Levalox

Package leaflet: Information for the user

Levalox, 5 mg/ml, infusion solution
levofloxacinum
Please read 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 needed.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same.
• 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 Levalox is and what it is used for
2. What you need to know before using Levalox
3. How to use Levalox
4. Possible side effects
5. How to store Levalox
6. Contents of the pack and other information

1. What Levalox is and what it is used for

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

• Lungs, in patients with pneumonia,
• Urinary tract, including kidneys or bladder,
• Prostate gland, in cases of chronic infection,
• Skin and subcutaneous tissue, including muscles. This is sometimes referred to as "soft tissues."

In certain situations, Levalox infusion solution may be used to prevent a lung disease called anthrax, which may occur after exposure to bacteria causing anthrax, or to treat this disease.

2. Important information before using Levalox

When not to use Levalox and to contact a doctor:

• If the patient is allergic to levofloxacin, any other quinolone antibiotic 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 experienced tendon problems, such as tendonitis, associated with treatment with quinolone antibiotics. A tendon is a cord connecting muscles to bones.
• If the medicine has been prescribed for a child or adolescent during the growth period.
• If the patient is pregnant, could become pregnant, or suspects she is pregnant.
• If the patient is breastfeeding.

Do not use this medicine if any of the above situations apply to the patient.
If in doubt, talk to a doctor, nurse or pharmacist before starting treatment with Levalox.
Warnings and precautions
Before starting treatment with Levalox, discuss with a doctor, pharmacist or nurse if the patient:

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

Before taking this medicine
Do not take antibacterial medicines containing fluoroquinolones or quinolones, including Levalox, if the patient has previously experienced any severe adverse reaction while taking a quinolone or fluoroquinolone. In such a case, inform the doctor as soon as possible.
While taking this medicine
If sudden, severe abdominal, back or chest pain occurs, which may be a sign of aneurysm or aortic dissection, seek immediate emergency care. The risk of these events may be higher when undergoing systemic corticosteroid therapy.
If sudden shortness of breath occurs, especially when lying down, or if swelling of the ankles, feet or abdomen is observed, or palpitations (sensation of rapid or irregular heartbeat) develop, consult a doctor immediately.
If sudden, involuntary jerks, muscle twitching or muscle spasms occur, contact a doctor immediately, as these may be symptoms of myoclonus. The doctor may decide to discontinue levofloxacin and initiate appropriate treatment.
If nausea, general malaise, severe discomfort or severe, persistent or worsening abdominal 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 in blood counts occur, the doctor may decide to discontinue treatment.
Rarely, tendon pain and swelling, tendon inflammation or tendon rupture may occur. The risk is increased in elderly patients (over 60 years), after organ transplantation, in patients with kidney problems or those receiving corticosteroid therapy. Tendon inflammation and rupture may occur within the first 48 hours of treatment, or even several months after discontinuation of Levalox. At the first sign of tendon pain or inflammation (e.g. in the ankle, wrist, elbow, shoulder or knee), discontinue Levalox, contact a doctor and rest the affected area. Avoid excessive physical exertion, as this may increase the risk of tendon rupture.
The patient may rarely experience symptoms of nerve damage (neuropathy), such as pain, burning, tingling, numbness and (or) weakness, especially in the feet and legs, and hands and arms. In such a case, discontinue Levalox and inform the doctor immediately to prevent progression to potentially irreversible disease.
Long-term, disabling and potentially irreversible serious adverse reactions
Antibacterial medicines containing fluoroquinolones/quinolones, including Levalox, have been associated with very rare but serious adverse reactions. Some of these were long-term (lasting for months or years), disabling or potentially irreversible. These include: tendon, muscle and joint pain in the upper and lower limbs, difficulty walking, abnormal sensations such as pricking, tingling, tickling, numbness or burning (paresthesia), sensory disturbances including disturbances in vision, taste, smell and hearing, depression, memory disturbances, severe fatigue and severe sleep disturbances.
If any of these adverse reactions occur after taking Levalox, contact a doctor immediately before continuing treatment. The patient and doctor will decide whether to continue treatment, also considering antibiotics from other classes.
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, often with blisters in the center, on the trunk. Oral, throat, nose, genital or eye ulcers (red, swollen eyes) may also occur. These severe rashes are often preceded by fever and (or) flu-like symptoms. These rashes may lead to extensive skin peeling, which may be life-threatening or fatal.
• In DRESS syndrome, flu-like symptoms and facial rash appear initially, followed by widespread rash with high fever, increased liver enzyme activity and elevated white blood cell count (eosinophilia) in blood tests, and enlarged lymph nodes. If a severe rash or any of these skin symptoms occur, discontinue levofloxacin and contact a doctor or seek immediate medical help.

If the patient is unsure whether any of the above situations apply, they should talk to a doctor, nurse or pharmacist before starting treatment with Levalox.
Children and adolescents
Levalox is contraindicated in children and adolescents.
Levalox with other medicines
Tell the doctor or pharmacist about all medicines currently used or recently used, and any medicines planned for use. This is because Levalox may affect the action of other medicines, and other medicines may affect the action of Levalox.
In particular, inform the doctor if the patient is taking any of the following medicines, as the risk of adverse reactions may increase when these medicines are taken together with Levalox:

• corticosteroids, sometimes called steroids – used for inflammatory conditions; the patient may be more susceptible to tendon inflammation and (or) tendon damage,
• warfarin – used to thin the blood; the patient may be more susceptible to bleeding; the doctor may recommend regular blood tests to monitor blood clotting,
• theophylline – used for breathing problems; the patient may be more susceptible to seizures (epileptic fits) when taking Levalox,
• non-steroidal anti-inflammatory drugs (NSAIDs) – used for pain and inflammation, such as acetylsalicylic acid, ibuprofen, fenbufen, ketoprofen, indomethacin; the patient may be more susceptible to seizures (epileptic fits) when taking Levalox,
• cyclosporine – used after organ transplantation; the patient may be more susceptible to cyclosporine adverse effects,
• medicines affecting heart rhythm; this includes medicines used for irregular 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 for gout, and cimetidine – used for peptic ulcer disease and heartburn; exercise particular caution when using either of these medicines with Levalox; the treating doctor may recommend a lower dose if the patient has kidney problems.

Urine tests detecting opioids
Urine tests detecting strong painkillers called opioids may give false positive results in patients taking Levalox. If a doctor orders a urine test, the patient should inform the doctor that they are taking Levalox.
Tuberculosis tests
This medicine may cause false negative results in certain laboratory tests used to detect tuberculosis-causing bacteria.
Pregnancy and breastfeeding
Do not use this medicine if the patient:

• is pregnant, could become pregnant, or suspects she is pregnant,
• is breastfeeding.

Driving and operating machinery
After taking this medicine, the patient may experience adverse effects including dizziness, drowsiness, vertigo (spinning sensation) or visual disturbances. Some of these adverse effects may impair concentration and reaction speed. In such a case, the patient should not drive or operate machinery requiring attention.
Levalox contains sodium
This medicine contains 354.20 mg of sodium (the main component of table salt) in 100 ml of solution. This corresponds to 17.7% of the maximum recommended daily dietary sodium intake for adults.

3. How to use Levalox

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

• Levalox infusion solution is intended for use in hospitals.
• The medicine will be administered to the patient by a doctor or nurse as an injection. The injection is given into one of the patient's veins and will take some time (this is called an intravenous infusion).
• Levalox infusion solution at a dose of 250 mg is administered over 30 minutes or longer.
• Levalox infusion solution 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 very rapid heartbeat and temporary drops in blood pressure are possible adverse reactions observed during infusions of similar antibiotics. If during the infusion the patient's blood pressure drops significantly, the infusion should be stopped immediately.

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

• The doctor will decide what dose of Levalox 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
Indication Dosing regimen
Pneumonia 500 mg once or twice daily
Urinary tract infections, including 500 mg once daily
kidney and bladder infections
Prostate infections 500 mg once daily
Skin and subcutaneous tissue infections, 500 mg once or twice daily
including muscle

Adults and elderly patients with renal function impairment
The doctor may recommend a reduced dose.
Children and adolescents
Levalox is contraindicated in children and adolescents.
Protection of the skin from sunlight
During treatment with this medicine and for 2 days after stopping it, direct exposure to sunlight should be avoided, as the patient's skin will be more sensitive to sunlight, which may lead to sunburn, tingling sensation, and the appearance of large blisters on the skin if the following precautions are not taken:

• use sunscreen creams with a high UV protection factor,
• always wear a hat and clothing covering arms and legs,
• avoid sunbathing.

Administration of a higher than recommended dose of Levalox
It is unlikely that a doctor or nurse would administer too high a dose of the medicine. The doctor or nurse will monitor the treatment progress and verify which medicine the patient is receiving. If the patient is unsure why they are receiving a particular dose, they should always ask.
If the patient receives too high a dose of Levalox, the following symptoms may occur: seizures (epileptic fit), confusion, dizziness, disturbances in consciousness, muscle tremors, and heart disturbances leading to irregular heartbeat, as well as nausea.
Missed dose of Levalox
The doctor or nurse will receive instructions regarding the timing and method of administering the medicine to the patient. It is unlikely that the patient will receive the medicine differently than prescribed. If the patient believes a dose has been missed, they should inform the doctor or nurse.
Stopping treatment with Levalox
The doctor or nurse will continue administering Levalox even if the patient feels better. If treatment is stopped too early, the infection may return, the patient's condition may worsen, or bacteria may become resistant to the medicine. 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 or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If the patient experiences any of the adverse reactions described below, stop using the
medicine Levalox and contact a doctor or nurse immediately:
Very rare: may affect up to 1 in 10,000 patients

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

Stop using Levalox and contact a doctor or nurse immediately if the patient experiences any of
the following adverse reactions – immediate treatment may be required:
Rare: may affect up to 1 in 1,000 patients

• Watery diarrhoea, which may contain blood, possibly accompanied by stomach cramps and high fever. These may be symptoms of serious intestinal problems.
• Pain and inflammation of tendons or ligaments, potentially leading to rupture. Most commonly affects the Achilles tendon.
• Seizures (epileptic fits).
• Seeing or hearing things that are not real (hallucinations, paranoia).
• Feelings of depression, psychiatric disturbances, anxiety (agitation), strange 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).
• Decreased blood sugar levels (hypoglycaemia) or decreased blood sugar leading to coma (hypoglycaemic coma). This is important in patients with diabetes.

Very rare: may affect up to 1 in 10,000 patients

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

Frequency not known: frequency 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.
• Loss of appetite, yellowing of the skin and whites of the eyes, dark urine, itching, abdominal tenderness. These may be symptoms of liver dysfunction, including liver damage leading to death.
• Changes in thoughts and beliefs (psychotic reactions) with risk of suicidal thoughts or attempts.
• Nausea, general malaise, discomfort or pain in the abdomen, or vomiting. These may be symptoms of pancreatitis (acute pancreatitis). See section 2.

If the patient experiences visual disturbances or any changes affecting the eyes during
treatment with Levalox, immediate consultation with an ophthalmologist is required.
Administration of quinolone and fluoroquinolone antibiotics has, in some cases and regardless of pre-existing risk factors, very rarely led to long-term (lasting for months or years) or permanent adverse reactions such as tendon inflammation, tendon rupture, joint pain, limb pain, difficulty walking, abnormal sensations such as pricking, tingling, tickling, burning, numbness or pain (neuropathy), fatigue, memory and concentration problems, mental health effects (which may include sleep disturbances, anxiety, panic attacks, depression and suicidal thoughts), and disturbances in hearing, vision, taste and smell.
In patients receiving fluoroquinolones, cases of aortic wall dilation and weakening or damage to the arterial wall (aneurysm and dissection) have been reported, which may result in rupture and lead to death, as well as cases of heart valve regurgitation. See also section 2.
Contact a doctor if any of the following adverse reactions worsen or persist for more than a few days:
Common: may affect up to 1 in 10 patients

• 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 a vein)

Uncommon: may affect up to 1 in 100 patients

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

Rare: may affect up to 1 in 1,000 patients

• Increased tendency to bruising and bleeding due to reduced platelet count (thrombocytopenia)
• Low white blood cell count (neutropenia)
• Excessive immune response (hypersensitivity)
• Tingling sensation in hands and feet (paraesthesia)
• Hearing problems (tinnitus) or vision problems (blurred vision)
• Unusually rapid heartbeat (tachycardia) or low blood pressure (hypotension)
• Decreased muscle strength. This is important in patients with myasthenia gravis (a rare neurological disorder)
• Changes in kidney function and sometimes kidney failure, possibly due to an allergic reaction in the kidneys called interstitial nephritis
• Fever
• Well-defined, erythematous lesions with or without blisters, developing within hours after administration of levofloxacin. These resolve with post-inflammatory pigmentation. Upon subsequent administration of levofloxacin, these lesions usually recur at the same site on the skin or mucous membranes.
• Memory disturbances

Frequency not known: frequency cannot be estimated from available data

• Decreased number of red blood cells (anaemia): this may cause paleness or yellowing of the skin due to destruction of red blood cells; decreased number of all types of blood cells (pancytopenia)
• Cessation of new blood cell production by the bone marrow, which may cause fatigue, reduced ability to fight infections and uncontrolled bleeding (bone marrow failure)
• Fever, sore throat and general malaise that does not resolve; this may be due to reduced white blood cell count (agranulocytosis)
• Circulatory arrest (shock resembling anaphylactic shock)
• Increased blood sugar levels (hyperglycaemia) or decreased blood sugar levels leading to coma (hypoglycaemic coma); this is important in patients with diabetes
• Changes in smell, loss of smell or taste (olfactory hallucinations, anosmia, ageusia)
• Feeling of intense excitement, elation, agitation or enthusiasm (mania)
• Problems with movement and walking (dyskinesia, extrapyramidal disorders)
• Transient loss of consciousness or fainting (syncope)
• Transient loss of vision, eye inflammation
• Hearing disturbances or hearing loss
• Irregular fast heartbeat, life-threatening arrhythmias, including cardiac arrest, changes in heart rhythm (so-called "QT interval prolongation" visible on ECG, i.e. test of the heart's electrical activity)
• Breathing difficulties or wheezing (bronchospasm)
• Allergic reactions affecting the lungs
• Pancreatitis
• Hepatitis
• 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 rupture and breakdown (rhabdomyolysis)
• Redness and swelling of joints (arthritis)
• Pain, including back, chest and limb pain
• Sudden, involuntary jerks, muscle twitches and muscle spasms (myoclonus)
• Porphyria attacks in patients with porphyria (a very rare metabolic disorder)
• Persistent headache with blurred vision (benign intracranial hypertension)

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor, pharmacist or nurse. Adverse reactions 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 reactions can also be reported to the responsible entity.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Levalox

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after the abbreviation
"EXP". The expiry date refers to the last day of the stated month.
The batch number is indicated on the packaging after the abbreviation "Lot".
Expiry after piercing the rubber stopper: the solution must be used immediately (within 3 hours).
Store in the original packaging to protect from light.
No special precautions regarding storage temperature are required.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such practices will help protect the environment.

6. Contents of the pack and other information

What Levalox contains

• The active substance is levofloxacin. 1 ml of infusion solution contains 5 mg levofloxacin as levofloxacin hemihydrate. 100 ml of infusion solution contains 500 mg levofloxacin as levofloxacin hemihydrate. The other ingredients are sodium chloride, hydrochloric acid concentrated (for pH adjustment) and water for injections. See section 2, "Levalox contains sodium".

What Levalox looks like and contents of the pack
A clear, yellowish-green solution, free from solid particles
pH: 4.5 - 5.1
Osmolality: 282 mOsmol/kg – 322 mOsmol/kg
Each vial contains 100 ml of infusion solution.
Pack sizes: 1, 5 and 10 vials, in a cardboard box.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
KRKA, d. d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Manufacturer
KRKA, d. d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
This medicinal product is authorised for marketing in the Member States of the European Economic Area under the following names:

For more detailed information, please contact the representative of the marketing authorization holder:
KRKA-POLSKA Sp. z o.o.
Równoległa Street 5
02-235 Warsaw
Phone: +48 22 57 37 500

Levalox, 5 mg/ml, solution for infusion
Levofloxacinum

Information intended exclusively for medical professionals:

Administration method
Levalox, infusion solution, is administered as a slow intravenous infusion once or twice daily.
The 250 mg intravenous infusion dose should be given over at least 30 minutes, or over at least
60 minutes for the 500 mg intravenous infusion dose.
The dosage depends on the type and severity of infection and on the susceptibility of the
presumed microorganism causing the infection. After initial intravenous administration of Levalox,
treatment may be continued with the appropriate oral formulation according to the Summary of
Product Characteristics for coated tablets, depending on the patient's condition. Due to the
bioequivalence of the intravenous and oral formulations, equivalent doses may be used.

Special precautions for disposal and preparation of the medicinal product for administration
Levalox infusion solution should be used immediately (within 3 hours) after piercing the rubber
stopper to avoid bacterial contamination. Protection from light during infusion is not required.
This medicinal product is for single use only.
The solution should be inspected visually before use. It should only be used if it is clear,
greenish-yellow, and free from particulate matter.
As with all medicinal products, any unused portions should be discarded in accordance with
local regulations.

Incompatibilities
Do not mix the medicinal product with heparin or with alkaline solutions (e.g. sodium bicarbonate).
Do not mix the medicinal product with other medicinal products except those listed below.

Mixing with other infusion solutions
Levalox infusion solution is compatible with the following infusion fluids:

• 0.9% sodium chloride solution,
• 5% glucose solution for injection,
• 2.5% glucose in Ringer's solution,
• complex parenteral nutrition solutions (amino acids, glucose, electrolytes).

Chemical and physical compatibility of Levalox infusion solution with the above-mentioned
solutions has been demonstrated at room temperature over a period of 4 hours.