Ciprofloxacin kabi 100 mg/50 ml infusion solution

Poland
Brand name Ciprofloxacin kabi 100 mg/50 ml infusion solution
Form solution for infusion
Active substance / Dosage
ciprofloxacin · 100 mg/50 ml
Prescription type Prescription only
ATC code
Registration number 100177161

Package leaflet: Information for the user

Ciprofloxacin Kabi 100 mg/50 ml infusion solution
Ciprofloxacin Kabi 200 mg/100 ml infusion solution
Ciprofloxacin Kabi 400 mg/200 ml infusion solution
Ciprofloxacinum
Please read this leaflet carefully before using this medicine, because it contains
important information for the patient.

  • Keep this leaflet so that you can read it again if necessary.
  • If you have any questions, please consult your doctor, pharmacist, or nurse.
  • If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Leaflet contents

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

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

The active substance in Ciprofloxacin Kabi is ciprofloxacin. Ciprofloxacin is an antibiotic belonging to the group of fluorochinolones. Ciprofloxacin works by killing bacteria that cause infections. It acts only against certain bacterial strains.

Adult patients
Ciprofloxacin Kabi is used in adult patients for the treatment of the following bacterial infections:

  • respiratory tract infections;
  • chronic or recurrent ear or sinus infections;
  • urinary tract infections;
  • testicular infections;
  • genital infections in women;
  • gastrointestinal and intra-abdominal infections;
  • skin and soft tissue infections;
  • bone and joint infections;
  • treatment of infections in patients with very low white blood cell counts (neutropenia);
  • prevention of infections in patients with very low white blood cell counts (neutropenia);
  • exposure to inhaled Bacillus anthracis (anthrax) spores.

If the infection is severe or caused by more than one type of bacteria, your doctor may prescribe an additional antibiotic to be used together with Ciprofloxacin Kabi.

Children and adolescents
Ciprofloxacin Kabi is used in children and adolescents, under the supervision of a specialist doctor, for the treatment of the following bacterial infections:

  • lung and bronchial infections in children and adolescents with cystic fibrosis;
  • complicated urinary tract infections, including kidney infections (pyelonephritis);
  • exposure to inhaled Bacillus anthracis (anthrax) spores.

Ciprofloxacin Kabi may also be used to treat other severe infections in children and adolescents if the doctor considers it necessary.

2. Important information before using Ciprofloxacin Kabi

When not to use Ciprofloxacin Kabi:

  • if the patient is allergic to ciprofloxacin, to other drugs in the group of quinolones, or to any of the other ingredients of this medicine (listed in section 6);
  • if the patient is taking tizanidine at the same time (see section 2 "Ciprofloxacin Kabi and other medicines").

Warnings and precautions
Before taking this medicine
Do not use antibacterial medicines containing fluoroquinolones or quinolones, including
Ciprofloxacin Kabi, if the patient has previously experienced any severe adverse reaction during treatment with a quinolone or fluoroquinolone. In such a case, inform the doctor as soon as possible.
Before using Ciprofloxacin Kabi
Tell the doctor, pharmacist, or nurse if the patient:

  • has ever had kidney function problems, as dose adjustment may be necessary;
  • has epilepsy or other neurological disorders;
  • has previously experienced tendon problems during treatment with antibiotics such as Ciprofloxacin Kabi;
  • has diabetes, as hypoglycaemia may occur after administration of ciprofloxacin;
  • has myasthenia (a type of muscle weakness), as symptoms may worsen;
  • has been diagnosed with aortic or large peripheral artery dilatation (aneurysm);
  • has previously experienced aortic dissection (tearing of the aortic wall);
  • has been diagnosed with heart valve insufficiency;
  • has a family history of aortic aneurysm or aortic dissection, or congenital heart valve disease, or other risk factors or predisposing conditions (e.g. connective tissue disorders such as Marfan syndrome or 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 arterial atherosclerosis, rheumatoid arthritis [joint disease], or endocarditis [heart infection]);
  • has heart disorders. Caution should be exercised when using the medicine in patients with congenital QT interval prolongation or with a family history of QT interval prolongation (visible on ECG, i.e. electrocardiogram), in patients with electrolyte imbalance (especially low potassium or magnesium levels in blood), with marked slowing of heart rate (called "bradycardia"), with impaired heart function (heart failure), after a previous heart attack (myocardial infarction), in women or elderly patients, or in patients taking other medicines causing abnormal ECG changes (see section 2 "Ciprofloxacin Kabi and other medicines");
  • or in their family has glucose-6-phosphate dehydrogenase (G6PD) deficiency, as use of ciprofloxacin carries a risk of haemolytic anaemia.

For treatment of certain urinary and genital tract infections, the doctor may additionally prescribe another antibiotic along with ciprofloxacin. If the patient's condition does not improve after three days of treatment, consult the doctor.
While using Ciprofloxacin Kabi
If any of the following symptoms occur while using Ciprofloxacin Kabi, inform the doctor immediately. The doctor will decide whether to discontinue treatment with Ciprofloxacin Kabi.
- Severe, sudden allergic reaction (anaphylactic reaction and/or shock, angioedema). Even after the first dose, in rare cases, a severe allergic reaction may occur with symptoms such as chest tightness, dizziness, nausea, fainting or dizziness upon standing. If this happens, stop using Ciprofloxacin Kabi and contact the doctor immediately.
- Rarely, joint pain and swelling, tendon inflammation or 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 treatment with Ciprofloxacin Kabi. If the first symptoms of tendon pain or inflammation occur (e.g. in the ankle, wrist, elbow, shoulder or knee joint), stop using Ciprofloxacin Kabi, contact the doctor and rest the affected area. Avoid excessive physical exertion, as this may increase the risk of tendon rupture.
- If sudden severe abdominal, back or chest pain occurs, which may indicate an aortic aneurysm or dissection, go immediately to the emergency department. 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 the ankles, feet or abdomen is observed, or palpitations (feeling of rapid or irregular heartbeat) appear, contact the doctor immediately.
- If sudden, severe abdominal, back or chest pain occurs, go immediately to the emergency department.
- If the patient has epilepsy or other neurological disorders, such as cerebral ischaemia or stroke, adverse effects related to the central nervous system may occur. If seizures occur, stop using Ciprofloxacin Kabi and contact the doctor immediately.
- 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 in the hands and arms. In such a case, stop using Ciprofloxacin Kabi and inform the doctor immediately to prevent progression to potentially irreversible disease.
- Psychiatric reactions may occur after the first dose of Ciprofloxacin Kabi. If the patient has depression or psychosis, symptoms of these conditions may worsen during treatment with Ciprofloxacin Kabi. If this happens, stop using Ciprofloxacin Kabi and contact the doctor immediately.
- Quinolone antibiotics may cause increased blood glucose levels above normal ( hyperglycaemia ) or decreased blood glucose levels below normal, which in severe cases may lead to loss of consciousness ( hypoglycaemic coma ) (see section 4). This is important in diabetic patients. Diabetic patients are advised to carefully monitor blood glucose levels.
- While taking antibiotics, including Ciprofloxacin Kabi, or even several weeks after stopping treatment, diarrhoea may occur. If it is severe or persistent, or if the patient notices blood or mucus in the stool, contact the doctor immediately. Stop using Ciprofloxacin Kabi immediately, as this may be life-threatening. Do not use medicines that inhibit or slow intestinal motility.
- If worsening of vision or any visual disturbances occur, consult an ophthalmologist immediately.
- While using Ciprofloxacin Kabi, the skin becomes more sensitive to sunlight and ultraviolet (UV) radiation. Avoid exposure to strong sunlight or artificial UV light (e.g. in tanning beds).
- If the patient is giving a blood or urine sample for testing, inform the doctor or laboratory staff that the patient is taking Ciprofloxacin Kabi.
- If the patient has kidney function disorders, inform the doctor, as dose adjustment may be necessary.
- Ciprofloxacin Kabi may cause liver damage. If the patient notices the following symptoms: loss of appetite, jaundice (yellowing of the skin), dark urine, skin itching or stomach irritation, stop using Ciprofloxacin Kabi immediately.
- Ciprofloxacin Kabi may reduce the number of white blood cells, which may lead to decreased resistance to infections. If the patient notices fever and a significant worsening of general condition or fever with local signs of infection, e.g. sore throat, laryngitis, oral cavity problems or urinary tract issues, contact the doctor immediately. A blood test will be ordered to check for reduced white blood cell count (agranulocytosis). Remember to inform the doctor about using this medicine.
Long-term, disabling and potentially irreversible serious adverse effects
Antibacterial medicines containing fluoroquinolones/quinolones, including Ciprofloxacin Kabi, have been associated with very rare but serious adverse effects. Some of these were long-term (lasting 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 (paresthesia), sensory disturbances including vision, taste, smell and hearing disorders, depression, memory disturbances, severe fatigue and severe sleep disturbances.
If any of these adverse effects occur after taking Ciprofloxacin Kabi, contact the doctor immediately before continuing treatment. The patient and doctor will decide whether to continue treatment, also considering antibiotics from other groups.
Ciprofloxacin Kabi and other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Do not use Ciprofloxacin Kabi together with tizanidine, as adverse effects such as low blood pressure and drowsiness may occur (see section 2 "When not to use Ciprofloxacin Kabi").
The following medicines may interact with Ciprofloxacin Kabi in the human body. Taking Ciprofloxacin Kabi together with these medicines may affect their therapeutic effect. It may also increase the likelihood of adverse effects.
If the patient is taking any of the following medicines, tell the doctor:

  • vitamin K antagonists (e.g. warfarin, acenocoumarol, phenprocoumon, fluindione) or other oral anticoagulants ("blood thinners");

  • probenecid (used in gout);

  • methotrexate (used in certain types of cancer, psoriasis, rheumatoid arthritis);

  • theophylline (used in respiratory disorders);

  • tizanidine (used to reduce excessive muscle tension in multiple sclerosis);

  • olanzapine (an antipsychotic medicine);

  • clozapine (an antipsychotic medicine);

  • ropinirole (used in Parkinson's disease);

  • phenytoin (used in epilepsy);

  • cyclosporine (used in skin diseases, rheumatoid arthritis and after transplantation);

  • other medicines that may affect heart rhythm: medicines belonging to the group of antiarrhythmics (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), tricyclic antidepressants, some antibacterial medicines (belonging to the macrolide group) or some antipsychotic medicines;

  • zolpidem (used in sleep disorders);

  • metoclopramide (used for nausea and vomiting);

  • omeprazole (used in treatment of stomach ulcers).

Ciprofloxacin Kabi may increase blood levels of the following medicines:

  • pentoxifylline (used in circulatory disorders);
  • caffeine;
  • duloxetine (used in depression, diabetic neuropathy or urinary incontinence);
  • lidocaine (used in heart rhythm disorders or for anaesthesia);
  • sildenafil (used, e.g., in erectile dysfunction);
  • agomelatine;
  • glibenclamide (used in diabetes).

Ciprofloxacin Kabi with food and drink
Food and drinks do not affect the use of Ciprofloxacin Kabi.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Use of Ciprofloxacin Kabi in pregnant women is not recommended.
Ciprofloxacin Kabi should not be used during breastfeeding, as ciprofloxacin passes into human milk and may be harmful to the child.
Driving and operating machinery
Ciprofloxacin Kabi may impair concentration. Adverse effects related to the nervous system may occur. Before driving or operating machinery, check how the patient reacts after taking Ciprofloxacin Kabi. If in doubt, consult the doctor.
Ciprofloxacin Kabi contains sodium
This medicine contains 347 mg of sodium (main component of table salt) in each 100 ml of volume. This corresponds to 17% of the maximum recommended daily dietary sodium intake for adults.

3. How to use Ciprofloxacin Kabi

This medicine should always be used exactly as directed by your doctor or pharmacist. If you have any doubts,
you should consult your doctor or pharmacist.
Your doctor will clearly explain what dose of Ciprofloxacin Kabi to use, how often, and for how long. This will
depend on the type and severity of the infection.
If the patient has impaired kidney function, this should be reported to the doctor, as the dose may need to be adjusted.
Treatment usually lasts from 5 to 21 days, but may be longer in severe infections.
Your doctor will administer each dose as a slow intravenous infusion into the bloodstream. The infusion time
in children is 60 minutes. In adult patients, the infusion time for Ciprofloxacin Kabi 400 mg/200 ml is 60 minutes,
and for Ciprofloxacin Kabi 200 mg/100 ml it is 30 minutes. Slow infusion helps prevent sudden adverse reactions.
It is important to drink plenty of fluids while receiving Ciprofloxacin Kabi.

Overdose of Ciprofloxacin Kabi
If the patient has received too high a dose of Ciprofloxacin Kabi, the following symptoms may occur:
dizziness, tremor, headache, fatigue, discomfort in the abdominal cavity, or confusion.
You should inform the doctor or nurse if any of these symptoms occur.

Missed dose of Ciprofloxacin Kabi
Do not administer a double dose to make up for a missed dose.

Discontinuation of Ciprofloxacin Kabi
It is important not to stop treatment prematurely, even if the patient feels better after a few days of treatment.
Stopping the medicine too early may result in incomplete treatment of the infection, and symptoms may return or worsen.
Antibiotic resistance may also develop.
If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Below are the most commonly occurring adverse reactions that a patient may recognize independently.
You must stop using Ciprofloxacin Kabi and contact your doctor immediately
to consider treatment with another antibiotic if any of the following adverse reactions occur:

Uncommon (may affect up to 1 in 100 patients):

  • Seizures (see section 2 "Warnings and precautions").

Rare (may affect up to 1 in 1,000 patients):

  • Severe, sudden allergic reaction accompanied by: chest tightness, dizziness, nausea or fainting, or dizziness upon standing (anaphylactic shock) (see section 2 "Warnings and precautions");
  • Tendon rupture, especially of the large tendon at the back of the ankle (Achilles tendon) (see section 2 "Warnings and precautions").

Very rare (may affect up to 1 in 10,000 patients):

  • Severe, life-threatening allergic reaction accompanied by: chest tightness, dizziness, nausea or fainting, or dizziness upon standing (anaphylactic reaction) (see section 2 "Warnings and precautions");
  • Muscle weakness, tendon inflammation, which may lead to tendon rupture, especially of the large tendon at the back of the ankle (Achilles tendon) (see section 2 "Warnings and precautions");
  • Severe, life-threatening skin rash, usually presenting as blisters or ulcers in the mouth, throat, nose, eyes, and other mucous membranes such as genital organs, which may progress to extensive blistering or skin peeling (Stevens-Johnson syndrome, toxic epidermal necrolysis).

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

  • Unusual sensations of pain, burning, tingling, numbness, or muscle weakness in the limbs (neuropathy) (see section 2 "Warnings and precautions");
  • Drug reaction causing rash, fever, internal organ inflammation, hematological disorders, and systemic illness (DRESS syndrome - drug reaction with eosinophilia and systemic symptoms, AGEP - acute generalized exanthematous pustulosis);
  • Syndrome associated with impaired water excretion from the body and reduced sodium concentration in the blood (SIADH, syndrome of inappropriate antidiuretic hormone secretion).

Other adverse reactions observed during treatment with Ciprofloxacin Kabi are listed below according to their frequency of occurrence.

Common (may affect up to 1 in 10 patients):

  • Nausea, diarrhoea, vomiting;
  • Joint pain, joint inflammation in children;
  • Injection site reaction, rash;
  • Transient increase in aminotransferase activity (a type of enzyme).

Uncommon (may affect up to 1 in 100 patients):

  • Joint pain in adult patients;
  • Fungal superinfections;
  • High eosinophil count (a type of white blood cell), increased or decreased platelet count (blood clotting factor);
  • Decreased appetite, loss of appetite (anorexia);
  • Excessive activity, restlessness, confusion, disorientation, hallucinations;
  • Headache, dizziness, sleep disturbances, taste disturbances, pricking, increased sensitivity to sensory stimuli, seizures (see section 2 "Warnings and precautions"), sensation of spinning;
  • Visual disturbances, including double vision;
  • Hearing loss;
  • Rapid heartbeat (tachycardia);
  • Blood vessel dilation, low blood pressure;
  • Stomach pain, digestive disorders such as indigestion (dyspepsia, heartburn), flatulence;
  • Liver function disorders, elevated levels of one of the blood substances (bilirubin), jaundice (cholestatic jaundice);
  • Itching, urticaria;
  • Impaired kidney function, kidney failure;
  • Muscle and bone pain, malaise (weakness), fever, fluid retention;
  • Increased alkaline phosphatase activity in blood (a specific blood substance).

Rare (may affect up to 1 in 1,000 patients):

  • Muscle pain, joint inflammation, increased muscle tension, cramps;
  • Antibiotic-associated inflammation of the intestine (colitis) (rarely may be fatal) (see section 2 "Warnings and precautions");
  • Changes in blood cell count (leukopenia, leukocytosis, neutropenia, anaemia), decreased number of red and white blood cells and platelets (pancytopenia), which may be fatal, bone marrow suppression, which may also be fatal (see section 2 "Warnings and precautions");
  • Allergic reaction, swelling (edema) or rapid swelling of the skin and mucous membranes (angioedema);
  • Increased blood sugar levels (hyperglycemia);
  • Decreased blood sugar levels (hypoglycemia) (see section 2 "Warnings and precautions");
  • Anxiety reactions, unusual dreams, depression (which may lead to suicidal thoughts, suicide attempts or suicide), psychiatric disorders (psychotic reactions which may lead to suicidal thoughts, suicide attempts or suicide) (see section 2 "Warnings and precautions");
  • Increased sensitivity to sensory stimuli, tremor, migraine, disturbance of the sense of smell (olfactory disturbances);
  • Tinnitus, hearing disturbances;
  • Fainting, inflammation of blood vessels (phlebitis);
  • Shortness of breath with asthmatic symptoms;
  • Pancreatitis;
  • Hepatitis, liver cell death (liver necrosis), very rarely leading to liver failure;
  • Photosensitivity (see section 2 "Warnings and precautions"), small pinpoint skin hemorrhages (petechiae);
  • Blood or crystals in urine (see section 2 "Warnings and precautions"), urinary tract inflammation;
  • Excessive sweating;
  • Elevated levels of the enzyme amylase.

Very rare (may affect up to 1 in 10,000 patients):

  • Specific decrease in red blood cell count (hemolytic anaemia), dangerous decrease in white blood cell count (agranulocytosis), potentially life-threatening (see section 2 "Warnings and precautions");
  • Allergic reaction known as serum sickness-like reaction (see section 2 "Warnings and precautions");
  • Coordination disturbances, unsteady gait, increased pressure on the brain (intracranial hypertension and pseudotumor cerebri);
  • Disturbed color vision;
  • Small dark spots visible under the skin or rashes;
  • Worsening of myasthenia symptoms (see section 2 "Warnings and precautions").

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

  • Feeling of intense excitement (mania) or feeling of great optimism and hyperactivity (hypomania);
  • Unusual acceleration of heart rate, life-threatening irregular heart rhythm, heart rhythm disturbances (known as QT interval prolongation, visible on ECG, i.e. electrocardiogram);
  • Effect on blood coagulation (in patients taking vitamin K antagonists);
  • Loss of consciousness due to severe drop in blood sugar levels (hypoglycemic coma). See section 2.

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 drug 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), fatigue, memory and concentration problems, mental health effects (including sleep disturbances, anxiety, panic attacks, depression, and suicidal thoughts), as well as hearing, vision, taste, and smell disturbances.

Cases of arterial wall dilation and weakening or arterial wall rupture (aneurysm and dissection) leading to rupture and potentially resulting in death, as well as cases of heart valve insufficiency, have been reported in patients receiving fluoroquinolones. See also section 2.

Reporting of adverse reactions

If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:

Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +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.

By reporting adverse reactions, additional information on the safety of this medicine can be collected.

5. How to store Ciprofloxacin Kabi

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging following “Expiry date”. The expiry date refers to the last day of the stated month.
Do not store in the refrigerator or freeze.
Store the infusion bag inside the outer bag until use to protect from light.
Store the infusion bottle inside the outer packaging until use to protect from light.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.

6. Contents of the package and other information

What Ciprofloxacin Kabi contains

  • The active substance is ciprofloxacin (in the form of hydrochloride).
  • The other ingredients are: sodium chloride, sulfuric acid, sodium hydroxide for pH adjustment, water for injections.

What Ciprofloxacin Kabi looks like and contents of the pack
Ciprofloxacin Kabi is a sterile, clear, colourless infusion solution.
The solution is contained in a transparent, flexible polyolefin bag placed inside an outer aluminium bag (Freeflex bags) or in a polyethylene bottle (KabiPac), packed in a cardboard box.

Ciprofloxacin Kabi 100 mg/50 ml, infusion solution
50 ml of solution contains 100 mg of ciprofloxacin.
Pack sizes:
1, 5, 10, 20, 30 or 40 bags;
1, 5, 10, 20, 30 or 40 bottles.

Ciprofloxacin Kabi 200 mg/100 ml, infusion solution
100 ml of solution contains 200 mg of ciprofloxacin.
Pack sizes:
1, 5, 10, 20, 30 or 40 bags;
1, 5, 10, 20, 30 or 40 bottles.

Ciprofloxacin Kabi 400 mg/200 ml, infusion solution
200 ml of solution contains 400 mg of ciprofloxacin.
Pack sizes:
1, 5, 10, 20, 30 or 40 bags;
1, 5, 10, 20, 30 or 40 bottles.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Fresenius Kabi Deutschland GmbH
D-61346 Bad Homburg v.d.H.
Germany

Manufacturer
Fresenius Kabi Polska Sp. z o.o.
Infusion Solutions Manufacturing Plant
ul. Sienkiewicza 25
99-300 Kutno
HP Halden Pharma AS
Svinesundsveien 80
1788 Halden
Norway

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

This medicinal product is authorised for marketing in the European Economic Area countries under the following names:
Austria: Ciprofloxacin Kabi 100 mg/50 ml, -200 mg/100 ml, -400 mg/200 ml Infusionslösung
Belgium: Ciprofloxacin Fresenius Kabi 200 mg/100 ml, -400 mg/200 ml solution for perfusion/Infusionslösung/oplossing voor intraveneuze infusie
Cyprus: Ciprofloxacin Kabi 200 mg/100 ml, -400 mg/200 ml διάλυμα για έγχυση
Czech Republic: Ciprofloxacin Kabi
Denmark: Ciprofloxacin Fresenius Kabi 2 mg/ml infusionsvæske
Finland: Ciprofloxacin Fresenius Kabi 2 mg/ml infuusioneste, liuos
Greece: Ciprofloxacin Kabi 200 mg/100 ml, -400 mg/200 ml διάλυμα για έγχυση
Spain: Ciprofloxacin Kabi 2 mg/ml solución para perfusión EFG
Netherlands: Ciprofloxacin Kabi 100 mg/50 ml, -200 mg/100 ml, -400 mg/200 ml oplossing voor infusie
Iceland: Ciprofloxacin Fresenius Kabi
Malta: Ciprofloxacin Kabi 200 mg/100 ml, -400 mg/200 ml solution for infusion
Germany: Ciprofloxacin Kabi 100 mg/50 ml, -200 mg/100 ml, 400 mg/200 ml Infusionslösung
Poland: Ciprofloxacin Kabi 100 mg/50 ml, -200 mg/100 ml, -400 mg/200 ml, roztwór do infuzji
Portugal: Ciprofloxacina Kabi
Slovakia: Ciprofloxacin Kabi 200 mg/100 ml, -400 mg/200 ml infúzny roztok
Sweden: Ciprofloxacin Fresenius Kabi 2 mg/ml infusionsvätska, lösning
Hungary: Ciprofloxacin Kabi 200 mg/100 ml, -400 mg/200 ml oldatos infúzió
Italy: Ciprofloxacin Kabi

Advice – Medical education
Antibiotics are used to treat bacterial infections. They are not effective against viral infections. Antibiotics should only be used for conditions as prescribed by a doctor. Despite antibiotic treatment, some bacteria may survive or multiply. This phenomenon is known as resistance: sometimes antibiotic treatment becomes ineffective.

Improper use of antibiotics increases resistance. It may even cause bacteria to become resistant, prolonging treatment or reducing the effectiveness of the antibiotic, if the patient does not follow the doctor's instructions regarding:

  • dosage;
  • frequency of administration;
  • duration of treatment.

Therefore, to maintain the effectiveness of this medicine, you should:
1 – use antibiotics only when prescribed by a doctor;
2 – strictly follow the doctor's instructions;
3 – do not reuse antibiotics without a doctor's prescription, even if the current illness appears similar to the one for which the antibiotic was originally prescribed;
4 – never give antibiotics to another person, as it may be inappropriate for their condition;
5 – after completing treatment, return any unused medicine to the pharmacy for proper disposal.


Information intended exclusively for healthcare professionals:

Ciprofloxacin Kabi should be administered as an intravenous infusion.
The infusion duration in children is 60 minutes. In adult patients, the infusion duration of
Ciprofloxacin Kabi 400 mg/200 ml is 60 minutes, and for Ciprofloxacin Kabi 200 mg/100 ml,
it is 30 minutes. Slow infusion into a large vein minimizes patient discomfort
and reduces the risk of venous irritation. The infusion solution may be administered directly
or after mixing with other compatible infusion solutions.
If compatibility with other infusion solutions or drugs has not been confirmed, the infusion solution
should be administered separately. Visible signs of incompatibility include, for example, precipitation,
turbidity, or discoloration.
Incompatibility occurs with all infusion solutions or drugs that are physically or chemically unstable at the pH of the solution (e.g., penicillins, heparin solutions), particularly when mixed with solutions whose pH has been adjusted to alkaline (pH of ciprofloxacin infusion solution: 4.0–4.9).
After initial intravenous administration, treatment may be continued with oral antibiotic therapy.