Levofloxacin aptapharma

Package leaflet: Information for the user

Levofloxacin AptaPharma, 5 mg/mL,
concentrate for solution for infusion
Levofloxacin
Please read all of this leaflet carefully before you are given this medicine because it contains important information for you.

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

Contents of the leaflet

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

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

Levofloxacin AptaPharma contains the active substance levofloxacin. Levofloxacin belongs to a group of medicines called antibiotics, specifically to the group of antibiotics known as "fluoroquinolones". It works by killing bacteria that cause infections in the body.

Levofloxacin AptaPharma as a concentrate for solution for infusion may be used to treat the following bacterial infections:

• Lungs, in patients with pneumonia,
• Urinary tract, including kidneys or bladder,
• Prostate gland, in case of long-term infection,
• Skin and underlying tissue, including muscles. This is sometimes referred to as "soft tissues".

In certain situations, Levofloxacin AptaPharma, concentrate for solution for infusion, may be used to prevent or treat a lung disease called anthrax, which may occur after exposure to the bacteria that cause anthrax.

2. Important information before using Levofloxacin AptaPharma

When not to use Levofloxacin AptaPharma and to contact your 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. Tendons are "cords" connecting muscles to bones.
• If this medicine has been prescribed for a child or adolescent who is still growing.
• If the patient is pregnant, could become pregnant, or suspects she may be pregnant.
• If the patient is breastfeeding.

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

• is 60 years of age or older,
• is taking corticosteroids, sometimes called steroids (see section “Levofloxacin AptaPharma and other medicines”),
• has received an organ transplant,
• has ever had seizures (epileptic fits),
• has ever had brain damage due to 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 prolonged QT interval (seen on ECG, i.e. test of electrical activity of the heart), has electrolyte disturbances in the blood (especially low levels of potassium or magnesium), has a slow heart rate (called "bradycardia"), has impaired heart function (heart failure), has had a previous heart attack (myocardial infarction), is female or elderly, or is taking other medicines causing unusual changes on ECG (see section “Levofloxacin AptaPharma and other medicines”),
• has diabetes,
• has ever had liver problems,
• has myasthenia gravis,
• has nerve damage (peripheral neuropathy),
• if the patient has been diagnosed with a dilated 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 regurgitation (valvular insufficiency),
• if 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)],
• has ever experienced severe skin rash, skin peeling, blistering and/or oral 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, often with blisters in the center, on the trunk. Oral, throat, nasal, genital ulcers and eye involvement (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.

• Red, scaly rash with subcutaneous nodules (including skin folds, chest, abdomen (including stomach), back and arms) and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized pustular rash).

If a severe rash or any of these skin symptoms occur, stop taking levofloxacin and contact your doctor or seek immediate medical help.
Do not take antibacterial medicines containing fluoroquinolones or quinolones, including Levofloxacin AptaPharma, if the patient has previously experienced any severe adverse reaction while taking a quinolone or fluoroquinolone. In such a case, inform your doctor immediately.
Discuss with your doctor, nurse or pharmacist if, during treatment:

• Sudden, severe abdominal, back or chest pain occurs, which may indicate an aortic aneurysm or dissection; immediate emergency department attendance is required. The risk of these events may be higher when treated with systemic corticosteroids.
• Sudden shortness of breath, especially when lying down, or swelling of the ankles, feet or abdomen, or palpitations (sensation of rapid or irregular heartbeat) occur; seek immediate medical advice.
• Sudden, involuntary jerks, muscle twitches or muscle cramps occur; contact your doctor immediately, as these may be signs of myoclonus. Your doctor may decide to discontinue levofloxacin and start appropriate treatment.
• Nausea, general malaise, severe discomfort, or severe, persistent or worsening abdominal pain or vomiting occur; contact your doctor immediately, as these may be symptoms of pancreatitis (acute inflammation of the pancreas).
• Fatigue, pale skin, bruising, uncontrolled bleeding, fever, sore throat, significant worsening of health or feeling of reduced immunity occur; contact your doctor immediately, as these may be symptoms of blood disorders. Your doctor should monitor the patient's blood count via complete blood count tests. If abnormalities occur, your doctor may decide to discontinue treatment.

Rarely, joint 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 treated with corticosteroids. Tendon inflammation and rupture may occur within the first 48 hours of treatment, and even several months after discontinuation of Levofloxacin AptaPharma. After the first symptoms of tendon pain or inflammation (e.g. in the ankle, wrist, elbow, shoulder or knee) occur, discontinue Levofloxacin AptaPharma, contact your 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 Levofloxacin AptaPharma and inform your doctor immediately to prevent progression to potentially irreversible disease.
Long-term, disabling and potentially irreversible serious adverse reactions
Antibacterial medicines containing fluoroquinolones or quinolones, including Levofloxacin
AptaPharma, have been associated with very rare but serious adverse reactions. Some of these
reactions were long-term (lasting 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 vision, taste, smell and hearing disturbances, depression, memory disturbances, severe
fatigue and severe sleep disturbances.
If any of these adverse reactions occur after taking Levofloxacin AptaPharma, contact your doctor
immediately before continuing treatment. The patient and doctor will decide whether to continue
treatment, also considering antibiotics from other classes.
If the patient is unsure whether any of the above situations apply, consult your doctor, nurse or
pharmacist before starting treatment with Levofloxacin AptaPharma.
Levofloxacin AptaPharma and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, and any medicines
planned for future use. This is because Levofloxacin AptaPharma may affect the action of other
medicines, and other medicines may affect the action of Levofloxacin AptaPharma.
In particular, inform your doctor if the patient is taking any of the following medicines,
as the risk of adverse reactions may increase when used concomitantly with Levofloxacin
AptaPharma:

• corticosteroids, sometimes called steroids – used for inflammatory conditions; the patient may be more susceptible to tendon inflammation and/or damage,
• warfarin – used to thin the blood; the patient may be more susceptible to bleeding; your 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 Levofloxacin AptaPharma,
• 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 Levofloxacin AptaPharma,
• cyclosporine – used after organ transplantation; the patient may be more susceptible to adverse effects of cyclosporine,
• 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 in gout; your doctor may recommend a lower dose if the patient has kidney problems.
• cimetidine – used in peptic ulcer disease and heartburn; your doctor may recommend a lower dose if the patient has kidney problems.

If any of the above situations apply, inform your doctor.
Urine tests for opioids
Urine tests for strong painkillers called opioids may give false positive results in patients taking Levofloxacin AptaPharma. If your doctor has ordered a urine test, inform them that you are taking Levofloxacin AptaPharma.
Tuberculosis tests
This medicine may give falsely 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 may be pregnant,
• is breastfeeding or plans to breastfeed.

Driving and operating machinery
After taking this medicine, the patient may experience adverse effects such as 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 perform any work requiring attention.
Levofloxacin AptaPharma contains sodium
This medicine contains 3.54 mg of sodium (the main component of table salt) per mL of infusion solution (equivalent to 354 mg of sodium in 100 mL of infusion solution). This corresponds to 17.7% of the maximum recommended daily dietary sodium intake for adults.

3. How to use Levofloxacin AptaPharma

How Levofloxacin AptaPharma infusion solution is administered

• Levofloxacin AptaPharma infusion solution is intended for use in hospitals.
• The medicine will be given to the patient by a doctor or nurse as an injection. The injection is administered into one of the patient's veins and will take a certain amount of time (this is called an intravenous infusion).
• The 500 mg dose of Levofloxacin AptaPharma infusion solution should be administered over 60 minutes or longer.
• When only half of the 500 mg dose of Levofloxacin AptaPharma is used (a 250 mg dose of levofloxacin in 50 mL of solution), the intravenous infusion time should be 30 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 side effects that have been observed during infusion of similar antibiotics. If the patient's blood pressure drops significantly during the infusion, the infusion should be stopped immediately.

What dose of Levofloxacin AptaPharma is used
If the patient is unsure why they are receiving Levofloxacin AptaPharma, or has any questions regarding the dose being used, they should consult their doctor, nurse, or pharmacist.

• The doctor will decide what dose of Levofloxacin AptaPharma 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 infections, including kidney and bladder infections: 500 mg once daily
Prostatitis: 500 mg once daily
Skin and soft tissue infections, including muscles: 500 mg once or twice daily

Adults and elderly patients with impaired renal function
The doctor may recommend a reduced dose.

Children and adolescents
Levofloxacin AptaPharma 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 sensations, and the development 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 and using sunbeds.

Use of a higher than recommended dose of Levofloxacin AptaPharma
It is unlikely that a doctor or nurse would administer too high a dose of the medicine. The doctor or nurse will monitor the patient's progress and verify which medicine is being administered. 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 Levofloxacin AptaPharma, the following symptoms may occur: seizures (epileptic fit), feeling disoriented, dizziness, disturbances in consciousness, muscle tremors, and heart disturbances leading to irregular heartbeat, as well as nausea.

Missing a dose of Levofloxacin AptaPharma
The doctor or nurse will have instructions regarding when and how to administer the medicine to the patient. It is unlikely that the patient will receive the medicine in a different way than prescribed. If the patient thinks a dose has been missed, they should inform the doctor or nurse.

Stopping treatment with Levofloxacin AptaPharma
The doctor or nurse will continue administering Levofloxacin AptaPharma 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 antibiotic. 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 there are any further doubts regarding the use of this medicine, please consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Adverse reactions are usually mild or moderate and most often resolve within a short time.
If the patient experiences any of the adverse reactions listed below, discontinue use of
Levofloxacin AptaPharma 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.

Discontinue use of Levofloxacin AptaPharma 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 abdominal 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, 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 (hypoglycaemia) or decreased blood glucose 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 the available data

• Severe skin rashes, including Stevens-Johnson syndrome and toxic epidermal necrolysis. These may present as red, target-like spots or circular lesions, 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.
• Red, scaly rash with subcutaneous nodules (including skin folds, chest, abdomen (including stomach), back and shoulders) and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis). See 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 behaviour (psychotic reactions) with risk of suicidal thoughts or attempts.
• Nausea, general malaise, discomfort or abdominal pain, or vomiting. These may be symptoms of pancreatitis (acute pancreatitis). See section 2.
• Burning pain (neuralgia)

If the patient experiences visual disturbances or any changes in the eyes during treatment with
Levofloxacin AptaPharma, consult an ophthalmologist immediately.
Administration of quinolone and fluoroquinolone antibiotics, in some cases regardless of pre-existing risk factors, has 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 arterial wall dilation and weakening or arterial wall damage (aneurysm and dissection) have been reported, which may result in rupture and lead to death, as well as cases of heart valve insufficiency. See also section 2.
Contact a doctor if any of the following adverse reactions worsen or persist for longer 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 blood
• Reactions at the infusion site
• Phlebitis (vein inflammation)

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, disorientation, nervousness, 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, excessive sweating
• Joint or muscle pain
• Abnormal blood test results due to liver (increased bilirubin levels) or kidney (increased creatinine levels) dysfunction
• 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 fast heartbeat (tachycardia) or low blood pressure (hypotension)
• Decreased muscle strength. This is important in patients with myasthenia gravis (a rare neurological disorder)
• Kidney function changes 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 levofloxacin administration. These resolve with post-inflammatory pigmentation. Upon subsequent administration of levofloxacin, these lesions usually reappear at the same skin or mucosal site.
• Memory disturbances

Frequency not known: frequency cannot be estimated from the available data

• Decreased number of red blood cells (anaemia): this may cause paleness or yellowing of the skin due to red blood cell damage; decreased number of all blood cell types (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 low white blood cell count (agranulocytosis)
• Circulatory arrest (shock resembling anaphylactic shock)
• Increased blood glucose (hyperglycaemia) or decreased blood glucose 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 vision loss, 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. electrocardiogram)
• Breathing difficulties or wheezing (bronchospasm)
• Pulmonary allergic reactions
• 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 lining of the mouth (oral mucositis)
• Rupture and breakdown of muscle tissue (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 of 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 marketing authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Levofloxacin AptaPharma

Keep this medicine out of the 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 specified month.
Store below 30°C.
Keep in the original packaging to protect from light. Protection from light is not required during infusion.
Levofloxacin AptaPharma should be used immediately (within 3 hours) after piercing the rubber stopper to avoid potential microbiological contamination.
From a microbiological point of view, the infusion solution should be used immediately. Otherwise, the user is responsible for the storage duration and conditions.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This helps protect the environment.

6. Contents of the packaging and other information

What Levofloxacin AptaPharma contains

• The active substance is levofloxacin. 1 mL of infusion solution contains 5 mg of levofloxacin as levofloxacin hemihydrate.
• The other components are sodium chloride, concentrated hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment), and water for injections.

What Levofloxacin AptaPharma looks like and contents of the pack
A clear, yellow to yellowish-green solution, free from solid particles. The solution is contained in a
plastic infusion bag with a capacity of 100 mL. The infusion bags are equipped with one plastic tube and one Minitulipe port (made of polycarbonate with a chlorobutyl rubber stopper) or a Twist off port (made of polypropylene).
Each single-dose infusion bag is sealed with a multilayer protective foil to protect against moisture and light. The bags are packed in cardboard boxes.
Levofloxacin AptaPharma is available in the following pack size:
500 mg levofloxacin in 100 mL infusion solution (100 mL infusion bag).
The cardboard box contains 20 infusion bags of 100 mL infusion solution.

Marketing Authorisation Holder
Apta Medica Internacional d.o.o.
Likozarjeva Ulica 6
1000 Ljubljana
Slovenia
Tel.: 00386 51 615 015
e-mail: [email protected]

Manufacturer
Laboratorios Normon, S.A.
Ronda de Valdecarrizo 6
28760 Tres Cantos, Madrid
Spain

This medicinal product is authorised in the European Economic Area member states under the following names:

Levofloxacin AptaPharma, 5 mg/ml,
infusion solution
Levofloxacinum

Information intended exclusively for healthcare professionals:

How to prepare the medicine
This medicine is intended for single use only.
The solution should be inspected visually before use. It may be used only if it is clear, yellowish-green, and free from particulate matter. Levofloxacin AptaPharma, infusion solution, should be used immediately to avoid any potential microbiological contamination.

Method of administration
Levofloxacin AptaPharma, infusion solution, is intended for intravenous use only by slow infusion; it may be administered once or twice daily. The 500 mg infusion dose should be administered over at least 60 minutes. When only half the dose is used (250 mg levofloxacin in 50 mL), the intravenous infusion time should be at least 30 minutes. The dose depends on the type and severity of infection, as well as on the susceptibility of the presumed causative microorganism.

Special precautions for disposal and preparation of the medicinal product for administration
The infusion solution is light-sensitive; the product should be stored closed in its outer multilayer foil protective pouches. Levofloxacin AptaPharma, infusion solution, should be used immediately (within 3 hours) after piercing the rubber stopper to avoid microbiological contamination. Protection from light during infusion is not required.

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
Levofloxacin AptaPharma, infusion solution, is compatible with the following infusion fluids:

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