Ciprofloxacin Kabi 100 mg/50 ml roztvur do infuzii

Leaflet accompanying the packaging: information for the user

Ciprofloxacin Kabi 100 mg/50 ml, solution for infusion

Ciprofloxacin Kabi 200 mg/100 ml, solution for infusion

Ciprofloxacin Kabi 400 mg/200 ml, solution for infusion

Ciprofloxacin

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

• You should keep this leaflet, so that you can read it again if you need to.
• In case of any doubts, you should consult a doctor, pharmacist, or nurse.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 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 packaging and other information

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

The active substance of Ciprofloxacin Kabi is ciprofloxacin. Ciprofloxacin is an antibiotic from the fluoroquinolone group. Ciprofloxacin works by killing the bacteria that cause infections. It only works on certain strains of bacteria.
Adult patients
Ciprofloxacin Kabi is used in adult patients to treat the following bacterial infections:

• respiratory tract infections;
• prolonged or recurrent ear or sinus infections;
• urinary tract infections;
• testicular infections;
• genital infections in women;
• gastrointestinal tract infections and intra-abdominal infections;
• skin and soft tissue infections;
• bone and joint infections;
• treatment of infections in patients with very low white blood cell count (neutropenia);
• prevention of infections in patients with very low white blood cell count (neutropenia);
• exposure to anthrax spores. If the infection is severe or caused by more than one type of bacteria, the doctor may prescribe an additional antibiotic to be used simultaneously with Ciprofloxacin Kabi.

Children and adolescents
Ciprofloxacin Kabi is used in children and adolescents, under the supervision of a specialist doctor, to treat 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 anthrax spores.

Ciprofloxacin Kabi can 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, other quinolone antibiotics, or any of the other ingredients of this medicine (listed in section 6);
• if the patient is taking tizanidine (see section 2 "Ciprofloxacin Kabi and other medicines").

Warnings and precautions

Before taking this medicine
Fluoroquinolone or quinolone antibacterial medicines, including Ciprofloxacin Kabi, should not be used if the patient has previously experienced a severe side effect while taking a quinolone or fluoroquinolone antibiotic. In such cases, the doctor should be informed as soon as possible.

Before using Ciprofloxacin Kabi

The doctor, pharmacist, or nurse should be informed if the patient:

• has ever had kidney problems, as the dose may need to be adjusted;
• has epilepsy or other neurological disorders;
• has had tendon problems during treatment with antibiotics such as Ciprofloxacin Kabi;
• has diabetes, as ciprofloxacin may cause hypoglycemia;
• has myasthenia gravis (a type of muscle weakness), as symptoms may worsen;
• has a dilated blood vessel (aortic aneurysm or large peripheral artery aneurysm);
• has had aortic dissection (tear in the aortic wall);
• has heart valve problems;
• has a family history of aortic aneurysm or aortic dissection, or congenital heart valve problems, or other risk factors or 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, or confirmed atherosclerosis, rheumatoid arthritis [joint disease], or endocarditis [heart infection]);
• has heart problems. Caution should be exercised when using the medicine in patients with congenital QT interval prolongation or a family history of QT interval prolongation (visible on an ECG), patients with disturbed mineral balance (especially low potassium or magnesium levels), significant bradycardia, heart failure, or a history of myocardial infarction (heart attack), in women, or in elderly patients, or when taking other medicines that may cause abnormal ECG changes (see section 2 "Ciprofloxacin Kabi and other medicines");
• or has a family history of glucose-6-phosphate dehydrogenase deficiency (G6PD), as ciprofloxacin may cause hemolytic anemia.

In the treatment of some urinary tract infections, the doctor may prescribe an additional antibiotic, in addition to ciprofloxacin. If the patient does not improve within three days of treatment, they should consult their doctor.

During treatment with Ciprofloxacin Kabi

If during treatment with Ciprofloxacin Kabiany of the following symptoms occur, the doctor should be informed immediately. The doctor will decide whether to discontinue treatment with Ciprofloxacin Kabi.
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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 the following symptoms: chest tightness, dizziness, nausea, fainting, or dizziness when standing up. If this happens, treatment with Ciprofloxacin Kabi should be discontinued and medical help should be sought immediately.
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Rarely, joint and tendon pain and inflammation, or tendon rupturemay occur. The risk is increased in elderly patients (over 60 years), after organ transplantation, in patients with kidney problems, or during corticosteroid treatment.
Tendon inflammation and rupture can occur within the first 48 hours of treatment and even several months after discontinuation of Ciprofloxacin Kabi. After the first symptoms of pain or tendon inflammation (e.g., in the ankle, wrist, elbow, shoulder, or knee), treatment with Ciprofloxacin Kabi should be discontinued, and medical help should be sought. The affected area should be rested, and excessive strain should be avoided, as it may increase the risk of tendon rupture.
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In case of sudden, severe abdominal, back, or chest pain, which may be a sign of aortic aneurysm or aortic dissection, immediate medical attention is required. The risk of these changes may be higher in patients treated with systemic corticosteroids.
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In case of sudden shortness of breath, especially when lying down, or swelling of the ankles, feet, or abdomen, or palpitations (feeling of rapid or irregular heartbeat), medical help should be sought immediately.
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In case of sudden, severe abdominal, back, or chest pain, immediate medical attention is required.
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If the patient has epilepsyor other neurological disorders, such as cerebral ischemia or stroke, adverse reactions related to the central nervous system may occur. If seizures occur, treatment with Ciprofloxacin Kabi should be discontinued, and medical help should be sought immediately.
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The patient may rarely experience symptoms of nerve damage (neuropathy), such as pain, burning, tingling, numbness, or weakness, especially in the feet and legs, and hands and arms. In such cases, treatment with Ciprofloxacin Kabi should be discontinued, and medical help should be sought immediately to prevent the development of potentially irreversible disease.
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After the first administration of Ciprofloxacin Kabi, psychotic reactionsmay occur. If the patient has depressionor psychosis, symptoms of these conditions may worsen during treatment with Ciprofloxacin Kabi. If this happens, treatment with Ciprofloxacin Kabi should be discontinued, and medical help should be sought immediately.
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Fluoroquinolone antibiotics may cause increased blood sugar levelsabove normal ( hyperglycemia) or decreased blood sugar levelsbelow normal, which can lead to loss of consciousness ( hypoglycemic coma) (see section 4). This is important for patients with diabetes. Patients with diabetes are advised to closely monitor their blood sugar levels.
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During treatment with antibiotics, including Ciprofloxacin Kabi, or even several weeks after discontinuation, diarrheamay occur. If it is severe or persistent, or if the patient notices blood or mucus in the stool, they should seek medical help immediately. Treatment with Ciprofloxacin Kabi should be discontinued, as it can be life-threatening. Medicines that slow down or stop bowel movements should not be taken.
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If the patient experiences vision problemsor any vision disturbances, they should consult an ophthalmologist immediately.
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During treatment with Ciprofloxacin Kabi, the skin becomes more sensitive to sunlightand ultraviolet radiation (UV). The patient should avoid exposure to strong sunlight or artificial UV radiation (e.g., in a solarium).
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If the patient is going to have a blood or urine test, they should inform their doctor or laboratory staff that they are taking Ciprofloxacin Kabi.
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If the patient has kidney problems, they should inform their doctor, as the dose may need to be adjusted.
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Ciprofloxacin Kabi may cause liver damage. If the patient notices any of the following symptoms: loss of appetite, jaundice (yellowing of the skin), dark urine, itching, or stomach upset, they should discontinue treatment with Ciprofloxacin Kabi immediately.
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Ciprofloxacin Kabi may decrease the number of white blood cells, which can lead to decreased resistance to infections. If the patient notices any of the following symptoms: fever and severe deterioration of general condition or fever with local signs of infection, such as sore throat, pharyngitis, oral cavity problems, or urinary tract problems, they should seek medical help immediately. A blood test will be ordered to check if the number of white blood cells has decreased (agranulocytosis). The patient should remember to inform their doctor that they are taking this medicine.

Long-term, disabling, and potentially irreversible severe side effects

Fluoroquinolone and quinolone antibacterial medicines, including Ciprofloxacin Kabi, have been associated with very rare but severe side effects. Some of these have been long-term (lasting for months or years), disabling, or potentially irreversible. These include: tendon pain, muscle pain, and joint pain in the upper and lower limbs, walking difficulties, abnormal sensations, such as tingling, burning, prickling, numbness, or weakness (paresthesia), sensory disturbances, including vision, taste, smell, and hearing disturbances, depression, memory impairment, severe fatigue, and severe sleep disturbances.
If any of these side effects occur after taking Ciprofloxacin Kabi, the patient should seek medical help immediately before continuing treatment. The patient and doctor will decide whether to continue treatment, also considering antibiotics from another group.

Ciprofloxacin Kabi and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Ciprofloxacin Kabi should not be taken simultaneously with tizanidine, as side 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 body. Taking Ciprofloxacin Kabi simultaneously with these medicines may affect their therapeutic effect. It may also increase the likelihood of side effects.

If the patient is taking any of the following medicines, they should inform their 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: antiarrhythmic medicines (e.g., quinidine, hydroquinidine, disopyramide, amiodarone, sotalol,

dofetilide, ibutilide), tricyclic antidepressants, certain antibacterial medicines (belonging to the macrolide group), or certain antipsychotic medicines;

• zolpidem (used in sleep disorders);
• metoclopramide (used in nausea and vomiting);
• omeprazole (used in stomach ulcer treatment).

Ciprofloxacin Kabi may increasethe levels of the following medicines in the blood:

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

Ciprofloxacin Kabi with food and drink

Food and drink do not affect the use of Ciprofloxacin Kabi.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.
It is recommended to avoid using Ciprofloxacin Kabi in pregnant women.
Ciprofloxacin Kabi should not be used during breastfeeding, as ciprofloxacin passes into human milk and may harm the baby.

Driving and using machines

Ciprofloxacin Kabi may cause drowsiness. Adverse reactions related to the nervous system may occur. Before driving or operating machinery, the patient should check how they react to Ciprofloxacin Kabi. In case of doubts, they should consult their doctor.

Ciprofloxacin Kabi contains sodium

This medicine contains 347 mg of sodium (the main component of common salt) per 100 ml. This corresponds to 17% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to use Ciprofloxacin Kabi

This medicine should always be used as directed by the doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.
The doctor will explain exactly how much 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 kidney problems, they should inform their doctor, as the dose may need to be adjusted.
Treatment usually lasts from 5 to 21 days, but in severe infections, it may be longer.
The doctor will administer each dose by slow intravenous infusion into the blood. The infusion time for children is 60 minutes. For 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 can help avoid sudden side effects.
The patient should remember to drink plenty of fluids during treatment with Ciprofloxacin Kabi.

Using a higher dose of Ciprofloxacin Kabi than recommended

If the patient receives too high a dose of Ciprofloxacin Kabi, the following symptoms may occur: dizziness, trembling, headache, fatigue, discomfort in the abdomen, or confusion.

The patient should inform their doctor or nurse if they experience any of these symptoms.

Missing a dose of Ciprofloxacin Kabi

A double dose should not be taken to make up for a missed dose.

Stopping treatment with Ciprofloxacin Kabi

It is essential not to stop treatment, even if the patient feels better after a few days of treatment. If the patient stops treatment too early, the infection may not be fully treated, and the symptoms of the infection may return or worsen. Resistance to the antibiotic may also develop.
In case of any further doubts about using this medicine, the patient should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Ciprofloxacin Kabi can cause side effects, although not everybody gets them.
The following are the most common side effects that the patient may recognize themselves.

The patient should stop using Ciprofloxacin Kabi and seek medical help immediately

to consider treatment with another antibiotic, if they experience any of the following side effects:
Uncommon(may affect up to 1 in 100 people):

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

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

• severe, sudden allergic reaction, which may include: chest tightness, dizziness, nausea, or fainting, or dizziness when standing up (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 people):

• severe, sudden allergic reaction, which may include: chest tightness, dizziness, nausea, or fainting, or dizziness when standing up (anaphylactic reaction) (see section 2 "Warnings and precautions");
• tendon 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, potentially life-threatening skin rash, usually in the form of blisters or ulcers in the mouth, throat, nose, eyes, and on other mucous membranes, such as the genitals, which may develop into widespread blisters or skin peeling (Stevens-Johnson syndrome, toxic epidermal necrolysis).

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

• nerve damage (neuropathy) (see section 2 "Warnings and precautions");
• drug reaction causing rash, fever, inflammation of internal organs, hematological disturbances, and systemic diseases (DRESS - drug reaction with eosinophilia and systemic symptoms, AGEP - acute generalized exanthematous pustulosis);
• syndrome associated with water retention disorder and decreased sodium levels in the blood (SIADH, syndrome of inappropriate secretion of antidiuretic hormone).

Other side effects observed during treatment with Ciprofloxacin Kabi are listed below by frequency of occurrence.
Common(may affect up to 1 in 10 people):

• nausea, diarrhea, vomiting;
• joint pain, arthritis in children;
• reaction at the injection site, rash;
• transient increase in liver enzyme activity (a type of enzyme in the blood).

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

• joint pain in adult patients;
• fungal superinfections;
• high eosinophil count (a type of white blood cell), increased or decreased blood clotting factor levels (platelet count);
• decreased appetite, loss of appetite (anorexia);
• excessive activity, agitation, confusion, disorientation;
• headache, dizziness, sleep disturbances, taste disturbances, paresthesia, excessive sensitivity to stimuli, seizures (see section 2 "Warnings and precautions"), feeling of spinning;
• vision disturbances, including double vision;
• hearing loss;
• rapid heartbeat (tachycardia);
• vasodilation, low blood pressure;
• stomach pain, digestive disturbances, such as indigestion (dyspepsia, heartburn), gas;
• liver function disturbances, increased bilirubin levels in the blood, jaundice (cholestatic jaundice);
• itching, hives;
• kidney function impairment, kidney failure;
• muscle and bone pain, general malaise (weakness), fever, fluid retention;
• increased alkaline phosphatase activity in the blood (a specific substance in the blood).

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

• muscle pain, arthritis, increased muscle tension, muscle spasms;
• antibiotic-associated colitis (inflammation of the colon) (rarely can be fatal) (see section 2 "Warnings and precautions");
• blood count changes (leukopenia, leukocytosis, neutropenia, anemia), decreased red and white blood cell and platelet count (pancytopenia), which can be life-threatening, bone marrow suppression, which can also be life-threatening (see section 2 "Warnings and precautions");
• allergic reaction, angioedema, or rapid swelling of the skin and mucous membranes (angioedema);
• high blood sugar levels (hyperglycemia);
• low blood sugar levels (hypoglycemia) (see section 2 "Warnings and precautions");
• anxiety reactions, unusual dreams, depression (which can lead to suicidal thoughts, suicide attempts, or suicide), psychotic disorders (which can lead to suicidal thoughts, suicide attempts, or suicide) (see section 2 "Warnings and precautions");
• excessive sensitivity to stimuli, tremors, migraines, disturbances in the sense of smell (smell disturbances);
• ringing in the ears, hearing disturbances;
• fainting, vasculitis (inflammation of blood vessels);
• shortness of breath with asthma-like symptoms;
• pancreatitis;
• liver inflammation, liver cell death (liver necrosis) very rarely leading to liver failure;
• sensitivity to light (see section 2 "Warnings and precautions"), small pinpoint bleeding under the skin (petechiae);
• blood or crystals in the urine (see section 2 "Warnings and precautions"), urinary tract inflammation;
• excessive sweating;
• increased amylase enzyme levels.

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

• specific decrease in red blood cell count (hemolytic anemia), life-threatening decrease in white blood cell count (agranulocytosis), which can be life-threatening (see section 2 "Warnings and precautions");
• allergic reaction called serum sickness (see section 2 "Warnings and precautions");
• coordination disturbances, unsteady gait, increased intracranial pressure 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 the available data):

• feeling of intense excitement (mania) or feeling of great optimism and overactivity (hypomania);
• abnormal heart rhythm, life-threatening irregular heart rhythm, heart rhythm disturbances (called QT interval prolongation, visible on an ECG),
• effect on blood clotting (in patients taking vitamin K antagonists);
• loss of consciousness due to severe drop in blood sugar levels (hypoglycemic coma). See section 2.

Administration of fluoroquinolone and quinolone antibiotics, in some cases regardless of pre-existing risk factors, has very rarely caused long-term (lasting for months or years) or permanent side effects, such as tendon inflammation, tendon rupture, joint pain, limb pain, walking difficulties, abnormal sensations, such as tingling, burning, prickling, numbness, or weakness (neuropathy), fatigue, memory impairment, severe sleep disturbances, and effects on mental health (including sleep disturbances, anxiety, panic attacks, depression, and suicidal thoughts) and hearing, vision, taste, and smell disturbances.
Aortic aneurysm or aortic dissection (a tear in the aortic wall) and heart valve problems have been reported in patients taking fluoroquinolones.

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, the patient should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
tel.: +48 22 49 21 301
fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl/
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Ciprofloxacin Kabi

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Expiry date". The expiry date refers to the last day of the month.
Do not store in the refrigerator or freeze.
Store the infusion bag in the outer bag until use, to protect it from light.
Store the infusion bottle in the outer packaging until use, to protect it from light.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Ciprofloxacin Kabi contains

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

What Ciprofloxacin Kabi looks like and contents of the packaging

Ciprofloxacin Kabi is a sterile, clear, colorless solution for infusion.
The solution is in a transparent, flexible polyolefin bag placed in an aluminum outer bag (Freeflex bags) or in a polyethylene bottle (KabiPac), in a cardboard box.
Ciprofloxacin Kabi 100 mg/50 ml, solution for infusion
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, solution for infusion
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, solution for infusion
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 authorization holder and manufacturer

Marketing authorization holder

Fresenius Kabi Deutschland GmbH
D-61346 Bad Homburg v.d.H.
Germany

Manufacturer

Fresenius Kabi Polska Sp. z o.o.
Infusion Fluids Factory
ul. Sienkiewicza 25
99-300 Kutno
HP Halden Pharma AS
Svinesundsveien 80
1788 Halden
Norway
To obtain more detailed information, the patient should contact the representative of the marketing authorization holder:
Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw
tel.: +48 22 345 67 89

This medicinal product is authorized in the Member States of the European Economic Area 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 pour perfusion/Infusionslösung/ oplossing voor intraveneuze infusie
Cyprus:
Ciprofloxacin Kabi 200mg/100ml, -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, solution for infusion
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
Date of last revision of the leaflet:05.03.2025

Advice - medical education

Antibiotics are used to treat bacterial infections. They do not work in viral infections.
Antibiotics should only be used in diseases where they have been prescribed by a doctor. Despite the action of antibiotics, some bacteria may survive or multiply. This phenomenon is called resistance: sometimes antibiotic treatment becomes ineffective.
Incorrect use of antibiotics increases resistance. It is possible to cause bacteria to become resistant and prolong treatment or reduce the effectiveness of the antibiotic if the patient does not follow the doctor's instructions regarding:

• dose size;
• frequency of administration;
• duration of treatment.

Consequently, to maintain the effectiveness of this medicine, the patient should:

• 1 – use antibiotics only when prescribed by a doctor;
• 2 – strictly follow the doctor's instructions;
• 3 – not use an antibiotic again without a doctor's prescription, even if the current illness is similar to the illness for which the antibiotic was prescribed;
• 4 – never give an antibiotic to another person, as it may be inappropriate for their illness;
• 5 – after completing treatment, return any unused medicine to the pharmacy, so that it can be disposed of properly.

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Information intended for healthcare professionals only:

Ciprofloxacin Kabi should be administered by intravenous infusion.
The infusion time for children is 60 minutes. For 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 into a large vein will minimize patient discomfort and reduce the risk of vein irritation. The infusion solution can be administered directly or after mixing with other compatible infusion solutions.
If compatibility with other infusion solutions or medicines has not been confirmed, the infusion solution should be administered separately. Visible signs of incompatibility include, for example, precipitation, clouding, or discoloration.
Incompatibility occurs with all infusion solutions or medicines that are physically or chemically unstable in the pH of the solution (e.g., penicillins, heparin solutions), especially after mixing with solutions whose pH has been adjusted to alkaline (pH of ciprofloxacin infusion solution: 4.0-4.9).
After initial intravenous administration, treatment can also be continued with oral antibiotics.