Package Insert: Information for the User

Moxifloxacino Kabi 400 mg/ 250 ml Solution for Infusion EFG

Read this package insert carefully before you start taking this medicine, because it contains important information for you.

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

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

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

• Pneumonia acquired outside of the hospital.
• Skin and soft tissue infections

Moxifloxacino is used solely for treating infections when standard antibiotics are ineffective or cannot be used..

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

Do not use Moxifloxacino Kabi

• if you are allergic to moxifloxacino or to other quinolones or to 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 damage or lesions related to antibiotic quinolone treatment (see sectionsWarnings and precautionsand 4.Adverse reactions),
• if you have a hereditary disease or have suffered from a disease related to an abnormal heart rhythm (observed on ECG, heart electrical recording),
• if you have electrolyte imbalances in the blood (especially low levels of potassium or magnesium 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 cause certain ECG disturbances (see section“Use of Moxifloxacino Kabi with other medications”),
• if you have severe liver disease or liver enzyme levels are 5 times above the upper limit of normal.

Warnings and Precautions

Before starting to take this medication

Do not take fluoroquinolone or quinolone antibacterial medications, including Moxifloxacino Kabi 400 mg/ 250 ml solution for infusion EFG, if you have experienced a severe adverse reaction to a quinolone or fluoroquinolone in the past. If this is the case, inform your doctor as soon as possible.

Consult your doctor before Moxifloxacino Kabi is administered to you for the first time. It is essential that they know that:

• Moxifloxacino Kabi maymodify the heart ECG, especially if you are a woman or an elderly patient.
• If you are currently taking anymedication that leads to a decrease in blood potassium levels, consult your doctor before Moxifloxacino Kabi is administered (see also sectionsDo not use Moxifloxacino KabiandUse of Moxifloxacino Kabi with other medications).
• If you are diabetic because you may experience a risk of changes in blood sugar levels with moxifloxacino.
• •If you have ever developed a severe skin rash or skin peeling, blisters and/or mouth sores after taking moxifloxacino.
• If you suffer fromepilepsyor another condition that may causeseizures, inform your doctor before Moxifloxacino Kabi is administered.
• If you have or have ever had anymental health problems, consult your doctor before Moxifloxacino Kabi is administered.
• If you havemyasthenia gravis(a rare disease that involves muscle weakness), because the use of Moxifloxacino Kabi may worsen your symptoms. If you think you are affected, consult your doctor immediately.
• If you have been diagnosed with an enlarged or a“bulge”of a large blood vessel (aortic aneurysm or aneurysm of a large peripheral vessel).
• If you have had a previous episode ofaortic dissection(tear in the aorta wall).
• If you have been diagnosed with heart valve insufficiency (regurgitation of heart valves).
• If you have a family history ofaortic aneurysmor aortic dissection, congenital heart valve disease or other risk factors or predisposing conditions (e.g., 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, hypertension or known atherosclerosis, rheumatoid arthritis (a joint disease) or endocarditis (a heart infection)).
• If you or a family member suffers fromglucose-6-phosphate dehydrogenase deficiency(a rare hereditary disease), inform your doctor, who will indicate if Moxifloxacino Kabi is suitable for you.
• Moxifloxacino Kabi should only be administered intravenously (into a vein) and should not be injected into arteries.

The treatment with Moxifloxacino Kabi should be interrupted immediately in the following cases:

• In rare cases, you may experience asevere and sudden allergic reaction(anaphylactic reaction) even with the first dose. Consult your doctor if you experience symptoms that may include chest tightness, dizziness, nausea, or fainting, or feeling vertigo when standing.
• Moxifloxacino Kabi may cause arapid and severe inflammation of the liver, which may lead to liver failure that puts your life at risk (including fatal cases, see section 4Adverse reactions).
• Antibiotics quinolones, including Moxifloxacino Kabi, may causeseizures. If this occurs, treatment with Moxifloxacino Kabi should be interrupted.
• You may experiencemental health problems, even 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-harm behaviors such as attempted suicide (see section4. Adverse reactions).
• In rare cases, you may experiencejoint pain and swelling, inflammation, or tendon rupture. The risk is higher if you are an elderly person (over 60 years old), have received an organ transplant, have kidney problems, or are taking corticosteroids. Tendon inflammation and rupture can occur in the first 48 hours of treatment and even several months after interrupting treatment with Moxifloxacino Kabi. At the first sign of joint pain or tendon inflammation (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking Moxifloxacino Kabi, contact your doctor, and keep the painful area at rest. Avoid any unnecessary exercise, as this may increase the risk of tendon rupture (see sectionsDo not use Moxifloxacino Kabiand4. Adverse reactions).

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

• If you noticepalpitations 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 (NET), and generalized acute pustular psoriasis (PEGA) and drug reaction with eosinophilia and systemic symptoms (DRESS or hypersensitivity syndrome) have been reported with the use of moxifloxacino.

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

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

• You may developdiarrheaduring or after taking antibiotics, including Moxifloxacino Kabi. If the diarrhea is severe or persistent, or if you notice blood or mucus in the stool, interrupt Moxifloxacino Kabi immediately and consult your doctor. In these situations, do not take medications that slow down or stop intestinal movement.
• If you experience sudden and intense pain in the abdomen, chest, or back, which may be symptoms of aortic dissection or aneurysm, go to the emergency room immediately. You may be at increased risk if you are receiving systemic corticosteroids.
• If you start experiencing sudden onset of shortness of breath, especially when lying down, or if you notice swelling in the ankles, feet, or abdomen or palpitations (sensation of rapid or irregular heartbeat), inform your doctor immediately.
• If your vision worsens or if you experience any othereye problemsduring treatment with Moxifloxacino Kabi, consult an ophthalmologist immediately (see sectionsDriving and use of machines and 4. Adverse reactions).
• 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 may cause loss of consciousness (hypoglycemic coma) (see section 4. Adverse reactionsIf you have diabetes, your blood sugar levels should be carefully controlled.

When Moxifloxacino Kabi is administered to you, you should be aware that:

• The risk of heart problems may increase with increasing doses and infusion rates into your veins.
• If you are an elderly person and have kidney problems, be careful to ensure adequate fluid intake, as dehydration may increase the risk of kidney failure.
• Quinolone antibiotics may increase the skin's sensitivity to sunlight or UV. You should avoid prolonged exposure to sunlight or direct sunlight and not use sunbeds or any type of UV lamp during Moxifloxacino Kabi administration (see section 4. Adverse reactions).
• There is limited experience with the use of intravenous/oral sequential Moxifloxacino Kabi in the treatment of hospital-acquired pneumonia.
• The efficacy of Moxifloxacino Kabi has not been established in the treatment of severe burns, deep tissue infections, or diabetic foot infections with osteomyelitis (bone marrow infections).

Severe, prolonged, and potentially irreversible adverse effects:

Fluoroquinolone or quinolone antibacterial medications, including Moxifloxacino Kabi, have been associated with rare but severe adverse effects, some of which were of long duration (persistent for months or years), incapacitating, or potentially irreversible. This includes tendon pain, muscle and joint pain in the upper and lower limbs, difficulty walking, abnormal sensations such as pins and needles, numbness, tingling, or burning, sensory disorders such as decreased vision, taste, smell, and hearing, depression, memory impairment, intense fatigue, and severe sleep disorders.

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

Children and adolescents

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

Use of Moxifloxacino Kabi with other medications

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

When receiving treatment with Moxifloxacino Kabi, you should be aware of the following:

If you are taking Moxifloxacino Kabi, along with other medications that affect the heart, there is a higher risk of heart rhythm disorders. Therefore, do not take Moxifloxacino Kabi at the same time as the following medications:

• antiarrhythmic medications (e.g., quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide),
• antipsychotics (e.g., phenothiazines, pimozide, sertindole, haloperidol, sulpiride),
• tricyclic antidepressants, some antimicrobials (e.g., saquinavir, sparfloxacin, intravenous erythromycin, pentamidine, antimalarials, particularly halofantrine),
• some antihistamines (terfenadine, astemizole, mizolastine),
• other medications such as cisapride, intravenous vincamine, bepridil, and difemanil).

While you are receiving treatment with Moxifloxacino Kabi, you should inform your doctor:

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

Pregnancy, lactation, and fertility

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

Do not useMoxifloxacino Kabi if you are pregnant or breastfeeding.

Animal studies do not indicate that fertility is affected by the use of this medication.

Driving and use of machines

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

Moxifloxacino Kabi contains sodium

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

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

The recommended dose in adults is onebottle or 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 for 60 minutes.

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

Treatment duration

Your doctor will decide on the duration of treatment with moxifloxacino. In some cases, your doctor may initiate treatment with moxifloxacino infusion solution and then continue with oral treatment with tablets.

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

It is essential to complete the treatment, even if you start feeling better after a few days. If you interrupt treatment too soon, the infection may not be fully cleared, the infection may recur, your condition may worsen, and you may also develop antibiotic resistance.

Do not exceed the recommended dose and treatment duration.

If you use more Moxifloxacino Kabi than you should

If you are concerned that you have 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 at 91 562 04 20, indicating the medication and the amount ingested.

If you forget to use Moxifloxacino Kabi

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

If you interrupt treatment with Moxifloxacino Kabi

If you interrupt treatment too soon, your infection may not be fully cleared. Consult your doctor if you plan to discontinue 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.

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

You should interrupt treatment and contact your doctor immediatelyif you experience the side effects listed below, as they may put your life at risk:

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

• Severe, sudden, and generalised allergic reaction, which very rarely includes life-threatening shock (e.g., difficulty breathing, low blood pressure, rapid pulse), swelling (including possible life-threatening swelling of the airways).
• 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 cases may evolve into 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, or suicide attempts).
• Irregular heart rate (Torsade des Pointes) that may put your life at risk.
• Acute, toxic liver inflammation with possible life-threatening risk of liver insufficiency (including fatal cases).
• Severe skin eruptions, including Stevens-Johnson syndrome and toxic epidermal necrolysis. These may appear on the trunk as red, target-like macules or circular patches often with blisters in the center, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes, and may 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 patches on the skin, usually on the lower legs, or effects such as joint pain).
• Tendon rupture, joint inflammation, muscle stiffness.
• Worsening of symptoms of myasthenia gravis.
• Decreased blood sugar levels.
• Loss of consciousness due to severe decrease in blood sugar levels (hypoglycemic coma) (very rare side effect).

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

• A generalised, scaly, and red rash with protuberances under the skin and blisters accompanied by fever at the start of treatment (generalised acute pustular psoriasis) (frequency of this side effect is "unknown").
• A generalised rash, 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-induced hypersensitivity syndrome) (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 may be caused by abnormal muscle breakdown that may put your life at risk 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 the electrocardiogram), in patients with low potassium levels in the blood (see section 2.What you need to know before starting to use 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), low or high levels of certain blood cells necessary for blood clotting (platelets), high levels of certain white blood cells (eosinophils), low blood clotting.
• Allergic reactions.
• Increased levels of lipids in the blood (fats).
• Anxiety, restlessness/agitation.
• Tickling sensation (pins and needles) and/or numbness, alteration of taste (in very rare cases, loss of taste), confusion, and disorientation, sleep disturbances (predominantly insomnia), tremors, sensation of dizziness (feeling of falling), drowsiness.
• Eye disorders, including double vision and blurred vision.
• Change in heart rhythm (observed on the electrocardiogram), palpitations, irregular and rapid heart rate, severe heart rhythm disturbances, angina pectoris (chest pain).
• Widening of blood vessels.
• Difficulty breathing, including asthma-like states.
• Loss of appetite and decreased food intake, flatulence, and constipation, gastrointestinal discomfort (indigestion or acid reflux), stomach inflammation, increased levels of a certain digestive enzyme in the blood (amylase).
• Liver function alteration (including increased levels of a liver enzyme in the blood (LDH), increased bilirubin in the blood, increased levels of a liver enzyme in the blood (gamma-glutamyltransferase and/or alkaline phosphatase).
• Itching, rash, urticaria, dry skin.
• Musculoskeletal pain and inflammation.
• Dehydration.
• Uncomfortable or painful feelings in the eyes, especially due to exposure to light (contact an ophthalmologist immediately).

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

• Increased uric acid levels in the blood.
• Emotional instability, hallucinations.
• Sensory disorders, alteration of smell (including loss of smell), abnormal dreams, balance and coordination disorders (due to dizziness), convulsions, concentration disorders, speech alteration, loss of memory, problems associated with the nervous system, such as pain, burning, tingling, numbness, or weakness in the limbs.
• Tinnitus or ringing in the ears, hearing loss (usually reversible).
• Fainting.
• Hypertension, hypotension.
• Difficulty swallowing, mouth inflammation, jaundice (yellowing of the white of the eyes or skin), liver inflammation.
• Tendon pain and inflammation (tendinitis), muscle cramps, muscle contractures, muscle weakness.
• Renal alterations (including increased levels of certain laboratory tests for the kidneys, such as urea and creatinine), kidney failure.
• Swelling (of hands, feet, ankles, lips, mouth, and throat)
• Uncomfortable or painful feelings in the eyes, especially due to exposure to light (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).
• Alterations in heart rhythm.
• Significant decrease in red and white blood cells and platelets (pancytopenia)

The administration of quinolone and fluoroquinolone antibiotics has been associated with very rare cases of long-lasting or permanent adverse reactions (even months or years) or permanent, such as tendon inflammation, tendon rupture, joint pain, limb pain, difficulty walking, abnormal sensations such as pinpricks, tingling, itching, numbness, or pain (neuropathy), depression, fatigue, sleep disturbances, memory loss, and hearing, vision, taste, and smell loss, in some cases regardless of the presence of pre-existing risk factors.

Cases of increased size and weakening or tearing of the aortic wall (aneurysms and dissections) have been reported, which could lead to rupture and be fatal, and heart valve insufficiency in patients who have received fluoroquinolones. See 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, red, and scaly patches with or without blisters that appear in the hours following moxifloxacino administration and disappear with residual post-inflammatory hyperpigmentation; they usually reappear in the same skin or mucosa area with subsequent moxifloxacino exposure

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

Common(may affect up to 1 in 10 people)

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

Uncommon(may affect up to 1 in 100 people)

• Abnormal acceleration of heart rhythm.
• 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 cases may evolve into potentially life-threatening complications.
• Convulsions.
• Hallucinations.
• Kidney failure (including increased levels of certain laboratory tests 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 levels of sodium and calcium in the blood.
• Reduced count of a certain type of red blood cell (hemolytic anemia).

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacistbefore they administer the next dose, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

As this medication will be administered by healthcare professionals, they will be responsible for the correct conservation of the product before and during 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 that appears on the label of the vial or on thebagand on the outer packaging after CAD. 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 observe 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 will also be responsible for the correct disposal of any unused Moxifloxacino Kabi.

Medications should not be thrown away through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Composition of Moxifloxacino Kabi vials:

• The active ingredient is moxifloxacino.
• Each vial of 250 ml contains 400 mg of moxifloxacino (as hydrochloride). Each ml contains 1.6 mg of moxifloxacino (as hydrochloride).
• Each bag of 250 ml 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 injection preparations (see section Moxifloxacino Kabi contains sodium).

Appearance of Moxifloxacino Kabi and packaging contents:

Moxifloxacino Kabi is a transparent yellow infusion solution.

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

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

Only some packaging sizes may be commercially available.

Marketing Authorization Holder and Responsible Manufacturer:

Marketing Authorization Holder:

Fresenius Kabi España, S.A.U.

Marina 16-18,

08005 Barcelona

Spain

Responsible Manufacturer of the vials:

Fresenius Kabi Polska Sp. z o.o.

ul. Sienkiewicza 25, 99-300 Kutno

Poland

Responsible Manufacturer of the bags:

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:

Last review date of thisleaflet::April 2024.

The detailed information of this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

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This information is intended solely for healthcare professionals:

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

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

The following solutions are incompatible with Moxifloxacino Kabi:

Sodium chloride solutions at 10% and 20%,

Bicarbonate sodium solutions at 4.2% and 8.4%