PATIENT INFORMATION LEAFLET

CEFOTAXIME TORLAN 2,000 mg powder for injection and for infusion EFG

Cefotaxime (as cefotaxime sodium)

Read this leaflet carefully before you start using the medicine.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others even if their symptoms are the same. It may harm them.
• If you think you have suffered a side effect, you can help us by reporting it directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

This medication belongs to a group of antibiotics called cephalosporins.

Cefotaxima TORLAN 2.000 mg is indicated for infections caused by germs sensitive to cefotaxima such as:

• otolaryngological infections,
• lower respiratory tract infections, including worsening of chronic bronchitis, bacterial pneumonia,
• renal and urinary tract infections,
• genital infections (pelvic inflammatory disease, prostatitis, gonorrhea),
• septicemia/bacteremia (infection due to the presence of bacteria in the blood),
• endocarditis (inflammation of the membrane that lines the inside of the heart),
• meningitis (except those caused by Listeria) and other central nervous system infections,
• ostearticular infections,
• skin and soft tissue infections,
• abdominal cavity infections (peritonitis, biliary tract infections).

Do not use CEFOTAXIMA TORLAN 2.000 mg

• If you are allergic or have had an allergic reaction to cefotaxime, other cephalosporins, or any of the components of Cefotaxima TORLAN 2.000 mg.
• By intramuscular route.
• If you have ever had a severe skin rash or peeling of the skin, blisters, or mouth sores after taking cefotaxime or other cephalosporins.

Do not use CEFOTAXIMA TORLAN 2000 mg or inform your doctor if any of them affect you.

Be especially careful with CEFOTAXIMA TORLAN 2.000 mg

• If you are allergic to penicillins and/or beta-lactam antibiotics. Consult your doctor if you have had an allergy to any medication before starting treatment with Cefotaxima TORLAN 2.000 mg.
• If you have had an immediate allergic reaction to cephalosporins. In case of doubt, the first administration should be made in the presence of a doctor.
• If you have diarrhea, especially if it is severe, persistent, and/or bloody during or after treatment with Cefotaxima TORLAN 2.000 mg, consult your doctor as it may be a symptom of an associated disease caused by the germ Clostridium difficile.
• Consult your doctor if you experience any discomfort, especially if you have been treated with Cefotaxima TORLAN 2.000 mg for a long time, to rule out another infection by resistant germs (superinfection), or if you have itching/irritation in the genitals to rule out an inflammation in the area due to the germ Candida spp.
• If you need to be treated for a period of more than 10 days, it is likely that your doctor will consider the convenience of a blood test to rule out the appearance of neutropenia (decrease in the number of white blood cell neutrophils).
• Some tests such as the Coombs test and glucosuria may be positive without actually being so, due to treatment with this medication.
• If you are going to undergo any diagnostic test (blood test, urine...) inform your doctor that you are being treated with this medication as it may alter the results.
• Severe skin reactions, such as Stevens-Johnson syndrome, toxic epidermal necrolysis, drug-induced eosinophilia, and systemic symptoms (DRESS), generalized acute pustular exanthema (PEGA), have been associated with cefotaxime treatment. Stop using cefotaxime and seek medical attention immediately if you observe any of the symptoms described in section 4 related to these severe skin reactions.

Use of other medications

Inform your doctor or pharmacist if you are using, or have recently used other medications, including those purchased without a prescription, homeopathic, herbal, and other health-related products, as it may be necessary to interrupt treatment or adjust the dose of one of them. Cefotaxima TORLAN should not be administered simultaneously with:

• Medications whose active ingredient is probenecid (for the treatment of gout) as it increases the concentration of cefotaxime in the blood.
• Nephrotoxic medications (which produce kidney toxicity), especially aminoglycosides, as it potentiates kidney toxicity, so your doctor should monitor your kidney function.
• Oral contraceptives, as the use of Cefotaxima TORLAN 2.000 mg may reduce their effectiveness.

Pregnancy and lactation

Consult your doctor or pharmacist before using any medication.

If you are pregnant, your doctor will decide whether to use this medication.

Women in lactation should consult their doctor before using this medication, as cefotaxime passes into breast milk.

Driving and operating machinery

No information is available or known about how Cefotaxima TORLAN 2.000 mg affects driving or operating machinery. Be careful not to perform tasks that may require special attention until you know how you tolerate the medication.

Important information about some of the components of CEFOTAXIMA TORLAN 2.000 mg

Patients with low-sodium diets should note that this medication contains 101 mg (4.40 mmol) of sodium per dose.

Follow exactly the administration instructions for CEFOTAXIMA TORLAN 2,000 mg indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

This medication can be administered intravenously through slow injection or infusion.

Remember that administration must be performed by medical personnel.

Your doctor will indicate the duration of treatment with Cefotaxima TORLAN 2,000 mg, do not discontinue treatment before.

As a general rule, treatments should be prolonged for at least 3 days after the disappearance of clinical symptoms of the infection. Remember to request the administration of your medication.

The normal dose is:

Adults and adolescents (12 to 18 years):The usual dosing regimen is 1 g of cefotaxime every 12 hours.

In severe cases, the daily dose can be increased up to 12 g. If the dose is greater than 2 g, the CEFOTAXIMA TORLAN 2,000 mg powder for injectable solution and for infusion EFG presentation is recommended. In these cases, if the daily dose is 4 g, it can be divided into 2 doses of 2 g each, administered at 12-hour intervals. If higher doses are necessary, the interval should be reduced.

Pediatric population (less than 12 years):According to the severity of the infection, 50-150 mg/kg/day divided into 2, 3, or 4 doses depending on the severity of the infection.

Patients with renal insufficiency:

In patients with decreased renal function, the maintenance dose should be reduced to half.

The initial dose depends on the sensitivity of the pathogen and the severity of the infection.

Patients undergoing hemodialysis:

1 to 2 g per day, depending on the severity of the infection. Cefotaxima TORLAN should be administered after the dialysis session on the day of hemodialysis.

If you estimate that the action of Cefotaxima TORLAN 2,000 mg is too strong or too weak, inform your doctor or pharmacist.

If you use more CEFOTAXIMA TORLAN 2,000 mg than you should:

Consult your doctor immediately or go to the nearest hospital. In case of overdose, particularly in patients with renal insufficiency, encephalopathy (deterioration of consciousness, abnormal movements, and seizures) could occur.

In case of accidental ingestion, consult your doctor or pharmacist or call the Toxicological Information Service. Telephone 91 562 04 20 indicating the medication and the amount used.

If you forgot to use CEFOTAXIMA TORLAN 2,000 mg:

Do not use a double dose to compensate for the missed doses.

If you interrupt treatment with CEFOTAXIMA TORLAN 2,000 mg:

Do not discontinue treatment before completing it, as the desired effect will not be achieved. It is very important to treat infections for the recommended time, otherwise, it could worsen.

If you have any other doubts about the use of this product, ask your doctor or pharmacist.

Like all medicines, CEFOTAXIMA TORLAN 2.000 mg may cause side effects, although not everyone will experience them.

If you consider that any of the side effects you experience are severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Stop using cefotaxima and inform your doctor immediately if you observe any of the following symptoms:

• Flat red patches, or circular or target-shaped patches on the chest, often with central blisters, skin peeling, mouth ulcers, throat ulcers, nasal ulcers, genital ulcers, and eye ulcers. These severe skin eruptions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).

• Generalized skin eruption, elevated body temperature, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

• Generalized red, scaly skin eruption, with lumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized pustular exanthema).

The following side effects have been reported according to the frequencies detailed below:

Frequent: at least 1 in 100 patients

Occasional: at least 1 in 1,000 patients

Rare: at least 1 in 10,000 patients

Very rare: less than 1 in 10,000 patients

Frequency unknown: cannot be estimated from available data

Blood and lymphatic system disorders:

Rare:Decreased white blood cell count (neutropenia) and hemolytic anemia (decreased red blood cell count).

Very rare:Decreased granulocytes (agranulocytosis), particularly if cefotaxima is administered for prolonged periods.

Frequency unknown:Eosinophilia (increased eosinophil count) and thrombocytopenia (decreased platelet count), reversible when treatment is discontinued.

Immune system disorders:

Very rare:Allergic reactions in the skin and severe allergic reaction with difficulty breathing and even loss of consciousness (anaphylaxis) that can lead to anaphylactic shock (severe allergic reaction that can be life-threatening).

Nervous system disorders:

Occasional:At high doses, particularly in patients with renal insufficiency, encephalopathy (deterioration of consciousness, abnormal movements, and seizures) may occur.

Cardiac disorders:

Frequency unknown:Arrhythmia (changes in heart rhythm) in case of rapid intravenous central injection.

Gastrointestinal disorders:

Frequent:Nausea, vomiting, abdominal pain, or diarrhea.

Diarhea may be a symptom of enterocolitis (inflammation of the small intestine and colon) in some cases, which may be accompanied by blood in stool. There is a particular form of enterocolitis that can occur with antibiotics.

Hepatobiliary disorders:

Occasional:Increased liver enzymes and/or bilirubin. Hepatitis (inflammation of the liver) with yellowing of the skin, mucous membranes, or eyes.

Skin and subcutaneous tissue disorders:

Frequent:Rash, pruritus, and with lower frequency, urticaria, skin irritation, and pruritus.

Frequency unknown:Vesicular eruptions (skin eruptions in the form of blisters), as with other antibiotics of this type.

Renal and urinary disorders:

Occasional:Decreased kidney function (increased creatinine) especially if treated simultaneously with a type of medication called aminoglycosides.

Transient elevation of urea nitrogen has also been observed.

Very rare:Interstitial nephritis (allergic type kidney inflammation).

Reproductive and breast disorders:

Occasional:Candidiasis (infection by Candida-type fungi), vaginitis (inflammation of the vaginal mucosa).

General disorders and administration site conditions:

Frequent:Venous wall inflammation and pain at the injection site, which can be prevented by administering Cefotaxima TORLAN more slowly (3 to 5 minutes).

Other:

Fever.

Especially in the case of prolonged treatments, other infections due to non-susceptible organisms may appear (cefotaxima).

In the case of borreliosis (borrelia infection) treatment, a Jarisch-Herxheimer reaction (inflammatory reaction) may occur in the first few days, and after several weeks, symptoms similar to those of the disease may appear.

If you consider that any of the side effects you experience are severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Keep out of reach and sight of children.

Store in the original container to protect it from light.

Do not store at a temperature above 25°C.

The maximum validity period once the injectable is reconstituted is 3 hours at 25°C.

Do not use CEFOTAXIMA TORLAN 2.000 mg after the expiration date that appears on the container after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Deposit the containers and medicines you no longer need at the SIGRE collection point of your usual pharmacy. Ask your pharmacist how to dispose of the containers and medicines you no longer need. In this way, you will help protect the environment.

Cefotaxima TORLAN 2.000 mg Composition

The active ingredient is cefotaxime (as cefotaxime sodium).

Each vial contains 2.000 mg of cefotaxime (as cefotaxime sodium).

The other components are: water for injection preparations.

Product Appearance and Packaging Contents

Cefotaxima TORLAN 2.000 mg is presented in the form of powder, white or almost white, or slightly yellowish. It is presented in boxes with 1 vial with 2.000 mg of cefotaxime powder and clinical packaging with 100 vials.

Other Presentations

Cefotaxima TORLAN 500 mg powder and solvent for injectable solution EFG: box with 1 vial + 1 ampoule of 2 ml of water for injection preparations. Clinical packaging with 100 vials + 100 ampoules.

Cefotaxima TORLAN 1.000 mg powder and solvent for intravenous injectable solution EFG: box with 1 vial + 1 ampoule of 4 ml of water for injection preparations. Clinical packaging with 100 vials + 100 ampoules.

Cefotaxima TORLAN 1.000 mg powder and solvent for intramuscular injectable solution EFG: box with 1 vial + 1 ampoule of 4 ml of lidocaine hydrochloride solution (40mg/4ml). Clinical packaging with 100 vials + 100 ampoules.

Marketing Authorization Holder and Responsible Manufacturer

LDP-LABORATORIOS TORLAN, S.A.

Barcelona, 135-B

08290 Cerdanyola del Vallès

Barcelona

This leaflet was approved in: January 2025

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Warning: To be used exclusively by a healthcare professional

This information is intended solely for doctors or healthcare professionals:

• Cefotaxime solution stability after reconstitution:

After reconstitution, cefotaxime can be stored for up to 3 hours at a temperature below +25° C and up to 6 hours between +2 and +8°.

The slightly yellowish color of the solution does not indicate a change in the efficacy of the antibiotic, nor in its tolerance. Solutions with a yellowish-brown or brown color should not be administered.

The stability of the cefotaxime solution at a concentration of 1g/250 ml is satisfactory in the following infusion liquids:

• Sodium chloride 0.9%
• Glucose 5%
• Ringer's solution
• Sodium lactate

How to prepare this medication

Cefotaxima TORLAN 2.000 mg will be administered intravenously according to the following instructions:

With the cefotaxime injection, inflammatory reactions of the venous wall and pain at the injection site have been observed, which can be avoided by administering it more slowly (3 to 5 minutes).

Recently, some cases of arrhythmia that pose a threat to life have been reported in patients to whom cefotaxime was administered intravenously quickly through a central venous catheter, so it is recommended to administer it intravenously slowly over 3 to 5 minutes.

Intravenous Route

For intravenous injection:Cefotaxima TORLAN 2.000 mg intravenous is administered intravenously slowly over 3 to 5 minutes, after dilution in a solvent, directly into the vein or through the distal end of the perfusion tube, after pinching the same.

For intravenous perfusion:

For a rapid perfusion, 2 g of Cefotaxima TORLAN will be dissolved in 40 ml of water for injection preparations or in a conventional perfusion solution and will be perfused over a period of 20 minutes.

For a slow perfusion, 2 g of Cefotaxima TORLAN will be dissolved in 100 ml of isotonic saline solution or glucose and will be perfused over 50 to 60 minutes (other perfusion solutions may also be used, except those containing sodium bicarbonate).

Further detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.es/