Cefotaxime Torlan 1000 mg powder and solvent for injectable solution IM EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

CEFOTAXIME TORLAN 1,000 mg powder and solvent for injectable solution for intramuscular injection EFG

Cefotaxime (as cefotaxime sodium)

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, consult your doctor or pharmacist.
• This medicine has been prescribed for you; do not give it to others, even if they have the same symptoms, as it may 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 1,000 mg powder and solvent for injectable solution for intramuscular injection is and what it is used for
2. Before you use CEFOTAXIME TORLAN 1,000 mg powder and solvent for injectable solution for intramuscular injection
3. How to use CEFOTAXIME TORLAN 1,000 mg powder and solvent for injectable solution for intramuscular injection
4. Possible side effects
5. How to store CEFOTAXIME TORLAN 1,000 mg powder and solvent for injectable solution for intramuscular injection
6. Further information

1. What Cefotaxime Torlan 1,000 mg powder and solvent for injectable solution is and what it is used for

Cefotaxime belongs to a group of antibiotics called cephalosporins.

Cefotaxime TORLAN 1,000 mg intramuscular is indicated for infections caused by microorganisms sensitive to cefotaxime, such as:

• otolaryngological infections,
• lower respiratory tract infections, including exacerbation 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 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,
• abdominal cavity infections (peritonitis, biliary tract infections).

2. Before using Cefotaxima Torlan 1,000 mg powder and solvent for intramuscular injectable solution

Do not use CEFOTAXIMA TORLAN 1,000 mg intramuscular

• If you are allergic or have had an allergic reaction to cefotaxime, other cephalosporins, or any of the components of Cefotaxima TORLAN 1,000 mg intramuscular.
• If you are allergic or have had an allergic reaction to lidocaine or other amide-type local anesthetics.
• If you have been diagnosed with severe heart failure or uncontrolled atrioventricular block.
• In children under 30 months of age.
• By intravenous 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 CEFOTAXIMA TORLAN 1,000 mg or inform your doctor if any of these apply to you.

Take special care with CEFOTAXIMA TORLAN 1,000 mg intramuscular

• If you are allergic to penicillins and/or antibiotics known as beta-lactams. Consult your doctor if you have ever had an allergic reaction to any medication before starting treatment with Cefotaxima TORLAN 1,000 mg intramuscular.
• 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 Cefotaxima TORLAN 1,000 mg intramuscular, consult your doctor, as this may be a symptom of Clostridium difficile-associated disease.
• Consult your doctor if you experience any discomfort, especially if you are undergoing prolonged treatment with Cefotaxima TORLAN 1,000 mg intramuscular, to rule out infection by resistant organisms (superinfection), or if you experience 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 neutropenia (decreased number of neutrophil white blood cells).
• Some laboratory tests, such as the Coombs test and urine glucose testing, may yield false-positive results due to treatment with this medicine.
• If you are scheduled to undergo any diagnostic tests (blood, urine, etc.), inform your doctor that you are being treated with this medicine, as it may alter test results.
• 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 with cefotaxime treatment. Discontinue cefotaxime and seek immediate medical attention if you notice any of the symptoms described in section 4 related to these serious skin reactions.

Use of other medicines

Inform your doctor or pharmacist if you are currently using, or have recently used, any other medicines, including over-the-counter products, 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. Cefotaxima TORLAN should not be administered simultaneously with:

• Medicines containing probenecid (used to treat gout), as this increases the blood concentration of cefotaxime.
• Nephrotoxic medicines (those causing kidney toxicity), especially aminoglycosides, as their combined use increases the risk of kidney toxicity; therefore, your doctor must monitor kidney function.
• Oral contraceptives, as the use of Cefotaxima TORLAN 1,000 mg intramuscular 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.

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

Driving and use of machines

There are no known data or no data available on the effects of Cefotaxima TORLAN 1,000 mg intramuscular on the ability to drive or operate machinery. Avoid performing tasks requiring special attention until you know how you tolerate the medicine.

Important information about some of the components of CEFOTAXIMA TORLAN 1,000 mg intramuscular

Patients on low-sodium diets should be aware that this medicine contains 50.5 mg (2.20 mmol) of sodium per dose.

Cefotaxima TORLAN 1,000 mg intramuscular contains lidocaine to improve local tolerance of intramuscular administration; therefore, it must not be administered intravenously or used in patients with a history of allergy to lidocaine.

3. How to use Cefotaxime Torlan 1,000 mg powder and solvent for intramuscular injectable solution

Follow exactly the administration instructions for CEFOTAXIME TORLAN 1,000 mg intramuscular as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

This medicine, Cefotaxime TORLAN 1,000 mg intramuscular, will be administered to you by intramuscular route.

Please remember that administration must be performed by medical personnel.

Your doctor will indicate how long your treatment with Cefotaxime TORLAN 1,000 mg intramuscular should last; do not stop your treatment early.

As a general rule, treatment should continue for at least 3 days after clinical symptoms of infection have disappeared.

The usual dose is:

Adults and adolescents (12 to 18 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. If the dose exceeds 2 g, intravenous injection with water for injection or perfusion solvents is recommended. In such cases, if the daily dose is 4 g, it may be divided into two 2-g doses administered at 12-hour intervals. If higher doses are required, the dosing interval should be reduced.

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

Other presentations may be more suitable depending on the required dose.

Presentations containing 1% lidocaine hydrochloride as solvent should only be used in children over 30 months of age.

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 think that the effect of Cefotaxime TORLAN 1,000 mg intramuscular is too strong or too weak, inform your doctor or pharmacist.

If you use more CEFOTAXIME TORLAN 1,000 mg intramuscular 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 seizures) 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 name of the medicine and the amount taken.

If you forget to use CEFOTAXIME TORLAN 1,000 mg intramuscular

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

If you interrupt treatment with CEFOTAXIME TORLAN 500 mg

Do not stop treatment prematurely, as the desired effect will not be achieved. It is very important to treat infections for the recommended duration; otherwise, the condition may 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 1,000 mg intramuscular may produce adverse effects, although not everyone experiences them.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects 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, non-elevated 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 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 the available data

Immune system disorders:

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

Skin and subcutaneous tissue disorders:

Common: rash (exanthema), itching (pruritus), and less frequently, hives, skin irritation, and itching (urticaria).

Frequency not known: vesicular eruptions (blister-like skin eruptions), common with other antibiotics of this type.

Cardiac disorders:

Frequency not known: Arrhythmia (changes in the heart's rhythm) in case of rapid central intravenous administration.

Gastrointestinal disorders:

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

Diarrhea may occasionally be a sign of enterocolitis (inflammation of the small intestine and colon), which may sometimes be accompanied by blood in the stool. A specific type of enterocolitis 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.

Blood and lymphatic system disorders:

Rare: decreased number of neutrophil white blood cells (neutropenia) and hemolytic anemia (decreased number of red blood cells).

Very rare: decreased 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 platelet count), which reverse quickly when treatment is discontinued.

Renal and urinary disorders:

Uncommon: reduced kidney function (increased creatinine), especially if being treated simultaneously with a class of medicines called 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).

Nervous system disorders:

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

Other:

Fever.

Especially in cases of prolonged treatment, other infections due to organisms not sensitive to Cefotaxime Torlan (cefotaxime) may occur.

If you are being treated for borreliosis (infection caused 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 occur.

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

5. Storage of Cefotaxime Torlan 1,000 mg powder and solvent for intramuscular injectable solution

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 reconstituted solution with the solvent is stable for 3 hours at a temperature not exceeding 25°C and for 6 hours if stored in the refrigerator (2-8°C).

Do not use CEFOTAXIME TORLAN 1,000 mg for intramuscular injection after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Additional Information

Composition of CEFOTAXIME TORLAN 1,000 mg for intramuscular injection

The active substance is cefotaxime (as cefotaxime sodium).

Each vial contains 1,000 mg of cefotaxime (as cefotaxime sodium).

Each solvent ampoule containing lidocaine contains 40 mg of lidocaine hydrochloride.

The other components are: water for injections.

Appearance of the product and contents of the pack

CEFOTAXIME TORLAN 1,000 mg for intramuscular injection is presented as a white or almost white, or slightly yellowish powder, and solvent for injectable solution. It is supplied in packs containing 1 vial with 1,000 mg of cefotaxime powder and 1 ampoule of 4 ml lidocaine hydrochloride (40 mg/4 ml) as solvent, and clinical packs containing 100 vials and 100 solvent ampoules.

Other presentations

CEFOTAXIME TORLAN 500 mg powder and solvent for injectable solution EFG: pack containing 1 vial + 1 ampoule of 2 ml water for injections. Pack containing 100 vials + 100 ampoules.

CEFOTAXIME TORLAN 1,000 mg powder and solvent for intravenous injectable solution EFG: pack containing 1 vial + 1 ampoule of 4 ml water for injections. Pack containing 100 vials + 100 ampoules.

CEFOTAXIME TORLAN 2,000 mg powder and solvent for injectable solution and for perfusion EFG: pack containing 1 vial + 1 ampoule of 10 ml water for injections. Pack containing 100 vials + 100 ampoules.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

LDP-LABORATORIOS TORLAN, S.A.

Ctra. de Barcelona, 135-B

08290 Cerdanyola del Vallès

Barcelona

This summary of product characteristics was approved in April 2024

Warning: For use by healthcare professionals only

This information is intended exclusively for physicians or healthcare professionals:

How to prepare this medicine

Cefotaxime TORLAN 1,000 mg for intramuscular injection will be administered according to the following instructions:

For intramuscular injection, the Cefotaxime TORLAN 1,000 mg vial should be dissolved in the accompanying ampoule containing 1% lidocaine hydrochloride. The freshly prepared solution should be injected deeply into the gluteal region by deep intramuscular injection. Because it contains lidocaine, intravenous administration of Cefotaxime TORLAN 1,000 mg for intramuscular injection is not permitted.

Never administer lidocaine to children under 30 months of age. It is recommended not to inject more than 4 ml into each gluteal region.

If the dose exceeds 2 g, or if Cefotaxime TORLAN 1,000 mg for intramuscular injection is to be administered more than twice daily, the presentation CEFOTAXIME TORLAN 2,000 mg powder and solvent for injectable solution and for perfusion EFG is recommended.

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/