PROXACIN 10 mg /Ml Concentrate

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Proxacin 1%
3. 10 mg/ml, concentrate for solution for infusion
   1. You should carefully read the contents of this leaflet before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
4. What is Proxacin 1% and what is it used for
5. Important information before using Proxacin 1%
   1. When not to use Proxacin 1%:
   2. Warnings and precautions
   3. During treatment with Proxacin 1%
   4. Proxacin 1% and other medicines
   5. Taking Proxacin 1% with food and drink
   6. Pregnancy and breastfeeding
   7. Driving and using machines
6. How to use Proxacin 1%
   1. Stopping treatment with Proxacin 1%
7. Possible side effects
   1. If you notice any of the following symptoms, you should stop taking Proxacin 1% and contact your doctor immediately
   2. as you may need to use a different antibiotic.
   3. Reporting side effects
8. How to store Proxacin 1%
9. Contents of the packaging and other information
   1. What Proxacin 1% contains
   2. What Proxacin 1% looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Date of approval of the leaflet:
   5. Advice - medical education
   6. Consequently, to maintain the effectiveness of this medicine, you should:
   7. PROXACIN 1%, 10 mg/ml, concentrate for solution for infusion
   8. Preparation of Proxacin 1% for administration
   9. Incompatibilities
   10. Administration
   11. Dosing

Leaflet attached to the packaging: patient information

Proxacin 1%

10 mg/ml, concentrate for solution for infusion

Ciprofloxacin

You should carefully read the contents of this leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Proxacin 1% and what is it 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 packaging and other information

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

Proxacin 1% contains the antibiotic ciprofloxacin, which belongs to the fluoroquinolone group. Ciprofloxacin works by killing the bacteria that cause infections. It only works on certain strains of bacteria.
Adults

• Lower respiratory tract infections caused by Gram-negative bacteria:
• exacerbation of chronic obstructive pulmonary disease: Proxacin 1% should only be used when other commonly recommended antibacterial agents for the treatment of these infections are considered inappropriate;
• pulmonary infections in patients with cystic fibrosis or bronchiectasis;
• community-acquired pneumonia.
• Chronic suppurative otitis media.
• Severe exacerbation of chronic sinusitis, particularly when caused by Gram-negative bacteria.
• Uncomplicated acute urinary tract infections. In uncomplicated urinary tract infections, Proxacin 1% should only be used when other commonly recommended antibacterial agents for the treatment of these infections are considered inappropriate.
• Acute pyelonephritis
• Complicated urinary tract infections
• Bacterial prostatitis
• Genital tract infections:
• epididymo-orchitis, including cases caused by susceptible Neisseria gonorrhoeae strains.
• pelvic inflammatory disease, including cases caused by susceptible Neisseria gonorrhoeae strains.
• Gastrointestinal infections (e.g., traveler's diarrhea).
• Intra-abdominal infections.
• Skin and soft tissue infections caused by Gram-negative bacteria.
• Malignant otitis externa.
• Bone and joint infections.
• Pulmonary anthrax (prevention of infection after contact with bacteria and treatment).

Ciprofloxacin can be used to treat patients with neutropenia and fever, which is presumed to be caused by a bacterial infection.
Children and adolescents

• Pulmonary infections caused by Pseudomonas aeruginosa in patients with cystic fibrosis.
• Complicated urinary tract infections and acute pyelonephritis.
• Pulmonary anthrax (prevention of infection after contact with bacteria and treatment).

Ciprofloxacin can also be used to treat severe infections in children and adolescents when it is considered necessary.
Treatment should only be prescribed by doctors who have experience in treating cystic fibrosis and/or severe infections in children and adolescents.

2. Important information before using Proxacin 1%

When not to use Proxacin 1%:

Warnings and precautions

Before starting treatment with Proxacin 1%, you should discuss it with your doctor or pharmacist.
You should not take antibacterial agents containing fluoroquinolones or quinolones, including Proxacin 1%, if you have ever had a severe side effect while taking a quinolone or fluoroquinolone. In such a case, you should inform your doctor as soon as possible.
Before administering Proxacin 1%, you should tell your doctor if:

• you have ever had kidney problems, as your treatment may need to be adjusted;
• you have epilepsy or other neurological disorders;
• you have ever had tendon problems during treatment with such antibiotics as Proxacin 1%;
• you have diabetes - after taking ciprofloxacin, your blood sugar level may decrease significantly (hypoglycemia may occur) - see also below and section 4;
• you have myasthenia gravis (a type of muscle weakness) - its symptoms may worsen;
• you have heart problems. You should be cautious when taking this type of medicine if: you have been diagnosed with congenital or familial QT interval prolongation (visible on an ECG - a test of heart electrical activity); you have been diagnosed with electrolyte imbalance in the blood (especially low potassium and magnesium levels in the blood); you have a very slow heart rate (called bradycardia); you have poor heart function (heart failure); you have had a heart attack; you are a woman or an elderly person; you are taking other medicines that may affect your ECG (see section 2 "Proxacin 1% and other medicines");
• you or a family member have a deficiency of glucose-6-phosphate dehydrogenase (G6PD), you should inform your doctor - after taking ciprofloxacin, anemia may occur;
• you have been diagnosed with an aneurysm of a large blood vessel (aortic or large peripheral artery aneurysm);
• you have had an aortic dissection (tear in the aortic wall) in the past;
• you have been diagnosed with heart valve problems.
• there have been cases of aortic aneurysm or dissection in your family, or other risk factors or conditions (e.g., Marfan syndrome, Ehlers-Danlos syndrome, Turner syndrome, Sjögren's syndrome [an autoimmune disease], or vascular diseases such as Takayasu arteritis, giant cell arteritis, Behçet's disease, hypertension, or confirmed atherosclerosis, rheumatoid arthritis [joint disease], or endocarditis [heart infection]).

In the treatment of some genital tract infections, your doctor may prescribe another antibiotic in addition to ciprofloxacin. If you do not improve within three days of treatment, you should consult your doctor.

During treatment with Proxacin 1%

If duringtreatment with Proxacin 1% you experience any of the following symptoms, you must
immediatelytell your doctor. Your doctor will decide whether to stop 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 symptoms such as: chest tightness, dizziness, nausea, fainting, or dizziness when standing up. If this happens, you should stop taking Proxacin 1% and contact your doctor immediately.
• Long-lasting, disabling, and potentially irreversible severe side effectsFluoroquinolone and quinolone antibacterial agents, including Proxacin 1%, have been associated with very rare but severe side effects. Some of these have been long-lasting (lasting for months or years), disabling, or potentially irreversible. These include: tendonitis, tendon rupture, joint pain, limb pain, walking difficulties, abnormal sensations (such as tingling, burning, itching, numbness, or pain), neuropathy, fatigue, memory and concentration problems, and effects on mental health (which may include sleep disturbances, anxiety, panic attacks, depression, and suicidal thoughts) as well as hearing, vision, taste, and smell disorders. If you experience any of these side effects after taking Proxacin 1%, you should contact your doctor immediately before continuing treatment. You and your doctor will decide whether to continue treatment, also considering antibiotics from another group.
• Rarely, pain and swelling of the joints and tendon inflammation or rupturemay occur. The risk is increased in elderly people (over 60 years old), after organ transplantation, in people with kidney problems, or during corticosteroid treatment. Tendon inflammation and rupture can occur within the first 48 hours of treatment and even several months after stopping treatment with Proxacin 1%. If you experience the first symptoms of pain or tendon inflammation (e.g., in the ankle, wrist, elbow, shoulder, or knee), you should stop taking Proxacin 1%, contact your doctor, and rest the affected area. You should avoid excessive strain, as it may increase the risk of tendon rupture.
• If you have epilepsyor other neurological disorders, such as cerebral ischemia (insufficient blood flow to the brain) or stroke, you may experience side effects affecting the central nervous system. If you experience seizures, you should stop taking Proxacin 1% and contact your doctor immediately.
• After the first dose of Proxacin 1%, psychotic reactionsmay occur. If you experience depressionor psychosis, your symptoms may worsen while taking Proxacin 1%. Rarely, depression or psychosis may develop into suicidal thoughts, which may lead to suicide attempts or suicide. If this happens, you should stop taking Proxacin 1% and contact your doctor immediately.
• You may rarely experience nerve damage symptoms(neuropathy), such as pain, burning, tingling, numbness, and/or weakness, especially in your feet and legs and hands and arms. In such a case, you should stop taking Proxacin 1% and immediately inform your doctor to prevent the development of a potentially irreversible disease.
• Quinolone antibiotics may cause high blood sugar levels(hyperglycemia) or low blood sugar levels(hypoglycemia), which may lead to loss of consciousness (hypoglycemic coma) in severe cases. This is important for patients with diabetes. Patients with diabetes are advised to carefully monitor their blood sugar levels. If you experience low blood sugar levels (hypoglycemia), you should contact your doctor immediately.
• During treatment with antibiotics, including Proxacin 1%, or even several weeks after stopping treatment, diarrheamay occur. If it is severe or persistent, or if you notice blood or mucus in your stool, you should stop taking the medicine and contact your doctor immediately, as it may be life-threatening. You should not take medicines that slow down or stop bowel movements, and you should contact your doctor.
• Vision or eye problems, you should consult an ophthalmologist immediately.
• If you are going to have a blood or urine test, you should inform your doctor or laboratory staff that you are taking Proxacin 1%.
• If you have kidney problems, you should tell your doctor, as your dose may need to be adjusted.
• Proxacin 1% may cause liver damage. If you notice any of the following symptoms, such as loss of appetite, jaundice (yellowing of the skin), dark urine, itching, or stomach upset, you should stop taking the medicine and contact your doctor immediately.
• Proxacin 1% may decrease the number of white blood cells, which can reduce your resistance to infections. If you notice symptoms such as fever and severe deterioration of your general condition or fever with local signs of infection, such as sore throat, laryngitis, oral cavity problems, or urinary tract problems, you should contact your doctor immediately. Your doctor will order a blood test to check if your white blood cell count has decreased (agranulocytosis). Remember to inform your doctor that you are taking this medicine.
• During treatment with Proxacin 1%, your skin becomes more sensitive to sunlight and ultraviolet radiation (UV). You should avoid exposure to strong sunlight or artificial UV radiation (e.g., in a solarium).

In case of sudden severe abdominal, back, or chest pain, which may be a sign of an aortic aneurysm or dissection, you should immediately go to the emergency department. The risk of these changes may be higher in patients treated with systemic corticosteroids.
In case of sudden shortness of breath, especially when lying down, or swelling of the ankles, feet, or abdomen, or palpitations (feeling of rapid or irregular heartbeat), you should immediately consult your doctor.

Proxacin 1% and other medicines

You should tell your doctor or pharmacist about all the medicines you are currently taking, have recently taken, or plan to take.
Do not take Proxacin 1% at the same time as tizanidine, as it may cause side effects such as low blood pressure and drowsiness (see section 2 "When not to use Proxacin 1%").
The following medicines will interact with Proxacin 1% in the body. Taking Proxacin 1% at the same time as these medicines may affect their therapeutic effect. It may also increase the likelihood of side effects.
If you are taking any of the following medicines, you should tell your doctor:

• vitamin K antagonists (e.g., warfarin, acenocoumarol, phenprocoumon, fluindione) or other oral anticoagulants ("blood thinners");
• probenecid (a medicine used in gout);
• methotrexate (a medicine used in certain types of cancer, psoriasis, or rheumatoid arthritis);
• theophylline (a medicine used in respiratory disorders);
• tizanidine (a medicine that reduces 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: antiarrhythmic medicines (e.g., quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), tricyclic antidepressants, some antibacterial agents (belonging to the macrolide group), some antipsychotic medicines;
• zolpidem (a medicine used in insomnia).

Proxacin 1% may increasethe 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 diseases and anesthesiology);
• sildenafil (a medicine used e.g., in erectile dysfunction);
• agomelatine (a medicine used in depression).

Taking Proxacin 1% with food and drink

Taking meals and drinks does not affect Proxacin 1%.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, you should consult your doctor or pharmacist before using this medicine.
It is recommended to avoid using Proxacin 1% during pregnancy.
You should not take Proxacin 1% while breastfeeding, as ciprofloxacin passes into breast milk and may harm your baby.

Driving and using machines

Proxacin 1% may cause drowsiness. Some side effects may affect the nervous system. Before driving or operating machinery, you should check how you react to the medicine you are taking.
In case of doubt, you should consult your doctor.

3. How to use Proxacin 1%

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

• Your doctor will administer each dose in a slow intravenous infusion into the blood (in a drip). The infusion time for children and adolescents is 60 minutes. For adult patients, a dose of 400 mg of Proxacin 1% is administered in an infusion lasting 60 minutes, and a dose of 200 mg of Proxacin 1% is administered in an infusion lasting 30 minutes. The slow infusion helps to avoid sudden side effects.
• You should remember to drink plenty of fluids during the entire treatment period with Proxacin 1%.

Stopping treatment with Proxacin 1%

It is important not to stop treatment, even if you feel better after a few days of taking the medicine. If you stop treatment too early, the infection may not be fully treated, and its symptoms may return or worsen. Resistance to the antibiotic may also develop.
If you have any further doubts about using this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Proxacin 1% can cause side effects, although not everybody gets them.
The most serious side effectsobserved during treatment with this medicine are listed below:

If you notice any of the following symptoms, you should stop taking Proxacin 1% and contact your doctor immediately

as you may need to use a different antibiotic.

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

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

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

• severe, sudden allergic reaction with symptoms such as chest tightness, dizziness, nausea, or fainting or dizziness when standing up (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 side effects(may occur in up to 1 in 10,000 people):

• severe, sudden allergic reaction with symptoms such as chest tightness, dizziness, nausea, or fainting or dizziness when standing up (anaphylactic reaction) (see section 2 "Warnings and precautions");
• weakness, tendonitis, which can 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 in the form of blisters or ulcers in the mouth, throat, nose, eyes, and genital areas, with subsequent spread of blisters or peeling of the skin (e.g., Stevens-Johnson syndrome or toxic epidermal necrolysis - Lyell's syndrome).

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

• neurological disorders, such as pain, burning, tingling, numbness, and/or weakness of the limbs (neuropathy) (see section 2 "Warnings and precautions");
• allergic reaction, which causes rash, fever, inflammation of internal organs, blood disorders, and systemic diseases (Drug Reaction with Eosinophilia and Systemic Symptoms - DRESS), acute generalized exanthematous pustulosis (AGEP).

Administration of quinolone and fluoroquinolone antibiotics, in some cases regardless of existing risk factors, has very rarely caused long-lasting (lasting for months or years) or permanent side effects, such as tendonitis, tendon rupture, joint pain, limb pain, walking difficulties, abnormal sensations (such as tingling, burning, itching, numbness, or pain), neuropathy, fatigue, memory and concentration problems, and effects on mental health (which may include sleep disturbances, anxiety, panic attacks, depression, and suicidal thoughts) as well as hearing, vision, taste, and smell disorders.
Other side effectsthat have been observed during treatment with Proxacin 1% are listed below, according to their frequency.

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

• nausea (vomiting), diarrhea, vomiting;
• joint pain in children;
• reaction at the injection site and infusion, rash;
• temporary increase in the activity of aminotransferases in the blood (a type of enzyme indicating liver function).

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

• joint pain in adults;
• fungal superinfections;
• high eosinophil count (a type of white blood cell), increased or decreased platelet count;
• decreased appetite;
• excessive psychomotor activity, agitation, confusion, disorientation, hallucinations;
• headache, dizziness, sleep disturbances, taste disturbances, sensory disturbances (tingling sensation), increased sensitivity to stimuli;
• vision disturbances (including double vision);
• rapid heartbeat (tachycardia);
• vasodilation, decreased blood pressure;
• abdominal pain, digestive disturbances, such as indigestion (dyspepsia, heartburn), gas;
• liver function disorders, increased bilirubin levels in the blood, jaundice (bile stasis);
• itching, hives;
• kidney function disorders, kidney failure;
• muscle and bone pain, general malaise (weakness), fever, fluid retention (edema);
• increased alkaline phosphatase activity in the blood (a certain substance found in the blood).

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

• muscle pain, arthritis, increased muscle tension or cramps;
• antibiotic-associated colitis (very rarely can be fatal) (see section 2 "Warnings and precautions");
• blood cell count changes (leukopenia, leukocytosis, neutropenia, anemia), decreased red and white blood cell and platelet count (pancytopenia), which can be life-threatening, bone marrow depression, which can also be life-threatening;
• allergic reactions, angioedema (see section 2 "Warnings and precautions");
• increased blood sugar levels (hyperglycemia) or decreased blood sugar levels (hypoglycemia), which may lead to diabetic coma in severe cases. This is important for patients with diabetes (see section 2 "Warnings and precautions");
• anxiety reactions, unusual dreams, depression (which may lead to suicidal thoughts or attempts and suicide) (see section 2 "Warnings and precautions");
• sensory disturbances (reduced skin sensitivity to touch), tremors, migraines, smell disturbances, vertigo of labyrinthine origin, fainting;
• tinnitus, hearing disturbances;
• fainting, vasculitis;
• shortness of breath, including asthma;
• pancreatitis;
• liver inflammation, liver cell death (liver necrosis) very rarely leading to life-threatening liver failure (see section 2 "Warnings and precautions");
• sensitivity to light (see section 2 "Warnings and precautions"), small dark spots visible under the skin (purpura);
• blood in the urine, crystals in the urine, urinary tract inflammation;
• excessive sweating;
• increased activity of the enzyme amylase.

Very rare side effects(may occur in less than 1 in 10,000 people):

• a specific type of reduced red blood cell count called hemolytic anemia; reduced white blood cell count, which can be life-threatening (agranulocytosis) (see section 2 "Warnings and precautions");
• allergic reaction similar to serum sickness (see section 2 "Warnings and precautions");
• coordination disorders, unsteady gait, brain pressure (increased intracranial pressure), and pseudotumor cerebri;
• color vision disturbances;
• various skin rashes or eruptions
• worsening of myasthenia symptoms (see section 2 "Warnings and precautions").

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

• abnormal heart rhythm: life-threatening irregular heartbeat, rapid heartbeat (called "QT interval prolongation", visible on an ECG - a test of heart electrical activity);
• a syndrome associated with impaired water excretion and decreased sodium levels in the blood (SIADH, syndrome of inappropriate secretion of antidiuretic hormone);
• loss of consciousness due to significantly decreased blood sugar levels (hypoglycemic coma). See section 2.
• blood clotting disorders (in patients treated with vitamin K antagonists);
• excessive excitement (mania) or excessive optimism and overactivity (hypomania).

Patients treated with fluoroquinolones have reported cases of aortic aneurysm or dissection, which can be fatal, as well as heart valve problems. See also section 2.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Proxacin 1%

Store in a temperature below 25°C. Protect from light. Do not freeze.
In refrigerated conditions, precipitation may occur, and freezing is not recommended.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the box, ampoule, or vial after: EXP. The expiry date refers to the last day of the month stated.
The batch number is stated on the box, ampoule, or vial after: Lot.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Proxacin 1% contains

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

What Proxacin 1% looks like and contents of the pack

Proxacin 1% is a light green or light yellow transparent liquid.
A cardboard box contains: 10 ampoules of 10 ml or 5 vials of 20 ml, or 10 vials of 20 ml.

Marketing authorization holder and manufacturer

Marketing authorization holder
Zentiva k.s.
U kabelovny 130
Dolní Měcholupy
102 37 Prague 10
Czech Republic
(logo of the marketing authorization holder)
Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
ul Pelplińska 19
83-200 Starogard Gdański
To obtain more detailed information on this medicine, you should contact the local representative of the marketing authorization holder:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
tel. +48 22 375 92 00

Date of approval of the leaflet:

Advice - medical education

Antibiotics are used to treat bacterial infections. They do not work in viral infections.
Antibiotics should only be used in diseases for which they have been prescribed by a doctor.
Despite the action of antibiotics, some bacteria may survive or multiply. This phenomenon is called resistance: some antibiotic therapies may become ineffective.
Incorrect use of antibiotics increases resistance. You may even cause bacteria to become resistant and prolong treatment or reduce the effectiveness of the antibiotic if you do not follow your doctor's instructions regarding:
­ dose size,
­ frequency of administration,
­ duration of treatment.

Consequently, 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 use an antibiotic again without a doctor's prescription, even if your current illness is similar to the illness for which the antibiotic was prescribed;
• 4 – never give an antibiotic to another person, as it may be inappropriate for their illness;
• 5 – after completing treatment, return any unused medicine to the pharmacy, so that it can be properly disposed of.

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Information intended only for healthcare professionals:

PROXACIN 1%, 10 mg/ml, concentrate for solution for infusion

Ciprofloxacin

Preparation of Proxacin 1% for administration

The product is a concentrate for solution for infusion - before administration, it must be diluted and then administered in an intravenous infusion.
For dilution, 0.9% sodium chloride solution or 5% glucose solution is used. The appropriate dose of the medicine should be diluted so that each 10 ml of the concentrate for infusion is diluted to a volume of not less than 50 ml (the resulting concentration should not be less than 1 mg/ml).
Due to the sensitivity of the solution to light and the possibility of microbial contamination, it should be administered immediately after dilution, in a slow intravenous infusion. Slow infusion into a large vein will minimize the patient's discomfort and reduce the risk of vein irritation.
Since the product is sensitive to light, the vial should only be removed from the packaging immediately before use.
Exposure to daylight for several days may reduce the effectiveness of the product. At low temperatures, a precipitate may form, so it is not recommended to store the product in the refrigerator.
Any unused product or waste material should be disposed of in accordance with local regulations.

Incompatibilities

Do not mix this medicinal product with other medicinal products, except for those mentioned above.
If it is necessary to administer ciprofloxacin in an infusion with other medicines, they should be administered separately, in accordance with the recommended dosing and administration route for each medicine.
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 assessed visually include, for example, precipitate, cloudiness, and discoloration.
Ciprofloxacin is incompatible with solutions of medicines that are physically or chemically unstable in the pH of the solution (e.g., penicillins, heparin solution), especially in combination with solutions added to achieve a basic pH (pH of ciprofloxacin solutions: 3.0 - 4.5).

Administration

The product is a concentrate for solution for infusion - before administration, it must be diluted and then administered in an intravenous infusion - see above.
Proxacin 1% solution for infusion should be visually inspected before use. You should not administer the solution if it is cloudy.
The prepared solution should be administered in a slow intravenous infusion. In children and adolescents, the infusion time is 60 minutes. In adult patients, the infusion time for a dose of 400 mg of ciprofloxacin in the solution for infusion is 60 minutes, and for a dose of 200 mg of ciprofloxacin in the solution for infusion - 30 minutes.
Slow infusion into a large vein will minimize the patient's discomfort and reduce the risk of vein irritation.
The solution for infusion can be administered directly or after mixing with other compatible infusion solutions listed above.

Dosing

• The dose depends on the indication, severity, and site of infection, susceptibility to ciprofloxacin of the microorganisms causing the infection, the patient's renal function, and, in children and adolescents, on body weight.
• The duration of treatment depends on the severity of the disease and its clinical and bacteriological course.
• After initial intravenous treatment, oral therapy with tablets may be switched to, if the physician considers it clinically justified. The switch to oral therapy should be made as soon as possible. In cases of severe infections or if the patient is unable to take tablets orally (e.g., patient with enteral nutrition), it is recommended to start therapy with intravenous ciprofloxacin until oral therapy is possible.
• During the treatment of infections caused by certain bacteria (e.g., Pseudomonas aeruginosa, Acinetobacter, or Staphylococcus spp.), it may be necessary to administer higher doses of ciprofloxacin and use it in combination with other appropriate antibacterial agents.
• Depending on the microorganism causing the infection, during the treatment of certain infections (e.g., pelvic inflammatory disease, intra-abdominal infections, infections in patients with neutropenia, and bone and joint infections), it may be necessary to use it in combination with another appropriate antibacterial agent.

Adults

Children and adolescents

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

In patients with hepatic impairment, no dose adjustment is necessary.
No studies have been conducted on dosing in children with renal and/or hepatic impairment.