MOXIFLOXACINE KABI 400 MG/250 ML SOLUTION FOR INFUSION

Introduction

Package Leaflet: Information for the User

Moxifloxacino Kabi 400 mg/250 ml solution for infusion EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

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

Contents of the Package Leaflet

1. What Moxifloxacino Kabi is and what it is used for
2. What you need to know before starting to use Moxifloxacino Kabi
3. How to use Moxifloxacino Kabi
4. Possible side effects
5. Storage of Moxifloxacino Kabi
6. Package contents and additional information

1. What Moxifloxacino Kabi is and what it is used for

Moxifloxacino Kabi contains moxifloxacino as the active ingredient, which belongs to the group of antibiotics called fluoroquinolones. Moxifloxacino acts by eliminating bacteria that cause infections, provided that these bacteria are sensitive to moxifloxacino.

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

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

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

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

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

Moxifloxacino is used only to treat infections when ordinary antibiotics do not work or cannot be used.

2. What you need to know before starting to use Moxifloxacino Kabi

Consult your doctor if you are not sure if you belong to one of the patient groups described below.

Do not use Moxifloxacino Kabi

• if you are allergic to moxifloxacin or other quinolones or to any of the other components of this medicine (included 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 suffer from any inherited disease or have suffered from any disease related to an abnormal heart rhythm (observed in ECG, heart electrical record),
• if you suffer from electrolyte imbalances in the blood (especially low potassium or magnesium levels in the blood),
• if you have a very slow heart rate (called “bradycardia”), have a weak heart (heart failure), have a history of heart rhythm disorders or are taking other medications that produce certain ECG disorders (see section “Use of Moxifloxacino Kabi with other medicines”). This is because Moxifloxacino Kabi can cause changes in the ECG, such as a prolongation of the QT interval, i.e., delay in the conduction of electrical signals in the heart,
• if you suffer from 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 medicine

You should not take antibacterial medicines that contain fluoroquinolones or quinolones, including Moxifloxacino Kabi 400 mg/250 ml solution for infusion EFG, if you have experienced any serious adverse reaction previously when taking a quinolone or a fluoroquinolone. If this is the case, you should inform your doctor as soon as possible.

Consult your doctor before you are administered Moxifloxacino Kabi for the first time. It is important that you know that:

• Moxifloxacino Kabi may modify the heart 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 you are administered Moxifloxacino Kabi (see also the sections Do not use Moxifloxacino Kabiand Use of Moxifloxacino Kabi with other medicines).
• If you are diabetic because you may experience a risk of change in blood sugar levels with moxifloxacin.
• 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 epilepsyor any other condition that may cause you to have seizures, inform your doctor before you are administered Moxifloxacino Kabi.
• If you have or have ever had any mental health problem, consult your doctor before you are administered Moxifloxacino Kabi.
• If you suffer from myasthenia gravis(a rare disease that involves muscle weakness), because the use of Moxifloxacino Kabi may worsen the symptoms of your disease. If you think you are affected, consult your doctor immediately.
• if you have been diagnosed with an increase in size or a “lump”of a large blood vessel (aortic aneurysm or large peripheral vessel aneurysm).
• if you have suffered a previous episode of aortic dissection(tear of the aortic wall).
• If you have been diagnosed with heart valve insufficiency (cardiac valve regurgitation).
• if you have a family history of aortic aneurysmor 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 autoimmune inflammatory disease), or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behçet's disease, arterial hypertension, or atherosclerosis, rheumatoid arthritis (a joint disease) or endocarditis (a heart infection)).
• If you or a family member suffers from glucose-6-phosphate dehydrogenase deficiency(a rare inherited disease), inform your doctor, who will indicate if Moxifloxacino Kabi is suitable for you.
• Moxifloxacino Kabi should only be administered intravenously (in a vein) and should not be injected into arteries.

Treatment with Moxifloxacino Kabi should be discontinued immediately in the following cases:

• In rare cases, you may suffer a sudden severe allergic reaction(anaphylactic reaction or shock) even with the first dose. Consult your doctor if you experience symptoms that may include chest tightness, dizziness, nausea, or fainting, or feel dizzy when standing up.
• Moxifloxacino Kabi may cause rapid and severe liver inflammation, which can lead to life-threatening liver failure (including fatal cases, see section 4 Possible side effects). 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 alterations in thoughts or insomnia.
• The quinolone antibiotics, including Moxifloxacino Kabi, may cause seizures. If this occurs, treatment with Moxifloxacino Kabi should be discontinued.
• You may experience mental health problemseven after the first administration of quinolone antibiotics, including Moxifloxacino Kabi. 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 Moxifloxacino Kabi should be discontinued.
• In rare cases, pain and swelling in the joints and inflammation or rupture of the tendonsmay occur. 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 Moxifloxacino Kabi. At the first sign of pain or inflammation of a tendon (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking Moxifloxacino Kabi, contact your doctor, and rest the affected area. Avoid any unnecessary exercise, as this could increase the risk of tendon rupture (see sections Do not use Moxifloxacino Kabiand 4. Possible side effects).

During treatment with Moxifloxacino Kabi, you should inform your doctor immediately:

• If you notice palpitations or irregular heartbeatsduring the treatment period. Your doctor may perform an ECG to measure your heart rate.
• Severe skin reactions

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

• SSJ/TEN may initially appear on the trunk as reddish target-like lesions or circular patches often with central blisters. Ulcers may also appear 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: mainly localized in skin folds, trunk, and upper limbs.
• Drug reaction with eosinophilia and systemic symptoms (DRESS) initially appears with pseudo-flu-like symptoms and a rash on the face, later, a widespread rash appears 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.

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

• You may develop diarrheaduring or after taking antibiotics, including Moxifloxacino Kabi. If the diarrhea is severe or persistent, or if you notice blood or mucus in your stool, stop taking Moxifloxacino Kabi immediately and consult your doctor. In these situations, you should not take medications that interrupt or slow down intestinal movement.
• If you feel a sudden and severe pain in the abdomen, chest, or back, which can 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), you should inform your doctor immediately.
• If your vision worsens or if you have any other eye disordersduring treatment with Moxifloxacino Kabi, consult an ophthalmologist immediately (see sections Driving and using machines and 4. Possible side effects).
• Fluoroquinolones may cause an increase in your blood sugar levels above normal levels (hyperglycemia) or a decrease in your blood sugar levels below normal levels (hypoglycemia), which in severe cases can cause loss of consciousness (hypoglycemic coma) (see section 4. Possible side effects). If you suffer from diabetes, your blood sugar levels should be carefully controlled.

When you are administered Moxifloxacino Kabi, you should keep in mind that:

• The risk of heart problems may increase with the increase in dose and infusion rate into your veins.
• If you are elderly and have kidney problems, be careful to drink enough fluids, as dehydration can increase the risk of kidney failure.
• Quinolone antibiotics may increase the sensitivity of your skin to sunlight or UV light. You should avoid prolonged exposure to sunlight or direct sunlight and should not use sunbeds or any type of UV lamp during treatment with Moxifloxacino Kabi (see section 4. Possible side effects).
• There is limited experience regarding the use of Moxifloxacino Kabi intravenous/oral sequential treatment for the treatment of lung infections (pneumonia) acquired outside the hospital.
• The efficacy of Moxifloxacino Kabi has not been established in the treatment of severe burns, deep tissue infections, and diabetic foot infections with osteomyelitis (bone marrow infections).

Severe, long-lasting, and potentially irreversible side effects:

Antibacterial medicines that contain fluoroquinolones or quinolones, including Moxifloxacino Kabi, have been associated with very rare but serious 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 pins and needles, tingling, prickling, numbness, or burning (paresthesia), sensory disorders such as decreased vision, taste, smell, and hearing, depression, decreased memory, intense fatigue, and severe sleep disorders.

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

Children and adolescents

This medicine should not be administered to children and adolescents under 18 years old because safety and efficacy have not been established for this age group (see section Do not use Moxifloxacino Kabi).

Use of Moxifloxacino Kabi with other medicines

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medicine.

When you receive treatment with Moxifloxacino Kabi, you should keep in mind the following

If you are using Moxifloxacino Kabi, along with other medicines that affect the heart, there is a greater risk that heart rhythm disorders may occur. Therefore, you should not take Moxifloxacino Kabi at the same time as the following medicines:

• medicines that belong 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 (terfenadine, astemizole, mizolastine),
• other medicines such as cisapride, intravenous vincamine, bepridil, and difemanil.

While you are being treated with Moxifloxacino Kabi, you should inform your doctor:

• if you are taking other medicines that may decrease potassium levels in the blood (e.g., some diuretics, some laxatives, and enemas (at high doses) or corticosteroids (anti-inflammatory medicines), amphotericin B),
• if you are taking other medicines that may cause a decrease in heart rate, as these may also increase the risk of serious heart rhythm disorders while using Moxifloxacino Kabi,
• if you are currently taking oral anticoagulants (e.g., warfarin), your doctor may need to monitor your blood coagulation time.

Use of Moxifloxacino Kabi with food, drinks, and alcohol

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

You should not drink alcohol while being treated with Moxifloxacino Kabi.

Pregnancy, breastfeeding, and fertility

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.

Do not useMoxifloxacino Kabi if you are pregnant or breastfeeding.

Studies in animals do not indicate that fertility is affected by the use of this medicine.

Driving and using machines

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

Moxifloxacino Kabi contains sodium

The maximum recommended daily dose of this medicine contains 1206 mg of sodium (main component of table salt/cooking salt). This is equivalent to 60% of the maximum recommended daily sodium intake for an adult.

3. How to use Moxifloxacino Kabi

Moxifloxacino will always be administered to you by a doctor or healthcare professional.

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

Moxifloxacino is for intravenous use (in a vein). 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.

Duration of treatment

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

It is essential that you 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.

If you use more Moxifloxacino Kabi than you should

If you are concerned about the possibility of having received too much moxifloxacino, 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 Moxifloxacino Kabi

If you are concerned about the possibility of having forgotten a dose of moxifloxacino, consult your doctor immediately.

If you stop treatment with Moxifloxacino Kabi

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 moxifloxacino before completing the full treatment.

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

4. Possible side effects

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

You must stop treatment and contact your doctor immediatelyif you experience the following side effects, as they can be life-threatening:

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

• Severe, sudden, and generalized allergic reaction, which very rarely includes life-threatening shock (e.g., difficulty breathing, low blood pressure, rapid pulse), swelling (including possible swelling of the airways that can be life-threatening).
• Depression (in very rare cases leading to self-harm, such as suicidal thoughts or attempts).
• Severe diarrhea with blood and/or mucus (antibiotic-associated colitis, including pseudomembranous colitis), which in very rare circumstances can lead to potentially life-threatening complications.
• Increased blood sugar levels.
• If you are elderly with kidney problems and notice a decrease in urine production, swelling in the legs, ankles, or feet, fatigue, nausea, drowsiness, shortness of breath, or confusion (these may be signs and symptoms of kidney failure).

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

• Feeling of loss of personality (not being oneself), dementia (possibly leading to self-harm, such as suicidal thoughts or attempts).
• Irregular heartbeat (Torsade des Pointes) that can be life-threatening or cause cardiac arrest.
• Fulminant (toxic) liver inflammation with possible life-threatening risk due to liver failure (including 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 (with possible life-threatening risk).
• Syndrome associated with alterations in water elimination and low sodium levels (SIADH) (very rare side effect).
• Inflammation of blood vessels (signs may include red spots on the skin, usually on the lower legs, or effects such as joint pain).
• Tendon rupture, joint inflammation, muscle stiffness.
• Worsening of myasthenia gravis symptoms has been observed.
• Low blood sugar levels.
• Loss of consciousness due to severely low blood sugar levels (hypoglycemic coma) (very rare side effect).

Side effects of unknown frequency(frequency cannot be estimated from available data)

• 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) (the frequency of this side effect is "unknown").
• 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) (the frequency of this side effect is "unknown").
• 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).

During treatment with Moxifloxacino Kabi, the following side effects have been observed.

Common side effects(may affect up to 1 in 10 people)

• Infections caused by resistant bacteria or fungi, e.g., oral and vaginal infections caused by Candida.
• Headache, dizziness.
• Change in heart rhythm (observed on an electrocardiogram), in patients with low potassium levels in the blood (see section 2. What you need to know before you start using Moxifloxacino Kabi).
• Nausea, vomiting, abdominal and stomach pain, diarrhea.
• Pain or inflammation at the injection site.

Uncommon side effects (may affect up to 1 in 100 people)

• Low red blood cell count, low white blood cell count, low levels of certain white blood cells (neutrophils), decrease or increase in certain blood cells necessary for blood clotting (platelets), increase in certain white blood cells (eosinophils), decrease in blood clotting.
• Allergic reactions.
• Increased blood lipid levels (fats).
• Anxiety, restlessness/agitation.
• Numbness or tingling sensation (pins and needles) and/or numbness, altered taste (in very rare cases, loss of taste), confusion and disorientation, sleep disorders (predominantly insomnia), tremors, sensation of vertigo (feeling of spinning and falling), drowsiness.
• Vision disorders, including double vision and blurred vision.
• Change in heart rhythm (observed on an electrocardiogram), palpitations, irregular and rapid heart rate, severe heart rhythm disorders, angina pectoris (chest pain).
• Dilation of blood vessels.
• Breathing difficulties, including asthma-like conditions.
• Lack of appetite and decreased food intake, flatulence and constipation, gastric discomfort (indigestion or acidity), stomach inflammation, increase in a specific digestive enzyme in the blood (amylase).
• Alteration of liver function (including increase in a specific liver enzyme in the blood (LDH), increase in bilirubin in the blood, increase in a specific liver enzyme in the blood (gamma-glutamyltransferase and/or alkaline phosphatase).
• Itching, rash, hives, dry skin.
• Joint and muscle pain.
• Dehydration.
• Malaise (mainly weakness or fatigue), back, limb, pelvis, and thorax pain, sweating.
• Inflammation of a vein.

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

• Increased uric acid levels in the blood.
• Emotional instability, hallucinations.
• Disorders of skin sensation, altered sense of smell (including loss of smell), abnormal dreams, balance and coordination disorders (due to dizziness), convulsions, concentration disorders, speech disorders, total or partial memory loss, problems associated with the nervous system, such as pain, burning, tingling, numbness, and/or weakness in the limbs.
• Ringing or noises in the ears, hearing impairment, including deafness (usually reversible).
• Fainting.
• Hypertension, hypotension.
• Difficulty swallowing, mouth inflammation, jaundice (yellowing of the whites of the eyes or skin), liver inflammation.
• Tendon pain and inflammation (tendinitis), muscle cramps, muscle spasms, muscle weakness.
• Kidney disorders (including increased laboratory test results for the kidneys, such as urea and creatinine), kidney failure.
• Swelling (of hands, feet, ankles, lips, mouth, and throat).
• Eye discomfort or pain, especially due to light exposure (contact an ophthalmologist immediately).

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

• Increased blood clotting, significant decrease in certain white blood cells (agranulocytosis).
• Increased skin sensitivity.
• Transient loss of vision (contact an ophthalmologist immediately).
• Heart rhythm disorders.
• Decrease in the number of red and white blood cells and platelets (pancytopenia).

The administration of antibiotics containing quinolones and fluoroquinolones 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 ideation), as well as alterations in hearing, vision, taste, and smell, have been associated with the administration of quinolone and fluoroquinolone antibiotics in some cases, regardless 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.

Unknown frequency(cannot be estimated from 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 moxifloxacino administration 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 following symptoms have been observed more frequently in patients treated intravenously:

Common(may affect up to 1 in 10 people)

• Increased levels of specific liver enzymes in the blood (gamma-glutamyl transferase).

Uncommon(may affect up to 1 in 100 people)

• Abnormal heart rhythm acceleration.
• Low blood pressure.
• Swelling (of hands, feet, ankles, lips, mouth, and throat).
• Severe diarrhea with blood and/or mucus (antibiotic-associated colitis), which in very rare circumstances can lead to potentially life-threatening complications.
• Convulsions.
• Hallucinations.
• Kidney failure (including increased laboratory test results for the kidneys, such as urea and creatinine), kidney failure.

The following side effects have been observed after treatment with other quinolone antibiotics and may also occur during treatment with Moxifloxacino Kabi

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

• Increased sodium and calcium levels in the blood.
• Reduced count of a specific type of red blood cell (hemolytic anemia).

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist before the next dose is administered, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Moxifloxacino Kabi

Since this medication will be administered by healthcare professionals, they will be responsible for the correct storage of the product before and during its use, as well as its correct disposal.

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

Do not use this medication after the expiration date shown on the label of the vial or bag and on the outer packaging after EXP. The expiration date is the last day of the month indicated.

Do not refrigerate or freeze.

Store the vial in the outer packaging to protect it from light.

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

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

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

Your doctor or hospital staff will be responsible for storing Moxifloxacino Kabi and are responsible for the quality of the product once opened or when not used immediately. They are also responsible for the correct disposal of any unused Moxifloxacino Kabi.

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

6. Container Content and Additional Information

Composition of Moxifloxacino Kabi vials:

• The active ingredient is moxifloxacin.
• Each 250 ml vial contains 400 mg of moxifloxacino (as hydrochloride). Each ml contains 1.6 mg of moxifloxacino (as hydrochloride).
• Each 250 ml bag contains 400 mg of moxifloxacino (as hydrochloride). Each ml contains 1.6 mg of moxifloxacino (as hydrochloride).
• The other components are sodium acetate trihydrate, sulfuric acid (for pH adjustment), anhydrous sodium sulfate, and water for injectable preparations (see section Moxifloxacino Kabi contains sodium).

Appearance of Moxifloxacino Kabi and Container Content

Moxifloxacino Kabi is a clear yellow solution for infusion.

Moxifloxacino Kabi is packaged in cardboard boxes containing a 250 ml low-density polyethylene vial (KabiPac) as primary packaging with a stopper containing a rubber disc to allow needle insertion. The packages contain 1, 10, 20, 25, or 40 vials.

Moxifloxacino Kabi is packaged in cardboard boxes containing polyolefin (freeflex) bags of 250 ml with an administration port (infusion port) and an addition port (injection port) with a polypropylene mouth and aluminum wrapping. The packages contain 1, 10, 20, 25, or 40 bags.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Fresenius Kabi España, S.A.U.

Marina 16-18,

08005 Barcelona

Spain

Manufacturer of the vials:

Fresenius Kabi Polska Sp. z o.o.

ul. Sienkiewicza 25, 99-300 Kutno

Poland

Manufacturer of thebags:

HP Halden Pharma AS

Svinesundsveien 80

1788 Halden

Norway

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

Date of the last revision of thisleaflet: March 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/

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This information is intended exclusively for healthcare professionals:

Moxifloxacino Kabi can be administered through a T-tube together with the following solutions: water for injectable preparations, sodium chloride 9 mg/ml (0.9%) solution for injection, glucose 5%/10%, Ringer's solution, sodium lactate compound solution (Hartmann's solution, Ringer-lactate solution).

Moxifloxacino Kabi should not be co-infused with other medicinal products.

The following solutions are incompatible with Moxifloxacino Kabi:

Sodium chloride solutions at 10% and 20%,

Sodium bicarbonate solutions at 4.2% and 8.4%