Biotaksim

Patient Information Leaflet

BIOTAKSYM, 1 g, powder for solution for injection or infusion
BIOTAKSYM, 2 g, powder for solution for injection or infusion
Cefotaximum
Please read all of this leaflet carefully before using this medicine, as it contains
important information for you.

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

Table of contents

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

1. What Biotaksym is and what it is used for

Biotaksym contains the third-generation cephalosporin antibiotic – cefotaxime.
After reconstitution and appropriate dilution, the medicine is administered intramuscularly or intravenously (by injection or infusion).
Cefotaxime is used:

• for the treatment of severe bacterial infections caused by susceptible organisms:
  • lower respiratory tract infections, including pneumonia;
  • urinary tract infections;
  • pelvic infections;
  • septicemia;
  • skin and soft tissue infections;
  • intra-abdominal infections, including peritonitis;
  • bone and joint infections;
  • central nervous system infections, including meningitis;
• for the prevention of perioperative infections.

2. Important information before using Biotaksym

When not to use Biotaksym:

• if the patient is allergic to cefotaxime or other cephalosporins;
• if the patient is taking penicillins, due to the risk of cross-reaction (see section: "Biotaksym and other medicines");
• if the patient has ever experienced severe skin rash, skin peeling, blisters, or oral mucosal ulcers after taking cefotaxime or other cephalosporins;
• with lidocaine-containing formulation:
• in patients allergic to lidocaine or other amide-type local anesthetics;
• for intravenous administration;
• in infants under 30 months of age;
• in patients with severe heart failure or heart block (without a pacemaker).

Warnings and precautions
Before starting treatment with Biotaksym, discuss this with your doctor or nurse.

• If the patient has allergies, especially to cephalosporins and penicillins (and other beta-lactam antibiotics); particular caution is required, as patients allergic to penicillins may also be allergic to cephalosporins (so-called cross-allergy). There is a risk of severe allergic reactions. If an allergic reaction occurs, treatment with cefotaxime must be discontinued immediately and appropriate therapy initiated if necessary. In managing severe reactions, adrenaline and other anti-shock medications (circulatory support agents, corticosteroids, and antihistamines) may be required.
• 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 during cefotaxime therapy. Treatment with cefotaxime should be discontinued and medical advice sought immediately if any symptoms associated with these serious skin reactions, described in section 4, occur.
• If the patient has impaired kidney function, the doctor may recommend monitoring kidney function and, if necessary, reducing the dose of the medicine.
• If neurological symptoms such as altered consciousness, abnormal movements, or seizures occur, the patient should consult a doctor before continuing treatment.
• If cefotaxime is used for a prolonged period, as with other antibiotics, initially susceptible strains may become resistant and overgrowth of Enterococcus spp. may occur. The doctor may then recommend performing an antibiogram.
• If diarrhea develops during treatment, the patient should consult a doctor for appropriate management. Very rarely, pseudomembranous colitis, presenting as diarrhea, may occur during or after antibiotic therapy. The condition may range from mild to severe. Mild cases usually resolve after discontinuation of the drug. In more severe cases, the doctor may prescribe metronidazole or vancomycin. Medications that inhibit peristalsis or have constipating effects should not be used.
• If the patient has a history of intestinal inflammation, especially colitis.
• If the patient is taking the medicine for longer than 7 days, the doctor may recommend monitoring white blood cell count and liver function.

Children
For infants up to 2 months of age, Biotaksym should be administered intravenously only.

Biotaksym and other medicines
Inform your doctor about all medicines currently used or recently used, as well as any medicines the patient plans to use.
Exercise caution when administering cefotaxime concomitantly with:

• bacteriostatic agents (e.g. tetracycline, erythromycin, chloramphenicol, sulfonamides) – may reduce the antibacterial effect of cefotaxime;
• aminoglycoside antibiotics (e.g. streptomycin) and potent diuretics (e.g. furosemide) – may increase the risk of nephrotoxicity;
• probenecid – increases cefotaxime serum concentration and prolongs its effect.

Effect on laboratory test results
Cefotaxime use may cause:

• false-positive results in urine glucose reduction tests;
• false-positive Coombs test results.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.

Pregnancy
The safety of cefotaxime use in pregnant women has not been established. Therefore, cefotaxime should not be used during pregnancy unless the expected benefits outweigh the potential risks.

Breastfeeding
Cefotaxime passes into human milk. An effect on the normal intestinal flora of breastfed newborns cannot be excluded, which may lead to diarrhea and colonization with yeast-like fungi. The newborn may also develop an allergic reaction.
The decision whether to discontinue breastfeeding or interrupt treatment should be discussed with the doctor, taking into account the benefits of breastfeeding for the child and the benefits of treatment for the mother.

Driving and operating machinery
There is no evidence that cefotaxime directly impairs the ability to drive vehicles or operate machinery. However, high doses of cefotaxime, particularly in patients with renal impairment, may cause disturbances in consciousness, movement disorders, and seizures. In such cases, driving vehicles or operating machinery should be avoided.

Biotaksym contains sodium
The medicine contains 48 mg of sodium (the main component of table salt) per gram. This corresponds to 2.4% of the maximum recommended daily dietary sodium intake for adults.
This should be taken into account in patients with reduced kidney function and in patients controlling dietary sodium intake.
Preparation of the medicine for administration – see section: "Information intended exclusively for healthcare professionals" at the end of the leaflet. When calculating the total sodium content in the prepared diluted solution, include sodium from the diluent. For accurate information on the sodium content in the solution used to dilute the medicine, refer to the patient leaflet of the diluent used.

3. How to use Biotaksym

This medicine should always be used exactly as prescribed by the doctor. In case of any doubts, consult
your doctor.
The dosage and method of administration are determined by the doctor depending on the severity and type of infection, age,
body weight, and the patient's kidney function.
Detailed dosage instructions, as well as directions for use and preparation of the medicine for administration,
are provided at the end of this leaflet, under the section “Information intended exclusively for healthcare professionals”.
Administration of a higher than recommended dose of Biotaksym
If the patient suspects that an excessive dose of Biotaksym has been administered, the doctor should be informed immediately.
Overdose is particularly likely in patients with impaired kidney function. Symptoms may include seizures, tremor, and coma.
In such cases, the administration of the medicine should be discontinued and appropriate treatment initiated.
Hemodialysis removes the drug from the body.
Missed dose of Biotaksym
If the patient suspects that a dose of Biotaksym has been missed, the doctor should be informed as soon as possible.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Below are the adverse reactions and their frequency of occurrence.
Cefotaxime should be discontinued immediately and a doctor should be informed if the patient
experiences any of the following symptoms:

• Red, non-elevated, target-shaped or circular spots on the trunk, often with centrally located blisters, skin peeling, 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).
• Extensive rash, high fever, and enlarged 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).

Very common (occurring in more than 1 in 10 patients):

• Pain at the injection site after intramuscular administration.

Uncommon (occurring in 1 to 10 out of 1,000 patients):

• Decreased white blood cell count, increased eosinophils (a type of white blood cell), decreased platelet count, Herxheimer reaction (symptoms appearing within a few weeks of starting Lyme disease treatment, such as skin rash, itching, fever, leukopenia, breathing difficulties, joint complaints),
• Seizures,
• Diarrhea,
• Increased liver enzyme activity (AlAT, AspAT, LDH, GGTP, alkaline phosphatase) and/or increased bilirubin concentration,
• Rash, skin itching, urticaria,
• Worsening kidney function and/or increased creatinine concentration (when used with aminoglycosides),
• Fever, inflammatory reactions at the injection site, including phlebitis or thrombophlebitis.

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

• Superinfections, decreased neutrophil count (a type of white blood cell), including life-threatening cases (neutropenia), hemolytic anemia,
• Anaphylactic reactions, angioedema, bronchospasm, anaphylactic shock,
• Headache, dizziness, encephalopathy (e.g. disturbances of consciousness, abnormal movements),
• Arrhythmia caused by rapid infusion via central venous catheter,
• Nausea, vomiting, abdominal pain,
• Pseudomembranous colitis, hepatitis (sometimes with jaundice), interstitial nephritis, systemic reactions to lidocaine after intramuscular administration (if the solution contains lidocaine).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform your 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 49 21 301
Fax: + 48 22 49 21 309
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 Biotaksym

Unopened vial
Do not store above 25°C. Keep in the original packaging to protect from light.
Reconstituted solution
After reconstitution and dilution, the prepared solution can be stored at 2°C to 8°C for 24 hours or below 25°C for 2 hours.
After reconstitution and dilution, the prepared solution does not require protection from light.
From a microbiological point of view, the medicinal product should be used immediately. If not used immediately, the user is responsible for the conditions and duration of storage.
Keep the medicine out of the sight and reach of children.
Do not use this medicinal product after the expiry date stated on the label. The expiry date refers to the last day of the stated month.
The marking on the packaging following the abbreviation EXP indicates the expiry date, and following the abbreviation Lot indicates the batch number.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Package Contents and Other Information

What Biotaksym Contains

• The active substance is cefotaxime. Each vial contains either 1 g or 2 g of cefotaxime in the form of cefotaxime sodium. The medicine does not contain any excipients.

What Biotaksym Looks Like and Contents of the Pack
The medicine is a white or slightly yellowish hygroscopic powder.
Biotaksym is intended for the preparation of a solution for injection or infusion.
The vial is a glass container closed with a rubber stopper and sealed with an aluminium cap or an aluminium cap with a flip-off seal, packed in a cardboard box.
The pack contains 1 or 10 vials.
Not all pack sizes may be available on the market.

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

Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
Zakłady Farmaceutyczne POLPHARMA S.A.
Production Plant in Duchnice
ul. Ożarowska 28/30, 05-850 Ożarów Mazowiecki

Information intended exclusively for medical professionals

BIOTAKSYM, 1 g, powder for solution for injection or infusion
BIOTAKSYM, 2 g, powder for solution for injection or infusion
Cefotaximum
Dosage
Adults and children over 12 years of age
For mild to moderate infections, 1 g is administered every 12 hours.
For severe infections, the daily dose may be increased up to 12 g given in 3 or 4 divided doses.
Daily doses up to 6 g should be divided into at least two doses given every 12 hours. Higher daily doses should be divided into at least 3 to 4 doses given every 8 or 6 hours.
Dosage guidelines are provided in the table below.

Infants and children up to 12 years of age
In infants and children up to 12 years of age, the dose of cefotaxime is 50 mg to 150 mg/kg body weight per day,
divided into 2 or 4 divided doses.
In very severe infections, especially those life-threatening, it may be necessary to increase the daily dose of
cefotaxime up to 200 mg/kg body weight per day in divided doses.
For children under 2 months of age, the drug should be administered intravenously only.

Premature infants and full-term newborns
The dose of cefotaxime should not exceed 50 mg/kg body weight per day, given in 2 to 4 divided doses.
In severe, life-threatening infections, it may be necessary to increase the daily dose to
150–200 mg/kg body weight per day, administered in divided doses.
In such cases, the dosing regimen recommended in the table below should be used:

Gonorrhea
Uncomplicated gonorrhea: single intramuscular injection of 1 g of cefotaxime. Before
initiating cefotaxime treatment, appropriate tests should be performed to ensure
that there is no concurrent syphilis infection.

Prophylaxis of perioperative infections
A single dose of 1 g cefotaxime should be administered 30 to 90 minutes before surgery.
Depending on the risk of infection, administration of the drug may be continued after the procedure.

Dosage in patients with renal impairment
Dose reduction is necessary only in cases of severe renal impairment (creatinine clearance less than 5 ml/min, serum creatinine concentration 751 micromoles/l). After administration of an initial loading dose of 1 g, the daily dose should be halved without changing the frequency of administration, e.g., reduce dose from 1 g every 12 hours to 500 mg every 12 hours, from 1 g every 8 hours to 500 mg every 8 hours, from 2 g every 8 hours to 1 g every 8 hours, etc.
In some patients, further dose adjustments may be necessary depending on the course of infection and the patient's general condition.

Method of administration
After appropriate dilution, the drug should be administered intravenously as a 3-5 minute injection or intramuscularly – deeply into the upper outer quadrant of the gluteus maximus muscle or the lateral part of the thigh. The drug may also be given as an intravenous infusion.

Method of piercing the vial
Pierce the stopper with a needle and inject the recommended volume of solvent into the vial. To pierce the stopper, use a needle with a diameter no greater than 0.8 mm (21 G on the Gauge [G] scale). The needle should be inserted perpendicularly at a 90° angle into the centrally marked area, as shown in the diagram below:

After adding the solvent to the vial, shake it until the preparation is completely dissolved. After 1-2 minutes, the solution becomes clear. Before administration, check whether the solution is clear and free from insoluble particles. The drug solution may be colorless or pale yellow.

Preparation of solutions for injections and infusions

Intramuscular injection
The medicinal product should be administered deep intramuscularly into the upper outer quadrant of the gluteus maximus muscle or the lateral part of the thigh. The vial contents should be dissolved in 4 ml of water for injections, 0.9% sodium chloride solution, or 1% lidocaine solution.
Do not administer intravenously the solution containing lidocaine.

Intravenous injection (over 3 to 5 minutes)
The vial contents should be dissolved in 10 ml of water for injections, 0.9% sodium chloride solution, or 5% glucose solution.

Intravenous infusion (over 20 to 60 minutes)
To prepare solutions for intravenous infusion, the powder should be dissolved in water for injections (as for intravenous injections). The resulting solution should then be diluted with one of the following solutions:

• 0.9% sodium chloride solution,
• 5% glucose solution,
• 5% glucose solution with 0.9% sodium chloride solution in a 1:1 ratio,
• 5% glucose solution with 0.9% sodium chloride solution in a 2:1 ratio,
• Ringer's solution,
• Ringer's lactate solution.

The use of infusion fluids containing sodium bicarbonate is not recommended due to the instability of cefotaxime in such solutions.

Cefotaxime and aminoglycosides must not be mixed in the same syringe or infusion fluid.
If simultaneous administration is necessary, these medicinal products should be injected at different sites.

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Document signed by
ARTUR ZUROWSKI
Date: 2026.01.28 13:28:54 CET