Moloxin

Package leaflet: Information for the user

Moloxin, 400 mg/250 ml, infusion solution
moxifloxacinum
Please read all of this leaflet carefully before using this medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

1. What Moloxin is and what it is 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 package and other information

1. What Moloxin is and what it is used for

Moloxin contains the active substance moxifloxacin, which belongs to a group of antibiotics called fluoroquinolones. Moloxin acts bactericidally against bacteria causing infections, provided the bacteria are susceptible to moxifloxacin.
Moloxin is used in adults for the treatment of 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 any doubts whether they belong to any of the groups described below, they should contact
their doctor.
When not to use Moloxin

• if the patient is allergic to moxifloxacin, other antibiotics from the quinolone group, 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 previously experienced tendon problems associated with treatment with other quinolone antibiotics (see section "Warnings and precautions" and section 4 "Possible side effects");
• if the patient has congenital or acquired conditions involving abnormal heart rhythm (visible on ECG – electrocardiogram);
• if the patient has electrolyte imbalance (especially low blood potassium or magnesium levels);
• if the patient has very slow heart rate (bradycardia);
• if the patient has impaired heart function (heart failure);
• if the patient has previously been diagnosed with heart rhythm disorders (arrhythmias);
• if the patient is taking medicines that may cause abnormal changes in the ECG (see section "Moloxin with other medicines"); Moloxin may cause changes in the ECG known as QT interval prolongation, which means delayed electrical signal conduction in the heart;
• if the patient has severe liver disease or liver enzyme (aminotransferase) activity exceeding five times the upper limit of normal.

Warnings and precautions
Before taking this medicine
Do not take antibacterial medicines containing fluoroquinolones or quinolones,
including Moloxin, if the patient has previously experienced any severe adverse
reaction while taking a quinolone or fluoroquinolone. In such a case, inform the doctor
as soon as possible.
Before starting treatment with Moloxin, discuss this with the doctor, pharmacist, or
nurse.

• Moloxin may alter the heart's ECG, especially in women and elderly patients. If the patient is currently taking medicines that reduce blood potassium levels, they should consult their doctor before starting Moloxin (see also section "When not to use Moloxin" and "Moloxin with other medicines").
• If the patient has been diagnosed with enlargement of a large blood vessel (aortic aneurysm or large peripheral artery).
• If the patient has previously experienced aortic dissection (tearing of the aortic wall).
• If the patient has been diagnosed with heart valve insufficiency.
• If there is a family history of aortic aneurysm or aortic dissection, congenital heart valve disease, or other risk factors or predisposing conditions (e.g. connective tissue disorders such as Marfan syndrome, Ehlers-Danlos syndrome, Turner syndrome, Sjögren's syndrome (an autoimmune inflammatory disease), or blood vessel diseases such as Takayasu arteritis, giant cell arteritis, Behçet's disease, hypertension, confirmed atherosclerosis, rheumatoid arthritis (joint disease), or endocarditis).
• In case of epilepsy or conditions that may cause seizures, consult the doctor before starting Moloxin.
• If the patient has or has ever had mental health problems, consult the doctor before starting Moloxin.
• If the patient suffers from myasthenia gravis (a type of muscle weakness, which in severe cases may lead to paralysis), taking Moloxin may worsen symptoms. If this occurs, consult the doctor immediately.
• If the patient or someone in their family has glucose-6-phosphate dehydrogenase deficiency (a rare inherited disorder), inform the doctor, who will assess whether Moloxin is appropriate for the patient.
• Moloxin must be administered intravenously only; it must not be administered intra-arterially. If the patient has diabetes, blood glucose levels should be monitored carefully, as changes in blood sugar levels may occur during moxifloxacin treatment.
• If the patient has ever experienced severe skin rash, skin peeling, blistering, and/or oral ulceration after taking moxifloxacin.

While using Moloxin

• If palpitations or irregular heartbeat occur during treatment, inform the doctor immediately. The doctor may recommend an ECG to check heart rhythm.

• Risk of heart function disturbances may increase with higher doses and faster intravenous infusion rates.

• There is a small risk of severe, sudden allergic reaction (anaphylactic reaction or anaphylactic shock) even after the first dose, with symptoms such as: chest tightness, dizziness, nausea or fainting, and a spinning sensation when
  standing up. If these occur, stop administering Moloxin
  as an infusion solution immediately.

• Moloxin may cause rapid and severe liver inflammation, which may lead to life-threatening liver failure (including death; see section 4 "Possible side effects"). If symptoms such as: rapid worsening

• of general well-being, yellowing of the whites of the eyes, dark urine,

• skin itching,

• tendency to bleed, or disturbances in thinking or insomnia occur, contact the doctor before taking the next dose.

• Quinolone antibiotics, including Moloxin, may cause seizures. If seizures occur, stop using Moloxin immediately.

• Long-lasting, disabling, and potentially irreversible serious adverse effects.

• Antibacterial medicines containing fluoroquinolones or quinolones, including Moloxin, have been associated with very rare but serious adverse effects. Some of these were long-lasting (persisting for months or years), disabling, or potentially irreversible. These include: tendon, muscle, and joint pain in the upper and lower limbs, difficulty walking, abnormal sensations such as pricking, tingling, tickling, numbness, or burning (paresthesias), sensory disturbances, including vision, taste, smell, and hearing, depression, memory disturbances, severe fatigue, and severe sleep disturbances. If any of these adverse effects occur after taking Moloxin, contact the doctor immediately before continuing treatment. The patient and doctor will decide whether to continue treatment, possibly considering antibiotics from another group.

• The patient may rarely experience symptoms of nerve damage (neuropathy) such as: pain, burning, tingling, numbness, and/or weakness, especially in the feet and legs, and hands and arms. In such a case, stop taking Moloxin and inform the doctor immediately to prevent progression to potentially irreversible disease.

• Psychiatric problems may occur, even during first use of quinolone antibiotics, including Moloxin. In very rare cases, depression or psychiatric problems may lead to suicidal thoughts and self-harming behaviors, such as suicide attempts (see section 4 "Possible side effects"). If such reactions occur, stop using Moloxin immediately.

• Diarrhea may occur during or after treatment with antibiotics, including Moloxin. If it worsens or persists for a long time, or if blood or mucus is seen in the stool, stop using Moloxin immediately and consult the doctor. In such cases, do not use medicines that stop or slow intestinal motility (peristalsis).

• Rarely, joint pain and swelling, inflammation, or rupture of tendons may occur. The risk is increased in elderly patients (over 60 years), after organ transplantation, in patients with kidney problems, or those receiving corticosteroid treatment. Tendon inflammation and rupture may occur within the first 48 hours of treatment or even several months after stopping Moloxin. If the first symptoms of tendon pain or inflammation occur (e.g. in the ankle, wrist, elbow, shoulder, or knee), stop taking Moloxin, contact the doctor, and rest the affected area. Avoid excessive physical effort, as this 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 indicate aortic aneurysm or dissection, seek emergency medical help immediately. The risk of these events may be higher in patients receiving systemic corticosteroids.

• If sudden shortness of breath occurs, especially when lying down, or if ankle, foot, or abdominal swelling or palpitations (sensation of rapid or irregular heartbeat) are observed, seek medical advice immediately.

• Elderly patients with kidney function disorders should drink adequate fluids, as dehydration may increase the risk of kidney failure.

• If vision worsens or other visual disturbances occur during Moloxin treatment, seek immediate advice from an ophthalmologist (see section 2 "Driving and operating machinery" and section 4 "Possible side effects").

• Fluoroquinolone antibiotics may cause increased blood glucose levels above normal (hyperglycemia) or decreased blood glucose levels below normal (hypoglycemia), which may potentially lead to loss of consciousness (hypoglycemic coma) in severe cases (see section 4 "Possible side effects"). In diabetic patients, blood glucose levels should be carefully monitored.

• Quinolone antibiotics may increase skin sensitivity to sunlight or UV radiation. During Moloxin treatment, avoid prolonged sun exposure, strong sunlight, and using tanning beds or other UV radiation sources (see section 4 "Possible side effects").

• Experience with sequential therapy (intravenous followed by oral) using Moloxin in the treatment of community-acquired pneumonia is limited.

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

Severe skin reactions
Severe skin reactions have been reported during moxifloxacin treatment, 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 present as reddish, target-like spots or circular lesions, often with blisters on the trunk. Oral, throat, nasal, genital, and ocular ulcers (red, swollen eyes) may also occur. The onset of such severe skin rashes is often preceded by fever and/or flu-like symptoms. These rashes may progress to widespread skin peeling and life-threatening complications or even death.
• AGEP rash typically appears early in treatment as a red, peeling, generalized rash with subcutaneous nodules and blisters, accompanied by fever. Most commonly affected areas: skin folds, trunk, and upper limbs.
• DRESS initially presents with flu-like symptoms and facial rash, followed by widespread rash with high fever. Blood tests show increased liver enzyme activity, elevated white blood cell count (eosinophilia), and enlarged lymph nodes. If severe rash or any of these skin symptoms occur, discontinue moxifloxacin and contact the doctor or seek immediate medical help.

Children and adolescents
Moloxin must not be used in children and adolescents under 18 years of age, as efficacy and safety have not been established in this age group (see section "When not to use Moloxin").
Moloxin with other medicines
Inform the doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take.
When using Moloxin, be aware that:

• The risk of heart rhythm disturbances increases when Moloxin is used with other medicines affecting heart function. Therefore, do not use Moloxin concurrently with the following medicines: drugs belonging to the antiarrhythmic group (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), antipsychotics (e.g. phenothiazines, pimozide, sertindole, haloperidol, sulpiride), tricyclic antidepressants, certain antimicrobial agents (e.g. saquinavir, sparfloxacin, intravenous erythromycin, pentamidine, antimalarials, particularly halofantrine), certain antihistamines (e.g.
  terfenadine, astemizole, mizolastine), and other drugs (e.g. cisapride, intravenous vinpocetine,
  bepridil, and difemanil).

• Inform the doctor if taking medicines that may reduce blood potassium levels [e.g. certain diuretics, certain laxatives and large-volume enemas, or corticosteroids (anti-inflammatory drugs), amphotericin B] or slow heart rate, as this may increase the risk of severe heart rhythm disturbances during Moloxin treatment.

• If oral anticoagulants (e.g. warfarin) are taken simultaneously, the doctor may order blood clotting time tests.

Moloxin with food and drink
Food, including dairy products, does not affect the action of Moloxin.
Pregnancy, breastfeeding, and effects on fertility
Do not use Moloxin during pregnancy or breastfeeding.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before using this medicine.
Animal studies did not show any effect of moxifloxacin on fertility.
Driving and operating machinery
Moloxin may cause dizziness, lightheadedness, sudden transient loss of vision, or brief fainting. If such symptoms occur, do not drive or operate machinery.
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 adult diet.

3. How to use Moloxin

Moloxin is always administered by a doctor or medical staff.
The recommended dose for adults is one vial once daily.
Moloxin is intended for intravenous administration. The treating physician should ensure that
the medicine is administered as a continuous infusion over at least 60 minutes.
There is no need to adjust the dose in elderly patients, patients with low body weight, or
patients with renal impairment.
The treating physician will decide on the duration of treatment with Moloxin. In some
cases, the physician may initiate treatment with Moloxin as an infusion solution,
followed by continuation of therapy with Moloxin tablets.
The duration of treatment depends on the type of infection and the patient's response to therapy. The
recommended treatment durations are listed below:

• Community-acquired pneumonia (lung infection): 7 to 14 days

In most patients with pneumonia, treatment was switched 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 duration of treatment (infusion followed by tablets) was 13 days.
It is important to complete the full course of treatment, even if the patient feels better after a few days.
Premature discontinuation of the medicine may result in the infection not being completely
eradicated, possible relapse or worsening of symptoms, and may also lead to the development of bacterial resistance to antibiotics.
Do not exceed the recommended dose or prolong the treatment duration (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 efficacy and safety have not been established in this age group (see section "When not to use Moloxin").
Use of a higher than recommended dose of Moloxin
If the patient suspects that an excessive dose of Moloxin has been administered, they should inform the doctor immediately.
Missed dose of Moloxin
If the patient suspects that a dose of Moloxin has been missed, they should inform the doctor as soon as possible.
Discontinuation of Moloxin treatment
If treatment is stopped too early, the infection may not be completely cured. If early discontinuation of Moloxin infusion solution or tablets is necessary, consult the physician.
If there are any further doubts regarding the use of this medicine, consult the doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Below are the most serious adverse reactions observed during treatment with moxifloxacin.
If any of the following adverse reactions occur:

• abnormally rapid heartbeat (uncommon adverse reaction),
• sudden worsening of general condition, yellowing of the whites of the eyes, dark urine, itching of the skin, tendency to bleed, and disturbances in thinking or insomnia [these may be signs and symptoms of fulminant hepatitis which can lead to life-threatening liver failure, including fatal outcome (very rare adverse reaction)],
• severe skin rash, including Stevens-Johnson syndrome and toxic epidermal necrolysis. This may present as reddish target-like patches or circular patches, often with blisters on the trunk, peeling skin, ulceration in the mouth, throat, nose, genital organs and eyes, and may be preceded by fever and flu-like symptoms (very rare adverse reactions, potentially life-threatening),
• red, peeling generalized rash with subcutaneous nodules and blisters, initially accompanied by fever during treatment (acute generalized exanthematous pustulosis) (frequency of this adverse reaction: "frequency not known" – frequency cannot be estimated from the available data),
• widespread rash, high fever, increased liver enzyme activity, blood test abnormalities (eosinophilia), swollen lymph nodes and involvement of other organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome) (frequency of this adverse reaction: "frequency not known"),
• syndrome related to impaired water excretion and low sodium levels (SIADH) (very rare adverse reaction),
• loss of consciousness due to significantly low blood sugar levels (hypoglycemic coma) (very rare adverse reaction),
• inflammation of blood vessels (symptoms may include red spots on the skin, usually on the lower legs, or tendon pain) (very rare adverse reaction),
• severe, rapidly generalized allergic reaction, including very rarely life-threatening anaphylactic shock (e.g. breathing difficulties, drop in blood pressure, rapid pulse) (uncommon adverse reaction),
• swelling, including swelling of the airways (uncommon adverse reaction, potentially life-threatening),
• seizures (uncommon adverse reaction),
• nervous system-related problems such as pain, burning sensation, tingling, numbness, and (or) weakness of limbs (uncommon adverse reaction),
• depression (very rarely leading to self-harm, e.g. hallucinations or suicidal thoughts or suicide attempts) (uncommon adverse reaction),
• psychiatric disturbances (possibly leading to self-harm, e.g. hallucinations or suicidal thoughts or suicide attempts) (very rare adverse reaction),
• severe diarrhea with blood and (or) mucus in stool (antibiotic-associated colitis, including pseudomembranous colitis), which very rarely may lead to life-threatening complications (uncommon adverse reactions),
• tendon pain and swelling (tendinitis) (uncommon adverse reaction) or tendon rupture (very rare adverse reaction),
• muscle weakness, tenderness or pain, especially if accompanied by general malaise, high fever or dark urine. This may be due to abnormal breakdown of muscle tissue, which can be life-threatening and lead to kidney problems (a condition known as rhabdomyolysis) (frequency of this adverse reaction: "frequency not known"), you should stop taking Moloxin immediately and contact your doctor without delay, as immediate medical attention may be required.

Additionally, if any of the following occur:

• transient loss of vision (very rare adverse reaction),
• discomfort or eye pain, particularly when exposed to light (very rare adverse reaction), you should contact an ophthalmologist immediately.

If the patient experiences life-threatening irregular heartbeat (torsade de pointes) or cardiac arrest while taking Moloxin (very rare adverse reaction), you should immediately inform the treating physician that the patient is taking Moloxin and must not restart treatment.
Exacerbation of myasthenia symptoms has been very rarely observed. If myasthenia symptoms worsen in a patient, immediate medical consultation is required.
If blood glucose levels increase or decrease in a diabetic patient (uncommon or very rare adverse reaction), you should immediately inform the doctor.
If an elderly patient with impaired kidney function develops reduced urine volume, swelling of hands, ankles or feet, fatigue, nausea, drowsiness, shortness of breath or confusion (these may be signs and symptoms of kidney failure; uncommon adverse reaction), immediate medical consultation is required.
Other adverse reactions observed during moxifloxacin treatment are listed below, categorized by frequency of occurrence:

Common adverse reactions (may occur in less than 1 in 10 people):

• nausea
• diarrhea
• dizziness
• stomach and abdominal pain
• vomiting
• headache
• increased blood levels of certain liver enzymes (aminotransferases)
• infections caused by resistant bacteria or fungi, e.g. oral and vaginal candidiasis due to Candida (candidiasis)
• pain or inflammation at the injection site
• heart rhythm disturbances (visible on ECG) in patients with low blood potassium levels

Uncommon adverse reactions (may occur in less than 1 in 100 people):

• rash
• gastrointestinal disturbances (dyspepsia and heartburn)
• taste disturbances (in very rare cases, loss of taste)
• sleep disturbances (mainly insomnia)
• increased blood levels of certain liver enzymes: gamma-glutamyltransferase and (or) alkaline phosphatase
• low levels of certain white blood cells (leukocytes, neutrophils)
• constipation
• itching
• dizziness (sensation of spinning or falling)
• somnolence
• flatulence
• heart rhythm disturbances (visible on ECG)
• liver function disorders, including increased blood levels of liver enzyme (LDH)
• decreased appetite and food intake
• low white blood cell count
• minor complaints such as back, chest, pelvic or limb pain
• increased platelet count, essential for blood clotting
• excessive sweating
• increased number of certain white blood cells (eosinophils)
• restlessness
• malaise (mainly weakness or fatigue)
• tremor
• joint pain
• palpitations
• irregular and rapid heartbeat
• breathing difficulties, including asthma-like symptoms
• increased blood levels of a digestive enzyme called amylase
• restlessness, especially motor restlessness, or agitation
• tingling and (or) numbness
• urticaria
• blood vessel dilation
• confusion and disorientation
• decreased platelet count essential for blood clotting
• vision disturbances, including double or blurred vision
• reduced blood coagulation
• increased blood lipid levels
• low red blood cell count (anemia)
• muscle pain
• allergic reaction
• increased blood bilirubin levels
• phlebitis (vein inflammation)
• gastritis (inflammation of the stomach mucosa)
• dehydration
• severe heart rhythm disturbances
• dry skin
• angina pectoris

Rare adverse reactions (may occur in less than 1 in 1,000 people):

• muscle twitching
• muscle cramps
• hallucinations
• high blood pressure
• swelling (hands, feet, ankles, lips, mouth or throat)
• low blood pressure
• kidney function disorders, including increased diagnostic test values for kidney function such as urea and creatinine levels
• hepatitis (liver inflammation)
• inflammation of the oral mucosa
• ringing or noise in the ears (tinnitus)
• jaundice (yellowing of the whites of the eyes and skin)
• skin sensation disturbances
• unusual dreams
• difficulty concentrating
• difficulty swallowing
• smell disturbances, including loss of smell
• balance disturbances and poor motor coordination (due to dizziness)
• partial or complete memory loss
• hearing disturbances, including deafness (usually transient)
• increased blood uric acid levels
• emotional lability
• speech disturbances
• fainting
• muscle weakness

Very rare adverse reactions (may occur in less than 1 in 10,000 people):

• arthritis (joint inflammation)
• heart rhythm disturbances
• increased skin sensitivity
• depersonalization (feeling of loss of self-identity)
• increased blood coagulation
• muscle stiffness
• severe decrease in a specific type of white blood cells (agranulocytosis)
• decreased number of red and white blood cells and platelets (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, well-demarcated, erythematous patches with or without blisters, appearing within hours after moxifloxacin administration and healing with post-inflammatory hyperpigmentation; these usually recur in the same area of skin or mucosa upon subsequent exposure to moxifloxacin.

Symptoms more frequently observed in patients receiving intravenous moxifloxacin:
Common:

• increased blood levels of liver enzymes (gamma-glutamyltransferase)

Uncommon:

• abnormally rapid heart rate
• hallucinations
• low blood pressure
• kidney function disorders, including increased diagnostic test values for kidney function such as urea and creatinine levels
• swelling (hands, feet, ankles, lips, mouth, throat)
• seizures

Administration of quinolone and fluoroquinolone antibiotics, in some cases regardless of pre-existing risk factors, has very rarely led to long-term (lasting for months or years) or permanent adverse reactions such as tendinitis, tendon rupture, joint pain, limb pain, difficulty walking, abnormal sensations such as pricking, tingling, tickling, burning, numbness or pain (neuropathy), fatigue, memory and concentration problems, mental health effects (which may include: sleep disturbances, anxiety, panic attacks, depression, suicidal ideation), and disturbances in hearing, vision, taste and smell.

In patients receiving fluoroquinolones, cases of aortic aneurysm and dissection (dilation and weakening or rupture of the aortic wall) have been reported, which may result in rupture and lead to death, as well as cases of heart valve regurgitation. See also section 2.

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

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

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Moloxin

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after the abbreviation
"EXP". The expiry date refers to the last day of the specified month.
The batch number is indicated on the packaging after the abbreviation "Lot".
No special storage instructions apply.
Use immediately after first opening.
This medicine is for single use only. Any unused solution must be disposed of according to local
regulations.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. Such measures help protect the
environment.

6. Contents of the pack and other information

What Moloxin contains

• The active substance is moxifloxacin. 1 ml of infusion solution contains moxifloxacin hydrochloride equivalent to 1.6 mg of moxifloxacin. Each 250 ml bottle of infusion solution contains moxifloxacin hydrochloride equivalent to 400 mg of moxifloxacin.
• The other ingredients (excipients) 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
A clear, slightly yellowish-green solution, practically free from visible particles.
pH: 5.5–6.5
Osmolality: 250–300 mosmol/kg
Each bottle contains 250 ml of infusion solution.
Packaging: 1, 5 and 10 bottles closed with a rubber stopper and an aluminium cap with a "tear-off" plastic overcap, packed in a cardboard box.
Not all pack sizes may be marketed.
Marketing Authorisation 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 authorised in the European Economic Area countries under the following names:

For more detailed information, contact the representative of the marketing authorization holder:
KRKA-POLSKA Sp. z o.o.
Równoległa 5 Street
02-235 Warsaw
Tel. 22 57 37 500

Information intended exclusively for medical professionals:
Moloxin, 400 mg/250 ml, infusion solution
Moxifloxacinum

Moloxin may be administered via a T-tube together 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,
• Compound sodium lactate solution (Hartmann's solution, Ringer's lactate solution).

Moloxin should not be administered simultaneously with other medicinal products.

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.