CEFOTAXIME TORLAN 1000 mg POWDER AND SOLVENT FOR INJECTION IM

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

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

1. What is Cefotaxima Torlan 1,000 mg powder and solvent for solution for intramuscular injection and what is it used for

Cefotaxime belongs to a group of antibiotics called cephalosporins.

Cefotaxima TORLAN 1,000 mg intramuscular is indicated in 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,
• Soft tissue and skin infections,
• Abdominal cavity infections (peritonitis, infections of the bile ducts).

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

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 local anesthetics of the amide type.
• If you have been diagnosed with severe heart failure or uncontrolled atrioventricular block.
• In children under 30 months.
• Via intravenous route.
• If you have ever suffered a severe skin rash or skin peeling, blisters, or sores in the mouth after taking cefotaxime or other cephalosporins.

Do not use CEFOTAXIMA TORLAN 1,000 mg or inform your doctor if any of the following apply to you

Be cautious with CEFOTAXIMA TORLAN 1,000 mg intramuscular

• 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 1,000 mg intramuscular.
• If you have had an immediate allergic reaction to cephalosporins. In case of doubt, the first administration should be done 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 1,000 mg intramuscular, 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 1,000 mg intramuscular 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 Candidaspp.
• 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 called neutrophils).
• Some tests such as the Coombs test and glucosuria may be positive without being so, due to treatment with this medication.
• If you are going to have any diagnostic tests (blood tests, urine tests...), inform your doctor that you are being treated with this medication, 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 taking cefotaxime 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 medications

Inform your doctor or pharmacist if you are using, or have recently used, other medications, including those purchased 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. Cefotaxima TORLAN should not be administered simultaneously with:

• medications whose active ingredient is probenecid (for the treatment of gout), as the concentration of cefotaxime in the blood increases.
• nephrotoxic medications (which produce kidney toxicity), especially aminoglycosides, as kidney toxicity is enhanced, and your doctor should 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 medication.

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

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

Driving and using machines

It is not known whether Cefotaxima TORLAN 1,000 mg intramuscular affects the ability to drive or use machines. Avoid performing tasks that require special attention until you know how you tolerate the medication.

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

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

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

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

Follow exactly the administration instructions of CEFOTAXIMA TORLAN 1,000 mg intramuscular indicated by your doctor. Consult your doctor or pharmacist if you have doubts.

You will be administered this medication, Cefotaxima TORLAN 1,000 mg intramuscular, by intramuscular route.

Remember that administration must be done by medical personnel.

Your doctor will indicate the duration of treatment with Cefotaxima TORLAN 1,000 mg intramuscular; do not suspend treatment before completing it.

As a general rule, treatments should be prolonged at least until 3 days after the disappearance of clinical symptoms of the infection.

The usual dose is:

Adults and adolescents (12 to 18 years):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, it is recommended to administer it intravenously with water for injection or perfusion solvents. 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 needed, the interval should be reduced.

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

There are other presentations more suitable depending on the dose.

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

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.

Hemodialysis patients:

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

If you think the action of Cefotaxima TORLAN 1,000 mg intramuscular is too strong or too weak, inform your doctor or pharmacist.

If you use more CEFOTAXIMA TORLAN 1,000 mg intramuscular 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 Toxicology Information Service. Phone 91 562 04 20 indicating the medication and the amount used.

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

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

If you interrupt treatment with CEFOTAXIMA TORLAN 500 mg

Do not suspend treatment before completing it, as the desired effect will not be achieved. It is very important to treat infections for the recommended time; otherwise, they 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 medications, CEFOTAXIMA TORLAN 1,000 mg intramuscular 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 effect not mentioned 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 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 according to the frequencies detailed below:

Frequent: at least 1 in every 100 patients

Uncommon: at least 1 in every 1,000 patients

Rare: at least 1 in every 10,000 patients

Very rare: less than 1 in every 10,000 patients

Frequency not known: cannot be estimated from available data

Immune system disorders:

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

Skin and subcutaneous tissue disorders:

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

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

Cardiac disorders:

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

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

Blood and lymphatic system disorders:

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

Very rare:decreased 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 reversible when treatment is discontinued.

Renal and urinary disorders:

Uncommon:decreased kidney function (increased creatinine), especially if being treated simultaneously with a type of medication 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).

Nervous system disorders:

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

Other:

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 effect not mentioned in this leaflet, inform your doctor or pharmacist.

5. Storage of Cefotaxima Torlan 1,000 mg powder and solvent for solution for intramuscular injection

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 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 CEFOTAXIMA TORLAN 1,000 mg intramuscular after the expiration date stated on the packaging after EXP. The expiration date is the last day of the month indicated.

Medications should not be thrown away down the drain or in the trash. Deposit the packaging and medications you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Additional Information

Composition of CEFOTAXIMA TORLAN 1,000 mg intramuscular

The active ingredient is cefotaxime (as cefotaxime sodium).

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

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

The other components are: water for injectable preparations.

Appearance of the product and packaging content

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

Other presentations

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

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

CEFOTAXIMA TORLAN 2,000 mg powder and solvent for injectable solution and for perfusion EFG: box with 1 vial + 1 ampoule of 10 ml of water for injectable preparations. Package with 100 vials + 100 ampoules.

Only some package 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 prospectus was approved in April 2024

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Warning: Use exclusively by a healthcare professional

This information is intended only for doctors or healthcare professionals:

How to prepare this medication

Cefotaxima TORLAN 1,000 mg intramuscular will be administered according to the following instructions:

For intramuscular injection, the vial of Cefotaxima TORLAN 1,000 mg intramuscular will be dissolved in the ampoule that comes with 1% lidocaine hydrochloride and the freshly prepared solution will be injected into the gluteal region in deep intramuscular injection. Since it contains lidocaine, intravenous administration of Cefotaxima TORLAN 1,000 mg intramuscular is not allowed.

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

If the dose is higher than 2g, or if Cefotaxima TORLAN 1,000 mg intramuscular is administered more than 2 times a day, the presentation CEFOTAXIMA TORLAN 2,000 mg powder and solvent for injectable solution and for perfusion EFG is recommended.

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/