Ceftriaxone LDP Torlan 1 g powder and solution for intramuscular injection solution EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ceftriaxone LDP Torlan 1 g powder and solution for injectable solution for intramuscular use 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 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.

Contents of the leaflet:

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

1. What is Ceftriaxone LDP Torlan 1 g powder and solution for injectable solution for intramuscular injection EFG and what is it 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 your doctor's instructions regarding dosage, dosing interval, and duration of treatment.

Do not store or reuse this medicine. If you have any antibiotic left over after completing your treatment, return it to the pharmacy for proper disposal. Do not dispose of medicines via the drain or in household waste.

Ceftriaxone LDP Torlan is indicated for the treatment of serious infections caused by microorganisms sensitive to ceftriaxone, such as: sepsis (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 1 g powder and solution for injectable solution for intramuscular injection EFG

Do not use Ceftriaxone LDP Torlan 1 g:

• if you are allergic (hypersensitive) to the active substance or to cephalosporins, penicillins, or any other so-called β-lactam antibiotics, 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 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 solutions or products containing calcium, even if administered via different infusion routes, as precipitates may form.

Take special care with Ceftriaxone LDP Torlan 1 g

• If you have previously experienced an allergic reaction to ceftriaxone or to any penicillin, or have had severe allergies or asthma, as ceftriaxone may cause allergic reactions that could, in some cases, 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) that 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 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 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 alter 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 taking 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 use of 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 1 g:

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 1 g powder and solution for injectable solution for intramuscular injection EFG

Ceftriaxone is administered by intramuscular route. 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.

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 intramuscular injection.

You will continue receiving this medicine 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 indicate when you should 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 3.5 ml of solution from the accompanying ampoule (a solution of lidocaine hydrochloride 35 mg/3.5 ml). Check that no foreign particles are visible and that the solution is not cloudy.

Adults and children over 12 years of age: 1 to 2 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 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 of age), a daily dose of 20–80 mg/kg body weight. For children weighing 50 kg or more, the dose should be administered 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, administration of ceftriaxone 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 adjustment is 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 intramuscular dose of 250 mg 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, provided 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.

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 1 g 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 used.

If you forget to use Ceftriaxone LDP Torlan 1 g

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

If you stop treatment with Ceftriaxone LDP Torlan 1 g

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 condition could 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 in newborns and premature infants due to precipitation of ceftriaxone-calcium salt in the lungs and kidneys of these patients have been reported. 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 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)

Blood and lymphatic system disorders

• Rare (between 1 and 10 in 10,000 patients): anemia (decreased hemoglobin concentration in blood), leukopenia (reduced number of white blood cells in blood), granulocytopenia (reduced number of granulocytes in blood), thrombocytopenia (reduced number of platelets 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 (reduction or absence of 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 affecting the gallbladder or liver, which may cause pain, nausea, vomiting, yellowing of the skin, 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 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 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 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 1 g powder and solution for injectable intramuscular 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.

After reconstitution, the solution is stable for 24 hours at a temperature of 25 °C or 2–8 °C (refrigerator).

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 in the solution.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at a SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to 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 1 g powder and solvent for injectable solution for intramuscular injection EFG

The active substance is ceftriaxone (as ceftriaxone sodium).

Each vial contains 1 g of ceftriaxone (as ceftriaxone sodium).

The other components are: 3.5 ml of lidocaine hydrochloride solution (35 mg/3.5 ml).

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, together with one ampoule of 3.5 ml lidocaine hydrochloride solution (35 mg/3.5 ml), in a carton containing 1 vial + 1 ampoule of 3.5 ml lidocaine hydrochloride solution (35 mg/3.5 ml). Pack size: 100 vials + 100 ampoules.

Each ampoule of solution contains 3.5 ml of lidocaine hydrochloride solution (35 mg/3.5 ml).

Other presentations

Ceftriaxone LDP Torlan 500 mg powder and solvent for intravenous injectable solution EFG: Carton with 1 vial + 1 ampoule of 5 ml water for injections. Pack size: 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 lidocaine hydrochloride solution (20 mg/2 ml). Pack size: 100 vials + 100 ampoules.

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

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

Ceftriaxone LDP Torlan 1 g powder and solvent for intravenous injectable solution EFG: Carton with 1 vial + 1 ampoule of 10 ml water for injections. Pack size: 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 exclusively 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 intended for intravenous administration, as precipitates may form.

Ceftriaxone must not be mixed or administered simultaneously with calcium-containing solutions (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 1 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 potency of the drug.

How to prepare this medicine

After reconstitution with 3.5 ml of lidocaine hydrochloride solution, the concentration of the solution is 285.71 mg of ceftriaxone (as ceftriaxone sodium) per ml.

The solution should 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, weight, and the severity of the infection.

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