Moxifloxacin Fresenius Kabi – Moxifloxacin uses, dose and side effects

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400 mg / 250 ml solution for infusion
Moxifloxacin

What Moxifloxacin Fresenius Kabi is and what it is used for

Moxifloxacin Fresenius Kabi contains the active substance moxifloxacin which belongs to a group of antibiotics called fluoroquinolones. Moxifloxacin Fresenius Kabi works by killing bacteria that cause infection if they are caused by bacteria that are sensitive to the active substance moxifloxacin.

Moxifloxacin Fresenius Kabi is used in adults to treat the following bacterial infections:

  • Pneumonia ( pneumonia ) that has been received outside of hospital.
  • Infection in the skin and soft tissues.

Moxifloxacin Fresenius Kabi is only used to treat these infections when standard antibiotics cannot be used or have not worked.

Moxifloxacin contained in Moxifloxacin Fresenius Kabi may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.

What you need to know before you are given Moxifloxacin Fresenius Kabi

Do not use Moxifloxacin Fresenius Kabi

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

  • If you are allergic to the active substance moxifloxacin, any other quinolone antibiotic or any of the other ingredients of this medicine (listed in section 6).
  • If you are pregnant or breastfeeding.
  • If you are younger than 18 years.
  • If you have a history of tinnitus or tendon problems related to quinolone antibiotics (see sections Warnings and precautions and 4. Possible side effects ) .
  • If you were born with or have ever experienced an abnormal heart rhythm (visible on ECG , heart examination using electrodes),
  • If you have an imbalance in your blood salts (especially low levels of potassium or magnesium in your blood),
  • If you have a very slow heart rhythm (called bradycardia ), have a weak heart ( heart failure ), have previously had an abnormal heart rhythm or are being treated with other medicines that may cause abnormal ECG changes (see section Other medicines and Moxifloxacin Fresenius Kabi ).This is because Moxifloxacin Fresenius Kabi can cause changes in the ECG , in the form of prolongation of the QT interval , which means a slower transmission of electrical signals.
  • If you have severe liver disease or elevated liver enzymes ( transaminases ) higher than 5 times the upper limit of normal.

Warnings and cautions

Before taking this medicine

You should not take antibacterial fluoroquinolone/quinolone medicines, including Moxifloxacin Fresenius Kabi if you have previously had any serious side effects from taking any quinolone or fluoroquinolone medicines. If this is the case, contact your doctor as soon as possible.

Talk to your doctor before taking Moxifloxacin Fresenius Kabi for the first time. You must know that:

  • Moxifloxacin Fresenius Kabi can alter your ECG , especially if you are a woman or older.
  • If you are taking any medicine that lowers potassium levels in your blood , consult your doctor before giving Moxifloxacin Fresenius Kabi (see also Do not use Moxifloxacin Fresenius Kabi and Other medicines and Moxifloxacin Fresenius Kabi ).
  • If you are diabetic because there is a risk of you getting altered blood sugar levels of moxifloxacin.
  • If you have ever developed severe rash or scaly skin, blisters and / or sores in your mouth after taking moxifloxacin.
  • If you suffer from epilepsy or any other condition that can cause seizures, tell your doctor before taking Moxifloxacin Fresenius Kabi.
  • If you have or have had problems with your mental health , talk to your doctor before taking Moxifloxacin Fresenius Kabi.
  • If you have myasthenia gravis (a rare disease that leads to muscle weakness), Moxifloxacin Fresenius Kabi may make the symptoms of your disease worse. If you think this has affected you, contact your doctor immediately.
  • If you have been diagnosed with an enlargement or “bulge” of a large blood vessel (aortic aneurysm or peripheral aneurysm in a large blood vessel).
  • If you have had an aortic dissection (a rupture in the aortic wall).
  • if you have been diagnosed with leaky heart valves.
  • If someone in your family has or has had an aortic aneurysm , aortic dissection or congenital heart valve disease, or has other risk factors or conditions that increase the risk of this (eg connective tissue diseases such as Marfan’s syndrome, or Ehlers-Danlos syndrome , Turner syndrome , Sjögren’s syndrome (en inflammatory autoimmune disease), or vascular diseases such as Takayasus arteritis, giant cell arteritis, Behçet’s disease, hypertension , atherosclerosis, rheumatoid arthritis (a joint disease) or endocarditis (an infection of the heart).
  • If you or anyone in your family has glucose -6-phosphate dehydrogenase deficiency (an uncommon inherited disease), tell your doctor, who will tell you if Moxifloxacin Fresenius Kabi is right for you.
  • Moxifloxacin Fresenius Kabi should only be given intravenously (into a vein), and should not be administered into an artery .

Treatment with Moxifloxacin Fresenius Kabi should be stopped immediately in the following cases:

  • There is a rare risk that you may have a severe, sudden allergic reaction (an anaphylactic reaction / shock), already at the first dose . Tell your doctor if you experience symptoms such as pressure over the chest, that you feel dizzy, feel unwell, feel faint or dizzy when you get up.
  • Moxifloxacin Fresenius Kabi can cause sudden and severe inflammation in the liver which can lead to life-threatening liver failure (including death, see section 4. Possible side effects ) . Contact your doctor before continuing treatment if you suddenly start to feel unwell or discover yellowing whites of the eyes, dark urine, itchy skin, bleeding tendencies or thought disorders and altered alertness
  • Quinolone – type antibiotics , including Moxifloxacin Fresenius Kabi, can cause seizures . If this happens, treatment with Moxifloxacin Fresenius Kabi must be stopped.
  • You may experience problems with your mental health when taking quinolone- type antibiotics , including Moxifloxacin Fresenius Kabi, for the first time. In very rare cases, depression and mental health problems have led to suicidal thoughts and behaviors such as suicide attempts (see section  4. Possible side effects ) . If you develop such reactions, treatment with Moxifloxacin Fresenius Kabi must be stopped.
  • In rare cases, pain and swelling in the joints and inflammation or rupture of tendons can occur. The risk is greater if you are older (over 60 years), have undergone an organ transplant, have kidney problems or if you are treated with cortisone ( corticosteroids ). Inflammation and rupture of tendons can occur within the first 48 hours after starting treatment but also up to several months after treatment with Moxifloxacin Fresenius Kabi has ended. At the first sign of pain or inflammationin a tendon (eg in the ankle, wrist, elbow, shoulder or knee), stop taking Moxifloxacin Fresenius Kabi, and consult a doctor and rest the painful area. Avoid unnecessary exertion as it may increase the risk of a tendon rupture (see sections Do not use Moxifloxacin Fresenius Kabi and 4. Possible side effects ) .

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

  • If you experience palpitations or irregular heartbeats during treatment, tell your doctor immediately. He / she may want to do an ECG to measure your heart rate.
  • Severe skin reactionsSevere skin reactions including Stevens Johnson syndrome, toxic epidermal necrolysis and acute generalized exanthematous pustulosis (AGEP) have been reported with moxifloxacin.
    • Stevens Johnson syndrome and toxic epidermal necrolysis may first appear as red, target-like spots or round spots, often with blisters in the center, on the torso. In addition, sores in the mouth, throat, nose, genitals and eyes (red and swollen eyes) may occur. These severe skin rashes are often preceded by fever and / or flu-like symptoms . The rash can develop into widespread skin peeling and complications that can be life-threatening or have a fatal outcome.
    • Acute generalized exanthematous pustulosis (AGEP) occurs at the beginning of treatment as red, widespread and flaky rash with bumps under the skin and blisters along with fever. Most often located in skin folds, on the upper body and on the arms.
    If you develop severe skin rash or any of these other skin symptoms, stop taking moxifloxacin and consult a doctor or seek medical attention immediately.
  • In rare cases, you may experience symptoms of nerve damage ( neuropathy ) such as pain, a burning sensation, tingling, numbness and / or weakness , especially in the feet and legs or hands and arms. If this happens, stop taking Moxifloxacin Fresenius Kabi and contact your doctor immediately to prevent the development of a possible permanent condition.
  • You may experience diarrhea during or after taking antibiotics , including Moxifloxacin Fresenius Kabi. If this becomes severe or long-lasting or if you notice that the stool contains blood or mucus, stop taking Moxifloxacin Fresenius Kabi immediately and contact your doctor. In this situation, do not take any medicine that stops or reduces bowel movement.
  • If you feel a sudden, severe pain in the abdomen, chest or back, you should immediately go to an emergency room as this may be a symptom of aortic aneurysm and aortic dissection. The risk of developing this may be increased if you are being treated with systemic corticosteroids (“cortisone”).
  • If you experience sudden shortness of breath, especially when you lie down in bed, or notice swelling in your ankles, feet or stomach, or have a new heartbeat (feeling of rapid or irregular heartbeat), contact a doctor immediately.
  • If you experience impaired vision or if you experience any other eye problems during treatment with Moxifloxacin Fresenius Kabi, contact an eye specialist immediately (see sections Driving and using machines and 4. Possible side effects )
  • Fluoroquinolones can cause an increase in your blood sugar level above normal ( hyperglycaemia ), or decrease your blood sugar level below normal ( hypoglycaemia ), which may lead to loss of consciousness (hypoglycaemic coma ) in severe cases (see section 4 Possible side effects ). If you have diabetes , your blood sugar should be monitored carefully.

When using Moxifloxacin Fresenius Kabi you should be aware that:

  • The risk of heart problems may increase with increasing dose and infusion rate into your vein.
  • If you are older and have kidney problems, be sure to drink enough as dehydration can increase the risk of kidney failure .
  • Quinolone antibiotics can make your skin more sensitive to sunlight or UV rays. You should avoid prolonged exposure to sunlight or strong sunlight and do not sunbathe in a solarium or use any other UV light lamp during treatment with Moxifloxacin Fresenius Kabi.
  • The experience of sequential intravenous / oral treatment with Moxifloxacin Fresenius Kabi in pneumonia ( out-of-hospital pneumonia ) is limited.
  • The effect of Moxifloxacin Fresenius Kabi in the treatment of severe burns, deep tissue infections or foot ulcers in diabetics with osteomyelitis ( bone marrow infection ) has not been established.

 Long-term, debilitating, and possibly lasting serious side effects Antibacterial
fluoroquinolone/quinolone drugs, including Moxifloxacin Fresenius Kabi, have been linked to very rare but serious side effects. Some of these have been long-lasting (up to months or years), disabling, and possibly permanent. This includes pain in the tendons, muscles, and joints of the arms and legs, difficulty walking, abnormal sensations such as ant crawling, tingling, tingling, numbness or a burning sensation ( paresthesia ), sensory disorders in the form of impaired vision, taste, smell and hearing, depression, memory loss, extreme fatigue, and severe sleep disorders.

If you get any of these side effects after taking Moxifloxacin Fresenius Kabi, talk to a doctor immediately before continuing with this treatment. You and your doctor will decide if you should continue treatment or consider using another type of antibiotic.

Children and young people

This medicine should not be given to children and adolescents under 18 years of age as efficacy and safety have not been established for this age group (see section Do not use Moxifloxacin Fresenius Kabi ).

Other medicines and Moxifloxacin Fresenius Kabi

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Please note the following when treating with Moxifloxacin Fresenius Kabi

If you use Moxifloxacin Fresenius Kabi and other medicines that may affect your heart, there is an increased risk of heart rhythm changes. Therefore, do not use Moxifloxacin Fresenius Kabi with the following medicines:

  • Drugs belonging to the antiarrhythmic group (eg quinidine, hydroquinidine, disopyramide , amiodarone , sotalol, dofetilide, ibutilide),
  • Antipsychotics (eg phentiazines, pimozide, sertindole, haloperidol , sultopride),
  • Tricyclic antidepressants , certain antimicrobials (eg saquvinavir, sparfloxacin, intravenous erythromycin, pentamidine, antimalarials, especially halofantrine),
  • Some antihistamines are (eg terfenadine, astemizole, mizolastine)
  • Other medicines (eg cisapride, intravenous vinegar, bepridil and difemanil).

You need to tell your doctor:

  • If you are also taking other medicines that can lower your potassium levels in the blood (eg certain diuretics , certain laxatives and enemas (in large doses ) or corticosteroids (anti-inflammatory drugs), amphotericin B),
  • If you are taking other medications that may cause a slower heartbeat as this may increase the risk of severe heart rhythm disturbances while you are being given Moxifloxacin Fresenius Kabi.
  • If you are being treated with oral anticoagulants (tablets that prevent blood clots, such as warfarin) at the same time, it may be necessary for your doctor to check your coagulation time.

Moxifloxacin Fresenius Kabi with food, drink and alcohol

The effect of Moxifloxacin Fresenius Kabi is not affected by food, including dairy products.

You should not drink alcohol during treatment with Moxifloxacin Fresenius Kabi.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Do not use Moxifloxacin Fresenius Kabi if you are pregnant or breastfeeding.

Animal studies do not suggest that your fertility will be impaired when using this medicine.

Driving and using machines

Moxifloxacin Fresenius Kabi can make you feel dizzy and faint, you may experience a sudden transient loss of vision or you may faint for a short time. If you feel this, do not drive or operate machinery.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Moxifloxacin Fresenius Kabi contains sodium

The maximum recommended daily dose of one of these medicines contains 1206 mg of sodium (found in table salt). This is equivalent to 60% of the maximum recommended daily intake of sodium for adults.

How to use Moxifloxacin Fresenius Kabi

Moxifloxacin Fresenius Kabi will always be given by a doctor or healthcare professional.

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

Moxifloxacin Fresenius Kabi is for intravenous use. Your doctor should be responsible for giving the infusion at the same rate for 60 minutes.

There is no need to change the dose to elderly patients, patients with low body weight, or patients with kidney problems.

Duration of treatment

The treating physician decides how long the treatment with Moxifloxacin Fresenius Kabi should last. In some cases, treatment with Moxifloxacin Fresenius Kabi infusion solution begins, and then treatment is continued with the corresponding tablets.

How long the treatment should last depends on the type of infection, and how well you respond to the treatment, but the recommended treatment time is:

Treatment of:Duration of treatment:
Pneumonia ( pneumonia ) that has been received outside of a hospital
Most patients with pneumonia are transferred to the corresponding tablets for oral treatment within 4 days
7 – 14 days
Infection in the skin and soft tissues for patients with complicated skin and soft tissue infections, the intravenous treatment lasts for about 6 days and the average total treatment time ( infusion followed by the corresponding tablets) is 13 days.7 – 21 days

You must complete the entire course, even if you feel better after a few days. If you stop using this medicine prematurely, your infection may not be treated enough, your infection may return or your general condition may worsen and you may even develop bacterial resistance to antibiotics.

The recommended dose and treatment time should not be exceeded.

If you take more Moxifloxacin Fresenius Kabi than you should

If you are concerned about an overdose of Moxifloxacin Fresenius Kabi, contact your doctor immediately.

If you forget a dose of Moxifloxacin Fresenius Kabi

If you are concerned about missing a dose of Moxifloxacin Fresenius Kabi, contact your doctor immediately.

If you stop using Moxifloxacin Fresenius Kabi

If treatment with this medicine is stopped too soon, your infection may not be treated properly. Consult your doctor if you wish to end treatment with Moxifloxacin Fresenius Kabi before completing the course.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Possible side effects

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

Tell your doctor immediately and stop treatment if you experience any of the following side effects, as they can be life-threatening:

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

  • Severe, sudden, general allergic reaction , including very rare life-threatening shock (for example, difficulty breathing, drop in blood pressure, rapid pulse ), swelling (including potentially life-threatening swelling of the airways).
  • Depression (can in very rare cases lead to self-harming behavior, such as suicidal ideation / thoughts or suicide attempts),
  • Severe diarrhea containing blood and / or mucus ( colitis caused by antibiotics , including pseudomembranous colitis ), which in some very rare cases can lead to life-threatening complications.
  • Elevated blood sugar.
  • If you are older, have kidney problems and notice a decrease in urine levels, swelling in the legs, ankles or feet, fatigue, nausea, drowsiness, difficulty breathing or confusion (these may be signs and symptoms of kidney failure ).

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

  • Feeling of loneliness (not being oneself), mental illness (may lead to self-harming behaviors, such as suicidal ideation / thoughts or suicide attempts).
  • Life-threatening irregular heartbeat ( Torsade de pointes ) or pause of the heartbeat.
  • Fulminant (dangerous) liver inflammation that can lead to life-threatening disruption of liver function (including death).
  • Severe skin rash including Steven Johnson syndrome and toxic epidermal necrolysis . These rashes may appear as red, target-like spots or round spots, often with blisters in the middle, torso, skin rash, sores in the mouth, throat, nose, genitals and eyes and may be preceded by fever and flu-like symptoms (may be life-threatening).
  • Syndrome linked to decreased water secretion and low sodium levels (SIADH).
  • Inflammation of blood vessels (signs may be red marks on the skin, usually on the shins, or symptoms such as joint pain).
  • Tendon rupture (tendon rupture), inflammation of the joints, muscle stiffness.
  • Deterioration of myasthenia gravis symptoms has been observed. 
  • Low blood sugar.
  • Loss of consciousness due to severe hypoglycaemia (hypoglycaemic coma ).

Has been reported (occurs in an unknown number of users)

  • A red, widespread, flaky rash with bumps under the skin and blisters along with fever at the beginning of treatment ( acute generalized exanthematous pustulosis ).
  • muscle weakness, soreness or pain and especially if you also feel sick, have a high body temperature or have dark urine. This can be caused by abnormal muscle breakdown which can be life threatening and lead to kidney problems (a condition called rhabdomyolysis )

The following side effects have been observed during treatment with Moxifloxacin Fresenius Kabi:

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

  • Infection is caused by resistant bacteria or fungi eg oral or vaginal infection is caused by Candida
  • Headache, dizziness
  • Changes in heart rate ( ECG ) in patients with low potassium levels in the blood (see section 2 What you need to know before taking Moxifloxacin Fresenius Kabi)
  • Nausea, vomiting, abdominal and abdominal pain, diarrhea
  • Increase of special liver enzymes ( transaminases ) in the blood
  • Pain or inflammation at the injection site.

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

  • Low number of red blood cells , low number of white blood cells , low number of special white blood cells ( neutrophils ), decrease or increase of special blood cells are necessary for coagulation , increased number of special white blood cells ( eosinophils ), decreased blood coagulation
  • Allergic reaction
  • Elevated amount of lipids (fats) in the blood
  • Anxiety, restlessness / agitation
  • Creeping sensation (tingling) and / or numbness, taste changes (in very rare cases lost sense of taste), confusion and disorientation, sleep disturbances (mainly insomnia), tremors, feeling dizzy (instability or risk of falling), drowsiness
  • Visual disturbances including double vision and blurred vision
  • Alteration of heart rhythm ( ECG ), palpitations, irregular and fast heartbeat, severe abnormal heart rhythm, angina pectoris (chest pain)
  • Dilation of blood vessels
  • Difficulty breathing including asthmatic conditions
  • Decreased appetite and decreased food intake, flatulence and constipation, upset stomach (indigestion / heartburn), inflammation of the stomach, increase in special digestive enzymes (amylase) in the blood
  • Impaired liver function (including increase in special liver enzymes (LDH) in the blood), increase in bilirubin in the blood, increase in special liver enzymes (gamma glutamyltransferase and / or alkaline phosphatase) in the blood
  • Itching , rash, hives, dry skin
  • Joint pain, muscle pain
  • Dehydration
  • Feeling sick (mainly feeling weak or tired), aches and pains in eg back, chest, pain in the pelvis and extremities , sweating
  • Inflammation in a friend.

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

  • Elevated uric acid level in the blood
  • Emotional instability, hallucination, decreased sensitivity of the skin, changes in the sense of smell (including lost sense of smell), abnormal dreams, disturbance of balance and poor coordination (due to dizziness), seizures, impaired concentration, impaired speech, partial or complete loss of memory, problems related to the nervous system such as pain, burning sensation, tingling, numbness and / or weakness in the arms and legs
  • Ringing / noise in the ears, hearing loss incl. deafness (usually transient)
  • Fainting
  • High blood pressure , low blood pressure
  • Difficulty swallowing, inflammation of the oral mucosa, jaundice (whites of the eyes or skin yellowing), inflammation of the liver
  • Pain and swelling of tendons (tendinitis), muscle cramps, muscle twitching, muscle weakness
  • Renal impairment (including elevated laboratory values ​​with respect to the kidneys, such as urea and creatinine ), renal failure
  • Swelling (hands, feet, ankles, lips, mouth, throat).
  • Discomfort or pain in the eyes, especially when exposed to light (contact an eye specialist immediately)

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

  • Increased blood coagulation, marked decrease in the number of special white blood cells ( agranulocytosis )
  • Increased sensitivity of the skin
  • Transient vision loss (contact an eye specialist immediately)
  • Abnormal heart rhythm
  • Decreased number of red and white blood cells and platelets (pancytopenia)

In very rare cases, long-term (up to several months or years) or permanent side effects, such as tendinitis, tendonitis, joint pain, pain in arms and legs, difficulty walking, abnormal sensations such as ant crawling, tingling, tingling, a burning sensation, numbness or pain ( neuropathy ), depression, fatigue, sleep disturbances, impaired memory and hearing loss, vision and taste and odor associated with treatment with quinolone and fluoroquinolone antibiotics, in some cases regardless of existing risk factors.

Cases of enlargement and weakening of an aortic wall or rupture of an aortic wall ( aneurysms and dissections), which can rupture and be life-threatening, as well as cases of leaking heart valves, have been reported in patients receiving fluoroquinolones. See also section 2.

The following symptoms have been observed more frequently in patients receiving intravenous therapy:

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

  • Increase in special liver enzymes in the blood (gamma-glutamyl transferase )

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

  • Abnormally fast heartbeat
  • Low blood pressure
  • Swelling (hands, feet, ankles, lips, mouth, throat)
  • Severe diarrhea containing blood and / or mucus ( colitis caused by antibiotics ), which in some very rare cases can lead to life-threatening complications
  • Cramps
  • Hallucinations
  • Renal impairment (including elevated laboratory values ​​with respect to the kidneys, such as urea and creatinine ), renal failure .

The following side effects have been reported after treatment with other quinolone antibiotics, and may also occur during treatment with Moxifloxacin Fresenius Kabi

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

  • Increased sodium levels in the blood, increased calcium levels in the blood
  • Decreased level of special type of red blood cells ( hemolytic anemia )
  • The skin becomes more sensitive to sunlight or UV light.

How to store Moxifloxacin Fresenius Kabi

As this product is provided by healthcare professionals, they are responsible for the proper storage of the product, both before and during use, as well as for proper destruction.

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

Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiration date is the last day of the specified month.

Store in a cold place. Do not freeze. Store the bottle in the outer carton. Sensitive to light.

For single use only. Unused solutions should be discarded.

When stored at a low temperature, a precipitate may form, which dissolves at room temperature.

Do not use this medicine if it contains any visible particles or if the solution is cloudy.

Your doctor or healthcare professional will normally store Moxifloxacin Fresenius Kabi, and they will be responsible for the quality of the product when it is opened and not used immediately. They are also responsible for the proper disposal of any residues of Moxifloxacin Fresenius Kabi.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Contents of the pack and other information

Content declaration

  • The active substance is moxifloxacin. Each 250 ml bottle contains 400 mg moxifloxacin (as hydrochloride). 1 ml contains 1.6 mg moxifloxacin (as hydrochloride).
  • The other ingredients are sodium acetate trihydrate, sulfuric acid (for pH adjustment), anhydrous sodium sulphate and water for injections (see section 2, Moxifloxacin Fresenius Kabi contains sodium ).

What the medicine looks like and contents of the pack

Moxifloxacin Fresenius Kabi is a clear, yellow solution for infusion.

Moxifloxacin Fresenius Kabi is packaged in cartons containing 250 ml low-density polyethylene bottles (KabiPac) as primary packaging, sealed with a rubber disc stopper to allow needle perforation. The cartons contain 1, 10, 20, 25, or 40 bottles.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Fresenius Kabi AB

751 74 Uppsala

Manufacturer

Fresenius Kabi Polska Sp. z oo

ul. Sienkiewicza 25, 99-300 Kutno

Poland

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