Cefotaxima torlan 1000 mg polvo y disolvente para solucion inyectable iv/im efg

PATIENT INFORMATION LEAFLET

CEFOTAXIME TORLAN 1,000 mg powder and solvent for solution for injection IV/IM EFG

Cefotaxime (as cefotaxime sodium)

Read this leaflet carefully before you start using the 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 pass it on to others even if their symptoms are the same. It may harm them.
• If you think you have suffered a side effect, you can help us by reporting it directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

1. Before using CEFOTAXIMA TORLAN 1.000 mg powder and solvent for injectable solution IV/IM
2. How to use CEFOTAXIMA TORLAN 1.000 mg powder and solvent for injectable solution IV/IM
3. Possible adverse effects
4. Storage of CEFOTAXIMA TORLAN 1.000 mg powder and solvent for injectable solution IV/IM
5. Additional information

1. WHAT ISCEFOTAXIMA TORLAN 1.000 mgpowder and solvent for injectable solution IV/IMAND FOR WHAT IT IS USED

This medicine belongs to a group of antibiotics called cephalosporins.

Cefotaxima TORLAN 1.000 mg IV/IM is indicated for infections caused by bacteria sensitive to cefotaxima such as:

- otolaryngological infections,

-lower respiratory tract infections, including worsening 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 that lines the inside of the heart),

-meningitis (except those caused by Listeria) and other central nervous system infections,

-ostearticular infections,

- skin and soft tissue infections,

- abdominal cavity infections (peritonitis, biliary tract infections).

Do not useCEFOTAXIMA TORLAN 1.000 mg IV/IM

• If you are allergic (hypersensitive) to cefotaxime, to other cephalosporins, or to any of the other components of CEFOTAXIMA TORLAN 1.000 mg IV/IM
• If you have ever had a severe skin rash or peeling of the skin, blisters, or mouth sores after taking cefotaxime or other cephalosporins.

Do not use CEFOTAXIMA TORLAN 1000 mg or inform your doctor if any of them affect you

Be especially careful withCEFOTAXIMA TORLAN 1.000 mg IV/IM

• 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 IV/IM.
• If you have had any type of immediate allergic reaction to cephalosporins. In case of doubt, the first administration will have to be carried out in the presence of a doctor.
• If you have diarrhea, especially if it is severe, persistent, and/or bloody during or after treatment with Cefotaxima TORLAN 1.000 mg IV/IM, consult your doctor as it may be a symptom of an associated disease caused by the germClostridium difficile.
• Consult your doctor if you experience any discomfort, especially if you have been treated with Cefotaxima TORLAN 1.000 mg IV/IM for a long time, to rule out another infection by resistant germs (superinfection), or if you experience itching/irritation in the genitals to rule out an inflammation in the area caused by the germCandidaspp.
• If you need to be treated for a period of 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 cell neutrophils).
• Some tests such as the Coombs test and glucosuria may be positive without actually being so, due to treatment with this medication.
• If you are going to undergo any diagnostic test (blood test, urine...) 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-induced eosinophilia, and systemic symptoms (DRESS), generalized acute pustular exanthema (PEGA), have been associated with treatment with cefotaxime. Stop taking cefotaxime and seek medical attention immediately 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, herbal, 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 it increases the concentration of cefotaxime in the blood.

- nephrotoxic medications (that produce kidney toxicity), especially aminoglycosides, as it potentiates kidney toxicity, so your doctor will have to monitor its functioning.

- oral contraceptives, as the use of Cefotaxima TORLAN 1.000 mg IV/IM may reduce their effectiveness.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

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

Women in the lactation period should consult their doctor before using this medication, as cefotaxime passes into breast milk.

Driving and operating machinery

No information is available or known about how Cefotaxima TORLAN 1.000 mg IV/IM affects driving or operating machinery. Be careful not to perform tasks that may require special attention until it is known how you tolerate the medication

Important information about some of the components ofCEFOTAXIMA TORLAN 1.000 mg IV/IM

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

Follow exactly the administration instructions for CEFOTAXIMA TORLAN 1.000 mg IV/IM indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

This medication can be administered intramuscularly by injection or intravenously by slow injection. For intramuscular administration, there are other preparations available on the market with lidocaine that reduce pain at the administration site, Cefotaxima TORLAN 1.000 mg powder and solvent for intramuscular injectable solution EFG.

Remember that administration should be performed by medical personnel.

Your doctor will indicate the duration of treatment with Cefotaxima TORLAN 1.000 mg IV/IM, do not suspend your treatment before.

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

Remember to request the administration of your medication.

The usual dose is:

Adults and adolescents (12 to 18 years):The usual posological schedule is 1 g of cefotaxine every 12 hours.

In severe cases, the daily dose can be increased up to 12 g. If the dose is greater than 2g, or if Cefotaxima TORLAN 1.000 mg is administered more than 2 times a day, the CEFOTAXIMA TORLAN 2.000 mg powder and solvent for injectable solution and for perfusion EFG presentation is recommended. 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 necessary, the interval should be reduced.

Pediatric population (less than 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.

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

Patients with renal insufficiency:

In patients with reduced renal function, the maintenance dose should be reduced to half.

The initial dose depends on the sensitivity of the pathogen and the severity of the infection.

Patients undergoing hemodialysis:

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

If you estimate that the action of Cefotaxima TORLAN 1.000 mg IV/IM is too strong or too weak, inform your doctor or pharmacist.

If you use more CEFOTAXIMA TORLAN 1.000 mg IV/IM than you should:

Consult your doctor immediately or go to the nearest hospital. In case of overdose, particularly in patients with renal insufficiency, encephalopathy (deterioration of consciousness, abnormal movements, and seizures) could occur.

In case of accidental ingestion, consult your doctor or pharmacist or call the Toxicological Information Service. Telephone 91 562 04 20 indicating the medication and the amount used.

If you forgot to use CEFOTAXIMA TORLAN 1.000 mg IV/IM:

Do not use a double dose to compensate for the missed doses.

If you interrupt treatment with CEFOTAXIMA TORLAN 1.000 mg IV/IM:

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, it could worsen.

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

Like all medications,CEFOTAXIMA TORLAN 1.000 mg IV/IMmay cause adverse effects, although not everyone will experience them.

If you consider that any of the adverse effects you are experiencing are severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

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

• Flat red patches, or circular or target-shaped patches on the chest, often with central blisters, skin peeling, mouth ulcers, throat ulcers, nasal ulcers, genital ulcers, and eye ulcers. These severe skin eruptions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).

• Generalized skin eruption, elevated body temperature, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

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

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

Frequent: at least 1 in 100 patients

Infrequent: 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 unknown: cannot be estimated from available data

Blood and lymphatic system disorders:

Rare:decreased white blood cell count (neutropenia) and hemolytic anemia (decreased red blood cell count).

Very rare:granulocytopenia (decreased granulocyte count), particularly if cefotaxima is administered for prolonged periods.

Frequency unknown:eosinophilia (increased eosinophil count) and thrombocytopenia (decreased platelet count), reversible when treatment is suspended.

Immune system disorders:

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

Nervous system disorders:

Infrequent:at high doses, particularly in patients with renal insufficiency, encephalopathy (deterioration of consciousness, abnormal movements, and seizures) may occur.

Cardiac disorders:

Frequency unknown:arrhythmia (changes in heart rhythm) in case of rapid intravenous central injection.

Gastrointestinal disorders:

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

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

Hepatobiliary disorders:

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

Skin and subcutaneous tissue disorders:

Frequent:skin eruption (exanthema), itching, and with lower frequency, rashes, skin irritation, and itching (urticaria).

Frequency unknown:vesicular eruptions (skin eruptions in the form of blisters), as with other antibiotics of this type.

Renal and urinary disorders:

Infrequent:renal dysfunction (increased creatinine) especially if treated simultaneously with a type of medication called aminoglycosides.

Transient elevation of urea nitrogen has also been observed.

Very rare:interstitial nephritis (allergic kidney inflammation).

Reproductive and breast disorders:

Infrequent:candidiasis (infection by Candida fungus), vaginitis (inflammation of the vaginal mucosa).

General disorders and administration site conditions:

Frequent:venous wall inflammation and pain at the injection site, which can be avoided by administering Cefotaxima TORLAN at a slower rate (3 to5 minutes).

Other:

Fever.

Especially in the case of prolonged treatments, other infections may appear due to organisms not sensitive to Cefotaxima TORLAN (cefotaxima).

In the case of borreliosis (infection by Borrelia) treatment, a Jarisch-Herxheimer reaction (inflammatory reaction) may appear in the first days, and after several weeks, other symptoms similar to the disease may appear.

If you consider that any of the adverse effects you are experiencing are severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Keep out of reach and sight of children.

Store in the original container to protect it from light.

Do not store at a temperature above25ºC.

The reconstituted solution with the solvent is stable for 3 hours at a temperature not above25ºCand for 6 hours if stored in a refrigerator (2-8ºC).

Do not use CEFOTAXIMA TORLAN 1.000 mg IV/IM afterthe expiration date that appears on the container after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the containers and medicines you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. In this way, you will help protect the environment.

Composition ofCEFOTAXIMA TORLAN 1.000 mg IV/IM

The active ingredient is cefotaxime (as cefotaxime sodium).

Each vial contains 1.000 mg of cefotaxime (as cefotaxime sodium).

The other components are: water for injection preparations.

Aspect of the product and content of the packaging

CEFOTAXIMA TORLAN 1.000 mgIV/IMis presented in the form of powder, white or almost white, or slightly yellowish, and injectable solution solvent. It is presented in boxes with 1 vial with 1.000 mg of cefotaxime powderand1 ampoule of 4 ml of water for injection preparations as solvent and clinical packaging with 100 vials and 100 ampoules of solvent.

Other presentations

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

CEFOTAXIMA TORLAN 1.000 mg powder and injectable solution solvent intramuscular EFG: box with 1 vial + 1 ampoule of 4 ml of lidocaine hydrochloride solution (40mg/4ml). Clinical packaging with 100 vials + 100 ampoules.

CEFOTAXIMA TORLAN 2.000 mg powder and injectable solution solvent and for perfusion EFG: box with 1 vial + 1 ampoule of 10 ml of water for injection preparations. Clinical packaging with 100 vials + 100 ampoules.

Only some sizes of packaging may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

LDP-LABORATORIOS TORLAN, S.A.

Ctra. de Barcelona, 135-B

08290 Cerdanyola del Vallès

Barcelona

This leaflet has been approved in: April 2024

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Warning: To be used exclusively by a healthcare professional

This information is intended solely for doctors or healthcare professionals:

-Stability of the reconstituted cefotaxime solution:

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

The slightly yellowish color of the solution does not indicate alteration of the antibiotic's efficacy, nor its tolerance. Solutions with yellowish-brown or brown color should not be administered.

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

• Sodium chloride 0.9%

• Glucose 5%

• Ringer's solution

• Sodium lactate

How to prepare this medication

Cefotaxima TORLAN 1.000 mg IV/IM will be administered according to the following instructions:

With the cefotaxime injection, inflammatory reactions of the venous wall and pain at the injection site have been observed, which can be avoided by administering it more slowly (3 to5 minutes).

Recently, some cases of arrhythmia that pose a threat to life have been reported in patients to whom cefotaxime was administered intravenously rapidly through a central venous catheter, so it is recommended to administer it intravenously slowly in3 to5 minutes.

Intravenous route

For intravenous injection: Cefotaxima TORLAN 1.000 mg IV/IM is administered intravenously slowly in3 to5 minutes, after dilution in solvent, directly into the vein or through the distal end of the perfusion tube, after pinching the same.

If higher doses are required,or if Cefotaxima TORLAN 1.000 mg is administered more than 2 times a day,there are other presentationsmore suitable for perfusion, CEFOTAXIMA TORLAN 2.000 mg powder and injectable solution solvent and for perfusion EFG.

For intravenous perfusion:The ampoule of solvent included in the packaging that contains 10 ml of water for injection preparations should never be used.

For rapid perfusion, 2 g of Cefotaxima TORLAN will be dissolved in 40 ml of water for injection preparations or in a conventional perfusion solution and perfused in a period of 20 minutes.

For slow perfusion, 2 g of Cefotaxima TORLAN will be dissolved in 100 ml of isotonic saline solution or glucose and perfused in50 to60 minutes (other perfusion solutions may also be used, except those containing sodium bicarbonate).

Intramuscular route

For intramuscular injection, the vial of Cefotaxima TORLAN 1.000 mg IV/IM will be dissolved in the ampoule that accompanies it with water for injection preparations and the freshly prepared solution will be injected into the gluteal region in intramuscular deep injection. The pain resulting from the intramuscular injection can be attenuated by dissolving Cefotaxima TORLAN 1.000 mg IV/IM in 4 ml of lidocaine solution 1%. Other presentations are available on the market that contain lidocaine Cefotaxima TORLAN 1.000 mg powder and injectable solution solvent intramuscular EFG.

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

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.es/