Tavanic: detailed information

Package leaflet: Information for the user

Tavanic, 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 questions, ask your doctor, nurse, or pharmacist.
If you experience any side effects, including any not listed in this leaflet, tell your doctor, nurse, or pharmacist. See section 4.

Table of contents

What Tavanic is and what it is used for
Important information before using Tavanic
How to use Tavanic
Possible side effects
How to store Tavanic
Contents of the pack and other information

1. What Tavanic is and what it is used for

The name of this medicine is Tavanic. Tavanic 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 that cause infections in the body.
Tavanic 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 long-term infection;
Skin and subcutaneous tissue, including muscles. This is sometimes referred to as "soft tissues."

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

2. Important information before using Tavanic

When not to use this medicine 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 previously experienced tendon problems, such as tendon inflammation, associated with treatment with quinolone antibiotics. A tendon is a structure connecting muscles to bones.
In children or adolescents during the growth period.
If the patient is pregnant, may become pregnant, or suspects she is pregnant.
If the patient is breastfeeding.

Do not use this medicine if any of the above statements apply to the patient.
In case of doubt, consult a doctor, nurse or pharmacist before starting treatment with Tavanic.

Warnings and precautions
Before starting treatment with this medicine, discuss with a doctor, nurse or pharmacist if the patient:

is 60 years of age or older;
is taking corticosteroids, sometimes called steroids (see section "Tavanic and other medicines");
has received an organ transplant;
has ever previously had seizures (epileptic fits);
has previously had brain damage caused by stroke or other brain injury;
has kidney disease;
has a diagnosed "glucose-6-phosphate dehydrogenase deficiency"; such patients may be more susceptible to serious blood disorders during treatment with this medicine;
has ever previously had psychiatric disorders;
has ever previously had heart-related diseases; caution is required during treatment with this medicine if the patient: has congenital or family history of QT interval prolongation (visible on ECG, i.e. test of electrical activity of the heart), has electrolyte imbalances in the blood (especially low potassium or magnesium levels), has very 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 "Tavanic and other medicines");
has diabetes;
has ever previously had liver disease;
has myasthenia gravis;
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);
the patient has been diagnosed with heart valve insufficiency;
if there is a family history of aortic aneurysm or aortic dissection, or 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, or confirmed atherosclerosis, rheumatoid arthritis [joint disease], or endocarditis [heart infection]);
has ever previously 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), and drug reaction with eosinophilia and systemic symptoms (DRESS).

SJS or TEN may initially appear as red, target-like or round spots, often with blisters in the center, on the trunk. Oral, throat, nasal, genital, or eye ulcers (red and 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 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, stop taking levofloxacin immediately and consult a doctor or seek urgent medical help.
Do not take antibacterial medicines containing fluoroquinolones or quinolones, including Tavanic, if the patient has previously experienced any severe adverse reaction during treatment with a quinolone or fluoroquinolone. In such a case, inform the doctor immediately.
If the patient is taking Tavanic:

If sudden severe abdominal, back or chest pain occurs, which may indicate an aortic aneurysm or dissection, seek emergency medical attention immediately. The risk of these conditions may be higher when receiving systemic corticosteroids.
If sudden shortness of breath, especially when lying down, or swelling of ankles, feet or abdomen, or palpitations (sensation of rapid or irregular heartbeat) occur, consult a doctor immediately.
If sudden, involuntary jerks, muscle twitches or muscle cramps 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 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 health, or feeling of reduced immunity 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 complete blood count tests. If abnormalities are detected, the doctor may decide to discontinue treatment.

Rarely, tendon pain, swelling, inflammation or 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 treatment. Tendon inflammation and rupture may occur within the first 48 hours of treatment, or even several months after stopping Tavanic. At the first sign of tendon pain or inflammation (e.g. in the ankle, wrist, elbow, shoulder or knee), discontinue Tavanic, contact a doctor and rest the affected area. Avoid excessive physical exertion, as this may increase the risk of tendon rupture.

Rarely, the patient may experience symptoms of nerve damage (neuropathy), such as pain, burning, tingling, numbness and/or weakness, especially in the feet, legs, hands and arms. In such cases, discontinue Tavanic immediately and inform the doctor promptly to prevent progression to potentially irreversible disease.

Long-term, disabling and potentially irreversible serious adverse reactions
Antibacterial medicines containing fluoroquinolones and/or quinolones, including Tavanic, 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 vision, taste, smell and hearing disorders, depression, memory impairment, severe fatigue and severe sleep disturbances.

If any of these adverse reactions occur after taking Tavanic, contact a doctor immediately before continuing treatment. The patient and doctor will decide whether to continue treatment, considering also antibiotics from other classes.

If the patient is unsure whether any of the above statements apply, before starting treatment with Tavanic infusion solution, the patient should consult a doctor, nurse or pharmacist.

Tavanic and other medicines
Inform the doctor or pharmacist about all medicines currently taken, recently taken, or planned for use. This is because Tavanic may affect the action of other medicines, and other medicines may affect the action of Tavanic.

In particular, inform the doctor if the patient is taking any of the following medicines. The risk of adverse reactions may increase when these medicines are used concomitantly with Tavanic.

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. The doctor may order regular blood tests to monitor blood clotting.
Theophylline – used for breathing problems. The patient may be more susceptible to seizures (epileptic fits) when taking Tavanic.
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 Tavanic.
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), 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. The treating doctor may recommend a lower dose if the patient has kidney problems.
Cimetidine – used for peptic ulcer disease and heartburn. The treating doctor may recommend a lower dose if the patient has kidney problems.

If any of the above statements apply to the patient, consult a doctor.

Urine tests for opioids
Urine tests detecting strong painkillers called opioids may yield false-positive results in patients taking Tavanic. If a doctor orders a urine test, the patient should inform the doctor that Tavanic is being taken.

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

Pregnancy and breastfeeding
Do not use this medicine if the patient:

is pregnant, may become pregnant, or suspects she is pregnant;
is breastfeeding.

Driving and operating machinery
After administration of this medicine, adverse reactions such as dizziness, drowsiness, vertigo (spinning sensation) or visual disturbances may occur. Some of these adverse reactions may impair concentration and reaction speed. In such cases, the patient should not drive or perform any work requiring attention.

Tavanic infusion solution contains sodium
The medicine contains 363 mg of sodium (the main component of table salt) in each 100 ml bottle of infusion solution. This corresponds to 18% of the maximum recommended daily dietary sodium intake for adults.

3. How to use Tavanic

How to administer Tavanic infusion solution

Tavanic infusion solution is intended for use in hospitals.
The medicine will be administered to the patient by a doctor or nurse as an intravenous injection. This injection is given into one of the patient's veins and will take some time (this is called an intravenous infusion).
The 500 mg Tavanic infusion solution should be administered over 60 minutes or longer.
The doctor will carefully monitor the patient's pulse and blood pressure. This is because very rapid heartbeat and temporary decreases in blood pressure are possible side effects that have been observed during infusions of similar antibiotics. If the patient's blood pressure significantly drops during the infusion, the infusion must be stopped immediately.

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

The doctor will decide the dose of Tavanic 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.
Prostate infections: 500 mg once daily.
Skin and soft tissue infections, including muscle: 500 mg once or twice daily.

Adults and elderly patients with impaired kidney function
The doctor may recommend a reduced dose.
Children and adolescents
This medicine must not be used in children and adolescents.
Skin protection from sunlight exposure
During treatment with this medicine and for 2 days after stopping it, direct exposure to sunlight should be avoided. This is because the patient's skin may become more sensitive to sunlight, which could lead to sunburn, tingling sensations, and the development of large blisters on the skin if the following precautions are not taken:

use high SPF sunscreens
always wear a hat and clothing covering arms and legs
avoid using sunbeds (tanning beds).

Administration of a higher than recommended dose of Tavanic
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 Tavanic, the following symptoms may occur: seizures (epileptic fit), confusion, dizziness, disturbances in consciousness, muscle tremors, and heart rhythm disturbances leading to irregular heartbeat, as well as nausea.

Missed dose of Tavanic
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 their doctor or nurse.

Stopping treatment with Tavanic
The doctor or nurse will continue administering Tavanic 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 intravenous treatment, the doctor may decide to switch the medicine to tablets to complete the prescribed treatment course.

If there are any further doubts regarding the use of this medicine, consult the doctor, nurse, or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will get them.
These side effects are usually mild or moderately severe and quickly resolve.
If the patient experiences any of the side effects listed below, stop taking the medicine
Tavanic and contact a doctor or nurse immediately.
Very rare (occur in 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.

Stop taking Tavanic and contact a doctor or nurse immediately if the patient experiences any of
the following side effects – immediate treatment may be necessary.
Rare (occur in fewer than 1 in 1,000 patients)

Watery diarrhoea, which may contain blood, possibly with abdominal cramps and high fever. These may be symptoms of a serious bowel disease.
Pain and inflammation of tendons or ligaments, possibly leading to rupture. Most commonly affects the Achilles tendon.
Seizures (epileptic fits).
Seeing or hearing things that are not real (hallucinations, paranoia).
Feeling depressed, psychiatric disturbances, anxiety (agitation), strange 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 sugar (hypoglycaemia) or decreased blood sugar leading to coma (hypoglycaemic coma). This is important in patients with diabetes.

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

Burning, tingling, pain or numbness. These may be symptoms of "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 or circular spots, 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 whites of the eyes, dark urine, itching, abdominal tenderness. These may be symptoms of liver dysfunction, including liver failure leading to death.
Changes in thoughts and behaviour (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 vision disturbances or any changes in the eyes during treatment with
Tavanic, consult an ophthalmologist immediately.
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 side effects, 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 aneurysm and dissection (aortic wall dilation and weakening or damage) 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 side effects worsen or persist for more than a few days:
Common (occur in fewer than 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 (vein inflammation).

Uncommon (occur in fewer than 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.
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 (increased bilirubin levels) or kidney (increased creatinine levels) dysfunction.
General weakness.

Rare (occur in fewer than 1 in 1,000 patients)

Increased tendency to bruise and bleed due to reduced platelet count (thrombocytopenia).
Reduced 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 abnormalities and sometimes kidney failure, possibly due to an allergic reaction in the kidneys known as interstitial nephritis.
Fever.
Well-demarcated, red spots with or without blisters, developing within hours after levofloxacin administration. These resolve with post-inflammatory pigmentation. Upon subsequent levofloxacin administration, these spots usually reappear in the same location 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 red blood cell damage; 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-like shock).
Increased blood sugar (hyperglycaemia). 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).
Pulmonary allergic reactions.
Pancreatitis.
Hepatitis (liver inflammation).
Increased skin sensitivity to sunlight and ultraviolet radiation (photosensitivity), skin discolouration (hyperpigmentation).
Blood vessel inflammation due to allergic reaction (vasculitis).
Inflammation of the lining of the mouth (oral mucositis).
Muscle breakdown (rhabdomyolysis).
Joint redness and swelling (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 side effects
If any side effects occur, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorisation holder or its representative in Poland.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Tavanic

Keep the medicine out of the sight and reach of children.
Store the bottle in the outer packaging to protect it from light. Protection from light is not necessary during infusion.
After opening the bottle (after piercing the rubber stopper), the solution should be used immediately (within 3 hours) to avoid bacterial contamination.
Do not use this medicine after the expiry date stated on the carton and on the bottle after "EXP".
The expiry date refers to the last day of the stated month.
Do not use this medicine if the solution is not clear, greenish-yellow, and/or contains particulate matter.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Tavanic contains
The active substance is levofloxacin. Tavanic infusion solution in a dose of 500 mg is available in a 100 ml glass bottle. Each ml of infusion solution contains 5 mg of levofloxacin.
The other components are: sodium chloride, sodium hydroxide, hydrochloric acid and water for injections.

What Tavanic infusion solution looks like and contents of the pack
Tavanic infusion solution is a clear, yellowish-green liquid, free from solid particles. It is supplied in glass bottles:

100 ml bottles available in packs containing one, 5 or 20 bottles.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sanofi-Aventis Deutschland GmbH
Brüningstrasse 50
D-65 926 Frankfurt am Main
Germany

Manufacturer
Sanofi-Aventis Deutschland GmbH
Brüningstrasse 50
D-65 926 Frankfurt am Main
Germany
Sanofi S.r.l.
Via Valcanello, 4
03012 Anagni
Italy

This leaflet does not contain all the information about this medicine. If you have any questions or doubts, please contact your doctor or pharmacist.
For more detailed information about the medicine and its names in the European Economic Area countries, please contact the local representative of the Marketing Authorisation Holder in Poland:
Sanofi Sp. z o.o.
ul. Marcina Kasprzaka 6
01-211 Warsaw
tel.: +48 22 280 00 00