher when treated with systemic corticosteroids.
• If sudden shortness of breath occurs, especially when lying down, or if swelling of ankles, feet or abdomen is observed, or palpitations (sensation of rapid or irregular heartbeat) appear, seek medical advice immediately.
• If sudden, involuntary jerks, muscle twitching or muscle cramps occur, contact the doctor immediately, as these may be symptoms of myoclonus. The doctor may decide to discontinue levofloxacin and initiate appropriate treatment.
• If nausea, general malaise, severe discomfort or persistent or worsening abdominal pain or vomiting occur, contact the doctor immediately, as these may be symptoms of pancreatitis (acute inflammation of the pancreas).
• If fatigue, pale skin, bruising, uncontrolled bleeding, fever, sore throat and significant deterioration in health or feeling of reduced immunity to infections occur, contact the doctor immediately, as these may be symptoms of blood disorders. The doctor should monitor the patient's blood count through a complete blood count test. If abnormalities in blood count occur, the doctor may decide to discontinue treatment.
• Rarely, joint pain and swelling, tendon inflammation or tendon rupture may occur. The risk is increased in elderly patients (over 60 years), after organ transplantation, in patients with kidney problems or those receiving corticosteroid treatment. Tendon inflammation and rupture may occur within the first 48 hours of treatment and even several months after discontinuation of Levofloxacin Kabi. After the first symptoms of tendon pain or inflammation (e.g. in the ankle, wrist, elbow, shoulder or knee) appear, discontinue Levofloxacin Kabi, contact the doctor and rest the affected area. Avoid excessive physical exertion, as it may increase the risk of tendon rupture.
• The patient may rarely experience symptoms of nerve damage (neuropathy), such as pain, burning, tingling, numbness and (or) weakness, especially in feet and legs and hands and arms. In such a case, discontinue Levofloxacin Kabi and inform the doctor immediately to prevent progression to potentially irreversible disease.

Long-term, disabling and potentially irreversible serious adverse reactions
Antibacterial medicines containing fluoroquinolones/quinolones, including Levofloxacin Kabi, have been associated with very rare but serious adverse reactions. Some of these were long-term (lasting for months or years), disabling or potentially irreversible.
These include: tendon, muscle and joint pain in upper and lower limbs, difficulty walking, abnormal sensations such as pricking, tingling, tickling, numbness or burning (paresthesia), sensory disturbances, including vision, taste, smell and hearing disturbances, depression, memory disturbances, severe fatigue and severe sleep disturbances.
If any of these adverse reactions occur after taking Levofloxacin Kabi, contact the doctor immediately before continuing treatment. The patient and doctor will decide whether to continue treatment, also considering antibiotics from other groups.
If the patient is unsure whether any of the above statements apply, consult a doctor, pharmacist or nurse before starting treatment with Levofloxacin Kabi.
Levofloxacin Kabi and other medicines
Inform the doctor or pharmacist about all medicines currently or recently taken, and about any medicines the patient plans to take. This is because Levofloxacin Kabi may affect the action of other medicines. Likewise, other medicines may affect the action of Levofloxacin Kabi.
In particular, inform the doctor if the patient is taking any of the following medicines. This is because the risk of adverse reactions may increase when these medicines are taken together with Levofloxacin Kabi.

• Glucocorticosteroids, sometimes called steroids – used in inflammatory conditions. The patient may be more susceptible to tendon inflammation and (or) tendon damage.
• Warfarin – used to thin the blood. The patient may be more susceptible to bleeding. The doctor may recommend regular blood tests to monitor blood clotting.
• Theophylline – used for breathing problems. The patient may be more susceptible to seizures (epileptic fit) when taking Levofloxacin Kabi.
• Non-steroidal anti-inflammatory drugs (NSAIDs) – used for pain and inflammation, e.g. acetylsalicylic acid, ibuprofen, fenbufen, ketoprofen, indometacin. The patient may be more susceptible to seizures (epileptic fit) when taking Levofloxacin Kabi.
• Cyclosporine – used after organ transplantation. The patient may be more susceptible to adverse effects of cyclosporine.
• Medicines affecting heart rhythm. This includes medicines used for irregular heart rhythm (antiarrhythmics, e.g. quinidine, hydroquinidine, disopyramide, sotalol, dofetilide, ibutilide and amiodarone), for depression (tricyclic antidepressants, e.g. amitriptyline and imipramine), for psychiatric disorders (antipsychotics) and for bacterial infections (macrolide antibiotics, e.g. erythromycin, azithromycin and clarithromycin).
• Probenecid – used in gout, and cimetidine – used in peptic ulcer disease and heartburn. Exercise particular caution when using either of these medicines with Levofloxacin Kabi. If the patient has kidney problems, the doctor may recommend a lower dose.

Urine tests for opioids
Urine tests detecting strong painkillers called opioids may give false positive results in patients taking Levofloxacin Kabi. If the doctor recommends a urine test, the patient should inform the doctor that Levofloxacin Kabi is being taken.
Tuberculosis tests
This medicine may give falsely negative results in certain laboratory tests used to detect bacteria causing tuberculosis.
Pregnancy and breastfeeding
Do not use this medicine if the patient:

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

Driving and operating machinery
After administration of this medicine, the patient may experience adverse reactions, including dizziness, drowsiness, vertigo (spinning sensation) or visual disturbances. Some of these adverse reactions may impair concentration and reaction speed. In such a case, the patient should not drive or perform any work requiring attention.
Levofloxacin Kabi contains sodium
This medicine contains 177 mg of sodium (the main component of table salt) in 50 mL. This corresponds to 8.85% of the maximum recommended daily sodium intake in the diet of adults.

3. How to use Levofloxacin Kabi

How Levofloxacin Kabi is administered

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

What dose of Levofloxacin Kabi is given
If the patient is unsure why they are receiving Levofloxacin Kabi or has any questions regarding the dose being administered, they should speak with their doctor, nurse, or pharmacist.

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

Adult and elderly patients

• Pneumonia: 500 mg once or twice daily.
• Urinary tract infections, including kidney or bladder infections: 500 mg once daily.
• Prostate infections: 500 mg once daily.
• Skin and subcutaneous tissue infections, including muscle: 500 mg once or twice daily.

Adult and elderly patients with impaired kidney function
The doctor may recommend a lower dose.
Children and adolescents
This medicine must not be used in children and adolescents.
Skin protection from sunlight
During treatment with this medicine and for 2 days after stopping it, direct exposure to sunlight should be avoided. This is because the patient's skin may become more sensitive to sunlight, which could lead to sunburn, tingling sensations, and the development of large blisters on the skin if the following precautions are not taken:

• Use UV-filter creams with a high sun protection factor;
• Always wear a hat and clothing covering arms and legs;
• Avoid sunbathing.

Administration of a higher than recommended dose of Levofloxacin Kabi
It is unlikely that a doctor or nurse would administer too high a dose of the medicine. The doctor or nurse will monitor the treatment progress and verify which medicine the patient is receiving. If the patient is unsure why they are receiving a particular dose, they should always ask.
If the patient receives too high a dose of Levofloxacin Kabi, the following symptoms may occur: seizures (seizure attack), confusion, dizziness, disturbances in consciousness, muscle tremors, heart disturbances leading to irregular heartbeat, as well as nausea.
Missed administration of Levofloxacin Kabi
The doctor or nurse will be familiar with the recommendations regarding the timing and method of administering the medicine to the patient. It is unlikely that the patient will receive the medicine differently than prescribed. If the patient believes a dose has been missed, they should inform the doctor or nurse.
Discontinuation of Levofloxacin Kabi treatment
The doctor or nurse will continue administering Levofloxacin Kabi even if the patient feels better. If treatment is stopped too early, the patient's condition may worsen or bacteria may become resistant to the medicine. After several days of intravenous treatment, the doctor may decide to switch to tablets to complete the recommended course of treatment.
If there are any further doubts regarding the use of this medicine, consult the doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
They are usually mild or moderately severe and often resolve within a short time.
If the patient experiences any of the adverse reactions described below, discontinue use of
Levofloxacin Kabi immediately and contact a doctor or nurse immediately.
Very rare (occurring in fewer than 1 in 10,000 patients)

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

If the patient experiences any of the severe adverse reactions described below, discontinue
use of Levofloxacin Kabi immediately and contact a doctor or nurse immediately,
as immediate treatment may be necessary.
Rare (occurring in fewer than 1 in 1,000 patients)

• Watery diarrhoea, which may contain blood, sometimes with abdominal cramps and high fever. These may be symptoms of serious intestinal problems.
• Pain and inflammation of tendons or ligaments, which may lead to rupture. Most commonly affects the Achilles tendon.
• Seizures (convulsions).
• Seeing or hearing things that are not real (hallucinations, paranoia).
• Feelings of depression, psychiatric disturbances, restlessness (agitation), unusual dreams or nightmares.
• Serious disturbances in mental function causing disorganized thinking and reduced awareness of surroundings (delirium).
• Widespread rash, high body temperature, increased liver enzyme activity, blood disorders (eosinophilia), swollen lymph nodes and other organs (drug reaction with eosinophilia and systemic symptoms, known as DRESS or drug hypersensitivity syndrome). See also section 2.
• Syndrome related to abnormal water excretion and low sodium levels (SIADH).
• Decreased blood sugar levels (hypoglycaemia) or hypoglycaemia leading to coma (hypoglycaemic coma). This is relevant in patients with diabetes.

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

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

Frequency not known (cannot be estimated from available data)

• Severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis. These may appear as red, target-like spots or circular lesions, often with central blisters on the trunk, skin peeling, mouth, throat, nose, genital or eye ulcers, and may be preceded by fever and flu-like symptoms. See also section 2.
• Loss of appetite, yellowing of the skin and whites of the eyes, dark urine, itching, abdominal tenderness. These may be symptoms of liver dysfunction, which may include fatal liver damage.
• Changes in thoughts and beliefs (psychotic reactions) with risk of suicidal thoughts or attempts.
• Nausea, general malaise, discomfort or pain in the abdomen, or vomiting. These may be symptoms of pancreatitis (acute pancreatitis). See section 2.

If the patient experiences visual disturbances or any changes in the eyes during
treatment with Levofloxacin Kabi, consult an ophthalmologist immediately.
Administration of quinolone and fluoroquinolone antibiotics has, in rare cases regardless of pre-existing risk factors, very rarely led to long-term (lasting for 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, tickling, burning, numbness or pain (neuropathy), fatigue, memory and concentration problems, psychiatric effects (including sleep disturbances, anxiety, panic attacks, depression and suicidal thoughts), and disturbances in hearing, vision, taste and smell.
In patients receiving fluoroquinolones, cases of arterial wall dilation and weakening or arterial rupture (aneurysm and dissection) have been reported, which may result in rupture and lead to death, as well as cases of heart valve regurgitation. See also section 2.
Contact a doctor if any of the following adverse reactions worsen or persist for more than a few days.
Common (occurring in fewer than 1 in 10 patients)

• Sleep disturbances.
• Headache, dizziness.
• Nausea, vomiting and diarrhoea.
• Increased activity of certain liver enzymes in the blood.
• Infusion site reactions.
• Phlebitis.

Uncommon (occurring in fewer than 1 in 100 patients)

• Changes in the number of other bacteria or fungi, fungal infection caused by Candida species, which may require treatment.
• Changes in white blood cell count shown in certain blood test results (leukopenia, eosinophilia).
• Anxiety, confusion, nervousness, drowsiness, tremors, sensation of spinning.
• Shortness of breath.
• Changes in taste sensation, loss of appetite, stomach upset or indigestion, stomach pain, bloating with flatulence or constipation.
• Itching and skin rash, severe itching or hives, excessive sweating.
• Joint or muscle pain.
• Abnormal blood test results due to impaired liver function (increased bilirubin levels) or kidney function (increased creatinine levels).
• General weakness.

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

• Increased tendency to bruise and bleed due to reduced platelet count (thrombocytopenia).
• Low white blood cell count (neutropenia).
• Excessive immune response (hypersensitivity).
• Decreased blood sugar levels (hypoglycaemia). This is important in diabetic patients.
• Tingling sensation in hands and feet (paresthesia).
• Hearing problems (tinnitus) or vision problems (blurred vision).
• Unusual, rapid heartbeat (tachycardia) or low blood pressure (hypotension).
• Muscle weakness. This is important in patients with myasthenia gravis (a rare neurological disorder).
• Changes in kidney function and sometimes kidney failure, which may be caused by an allergic reaction in the kidneys called interstitial nephritis.
• Fever.
• Well-demarcated, red, blistering or non-blistering lesions developing within hours after levofloxacin administration. These resolve with post-inflammatory pigmentation. Upon subsequent administration of levofloxacin, these lesions usually reappear at the same site on the skin or mucous membranes.
• Memory disturbances.

Frequency not known (cannot be estimated from available data)

• Decreased number of red blood cells (anaemia): this may cause paleness or yellowing of the skin due to red blood cell damage; decreased number of all types of blood cells (pancytopenia).
• Cessation of new blood cell production by the bone marrow, which may cause fatigue, reduced ability to fight infections and uncontrolled bleeding (bone marrow failure).
• Fever, sore throat and persistent general malaise. This may be due to reduced white blood cell count (agranulocytosis).
• Circulatory collapse (anaphylactic shock-like reaction).
• Increased blood sugar levels (hyperglycaemia). This is important in diabetic patients.
• Changes in smell, loss of smell or taste (olfactory hallucinations, anosmia, ageusia).
• Feeling of intense excitement, elation, agitation or enthusiasm (mania).
• Problems with movement and walking (dyskinesia, extrapyramidal disorders).
• Transient loss of consciousness or fainting (syncope).
• Transient loss of vision.
• Hearing disturbances or hearing loss.
• Irregular, rapid heartbeat, life-threatening arrhythmias, including cardiac arrest, changes in heart rhythm (so-called "QT interval prolongation" visible on ECG, i.e. electrocardiogram).
• Breathing difficulties or wheezing (bronchospasm).
• Allergic reactions affecting the lungs.
• Pancreatitis.
• Hepatitis.
• Increased skin sensitivity to sunlight and ultraviolet radiation (photosensitivity), skin discoloration (hyperpigmentation).
• Inflammation of blood vessels due to allergic reaction (vasculitis).
• Inflammation of the mucous membrane lining the mouth (oral mucositis).
• Muscle breakdown and disintegration (rhabdomyolysis).
• Redness and swelling of joints (arthritis).
• Pain, including back, chest and limb pain.
• Sudden, involuntary jerks, muscle twitching and muscle cramps (myoclonus).
• Porphyria attacks in patients with porphyria (a very rare metabolic disorder).
• Persistent headache with or without blurred vision (benign intracranial hypertension).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Levofloxacin Kabi

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and
container/bag after: EXP. The expiry date refers to the last day of the stated month.
KabiPac container
Store the container in the outer packaging to protect from light.
Do not store in the refrigerator and do not freeze.
freeflex bag
Do not store at temperatures above 25°C.
Store the bag in the outer packaging to protect from light.
Do not store in the refrigerator and do not freeze.
Protection from light during infusion is not required.
Levofloxacin Kabi should only be used if the solution is clear, yellowish-green, and free from visible solid particles. Any unused solution should be discarded.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Following this advice helps protect the environment.

6. Contents of the pack and other information

What Levofloxacin Kabi contains

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

What Levofloxacin Kabi looks like and contents of the pack
Levofloxacin Kabi is available as an infusion solution (administered intravenously). The solution
is transparent, yellowish-green in colour. It is supplied in:

• Polyethylene container (KabiPac) with a capacity of 100 mL, containing 50 mL or 100 mL of solution (1, 10, 20 or 25 containers in a cardboard box);
• Polyolefin bag of free flex type with a capacity of 100 mL, containing 50 mL or 100 mL of solution (10 or 20 bags in a cardboard box).

Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw
Manufacturer
KabiPac containers
Fresenius Kabi Polska Sp. z o.o.
Infusion Fluids Manufacturing Plant
ul. Sienkiewicza 25
99-300 Kutno
free flex bags
HP Halden Pharma AS
Svinesundsveien 80
1788 Halden
Norway
For further information, please contact the Marketing Authorisation Holder:
Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw
Tel.: +48 22 345 67 89
This medicinal product is authorised in the European Economic Area Member States
under the following names:
Austria Levofloxacin Kabi 5 mg/ml Infusionslösung
Belgium Levofloxacine Fresenius Kabi 5mg/ml oplossing voor infusie
Bulgaria Левофлоксацин Каби 5 mg/ml инфузионен разтвор
Cyprus Levofloxacin Kabi 5 mg/ml διάλυμα για έγχυση
Czech Republic Levofloxacin Kabi
Germany Levofloxacin Kabi 5 mg/ml Infusionslösung
Finland Levofloxacin Fresenius Kabi 5 mg/ml infuusioneste, liuos
Hungary Levofloxacin Kabi 5 mg/ml oldatos infúzió
Ireland Levofloxacin 5 mg/ml solution for infusion
Italy Levofloxacina Kabi
Luxembourg Levofloxacin Kabi 5 mg/ml Infusionslösung
Malta Levofloxacin 5 mg/ml solution for infusion
Netherlands Levofloxacine Fresenius Kabi 5mg/ml oplossing voor infusie
Poland Levofloxacin Kabi
Portugal Levofloxacina Kabi
Romania Levofloxacin Kabi 5 mg/ml solutie perfuzabila
Slovakia Levofloxacin Kabi 5mg/ml infúzny roztok
Slovenia Levofloksacin Kabi 5 mg/ml raztopina za infundiranje
Spain Levofloxacino Kabi 5 mg/ml solución para perfusión

Information intended exclusively for healthcare professionals:

Administration

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

Duration of infusion

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

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

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

Dosing in patients with renal impairment (creatinine clearance ≤50 mL/min)

There is no need to administer additional doses after haemodialysis or continuous ambulatory peritoneal dialysis (CAPD).
Compatible solutions
Mixing with other infusion solutions.
Levofloxacin Kabi, solution for infusion, is compatible with the following infusion fluids:

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

Pharmaceutical incompatibilities

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

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