Levofloxacin sandoz

Patient Information Leaflet

Levofloxacin Sandoz, 5 mg/ml, infusion solution
Levofloxacinum
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 further questions, please consult your doctor, pharmacist, or nurse.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents

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

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

Levofloxacin Sandoz contains an active substance called levofloxacin – a medicine belonging to a group of antibiotics. Levofloxacin is a fluoroquinolone antibiotic. It acts by killing bacteria causing infections in the body.
Levofloxacin Sandoz 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 long-term infection)
skin and subcutaneous tissue, including muscles (sometimes referred to as "soft tissues").
In certain specific situations, Levofloxacin Sandoz infusion solution may also be used to prevent a lung disease called anthrax, which may occur following exposure to anthrax-causing bacteria, or to treat this disease.

2. Important information before using Levofloxacin Sandoz

When not to use Levofloxacin Sandoz
if the patient is allergic to levofloxacin, to any other antibiotic of 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, e.g. tendon inflammation associated with treatment with a quinolone antibiotic (tendon is a "cord" connecting muscles to bones)
if the patient is a child or adolescent during the growth period
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, this medicine must not be used. If in doubt, consult a doctor, pharmacist or nurse before starting treatment with Levofloxacin Sandoz.

Warnings and precautions
Before starting treatment with this medicine
If the patient has previously experienced any severe adverse reaction to antibacterial medicines of the fluoroquinolone or quinolone group, such medicines (including Levofloxacin Sandoz) must not be taken.

Before starting treatment with Levofloxacin Sandoz, 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 Sandoz 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 impaired kidney function
the patient has a deficiency of an enzyme called glucose-6-phosphate dehydrogenase (increased 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), if the patient has electrolyte imbalances in the blood (especially low potassium or magnesium levels), slow heart rate (bradycardia), weakened heart muscle (heart failure), history of heart attack, is female or elderly, or is taking medicines causing atypical changes in the ECG (see section "Levofloxacin Sandoz 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 a dilated large 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 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])
the patient has ever experienced severe skin rash, skin peeling, blistering and/or oral mucosal 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), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP).

SJS or TEN may initially appear as red, target-like or circular spots on the trunk, often with blisters in the center. Oral, throat, nasal, genital, and eye ulcers (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 with high fever, increased liver enzyme activity and elevated white blood cell count (eosinophilia) in blood tests, and enlarged lymph nodes.

A red, scaly, widespread rash with subcutaneous nodules (including skin folds, trunk [including abdomen], back and arms) and blisters, accompanied by fever. Symptoms typically appear early in treatment (acute generalized exanthematous pustulosis).

If a severe rash or any of these skin symptoms occur, stop taking levofloxacin immediately and consult a doctor or seek urgent medical attention.

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

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

During treatment with Levofloxacin Sandoz, contact a doctor, nurse or pharmacist if:
sudden severe abdominal, back or chest pain occurs, which may indicate an aneurysm or aortic dissection – immediate medical attention at an emergency department is required. The risk of these events may be higher when corticosteroids are used concomitantly.
sudden shortness of breath occurs, especially when lying flat in bed, or if ankle, foot or abdominal swelling or palpitations (sensation of rapid or irregular heartbeat) are noticed – contact a doctor immediately.
sudden, involuntary muscle jerks, twitches or muscle spasms occur – seek immediate medical attention, as these may be symptoms of myoclonus. The doctor may decide to discontinue levofloxacin and initiate appropriate treatment.
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).
fatigue, paleness, bruising, uncontrolled bleeding, fever, sore throat, significant worsening of health or feeling of reduced immunity occur – contact a doctor immediately, as these may be symptoms of blood disorders. The doctor should monitor the patient's blood count via a complete blood count test. If abnormalities are detected, the doctor may decide to discontinue treatment.

Rarely, joint pain and swelling, and tendon inflammation or rupture may occur. The risk is higher in the following: elderly patients (over 60 years), organ transplant recipients, patients with impaired kidney function, or those receiving corticosteroids. Tendon inflammation or rupture may occur within the first 48 hours of treatment, but even several months after discontinuation of Levofloxacin Sandoz. If initial symptoms of tendon pain or inflammation (e.g. in the ankle, wrist, elbow, shoulder or knee) occur, discontinue Levofloxacin Sandoz, contact a doctor and rest the affected area. Avoid unnecessary physical exertion, as it may increase the risk of tendon rupture.

In rare cases, nerve damage symptoms (neuropathy) such as pain, burning sensation, tingling, numbness and/or weakness, especially in the feet and legs or hands and arms, may occur. If these symptoms occur, discontinue Levofloxacin Sandoz immediately and notify a doctor without delay to prevent irreversible damage.

Long-term, disabling and potentially irreversible serious adverse reactions
Treatment with antibacterial medicines containing quinolones and fluoroquinolones, including Levofloxacin Sandoz, has been associated with very rare but serious adverse reactions, 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, pricking, tickling, numbness or burning (paresthesia), sensory disturbances including impaired vision, taste, smell, hearing, depression, memory disturbances, severe fatigue and serious sleep disorders.

If any of these adverse reactions occur after taking Levofloxacin Sandoz, contact a doctor immediately before continuing treatment. The doctor will discuss further treatment options, including switching to an antibiotic from another class.

Levofloxacin Sandoz 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 Sandoz 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 concomitant use with Levofloxacin Sandoz may increase the risk of adverse reactions:
corticosteroids, sometimes called steroids (used in inflammatory conditions); increased risk of tendon inflammation and/or damage
warfarin (used to reduce blood clotting); increased risk of bleeding; the doctor may recommend regular blood tests to monitor blood clotting
theophylline (used for breathing disorders); increased risk of seizures (epileptic fits) when taking Levofloxacin Sandoz
non-steroidal anti-inflammatory drugs (NSAIDs) (used to treat pain and inflammation), such as acetylsalicylic acid, ibuprofen, fenbufen, ketoprofen, indometacin; increased risk of seizures (epileptic fits) when taking Levofloxacin Sandoz
cyclosporine (used after organ transplantation); increased risk of its adverse effects
medicines affecting heart rhythm – 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 to treat gout) and cimetidine (used to treat peptic ulcer and heartburn) – particular caution is required when using either of these with Levofloxacin Sandoz; 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 laboratory that the patient is receiving Levofloxacin Sandoz.

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

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 Sandoz may cause adverse effects such as dizziness, drowsiness, vertigo (peripheral-type dizziness) or visual disturbances. Some of these effects may impair concentration and reaction speed. In such cases, do not drive or perform tasks requiring alertness.

Levofloxacin Sandoz contains sodium
50 ml infusion bag
This medicine contains 178.4 mg of sodium (the main component of table salt) per bag. This corresponds to 8.92% of the maximum recommended daily sodium intake in the adult diet.
100 ml infusion bag
This medicine contains 357.0 mg of sodium (the main component of table salt) per bag. This corresponds to 17.85% of the maximum recommended daily sodium intake in the adult diet.

3. How to use Levofloxacin Sandoz

This medicine should always be used exactly as directed by your doctor or pharmacist. If in doubt,
please consult your doctor or pharmacist.
How is Levofloxacin Sandoz administered
Levofloxacin Sandoz solution for infusion is intended for use in hospitals.
The medicine will be administered to the patient by infusion by a doctor or nurse. The infusion is given into one of the patient's veins and takes a certain amount of time (this is called intravenous infusion).
Levofloxacin Sandoz at a dose of 250 mg is administered over 30 minutes or longer.
Levofloxacin Sandoz at a dose of 500 mg is administered over 60 minutes or longer.
The doctor will closely monitor the patient's pulse and blood pressure, as with similar antibiotics, very rapid heartbeat and transient drop in blood pressure have been observed during infusion. If the patient's blood pressure drops significantly during the infusion, the infusion will be stopped immediately.
What dose of Levofloxacin Sandoz is administered
If the patient is unsure why they are receiving Levofloxacin Sandoz or has any questions about the dose being administered, they should speak with their doctor, pharmacist, or nurse.
The doctor will decide what dose of Levofloxacin Sandoz 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 soft 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 stopping treatment, avoid direct sunlight, as the skin becomes more sensitive to sunlight and burns or blisters may occur in individuals who do not follow the advice below:
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.
Overdose of Levofloxacin Sandoz
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.
An overdose of Levofloxacin Sandoz may cause the following symptoms: seizures (epileptic fit), confusion, dizziness, disturbances of consciousness, muscle tremors and heart disturbances leading to irregular heartbeat, as well as nausea.
Missed dose of Levofloxacin Sandoz
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 thinks a dose has been missed, they should inform the doctor or nurse.
Stopping Levofloxacin Sandoz treatment
The doctor or nurse will continue administering Levofloxacin Sandoz even if the patient feels better. Stopping the medicine 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 prescribed course of treatment.
If you have any further doubts regarding the use of this medicine, please consult your doctor, nurse, or pharmacist.

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 any of the following adverse effects occur, stop administering Levofloxacin Sandoz
immediately and contact your 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 administering Levofloxacin Sandoz
immediately and contact your doctor, pharmacist or nurse without delay, 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 severe intestinal disorders.
Pain and inflammation of tendons or ligaments, which may lead to tendon 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 composition (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 associated with impaired water excretion and low sodium levels (SIADH).
Reduced blood sugar 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)
Sensation of burning, tingling, pain or numbness. These may be symptoms of a condition called neuropathy.
Frequency not known (cannot be estimated from available data)
Severe skin rashes, 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 ulcers, throat, nose, genital or eye lesions, and may be preceded by fever and flu-like symptoms. See also section 2.
Red, peeling, widespread rash with subcutaneous nodules (including skin folds, trunk (including abdomen), back and shoulders) and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalised exanthematous pustulosis). See also section 2.
Loss of appetite, yellowing of the skin and eyes, dark urine, itching or tenderness in the abdomen. 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, and panic attacks.
Nausea, general malaise, severe discomfort or pain in the stomach area, or vomiting. These may be symptoms of pancreatitis (see section 2).
Burning nerve pain (neuralgia).
If any visual disturbances or other eye-related changes occur during treatment with Levofloxacin Sandoz, consult an ophthalmologist immediately.
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, abnormal sensations such as tingling, tickling, pricking, burning, numbness or pain (neuropathy), fatigue, memory and concentration problems, psychiatric effects (which may include sleep disturbances, anxiety, panic attacks, depression and suicidal thoughts), as well as hearing, vision, taste and smell impairment. Some of these occurred independently of existing risk factors.
In patients receiving fluoroquinolones, cases of aortic wall expansion and weakening or rupture (aneurysm and dissection), which may result in rupture and lead to death, as well as cases of heart valve regurgitation, have been reported. See also section 2.
Inform your doctor if any of the listed adverse effects 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.
Reactions at the infusion site.
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, which may require treatment.
Changes in white blood cell count (leukopenia, eosinophilia), detected in certain blood tests.
Tension (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 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 response (hypersensitivity).
Tingling in hands and feet (paresthesia).
Hearing disorders (tinnitus) or vision disturbances (blurred vision).
Unusually rapid heartbeat (tachycardia) or low blood pressure (hypotension).
Reduced muscle strength, which is relevant in patients with myasthenia gravis (a rare neurological disorder).
Kidney dysfunction and, rarely, kidney failure due to allergic kidney reaction (interstitial nephritis).
Fever.
Well-demarcated, erythematous lesions with or without blisters, developing within hours after levofloxacin administration. These resolve with post-inflammatory pigmentation. Upon subsequent administration of levofloxacin, the lesions usually reappear in the same location on the skin or mucous membranes.
Memory disturbances.
Frequency not known (cannot be estimated from available data)
Reduced number of red blood cells (anaemia): may cause paleness or yellowing of the skin due to red blood cell damage, reduced 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 (shock resembling anaphylactic shock).
Increased blood sugar levels (hyperglycaemia). This is important for 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 (dyskinesias, extrapyramidal disorders).
Transient loss of consciousness or fainting (syncope).
Transient loss of vision, 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. recording of the heart's electrical activity).
Breathing difficulties or wheezing (bronchospasm).
Lung allergic reactions.
Pancreatitis.
Hepatitis (liver inflammation).
Increased sensitivity of the skin 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 twitches and muscle cramps (myoclonus).
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 you experience any adverse effects, including any 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 of the 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 effects can also be reported to the responsible entity.
Reporting adverse effects helps provide more information on the safety of this medicine.

5. How to store Levofloxacin Sandoz

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP.
The expiry date refers to the last day of the stated month.
Store in the original packaging to protect from light. There are no special requirements
regarding the storage temperature of the medicinal product.
Levofloxacin in infusion solution at a concentration of 5 mg/ml, when mixed with 9 mg/ml (0.9%)
sodium chloride solution, 50 mg/ml (5%) glucose solution, and 25 mg/ml (2.5%) glucose
in Ringer's solution, remains stable for 8 hours at room temperature and does not require
protection from light.
Medicines must not be disposed of via the sewage system 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 Sandoz contains
The active substance is levofloxacin. Each ml of infusion solution contains 5 mg
of levofloxacin (as levofloxacin hemihydrate).
Each 50 ml bag of infusion solution contains 250 mg levofloxacin (as levofloxacin hemihydrate).
Each 100 ml bag of infusion solution contains 500 mg levofloxacin (as levofloxacin hemihydrate).
The other ingredients are: sodium chloride, sodium hydroxide (for pH adjustment), concentrated hydrochloric acid (for pH adjustment), and water for injections.

What Levofloxacin Sandoz looks like and contents of the pack
A LDPE bag containing a clear, yellowish-green solution free from particulate matter.
Pack sizes:
1 x 50 ml, 5 x 50 ml, 10 x 50 ml, 20 x 50 ml
1 x 100 ml, 5 x 100 ml, 10 x 100 ml, 20 x 100 ml
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria

Manufacturer
Lek Pharmaceuticals d.d.
Verovškova 57
1526 Ljubljana, Slovenia
Zakłady Farmaceutyczne Polpharma S.A.
ul. Pelplińska 19
83-200 Starogard Gdański, Poland

For further information about the medicinal product and its names in the European Economic Area countries, please contact:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warszawa, Poland
Tel: +48 22 209 70 00

Information intended exclusively for healthcare professionals:
Special precautions for the preparation and disposal of the medicinal product

2. Remove the protective foil.
3. Connect the infusion set with the dual-lumen needle.
4. Hang the bag on a support.

Protection of the bag contents from light is not required during infusion.
Physical incompatibility of levofloxacin with heparin and alkaline solutions (e.g., sodium bicarbonate) has been demonstrated.
Do not mix Levofloxacin Sandoz 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.