CEFTRIAXONE LDP TORLAN 1 g POWDER FOR INJECTION AND INFUSION SOLUTION

Introduction

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

Ceftriaxone (in the form of ceftriaxone sodium)

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

Contents of the pack:

1. What Ceftriaxone LDP Torlan is and what it is used for.
2. What you need to know before you use Ceftriaxone LDP Torlan.
3. How to use Ceftriaxone LDP Torlan
4. Possible side effects.
5. Storage of Ceftriaxone LDP Torlan
6. Pack contents and further 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.

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

? bones and joints

? skin and soft tissues

? blood

? heart

Ceftriaxone can be used:

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

? to treat patients with low white blood cell counts (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 your condition worsens or does not improve.

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

Do not use Ceftriaxone LDP Torlan:

• if you are allergic to ceftriaxone or any of the other ingredients 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 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.

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

Ceftriaxone LDP Torlan should not be administered to babies if:

?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 the white of the eye) or is going to be given a product containing calcium in a vein.

Warnings and precautions

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

? if you have recently received or are going to receive a product containing calcium.

? if you have recently had diarrhea after 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 diseases, such as hemolytic anemia (reduction of your red blood cells that can make your skin pale yellow and cause weakness and shortness of breath).

? if you are on a low-sodium diet.

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

If you need a blood or urine test

If you are going to receive ceftriaxone for a long time, you may need to have periodic blood tests. Ceftriaxone may affect the result of a urine sugar test (glucosuria) and a blood test called the Coombs test. If you are having tests:

• tell the person taking the sample that you have received ceftriaxone.

If you are diabetic or need to control your blood sugar levels (glycemia), you should not use certain glucose control systems that may provide incorrect glucose estimates while you are being treated with ceftriaxone. If you use such a system, consult the instructions for use and talk to your doctor, pharmacist, or nurse. If necessary, alternative test methods should be used.

Children

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

? your child has recently been given or is going to be given a product containing calcium in a vein.

Other medicines and Ceftriaxone LDP Torlan

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

Particularly, tell your doctor or pharmacist if you are taking any of the following medicines:

? a type of antibiotic called 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 are planning to have a baby, ask your doctor for advice before taking this medicine.

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

Driving and using machines

Ceftriaxone may cause dizziness. If you feel dizzy, do not drive or use tools or machines. Talk to your doctor if you have this symptom.

Ceftriaxone LDP Torlan contains sodium

Vial of 1 g: this medicine contains 82.9 mg of sodium (the main component of cooking salt) in each vial. This is equivalent to 4.14% of the maximum recommended daily intake of sodium in the adult diet, which should be taken into account in patients with low-sodium diets.

3. How to use Ceftriaxone LDP Torlan

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

? by intravenous perfusion or

? by direct injection into a vein or

? into a muscle

Ceftriaxone is prepared for administration by a doctor, pharmacist, or nurse. It should not be mixed or administered simultaneously with other injected 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 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.

Adults, elderly patients, and children from 12 years of age with a weight of 50 kg or more:

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

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

? 50 to 80 mg of ceftriaxone per kilogram of the child's weight once a day, depending on the type and severity of the infection. If the infection is severe, your doctor will prescribe a higher dose, up to 100 mg per kilogram of weight up to a maximum of 4 g per day. If your daily dose is more than 2 g, it may be administered as a single dose per day or as two separate doses.

? Children with a weight of 50 kg or more should receive the recommended adult dose.

Newborns (0-14 days)

? 20 to 50 mg of ceftriaxone per kilogram of the baby's weight once a day, depending on the type and severity of the infection.

? The maximum daily dose should not exceed 50 mg per kilogram of the baby's weight.

Patients with liver or kidney problems

If you have altered liver or kidney function, you may receive a different dose than recommended. Your doctor will decide how much ceftriaxone you need and will examine you thoroughly according to the severity of the kidney or liver disease.

If you use more Ceftriaxone LDP Torlan than you should

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

If you forget to use Ceftriaxone LDP Torlan

If you miss a dose of this medicine, you should receive it as soon as possible. However, if it is almost time for the next injection, skip the missed injection. You should not receive 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 on the use of this medicine, ask your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects

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

If you have a severe allergic reaction, tell your doctor immediately.

The signs may be:

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

? sudden swelling of hands, feet, and ankles.

? Chest pain in the context of allergic reactions, which can be a symptom of allergy-induced heart attack (Kounis syndrome).

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

If you have a severe skin rash, inform a doctor immediately. The symptoms may include:

? a severe rash that develops rapidly, with blisters or skin peeling, 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 skin rash, high body temperature, elevated liver enzyme values, blood abnormalities (eosinophilia), increased lymph node size, 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 treatment with ceftriaxone for infections with spirochetes such as Lyme disease.

Other possible side effects:

Common (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 liver function test results.

? 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 coagulation problems. The signs may include frequent bruising, as well as pain and swelling of the joints.

? Headache.

? Dizziness.

? Feeling unwell or sick.

? Itching (pruritus).

? Pain or burning sensation at the injection site. Pain at the injection site.

? Elevated body temperature (fever).

? Altered kidney function (increased blood creatinine)

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

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

? Difficulty breathing (bronchospasm).

? Urticaria (hives) that can cover a large area of the body, with itching and swelling.

? Blood or sugar in the urine.

? Edema (swelling due to fluid accumulation).

? Chills.

? 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.

Frequency not known (cannot be estimated from available data)

? Secondary infection that may not have responded to previous antibiotic treatment.

? Hemolytic anemia (a form of anemia with destruction of red blood cells).

? Agranulocytosis (severe decrease in white blood cells).

? Seizures.

? Vertigo (feeling of spinning).

? Pancreatitis (inflammation of the pancreas). The signs may include severe stomach pain that radiates to the back.

? Stomatitis (inflammation of the mucous membrane lining the mouth).

? Glossitis (inflammation of the tongue). The signs may include swelling, redness, and pain in the tongue.

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

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

? Kidney problems caused by ceftriaxone-calcium deposits. You may have pain when urinating or a decreased amount of urine.

? 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 some glucose tests (blood sugar), consult your doctor.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: 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

• The storage of ceftriaxone is the responsibility of your doctor or pharmacist, who will also be responsible for disposing 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 is the last day of the month stated.
• This medicine does not require special temperature storage conditions.

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

The 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 point of view, the product (reconstituted/diluted) should be used immediately. If not used immediately, the storage times and conditions before administration are the responsibility of the user and should not normally exceed 24 hours (8 hours for IV) at 2-8°C, unless the reconstitution, dilution, etc. have taken place in validated aseptic conditions.

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

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

6. Container Content and Additional Information

Composition of Ceftriaxone LDP Torlan

The active ingredient of Ceftriaxone LDP Torlan 1g powder for injection and infusion solution is ceftriaxone.

1g: 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 include other components.

Product Appearance and Container Content

• Ceftriaxone is a powder for injection and infusion solution. It is a crystalline powder of almost white or yellowish color. It is presented in a glass vial, closed with a rubber stopper and sealed with a flip-off cap.

Ceftriaxone LDP Torlan is presented in packs of 1, 10, and 100 vials. Only some pack sizes may be marketed

HOLDER OF THE MARKETING AUTHORIZATION 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 the Last Revision of this Prospectus: May 2024

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

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This information is intended only for healthcare professionals:

INFORMATION FOR HEALTHCARE PROFESSIONALS

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

Ceftriaxone (in the form of ceftriaxone sodium)

Consult the complete prescribing information in the Summary of Product Characteristics or the Technical Data Sheet.

Instructions for Use

Ceftriaxone LDP Torlan 1 g must be reconstituted before use. The reconstituted solution is for single use. Discard the leftover 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.

For intravenous injection:It is recommended to reconstitute each vial with 10 ml of water for injectable preparations. The injection of the reconstituted vial should be slow but uninterrupted for approximately 3-5 minutes directly into a vein or through an intravenous infusion cannula.

For intramuscular administration:It is recommended to dissolve the contents of the vial of Ceftriaxone LDP Torlan 1 g in 3.5 ml of 1% lidocaine solution. Since direct intramuscular injection can cause pain, the use of a local anesthetic such as lidocaine allows for increased local tolerance. The injection should be quick and uninterrupted.

Lidocaine solutions should not be administered intravenously.

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

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

The dose and administration regimen 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 (see Incompatibilities section below).

The solution should be examined before injection for particles or turbidity. If foreign particles are observed, the solution should be discarded.

The 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 point of view, the product (reconstituted/diluted) should be used immediately. If not used immediately, the storage times and conditions before administration are the responsibility of the user and should not normally exceed 24 hours (8 hours for IV) at 2-8°C, unless the reconstitution, dilution, etc. have taken place in validated aseptic conditions.

Incompatibilities

According to specialized literature, ceftriaxone is not compatible with amsacrine, vancomycin, fluconazole, aminoglycosides, and labetalol.

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

If combined treatment with ceftriaxone and another antibiotic is planned, administration should not be carried out with the same syringe or in the same infusion solution.