Moxifloxacin kabi

Patient Information Leaflet

Moxifloxacin Kabi, 400 mg/250 ml, infusion solution
Moxifloxacinum
Please read all of this leaflet carefully before using this medicine, as it contains
important information for you.
­ Keep this leaflet, you may need to read it again.
­ If you have any further questions, please ask your doctor or pharmacist.
­ If you get any side effects, including any not listed in this leaflet, tell your doctor or pharmacist.
See section 4.
Contents of the leaflet

1. What Moxifloxacin Kabi is and what it is used for
2. What you need to know before using Moxifloxacin Kabi
3. How to use Moxifloxacin Kabi
4. Possible side effects
5. How to store Moxifloxacin Kabi
6. Contents of the pack and other information

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

Moxifloxacin Kabi contains the active substance - moxifloxacin, which belongs to a group of
antibiotics called fluoroquinolones. Moxifloxacin Kabi acts bactericidally against bacteria
causing infections, provided these bacteria are susceptible to moxifloxacin.
Moxifloxacin Kabi is used in adult patients for the treatment of the following bacterial
infections:
­ lung infection (pneumonia) acquired outside the hospital;
­ skin and soft tissue infections.
Moxifloxacin Kabi is used to treat the above infections only when commonly used antibiotics
cannot be used or are ineffective.

2. Important information before using Moxifloxacin Kabi

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 Moxifloxacin Kabi
­ 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 or breastfeeding.
­ In patients under 18 years of age.
­ If the patient has previously experienced tendon disease or tendon function disorders
related to treatment with quinolone antibiotics (see sections Warnings and precautions and 4. Possible
side effects).
­ If the patient has a congenital or acquired abnormal heart rhythm (visible on ECG –
electrocardiogram, a test measuring the heart's electrical activity).
­ If the patient has electrolyte imbalance (especially low blood potassium or magnesium levels).
­ If the patient has: very slow heart rate (called "bradycardia"), weak heart
(heart failure), previously diagnosed heart rhythm disorders, or if the patient is
taking medications causing atypical changes in the ECG recording (see section Moxifloxacin
Kabi and other medicines). Moxifloxacin Kabi may cause changes in the ECG, known
as QT interval prolongation, which means delayed electrical conduction
in the heart.
­ If the patient has severe liver disease or liver enzyme activity
(aminotransferases) exceeds five times the upper limit of normal.
Warnings and precautions
Before taking this medicine
Do not take antibacterial medicines containing fluoroquinolones or quinolones,
including Moxifloxacin Kabi, 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 Moxifloxacin Kabi, discuss this with your doctor or pharmacist.
It is important that the patient knows the following before starting treatment:
­ Moxifloxacin Kabi may alter the heart's ECG, especially in women and elderly patients;
­ if the patient is also taking medicines that lower blood potassium levels, consult the doctor
before starting Moxifloxacin Kabi (see also sections When not to use Moxifloxacin Kabi and
Moxifloxacin Kabi and other medicines);
­ if the patient has diabetes, consult the doctor before starting Moxifloxacin Kabi, as there is a risk
of blood sugar level changes during moxifloxacin treatment;
­ if the patient has ever experienced severe skin rash or skin peeling, blisters and (or) oral ulcers
after taking moxifloxacin, consult the doctor before starting Moxifloxacin Kabi;
­ if the patient has epilepsy or conditions that may cause seizures, inform the doctor
before starting Moxifloxacin Kabi;
­ if the patient has or has ever had mental health problems, consult the doctor before starting
Moxifloxacin Kabi;
­ if the patient has myasthenia gravis (a rare disease causing muscle weakness), using
Moxifloxacin Kabi may worsen symptoms; if this occurs, consult the doctor immediately;
­ if the patient has been diagnosed with aortic or large peripheral artery dilation (aneurysm),
consult the doctor;
­ if the patient has previously experienced aortic dissection (tearing of the aortic wall),
consult the doctor;
­ if the patient has been diagnosed with heart valve insufficiency, consult the doctor;
­ 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 vascular diseases such as Takayasu arteritis, giant cell arteritis,
Behçet's disease, hypertension, confirmed atherosclerosis, rheumatoid arthritis [joint disease],
or endocarditis [heart infection]), consult the doctor;
­ if the patient or anyone in their family has glucose-6-phosphate dehydrogenase deficiency
(a rare inherited disorder), inform the doctor, who will assess whether Moxifloxacin Kabi is
appropriate;
­ Moxifloxacin Kabi must be administered intravenously (into a vein) only and must not be given
intra-arterially.
Circumstances requiring immediate discontinuation of Moxifloxacin Kabi
­ There is a small risk of severe, sudden allergic reaction (anaphylactic reaction or
anaphylactic shock), even after the first dose. Inform the doctor if the patient experiences
symptoms such as: chest tightness, dizziness, nausea or fainting, or a spinning sensation
when standing up.
­ Moxifloxacin Kabi may cause severe, rapidly progressing liver inflammation,
which may lead to life-threatening liver failure (including fatal outcomes, see section 4. Possible
side effects). If the patient experiences symptoms such as: sudden worsening of general condition,
yellowing of the whites of the eyes, dark urine, itchy skin, tendency to bleed, or disturbances
in thinking or insomnia, contact the doctor before taking the next dose.
­ Antibiotics from the quinolone group, including Moxifloxacin Kabi, may cause seizures.
If seizures occur, discontinue Moxifloxacin Kabi immediately.
­ Mental health problems may occur, even after the first dose of a quinolone antibiotic,
including Moxifloxacin Kabi. Very rarely, depression or mental health problems may lead to
suicidal thoughts and self-harming behaviors, including suicide attempts (see section 4. Possible
side effects). If such reactions occur, discontinue Moxifloxacin Kabi immediately.
­ Rarely, pain and swelling of joints and tendon inflammation or tendon rupture 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 and even several months after
stopping Moxifloxacin Kabi. If the first symptoms of tendon pain or inflammation occur
(e.g. in the ankle, wrist, elbow, shoulder, or knee), discontinue Moxifloxacin Kabi, contact the doctor,
and rest the affected area. Avoid excessive physical strain, as this may increase the risk of tendon rupture
(see sections When not to use Moxifloxacin Kabi and 4. Possible side effects).
Symptoms requiring immediate medical attention during treatment with Moxifloxacin Kabi
­ Palpitations or irregular heartbeat occurring during treatment. The doctor may order
an ECG to check heart rhythm.
­ 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 appear as reddish, target-like spots or circular lesions, often with blisters
on the trunk. Oral, throat, nasal, genital, and eye ulcers may also occur
(red, swollen eyes). Such severe rashes are often preceded by fever and (or) flu-like symptoms.
Severe rashes may progress to widespread skin peeling and life-threatening complications or death.
­ AGEP rash appears early in treatment as a red, peeling, generalized rash with subcutaneous
pustules and blisters, accompanied by fever. Most common sites: skin folds, trunk, and upper limbs.
­ In DRESS syndrome, flu-like symptoms and facial rash appear initially, followed by widespread
rash with high fever, increased liver enzyme activity and elevated white blood cell count
(eosinophilia) in blood tests, 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.
­ The patient may rarely experience symptoms of nerve damage (neuropathy), such as pain,
burning, tingling, numbness, and (or) weakness, especially in feet and legs, and hands and arms.
In such cases, discontinue Moxifloxacin Kabi and contact the doctor immediately to prevent
potentially irreversible disease progression.
­ Diarrhea occurring during or after antibiotic treatment, including Moxifloxacin Kabi.
If it worsens or persists, or if blood or mucus is present in the stool, discontinue Moxifloxacin Kabi
immediately and consult the doctor. In such cases, do not use medications that stop or slow
intestinal motility (peristalsis).
­ 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 such events may be higher
in patients receiving systemic corticosteroids.
­ If sudden shortness of breath occurs, especially when lying down, or if swelling of ankles, feet,
or abdomen, or palpitations (feeling of rapid or irregular heartbeat) are observed, seek medical
attention immediately.
­ Worsening of vision or any visual disturbances. If any of these symptoms occur during
Moxifloxacin Kabi treatment, consult an ophthalmologist immediately (see sections Driving and
operating machinery and 4. Possible side effects).
­ Fluoroquinolone antibiotics may cause increased blood sugar levels above normal (hyperglycemia)
or decreased blood sugar levels below normal (hypoglycemia), which may eventually 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.
While using Moxifloxacin Kabi, the patient should know that:
­ Risk of heart problems may increase with higher doses and faster intravenous infusion rates;
­ elderly patients with kidney problems should drink adequate fluids, as dehydration may
increase the risk of kidney failure;
­ quinolone antibiotics may increase skin sensitivity to sunlight and UV radiation;
during Moxifloxacin Kabi treatment, avoid prolonged sun exposure, intense sunlight, and using
tanning beds or other UV sources (see section 4. Possible side effects);
­ limited experience exists with sequential therapy (intravenous followed by oral) using
Moxifloxacin Kabi in the treatment of community-acquired pneumonia;
­ the effectiveness of Moxifloxacin Kabi has not been established in treating severe burns,
deep tissue infections, or diabetic foot infections with osteomyelitis (bone marrow infection).
Long-term, disabling, and potentially irreversible serious side effects
Antibacterial medicines containing fluoroquinolones/quinolones, including Moxifloxacin Kabi, have been
associated with very rare but serious adverse reactions. Some of these were long-term (lasting months or years),
disabling, or potentially irreversible. These include: tendon, muscle, and joint pain in upper and lower limbs,
difficulty walking, abnormal sensations such as pricking, tingling, tickling, numbness, or burning (paresthesia),
sensory disturbances including vision, taste, smell, and hearing, depression, memory disturbances, severe fatigue,
and severe sleep disorders.
If any of these adverse reactions occur after taking Moxifloxacin Kabi, contact the doctor immediately before
continuing treatment. The patient and doctor will decide whether to continue treatment, considering also
antibiotics from other classes.
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 Moxifloxacin Kabi).
Moxifloxacin Kabi and other medicines
Inform the doctor or pharmacist about all medicines currently or recently used, as well as any medicines
the patient plans to use.
What to know when using Moxifloxacin Kabi with other medicines
The risk of heart rhythm disorders increases when Moxifloxacin Kabi is used with other medicines
affecting heart function. Therefore, do not use Moxifloxacin Kabi simultaneously with the following medicines:
­ antiarrhythmic drugs (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide);
­ antipsychotics (e.g. phenothiazines, pimozide, sertindole, haloperidol, sulpiride);
­ tricyclic antidepressants;
­ certain antibacterial drugs (e.g. saquinavir, sparfloxacin, intravenous erythromycin, pentamidine,
antimalarials, especially halofantrine);
­ certain antihistamines (e.g. terfenadine, astemizole, mizolastine);
­ other medicines such as cisapride, intravenous vinpocetine, bepridil, and difemanil.
Inform the doctor:
­ if the patient is taking other medicines that may reduce blood potassium levels [e.g. certain
diuretics, certain laxatives and large-volume enemas, or corticosteroids (anti-inflammatory drugs),
amphotericin B];
­ if the patient is taking other medicines that may slow heart rate, as they may also increase
the risk of serious heart rhythm disorders during Moxifloxacin Kabi treatment;
­ if the patient is taking oral anticoagulants (e.g. warfarin), the doctor may order blood clotting tests.
Moxifloxacin Kabi with food, drink, and alcohol
Food, including dairy products, does not affect the action of Moxifloxacin Kabi.
Do not drink alcohol during treatment with Moxifloxacin Kabi.
Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects pregnancy, or plans to have a child,
they should consult a doctor or pharmacist before using this medicine.
Do not use Moxifloxacin Kabi during pregnancy or breastfeeding.
Animal studies have not shown fertility disturbances related to this medicine.
Driving and operating machinery
Moxifloxacin Kabi may cause dizziness, lightheadedness, sudden transient loss of vision,
or brief fainting. If such symptoms occur, do not drive or operate machinery.
Moxifloxacin Kabi contains sodium
The maximum recommended daily dose of this medicine contains 1206 mg of sodium (main component
of table salt). This corresponds to 60% of the maximum recommended daily sodium intake in the diet
for adults.

3. How to use Moxifloxacin Kabi

Moxifloxacin Kabi is always administered by a doctor or healthcare professional.
The recommended dose in adult patients is one bottle or bag, once daily.
Moxifloxacin Kabi is intended for intravenous administration (into a vein). The doctor should ensure
that the medicine is given as a continuous infusion lasting at least 60 minutes.
Dose adjustment is not required in elderly patients, patients with low body weight, or patients with renal impairment.
Duration of treatment
The doctor will decide how long treatment with Moxifloxacin Kabi should last. In some cases, the doctor may start treatment with Moxifloxacin Kabi as an infusion solution,
and then continue treatment with an appropriate tablet formulation.
The duration of treatment depends on the type of infection and the patient's response to therapy. The recommended duration of treatment is given below.

It is important to complete the full course of treatment, even if the patient feels better after a few days.
If treatment is stopped too early, the infection may not be completely cured, the illness may return or the patient's condition may worsen, and bacteria may develop resistance to the antibiotic.
Do not exceed the recommended dose or duration of treatment.
Administration of a higher than recommended dose of Moxifloxacin Kabi
If the patient suspects that they have received too high a dose of Moxifloxacin Kabi, they should inform their doctor immediately.
Missed dose of Moxifloxacin Kabi
If the patient suspects that a dose of Moxifloxacin Kabi has been missed, they should inform their doctor immediately.
Discontinuation of Moxifloxacin Kabi treatment
If treatment is stopped too early, the infection may not be completely cured. If the patient wishes to discontinue taking Moxifloxacin Kabi earlier, they should consult their doctor.
If there are any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You must contact a doctor immediately and stop treatment if the patient experiences any of the
adverse reactions described below, which may be life-threatening.

Uncommon adverse reactions (may occur in fewer than 1 in 1,000 patients):
­ severe, rapidly generalizing allergic reaction, including very rare life-threatening shock
(e.g. breathing difficulties, drop in blood pressure, rapid heartbeat), swelling (including
potentially life-threatening swelling of the airways);
­ depression (very rarely leading to self-harm, e.g. suicidal thoughts or attempts);
­ severe diarrhoea with blood and/or mucus in stool (antibiotic-associated colitis, including
pseudomembranous colitis), very rarely leading to life-threatening complications;
­ increased blood glucose levels;
­ reduced urine output, swelling of legs, ankles or feet, fatigue, nausea, drowsiness,
shortness of breath or confusion in elderly patients with kidney disease (these may be
subjective and objective signs of kidney failure).

Very rare adverse reactions (may occur in fewer than 1 in 10,000 patients):
­ depersonalization (feeling of altered self-identity), psychosis (which may lead to self-harm,
e.g. suicidal thoughts or attempts);
­ life-threatening irregular heartbeat (torsade de pointes) or cardiac arrest;
­ fulminant (dangerous) hepatitis, potentially leading to life-threatening liver failure (including
fatal outcome);
­ severe skin rash, including Stevens-Johnson syndrome and toxic epidermal necrolysis. May
present as reddish, target-like spots or circular lesions, often with blisters on the trunk, skin
peeling, oral, throat, nasal, genital or ocular ulcers, and may be preceded by fever and
flu-like symptoms (potentially life-threatening adverse reactions);
­ syndrome related to impaired water excretion and low sodium levels (SIADH);
­ vasculitis (may present as red blisters on the skin, usually on the calves, or joint pain);
­ tendon rupture, joint inflammation, muscle stiffness;
­ exacerbation of myasthenia symptoms has been observed;
­ decreased blood glucose levels;
­ loss of consciousness due to significant drop in blood glucose (hypoglycaemic coma).

Frequency not known (frequency cannot be estimated from available data):
­ red, peeling, generalized rash with subcutaneous nodules and blisters, initially accompanied
by fever (acute generalized exanthematous pustulosis);
­ widespread rash, high fever, increased liver enzyme activity, blood abnormalities
(eosinophilia), swollen lymph nodes and involvement of other organs (drug reaction with
eosinophilia and systemic symptoms, known as DRESS or drug hypersensitivity syndrome);
­ muscle weakness, tenderness or pain, especially if accompanied by malaise, high fever or
dark urine. This may be due to abnormal muscle tissue breakdown, which may be life-threatening
and lead to kidney problems (a condition known as rhabdomyolysis).

The following adverse reactions have been observed during treatment with moxifloxacin.

Common adverse reactions (may occur in fewer than 1 in 10 patients):
­ infections caused by resistant bacteria or fungi, e.g. oral or vaginal candidiasis caused by
Candida;
­ headache, dizziness;
­ changes in heart rhythm (visible on ECG) in patients with low blood potassium levels (see
section 2. Important information before using Moxifloxacin Kabi);
­ nausea, vomiting, stomach and abdominal pain, diarrhoea;
­ increased blood levels of liver enzymes (aminotransferases);
­ pain or inflammation at the injection site.

Uncommon adverse reactions (may occur in fewer than 1 in 100 patients):
­ low red blood cell count, low white blood cell count, low levels of certain types of white
blood cells (neutrophils), decreased or increased number of blood cells essential for
clotting (platelets), increased number of certain white blood cells (eosinophils), reduced
blood clotting ability;
­ allergic reactions;
­ increased blood lipid (fat) levels;
­ anxiety, motor restlessness and/or agitation;
­ tingling and/or numbness, taste disturbances (very rarely loss of taste), confusion and
disorientation, sleep disturbances (mainly insomnia), tremors, dizziness (sensation of
spinning or falling), drowsiness;
­ visual disturbances, including double or blurred vision;
­ changes in heart rhythm (visible on ECG), palpitations, irregular and rapid heartbeat,
severe heart rhythm disturbances, angina (chest pain);
­ blood vessel dilation;
­ breathing difficulties, including asthma-like symptoms;
­ decreased appetite and food intake, bloating and constipation, gastrointestinal disturbances
(indigestion, heartburn), inflammation of the stomach mucosa, increased blood levels of
digestive enzyme (amylase);
­ liver function disturbances [including increased blood levels of liver enzyme LDH, increased
bilirubin levels, increased activity of liver enzymes – gamma-glutamyltransferase and/or
alkaline phosphatase];
­ itching, rash, urticaria, dry skin;
­ joint pain, muscle pain;
­ dehydration;
­ malaise (mainly weakness or fatigue), back, chest, pelvic or limb pain, excessive sweating;
­ phlebitis.

Rare adverse reactions (may occur in fewer than 1 in 1,000 patients):
­ increased blood uric acid levels;
­ emotional lability, hallucinations;
­ disturbances in skin sensation, smell disturbances (including loss of smell), unusual dreams,
balance disorders and poor motor coordination (due to dizziness), seizures, concentration
difficulties, speech disturbances, partial or complete memory loss, neurological disturbances
such as pain, burning, tingling, numbness and/or weakness in limbs;
­ ringing or buzzing in the ears, hearing disturbances, including deafness (usually transient);
­ fainting;
­ high blood pressure, low blood pressure;
­ difficulty swallowing, inflammation of the oral mucosa;
­ jaundice (yellowing of the whites of the eyes and skin), hepatitis;
­ tendon pain and swelling (tendinitis), muscle cramps, muscle twitching, muscle weakness;
­ kidney function disturbances (including increased values in kidney function tests such as
urea and creatinine levels), kidney failure;
­ swelling (hands, feet, ankles, lips, mouth, throat);
­ eye discomfort or pain, especially when exposed to light (immediate consultation with an
ophthalmologist is required).

Very rare adverse reactions (may occur in fewer than 1 in 10,000 patients):
­ increased blood coagulability, marked decrease in certain white blood cells (agranulocytes);
­ increased skin sensitivity;
­ transient loss of vision (immediate consultation with an ophthalmologist is required);
­ abnormal heart rhythm;
­ decreased number of red blood cells, white blood cells and platelets (pancytopenia).

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 tendon inflammation, tendon rupture, joint pain, limb pain, difficulty walking,
abnormal sensations such as pricking, tingling, tickling, burning, numbness or pain (neuropathy),
depression, fatigue, sleep disturbances, memory problems, and disturbances in hearing, vision,
taste and smell.

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

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

• increased skin sensitivity to sunlight or UV radiation (see also section 2. Warnings and precautions);
• sharply defined, erythematous lesions with or without blisters, appearing within hours after moxifloxacin administration and healing with post-inflammatory residual pigmentation; these usually recur at the same skin or mucosal site upon subsequent exposure to moxifloxacin.

The symptoms described below have been more frequently observed in patients receiving
moxifloxacin intravenously.

Common adverse reactions (may occur in fewer than 1 in 10 patients):
­ increased blood levels of the liver enzyme gamma-glutamyltransferase.

Uncommon adverse reactions (may occur in fewer than 1 in 100 patients):
­ abnormally rapid heart rate;
­ low blood pressure;
­ swelling (hands, feet, ankles, lips, mouth, throat);
­ severe diarrhoea with blood and/or mucus (antibiotic-associated colitis), very rarely leading
to life-threatening complications;
­ seizures;
­ hallucinations;
­ kidney function disturbances (including increased values in kidney function tests such as
urea and creatinine levels), kidney failure.

The adverse reactions listed below occurred after treatment with other quinolone antibiotics
and therefore may also occur after administration of Moxifloxacin Kabi.

Very rare adverse reactions (may occur in fewer than 1 in 10,000 patients):
­ increased blood sodium levels, increased blood calcium levels;
­ increased breakdown of red blood cells (haemolytic anaemia).

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

5. How to store Moxifloxacin Kabi

The medicine is administered by qualified medical personnel who are responsible for
proper storage of the medicine both before and during administration to the patient,
as well as for its proper disposal.
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the vial or bag under "EXP". The expiry date refers to the last day of the stated month.
Do not store in the refrigerator or freeze.
Store the vial in the outer packaging to protect from light.
For single use only. Any unused solution should be discarded.
Storage at low temperatures may cause a precipitate to form, which will redissolve at room temperature.
Do not use this medicine if visible particles are present or if the solution is cloudy.
The physician or medical personnel are responsible for the storage of Moxifloxacin Kabi, the quality of the medicine after opening the packaging, and if it is not used immediately. They are also responsible for the proper disposal of any unused remnants of the medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Moxifloxacin Kabi contains
­ The active substance is moxifloxacin. Each bottle or bag with a volume of 250 ml contains 400 mg of moxifloxacin (as moxifloxacin hydrochloride). 1 ml contains 1.6 mg of moxifloxacin (as moxifloxacin hydrochloride).
­ Other ingredients are: sodium acetate trihydrate, sodium sulfate anhydrous, sulfuric acid (for pH adjustment), and water for injections (see section Moxifloxacin Kabi contains sodium).

What Moxifloxacin Kabi looks like and contents of the pack
Moxifloxacin Kabi is a clear, yellow infusion solution.
1, 10, 20, 25 or 40 bags in a cardboard box.
Polyolefin bag (free flex) with two ports (with an injection port and an infusion port), contained in an outer aluminium bag, containing 250 ml of solution.
1, 10, 20, 25 or 40 bottles in a cardboard box.
LDPE bottles (KabiPac) containing 250 ml of solution.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw
Poland

Manufacturer
KabiPac bottles
Fresenius Kabi Polska Sp. z o.o.
ul. Sienkiewicza 25
99-300 Kutno
Poland

free flex bags
HP Halden Pharma AS
Svinesundsveien 80
1788 Halden
Norway

For further information, please contact the Marketing Authorisation Holder:
Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw
Poland
Tel.: +48 22 345 67 89

This medicinal product is authorised in the European Economic Area countries under the following names:
Austria Moxifloxacin Kabi 400 mg Infusionslösung
Belgium Moxifloxacine Fresenius Kabi 400 mg/250 ml oplossing voor infusie
Bulgaria Моксифлоксацин Каби 400 mg/250 ml инфузионен разтвор
Croatia Moxifloxacin Kabi 400 mg/250 ml otopina za infuziju
Czech Republic Moxifloxacin Kabi 400 mg/250 ml infuzní roztok
Denmark Moxifloxacin Fresenius Kabi
Finland Moxifloxacin Fresenius Kabi 400 mg/250 ml infuusioneste, liuos
Spain Moxifloxacino Kabi 400 mg/250 ml solución para perfusión
Netherlands Moxifloxacine Fresenius Kabi 400 mg/250 ml oplossing voor infusie
Ireland Moxifloxacin 400 mg/250 ml solution for infusion
Luxembourg Moxifloxacin Kabi 400 mg/250 ml solution pour perfusion
Germany Moxifloxacin Kabi 400 mg Infusionslösung
Poland Moxifloxacin Kabi
Romania Moxifloxacina Kabi 400 mg/250 ml soluţie perfuzabilă
Slovakia Moxifloxacin Kabi 400 mg/250 ml infúzny roztok
Slovenia Moksifloksacin Kabi 400 mg/250 ml raztopina za infundiranje
Sweden Moxifloxacin Fresenius Kabi 400 mg/250 ml, infusionsvätska, lösning
Hungary Moxifloxacin Kabi 400 mg/250 ml oldatos infúzió

Information intended exclusively for medical professionals:

Moxifloxacin Kabi may be administered through a three-way stopcock together with the following solutions:
Water for Injections, 0.9% sodium chloride solution, 5% and 10% glucose solution, Ringer's solution,
compound sodium lactate solution (Hartmann's solution, Ringer's solution with lactate).
Moxifloxacin Kabi must not be administered simultaneously with other medicinal products.
The following solutions have been shown to be incompatible with moxifloxacin infusion solution:
­ 10% and 20% sodium chloride solutions;
­ 4.2% and 8.4% sodium bicarbonate solutions.