Ceftriaxone LDP Torlan 1 g powder for injection and for infusion EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Ceftriaxone LDP Torlan 1 g powder for injectable solution and for infusion EFG

Ceftriaxone (in the form of ceftriaxone sodium)

Read the entire leaflet carefully before you start using this medicine, as it contains important information for you

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only and must not be given to others, even if they have the same symptoms as you, since it could harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if the effects are not listed in this leaflet. See section 4.

Leaflet contents:

1. What Ceftriaxone LDP Torlan is and what it is used for.
2. What you need to know before using Ceftriaxone LDP Torlan.
3. How to use Ceftriaxone LDP Torlan.
4. Possible adverse effects.
5. Storage of Ceftriaxone LDP Torlan.
6. Package contents and additional information.

1. What Ceftriaxone LDP Torlan is and what it is used for

Ceftriaxone is an antibiotic for adults and children (including newborn babies). It works by killing the bacteria that cause infections. It belongs to a group of medicines called 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 to follow the instructions regarding dosage, dosing interval, and duration of treatment as directed by your physician. Do not keep or reuse this medication. If you have leftover antibiotics after completing the treatment, return them to the pharmacy for proper disposal. Medicines must not be disposed of via wastewater or household waste.

Ceftriaxone is used to treat infections of:

? the brain (meningitis)

? the lungs

? the middle ear

? the abdomen and abdominal wall (peritonitis)

? the urinary tract and kidneys

? the bones and joints

? the skin and soft tissues

? the blood

? the heart

Ceftriaxone may be used:

? to treat specific sexually transmitted infections (gonorrhoea and syphilis).

? to treat patients with low levels of white blood cells (neutropenia) who have fever due to a bacterial infection.

? to treat chest infections in adults with chronic bronchitis.

? to treat Lyme disease (transmitted by ticks) in adults and children, including newborns from 15 days of age.

? to prevent infections during surgical procedures.

You should consult a doctor if you get worse or do not improve.

2. What you need to know before starting to use Ceftriaxone LDP Torlan

Do not use Ceftriaxone LDP Torlan:

• if you are allergic to ceftriaxone or to any of the other components of this medicine (listed in section 6).

? 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 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.

? if you are allergic to lidocaine and are due to receive ceftriaxone by intramuscular injection.

The input provided is empty. Please provide the text you would like translated.

Ceftriaxone LDP Torlan must not be administered to babies if:

• They are premature babies (born before 41 weeks of gestation).
• They have high levels of bilirubin in the blood (hyperbilirubinemia), especially if they are premature.
• They have a known allergy to ceftriaxone or any other cephalosporin antibiotic.
• They have a history of severe allergic reactions (anaphylaxis) to penicillins or other beta-lactam antibiotics.
• They have severe liver or kidney dysfunction.
• They have a condition called "jaundice" or elevated bilirubin levels that could increase the risk of kernicterus.
• They are receiving calcium-containing intravenous solutions, as ceftriaxone and calcium can form precipitates when administered together, especially in neonates.

? the baby is premature.

? the baby is a newborn (up to 28 days of age) and has certain blood problems or jaundice (yellowing of the skin or whites of the eyes), or if a product containing calcium is to be administered intravenously.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before taking Ceftriaxone:

? if you have recently received or are about to receive any product containing calcium.

? if you have recently had diarrhea following antibiotic treatment; if you have ever had intestinal problems, particularly colitis (inflammation of the intestine).

? if you have had liver or kidney problems (see section 4).

? if you have gallstones or kidney stones.

? if you have had other illnesses, for example, hemolytic anemia (reduction in your red blood cells that may cause your skin to appear pale yellow, weakness, and shortness of breath).

? if you are on a low-sodium diet.

? if you are experiencing or have experienced a combination of any of the following symptoms: rash, redness of the skin, blistering of the lips, eyes, and mouth, skin peeling, high fever, flu-like symptoms, increased levels of liver enzymes observed in blood tests, an increase in a type of white blood cell (eosinophilia), and swollen lymph nodes (signs of severe skin reactions, see also section 4 "Possible side effects").

If you need blood or urine tests

If you are to receive ceftriaxone for a prolonged period, you may need periodic blood tests. Ceftriaxone may affect the results of a urine glucose test (glucosuria) and a blood test called the Coombs test. If you are undergoing tests:

• inform the person collecting the sample that you have received ceftriaxone.

If you are diabetic or need to monitor your blood glucose level (glycemia), you should not use certain glucose monitoring systems that may provide inaccurate estimated glucose values while you are being treated with ceftriaxone. If you use such a system, consult the user instructions and speak with your doctor, pharmacist, or nurse. Alternative testing methods should be used if necessary.

Children

Before your child receives ceftriaxone, consult your doctor, pharmacist, or nurse if:

? a product containing calcium has recently been administered intravenously or is scheduled to be administered.

Other medicines and Ceftriaxone LDP Torlan

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.

In particular, inform your doctor or pharmacist if you are taking any of the following medicines:

? an antibiotic called an aminoglycoside.

? an antibiotic called chloramphenicol (used to treat infections, especially of the eyes).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

Your doctor will assess the expected benefits of treatment with ceftriaxone against the potential risks to your baby.

Driving and using machines

Ceftriaxone may cause dizziness. If you feel dizzy, do not drive or operate tools or machinery. Speak with your doctor if you experience this symptom.

Ceftriaxone LDP Torlan contains sodium

1 g vial: this medicine contains 82.9 mg of sodium (the main component of table salt for cooking) per vial. This corresponds to 4.14% of the maximum recommended daily dietary sodium intake for adults, which should be considered in patients on low-sodium diets.

3. How to use Ceftriaxone LDP Torlan

Ceftriaxone is usually administered by a doctor or nurse. It can be given:

• by intravenous infusion, or

• by direct injection into a vein, or

• into a muscle

Ceftriaxone is prepared for administration by a doctor, pharmacist, or nurse. It must not be mixed or administered simultaneously with other injectable products containing calcium.

Recommended dose

Your doctor will decide the correct dose of ceftriaxone for you. The dose will depend on the type and severity of the infection, whether you are already receiving other antibiotics, your body weight and age, as well as the condition of your liver and kidneys. The number of days or weeks you will receive ceftriaxone will depend on the type of infection you have.

Adults, elderly patients, and children aged 12 years and older with a body weight of 50 kg or more:

• 1 to 2 g once daily, depending on the type and severity of the infection. If your infection is severe, your doctor may prescribe a higher dose (up to 4 g per day). If your daily dose exceeds 2 g, it may be administered as a single daily dose or as two separate doses.

Newborns, infants, and children from 15 days to 12 years of age with a body weight below 50 kg:

• 50 to 80 mg of ceftriaxone per kg of body weight once daily, depending on the type and severity of the infection. If the infection is severe, your doctor may prescribe a higher dose of up to 100 mg per kg of body weight, up to a maximum of 4 g per day. If your daily dose exceeds 2 g, it may be administered as a single daily dose or as two separate doses.

• Children weighing 50 kg or more should receive the adult recommended dose.

Newborns (0–14 days):

• 20 to 50 mg of ceftriaxone per kg of body weight once daily, depending on the type and severity of the infection.

• The maximum daily dose must not exceed 50 mg per kg of the infant's body weight.

Patients with liver or kidney problems

If you have impaired kidney or liver function, you may receive a different dose than the one recommended. Your doctor will decide how much ceftriaxone you need and will carefully monitor you based on the severity of your kidney or liver disease.

If you use more Ceftriaxone LDP Torlan than you should

If you accidentally receive a higher dose than prescribed, contact your doctor or go to the nearest hospital as soon as possible. In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone: 91 562 04 20, stating the name of the medicine and the amount ingested.

If you forget to use Ceftriaxone LDP Torlan

If you miss a dose of this medicine, it should be administered as soon as possible. However, if it is almost time for your next injection, skip the missed dose. Do not administer a double dose (two injections at the same time) to make up for a missed dose.

If you stop using Ceftriaxone LDP Torlan

Do not stop receiving ceftriaxone unless your doctor tells you to. If you have any further questions about the use of this medicine, ask your doctor or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Serious adverse effects

Severe allergic reactions (frequency unknown, cannot be estimated from available data)

If you experience a severe allergic reaction, inform your doctor immediately.

Signs may include:

? Sudden swelling of the face, throat, lips, or mouth, which may cause difficulty breathing or swallowing.

? Sudden swelling of hands, feet, and ankles.

? Chest pain in the context of allergic reactions, which may be a symptom of a heart attack triggered by the allergy (Kounis syndrome).

Severe skin reactions (frequency unknown, cannot be estimated from available data)

If you develop a severe skin rash, inform a doctor immediately. Symptoms may include:

? A severe rash that develops rapidly, with blisters or peeling skin and possibly blisters in the mouth (Stevens-Johnson syndrome and toxic epidermal necrolysis, also known as SJS and TEN).

? A combination of any of the following symptoms: widespread rash, high body temperature, elevated liver enzyme levels, blood abnormalities (eosinophilia), enlarged lymph nodes, and involvement of other organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome).

? Jarisch-Herxheimer reaction, which causes fever, chills, headache, muscle pain, and skin rash, usually self-limiting. This occurs shortly after starting ceftriaxone treatment for spirochetal infections such as Lyme disease.

Other possible adverse effects:

Frequent (may affect up to 1 in 10 people)

? Abnormalities in white blood cell counts (e.g., decreased leukocyte count and increased eosinophils) and platelets (decreased platelet count).

? Loose stools or diarrhea.

? Changes in blood test results assessing liver function.

? Skin rash.

Uncommon (may affect up to 1 in 100 people)

? Fungal infections (e.g., oral candidiasis).

? Decreased white blood cell count (granulocytopenia).

? Decreased red blood cell count (anemia).

? Blood clotting problems. Signs may include frequent bruising, as well as joint pain and swelling.

? Headache.

? Dizziness.

? Feeling unwell or sick.

? Pruritus (itching).

? Pain or burning sensation at the site or vein where this medicine was injected. Pain at the injection site.

? High temperature (fever).

? Impaired kidney function (increased blood creatinine).

Rare (may affect up to 1 in 1,000 people)

? Inflammation of the large intestine (colon). Signs may include diarrhea, usually with blood and mucus, stomach pain, and fever.

? Difficulty breathing (bronchospasm).

? Hives (urticaria), which may cover large parts of the body, with itching and swelling.

? Blood or sugar in the urine.

? Edema (fluid accumulation causing swelling).

? Chills.

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

Frequency not known (cannot be estimated from available data)

? Secondary infection that may not have responded to a previously prescribed antibiotic.

? Hemolytic anemia (a type of anemia involving destruction of red blood cells).

? Agranulocytosis (severe decrease in white blood cells).

? Seizures.

? Dizziness (sensation of lightheadedness).

? Inflammation of the pancreas (pancreatitis). Signs may include severe stomach pain radiating to the back.

? Inflammation of the mucous membrane lining the mouth cavity (stomatitis).

? Inflammation of the tongue (glossitis). Signs may include swelling, red discoloration, and pain of the tongue.

? Problems with the gallbladder or liver, which may cause pain, nausea, vomiting, yellowing of the skin, itching, abnormally dark urine, and clay-colored stools.

? Neurological disorder that may occur in newborns with severe jaundice (bilirubin encephalopathy - kernicterus).

? Kidney problems caused by deposits of calcium-ceftriaxone. You may experience pain when urinating or reduced urine output.

? False positive result in the Coombs test (a test to detect certain blood abnormalities).

? False positive result for galactosemia (abnormal accumulation of galactose in the blood).

? Ceftriaxone may interfere with certain blood glucose tests (blood sugar tests); consult your doctor.

Reporting of adverse effects

If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: 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

• Storage of ceftriaxone is the responsibility of your doctor or pharmacist, who will also ensure proper disposal of any unused ceftriaxone. Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the carton or vial. The expiry date refers to the last day of the month indicated.
• This medicine does not require special storage temperature conditions.

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

Reconstituted solutions maintain their chemical and physical stability for 3 hours at 25°C and for 24 hours in the refrigerator (2°C–8°C).

From a microbiological standpoint, the product (reconstituted/diluted) should be used immediately. If not used immediately, the storage times and conditions prior to administration are the responsibility of the user and normally should not exceed 24 hours (8 hours for IV) at 2–8°C, unless reconstitution, dilution, etc., have been carried out under validated aseptic conditions.

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

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

6. Package contents and additional information

Composition of Ceftriaxone LDP Torlan

The active substance in Ceftriaxone LDP Torlan 1 g powder for injectable solution and for infusion is ceftriaxone.

1 g: each vial contains ceftriaxone sodium equivalent to 1 g of ceftriaxone.

Each gram of ceftriaxone sodium contains approximately 3.6 mmol (82.9 mg) of sodium.

Ceftriaxone does not contain any other excipients.

Appearance of the product and contents of the pack

• Ceftriaxone is a powder for injectable solution and for infusion. It is a crystalline powder, almost white or slightly yellowish in colour. It is supplied in a glass vial, closed with a rubber stopper and sealed with a flip-off cap.

? Ceftriaxone LDP Torlan is available in pack sizes of 1, 10 and 100 vials. Only certain pack sizes may be commercially available.

MARKETING AUTHORISATION HOLDER AND MANUFACTURING RESPONSIBLE

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 last 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/

---

This information is intended for healthcare professionals only:

INFORMATION FOR HEALTHCARE PROFESSIONALS

Ceftriaxone LDP Torlan 1 g powder for injectable solution and for infusion EFG

Ceftriaxone (as ceftriaxone sodium)

Refer to the full prescribing information in the Technical Data Sheet or Summary of Product Characteristics.

Instructions for use

Ceftriaxone LDP Torlan 1 g must be reconstituted before use. The reconstituted solution is for single use only. Any unused solution should be discarded.

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

For intravenous injection: It is recommended to reconstitute each vial with 10 ml of water for injections. The injection from the reconstituted vial should be administered slowly but continuously over approximately 3–5 minutes directly into a vein or via an intravenous infusion line.

For intramuscular administration: It is recommended to dissolve the contents of the Ceftriaxone LDP Torlan 1 g vial in 3.5 ml of 1% lidocaine solution. Since direct intramuscular injection may cause pain, the use of a local anaesthetic such as lidocaine improves local tolerance. The injection should be administered quickly and continuously.

Solutions of lidocaine must not be administered intravenously.

For intravenous infusion: It is recommended to dissolve the contents of the Ceftriaxone LDP Torlan 1 g vial at a concentration of 50 mg/ml (2 g in 40 ml) using solvents suitable for this route of administration, such as:

• 0.9% NaCl
• 5% Glucose
• 10% Glucose
• 2.5% Glucose and 0.45% sodium chloride
• 6% Hydroxyethyl starch

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 solvents other than those listed above (see section Incompatibilities below).

The solution should be inspected visually for particulate matter or discoloration before injection. If foreign particles are observed, the solution must be discarded.

Reconstituted solutions maintain their chemical and physical stability for 3 hours at 25°C and for 24 hours under refrigeration (2°C–8°C).

From a microbiological standpoint, the product (reconstituted/diluted) should be used immediately. If not used immediately, the storage times and conditions prior to administration are the responsibility of the user and normally should not exceed 24 hours (8 hours for IV) at 2–8°C, unless reconstitution or dilution has been carried out under validated aseptic conditions.

Incompatibilities

According to specialized literature, ceftriaxone is incompatible with amsacrine, vancomycin, fluconazole, aminoglycosides and labetalol.

Solutions containing ceftriaxone must not be mixed or combined with other compounds, except those mentioned in the section Instructions for use. In particular, diluents containing calcium (e.g., Ringer's solution or Hartmann's solution) must not be used to reconstitute ceftriaxone vials or for subsequent dilution of a reconstituted vial for intravenous administration, as a precipitate may form. Ceftriaxone must not be mixed or administered simultaneously with calcium-containing solutions, including total parenteral nutrition solutions.

If combination therapy with ceftriaxone and another antibiotic is planned, administration must not be performed using the same syringe or in the same infusion solution.