Cefotaxime dali pharma

Package leaflet: Information for the user

Cefotaxime Dali Pharma, 0.5 g, powder for solution for injection
Cefotaximum
Please read all of this leaflet carefully before using this medicine, as it contains
important information for the patient.

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

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 belonging to the so-called cephalosporin group) is an antibacterial agent.
It is used in the treatment of severe, acute and chronic bacterial infections caused by pathogens sensitive to cefotaxime:

• respiratory tract infections,
• infections of the throat, nose and ears,
• kidney and urinary tract infections,
• skin and soft tissue infections,
• bone and joint infections,
• genital organ infections, including gonorrhoea,
• abdominal infections (including peritonitis),
• meningitis (inflammation of the meninges),
• blood poisoning (septicaemia),
• heart inflammation (endocarditis),
• Lyme disease (particularly stages II and III) (infection mainly transmitted by tick bites).

Cefotaxime Dali Pharma may also be used for the prevention of 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 sodium cefotaxime.
• if the patient has proven hypersensitivity to other cephalosporins.
• if the patient has experienced a severe or serious allergic reaction to penicillins or other beta-lactam antibiotics. Cross-reactions between penicillins and cephalosporins may occur.
• if the patient has ever experienced severe skin rash, skin peeling, blisters, or oral mucosal ulcers after taking cefotaxime or other cephalosporins.

Cefotaxime Dali Pharma with lidocaine must never be used:

• intravenously
• in infants under 30 months of age
• in patients who previously experienced hypersensitivity to this product
• in patients with uncontrolled heart block (without a pacemaker)
• in patients with severe heart failure. Refer to technical information regarding lidocaine-containing preparations

Warnings and precautions
When to exercise special caution when using Cefotaxime Dali Pharma
Severe 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.
Discontinue cefotaxime and immediately consult a doctor if any symptoms related to these severe skin reactions, described in section 4, occur.
Before starting or during treatment with Cefotaxime Dali Pharma, discuss with your doctor or pharmacist:

• if the patient has any allergy to penicillins or other beta-lactam antibiotics (contraindications regarding known hypersensitivity reactions – see above under “When not to use Cefotaxime Dali Pharma”).
• if the patient has an allergic reaction (e.g. hay fever, bronchial asthma, urticaria) or has had such reactions in the past. In such cases, the patient has an increased risk of serious (and in rare cases, even fatal) hypersensitivity reactions. Severe, acute (including fatal) hypersensitivity reactions (e.g. angioedema, bronchospasm, anaphylaxis up to shock) may occur after cefotaxime administration. If the patient experiences chest tightness, dizziness, discomfort, or weakness, this may indicate 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 must be discontinued.
• if the patient develops any skin or mucosal changes during treatment (see section 4, “Possible side effects”). Cefotaxime Dali Pharma may cause serious skin reactions requiring treatment. Inform the doctor immediately if such symptoms occur.
• if severe, persistent diarrhea develops during or up to several weeks after treatment. Inform the doctor immediately, as diarrhea in its most severe form (called pseudomembranous colitis) can be fatal and requires treatment. Do not take drugs that inhibit intestinal motility.
• if the patient knows their kidney function is impaired. Inform the doctor so this can be considered when determining dosage. Kidney function monitoring is also required.
• if the patient is being treated with aminoglycosides (a group of antibiotics), probenecid (a medication for gout), or other drugs that may be harmful to the kidneys, either concurrently or after cefotaxime treatment. The doctor must monitor kidney function, as the nephrotoxic effects of these substances may be enhanced, requiring appropriate caution.
• if motor disturbances, seizures, confusion, or disturbances of consciousness occur. These may be symptoms of a condition called encephalopathy. The risk of this adverse effect is increased with high doses of cefotaxime, overdose, or impaired kidney function. If such reactions occur, inform the doctor immediately.
• if treatment lasts longer than 7 to 10 days. In such cases, blood tests should be performed, as blood changes may occur (see also section 4 “Possible side effects”).
• if the patient shows signs of a new infection (e.g. fungal infection of mucous membranes with redness and white deposits). Any antibiotic use may lead to overgrowth of pathogens resistant to the drug used. Watch for signs of a new infection and inform the doctor if necessary.
• if the patient plans to undergo laboratory diagnostic tests: the Coombs test or urine glucose 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 glucose tests using non-specific reducing reagents, but not in tests based on glucose oxidase.

If Cefotaxime Dali Pharma is injected too rapidly (in less than 1 minute)
through a central venous catheter (CVC), severe cardiac arrhythmias may occur (see also
section 3).
Cefotaxime Dali Pharma and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Other antibiotics
Concurrent use of certain other antibiotics may reduce the effectiveness of Cefotaxime Dali
Pharma. Inform the doctor if the patient is taking or has recently taken another
antibiotic.
Diuretics and other potentially nephrotoxic drugs
When used concurrently with other drugs that may harm the kidneys, such as antibiotics (e.g. aminoglycosides, polymyxin B, and colistin) or highly effective diuretics (diuretics such as furosemide), cefotaxime may enhance the nephrotoxic effects of these drugs.
Kidney function should be monitored when these drugs are used concurrently with cefotaxime (see section 2, “Warnings and precautions”).
Probenecid
Concurrent administration of probenecid leads to increased serum concentration of cefotaxime and thus increased activity of Cefotaxime Dali Pharma, as probenecid inhibits its renal excretion. Inform the doctor about probenecid use, especially in patients with impaired kidney function, so this can be considered when determining dosage.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a
child, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
There are insufficient data on the use of Cefotaxime Dali Pharma in pregnant women.
Animal studies have not shown harmful effects of cefotaxime.
However, during pregnancy, especially in the first trimester, Cefotaxime Dali Pharma
should be used only after careful benefit-risk assessment by the treating physician.
Breastfeeding
Cefotaxime passes into human milk. If Cefotaxime Dali Pharma is used during breastfeeding, it may affect the infant's normal intestinal flora, leading to diarrhea and colonization with yeast-like fungi, and may also cause sensitization. Taking into account 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 operating machinery
Based on previous experience, Cefotaxime Dali Pharma in small and medium doses
does not affect concentration or reaction time.
If any adverse reactions occur, such as dizziness, seizures, confusion,
disturbances of consciousness and movement, which may be related to encephalopathy, the patient should not drive
or operate machinery.
Cefotaxime Dali Pharma contains sodium
This medicine contains approximately 1 mmol (24 mg) of sodium (main component of table salt) per vial.
This corresponds to 1.2% of the maximum recommended daily dietary sodium intake for adults. This should be taken into account in patients on a sodium-controlled (low sodium / low salt) diet.
3. How to use Cefotaxime Dali Pharma
This medicine should always be used as directed by the doctor.
The dose, route of administration, intervals between injections, and duration of treatment depend on the pathogen's susceptibility, severity of infection, and the patient's condition. Unless otherwise directed by the doctor, the usual dose is:
Adults and adolescents over 12 years of age usually receive 1 to 2 g of cefotaxime every 12 hours. In severe cases, the daily dose may be increased up to 12 g of cefotaxime. Daily doses up to 6 g of cefotaxime may 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 given every 8 or 6 hours.
The following table may serve as a dosing guideline:

In the treatment of gonorrhoea, 0.5 g of cefotaxime is administered intramuscularly as a single dose in adults.
An increase in dose may be necessary in case of less sensitive microorganisms. Syphilis should be excluded before initiating treatment.

In perioperative prophylaxis of infections, it is recommended to administer 1–2 g of cefotaxime 30–60 minutes before the start of surgery. Depending on the risk of infection, this same dose may be administered repeatedly.

In 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 daily), but in individual cases, it was also administered in 2 divided doses (3 g of cefotaxime twice daily). These dosing recommendations are not based on controlled clinical trials, but on observations of individual cases.

Combination therapy
Combination therapy with Cefotaxime Dali Pharma and aminoglycosides is indicated in the absence of susceptibility test results in severe, life-threatening infections. When using cefotaxime in combination with aminoglycosides, renal function should be monitored.
In Pseudomonas aeruginosa infections, combination with other antibiotics effective against Pseudomonas may 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 up to 12 years of age receive 50 to 100 mg (up to 150 mg) of cefotaxime per kilogram of body weight per day, depending on the severity of infection. The daily dose is divided into 2 or more equal doses administered at intervals of 12 (down to 6) hours.
In individual cases—particularly in life-threatening situations—the daily dose may need to be increased up to 200 mg of cefotaxime per kilogram of body weight.

In preterm infants, considering the immature renal function, doses exceeding 50 mg of cefotaxime per kilogram of body weight per day should not be administered.

In patients with severe renal impairment (creatinine clearance less than 10 mL/min), after the initial normal dose (first dose at the beginning of treatment), the maintenance dose must be reduced to half the normal dose, maintaining the dosing interval.
Patients undergoing hemodialysis receive 1 to 2 g of cefotaxime per day, depending on the severity of infection. On the day of hemodialysis, cefotaxime should be administered after dialysis is completed.
Patients undergoing peritoneal dialysis receive 1 to 2 g of cefotaxime per day, depending on the severity of infection. Cefotaxime is not removed during peritoneal dialysis.

Cefotaxime Dali Pharma 0.5 g is administered intravenously (into a vein), but may also be administered intramuscularly.

Elderly patients
In elderly patients, renal function should be carefully monitored and the dose appropriately adjusted.

Method of administration

Intravenous injection
For intravenous injection, 0.5 g of cefotaxime is dissolved in at least 2 mL of water for injections 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 injections. The injection should then be administered deeply into the gluteal muscle. Pain associated with intramuscular injection can be avoided by dissolving 0.5 g of cefotaxime in 2 mL of 1% lidocaine solution. Intravascular injection (injection into a blood vessel) must be avoided, as lidocaine may cause restlessness, tachycardia, cardiac conduction disturbances, as well as vomiting and seizures. Cefotaxime Dali Pharma with lidocaine should not be administered to children under 30 months of age. The instructions for use of lidocaine-containing preparations 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 administered more than twice daily, intravenous injection is recommended.

Compatibility
Unless chemical and physical compatibility with other infusion solutions has been demonstrated, 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 pH greater than 7,
• aminoglycosides.

Cefotaxime Dali Pharma should not be mixed with other antibiotics or drugs in the same syringe. Cefotaxime Dali Pharma must not be mixed with aminoglycoside antibiotics in an infusion set or in a 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.

Administration of a higher than recommended dose of Cefotaxime Dali Pharma
Beta-lactam antibiotics, including cefotaxime, may lead to so-called encephalopathy, which may be accompanied by central nervous system excitation, myoclonus, seizures, confusion, disturbances of consciousness and movement. The risk is higher with large doses, overdose, renal impairment, epilepsy, or meningitis.
If Cefotaxime Dali Pharma is injected too rapidly (in less than 1 minute) through a central venous catheter (CVC), severe cardiac arrhythmias may occur (see also section 2).
If a patient suspects having received too much Cefotaxime Dali Pharma, they should contact a doctor or nurse immediately.

Missed dose of Cefotaxime Dali Pharma
If a patient suspects having missed a dose of Cefotaxime Dali Pharma, they should inform the doctor or nurse immediately. A double dose must not be administered to make up for the missed dose.

If there are any further questions regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Treatment with cefotaxime must be stopped immediately and the doctor informed if the patient
notices any of the following symptoms:
Uncommon (may affect up to 1 in 100 people)

• seizures.

Frequency unknown (cannot be estimated from available data)

• severe acute allergic reactions up to life-threatening shock, as well as swelling (Quincke's oedema) and narrowing of the airways (bronchospasm). If you feel chest tightness, dizziness, discomfort or weakness, this may be a sign of such an allergic reaction.
• red, non-elevated, target-shaped or round spots on the trunk, often with centrally located blisters, peeling skin, and ulceration of 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 body temperature 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 generalised exanthematous pustulosis).
• severe, persistent diarrhoea or blood in the stool due to potentially life-threatening intestinal inflammation.
• red blood cells break down (haemolytic anaemia), urine becomes brownish-red.
• acute kidney failure.

Immediately inform your doctor or nurse if the following serious adverse effects occur – medical
assistance will likely be required:
Frequency unknown (cannot be estimated from available data)

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

Tell your doctor, especially if any of the adverse effects listed below are severe or last longer than a few days:
Very common (may affect more than 1 in 10 people)

• pain at the injection site, induration 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 eosinophil blood cells (eosinophilia);
• decrease in platelet count (thrombocytopenia) and certain white blood cells (leukopenia, granulocytopenia);
• Jarisch-Herxheimer reaction (explanation below);
• diarrhoea;
• loss of appetite;
• increased levels of bilirubin (bile pigment in blood) and (or) liver enzymes in serum (AlAT, AspAT, Gamma-GT, alkaline phosphatase, LDH);
• allergic reactions such as rash, itching, urticaria;
• impaired kidney function, e.g. increased levels of creatinine and urea in serum;
• fever;
• inflammatory reactions at the injection site up to phlebitis (inflammation of veins and (or) thrombophlebitis).

Frequency unknown (cannot be estimated from available data)

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

Jarisch-Herxheimer reaction: This 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 partly correspond to the symptoms of the underlying disease in treated patients.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. Adverse effects 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 effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Cefotaxime Dali Pharma
Keep the 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 stated month.

Storage conditions
Before opening: No special temperature requirements for storage of the medicine.
Keep vials in the outer packaging to protect from light.

Reconstituted solution: Chemical and physical in-use stability 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 responsibility for storage conditions and duration prior to use lies with the user and must not exceed the times indicated above for chemical and physical stability during use.

Do not dispose of medicines via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the package and other information

What Cefotaxime Dali Pharma contains

• The active substance is cefotaxime sodium. 1 vial of Cefotaxime Dali Pharma 0.5 g contains 0.524 g of cefotaxime sodium (equivalent to 0.5 g of cefotaxime).
• Other components: None.

What Cefotaxime Dali Pharma looks like and contents of the pack
White to slightly yellowish powder.
Cefotaxime Dali Pharma 0.5 g powder for solution for injection is packed in a colourless and transparent type III glass vial with a capacity of 15 mL, closed with a chlorobutyl rubber stopper type I (locally coated with FEP) and secured with a grey aluminium flip-off cap.
Pack sizes: 10 tightly sealed vials.
Marketing Authorisation Holder
Dali Pharma GmbH
Brehmstraße 56
40239 Düsseldorf
Germany
e-mail: [email protected]
Importer
SciencePharma Sp. z o.o.
Chełmska 30/34
00-725 Warsaw
Poland
This medicinal product is authorised 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

Information intended exclusively for healthcare professionals:

PREPARATION OF MEDICINAL PRODUCT AND METHOD OF ADMINISTRATION
The solution should be used only if it is clear and free from particles.
Intravenous injection
Dissolve Cefotaxime Dali Pharma 0.5 g in 2 mL of water for injections. Shake the vial until the contents are completely dissolved. Inject the solution directly into the vein over 3 to 5 minutes.

During rapid intravenous injection via central venous catheter, potentially life-threatening cardiac arrhythmias have been observed.

Intramuscular injection

Dissolve Cefotaxime Dali Pharma 0.5 g in 2 mL of water for injections. Shake the vial until the contents are completely dissolved. The injection should be administered deeply into the gluteal muscle.

Pain during intramuscular injection can be avoided by dissolving 0.5 g of cefotaxime in 2 mL of 1% lidocaine solution. Intravascular injection must be avoided, as lidocaine may cause restlessness, tachycardia, cardiac conduction disturbances, as well as nausea and seizures following intravenous administration. Cefotaxime Dali Pharma with lidocaine should not be administered to children under 30 months of age. The instructions for use of the lidocaine-containing preparation should be taken into account.
Do not inject more than 4 mL at one site. If the daily dose exceeds 2 g of cefotaxime or if Cefotaxime Dali Pharma is administered more than twice daily, intravenous injection is recommended.
Cefotaxime and aminoglycosides should not be mixed in the same syringe or infusion fluid. If simultaneous administration is necessary, these drugs should be administered at different sites.
SHELF LIFE AND SPECIAL PRECAUTIONS FOR STORAGE
Before opening: 2 years. This medicinal product does not require any special temperature storage conditions. Store vials in the outer packaging to protect from light.
Reconstituted solution: Chemically and physically stable for up to 4 hours at 25°C.
From a microbiological standpoint, unless the method of opening/reconstitution/dilution precludes the risk of microbial contamination, the product should be used immediately after opening. If not used immediately, the responsibility for storage conditions and duration prior to use lies with the user and should not normally exceed the times indicated above for chemical and physical stability during use.