Patient Information
Ciprofloxacin Kabi 2 mg /ml Solution for Infusion EFG
Ciprofloxacin
Read this entire leaflet carefully before you start using this medicine because it contains important information for you
-Keep this leaflet, as you may need to read it again.
-Ask your doctor, pharmacist or nurse if you have any questions.
-Report any side effects to your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.
This medication is for hospital use only.
Ciprofloxacino Kabi contains the active ingredient ciprofloxacin. Ciprofloxacin is an antibiotic that belongs to the fluoroquinolone family. Ciprofloxacin acts by eliminating the bacteria that cause infections. It only acts on specific strains of bacteria.
"Antibiotics are used to treat bacterial infections and do not work for viral infections such as the flu or a cold. It is essential to follow the instructions regarding dosage, administration interval, and treatment duration as indicated by your doctor. Do not store or reuse this medication. If you have leftover antibiotics after treatment, return them to the pharmacy for proper disposal. Do not dispose of medications through the drain or in the trash." |
Adults
Ciprofloxacino Kabi is used in adults to treat the following bacterial infections:
In cases of severe infection or infection caused by multiple types of bacteria, you may be administered additional antibiotic treatment in addition to Ciprofloxacino Kabi.
Children and adolescents
Ciprofloxacino Kabi is used in children and adolescents, under specialized medical supervision, to treat the following bacterial infections:
Ciprofloxacino Kabi may also be used to treat severe infections in children and adolescents when necessary.
Advertencias y precauciones
Antes de empezar a tomar este medicamento
You should not take antibacterial medications that contain fluoroquinolones or quinolones, including Ciprofloxacino Kabi, if you have experienced a severe reaction to a quinolone or fluoroquinolone in the past. If this is the case, you should inform your doctor as soon as possible.
Consult your doctor, pharmacist or nurse before starting to use Ciprofloxacino 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.
Mientras está en tratamiento con Ciprofloxacino Kabi
Inform your doctor immediately if any of the following situations occurduring treatment with Ciprofloxacino Kabi. Your doctor will decide whether to stop treatment with Ciprofloxacino Kabi.
In rare cases, you may experiencepain and swelling in the joints and inflammation or rupture of the tendons. The risk is higher if you are an elderly person (over 60 years old), have received an organ transplant, have kidney problems or are taking corticosteroids. Tendon inflammation and rupture can occur in the first 48 hours of treatment and even several months after stopping treatment with Ciprofloxacino Kabi. At the first sign of pain or inflammation of a tendon (e.g. in the ankle, wrist, elbow, shoulder or knee), stop taking Ciprofloxacino Kabi, contact your doctor and keep the painful area at rest. Avoid any unnecessary exercise, as this may increase the risk of tendon rupture.
Efectos adversos graves incapacitantes, de duración prolongada, y potencialmente irreversibles
Antibacterial medications that contain fluoroquinolones or quinolones, including Ciprofloxacino Kabi, have been associated with rare but severe adverse effects, some of which were of long duration (persistent for months or years), disabling or potentially irreversible. This includes pain in the tendons, muscles and joints of the upper and lower limbs, difficulty walking, abnormal sensations such as pinpricks, tingling, numbness or burning (paresthesia), sensory disorders such as decreased vision, taste, smell and hearing, depression, decreased memory, intense fatigue and severe sleep disorders.
If you experience any of these adverse effects after taking Ciprofloxacino Kabi, contact your doctor immediately before continuing treatment. You and your doctor will decide whether to continue or not with the treatment, considering also the use of an antibiotic of another class.
Uso de Ciprofloxacino Kabi con otros medicamentos.
Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medication.
No utilice Ciprofloxacino Kabi al mismo tiempo que tizanidina, because this could cause adverse effects, such as low blood pressure and drowsiness (see section 2“Nouse Ciprofloxacino Kabi”).
It is known that the following medications interact with Ciprofloxacino Kabi in the body. Taking Ciprofloxacino Kabi at the same time as these medications may affect the therapeutic effect of these medications. It may also increase the likelihood of adverse effects.
Informe a su médico si está tomando:
Ciprofloxacino Kabi mayincreasethe blood levels of the following medications:
Toma de Ciprofloxacino Kabi con alimentos y bebidas
Food and beverages do not affect your treatment with Ciprofloxacino Kabi.
Embarazo y lactancia
If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication.
It is preferable to avoid the use of Ciprofloxacino Kabi during pregnancy.
Do not use Ciprofloxacino Kabi during lactation, as ciprofloxacin is excreted through breast milk and may cause harm to your baby.
Conducción y uso de máquinas
Ciprofloxacino Kabi may decrease your alertness. Some neurological effects may occur. Therefore, make sure you know how you react to Ciprofloxacino Kabi before driving a vehicle or using a machine. If in doubt, consult your doctor.
Ciprofloxacino Kabi contiene sodio.
This medication contains 347 mg of sodium (main component of table salt) in each 100 ml volume. This is equivalent to 17% of the maximum recommended daily intake for an adult.
Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.
Your doctor will explain exactly how much Ciprofloxacino Kabi you should be administered, 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. Treatment usually lasts 5 to 21 days, but may last longer for severe infections.
Your doctor will administer each dose through slow infusion, via a vein, into the bloodstream. In children, the infusion duration is 60 minutes. In adult patients, the infusion time is 60 minutes for 400 mg of Ciprofloxacino Kabi, and 30 minutes for 200 mg of Ciprofloxacino Kabi. Slow infusion administration prevents immediate adverse reactions.
Remember to drink an abundant amount of liquids while taking Ciprofloxacino Kabi.
If you take more Ciprofloxacino Kabi than you should
If you have received more Ciprofloxacino 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 forgot to take a dose of Ciprofloxacino Kabi
You should not be given a double dose to compensate for missed doses.
If you interrupt treatment with Ciprofloxacino Kabi
It is essential that you complete the treatment, even if you start feeling better after a few days. If you stop using this medication too soon, your infection may not be fully cured, and symptoms may return or worsen. You may develop antibiotic resistance.
If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.
The following section contains the most serious side effects that you may be able to recognize yourself:
Stop taking Ciprofloxacino Kabi and contact your doctor immediatelyto consider another antibiotic treatment if you notice any of the following serious side effects:
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 available data)
Other side effects that have been observed during treatment with Ciprofloxacino Kabi are listed below according to the probability that they present:
Frequent side effects(may affect 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)
Rare side effects(may affect 1 in 1,000 people):
-superinfections caused by fungi
-elevated eosinophil count, a type of white blood cell, increase or decrease of a blood clotting factor (thrombocytes)
-decreased appetite, loss of appetite (anorexia)
-hyperactivity, agitation, confusion, disorientation, hallucinations
-headache, dizziness, sleep problems or taste disturbances, paresthesias and
numbness, unusual sensitivity to sensory stimuli, convulsions (see section 2: Warnings and precautions), vertigo
-vision problems, including double vision
-hearing loss
-increased heart rate (tachycardia)
-expansion of blood vessels (vasodilation), decreased blood pressure
-abdominal pain, digestive problems such as slow digestion (indigestion/acid reflux), flatulence
-liver function alteration, increase in blood levels of a certain substance (bilirubin), jaundice (cholestatic icterus)
-itching, rashes
-renal function impairment, renal insufficiency
-muscle and bone pain, feeling unwell (asthenia), fever, fluid retention
-increase in alkaline phosphatase levels in the blood (a blood substance)
Rare side effects(may affect 1 in 1,000 people):
-increased blood sugar levels (hyperglycemia)
-decreased skin sensitivity, tremors, migraine, sense disturbances
-tinnitus (ringing in the ears), hearing deterioration
-fainting, inflammation of blood vessels (vasculitis)
-breathing difficulties, including asthma-like symptoms
-pancreatitis
hepatitis, liver cell death (necrosis), which very rarely leads to liver insufficiency with a risk of death and possible fatal outcome.
-light sensitivity (see section 2: Warnings and precautions), non-specific blistering, small hemorrhages under the skin (petechiae)
-blood or crystals in the urine, (see section 2:Warnings and precautions), urinary tract inflammation
-excessive sweating
-increase in amylase enzyme levels
Very rare side effects(may affect 1 in 10,000 people):
-coordination disorder, instability when walking (gait disorders), increased intracranial pressure and pseudotumor cerebri
-color distortion
-various skin eruptions or exanthems (e.g. the potentially fatal Stevens-Johnson syndrome or toxic epidermal necrolysis)
Frequency not known(cannot be estimated from available data)
-abnormally fast heart rate, irregular heart rate that can put the patient's life at risk, alterations in heart rhythm (called "prolongation of the QT interval", detected in the ECG, heart electrical activity).
-Influence on blood coagulation (in patients treated with vitamin K antagonists).
The administration of antibiotics containing quinolones and fluoroquinolones has been associated with very rare cases of long-lasting or permanent adverse reactions (even months or years) such as tendon inflammation, tendon rupture, joint pain, limb pain, difficulty walking, abnormal sensations such as pinpricks, tingling, numbness, burning, or pain (neuropathy), depression, fatigue, sleep disturbances, memory impairment, and hearing, vision, taste, and smell disturbances, in some cases regardless of the presence of pre-existing risk factors.
Cases of increased size and weakening or rupture of the aortic wall (aneurysms and dissections) have been reported, which could lead to rupture and be fatal, and heart valve insufficiency 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 does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.
Keep this medication out of the sight and reach of children.
Do not use this medication after the expiration date that appears on the packaging under the indication CAD. The expiration date is the last day of the month indicated.
Medicines should not be disposed of through the drains or in the trash. Ask your pharmacist how to dispose of unused packaging and medications. This will help protect the environment.
Composition of Ciprofloxacin Kabi
-The active ingredient is ciprofloxacin (as ciprofloxacin hydrogen sulfate).
-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 package
Ciprofloxacin Kabi is a sterile, transparent, and colorless solution.
It is packaged in a flexible and transparent polyolefin bag with an aluminum overbag (Freeflex bags) or in a polyethylene flask (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 Responsible Manufacturer
Marketing Authorization Holder:
Fresenius Kabi España, S.A.U.
C/ Marina, 16-18
08005 Barcelona (Spain)
Responsible 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 medicinal product 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 mlδι?λυμαγια?γχυση
CZ: Ciprofloxacin Kabi 100 mg/50 ml, -200 mg/ 100 ml, -400 mg/200 ml infuzní roztok
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 mlδι?λυμαγια?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
IT: Ciprofloxacin Kabi 100 mg/50 ml, -200 mg/ 100 ml, -400 mg/200 ml soluzione per infusione
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 100 mg/50 ml, -200 mg/ 100 ml, -400 mg/200 ml Solução para perfusão
SE: Ciprofloxacin Fresenius Kabi 2 mg/ml infusionsvätska, lösning
SK: Ciprofloxacin Kabi 200 mg/ 100 ml, -400 mg/200 ml infúzny roztok
UK: Ciprofloxacin Kabi 100 mg/50 ml, -200 mg/ 100 ml, -400 mg/200 ml solution for infusion
Last review date of this leaflet:March 2021
The detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)www.aemps.gob.es
Advice on proper use
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.
Abuse of antibiotics increases resistance. You may even help bacteria become more resistant and delay your recovery or reduce the effectiveness of antibiotics if you do not respect:
- the dose
- the frequency of intake
- the duration of treatment
Consequently, in order to maintain the effectiveness of this medicinal product:
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The following information is intended only for healthcare professionals
Ciprofloxacin Kabi should 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 in a large vein will minimize patient discomfort and reduce the risk of venous irritation. The infusion solution can be infused directly or after mixing it with another compatible infusion solution.
Unless compatibility with other infusion solutions or drugs has been confirmed, the infusion solution should be administered separately. Visual signs of incompatibility include precipitation, turbidity, and color change.
Incompatibility occurs with all infusion solutions or drugs that are physically or chemically unstable at the pH of the solution (e.g., penicillins, heparin solutions), especially in association with solutions adjusted to an alkaline pH (pH of ciprofloxacin infusion solutions: 4.0 - 4.9).
After starting intravenous administration of the treatment, it can be continued orally.
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