Package leaflet: Information for the user

LEVOFLOXACIN Bioindustria L.I.M. 5 mg/ml infusion solution

Levofloxacin
Generic medicine
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.

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

Contents of this leaflet:

What LEVOFLOXACIN Bioindustria L.I.M. is and what it is used for
What you need to know before using LEVOFLOXACIN Bioindustria L.I.M.
How to use LEVOFLOXACIN Bioindustria L.I.M.
Possible side effects
How to store LEVOFLOXACIN Bioindustria L.I.M.
Contents of the pack and other information

1. What LEVOFLOXACINA Bioindustria L.I.M. is and what it is used for

LEVOFLOXACINA Bioindustria L.I.M. contains the active substance called levofloxacin. This
medicine belongs to a group of medicines known as antibiotics. Levofloxacin is a
"quinolone"-type antibiotic. This medicine works by killing the bacteria responsible for infections
in the body.
LEVOFLOXACINA Bioindustria L.I.M. 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 Bioindustria L.I.M. may be used to reduce
the likelihood of developing a lung disease called anthrax or to prevent worsening of the
disease after exposure to the bacterium that causes anthrax.

2. What you should know before taking LEVOFLOXACIN Bioindustria L.I.M.

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: rash, difficulty swallowing or breathing, swelling of the lips, face, throat or tongue
you have had epilepsy
you have previously experienced tendon problems, such as tendinitis, related to treatment with a "quinolone antibiotic". Tendons are fibrous structures that connect muscles to the skeleton
you are a child or adolescent during the growth period
you are pregnant, may become pregnant, or think you might be
you are breastfeeding

Do not take this medicine if any of the above applies to you. If you have any
doubts, consult your doctor, nurse or pharmacist before taking LEVOFLOXACIN
Bioindustria L.I.M.
Warnings and precautions
Before taking this medicine
You must not take quinolone/fluoroquinolone antibacterial medicines, including
Levofloxacin Bioindustria L.I.M., if in the past you have had any serious adverse reaction during treatment with a quinolone or fluoroquinolone. In such a case, inform your doctor as soon as possible.
Consult your doctor, nurse or pharmacist before taking this medicine if:

you have developed a severe skin reaction or skin peeling, blisters and/or mouth ulcers after taking any medicine containing levofloxacin
you are aged 60 years or older
you are taking corticosteroids, sometimes called steroids (see section “Other medicines and LEVOFLOXACIN Bioindustria L.I.M.”)
you have undergone an organ transplant
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 LEVOFLOXACIN Bioindustria L.I.M.”)
you have diabetes
you have had liver problems
you have myasthenia gravis
you have nerve problems (peripheral neuropathy)
you have been diagnosed with an enlargement or “bulging” of a large blood vessel (aortic aneurysm or peripheral aneurysm of a large blood vessel)
you have previously experienced episodes of aortic dissection (a tear in the wall of the aorta)
you have been diagnosed with insufficiency of one of the heart valves (aortic or mitral regurgitation)
you have a family history of aortic aneurysm or aortic dissection, congenital heart valve disease, or other risk factors or predisposing conditions (e.g. connective tissue disorders such as Marfan syndrome, Ehlers-Danlos syndrome, Turner syndrome, Sjögren's syndrome [an autoimmune inflammatory disease], or if you suffer from vascular diseases such as Takayasu arteritis, giant cell arteritis, Behçet's disease, known high blood pressure or atherosclerosis, rheumatoid arthritis [an autoimmune inflammatory disease] or endocarditis [an inflammation of the heart]).

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

SJS and TEN may initially appear on the body as reddish spots or circular patches, often with central blisters. Mouth, throat, nose, genital, and eye ulcers (red and swollen eyes) may also occur. 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 complications that may lead to death.
DRESS initially presents with flu-like symptoms and a skin rash on the face, followed by widespread skin rash with fever, elevated liver enzyme levels in blood tests, increased levels of a type of white blood cell (eosinophilia), and swollen lymph nodes.

If you develop a severe skin rash or any of these other skin symptoms, stop taking levofloxacin and contact your doctor or seek immediate medical assistance.
While taking this medicine:

If you experience sudden, severe pain in the abdomen, chest, or back, which may be a sign of aneurysm or aortic dissection, go immediately to the emergency room. The risk may be higher if you are taking systemic corticosteroid medicines. Inform your doctor immediately if you notice sudden onset of shortness of breath, especially when lying down, or swelling of the ankles, feet or abdomen, or new episodes of heart palpitations (sensation of rapid or irregular heartbeat).
If you begin to experience sudden involuntary jerks, muscle fasciculations, or contractions
consult a doctor immediately, as these may be signs of myoclonus. Your doctor may need to discontinue treatment with levofloxacin and start appropriate therapy.
If you experience nausea, general malaise, severe discomfort, persistent pain or worsening pain in the stomach area, or vomiting – consult a doctor immediately, as these may be signs of pancreas inflammation (acute pancreatitis).
If you experience fatigue, pale skin, bruising, uncontrolled bleeding, fever, sore throat, severe worsening of your general condition, or feel that your resistance to infections has decreased – consult a doctor immediately, as these may be signs of blood disorders. Your doctor should monitor your blood with a complete blood count. If blood counts are abnormal, your doctor may need to discontinue treatment.

Rarely, joint pain and swelling, tendon inflammation or rupture may occur. The risk is higher if you are elderly (over 60 years), have received an organ transplant, have kidney problems, or are being treated with corticosteroids. Tendon inflammation and rupture may occur within the first 48 hours of treatment and up to several months after stopping treatment with LEVOFLOXACIN Bioindustria L.I.M.
At the first signs of tendon pain or inflammation (e.g., in the ankle, wrist, elbow, shoulder or knee), stop treatment with LEVOFLOXACIN Bioindustria L.I.M., consult your doctor, and rest the affected area. Avoid any unnecessary movement, as the risk of tendon rupture may increase.
Rarely, symptoms of nerve damage (neuropathy) such as pain, burning, tingling, numbness and/or weakness, particularly in the feet and legs or hands and arms, may occur. In such cases, stop treatment with LEVOFLOXACIN Bioindustria L.I.M. and inform your doctor immediately to prevent permanent nerve damage.
Serious, prolonged, disabling, and potentially irreversible side effects
Fluoroquinolone/quinolone antibacterial medicines, including LEVOFLOXACIN Bioindustria L.I.M., have been associated with very rare but serious side effects, some of which may be prolonged (lasting months or years), disabling, or may not improve. These include tendon, muscle and joint pain in the arms and legs, difficulty walking, abnormal sensations such as pricking, tingling, itching, numbness or burning (paresthesia), sensory organ disturbances such as changes in vision, taste, smell and hearing, depression, memory impairment, severe fatigue, and severe sleep disturbances.
If you experience any of these side effects after taking LEVOFLOXACIN Bioindustria L.I.M., consult your doctor immediately before continuing treatment. Your doctor will decide with you whether to continue treatment and may also consider using an antibiotic from another class.
If you have any doubts whether any of the above may apply to you, consult your doctor, nurse or pharmacist before taking LEVOFLOXACIN Bioindustria L.I.M.
Other medicines and LEVOFLOXACIN Bioindustria L.I.M.
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine. This is because LEVOFLOXACIN Bioindustria L.I.M. may affect the way other medicines work. Some medicines may also affect the way LEVOFLOXACIN Bioindustria L.I.M. works.
In particular, inform your doctor if you are taking any of the following medicines. This is because
administration of LEVOFLOXACIN Bioindustria L.I.M. together with other medicines may increase
the likelihood of experiencing side effects:

corticosteroids, sometimes called steroids – used to treat inflammation. The risk of developing tendon inflammation and/or 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 LEVOFLOXACIN Bioindustria L.I.M.;
non-steroidal anti-inflammatory drugs (NSAIDs) – used for pain and inflammation, such as aspirin, ibuprofen, fenbufen, ketoprofen and indomethacin. The risk of seizures when taken together with LEVOFLOXACIN Bioindustria L.I.M. is higher;
ciclosporin – used for organ transplants. The risk of experiencing typical ciclosporin side effects is higher;
medicines known to affect heart rhythm. These include medicines used to treat abnormal heart rhythm (antiarrhythmics such as quinidine, hydroquinidine, disopyramide, sotalol, dofetilide, ibutilide and amiodarone), depression (tricyclic antidepressants such as amitriptyline and imipramine), psychiatric disorders (antipsychotics), and bacterial infections (macrolide antibiotics such as erythromycin, azithromycin and clarithromycin);
probenecid – used to treat gout. Your doctor may prescribe a lower dose if you have kidney problems;
cimetidine – used for ulcers and heartburn. Your doctor may prescribe a lower dose if you have kidney problems.

Consult your doctor if any of the above applies to you.
Urine testing for opioids
In patients taking LEVOFLOXACIN Bioindustria L.I.M., urine tests may yield "false-positive" results for strong painkillers called "opioids". If your doctor considers it necessary to perform urine tests, inform them that you are taking LEVOFLOXACIN Bioindustria L.I.M.
Tuberculosis testing
This medicine may cause "false-negative" results in certain laboratory tests used to detect bacteria causing tuberculosis.
Pregnancy and breastfeeding
Do not take this medicine if:

you are pregnant, may become pregnant, or think you might be
you are breastfeeding or think you might breastfeed

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 impair concentration and reaction speed. If this occurs, do not drive or operate machinery requiring high attention.
LEVOFLOXACIN Bioindustria L.I.M. contains sodium
This medicine contains 354 mg (15.4 mmol) of sodium in 100 ml of solution, equivalent to 17.7% of the maximum daily intake recommended by the WHO, which corresponds to 2 g of sodium per adult.

3. How to take LEVOFLOXACINA Bioindustria L.I.M.

How LEVOFLOXACINA Bioindustria L.I.M. is administered

LEVOFLOXACINA Bioindustria L.I.M. 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 Bioindustria L.I.M. 250 mg infusion solution, the infusion time must be 30 minutes or longer.
For LEVOFLOXACINA Bioindustria L.I.M. 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 you are receiving the infusion, it will be stopped immediately.

How much LEVOFLOXACINA Bioindustria L.I.M. is administered
If you have any doubts about why you are being given LEVOFLOXACINA Bioindustria L.I.M. or if you would like more information about the amount of LEVOFLOXACINA Bioindustria L.I.M. you have been given, please consult your doctor, nurse or pharmacist.

Your doctor will decide how much LEVOFLOXACINA Bioindustria L.I.M. 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

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 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 the end of treatment. This is because your skin will become much more sensitive to sunlight and may burn, itch or develop severe blisters 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 Bioindustria L.I.M. than you should
It is unlikely that your doctor or nurse will inject you with an excessive amount of this medicine. 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 is being given to you.
Receiving an excessive amount of LEVOFLOXACINA Bioindustria L.I.M. 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 discomfort (nausea).

If you miss a dose of LEVOFLOXACINA Bioindustria L.I.M.
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 Bioindustria L.I.M.
Your doctor or nurse will continue to administer LEVOFLOXACINA Bioindustria L.I.M. even if you start feeling better. If administration is stopped too early, the infection may recur, your condition may worsen, or bacteria may develop resistance to the medicine. After a few days of treatment with the infusion solution, your doctor may decide to switch the route of administration from infusion to tablets to complete the treatment course.

If you have any questions about the use of this medicine, 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 resolve within a short time.

Stop taking LEVOFLOXACIN Bioindustria L.I.M. and contact a doctor or nurse immediately if you experience any of the following side effects:

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

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

Stop taking LEVOFLOXACIN Bioindustria L.I.M. and contact a doctor or nurse immediately if you experience any of the following side effects – you may require 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 intestinal problem
pain and inflammation of tendons or ligaments, which in some cases may rupture. The Achilles tendon is most commonly affected
seizures
seeing or hearing things that are not real (hallucinations, paranoia), changes in thoughts and beliefs (psychotic reactions)
feeling depressed, mental health problems, feeling restless (agitation), unusual or vivid dreams or nightmares
widespread rash, fever, elevated liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes, and involvement of other organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome). See also section 2
syndrome associated with inadequate water excretion and low sodium levels (SIADH)
decreased blood sugar levels (hypoglycaemia) or decreased blood sugar leading to coma (hypoglycaemic coma). This is important for people with diabetes.

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

burning, tingling, pain, or numbness. These symptoms may indicate a condition called "neuropathy"

Not known (frequency cannot be estimated from the available data)

severe skin rashes including Stevens-Johnson syndrome and toxic epidermal necrolysis. These may appear on the body as reddish spots or circular patches, often with central blisters, 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 or eyes, dark-coloured urine, itching, or abdominal pain. These may be signs of liver problems, including potentially fatal liver failure (liver failure that may lead to death)
changes in thoughts and beliefs (psychotic reactions) with risk of suicidal thoughts or suicide attempts
nausea, general feeling of illness, stomach discomfort or pain, or vomiting. These may be signs of inflammation of the pancreas (acute pancreatitis). See section 2.

If your vision becomes blurred or if you experience any eye discomfort while taking LEVOFLOXACIN Bioindustria L.I.M., consult an ophthalmologist immediately.

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

Common (may affect up to 1 in 10 people)

difficulty sleeping
headache, dizziness
feeling unwell (nausea, vomiting), diarrhoea
increased liver enzyme levels in blood tests
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 tests (leucopenia, eosinophilia)
feeling anxious, confused, nervous, drowsy, tremor, dizziness
shortness of breath (dyspnoea)
altered taste, loss of appetite, stomach discomfort 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 real (hallucinations, paranoia), changes in thoughts and beliefs (psychotic reactions) with possible development of suicidal ideation or suicide attempts
feeling depressed, mental health problems, feeling restless (agitation), unusual or vivid 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 nervous system disorder)
changes in kidney function and occasional kidney failure, which may be caused by an allergic reaction affecting the kidneys called interstitial nephritis
fever
clearly defined erythematous patches, with or without blistering, appearing within a few hours after levofloxacin administration and healing with residual redness; these usually recur at the same skin or mucosal site upon subsequent exposure to levofloxacin
poor memory

Not known (frequency cannot be estimated from the available data)

decreased red blood cells (anaemia). This may lead to paleness or yellowish skin due to damage to red blood cells and reduced numbers of all types of blood cells (pancytopenia)
bone marrow stops producing new blood cells, 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 a reduced number of white blood cells in the blood (agranulocytosis)
lack of blood flow (anaphylactic shock)
increased blood sugar levels (hyperglycaemia). This is important for people with diabetes
change in smell perception, loss of smell or taste (parosmia, anosmia, ageusia)
feeling extremely excited, euphoric, agitated, or enthusiastic (mania)
difficulty moving or walking (dyskinesia, extrapyramidal disorders)
temporary loss of consciousness or posture (syncope)
temporary loss of vision, eye inflammation
worsening or loss of hearing
unusually fast heartbeat, irregular heartbeat with life-threatening risk including cardiac arrest, changes in heartbeat rhythm (known as "QT interval prolongation" 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 skin sensitivity to sunlight or ultraviolet rays (photosensitivity), darker skin areas (hyperpigmentation)
inflammation of blood vessels throughout the body due to an allergic reaction (vasculitis)
inflammation of the internal tissues of the mouth (stomatitis)
muscle tearing and muscle breakdown (rhabdomyolysis)
redness and swelling of the joints (arthritis)
pain, including back, chest, and extremity pain
sudden involuntary jerks, fasciculations, or muscle contractions (myoclonus)
porphyria attacks in patients who already have porphyria (a very rare metabolic disorder)
persistent headache with or without blurred vision (benign intracranial hypertension)

Very rare cases of prolonged (lasting months or years) or permanent adverse drug reactions such as tendon inflammation, tendon rupture, joint pain, arm or leg pain, difficulty walking, abnormal sensations such as pricking, tingling, tickling, burning, numbness, or pain (neuropathy), fatigue, memory and concentration impairment, mental health effects (including sleep disorders, anxiety, panic attacks, depression, and suicidal thoughts), and changes in hearing, vision, taste, or smell have been reported with the use of quinolone and fluoroquinolone antibiotics, in some cases regardless of pre-existing risk factors.

Cases of aortic wall dilation or tearing (aneurysms and dissections), with possible rupture that may be fatal, as well as cases of blood regurgitation from heart valves, have been reported in patients treated with fluoroquinolones. See also section 2.

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the following website:
http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse

By reporting side effects, you help provide more information on the safety of this medicine.

5. How to store LEVOFLOXACIN Bioindustria L.I.M.

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after “EXP.”.
The expiry date refers to the last day of that month, for the product in its original packaging and
properly stored.
Store in the original container to protect the medicine from light.
Check the vial before use; the solution should only be used if it is clear and free from particles.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What LEVOFLOXACIN Bioindustria L.I.M. contains

The active substance is levofloxacin. 100 ml of solution contain 500 mg of levofloxacin.
The other components are: sodium chloride (Na concentration: 154 mmol/l), hydrochloric acid 37%, water for injections.

Description of the appearance of LEVOFLOXACIN Bioindustria L.I.M. and package contents
LEVOFLOXACIN Bioindustria L.I.M. is a clear, yellowish-green solution free from particles
and is available in packs containing 1, 5 and 50 vials of 50 ml or in packs containing 1, 5 and 25
vials of 100 ml.
It is possible that not all pack sizes are marketed.

Marketing Authorization Holder and Manufacturer
Bioindustria Laboratorio Italiano Medicinali S.p.A.
(Bioindustria L.I.M. S.p.A.)
Via De Ambrosiis, 2
15067 Novi Ligure (AL)
Italy

Package leaflet: information for the physician

LEVOFLOXACIN Bioindustria L.I.M. 5 mg/ml infusion solution

Levofloxacin
Generic medicinal product

The following information is intended exclusively for healthcare professionals:

Before prescribing LEVOFLOXACIN Bioindustria L.I.M., national and/or local guidelines on the appropriate use of fluoroquinolones must be taken into consideration.

Posology and method of administration

The following doses of LEVOFLOXACIN Bioindustria L.I.M. are recommended:

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

| Indications (depending on severity) | Daily doses | Total duration of treatment (depending on severity) | |--- |--- |---| | Community-acquired pneumonia | 500 mg once or twice daily | 7–14 days | | Pyelonephritis | 500 mg once daily | 7–10 days | | Complicated urinary tract infections | 500 mg once daily | 7–14 days | | Chronic bacterial prostatitis | 500 mg once daily | 28 days | | Complicated skin and soft tissue infections | 500 mg once or twice daily | 7–14 days | | Inhalational anthrax | 500 mg once daily | 8 weeks |

The duration of treatment includes both intravenous and oral therapy. The switch from intravenous to oral treatment depends on the clinical condition, but normally occurs after 2–4 days.

Special populations

Impaired renal function (Creatinine clearance ≤ 50 ml/min)

| Creatinine clearance | Initial dose: 250 mg | Initial dose: 500 mg | Initial dose: 500 mg | |--- |--- |--- |---| | | | | | | | 250 mg/24 h | 500 mg/24 h | 500 mg/12 h | | 50–20 ml/min | Subsequent doses: 125 mg/24 h | Subsequent doses: 250 mg/24 h | Subsequent doses: 250 mg/12 h | | 19–10 ml/min | Subsequent doses: 125 mg/48 h | Subsequent doses: 125 mg/24 h | Subsequent doses: 125 mg/12 h | | < 10 ml/min (including hemodialysis and continuous ambulatory peritoneal dialysis*) | Subsequent doses: 125 mg/48 h | Subsequent doses: 125 mg/24 h | Subsequent doses: 125 mg/24 h |

* Additional doses are not required after hemodialysis or continuous ambulatory peritoneal dialysis.

Impaired hepatic function

No dosage adjustment is necessary since levofloxacin is not significantly metabolized by the liver and is primarily excreted renally.

Overdose

In case of overdose, symptomatic treatment should be initiated. ECG monitoring should be performed due to the possibility of QT interval prolongation.

Hemodialysis, including peritoneal dialysis and continuous ambulatory peritoneal dialysis (CAPD), is not effective in removing levofloxacin. No specific antidotes are known.

Incompatibilities

In the absence of compatibility studies, LEVOFLOXACIN Bioindustria L.I.M. 5 mg/ml infusion solution must not be mixed with any other medicinal product.

Shelf life

Shelf life of the unopened package: 3 years.
Shelf life after removal from the outer packaging: 3 days (under indoor lighting conditions).
Shelf life after piercing the rubber stopper: immediate use (see section "Instructions for use").

Due to the risk of microbiological contamination, the product should be used immediately. If the medicinal product is not used immediately, the duration and conditions of storage during use are the responsibility of the user.

For further information, please refer to the Summary of Product Characteristics.