Levofloxacin polpharma

Package leaflet: Information for the user

Warning! Keep the leaflet, information on the immediate packaging in a foreign language.
Levofloxacin Polpharma (Levofloxacino Normon), 5 mg/ml, infusion solution
Levofloxacinum
Levofloxacin Polpharma and Levofloxacino Normon are different trade names of the same
medicinal product.
Please read all of this leaflet carefully before using this medicine because it contains
important information for you.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Leaflet contents

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

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

Levofloxacin Polpharma contains the active substance called levofloxacin – a medicine belonging to the group of antibiotics. Levofloxacin is a quinolone antibiotic. It acts bactericidally against bacteria causing infections in the body.
Levofloxacin Polpharma in the form of infusion solution may be used to treat the following infections:

• lungs (in patients with pneumonia)
• urinary tract, including kidneys or bladder
• prostate gland (in case of chronic infection)
• skin and subcutaneous tissue, including muscles (sometimes referred to as "soft tissues").

In certain specific situations, Levofloxacin Polpharma in the form of infusion solution may be used to prevent a lung disease called anthrax, which may occur after exposure to anthrax-causing bacteria, or to treat this disease.

2. Important information before using Levofloxacin Polpharma

When not to use Levofloxacin Polpharma

• if the patient is allergic to levofloxacin, to any other antibiotic in the quinolone group (such as 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 the lips, face, throat or tongue.
• if the patient has ever had epilepsy,
• if the patient has ever had tendon problems, such as tendon inflammation associated with quinolone antibiotic treatment (tendons are the "cords" connecting muscles to bones),
• if the patient is a child or adolescent still growing,
• if the patient is pregnant, could become pregnant, or suspects she may be pregnant,
• if the patient is breastfeeding.

If any of the above apply to the patient, this medicine should not be used. If in doubt, consult a doctor, pharmacist or nurse before starting treatment with Levofloxacin Polpharma.

Warnings and precautions

Before starting treatment with this medicine

If the patient has previously experienced any severe adverse reaction to antibacterial medicines from the fluoroquinolone or quinolone group, such medicines (including Levofloxacin Polpharma) should not be taken.

Before starting treatment with Levofloxacin Polpharma, discuss with a doctor, pharmacist or nurse if:

• the patient is 60 years of age or older,
• the patient is receiving corticosteroids (sometimes called steroids) – see section "Levofloxacin Polpharma and other medicines",
• the patient has received an organ transplant,
• the patient has ever had seizures (epileptic fits),
• the patient has previously had brain damage due to stroke or head injury,
• the patient has kidney function impairment,
• the patient has a deficiency of the enzyme called glucose-6-phosphate dehydrogenase (this increases the risk of severe blood disorders),
• the patient has ever had psychiatric disorders,
• the patient has ever had heart problems: caution is required during treatment with this medicine if the patient, or a family member, has been diagnosed with QT interval prolongation (seen on ECG – a test measuring the electrical activity of the heart), the patient has electrolyte imbalances in the blood (especially low potassium or magnesium levels), slow heart rate (bradycardia), weakened heart muscle (heart failure), has had a heart attack, is female or elderly, or is taking medicines that cause unusual changes in the ECG (see section "Levofloxacin Polpharma and other medicines"),
• the patient has diabetes,
• the patient has previously had liver function disorders,
• the patient has myasthenia gravis,
• the patient has been diagnosed with an enlarged major blood vessel (aortic aneurysm or large peripheral artery aneurysm),
• the patient has nerve disorders (peripheral neuropathy),
• the patient has previously experienced aortic dissection (tearing of the aortic wall),
• the patient has been diagnosed with heart valve insufficiency,
• there is 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 vascular diseases such as Takayasu arteritis, giant cell arteritis, Behçet's disease, hypertension, confirmed atherosclerosis, rheumatoid arthritis [joint disease], or endocarditis [heart infection]),
• the patient has ever experienced severe skin rash, skin peeling, blistering and/or mouth 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 as red, target-like or circular spots on the trunk, often with blisters in the center. Mouth ulcers, throat, nose, genital organs, and eyes (red, 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, which can be life-threatening or fatal.

• In DRESS syndrome, flu-like symptoms and facial rash appear initially, followed by widespread rash, high fever, elevated liver enzymes and increased 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.

If any severe adverse reaction occurred previously with fluoroquinolone or quinolone antibiotics, antibacterial medicines from these groups should not be taken. In such cases, contact a doctor immediately.

If in doubt whether any of the above conditions apply, consult a doctor, pharmacist or nurse before starting treatment with Levofloxacin Polpharma.

Quinolone antibiotics may cause blood glucose levels to rise above normal (hyperglycaemia) or fall below normal, which in severe cases may lead to loss of consciousness (hypoglycaemic coma) (see section 4). This is important for diabetic patients. Diabetic patients should carefully monitor their blood glucose levels.

During treatment with Levofloxacin Polpharma, contact a doctor, nurse or pharmacist:

• if sudden, severe abdominal, back or chest pain occurs, which may be a sign of aortic aneurysm or dissection – seek emergency medical attention immediately. The risk of these conditions may be higher if the patient is being treated with systemic corticosteroids.
• if sudden shortness of breath occurs, especially when lying flat, or if the patient notices swelling of the ankles, feet or abdomen, or palpitations (a sensation of rapid or irregular heartbeat) – contact a doctor immediately.
• if sudden, involuntary muscle jerks, tremors or muscle spasms occur – contact a doctor immediately, as these may be symptoms of myoclonus. The doctor may decide to discontinue levofloxacin and start appropriate treatment.
• if nausea, general malaise, severe discomfort or persistent or worsening stomach pain or vomiting occur – contact a doctor immediately, as these may be symptoms of pancreatitis (acute inflammation of the pancreas).
• if fatigue, pale skin, bruising, uncontrolled bleeding, fever, sore throat, significant worsening of general health or a feeling of reduced resistance to infections occur – contact a 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 are detected, the doctor may decide to discontinue treatment.

Rarely, joint pain and swelling, tendon inflammation or tendon rupture may occur. The risk is higher in patients who are elderly (over 60 years), have had an organ transplant, have kidney function impairment, or are being treated with corticosteroids. Tendon inflammation or rupture may occur within the first 48 hours of treatment, but even several months after stopping Levofloxacin Polpharma. If early symptoms of tendon pain or inflammation occur (e.g. in the ankle, wrist, elbow, shoulder or knee), stop taking Levofloxacin Polpharma, contact a doctor and rest the affected area. Avoid unnecessary physical exertion, as it may increase the risk of tendon rupture.

In rare cases, symptoms of nerve damage (neuropathy) may occur, such as pain, burning, tingling, numbness and/or weakness, especially in the feet and legs or hands and arms. If these occur, stop taking Levofloxacin Polpharma immediately and contact a doctor to avoid irreversible damage.

Long-term, disabling and potentially irreversible serious adverse effects

Treatment with antibacterial medicines containing quinolones and fluoroquinolones, including Levofloxacin Polpharma, has been associated with very rare but serious adverse effects, some of which are long-lasting (lasting months or years), disabling or potentially irreversible. These include tendon, muscle and joint pain in the upper and lower limbs, difficulty walking, unusual sensations such as tingling, prickling, tickling, numbness or burning (paresthesia), sensory disturbances including impaired vision, taste, smell and hearing, depression, memory problems, severe fatigue and serious sleep disturbances.

If any of these adverse effects occur after taking Levofloxacin Polpharma, consult a doctor immediately before continuing treatment. The doctor will discuss whether to continue treatment, possibly considering switching to an antibiotic from another group.

Levofloxacin Polpharma and other medicines

Inform the doctor or pharmacist about all medicines currently or recently taken, as well as any medicines planned for future use. Levofloxacin Polpharma and other medicines may interact and affect each other's actions.

In particular, inform the doctor if the patient is taking any of the following medicines, as their use together with Levofloxacin Polpharma may increase the risk of adverse effects:

• corticosteroids, sometimes called steroids (used for inflammatory conditions); the patient may be more susceptible to tendon inflammation and/or injury,
• warfarin (used to reduce blood clotting); the patient may be more prone to bleeding; the doctor may recommend regular blood clotting tests,
• theophylline (used for breathing disorders); the patient may be more prone to seizures (epileptic fits) when taking Levofloxacin Polpharma,
• non-steroidal anti-inflammatory drugs (NSAIDs) (used for pain and inflammation), such as acetylsalicylic acid, ibuprofen, fenbufen, ketoprofen, indomethacin; the patient may be more prone to seizures (epileptic fits) when taking Levofloxacin Polpharma,
• cyclosporine (used after organ transplantation); the patient may be more susceptible to its adverse effects,
• medicines affecting heart rhythm – this includes medicines used for heart rhythm disorders (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 peptic ulcer and heartburn) – particular caution is required when using either of these with Levofloxacin Polpharma; in patients with impaired kidney function, the doctor may prescribe a lower dose.

If the patient is taking any of the listed medicines, inform the doctor.

Urine tests for opioids

Patients treated with levofloxacin may have false-positive results in urine tests for strong painkillers (so-called opioids). If a urine test is ordered, inform the doctor that the patient is receiving Levofloxacin Polpharma.

Tuberculosis tests

This medicine may cause false-negative results in certain laboratory tests detecting bacteria causing tuberculosis.

Pregnancy and breastfeeding

Do not use this medicine if:

• the patient is pregnant, could become pregnant, or suspects she may be pregnant,
• the patient is breastfeeding or plans to breastfeed.

Driving and operating machinery

Levofloxacin Polpharma may cause adverse effects such as dizziness, drowsiness, vertigo (spinning sensation) or visual disturbances. Some of these effects may affect concentration and reaction speed. In such cases, do not drive or perform tasks requiring attention.

Levofloxacin Polpharma contains sodium

This medicine contains 354 mg of sodium (the main component of table salt) per bag. This corresponds to 17.7% of the maximum recommended daily sodium intake in the adult diet.

3. How to use Levofloxacin Polpharma

This medicine should always be used as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
How Levofloxacin Polpharma is administered

• Levofloxacin Polpharma in the form of an infusion solution is intended for use in hospitals.
• The medicine is administered to the patient by infusion by a doctor or nurse. The infusion is given into one of the patient's veins and lasts for a certain period of time (this is called intravenous infusion).
• Levofloxacin Polpharma 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, as very rapid heartbeat and temporary reduction in blood pressure have been observed during infusions of similar antibiotics. If the patient's blood pressure drops significantly during the infusion, the infusion will be stopped immediately.

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

• The doctor will decide what dose of Levofloxacin Polpharma 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.

Adults and elderly patients

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

Adults and elderly patients with impaired kidney function
The doctor may use a lower dose.
Children and adolescents
This medicine must not be used in children and adolescents.
Skin protection from light
During treatment with this medicine and for 2 days after treatment ends, direct sunlight should be avoided, as the skin becomes more sensitive to sunlight and burns or blisters may occur in individuals who do not follow the following precautions:

• Use sunscreen creams with a high sun protection factor,
• Always wear a hat and clothing covering the skin of hands and legs,
• Do not use sunbeds.

Administration of a higher than recommended dose of Levofloxacin Polpharma
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 control the administration of the medicine. If in doubt about why a particular dose is being administered, always ask.
Administration of an excessive dose of Levofloxacin Polpharma may cause the following symptoms: seizures (seizure attack), confusion, dizziness, disturbances in consciousness, muscle tremors, and heart disturbances leading to irregular heartbeat, as well as nausea.
Missing a dose of Levofloxacin Polpharma
The doctor or nurse will receive instructions regarding the timing of administering the medicine to the patient. It is unlikely that the patient will receive the medicine differently than prescribed. However, if the patient believes a dose has been missed, they should inform the doctor or nurse.
Stopping treatment with Levofloxacin Polpharma
The doctor or nurse will continue administering the medicine, even if the patient feels better. Stopping treatment too early may cause the infection to return, worsen the illness, or lead to the development of antibiotic-resistant bacteria. After several days of treatment with the infusion solution, the doctor may decide to switch to tablets to complete the recommended treatment course.
If there are any further doubts regarding the use of this medicine, consult a doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
These adverse effects are usually mild or moderate in intensity and resolve quickly.
If the following adverse effect occurs, stop using the medicine immediately
and contact a doctor or nurse without delay:
Very rare (may affect fewer than 1 in 10,000 patients)

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

If any of the following serious adverse effects occur, stop using the medicine immediately
and contact a doctor, pharmacist or nurse, as urgent treatment may be required:
Rare (may affect fewer than 1 in 1,000 people)

• Watery diarrhoea, which may contain blood: may be accompanied by abdominal cramps and high fever. These may be symptoms of serious intestinal disorders.
• Pain and inflammation of tendons or ligaments, which may lead to rupture. Most commonly affects the Achilles tendon.
• Seizures.
• Seeing or hearing non-existent things (hallucinations, paranoia).
• Feelings of depression, mental disturbances, agitation, unusual dreams or nightmares.
• Widespread rash, high body temperature, increased liver enzyme activity, abnormal blood counts (eosinophilia), swollen lymph nodes and other organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome). See also section 2.
• Syndrome associated with abnormal water excretion and low sodium levels (SIADH).
• Decreased blood glucose levels (hypoglycaemia) or hypoglycaemia leading to coma (hypoglycaemic coma). This is important in patients with diabetes.

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

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

Frequency not known (frequency cannot be determined from available data)

• Severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis. These may present as red, target-like spots or circular patches, 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 eyes, dark urine, itching or abdominal tenderness. These may be symptoms of liver disorders, including life-threatening liver failure.
• Changes in thinking and perception (psychotic reactions) with risk of suicidal thoughts or attempts.
• Nausea, general malaise, severe discomfort or pain in the stomach area, or vomiting. These may be symptoms of pancreatitis (see section 2).

If any visual disturbances or other eye-related changes occur during treatment with Levofloxacin Polpharma,
prompt consultation with an ophthalmologist is required.
Very rare cases of prolonged (lasting months or even years) or permanent adverse reactions have been
associated with the use of quinolone and fluoroquinolone antibiotics, such as tendon inflammation,
tendon rupture, joint pain, limb pain, difficulty walking, sensory disturbances such as tingling,
prickling, stabbing, burning, numbness or pain (neuropathy), fatigue, memory and concentration
impairment, psychiatric effects (including sleep disturbances, anxiety, panic attacks, depression and
suicidal thoughts), as well as impaired hearing, vision, taste and smell. Some of these occurred
independent of known risk factors.
Cases of arterial wall dilation and weakening or arterial wall rupture (aneurysm and dissection),
which may lead to rupture and death, as well as cases of heart valve regurgitation, have been reported
in patients receiving fluoroquinolones. See also section 2.
Inform your doctor if any of the adverse effects listed above worsen or persist for more than a few days:
Common (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

• Changes in the number of other bacteria or fungi, fungal infection (e.g. candidiasis), which may require treatment.
• Changes in white blood cell count (leukopenia, eosinophilia), detected in certain blood tests.
• Restlessness (anxiety), confusion, nervousness, drowsiness, tremor and sensation of spinning (dizziness).
• Shortness of breath.
• Altered taste sensation, loss of appetite, stomach upset or indigestion, stomach pain, bloating or constipation.
• Itching and skin rash, severe itching or urticaria (hives), excessive sweating.
• Joint or muscle pain.
• Abnormal blood test results indicating liver (increased bilirubin levels) or kidney (increased creatinine levels) disorders.
• General weakness.

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

• Easy bruising and bleeding due to reduced platelet count (thrombocytopenia).
• Low white blood cell count (neutropenia).
• Severe immune reaction (hypersensitivity).
• Tingling in hands and feet (paresthesia).
• Hearing disturbances (tinnitus) or visual disturbances (blurred vision).
• Unusually rapid heartbeat (tachycardia) or low blood pressure (hypotension).
• Muscle weakness, which is significant in patients with myasthenia gravis (a rare neurological disorder).
• Kidney function disorders and, rarely, kidney failure due to allergic kidney reaction (interstitial nephritis).
• Fever.
• Well-demarcated, erythematous spots with or without blisters, developing within hours after levofloxacin administration. These resolve with post-inflammatory pigmentation. Upon subsequent administration of levofloxacin, these lesions typically recur 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): may cause pallor or jaundice due to red blood cell destruction, decreased number of all blood cell types (pancytopenia).
• Cessation of new blood cell production by the bone marrow, which may lead to 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 arrest (anaphylactic shock-like reaction).
• Increased blood glucose levels (hyperglycaemia). This is important for diabetic patients.
• Changes in smell, loss of smell or taste (olfactory hallucinations, anosmia, ageusia).
• Feeling of intense excitement, euphoria, agitation or enthusiasm (mania).
• Problems with movement and walking (dyskinesias, extrapyramidal disorders).
• Transient loss of consciousness or fainting (syncope).
• Transient vision loss, eye inflammation.
• Hearing disturbances or hearing loss.
• Abnormally rapid heart rhythm, life-threatening irregular heartbeat, including cardiac arrest, changes in heart rhythm (so-called "QT prolongation" visible on ECG, i.e. electrocardiogram, the recording of the heart's electrical activity).
• Breathing difficulties or wheezing (bronchospasm).
• Lung allergic reactions.
• Pancreatitis.
• Hepatitis (liver inflammation).
• Increased skin sensitivity to sunlight and ultraviolet radiation (photosensitivity), skin discolouration (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).
• Acute porphyria attacks in patients with porphyria (a very rare metabolic disorder).
• Persistent headache with blurred vision or without visual disturbances (benign intracranial hypertension).

Reporting of adverse effects
If any adverse symptoms occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects 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
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Levofloxacin Polpharma

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Do not store above 30°C. Keep the bag in its outer packaging to protect from light.
The levofloxacin infusion solution should be used immediately (within 3 hours) after piercing the rubber stopper to prevent bacterial contamination. Protection from light is not required during infusion.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the package and other information

What Levofloxacin Polpharma contains

• The active substance is levofloxacin. Each ml of infusion solution contains 5 mg of levofloxacin (as levofloxacin hemihydrate). Each 100 ml bag of infusion solution contains 500 mg of levofloxacin (as levofloxacin hemihydrate).
• Other ingredients: sodium chloride, sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment), and water for injections.

What Levofloxacin Polpharma looks like and contents of the pack
Levofloxacin Polpharma is a clear, yellow-green solution free from solid particles.
The medicine is available in a cardboard box containing 10 bags. The bag is made of plastic material, contains 100 ml of infusion solution, and is placed in a protective foil pouch.
Marketing authorisation holder in Spain, the country of export, and manufacturer:
Laboratorios Normon, S.A.
Ronda de Valdecarrizo, 6
28760 Tres Cantos, Madrid
Spain
Parallel importer:
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19
83-200 Starogard Gdański
Repackaged in:
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
LABOR Przedsiębiorstwo Farmaceutyczno-Chemiczne Sp. z o.o.
ul. Długosza 49
51-162 Wrocław
Spanish marketing authorisation number, country of export: 603189.6
Parallel import authorisation number: 4/26
(parallel importer's logo)

Information intended exclusively for medical professionals:

Special precautions for preparation and disposal of the medicinal product
Preparation for administration:

1. Inspect the contents of the bag before use. Only a clear, yellow-green solution free from particulate matter should be administered.
2. Remove the protective cap.
3. Connect an infusion set with a dual-channel spike.
4. Hang the bag on an infusion stand.

Protection of the bag contents from light during infusion is not required.
Physical incompatibility of levofloxacin with heparin and alkaline solutions (e.g. sodium bicarbonate) has been demonstrated.
Do not mix Levofloxacin Polpharma with other medicinal products except for the infusion solutions listed below:

• 9 mg/ml (0.9%) sodium chloride solution
• 50 mg/ml (5%) glucose solution
• 25 mg/ml (2.5%) glucose solution in Ringer's solution

For single use only. Any unused portion of the solution must be discarded.
Any unused medicinal product or waste material must be disposed of in accordance with local regulations.