Ceftriaxone LDP Torlan 2 g powder for solution for infusion EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ceftriaxone LDP Torlan 2 g powder for solution for infusion 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 and should not be given to other people, even if they have the same symptoms as you, because it could be harmful to them.
• If you think any of the side effects you experience are 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 2 g powder for solution for infusion EFG is and what it is used for.
2. What you need to know before using Ceftriaxone LDP Torlan 2 g powder for solution for infusion EFG.
3. How to use Ceftriaxone LDP Torlan 2 g powder for solution for infusion EFG.
4. Possible side effects.
5. How to store Ceftriaxone LDP Torlan 2 g powder for solution for infusion EFG.
6. Contents of the pack and other information.

1. What Ceftriaxone LDP Torlan 2 g powder for solution for infusion EFG is and what it is used for

This medicine is an antibiotic belonging to the group known as cephalosporins.

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

It is important that you follow the instructions regarding dose, dosing interval, and duration of treatment as directed by your doctor.

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 the sink or in 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 2 g powder for solution for infusion EFG

Do not use Ceftriaxone LDP Torlan 2 g:

• 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 components 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 rapid and severe 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.

Warnings and precautions

• If you have previously experienced an allergic reaction to ceftriaxone or to any penicillin, or have suffered from severe allergies or asthma, as ceftriaxone could 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 had gastrointestinal disorders, particularly colitis.
• If you are undergoing prolonged treatment with ceftriaxone, other infections (superinfections) may occur due to overgrowth of organisms such as enterococci or Candida.
• During prolonged treatment, your doctor should perform periodic blood tests.
• If signs and symptoms of gallbladder disease appear due to precipitation of calcium-ceftriaxone, accompanied by abnormalities on gallbladder ultrasound. The risk of such abnormalities may increase with treatment lasting more than 14 days, in patients with renal failure, dehydration, or total parenteral nutrition, as well as in very young children. If such events occur, ceftriaxone treatment must 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).

Other medicines and Ceftriaxone LDP Torlan

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

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

• Probenecid (a medicine used to treat gout)
• Other antibiotics (medicines used to treat infections)
• Hormonal contraceptives. Additional contraceptive measures are recommended during treatment and for one month following 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, and he or she will decide whether its use is appropriate. Taking medicines during pregnancy may be harmful to the embryo or fetus and should be monitored by your doctor.

Driving and using machines

It has not been demonstrated that the use of 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 2 g:

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

3. How to use Ceftriaxone LDP Torlan 2 g powder for solution for infusion EFG

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

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 alter 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 infusion.

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 following your surgical procedure.

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

Adults and children over 12 years of age: 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 doses are recommended, administered once daily: 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, the infusion should last at least 30 minutes. The duration of therapy depends on the course of the disease. As with antibiotic therapy in general, administration of ceftriaxone should continue for a minimum of 48 to 72 hours after fever has subsided or until evidence of bacterial eradication is obtained.

Elderly patients: In elderly patients, no adjustment of the recommended adult doses is required.

Treatment of bacterial meningitis (infants and children): Initial 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 infection: For the treatment of gonorrhea, a single 250 mg intramuscular dose is recommended.

Perioperative prophylaxis: 1 to 2 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 hepatic 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.

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 2 g than you should

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

If you forget to use Ceftriaxone LDP Torlan 2 g

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

If you stop treatment with Ceftriaxone LDP Torlan 2 g

Do not discontinue treatment prematurely, as the desired effect will not be achieved. It is very important to treat infections for the recommended duration; otherwise, the infection may worsen.

If you have any further questions about the use of this product, consult your doctor or pharmacist.

4. Possible adverse effects

Ceftriaxone must not be mixed or administered simultaneously with calcium-containing solutions or products, 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, Ceftriaxone LDP Torlan may cause adverse effects, although not everyone experiences them.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects 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).

Disorders of the blood and lymphatic system

• Rare (between 1 and 10 in 10,000 patients): anaemia (decreased haemoglobin concentration in blood), leucopenia (reduced number of white blood cells in blood), granulocytopenia (reduced granulocyte count in blood), thrombocytopenia (reduced number of platelets in blood), and eosinophilia (increased levels of a specific type of white blood cells).
• Very rare (less than 1 in 10,000 patients): coagulation disorders, agranulocytosis (reduced 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): diarrhoea, nausea, stomatitis (inflammation of the mucous lining of the mouth), and glossitis (inflammation of the tongue).
• Very rare (less than 1 in 10,000 patients): pseudomembranous colitis (acute and severe diarrhoea caused by bacterial superinfection), pancreatitis, gastrointestinal haemorrhage.

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 affecting the gallbladder or liver, which may cause pain, nausea, vomiting, yellowing of the skin, itching, abnormally dark urine, and clay-coloured stools.

Skin and subcutaneous tissue disorders

• Uncommon (between 1 and 10 in 1,000 patients): exanthema (skin rash), allergic dermatitis (skin inflammation), rash, oedema (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 output), increased serum creatinine (a parameter detected in blood tests).
• Very rare (less than 1 in 10,000 patients): renal precipitation of sodium-ceftriaxone in paediatric patients, haematuria (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 occur even less frequently 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 adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can 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 2 g powder for solution for infusion EFG

Keep out of the reach and sight of children.

This medicine does not require special storage temperature conditions.

Keep 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 you notice particles or cloudiness.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the container and additional information

Composition of Ceftriaxone LDP Torlan 2 g powder for solution for infusion EFG

The active substance is ceftriaxone (as ceftriaxone sodium).

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

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, in pack sizes of 1 vial, 10 vials, and 50 vials.

Other presentations

Ceftriaxone LDP Torlan 500 mg powder and solvent for intravenous injectable solution EFG: Kit containing 1 vial + 1 ampoule of 5 ml water for injections. Pack of 100 vials + 100 ampoules.

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

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

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

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

Only certain pack sizes may be commercially available.

MARKETING AUTHORISATION HOLDER AND 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

Date of most recent review of this leaflet: May 2024

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

Warning: For use exclusively by healthcare professionals

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 vials of ceftriaxone or to dilute reconstituted vials when administration is intended via IV route, as this may lead to precipitate formation.

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

After reconstitution with 40 ml of solvent, the solution concentration is 50 mg of ceftriaxone (as ceftriaxone sodium) per ml.

The solution must be visually inspected before intravenous infusion 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, weight, and the severity of the infection.

The solution must not be mixed with solutions containing other antibiotics or with solutions other than those listed above.