Patient info

Ciprofloxacin 400 mg / 200 ml solution for infusion – patient leaflet, side effects, dosage

Updated:
Medicine strength:
400 mg / 200 ml
Contains active substance:
Similar medicines:

Patient leaflet - Ciprofloxacin 400 mg / 200 ml solution for infusion

1. What Ciprofloxacin is what it is used for

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

Adults

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

  • respiratory tract infections
  • long lasting or recurring ear or sinus infections
  • urinary tract infections
  • infections of the testicles
  • genital organ infections in women
  • gastro-intestinal tract infections and intra-

    abdominal infections

  • skin and soft tissue infections
  • bone and joint infections
  • to treat infections in patients with a very low white

    blood cell count (neutropenia)

  • to prevent infections in patients with a very low

    white blood cell count (neutropenia)

  • anthrax inhalation exposure

If you have a severe infection or one that is caused by more than one type of bacterium, you may be given additional antibiotic treatment in addition to Ciprofloxacin.

Children and adolescents

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

  • lung and bronchial infections in children and

    adolescents suffering from cystic fibrosis

  • complicated urinary tract infections, including infections

    that have reached the kidneys (pyelonephritis)

  • anthrax inhalation exposure

Ciprofloxacin may also be used to treat other specific severe infections in children and adolescents when your doctor considered this necessary.

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

You must NOT be given Ciprofloxacin if you are:

  • allergic to ciprofloxacin, to other quinolone drugs or to

    any of the other ingredients of this medicine (listed in section 6).

  • taking tizanidine (see Section 2: Other medicines

    and Ciprofloxacin)

Warnings and precautions

Before taking this medicine

You should not take fluoroquinolone/quinolone antibacterial medicines, including Ciprofloxacin, if you have experienced any serious adverse reaction in the past when taking a quinolone or fluoroquinolone. In this situation, you should inform your doctor as soon as possible.

Before you are given Ciprofloxacin talk to your doctor, pharmacist, nurse or healthcare professional :

  • if you have ever had kidney problems because

    your treatment may need to be adjusted

  • if you suffer from epilepsy or other neurological

    conditions

  • if you have a history of tendon problems during

    previous treatment with antibiotics such as Ciprofloxacin

  • if you are diabetic because you may experience a

    risk of hypoglycaemia with ciprofloxacin

  • if you have myasthenia gravis (a type of muscle

    weakness) because symptoms can be exacerbated

  • if you have been diagnosed with an enlargement

    or "bulge" of a large blood vessel (aortic aneurysm or large vessel peripheral aneurysm)

  • if you have experienced a previous episode of

    aortic dissection (a tear in the aorta wall)

  • if you have been diagnosed with leaking heart

    valves (heart valve regurgitation).

  • if you have a family history of aortic aneurysm or

    aortic dissection or congenital heart valve disease, or other risk factors or predisposing conditions (e.g. connective tissue disorders such as Marfan syndrome or Ehlers-Danlos syndrome, Turner syndrome, Sjögren's syndrome [an inflammatory autoimmune disease], or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behcet's disease, high blood pressure, or known atherosclerosis, rheumatoid arthritis [a disease of the joints] or endocarditis [an infection of the heart]).

  • if you have heart problems. Caution should be taken

    when using this kind of medicine, if you were born with or have family history of prolonged QT interval (seen on ECG, electrical recording of the heart), have salt imbalance in the blood (especially low level of potassium or magnesium in the blood), have a very slow heart rhythm (called 'bradycardia'), have a weak heart (heart failure), have a history of heart attack (myocardial infarction), you are female or elderly or you are taking other medicines that result in abnormal ECG changes (see section 2: Other medicines and Ciprofloxacin).

  • if you or a member of your family is known to have a

    deficiency in glucose-6-phosphate dehydrogenase (G6PD), since you may experience a risk of anemia with ciprofloxacin.

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

While under treatment with Ciprofloxacin

Tell your doctor immediately, if any of the following occurs during treatment with Ciprofloxacin. Your doctor will decide whether treatment with Ciprofloxacin needs to be stopped.

  • Severe, sudden allergic reaction (an anaphylactic

    reaction/shock, angio-oedema). Even with the first dose, there is a rare chance that you may experience a severe allergic reaction with the following symptoms: tightness in the chest, feeling dizzy, feeling sick or faint, or experience dizziness on standing. If this happens, tell your doctor immediately since the administration of Ciprofloxacin will have to be stopped.

  • You may experience psychiatric reactions when

    taking ciprofloxacin. If you suffer from depression or psychosis, your symptoms may become worse under treatment with Ciprofloxacin. In rare cases, depression or psychosis can progress to thoughts of suicide or suicide attempts. If this happens, stop taking Ciprofloxacin and contact your doctor immediately. You may not notice some changes in your mood and behaviour so it is very important to tell your friends and family that you are taking Ciprofloxacin, and that there may be rare psychiatric side effects. Others may notice changes and help you quickly identify any symptoms that you need to talk to your doctor about.

  • Pain and swelling in the joints and inflammation

    or rupture of tendons may occur rarely. Your risk is increased if you are elderly (above 60 years of age), have received an organ transplant, have kidney problems or if you are being treated with corticosteroids. Inflammation and ruptures of tendons may occur within the first 48 hours of treatment and even up to several months after stopping of Ciprofloxacin therapy. At the first sign of pain or inflammation of a tendon (for example in your ankle, wrist, elbow, shoulder or knee), stop taking Ciprofloxacin, contact your doctor and rest the painful area. Avoid any unnecessary exercise as this might increase the risk of a tendon rupture.

  • If you feel sudden, severe pain in your abdomen,

    chest or back, which can be symptoms of aortic aneurysm and dissection, go immediately to an emergency room. Your risk may be increased if you are being treated with systemic corticosteroids.

  • If you start experiencing a rapid onset of shortness

    of breath, especially when you lie down flat in your bed, or you notice swelling of your ankles, feet or abdomen, or a new onset of heart palpitations (sensation of rapid or irregular heartbeat), you should inform a doctor immediately.

  • If you suffer from epilepsy or other neurological

    conditions such as cerebral ischemia or stroke, you may experience side effects associated with the central nervous system. If seizure happens, stop taking Ciprofloxacin and contact your doctor immediately.

    • You may rarely experience symptoms of nerve damage (neuropathy) such as pain, burning, tingling, numbness and/or weakness especially in the feet and legs or hands and arms.. If this happens, stop taking Ciprofloxacin and inform your doctor immediately in order to prevent the development of potentially irreversible condition.
    • Hypoglycemia has been reported most often in diabetic patients, predominantly in elderly population. If this happens, contact your doctor immediately.
    • Diarrhoea may develop while you are on antibiotics, including Ciprofloxacin, or even several weeks after you have stopped using them. If it becomes severe or persistent or you notice that your stool contains blood or mucus tell your doctor immediately. Ciprofloxacin treatment will have to be stopped immediately, as this can be life-threatening. Do not take medicines that stop or slow down bowel movements.
    • If your eyesight becomes impaired or if your eyes seem to be otherwise affected, consult an eye specialist immediately.
    • Your skin becomes more sensitive to sunlight or ultraviolet (UV) light under treatment with Ciprofloxacin. Avoid exposure to strong sunlight or artificial UV light such as sunbeds.
    • Tell the doctor or laboratory staff that you are taking Ciprofloxacin if you have to provide a blood or urine sample.
    • If you suffer from kidney problems, tell the doctor because your dose may need to be adjusted.
    • Ciprofloxacin may cause liver damage.

      If you notice any symptoms such as loss of appetite, jaundice (yellowing of the skin), dark urine, itching, or tenderness of the stomach, Ciprofloxacin must be stopped immediately.

    • Ciprofloxacin may cause a reduction in the number of white blood cells and your resistance to infection may be decreased. If you experience an infection with symptoms such as fever and serious deterioration of your general condition, or fever with local infection symptoms such as sore throat/pharynx/mouth or urinary problems you should see your doctor immediately. A blood test will be taken to check possible reduction of white blood cells (agranulocytosis). It is important to inform your doctor about your medicine.

Prolonged, disabling and potentially irreversible serious side effects:

Fluoroquinolone/quinolone antibacterial medicines, including Ciprofloxacin, have been associated with rare but serious side effects, some of them being long lasting (continuing for months or years), disabling or potentially irreversible. This includes tendon, muscle and joint pain of the upper and lower limbs, difficulty in walking, abnormal sensations such as pins and needles, tingling, tickling, numbness or burning (paraesthesia), sensory disorders including impairment of vision, taste and smell, and hearing, mental health effects which may include, but are not necessarily limited to, anxiety, panic attacks, confusion, or depression, memory impairment, severe fatigue, and severe sleep disorders. There are no medicines that have been established as being effective treatments for the symptoms of long lasting or disabling side effects associated with fluoroquinolones.

If you experience any of these side effects after taking Ciprofloxacin, then do not take any further doses and contact your doctor immediately. You and your doctor will decide on whether to continue treatment considering alternative options.

Other medicines and Ciprofloxacin

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

Do not use Ciprofloxacin together with tizanidine, because this may cause side effects such as low blood pressure and sleepiness (see Section 2: “You must not be given Ciprofloxacin”).

The following medicines are known to interact with Ciprofloxacin in your body. Using Ciprofloxacin together with these medicines can influence the therapeutic effect of these medicines. It can also increase the probability of experiencing side effects.

Tell your doctor if you are taking:

  • Vitamin K antagonists (e.g. warfarin acenocoumarol, phenprocoumon or fluindione) or other oral anti-coagulants (to thin the blood)
  • probenecid (for gout)
  • methotrexate (for certain types of cancer, psoriasis, rheumatoid arthritis)
  • theophylline (for breathing problems)
  • tizanidine (for muscle spasticity in multiple sclerosis)
  • olanzapine (an antipsychotic)
  • clozapine (an antipsychotic)
  • ropinirole (for Parkinson's disease)
  • phenytoin (for epilepsy)
  • cyclosporin (for skin conditions, rheumatoid arthritis and in organ transplantation)
  • other medicines that can alter your heart rhythm:

    medicines that belong to the group of anti- arrhythmics (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), tricyclic antidepressants, some antimicrobials (that belong to the group of macrolides), some antipsychotics.

  • zolpidem (for sleep disorders)
  • metoclopramide (for nausea and vomiting)
  • omeprazole (for stomach ulcers)

Ciprofloxacin may increase the levels of the following medicines in your blood:

  • 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)

Ciprofloxacin with food and drink

Food and drink does not affect your treatment with Ciprofloxacin.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

It is preferable to avoid the use of Ciprofloxacin during pregnancy. Do not take Ciprofloxacin during breast feeding because ciprofloxacin is excreted in breast milk and can be harmful for your child.

Driving and using machines

Ciprofloxacin may make you feel less alert. Some neurological adverse events can occur. Therefore, make sure you know how you react to Ciprofloxacin before driving a vehicle or operating machinery. If in doubt, talk to your doctor.

Ciprofloxacin contains sodium

If you are on a low-sodium diet, take into account that 100 ml of Ciprofloxacin contain 15.1 mmol (= 347 mg) sodium.

3. How to use Ciprofloxacin

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Your doctor will explain to you exactly how much Ciprofloxacin you will be given as well as how often and for how long. This will depend on the type of infection you have and how bad it is.

Tell your doctor if you suffer from kidney problems because your dose may need to be adjusted.

Treatment usually lasts between 5 and 21 days, but may be longer for severe infections.

Your doctor will give you each dose by slow infusion through a vein into your bloodstream. For children, the infusion duration is 60 minutes. In adult patients, infusion time is 60 minutes for 400 mg Ciprofloxacin and 30 minutes for 200 mg Ciprofloxacin. Administering the infusion slowly helps prevent immediate side effects occurring.

Remember to drink plenty of fluids while you are taking Ciprofloxacin.

If you receive more Ciprofloxacin than you should

In case you have received more Ciprofloxacin than you should you may experience e.g. dizziness, tremor, headache, tiredness, abdominal discomfort or confusion. Please tell your doctor or nurse if you experience any of these symptoms.

If a dose of Ciprofloxacin is forgotten

You will not be given a double dose to make up for a forgotten dose.

If you stop your course of Ciprofloxacin

  • It is important that you finish the course of treatment even if you begin to feel better after a few days. If you stop using this medicine too soon your infection may not be completely cured and the symptoms of the infection may return or get worse. You might also develop resistance to the antibiotic.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following information is intended for healthcare professionals only:

Ciprofloxacin should be administered by intravenous infusion. For children, the infusion duration is 60 minutes. In adult patients, infusion time is 60 minutes for 400 mg Ciprofloxacin and 30 minutes for 200 mg Ciprofloxacin. Slow infusion into a large vein will minimise patient discomfort and reduce the risk of venous irritation. The infusion solution can be infused either directly or after mixing with other compatible infusion solutions.

Unless compatibility with other infusion solutions/drugs has been confirmed, the infusion solution must always be administered separately. The visual signs of incompatibility are e.g. precipitation, clouding, and discolouration.

Incompatibility appears with all infusion solutions/ drugs that are physically or chemically unstable at the pH of the solution (e.g. penicillin, heparin solutions), especially in combination with solutions adjusted to an alkaline pH (pH of the ciprofloxacin infusion solutions: 4.0-4.9).

After intravenous initiation of treatment, the treatment can be continued orally as well.

The following section contains the most serious side effects that you can recognize yourself:

Stop taking Ciprofloxacin and contact your doctor immediately in order to consider another antibiotic treatment if you notice any of the following serious side effects:

Uncommon (may affect up to 1 in 100 people)

  • Seizure (see Section 2: Warnings and precautions)

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

  • Severe, sudden allergic reaction with symptoms

    such as tightness in the chest, feeling dizzy, sick or faint, or experience dizziness when standing up (anaphylactic shock) (see Section 2: Warnings and precautions)

  • Tendon rupture, particularly affecting the large

    tendon at the back of the ankle (Achilles tendon) (see Section 2: Warnings and precautions)

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

  • Severe, sudden allergic reaction with symptoms

    such as tightness in the chest, feeling dizzy, sick or faint, or experience dizziness when standing up (anaphylactic reaction) (see Section 2: Warnings and precautions)

  • Muscle weakness, inflammation of the tendons

    which could lead to rupture of the tendon, particularly affecting the large tendon at the back of the ankle (Achilles tendon) (see Section 2: Warnings and precautions)

  • A serious life-threatening skin rash, usually in the

    form of blisters or ulcers in the mouth, throat, nose, eyes and other mucous membranes such as genitals which may progress to widespread blistering or peeling of the skin (Stevens-Johnson syndrome, toxic epidermal necrolysis).

Not known (frequency cannot be estimated from the

available data)

  • Unusual feelings of pain, burning tingling,

    numbness or muscle weakness in the extremities (neuropathy) (see Section 2: Warnings and precautions)

  • A drug reaction that causes rash, fever, inflammation

    of internal organs, hematologic abnormalities and systemic illness (DRESS Drug Reaction with Eosinophilia and Systemic Symptoms, AGEP Acute Generalised Exanthematous Pustulosis).

  • Syndrome associated with impaired water

    excretion and low levels of sodium (SIADH)

Other side effects which have been observed during treatment with Ciprofloxacin are listed below by how likely they are:

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

  • nausea, diarrhoea, vomiting
  • joint pains and join inflammation in children
  • local reaction at the injection site, rash
  • temporary increased amounts of substances in the

    blood (transaminases)

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

  • joint pain in adults
  • fungal superinfections
  • a high concentration of eosinophils, a type of white

    blood cell, increased or decreased amounts of a blood clotting factor (thrombocytes)

  • loss of appetite (anorexia)
  • hyperactivity, agitation, confusion, disorientation,

    hallucinations

  • headache, dizziness, sleeping problems, taste

    disorders, pins and needles, unusual sensitivity to stimuli of the senses, see Section 2: Warnings and precautions), giddiness

  • eyesight problems, including double vision
  • loss of hearing
  • rapid heartbeat (tachycardia)
  • expansion of the blood vessels (vasodilation), low

    blood pressure

  • abdominal pain, digestive problems such as

    stomach upset (indigestion/heartburn), wind

  • liver disorders, increased amounts of one

    substance in the blood (bilirubin), jaundice (cholestatic icterus)

  • itching, hives
  • poor kidney function, kidney failure
  • pains in your muscles and bones, feeling unwell

    (asthenia), fever, fluid retention

  • increase in blood alkaline phosphatase (a certain

    substance in the blood)

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

  • Cases of long lasting (up to months or years) or

    permanent adverse drug reactions have been associated with quinolone and fluoroquinolone antibiotics. These may include tendon inflammations, tendon rupture, joint pain, pain in the limbs, difficulty in walking, abnormal sensations such as pins and needles, tingling, pricking , burning, numbness or pain (neuropathy), fatigue, sleep disorders, memory impairment, mental health effects which may include, but are not necessarily limited to, anxiety, panic attacks, confusion, or depression, as well as impairment of hearing, vision, and taste and smell. There are no medicines that have been established as being effective treatments for the symptoms of long lasting or disabling side effects associated with fluoroquinolones.

  • muscle pain, inflammation of the joints, increased

    muscle tone, cramping

  • inflammation of the bowel (colitis) linked to

    antibiotic use (can be fatal in rare cases) (see Section 2: Warnings and precautions)

  • changes to the blood count (leukopenia,

    leukocytosis, neutropenia, anaemia), a drop in the number of red and white blood cells and platelets (pancytopenia), which may be fatal, bone marrow depression which may also be fatal (see Section 2: Warnings and precautions)

  • allergic reaction, allergic swelling (oedema), rapid

    swelling of the skin and mucous membranes (angiooedema)

  • increased blood sugar (hyperglycemia)
  • decreased blood sugar (hypoglycaemia) (see

    Section 2: Warnings and precautions)

  • anxiety reaction, strange dreams, depression

    (potentially leading to thoughts of suicide, suicide attempts, or completed suicide), mental disturbances (psychotic reactions potentially leading to thoughts of suicide, suicide attempts, or completed suicide) (see Section 2: Warnings and precautions)

  • decreased skin sensitivity, tremor, migraine,

    disorder of sense of smell (olfactory disorders)

  • tinnitus, impaired hearing
  • fainting, inflammation of the blood vessel (vasculitis)
  • shortness of breath including asthmatic symptoms
  • pancreatitis
  • hepatitis, death of liver cells (liver necrosis) very

    rarely leading to life-threatening liver failure with possibly fatal outcome

  • sensitivity to light (see Section 2: Warnings and

    precautions), small, pin-point bleeding under the skin (petechiae)

  • blood or crystals in the urine (see Section 2: Warnings

    and precautions), urinary tract inflammation

  • excessive sweating
  • increased levels of the enzyme amylase

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

  • a special type of reduced red blood cell count

    (haemolytic anaemia); a dangerous drop in a type of white blood cells (agranulocytosis) which can be fatal (see section 2: Warnings and precautions)

  • allergic reaction called serum sickness-like reaction

    (see Section 2: Warnings and precautions)

  • disturbed coordination, unsteady walk (gait

    disturbance), pressure on the brain (intracranial pressure and pseudotumor cerebri)

  • Visual colour change distortions
  • various skin eruptions or rashes (e.g. the

    potentially fatal Stevens-Johnson syndrome or toxic epidermal necrolysis)

  • worsening of the symptoms of myasthenia gravis

    (see Section 2: Warnings and precautions)

Not known (frequency cannot be estimated from the available data)

  • Feeling highly excited (mania) or feeling great

    optimism and overactivity (hypomania)

  • Abnormal fast heart rhythm, life-threatening

    irregular heart rhythm, alteration of the heart rhythm (called 'prolongation of QT interval', seen on ECG, electrical activity of the heart)

  • International normalised ratio increased (in

    patients treated with Vitamin K antagonists)

Cases of an enlargement and weakening of the aortic wall or a tear in the aortic wall (aneurysms and dissections), which may rupture and may be fatal, and of leaking heart valves have been reported in patients receiving fluoroquinolones. See also section 2.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, nurse or healthcare professional . This includes any possible side effects not listed in this leaflet.You can also report side effects directly via the Yellow Card Scheme.

Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Goog le Play or AppleApp Store.

By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Ciprofloxacin

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the packaging after “Exp”. The expiry date refers to the last day of that month.

  • Do not refrigerate or freeze.
  • Store the infusion bag in the overpouch until it is

    used in order to protect from light.

    • Store the infusion bottle in the outer carton until it is used in order to protect from light.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and further information

What Ciprofloxacin contains

  • The active substance is ciprofloxacin (as hydrogen sulphate).
  • The other ingredients are sodium chloride, sulphuric acid, sodium hydroxide for pH adjustment, water for injections

What Ciprofloxacin looks like and contents of the pack

Ciprofloxacin is a sterile, clear and colourless solution. Ciprofloxacin is contained in a clear flexible polyolefine bag with aluminium overpouch (Freeflex bags) or in a polyethylene bottle (KabiPac).

50 ml solution contains 100 mg ciprofloxacin. 100 ml solution contains 200 mg ciprofloxacin. 200 ml solution contains 400 mg ciprofloxacin.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Fresenius Kabi Limited,

Cestrian Court, Eastgate Way

Manor Park, Runcorn

Cheshire, WA7 1NT

UK

Manufacturers:

HP Halden Pharma AS

Svinesundsveien 80

1788 Halden, Norway

Fresenius Kabi Polska Sp. z o.o.

Wytwórnia Płynów Infuzyjnych

99-300 Kutno

Sienkiewicza 25

Poland

This medicinal product is authorised in the Member States of the EEA under following names:

AT: Ciprofloxacin 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 200mg/100ml, -400 mg/ 200 ml

διάλυμα για έγχυση

CZ: Ciprofloxacin 200 mg/ 100 ml, -400 mg/200 ml, infuzní roztok

DE: Ciprofloxacin 100 mg/50 ml, -200 mg/100 ml,

400 mg/200 ml Infusionslösung

DK: Ciprofloxacin Fresenius Kabi 2 mg/ml infusionsvæske

EL: Ciprofloxacin 200 mg/ 100 ml, -400 mg/200 ml

διάλυμα για έγχυση

ES: Ciprofloxacin 2 mg/ml solución para perfusión FI: Ciprofloxacin Fresenius Kabi 2 mg/ml infuusioneste, liuos

HU: Ciprofloxacin 200 mg/100 ml, -400 mg/200 ml oldatos infúzió

IT: Ciprofloxacin 100 mg/50 ml, -200 mg/ 100 ml,

-400 mg/200 ml soluzione per infusione NL: Ciprofloxacin 100 mg/50 ml, -200 mg/ 100 ml,

-400 mg/200 ml oplossing voor infusie PL: Ciprofloxacin 100 mg/50 ml, -200 mg/ 100 ml,

-400 mg/200 ml roztwór do infuzji

PT: Ciprofloxacin 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 200 mg/ 100 ml, -400 mg/200 ml infúzny roztok

UK: Ciprofloxacin 100 mg/50 ml, -200 mg/ 100 ml,

-400 mg/200 ml solution for infusion

This leaflet was last revised in June 2024

Advice/medical education

Antibiotics are used to cure bacterial infections. They are ineffective 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 called resistance: some antibiotic treatments become ineffective.

Misuse of antibiotics increases resistance. You may even help bacteria become resistant and therefore delay your cure or decrease antibiotic efficacy if you do not respect appropriate:

  • dosage
  • schedules
  • duration of treatment

Consequently, to preserve the efficacy of this drug:

  1. 1. Use antibiotics only when prescribed.
  2. 2. Strictly follow the prescription.
  3. 3. Do not re-use an antibiotic without medical prescription, even if you want to treat a similar illness.
  4. 4.

    Never give your antibiotic to another person;

    maybe it is not adapted to her/his illness.

  5. 5. After completion of treatment, return all unused drugs to your chemist's shop to ensure they will be disposed of correctly

INDEKS, WYDANIE ULOTKI: U15730/K GB

KOREKTA: 0

WERSJA: K

DATA: 02.07.2024

About this document

Source: MHRA - Medicines and Healthcare products Regulatory Agency (products.mhra.gov.uk) · Marketing authorisation: PL 08828/0172

Last revision stated in the text: June 2024 · MHRA data as of 13 October 2026

Found a mistake? Tell us on the contact page.

The information on this site does not replace the advice of a doctor or pharmacist.

Facts about Ciprofloxacin 400 mg / 200 ml solution for infusion

Active substance Ciprofloxacin
Strength 400 mg / 200 ml
Pharmaceutical form Clear, colourless solution
pH of the solution: 4.0 to 4.9
Excipients Sodium chloride, Sulphuric acid, Sodium hydroxide for pH adjustment, Water for injections
Shelf life Ciprofloxacin 400 mg/200 ml: Solution for Infusion
24 months
Ciprofloxacin 400mg/200ml: Bottles
36 mths
From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.
Storage Do not refrigerate or freeze.
Keep infusion bag in the overpouch until ready to use in order to protect from light. Keep the infusion bottle in the outer carton until ready to use in order to protect from light. For storage conditions of the medicinal product see section 6.3.
Drug group (ATC) Fluoroquinolones
  1. J Antiinfectives for systemic use
    1. J01 Antibacterials for systemic use
      1. J01M Quinolone antibacterials
        1. J01MA Fluoroquinolone antibacterials, systemic
          1. J01MA02 ciprofloxacin
Marketing authorisation PL 08828/0172 (first authorised 23 September 2010)
Marketing authorisation holder Fresenius Kabi Limited

Sources: the MHRA product information (products.mhra.gov.uk) and the NHS Dictionary of Medicines and Devices (dm+d), release 10.2.0 of 19 October 2026, NHS Business Services Authority. Contains public sector information licensed under the Open Government Licence v3.0.