CEFTRIAXONE LDP TORLAN 250 mg POWDER AND SOLVENT FOR INTRAVENOUS INJECTION SOLUTION

Introduction

Package Leaflet: Information for the User

CeftriaxoneLDP Torlan 250 mgPowder and solvent for solution for intravenous injection EFG

ceftriaxone (as ceftriaxone sodium)

Read all of this leaflet carefully before you start using this medicine.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you, do not pass it on to others, as it may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

Contents of the pack:

1. What Ceftriaxone LDP Torlan 250 mg powder and solvent for solution for intravenous injection EFG is and what it is used for.
2. What you need to know before you use Ceftriaxone LDP Torlan 250 mg powder and solvent for solution for intravenous injection EFG.
3. How to use Ceftriaxone LDP Torlan 250 mg powder and solvent for solution for intravenous injection EFG.
4. Possible side effects.
5. Storage of Ceftriaxone LDP Torlan 250 mg powder and solvent for solution for intravenous injection EFG.
6. Pack contents and further information.

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

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

This medicine is an antibiotic that belongs to a group of medicines called 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 blood), bacterial meningitis, abdominal infections (such as peritonitis and infections of the biliary tract), infections of the bones and joints, 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 a tick bite), in cases where intravenous administration is required.

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

2. What you need to know before you use Ceftriaxone LDP Torlan 250 mg powder and solvent for solution for intravenous injection 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 antibiotic of the so-called β-lactam group or to any of the other components of Ceftriaxone LDP Torlan. If you 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 are sudden swelling 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 rash.
• in newborns with jaundice (yellowing of the skin due to excess bilirubin) or hypoalbuminemia (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).
• ceftriaxone must not be mixed or administered simultaneously with solutions or products containing calcium, even if different infusion routes are used, as precipitates may form.

Be careful with Ceftriaxone LDP Torlan 250 mg:

• If you have had any allergic reaction to ceftriaxone or any penicillin or have suffered from severe allergies or asthma, as ceftriaxone may cause allergic reactions that can be fatal (anaphylaxis). If this happens, contact your doctor or go to the nearest hospital immediately.
• If you experience severe and prolonged diarrhea during or after using this medicine, it may be due to a type of colitis (pseudomembranous colitis) that can be severe. In this case, your doctor will stop the administration of ceftriaxone 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 the overgrowth of some organisms such as enterococci or candida.
• When undergoing prolonged treatments, your doctor should perform periodic blood tests.
• If, due to the sedimentation of ceftriaxone calcium, signs and symptoms of gallbladder disease appear, accompanied by alterations in gallbladder ultrasound. 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. If this occurs, the medication with ceftriaxone should be discontinued.
• Before starting treatment with Ceftriaxone LDP Torlan, if you have severe liver or kidney disease, as you may need a dose adjustment or if you are at risk of developing pancreatitis (inflammation of the pancreas).
• If you are going to undergo any diagnostic test (including blood tests, urine tests, skin tests that use allergens, etc.), inform your doctor that you are using this medicine, as it may alter the results.
• If you have liver or kidney problems (see section 4).

Use of other medicines

Tell your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.

Your doctor will be particularly careful during the simultaneous use of ceftriaxone with:

• Probenecid (a medicine used to treat gout)
• Other antibiotics (medicines used for infections)
• Hormonal contraceptives. It is recommended to take additional measures during the treatment period and in the following month.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

If you are pregnant or think you may be pregnant, inform your doctor before using this medicine, and he will decide whether to use it. The use of medicines during pregnancy can be hazardous 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 can affect your ability to drive vehicles or operate tools or machines, but you should take into account that ceftriaxone can occasionally cause dizziness.

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

Patients on low-sodium diets should note 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 solution for intravenous injection EFG

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

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

Never modify the dose on your own. If you think the effect of Ceftriaxone LDP Torlan is too strong or too weak, tell your doctor or pharmacist. Ceftriaxone LDP Torlan is administered by intravenous injection.

Your doctor will indicate the duration of your treatment with Ceftriaxone LDP Torlan, which varies depending on the nature of your disease and your response to treatment. You will continue to receive this medicine for at least 2 to 3 days after you have recovered from your disease or to prevent infections for a few days after your surgery.

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

Your doctor will indicate when to interrupt the treatment. Do not prolong it on your own.

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

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, consult the Toxicology Information Service. Phone 91 562 04 20 indicating the product and the amount administered. Bring 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 interrupt the treatment with Ceftriaxone LDP Torlan 250 mg:

If you have any other doubts about the use of this product, ask your doctor or pharmacist.

4. Possible side effects

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

There have been reports of reactions that have caused the death of newborns and premature babies due to the formation of precipitates of ceftriaxone calcium in the lungs and kidneys of these patients. In some cases, the infusion routes and administration times of ceftriaxone and calcium-containing solutions were different.

Like all medicines, Ceftriaxone LDP Torlan can have side effects, although not everyone gets them.

If you think any of the side effects you are suffering from is serious, or if you notice any side effects not mentioned in this leaflet, tell your doctor or pharmacist.

Infections and infestations

• Rare (between 1 and 10 in every 10,000 patients): vulvovaginitis (infections of the female genital tract 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 the number of white blood cells in blood), granulocytopenia (decrease in the number of granulocytes in blood), thrombocytopenia (decrease in the number of platelets in blood), and eosinophilia (increase in a certain group of white blood cells).
• Very rare (in 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 after high doses.

Immune system disorders

• Rare (between 1 and 10 in every 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 can be a symptom of a heart attack triggered by the allergy (Kounis syndrome).

Nervous system disorders

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

Gastrointestinal disorders

• Frequent (between 1 and 10 in every 100 patients): diarrhea, nausea, stomatitis (inflammation of the mouth mucosa), and glossitis (inflammation of the tongue).
• Very rare (in less than 1 in every 10,000 patients): pseudomembranous colitis (severe and acute diarrhea caused by a superinfection by a bacterium), pancreatitis, gastrointestinal bleeding.

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 not known

Problems with the gallbladder or liver, which can cause pain, nausea, vomiting, yellowing of the skin, itching, abnormal urine, and clay-colored stools.

Skin and subcutaneous tissue disorders

• Uncommon (between 1 and 10 in every 1,000 patients): exanthema (skin rash), allergic dermatitis (skin inflammation), rash (exanthema), edema (fluid accumulation in tissues), and erythema multiforme.
• Very rare (in less than 1 in every 10,000 patients): Stevens-Johnson syndrome, toxic epidermal necrolysis, or Lyell syndrome (skin destruction with epidermal detachment that starts 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 (in less than 1 in every 10,000 patients): renal precipitation of ceftriaxone sodium 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 (inflammation of the veins) that can be even less frequent if administered slowly over a period of 2-4 minutes.

Treatment with ceftriaxone, particularly in elderly patients with severe kidney problems or nervous system problems, can rarely cause decreased consciousness, abnormal movements, agitation, and convulsions.

Reporting of side effects:

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines (Website: www.notificaRAM.es). By reporting side 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 solution for intravenous injection EFG

Keep out of the reach and sight of children.

This medicine does not require special temperature storage conditions.

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

Do not use Ceftriaxone LDP Torlan after the expiration date stated on the packaging after "EXP". The expiration date is the last day of the month indicated.

Before reconstitution, store in the original packaging, closed.

The reconstituted solution remains stable for 3 hours at 25°C and 24 hours in the refrigerator (2-8°C).

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

Medicines should not be disposed of via wastewater or household waste. Place the packaging and medicines you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medicines you no longer need. This way, you will help protect the environment.

6. Container Content and Additional Information

Composition of Ceftriaxone LDP Torlan 250 mg Powder and Solvent for Intravenous Injectable 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 injectable preparations.

Product Appearance and Container Content

Ceftriaxone LDP Torlan is presented in a glass vial, closed with a rubber stopper and sealed with a flip-off cap, and a glass ampoule of solvent, in a box with 1 vial + 1 ampoule of 5 ml of water for injectable preparations, and in a package of 100 vials + 100 ampoules.

Each solvent ampoule contains 5 ml of water for injectable preparations.

Other Presentations

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

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

Ceftriaxone LDP Torlan 2 g powder for solution for perfusion EFG: Box with 1 vial. Package with 10 vials. Package of 50 vials.

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

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

Only some package 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 prospectus was revised in:May 2024

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Warning: Use exclusively by a healthcare professional

This information is intended only for doctors or healthcare professionals:

Solutions containing ceftriaxone should not be mixed or added with other agents. 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 they 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 sheet and section 6 of the prospectus).

Ceftriaxone LDP Torlan 250 mg intravenous should be reconstituted before use. The reconstituted solution is for single use. Discard excess 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 solvent from the accompanying ampoule (5 ml of water for injectable preparations).

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

The solution should be examined before injection for particles or turbidity. If foreign 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.