Actira 400 mg/250 ml solution for infusion: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Actira 400 mg/250 ml solution for infusion

For use in adults

Moxifloxacin

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

Keep this leaflet, as you may need to read it again.
If you have any questions, consult your doctor, pharmacist or nurse.
If you experience any adverse reactions, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Actira is and what it is used for

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

Antibiotics are used to treat bacterial infections and are not effective against viral infections such as influenza or the common cold.

It is important that you follow your doctor's instructions regarding dosage, dosing interval, and duration of treatment.

Do not store or reuse this medicine. If you have any antibiotic left over after completing treatment, return it to the pharmacy for proper disposal. Medicines must not be disposed of via wastewater or household waste.

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

Community-acquired lung infection (pneumonia).
Skin and soft tissue infections

2. What you need to know before starting to use Actira

Consult your doctor if you are unsure whether you belong to any of the patient groups described below.

Do not use Actira

If you are allergic to the active substance moxifloxacin, to other quinolones, or to any of the other components 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 disorders or tendon damage related to treatment with quinolone antibiotics (see sections Warnings and precautions and 4. Possible side effects).
If you have a hereditary condition or have suffered from a disease associated with an abnormal heart rhythm (observed on ECG, the heart's electrical recording), have electrolyte imbalances 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 disturbances, or are taking other medications that may cause certain ECG changes (see section Other medicines and Actira).

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

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

Warnings and precautions

Before starting to take this medicine

Do not take antibacterial medicines containing fluoroquinolones or quinolones, including Actira, if you have previously experienced a serious adverse reaction to a quinolone or fluoroquinolone. If this applies to you, inform your doctor as soon as possible.

Consult your doctor before Actira is first administered to you

Actira may alter the heart's ECG , especially if you are female or elderly. If you are currently taking any medication that causes low potassium levels in the blood , consult your doctor before Actira is administered (see also sections Do not take Actira and Other medicines and Actira ).
If you have ever developed a severe skin rash, skin peeling, blisters, and/or mouth sores after taking moxifloxacin.
If you have epilepsy or another 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 , using Actira may worsen your symptoms. If you think you are affected, consult your doctor immediately.
If you have been diagnosed with an enlargement or a "lump" in a large blood vessel (aortic aneurysm or peripheral large vessel aneurysm).
If you have previously experienced an episode of aortic dissection (tear in the wall of the aorta).
If you have been diagnosed with heart valve insufficiency (regurgitation of heart valves).
If you have a family history of aortic aneurysm or aortic dissection, congenital heart valve disease , or 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 inflammatory autoimmune disease), or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behçet's disease, known hypertension or atherosclerosis), rheumatoid arthritis (a joint disease), or endocarditis (a heart infection).
If you are diabetic , because you may be at risk of changes in blood sugar levels with moxifloxacin.
If you or a family member has glucose-6-phosphate dehydrogenase deficiency (a rare inherited disorder), inform your doctor, who will determine whether Actira is suitable for you.
Actira must be administered only by intravenous route (into a vein) and must not be injected into arteries.

During treatment with Actira

If you notice palpitations or irregular heartbeats during treatment, inform your doctor immediately. Your doctor may perform an ECG to monitor your heart rhythm.
The risk of heart problems may increase with higher doses and faster infusion rates into your veins.
Rarely, you may experience a sudden, severe allergic reaction (anaphylactic reaction or shock), even with the first dose, with symptoms that may include chest tightness, chest pain, difficulty breathing, dizziness, nausea, fainting, or vertigo when standing. If this occurs, treatment with Actira infusion solution must be stopped immediately.
Actira may cause rapid and severe liver inflammation , which may 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 yellowing of the whites of your eyes, dark urine, itchy skin, tendency to bleed, or changes in thinking or insomnia.
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 syndrome or drug hypersensitivity syndrome).

SJS/TEN may initially appear on the trunk as red, target-like spots or circular lesions, often with central blisters. Mouth, throat, nose, genital, and eye ulcers (red, swollen eyes) may also occur. These severe skin rashes are often preceded by fever and/or flu-like symptoms. The rashes may progress to widespread skin peeling and complications that may be life-threatening or fatal.
AGEP appears at the beginning of treatment as a widespread, red, scaly rash with bumps under the skin and blisters, accompanied by fever. The most common sites: mainly in skin folds, trunk, and upper limbs.
Drug reaction with eosinophilia and systemic symptoms (DRESS) initially presents with flu-like symptoms and a facial rash, followed by a widespread rash with high fever, elevated liver enzyme levels in blood tests, increased white blood cell count (eosinophilia), and enlarged lymph nodes.

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

Quinolone antibiotics, including Actira, may cause seizures . If this occurs, treatment with Actira must be discontinued.
Severe, disabling, long-lasting, and potentially irreversible adverse effects. Antibacterial medicines containing fluoroquinolones or quinolones, including Actira, have been associated with very rare but serious adverse effects, some of which were long-lasting (persisting for months or years), disabling, or potentially irreversible. These include pain in tendons, muscles, and joints of the upper and lower limbs, difficulty walking, abnormal sensations such as pricking, tingling, pins and needles, numbness, or burning (paresthesia), sensory disturbances such as decreased vision, taste, smell, or hearing, depression, memory impairment, severe fatigue, and serious sleep disorders.

If you experience any of these adverse effects after taking Actira, contact your doctor immediately before continuing treatment. You and your doctor will decide whether to continue or discontinue treatment, possibly considering the use of an antibiotic from another class.

Rarely, you may experience symptoms of nerve damage (neuropathy) such as pain, burning, tingling, numbness, and/or weakness, especially in the feet and legs or hands and arms. If this occurs, stop taking Actira and inform your doctor immediately to prevent potentially irreversible damage.
You may experience mental health problems even after the first dose of quinolone antibiotics, including Actira. In very rare cases, mental health problems and depression have progressed to suicidal thoughts and self-harming behaviors such as suicide attempts (see section 4. Possible side effects ). If you develop these reactions, treatment with Actira must be discontinued.
You may develop diarrhea during or after taking antibiotics, including Actira. If 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 stop or slow intestinal movement.
Rarely, joint pain and swelling, tendon inflammation, or tendon rupture may occur (see sections Do not take Actira 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 taking corticosteroids. Tendon inflammation and rupture may occur within the first 48 hours of treatment or even several months after stopping Actira. At the first sign of tendon pain or swelling (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking Actira, contact your doctor, and rest the affected area. Avoid unnecessary physical activity, as this may increase the risk of tendon rupture.
If you experience sudden, severe pain in the chest, abdomen, or back , which may be symptoms of aortic dissection or aneurysm, go immediately to an emergency department. The risk may increase if you are receiving systemic corticosteroid treatment.
If you suddenly develop shortness of breath, especially when lying down, or notice swelling in your ankles, feet, or abdomen, or the onset of palpitations (sensation of rapid or irregular heartbeat), inform your doctor immediately.
If you are elderly and have kidney problems , take care to maintain adequate fluid intake, as dehydration may increase the risk of kidney failure.
If your vision worsens or your eyes appear otherwise affected, consult an ophthalmologist immediately (see sections Driving and use of machines and 4. Possible side effects).
Fluoroquinolones may cause an increase in your blood sugar levels above normal (hyperglycemia), or a decrease in your 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 should be carefully monitored.
Quinolone antibiotics may increase skin sensitivity to sunlight or UV light . You should avoid prolonged exposure to sunlight or direct sunlight and must not use sunbeds or any type of UV lamp during Actira treatment (see section 4. Possible side effects).
Limited experience is available regarding the use of intravenous/oral sequential Actira in the treatment of community-acquired lung infections (pneumonia).
The efficacy of Actira has not been established in the treatment of severe burns, deep tissue infections, or diabetic foot infections with osteomyelitis (bone marrow infections).

Children and adolescents

Do not give this medicine to children and adolescents under 18 years of age, as efficacy and safety have not been established in this age group (see section Do not use Actira ).

Other medicines and Actira

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines in addition to Actira.

With Actira, consider the following:

If you are taking Actira and other medicines that affect the heart, there is an increased risk of heart rhythm disturbances. Therefore, do not take Actira at the same time as the following drugs: medicines belonging to the antiarrhythmic class (e.g., quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), antipsychotics (e.g., phenothiazines, pimozide, sertindole, haloperidol, sultopride), tricyclic antidepressants, certain antimicrobials (e.g., saquinavir, sparfloxacin, intravenous erythromycin, pentamidine, antimalarials, particularly halofantrine), certain antihistamines (e.g., terfenadine, astemizole, mizolastine), and other drugs (e.g., cisapride, intravenous vincamine, bepridil, and difemethilene).
While taking Actira, inform your doctor if you are taking other medicines that may lower potassium levels in the blood (e.g., loop and thiazide diuretics, laxatives and enemas (high doses), or corticosteroids (anti-inflammatory medicines), amphotericin B) or that may slow heart rate, as these may also increase the risk of serious heart rhythm disturbances.
If you are currently taking oral anticoagulants (e.g., warfarin), your doctor may need to monitor your blood clotting time.

Actira with food and drinks

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

Pregnancy, breastfeeding, and fertility

Do not use Actira during pregnancy or while 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 medicine.

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

Driving and use of machines

Actira may cause dizziness or vertigo, sudden transient loss of vision, or fainting. If you experience these symptoms, do not drive or operate machinery.

Actira contains sodium

This medicine contains 787 milligrams (approximately 34 millimoles) of sodium (the main component of table/cooking salt) in each 250 ml infusion solution vial. This corresponds 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 daily.

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

Dose adjustment is not required in elderly patients, patients with low body weight, or patients with kidney problems.

Your doctor will decide the duration of treatment with Actira. In some cases, your doctor may start treatment with Actira infusion solution and subsequently 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 pulmonary infections (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 approximately 6 days, and the average total treatment duration (infusion followed by tablets) is 13 days.

It is important to complete the full course of treatment, even if you start to feel better after a few days. If you stop treatment too early, the infection may not be completely cured, it may return or worsen, and it could lead to bacterial resistance to the antibiotic.

The recommended dose and duration of treatment must not be exceeded (see section 2 What you need to know before starting to take Actira, Warnings and precautions).

If you use more Actira than you should

If you are concerned that you may have received too much Actira, consult your doctor immediately.

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

If you forget to use Actira

If you are concerned that you may have missed a dose of Actira, consult your doctor immediately.

If you stop using Actira

If you stop taking this medicine too early, your infection may not be completely cured. Consult your doctor if you intend to discontinue treatment with Actira infusion solution before completing the full course of treatment.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

The most serious adverse effects observed during treatment with Actira are listed below:

If you notice

an abnormally fast heart rate (rare adverse effect)
a sudden feeling of illness or notice yellowing of the whites of the eyes, dark urine, skin itching, tendency to bleed, or changes in thinking or wakefulness (these may be signs and symptoms of fulminant liver inflammation, which could potentially lead to fatal liver failure) (very rare adverse effect; fatal cases have been reported)
severe skin rashes including Stevens-Johnson syndrome and toxic epidermal necrolysis. These may appear on the trunk as red, target-like spots or circular lesions, often with blisters in the center, skin peeling, mouth, throat, nose, genital, and eye ulcers, and may be preceded by fever and flu-like symptoms (very rare adverse effects, potentially life-threatening)
a widespread 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 adverse effect is "not known")
widespread rash, high body temperature, elevated 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-induced hypersensitivity syndrome) (frequency of this adverse effect is "not known")
syndrome associated with disturbances in water excretion and low sodium levels (SIADH) (very rare adverse effect)
loss of consciousness due to severely low blood sugar levels (hypoglycemic coma) (very rare adverse effect)
inflammation of blood vessels (signs may include red spots on the skin, usually on the legs, or symptoms such as joint pain) (very rare adverse effect)
sudden, severe, generalized allergic reaction, very rarely including life-threatening shock (e.g. difficulty breathing, drop in blood pressure, rapid pulse) (rare adverse effect)
chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome (frequency not known: cannot be estimated from available data)
swelling, including swelling of the airways (rare adverse effect, potentially fatal)
seizures (rare adverse effect)
nervous system problems such as pain, burning, tingling, numbness, and/or weakness in the limbs (rare adverse effect)
depression (in very rare cases progressing to self-harm, suicidal thoughts/ideation, or suicide attempts) (rare adverse effect)
psychosis (which may lead to self-harming behaviors such as suicidal thoughts/ideation or suicide attempts) (very rare adverse effect)
severe diarrhea with blood and/or mucus (antibiotic-associated colitis including pseudomembranous colitis), which in very rare circumstances may lead to life-threatening complications (rare adverse effect)
pain and inflammation of tendons (tendinitis) (rare adverse effect) or tendon rupture (very rare adverse effect)
muscle weakness, sensitivity, or pain, particularly if you also feel unwell, have fever, or dark urine. These symptoms may be caused by abnormal muscle breakdown, which can be life-threatening and lead to kidney problems (a condition called rhabdomyolysis) (frequency of this adverse effect is "not known")

Stop taking Actira and contact your doctor immediately, as you may require urgent medical attention.

Additionally, if you notice

Transient loss of vision (very rare adverse effect),
Eye discomfort or pain, especially due to light exposure (very rare to rare adverse 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 adverse effects), inform your doctor immediately that you have been taking Actira and do not restart treatment.

In very rare cases, symptoms of myasthenia gravis have been observed to worsen. If this occurs, consult your doctor immediately.

If you have diabetes and notice that your blood sugar levels increase or decrease (rare or very rare adverse effect), inform your doctor immediately.

If you are elderly with 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 and symptoms of kidney failure, a rare adverse effect), consult your doctor immediately.

The following other adverse effects have been observed during treatment with Actira, categorized by their frequency:

Common (may affect up to 1 in 10 people)

nausea
diarrhea
dizziness
abdominal and stomach pain
vomiting
headache
increased levels of a 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 blood potassium levels

Uncommon (may affect up to 1 in 100 people)

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

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

muscle cramps
muscle spasms
hallucinations
increased blood pressure
swelling (of hands, feet, ankles, lips, mouth, and throat)
decreased blood pressure
kidney abnormalities (including increased laboratory test results for 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)
skin sensitivity changes
abnormal dreams
difficulty concentrating
difficulty swallowing
smell disturbances (including loss of smell)
balance disorders and lack of coordination (due to dizziness)
complete or partial memory loss
hearing impairments including deafness (usually reversible)
increased uric acid in blood
emotional instability
speech disorders
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
irregular heartbeat
increased skin sensitivity
depersonalization disorder (feeling detached from oneself)
increased blood clotting
muscle stiffness
significant decrease in certain white blood cells (agranulocytosis)

Frequency not known (cannot be estimated from available data)

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

? clearly demarcated erythematous spots with or without blisters appearing within hours after moxifloxacin administration and disappearing with post-inflammatory hyperpigmentation; these often reappear in the same skin or mucosal site upon subsequent exposure to moxifloxacin

The administration of antibiotics containing quinolones and fluoroquinolones has been associated with very rare cases of long-term (even months or years) or permanent adverse reactions, such as tendon inflammation, tendon rupture, joint pain, limb pain, difficulty walking, abnormal sensations such as pricking, tingling, pins and needles, burning, numbness, or pain (neuropathy), fatigue, memory and concentration impairment, mental health effects (which may include 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.

Cases of aortic wall enlargement and weakening or tearing (aneurysms and dissections), which could lead to rupture and potentially be fatal, and cardiac valve insufficiency have been reported in patients receiving 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):

increased levels of 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 cases may progress to potentially life-threatening complications
abnormally rapid heart rate
hallucinations
low blood pressure
kidney abnormalities (including increased results in specific kidney blood tests such as urea and creatinine)
kidney failure
swelling (of hands, feet, ankles, lips, mouth, throat)
seizures

Additionally, very rare cases of the following adverse effects, described after treatment with other quinolone antibiotics, may possibly also occur during treatment with Actira: increased pressure in the skull (symptoms include headache, visual problems such as blurred vision, "blind spots", double vision, vision loss), increased levels of sodium and calcium in blood, reduced count of a certain type of red blood cells (hemolytic anemia).

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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 expiry date stated on the vial bag and outer carton after EXP. The expiry date refers to the last day of the month indicated.

Do not store at temperatures below 15 ºC.

Use immediately after first opening and/or dilution.

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

Precipitation may occur when stored refrigerated, but it will redissolve at room temperature.

Do not use this medicine if visible particles are observed or if the solution is cloudy.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Actira

The active substance is moxifloxacin. One vial or bag contains 400 milligrams of moxifloxacin (as hydrochloride). One millilitre contains 1.6 milligrams of moxifloxacin (as 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 injections (see section Actira contains sodium).

Appearance of Actira and contents of the pack

Actira is a yellow, clear solution for infusion.

Actira is supplied in cardboard boxes containing one 250 ml glass vial with a chlorobutyl or bromobutyl rubber stopper. Actira is available in packs containing 1 vial and in packs containing 5 vials (consisting of individual boxes each containing 1 vial).

Actira is also supplied in cardboard boxes containing 250 ml polyolefin bags with a polypropylene neck sealed with an aluminium foil wrapper. These are available in packs of 5 and 12 bags.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 authorised 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 most recent review of this product information: January 2026

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

The following information is intended for healthcare professionals only:

Actira may be administered via a Y-connector together with the following solutions: water for injections, 0.9% sodium chloride, 1 molar sodium chloride, 5%/10%/40% glucose, 20% xylitol, Ringer's solution, compound sodium lactate solution (Hartmann's solution, Ringer's lactate solution).

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

The following solutions are incompatible with Actira:

10% and 20% sodium chloride solutions,

4.2% and 8.4% sodium hydrogen carbonate solutions