Ceftriaxone LDP Torlan 500 mg powder and solvent for intravenous solution for injection EFG

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the User

Ceftriaxone LDP Torlan 500 mg powder and solvent for intravenous injectable solution EFG

ceftriaxone (as ceftriaxone sodium)

Read the entire leaflet carefully before you start using this 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 give it to others, even if they have the same symptoms, as it may harm them.
• If you consider any of the side effects you experience to be serious, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Leaflet Contents:

1. What Ceftriaxone LDP Torlan 500 mg powder and solvent for intravenous injectable solution EFG is and what it is used for.
2. What you need to know before using Ceftriaxone LDP Torlan 500 mg powder and solvent for intravenous injectable solution EFG.
3. How to use Ceftriaxone LDP Torlan 500 mg powder and solvent for intravenous injectable solution EFG.
4. Possible side effects.
5. How to store Ceftriaxone LDP Torlan 500 mg powder and solvent for intravenous injectable solution EFG.
6. Contents of the pack and other information.

1. What Ceftriaxone LDP Torlan 500 mg powder and solvent for intravenous injectable solution EFG is and what it is used for

This medicine is an antibiotic belonging to a group called cephalosporins.

Antibiotics are used to treat bacterial infections and are not effective against viral infections such as flu or the common cold.

It is important that you follow your doctor's instructions regarding dose, dosing interval, and duration of treatment.

Do not store or reuse this medicine. If you have any antibiotic left over after completing treatment, return it to the pharmacy for proper disposal. Medicines must not be disposed of via wastewater or household waste.

Ceftriaxone LDP Torlan is indicated for the treatment of serious infections caused by microorganisms sensitive to ceftriaxone, such as: septicemia (infection caused by pathogenic bacteria entering the bloodstream), 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 infections (including gonococcal disease), and stages II and III of Lyme disease (an infection caused by tick bite).

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

2. What you need to know before using Ceftriaxone LDP Torlan 500 mg powder and solvent for intravenous injectable solution EFG

Do not use Ceftriaxone LDP Torlan 500 mg:

• if you are allergic (hypersensitive) to the active substance or to cephalosporins, penicillins, or any other antibiotics known as β-lactams, or to any of the other ingredients of Ceftriaxone LDP Torlan. If you have previously experienced 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 swelling of the throat or face making it difficult to breathe or swallow, sudden swelling of hands, feet, and ankles, chest pain, or a severe and rapidly developing skin rash.
• in newborns with jaundice (yellowing of the skin due to excess bilirubin) or hypoalbuminemia (deficiency of a blood protein called albumin), or in premature infants due to the risk of developing hyperbilirubinemic encephalopathy (a condition that may cause brain damage due to bilirubin accumulation and can be fatal).
• ceftriaxone must not be mixed or administered simultaneously with calcium-containing solutions or products, even if administered via different infusion routes, as precipitates may form.

Take special care with Ceftriaxone LDP Torlan 500 mg

• If you have previously experienced an allergic reaction to ceftriaxone or any penicillin, or have had severe allergies or asthma, as ceftriaxone may cause allergic reactions, which in some cases could be fatal (anaphylaxis). If this occurs, contact a doctor immediately or go to the nearest hospital.
• If you develop severe and persistent diarrhea during or after treatment with this medicine, it may be due to a type of colitis (pseudomembranous colitis) which can be serious. In such cases, your doctor will discontinue ceftriaxone and initiate appropriate treatment. Inform your doctor if you have previously suffered from gastrointestinal disorders, particularly colitis.
• If undergoing prolonged treatment with ceftriaxone, other infections (superinfections) may occur due to overgrowth of certain organisms such as enterococci or Candida.
• During prolonged treatment, your doctor should perform periodic blood tests.
• If signs and symptoms of gallbladder disease appear, accompanied by ultrasound abnormalities of the gallbladder due to precipitation of calcium-ceftriaxone complexes. The risk of such abnormalities may increase with treatments longer than 14 days, in patients with renal failure, dehydration, or total parenteral nutrition, as well as in very young children. If this occurs, treatment with ceftriaxone should be discontinued.
• Before starting treatment with Ceftriaxone LDP Torlan, if you have severe liver or kidney disease, as you may require dose adjustment, or if you are at risk of developing pancreatitis (inflammation of the pancreas).
• If you are scheduled to undergo any diagnostic tests (including blood and urine tests, skin tests using allergens, etc.), inform your doctor that you are taking this medicine, as it may interfere with test results.
• If you have liver or kidney problems (see section 4).

Use of other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

Your doctor will exercise particular caution when using ceftriaxone concomitantly with:

• Probenecid (a medicine used to treat gout)
• Other antibiotics (medicines used for infections)
• Hormonal contraceptives. Additional contraceptive measures are recommended during treatment and for one month after its completion.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

If you are pregnant or think you might be pregnant, inform your doctor before using this medicine; your doctor will decide whether it is appropriate to use it. Taking medicines during pregnancy may be harmful to the embryo or fetus and should be monitored by your doctor.

Driving and use of machines

It has not been demonstrated that Ceftriaxone LDP Torlan affects your ability to drive vehicles or operate tools or machinery. However, it should be noted that ceftriaxone may occasionally cause dizziness.

Important information about some of the components of Ceftriaxone LDP Torlan 500 mg:

Patients on low-sodium diets should be aware that this medicine contains 82.8 mg (3.6 mmol) of sodium per dose.

3. How to use Ceftriaxone LDP Torlan 500 mg powder and solvent for intravenous injectable solution EFG

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 appropriate dose and duration of treatment.

Never change the dose on your own. If you feel that the effect of Ceftriaxone LDP Torlan is too strong or too weak, inform your doctor or pharmacist. Ceftriaxone LDP Torlan is administered by intravenous injection.

You will continue receiving this medication for at least 2 to 3 days after recovery from your illness, or to prevent infections for several days after your surgical procedure.

Your doctor will tell you when to stop treatment. Do not extend it on your own.

Ceftriaxone LDP Torlan must be reconstituted immediately before use. To do this, dissolve the powder in the vial with 5 ml of solvent from the accompanying ampoule (5 ml of water for injections). Check that no foreign particles are visible and that the solution is not cloudy.

Adults and children over 12 years of age: 2 to 4 vials (1 to 2 g of ceftriaxone) every 24 hours, meaning 1–2 g/day; in severe cases, the dose may be increased to 4 g/day.

Newborns, infants, and children under 12 years of age: The following once-daily doses are recommended: in newborns (up to 14 days), 20 to 50 mg/kg body weight; do not exceed this dose. In infants and children (from 15 days to 12 years), a daily dose of 20–80 mg/kg body weight. For children weighing 50 kg or more, administration should be by infusion over at least 30 minutes. The duration of therapy varies depending on the course of the disease. As with antibiotic therapy in general, ceftriaxone administration should continue for a minimum of 48 to 72 hours after defervescence or until evidence of bacterial eradication is obtained.

Elderly patients: In elderly patients, dose adjustments are not required compared to the recommended adult doses.

Treatment of bacterial meningitis (infants and children): Start with a dose of 100 mg/kg (not exceeding 4 g) once daily. As soon as the causative microorganism is identified and its sensitivity determined, the dose may be reduced.

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

Perioperative prophylaxis: 2 to 4 vials (1 to 2 g of ceftriaxone) administered 30–90 minutes before surgery.

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

Treatment of patients undergoing dialysis: No additional supplemental dose is required after dialysis; however, serum concentrations should be monitored to determine whether dose adjustments are needed, as elimination rates in these patients may be reduced.

If you use more Ceftriaxone LDP Torlan 500 mg than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and amount taken.

If you forget to use Ceftriaxone LDP Torlan 500 mg

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

If you stop treatment with Ceftriaxone LDP Torlan 500 mg

Do not stop treatment prematurely, 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

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

Cases of fatal reactions have been reported in newborns and premature infants due to the formation of calcium-ceftriaxone precipitates in the lungs and kidneys of these patients. In some cases, ceftriaxone and calcium-containing solutions were administered via different infusion routes and at different times.

Like all medicines, Ceftriaxona LDP Torlan may have adverse effects, although not everyone will experience them.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effect not listed in this leaflet, inform your doctor or pharmacist.

Infections and infestations

• Rare (between 1 and 10 in 10,000 patients): vulvovaginitis (infections of the female genital tract caused by bacteria)

Blood and lymphatic system disorders

• Rare (between 1 and 10 in 10,000 patients): anemia (decreased hemoglobin concentration in blood), leukopenia (decreased number of white blood cells in blood), granulocytopenia (decreased granulocyte count in blood), thrombocytopenia (decreased platelet count in blood), and eosinophilia (increase in a specific group of white blood cells).
• Very rare (less than 1 in 10,000 patients): coagulation disorders, agranulocytosis (decreased or absent white blood cells in blood), particularly after 10 days of treatment or following high doses.

Immune system disorders

• Rare (between 1 and 10 in 10,000 patients): anaphylactic (allergic) or anaphylactoid reactions and urticaria (generalized itching of the skin).
• Frequency not known: Chest pain in the context of allergic reactions, which may be a symptom of myocardial infarction triggered by allergy (Kounis syndrome).

Nervous system disorders

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

Gastrointestinal disorders

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

Hepatobiliary disorders

• Rare (between 1 and 10 in 10,000 patients): symptomatic precipitation of calcium-ceftriaxone in the gallbladder and increased liver enzymes (parameters detected in blood tests).
• Frequency not known: Problems with the gallbladder or liver, which may cause pain, nausea, vomiting, yellowing of the skin (jaundice), itching, abnormally dark urine, and clay-colored stools.

Skin and subcutaneous tissue disorders

• Uncommon (between 1 and 10 in 1,000 patients): exanthema (skin rash), allergic dermatitis (skin inflammation), rash, edema (fluid accumulation in tissues), and erythema multiforme.
• Very rare (less than 1 in 10,000 patients): Stevens-Johnson syndrome, toxic epidermal necrolysis, or Lyell's syndrome (skin destruction with epithelial detachment starting with blister formation but without inflammation).

Renal and urinary disorders

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

General disorders and administration site conditions

• Rare (between 1 and 10 in 10,000 patients): fever and chills, phlebitis (vein inflammation), which may be even less frequent if administered via slow injection over a period of 2–4 minutes.

Treatment with ceftriaxone, particularly in elderly patients with severe kidney problems or neurological disorders, may rarely cause decreased consciousness, abnormal movements, agitation, and seizures.

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines (Website: www.notificaRAM.es). By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ceftriaxone LDP Torlan 500 mg powder and solvent for intravenous injectable solution EFG

Keep out of the reach and sight of children.

This medicine does not require special storage temperature conditions.

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

After reconstitution, 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 expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month indicated.

Do not use Ceftriaxone LDP Torlan if particles or cloudiness are observed.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ceftriaxone LDP Torlan 500 mg powder and solvent for injectable intravenous solution EFG

The active substance is ceftriaxone (as ceftriaxone sodium).

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

The other components are: water for injections.

Appearance of the product and contents of the pack

Ceftriaxone LDP Torlan is supplied in a glass vial closed with a rubber stopper and sealed with a flip-off cap, and a glass ampoule of solvent, in a carton pack containing 1 vial + 1 ampoule of 5 ml of water for injections, and in a pack of 100 vials + 100 ampoules of 5 ml water for injections.

Each solvent ampoule contains 5 ml of water for injections.

Other presentations

Ceftriaxone LDP Torlan 1 g powder and solvent for injectable intravenous solution EFG: Carton pack with 1 vial + 1 ampoule of 10 ml of water for injections. Pack of 100 vials + 100 ampoules.

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

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

Ceftriaxone LDP Torlan 250 mg powder and solvent for injectable intravenous solution EFG: Carton pack with 1 vial + 1 ampoule of 5 ml of water for injections. Pack of 100 vials + 100 ampoules.

Ceftriaxone LDP Torlan 1 g powder and solution for injectable intramuscular solution EFG: Carton pack with 1 vial + 1 ampoule of 3.5 ml of lidocaine hydrochloride solution (35 mg/3.5 ml). Pack of 100 vials + 100 ampoules.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

LDP-Laboratorios Torlan, S.A.

Ctra. Barcelona 135 B

08290-Cerdanyola del Vallès (Barcelona)

Spain

This leaflet was last reviewed in: May 2024

Warning: For use by healthcare professionals only

This information is intended solely for physicians or healthcare professionals:

Solutions containing ceftriaxone must not be mixed or combined with other agents. In particular, diluents containing calcium (e.g., Ringer's solution, Hartmann's solution) must not be used to reconstitute ceftriaxone vials or to dilute reconstituted vials when administered intravenously, as precipitates may form.

Ceftriaxone must not be mixed or administered simultaneously with solutions containing calcium (see sections 4.2, 4.3, 4.4, and 4.8 of the Summary of Product Characteristics and section 6 of the Patient Information Leaflet).

Ceftriaxone LDP Torlan 500 mg must be reconstituted before use. The reconstituted solution is for single use only. Any unused solution must be discarded.

The reconstituted solution is clear and yellow or slightly yellowish. During storage of prepared solutions, an increase in color intensity may occur without affecting the drug's potency.

How to prepare this medicine

For intravenous administration, the contents of the vial should be dissolved in 5 ml of the solvent from the accompanying ampoule (5 ml of water for injections).

After reconstitution with 5 ml of solvent, the concentration of the solution is 100 mg of ceftriaxone (as ceftriaxone sodium) per ml.

The solution should be inspected before injection for the presence of particles or turbidity. If foreign particles are observed, the solution must be discarded.

The dose and administration regimen used depend on the patient's age and weight, as well as the severity of the infection.

The solution must not be mixed with solutions containing other antibiotics or with other solutions different from those specified above.