Cefotaxime Torlan 2000 mg powder for injection and for infusion EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

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

Cefotaxime (as sodium cefotaxime)

Read the entire leaflet carefully before you start using this 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 and should not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you consider any of the side effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Leaflet contents:

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

1. What Cefotaxima Torlan 2.000 powder for injectable solution and for infusion is and what it is used for

This medicine belongs to a group of antibiotics called cephalosporins.

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

• otorhinolaryngological infections,
• lower respiratory tract infections, including exacerbation of chronic bronchitis and 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 lining the interior of the heart),
• meningitis (except those caused by Listeria) and other central nervous system infections,
• osteoarticular infections,
• skin and soft tissue infections,
• intra-abdominal infections (peritonitis, biliary tract infections).

2. Before using Cefotaxime Torlan 2,000 mg powder for injectable solution and for infusion

Do not use CEFOTAXIME TORLAN 2,000 mg

• If you are allergic or have had any allergic reaction to cefotaxime, other cephalosporins, or any of the components of Cefotaxime Torlan 2,000 mg.
• By intramuscular route.
• If you have ever experienced a severe skin rash, skin peeling, blisters, or mouth sores after taking cefotaxime or other cephalosporins.

Do not use CEFOTAXIME TORLAN 2,000 mg or inform your doctor if any of these apply to you.

Take special care with CEFOTAXIME TORLAN 2,000 mg

• If you are allergic to penicillins and/or antibiotics known as beta-lactams. Consult your doctor if you have ever had any allergic reaction to any medication before starting treatment with Cefotaxime Torlan 2,000 mg.
• If you have previously experienced an immediate allergic reaction to cephalosporins. In case of doubt, the first dose should be administered under medical supervision.
• If you develop diarrhea, especially if it is severe, persistent, and/or bloody during or after treatment with Cefotaxime Torlan 2,000 mg, consult your doctor, as this may be a sign of Clostridium difficile-associated disease.
• Consult your doctor if you experience any discomfort, especially if you are on treatment with Cefotaxime Torlan 2,000 mg for a prolonged period, to rule out infection by resistant organisms (superinfection), or if you develop genital itching/irritation to exclude inflammation in the area due to Candida spp.
• If you require treatment for longer than 10 days, your doctor may consider performing a blood test to rule out the development of neutropenia (reduced number of neutrophil white blood cells).
• Certain tests such as the Coombs test and urine glucose test may yield false-positive results due to treatment with this medicine.
• If you are scheduled for any diagnostic tests (blood tests, urine tests, etc.), inform your doctor that you are being treated with this medicine, as it may alter test results.
• Severe skin reactions have been reported with cefotaxime treatment, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP). Discontinue cefotaxime and seek immediate medical attention if you notice 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 currently using, or have recently used, any other medicines, including those obtained without a prescription, homeopathic remedies, herbal medicines, and other health-related products, as it may be necessary to interrupt treatment or adjust the dose of one of them. Cefotaxime Torlan should not be administered simultaneously with:

• Medicines containing probenecid (used for the treatment of gout), as this increases the blood concentration of cefotaxime.
• Nephrotoxic medicines (those causing kidney toxicity), especially aminoglycosides, as kidney toxicity may be enhanced; therefore, your doctor must monitor kidney function.
• Oral contraceptives, as the use of Cefotaxime Torlan 2,000 mg may reduce their effectiveness.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

During pregnancy, your doctor will decide whether it is appropriate to use this medicine.

Women who are breastfeeding should consult their doctor before using this medicine, as cefotaxime passes into breast milk.

Driving and using machines

No or limited data are available on the effects of Cefotaxime Torlan 2,000 mg on the ability to drive or operate machinery. Avoid performing tasks that require special attention until you know how you tolerate the medicine.

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

Patients on a low-sodium diet should be aware that this medicine contains 101 mg (4.40 mmol) of sodium per dose.

3. How to use Cefotaxime Torlan 2000 mg powder for injectable solution and for infusion

Follow exactly the administration instructions for CEFOTAXIME TORLAN 2000 mg given 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 performed by medical personnel.

Your doctor will indicate the duration of treatment with Cefotaxime Torlan 2000 mg; do not stop your treatment prematurely.

As a general rule, treatment should continue for at least 3 days after the clinical symptoms of infection have disappeared. Remember to request administration of your medication.

The usual dose is:

Adults and adolescents (12 to 18 years): 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. If the dose exceeds 2 g, the presentation CEFOTAXIME TORLAN 2000 mg powder for injectable solution and for infusion EFG is recommended. In these cases, if the daily dose is 4 g, it may be divided into two doses of 2 g each, administered at 12-hour intervals. If higher doses are required, the dosing interval should be shortened.

Paediatric population (under 12 years): 50–150 mg/kg/day depending on the severity of the infection, divided into 2, 3, or 4 doses according to the severity of the infection.

Patients with renal impairment:

In patients with reduced 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.

Haemodialysis patients:

1 to 2 g daily, depending on the severity of the infection. On the day of haemodialysis, Cefotaxime Torlan should be administered after the dialysis session.

If you feel that the effect of Cefotaxime Torlan 2000 mg is too strong or too weak, inform your doctor or pharmacist.

If you use more CEFOTAXIME TORLAN 2000 mg than you should

Contact your doctor immediately or go to the nearest hospital. In case of overdose, particularly in patients with renal impairment, encephalopathy (impaired consciousness, abnormal movements, and convulsions) may occur.

In case of accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount taken.

If you forget to use CEFOTAXIME TORLAN 2000 mg

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

If you stop treatment with CEFOTAXIME TORLAN 2000 mg

Do not discontinue treatment prematurely, as the desired effect may not be achieved. It is very important to treat infections for the recommended duration; otherwise, the infection could worsen.

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

4. Possible adverse effects

Like all medicines, CEFOTAXIME TORLAN 2,000 mg may produce adverse effects, although not everyone will experience them.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effect not listed in this leaflet, inform your doctor or pharmacist.

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

• Red, flat patches or circular or target-like 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).

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

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

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

Common: 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 neutrophil cells (neutropenia) and hemolytic anemia (reduction 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 specific group of white blood cells) and thrombocytopenia (reduction in the number of platelets), both of which reverse rapidly upon discontinuation of treatment.

Immune system disorders:

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

Nervous system disorders:

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

Cardiac disorders:

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

Gastrointestinal disorders:

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

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

Hepatobiliary disorders:

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

Skin and subcutaneous tissue disorders:

Common: rash (exanthema), itching (pruritus), and less frequently, hives and skin irritation and itching (urticaria).
Frequency not known: vesicular eruptions (blister-like skin eruptions), as seen with other antibiotics of this type.

Renal and urinary disorders:

Uncommon: reduced kidney function (increased creatinine), especially if being treated simultaneously with a class of medicines known as aminoglycosides.
A transient increase in blood urea nitrogen has also been observed.
Very rare: interstitial nephritis (allergic-type inflammation of the kidney).

Reproductive system and breast disorders:

Uncommon: candidiasis (fungal infection caused by Candida), vaginitis (inflammation of the vaginal mucosa).

General disorders and administration site conditions:

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

Other:

Fever.

Especially during prolonged treatment, other infections due to organisms not sensitive to Cefotaxime TORLAN (cefotaxime) may occur.

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

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

5. Storage of Cefotaxime Torlan 2,000 mg powder for injectable solution and for infusion

Keep out of the reach and sight of children.

Store in the original container to protect from light.

Do not store above 25°C.

The maximum shelf life after reconstitution of the injectable solution is 3 hours at 25°C.

Do not use CEFOTAXIME TORLAN 2,000 mg after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

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

6. Additional Information

Composition of CEFOTAXIMA TORLAN 2,000 mg

The active substance 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 contents of the container

CEFOTAXIMA TORLAN 2,000 mg is presented as a powder, white or almost white, or slightly yellowish. It is supplied in boxes containing 1 vial with 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 containing 1 vial + 1 ampoule of 2 ml water for injectable preparations. Clinical pack with 100 vials + 100 ampoules.

CEFOTAXIMA TORLAN 1,000 mg powder and solvent for intravenous solution EFG: pack containing 1 vial + 1 ampoule of 4 ml 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 containing 1 vial + 1 ampoule of 4 ml lidocaine hydrochloride solution (40 mg/4 ml). 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 leaflet was last approved in: January 2025

Warning: For use by healthcare professionals only

This information is intended solely for physicians or healthcare professionals:

• Stability of reconstituted cefotaxime solution:

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

A slightly yellow coloration of the solution does not indicate loss of antibiotic efficacy or reduced tolerance. Solutions with a brownish-yellow or brown color must not be administered.

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

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

How to prepare this medicine

Cefotaxima TORLAN 2,000 mg will be administered intravenously according to the following instructions:

Inflammatory reactions of the vein wall and pain at the injection site have been observed with cefotaxime injection; these can be avoided by administering the drug more slowly (over 3 to 5 minutes).

Recently, some cases of life-threatening arrhythmias have been reported in patients who received cefotaxime administered rapidly via central venous catheter; therefore, intravenous administration over 3 to 5 minutes by slow infusion is recommended.

Intravenous route

For intravenous injection: Cefotaxima TORLAN 2,000 mg for intravenous use should be administered by slow intravenous injection over 3 to 5 minutes, after dilution in solvent, either directly into the vein or through the distal end of an infusion line, with the line clamped during administration.

For intravenous infusion:

For rapid infusion, dissolve 2 g of Cefotaxima TORLAN in 40 ml of water for injectable preparations or in a conventional infusion solution, and administer over 20 minutes.

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

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.es/