Cefotaxime Dali Pharma

B. PATIENT INFORMATION LEAFLET

Leaflet attached to the packaging: information for the user

Cefotaxime Dali Pharma, 1 g, powder for solution for injection or infusion

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, please 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 cases of severe, acute and chronic bacterial infections, if they are caused by pathogens sensitive to cefotaxime:

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

Cefotaxime Dali Pharma may also be used to prevent surgical 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 had hypersensitivity to this product
• in patients with uncontrolled heart block (without a pacemaker)
• in patients with severe heart failure. The technical information for the lidocaine-containing preparation should be taken into account

Warnings and precautions

When to be particularly careful when using Cefotaxime Dali Pharma

Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP), have been reported with cefotaxime use.
Discontinue cefotaxime and seek medical attention immediately if any symptoms of these severe skin reactions occur, as described in section 4.
Before starting Cefotaxime Dali Pharma or during treatment, discuss the following with your doctor or pharmacist:

• if the patient has any allergy to penicillins or other beta-lactam antibiotics (contraindications for known hypersensitivity reactions - see above in the "When not to use Cefotaxime Dali Pharma" section).
• if the patient has an allergic reaction (e.g., hay fever, asthma, hives) or if the patient has had one in the past. The patient is then at increased risk of serious (and in exceptional cases fatal) hypersensitivity reactions. After cefotaxime administration, severe acute (including fatal) hypersensitivity reactions (e.g., angioedema, bronchospasm, anaphylaxis to shock) may occur. If the patient feels chest tightness, 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 any skin or mucous membrane changes occur during treatment (see section 4, "Possible side effects"). Cefotaxime Dali Pharma may cause serious skin reactions requiring treatment. The doctor should be informed immediately if such symptoms occur.
• if severe, persistent diarrhea develops during or up to several weeks after treatment. The doctor should be informed immediately, as diarrhea in its most severe form (pseudomembranous colitis) can be life-threatening and requires treatment. Anti-diarrheal medications should not be taken.
• if the patient knows that their kidney function is impaired. The doctor should be informed so that they can take this into account when determining the dosage. Kidney function monitoring is also necessary.
• if the patient is being treated with aminoglycosides (a group of antibiotics), probenecid (a medication for gout), or other medications that may be harmful to the kidneys at the same time or after cefotaxime use. The doctor must monitor kidney function, as the harmful effect of these substances on the kidneys may be increased and caution is required.
• if movement disorders, seizures, confusion, or changes in consciousness occur. These may be symptoms of a condition called encephalopathy. The risk of this side effect is increased in cases of high doses, overdose, or impaired kidney function. If such reactions occur, the doctor should be informed immediately.
• 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 the patient shows signs of a new infection (e.g., thrush with redness and white patches). Any antibiotic use can lead to the proliferation of pathogens that are insensitive to the used drug. Signs of a new infection should be sought, and the doctor should be informed if necessary.
• If the patient intends 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 disturbances 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 might take.
Other antibiotics
Concomitant use of some other antibiotics may reduce the effectiveness of Cefotaxime Dali Pharma. Inform your doctor if you are taking or have recently taken another antibiotic.
Diuretics and other potentially kidney-damaging medicines
When used concomitantly 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 Cefotaxime Dali Pharma activity, as probenecid inhibits its renal excretion. Inform your doctor about probenecid use, 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 are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
There is limited experience with the use of Cefotaxime Dali Pharma in pregnant women.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition, or postnatal development.
However, during pregnancy, especially during the first three months, Cefotaxime Dali Pharma should only be used after a careful benefit/risk evaluation by the treating physician.
Breastfeeding
Cefotaxime passes into breast milk. If Cefotaxime Dali Pharma is used during breastfeeding, it may affect the physiological intestinal flora of the infant, causing diarrhea and colonization with yeast-like fungi, as well as hypersensitivity. 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 Cefotaxime Dali Pharma treatment.

Driving and using machines

Based on previous experience, Cefotaxime Dali Pharma in small and medium doses does not affect concentration and reaction time.
If side effects such as dizziness, seizures, confusion, changes in consciousness, and movement disorders occur, which may be related to encephalopathy, do not drive or operate machinery.

Cefotaxime Dali Pharma contains sodium

This medicine contains approximately 2.1 mmol (48 mg) of sodium (the main component of table salt) per vial.
This corresponds to 2.4% of the maximum recommended daily sodium intake in the diet for adults. This should be taken into account for 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 exactly as your doctor has instructed.
The dose, type of application, intervals between injections, and duration of treatment depend on the susceptibility of the pathogen, the severity of the infection, and the patient's condition. Unless otherwise instructed by your doctor, the usual dose is:
Adults and adolescents over 12 yearsusually receive 1 to 2 grams of cefotaxime every 12 hours. In severe cases, the daily dose can be increased to 12 grams of cefotaxime. Daily doses of up to 6 grams 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 8- or 6-hour intervals.
The following table can serve as a guideline for dosing:

In the treatment of gonorrhea, 0.5 grams of cefotaxime is administered intramuscularly in a single dose.
A dose increase may be necessary in cases of less sensitive microorganisms. Syphilis should be ruled out before starting treatment.
In surgical prophylaxis, 1-2 grams of cefotaxime is recommended 30-60 minutes before the start of surgery. Depending on the risk of infection, the same dose can be administered repeatedly.
In the case of Lyme disease, a daily dose of 6 grams of cefotaxime is used (for 14 to 21 days). The daily dose was usually divided into 3 divided doses (2 grams of cefotaxime 3 times a day), but in individual cases, it was also administered in 2 divided doses (3 grams 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 cases of severe, life-threatening infections. When using cefotaxime in combination with aminoglycosides, kidney function should be monitored.
In cases 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 12- (to 6) hour intervals.
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 preterm 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 (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 grams 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 grams of cefotaxime per day, depending on the severity of the infection. Cefotaxime is not removed during peritoneal dialysis.
Cefotaxime Dali Pharma 1 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

In the case of intravenous injection, 1 gram of cefotaxime is dissolved in at least 4 mL of water for injection, and then injected directly into a vein over 3 to 5 minutes.

Infusion

To prepare the infusion solution, the dry cefotaxime powder should first be dissolved in 5 mL of water for injection or one of the compatible solutions, and then added to 40-50 mL of water for injection or a compatible infusion solution and mixed.
In the case of short-term infusion, 1 gram of cefotaxime is dissolved in 40-50 mL of water for injection or a compatible solution, and then administered intravenously over approximately 20 minutes.

Intramuscular injection

In the case of intramuscular injection, 1 gram of cefotaxime is dissolved in 4 mL of water for injection. The injection should then be administered deep into the gluteal muscle. Pain at intramuscular injection can be avoided by dissolving 1 gram of cefotaxime in 4 mL of 1% lidocaine solution. Intra-arterial injection (injection into a blood vessel) should be avoided, as lidocaine can cause restlessness, tachycardia, conduction disorders in the heart, as well as nausea 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 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 grams of cefotaxime or if Cefotaxime Dali Pharma is injected more than twice a day, intravenous injection is recommended.

Miscibility

Unless otherwise shown to be chemically and physically compatible with other infusion solutions, the cefotaxime solution should always be administered separately from them.

Major 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, sodium lactate, glucose, or Ringer's solution.
The duration of treatment depends on the course of the disease.

Using 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 disturbances may occur (see also section 2).
If you think you have taken 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, inform your doctor or nurse immediately. Do not take a double dose to make up for a missed dose.
If you have any further questions on the use of 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.

Stop using cefotaxime and inform 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 tightness, dizziness, discomfort, or weakness, it may be a sign of such a hypersensitivity reaction.
• red, non-raised, target-like or circular 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 fever, and swollen lymph nodes (DRESS or drug hypersensitivity syndrome).
• widespread 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.

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

Frequency not known(frequency 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, genitals, and anus.
• sharp decrease in the number of all blood cells and bone marrow failure. In this situation, acute symptoms of infection and inflammation (see above), bleeding, bruising (decreased platelet count), fatigue, pallor, or shortness of breath (decreased red blood cell count) may occur.

Tell your doctor, especially if one of the following side effects gets serious 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 and certain white blood cells (thrombocytopenia, 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, GGT, 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 (vein inflammation and/or thrombophlebitis).

Frequency not known(frequency 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 Lyme disease treatment, 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, please tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocides
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: No special storage temperature 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 precludes the risk of microbial contamination, the product should be used immediately. If not used immediately, the storage times and conditions before use are the responsibility of the user and are not normally longer than 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 1 vial of Cefotaxime Dali Pharma 1 g contains 1.048 g of cefotaxime sodium (which corresponds to 1 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 1 g powder for solution for injection/infusion is packaged in a clear and colorless 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 blue 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 1 g, powder for solution for injection/infusion
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 ADMINISTRATION

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

Intravenous injection:

Cefotaxime Dali Pharma 1 g should be dissolved in 4 mL of water for injection. Shake the vial until the contents are completely dissolved. The solution should be injected directly into a vein over 3 to 5 minutes.

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

Infusion

In the case of short-term infusion, Cefotaxime Dali Pharma 1 g should be dissolved in 40 to 50 mL of water for injection or a compatible solution (listed below), and then administered intravenously over approximately 20 minutes.

To prepare the infusion solution, the dry cefotaxime powder should first be dissolved in 5 mL of water for injection or one of the compatible solutions, and then added to water for injection or a compatible infusion solution to a volume of 40-50 mL and mixed.
After administration, it is recommended to flush the intravenous line with a 9 mg/mL (0.9%) sodium chloride solution for injection to ensure the administration of the full dose.
Cefotaxime is compatible with several commonly used intravenous infusion solutions, e.g., lidocaine, sodium chloride solution, glucose, Ringer's solution.
Pharmaceutical incompatibilities
Cefotaxime Dali Pharma should not be mixed with: sodium bicarbonate solutions, infusion solutions with a pH greater than 7, aminoglycosides.
Cefotaxime and aminoglycosides should not be mixed in the same syringe or infusion fluid.
If concomitant administration is necessary, the medicines should be injected at different sites.

Intramuscular injection

Cefotaxime Dali Pharma 1 g should be dissolved in 4 mL of water for injection. Shake the vial until the contents are completely dissolved. The injection should then be administered deep into the gluteal muscle.

Pain at intramuscular injection can be avoided by dissolving 1 gram of cefotaxime in 4 mL of 1% lidocaine solution. Intra-arterial injection (injection into a blood vessel) should be avoided, as lidocaine can cause restlessness, tachycardia, conduction disorders in the heart, as well as nausea 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 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 grams of cefotaxime or if Cefotaxime Dali Pharma is injected more than twice a day, intravenous injection is recommended.

SHELF LIFE AND SPECIAL PRECAUTIONS FOR STORAGE

Before opening: 2 years. This medicinal product does not require any special storage temperature instructions. 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 precludes the risk of microbial contamination, the product should be used immediately. If not used immediately, the storage times and conditions before use are the responsibility of the user and are not normally longer than the times stated above for chemical and physical stability during use.