Tarcefoksym

Package leaflet: Information for the user

Tarcefoksym, 2 g, powder for solution for injection and infusion
Cefotaximum
Please read all of this leaflet carefully before using this medicine, because 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 or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This 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, inform your doctor or pharmacist. See section 4.

Table of contents

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 cefotaxime as the active substance, which belongs to the group of antibiotics known as cephalosporins. Cefotaxime exerts bactericidal activity against many Gram-positive and Gram-negative bacteria.
Tarcefoksym is indicated for the treatment of severe infections caused by bacteria sensitive 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 gonorrhoea in cases of penicillin allergy or resistance (penicillinase-producing strains of Neisseria gonorrhoeae).
• Infections in obstetrics and gynaecology.
• Intra-abdominal infections: e.g. peritonitis.
• Skin and soft tissue infections: e.g. cellulitis, wound infections.
• Bone and joint infections: e.g. osteomyelitis, septic arthritis.
• Meningitis.
• Prophylactically before surgical procedures, especially in the abdominal cavity, gastrointestinal tract, and genitourinary tract, during caesarean section, when 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 severe skin rash, skin peeling, blisters, or oral ulcers after taking cefotaxime or other cephalosporins.
If any of the above conditions occur, Tarcefoksym must not be used and the patient should inform their doctor.
Warnings and precautions

Before starting treatment, inform the doctor if the patient:

• has previously experienced an allergic reaction to any antibiotic;
• has previously experienced any other allergic reaction; hypersensitivity reactions to cefotaxime may be more frequent in individuals with a predisposition to allergic reactions to various substances; these reactions may vary in symptoms and severity – from skin changes to anaphylactic shock (a severe allergic reaction); therefore, if skin changes (e.g. urticaria, itching) appear during treatment with Tarcefoksym, which may indicate an allergic reaction, the doctor should be informed immediately;
• has previously suffered from gastrointestinal disorders, particularly colitis;
• has been diagnosed with renal impairment. The doctor will adjust the dosage according to the degree of renal dysfunction.

When to exercise special caution when using Tarcefoksym
Serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), and acute generalized exanthematous pustulosis (AGEP), have been reported with cefotaxime use. Treatment with cefotaxime must be discontinued and medical advice sought immediately if any symptoms associated with these serious skin reactions occur, as described in section 4.
Like other cephalosporin antibiotics, prolonged use of Tarcefoksym may lead to blood cell disorders (see section 4. Possible adverse effects). If treatment lasts longer than 10 days, the doctor will order a peripheral blood morphology test.
If the patient develops diarrhoea during or after treatment with Tarcefoksym, this should be reported to the doctor. It may be a symptom of pseudomembranous colitis – a complication associated with antibiotic use. If diarrhoea occurs, Tarcefoksym should be discontinued, and appropriate treatment initiated in more severe cases. Medicinal products that inhibit intestinal peristalsis or other constipating agents should not be used.
If in doubt, consult a doctor or pharmacist.
Tarcefoksym and other medicines
Inform the doctor about all medicines currently taken or recently used, as well as any medicines the patient plans to take.
In particular, inform the doctor if the patient is taking:

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

Patients allergic to penicillins may also be allergic to cephalosporins (so-called cross-allergy).
Effect on laboratory test results
In patients treated with Tarcefoksym, urine glucose tests may yield false-positive results; therefore, enzymatic tests are recommended if such testing is required.
Tarcefoksym may cause a false-positive Coombs test. This may interfere with blood cross-matching procedures.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, 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 its use absolutely necessary.
If the patient is breastfeeding
The drug passes into breast milk in small amounts and therefore may be administered to breastfeeding women only if clearly necessary.
Driving and operating machinery
Tarcefoksym has not been shown to impair the ability to drive or operate machinery.
However, if adverse effects affecting concentration occur (e.g. headache; see section 4. Possible adverse effects), driving or operating machinery is not recommended.
Tarcefoksym contains sodium
This medicine contains 96 mg of sodium (the main component of table salt) per vial. This corresponds to 4.8% of the maximum recommended daily sodium intake in the adult diet. Considering the dosing regimen described in section 3, the maximum amount of sodium that may be administered to a patient at the maximum daily dose is 576 mg, which corresponds to 28.8% of the maximum 2 g daily sodium intake recommended by WHO for adults. This should be taken into account in patients who are monitoring their dietary sodium intake.

3. How to use Tarcefoksym

Tarcefoksym should always be used exactly as directed by your doctor. If you have any doubts, you should
consult your doctor.
Your doctor will determine the appropriate dose based on the severity of the infection, the susceptibility of the
causative microorganism, the patient's condition, age, and body weight.
Tarcefoksym is also available as a powder for solution for injection in a strength of 1 g.

Adults
Therapeutic use:

• Uncomplicated infections: 1 g every 12 hours;
• Moderate to 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 up to 2 g every 4 hours (maximum 12 g per day);
• Uncomplicated gonorrhea: single dose of 1 g.

Prophylactic use:

• Before surgical procedures: 1 g administered intravenously or intramuscularly 90 to 30 minutes before surgery;
• Caesarean section: the first 1 g dose should be given as soon as possible after clamping of the umbilical cord, followed by the same dose administered intravenously or intramuscularly at 6 and 12 hours postpartum.

Children
The following are the usual recommended doses.

Newborns: 50 mg/kg body weight per day, administered intramuscularly or intravenously in 2 to 4 divided doses.
In severe infections, the dose may be increased to 150–200 mg/kg body weight per day in divided doses.

Infants and children: 100–150 mg/kg body weight per day, administered intramuscularly or intravenously in 2 to 4 divided doses.
In severe infections, the daily dose may be increased up to 200 mg/kg body weight.

Children over 12 years of age (with body weight over 50 kg): dosing as in adults.

Duration of treatment
The duration of treatment depends on the severity and type of infection.
Your doctor will determine the appropriate treatment duration, which should be strictly followed.
Instructions for administration and preparation of solutions are provided at the end of this leaflet, under the section “Information intended exclusively for healthcare professionals.”

Use of a higher than recommended dose of Tarcefoksym
Since Tarcefoksym will be administered by a doctor or nurse, it is unlikely that an incorrect dose will be given. However, if you suspect that an overdose has occurred, you should inform your doctor immediately.

Missed dose of Tarcefoksym
Do not take a double dose to make up for a missed dose.

Stopping treatment with Tarcefoksym
It is important to follow the prescribed treatment regimen exactly. Do not stop treatment early just because you feel better. Premature discontinuation of therapy may result in recurrence of the infection.
If you feel worse during treatment or do not feel well after completing the prescribed course of treatment, you should contact your doctor.

If you have any further questions about the use of this medicine, please consult your doctor.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
Serious adverse reactions
Treatment with cefotaxime should be stopped immediately and a doctor should be informed if the patient notices any of the following symptoms:

• Red, non-elevated, target-shaped or circular spots on the trunk, often with centrally located blisters, peeling skin, and ulcers in the mouth, throat, nose, genital organs, 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 fever, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
• Red, scaly, widespread rash with subcutaneous nodules 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, eyelid, facial or lip swelling, severe skin rashes which may involve blistering affecting the eyes, mouth, throat and genital organs, loss of consciousness (fainting).
• Diarrhea that is severe, persistent, or contains blood, accompanied by abdominal pain or fever. This may be a sign of a serious intestinal inflammation (called pseudomembranous colitis), which may occur after antibiotic use.

Other adverse reactions that may occur after treatment with Tarcefoksym

• Bacterial or fungal infections (e.g. vaginal candidiasis).
• Anaemia caused by red blood cell breakdown, decreased number of white blood cells, platelets, increased number of eosinophils.
• Headache, disorders of the central nervous system, manifested for example by disturbances of consciousness, seizures (mainly in patients with renal impairment receiving high doses of the drug).
• Rare cases of cardiac arrhythmias have been observed due to too rapid intravenous administration.
• Epigastric pain, nausea, vomiting, diarrhea.
• Transient increase in bilirubin concentration and activity of certain liver enzymes; yellowing of the skin and eyes, fatigue or fever, dark urine (these are symptoms of hepatitis and cholestatic jaundice).
• Transient increase in urea and creatinine levels, rarely interstitial nephritis.
• Pain, irritation, phlebitis at the injection site.

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform a doctor, pharmacist or nurse. Adverse reactions 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 4921301; fax: +48 22 4921309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Tarcefoksym

Keep the medicine out of the sight and reach of children.
Store 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 stated month.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the package and other information

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

What Tarcefoksym looks like and contents of the pack
White or pale yellow powder.
Pack: 1 vial in a cardboard box.

Marketing Authorisation Holder and Manufacturer
Tarchomin Pharmaceutical Works "Polfa" Joint Stock Company
A. Fleminga 2
03-176 Warsaw
Telephone number: 22 811-18-14
For further information, please contact the Marketing Authorisation Holder.

Information intended exclusively for medical professionals

Route of administration
Intramuscular administration
Doses exceeding 1 g should be injected at two different sites. To reduce pain, the drug should be administered into large muscle groups.

Intravenous administration
Recommended in severe infections (sepsis, meningitis) and in patients with life-threatening conditions.
The drug should be administered intravenously slowly over 3 to 5 minutes or given as an infusion over 20 to 60 minutes.
Rapid intravenous administration (in less than 60 seconds), especially into large veins, may cause life-threatening cardiac arrhythmias.

Preparation of solutions
Intramuscular injection
Dissolve the contents of a 2 g vial in 10 ml of water for injections or in 1% lidocaine solution.
The cefotaxime solution in 1% lidocaine should be administered immediately after preparation.
Lidocaine solution should be used only for intramuscular injections.
➢ The drug prepared in lidocaine solution must not be administered:

• intravenously;
• to children under 30 months of age;
• to patients hypersensitive to lidocaine;
• to patients with atrioventricular conduction disorders (except patients with implanted pacemakers);
• to patients with severe circulatory failure.

Intravenous injection
Dissolve the contents of a 2 g vial in 10 ml of water for injections, 0.9% sodium chloride solution, or 5% glucose solution.
Cefotaxime must not be mixed in the same syringe with aminoglycosides.
A solution of 1 g cefotaxime in 14 ml of water for injections is isotonic.

Intravenous infusion
Cefotaxime may be administered as intravenous infusions. To prepare the infusion solution, dissolve the contents of a 2 g vial in 50 ml to 100 ml of 0.9% sodium chloride solution or 5% glucose solution. The infusion should be administered over 20 to 60 minutes.
According to good practice, the solution should be administered immediately after preparation.
Cefotaxime solutions for intravenous administration, prepared in 0.9% sodium chloride solution, remain stable for 24 hours when stored at 2°C to 8°C (refrigerated). When prepared in 5% glucose solution, stability lasts for 12 hours at 2°C to 8°C (refrigerated).
A change in solution color from light yellow to dark yellow does not affect the activity or properties of the product.

Pharmaceutical incompatibilities
Cefotaxime must not be mixed in the same syringe with aminoglycosides. Cefotaxime is most effective against bacteria in solutions with a pH of 5 to 7. Cefotaxime solution should not be diluted with solvents having a pH above 7.5 or with sodium bicarbonate solution.