Cefotaxime Torlan 500 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 500 mg powder and solvent for injectable solution EFG

Cefotaxime (as cefotaxime sodium)

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

• Keep this leaflet as 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 only. Do not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you think any of the side effects you experience is serious, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Leaflet contents :

1. What CEFOTAXIME TORLAN 500 mg powder and solvent for injectable solution is and what it is used for
2. Before you use CEFOTAXIME TORLAN 500 mg powder and solvent for injectable solution
3. How to use CEFOTAXIME TORLAN 500 mg powder and solvent for injectable solution
4. Possible side effects
5. How to store CEFOTAXIME TORLAN 500 mg powder and solvent for injectable solution
6. Further information

1. What Cefotaxime Torlan 500 mg powder and solvent for injectable solution is and what it is used for

This medicine belongs to a group of antibiotics called cephalosporins.

Cefotaxima TORLAN 500 mg 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 Cefotaxime Torlan 500 mg powder and solvent for injectable solution

Do not use CEFOTAXIMA TORLAN 500 mg

• If you are allergic (hypersensitive) to cefotaxime, to other cephalosporins, or to any of the other components of CEFOTAXIMA TORLAN 500 mg.
• 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 500 mg or inform your doctor if any of the following apply to you

Take special care with CEFOTAXIMA TORLAN 500 mg

• 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 medicine before starting treatment with Cefotaxime Torlan 500 mg.
• If you have previously experienced any 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 500 mg, consult your doctor, as this may be a sign of an infection associated with the bacterium Clostridium difficile.
• Consult your doctor if you experience any discomfort, especially if you are receiving injectable Cefotaxime Torlan 500 mg for a prolonged period, to rule out superinfection caused by resistant organisms, 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 neutropenia (decrease in the 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 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 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). Stop using 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 taking, or have recently taken, 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 or more 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 their combined use may increase kidney toxicity; your doctor must monitor kidney function.
• Oral contraceptives, as the use of Cefotaxime Torlan 500 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.

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 Cefotaxime Torlan 500 mg 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 500 mg

Patients on low-sodium diets should be aware that this medicine contains 25.25 mg (1.10 mmol) of sodium per dose.

3. How to use Cefotaxime Torlan 500 mg powder and solvent for injectable solution

Follow exactly the administration instructions for CEFOTAXIME TORLAN 500 mg given by your doctor. Consult your doctor or pharmacist if you have any doubts.

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

Remember that administration must be performed by medical personnel.

Your doctor will indicate how long your treatment with Cefotaxime Torlan 500 mg should last; do not stop your treatment early.

As a general rule, treatment should always continue for at least 3 days after clinical symptoms of infection have disappeared. 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 presentation CEFOTAXIME TORLAN 2,000 mg powder and solvent 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): 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.

Presentations containing 1% lidocaine hydrochloride as solvent must 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 the effect of Cefotaxime Torlan 500 mg is too strong or too weak, inform your doctor or pharmacist.

If you use more CEFOTAXIME TORLAN 500 mg than you should

Contact your doctor immediately or go to the nearest hospital. In case of overdose, especially 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 500 mg

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

If you stop treatment with CEFOTAXIME TORLAN 500 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 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 500 mg 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).

• Generalized skin 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:

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

Immune system disorders:

Very rare: allergic skin 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 heart beat rhythm) in case of rapid central intravenous injection.

Gastrointestinal disorders:

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

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

Skin and subcutaneous tissue disorders:

Frequent: rash (exanthema), itching (pruritus), and less frequently, hives, 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 concomitantly treated 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:

Frequent: 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 in 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 mentioned in this leaflet, inform your doctor or pharmacist.

5. Storage of Cefotaxime Torlan 500 mg

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 a temperature not exceeding 25°C and for 6 hours if stored in the refrigerator (2-8°C).

Do not use CEFOTAXIME TORLAN 500 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 medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, 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 500 mg

The active substance is cefotaxime (as cefotaxime sodium).

Each vial contains 500 mg of cefotaxime (as cefotaxime sodium).

The other components are: water for injections.

Appearance of the product and contents of the pack

CEFOTAXIME TORLAN 500 mg is presented as a white or almost white powder, or slightly yellowish, and solvent for injectable solution. It is available in boxes containing 1 vial with 500 mg of cefotaxime powder and 1 ampoule of 2 ml water for injections as solvent, and clinical packs containing 100 vials and 100 solvent ampoules.

Other presentations

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

CEFOTAXIME TORLAN 1,000 mg powder and solvent for intramuscular injectable solution EFG: box with 1 vial + 1 ampoule of 4 ml hydrochloride lidocaine 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: box with 1 vial + 1 ampoule of 10 ml water for injections. Clinical pack with 100 vials + 100 ampoules.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

LDP-LABORATORIOS TORLAN, S.A.

Crta 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 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 a loss of antibiotic efficacy or reduced tolerability. Solutions with brownish 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 perfusion fluids:

• Sodium chloride 0.9%

• Glucose 5%

• Ringer's solution

• Sodium lactate

• -How to prepare this medicine

Cefotaxime TORLAN 500 mg should be administered according to the following instructions:

Intravenous route

Inflammatory reactions of the venous wall and pain at the injection site have been observed with cefotaxime injection; these may 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 receiving cefotaxime administered rapidly intravenously via a central venous catheter; therefore, slow intravenous administration over 3 to 5 minutes is recommended.

For intravenous injection: Cefotaxime TORLAN 500 mg 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 prior clamping of the line.

If higher doses are required or if Cefotaxime TORLAN 1,000 mg is administered more than twice daily, the presentation CEFOTAXIME TORLAN 2,000 mg powder and solvent for injectable and perfusion solution EFG is recommended.

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

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 Cefotaxime TORLAN 500 mg vial in the accompanying ampoule of water for injections and inject the freshly prepared solution deeply into the gluteal region. The pain associated with intramuscular injection may be reduced by dissolving Cefotaxime TORLAN 500 mg 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 in 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/