PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Avalox 400 mg film-coated tablets

For use in adults
Moxifloxacin
Please read this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Avalox is and what it is used for
What you need to know before taking Avalox
How to take Avalox
Possible side effects
How to store Avalox
Contents of the pack and other information

1. What Avalox is and what it is used for

Avalox contains the active substance moxifloxacin, which belongs to a group of antibiotics called fluorochinolones. Avalox works by killing the bacteria that cause infections.
Avalox is used in patients aged 18 years and older to treat the following bacterial infections when caused by bacteria that are susceptible to moxifloxacin. Avalox should only be used to treat these infections when commonly used antibiotics cannot be used or have not worked:
Sinus infection, sudden worsening of a long-standing airway inflammation, or pneumonia acquired outside the hospital (with the exception of severe cases).
Mild to moderate infections of the upper female genital tract (pelvic inflammatory disease), including infections of the fallopian tubes and the uterine mucosa.
Avalox tablets alone are not sufficient for the treatment of this type of infection, and your doctor will therefore prescribe an additional antibiotic to be used together with Avalox tablets (see section 2. What you should know before taking Avalox, Warnings and precautions, Inform your doctor before taking Avalox).
If the following bacterial infections have shown improvement during initial treatment with Avalox infusion solution, your doctor may also prescribe Avalox tablets to complete the course of treatment: pneumonia acquired outside the hospital, skin and soft tissue infections.
Avalox tablets must not be used to initiate treatment for any type of skin and soft tissue infection or for severe lung infections.

2. What you should know before taking Avalox

Contact your doctor if you think you may belong to any of the patient groups described below.
Do not take Avalox

If you are allergic to the active substance moxifloxacin, to any other quinolone antibiotic, or to any of the other ingredients of this medicine (listed in section 6).
If you are pregnant or breastfeeding.
If you are under 18 years of age.
If you have a history of tendon disease or disorder related to treatment with quinolone antibiotics (see sections Warnings and precautions … and 4. Possible side effects).
If you were born with, or have had, any condition causing heart rhythm abnormalities (detected on ECG, the electrical recording of the heart), have an electrolyte imbalance (especially low levels of potassium or magnesium in the blood), have a very slow heart rate (called "bradycardia"), have heart failure, have a history of heart rhythm abnormalities, or are taking other medicines that cause ECG changes (see section Other medicines and Avalox). This is because Avalox may cause ECG changes, including QT interval prolongation, which is a delay in the conduction of electrical signals.
If you have severe liver disease or liver enzyme (transaminase) levels increased by more than 5 times the upper limit of normal.

Warnings and precautions
Before taking this medicine
Do not take antibacterial medicines containing fluoroquinolones/quinolones, including Avalox, if in the past
you have experienced any serious adverse reaction during treatment with a quinolone or fluoroquinolone. In
such a case, inform your doctor as soon as possible.
Tell your doctor before taking Avalox

Avalox may alter the ECG, especially in women and elderly people. If you are taking medicines that reduce potassium levels in the blood, consult your doctor before taking Avalox (see also section Do not take Avalox and Other medicines and Avalox).
If you have ever developed a severe skin rash or skin peeling, blisters and/or sores in the mouth after taking moxifloxacin.
If you suffer from epilepsy or from a condition that makes you prone to seizures, consult your doctor before taking Avalox.
If you have or have had mental health problems in the past, consult your doctor before taking Avalox.
If you have myasthenia gravis, taking Avalox may worsen the symptoms of the disease. If you think you may have this condition, contact your doctor immediately.
If you have been diagnosed with an enlargement or "bulging" of a large blood vessel (aortic aneurysm or peripheral aneurysm of a large blood vessel).
If you have previously experienced episodes of aortic dissection (a tear in the wall of the aorta).
If you have been diagnosed with insufficiency of one of the heart valves (aortic or mitral regurgitation).
If you have 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, Ehlers-Danlos syndrome, Turner syndrome, Sjögren's syndrome [an autoimmune inflammatory disease], or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behcet's disease, known high blood pressure or atherosclerosis, rheumatoid arthritis [an autoimmune inflammatory disease] or endocarditis [inflammation of the heart]).
If you are a diabetic, because moxifloxacin may cause a change in blood sugar levels.
If you, or someone in your family, suffer from glucose-6-phosphate dehydrogenase deficiency (a rare inherited condition), inform your doctor, who will determine whether Avalox is suitable for you.
In case of complicated upper genital tract infection in women (e.g., associated with tubo-ovarian or pelvic abscess), for which your doctor considers intravenous treatment necessary, treatment with Avalox tablets is not appropriate.
For the treatment of mild to moderate upper genital tract infections in women, your doctor must prescribe another antibiotic in addition to Avalox. If symptoms do not improve after 3 days of treatment, consult your doctor. When taking Avalox
If you experience palpitations or irregular heartbeat during treatment, inform your doctor immediately, who may perform an ECG to assess your heart rhythm.
The risk of heart problems may increase with higher doses. Therefore, you must follow the recommended dosage.
There is a remote possibility of a severe and sudden allergic reaction (an anaphylactic reaction/anaphylactic shock), even after the first dose, with symptoms such as chest tightness, chest pain, shortness of breath, dizziness, nausea or fainting, or dizziness when standing up. In this case, stop taking Avalox and contact your doctor immediately.
Avalox may cause severe and rapidly progressing liver inflammation, which may lead to life-threatening liver failure (including fatal cases, see section 4. Possible side effects). Contact your doctor before continuing treatment if you rapidly develop signs such as feeling unwell and/or nausea associated with yellowing of the whites of the eyes, dark urine, itching, tendency to bleed, or hepatic encephalopathy (symptoms of reduced liver function or rapidly progressing severe liver inflammation).
Severe skin reactions

Severe skin reactions have been reported with moxifloxacin use, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), acute generalized exanthematous pustulosis (AGEP), and drug reaction with eosinophilia and systemic symptoms (DRESS).

SJS/TEN may initially appear as reddish spots or circular patches, often with central blisters, on the trunk. In addition, ulcers may occur in the mouth, throat, nose, genitals, and eyes (red and swollen eyes). These severe skin rashes are often preceded by fever and/or flu-like symptoms. The rashes may progress to widespread skin peeling and life-threatening complications or may be fatal.
AGEP appears at the beginning of treatment as a red, scaly skin rash with bumps under the skin and blisters, accompanied by fever. The most common locations are skin folds, trunk, and upper limbs.
DRESS initially appears as flu-like symptoms and a rash on the face, followed by a widespread rash accompanied by increased body temperature, elevated liver enzymes detected in blood tests, increased levels of a type of white blood cell (eosinophilia), and swollen lymph nodes.

If you develop a severe skin rash or other skin-related symptoms, stop taking moxifloxacin and contact your doctor or seek immediate medical attention.

Quinolone antibiotics, including Avalox, may cause seizures. If this occurs, treatment with Avalox must be stopped.
Severe, prolonged, disabling, and potentially irreversible side effects

Fluoroquinolone/quinolone antibacterial medicines, including Avalox, have been associated with very rare but serious side effects, some of which are prolonged (lasting months or years), disabling, or may not improve. These include tendon, muscle, and joint pain in arms and legs, difficulty walking, abnormal sensations such as tingling, prickling, itching, numbness, or burning (paresthesia), sensory organ disturbances such as changes in vision, taste, smell, or hearing, depression, memory impairment, severe fatigue, and severe sleep disturbances.
If you experience any of these side effects after taking Avalox, contact your doctor immediately before continuing treatment. Your doctor will decide together with you whether to continue treatment and may consider using an antibiotic from another class.

Rarely, symptoms of nerve damage (neuropathy) such as pain, burning, tingling, numbness, and/or weakness, particularly in the feet and legs or hands and arms, may occur. In such cases, stop treatment with Avalox and inform your doctor immediately to prevent permanent nerve damage.
You may experience mental health problems even when taking quinolone antibiotics, including Avalox, for the first time. In very rare cases, depression or mental health problems have led to suicidal thoughts and self-harming behaviors, including suicide attempts (see section 4. Possible side effects). If you develop such reactions, treatment with Avalox must be stopped.
During or after taking antibiotics (including Avalox), diarrhea may occur. If it worsens or persists, or if you notice blood or mucus in your stool, stop taking Avalox immediately and consult your doctor. In this situation, do not take medicines that block or reduce intestinal movements.

Rarely, joint pain and swelling, and tendon inflammation or rupture may occur (see sections Do not take Avalox and 4. Possible side effects). The risk is higher if you are elderly (over 60 years), have received an organ transplant, have kidney problems, or are taking corticosteroids. Tendon inflammation and ruptures may occur within the first 48 hours of treatment and up to several months after stopping Avalox. At the first sign of tendon pain or inflammation (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking Avalox, contact your doctor, and rest the affected area. Avoid unnecessary physical activity, as the risk of tendon rupture may increase.

If you experience sudden abdominal, chest, or back pain, which may be a sign of aortic aneurysm or dissection, go to the emergency room immediately. The risk may be higher if you are taking systemic corticosteroid medicines.
Inform your doctor immediately if you notice a sudden onset of shortness of breath, especially when lying down, or swelling of the ankles, feet, or abdomen, or new episodes of heart palpitations (sensation of rapid or irregular heartbeat).
If you are elderly and have kidney problems, try to drink sufficient fluids, as dehydration may increase the risk of kidney failure.
If you notice weakening of vision or other eye-related effects, consult an ophthalmologist immediately (see sections 2. Driving and use of machines and 4. Possible side effects).
Fluoroquinolone antibiotics may cause an increase in your blood sugar levels above normal (hyperglycemia), or a decrease in blood sugar levels below normal (hypoglycemia), which in severe cases may lead to loss of consciousness (hypoglycemic coma) (see section 4. Possible side effects). If you have diabetes, your blood sugar levels must be closely monitored.
Quinolone antibiotics may make your skin more sensitive to sunlight or UV light. Avoid prolonged exposure to sunlight, intense sunlight, and do not use sunbeds or UV lamps during treatment with Avalox (see section 4. Possible side effects).
The efficacy of moxifloxacin infusion solution in the treatment of severe burns, deep tissue infections, significant purulent ulcers (abscesses), and diabetic foot infections with osteomyelitis (bone marrow infection) has not been demonstrated.

Children and adolescents
Do not administer this medicine to children and adolescents under 18 years of age, as efficacy and tolerability have not been established in this age group (see section Do not take Avalox).
Other medicines and Avalox
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines besides Avalox.
Regarding Avalox, please note:

If you are taking Avalox and other medicines that affect the heart, there is an increased risk of heart rhythm disturbances. Therefore, do not take Avalox with the following medicines: medicines belonging to the antiarrhythmic group (e.g., quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), antipsychotics (e.g., phenothiazines, pimozide, sertindole, haloperidol, sulpiride), tricyclic antidepressants, some antimicrobials (e.g., saquinavir, sparfloxacin, intravenous erythromycin, pentamidine, antimalarials, particularly halofantrine), some antihistamines (e.g., terfenadine, astemizole, mizolastine), and other medicines (e.g., cisapride, intravenous vincamine, bepridil, difemelane).
You must inform your doctor if you are taking other medicines that may reduce potassium levels in the blood (e.g., certain diuretics, laxatives and enemas [at high doses], or corticosteroids [anti-inflammatory medicines], amphotericin B) or slow the heart rate, as these may also increase the risk of serious heart rhythm disturbances during Avalox treatment.
Medicines containing magnesium or aluminium, such as antacids for indigestion, iron or zinc, didanosine, or sucralfate used for gastrointestinal disorders, may reduce the effect of Avalox tablets. If you take any of these medicines, take the Avalox tablet 6 hours before or 6 hours after.
Taking oral medicinal charcoal together with Avalox tablets reduces the effect of Avalox. Therefore, it is recommended not to use these medicines together. If you are taking oral anticoagulants (e.g., warfarin), your doctor may need to monitor your blood clotting time frequently.

Avalox with food and drink
The effect of Avalox is not affected by food, including milk, dairy products, and cheese.
Pregnancy, breastfeeding, and fertility
Do not take Avalox if you are pregnant or breastfeeding.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning a pregnancy, consult your doctor or pharmacist before taking this medicine.
Animal studies have not shown that this medicine impairs fertility.
Driving and use of machines
Avalox may cause dizziness or lightheadedness, sudden temporary loss of vision, or brief loss of consciousness. If you experience these effects, do not drive or operate machinery.
Avalox contains lactose and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking Avalox.
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e., essentially 'sodium-free'.

3. How to take Avalox

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

The recommended dose for adults is one 400 mg film-coated tablet once daily.
Avalox tablets are for oral use. Swallow the tablet whole (to avoid the bitter taste) with plenty of water or another drink. You may take Avalox with or without food. It is recommended to take the tablet at approximately the same time each day.

Dose adjustment is not required in elderly patients, patients with low body weight, or patients with renal impairment.

The duration of treatment depends on the type of infection. Unless otherwise directed by your doctor, the recommended treatment duration for Avalox film-coated tablets is:

Acute exacerbation of chronic bronchitis (including acute exacerbation of chronic obstructive pulmonary disease and bronchitis): 5–10 days
Community-acquired pneumonia (lung infection), except in severe cases: 10 days
Acute bacterial sinusitis (acute infection of the paranasal sinuses): 7 days
Mild to moderate upper female genital tract infections (pelvic inflammatory disease), including infections of the fallopian tubes and endometrium: 14 days

When Avalox film-coated tablets are used to complete a treatment course initially started with Avalox infusion solution, the recommended durations are:

Community-acquired pneumonia (lung infection): 7–14 days. Most patients with pneumonia are switched to oral treatment with Avalox film-coated tablets within 4 days
Skin and soft tissue infections: 7–21 days. Most patients with skin and soft tissue infections are switched to oral treatment with Avalox film-coated tablets within 6 days

Do not exceed the recommended dose or treatment duration (see section 2. What you should know before taking Avalox, Warnings and precautions).

If you take more Avalox than you should
If you take more than the prescribed dose of one tablet per day, contact a doctor immediately. If possible, bring any remaining tablets, the packaging, or this leaflet with you to show the doctor or pharmacist what you have taken.

If you forget to take Avalox
If you forget to take a tablet, take it as soon as you remember, on the same day. If you miss an entire day, take your usual dose (one tablet) the next day. Do not take a double dose to make up for a forgotten tablet.

If you are unsure what to do, consult your doctor or pharmacist.

If you stop taking Avalox
If you stop taking this medicine too early, your infection may not be completely cured. Consult your doctor if you wish to stop taking the tablets before completing the treatment course.

If you have any questions about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The most serious side effects observed during treatment with Avalox are listed below:
If you experience:

a very fast heartbeat (uncommon side effect);
a sudden feeling of illness or notice yellowing of the whites of the eyes, dark urine, skin itching, tendency to bleed, or disturbances in cognitive function or insomnia (these may be signs and symptoms of fulminant hepatitis which could lead to potentially fatal liver failure) (very rare side effect; fatal cases have been reported);
severe skin rashes including Stevens-Johnson syndrome and toxic epidermal necrolysis. These may appear as red, spot-like or circular patches, often with central blisters on the trunk, skin peeling, mouth, throat, nose, genital or eye ulcers, and may be preceded by fever and flu-like symptoms (very rare side effects, potentially fatal);
a red, scaly skin rash with bumps under the skin and blisters accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis) (frequency of this side effect is "not known");
widespread rash, high body temperature, increased liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes and involvement of other body organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome) (frequency of these side effects is "not known");
syndrome associated with reduced water excretion and low sodium levels (SIADH) (very rare side effect);
loss of consciousness due to a severe drop in blood sugar levels (hypoglycaemic coma) (very rare side effect);
inflammation of blood vessels (signs may include red spots on the skin, usually on the lower legs, or symptoms such as joint pain) (very rare side effect);
a sudden, severe and generalized allergic reaction, very rarely including potentially fatal shock (e.g. breathing difficulties, drop in blood pressure, rapid pulse) (uncommon side effect);
chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome (frequency not known: frequency cannot be determined from available data);
swelling, including swelling of the airways (uncommon side effect, potentially fatal);
seizures (uncommon side effect);
nervous system disorders such as pain, burning, tingling, numbness and/or weakness in the extremities (uncommon side effect);
depression (which in very rare cases may lead to self-harm, such as suicidal ideation/suicidal thoughts, or suicide attempts) (uncommon side effect);
psychosis (which may lead to self-harm, such as suicidal ideation/suicidal thoughts, or suicide attempts) (very rare side effect);
severe diarrhoea with blood and/or mucus (antibiotic-associated colitis, including pseudomembranous colitis), which in very rare circumstances may progress to potentially fatal complications (uncommon side effects);
tendon pain and swelling (tendinitis) (uncommon side effect) or tendon rupture (very rare side effect);
muscle weakness, tenderness or pain, and particularly at the same time, feeling unwell, high temperature or dark urine. These may be caused by abnormal muscle damage which can be life-threatening and lead to kidney problems (a condition called rhabdomyolysis) (frequency of this side effect is "not known"); stop taking Avalox and contact your doctor immediately, as urgent medical advice is needed.

Additionally, if you experience:

temporary loss of vision (very rare side effect),
eye disturbances or pain, especially due to light exposure (side effect ranging from very rare to uncommon)

seek immediate advice from an ophthalmologist.
If you have experienced a potentially fatal irregular heartbeat (torsades de pointes) or cardiac arrest while taking Avalox (very rare side effects), inform your doctor immediately
that you have taken Avalox and do not restart treatment.
In very rare cases, worsening of symptoms of myasthenia gravis has been observed. If this occurs, seek immediate medical advice.
If you have diabetes and notice your blood sugar levels rising or falling (uncommon or very rare side effect), inform your doctor immediately.
If you are elderly and already have kidney problems and notice reduced urine output, swelling in the legs, ankles or feet, fatigue, nausea, drowsiness, shortness of breath or confusion (these may be signs of kidney failure, an uncommon side effect), seek immediate medical advice.
Other side effects observed during treatment with Avalox are listed below according to their likelihood:

Common: (may affect up to 1 in 10 people)

nausea
diarrhoea
dizziness
stomach discomfort and abdominal pain
vomiting
headache
increase in a specific liver enzyme in the blood (transaminases)
infections caused by resistant bacteria or fungi, such as oral or vaginal infections caused by Candida
pain or inflammation at the site of infection
change in heart rhythm (ECG) in patients with low potassium levels in the blood

Uncommon: (may affect up to 1 in 100 people)

skin rash
stomach disturbances (indigestion/heartburn)
altered sense of taste (in very rare cases, loss of taste)
sleep disturbances (mainly insomnia)
increase in a specific liver enzyme in the blood (gamma-glutamyl transferase and/or alkaline phosphatase)
decrease in certain white blood cells in the blood (leukocytes, neutrophils)
constipation
itching
sensation of dizziness (feeling of spinning or falling)
drowsiness
flatulence
change in heart rhythm (ECG)
impaired liver function (including increase in a specific liver enzyme in the blood (LDH))
reduced appetite and food intake
low white blood cell count
pains, such as back pain, chest pain, pelvic pain, limb pain
increase in blood cells specialized for clotting
sweating
increase in specialized white blood cells (eosinophils)
anxiety
feeling unwell (mainly weakness or fatigue)
tremor
joint pain
palpitations
irregular and rapid heartbeat
breathing difficulties including asthmatic conditions
increase in a specific digestive enzyme in the blood (amylase)
restlessness/agitation
sensation of tingling (pricking and stinging) and/or numbness
urticaria (hives)
dilation of blood vessels
confusion and disorientation
decrease in blood cells specialized for clotting
visual disturbances including diplopia (double vision) and blurred vision
reduced blood clotting
increase in lipids (fats) in the blood
decrease in red blood cells in the blood
muscle pain
allergic reaction
increased bilirubin in the blood
inflammation of the stomach
dehydration
severe abnormalities in heart rhythm
dryness of the skin
angina pectoris

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

muscle spasms
muscle cramps
hallucinations
high blood pressure
swelling (swelling of hands, feet, ankles, lips, mouth, throat)
low blood pressure
impaired kidney function (including increase in laboratory parameters indicating kidney function, such as urea and creatinine)
liver inflammation
mouth inflammation
ringing or noises in the ears
jaundice (yellowing of the whites of the eyes or skin)
impaired skin sensitivity
abnormal dreams
difficulty concentrating
difficulty swallowing
smell disturbances (including loss of smell)
balance disorders and poor coordination (due to dizziness)
partial or complete memory loss
hearing impairment including deafness (usually reversible)
increased uric acid in the blood
emotional instability
difficulty speaking
fainting
muscle weakness

Very rare: (may affect up to 1 in 10,000 people)

decrease in red blood cells, white blood cells and platelets (pancytopenia)
joint inflammation
heart rhythm abnormalities
increased skin sensitivity
depersonalization (feeling detached from oneself)
increased blood clotting
muscle stiffness
significant reduction in specialized white blood cells (agranulocytosis)

Not known: (frequency cannot be estimated from available data)

Increased skin sensitivity to sunlight or UV light (see also section 2, Warnings and precautions).
Well-defined erythematous patches with or without blisters, appearing within hours of moxifloxacin administration and healing with post-inflammatory hyperpigmentation; usually recurring at the same skin or mucosal site upon subsequent exposure to moxifloxacin.

Cases of dilation and weakening of the aortic wall or aortic wall tear (aneurysms and dissections), with possible rupture that can be fatal, as well as cases of blood regurgitation from heart valves, have been reported in patients treated with fluoroquinolones. See also section 2.

Additionally, very rare cases of the following side effects, which cannot be ruled out from occurring also during treatment with Avalox, have been reported with other quinolone antibiotics: increased sodium levels in the blood, increased calcium levels in the blood, a specific type of decrease in red blood cells (haemolytic anaemia).

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the website [insert national reporting system address here].

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Avalox

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after "Exp.". The expiry date refers to the last day of that month.
Do not store above 25°C.
Keep in the original packaging to protect the medicine from moisture.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Avalox contains

The active substance is moxifloxacin. Each film-coated tablet contains 400 milligrams of moxifloxacin as hydrochloride.
The excipients are: Tablet core: microcrystalline cellulose, sodium croscarmellose, monohydrate lactose (see section Avalox contains lactose), and magnesium stearate. Film coating: hypromellose, macrogol 4000, iron oxide (E172), and titanium dioxide (E171).

What Avalox looks like and contents of the pack
Each film-coated tablet is dull red in colour, oval-shaped, convex with bevelled edges, and measures 17 x 7 mm. It is marked with “M400” on one side and “BAYER” on the other.
Avalox is packaged in cartons containing blisters made of transparent colourless polypropylene or white opaque polypropylene/aluminum, or blisters made of transparent colourless polyvinyl chloride/polyvinylidene chloride/aluminum.
Avalox is available in retail packs containing 5, 7 or 10 film-coated tablets, in hospital packs containing 25, 50 or 70 film-coated tablets, and in multiple hospital packs consisting of 5 cartons each containing 16 tablets or 10 cartons each containing 10 tablets.
Avalox is also available as a medical sample pack containing one film-coated tablet in a cardboard carton with an aluminum/aluminum blister.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Bayer S.p.A. Viale Certosa 130 - Milan, Italy

Manufacturer:
The manufacturer is identified by the batch number printed on the side flap of the carton and on each blister:
If the first and second characters are BX, the manufacturer is

Bayer AG Kaiser-Wilhelm-Allee 51368 Leverkusen, Germany

If the first and second characters are IT, the manufacturer is

Bayer HealthCare Manufacturing S.r.l. Via delle Groane, 126, 20024 Garbagnate Milanese, Italy

This medicinal product is authorised in the European Economic Area Member States under the following names:
Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Greece, Luxembourg, Portugal, Sweden: Avelox
France: Izilox
Germany, Italy, Romania: Avalox

PATIENT INFORMATION LEAFLET

Avalox 400 mg/250 ml infusion solution

For use in adults
Moxifloxacin
Please read this leaflet carefully before using this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, pharmacist or nurse.
If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

What Avalox is and what it is used for
What you need to know before being administered Avalox
How to use Avalox
Possible side effects
How to store Avalox
Contents of the pack and other information

1. What Avalox is and what it is used for

Avalox contains the active substance moxifloxacin, which belongs to a group of antibiotics called fluoroquinolones. Avalox works by killing bacteria that cause infections, provided these bacteria are susceptible to moxifloxacin.
Avalox is used in adults to treat the following bacterial infections:

Lung infection (pneumonia) acquired outside the hospital
Skin and soft tissue infections

2. What you should know before taking Avalox

Contact your doctor if you think you may belong to any of the patient groups described below.
Do not take Avalox

If you are allergic to the active substance moxifloxacin, to any other quinolone antibiotic, or to any of the other ingredients of this medicine (listed in section 6).
If you are pregnant or breastfeeding.
If you are under 18 years of age.
If you have a history of tendon disease or tendon disorders related to treatment with quinolone antibiotics (see sections Warnings and precautions and 4. Possible side effects).
If you were born with, or have ever had, any condition causing heart rhythm abnormalities (detected on ECG, the electrical recording of the heart), have an imbalance of salts in the blood (especially low levels of potassium or magnesium in the blood), have a very slow heart rate (called "bradycardia"), have a weak heart (heart failure), have a history of heart rhythm abnormalities, or are taking other medicines that cause ECG changes (see section Other medicines and Avalox). This is because AVALOX

can cause ECG changes, including QT interval prolongation, i.e.
a delay in the conduction of electrical signals.

If you have severe liver disease or liver enzymes (transaminases) increased by more than 5 times the upper limit of normal.

Warnings and precautions
Before taking this medicine
Do not take quinolone/fluoroquinolone antibacterial medicines, including Avalox, if in the past
you have experienced any serious adverse reaction during treatment with a quinolone or fluoroquinolone. In such
a case, inform your doctor as soon as possible.
Tell your doctor before Avalox is administered to you for the first time

Avalox can alter the ECG, especially in women and elderly people. If you are taking medicines that reduce potassium levels in the blood, consult your doctor before Avalox is administered (see also sections Do not use Avalox and Other medicines and Avalox).
If you have ever developed a severe skin rash or skin peeling, blisters and/or sores in the mouth after taking moxifloxacin.
If you suffer from epilepsy or a condition that makes you prone to seizures, consult your doctor before Avalox is administered.
If you have ever had mental health problems, consult your doctor before Avalox is administered.
If you suffer from myasthenia gravis, taking Avalox may worsen the symptoms of the disease. If you think you may be affected, contact your doctor immediately.
If you have been diagnosed with an enlargement or "bulging" of a large blood vessel (aortic aneurysm or peripheral aneurysm of a large blood vessel).
If you have previously experienced episodes of aortic dissection (a tear in the wall of the aorta).
If you have been diagnosed with insufficiency of one of the heart valves (aortic or mitral regurgitation).
If you have 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, Ehlers-Danlos syndrome, Turner syndrome, Sjögren's syndrome [an autoimmune inflammatory disease], or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behcet's disease, known high blood pressure or atherosclerosis, rheumatoid arthritis [an autoimmune inflammatory disease] or endocarditis [inflammation of the heart]).
If you are a diabetic patient, because with moxifloxacin there may be a risk of changes in blood sugar levels.
If you, or someone in your family, suffer from glucose-6-phosphate dehydrogenase deficiency (a rare inherited disorder), inform your doctor, who will advise whether Avalox is suitable for you.
Avalox must be administered exclusively by intravenous (into a vein) route and must not be administered into an artery. When using Avalox
If you experience palpitations or irregular heartbeat during treatment, inform your doctor immediately, who may perform an ECG to monitor your heart rhythm.
The risk of heart problems may increase with higher doses and faster intravenous infusion rates.
There is a remote possibility of a severe and sudden allergic reaction (an anaphylactic reaction/anaphylactic shock) even after the first dose, with symptoms such as chest tightness, chest pain, shortness of breath, dizziness, nausea or fainting, dizziness when standing. In such a case, stop the infusion of Avalox solution immediately.
Avalox may cause severe and rapidly progressing liver inflammation, which may lead to life-threatening liver failure (including fatal cases, see section 4. Possible side effects). Contact your doctor before continuing treatment if you experience sudden malaise or notice

yellowing of the whites of the eyes, dark urine, itching, tendency to bleed, or disturbances in thinking or attention.

Severe skin reactions Severe skin reactions have been reported with moxifloxacin, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), acute generalized exanthematous pustulosis (AGEP), and drug reaction with eosinophilia and systemic symptoms (DRESS).
SJS/TEN may initially appear as reddish spots or circular patches, often with central blisters, on the trunk. In addition, ulcers may occur in the mouth, throat, nose, genitals, and eyes (red and swollen eyes). These severe skin rashes are often preceded by fever and/or flu-like symptoms. Skin rashes may progress to widespread skin peeling and life-threatening complications or may be fatal.
AGEP appears at the beginning of treatment as a red, scaly rash with bumps under the skin and blisters, accompanied by fever. The most common location is mainly in skin folds, on the trunk, and on the upper limbs.
DRESS initially appears as flu-like symptoms and a rash on the face, followed by a widespread rash accompanied by increased body temperature, elevated liver enzymes detected in blood tests, increased levels of a type of white blood cell (eosinophilia), and swollen lymph nodes. If you develop a severe skin rash or other skin-related symptoms, stop taking moxifloxacin and contact your doctor or seek immediate medical help.
Quinolone antibiotics, including Avalox, may cause seizures. If this occurs, treatment with Avalox must be stopped.
Serious, prolonged, disabling, and potentially irreversible side effects Fluoroquinolone/quinolone antibacterial medicines, including Avalox, have been associated with very rare but serious side effects, some of which may be prolonged (lasting months or years), disabling, or may not improve. These include tendon, muscle, and joint pain in arms and legs, difficulty walking, abnormal sensations such as tingling, prickling, itching, numbness, or burning (paresthesia), sensory organ disturbances such as changes in vision, taste, smell, or hearing, depression, memory impairment, severe fatigue, and severe sleep disturbances. If you experience any of these side effects after taking Avalox, contact your doctor immediately before continuing treatment. Your doctor will decide with you whether to continue treatment and may consider using an antibiotic from another class.
Rarely, symptoms of nerve damage (neuropathy) such as pain, burning, tingling, numbness, and/or weakness may occur, particularly in the feet and legs or hands and arms. In such cases, stop treatment with Avalox and inform your doctor immediately to avoid permanent nerve damage.
You may experience mental health problems even when taking quinolone antibiotics, including Avalox, for the first time. In very rare cases, depression or mental health problems have led to suicidal thoughts and self-harming behaviors, such as suicide attempts (see section 4. Possible side effects). If you develop such reactions, treatment with Avalox must be stopped.
During or after taking antibiotics, including Avalox, you may develop diarrhea. If it worsens or persists, or if you notice blood or mucus in your stool, stop taking Avalox immediately and consult your doctor. In this situation, do not take medicines that block or reduce intestinal movements.
Rarely, joint pain and swelling, and tendon inflammation or rupture may occur (see section 2. Do not take Avalox and 4. Possible side effects). The risk is higher if you are elderly (over 60 years), have had an organ transplant, have kidney problems, or are being treated with corticosteroids. Tendon inflammation and rupture may occur within the first

48 hours of treatment and up to several months after stopping treatment with Avalox. At the first signs of tendon pain or inflammation (e.g. in the ankle, wrist, elbow, shoulder, or knee),
stop treatment with Avalox, contact your doctor, and rest the affected area. Avoid any unnecessary movement, as the risk of tendon rupture may increase.

If you experience sudden abdominal, chest, or back pain, which may be a symptom of aortic aneurysm and dissection, go immediately to the emergency room. The risk may be higher if you are taking systemic corticosteroid medicines.
Inform your doctor immediately if you notice a sudden onset of shortness of breath, especially when lying down, or swelling of the ankles, feet, or abdomen, or new episodes of heart palpitations (sensation of rapid or irregular heartbeat).
If you are elderly and have kidney problems, try to drink sufficient fluids, as dehydration may increase the risk of kidney failure.
If you notice weakening of vision or if your eyes show other types of adverse effects, consult an ophthalmologist immediately (see sections 2. Driving and use of machines and 4. Possible side effects).
Fluoroquinolone antibiotics may cause an increase in your blood sugar levels above normal (hyperglycemia), or a decrease in blood sugar levels below normal (hypoglycemia), which in severe cases may potentially lead to loss of consciousness (hypoglycemic coma) (see section 4. Possible side effects). If you have diabetes, blood sugar levels must be closely monitored.
Quinolone antibiotics may make your skin more sensitive to sunlight or UV light. Avoid prolonged exposure to sunlight, intense sunlight, and do not use sunbeds or UV lamps during treatment with Avalox (see section 4. Possible side effects).
Experience with sequential use of Avalox (intravenous/oral) for the treatment of community-acquired lung infection (pneumonia) is limited.
The efficacy of Avalox in the treatment of severe burns, deep tissue infections, significant purulent ulcers (abscesses), and diabetic foot infections with osteomyelitis (bone marrow infection) has not been demonstrated.

Children and adolescents
This medicine must not be given to children and adolescents under 18 years of age because
the efficacy and safety of moxifloxacin have not been established in this age group (see section
Do not use Avalox).
Other medicines and Avalox
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine besides Avalox.
Regarding Avalox, be aware that:
If you are taking Avalox and other medicines that affect the heart, there is an increased risk of heart rhythm disturbances. Therefore, do not use Avalox with the following medicines: medicines belonging to the antiarrhythmic group (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide),
antipsychotics (e.g. phenothiazines, pimozide, sertindole, haloperidol, sulpiride), tricyclic antidepressants, some antimicrobials (e.g. saquinavir, sparfloxacin, intravenous erythromycin, pentamidine, antimalarials, especially halofantrine), some antihistamines (e.g. terfenadine, astemizole, mizolastine), and other medicines (e.g. cisapride, intravenous vincamine, bepridil, difemethil).
You must inform your doctor if you are taking other medicines that may reduce potassium levels in the blood (e.g. certain diuretics, certain laxatives and enemas [at high doses], or corticosteroids [anti-inflammatory drugs], amphotericin B) or that slow the heart rate, as these may also increase the risk of serious heart rhythm disturbances during Avalox treatment.

If you are taking oral anticoagulants (e.g. warfarin), your doctor may need to frequently monitor your blood clotting time.

Avalox with food and drink
The effect of Avalox is not affected by food, including milk, dairy products, and cheese.
Pregnancy, breastfeeding, and fertility
Do not take Avalox if you are pregnant or breastfeeding.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning a pregnancy, consult your doctor or pharmacist before taking any medicine. Animal studies have not indicated that your fertility is impaired by this medicine.
Driving and use of machines
Avalox may cause dizziness or lightheadedness, sudden temporary loss of vision, or brief loss of consciousness. If you experience these effects, do not drive or operate machinery.
Avalox contains sodium
This medicine contains 787 milligrams (approximately 34 millimoles) of sodium per dose (the main component of table salt) in each vial containing 250 milliliters of infusion solution. This corresponds to 39.35% of the maximum daily recommended sodium intake for an adult.

3. How to use Avalox

Avalox will always be administered by a doctor or healthcare professional.
The recommended dose for adults is one bag-bottle once daily.
Avalox is for intravenous use. The doctor must ensure that the infusion is given at a constant rate over a period of 60 minutes.
Dose adjustment is not necessary in elderly patients, patients with low body weight, or patients with renal impairment.
Your doctor will decide on the duration of your treatment with Avalox. In some cases, the doctor may start treatment with Avalox infusion solution and subsequently continue with Avalox tablets.
The duration of treatment depends on the type of infection and your response to therapy. However, the recommended duration of use is:

Community-acquired lung infection (pneumonia): 7–14 days. Most patients with pneumonia were switched to oral treatment with Avalox tablets within 4 days.
Skin and soft tissue infections: 7–21 days. For patients with complicated skin and soft tissue infections, the average duration of intravenous treatment was approximately 6 days, with a mean total treatment duration (infusion followed by tablets) of 13 days.

It is important that you complete the full course of treatment, even if you start to feel better after a few days. If you stop taking this medicine too early, your infection may not be completely cured, it could relapse or worsen, and you may also develop bacterial resistance to the antibiotic.
You must not exceed the recommended dose or duration of treatment (see section 2. What you should know before taking Avalox, Warnings and precautions).
If you receive more Avalox than you should
If you think you have been given too much Avalox, contact your doctor immediately.
If you miss a dose of Avalox
If you think you have missed a dose of Avalox, contact your doctor immediately.
If you stop treatment with Avalox
If treatment with this medicine is stopped too early, your infection may not be completely cured. Consult your doctor if you wish to discontinue treatment with Avalox infusion solution or Avalox tablets before the end of the treatment course.
If you have any questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The most serious side effects observed during treatment with Avalox are listed below:
If you experience:

excessively rapid heartbeat (uncommon side effect);
sudden feeling of illness or notice yellowing of the whites of the eyes, dark urine, skin itching, tendency to bleed, or disturbances in cognitive function or insomnia (these may be signs and symptoms of fulminant liver inflammation which could lead to potentially fatal liver failure) (very rare side effect; fatal cases have been reported);
severe skin rashes including Stevens-Johnson syndrome and toxic epidermal necrolysis. These may appear as red spots or circular lesions, often with central blisters on the trunk, skin peeling, mouth ulcers, and sores in the throat, nose, genitals, and eyes, and may be preceded by fever and flu-like symptoms (very rare side effects, potentially fatal);
red, scaly rash with bumps under the skin and blisters accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis) (frequency of this side effect is "not known");
widespread rash, high body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes, and involvement of other organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome) (frequency of these side effects is "not known");
syndrome associated with reduced water excretion and low sodium levels (SIADH) (very rare side effect);
loss of consciousness due to a severe drop in blood sugar levels (hypoglycaemic coma) (very rare side effect);
inflammation of blood vessels (signs may include red skin spots, usually on the lower legs, or symptoms such as joint pain) (very rare side effect);
sudden, severe, generalized allergic reaction, very rarely including potentially fatal shock (e.g. breathing difficulties, drop in blood pressure, rapid pulse) (uncommon side effect);
chest pain, which may indicate a potentially serious allergic reaction called Kounis syndrome (frequency not known: frequency cannot be determined from available data);
swelling, including swelling of the airways (uncommon side effect, potentially fatal);
seizures (uncommon side effect);
nervous system disorders such as pain, burning, tingling, numbness and/or weakness in the extremities (uncommon side effect);
depression (which in very rare cases may lead to self-harm, including suicidal ideation/thoughts or suicide attempts) (uncommon side effect);
psychosis (which may lead to self-harm, including suicidal ideation/thoughts or suicide attempts) (very rare side effect);
severe diarrhoea with blood and/or mucus (antibiotic-associated colitis, including pseudomembranous colitis), which in very rare circumstances may progress to potentially fatal complications (uncommon side effects);
pain and swelling of tendons (tendinitis) (uncommon side effect) or tendon rupture (very rare side effect);
muscle weakness, tenderness or pain, and particularly at the same time feeling unwell, high temperature or dark urine. These may be caused by abnormal muscle damage which can be life-threatening and lead to kidney problems (a condition called rhabdomyolysis) (frequency of this side effect is "not known"); stop taking Avalox and contact your doctor immediately, as urgent medical advice is required.

Additionally, if you experience:

temporary loss of vision (very rare side effect), eye disturbances or eye pain, especially due to light exposure (very rare to uncommon adverse effect), seek immediate advice from an ophthalmologist.

If you have experienced potentially fatal irregular heartbeats (torsades de pointes) or cardiac arrest while taking Avalox (very rare side effects), inform your doctor immediately
that you have taken Avalox and do not restart treatment.
In very rare cases, worsening of symptoms of myasthenia gravis has been observed. If this occurs, seek immediate medical advice.
If you have diabetes and notice your blood sugar levels rising or falling (uncommon to very rare side effect), inform your doctor immediately.
If you are elderly and already have kidney problems and notice reduced urine output, swelling in legs, ankles or feet, fatigue, nausea, drowsiness, shortness of breath or confusion (these may be signs of kidney failure, a rare side effect), seek immediate medical advice.
Other side effects observed during treatment with Avalox are listed below according to their likelihood:
Common: (may affect up to 1 in 10 people)

nausea
diarrhoea
dizziness
stomach discomfort and abdominal pain
vomiting
headache
increase in a specific liver enzyme in the blood (transaminases)
infections caused by resistant bacteria or fungi, such as oral or vaginal candidiasis
pain or inflammation at the site of infection
changes in heart rhythm (ECG) in patients with low blood potassium levels

Uncommon: (may affect up to 1 in 100 people)

skin rash
stomach disturbances (indigestion/heartburn)
altered sense of taste (in very rare cases, loss of taste)
sleep disturbances (mainly insomnia)
increase in a specific liver enzyme in the blood (gamma-glutamyl transferase and/or alkaline phosphatase)
decrease in certain white blood cells in the blood (leukocytes, neutrophils)
constipation
itching
sensation of dizziness (feeling of spinning or falling)
drowsiness
flatulence
changes in heart rhythm (ECG)
impaired liver function (including increase in a specific liver enzyme in the blood (LDH))
reduced appetite and food intake
low white blood cell count
pain, such as back pain, chest pain, pelvic pain, pain in extremities
increase in blood cells specialized in blood clotting
sweating
increase in specialized white blood cells (eosinophils)
anxiety
feeling unwell (mainly weakness or fatigue)
tremor
joint pain
palpitations
irregular and rapid heartbeat
breathing difficulties including asthma-like conditions
increase in a specific digestive enzyme in the blood (amylase)
restlessness/agitation
tingling sensation (pricking and stinging) and/or numbness
urticaria
dilation of blood vessels
confusion and disorientation
decrease in blood cells specialized in blood clotting
visual disturbances including diplopia (double vision) and blurred vision
reduced blood clotting
increase in lipids (fats) in the blood
decrease in red blood cells
muscle pain
allergic reaction
increased bilirubin in the blood
inflammation of a vein
inflammation of the stomach
dehydration
severe abnormalities in heart rhythm
dry skin
angina pectoris

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

muscle spasms
muscle cramps
hallucinations
high blood pressure
swelling (swelling of hands, feet, ankles, lips, mouth, throat)
low blood pressure
impaired kidney function (including increased laboratory markers of kidney function such as urea and creatinine)
liver inflammation
mouth inflammation
ringing/noises in the ears
jaundice (yellowing of the whites of the eyes or skin)
impaired skin sensitivity
abnormal dreams
difficulty concentrating
difficulty swallowing
smell disturbances (including loss of smell)
balance disorders and poor coordination (due to dizziness)
partial or complete memory loss
hearing impairment including deafness (usually reversible)
increased uric acid in the blood
emotional instability
difficulty speaking
fainting
muscle weakness

Very rare: (may affect up to 1 in 10,000 people)

decrease in red blood cells, white blood cells and platelets (pancytopenia)
joint inflammation
heart rhythm abnormalities
increased skin sensitivity
depersonalization (feeling detached from oneself)
increased blood clotting
muscle stiffness
significant reduction in specialized white blood cells (agranulocytosis)

Not known: (frequency cannot be estimated from available data)

Increased sensitivity of the skin to sunlight or UV light (see also section 2, Warnings and precautions)
Well-defined erythematous patches with or without blisters, appearing within hours of moxifloxacin administration and healing with residual post-inflammatory hyperpigmentation; usually recur at the same skin or mucosal site upon subsequent exposure to moxifloxacin

Very rare cases of prolonged (lasting months or years) or permanent adverse drug reactions, such as tendon inflammation, tendon rupture, joint pain, pain in arms or legs, difficulty walking, abnormal sensations such as tingling, pins and needles, tickling, burning, numbness or pain (neuropathy), fatigue, memory and concentration impairment, mental health effects (which may include sleep disturbances, anxiety, panic attacks, depression and suicidal ideation), and changes in hearing, vision, taste and smell, have been associated with the use of quinolone and fluoroquinolone antibiotics, in some cases regardless of pre-existing risk factors.
Cases of aortic wall dilation and weakening or aortic wall rupture (aneurysms and dissections), with possible fatal rupture, as well as cases of regurgitation of blood from heart valves, have been reported in patients treated with fluoroquinolones. See also section 2.
The following symptoms have been observed more frequently in patients treated intravenously:
Common: (may affect up to 1 in 10)
increase in a specific liver enzyme in the blood (gamma-GT)
Uncommon: (may affect up to 1 in 100)

severe diarrhoea with blood and/or mucus (antibiotic-associated colitis) which in very rare circumstances may progress to potentially fatal complications
abnormal and rapid heartbeat
hallucinations
low blood pressure
kidney damage (including increased renal laboratory test values such as urea and creatinine)
kidney failure
oedema (swelling of hands, feet, ankles, lips, mouth, throat)
seizures

Additionally, very rare cases of the following side effects, which cannot be excluded from possibly occurring during treatment with Avalox, have been reported with other quinolone antibiotics: increased pressure in the skull (symptoms include headache, vision disturbances including blurred vision, blind spots, double vision, vision loss), increased blood sodium levels, increased blood calcium levels, a specific type of decrease in red blood cells (haemolytic anaemia).
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse.
You can also report side effects directly via the national reporting system at the following address.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Avalox

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label of the bottle-bag and on the carton following Exp.. The expiry date refers to the last day of that month.
Do not store at temperatures below 15°C.
Use immediately after opening and/or dilution.
This product is for single use only. Any unused solution must be discarded.
If the product is stored at low temperatures, precipitation of the solute may occur, which will redissolve at room temperature.
Do not use this medicine if you see visible particles or if the solution is cloudy.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Avalox contains

The active substance is moxifloxacin. Each infusion bag contains 400 milligrams of moxifloxacin (as hydrochloride). 1 millilitre contains 1.6 mg of moxifloxacin (as hydrochloride).
The other components are sodium chloride, hydrochloric acid 1N (for pH adjustment), sodium hydroxide solution 2N (for pH adjustment), and water for injections (see section Avalox contains sodium).

Description of the appearance of Avalox and contents of the pack
Avalox is a clear yellow infusion solution.
Avalox is packaged in cardboard cartons containing one 250 ml glass bottle with a chlorobutyl or bromobutyl rubber stopper. Avalox is available in packs of 1 bottle and multiple packs of 5 bottles, each containing one bottle.
Avalox is also packaged in cardboard cartons containing 250 ml polyolefin bags with a polypropylene connector, sealed in an aluminium overwrap. Packs containing 5 and 12 bags are available.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: Bayer S.p.A., Viale Certosa 130 - Milan, Italy
Manufacturer: Bayer AG, D-51368 Leverkusen, Germany

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Austria, Belgium, Cyprus, Czech Republic, Estonia, Greece, Hungary, Latvia, Lithuania, Luxembourg, Romania, Slovakia, Sweden: Avelox
France: Izilox
Germany, Italy: Avalox
Spain: Actira

The following information is intended exclusively for medical or healthcare professionals:
Avalox may be administered via a Y-tube together with the following solutions:
water for injections, sodium chloride 0.9%, sodium chloride 1 molar, glucose 5%/10%/40%, xylitol 20%, Ringer's solution, compound sodium lactate solution (Hartmann's solution, Ringer's lactate solution).
Avalox must not be infused together with other medicinal products.
The following infusion solutions have been found incompatible with Avalox infusion solution:
Sodium chloride 10% and 20% solutions
Sodium bicarbonate 4.2% and 8.4% solutions