Cipronex

Package leaflet: Information for the user

Cipronex, 2 mg/ml, infusion solution
Ciprofloxacinum
Please read the entire leaflet carefully before use, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If any adverse reactions occur in the patient, including any adverse reactions not listed in this leaflet, inform your doctor or nurse immediately. See section 4.

Table of contents

1. What Cipronex is and what it is used for
2. Important information before using Cipronex
3. How to use Cipronex
4. Possible side effects
5. How to store Cipronex
6. Contents of the pack and other information

1. What Cipronex is and what it is used for

Cipronex is an antibiotic belonging to the fluoroquinolone group. The active substance is ciprofloxacin.
Ciprofloxacin works by destroying bacteria that cause infections. It acts only against certain bacterial strains.

Adults

• Lower respiratory tract infections caused by Gram-negative bacteria
• Exacerbations of chronic obstructive pulmonary disease (COPD); Cipronex should be used in exacerbations of COPD only when the use of other antibacterial agents commonly recommended for treatment of these infections is considered inappropriate.
• Bronchopulmonary infections in cystic fibrosis or bronchiectasis
• Community-acquired pneumonia
• Chronic suppurative otitis media
• Acute exacerbation of chronic sinusitis, particularly caused by Gram-negative bacteria
• Uncomplicated acute cystitis. Cipronex should be used in uncomplicated acute cystitis only when the use of other antibacterial agents commonly recommended for treatment of this infection is considered inappropriate.
• Acute pyelonephritis
• Complicated urinary tract infections
• Bacterial prostatitis
• Epididymitis and orchitis, including those caused by susceptible strains of Neisseria gonorrhoeae
• Pelvic inflammatory disease, including that caused by susceptible strains of Neisseria gonorrhoeae. If infection with Neisseria gonorrhoeae is suspected or confirmed in the above-mentioned genital tract infections, it is particularly important to obtain local data on ciprofloxacin resistance and to confirm susceptibility based on laboratory testing.
• Gastrointestinal infections (e.g. traveller's diarrhoea)
• Intra-abdominal infections
• Skin and soft tissue infections caused by Gram-negative bacteria
• Malignant external otitis
• Bone and joint infections
• Inhalational anthrax (post-exposure prophylaxis and treatment)

Ciprofloxacin may be used to treat febrile neutropenia presumed to be caused by bacterial infection.

Children and adolescents

• Bronchopulmonary infections caused by Pseudomonas aeruginosa in patients with cystic fibrosis
• Complicated urinary tract infections and acute pyelonephritis
• Inhalational anthrax (post-exposure prophylaxis and treatment)

Ciprofloxacin may also be used to treat severe infections in children and adolescents if the physician considers it necessary.
Treatment should be initiated only by physicians experienced in managing cystic fibrosis and/or severe infections in children and adolescents.
Official guidelines on the appropriate use of antibacterial agents should be taken into account.

2. Important information before using Cipronex

When not to use Cipronex:

• if the patient is allergic to ciprofloxacin, to other drugs in the quinolone group, or to any of the other ingredients of this medicine (listed in section 6);
• if the patient is taking tyzanicline at the same time (see section 2. – "Cipronex with other medicines").

Warnings and precautions
Before starting treatment with Cipronex, discuss the following with your doctor:

• if the patient has been diagnosed with enlargement of a large blood vessel (aortic aneurysm or large peripheral artery);
• if the patient has previously experienced aortic dissection (tearing of the aortic wall);
• if the patient has been diagnosed with heart valve insufficiency;
• if there is 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 vascular Ehlers-Danlos syndrome, Turner syndrome, Sjögren's syndrome [an autoimmune inflammatory disease], or vascular diseases such as Takayasu arteritis, giant cell arteritis, Behçet's disease, hypertension, confirmed atherosclerosis, rheumatoid arthritis [joint disease], or endocarditis [heart infection]);
• if the patient has or has ever had kidney problems, as the dose of the medicine may need to be adjusted;
• if the patient has epilepsy or other neurological disorders;
• if the patient has previously experienced tendon problems during treatment with antibiotics such as Cipronex;
• if the patient has diabetes – see below – subsection "While taking this medicine" and section 4;
• if the patient has myasthenia gravis (a type of muscle weakness);
• if the patient has previously had an irregular heart rhythm (arrhythmia);
• if the patient has been diagnosed with congenital or familial prolonged QT interval (visible on ECG – an examination of the heart's electrical activity);
• if the patient has electrolyte imbalance in the blood (especially low potassium and magnesium levels);
• if the patient has a very slow heart rate (called bradycardia);
• if the patient has impaired heart function (heart failure);
• if the patient has had a myocardial infarction;
• if the patient is a woman or an elderly person;
• if the patient is taking other medicines that may cause changes in the ECG (see section – "Cipronex with other medicines"). Do not take antibacterial medicines containing fluoroquinolones or quinolones (e.g. pefloxacin, moxifloxacin), including this medicine Cipronex, if the patient has previously experienced any severe adverse reaction while taking a quinolone or fluoroquinolone. In such a case, inform the doctor as soon as possible.

While taking this medicine
If any of the following symptoms occur while taking Cipronex, the patient should
immediately inform the doctor. The doctor will decide whether to discontinue treatment with
Cipronex.

• Severe, sudden allergic reaction (anaphylactic reaction or shock, angioedema). Although unlikely, a severe allergic reaction may occur even after the first dose, with symptoms such as: chest tightness, dizziness, nausea, fainting or dizziness upon standing. If this occurs, stop taking Cipronex and contact a doctor immediately.
• While taking this medicine, joint pain and swelling, inflammation or tendon rupture may rarely occur. The risk is increased in elderly patients (over 60 years), after organ transplantation, in patients with kidney problems or those receiving corticosteroid treatment. Tendon inflammation and rupture may occur within the first 48 hours of treatment, or even several months after discontinuation of Cipronex. After the first symptoms of tendon pain or inflammation (e.g. in the ankle, wrist, elbow, shoulder or knee) appear, the patient should stop taking Cipronex, contact a doctor, and rest the affected area. Avoid excessive physical exertion, as this may increase the risk of tendon rupture.
• If the patient has epilepsy or other neurological disorders, such as cerebral ischemia or stroke, adverse reactions from the central nervous system may occur. If this happens, stop taking Cipronex and contact a doctor immediately.
• Psychiatric reactions may occur after the first dose of Cipronex. If the patient has depression or psychosis, symptoms of these conditions may worsen during treatment with Cipronex. If this occurs, stop taking Cipronex and contact a doctor immediately.
• The patient may rarely experience symptoms of nerve damage (neuropathy), such as pain, burning, tingling, numbness and/or weakness, especially in the feet and legs, and hands and arms. In such a case, stop taking Cipronex and inform the doctor immediately to prevent the development of potentially irreversible disease.
• Quinolone antibiotics may cause blood glucose levels to rise above normal (hyperglycemia) or drop below normal, potentially leading to loss of consciousness (hypoglycemic coma) in severe cases (see section 4). This is important for diabetic patients. Diabetic patients are advised to carefully monitor their blood glucose levels.
• Diarrhea may occur while taking antibiotics, including Cipronex, or even several weeks after treatment has ended. If diarrhea is severe or persistent, or if the patient notices blood or mucus in the stool, treatment with Cipronex should be stopped immediately, as this may be life-threatening. Do not take medicines that inhibit or slow intestinal motility and contact a doctor.
• If the patient is providing a blood or urine sample for analysis, inform the doctor or laboratory staff that Cipronex is being taken.
• Cipronex may cause liver damage. If the patient notices symptoms such as: loss of appetite, jaundice (yellowing of the skin), dark urine, itching or stomach irritation, stop taking Cipronex and contact a doctor immediately.
• Cipronex may reduce the number of white blood cells, which may reduce resistance to infections. If the patient notices symptoms such as fever and severe worsening of general condition, or fever with local signs of infection such as: sore throat, laryngitis, oral cavity problems, or urinary tract issues, contact a doctor immediately. A blood test will be ordered to check for a reduction in white blood cells (agranulocytosis). Remember to inform the doctor about taking this medicine.
• If the patient or their family has glucose-6-phosphate dehydrogenase (G6PD) deficiency, inform the doctor, as ciprofloxacin use carries a risk of anemia.
• While taking Cipronex, the skin becomes more sensitive to sunlight and ultraviolet (UV) radiation. Avoid exposure to strong sunlight or artificial UV radiation (e.g. in a solarium).
• If vision becomes impaired or the patient experiences other eye-related symptoms, consult an ophthalmologist immediately.
• In case of sudden severe abdominal, back or chest pain, which may be a symptom of aneurysm or aortic dissection, go immediately to the emergency department. The risk of these conditions may be higher if systemic corticosteroids are being used.
• If sudden shortness of breath occurs, especially after lying down, or if swelling of the ankles, feet or abdomen is observed, or palpitations (sensation of rapid or irregular heartbeat) appear, seek medical advice immediately.
• Long-term, disabling and potentially irreversible serious adverse reactions: Antibacterial medicines containing fluoroquinolones/quinolones, including Cipronex, have been associated with very rare but serious adverse reactions. Some of these were long-term (lasting for months or years), disabling or potentially irreversible. These include: tendon, muscle and joint pain in the upper and lower limbs, difficulty walking, abnormal sensations such as pricking, tingling, tickling, numbness or burning (paresthesia), sensory disturbances, including vision, taste, smell and hearing disorders, depression, memory disturbances, severe fatigue and severe sleep disturbances. If any of these adverse reactions occur after taking Cipronex, contact the doctor immediately before continuing treatment. The patient and doctor will decide whether to continue treatment, also considering antibiotics from other groups.

Cipronex with other medicines
Tell the doctor about all medicines currently used or recently used,
as well as medicines the patient plans to use.
Do not use Cipronex together with tyzanicline, as this may cause adverse reactions such as low blood pressure and drowsiness (see section 2. – "When not to use Cipronex").
The following medicines may interact with Cipronex in the human body.
Taking Cipronex together with these medicines may affect their therapeutic effect.
It may also increase the likelihood of adverse reactions.
If the patient is taking other medicines that may affect heart rhythm, such as antiarrhythmic drugs (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), tricyclic antidepressants, certain antibacterial drugs (macrolide group), or certain antipsychotic drugs, the patient must inform the doctor.
Inform the doctor if the patient is taking any of the following medicines:

• warfarin or another oral anticoagulant (e.g. acenocoumarol, phenprocoumon, fluindione);
• probenecid (used in gout);
• methotrexate (used in certain types of cancer, psoriasis, rheumatoid arthritis);
• theophylline (used in respiratory disorders);
• tyzanicline (used to reduce excessive muscle tension in multiple sclerosis);
• clozapine (an antipsychotic medicine);
• ropinirole (used in Parkinson's disease);
• phenytoin (used in epilepsy);
• metoclopramide (prevents nausea and vomiting);
• omeprazole (used to treat heartburn and peptic ulcer disease);
• cyclosporine (used after organ transplantation);
• glibenclamide (used in diabetes).

Cipronex may increase the blood concentration of the following medicines:

• pentoxifylline (used in circulatory disorders);
• caffeine;
• duloxetine (used in depression, diabetic neuropathy, urinary incontinence);
• lidocaine (used in anesthesia, pain relief, and cardiac arrhythmias);
• sildenafil (used in erectile dysfunction);
• agomelatine;
• zolpidem.

Taking Cipronex with food and drink
Food and drink do not affect the use of Cipronex.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult a doctor before using this medicine.
It is best to avoid using Cipronex during pregnancy.
Breastfeeding women should not take Cipronex, as ciprofloxacin passes into breast milk and may be harmful to the child.
Driving and operating machinery
Cipronex may impair concentration. Some neurological adverse effects may occur. Before driving or operating machinery, the patient should assess how he or she reacts to Cipronex. If in doubt, consult a doctor.
Cipronex contains sodium
The medicine contains 177 mg of sodium (main component of table salt) in each 50 ml container.
This corresponds to 8.9% of the maximum recommended daily sodium intake in the diet of adults.
The medicine contains 354 mg of sodium (main component of table salt) in each 100 ml container.
This corresponds to 17.7% of the maximum recommended daily sodium intake in the diet of adults.
The medicine contains 708 mg of sodium (main component of table salt) in each 200 ml container.
This corresponds to 35.4% of the maximum recommended daily sodium intake in the diet of adults.
If taking 110 ml or more of Cipronex per day for a prolonged period (daily for longer than one month), patients, especially those monitoring sodium intake in their diet, should contact their doctor or pharmacist.
The medicine can be mixed with the following intravenous infusion solutions: physiological saline, Ringer's solution, Ringer's lactate solution, 5% and 10% glucose solution, 10% fructose solution. The sodium content originating from the diluent should be taken into account when calculating the total sodium content in the prepared diluted product. For accurate information on the sodium content in the solution used to dilute the medicine, refer to the product characteristics of the diluent used.

3. How to use Cipronex

This medicine should always be used as directed by the physician. The doctor will explain exactly what dose of Cipronex should be used, how often, and for how long. This will depend on the type and severity of the infection.
If the patient has kidney problems, the doctor should be informed, as the dose may need to be adjusted.
Treatment usually lasts from 5 to 21 days, but may be longer in severe infections.
The doctor will administer each dose intravenously by slow infusion. The infusion time in children is 60 minutes. In adult patients, the infusion time for the 400 mg/200 ml ciprofloxacin solution is 60 minutes, and for the 200 mg/100 ml solution – 30 minutes. Slow infusion helps avoid sudden adverse reactions.
It is important to drink plenty of fluids during treatment with Cipronex.
A detailed description of the method of use and preparation of the medicine for administration is provided at the end of this leaflet under the section "Information intended exclusively for healthcare professionals".

Discontinuation of Cipronex
It is important not to stop treatment even if symptoms improve after a few days of taking the medicine. Premature discontinuation of treatment may result in incomplete eradication of the infection, and symptoms may return or worsen. Antibiotic resistance may also develop.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
The most serious adverse reactions observed during treatment with this medicine are listed
below.
If you notice any of the symptoms listed below, stop taking Cipronex
immediately and contact your doctor without delay, as another antibiotic may need to be used.
Rare adverse reactions (occurring no more frequently than in 1 out of 1,000 patients):

• seizures (see section 2. Warnings and precautions);
• depression (potentially leading to suicidal thoughts, suicide attempts or suicide) (see section 2. Warnings and precautions);
• allergic reaction, swelling (oedema) or rapid swelling of the skin and mucous membranes (angioedema) (see section 2. Warnings and precautions).

Very rare adverse reactions (occurring less frequently than in 1 out of 10,000 patients):

• severe, sudden allergic reaction with symptoms such as chest tightness, dizziness, nausea or fainting, or dizziness upon standing (anaphylactic reaction/anaphylactic shock) (see section 2. Warnings and precautions);
• muscle weakness;
• tendon inflammation, which may lead to tendon rupture, especially of the large tendon at the back of the ankle (Achilles tendon) (see section 2. Warnings and precautions);
• life-threatening skin rash, usually presenting as blisters or ulceration of the mouth, throat, nose, eyes and mucous membranes of the genital organs, followed by spreading blisters or skin peeling (e.g. bullous erythema multiforme – Stevens-Johnson syndrome or toxic epidermal necrolysis – Lyell's syndrome);
• liver cell death (hepatic necrosis), very rarely leading to life-threatening liver failure, which may present with symptoms such as: loss of appetite, diarrhoea, fever, skin rash, itching, abdominal distension, pain in the right upper abdomen, nausea and vomiting (see section 2. Warnings and precautions);
• mental disturbances (psychotic reactions potentially leading to suicidal thoughts, suicide attempts or suicide) (see section 2. Warnings and precautions).

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

• heart disorders, such as: very rapid heartbeat, life-threatening irregular heartbeat, cardiac rhythm disorders (known as "QT interval prolongation", visible on ECG – electrocardiogram);
• drug hypersensitivity reaction causing rash, fever, internal organ inflammation, haematological disorders and systemic illness (drug reaction with eosinophilia and systemic symptoms, abbreviated as DRESS; acute generalised exanthematous pustulosis, abbreviated as AGEP);
• nervous system disorders such as pain, burning, tingling, numbness and (or) limb weakness (neuropathy);
• loss of consciousness due to a significant drop in blood glucose levels (hypoglycaemic coma). See section 2.

In patients receiving fluorquinolones, cases of arterial wall dilation and weakening or arterial wall rupture (aneurysm and dissection) have been reported, which may result in rupture and lead to death, as well as cases of heart valve insufficiency. See also section 2.
Administration of quinolone and fluoroquinolone antibiotics, in some cases regardless of pre-existing risk factors, has very rarely led to long-term (lasting for months or years) or permanent adverse reactions such as tendon inflammation, tendon rupture, joint pain, limb pain, difficulty walking, abnormal sensations such as pricking, tingling, tickling, burning, numbness or pain (neuropathy), fatigue, memory and concentration disturbances, mental health disorders (which may include sleep disturbances, anxiety, panic attacks, depression and suicidal thoughts), as well as hearing, vision, taste and smell disturbances.
Other adverse reactions observed during treatment with Cipronex are
listed below, according to their likelihood of occurrence.
Common adverse reactions (occurring no more frequently than in 1 out of 10 patients):

• nausea (feeling sick), diarrhoea;
• local reaction at injection or infusion site;
• joint pain and arthritis in children.

Uncommon adverse reactions (occurring no more frequently than in 1 out of 100 patients):

• joint pain in adults;
• fungal superinfections;
• high levels of eosinophils (a type of white blood cells);
• decreased appetite;
• excessive activity or restlessness;
• headache, dizziness, sleep problems or taste disturbances;
• vomiting, stomach pain, digestive disorders such as upset stomach (dyspepsia, heartburn) or gas (flatulence);
• increased levels of certain substances in the blood [aminotransferases and (or) bilirubin];
• rash, itching or hives;
• impaired kidney function;
• muscle and bone pain, malaise (weakness) or fever;
• increased blood levels of alkaline phosphatase (enzyme).

Rare adverse reactions (occurring no more frequently than in 1 out of 1,000 patients):

• muscle pain, arthritis, increased muscle tension or cramps;
• antibiotic-associated inflammation of the intestine (colon) (very rarely may be fatal) (see section 2. Warnings and precautions);
• changes in blood cell counts (leukopenia, leukocytosis, neutropenia, anaemia), increased or decreased number of blood clotting factors (platelets);
• increased blood glucose levels (hyperglycaemia);
• confusion, disorientation, anxiety reactions, unusual dreams or hallucinations;
• pricking sensation, increased sensitivity to sensory stimuli, reduced skin sensitivity, tremor or dizziness;
• visual disturbances, including double vision (see section 2. Warnings and precautions);
• tinnitus, hearing loss, hearing disturbances;
• rapid heartbeat (tachycardia);
• blood vessel dilation, low blood pressure or fainting;
• shallow breathing, including asthma-like symptoms;
• liver function disorders, cholestatic jaundice or hepatitis;
• light sensitivity (see section 2. Warnings and precautions);
• kidney failure, blood or crystals in urine, urinary tract inflammation;
• fluid retention or excessive sweating;
• increased activity of an enzyme called amylase.

Very rare adverse reactions (occurring less frequently than in 1 out of 10,000 patients):

• a specific type of reduced red blood cell count (haemolytic anaemia); dangerous reduction in white blood cell count (agranulocytosis) (see section 2. Warnings and precautions); reduced red and white blood cells and platelets (aplastic anaemia), which may be fatal, and bone marrow suppression, which may also be fatal;
• allergic reaction resembling serum sickness (see section 2. Warnings and precautions);
• migraine, coordination disorders, unsteady gait (gait disturbances), smell disturbances, increased intracranial pressure (pseudotumour cerebri);
• colour vision disturbances;
• inflammation of blood vessel walls (vasculitis);
• pancreatitis;
• small dark spots visible under the skin (purpura); various skin lesions or rashes;
• worsening of myasthenia symptoms (see section 2. Warnings and precautions).

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

• a disease syndrome associated with impaired water excretion from the body and reduced sodium concentration in the blood (SIADH, syndrome of inappropriate secretion of antidiuretic hormone);
• feeling of excessive excitement (mania) or excessive optimism combined with increased activity (hypomania);
• effect on blood coagulation (in patients treated with vitamin K antagonists).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed
in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps to gather more information on the safety of this medicine.

5. How to store the medicine Cipronex

Keep the medicine out of sight and reach of children.
Store in the original packaging. Do not store at temperatures above 25°C.
Do not store in the refrigerator or freeze.
Protect from exposure to vapours and chemically active gases or gases with strong odours.
The solution is sensitive to light; therefore, remove the container from its packaging immediately before use.
If the medicine is continuously exposed to daylight for longer than 3 days, its full efficacy is not guaranteed.
Any unused solution should be discarded.
Do not use this medicine after the expiry date stated on the container or carton.
The expiry date refers to the last day of the stated month.
The label on the packaging shows the expiry date after the abbreviation EXP and the batch number after the abbreviation Lot.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the package and other information

What Cipronex contains

• The active substance is ciprofloxacin. One 50 ml container contains 100 mg of ciprofloxacin (as ciprofloxacin hydrochloride monohydrate). One 100 ml container contains 200 mg of ciprofloxacin (as ciprofloxacin hydrochloride monohydrate). One 200 ml container contains 400 mg of ciprofloxacin (as ciprofloxacin hydrochloride monohydrate).
• Other ingredients: sodium lactate, sodium chloride, hydrochloric acid, water for injections.

What Cipronex looks like and contents of the pack
Cipronex is a clear infusion solution with a slightly yellowish-green tint, contained in a polyethylene container with an Insocap-type adapter, packed in a cardboard box.
The pack contains:
One 50 ml container;
One or 40 containers of 100 ml;
One or 20 containers of 200 ml.

Marketing Authorisation Holder and Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01

Advice – Medical education
Antibiotics are used to treat bacterial infections. They do not work in viral infections.
Antibiotics should be used only for diseases for which a doctor has prescribed them. Despite their effectiveness, some bacteria may survive or multiply during antibiotic treatment. This phenomenon is known as resistance: sometimes antibiotic treatment becomes ineffective.
Improper use of antibiotics increases resistance. It may even cause bacteria to become resistant, prolonging treatment or reducing the antibiotic's effectiveness, if the patient does not follow the doctor's instructions regarding:

• dose size;
• frequency of administration;
• duration of treatment.

Therefore, to preserve the effectiveness of this medicine:
1 – Use antibiotics only when prescribed by a doctor.
2 – Strictly follow the doctor's instructions.
3 – Do not take the antibiotic again without a doctor's prescription, even if the current illness seems similar to the one previously treated with the antibiotic.
4 – Never give the antibiotic to another person, as it may be inappropriate for their condition.
5 – After completing treatment, return any unused medicine to the pharmacy for proper disposal.

Information intended exclusively for healthcare professionals

Detailed information about this medicinal product, including information intended exclusively for healthcare professionals, is available in the Product Characteristics section on the website: www.urpl.gov.pl.
The Cipronex product should be administered as an intravenous infusion.
Low temperature may cause precipitation, which dissolves at room temperature. The medicinal product should be warmed to room temperature before administration.
After checking the integrity of the container and removing the protective film, the container should be connected to an infusion set with a dual-channel needle. The infusion duration in children is 60 minutes. In adult patients, the infusion time for the 400 mg/200 ml ciprofloxacin solution is 60 minutes, and for the 200 mg/100 ml solution

• 30 minutes. Slow infusion into a large vein will help minimize patient discomfort and reduce the risk of venous irritation. The infusion solution may be administered directly or after mixing with other compatible infusion solutions.

The infusion solution should always be administered separately unless compatibility with other solutions (medicinal products) has been confirmed. Visible signs of pharmaceutical incompatibility include, for example, precipitation, cloudiness, and discoloration.
Pharmaceutical incompatibilities occur with all infusion solutions (medicinal products) that are physically or chemically unstable at the pH of these solutions (e.g., penicillin solutions, heparin solutions), especially when combined with solutions adjusted to an alkaline pH (pH of ciprofloxacin solutions: 3.5–4.6).
After initial intravenous administration, treatment may be continued orally.