Cefotaxime Sala 1 g powder for injection solution EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Cefotaxime Sala 1 g powder for injectable solution EFG

Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you personally and you must not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What you need to know before starting to use Cefotaxime Sala

3. How to use Cefotaxime Sala

1. Possible adverse effects

5. Storage of Cefotaxime Sala

Store at room temperature between 15°C and 30°C. Protect from light and moisture. Keep the container tightly closed. Keep out of reach of children. Do not use after the expiration date stated on the label. Keep the medicine in its original packaging to protect from light.

6. Contents of the pack and other information

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 fight bacteria.

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

It is important that you follow your doctor's instructions regarding dose, dosing interval, and duration of treatment.

Do not store or reuse this medicine. If you have leftover antibiotic after completing treatment, return it to the pharmacy for proper disposal. Medicines must not be disposed of via the drain or in household waste.

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

• respiratory tract 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),
• inflammation of the heart (endocarditis),
• Lyme disease (especially stages II and III) (infection mainly caused by tick bites).

In addition, it is indicated for the prevention of infections following surgical procedures in patients at higher risk of infection.

2. What you need to know before using Cefotaxime S.A.L.A. 1 g powder for injectable solution EFG

Do not use Cefotaxime Sala:

• if you are allergic to cefotaxime or to 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 to other beta-lactam antibiotics. Penicillins and cephalosporins may cause cross-reactions.

- if you have ever had a severe skin rash, peeling skin, blisters, or mouth sores after taking cefotaxime or other cephalosporins.

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 section "Do not use Cefotaxima Sala").
• If you have an allergic reaction (e.g., hay fever, bronchial asthma, hives) or if you have a history of such conditions. In this case, you have a higher risk of more severe hypersensitivity reactions (rarely fatal). If you experience chest tightness, dizziness, nausea, or weakness, these may be signs of a hypersensitivity reaction (see section 4).
• If a hypersensitivity reaction occurs, treatment must be discontinued.
• If you develop severe or persistent diarrhoea during treatment or for several weeks after completion. Inform your doctor immediately, as diarrhoea in its most severe form (called pseudomembranous colitis) can be fatal and requires treatment. Do not take any medication that reduces intestinal activity.
• If you know you have renal impairment. Inform your doctor; if necessary, your dose may be adjusted. Your kidney function should be monitored.
• If you are receiving concomitant or subsequent treatment with aminoglycosides (other antibiotics), probenecid (for gout), or other medicines that may cause kidney damage. A doctor should monitor your kidney function, as these substances may increase harmful effects on the kidneys and require caution.
• If you experience movement disorders, seizures, confusion, or altered consciousness. These may be signs of what is called encephalopathy. There is a risk of these adverse effects occurring when high doses are administered, in cases of overdose, or if you have renal impairment. If these reactions occur, consult your doctor immediately.
• If your treatment lasts longer than 7 to 10 days. In this case, blood tests should be performed to monitor for possible blood changes (see also section 4).
• If you show signs of a new infection (e.g., fungal infection of mucous membranes with redness and a whitish surface). The use of antibiotics may increase the number of pathogens not sensitive to the medicine used. Watch for signs of a new infection and inform your doctor if necessary.

Take special care with Cefotaxima Sala

Serious 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 in association with cefotaxime treatment. Stop taking cefotaxime and seek immediate medical attention if you notice any of the symptoms described in section 4 related to these serious skin reactions.

Other medicines and Cefotaxima Sala

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine.

Other antibiotics

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

Diuretics and medicines possibly harmful to the kidneys

When cefotaxime is used together with medicines that may have a harmful effect on the kidneys, such as aminoglycosides (other antibiotics) or medicines with a high potential to cause dehydration (diuretics, such as furosemide), the nephrotoxic effect of these medicines may be increased. If administered concomitantly, renal function should be monitored (see section 2 "Warnings and precautions").

Probenecid

Concomitant administration of probenecid leads to increased serum concentrations of cefotaxime and thus prolongs its effect, as probenecid limits the renal elimination of cefotaxime. Inform your doctor if you are taking probenecid, especially if you have renal impairment, so that your dose may be adjusted if necessary.

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 studies did not show signs of teratogenic effects of cefotaxime.

Nevertheless, cefotaxime should only be used during pregnancy, especially during the first trimester, after a strict assessment 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 disturbances in intestinal flora leading to diarrhoea, fungal overgrowth, and may also cause sensitization. The doctor will decide whether to discontinue breastfeeding or discontinue treatment with cefotaxime, taking into account the benefit of breastfeeding for the child and the benefit of treatment for the mother.

Driving and use of machines

Based on previous experience, cefotaxime at low and medium doses has no effect on concentration or reaction ability.

If you experience adverse effects such as dizziness or encephalopathy, which may be associated with seizures, confusion, altered consciousness, or movement disorders, you should not drive or operate machinery.

Cefotaxima Sala contains sodium

This medicine contains 50.6 mg (2.20 mmol) of sodium per dose, equivalent to 2.5% of the maximum daily recommended dietary intake of sodium for an adult.

3. How to use Cefotaxime Sala

Follow exactly the instructions for administering this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist. Cefotaxime will be administered intravenously or intramuscularly. Remember to use your medicine as prescribed.

Your doctor will determine the appropriate dose, the duration of treatment, and the route of administration; do not stop or extend the treatment prematurely.

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

Unless otherwise directed by the physician, the recommended dosage is:

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

The following table may be considered as a dosage guideline:

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 higher dose may be required. Before starting treatment, test 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 pathogenic microorganisms may require a higher dose. Before initiating treatment, test 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 divided doses (2 g of cefotaxime 3 times daily), but in some cases it has been administered as 2 divided doses (3 g of cefotaxime twice daily). Dosing recommendations are not based on comparative clinical trials but on observations from individual patients.

Combination therapy

In severe infections posing a life-threatening risk, combination therapy with cefotaxime and aminoglycosides is indicated, even without prior antibiogram. When combined with aminoglycosides, renal function must be monitored.

In infections caused by Pseudomonas aeruginosa, combination therapy with other antibiotics effective against Pseudomonas may also be indicated.

For infection prophylaxis in patients with weakened immune systems, combination therapy with other appropriate antibiotics may also be indicated.

Infants and children up to 12 years of age receive 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 should be divided into 2 or more equal divided doses administered at intervals of 12 (to 6) hours. In individual cases, especially in life-threatening situations, the daily dose may be increased to 200 mg of cefotaxime per kilogram of body weight.

In premature infants, it must be considered that renal 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 renal impairment (creatinine clearance less than 10 ml/min), after the initial normal dose (the first dose at the beginning of treatment), the maintenance dose may be reduced to half the normal dose, maintaining the same dosing interval.

Patients undergoing 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.

Patients undergoing 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 1g is administered intravenously (into a vein), but may also be administered intramuscularly.

Elderly patients

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

Intravenous injection

For intravenous administration, dissolve 1 g of cefotaxime in at least 4 ml of water for injections and administer slowly intravenously over a period of 3 to 5 minutes.

Intravenous infusion

Use the 2-gram formulation.

Intramuscular injection

For intramuscular injection, dissolve 1 g of cefotaxime in 4 ml of water for injections. The injection should then be administered deeply into the gluteal muscle. It is recommended not to inject more than 4 ml on one side. If the daily dose exceeds 2 g of cefotaxime or if cefotaxime is injected more than twice daily, intravenous administration is recommended. Intramuscular injection with water for injections may be painful.

Compatibility

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

Cefotaxime is incompatible with:

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

In general, cefotaxime should not be mixed or administered together with other antibiotics or medications in the same syringe. Cefotaxime must not be mixed with aminoglycoside antibiotics in an infusion set or in a syringe.

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

If you use more Cefotaxima Sala than you should

Beta-lactam antibiotics, including cefotaxime, may cause so-called encephalopathies, accompanied by central nervous system excitation, myoclonus, seizures, confusion, altered consciousness, and movement disorders. This risk exists when higher doses are used, in cases of overdose, and in patients with impaired renal function or who have epilepsy or meningitis.

If cefotaxime is injected too rapidly via a central venous catheter (CVC) (in less than 1 minute), it may cause a serious cardiac arrhythmia.

If you think you have received too much cefotaxime, speak immediately with your doctor or medical staff. You may also call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount administered.

If you forget to use Cefotaxima Sala

Your doctor or nurse will have instructions on when to administer the medication, so it is unlikely that the medication will not be administered according to instructions. If you think a dose has been missed, speak with your doctor or nurse.

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

4. Possible adverse effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

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

• Seizures (uncommon, 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, including swelling (angioedema) and narrowing of the airways (bronchospasms). If you experience chest tightness, or feel dizzy, sick, or weak, these could be signs of a hypersensitivity reaction.
• Non-elevated reddish patches, or circular or target-shaped rashes on the chest, often with central blisters, skin peeling, and ulcers in the mouth, throat, nose, genitals, and eyes. These serious skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Widespread skin rash, high body temperature, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
• Generalized red, scaly rash with lumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).
• Persistent severe diarrhoea or blood in the stools due to possible life-threatening intestinal inflammation.
• Decrease in red blood cells (haemolytic anaemia), change in urine colour (to reddish-brown).
• Acute kidney failure.

Inform your doctor or nurse if you experience any of the following side effects with a frequency not known (cannot be estimated from available data):

• Jaundice as a sign of possible hepatitis.
• Severe decrease in white blood cells (agranulocytosis), which may be detected by sudden signs of infection, as well as inflammation of the oral, nasal, pharyngeal, genital, and anal areas.
• Marked decrease in all blood cells and bone marrow failure. Acute signs of infection and inflammation (see above), bleeding, bruising (due to decreased platelets), fatigue, paleness, or difficulty breathing (due to decreased red blood cells) may also occur.

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

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

• Pain at the injection site, including 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 eosinophils (eosinophilia).
• Decrease in platelet count (thrombocytopenia) and certain white blood cells (leucopenia, granulocytopenia).
• Jarisch-Herxheimer reaction (see explanation below).
• Diarrhoea.
• Loss of appetite.
• Increase in bilirubin (a bile pigment in the blood) and liver enzymes in serum (SGOT, SGPT, γ-GT, alkaline phosphatase, LDH).
• Allergic reactions such as rash, itching, hives.
• Impaired kidney function, e.g., increased serum creatinine and urea concentrations.
• Fever.

• Inflammatory reactions at the injection site and inflammation of veins (phlebitis/thrombophlebitis).

Frequency not known (cannot be estimated from available data)

• Secondary infections by bacteria or fungi (e.g., in the mouth or vagina).
• Decrease in certain white blood cells (neutropenia).
• Tachycardia, cardiac arrhythmia (after rapid administration via a central venous access).
• Central nervous system excitation, altered consciousness, confusion, movement disorders, muscle spasms (encephalopathy symptoms, especially with high doses, overdose, or impaired renal function).
• Headache.
• Dizziness.
• Nausea, vomiting, abdominal pain.
• Kidney inflammation (interstitial nephritis).
• Intolerance reactions such as sensation of warmth 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 reported: rash, itching, fever, decreased white blood cells, increased liver enzymes, difficulty breathing, and joint pains. These symptoms partially correspond to the underlying disease symptoms in treated patients.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting side effects, you can help provide 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 expiry date stated on the label after EXP. The expiry date refers to the last day of the month indicated.

Store in the original packaging to protect from light.

Do not store above 25°C.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

Reconstituted solution

The physical and chemical stability of the reconstituted solution (1 g/4 ml of water for injection) has been demonstrated for 8 hours at 25°C and 24 hours at 2-8°C.

From a microbiological standpoint, it is recommended that solutions be used immediately after preparation. If not administered immediately, the duration and conditions of storage prior to use are the responsibility of the user and should normally not exceed 24 hours at 2°C - 8°C, unless reconstitution has been carried out under controlled and validated aseptic conditions.

6.

Composition of Cefotaxime Sala

The active substance is cefotaxime. Each vial contains: Cefotaxime 1 g (as sodium cefotaxime).

Appearance of the product and contents of the container

The powder is white or slightly yellowish in 1 g vials made of type II glass, with a bromobutyl stopper and an aluminum cap with polypropylene covering.

Cefotaxime Sala 1 g is available in two pack sizes:

• Package containing one vial
• Clinical pack containing 100 vials

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Headquarters:

Laboratorio Reig Jofre, S.A.

Gran Capitán, 10
08970 Sant Joan Despí
Barcelona, Spain

Manufacturer:

Reig Jofre, S.A. Jarama 111

Toledo 45007. Spain

Date of the most recent review of this leaflet: March 2025

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