Ciprofloxacin Kabi 2 mg/ml solution for infusion EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Ciprofloxacin Kabi 2 mg/ml infusion solution EFG

Ciprofloxacin

Read the entire leaflet carefully before you are given this medicine, because it contains important information for you

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• If you experience any adverse reactions, consult your doctor, pharmacist or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Ciprofloxacin Kabi is and what it is used for
2. What you need to know before being given 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

This medicine is for hospital use only.

Ciprofloxacin Kabi contains the active substance ciprofloxacin. Ciprofloxacin is an antibiotic that belongs to the fluoroquinolone family. Ciprofloxacin works by killing the bacteria that cause infections. It is only effective against specific strains of bacteria.

Adults

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

• respiratory tract infections
• prolonged or recurrent ear or sinus infections
• urinary tract infections
• infections of the testicles
• infections of the female genital organs
• gastrointestinal and intra-abdominal tract 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)
• inhalation anthrax exposure

If you have a severe infection or if the infection is caused by more than one type of bacteria, you may be given additional antibiotic treatment alongside Ciprofloxacin Kabi.

Children and adolescents

Ciprofloxacin Kabi is used in children and adolescents, under specialized medical supervision, to treat the following bacterial infections:

• lung and bronchial infections in children and adolescents with cystic fibrosis
• complicated urinary tract infections, including infections that have reached the kidneys (pyelonephritis)
• inhalation anthrax exposure

Ciprofloxacin Kabi may also be used for the treatment of severe infections in children and adolescents when considered necessary.

2. What you need to know before you are given Ciprofloxacin Kabi

Do not use Ciprofloxacin Kabi:

• If you are allergic to the active substance, to other quinolones, or to any of the other components of this medicine (listed in section 6).
• If you are taking tizanidine (see section 2: Use of other medicines).

Warnings and precautions

Before starting this medicine

You must not take antibacterial medicines containing fluoroquinolones or quinolones, including Ciprofloxacin Kabi, if you have previously experienced a serious adverse reaction to a quinolone or fluoroquinolone. If this applies to you, inform your doctor as soon as possible.

Consult your doctor, pharmacist, or nurse before starting to use Ciprofloxacin Kabi if:

• you have ever had kidney problems, as your treatment may need adjustment

• you suffer from epilepsy or other neurological conditions

• you have a history of tendon problems during previous treatment with antibiotics such as Ciprofloxacin Kabi

• you have diabetes, as you may be at risk of hypoglycaemia with ciprofloxacin

• you suffer from myasthenia gravis (a type of muscle weakness), as symptoms may worsen

• you have been diagnosed with enlargement or a “bulge” in a large blood vessel (aortic aneurysm or aneurysm of a large peripheral vessel)

• you have previously experienced an episode of aortic dissection (tear in the wall of the aorta)

• you have been diagnosed with heart valve insufficiency (regurgitation of heart valves)

• you have a family history of aortic aneurysm or aortic dissection, congenital heart valve disease, or other risk factors or predisposing disorders (e.g. connective tissue disorders such as Marfan syndrome or vascular Ehlers-Danlos syndrome, Turner syndrome or Sjögren’s syndrome (an inflammatory autoimmune disease), or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behçet’s disease, known hypertension or atherosclerosis), rheumatoid arthritis (a joint disease), or endocarditis (a heart infection)

• you have heart problems. This type of medicine should be used with caution if you were born with or have a family history of prolonged QT interval (detected on ECG, electrocardiogram, or electrical recording of the heart), if you have an electrolyte imbalance in the blood (especially low levels of potassium or magnesium in the blood), if you have a very slow heart rate (called bradycardia), if you have a weak heart (heart failure), a history of heart attack (myocardial infarction), if you are female or elderly, or if you are taking other medicines that cause abnormal changes in the electrocardiogram (see section 2 “Use of Ciprofloxacin Kabi with other medicines”)

• you or a family member has glucose-6-phosphate dehydrogenase (G6PD) deficiency, as you may be at risk of anaemia with ciprofloxacin.

For the treatment of certain genital tract infections, your doctor may prescribe another antibiotic in addition to ciprofloxacin. If there is no improvement in symptoms after 3 days of treatment, please consult your doctor.

While being treated with Ciprofloxacin Kabi

Inform your doctor immediately if any of the following situations occur during treatment with Ciprofloxacin Kabi. Your doctor will decide whether treatment with Ciprofloxacin Kabi needs to be discontinued.

• Sudden, severe allergic reaction (anaphylactic reaction or shock, angioedema). There is a small chance that even with the first dose, you may experience a severe allergic reaction, with symptoms such as chest tightness, dizziness, nausea or fainting, or dizziness upon standing. If this occurs, inform your doctor immediately, as administration of Ciprofloxacin Kabi must be stopped.

Rarely, joint pain and swelling, and inflammation or rupture of tendons may occur. The risk is higher if you are elderly (over 60 years), have received an organ transplant, have kidney problems, or are being treated with corticosteroids. Tendon inflammation and rupture may occur within the first 48 hours of treatment and even up to several months after stopping treatment with Ciprofloxacin Kabi. At the first sign of tendon pain or swelling (e.g. in the ankle, wrist, elbow, shoulder, or knee), stop taking Ciprofloxacin Kabi, contact your doctor, and rest the affected area. Avoid unnecessary physical activity, as this may increase the risk of tendon rupture.

• If you experience sudden, severe pain in the abdomen, chest, or back, which may be symptoms of aortic dissection or aneurysm, go immediately to an emergency department. The risk may be increased if you are receiving systemic corticosteroid treatment.

• If you begin to experience sudden shortness of breath, especially when lying down, or notice swelling in your ankles, feet, or abdomen, or develop palpitations (sensation of rapid or irregular heartbeat), inform your doctor immediately.

• If you suffer from epilepsy or another neurological condition, such as cerebral ischaemia or stroke, you may experience adverse effects related to the central nervous system. If seizures occur, stop taking Ciprofloxacin Kabi and contact your doctor immediately.

• Rarely, you may experience symptoms of nerve damage (neuropathy) such as pain, burning, tingling, numbness, and/or weakness, especially in the feet and legs or in the hands and arms. If this occurs, stop taking Ciprofloxacin Kabi and inform your doctor immediately to prevent the development of a potentially irreversible disorder.

• You may experience psychiatric reactions after the first dose of ciprofloxacin. If you suffer from depression or psychosis, your symptoms may worsen during treatment with Ciprofloxacin Kabi. If this occurs, stop taking Ciprofloxacin Kabi and contact your doctor immediately.

• Quinolone antibiotics may cause an increase in your blood sugar levels above normal (hyperglycaemia), or a decrease in your blood sugar levels below normal, potentially leading to loss of consciousness (hypoglycaemic coma) in severe cases (see section 4). This is important for people with diabetes. If you have diabetes, you should carefully monitor your blood sugar levels.

• Diarrhoea may develop during use of antibiotics, including Ciprofloxacin Kabi, or even several weeks after stopping them. If it becomes severe or persistent, or if you notice blood or mucus in your stools, inform your doctor immediately. Treatment with Ciprofloxacin Kabi must be stopped immediately, as this may be life-threatening. Do not take medicines that stop or delay intestinal movements.

• If your vision worsens or if you experience any other eye disturbances during treatment with Ciprofloxacin Kabi, consult an ophthalmologist immediately.

• Your skin may become more sensitive to sunlight or ultraviolet (UV) light during treatment with Ciprofloxacin Kabi. Avoid exposure to intense sunlight or artificial UV light, such as sunbeds.

• While taking Ciprofloxacin Kabi, inform your doctor or laboratory staff if you need to undergo a blood or urine test.

• If you have kidney problems, inform your doctor, as your dose may need adjustment.

• Ciprofloxacin Kabi may cause liver injury. If you notice symptoms such as loss of appetite, jaundice (yellowing of the skin), dark urine, itching, or stomach pain, stop taking Ciprofloxacin Kabi immediately.

• Ciprofloxacin Kabi may cause a decrease in white blood cell count and possibly reduce your resistance to infections. If you develop an infection with symptoms such as fever and severe deterioration in your general condition, or fever with signs of local infection such as sore throat/pharynx/mouth, or urinary problems, consult your doctor immediately. A blood test will be performed to check for possible reduction in white blood cells (agranulocytosis). It is important that you inform your doctor about your medication.

Severe, disabling, long-lasting, and potentially irreversible adverse effects

Antibacterial medicines containing fluoroquinolones or quinolones, including Ciprofloxacin Kabi, have been associated with very rare but serious adverse effects, some of which were long-lasting (persisting 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, pins and needles, numbness, or burning (paraesthesia), sensory disturbances such as reduced vision, taste, smell, or hearing, depression, memory impairment, severe fatigue, and serious sleep disorders.

If you experience any of these adverse effects after taking Ciprofloxacin Kabi, contact your doctor immediately before continuing treatment. You and your doctor will decide whether to continue or discontinue treatment, considering also the use of an antibiotic from another class.

Use of Ciprofloxacin Kabi with other medicines

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

Do not use Ciprofloxacin Kabi at the same time as tizanidine, as this could cause adverse effects such as low blood pressure and drowsiness (see section 2 “Do not use Ciprofloxacin Kabi”).

The following medicines are known to interact in your body with Ciprofloxacin Kabi. Taking Ciprofloxacin Kabi at the same time as these medicines may affect the therapeutic effect of these medicines. It may also increase the likelihood of experiencing adverse effects.

Inform your doctor if you are taking:

• Vitamin K antagonists (e.g. warfarin, acenocoumarol, phenprocoumon, or fluindione) or other oral anticoagulants (to thin the blood)

• probenecid (for gout)

• methotrexate (for certain types of cancer, psoriasis, rheumatoid arthritis)

• theophylline (for respiratory problems)

• tizanidine (for muscle spasticity in multiple sclerosis)

• olanzapine (an antipsychotic)

• clozapine (an antipsychotic)

• ropinirole (for Parkinson’s disease)

• phenytoin (for epilepsy)

• cyclosporine (for skin diseases, rheumatoid arthritis, or organ transplantation)

• other medicines that may alter heart rhythm, medicines belonging to the antiarrhythmic group (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), tricyclic antidepressants, some antimicrobials (belonging to the macrolide group), some antipsychotics.

• zolpidem (for sleep disorders)

• metoclopramide (for nausea and vomiting)

• omeprazole (for stomach ulcer)

Ciprofloxacin Kabi may increase blood levels of the following medicines:

• pentoxifylline (for circulatory disorders)

• caffeine

• duloxetine (for depression, diabetic nerve damage, or incontinence)

• lidocaine (for heart conditions or anaesthetic use)

• sildenafil (e.g. for erectile dysfunction)

• agomelatine

• glibenclamide (for diabetes)

Taking Ciprofloxacin Kabi with food and drinks

Food and drinks do not affect your treatment with Ciprofloxacin Kabi.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

It is preferable to avoid using Ciprofloxacin Kabi during pregnancy.

Do not use Ciprofloxacin Kabi during breastfeeding, as ciprofloxacin is excreted in breast milk and may harm your baby.

Driving and using machines

Ciprofloxacin Kabi may reduce your level of alertness. Some neurological effects may occur. Therefore, make sure you know how you react to Ciprofloxacin Kabi before driving or operating machinery. If in doubt, consult your doctor.

Ciprofloxacin Kabi contains sodium

This medicine contains 347 mg of sodium (the main component of table salt) in each 100 ml volume. This corresponds to 17% of the maximum recommended daily dietary intake for an adult.

3. How to use Ciprofloxacin Kabi

Follow exactly the instructions for using this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Your doctor will explain exactly how much Ciprofloxacin Kabi you should be given, how often, and for how long. This will depend on the type of infection you have and its severity.

Inform your doctor if you have kidney problems, as your dose may need to be adjusted. Treatment usually lasts from 5 to 21 days, but may be longer for severe infections.

Your doctor will administer each dose by slow intravenous infusion into the bloodstream. In children, the infusion duration is 60 minutes. In adult patients, the infusion time is 60 minutes for 400 mg of Ciprofloxacin Kabi and 30 minutes for 200 mg of Ciprofloxacin Kabi. Slow infusion helps prevent immediate adverse reactions.

Remember to drink plenty of fluids while taking Ciprofloxacin Kabi.

If you receive more Ciprofloxacin Kabi than you should

If you have received more Ciprofloxacin Kabi than you should, you may experience dizziness, tremors, headache, fatigue, abdominal discomfort, or confusion.

Please inform your doctor or nurse if you experience any of these symptoms.

If you miss a dose of Ciprofloxacin Kabi

Do not administer a double dose to make up for a missed dose.

If you stop treatment with Ciprofloxacin Kabi

It is important that you complete the full course of treatment, even if you start to feel better after a few days. If you stop using this medicine too early, your infection may not be completely cured, and symptoms may return or worsen. You may also develop resistance to the antibiotic.

If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

The following section includes the most serious adverse effects that you can recognize yourself:

Stop taking Ciprofloxacin Kabi and contact your doctor immediately to consider alternative antibiotic treatment if you notice any of the following serious adverse 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 and sudden allergic reaction with symptoms such as chest tightness, dizziness, nausea, or fainting, or experiencing dizziness upon standing (anaphylactic shock) (see section 2: Warnings and precautions)
• tendon rupture, particularly affecting the long 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 and sudden allergic reaction with symptoms such as chest tightness, dizziness, nausea, or fainting, or experiencing dizziness upon standing (anaphylactic reaction) (see section 2: Warnings and precautions)
• muscle weakness, tendon inflammation that may lead to tendon rupture, especially of the long tendon at the back of the ankle (Achilles tendon) (see section 2: Warnings and precautions)
• skin rashes with risk of death, typically presenting as blisters or ulcers in the mouth, throat, nose, eyes, and other mucous membranes such as the genitals, which may progress to widespread 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)
• a drug reaction causing skin rash, fever, internal organ inflammation, blood abnormalities, and systemic illness (DRESS - Drug Reaction with Eosinophilia and Systemic Symptoms, AGEP - Acute Generalized Exanthematous Pustulosis)
• syndrome associated with inadequate water excretion and low sodium concentrations (SIADH)

Other adverse effects observed during treatment with Ciprofloxacin Kabi are listed below by frequency:

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

• nausea, diarrhea, vomiting
• joint pain and inflammation in children
• local reaction at the injection site, skin rash
• temporary increase in blood levels of certain substances (transaminases)

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

• joint pain in adults
• fungal superinfections (fungal infections)
• elevated eosinophil count (a type of white blood cell), increase or decrease in a blood clotting factor (platelets)
• decreased appetite, loss of appetite (anorexia)
• hyperactivity, agitation, confusion, disorientation, hallucinations
• headache, dizziness, sleep disturbances or taste disorders, tingling and numbness, unusual sensitivity to sensory stimuli, seizures (see section 2: Warnings and precautions), vertigo
• vision problems, including double vision
• hearing loss
• increased heart rate (tachycardia)
• dilation of blood vessels (vasodilation), decreased blood pressure
• abdominal pain, digestive problems such as slow digestion (indigestion/heartburn), flatulence
• impaired liver function, increased blood levels of a substance (bilirubin), jaundice (cholestatic jaundice)
• itching, hives
• impaired kidney function, kidney failure
• muscle and bone pain, feeling of malaise (asthenia), fever, fluid retention
• increased blood alkaline phosphatase levels (a blood substance)

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

• muscle pain, joint inflammation, increased muscle tone, cramps
• inflammation of the intestine (colitis) associated with antibiotic use (can be fatal in very rare cases) (see section 2: Warnings and precautions)
• changes in blood cell count (leukopenia, leukocytosis, neutropenia, anemia), decreased levels of red blood cells, white blood cells, and platelets (pancytopenia) which may be life-threatening, bone marrow suppression which may be life-threatening (see section 2: Warnings and precautions)
• allergic reaction, swelling (edema), or rapid swelling of the skin and mucous membranes (angioedema)
• increased blood sugar (hyperglycemia)
  • decreased blood sugar (hypoglycemia) (see section 2: Warnings and precautions)
  • anxiety reactions, strange dreams, depression (which may progress to suicidal thoughts, suicide attempts, or completed suicide), mental disturbances (psychotic reactions which may progress to suicidal thoughts, suicide attempts, or completed suicide) (see section 2: Warnings and precautions)
• decreased skin sensitivity, tremors, migraine, disturbances in the sense of smell
• tinnitus (ringing in the ears), hearing impairment
• fainting, inflammation of blood vessels (vasculitis)
• difficulty breathing, including asthmatic symptoms
• pancreatitis
• hepatitis, death of liver cells (hepatic necrosis), which very rarely leads to life-threatening liver failure with potentially fatal outcome
• sensitivity to light (see section 2: Warnings and precautions), nonspecific blister formation, small hemorrhages at points under the skin (petechiae)
• blood or crystals in urine (see section 2: Warnings and precautions), inflammation of the urinary tract
• excessive sweating
• increased levels of the enzyme amylase

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

• a specific type of decrease in blood cell count (hemolytic anemia), a dangerous decrease in a type of white blood cells (agranulocytosis) which may be life-threatening (see section 2: Warnings and precautions)
• an allergic reaction known as serum sickness-like reaction (see section 2: Warnings and precautions)
• coordination disorder, unsteadiness when walking (gait disturbances), pressure in the brain (increased intracranial pressure and pseudotumor cerebri)
• distortion of colors
• various skin rashes or exanthems (e.g., the potentially life-threatening Stevens-Johnson syndrome or toxic epidermal necrolysis)
  • worsening of symptoms of myasthenia gravis (see section 2: Warnings and precautions)

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

• feeling highly excited (mania) or feeling great optimism and hyperactivity (hypomania)
• abnormally fast heart rate, irregular heartbeat that may be life-threatening, disturbances in heart rhythm (known as "QT interval prolongation," detected on ECG, electrical activity of the heart)
• Effect on blood coagulation (in patients treated with Vitamin K antagonists)
  • Loss of consciousness due to a severe drop in blood sugar levels (hypoglycemic coma). See section 2.

Administration of antibiotics containing quinolones and fluoroquinolones has been associated with very rare cases of long-lasting (even months or years) or permanent adverse reactions, such as tendon inflammation, tendon rupture, joint pain, limb pain, difficulty walking, abnormal sensations such as pricking, tingling, pins and needles, burning, numbness, or pain (neuropathy), fatigue, memory and concentration impairment, effects on mental health (which may include sleep disorders, anxiety, panic attacks, depression, and suicidal ideation), as well as disturbances in hearing, vision, taste, and smell. These have been associated with quinolone and fluoroquinolone antibiotic use, in some cases regardless of pre-existing risk factors.

Cases of enlargement and weakening or tearing of the aortic wall (aneurysms and dissections), which could lead to rupture and potentially be fatal, and heart valve insufficiency have been reported in patients receiving fluoroquinolones. See also section 2.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 under the label EXP. The expiry date refers to the last day of the month indicated.

• Do not refrigerate or freeze.
• Store the infusion bag in its overpouch until use to protect it from light.
• Store the infusion vial in the outer carton until use to protect it from light.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of unused medicines and their packaging. This helps protect the environment.

6. Contents of the pack and other information

Composition of Ciprofloxacin Kabi

• The active substance is ciprofloxacin (as ciprofloxacin hydrogensulfate).
• The other components are sodium chloride, sulfuric acid, sodium hydroxide for pH adjustment, and water for injection.

Appearance of the product and contents of the container

Ciprofloxacin Kabi is a sterile, clear, and colourless solution.

It is packaged in a flexible, transparent polyolefin bag with an aluminum overpouch (Freeflex bags) or in a polyethylene bottle (KabiPac).

50 ml of solution contains 100 mg of ciprofloxacin.

100 ml of solution contains 200 mg of ciprofloxacin.

200 ml of solution contains 400 mg of ciprofloxacin.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Fresenius Kabi España, S.A.U.
C/ Marina, 16-18
08005 Barcelona (Spain)

Manufacturer:

HP Halden Pharma AS
Svinesundsveien 80
1788 Halden
Norway

Fresenius Kabi Polska Sp. z o.o.
Wytwórnia Płynów Infuzyjnych
Sienkiewicza 25
99-300 Kutno
Poland

This medicinal product is authorized in the European Economic Area member states under the following names:

AT: Ciprofloxacin Kabi 100 mg/50 ml, -200 mg/ 100 ml, -400 mg/200 ml Infusionslösung
BE: Ciprofloxacin Fresenius Kabi 200 mg/100 ml, -400 mg/200 ml solution pour perfusion/Infusionslösung/oplossing voor intraveneuze infusie
CY: Ciprofloxacin Kabi 200mg/100ml, -400 mg/ 200 ml διάλυμα για έγχυση
CZ: Ciprofloxacin Kabi
DE: Ciprofloxacin Kabi 100 mg/50 ml, -200 mg/100 ml, 400 mg/200 ml Infusionslösung
DK: Ciprofloxacin Fresenius Kabi 2 mg/ml infusionsvæske
EL: Ciprofloxacin Kabi 200 mg/ 100 ml, -400 mg/200 ml διάλυμα για έγχυση
ES: Ciprofloxacino Kabi 2 mg/ml solución para perfusión EFG
FI: Ciprofloxacin Fresenius Kabi 2 mg/ml infuusioneste, liuos
HU: Ciprofloxacin Kabi 200 mg/100 ml, -400 mg/200 ml oldatos infúzió
IS: Ciprofloxacin Fresenius Kabi
IT: Ciprofloxacin Kabi
MT: Ciprofloxacin Kabi 200 mg/100 ml, -400 mg/200 ml solution for infusion
NL: Ciprofloxacin Kabi 100 mg/50 ml, -200 mg/ 100 ml, -400 mg/200 ml oplossing voor infusie
PL: Ciprofloxacin Kabi 100 mg/50 ml, -200 mg/ 100 ml, -400 mg/200 ml roztwór do infuzji
PT: Ciprofloxacin Kabi
SE: Ciprofloxacin Fresenius Kabi 2 mg/ml infusionsvätska, lösning
SK: Ciprofloxacin Kabi 200 mg/ 100 ml, -400 mg/200 ml infúzny roztok

Date of most recent revision of this leaflet: March 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) www.aemps.gob.es

Advice / Medical education

Antibiotics are used to treat bacterial infections. They are not effective against viral infections.

If your doctor has prescribed antibiotics, you need them specifically for your current illness.

Despite antibiotic treatment, some bacteria may survive or grow. This phenomenon is known as resistance: some antibiotic treatments become ineffective.

Improper use of antibiotics increases resistance. You may even help bacteria become more resistant, thereby delaying your recovery or reducing the effectiveness of antibiotics if you do not follow:

• the dose
• the frequency of doses
• the duration of treatment

Therefore, in order to maintain the effectiveness of this medicine:

1. Use antibiotics only when prescribed by a doctor.
2. Follow the prescription exactly.
3. Do not reuse an antibiotic without a medical prescription, even if you wish to treat a similar illness.
4. Never give your antibiotics to another person; they may not be suitable for their condition.
5. After completing a course of treatment, return any unused medicines to the pharmacy to ensure they are properly disposed of.

The following information is intended for healthcare professionals only

Ciprofloxacin Kabi must be administered by intravenous infusion. In children, the infusion duration is 60 minutes. In adult patients, the infusion time is 60 minutes for 400 mg of Ciprofloxacin Kabi and 30 minutes for 200 mg of Ciprofloxacin Kabi. A slow infusion into a large vein will minimize patient discomfort and reduce the risk of venous irritation. The infusion solution may be administered directly or after mixing with another compatible infusion solution.

Unless compatibility with other infusion solutions or medicinal products has been confirmed, the infusion solution must always be administered separately. Visual signs of incompatibility include, for example, precipitation, turbidity, and colour change.

Incompatibility occurs with all infusion solutions or medicinal products that are physically or chemically unstable at the pH of the solution (e.g., penicillins, heparin solutions), particularly when combined with solutions adjusted to an alkaline pH (pH of ciprofloxacin infusion solutions: 4.0 – 4.9).

After initiating intravenous treatment, therapy may be continued orally.