Label: information for the user

Ceftriaxone LDP Torlan 2 g powderfor infusion solutionEFG

ceftriaxone (as ceftriaxone sodium)

Read the label carefully before starting to use the medication.

• Keep this label, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed for you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you consider that any of the adverse effects you are experiencing is severe or if you notice any adverse effect not mentioned in this label, inform your doctor or pharmacist.

This medication is an antibiotic that belongs to the group known as cephalosporins.

Antibiotics are used to treat bacterial infections and do not work for viral infections such as the flu or a cold.

It is essential that you follow the instructions regarding the dose, administration interval, and treatment duration indicated by your doctor.

Do not store or reuse this medication. If there is any leftover antibiotic after treatment, return it to the pharmacy for proper disposal. Do not dispose of medications through the drain or in the trash.

Ceftriaxone LDP Torlan is indicated for the treatment of severe infections caused by sensitive microorganisms to ceftriaxone, such as: septicemia (infection caused by the passage of pathogenic bacteria into the blood), bacterial meningitis, abdominal infections (such as peritonitis and biliary tract infections), bone and joint infections, complicated skin and soft tissue infections, complicated urinary tract infections including pyelonephritis (kidney infection), respiratory infections, genital infections (including gonorrhea) and stages II and III of Lyme disease (infection caused by tick bite).

Ceftriaxone LDP Torlan is also indicated to prevent infections before or after a surgical operation.

Do not use Ceftriaxona LDP Torlan 2 g :

• If you are allergic (hypersensitive) to the active ingredient or to cephalosporins, penicillins, or any other β-lactam antibiotics, or to any of the other components of Ceftriaxona LDP Torlan.If you have had a sudden or severe allergic reaction to penicillin or other similar antibiotics (such as cephalosporins, carbapenems, or monobactams); signs of such a reaction include sudden inflammation of the throat or face that makes it difficult to breathe or swallow, sudden swelling of hands, feet, and ankles, chest pain, or a severe and rapid skin rash.
• In newborns with jaundice (yellow discoloration of the skin due to excess bilirubin) or hypoproteinemia (deficiency of a blood protein called albumin), or in premature babies due to the risk of developing hyperbilirubinemic encephalopathy (a disease that can cause brain damage due to bilirubin accumulation and be fatal).
• Ceftriaxona should not be mixed or administered simultaneously with solutions or products containing calcium, even if used through different infusion routes, as they may form precipitates.

Warnings and precautions

• If you have had any allergic reaction to ceftriaxona or to any penicillin or have had severe allergies or asthma, as ceftriaxona may cause allergic reactions that, in some cases, can be fatal (anaphylaxis). If this occurs, contact a doctor immediately or go to the nearest hospital.
• If you experience intense and prolonged diarrhea during or after using this medication, it may be due to a type of colitis (pseudomembranous colitis) that can be severe. In this case, your doctor will discontinue ceftriaxona administration and initiate appropriate treatment. Inform your doctor if you have had gastrointestinal diseases, particularly colitis.
• If you are undergoing prolonged treatment with ceftriaxona, other infections (superinfections) may appear due to the overgrowth of certain organisms such as enterococci or Candida.
• When undergoing prolonged treatments, your doctor should perform periodic blood tests.
• If, due to ceftriaxona calcium sedimentation, signs and symptoms of gallbladder disease appear, accompanied by alterations in gallbladder echography. The risk of these alterations may increase in treatments lasting more than 14 days, in patients with renal failure, dehydration, or total parenteral nutrition, as well as in very young children. In case of occurrence, the medication with ceftriaxona should be discontinued.
• Before starting treatment with Ceftriaxona LDP Torlan, if you have severe liver or kidney disease, as you may need a dose adjustment or if you have a risk of developing pancreatitis (inflammation of the pancreas)
• If you are to undergo any diagnostic tests (including blood, urine, skin tests using allergens, etc...) inform your doctor that you are using this medication, as it may alter the results.
• If you have liver or kidney problems (see section 4).

Other medications and Ceftriaxona LDP Torlan

Inform your doctor or pharmacist if you are using or have recently used other medications, including those obtained without a prescription.

Your doctor will exercise special caution during the simultaneous use of ceftriaxona with:

• Probenecid (a medication used to treat gout)
• Other antibiotics (medications used to treat infections)
• Hormonal contraceptives. It is recommended to take additional precautions during treatment and for one month after

Pregnancy and lactation

Consult your doctor or pharmacist before using any medication.

If you are pregnant or believe you may be, inform your doctor before using this medication, and they will decide whether it is advisable to use it. The consumption of medications during pregnancy can be hazardous to the embryo or fetus and should be monitored by your doctor.

Driving and operating machinery

No adverse effects on the ability to drive vehicles or operate tools or machines have been demonstrated, but it should be noted that Ceftriaxona LDP Torlan may occasionally cause dizziness.

Important information about some of the components of Ceftriaxona LDP Torlan 2 g:

This medication contains 165.6 mg (7.2 mmol) of sodium (main component of table salt/cooking salt) in each dose unit. This corresponds to 8.28% of the maximum daily sodium intake recommended for an adult.

Ceftriaxone is administered intravenously. Consult your doctor or pharmacist if you have any doubts.

Depending on your illness, age, weight, and response to treatment with Ceftriaxone LDP Torlan, your doctor will prescribe the most suitable dose and treatment duration.

Never modify the dose on your own. If you estimate that the action of Ceftriaxone LDP Torlan is too strong or weak, inform your doctor or pharmacist. Ceftriaxone LDP Torlan is administered through intravenous infusion.

You will continue to receive this medication for at least 2 to 3 days after recovering from your illness or to prevent infections for some days after your surgical operation.

Your doctor will indicate when you should interrupt treatment. Do not prolong it on your own.

Adults and children over 12 years:1 to 2 g of ceftriaxone every 24 hours, which means 1-2 g/day; in severe cases, the dose may be increased to 4 g/day.

Newborns, infants, and children under 12 years:It is recommended to administer the following doses once a day: in newborns (up to 14 days), 20 to 50 mg/Kg of weight; do not exceed that dose.

In infants and children (from 15 days to 12 years), a daily dose of 20-80 mg/Kg of weight. For children over 50 Kg, it should be administered in infusion for at least 30 minutes. The duration of therapy varies with the course of the disease. As in antibiotic therapy in general, the administration of ceftriaxone will continue for a minimum of 48 to 72 hours after the disappearance of fever or after obtaining evidence of bacterial eradication.

Geriatric patients:In the case of elderly patients, there is no need to modify the recommended adult doses.

Bacterial meningitis treatment (infants and children):Start with doses of 100 mg/Kg (do not exceed 4 g) once a day. As soon as the causal microorganism is identified and its sensitivity is determined, the dose can be reduced.

Gonococcal disease:For the treatment of gonorrhea, a single intramuscular dose of 250 mg is recommended.

Perioperative prophylaxis:1 to 2 vials (1 to 2 g of ceftriaxone) administered 30-90 minutes before the intervention.

Patients with renal or hepatic impairment:In patients with impaired renal function, it is not necessary to reduce the dose of Ceftriaxone LDP Torlan, as long as liver function remains normal. Only in cases of pre-terminal renal failure (creatinine clearance less than 10 ml/min) the dose should not exceed 2 g/day.

Treatment of patients on dialysis:No additional supplementary dose is required after dialysis, however, serum concentrations will be monitored to determine if dose adjustments are necessary, as the elimination rate in these patients may be reduced.

If you use more Ceftriaxone LDP Torlan 2 g than you should

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

If you forgot to use Ceftriaxone LDP Torlan 2 g

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

If you interrupt treatment with Ceftriaxone LDP Torlan 2 g

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 may worsen.

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

Ceftriaxone should not be mixed or administered simultaneously with solutions or products containing calcium, even if different routes of infusion are used.

Cases of reactions that have caused the death of newborns and premature infants due to the formation of calcium ceftriaxone precipitates in the lungs and kidneys of these patients have been described. In some cases, the infusion routes and administration times of ceftriaxone and calcium-containing solutions were different.

Like all medicines, Ceftriaxone LDP Torlan may cause side effects, although not everyone will experience them.

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

Infections and infestations

- Rare (between 1 and 10 in every 10,000 patients): vulvovaginitis (bacterial infections of the female genital tract).

Blood and lymphatic system disorders

• Rare (between 1 and 10 in every 10,000 patients): anemia (decrease in hemoglobin concentration in blood), leucopenia (decrease in white blood cell count), granulocytopenia (decrease in granulocyte count), thrombocytopenia (decrease in platelet count), and eosinophilia (increase in a certain group of white blood cells).
• Very rare (less than 1 in every 10,000 patients): coagulation disorders, agranulocytosis (decrease or absence of white blood cells in the blood), especially after 10 days of treatment or high doses.

Immune system disorders

• Rare (between 1 and 10 in every 10,000 patients): anaphylactic or anaphylactoid reactions and urticaria (generalized skin itching).
• Frequency unknown: Chest pain in the context of allergic reactions, which may be a symptom of allergy-induced heart attack (Kounis syndrome).

Nervous system disorders

• Rare (between 1 and 10 in every 10,000 patients): headache and dizziness.

Gastrointestinal disorders

• Common (between 1 and 10 in every 100 patients): diarrhea, nausea, stomatitis (inflammation of the mucous membrane of the mouth), and glossitis (inflammation of the tongue).
• Very rare (less than 1 in every 10,000 patients): pseudomembranous colitis (acute and severe diarrhea caused by bacterial overinfection), pancreatitis, gastrointestinal hemorrhage.

Hepatobiliary disorders

• Rare (between 1 and 10 in every 10,000 patients): symptomatic precipitation of ceftriaxona calcium in the gallbladder and increase in liver enzymes (parameters detected in blood tests).

- With frequency "unknown": Problems with the gallbladder or liver, which may

cause pain, nausea, vomiting, yellow skin discoloration, itching, abnormally dark urine, and clay-colored stools.

Skin and subcutaneous tissue disorders

• Uncommon (between 1 and 10 in every 1,000 patients): exanthema (skin eruption), allergic dermatitis (inflammation of the skin), rash (exanthema), edema (accumulation of fluid in tissues), and erythema multiforme.
• Very rare (less than 1 in every 10,000 patients): Stevens-Johnson syndrome, toxic epidermal necrolysis, or Lyell syndrome (skin destruction with epidermal detachment that begins with the formation of blisters but without inflammation).

Renal and urinary disorders

• Rare (between 1 and 10 in every 10,000 patients): oliguria (decrease in urine production), increase in serum creatinine (parameter detected in blood tests).
• Very rare (less than 1 in every 10,000 patients): renal precipitation of ceftriaxone sodium in pediatric patients, hematuria (presence of blood in urine).

General disorders and administration site conditions

• Rare (between 1 and 10 in every 10,000 patients): fever and chills, phlebitis (inflammation of veins) that may be even less frequent if applied through a slow injection over a period of 2-4 minutes).

Ceftriaxone treatment, particularly in elderly patients with severe kidney problems or nervous system problems, rarely may cause decreased consciousness, abnormal movements, agitation, and convulsions.

Reporting of side effects:

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use (Website: www.notificaRAM.es) By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep out of reach and sight of children.

This medication does not require special temperature conditions for conservation.

Store the vial in the outer packaging to protect it from light

Once reconstituted, the solution is stable for 3 hours at 25 °C and for 24 hours in the refrigerator (2-8 °C).

Do not use Ceftriaxone LDP Torlan after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

Do not use Ceftriaxone LDP Torlan if you observe particles or turbidity.

Medicines should not be thrown down the drains or in the trash. Ask your pharmacist how to dispose of the packaging and medicines that you do not need. In this way, you will help protect the environment.

Ceftriaxone LDP Torlan 2 g Powder for Solution for Infusion EFG Composition

The active ingredient is ceftriaxone (as ceftriaxone sodium).

Each vial contains 2 g of ceftriaxone (as ceftriaxone sodium).

Appearance of the Product and Contents of the Container

Ceftriaxone LDP Torlan is presented in a glass vial, closed with a rubber stopper and sealed with a flip-off capsule, and in a pack of 1 vial, 10 vials, and 50 vials.

Other Presentations

Ceftriaxone LDP Torlan 500 mg Powder and Diluent for Intravenous Injection EFG: Box with 1 vial + 1 ampoule of 5 ml of water for injectable preparations. Pack of 100 vials + 100 ampoules.

Ceftriaxone LDP Torlan 500 mg Powder and Solution for Intramuscular Injection EFG: Box with 1 vial + 1 ampoule of 2 ml of lidocaine hydrochloride solution (20mg/2ml). Pack of 100 vials + 100 ampoules.

Ceftriaxone LDP Torlan 1 g Powder and Diluent for Intravenous Injection EFG: Box with 1 vial + 1 ampoule of 10 ml of water for injectable preparations. Pack of 100 vials + 100 ampoules.

Ceftriaxone LDP Torlan 250 mg Powder and Diluent for Intravenous Injection EFG: Box with 1 vial + 1 ampoule of 5 ml of water for injectable preparations. Pack of 100 vials + 100 ampoules.

Ceftriaxone LDP Torlan 1 g Powder and Solution for Intramuscular Injection EFG: Box with 1 vial + 1 ampoule of 3.5 ml of lidocaine hydrochloride solution (35mg/3.5ml). Pack of 100 vials + 100 ampoules.

Only some pack sizes may be marketed.

MARKETING AUTHORIZATION HOLDER AND RESPONSIBLE MANUFACTURER

LDP-Laboratorios TORLAN S.A

Ctra de Barcelona, 135 B

08290 Cerdanyola del Vallès,Barcelona

Spain

Local Representative

LAPHYSAN, SAU

C/ Anabel Segura nº11. Edificio A. Planta 4. Puerta D

28108 Alcobendas, Madrid

Spain

Last review date of this leaflet: May 2024

For detailed and updated information on this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

----------------------------------------------------------------------------------------------------------------

Warning: To be used exclusively by a healthcare professional

This information is intended solely for doctors or healthcare professionals:

Solutions containing ceftriaxone should not be mixed or added to other agents.

Particularly, diluents containing calcium (e.g., Ringer's solution, Hartmann's solution)

should not be used to reconstitute ceftriaxone vials or to dilute reconstituted vials

before IV administration as it may form precipitates.

Ceftriaxone should not be mixed or administered simultaneously with solutions containing calcium (see sections 4.2, 4.3, 4.4, and 4.8 of the technical dossier and section 6 of the leaflet).

CEFTRIAXONE LDP TORLAN 2g must be reconstituted before use. The reconstituted solution is for single use. Discard any remaining solution.

The reconstituted solution is clear and yellow or slightly yellowish. During the storage of pre-prepared solutions, a darkening of the color may occur without affecting the potency of the drug.

How to prepare this medicine

To administer by intravenous infusion, dissolve the CEFTRIAXONE LDP TORLAN 2g powder for solution for infusion EFG in 40 ml of one of the following calcium-free infusion solutions: sodium chloride 0.9%, sodium chloride 0.45% + glucose 2.5%, glucose 5%, glucose 10%, dextran 6% in glucose 5%, starch hydroxyethylated 6-10% or sterile water for injectable preparations. The intravenous infusion should be administered over 30 minutes.

Once reconstituted with the 40 ml of diluent, the concentration of the solution is 50 mg of ceftriaxone (as ceftriaxone sodium) per ml.

The solution should be inspected before administering it by intravenous infusion for the presence of particles or turbidity. If particles or turbidity are observed, the solution should be discarded.

The dose and administration schedule used is based on the patient's age and weight, as well as the severity of the infection.

The solution should not be mixed with solutions containing other antibiotics or in other solutions different from those mentioned above.

.