CEFOTAXIME TORLAN 2000 mg POWDER FOR INJECTION AND INFUSION SOLUTION

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

CEFOTAXIMA TORLAN 2,000 mg powder for solution for injection and infusion EFG

Cefotaxime (as cefotaxime sodium)

Read all of this leaflet carefully before you start using this medicine.

• 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, do not pass it on to others, as it may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the pack:

1. What CEFOTAXIMA TORLAN 2,000 mg powder for solution for injection and infusion is and what it is used for
2. Before you use CEFOTAXIMA TORLAN 2,000 mg powder for solution for injection and infusion
3. How to use CEFOTAXIMA TORLAN 2,000 mg powder for solution for injection and infusion
4. Possible side effects
5. Storage of CEFOTAXIMA TORLAN 2,000 mg powder for solution for injection and infusion
6. Further information

1. What is Cefotaxima Torlan 2,000 powder for solution for injection and infusion and what is it used for

This medicine belongs to a group of antibiotics called cephalosporins.

Cefotaxima TORLAN 2,000 mg is indicated for infections caused by germs sensitive to cefotaxime, such as:

• Ear, nose, and throat infections,
• Lower respiratory tract infections, including exacerbation of chronic bronchitis, bacterial pneumonia,
• Kidney 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 lining the inside of the heart),
• Meningitis (except those caused by Listeria) and other central nervous system infections,
• Osteoarticular infections,
• Skin and soft tissue infections,
• Abdominal cavity infections (peritonitis, infections of the bile ducts).

2. Before using Cefotaxima Torlan 2,000 mg powder for solution for injection and infusion

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.
• Via intramuscular route.
• If you have ever suffered from a severe skin rash, skin peeling, blisters, or sores in the mouth after taking cefotaxime or other cephalosporins.

Do not use CEFOTAXIMA TORLAN 2,000 mg or inform your doctor if any of the following apply to you.

Be cautious with CEFOTAXIMA TORLAN 2,000 mg

• If you are allergic to penicillins and/or beta-lactam antibiotics. Consult your doctor if you have had any type of 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 carried out in the presence of a doctor.
• In case of 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 disease associated with the germ Clostridium difficile.
• Consult your doctor if you experience any discomfort, especially if you are being treated with Cefotaxima TORLAN 2,000 mg for a long time, to rule out another infection by resistant germs (superinfection), or if you experience itching/irritation in the genital area to rule out inflammation in the area due to the germ Candida spp.
• If you need to be treated for 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 cells).
• Some tests, such as the Coombs test and glucosuria, may be positive without being so, due to treatment with this medicine.
• If you are going to undergo any diagnostic tests (blood tests, urine tests...), inform your doctor that you are being treated with this medicine, as it may alter the results.
• Severe skin reactions, such as Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP), have been reported in association with cefotaxime treatment. Stop using cefotaxima and seek immediate medical attention if you observe any of the symptoms described in section 4 related to these severe skin reactions.

Use of other medicines

Inform your doctor or pharmacist if you are using, or have recently used, other medicines, including those obtained without a prescription, homeopathic medicines, herbal remedies, 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:

• medicines whose active ingredient is probenecid (for the treatment of gout), as the concentration of cefotaxime in the blood increases.
• with nephrotoxic medicines (which produce kidney toxicity), especially aminoglycosides, as kidney toxicity is potentiated, and your doctor should monitor kidney function.
• oral contraceptives, as the use of Cefotaxima TORLAN 2,000 mg may reduce their effectiveness.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

In case of pregnancy, your doctor will decide whether to use this medicine.

Breastfeeding women should consult their doctor before using this medicine, as cefotaxime passes into breast milk.

Driving and using machines

It is not known whether Cefotaxima TORLAN 2,000 mg affects the ability to drive or operate machinery, so avoid tasks that require special attention until you know how you tolerate the medicine.

Important information about some of the components of CEFOTAXIMA TORLAN 2,000 mg

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

3. How to use Cefotaxima Torlan 2,000 mg powder for solution for injection and infusion

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

This medicine can be administered intravenously by slow injection or infusion.

Remember that administration must be carried out by medical personnel.

Your doctor will indicate the duration of treatment with Cefotaxima TORLAN 2,000 mg; do not suspend treatment before completing it.

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

The usual dose is:

Adults and adolescents (12 to 18 years old):the usual dosage is 1 g of cefotaxime every 12 hours.

In severe cases, the daily dose may be increased up to 12 g. If the dose is higher than 2 g, the presentation CEFOTAXIMA TORLAN 2,000 mg powder for solution for injection and infusion EFG 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 (under 12 years old):depending on 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 impairment:

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

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

Hemodialyzed patients:

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

If you think the effect 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 impairment, encephalopathy (deterioration of consciousness, abnormal movements, and convulsions) may occur.

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

If you forget to use CEFOTAXIMA TORLAN 2,000 mg

Do not use a double dose to make up for forgotten doses.

If you stop treatment with CEFOTAXIMA TORLAN 2,000 mg

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

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

4. Possible side effects

Like all medicines, CEFOTAXIMA TORLAN 2,000 mg can cause side effects, although not everyone gets them.

If you think any of the side effects you are experiencing is serious, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

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

• Red 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 can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).

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

• Generalized skin rash, red and scaly, with bumps under the skin and blisters, accompanied by fever. The symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis).

The following side effects have been reported with the following frequencies:

Frequent:at least 1 in 100 patients

Uncommon: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 not known:cannot be estimated from available data

Blood and lymphatic system disorders:

Rare:decrease in the number of white blood cells (neutropenia) and hemolytic anemia (decrease in the number of red blood cells in the blood).

Very rare:decrease in granulocytes (agranulocytosis), particularly if cefotaxime is administered for prolonged periods.

Frequency not known:eosinophilia (increase in a certain group of white blood cells) and thrombocytopenia (reduction in the number of platelets), which are rapidly reversible when treatment is discontinued.

Immune system disorders:

Very rare:allergic skin reactions and severe allergic reactions that can cause difficulty breathing and even loss of consciousness (anaphylaxis), which can lead to anaphylactic shock (a severe allergic reaction that can be life-threatening).

Nervous system disorders:

Uncommon:at high doses, particularly in patients with renal impairment, encephalopathy (deterioration of consciousness, abnormal movements, and convulsions) may occur.

Cardiac disorders:

Frequency not known:arrhythmia (changes in heart rhythm) in case of rapid central intravenous injection.

Gastrointestinal disorders:

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

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

Hepatobiliary disorders:

Uncommon:increase in 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 (exanthema), itching (pruritus), and less frequently, hives, skin irritation, and itching (urticaria).

Frequency not known:vesicular eruptions (skin rashes in the form of blisters), as with other antibiotics of this type.

Renal and urinary disorders:

Uncommon:decreased kidney function (increased creatinine), especially if treated simultaneously with a type of medicine called aminoglycosides.

Transient elevation of urea nitrogen has also been observed.

Very rare:interstitial nephritis (allergic-type kidney inflammation).

Reproductive system and breast disorders:

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

General disorders and administration site conditions:

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

Others:

Fever.

Especially in the case of prolonged treatments, other infections due to organisms not sensitive to Cefotaxima TORLAN (cefotaxime) may appear.

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

If you think any of the side effects you are experiencing is serious, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

5. Storage of Cefotaxima Torlan 2,000 mg powder for solution for injection and infusion

Keep out of the reach and sight of children.

Store in the original package to protect from light.

Do not store 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 stated on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need in the SIGRE point of your usual pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Additional Information

Composition of CEFOTAXIMA TORLAN 2,000 mg

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 injectable preparations.

Appearance of the Product and Packaging Contents

CEFOTAXIMA TORLAN 2,000 mg is presented in the form of a powder, white or almost white, or slightly yellowish in color. It is presented in packs with 1 vial containing 2,000 mg of cefotaxime powder and clinical packs with 100 vials.

Other Presentations

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

CEFOTAXIMA TORLAN 1,000 mg powder and solvent for intravenous injectable solution EFG: pack with 1 vial + 1 ampoule of 4 ml of water for injectable preparations. Clinical pack with 100 vials + 100 ampoules.

CEFOTAXIMA TORLAN 1,000 mg powder and solvent for intramuscular injectable solution EFG: pack with 1 vial + 1 ampoule of 4 ml of lidocaine hydrochloride solution (40mg/4ml). Clinical pack with 100 vials + 100 ampoules.

Marketing Authorization Holder and Manufacturer

LDP-LABORATORIOS TORLAN, S.A.

Ctra. de Barcelona, 135-B

08290 Cerdanyola del Vallès

Barcelona

This prospectus was approved in: January 2025

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Warning: For use exclusively by a healthcare professional

This information is intended only for doctors or healthcare professionals:

• Stability of the reconstituted cefotaxime solution:

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°C.

The slightly yellowish color of the solution does not indicate a change in the efficacy of the antibiotic or its tolerance. Solutions with a brown or dark yellow color should not be administered.

The stability of the cefotaxime solution at a concentration of 1g/250 ml is satisfactory in the following perfusion 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 injection of cefotaxime, inflammatory reactions of the venous wall and pain at the injection site have been observed, which can be avoided with slower administration (3 to 5 minutes).

Recently, some cases of life-threatening arrhythmias have been reported in patients who received cefotaxime intravenously through a central venous catheter, so its administration is recommended intravenously over 3 to 5 minutes.

Intravenous Route

For intravenous injection: CEFOTAXIMA TORLAN 2,000 mg intravenously is administered slowly over 3 to 5 minutes, after dilution in solvent, directly into the vein or through the distal end of the perfusion tube, after clamping it.

For intravenous perfusion:

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

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

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