Ciprofloxacin Kabi 400 mg/200 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 side effects, including any side effects 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 a very low white blood cell count (neutropenia);
• prevention of infections in patients with a 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:

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. 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 of the medicine 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 the symptoms may worsen;
• has an aortic aneurysm or a large peripheral arterial aneurysm;
• has had an aortic dissection (tear in the aortic wall);
• has a heart valve problem;
• has a family history of aortic aneurysm or aortic dissection, 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 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 elderly patients, or patients 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 another antibiotic in addition to ciprofloxacin. If the patient does not improve within three days of treatment, they should consult their doctor.

While using Ciprofloxacin Kabi

If while using Ciprofloxacin Kabiany of the following symptoms occur, the doctor should be informed immediately. The doctor will decide whether to stop using 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 the following symptoms: chest tightness, dizziness, nausea, fainting, or dizziness when standing up. If this happens, Ciprofloxacin Kabi should be discontinued and medical help should be sought immediately.
Pain and swelling of the joints and tendons, as well as tendon inflammation or rupture. The risk is increased in elderly patients (over 60 years), after organ transplantation, in patients with kidney problems, or those taking corticosteroids.
Tendon inflammation and rupture can occur within the first 48 hours of treatment and even several months after stopping Ciprofloxacin Kabi. After the first symptoms of pain or tendon inflammation (e.g., in the ankle, wrist, elbow, shoulder, or knee), Ciprofloxacin Kabi should be discontinued, and the doctor should be consulted. The affected area should be rested, and excessive stress should be avoided, as it may increase the risk of tendon rupture.
Sudden, severe abdominal, back, or chest pain, which may be a sign of an aortic aneurysm or aortic dissection. The risk of these changes may be higher in patients taking systemic corticosteroids.
Sudden, severe shortness of breath, especially when lying down, or swelling of the ankles, feet, or abdomen, or an irregular heartbeat(palpitations), the doctor should be consulted immediately.
If the patient has epilepsyor other neurological disorders, side effects related to the central nervous system may occur. If seizures occur, Ciprofloxacin Kabi should be discontinued, and the doctor should be consulted immediately.
Rarely, symptoms of nerve damage (neuropathy), such as pain, burning, tingling, numbness, or weakness, especially in the feet and legs, and hands and arms, may occur. In such cases, Ciprofloxacin Kabi should be discontinued, and the doctor should be informed immediately to prevent the development of potentially irreversible disease.
After the first administration of Ciprofloxacin Kabi, psychiatric reactionsmay occur. If the patient has depressionor psychosis, the symptoms of these diseases may worsen during treatment with Ciprofloxacin Kabi. If this happens, Ciprofloxacin Kabi should be discontinued, and the doctor should be consulted immediately.
Fluoroquinolone antibiotics may cause an increase in blood sugar levelsabove normal ( hyperglycemia) or a decrease in blood sugar levels below 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 carefully monitor their blood sugar levels.
During the use of antibiotics, including Ciprofloxacin Kabi, or even several weeks after the end of treatment, diarrheamay occur. If it is severe or persistent, or if the patient notices blood or mucus in the stool, they should consult their doctor immediately. Ciprofloxacin Kabi should be discontinued immediately, as it can be life-threatening. Medicines that slow down or inhibit intestinal movements should not be used.
If the patient experiences a worsening of visionor any visual disturbances, they should consult an ophthalmologist immediately.
During the use of 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).
If the patient is giving a blood or urine sample for analysis, they should inform their doctor or laboratory staff that they are taking Ciprofloxacin Kabi.
If the patient has kidney problems, they should inform their doctor, as the dose may need to be adjusted.
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 Ciprofloxacin Kabi immediately.
Ciprofloxacin Kabi may decrease the number of white blood cells, which can lead to a decrease in resistance to infections. If the patient notices any of the following symptoms during an infection: fever and severe deterioration of general condition or fever with local signs of infection, such as sore throat, laryngitis, oral cavity problems, or urinary tract problems, they should consult their doctor immediately. A blood test will be ordered to check if the number of white blood cells has decreased (agranulocytosis). It is essential to remind the doctor about the use of 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 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 visual, taste, and smell disturbances, as well as hearing disturbances, depression, memory disturbances, severe fatigue, and severe sleep disturbances.
If any of these side effects occur after taking Ciprofloxacin Kabi, the doctor should be consulted 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 doctor or pharmacist should be informed about all medicines the patient is currently taking or has 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 will interact with Ciprofloxacin Kabi in the human body. Taking Ciprofloxacin Kabi simultaneously with these medicines may affect their therapeutic effect. This 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 anticoagulant medicines ("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 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 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 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 using 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 be harmful to the baby.

Driving and using machines

Ciprofloxacin Kabi may cause drowsiness. Side effects 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) in each 100 ml of the solution. 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 doctor or pharmacist should be consulted.
The doctor will explain exactly 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 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 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 can help avoid sudden side effects.
It is essential to drink plenty of fluids while using 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, tremors, headache, fatigue, discomfort in the abdominal cavity, or a feeling of 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 used to make up for a missed dose.

Stopping the use of Ciprofloxacin Kabi

It is essential not to stop treatment, even if the patient feels better after a few days of using the medicine. If the patient stops using the medicine 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 further doubts about the use of this medicine, the doctor, pharmacist, or nurse should be consulted.

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 consult their doctor 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, accompanied by: 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, accompanied by: chest tightness, dizziness, nausea, or fainting, or dizziness when standing up (anaphylactic reaction) (see section 2 "Warnings and precautions");
• tendon weakness, tendon inflammation, which can 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 in the form of blisters or ulcers in the mouth, throat, nose, eyes, and other mucous membranes, such as the genitals, which can develop into widespread blisters or skin peeling (Stevens-Johnson syndrome, toxic epidermal necrolysis).

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

• abnormal sensations of pain, burning, tingling, numbness, or weakness (neuropathy) (see section 2 "Warnings and precautions");
• drug reaction causing rash, fever, inflammation of internal organs, hematological disorders, and systemic diseases (DRESS syndrome - drug reaction with eosinophilia and systemic symptoms, AGEP - acute generalized exanthematous pustulosis);
• a syndrome associated with impaired water excretion 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 according to their frequency.
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 the activity of aminotransferases (a type of enzyme).

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

• joint pain in adult patients;
• fungal superinfections;
• high levels of eosinophils (a type of white blood cell), increased or decreased levels of clotting factors (platelets);
• decreased appetite, loss of appetite (anorexia);
• excessive activity, agitation, confusion, disorientation, hallucinations;
• headache, dizziness, sleep disturbances, taste disturbances, paresthesia, excessive sensitivity to stimuli, seizures (see section 2 "Warnings and precautions"), feeling of spinning;
• visual disturbances, including double vision;
• hearing loss;
• rapid heartbeat (tachycardia);
• vasodilation, low blood pressure;
• stomach pain, digestive disturbances, such as indigestion (dyspepsia), flatulence;
• liver function disorders, increased levels of a substance in the blood (bilirubin), jaundice (cholestatic jaundice);
• itching, hives;
• kidney function impairment, kidney failure;
• muscle and bone pain, general malaise (weakness), fever, fluid retention;
• increased activity of alkaline phosphatase 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;
• inflammation of the colon (large intestine) associated with antibiotic use (rarely can be fatal) (see section 2 "Warnings and precautions");
• changes in blood cell count (leukopenia, leukocytosis, neutropenia, anemia), decreased count of red and white blood cells and platelets (pancytopenia), which can be life-threatening, bone marrow depression, which can also be life-threatening (see section 2 "Warnings and precautions");
• allergic reaction, swelling (angioedema) 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 can lead to suicidal thoughts, suicide attempts, or suicide), psychiatric disturbances (psychotic reactions that can lead to suicidal thoughts, suicide attempts, or suicide) (see section 2 "Warnings and precautions");
• excessive sensitivity to stimuli, tremors, migraine, disturbances in the sense of smell (smell disturbances);
• ringing in the ears, hearing disturbances;
• fainting, inflammation of blood vessels (vasculitis);
• 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"), minor, pinpoint bleeding under the skin (petechiae);
• blood or crystals in the urine (see section 2 "Warnings and precautions"), urinary tract inflammation;
• excessive sweating;
• increased levels of the enzyme amylase.

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

• specific decrease in the number of red blood cells (hemolytic anemia), life-threatening decrease in the number of white blood cells (agranulocytosis), which can be life-threatening (see section 2 "Warnings and precautions");
• allergic reaction called serum sickness (see section 2 "Warnings and precautions");
• coordination disorders, unsteady gait, pressure on the brain (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 (known as QT interval prolongation, visible on an ECG), influence on blood clotting (in patients taking vitamin K antagonists);
• loss of consciousness due to a significant drop in blood sugar levels (hypoglycemic coma). See section 2.

The 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 disturbances, and severe sleep disturbances, as well as effects on mental health (including sleep disturbances, anxiety, panic attacks, depression, and suicidal thoughts) and hearing, vision, taste, and smell disturbances.
Patients treated with fluoroquinolones have reported cases of aortic aneurysm or aortic dissection, and aortic valve regurgitation. See also section 2.

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, the doctor, pharmacist, or nurse should be informed. 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.
Ciprofloxacin Kabi should not be used after the expiry date stated on the packaging after "Expiry date". The expiry date refers to the last day of the month.
The medicine should not be stored in the refrigerator or frozen.
The infusion bag should be stored in the outer bag until use to protect it from light.
The infusion bottle should be stored 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 of Ciprofloxacin Kabi is ciprofloxacin (in the form of hydrochloride).
• The other ingredients are: sodium chloride, sulfuric acid, sodium hydroxide to adjust the pH, water for injections.

What Ciprofloxacin Kabi looks like and what the pack contains

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 the 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 the 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 the 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 representative of the marketing authorization holder should be contacted:
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 be used in diseases for which the doctor has prescribed them. Despite the action of antibiotics, some bacteria may survive or multiply. This phenomenon is called resistance: sometimes antibiotic treatment becomes ineffective.
Improper 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 use;
• duration of treatment.

Consequently, to maintain the effectiveness of this medicine:

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

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Information intended exclusively for healthcare professionals:

Ciprofloxacin Kabi should be administered by intravenous infusion.
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 into a large vein will minimize the patient's 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, precipitate formation, 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 (the pH of the ciprofloxacin infusion solution: 4.0-4.9).
After initial intravenous administration, treatment can also be continued by administering the antibiotic orally.