Label: information for the user

CeftriaxoneLDP Torlan 250 mgPowder and solvent for intravenous injectable solution EFG

ceftriaxone (as ceftriaxone sodium)

Read the entire 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 experience any adverse effects, consult your doctor or pharmacist or nurse, even if they are not listed in this label. See section 4.

Ceftriaxone LDP Torlan is presented in the form of a powder for injectable solution. Each container contains a vial and each vial contains 250 mg of ceftriaxone (in the form of ceftriaxone sodium). The other components (excipients) are 5 ml of water for injectable preparations. Once the solution is reconstituted, it contains 50 mg of ceftriaxone per ml.

This medication is an antibiotic that belongs to a group of medications called cephalosporins.

Ceftriaxone LDP Torlan is indicated for the treatment of severe infections caused by susceptible microorganisms, 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 tract infections, genital tract infections (including gonorrhea) and stages II and III of Lyme disease (infection caused by tick bite), in cases where intravenous administration is required.

Ceftriaxone LDP Torlan is also indicated for the prevention of infections before or after a surgical operation.

Do not use Ceftriaxona LDP Torlan 250 mg:

• 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.Ifyou 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 eruption.
• in newborns with jaundice (yellow discoloration of the skin due to excess bilirubin) or hypoproteinemia (deficit 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).
• do not mix or administer Ceftriaxona LDP Torlan simultaneously with solutions or products containing calcium, even if used through different infusion routes, as they may form precipitates.

Be especially careful with Ceftriaxona LDP Torlan 250 mg:

• If you have had any allergic reaction to ceftriaxone or to any penicillin or have suffered from severe allergies or asthma, as ceftriaxone 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 ceftriaxone, other infections (superinfections) may occur due to overgrowth of certain organisms such as enterococci or Candida.
• Your doctor should perform periodic blood tests when you are on prolonged treatment.
• If, due to ceftriaxone 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 ceftriaxone 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).

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.

Your doctor will take special care during the simultaneous use of ceftriaxone 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 breastfeeding

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 with the use of Ceftriaxona LDP Torlan, but it should be noted that Ceftriaxona LDP Torlan may occasionally cause dizziness.

Important information about some of the components of Ceftriaxona LDP Torlan 250 mg intravenous:

Patients with low-sodium diets should note that this medication contains 82.8 mg (3.6 mmol) of sodium per dose.

Follow exactly the administration instructions for Ceftriaxone LDP Torlan as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts. Ceftriaxone will be administered intravenously.

Your doctor will prescribe the most suitable dose depending on the nature of your illness, age, weight, and your individual response to Ceftriaxone LDP Torlan.

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 a vein injection.

Your doctor will indicate the duration of your treatment with Ceftriaxone LDP Torlan, which varies depending on the nature of your illness and your response to treatment. 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.

Do not suspend treatment beforehand, as the desired effect will not be achieved. It is very important to treat infections for the recommended time; otherwise, it could worsen.

Your doctor will inform you when to interrupt treatment. Do not prolong it on your own.

Ceftriaxone LDP Torlan must be reconstituted before use. Check that there are no foreign particles or turbid coloration.

If you use more Ceftriaxone LDP Torlan 250 mg than you should:

Urgently contact your doctor or pharmacist, or go to the nearest hospital.

In case of overdose or accidental administration to another person, consult the Toxicological Information Service. Phone 91 562 04 20 indicating the product and the amount administered. Carry this leaflet with you.

If you forgot to use Ceftriaxone LDP Torlan 250 mg: Do not use a double dose to compensate for the missed doses.

If you interrupt treatment with Ceftriaxone LDP Torlan 250 mg:

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 they are used through different infusion routes.

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 are experiencing 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 (feminine genital tract infections caused by bacteria)

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 oral mucosa), 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 ceftriaxone calcium in the gallbladder and increased liver enzymes (parameters detected in blood tests).
• Frequency "unknown"

Problems with the gallbladder or liver, which may cause pain, nausea, vomiting, yellow skin discoloration, itching, 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 (skin inflammation), rash (exanthema), edema (fluid accumulation 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 blister formation but without inflammation).

Renal and urinary disorders

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

General disorders and administration site conditions

• Rare (between 1 and 10 in every 10,000 patients): fever and chills, phlebitis (vein inflammation) 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 not mentioned in this leaflet. You can also report them directly through the Spanish System for 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.

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.

Before reconstitution, keep in its original, closed packaging.

The reconstituted solution maintains its stability for 3 hours at 25 °C and 24 hours in a refrigerator (2-8 °C).

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

Medicines should not be disposed of through drains or trash. Deposit the containers and medicines you no longer need at the SIGRE collection point of 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.

Ceftriaxone LDP Torlan 250 mg powder and diluent for intravenous solution EFG

The active ingredient is ceftriaxone (as ceftriaxone sodium).

Each vial contains 250 mg of ceftriaxone (as ceftriaxone sodium).

The other components are: water for injection.

Appearance of the product and contents of the package

Ceftriaxone LDP Torlan is presented in a glass vial, closed with a rubber stopper and sealed with a flip-off capsule, and a glass ampoule of diluent, in a pack with 1 vial + 1 ampoule of 5 ml of water for injection, and in a pack of 100 vials + 100 ampoules.

Each ampoule of diluent contains 5 ml of water for injection.

Other presentations

Ceftriaxone LDP Torlan 500 mg powder and diluent for intravenous solution EFG: Pack with 1 vial + 1 ampoule of 5 ml of water for injection. Pack of 100 vials + 100 ampoules.

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

Ceftriaxone LDP Torlan 2 g powder for solution for infusion EFG: Pack with 1 vial. Pack with 10 vials. Pack of 50 vials.

Ceftriaxone LDP Torlan 1 g powder and diluent for intravenous solution EFG: Pack with 1 vial + 1 ampoule of 10 ml of water for injection. Pack of 100 vials + 100 ampoules.

Ceftriaxone LDP Torlan 1 g powder and solution for intramuscular solution EFG: Pack 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 manufacturer responsible

LDP-Laboratorios Torlan, S.A.

Ctra. Barcelona 135 B

08290-Cerdanyola del Vallès (Barcelona)

Spain

This leaflet has been revised in:May 2024

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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 have other agents added to them. In particular, diluents containing calcium (e.g. Ringer's solution, Hartmann's solution) should not be used to reconstitute ceftriaxone vials or to dilute reconstituted vials when administered intravenously, 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 data sheet and section 6 of the leaflet).

Ceftriaxone LDP Torlan 250 mg intravenous should 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 prepared solutions, an increase in the intensity of the color may occur without affecting the potency of the drug.

How to prepare this medication

For intravenous administration, the contents of the vial are dissolved in 5 ml of diluent from the accompanying ampoule (5 ml of water for injection).

Once reconstituted with the 5 ml of diluent, the concentration of the solution is 50 mg of ceftriaxone (as ceftriaxone sodium) per ml.

The solution should be examined before injecting it for the presence of particles or turbidity. If particles 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.