Moloxin

Leaflet accompanying the packaging: information for the user

Moloxin, 400 mg/250 ml, solution for infusion

Moxifloxacin

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Moloxin and what is it used for
• 2. Important information before using Moloxin
• 3. How to use Moloxin
• 4. Possible side effects
• 5. How to store Moloxin
• 6. Contents of the packaging and other information

1. What is Moloxin and what is it used for

Moloxin contains the active substance moxifloxacin, which belongs to a group of antibiotics called fluoroquinolones. Moloxin works bactericidally on bacteria that cause infections, if they are caused by bacteria sensitive to moxifloxacin. Moloxin is used in adults to treat the following bacterial infections:

• lung infection (pneumonia) acquired outside the hospital
• skin and soft tissue infections

2. Important information before using Moloxin

If the patient has doubts about whether they belong to any of the groups described below, they should consult a doctor.

When not to use Moloxin

• if the patient is allergic to moxifloxacin, other quinolone antibiotics, or any of the other ingredients of this medicine (listed in section 6);
• during pregnancy and breastfeeding;
• in patients under 18 years of age;
• if the patient has had tendon problems in the past related to treatment with other quinolone antibiotics (see section "Warnings and precautions" and section 4 "Possible side effects");
• if the patient has congenital or acquired conditions related to abnormal heart rhythm (visible in ECG - recording of heart electrical activity);
• if the patient has electrolyte imbalance disorders (especially decreased potassium or magnesium levels in the blood);
• if the patient has very slow heart rate (bradycardia);
• if the patient has heart failure;
• if the patient has had arrhythmias in the past;
• if the patient is taking medicines that may cause abnormal changes in the ECG recording (see section "Moloxin and other medicines"); Moloxin may cause changes in the ECG recording, called QT interval prolongation, which means delayed conduction of electrical signals in the heart;
• if the patient has severe liver disease or liver enzyme activity (aminotransferases) exceeds 5 times the upper limit of normal.

Warnings and precautions

Before taking this medicine

You should not take antibacterial medicines containing fluoroquinolones or quinolones, including Moloxin, if you have experienced any severe side effects in the past while taking a quinolone or fluoroquinolone. In such a situation, you should inform your doctor as soon as possible.

Before starting Moloxin, you should discuss it with your doctor, pharmacist, or nurse.

• Moloxin may change the heart's ECG recording, especially in women and the elderly. If you are currently taking medicines that lower potassium levels in the blood, you should consult your doctor before starting Moloxin (see also section "When not to use Moloxin" and section "Moloxin and other medicines").
• If you have been diagnosed with a large blood vessel enlargement (aortic or large peripheral artery aneurysm).
• If you have had an aortic dissection (tear in the aortic wall) in the past.
• If you have been diagnosed with heart valve regurgitation.
• If there have been cases of aortic aneurysm or aortic dissection in your family, or other risk factors or predisposing conditions (e.g., connective tissue diseases such as Marfan syndrome, Ehlers-Danlos syndrome, Turner syndrome, or Sjögren's syndrome (an autoimmune inflammatory disease) or vascular diseases such as Takayasu arteritis, giant cell arteritis, Behçet's disease, hypertension, or confirmed atherosclerosis, rheumatoid arthritis (joint disease), or endocarditis).
• In case of epilepsyor conditions that may cause seizures, you should consult your doctor before starting Moloxin.
• If you have or have had mental health problems, you should consult your doctor before starting Moloxin.
• If you have myasthenia gravis(a type of muscle weakness that can lead to paralysis in severe cases), taking Moloxin may worsen the symptoms of the disease. If this happens, you should consult your doctor immediately.
• If you or someone in your family has had glucose-6-phosphate dehydrogenase deficiency(a rare inherited disease), you should tell your doctor, who will assess whether Moloxin is a suitable medicine for you.
• Moloxin can only be administered intravenously, not intra-arterially. If you have diabetes, because moxifloxacin may increase the risk of changes in blood sugar levels.
• If you have ever experienced a severe skin rash or skin peeling after taking moxifloxacin, with blisters and (or) ulcers.

During Moloxin treatment

• If heart palpitations or irregular heartbeatoccur during treatment, you should tell your doctor immediately. The doctor may recommend an ECG test to check the heart rhythm.
• The risk of heart rhythm disordersmay increase with increasing dose and infusion rate.
• There is a small risk of severe, sudden allergic reactions(anaphylactic or anaphylactoid reactions) even after the first dose of the medicine, with symptoms such as chest tightness, dizziness, nausea, or fainting and a feeling of spinning when standing up.

If these symptoms occur, you should stop taking Moloxin infusion solution immediately.

• Moloxin may cause liver inflammation with a rapid and severe course, which can lead to life-threatening liver failure (including death, see section 4 "Possible side effects"). If symptoms such as rapid deterioration of well-being, yellowing of the eyes, dark urine, itching, tendency to bleed, and disorders of thinking or insomnia occur, you should consult your doctor before taking the next dose.
• Antibiotics from the quinolone group, including Moloxin, may cause seizures. If seizures occur, you should stop taking Moloxin immediately.
• Long-term, disabling, and potentially irreversible severe side effects.
• Antibacterial medicines containing fluoroquinolones or quinolones, including Moloxin, have been associated with very rare but severe side effects. Some of them were long-term (lasting for months or years), disabling, or potentially irreversible. These include: tendon pain, muscle and joint pain in the upper and lower limbs, difficulty walking, abnormal sensations such as tingling, burning, itching, numbness, or burning, sensory disorders, including vision, taste, and smell disorders, depression, memory disorders, severe fatigue, and severe sleep disorders. If you experience any of these side effects after taking Moloxin, you should consult your doctor immediately before continuing treatment. You and your doctor will decide whether to continue treatment, also considering antibiotics from another group.
• You may rarely experience nerve damage symptoms(neuropathy) such as pain, burning, tingling, numbness, and (or) weakness, especially in the feet and legs and hands and arms. In such a case, you should stop taking Moloxin and immediately inform your doctor to prevent the development of potentially irreversible disease.
• You may experience mental health problems, even during the first use of quinolone antibiotics, including Moloxin. In very rare cases, depression or mental health problems may lead to suicidal thoughts and self-aggressive behaviors, such as suicide attempts (see section 4 "Possible side effects"). If you experience such reactions, you should stop taking Moloxin immediately.
• During or after the use of antibiotics, including Moloxin, diarrheamay occur. If it worsens or lasts longer, or if blood or mucus is found in the stool, you should stop taking Moloxin and consult your doctor. In such a situation, you should not use medicines that slow down or stop bowel movements (peristalsis).
• You may rarely experience joint pain and swelling and tendon inflammation or rupture. The risk is increased in the elderly (over 60 years), after organ transplantation, in cases of kidney problems, or during corticosteroid treatment. Tendon inflammation and rupture may occur within the first 48 hours of treatment and even up to several months after stopping Moloxin treatment. After the first symptoms of pain or tendon inflammation (e.g., in the ankle, wrist, elbow, shoulder, or knee), you should stop taking Moloxin, consult your doctor, and rest the affected area. You should avoid excessive exertion, as it may increase the risk of tendon rupture (see section 2 "When not to use Moloxin" and section 4 "Possible side effects").
• In case of sudden severe abdominal, back, or chest pain, which may be a sign of aneurysm and aortic dissection, you should immediately go to the emergency room. The risk of these changes may be higher during systemic corticosteroid treatment.
• In case of sudden shortness of breath, especially when lying down, or swelling of the ankles, feet, or abdomen, or palpitations (feeling of rapid or irregular heartbeat), you should immediately consult your doctor.
• Elderly patients with renal impairmentshould drink an adequate amount of fluids, as dehydration may increase the risk of renal failure.
• If your vision worsens or you experience other vision disorders during Moloxin treatment, you should immediately consult an ophthalmologist (see section 2 "Driving and using machines" and section 4 "Possible side effects").
• Fluoroquinolone antibiotics may cause increased blood sugar levelsabove normal (hyperglycemia) or decreased blood sugar levelsbelow normal (hypoglycemia), which can potentially lead to loss of consciousness (hypoglycemic coma) in severe cases (see section 4 "Possible side effects"). In diabetic patients, blood sugar levels should be closely monitored.
• Quinolone antibiotics may increase sensitivity of the skin to sunlight or UV radiation. During Moloxin treatment, you should avoid prolonged sun exposure, strong sunlight, and use of sunbeds or other sources of UV radiation (see section 4 "Possible side effects").
• There is limited experience with the use of sequential therapy (first intravenous, then oral) with Moloxin in the treatment of community-acquired pneumonia.
• The efficacy of moxifloxacin has not been established in the treatment of severe burns, deep tissue infections, and diabetic foot infections with osteomyelitis (bone infection).

Severe skin reactions

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

• SJS/TEN may initially appear as reddish targets or circular spots, often with blisters on the torso. They may also cause ulcers in the mouth, throat, nose, genitals, and eyes (red and swollen eyes). The onset of these severe skin rashes is often preceded by fever and flu-like symptoms. The rashes may progress to widespread skin peeling and life-threatening complications or lead to death.
• AGEP appears at the beginning of treatment as a red, scaly, generalized rash with bumps under the skin and blisters, accompanied by fever. The most common location is localized mainly in skin folds, torso, and upper limbs.
• In DRESS, initial symptoms include flu-like symptoms and a rash on the face, followed by a widespread rash with high body temperature, elevated liver enzymes, and increased white blood cell count (eosinophilia), as well as swollen lymph nodes. If a severe rash or any of these skin symptoms occur, you should stop taking moxifloxacin and consult your doctor or seek immediate medical attention.

Children and adolescents

This medicine should not be used in children and adolescents under 18 years of age, as the efficacy and safety of its use in this age group have not been established (see section "When not to use Moloxin").

Moloxin and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

When taking Moloxin, you should be aware that:

• Concomitant use of Moloxin with other medicines that affect heart function increases the risk of heart rhythm disorders. Therefore, you should not take Moloxin with the following medicines: antiarrhythmic medicines (e.g., quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), antipsychotic medicines (e.g., phenothiazines, pimozide, sertindole, haloperidol, sultopride), tricyclic antidepressants, some anti-infective medicines (e.g., saquinavir, sparfloxacin, intravenous erythromycin, pentamidine, antimalarial medicines, especially halofantrine), some antihistamines (e.g., terfenadine, astemizole, mizolastine), and other medicines (e.g., cisapride, intravenous vincamine, bepridil, and difemanil).

You should inform your doctor about taking medicines that may lower potassium levels in the blood [e.g., certain diuretics, certain laxatives, and enemas (in large doses) or corticosteroids (anti-inflammatory medicines), amphotericin B] or slow down the heart rate, as this may increase the risk of severe heart rhythm disorders during Moloxin treatment.

• In case of concomitant use of oral anticoagulants (e.g., warfarin), your doctor may order blood coagulation tests.

Moloxin with food and drink

Food, including dairy products, does not affect the action of Moloxin.

Pregnancy, breastfeeding, and fertility

Moloxin should not be used during pregnancy and breastfeeding.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, you should consult your doctor or pharmacist before using this medicine.

Animal studies have not shown any effect of moxifloxacin on fertility.

Driving and using machines

Moloxin may cause dizziness and a feeling of fainting, sudden, transient loss of vision, or may cause short-term fainting. If you experience such symptoms, you should not drive vehicles or operate machines.

Moloxin contains sodium

This medicine contains 812 mg of sodium (the main component of table salt) in 250 ml of solution. This corresponds to 40.6% of the maximum recommended daily sodium intake in the diet for adults.

3. How to use Moloxin

Moloxin is always administered by a doctor or medical staff.

The recommended dose for adults is one vial once a day.

Moloxin is intended for intravenous administration. The attending physician should ensure that the medicine is administered in a continuous infusion for at least 60 minutes.

There is no need to modify the dose in elderly patients, those with low body weight, or those with renal impairment.

The attending physician will decide on the duration of Moloxin treatment. In some cases, the doctor may start treatment with Moloxin infusion solution and then continue therapy with Moloxin tablets.

The duration of treatment depends on the type of infection and the patient's response to treatment. The recommended treatment duration is as follows:

• Community-acquired pneumonia: 7 to 14 days

In most patients with pneumonia, treatment was changed to oral moxifloxacin tablets within 4 days.

• Skin and soft tissue infections: 7 to 21 days

In patients with complicated skin and skin structure infections, the mean duration of intravenous treatment was approximately 6 days, and the mean total treatment duration (infusion and then tablets) was 13 days.

It is essential to complete the full treatment cycle, even if you feel better after a few days.

If you stop taking the medicine too early, the infection may not be completely cured, the disease may recur, or your condition may worsen, and bacteria may develop resistance to the antibiotic.

Do not exceed the recommended dose or prolong treatment (see section 2 "Important information before using Moloxin", "Warnings and precautions").

Use in children and adolescents

This medicine should not be used in children and adolescents under 18 years of age, as the efficacy and safety of its use in this age group have not been established (see section "When not to use Moloxin").

Using a higher than recommended dose of Moloxin

If you suspect that you have received too much Moloxin, you should tell your doctor as soon as possible.

Missing a dose of Moloxin

If you suspect that a dose of Moloxin has been missed, you should tell your doctor as soon as possible.

Stopping Moloxin treatment

If the infusion is stopped too early, the infection may not be completely cured. If it is necessary to stop Moloxin infusion solution or tablet treatment early, you should consult your doctor.

If you have any further doubts about using this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

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

The following are the most serious side effectsobserved during moxifloxacin treatment:

• abnormal heart rhythm (rare side effect)
• rapid deterioration of well-being, yellowing of the eyes, dark urine, itching, tendency to bleed, and disorders of thinking or insomnia (may be symptoms of severe liver inflammation that can lead to life-threatening liver failure, including death; very rare side effect)
• severe skin rash, including Stevens-Johnson syndrome and toxic epidermal necrolysis. It may appear as reddish targets or circular spots, often with blisters on the torso, peeling skin, ulcers in the mouth, throat, nose, genitals, and eyes, and may be preceded by fever and flu-like symptoms (very rare side effects, potentially life-threatening)
• red, scaly, generalized rash with bumps under the skin and blisters, which is accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis; frequency of this side effect is unknown)
• widespread rash, high body temperature, elevated liver enzymes, and increased white blood cell count (eosinophilia), as well as swollen lymph nodes (drug reaction with eosinophilia and systemic symptoms; frequency of this side effect is unknown)
• syndrome associated with water retention and low sodium levels (SIADH; very rare side effect)
• loss of consciousness due to significantly decreased blood sugar levels (hypoglycemic coma; very rare side effect)
• vasculitis (which may cause red spots on the skin, usually on the lower legs, or tendon pain; very rare side effect)
• severe, life-threatening allergic reaction, including anaphylactic shock (e.g., difficulty breathing, low blood pressure, rapid heartbeat; rare side effect)
• swelling, including swelling of the airways (rare side effect, potentially life-threatening)
• seizures (rare side effect)
• nervous system problems, such as pain, burning, tingling, numbness, and (or) weakness (rare side effect)
• depression (very rarely leading to self-harm, e.g., suicidal thoughts or attempts; rare side effect)
• psychiatric disorders (which may lead to self-harm, e.g., suicidal thoughts or attempts; very rare side effect)
• severe diarrhea with blood and (or) mucus in the stool (antibiotic-associated colitis, including pseudomembranous colitis), which can very rarely be associated with life-threatening complications (rare side effects)
• tendon pain and swelling (tendinitis) or tendon rupture (very rare side effect)
• weakness, tenderness, or muscle pain, especially if accompanied by malaise, high fever, or dark urine. This may be caused by abnormal muscle tissue breakdown, which can be life-threatening and lead to kidney problems (a condition known as rhabdomyolysis); you should stop taking Moloxin and immediately consult your doctor, as immediate medical attention may be necessary.

In addition, if you experience:

• transient loss of vision (very rare side effect)
• discomfort or eye pain, especially when exposed to light (very rare side effect); you should immediately consult an ophthalmologist.

If you experience a life-threatening irregular heartbeat (torsades de pointes) or cardiac arrest while taking Moloxin (very rare side effect), you should immediately inform your attending doctor that you are taking Moloxin and not resume treatment.

Very rarely, worsening of myasthenia symptoms has been observed. If your myasthenia symptoms worsen, you should immediately consult your doctor.

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

If you are an elderly patient with renal impairment and experience decreased urine output, swelling of the feet, ankles, or abdomen, or feelings of fatigue, nausea, drowsiness, shortness of breath, or confusion (which may be symptoms of renal failure; rare side effect), you should immediately consult your doctor.

Other side effectsobserved during moxifloxacin treatment are presented below, according to their frequency:

Common side effects (may occur in less than 1 in 10 people):

• nausea
• diarrhea
• dizziness
• abdominal pain
• vomiting
• headache
• increased activity of certain liver enzymes (aminotransferases) in the blood
• infections caused by resistant bacteria or fungi, e.g., thrush in the mouth and vagina caused by Candida(candidiasis)
• pain or inflammation at the injection site
• heart rhythm disorders (visible in ECG) in patients with low potassium levels in the blood

Uncommon side effects (may occur in less than 1 in 100 people):

• rash
• gastrointestinal disorders (dyspepsia and heartburn)
• taste disorders (including loss of taste in very rare cases)
• sleep disorders (mainly insomnia)
• increased activity of certain liver enzymes (gamma-glutamyltransferase and (or) alkaline phosphatase) in the blood
• low white blood cell count (leukopenia, neutropenia)
• constipation
• itching
• dizziness (feeling of spinning or rotating)
• drowsiness
• wind
• heart rhythm disorders (visible in ECG)
• liver function disorders, including increased activity of the liver enzyme LDH in the blood
• decreased appetite and food intake
• low white blood cell count
• minor complaints such as back, chest, pelvic, or limb pain
• increased platelet count in the blood
• excessive sweating
• increased eosinophil count in the blood
• anxiety
• malaise (mainly weakness or fatigue)
• tremors
• joint pain
• palpitations
• irregular and rapid heartbeat
• breathing difficulties, including asthma symptoms
• increased activity of the digestive enzyme amylase in the blood
• anxiety, especially motor anxiety, or agitation
• tingling or (and) numbness
• hives
• vasodilation
• confusion and disorientation
• decreased platelet count in the blood
• vision disorders, including double or blurred vision
• decreased blood clotting
• increased blood lipid levels
• low red blood cell count (anemia)
• muscle pain
• allergic reaction
• increased bilirubin levels in the blood
• phlebitis
• gastritis
• dehydration
• severe heart rhythm disorders
• dry skin
• angina pectoris

Rare side effects (may occur in less than 1 in 1000 people):

• muscle tremors
• muscle cramps
• hallucinations
• high blood pressure
• swelling (of hands, feet, ankles, lips, mouth, or throat)
• low blood pressure
• kidney function disorders, including increased values of kidney function tests such as urea and creatinine
• hepatitis
• stomatitis
• ringing or noise in the ears (tinnitus)
• jaundice (yellowing of the eyes and skin)
• skin sensation disorders
• unusual dreams
• concentration disorders
• swallowing difficulties
• smell disorders, including loss of smell
• balance and coordination disorders (due to dizziness)
• partial or complete memory loss
• hearing disorders, including deafness (usually transient)
• increased uric acid levels in the blood
• emotional instability
• speech disorders
• fainting
• muscle weakness

Very rare side effects (may occur in less than 1 in 10,000 people):

• arthritis
• heart rhythm disorders
• increased skin sensitivity
• depersonalization (feeling of loss of one's identity)
• increased blood clotting
• muscle stiffness
• significant decrease in a specific type of white blood cell (agranulocytosis)
• decrease in red and white blood cell and platelet count (pancytopenia)

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

• Increased sensitivity of the skin to sunlight or UV radiation (see also section 2, Warnings and precautions).
• Acute, limited, reddish spots with blisters or without blisters, which appear within a few hours after moxifloxacin administration and heal with post-inflammatory hyperpigmentation; they usually recur in the same area of skin or mucous membrane after re-exposure to moxifloxacin.

Symptoms that were more frequently observed in patients receiving moxifloxacin intravenously:

Common:

• increased activity of the liver enzyme gamma-glutamyltransferase in the blood

Uncommon:

• abnormal heart rhythm
• hallucinations
• low blood pressure
• kidney function disorders, including increased values of kidney function tests such as urea and creatinine
• swelling (of hands, feet, ankles, lips, mouth, or throat)
• seizures

The use of quinolone and fluoroquinolone antibiotics, in some cases regardless of existing risk factors, has very rarely caused long-term (lasting for months or years) or permanent side effects, such as tendon inflammation, tendon rupture, joint pain, limb pain, difficulty walking, abnormal sensations such as tingling, burning, itching, numbness, or burning, neuropathy, fatigue, memory and concentration disorders, and effects on mental health (which may include sleep disorders, anxiety, panic attacks, depression, suicidal thoughts or behaviors). In patients treated with fluoroquinolones, cases of aortic aneurysm and aortic dissection have been reported, which can be fatal, as well as cases of heart valve regurgitation. See also section 2.

Additionally, the following side effects have been very rarely reported during treatment with other quinolone antibiotics, which may also occur during Moloxin treatment:

• increased intracranial pressure (symptoms include headache, vision problems, including blurred vision, "blind" spots, double vision, loss of vision)
• increased sodium levels in the blood
• increased calcium levels in the blood
• increased breakdown of red blood cells (hemolytic anemia)

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:

Al. Jerozolimskie 181C, 02-222 Warsaw

Tel.: +48 22 49 21 301

Fax: +48 22 49 21 309

Website: https://smz.ezdrowie.gov.pl

Side effects can also be reported to the marketing authorization holder.

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

5. How to store Moloxin

The medicine should be stored out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month.

The batch number is stated on the packaging after "Lot".

There are no special precautions for storage.

Use immediately after opening.

The medicine is for single use only. Unused solution should be disposed of in accordance with local regulations.

Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Moloxin contains

• The active substance of the medicine is moxifloxacin. 1 ml of the solution for infusion contains moxifloxacin hydrochloride equivalent to 1.6 mg of moxifloxacin. Each 250 ml vial contains moxifloxacin hydrochloride equivalent to 400 mg of moxifloxacin.
• The other ingredients are: sodium chloride, sodium lactate (solution), and water for injections. See section 2 "Moloxin contains sodium".

What Moloxin looks like and contents of the pack

Clear, pale yellow-green solution, practically free from particles.

pH: 5.5-6.5

Osmolality: 250-300 mosmol/kg

Each vial contains 250 ml of solution for infusion.

Packaging:1, 5, and 10 vials closed with a rubber stopper and an aluminum cap and a plastic tear-off cap, in a cardboard box.

Not all pack sizes may be marketed.

Marketing authorization holder

KRKA, d. d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer

KRKA, d. d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

TAD Pharma GmbH Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

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

To obtain more detailed information, you should contact the representative of the marketing authorization holder:

KRKA-POLSKA Sp. z o.o.

ul. Równoległa 5

02-235 Warsaw

Tel. 22 57 37 500

Date of last revision of the leaflet:06.02.2025

Information intended for healthcare professionals only:

Moloxin, 400 mg/250 ml, solution for infusion

Moxifloxacin

Moloxin can be administered through a "T" connector with the following solutions:

• water for injections
• 9 mg/ml (0.9%) sodium chloride solution
• 1 mol/ml (1 molar) sodium chloride solution
• 50 mg/ml, 100 mg/ml, 400 mg/ml (5%/10%/40%) glucose solution
• 200 mg/ml (20%) xylitol solution
• Ringer's solution
• lactated Ringer's solution (Hartmann's solution, Ringer's solution with lactate)

Moloxin should not be administered with other medicines.

The following solutions are incompatible with Moloxin:

• 100 mg/ml (10%) and 200 mg/ml (20%) sodium chloride solution
• 42 mg/ml (4.2%) and 84 mg/ml (8.4%) sodium bicarbonate solution