


Ask a doctor about a prescription for CIPROFLOXACIN KABI 2 mg/ml SOLUTION FOR INFUSION
Prospect: Information for the user
Ciprofloxacin Kabi 2 mg/ml solution for infusion EFG
Ciprofloxacin
Read the entire prospectus carefully before this medication is administered to you, as it contains important information for you
Contents of the prospectus
This medication is for hospital use only.
Ciprofloxacin Kabi contains the active ingredient ciprofloxacin. Ciprofloxacin is an antibiotic that belongs to the fluoroquinolone family. Ciprofloxacin works by eliminating the bacteria that cause infections. It only works with specific strains of bacteria.
"Antibiotics are used to treat bacterial infections and are not effective against viral infections such as the flu or the common cold. It is essential that you follow the instructions regarding dosage, administration interval, and treatment duration indicated by your doctor. Do not store or reuse this medication. If you have any leftover antibiotic after completing treatment, return it to the pharmacy for proper disposal. Do not throw medications down the drain or in the trash." |
Adults
Ciprofloxacin Kabi is used in adults to treat the following bacterial infections:
In case 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, in addition to Ciprofloxacin Kabi.
Children and adolescents
Ciprofloxacin Kabi is used in children and adolescents, under specialized medical supervision, to treat the following bacterial infections:
Ciprofloxacin Kabi may also be used to treat severe infections in children and adolescents when necessary.
Do not use Ciprofloxacin Kabi:
Warnings and precautions
Before starting treatment with this medication
You should not take antibacterial medications that contain fluoroquinolones or quinolones, including Ciprofloxacin Kabi, if you have experienced a severe adverse reaction in the past when taking a quinolone or fluoroquinolone. If this is the case, you should inform your doctor as soon as possible.
Consult your doctor, pharmacist, or nurse before starting treatment with Ciprofloxacin Kabi if:
For the treatment of some 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 it is necessary to interrupt treatment with Ciprofloxacin Kabi.
Rarely, joint pain and swelling and tendon inflammation or rupturemay occur. The risk is higher if you are an elderly person (over 60 years old), have received an organ transplant, have kidney problems, or are being treated with corticosteroids. Tendon inflammation and rupture can occur within the first 48 hours of treatment and even several months after discontinuing treatment with Ciprofloxacin Kabi. At the first sign of pain or tendon inflammation (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking Ciprofloxacin Kabi, contact your doctor, and rest the affected area. Avoid any unnecessary exercise, as this could increase the risk of tendon rupture.
Severe, disabling, long-lasting, and potentially irreversible adverse effects
Antibacterial medications that contain fluoroquinolones or quinolones, including Ciprofloxacin Kabi, have been associated with very rare but severe adverse effects, some of which were long-lasting (persistent for months or years), disabling, or potentially irreversible. These include tendon pain, muscle and joint pain in the upper and lower limbs, difficulty walking, abnormal sensations such as pins and needles, tingling, numbness, or burning (paresthesia), sensory disorders such as decreased vision, taste, smell, and hearing, depression, memory loss, intense fatigue, and severe 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, also considering the use of an antibiotic from another class.
Use of Ciprofloxacin Kabi with other medications.
Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.
Do not use Ciprofloxacin Kabi at the same time as tizanidine, as this may cause adverse effects such as low blood pressure and drowsiness (see section 2 "Do not use Ciprofloxacin Kabi").
It is known that the following medications interact with Ciprofloxacin Kabi in your body. Taking Ciprofloxacin Kabi at the same time as these medications may affect their therapeutic effect or increase the likelihood of adverse effects.
Inform your doctor if you are taking:
Ciprofloxacin Kabi may increaseblood levels of the following medications:
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 plan to become pregnant, consult your doctor or pharmacist before using this medication.
It is recommended 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 decrease your alertness. Some neurological effects may occur. Therefore, make sure you know how you react to Ciprofloxacin Kabi before driving a vehicle or using a machine. If in doubt, consult your doctor.
Ciprofloxacin Kabi contains sodium.
This medication contains 347 mg of sodium (the main component of table salt) per 100 ml. This is equivalent to 17% of the maximum recommended daily dietary intake for an adult.
Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.
Your doctor will explain exactly how much Ciprofloxacin Kabi should be administered to you, 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 it may be necessary to adjust your dose. The treatment usually lasts from 5 to 21 days, but it can last longer for severe infections.
Your doctor will administer each dose through slow infusion, into a vein, and 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. The slow administration of the infusion prevents immediate adverse reactions.
Remember to drink plenty of fluids while taking Ciprofloxacin Kabi.
If you take more Ciprofloxacin Kabi than you should
In case 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
You should not be given a double dose to make up for missed doses.
If you stop treatment with Ciprofloxacin Kabi
It is essential that you complete the full treatment, even if you start to feel better after a few days. If you stop using this medication too soon, your infection may not be completely cured, and the symptoms may return or worsen. You may develop resistance to the antibiotic.
If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.
Like all medications, this medication can cause side effects, although not everyone will experience them.
The following section contains the most serious side effects that you may recognize yourself:
Stop taking Ciprofloxacin Kabi and contact your doctor immediatelyto consider another treatment with antibiotics if you notice any of the following serious side effects:
Uncommon(may affect up to 1 in 100 people)
Rare(may affect up to 1 in 1,000 people)
Very rare(may affect up to 1 in 10,000 people)
Frequency not known(cannot be estimated from the available data)
Other side effects that have been observed during treatment with Ciprofloxacin Kabi are listed below according to their probability:
Common side effects(may affect up to 1 in 10 people):
Uncommon side effects(may affect up to 1 in 100 people):
visual problems, including double vision
itching, hives
increased blood alkaline phosphatase levels
Rare side effects(may affect up to 1 in 1,000 people):
hepatitis, liver cell death (necrosis), which can very rarely lead to liver failure with a risk of death and potential fatal outcome.
Very rare side effects(may affect up to 1 in 10,000 people):
Frequency not known(cannot be estimated from the available data)
The 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, walking difficulties, abnormal sensations such as pinching, tingling, burning, numbness, or pain (neuropathy), fatigue, decreased memory and concentration, effects on mental health (including sleep disorders, anxiety, panic attacks, depression, and suicidal ideation), as well as alterations in hearing, vision, taste, and smell, have been associated with the administration of quinolone and fluoroquinolone antibiotics, in some cases regardless of pre-existing risk factors.
There have been reports of increased size and weakening or tearing of the aortic wall (aneurysms and dissections), which could lead to rupture and be fatal, and cardiac valve failure in patients who have received fluoroquinolones. See also section 2.
Reporting of side effects
If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that is not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.
Keep this medication out of sight and reach of children.
Do not use this medication after the expiration date stated on the packaging under the indication CAD. The expiration date is the last day of the month indicated.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.
Ciprofloxacin Kabi composition
Product appearance and packaging contents
Ciprofloxacin Kabi is a sterile, transparent, and colorless solution.
This is packaged in a flexible and transparent polyolefin bag with an aluminum outer bag (Freeflex bags) or in a polyethylene vial (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 Plynów Infuzyjnych
99-300 Kutno
Sienkiewicza 25
Poland
This medication is authorized in the member states of the European Economic Area with 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 δι?λυμα για ?γχυση
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 δι?λυμα για ?γχυση
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 the last revision of this leaflet:March 2025
Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) www.aemps.gob.es
Medical advice/education
Antibiotics are used to cure bacterial infections. They are not effective against viral infections.
If your doctor has prescribed antibiotics, you need them precisely for your current illness.
Despite antibiotics, some bacteria may survive or grow. This phenomenon is known as resistance: some antibiotic treatments become ineffective.
Misuse of antibiotics increases resistance. You can even help bacteria become more resistant and, therefore, delay your recovery or reduce the effectiveness of antibiotics if you do not respect:
Consequently, to maintain the effectiveness of this medication:
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The following information is intended only for healthcare professionals
Ciprofloxacin Kabi should be administered through 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. Slow infusion into a large vein will minimize patient discomfort and reduce the risk of venous irritation. The infusion solution can be administered directly or after mixing with another compatible infusion solution.
Unless compatibility with other infusion solutions or medications has been confirmed, the infusion solution should always be administered separately. Visual signs of incompatibility are, for example, precipitation, clouding, and color change.
Incompatibility occurs with all infusion solutions or medications that are physically or chemically unstable at the pH of the solution (e.g., penicillins, heparin solutions), especially in combination with solutions adjusted to an alkaline pH (pH of ciprofloxacin infusion solutions: 4.0 - 4.9).
After starting intravenous treatment, it can also be continued orally.
The best alternatives with the same active ingredient and therapeutic effect.
Discuss dosage, side effects, interactions, contraindications, and prescription renewal for CIPROFLOXACIN KABI 2 mg/ml SOLUTION FOR INFUSION – subject to medical assessment and local rules.