Cefotaxime Dali Pharma

B. PATIENT INFORMATION LEAFLET

Leaflet accompanying the packaging: information for the user

Cefotaxime Dali Pharma, 0.5 g, powder for solution for injection

Cefotaxime

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

• Keep this 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 any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

1. What Cefotaxime Dali Pharma is and what it is used for

Cefotaxime Dali Pharma (an antibiotic from the group of so-called cephalosporins) is a medicine that fights bacteria.
It is used in the case of severe, acute and chronic bacterial infections, if they are caused by pathogens sensitive to cefotaxime:

• respiratory tract infection,
• throat, nose, and ear infection,
• kidney and urinary tract infection,
• skin and soft tissue infection,
• bone and joint infection,
• genital organ infection, including gonorrhea,
• abdominal infection (including peritonitis),
• meningitis (meningoencephalitis),
• blood poisoning (sepsis),
• heart infection (endocarditis),
• Lyme disease (especially stages II and III) (infection caused mainly by tick bites)

Cefotaxime Dali Pharma may also be used to prevent perioperative infections when the patient is at increased risk of infection.

2. Important information before using Cefotaxime Dali Pharma

When not to use Cefotaxime Dali Pharma

• if the patient is allergic to cefotaxime sodium.
• if the patient has a proven hypersensitivity to other cephalosporins.
• if the patient has an acute or severe allergic reaction to penicillins or other beta-lactam antibiotics. Cross-reactions may occur between penicillins and cephalosporins.
• if the patient has ever had a severe skin rash or exfoliation after taking cefotaxime or other cephalosporins.

Cefotaxime Dali Pharma with lidocaine additive should never be used:

• intravenously
• in infants under 30 months of age
• in patients who have previously shown hypersensitivity to this product
• in patients with uncontrolled heart block (without a pacemaker)
• in patients with severe heart failure. The technical information regarding the lidocaine-containing preparation should be taken into account

Warnings and precautions

When to exercise special caution when using Cefotaxime Dali Pharma

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), and acute generalized exanthematous pustulosis (AGEP).
You should stop using cefotaxime and immediately consult a doctor if you experience any symptoms associated with these severe skin reactions, described in section 4.
Before starting treatment with Cefotaxime Dali Pharma or during treatment, you should discuss the following with your doctor or pharmacist:

• if you have any allergy to penicillins or other beta-lactam antibiotics (contraindications regarding known hypersensitivity reactions - see above in the "When not to use Cefotaxime Dali Pharma" section).
• if you have an allergic reaction (e.g. hay fever, asthma, hives) or if you have had one in the past. You are then at increased risk of serious (and in exceptional cases life-threatening) hypersensitivity reactions. After using cefotaxime, severe acute (including life-threatening) hypersensitivity reactions (e.g. angioedema, bronchospasm, anaphylaxis to shock) may occur. If you feel chest pressure, dizziness, discomfort, or weakness, it may be a sign of such a hypersensitivity reaction (see section 2 "When not to use Cefotaxime Dali Pharma" and section 4 "Possible side effects"). If a hypersensitivity reaction occurs, treatment should be discontinued.
• if you experience any skin or mucous membrane changes (see section 4, "Possible side effects"). Cefotaxime Dali Pharma may cause serious skin reactions that require treatment. You should immediately tell your doctor if you experience such symptoms.
• if you develop severe, persistent diarrhea during or up to several weeks after treatment. You should immediately tell your doctor, as diarrhea in its most severe form (called pseudomembranous colitis) can be life-threatening and needs to be treated. You should not take medications that slow down bowel movements.
• if you know that your kidney function is impaired. You should tell your doctor so that they can take this into account when determining the dosage. It is also necessary to monitor kidney function.
• if you are being treated with aminoglycosides (a group of antibiotics), probenecid (a medicine for gout), or other medications that may be harmful to the kidneys at the same time or after using cefotaxime. Your doctor must monitor kidney function, as the harmful effect of these substances on the kidneys may be increased and caution is required.
• if you experience movement disorders, seizures, confusion, or changes in consciousness. These may be symptoms of a condition called encephalopathy. The risk of this side effect is increased in cases of high doses of cefotaxime, overdose, or impaired kidney function. If you experience such reactions, you should immediately inform your doctor.
• if treatment lasts longer than 7 to 10 days. In such cases, blood tests should be performed, as changes in the blood may occur (see also section 4 "Possible side effects").
• if you experience signs of a new infection (e.g. thrush with redness and white patches). Any use of antibiotics can lead to the proliferation of pathogens that are insensitive to the used medicine. You should look for signs of a new infection and inform your doctor if necessary.
• if you intend to perform laboratory diagnostic tests: Coombs test or urine sugar test. Cefotaxime may cause a positive Coombs test result in some patients and may also affect cross-matching. Cefotaxime may cause false-positive results in urine sugar tests using non-specific reducing agents, but not in tests based on glucose oxidase.

If Cefotaxime Dali Pharma is injected too quickly (in less than 1 minute) through a central venous catheter (CVC), severe heart rhythm disorders may occur (see also section 3).

Cefotaxime Dali Pharma and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
Other antibiotics
Concomitant use of certain other antibiotics may reduce the effectiveness of Cefotaxime Dali Pharma. You should inform your doctor if you are taking or have recently taken another antibiotic.
Diuretics and other potentially kidney-damaging medicines
In the case of concomitant use with other medicines that may have a harmful effect on the kidneys, such as antibiotics (e.g. aminoglycosides, polymyxin B, and colistin) or highly effective diuretics (e.g. furosemide), cefotaxime may increase the kidney-damaging effect of these medicines.
During concomitant use of these medicines with cefotaxime, kidney function should be monitored (see section 2, "Warnings and precautions").
Probenecid
Concomitant administration of probenecid leads to an increase in cefotaxime serum concentration, and thus to an increase in the activity of Cefotaxime Dali Pharma, as probenecid inhibits its renal excretion. You should inform your doctor about the use of probenecid, especially in patients with impaired kidney function, so that they can take this into account when determining the dosage.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
There is insufficient data on the use of Cefotaxime Dali Pharma in pregnant women.
Animal studies have not shown any harmful effects of cefotaxime.
However, during pregnancy, especially in the first three months, Cefotaxime Dali Pharma should only be used after a careful assessment of the benefit-risk ratio by the treating doctor.
Breastfeeding
Cefotaxime passes into breast milk. If Cefotaxime Dali Pharma is used during breastfeeding, it may affect the physiological intestinal flora, and the child may experience diarrhea and colonization with yeast-like fungi, as well as an allergic reaction. Considering both the benefits of breastfeeding for the infant and the benefits of treatment for the mother, the doctor will decide whether to discontinue breastfeeding or discontinue treatment with Cefotaxime Dali Pharma.

Driving and using machines

According to previous experience, Cefotaxime Dali Pharma in small and medium doses does not affect concentration and reaction time.
If you experience any side effects, such as dizziness, seizures, confusion, changes in consciousness, and movement disorders, which may be related to encephalopathy, you should not drive vehicles or operate machines.

Cefotaxime Dali Pharma contains sodium

This medicine contains approximately 1 mmol (24 mg) of sodium (the main component of table salt) per vial.
This corresponds to 1.2% of the maximum recommended daily sodium intake in the diet for adults. This should be taken into account in patients with controlled sodium content (low sodium/low salt) in their diet.

3. How to use Cefotaxime Dali Pharma

This medicine should always be used as directed by your doctor.
The dose, type of application, intervals between injections, and treatment duration depend on the pathogen's sensitivity, the severity of the infection, and the patient's condition. Unless your doctor has prescribed otherwise, the usual dose is:
Adults and adolescents over 12 yearsusually receive 1 to 2 g of cefotaxime every 12 hours. In severe cases, the daily dose can be increased to 12 g of cefotaxime. Daily doses of up to 6 g of cefotaxime can be divided into at least two single doses every 12 hours.
Higher daily doses should be divided into at least 3 to 4 single doses at intervals of 8 or 6 hours.
The following table can serve as a guideline for dosing:

In the treatment of gonorrheain adults, 0.5 g of cefotaxime is administered intramuscularly in a single dose.
A dose increase may be necessary in the case of less sensitive microorganisms. Syphilis should be ruled out before starting treatment.
In the case of perioperative infection prophylaxis, 1-2 g of cefotaxime is recommended to be administered 30-60 minutes before the start of surgery. Depending on the risk of infection, the same dose can be administered multiple times.
In the case of Lyme disease, a daily dose of 6 g of cefotaxime is used (for 14 to 21 days). The daily dose was usually divided into 3 divided doses (2 g of cefotaxime 3 times a day), but in individual cases, it was also administered in 2 divided doses (3 g of cefotaxime 2 times a day). These dosing recommendations are not based on controlled clinical trials but on individual case observations.

Combination therapy

Combination therapy with Cefotaxime Dali Pharma and aminoglycosides is indicated in the absence of antibiogram results in the case of severe, life-threatening infections. When using cefotaxime in combination with aminoglycosides, attention should be paid to kidney function.
In the case of Pseudomonas aeruginosainfections, combination with other antibiotics effective against Pseudomonasmay also be indicated.
Concomitant use of cefotaxime with other appropriate antibiotics may also be indicated for infection prophylaxis in patients with impaired immune systems.
Infants and children under 12 yearsreceive 50 to 100 mg (up to 150 mg) of cefotaxime per kilogram of body weight per day, depending on the severity of the infection. The daily dose is divided into 2 or more equal doses, which are administered at intervals of 12 (to 6) hours.
In individual cases - especially in life-threatening situations - it may be necessary to increase the daily dose to 200 mg of cefotaxime per kilogram of body weight.
In premature infants, considering the not fully developed kidney function, the dose should not exceed 50 mg of cefotaxime per kilogram of body weight per day.
In patients with severe kidney function disorders(creatinine clearance less than 10 mL/minute), after the normal initial dose (the first dose at the start of treatment), the maintenance dose must be reduced to half the normal dose, maintaining the interval between doses.
Patients undergoing hemodialysis receive 1 to 2 g of cefotaxime per day, depending on the severity of the infection. On the day of hemodialysis, cefotaxime should be administered after dialysis.
Patients undergoing peritoneal dialysis receive 1 to 2 g of cefotaxime per day, depending on the severity of the infection. Cefotaxime is not removed during peritoneal dialysis.
Cefotaxime Dali Pharma 0.5 g is administered intravenously (into a vein), but it can also be administered intramuscularly.

Elderly patients

In elderly patients, kidney function should be carefully monitored and the dose adjusted accordingly.
Method of administration

Intravenous injection

For intravenous injection, 0.5 g of cefotaxime is dissolved in at least 2 mL of water for injection, and then injected directly into a vein over 3 to 5 minutes.

Intramuscular injection

For intramuscular injection, 0.5 g of cefotaxime is dissolved in 2 mL of water for injection. The injection should be administered deep into the gluteal muscle. Pain at the injection site can be avoided by dissolving 0.5 g of cefotaxime in 2 mL of 1% lidocaine solution. Injections into blood vessels should be avoided, as lidocaine can cause restlessness, tachycardia, cardiac conduction disorders, as well as vomiting and seizures after intravenous administration. Cefotaxime Dali Pharma with lidocaine additive should not be administered to children under 30 months of age. The instructions for the use of the lidocaine-containing preparation should be taken into account.
It is recommended not to inject more than 4 mL of cefotaxime solution on one side. If the daily dose exceeds 2 g of cefotaxime or if Cefotaxime Dali Pharma is injected more than twice a day, intravenous injection is recommended.

Miscibility

Unless chemical and physical compatibility with other infusion solutions has been demonstrated, the cefotaxime solution should always be administered separately from them.

Important incompatibilities

The following substances/solutions are incompatible with Cefotaxime Dali Pharma:

• sodium bicarbonate solution,
• infusion solutions with a pH greater than 7,
• aminoglycosides. Cefotaxime Dali Pharma should not be mixed with other antibiotics or medicines in a syringe. Cefotaxime Dali Pharma should not be mixed with aminoglycoside antibiotics in an infusion set or syringe.

Compatibility with infusion solutions

Cefotaxime Dali Pharma can also be dissolved in lidocaine.
The duration of treatment depends on the course of the disease.

Use of a higher dose of Cefotaxime Dali Pharma than recommended

Beta-lactam antibiotics, including cefotaxime, can cause so-called encephalopathies, which may be accompanied by central nervous system stimulation, myoclonus, seizures, confusion, changes in consciousness, and movement disorders. The risk is higher in cases of high doses, overdose, impaired kidney function, epilepsy, or meningitis.
If Cefotaxime Dali Pharma is injected too quickly (in less than 1 minute) through a central venous catheter (CVC), severe heart rhythm disorders may occur (see also section 2).
If you think you have used too much Cefotaxime Dali Pharma, contact your doctor or nurse immediately.

Missing a dose of Cefotaxime Dali Pharma

If you think you have missed a dose of Cefotaxime Dali Pharma, tell your doctor or nurse immediately. Do not take a double dose to make up for a missed dose.
If you have any further questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

You should stop using cefotaxime and tell your doctor immediately if you notice any of the following symptoms:

Uncommon(may affect up to 1 in 100 people)

• seizures.

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

• severe acute hypersensitivity reactions to life-threatening shock, as well as angioedema and bronchospasm. If you feel chest pressure, dizziness, discomfort, or weakness, it may be a sign of such a hypersensitivity reaction.
• red, non-raised, target-like or round patches on the torso, often with centrally located blisters, exfoliation of the skin, 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 or drug hypersensitivity syndrome).
• extensive red scaly rash with thickening under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).
• severe, persistent diarrhea or blood in the stool due to potentially life-threatening colitis.
• red blood cells break down (hemolytic anemia), urine turns brown-red.
• acute kidney failure.

You should tell your doctor or nurse immediately if you experience any of the following serious side effects - medical attention may be necessary:

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

• jaundice as a sign of possible liver inflammation.
• severe reduction in the number of certain white blood cells (agranulocytosis), which may manifest as acute symptoms of infection and inflammation in the mouth, nose, throat, genital organs, and anus.
• sudden drop in the number of all blood cells and bone marrow failure. In this situation, acute symptoms of infection and inflammation (see above), bleeding, bruising (reduced platelet count), fatigue, pallor, or shortness of breath (reduced red blood cell count) may occur.

You should tell your doctor, especially if one of the following side effects occurs to a significant degree or lasts longer than a few days:

Very common(may affect more than 1 in 10 people)

• pain at the injection site, hardening after intramuscular administration.

Common(may affect up to 1 in 10 people)

• joint problems (e.g. swelling).

Uncommon(may affect up to 1 in 100 people)

• increase in eosinophilic blood cells (eosinophilia);
• decrease in platelet count (thrombocytopenia) and certain white blood cells (leukopenia, granulocytopenia);
• Jarisch-Herxheimer reaction (see below);
• diarrhea;
• loss of appetite;
• increase in bilirubin (bile pigment in the blood) and/or liver enzymes in the serum (ALT, AST, Gamma-GT, alkaline phosphatase, LDH);
• allergic reactions in the form of rash, itching, hives;
• kidney function disorders, e.g. increased creatinine and urea levels in the serum;
• fever;
• inflammatory reactions at the injection site up to phlebitis (inflammation of the veins and/or thrombophlebitis).

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

• recurrent infections caused by bacteria or fungi (e.g. in the mouth or vagina);
• decrease in the number of certain white blood cells (neutropenia);
• rapid heartbeat, irregular heartbeat (after rapid administration through central venous access);
• central nervous system stimulation, changes in consciousness, confusion, movement disorders, muscle tremors (symptoms of encephalopathy; especially with high doses, overdose, and impaired kidney function);
• headache;
• dizziness;
• nausea, vomiting, abdominal pain;
• kidney inflammation (interstitial nephritis);
• intolerance reactions in the form of a feeling of heat or nausea after rapid intravenous administration.

Jarisch-Herxheimer reaction: may develop at the beginning of treatment for spirochetal infections (e.g. Lyme disease) and may be accompanied by fever, chills, headache, and joint problems. After several weeks of treatment for Lyme disease, one or more of the following symptoms have been reported: rash, itching, fever, decreased white blood cell count, increased liver enzyme activity, breathing difficulties, joint problems. These symptoms partially correspond to the symptoms of the underlying disease being treated.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, 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 Cefotaxime Dali Pharma

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and vial after "EXP".
The expiry date refers to the last day of the month stated.
Storage conditions
Before opening: There are no special storage instructions for the medicine.
Store the vials in the outer packaging to protect from light.
Solution after reconstitution: The chemical and physical stability of the solution for use has been demonstrated for 4 hours at 25°C. From a microbiological point of view, unless the method of opening/reconstitution/dilution excludes the risk of microbial contamination, the product should be used immediately. If not used immediately, the user is responsible for the storage conditions prior to administration and the storage time should not normally exceed the times stated above for chemical and physical stability during use..
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 Cefotaxime Dali Pharma contains

• The active substance of the medicine is cefotaxime sodium. One vial of Cefotaxime Dali Pharma 0.5 g contains 0.524 g of cefotaxime sodium (which corresponds to 0.5 g of cefotaxime).
• Other ingredients: None.

What Cefotaxime Dali Pharma looks like and contents of the pack

White to light yellow powder.
Cefotaxime Dali Pharma 0.5 g powder for solution for injection is packaged in a colorless and transparent glass vial of type III with a capacity of 15 mL, closed with a rubber stopper of type I (locally coated with FEP) and secured with a gray aluminum flip-off cap.
Pack sizes: 10 tightly closed vials.

Marketing authorization holder

Dali Pharma GmbH
Brehmstraße 56
40239 Düsseldorf
Germany
e-mail: [email protected]

Importer

Health-Med Sp. z o.o. sp. j.
Chełmska 30/34
00-725 Warsaw
Poland

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Germany
Cefotaxim Dali Pharma 0.5 g, Pulver zur Herstellung einer Injektionslösung
Poland
Cefotaxime Dali Pharma
Date of last revision of the leaflet:February 2025
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Information intended for healthcare professionals only:

PREPARATION OF THE MEDICINAL PRODUCT AND METHOD OF ADMINISTRATION

The solution should only be used if it is clear and free of particles.

Intravenous injection

Cefotaxime Dali Pharma 0.5 g is dissolved in 2 mL of water for injection. The vial is shaken until the contents are completely dissolved. The solution is injected directly into a vein over 3 to 5 minutes.

Potentially life-threatening heart rhythm disorders have been observed during rapid injection through a central venous catheter.

Intramuscular injection

Cefotaxime Dali Pharma 0.5 g is dissolved in 2 mL of water for injection. The vial is shaken until the contents are completely dissolved. The injection is administered deep into the gluteal muscle.

Pain at the injection site can be avoided by dissolving 0.5 g of cefotaxime in 2 mL of 1% lidocaine solution. Injections into blood vessels should be avoided, as lidocaine can cause restlessness, tachycardia, cardiac conduction disorders, as well as vomiting and seizures after intravenous administration. Cefotaxime Dali Pharma with lidocaine additive should not be administered to children under 30 months of age. The instructions for the use of the lidocaine-containing preparation should be taken into account.
Do not inject more than 4 mL of cefotaxime solution on one side. If the daily dose exceeds 2 g of cefotaxime or if Cefotaxime Dali Pharma is injected more than twice a day, intravenous injection is recommended.
Cefotaxime and aminoglycosides should not be mixed in the same syringe or infusion fluid.
If necessary, these medicines should be injected at different sites.

SHELF LIFE AND SPECIAL PRECAUTIONS FOR STORAGE

AND DISPOSAL

Before opening: 2 years. This medicinal product does not require any special storage conditions. Store the vials in the outer packaging to protect from light.
Solution after reconstitution: The chemical and physical stability of the solution for use has been demonstrated for 4 hours at 25°C.
From a microbiological point of view, unless the method of opening/reconstitution/dilution excludes the risk of microbial contamination, the product should be used immediately. If not used immediately, the user is responsible for the storage conditions prior to administration and the storage time should not normally exceed the times stated above for chemical and physical stability during use.