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Ciprofloxacino kabi 2 mg/ml solucion para perfusion efg

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Introduction

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.

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

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:

  • respiratory tract infections
  • prolonged or recurrent ear or sinus infections
  • urinary tract infections
  • testicular infections
  • female genital organ infections
  • gastrointestinal and intrabdominal 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 by inhalation

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:

  • lung and bronchial infections in children and adolescents with cystic fibrosis
  • complicated urinary tract infections, including kidney infections (pyelonephritis)
  • exposure to anthrax by inhalation

Ciprofloxacino Kabi may also be used to treat severe infections in children and adolescents when necessary.

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

Nouse Ciprofloxacino Kabi:

  • If you are allergic to the active ingredient, to other quinolones or to any of the other components of this medication (including those listed in section 6).
  • If you are taking tizanidine (see section 2: Use of other medications).

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:

  • You have ever had kidney problems, as your treatment may need to be adjusted.
  • You suffer from epilepsy or other neurological conditions.
  • You have a history of tendon problems during previous treatment with antibiotics such as Ciprofloxacino Kabi.
  • You are diabetic, as you may be at risk of hypoglycemia with ciprofloxacin.
  • You suffer from myasthenia gravis (a type of muscle weakness), as your symptoms may worsen.
  • You have been diagnosed with an aneurysm of a large blood vessel (aortic aneurysm or aneurysm of a large peripheral vessel).
  • You have had a previous 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 conditions (e.g. Marfan syndrome or Ehlers-Danlos vascular syndrome, Turner syndrome or Sjögren's syndrome (an autoimmune inflammatory disease), or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behçet's disease, hypertension or atherosclerosis known), rheumatoid arthritis (a joint disease) or endocarditis (a heart infection).
  • You have heart problems.This type of medication should be used with caution if you were born or have a family history of prolonged QT interval (detected on ECG, electrocardiogram or heart electrical recording), if you suffer from electrolyte imbalance in the blood (especially low levels of potassium or magnesium in the blood), if you have a very slow heart rate (bradycardia), if you have a weak heart (heart failure), a history of heart attack (myocardial infarction), if you are a woman or elderly, or if you are taking another medication that causes abnormal changes in the electrocardiogram (see section 2 “Use of Ciprofloxacino Kabi with other medications”).
  • You or a family member has a deficiency in glucose-6-phosphate dehydrogenase (G6PD), as you may be at risk of anemia with ciprofloxacin.

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.

  • Severe and sudden allergic reaction(anaphylactic reaction or angioedema). There is a reduced possibility that, even with the first dose, you may experience a severe allergic reaction, with the following symptoms: chest tightness, dizziness, nausea or fainting, or dizziness when standing up.Inform your doctor immediately as the administration of Ciprofloxacino Kabi must be stopped.

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.

  • If you experience asudden and intense pain in the abdomen, chest or back,which may be symptoms of aortic dissection or aneurysm, go to an emergency service immediately. The risk may be increased if you are receiving systemic corticosteroids.
  • If you start to experience a sudden appearance of shortness of breath, especially when lying in bed, or if you notice swelling in the ankles, feet or abdomen or the appearance of palpitations (sensation of rapid or irregular heartbeat), you must inform your doctor immediately.
  • If you sufferepilepsy or other neurological conditions, such as ischemia or cerebral infarction, you may experience adverse effects associated with the central nervous system. If seizures occur, stop taking Ciprofloxacino Kabi and contact your doctor immediately.
  • In rare cases, you may experience symptoms ofnerve damage (neuropathy)such as pain, burning, tingling, numbness and/or weakness, especially in the feet and legs or hands and arms. If this occurs, stop taking Ciprofloxacino Kabi and inform your doctor immediately to prevent the development of a potentially irreversible disorder.
  • You may experiencepsychiatric reactionsafter the first administration of ciprofloxacin. If you sufferdepression or psychosis, your symptoms may worsen with treatment with Ciprofloxacino Kabi. If this occurs, stop taking Ciprofloxacino Kabi and contact your doctor immediately.
  • Antibiotics of the quinolone class may cause anincrease in your blood sugar levelsabove normal levels (hyperglycemia), or adecrease in your blood sugar levelsbelow normal levels, which may cause a loss of consciousness (hypoglycemic coma) in severe cases (see section 4). This is important for people with diabetes. If you have diabetes, you must carefully control your blood sugar levels.
  • You may developdiarrheaduring the use of antibiotics, including Ciprofloxacino Kabi, or even several weeks after stopping their use. If this becomes intense or persistent, or if you notice that your stools contain blood or mucus, inform your doctor immediately. Treatment with Ciprofloxacino Kabi should be stopped immediately, as it may put your life at risk. Do not take medications that slow down or delay bowel movements.
  • If yourvision worsensor if you have any other eye changes during treatment with Ciprofloxacino Kabi, consult an ophthalmologist immediately.
  • Your skin becomes moresensitive to sunlight or ultraviolet (UV) lightduring treatment with Ciprofloxacino Kabi. Avoid exposure to intense sunlight or artificial ultraviolet light, such as tanning beds.
  • While taking Ciprofloxacino Kabi, inform your doctor or laboratory personnel if you need to undergo ablood or urine test.
  • If you havekidney problems, inform your doctor as your dose may need to be adjusted.
  • Ciprofloxacino Kabi may causeliver damage. If you notice symptoms such as loss of appetite, jaundice (yellowing of the skin), dark urine, itching or stomach pain, stop taking Ciprofloxacino Kabi immediately.
  • Ciprofloxacino Kabi may cause a decrease in white blood cell count and possiblydecrease your resistance to infections. If you experience an infection with symptoms such as fever and severe deterioration of your general condition, or fever with symptoms of local infection such as sore throat/pharynx/mouth, or urinary problems, you must consult your doctor immediately. A blood test will be performed to examine the possible decrease in white blood cells (agranulocytosis). It is essential that you inform your doctor about your medication.

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 2Nouse 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:

  • Anticoagulants (e.g. warfarin, acenocoumarol, phenprocoumon or fluindione) or other oral anticoagulants (to thin the blood)
  • probenecid (for gout)
  • metotrexate (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)
  • ciclosporins (for skin diseases, rheumatoid arthritis or organ transplants)
  • other medications that may alter heart rhythm, medications belonging to the group of antiarrhythmics (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), tricyclic antidepressants, some antimicrobials (belonging to the group of macrolides), some antipsychotics.
  • zolpidem (for sleep disorders)
  • metoclopramide (for nausea and vomiting)
  • omeprazole (for stomach ulcers)

Ciprofloxacino Kabi mayincreasethe blood levels of the following medications:

  • pentoxifylline (for circulatory disorders)
  • caffeine
  • duloxetine (for depression, diabetic nerve damage or incontinence)
  • lidocaine (for heart conditions or anesthetic use)
  • sildenafil (e.g. for erectile dysfunction)
  • agomelatine
  • glibenclamide (for diabetes)

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.

3. How to use Ciprofloxacino kabi

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.

4. Possible Adverse Effects

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

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)

  • severe and sudden allergic reaction with symptoms such as chest tightness, dizziness, nausea, or fainting, or experiencing dizziness when standing up (anaphylactic shock) (see section 2: Warnings and precautions)
  • tendon rupture, which particularly affects the long tendon in 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 when standing up (anaphylactic reaction) (see section 2: Warnings and precautions)
  • muscle weakness, inflammation of the tendons that can lead to tendon rupture, especially the long tendon in the back of the ankle (Achilles tendon) (see section 2: Warnings and precautions)
  • skin eruptions with a risk of death, usually in the form of blisters or ulcers in the mouth, throat, nose, eyes, and other mucous membranes, such as the genitals, which can progress to generalized 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)
  • reaction to a drug that causes skin rash, fever, inflammation of internal organs, hematological changes, and systemic disease (DRESS - Drug Reaction with Eosinophilia and Systemic Symptoms, PEGA - Acute Generalized Pustular Erythroderma)
  • syndrome associated with deficient water secretion and low sodium concentrations (SIADH, by its English acronym).

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):

  • joint pain in adults

-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):

  • muscle pain, joint inflammation, increased muscle tone, cramps
  • inflammation of the intestine (colitis) associated with antibiotic use (can be fatal in rare cases) (see section 2: Warnings and precautions)
  • changes in blood cell count (leucopenia, leucocytosis, neutropenia, anemia), decrease in the number of red and white blood cells and platelets (pancytopenia) that can put the patient's life at risk, medullary depression that can put the patient's life at risk (see section 2: Warnings and precautions)
  • allergic reaction, swelling (edema) 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, strange dreams, depression (which can progress to suicidal thoughts, attempts, or completed suicide), mental alterations (psychotic reactions that can progress to suicidal thoughts, attempts, or completed suicide) (see section 2: Warnings and precautions)

-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):

  • a type of anemia characterized by the destruction of red blood cells (hemolytic anemia), a dangerous decrease in a type of white blood cell (agranulocytosis) that can put the patient's life at risk (see section 2: Warnings and precautions).
  • allergic reaction known as serum sickness-like reaction (see section 2: Warnings and precautions)

-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)

  • worsening of symptoms of myasthenia gravis (see section 2: Warnings and precautions)

Frequency not known(cannot be estimated from available data)

  • feeling extremely excited (mania) or feeling extremely optimistic and hyperactive (hypomania)

-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).

  • loss of consciousness due to severe decrease in blood sugar levels (hypoglycemic coma). See section 2.

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.

5. Storage of Ciprofloxacino Kabi

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.

  • Do not refrigerate or freeze.
  • Store the infusion bag in the outer bag until use to protect it from light.
  • Store the infusion bottle in the outer case until use to protect it from light

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.

6. Contents of the packaging and additional information

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:

  1. Use antibiotics only when prescribed.
  2. Follow the prescription strictly.
  3. Do not reuse an antibiotic without a doctor's prescription, even if you want to treat a similar illness.
  4. Never give your antibiotic to someone else; it may not be adapted to their illness.
  5. After completing a treatment, return all unused medicines to the pharmacy to ensure they are disposed of correctly.

---------------------------------------------------------------------------------------------------------------------

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.

Страна регистрации
Активное вещество
Требуется рецепт
Да
Производитель
Состав
Cloruro de sodio (8,49 g mg), Hidroxido de sodio (e 524) (233 mg mg)
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Doctor

Andrei Popov

General Medicine6 лет опыта

Dr. Andrei Popov is a licensed pain management specialist and general practitioner based in Spain. He provides expert online care for adults dealing with both chronic and acute pain, as well as a wide range of everyday health concerns.

He specialises in diagnosing and treating pain conditions that affect quality of life, including: • Chronic pain lasting more than 3 months • Migraines and recurring headaches • Neck, back, lower back, and joint pain • Post-traumatic pain following injury or surgery • Nerve-related pain, fibromyalgia, and neuralgia In addition to pain management, Dr. Popov helps patients with: • Respiratory infections (colds, bronchitis, pneumonia) • High blood pressure and metabolic conditions such as diabetes • Preventive care and routine health check-ups

Online consultations last up to 30 minutes and include a detailed symptom review, personalised treatment planning, and medical follow-up when needed.

Dr. Popov’s approach is rooted in evidence-based medicine, combined with individualised care tailored to each patient’s history, lifestyle, and clinical needs.

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5.01 отзыв
Doctor

Yevgen Yakovenko

General Surgery11 лет опыта

Dr. Yevgen Yakovenko is a licensed surgeon and general practitioner in Spain, with a diverse clinical background in general and pediatric surgery, internal medicine, and pain management. With a strong focus on both practice and research, he provides comprehensive medical consultations for adults and children, covering both surgical and therapeutic needs.

Dr. Yakovenko offers expert care in the following areas: • Diagnosis and treatment of acute and chronic pain • Pre- and postoperative care, including risk assessment and follow-up • Surgical conditions such as hernias, gallbladder disease, and appendicitis • Pediatric surgery consultations, including congenital conditions and minor procedures • Trauma care: fractures, soft tissue injuries, and wound management • Oncological surgery consultation and post-treatment care • Cardiovascular and respiratory conditions (internal medicine) • Orthopedic concerns and post-trauma rehabilitation • Radiological interpretation for surgical planning

In addition to his clinical work, Dr. Yakovenko actively participates in medical research and international collaboration. He is a member of the German Surgeons Association (BDC), affiliated with the General Practitioners Association of Las Palmas, and works with the German Consulate in the Canary Islands. He regularly attends international medical conferences and has authored scientific publications.

With over a decade of multidisciplinary experience, Dr. Yakovenko delivers precise, evidence-based care tailored to each patient’s needs.

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