Cefotaxime Torlan 1000 mg powder and solvent for injection solution IV/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 IV/IM 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you; do not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you think any of the side effects you experience is 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 IV/IM is and what it is used for

1. Before using CEFOTAXIME TORLAN 1,000 mg powder and solvent for injectable solution IV/IM

2. How to use CEFOTAXIME TORLAN 1,000 mg powder and solvent for injectable solution IV/IM

3. Possible side effects

4. Storage of CEFOTAXIME TORLAN 1,000 mg powder and solvent for injectable solution IV/IM

5. Additional information

6. WHAT CEFOTAXIME TORLAN 1,000 mg POWDER AND SOLVENT FOR INJECTABLE SOLUTION IV/IM IS AND WHAT IT IS USED FOR

This medicine belongs to a group of antibiotics called cephalosporins.

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 the instructions regarding dose, dosing interval, and duration of treatment as prescribed by your doctor.

Do not store or reuse this medicine. If you have any antibiotic left after completing your treatment, return it to the pharmacy for proper disposal. Do not dispose of medicines via wastewater or household waste.

Cefotaxime TORLAN 1,000 mg IV/IM is indicated for infections caused by germs sensitive to cefotaxime, such as:

• Otorhinolaryngological infections,
• Lower respiratory tract infections, including acute 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 inside 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. What you need to know before using CEFOTAXIME TORLAN 1,000 mg powder and solvent for injectable solution IV/IM

Do not use CEFOTAXIME TORLAN 1,000 mg IV/IM

• If you are allergic (hypersensitive) to cefotaxime, to other cephalosporins, or to any of the other components of CEFOTAXIME TORLAN 1,000 mg IV/IM
• 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 1,000 mg or inform your doctor if any of these apply to you.

Take special care with CEFOTAXIME TORLAN 1,000 mg IV/IM

• If you are allergic to penicillins and/or to 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 1,000 mg IV/IM.
• If you have previously experienced an immediate allergic reaction to cephalosporins. If in doubt, the first dose should be administered under medical supervision.
• If you develop diarrhoea, especially if it is severe, persistent, and/or bloody, during or after treatment with Cefotaxime TORLAN 1,000 mg IV/IM, 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 undergoing prolonged treatment with Cefotaxime TORLAN 1,000 mg IV/IM, to rule out superinfection by resistant organisms, or if you experience genital itching/irritation, which may indicate inflammation 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 (reduced number of neutrophil white blood cells).
• Certain 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 for any diagnostic tests (blood, urine, etc.), inform your doctor that you are being treated with this medicine, as it may interfere with test results.
• Serious 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 experience any of the symptoms described in section 4 related to these serious skin reactions.

Use with 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 must 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 damage; therefore, your doctor must monitor kidney function.
• Oral contraceptives, as treatment with Cefotaxime TORLAN 1,000 mg IV/IM 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 using machines

There are no known data or no data available on the effects of CEFOTAXIME TORLAN 1,000 mg IV/IM on the ability to drive or operate machinery. Avoid performing tasks requiring high concentration until you know how you tolerate the medicine.

Important information about some of the components of CEFOTAXIME TORLAN 1,000 mg IV/IM

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

3. How to use CEFOTAXIME TORLAN 1,000 mg powder and solvent for injectable solution IV/IM

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

This medicine can be administered by intramuscular injection or by intravenous injection slowly. For intramuscular administration, other formulations containing lidocaine are available on the market to reduce injection site pain: Cefotaxime TORLAN 1,000 mg powder and solvent for intramuscular injectable solution EFG.

Remember that administration must be performed by medical personnel.

Your doctor will determine the duration of treatment with Cefotaxime TORLAN 1,000 mg IV/IM; do not stop treatment prematurely.

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

Remember to request administration of your medication as scheduled.

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, or if Cefotaxime TORLAN 1,000 mg is administered more than twice daily, the CEFOTAXIME TORLAN 2,000 mg powder and solvent for injectable solution and infusion EFG formulation is recommended. In such 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): Depending on the severity of infection, 50–150 mg/kg/day divided into 2, 3, or 4 doses according to the severity of the infection.

Formulations containing 1% lidocaine hydrochloride as solvent must not be used in children under 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 susceptibility of the pathogen and the severity of the infection.

Haemodialysis patients:

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

If you feel that the effect of Cefotaxime TORLAN 1,000 mg IV/IM is too strong or too weak, inform your doctor or pharmacist.

If you use more CEFOTAXIME TORLAN 1,000 mg IV/IM than you should

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

In case of accidental ingestion, contact 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 IV/IM

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

If you stop treatment with CEFOTAXIME TORLAN 1,000 mg IV/IM

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 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 IV/IM can cause 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 effects not listed in this leaflet, inform your doctor or pharmacist.

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

• Red, flat patches or circular or target-like patches 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 rash, high body temperature, and swollen 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).

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 neutrophil white blood cells (neutropenia) and haemolytic anaemia (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 specific group of white blood cells) and thrombocytopenia (reduction in the number of platelets), which reverse rapidly when treatment is discontinued.

Immune system disorders:

Very rare: skin allergic reactions and severe allergic reaction presenting with breathing difficulties 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 the heart beat rhythm) in case of rapid central intravenous injection.

Gastrointestinal disorders:

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

Diarrhoea may occasionally be a symptom of enterocolitis (inflammation of the small intestine and colon), which in some cases may be accompanied by blood in the 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, skin irritation, and itching (urticaria).

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

Renal and urinary disorders:

Uncommon: decreased 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).

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

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

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 CEFOTAXIMA TORLAN 1,000 mg powder and solvent for injectable solution IV/IM

Keep out of the reach and sight of children.

Store in the original packaging to protect from light.

Do not store above 25°C.

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

Do not use CEFOTAXIMA TORLAN 1,000 mg IV/IM 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 medicines and their containers at a pharmacy’s SIGRE collection point. If you have any doubts, ask your pharmacist how to dispose of unused medicines and containers. This will help protect the environment.

6. Additional Information

Composition of CEFOTAXIME TORLAN 1,000 mg IV/IM

The active substance is cefotaxime (as cefotaxime sodium).

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

The other components are: water for injections.

Appearance of the medicinal product and contents of the container

CEFOTAXIME TORLAN 1,000 mg IV/IM is presented as a white or almost white, or slightly yellowish powder, and solvent for injectable solution. It is available in packs containing 1 vial with 1,000 mg of cefotaxime powder and 1 ampoule of 4 ml of water for injections 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. Clinical pack with 100 vials + 100 ampoules.

CEFOTAXIME 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.

CEFOTAXIME TORLAN 2,000 mg powder and solvent for injectable and perfusion solution EFG: pack containing 1 vial + 1 ampoule of 10 ml water for injections. Clinical pack with 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 leaflet was approved in: April 2024

Warning: Use exclusively by a healthcare professional

This information is intended only for doctors 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 any loss of antibiotic efficacy or reduced tolerance. Solutions with brownish-yellow or brown coloration 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

Cefotaxime TORLAN 1,000 mg IV/IM should be administered according to the following instructions:

Inflammatory reactions of the venous wall and pain at the injection site have been observed with cefotaxime injection, which can be avoided by slower administration (over 3 to 5 minutes).

Recently, some cases of life-threatening arrhythmias have been reported in patients receiving cefotaxime via rapid intravenous injection through a central venous catheter; therefore, slow intravenous administration over 3 to 5 minutes is recommended.

Intravenous route

For intravenous injection: Cefotaxime TORLAN 1,000 mg IV/IM is administered by slow intravenous injection over 3 to 5 minutes, after dilution in solvent, directly into the vein or via the distal end of an infusion line, with temporary clamping of the line.

If higher doses are required, or if Cefotaxime TORLAN 1,000 mg is administered more than twice daily, other more suitable presentations for infusion are available: CEFOTAXIME TORLAN 2,000 mg powder and solvent for injectable and perfusion solution EFG.

For intravenous infusion: The solvent ampoule included in the pack containing 10 ml of water for injections must never be used.

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

For slow infusion, dissolve 2 g of Cefotaxime 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).

Intramuscular route

For intramuscular injection, dissolve the vial of Cefotaxime TORLAN 1,000 mg IV/IM in the accompanying ampoule of water for injections and inject the freshly prepared solution deep into the gluteal region. Pain associated with intramuscular injection may be reduced by dissolving Cefotaxime TORLAN 1,000 mg IV/IM in 4 ml of 1% lidocaine solution. Other presentations containing lidocaine are available on the market: Cefotaxime TORLAN 1,000 mg powder and solvent for intramuscular injectable solution EFG.

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

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/