Ceftriaxone LDP Torlan 250 mg powder and solvent for intravenous injection solution EFG

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the User

CeftriaxoneLDP Torlan 250 mg Powder and solvent for injectable intravenous 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 refer to 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 it may harm them.
• If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are side effects not listed in this leaflet. See section 4.

Leaflet Contents:

1. What CeftriaxoneLDP Torlan 250 mg powder and solvent for injectable intravenous solution EFG is and what it is used for.
2. What you need to know before using CeftriaxoneLDP Torlan 250 mg powder and solvent for injectable intravenous solution EFG.
3. How to use CeftriaxoneLDP Torlan 250 mg powder and solvent for injectable intravenous solution EFG.
4. Possible side effects.
5. How to store CeftriaxoneLDP Torlan 250 mg powder and solvent for injectable intravenous solution EFG.
6. Contents of the pack and other information.

CeftriaxoneLDP Torlan is presented as a powder for injectable solution. Each pack contains one vial, and each vial contains 250 mg of ceftriaxone (as ceftriaxone sodium). The other components (excipients) are 5 ml of water for injections. Once reconstituted, the solution contains 50 mg of ceftriaxone per ml.

1. What Ceftriaxone LDP Torlan 250 mg powder and solvent for intravenous injectable solution EFG is and what it is used for

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

Ceftriaxone LDP Torlan is indicated for the treatment of severe infections caused by microorganisms sensitive to ceftriaxone, such as: septicemia (infection caused by the passage of pathogenic bacteria into the bloodstream), bacterial meningitis, abdominal infections (such as peritonitis and infections of the biliary tract), bone and joint infections, complicated skin and soft tissue infections, complicated urinary tract infections including pyelonephritis (in the kidney), respiratory tract infections, genital tract infections (including gonococcal disease), 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 surgical procedures.

2. What you need to know before using Ceftriaxone LDP Torlan 250 mg powder and solvent for intravenous injectable solution EFG

Do not use Ceftriaxone LDP Torlan 250 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 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 causing difficulty breathing or swallowing, 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 solutions or products containing calcium, even if administered via different infusion routes, as precipitates may form.

Take special care with Ceftriaxone LDP Torlan 250 mg:

• If you have previously experienced an allergic reaction to ceftriaxone or to any penicillin, or have suffered from 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 persistent and severe diarrhea during or after using 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 had gastrointestinal disorders, 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.
• 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 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 using or have recently used 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 to treat infections)
• Hormonal contraceptives. Additional contraceptive measures are recommended during treatment and for the following month

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 or not it is appropriate to use. Taking medicines during pregnancy may be harmful to the embryo or fetus and must 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 LDP Torlan may occasionally cause dizziness.

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

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 250 mg powder and solvent for intravenous injectable solution EFG

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

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

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.

Your doctor will determine 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 receiving this medicine for at least 2 to 3 days after recovery from your illness or to prevent infections for a few days after your surgical procedure.

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

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

Ceftriaxone LDP Torlan must be reconstituted before use. Check that no foreign particles are visible and that the solution is not cloudy or discolored.

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

Contact your doctor or pharmacist urgently, or go to the nearest hospital.

In case of overdose or accidental administration to another person, contact the Toxicology Information Service at telephone number 91 562 04 20, indicating the product and the amount administered. Take this leaflet with you.

If you forget to use Ceftriaxone LDP Torlan 250 mg: Do not use a double dose to make up for forgotten doses.

If you stop treatment with Ceftriaxone LDP Torlan 250 mg:

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 calcium-containing solutions or products, even if different infusion routes are used.

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

Like all medicines, Ceftriaxona LDP Torlan may have 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 (decreased number of white blood cells in blood), granulocytopenia (decreased number of granulocytes in blood), thrombocytopenia (decreased number of platelets in blood), and eosinophilia (increase in a specific type of white blood cells).
• Very rare (less than 1 in 10,000 patients): coagulation disorders, agranulocytosis (decrease or absence of white blood cells in blood), especially after 10 days of treatment or after high doses.

Disorders of the immune system

• 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 oral mucosa), 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 with 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 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 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 be even less frequent if administered by slow injection over a period of 2–4 minutes).

Treatment with ceftriaxone, particularly in elderly patients with serious 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 they are possible adverse effects 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 250 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.

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

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.

Before reconstitution, keep in the original container, closed.

The reconstituted solution remains stable for 3 hours at 25°C and for 24 hours under refrigeration (2–8°C).

Do not use Ceftriaxone LDP Torlan if you notice particles or cloudiness.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ceftriaxone LDP Torlan 250 mg powder and solvent for intravenous injectable solution EFG

The active substance is ceftriaxone (as ceftriaxone sodium).

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

The other components are: water for injections.

Appearance of the product and contents of the container

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 containing 1 vial + 1 ampoule of 5 ml of water for injections, and in a pack of 100 vials + 100 ampoules.

Each solvent ampoule contains 5 ml of water for injections.

Other presentations

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

Ceftriaxone LDP Torlan 500 mg powder and solution for intramuscular injectable solution EFG: Carton 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 with 1 vial. Pack with 10 vials. Pack of 50 vials.

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

Ceftriaxone LDP Torlan 1 g powder and solution for intramuscular injectable solution EFG: Carton 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: Use only by a healthcare professional

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 leaflet).

Ceftriaxone LDP Torlan 250 mg for intravenous use 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, dissolve the contents of the vial in 5 ml of solvent from the accompanying ampoule (5 ml of water for injections).

After reconstitution with 5 ml of solvent, the solution concentration is 50 mg of ceftriaxone (as ceftriaxone sodium) per ml.

The solution must be inspected visually for particulate matter or turbidity before injection. 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 mentioned above.