Tarcefoksim

Package Leaflet: Information for the User

Tarcefoksym, 2 g, powder for solution for injection and infusion

Cefotaxime

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist. See section 4.

Contents of the Package Leaflet

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

1. What Tarcefoksym is and what it is used for

Tarcefoksym contains the active substance cefotaxime, which belongs to the group of cephalosporin antibiotics. Cefotaxime has a bactericidal effect on many Gram-positive and Gram-negative bacteria.
Tarcefoksym is indicated for the treatment of severe infections caused by bacteria susceptible to cefotaxime.

• Lower respiratory tract infections: especially acute and chronic bronchitis, bacterial pneumonia, lung abscess.
• Urinary tract infections: e.g. acute and chronic pyelonephritis, cystitis, asymptomatic bacteriuria.
• Uncomplicated gonorrhea in case of penicillin allergy or resistance (Neisseria gonorrhoeae strains producing penicillinase).
• Infections in obstetrics and gynecology.
• Infections of the abdominal cavity: e.g. peritonitis.
• Infections of the skin and soft tissues: e.g. cellulitis, wound infections.
• Infections of bones and joints: e.g. osteomyelitis, septic arthritis.
• Meningitis.
• Prophylactically before surgical procedures, especially in the abdominal cavity, gastrointestinal tract, genitourinary tract, during cesarean section, if there is a risk of bacterial infection.

2. Important information before using Tarcefoksym

When not to use Tarcefoksym

• If the patient is allergic to cefotaxime, penicillins, and/or cephalosporins

If the patient has ever experienced a severe skin rash or exfoliation after taking cefotaxime or other cephalosporins.
In such cases, Tarcefoksym should not be taken and the doctor should be informed.

Warnings and precautions

Before starting treatment, the doctor should be informed if the patient:

• has a history of allergic reactions to any antibiotic;
• has a history of other allergic reactions; allergic reactions to cefotaxime may occur more frequently in people with a tendency to allergic reactions to many different substances; these reactions can have various symptoms and severity - from skin changes to anaphylactic shock (severe allergic reaction); therefore, if skin changes (e.g. hives, itching) that may be symptoms of an allergic reaction occur during Tarcefoksym treatment, the doctor should be informed;
• has a history of gastrointestinal diseases, especially colitis;
• has kidney failure. The doctor will recommend the appropriate dosage, depending on the degree of kidney failure.

When to exercise special caution when using Tarcefoksym

In connection with the use of cefotaxime, severe skin reactions have been reported, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP). The use of cefotaxime should be discontinued and the doctor should be informed immediately if any symptoms related to these severe skin reactions occur, as described in section 4.
Tarcefoksym, like other cephalosporin antibiotics, may cause changes in blood cell count (see section 4. Possible side effects) when used for a long time. If treatment lasts for more than 10 days, the doctor will order a blood morphology test.
If the patient experiences diarrhea during or after Tarcefoksym treatment, the doctor should be informed. This may be a symptom of pseudomembranous colitis - a complication associated with antibiotic use. If diarrhea occurs, the use of Tarcefoksym should be discontinued, and in severe cases, appropriate treatment should be applied. Medications that slow down intestinal peristalsis or have a constipating effect should not be taken.

In case of doubts, consult a doctor or pharmacist.

Tarcefoksym and other medicines

The doctor should be informed about all medicines currently or recently taken by the patient, as well as about medicines planned to be taken.
In particular, the doctor should be informed if the patient is taking:

• other antibiotics with a bacteriostatic effect (e.g. tetracyclines, erythromycin, chloramphenicol, or sulfonamides); they may inhibit the bactericidal effect of cephalosporins, which is especially important during the treatment of severe infections;
• aminoglycoside antibiotics, colistin, polymyxins, vancomycin, furosemide, or ethacrynic acid; the administration of these medicines in high doses simultaneously with Tarcefoksym increases the risk of kidney damage;
• probenecid, given simultaneously with Tarcefoksym, increases the concentration of cefotaxime in the blood serum and prolongs its stay in the serum.

Patient allergic to penicillins may also be allergic to cephalosporins (so-called cross-allergy).
Effect on laboratory test results
Patients treated with Tarcefoksym may have false-positive glucose urine test results, so if such a test is necessary, it is recommended to use enzymatic tests.
Tarcefoksym may cause a false-positive Coombs test result. This may make it difficult to perform blood group compatibility tests.

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 or pharmacist before using this medicine.
If the patient is pregnant or suspects she may be pregnant
She should avoid using Tarcefoksym unless the doctor considers it absolutely necessary.
If the patient is breastfeeding
The medicine passes into breast milk in small amounts, so it can be given to breastfeeding women only if necessary.

Driving and using machines

It has not been found that Tarcefoksym affects the ability to drive or use machines.
However, if side effects occur that impair concentration (e.g. headache; see section 4. Possible side effects), driving or operating machines is not recommended.

Tarcefoksym contains sodium

The medicine contains 96 mg of sodium (the main component of common salt) per vial. This corresponds to 4.8% of the maximum recommended daily sodium intake in adults. Considering the dosage regimen presented in section 3, the maximum amount of sodium that can be administered to the patient in the maximum daily dose is 576 mg, which corresponds to 28.8% of the WHO-recommended maximum daily sodium intake of 2 g in adults. This should be taken into account in patients controlling their sodium intake.

3. How to use Tarcefoksym

Tarcefoksym should always be used according to the doctor's recommendations. In case of doubts, consult a doctor.
The doctor will choose the dose depending on the severity of the infection, the sensitivity of the microorganism causing the infection, the patient's condition, age, and weight.
Tarcefoksym is also available in the form of a powder for solution for injection with a strength of 1 g.

Adults

Therapeutically:

• uncomplicated infections: 1 g every 12 hours;
• moderately severe infections: 2 g every 12 hours;
• severe infections (e.g. sepsis): 2 g every 6 to 8 hours;
• life-threatening infections: doses may be increased to 2 g every 4 hours (up to 12 g per day);
• uncomplicated gonorrhea: 1 g as a single dose.

Prophylactically:

• before surgery: 1 g intravenously or intramuscularly 90 to 30 minutes before surgery;
• cesarean section: the first dose of 1 g is given as soon as possible after the umbilical cord is clamped, and the same dose is given intravenously or intramuscularly after 6 and 12 hours.

Children

The following doses are usually used.
Newborns: 50 mg/kg body weight per day intramuscularly or intravenously in 2 to 4 divided doses.
In severe infections, 150 to 200 mg/kg body weight per day can be given in divided doses.
Infants and children: 100 to 150 mg/kg body weight per day intramuscularly or intravenously in 2 to 4 divided doses. In severe infections, the daily dose of the medicine can be increased to 200 mg/kg body weight.
Children over 12 years old(with a body weight over 50 kg): the dosage is the same as for adults.

Treatment duration

The treatment duration depends on the severity and type of infection.
The doctor will determine the appropriate treatment duration, which should be followed.
The method of administration and preparation of solutions is given at the end of the package leaflet, in the section "Information intended exclusively for healthcare professionals".

Using a higher dose of Tarcefoksym than recommended

Since Tarcefoksym will be administered by a doctor or nurse, it is unlikely that an incorrect dose will be given. However, if the patient suspects that they have been given too much medicine, they should inform the doctor immediately.

Missing a dose of Tarcefoksym

A double dose should not be used to make up for a missed dose.

Stopping Tarcefoksym treatment

It is important to use the medicine according to the recommended treatment cycle. Treatment should not be discontinued because the patient feels better. If the treatment cycle is interrupted too early, the infection may recur.
If the patient feels worse during treatment or does not feel well after completing the recommended treatment cycle, they should consult a doctor.

In case of any further doubts about using this medicine, consult a doctor.

4. Possible side effects

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

Severe side effects

Tarcefoksym should be discontinued immediately and the doctor informed if the patient notices any of the following symptoms:

• Red, non-raised, target-like or round spots on the torso, often with centrally located blisters, exfoliation, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome or toxic epidermal necrolysis).
• Widespread rash, high body temperature, and enlarged lymph nodes (DRESS or drug hypersensitivity syndrome).
• Red, scaly, widespread rash with thickening under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).
• Allergic reactions, such as sudden shortness of breath and chest tightness, swelling of the eyelids, face, or lips, severe skin rashes that may be accompanied by blistering of the eyes, mouth, throat, and genitals, loss of consciousness (fainting).
• Severe diarrhea, lasting for a long time or containing blood, accompanied by abdominal pain or fever. This may be a symptom of severe colitis (pseudomembranous colitis), which can occur after antibiotic use.

Other side effects that may occur after Tarcefoksym treatment

• Bacterial or fungal infections (e.g. vaginal).
• Anemia caused by the breakdown of red blood cells, decreased white blood cell count, platelet count, increased eosinophil count.
• Headache, central nervous system disorders, which may include symptoms such as consciousness disorders, seizures (mainly in patients with kidney failure, receiving high doses of the medicine).
• Rare cases of heart rhythm disorders have been observed due to too rapid intravenous administration.
• Abdominal pain, nausea, vomiting, diarrhea.
• Transient increase in bilirubin levels and activity of some liver enzymes; yellowing of the skin and eyes, feeling of fatigue or fever, dark urine color (these are symptoms of hepatitis and cholestatic jaundice).
• Transient increase in urea and creatinine levels, rarely interstitial nephritis.
• Pain, irritation, inflammation of the vein at the injection site.

Reporting side effects

If side effects occur, including those not listed in this package leaflet, the doctor, pharmacist, or nurse should be informed. 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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Tarcefoksym

The medicine should be stored out of sight and reach of children.
Store in a temperature below 25°C. Protect from light.
Do not use this medicine after the expiry date (EXP) stated on the packaging. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Tarcefoksym contains

The active substance of the medicine is cefotaxime.
One vial contains 2 g of cefotaxime in the form of cefotaxime sodium salt.
The medicine does not contain other ingredients.

What Tarcefoksym looks like and contents of the pack

White or light yellow powder.
Packaging:1 vial in a cardboard box.

Marketing authorization holder and manufacturer

Tarchomińskie Zakłady Farmaceutyczne "Polfa" Spółka Akcyjna
ul. A. Fleminga 2
03-176 Warsaw
Phone number: 22 811-18-14
For more detailed information, please contact the marketing authorization holder.

Date of last revision of the package leaflet

Information intended exclusively for healthcare professionals

Method of administration
Intramuscular injection
Doses exceeding 1 g are recommended to be injected into two different sites. To reduce pain, the medicine should be injected into large muscle groups.
Intravenous injection
It is recommended in severe infections (sepsis, meningitis) and in patients in life-threatening conditions.
The medicine should be injected intravenously slowly over 3 to 5 minutes or administered as an infusion over 20 to 60 minutes.
In accordance with good practice, the solution should be administered immediately after preparation.
Solutions of cefotaxime for intravenous administration prepared in 0.9% sodium chloride solution are stable for 24 hours at a temperature of 2°C to 8°C (refrigerator), while in 5% glucose solution they are stable for 12 hours at a temperature of 2°C to 8°C (refrigerator).
The coloration of the solutions from light yellow to dark yellow does not affect the activity or properties of the preparation.

Incompatibilities

Cefotaxime should not be mixed in a syringe with aminoglycosides. Cefotaxime is most effective against bacteria in solutions with a pH of 5 to 7. The cefotaxime solution should not be diluted with solvents with a pH above 7.5 or sodium bicarbonate solution.