ACTIRA 400 MG/ 250 ML SOLUTION FOR INFUSION

Introduction

Package Leaflet: Information for the User

Actira 400 mg/ 250 ml Solution for Infusion

For use in adults

Moxifloxacin

Read all of this leaflet carefully before you start taking 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 pack

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

1. What is Actira and what is it used for

Actira contains moxifloxacin as the active substance, which belongs to the group of antibiotics called fluoroquinolones. Actira works by killing bacteria that cause infections, provided that these bacteria are sensitive to moxifloxacin.

Antibiotics are used to treat bacterial infections and do not work for viral infections such as the flu or the common cold.

It is essential that you follow the instructions regarding dosage, administration interval, and treatment duration as indicated by your doctor.

Do not store or reuse this medication. If you have any leftover antibiotic after completing treatment, return it to the pharmacy for proper disposal. Do not throw away medications down the drain or in the trash.

Actira is indicated in adults for the treatment of the following bacterial infections:

• Community-acquired pneumonia (lung infection).

Skin and soft tissue infections

2. What you need to know before you use Actira

Consult your doctor if you are unsure about belonging to one of the patient groups described below.

Do not use Actira

• If you are allergic to the active substance moxifloxacin, other quinolones, or any of the other components of this medication (listed in section 6).
• If you are pregnant or breastfeeding.
• If you are under 18 years old.
• If you have a history of tendon disorders or injuries related to treatment with quinolone antibiotics (see sections Warnings and precautionsand 4. Possible side effects).
• If you have a hereditary or acquired condition that may affect your heart rhythm (observed in ECG, heart electrical record), have electrolyte imbalances in the blood (especially low potassium or magnesium levels), have a slow heart rate (called "bradycardia"), have a weak heart (heart failure), have a history of heart rhythm disorders, or are taking other medications that may cause certain ECG disorders (see section Other medications and Actira).

This is because Actira may cause changes in the ECG, such as a prolongation of the QT interval, i.e., delayed conduction of electrical signals in the heart.

• If you have severe liver disease or liver enzyme levels (transaminases) are 5 times above the upper limit of normal.

Warnings and precautions

Before starting to take this medication

You should not take antibacterial medications containing fluoroquinolones or quinolones, including Actira, if you have experienced a severe adverse reaction in the past when taking a quinolone or fluoroquinolone. If this is the case, you should inform your doctor as soon as possible.

Consult your doctor before Actira is administered to you for the first time

• Actira may modify your heart's ECG, especially if you are a woman or an elderly patient. If you are currently taking any medication that leads to a decrease in potassium levels in the blood, consult your doctor before Actira is administered (see also sections Do not take Actiraand Other medications and Actira).

• If you have ever developed a severe skin rash or skin peeling, blisters, and/or soresafter taking moxifloxacin.

• If you suffer from epilepsyor any other condition that may cause seizures, inform your doctor before Actira is administered.

• If you have or have ever had any mental health problems, consult your doctor before Actira is administered.

• If you have myasthenia gravis, the use of Actira may worsen the symptoms of your disease. If you think you are affected, consult your doctor immediately.

• If you have been diagnosed with an enlargement or "lump" of a large blood vessel(aortic aneurysm or large peripheral vessel aneurysm).

• If you have had a previous episode of aortic dissection(tear in the aortic wall).

• If you have been diagnosed with heart valve insufficiency(heart valve regurgitation)

• If you have a family history of aortic aneurysm or aortic dissection, congenital heart valve diseaseor other risk factors or predisposing disorders (e.g., connective tissue disorders such as Marfan syndrome or Ehlers-Danlos vascular syndrome, Turner syndrome, or Sjögren's syndrome (an autoimmune inflammatory disease) or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behçet's disease, high blood pressure, or atherosclerosis), rheumatoid arthritis (a joint disease), or endocarditis (a heart infection).

• If you are diabeticbecause you may experience a risk of change in blood sugar levelswith moxifloxacin.

• If you or a family member has glucose-6-phosphate dehydrogenase deficiency(a rare hereditary disease), inform your doctor, who will indicate whether Actira is suitable for you.

• Actira should only be administered intravenously (into a vein) and should not be injected into arteries.

During treatment with Actira

• If you notice palpitations or irregular heartbeats during the treatment period, you should inform your doctor immediately. Your doctor may perform an ECG to measure your heart rate.

• The risk of heart problemsmay increase with the increase in dose and infusion rate into your veins.

• In rare cases, you may experience a sudden severe allergic reaction(anaphylactic shock) even with the first dose, with symptoms that may include chest tightness, dizziness, nausea, or fainting, or feeling dizzy when standing up. If this occurs, treatment with Actira solution for infusion must be discontinued immediately.

• Actira may cause rapid and severe liver inflammation, which can lead to life-threatening liver failure (including fatal cases, see section 4 Possible side effects). Please consult your doctor before continuing treatment if you suddenly feel unwell or notice that the whites of your eyes turn yellow, dark urine, skin itching, bleeding tendency, or changes in thoughts or insomnia.

• Severe skin reactions

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

• Stevens-Johnson syndrome/TEN may initially appear as red target-like spots or circular patches on the trunk, often with central blisters. They can also appear as ulcers 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 can progress to widespread skin peeling and life-threatening complications.
• AGEP appears at the start of treatment as a red, scaly, and widespread rash with bumps under the skin and blisters, accompanied by fever. The most common location is mainly localized to skin folds, trunk, and upper limbs.
• Drug reaction with eosinophilia and systemic symptoms (DRESS) appears initially with flu-like symptoms and a rash on the face, later appearing as a widespread rash with high body temperature, increased liver enzyme levels in blood tests, and increased eosinophilia and lymph node enlargement.

If you develop a severe rash or any of these skin symptoms, stop taking moxifloxacin and contact your doctor or seek medical attention immediately.

• Quinolone antibiotics, including Actira, may cause seizures. If this occurs, treatment with Actira must be discontinued.

• Severe, disabling, and potentially irreversible side effects. Antibacterial medications containing fluoroquinolones or quinolones, including Actira, have been associated with very rare but severe side effects, some of which were long-lasting (persistent for months or years), disabling, or potentially irreversible. This includes pain in the tendons, muscles, and joints of the upper and lower limbs, difficulty walking, abnormal sensations such as pinching, tingling, prickling, numbness, or burning (paresthesia), sensory disorders such as decreased vision, taste, smell, or hearing, depression, decreased memory, intense fatigue, and severe sleep disorders.

If you experience any of these side effects after taking Actira, contact your doctor immediately before continuing treatment. You and your doctor will decide whether to continue or not, considering the use of an antibiotic from another class.

• In rare cases, you may experience nerve damage symptomssuch as pain, burning, tingling, numbness, and/or weakness, especially in feet and legs or hands and arms. If this happens, stop taking Actira and inform your doctor immediately to prevent the development of a potentially irreversible disorder.

• You may experience mental health problemseven after the first administration of quinolone antibiotics, including Actira. In very rare cases, mental health problems and depression have evolved into suicidal thoughts and self-harming behaviors such as suicide attempts (see section 4. Possible side effects). If you develop these reactions, treatment with Actira should be discontinued.

• You may develop diarrhea during or after taking antibiotics, including Actira. If the diarrhea is severe or persistent, or if you notice blood or mucus in your stool, stop using Actira immediately and consult your doctor. In these situations, do not take medications that interrupt or slow down bowel movements.

• In rare cases, pain and swelling in the joints and tendon inflammation or rupturemay occur (see sections Do not take Actiraand 4. Possible side effects). The risk is higher if you are an elderly person (over 60 years old), have received an organ transplant, have kidney problems, or are being treated with corticosteroids. Tendon inflammation and rupture can occur within the first 48 hours of treatment and even several months after discontinuing treatment with Actira. At the first sign of pain or tendon inflammation (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking Actira, contact your doctor, and rest the affected area. Avoid any unnecessary exercise, as this may increase the risk of tendon rupture.

• If you feel a strong and sudden chest, abdominal, or back pain, which may be symptoms of aortic dissection or aneurysm, go to the emergency room immediately. The risk may increase if you are receiving systemic corticosteroid treatment.

• If you start experiencing sudden shortness of breath, especially when lying down, or if you notice swelling in your ankles, feet, or abdomen, or the appearance of heart palpitations (feeling of rapid or irregular heartbeat), inform your doctor immediately.

• If you are elderly and have kidney problems, be careful to drink enough fluids, as dehydration can increase the risk of kidney failure.

• If your vision worsens or if your eyes seem to be affected in any way, consult an ophthalmologist immediately (see sections Driving and using machinesand 4. Possible side effects).

• Fluoroquinolones may cause an increase in your blood sugar levelsabove normal levels (hyperglycemia) or a decrease in your blood sugar levelsbelow normal levels (hypoglycemia), which in severe cases can cause loss of consciousness (hypoglycemic coma) (see section 4. Possible side effects). If you have diabetes, your blood sugar levels should be carefully monitored.

• Quinolone antibiotics may increase the sensitivity of your skin to sunlight or UV. You should avoid prolonged exposure to sunlight or direct sunlight and should not use sunbeds or any type of UV lamp during treatment with Actira (see section 4 Possible side effects).

• There is limited experience regarding the use of intravenous/oral sequential Actira in the treatment of community-acquired pneumonia.

• The efficacy of Actira has not been established in the treatment of severe burns, deep tissue infections, and diabetic foot infections with osteomyelitis (bone marrow infections).

Children and adolescents

Do not give this medication to children and adolescents under 18 years old because efficacy and safety have not been established for this age group (see section Do not take Actira).

Other medications and Actira

Tell your doctor or pharmacist if you are using, have recently used, or might use other medications in addition to Actira.

With Actira, you should consider the following:

• If you are using Actira and other medications that affect the heart, there is a higher risk of heart rhythm disorders. Therefore, you should not use Actira at the same time as the following medications: medications belonging to the class of antiarrhythmics (e.g., quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), antipsychotics (e.g., phenothiazines, pimozide, sertindole, haloperidol, sultopride), tricyclic antidepressants, some antimicrobials (e.g., saquinavir, sparfloxacin, intravenous erythromycin, pentamidine, antimalarials, particularly halofantrine), some antihistamines (e.g., terfenadine, astemizole, mizolastine), and other medications (e.g., cisapride, intravenous vincamine, bepridil, and difemanil).
• While using Actira, you should inform your doctor if you are taking other medications that may decrease potassium levels in the blood (e.g., loop and thiazide diuretics, laxatives, and enemas (high doses) or corticosteroids (anti-inflammatory medications), amphotericin B) or cause a decrease in heart rate, as these may also increase the risk of severe heart rhythm disorders.
• If you are currently taking oral anticoagulants (e.g., warfarin), your doctor may need to monitor your blood coagulation time.

Actira with food and drinks

The effect of Actira is not altered by food, including dairy products.

Pregnancy, breastfeeding, and fertility

Do not use Actira during pregnancy or breastfeeding.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Animal studies do not indicate that fertility may be affected by taking this medication.

Driving and using machines

Actira may cause dizziness or vertigo; you may experience a sudden transient loss of vision or faint for a moment. If you experience these symptoms, do not drive vehicles or operate machinery.

Actira contains sodium

This medication contains 787 milligrams (approximately 34 millimoles) of sodium (the main component of table salt/cooking salt) in each 250 ml vial of solution for infusion. This is equivalent to 39.35% of the maximum recommended daily sodium intake for an adult.

3. How to use Actira

Actira will always be administered by a doctor or healthcare professional.

The recommended dose in adults is one vial/bag, once a day.

Actira is administered intravenously. Your doctor must ensure that the infusion is administered at a constant flow rate over 60 minutes.

No dose adjustment is necessary in elderly patients, in patients with low body weight, or in patients with kidney problems.

Your doctor will decide the duration of treatment with Actira. In some cases, your doctor may start treatment with Actira solution for infusion and then continue treatment with Actira tablets.

The duration of treatment depends on the type of infection and how you respond to treatment, but the recommended treatment durations are as follows:

• Community-acquired pneumonia: 7-14 days.

Most patients with pneumonia switch to oral treatment with Actira tablets after 4 days.

• Skin and soft tissue infections: 7-21 days.

In patients with severe skin and soft tissue infections, the average duration of intravenous treatment is around 6 days, and the average total treatment duration (infusion followed by tablets) is 13 days.

It is essential to complete the full treatment, even if you start to feel better after a few days. If you stop treatment too soon, the infection may not be completely cured, the infection may return, or your condition may worsen, and you may also develop bacterial resistance to the antibiotic.

Do not exceed the recommended dose and treatment duration (see section 2, What you need to know before taking Actira, Warnings and precautions).

If you use more Actira than you should

If you are concerned about receiving too much Actira, consult your doctor immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to use Actira

If you are concerned about missing a dose of Actira, consult your doctor immediately.

If you stop treatment with Actira

If you stop taking this medication too soon, your infection may not be completely cured. Consult your doctor if you intend to stop treatment with Actira solution for infusion before completing the full treatment.

If you have any further questions about the use of this medication, ask your doctor, pharmacist, or nurse.

4. Possible side effects

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

The most serious side effectsobserved during treatment with Actira are listed below:

If you notice

• an abnormally fast heart rate (rare side effect)
• a sudden feeling of discomfort or notice a yellowish discoloration of the whites of the eyes, dark urine, skin itching, tendency to bleed, or alterations in thought or wakefulness (these can be signs and symptoms of a fulminant liver inflammation that can potentially lead to fatal liver failure, very rare side effect, with reported fatal cases)
• severe skin eruptions, including Stevens-Johnson syndrome and toxic epidermal necrolysis. These can appear on the trunk as reddish spots in a target shape or circular patches, often with blisters in the center, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes, and can be preceded by fever and flu-like symptoms (very rare side effects, potentially life-threatening)
• a red, scaly, and generalized eruption with bumps under the skin and blisters, accompanied by fever at the start of treatment (acute generalized exanthematous pustulosis, frequency not known)
• a generalized eruption, high body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), enlarged lymph nodes, and involvement of other body organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome, frequency not known)
• syndrome associated with alterations in water elimination and low sodium levels (SIADH, very rare side effect)
• loss of consciousness due to a severe decrease in blood sugar levels (hypoglycemic coma, very rare side effect)
• inflammation of blood vessels (the signs can be red spots on the skin, usually on the legs, or effects such as joint pain, very rare side effect)
• severe allergic reaction, sudden and generalized, including very rarely life-threatening shock (e.g., difficulty breathing, decreased blood pressure, rapid pulse, very rare side effect)
• swelling, including swelling of the airways (rare side effect, potentially fatal)
• seizures (rare side effect)
• problems associated with the nervous system, such as pain, burning, tingling, numbness, and/or weakness in the limbs (rare side effect)
• depression (in very rare cases, evolved into self-harm, suicidal thoughts or attempts, rare side effect)
• madness (which can lead to self-harming behaviors, such as suicidal thoughts or attempts, very rare side effect)
• severe diarrhea with blood and/or mucus (antibiotic-associated colitis, including pseudomembranous colitis), which, in very rare circumstances, can lead to life-threatening complications (rare side effect)
• tendon pain and inflammation (tendinitis, rare side effect) or tendon rupture (very rare side effect)
• muscle weakness, sensitivity, or pain, particularly if you also feel unwell, have a fever, or your urine is dark. These symptoms can be caused by abnormal muscle breakdown, which can be life-threatening and cause kidney problems (a condition called rhabdomyolysis, frequency not known)

stop taking Actira and contact your doctor immediatelyas you may need urgent medical attention.

Additionally, if you notice

• transient loss of vision (very rare side effect),
• eye discomfort or pain, especially due to light exposure (very rare to rare side effect),

contact an ophthalmologist immediately.

If you have experienced potentially life-threatening irregular heartbeats (Torsade de Pointes) or cardiac arrest while taking Actira (very rare side effects), inform your doctor immediately that you have been taking Actira and do not restart treatment.

In very rare cases, myasthenia gravis symptoms may worsen. If this occurs, consult your doctor immediately.

If you have diabetes and notice that your blood sugar level increases or decreases (rare or very rare side effect), inform your doctor immediately.

If you are elderly with kidney problems and observe a decrease in urine production, swelling in the legs, ankles, or feet, fatigue, nausea, drowsiness, shortness of breath, or confusion (these can be signs and symptoms of kidney failure, a rare side effect), consult your doctor immediately.

The following other side effectshave been observed during treatment with Actira, according to their frequency:

Common(may affect up to 1 in 10 people)

• nausea
• diarrhea
• dizziness
• abdominal and stomach pain
• vomiting
• headache
• increase in a specific liver enzyme in the blood (transaminases)
• infections caused by resistant bacteria or fungi, e.g., oral and vaginal infections caused by Candida.
• pain or inflammation at the injection site
• change in heart rhythm (ECG), in patients with low potassium levels in the blood

Uncommon(may affect up to 1 in 100 people)

• rash
• gastric discomfort (indigestion/heartburn)
• alteration of taste (in very rare cases, loss of taste)
• sleep disorders (predominantly insomnia)
• increase in a liver enzyme in the blood (gamma-glutamyl-transferase and/or alkaline phosphatase)
• low levels of certain white blood cells (leukocytes, neutrophils)
• constipation
• itching
• feeling of vertigo (feeling that everything is spinning or falling)
• drowsiness
• flatulence
• change in heart rhythm (ECG)
• liver function disorder (including increase in liver enzyme levels in the blood, LDH)
• decreased appetite and food intake
• low white blood cell count
• discomfort and pain, such as back, limb, pelvis, and chest pain
• increase in certain blood cells necessary for blood coagulation
• sweating
• increase in certain white blood cells (eosinophils)
• anxiety
• malaise (mainly weakness or fatigue)
• tremors
• joint pain
• palpitations
• irregular and rapid heartbeat
• breathing difficulties, including asthmatic conditions
• increase in a digestive enzyme in the blood (amylase)
• restlessness/agitation
• tingling sensation (pins and needles) and/or numbness
• skin rash
• dilation of blood vessels
• confusion and disorientation
• decrease in blood cells necessary for blood coagulation
• vision disorders, including double vision and blurred vision
• decrease in blood coagulation
• increase in blood lipids (fats)
• low red blood cell count
• muscle pain
• allergic reactions
• increase in bilirubin in the blood
• vein inflammation
• stomach inflammation
• dehydration
• severe heart rhythm disorders
• dry skin
• angina pectoris

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

• muscle cramps
• muscle contractures
• hallucinations
• increased blood pressure
• swelling (of hands, feet, ankles, lips, mouth, and throat)
• decreased blood pressure
• kidney disorders (including increased results in special kidney function tests, such as urea and creatinine)
• liver inflammation
• mouth inflammation
• ringing/ noises in the ears
• jaundice (yellowish discoloration of the whites of the eyes or skin)
• skin sensitivity disorders
• abnormal dreams
• concentration disorders
• difficulty swallowing
• smell disorders (including loss of smell)
• balance and coordination disorders (due to dizziness)
• total or partial memory loss
• hearing disorders, including deafness (usually reversible)
• increase in uric acid in the blood
• emotional instability
• speech disorders
• fainting
• muscle weakness

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

• decrease in the number of red and white blood cells and platelets (pancytopenia)
• joint inflammation
• irregular heartbeat
• increased skin sensitivity
• depersonalization disorder (feeling of not being oneself)
• increased blood coagulation
• muscle stiffness
• significant decrease in certain white blood cells (agranulocytosis)

Frequency not known(cannot be estimated from the available data)

? increased skin sensitivity to sunlight or UV radiation (see also section 2, Warnings and precautions)

? clearly defined erythematous patches with/without blisters that appear in the hours following administration of moxifloxacino and disappear with residual post-inflammatory hyperpigmentation; they usually reappear in the same area of the skin or mucosa with subsequent exposure to moxifloxacino

The administration of quinolone and fluoroquinolone antibiotics has been associated with very rare cases of long-lasting (even months or years) or permanent adverse reactions, such as tendon inflammation, tendon rupture, joint pain, limb pain, difficulty walking, abnormal sensations such as pins and needles, tingling, burning, numbness, or pain (neuropathy), fatigue, decreased memory and concentration, effects on mental health (including sleep disorders, anxiety, panic attacks, depression, and suicidal thoughts), decreased hearing, vision, taste, and smell, in some cases regardless of the presence of pre-existing risk factors.

There have been reports of increased size and weakening or tearing of the aortic wall (aneurysms and dissections), which could lead to rupture and be fatal, and heart valve disorders in patients who have received fluoroquinolones (see also section 2, Warnings and precautions).

The following symptoms have been observed more frequently in patients treated intravenously:

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

• increase in a specific liver enzyme in the blood (gamma-glutamyl-transferase)

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

• severe diarrhea with blood and/or mucus (antibiotic-associated colitis), which, in very rare circumstances, can lead to life-threatening complications
• abnormal heart rate acceleration
• hallucinations
• low blood pressure
• kidney disorders (including increased results in special kidney function tests, such as urea and creatinine)
• kidney failure
• swelling (of hands, feet, ankles, lips, mouth, and throat)
• seizures

Additionally, very rare cases of the following side effects have been reported after treatment with other quinolone antibiotics and may also occur during treatment with Actira: increased pressure in the skull (symptoms include headache, vision problems such as blurred vision, blind spots, double vision, loss of vision), increased sodium and calcium levels in the blood, decreased count of a specific type of red blood cell (hemolytic anemia).

Reporting of side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are possible side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Actira

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date stated on the label of the vial/bag and on the carton after EXP. The expiration date is the last day of the month indicated.

Do not store below 15°C.

Use immediately after first opening and/or dilution.

This medicine is for single use only. Any unused solution should be discarded.

At refrigerator temperatures, precipitation may occur, which will redissolve at room temperature.

Do not use this medicine if you notice visible particles or if the solution is cloudy.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Container Content and Additional Information

Composition of Actira

• The active ingredient is moxifloxacino. A vial or bag contains 400 milligrams of moxifloxacino (in the form of hydrochloride). 1 milliliter contains 1.6 milligrams of moxifloxacino (in the form of hydrochloride).
• The other components are sodium chloride, hydrochloric acid 1 N (for pH adjustment), sodium hydroxide solution 2 N (for pH adjustment), and water for injectable preparations (see section Actira contains sodium).

Appearance of Actira and Container Content

Actira is a clear yellow solution for infusion.

Actira is presented in cardboard boxes containing a 250-milliliter glass vial with a chlorobutyl or bromobutyl rubber stopper. Actira is available in packs with 1 vial and in packs with 5 vials (consisting of single units containing 1 vial).

Actira is packaged in cardboard boxes containing 250-milliliter polyolefin bags with a polypropylene mouth sealed with an aluminum foil wrapper. They are available in packs of 5 and 12 bags.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Bayer Hispania, S.L.

Avda. Baix Llobregat, 3-5

08970 Sant Joan Despí (Barcelona).

Spain

Manufacturer:

Bayer AG

Kaiser-Wilhelm-Allee

51368 Leverkusen

Germany

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, Greece, Hungary, Ireland, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Slovakia, Slovenia, Sweden, United Kingdom: Avelox.

France: Izilox

Germany, Italy: Avalox

Spain: Actira

Date of the Last Revision of thisleaflet:February 2025

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

The following information is intended for healthcare professionals only:

Actira can be administered through a T-tube together with the following solutions: water for injectable preparations, sodium chloride 0.9%, sodium chloride 1 molar, glucose 5%/10%/40%, xylitol 20%, Ringer's solution, lactated sodium solution (Hartmann's solution, Ringer-lactate solution).

Actira must not be co-infused with other medicinal products.

The following solutions are incompatible with Actira:

Sodium chloride solutions at 10% and 20%,

Sodium hydrogen carbonate solutions at 4.2% and 8.4%