CEFOTAXIME SALA 2 g POWDER FOR INJECTION AND INFUSION SOLUTION

3.

1. Possible side effects

5.

6.

1. What is Cefotaxime Sala and what is it used for

Cefotaxime (an antibiotic belonging to the group of medicines known as cephalosporins) is a medicine used to combat bacteria.

Antibiotics are used to treat bacterial infections and are not effective against viral infections such as the flu or the common cold.

It is essential that you follow the instructions regarding dosage, administration interval, and treatment duration as indicated by your doctor.

Do not store or reuse this medicine. If you have any leftover antibiotic after completing the treatment, return it to the pharmacy for proper disposal. Do not throw away medicines via wastewater or household waste.

It is indicated for infections caused by germs sensitive to cefotaxime:

• respiratory infections,
• otorhinolaryngological infections,
• renal and urinary tract infections,
• skin and soft tissue infections,
• bone and joint infections,
• gynecological infections, including gonorrhea,
• abdominal infections (including peritonitis),
• meningitis,
• blood poisoning (sepsis),
• heart inflammation (endocarditis),
• Lyme disease (especially in stages II and III) (infection mainly caused by tick bites).

Additionally, for the prevention of infections after surgical interventions in patients with a higher risk of infections.

2. What you need to know before you use Cefotaxime Sala 2 g powder for solution for injection and infusion EFG

Do not use Cefotaxime Sala:

• if you are allergic to cefotaxime or other cephalosporins, or to any of the components of this medicine (listed in section 6).
• if you have previously had an acute or severe hypersensitivity reaction to penicillin or other beta-lactam antibiotics. Penicillin and cephalosporins can cause cross-reactions.

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Warnings and precautions:

Consult your doctor or pharmacist before starting to use cefotaxime:

• If you are allergic to penicillin or other beta-lactam antibiotics in any form (for contraindications due to known hypersensitivity reactions, see above in the section "Do not use Cefotaxime Sala").
• If you have an allergic reaction (e.g., hay fever, bronchial asthma, hives) or if you are known to have a history of allergies. In this case, you have a higher risk of more severe hypersensitivity reactions (which can be fatal in exceptional cases). If you experience a feeling of chest tightness, or feel dizzy, sick, or weak, these may be signs of a hypersensitivity reaction (see section 4).
• If a hypersensitivity reaction occurs, treatment should be discontinued.
• If you experience severe or persistent diarrhea during treatment or for several weeks after its completion. Inform your doctor immediately, as diarrhea in its most severe form (called pseudomembranous colitis) can be life-threatening and requires treatment. Do not take any medication that limits intestinal activity.
• If you know you have kidney failure. Inform your doctor in this case; if necessary, they may adjust your dose. It is essential to monitor your kidney function.
• If you are receiving concurrent or subsequent treatment with aminoglycosides (other antibiotics) or probenecid (for gout) or other medications that can cause kidney damage. A doctor should monitor your kidney function, as these substances can increase the harmful effects on the kidneys, and caution is needed.
• If you experience movement disorders, have seizures, or confusion, or have altered consciousness. These may be signs of what is called encephalopathy. There is a risk of these adverse effects when high doses are administered, in case of overdose, or if you have kidney failure. If these reactions occur, consult your doctor immediately.
• If your treatment lasts more than 7 to 10 days. In this case, blood control tests should be performed because changes in the blood may appear (see also section 4).
• If you have signs of a new infection (e.g., fungal infection of the mucous membranes with redness and a white surface). The use of antibiotics can increase the amount of pathogens that are not sensitive to the used medication. Be vigilant for signs of a new infection and inform your doctor if necessary.

Be careful withCefotaxime Sala

Severe skin reactions, such as Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP), have been reported with cefotaxime. Stop taking cefotaxime and seek medical attention immediately if you observe any of the symptoms described in section 4 related to these severe skin reactions.

Other medicines and Cefotaxime Sala

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Other antibiotics

The concurrent use of some antibiotics may reduce the effect of cefotaxime. Inform your doctor if you are taking or have recently taken other antibiotics.

Diuretics and potentially kidney-damaging medications

When cefotaxime is used in conjunction with medications that can have a harmful effect on the kidneys, such as aminoglycosides (other antibiotics) or medications with a high capacity to cause dehydration (diuretics, such as furosemide), it can increase the harmful effect on the kidneys of these medications. If administered concomitantly, kidney function should be monitored (see section 2 "Warnings and precautions").

Probenecid

The simultaneous administration of probenecid results in an increase in cefotaxime serum concentration and, therefore, an extension of its effect, because probenecid limits the elimination of cefotaxime by the kidneys. Inform your doctor if you are taking probenecid, especially if you have kidney failure, so that, if necessary, they can adjust your dose.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy:

There are insufficient data on the use of cefotaxime in pregnant women. Animal experiments did not show signs of teratogenic properties of cefotaxime.

However, cefotaxime should only be used during pregnancy, especially in the first trimester, after a strict evaluation of the risks and benefits of treatment by a specialist.

Breastfeeding:

Cefotaxime is excreted in breast milk only in small amounts. If you receive cefotaxime during breastfeeding, it may cause changes in the intestinal flora with diarrhea, fungal growth, and may also cause sensitization. The doctor will decide whether it is necessary to interrupt breastfeeding or discontinue treatment with cefotaxime, considering the benefit of breastfeeding for the child and the benefit of treatment for the mother.

Driving and using machines

According to previous experience, cefotaxime in low and medium doses does not have any effect on concentration or reaction ability.

If you experience side effects such as dizziness or encephalopathy, which can be associated with seizures, confusion, altered consciousness, and movement disorders, you should not drive or use machines.

Cefotaxime Salacontains sodium

This medicine contains 101.2 mg (4.40 mmol) of sodium per dose, which is equivalent to 5.1% of the maximum recommended daily intake of sodium in the diet for an adult.

3. How to use Cefotaxime Sala

Follow the instructions for administration of this medicine exactly as indicated by your doctor. In case of doubt, consult your doctor or pharmacist. Cefotaxime will be administered intravenously. Remember to use your medicine.

Your doctor will indicate the appropriate dose and determine the duration of your treatment and the form of administration; do not suspend it before or prolong it.

The dose, form of administration, and time intervals between injections depend on the dose, sensitivity of the pathogen, severity of the infection, and the patient's condition.

Unless the doctor indicates otherwise, the recommended dose is:

Adults and children over 12 years:the usual dosage is 1 g of cefotaxime every 12 hours. In severe cases, the daily dose can be increased up to 12 g. Daily doses up to 6 g can be divided into at least two fractionated doses administered at 12-hour intervals. Higher daily doses should be divided into at least 3-4 fractionated doses with administration intervals of 6 or 8 hours.

The following table can be considered a guideline for administration:

For the treatment of gonorrhea in adults, a single dose of 0.5 g of cefotaxime should be administered intramuscularly. In less sensitive pathogens, a dose increase may be necessary. Before starting treatment, check for the presence of syphilis.

For perioperative prophylaxis of infections, administration of 1-2 g of cefotaxime 30-60 minutes before surgery is recommended. Less sensitive pathogens may require a higher dose. Before starting treatment, check for the presence of syphilis.

For Lyme disease, the daily dose is 6 g of cefotaxime (for 14 to 21 days). In most cases, the daily dose is divided into 3 fractionated doses (2 g of cefotaxime 3 times a day), but in some cases, it has been administered in 2 fractionated doses (3 g of cefotaxime 2 times a day). The recommendations for the dosage regimen are not based on comparative clinical trials but on observations of individual patients.

Combined treatment

In severe infections that pose a vital risk, combined treatment with cefotaxime and aminoglycosides is indicated without an antibiogram. When combined with aminoglycosides, kidney function should be monitored.

In cases of Pseudomonas aeruginosainfection, combined treatment with other antibiotics effective against Pseudomonasmay also be indicated.

For the prophylaxis of infections in patients with a weakened immune system, combined treatment with other appropriate antibiotics may also be indicated.

Infants and children up to 12 yearsreceive 50 to 100 mg of cefotaxime (up to 150 mg) per kilogram of body weight daily, depending on the severity of the infection. The daily dose will be divided into 2 or more identical fractionated doses, which will be administered at intervals of 12 (to 6) hours. In individual cases, especially in life-threatening situations, the daily dose can be increased to 200 mg of cefotaxime per kilogram of body weight.

In premature babies, it should be taken into account that kidney function is not yet fully developed, and the dose should not exceed 50 mg of cefotaxime per kilogram of body weight per day.

In patients with severe kidney failure(creatinine clearance less than 10 ml/minute), after the initial normal dose (the first dose at the start of treatment), the maintenance dose can be reduced to half of the normal dose, maintaining the administration interval.

Patient on hemodialysis receive 1 to 2 g of cefotaxime daily, depending on the severity of the infection. On the day of hemodialysis, cefotaxime should be administered after dialysis.

Patient on peritoneal dialysis receive 1 to 2 g of cefotaxime daily, depending on the severity of the infection. Cefotaxime is not eliminated by peritoneal dialysis.

Cefotaxime Sala 2g is administered intravenously (in a vein).

Elderly patients

In elderly patients, kidney function should be carefully monitored, and the dose should be adjusted if necessary.

Intravenous injection

For intravenous administration, dissolve 2 g of cefotaxime in at least 10 ml of water for injectable preparations and administer directly intravenously slowly over a period of 3 to 5 minutes.

Intravenous infusion

For intravenous infusion, reconstitute the vial contents in 10 ml of water for injectable preparations.

For rapid intravenous infusion, dissolve 2 g of cefotaxime in 40 ml of water for injectable preparations or isotonic sodium chloride solution and infuse over approximately 20 minutes.

For slow intravenous infusion, dissolve 2 g of cefotaxime in 100 ml of isotonic sodium chloride solution or a glucose solution and infuse over a period of 50 to 60 minutes.

Intramuscular injection

Cefotaxime Sala 2 g should not be administered intramuscularly. Use Cefotaxime Sala 1 g.

Compatibility

Unless the physicochemical compatibility with other infusion solutions has been demonstrated, the cefotaxime solution should, in principle, be administered separately from them.

Cefotaxime is not compatible with:

• sodium bicarbonate solution,
• infusion solutions with a pH greater than 7,
• aminoglycosides.

In general, cefotaxime should not be mixed or administered with other antibiotics or medications in the same syringe. Cefotaxime should not be mixed with aminoglycoside antibiotics in the infusion equipment or syringe.

The duration of treatment depends on the evolution of the disease.

If you use more Cefotaxime Sala than you should

Beta-lactam antibiotics, including cefotaxime, can cause what is called encephalopathy, accompanied by central nervous system excitement, myoclonus, seizures, confusion, altered consciousness, and movement disorders. There is a risk of these adverse effects when high doses are used, in case of overdose, or in patients with impaired kidney function or who suffer from epilepsy or meningitis.

If cefotaxime is injected through a central venous catheter (CVC) too quickly (in less than 1 minute), it can cause a severe cardiac arrhythmia.

If you think you have received too much cefotaxime, talk to your doctor or medical staff immediately. You can also call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount administered.

If you forget to use Cefotaxime Sala

Your doctor or nurse will have instructions on when to administer the medicine, so it is unlikely that you will not receive the medicine following the instructions. If you think you have forgotten a dose, talk to your doctor or nurse.

If you have any other questions about the use of this medicine, ask your doctor, pharmacist, or nurse

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not all people suffer from them.

Stop taking cefotaxime and inform your doctor immediately if you notice any of the following symptoms:

• Seizures (rare, may affect up to 1 in 100 people)

• Frequency not known (cannot be estimated from available data)
  • Severe acute hypersensitivity reactions and life-threatening allergic reactions, as well as swelling (Quincke's edema) and narrowing of the airways (bronchospasm). If you experience chest tightness, or feel dizzy, sick, or weak, these could be signs of a hypersensitivity reaction.
  • Red, non-raised patches, or circular or target-shaped patches on the chest, often with central blisters, skin peeling, 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, toxic epidermal necrolysis).
  • Widespread skin rash, high body temperature, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
  • Widespread, red, and scaly skin rash, with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis).
  • Persistent severe diarrhea or blood in the stool due to possible life-threatening intestinal inflammation.
  • Decrease in red blood cells (hemolytic anemia), change in urine color (to a brownish-red color).
  • Acute kidney failure.

Tell your doctor or nurse if you experience any of the following side effects with an unknown frequency (cannot be estimated from available data):

• Jaundice as a sign of possible hepatitis.
• Severe decrease in white blood cells (agranulocytosis), which can be detected by the appearance of acute signs of infection, as well as inflammation of the oral, nasal, pharyngeal, genital, and anal areas.
• Sharp decrease in the number of all blood cells and bone marrow failure. You may also experience acute signs of infection and inflammation (see above), bleeding, bruising (decrease in platelets), fatigue, paleness, or difficulty breathing (decrease in red blood cells).

Tell your doctor or nurse if any of the following side effects worsen or last more than a few days:

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

• Pain at the injection site, also hardening due to 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)

• Increased blood eosinophils (eosinophilia).
• Decrease in platelets (thrombocytopenia) and certain white blood cells (leukopenia, granulocytopenia).
• Jarisch-Herxheimer reaction (see explanation below).
• Diarrhea.
• Lack of appetite.
• Increased bilirubin (bile pigment in the blood) and liver enzymes in serum (SGOT, SGPT, γ-GT, alkaline phosphatase, LDH).
• Allergic reactions in the form of rash, itching, hives.
• Limitation of renal function, e.g., increased creatinine and urea concentrations in serum.
• Fever.

-Inflammatory reactions at the injection site and vein inflammation (phlebitis/thrombophlebitis).

Frequency not known(cannot be estimated from available data)

• Superinfections by bacteria or fungi (e.g., in the mouth or vagina).
• Decrease in certain white blood cells (neutropenia).
• Tachycardia, cardiac arrhythmia (after rapid administration through a central venous access).
• Excitation of the central nervous system, altered consciousness, confusion, movement disorders, muscle spasms (symptoms of encephalopathy, especially with high doses, in case of overdose, or with impaired renal function).
• Headache.
• Dizziness.
• Nausea, vomiting, abdominal pain.
• Kidney inflammation (interstitial nephritis).
• Intolerance reactions in the form of a feeling of heat or nausea with faster intravenous administration.

Jarisch-Herxheimer reaction:

When starting treatment for spirochetal infections (e.g., Lyme disease), you may experience fever, chills, headache, and joint pain. After several weeks of treatment for Lyme disease, one or more of the following symptoms have been described: rash, itching, fever, decrease in white blood cells, increase in liver enzymes, difficulty breathing, and joint pain. These symptoms partially correspond to the underlying symptoms of the treated patients.

Reporting side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are possible side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Cefotaxime Sala

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date stated on the label after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

Reconstituted solution

The physical and chemical stability of the reconstituted solution (2g/10ml of water for injection) has been demonstrated for 8 hours at 25°C and 24 hours at 2-8°C.

From a microbiological point of view, it is recommended to use the solutions immediately after preparation. If not administered immediately, the time and conditions under which they can be stored will be the responsibility of the user and should not normally exceed 24 hours at 2°C - 8°C, unless the reconstitution has been carried out under controlled and validated aseptic conditions.

6. Package contents and additional information

Composition of Cefotaxima Sala

The active ingredient is cefotaxime. Each vial contains: Cefotaxime 2 g (as cefotaxime sodium).

Appearance of the product and package contents

The powder is white or slightly yellowish in type II glass vials with a bromobutyl stopper and an aluminum cap with a polypropylene cover.

Cefotaxima sala 2 g is available in two formats:

• Package with one vial
• Clinical package with 50 vials

Only some pack sizes may be marketed.

Marketing authorization holder and manufacturer

Holder:

Laboratorio Reig Jofre, S.A.

Gran Capitán, 10 08970 Sant Joan Despí Barcelona, Spain

Manufacturer:

Laboratorio Reig Jofre, S.A. Jarama 111

Toledo 45007, Spain

Date of the last revision of this leaflet: March 2025

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es