Levofloxacin Kabi

PACKAGE LEAFLET: Information for the user

LEVOFLOXACIN KABI 5 mg/ml infusion solution

Equivalent medicine
Please read this leaflet carefully before using this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• If you experience any side effects, including those not listed in this leaflet, inform your doctor, nurse or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Levofloxacina Kabi infusion solution is and what it is used for

The name of the medicine is Levofloxacina Kabi. Levofloxacina Kabi infusion solution contains the
active substance called levofloxacin. This medicine belongs to a group of medicines
known as antibiotics. Levofloxacin is a "quinolone" antibiotic. This medicine works
by killing the bacteria responsible for infections in the body.
Levofloxacina Kabi infusion solution can be used to treat the following infections:

• of the lungs, in patients with pneumonia
• of the urinary tract, including kidneys and bladder
• of the prostate, where a persistent infection may develop
• of the skin and subcutaneous tissue, including muscles. These are sometimes referred to as "soft tissues."

In certain special situations, Levofloxacina Kabi infusion solution may be used to
reduce the likelihood of developing or worsening a lung disease called anthrax after
exposure to the bacterium that causes anthrax.

2. What you need to know before using Levofloxacina Kabi infusion solution

Do not take this medicine and inform your doctor if:

• you are allergic (hypersensitive) to levofloxacin, to any other quinolone antibiotic 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 the lips, face, throat or tongue
• you have had epilepsy
• you have had tendon problems, such as tendinitis, related to treatment with a "quinolone antibiotic". Tendons are fibrous structures connecting muscles to the skeleton
• you are a child or adolescent during the growth period
• you are pregnant, could become pregnant, or think you may be pregnant
• you are breast-feeding.

Do not take this medicine if any of the above applies to you. If you have any
doubt, consult your doctor, nurse or pharmacist before taking Levofloxacina Kabi.
Warnings and precautions
Consult your doctor, nurse or pharmacist before taking this medicine if:

• you are 60 years old or older
• you are taking corticosteroids, sometimes called steroids (see "Other medicines and Levofloxacina Kabi")
• you have had seizures
• you have suffered brain damage due to stroke or other brain injury
• you have kidney problems
• you suffer from a condition known as "glucose-6-phosphate dehydrogenase deficiency". Administration of this medicine increases the likelihood of developing serious blood-related problems
• you have had mental health problems
• you have had heart problems: you should exercise caution when using this type of medicine if you were born with or have a family history of QT interval prolongation (seen on electrocardiogram, the heart's electrical trace), have an electrolyte imbalance in the blood (especially low levels of potassium or magnesium in the blood), have a very slow heart rate (called bradycardia), have a weak heart (heart failure), have had a heart attack (myocardial infarction), are female or elderly, or are taking other medicines that may alter the electrocardiogram (see section "Other medicines and Levofloxacina Kabi")
• if you have been diagnosed with an increase in size or "enlargement" of a large blood vessel (aortic aneurysm or peripheral aneurysm of a large blood vessel)
• if you have previously experienced episodes of aortic dissection (a tear in the wall of the aorta)
• if you have a family history of aortic aneurysm, aortic dissection, or other risk factors or predisposing conditions (e.g. connective tissue disorders such as Marfan syndrome, vascular Ehlers-Danlos syndrome, or if you have vascular diseases such as Takayasu arteritis, giant cell arteritis, Behcet's syndrome, high blood pressure, or known atherosclerosis)
• you have diabetes
• you have had liver problems
• you have myasthenia gravis.

If you have any doubt whether any of the above may apply to you, consult your doctor,
nurse or pharmacist before taking Levofloxacina Kabi.
If you experience sudden pain in the abdomen, chest, or back, go immediately to
the emergency room.
Other medicines and Levofloxacina Kabi
Inform your doctor or pharmacist if you are taking, have recently taken, or might
take any other medicine. This is because Levofloxacina Kabi may affect the way
other medicines work. Some medicines may also affect the way Levofloxacina Kabi works.
In particular, inform your doctor if you are taking any of the following medicines. This
is because administration of Levofloxacina Kabi in combination with other medicines may
increase the likelihood of you experiencing side effects:

• corticosteroids, sometimes called steroids – used to treat inflammation. The risk of developing tendon inflammation and/or tendon rupture is higher.
• warfarin – used to thin the blood. The risk of bleeding is higher. Your doctor may ask you to have regular blood tests to monitor blood clotting.
• theophylline – used for respiratory problems. The risk of seizures is higher if you take theophylline together with Levofloxacina Kabi.
• non-steroidal anti-inflammatory drugs (NSAIDs) – used for pain and to treat inflammation, such as aspirin, ibuprofen, fenbufen, ketoprofen and indomethacin. The risk of seizures is higher when taken together with Levofloxacina Kabi.
• cyclosporine – used in organ transplants. The risk of experiencing typical side effects of cyclosporine is higher.
• medicines known for their effects on heart rhythm. These include medicines used to treat 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 to treat gout, and cimetidine – used for ulcers and heartburn. Particular caution is required when using any of these medicines together with Levofloxacina Kabi. If you have kidney problems, your doctor may prescribe a lower dose.

Urine testing for opioids
In patients taking Levofloxacina Kabi, urine tests may give "false-positive" results for strong painkillers called "opioids". If your doctor considers it necessary to perform urine tests, inform them that you are taking Levofloxacina Kabi.
Tuberculosis testing
This medicine may cause "false-negative" results in certain laboratory tests used to detect the bacterium causing tuberculosis.
Pregnancy and breast-feeding
Do not take this medicine if:

• you are pregnant, could become pregnant, or think you may be pregnant
• you are breast-feeding or think you may breast-feed.

Driving and using machines
Side effects may occur after taking this medicine, including dizziness, drowsiness, subjective sensation of movement (vertigo), or visual disturbances. Some of these side effects may affect your ability to concentrate and your reaction speed. If this occurs, do not drive or operate machinery or perform activities requiring a high level of attention.
Levofloxacina Kabi infusion solution contains sodium
This medicine contains 15.4 mmol (354.2 mg) of sodium per 100 ml and 7.7 mmol (177.1 mg) of sodium per 50 ml. This should be taken into account in patients on a low-sodium diet.

3. How to use Levofloxacina Kabi infusion solution

How to use Levofloxacina Kabi infusion solution

• Levofloxacina Kabi infusion solution is a medicine intended for hospital use only.
• The medicine will be administered to you by a doctor or nurse via injection. The injection will be given into one of your veins and will last for a certain period of time (this procedure is called intravenous infusion).
• For Levofloxacina Kabi 250 mg infusion solution, the infusion time must be 30 minutes or longer.
• For Levofloxacina Kabi 500 mg infusion solution, the infusion time must be 60 minutes or longer.
• Heart rate and blood pressure must be monitored continuously. This is because an abnormally increased heart rate and a temporary drop in blood pressure are possible side effects that have been observed during infusion of a similar antibiotic. If your blood pressure drops significantly while the infusion is being administered, the infusion will be stopped immediately.

How much Levofloxacina Kabi infusion solution is administered
If you have any doubts about why you are being given Levofloxacina Kabi or if you would like more information about the amount of Levofloxacina Kabi you have been given, please consult your doctor, nurse, or pharmacist.

• Your doctor will decide how much Levofloxacina Kabi you should be given.
• The dosage depends on the type of infection you have and the location of the infection in your body.
• The duration of treatment will depend on the severity of the infection.

Adults and elderly patients

• Pneumonia: 500 mg once or twice daily
• Urinary tract infection, including kidneys and bladder: 500 mg once daily
• Prostate infection: 500 mg once daily
• Skin and subcutaneous tissue infection, including muscles: 500 mg once or twice daily

Adults and elderly patients with kidney problems
Your doctor may consider it necessary to reduce the dose.
Children and adolescents
This medicine must not be given to children or adolescents.
Protect your skin from sunlight
Do not expose yourself to direct sunlight during treatment with this medicine and for 2 days after treatment has ended. This is because your skin will become much more sensitive to sunlight and may burn, itch, or develop severe lesions if you do not follow these precautions:

• Make sure to use a high-protection-factor sunscreen
• Always wear a hat and clothing covering arms and legs
• Avoid sunbeds

If you receive more Levofloxacina Kabi infusion solution than you should
It is unlikely that you will be injected with an excessive amount of this medicine by your doctor or nurse. Your doctor and nurse will monitor your progress and ensure the correct dose is administered. If you have any doubts, always ask why a particular dose of the medicine is being given to you.
Receiving too much Levofloxacina Kabi may cause the following effects: seizures (epileptic fits), confusion, dizziness, feeling faint, tremor, and heart problems – which may lead to irregular heartbeats and feelings of sickness (nausea).

If you miss a dose of Levofloxacina Kabi infusion solution
Your doctor or nurse will receive instructions on when to administer the medicine to you. It is unlikely that this medicine will not be administered as prescribed. However, if you think you have missed a dose, inform your doctor or nurse.

If you stop treatment with Levofloxacina Kabi infusion solution
Your doctor or nurse will continue to administer Levofloxacina Kabi even if you start to feel better. If treatment is stopped too early, your condition may worsen or bacteria may develop resistance to the medicine. After several days of treatment with the infusion solution, your doctor may decide to switch the route of administration to tablets to complete the treatment course.

If you have any questions about the use of this medicine, please consult your doctor, nurse, or pharmacist.

4. Possible side effects

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

Stop taking Levofloxacina Kabi and immediately contact a doctor or nurse if you notice the following side effects:

Very rare (may affect up to 1 in 10,000 people)

• an allergic reaction. Signs may include: skin rash, difficulty swallowing or breathing, swelling of the lips, face, throat or tongue.

Stop taking Levofloxacina Kabi and immediately contact a doctor or nurse if you notice any of the following side effects – you may need urgent medical treatment:

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

• watery diarrhoea, possibly with blood, sometimes accompanied by stomach cramps and high fever. This may be a sign of a serious bowel problem
• pain and inflammation of tendons or ligaments, which in some cases may rupture. The Achilles tendon is most commonly affected
• seizures.

Very rare (may affect up to 1 in 10,000 people)

• burning, tingling, pain or numbness. These symptoms may be signs of a condition called "neuropathy".

Other:

• severe skin rash which may include lesions or peeling of the skin around the lips, eyes, mouth, nose and genitals
• loss of appetite, yellowing of the skin or eyes, dark-coloured urine, itching or sore stomach (abdomen). These may be signs of liver problems, which could include fatal liver failure (liver failure that can lead to death).

If your vision becomes blurred or if you experience any discomfort in your eyes while taking Levofloxacina Kabi, consult an ophthalmologist immediately.

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

Common: (may affect up to 1 in 10 people)

• difficulty sleeping
• headache, dizziness
• feeling unwell (nausea, vomiting) and diarrhoea
• increased levels of liver enzymes in the blood
• reactions at the infusion site
• inflammation of a vein

Uncommon (may affect up to 1 in 100 people)

• changes in the number of other bacteria or fungi, fungal infection called Candida, which may require treatment
• changes in white blood cell count shown in blood test results (leucopenia, eosinophilia)
• feeling stressed (anxiety), confusion, nervousness, drowsiness, tremor, dizziness
• shortness of breath (dyspnoea)
• altered taste, loss of appetite, stomach upset or indigestion (dyspepsia), stomach pain, bloating (flatulence), constipation
• itching and skin rash, severe itching or hives, excessive sweating (hyperhidrosis)
• joint pain or muscle pain
• blood tests may show abnormal results due to liver problems (increased bilirubin) or kidney problems (increased creatinine)
• generalised weakness

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

• bruising and increased tendency to bleed due to reduced platelet count in the blood (thrombocytopenia)
• low white blood cell count (neutropenia)
• exaggerated immune response (hypersensitivity)
• decreased blood sugar levels (hypoglycaemia). This is important for people with diabetes
• seeing or hearing things that are not there (hallucinations, paranoia), changes in thinking and behaviour (psychotic reactions), possibly leading to suicidal thoughts or suicide attempts
• feeling depressed, mental disturbances, restlessness (agitation), abnormal dreams or nightmares
• tingling sensation in hands and feet (paraesthesia)
• hearing problems (tinnitus) or vision problems (blurred vision)
• unusually fast heartbeat (tachycardia) or low blood pressure (hypotension)
• muscle weakness. This is important for patients with myasthenia gravis (a rare disorder of the nervous system)
• changes in kidney function and occasional kidney failure, which may be caused by an allergic reaction affecting the kidneys called interstitial nephritis
• fever

Other side effects include:

• decreased red blood cells (anaemia). This may lead to paleness or yellowish skin due to damage to red blood cells and a decrease in all types of blood cells (pancytopenia)
• fever, sore throat and a general feeling of being unwell that does not go away. This may be due to a reduced number of white blood cells in the blood (agranulocytosis)
• lack of blood flow (anaphylactic shock)
• increased blood sugar levels (hyperglycaemia) or decreased blood sugar levels leading to coma (hypoglycaemic coma). This is important for people with diabetes
• changes in the smell of things, loss of smell or taste (parosmia, anosmia, ageusia), difficulty moving or walking (dyskinesia, extrapyramidal disorders)
• temporary loss of consciousness or posture (syncope)
• temporary loss of vision
• worsening or loss of hearing
• unusually fast heartbeat, irregular heartbeat with life-threatening risk including cardiac arrest, changes in heartbeat (called "prolongation of the QT interval" seen on electrocardiogram, electrical activity of the heart)
• difficulty breathing or wheezing (bronchospasm)
• allergic reactions affecting the lungs
• pancreatitis
• inflammation of the liver (hepatitis)
• increased sensitivity of the skin to sunlight or ultraviolet rays (photosensitivity)
• inflammation of blood vessels carrying blood throughout the body due to an allergic reaction (vasculitis)
• inflammation of the internal tissues of the mouth (stomatitis)
• muscle breakdown and destruction (rhabdomyolysis)
• redness and swelling of the joints (arthritis)
• pain, including back, chest and extremity pain
• attacks of porphyria in patients who already suffer from porphyria (a very rare metabolic disorder)
• persistent headache with or without blurred vision (benign intracranial hypertension)

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Levofloxacina Kabi infusion solution

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and on the
vial/bag after EXP. The expiry date refers to the last day of that month.
Kabipac vials:
Keep the medicine in the 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.
Do not use Levofloxacina Kabi after the expiry date stated on the vial/bag and on the
packaging after EXP.
The expiry date refers to the last day of the month.
Levofloxacina Kabi should only be used if the solution is clear, yellowish-green, and free from
visible particles. Discard any unused solution.
Do not dispose of any medicine via wastewater or household waste. Ask your nurse or
pharmacist how to dispose of medicines no longer required. This will help protect
the environment.

6. Package contents and other information

What Levofloxacina Kabi infusion solution contains

• The active substance is levofloxacin.
• Each ml of infusion 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.

Description of the appearance of Levofloxacina Kabi infusion solution and contents of the
package
Levofloxacina Kabi is supplied as an infusion solution (to be administered by intravenous infusion drop by drop). The solution is clear and yellowish-green in colour.
It is available in:

• 100 ml polyethylene KabiPac bottles filled with 50 or 100 ml (1, 10, 20 and 25 bottles per carton)
• 100 ml polyolefin Freeflex bags filled with 50 or 100 ml (10 and 20 bags per pack)

Not all pack sizes may be marketed.
Marketing Authorisation Holder
Fresenius Kabi Italia S.r.l.
Via Camagre, 41
37063 Isola della Scala (VR)
Manufacturer
Bottles:
Fresenius Kabi Polska Sp. z.o.o.
Wytwórnia Płynów Infuzyjnych
99-300 Kutno
Sienkiewicza 25
Poland
and
Freeflex bags:
Fresenius Kabi Norge AS
Svinesundsveien 80,
NO-1788 Halden
Norway
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 Levofloxacin Kabi 5 mg/ml Инфузионен разтвор
Cyprus Levofloxacin Kabi 5 mg/ml διάλυμα για έγχυση
Czech Republic Levofloxacin Kabi 5mg/ml infuzní roztok
Germany Levofloxacin Kabi 5 mg/ml Infusionslösung
Greece Levofloxacin Kabi 5 mg/ml διάλυμα για έγχυση
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 5 mg/ml soluzione per infusione
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
United Kingdom Levofloxacin 5 mg/ml solution for infusion
This leaflet was last approved on

The following information is intended exclusively for medical professionals or healthcare
providers
Administration

• Levofloxacina Kabi must be administered by slow intravenous infusion.
• Inspect bottles/bags before use. The product should only be used if the solution is clear, yellowish-green, and practically free from particles.

Infusion times

• The recommended infusion time is at least 30 minutes for 250 mg and 60 minutes for 500 mg of Levofloxacina Kabi.
• No light protection is required during infusion.
• Infusions of ofloxacin (a compound related to levofloxacin) are known to cause tachycardia (abnormally rapid heartbeat) and reduction in blood pressure, rarely leading to collapse.
• If a significant drop in blood pressure occurs during levofloxacin infusion, the infusion must be stopped immediately.

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

• The dosage in patients with normal renal function depends on the indications described in section 3 "How to take Levofloxacina Kabi"

Dosage in patients with reduced renal function (creatinine clearance ≤ 50 ml/min)

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

Compatibility

Mixing with other infusion solutions:
Levofloxacina 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

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

Storage

• Store the medicinal product in the outer packaging to protect it from light.
• Do not refrigerate or freeze.
• Levofloxacina Kabi must be used immediately (within 3 hours) after opening to prevent any bacterial contamination.