Proxacin 1%

Package leaflet: Information for the patient

Proxacin 1%
10 mg/ml, concentrate for solution for infusion
Ciprofloxacinum
Please read carefully the entire leaflet before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

1. What Proxacin 1% is and what it is used for

Proxacin 1% contains an antibiotic from the fluoroquinolone group – ciprofloxacin. Ciprofloxacin
acts by destroying bacteria causing infections. It is effective only against certain bacterial strains.
Adults

• Lower respiratory tract infections caused by Gram-negative bacteria:
  • exacerbation of chronic obstructive pulmonary disease (COPD): Proxacin 1% should be used only when other antibacterial agents commonly recommended for treating these infections are considered inappropriate;
  • bronchopulmonary infections in cystic fibrosis or bronchiectasis;
  • community-acquired pneumonia.
• Chronic suppurative otitis media.
• Severe exacerbation of chronic sinusitis, particularly caused by Gram-negative bacteria.
• Uncomplicated acute cystitis. In uncomplicated cystitis, Proxacin 1% should be used only when other antibacterial agents commonly recommended for treating these infections are considered inappropriate.
• Acute pyelonephritis.
• Complicated urinary tract infections.
• Bacterial prostatitis.
• Genitourinary tract infections:
  • epididymitis and orchitis, including those caused by susceptible strains of Neisseria gonorrhoeae.
  • pelvic inflammatory disease, including that caused by susceptible strains of Neisseria gonorrhoeae.
• 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.
• Pulmonary anthrax (post-exposure prophylaxis and treatment).

Ciprofloxacin may also be used in the treatment of febrile neutropenic patients, when a bacterial
infection is suspected.
Children and adolescents

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

Ciprofloxacin may also be used to treat severe infections in children and adolescents if considered necessary.
Such treatment should be initiated only by physicians experienced in managing cystic fibrosis and/or severe infections in children and adolescents.

2. Important information before using Proxacin 1%

When not to use Proxacin 1%:

• if the patient is allergic to ciprofloxacin, to other drugs in the quinolone group, or to any of the other ingredients of Proxacin 1% (listed in section 6);
• if the patient is taking tizanidine at the same time – see section 2 "Proxacin 1% and other medicines".

Warnings and precautions
Before starting treatment with Proxacin 1%, discuss this with your doctor or pharmacist.
Do not take antibacterial medicines containing fluoroquinolones or quinolones,
including Proxacin 1%, if the patient has previously experienced any severe adverse
reaction while taking a quinolone or fluoroquinolone. In such a case, contact your doctor as
soon as possible.
Before administering Proxacin 1%, tell your doctor if:

• the patient has ever had kidney problems, as treatment may need to be adjusted;
• the patient suffers from epilepsy or has other neurological disorders;
• the patient has previously had tendon problems while being treated with antibiotics such as Proxacin 1%;
• the patient has diabetes – after using ciprofloxacin, blood sugar levels may drop significantly (hypoglycaemia) – see also below and section 4;
• the patient has myasthenia gravis (a type of muscle weakness) – symptoms may worsen;
• the patient has heart problems. Caution is required when using this type of medicine if: the patient has been diagnosed with congenital or familial QT interval prolongation (visible on ECG – an examination of the heart's electrical activity); the patient has electrolyte imbalance in the blood (especially low potassium and magnesium levels); the patient has a very slow heart rate (bradycardia); the patient has heart failure; the patient has had a myocardial infarction; the patient is female or elderly; the patient is taking other medicines that may cause changes in the ECG (see section 2 "Proxacin 1% and other medicines");
• the patient or their family has glucose-6-phosphate dehydrogenase (G6PD) deficiency, inform the doctor – anaemia may occur after using ciprofloxacin;
• the patient has been diagnosed with a dilated large blood vessel (aortic aneurysm or large peripheral artery);
• the patient has previously experienced aortic dissection (tearing of the aortic wall);
• the patient has been diagnosed with heart valve insufficiency.
• in the family there have been cases of aortic aneurysm or aortic dissection, or congenital heart valve disease, or other risk factors or predisposing conditions (e.g. connective tissue diseases 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, or confirmed arterial atherosclerosis, rheumatoid arthritis [joint disease] or endocarditis [heart infection]).

In treating certain urinary and genital tract infections, the doctor may additionally prescribe another antibiotic alongside
ciprofloxacin. If the patient's condition does not improve after three days of treatment, consult the doctor.
While using Proxacin 1%
If during treatment with Proxacin 1% any of the following symptoms occur, you must
immediately inform your doctor. The doctor will decide whether to discontinue treatment with
Proxacin 1%.

• Severe, sudden allergic reaction (anaphylactic reaction or shock, angioedema). This is unlikely, but even after the first dose a severe allergic reaction may occur, with the following symptoms: chest tightness, dizziness, nausea, fainting or dizziness upon standing. If this happens, stop using Proxacin 1% and contact your doctor immediately.
• Long-lasting, disabling and potentially irreversible severe adverse effects Antibacterial medicines containing fluoroquinolones/quinolones, including Proxacin 1%, have been associated with very rare but serious adverse effects. Some of these were long-lasting (persisting for months or years), disabling or potentially irreversible. These include: tendon inflammation, tendon rupture, joint pain, limb pain, difficulty walking, abnormal sensations such as pricking, tingling, tickling, numbness or pain (neuropathy), fatigue, memory and concentration problems, mental health effects (which may include sleep disturbances, anxiety, panic attacks, depression and suicidal thoughts), and disturbances in hearing, vision, taste and smell. If any of these adverse effects occur after taking Proxacin 1%, contact your doctor immediately before continuing treatment. The patient and doctor will decide whether to continue treatment, also considering antibiotics from other groups.
• Rarely, joint pain and swelling, inflammation or rupture of tendons may 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, and even several months after stopping Proxacin 1%. If the first symptoms of tendon pain or inflammation occur (e.g. in the ankle, wrist, elbow, shoulder or knee), stop taking Proxacin 1%, contact your 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 ischaemia (inadequate blood flow to the brain) or stroke, adverse effects on the central nervous system may occur. If seizures occur, stop using Proxacin 1% immediately and contact your doctor.
• After the first dose of Proxacin 1%, psychiatric reactions may occur. If the patient has depression or psychosis, symptoms of these conditions may worsen during treatment with Proxacin 1%. Rarely, depression or psychosis may progress to suicidal thoughts, potentially leading to suicide attempts or suicide. If this happens, stop using Proxacin 1% and contact your 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 Proxacin 1% and inform your doctor immediately to prevent the development of potentially irreversible disease.
• Quinolone antibiotics may cause increased blood sugar levels above normal (hyperglycaemia) or decreased blood sugar levels below normal (hypoglycaemia), which in severe cases may lead to loss of consciousness (hypoglycaemic coma) (see section 4). This is important for diabetic patients. Diabetic patients are advised to carefully monitor blood sugar levels. If blood sugar levels drop below normal (hypoglycaemia), contact your doctor immediately.
• While taking antibiotics, including Proxacin 1%, or even several weeks after stopping treatment, diarrhoea may occur. If it is severe or persistent, or if the patient notices blood or mucus in the stool, stop using the medicine and contact your doctor immediately, as this may be life-threatening. Do not take medicines that inhibit or slow down intestinal motility and contact your doctor.
• Vision disturbances or other eye-related problems should be promptly consulted with an ophthalmologist.
• If the patient is giving a blood or urine sample for analysis, they should inform the doctor or laboratory staff about using Proxacin 1%.
• If the patient has kidney problems, inform the doctor, as dose adjustment may be necessary.
• Proxacin 1% may cause liver damage. If the patient notices any of the following symptoms: loss of appetite, jaundice (yellowing of the skin), dark urine, skin itching or stomach irritation, stop using the medicine and contact your doctor immediately.
• Proxacin 1% may reduce the number of white blood cells, which may lead to reduced resistance to infections. If the patient notices that during an infection symptoms such as fever and severe worsening of general condition occur, or fever with local infection symptoms such as: sore throat, laryngitis, mouth sores and urinary problems, contact your doctor immediately. The doctor will order a blood test to check for reduced white blood cell count (agranulocytosis). Remember to inform the doctor about taking this medicine.
• While taking Proxacin 1%, the skin becomes more sensitive to sunlight and ultraviolet (UV) radiation. Avoid exposure to strong sunlight or artificial UV rays (e.g. in a solarium).

­ In case of sudden, severe abdominal, back or chest pain, which may be a symptom of an aneurysm or aortic dissection, go immediately to the emergency department. The risk of these conditions may be higher during treatment with systemic corticosteroids.
­ In case of sudden shortness of breath, especially when lying down, or if swelling of the ankles, feet or abdomen is observed, or palpitations (sensation of rapid or irregular heartbeat) occur, seek medical advice immediately.
Proxacin 1% and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used or planned to be used by the patient.
Do not use Proxacin 1% together with tizanidine, as this may cause adverse effects such as low blood pressure and drowsiness (see section 2 "When not to use Proxacin 1%").
The following medicines may interact with Proxacin 1% in the human body.
Taking Proxacin 1% together with these medicines may affect their therapeutic effect. It may also increase the likelihood of adverse effects. If the patient is taking any of the following medicines, inform the doctor:

• vitamin K antagonists (e.g. warfarin, acenocoumarol, phenprocoumon, fluindione) or other oral anticoagulant (blood-thinning) medicine;
• probenecid (a medicine used in gout);
• methotrexate (a medicine used in certain types of cancer, psoriasis, rheumatoid arthritis);
• theophylline (a medicine used in respiratory disorders);
• tizanidine (a medicine reducing excessive muscle tension in multiple sclerosis);
• olanzapine (an antipsychotic medicine);
• clozapine (an antipsychotic medicine);
• ropinirole (a medicine used in Parkinson's disease);
• phenytoin (a medicine used in epilepsy);
• cyclosporine (a medicine used in skin diseases, rheumatoid arthritis and after organ transplantation);
• other medicines that may affect heart rhythm: medicines belonging to the antiarrhythmic group (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), tricyclic antidepressants, some antibacterial medicines (belonging to the macrolide group), some antipsychotic medicines;
• zolpidem (a medicine used in insomnia).

Proxacin 1% may increase blood levels of the following medicines:

• pentoxifylline (a medicine used in circulatory disorders);
• caffeine;
• duloxetine (a medicine used in depression, diabetic neuropathy and urinary incontinence);
• lidocaine (a medicine used in heart conditions and anaesthesiology);
• sildenafil (a medicine used, e.g., in erectile dysfunction);
• agomelatine (a medicine used in depression).

Taking Proxacin 1% with food and drink
Meals and drinks do not affect Proxacin 1%.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a
child, she should consult her doctor or pharmacist before using this medicine.
It is best to avoid using Proxacin 1% during pregnancy.
Do not take Proxacin 1% while breastfeeding, as ciprofloxacin passes into breast milk and may be harmful to the child.
Driving and operating machinery
Proxacin 1% may impair concentration. Some adverse effects affecting the nervous system may occur. Before driving or operating machinery, the patient should check how they react to Proxacin 1%.
If in doubt, consult your doctor.

3. How to use Proxacin 1%

Your doctor will explain exactly what dose of Proxacin 1% to use, how often to take the medicine,
and how long to continue treatment. This will depend on the type and severity of the infection.
If the patient has kidney problems, it is important to inform the doctor, as the dose may need to be adjusted.
Treatment usually lasts from 5 to 21 days, but may be longer in severe infections.

• Your doctor will administer each dose as a slow intravenous infusion into the bloodstream (via drip). The infusion time for children and adolescents is 60 minutes. For adult patients, a 400 mg dose of Proxacin 1% is given as an infusion lasting 60 minutes, while a 200 mg dose of Proxacin 1% is given as an infusion lasting 30 minutes. Administering the infusion slowly helps avoid sudden adverse reactions.
• It is important to drink plenty of fluids throughout the entire period of taking Proxacin 1%.

Stopping treatment with Proxacin 1%
It is important not to stop treatment early, even if the patient feels better after a few days of taking the medicine. Stopping treatment too soon may result in the infection not being fully cured, and symptoms may return or worsen. Bacterial resistance to the antibiotic may also develop.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although they do not occur in everyone.
The most serious adverse effects observed during treatment with this medicine are listed below:
If you notice any of the symptoms listed below, stop taking
Proxacin 1% immediately and contact your doctor straight away,
as another antibiotic may need to be prescribed.

Uncommon adverse effects (may occur in no more than 1 in 100 patients):

• seizures (see section 2. "Warnings and precautions").

Rare adverse effects (may occur in no more than 1 in 1,000 patients):

• severe, sudden allergic reaction with symptoms such as chest tightness, dizziness, nausea or fainting, or dizziness upon standing (anaphylactic shock) (see section 2. "Warnings and precautions");
• tendon rupture, especially of the large tendon at the back of the ankle (Achilles tendon) (see section 2. "Warnings and precautions");

Very rare adverse effects (may occur in fewer than 1 in 10,000 patients):

• severe, sudden allergic reaction with symptoms such as chest tightness, dizziness, nausea or fainting, or dizziness upon standing (anaphylactic reaction) (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 mucous membranes of the mouth, throat, nose, eyes, and genital organs, followed by spreading of blisters or peeling of the skin (e.g. bullous erythema multiforme – Stevens-Johnson syndrome or toxic epidermal necrolysis – Lyell's syndrome).

Frequency of adverse effects unknown (frequency cannot be estimated from available data):

• nervous system disorders such as pain, burning, tingling, numbness and/or limb weakness (neuropathy) (see section 2. "Warnings and precautions");
• hypersensitivity reaction causing rash, fever, internal organ inflammation, haematological disorders and systemic illness (drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP)).

Administration of quinolone and fluoroquinolone antibiotics has very rarely led, in some cases regardless of pre-existing risk factors, to long-term (lasting for months or years) or permanent adverse effects 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 problems, mental health effects (including sleep disturbances, anxiety, panic attacks, depression and suicidal thoughts), and disturbances in hearing, vision, taste and smell.

Other adverse effects observed during treatment with Proxacin 1% are listed below, according to their likelihood of occurrence.

Common adverse effects (may occur in no more than 1 in 10 patients):

• nausea, diarrhoea, vomiting;
• joint pain and inflammation in children;
• reaction at injection and infusion site, rash;
• transient increase in blood aminotransferase activity (a type of enzyme indicating liver function).

Uncommon adverse effects (may occur in no more than 1 in 100 patients):

• joint pain in adults;
• fungal superinfections;
• high levels of eosinophils (a type of white blood cell), increase or decrease in platelet count;
• decreased appetite;
• excessive psychomotor activity, restlessness, confusion, disorientation, hallucinations;
• headache, dizziness, sleep disturbances, taste disturbances, sensory disturbances (pricking sensation), increased sensitivity to sensory stimuli;
• visual disturbances (including double vision);
• hearing loss;
• rapid heartbeat (tachycardia);
• blood vessel dilation, decreased blood pressure;
• abdominal pain, digestive disturbances such as indigestion (dyspepsia, heartburn), flatulence;
• liver function disorder, increased blood levels of a substance called bilirubin, jaundice (cholestasis);
• skin itching, urticaria;
• kidney function disorder, kidney failure;
• muscle and bone pain, malaise (weakness), fever, fluid retention (oedema);
• increased blood alkaline phosphatase activity (a specific substance present in blood).

Rare adverse effects (may occur in no more than 1 in 1,000 patients):

• muscle pain, joint inflammation, increased muscle tension or cramps;
• inflammation of the intestine (colitis) associated with antibiotic use (very rarely may be fatal) (see section 2. "Warnings and precautions");
• changes in blood cell count (leukopenia, leukocytosis, neutropenia, anaemia), reduction in red and white blood cells and platelets (pancytopenia), which may result in death, bone marrow suppression, which may also result in death;
• allergic reactions, swelling (oedema) of allergic origin or rapid swelling of the skin and mucous membranes (angioedema) (see section 2. "Warnings and precautions");
• increased blood sugar levels (hyperglycaemia) or decreased blood sugar levels (hypoglycaemia), which may lead to diabetic coma in severe cases. This is important for people with diabetes (see section 2. "Warnings and precautions");
• anxiety reactions, unusual dreams, depression (which may lead to suicidal thoughts or suicidal ideation and attempts and suicide), psychiatric disorders [psychotic reactions which may lead to suicidal thoughts, suicide attempts or suicide] (see section 2. "Warnings and precautions");
• sensory disturbances (reduced skin sensitivity to touch), tremor, migraine, smell disturbances, labyrinthine dizziness, fainting;
• tinnitus, hearing disturbances;
• fainting, vasculitis;
• shortness of breath, including asthmatic condition;
• pancreatitis;
• hepatitis, liver cell death (liver necrosis), very rarely leading to life-threatening liver failure (see section 2. "Warnings and precautions");
• photosensitivity (see section 2. "Warnings and precautions"), small dark spots visible under the skin (petechiae);
• blood in urine, crystals in urine, urinary tract inflammation;
• excessive sweating;
• increased activity of an enzyme called amylase.

Very rare adverse effects (may occur in fewer than 1 in 10,000 patients):

• a specific type of reduced red blood cell count called haemolytic anaemia; reduced white blood cell count which may be life-threatening (agranulocytosis) (see section 2. "Warnings and precautions");
• serum sickness-like allergic reaction (see section 2. "Warnings and precautions");
• coordination disturbances, unsteady gait, increased pressure on the brain (intracranial hypertension) and pseudotumour cerebri;
• impaired colour vision;
• various skin lesions or rashes;
• worsening of myasthenia gravis symptoms (see section 2. "Warnings and precautions").

Frequency of adverse effects unknown (frequency cannot be estimated from available data):

• abnormal fast heart rhythm: life-threatening irregular heartbeat, rapid heartbeat (known as "QT prolongation", visible on ECG – an examination of the heart's electrical activity);
• a disease syndrome associated with impaired water excretion from the body and reduced sodium concentration in the blood (SIADH – syndrome of inappropriate antidiuretic hormone secretion);
• loss of consciousness due to significant reduction in blood sugar levels (hypoglycaemic coma). See section 2.
• blood coagulation disorders (in patients treated with vitamin K antagonists);
• feeling of excessive excitement (mania) or feeling of excessive optimism and hyperactivity (hypomania).

In patients receiving fluoroquinolones, cases of arterial wall dilation and weakening or arterial 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.

Reporting of adverse effects
If you experience any adverse effects, including any not listed in this leaflet, tell your doctor, pharmacist or nurse.
Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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 effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps provide more information on the safety of the medicine.

5. How to store Proxacin 1%

Store below 25°C. Protect from light. Do not freeze.
Precipitation may occur under refrigerated conditions; freezing is not recommended.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, ampoule or vial after:
EXP. The expiry date refers to the last day of the stated month.
The batch number is indicated on the carton, ampoule or vial after: Lot.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. These measures will help protect
the environment.

6. Contents of the pack and other information

What Proxacin 1% contains

• The active substance is ciprofloxacin. 1 ml of concentrate for infusion solution contains 10 mg of ciprofloxacin.
• Other ingredients: lactic acid, hydrochloric acid 10%, water for injections.

What Proxacin 1% looks like and contents of the pack
Proxacin 1% is a clear greenish-yellow or pale yellow transparent liquid.
The cardboard pack contains: 10 ampoules of 10 ml each, or 5 vials of 20 ml each, or 10 vials of 20 ml each.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Zentiva k.s.
U kabelovny 130
Dolní Měcholupy
102 37 Prague 10
Czech Republic
(logo of the marketing authorisation holder)

Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
Pelplińska Street 19
83-200 Starogard Gdański
Poland

For further information regarding this medicinal product, please contact the local representative of the marketing authorisation holder:
Zentiva Polska Sp. z o.o.
Bonifraterska Street 17
00-203 Warsaw
Phone: +48 22 375 92 00

Advice – Medical education
Antibiotics are used to treat bacterial infections. They are not effective against viral infections.
Antibiotics should be used only for diseases in which a doctor has recommended them. Despite antibiotic treatment, some bacteria may survive or multiply. This phenomenon is known as resistance: certain antibiotic therapies become ineffective.
Improper use of antibiotics increases resistance. It may even cause bacteria to become resistant, prolonging treatment or reducing the antibiotic's effectiveness, especially if the patient does not follow the doctor's instructions regarding:
- dosage,
- frequency of administration,
- duration of treatment.

Therefore, to maintain the effectiveness of this medicine, you should:
1 – use antibiotics only when prescribed by a doctor;
2 – strictly follow the doctor's instructions;
3 – do not reuse antibiotics without a doctor's prescription, even if the current illness resembles the one for which the antibiotic was previously prescribed;
4 – never give antibiotics 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 medical professionals:

PROXACIN 1%, 10 mg/ml, concentrate for solution for infusion
Ciprofloxacinum
Preparation of Proxacin 1% for administration
This product is a concentrate for solution for infusion – it must be diluted before administration and then administered as intravenous infusion.
For dilution, 0.9% sodium chloride solution or 5% glucose solution may be used. The appropriate dose should be diluted so that each 10 ml of concentrate is diluted to a final volume of not less than 50 ml (resulting concentration should be no less than 1 mg/ml).
Due to the photosensitivity of the solution and the risk of microbiological contamination, the solution should be administered immediately after dilution, via slow intravenous infusion. Slow infusion into a large vein minimizes patient discomfort and reduces the risk of venous irritation.
Since the product is light-sensitive, the vial should be removed from its packaging only immediately before use. Prolonged exposure to daylight over several days may reduce the efficacy of the product. A precipitate may form at low temperatures; therefore, storage in the refrigerator is not recommended.
Any unused medicinal product or waste material should be disposed of in accordance with local regulations.
Pharmaceutical incompatibilities
Do not mix this medicinal product with other medicinal products except those mentioned above.
If concomitant administration of ciprofloxacin by infusion with other drugs is necessary, they should be administered separately, in accordance with the recommended dosage and route of administration for each drug.
If compatibility with other solutions or medicinal products has not been confirmed, the infusion solution should always be administered separately. Signs of incompatibility that can be observed visually include precipitation, cloudiness, and discoloration.
Ciprofloxacin is incompatible with medicinal solutions that are physically or chemically unstable at the solution's pH (e.g. penicillins, heparin solution), particularly when combined with solutions added to achieve an alkaline pH (the pH of ciprofloxacin solutions: 3.0–4.5).
Method of administration
This product is a concentrate for solution for infusion – it must be diluted before administration and then administered as intravenous infusion – see above.
The Proxacin 1% infusion solution should be visually inspected prior to use. The solution must not be administered if it is cloudy.
The prepared solution should be administered by slow intravenous infusion. In children and adolescents, the infusion time is 60 minutes. In adult patients, the infusion time for a 400 mg dose of ciprofloxacin in infusion solution is 60 minutes, and for a 200 mg dose of ciprofloxacin in infusion solution is 30 minutes.
Slow infusion into a large vein minimizes patient discomfort and reduces the risk of venous irritation.
The infusion solution may be administered directly or after mixing with other compatible infusion solutions listed above.
Dosage

• The dosage depends on the indication, severity and site of infection, microbial susceptibility to ciprofloxacin, patient's renal function, and in children and adolescents, body weight.
• Duration of treatment depends on the severity of the disease and its clinical and bacteriological course.
• After initial intravenous therapy, oral treatment with tablets may be initiated if clinically appropriate. Transition from intravenous to oral therapy should occur as soon as possible. In cases of severe infections or when the patient cannot take oral tablets (e.g. parenterally fed patients), intravenous ciprofloxacin therapy is recommended until oral treatment becomes feasible.
• During treatment of infections caused by certain bacteria (e.g. Pseudomonas aeruginosa, Acinetobacter, or Staphylococcus spp.), higher doses of ciprofloxacin and combination with other appropriate antibacterial agents may be necessary.
• Depending on the causative microorganism, in the treatment of certain infections (e.g. pelvic inflammatory disease, intra-abdominal infections, infections in neutropenic patients, and bone and joint infections), combination with another appropriate antibacterial agent may be required.

Adults

Children and adolescents

Elderly patients
Elderly patients should be given a dose adjusted according to the severity of infection and creatinine clearance.
Renal and hepatic impairment
Recommended initial and maintenance dose in patients with renal impairment:

In patients with hepatic impairment, dose adjustment is not necessary.
Studies on dosing in children with renal and/or hepatic impairment have not been conducted.