Patient Information: Prospect

Ceftriaxone LDP Torlan 1g Powder for Injectable Solution and for Infusion EFG

Ceftriaxone (in the form of ceftriaxone sodium)

Read this prospectus carefully before starting to use this medication, as it contains important information for you

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only for you and should not be given to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they do not appear in this prospectus. See section 4.

Ceftriaxone is an antibiotic for adults and children (including newborn babies). It works by eliminating the bacteria causing 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

?the bones and joints

?the skin and soft tissues

?the blood

?the 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 a surgical procedure.

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

No use Ceftriaxona LDP Torlan:

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

if you have had a sudden or severe allergic reaction to penicillin or other similar antibiotics (such as cefalosporins, carbapenems, or monobactams); signs of such a reaction include sudden inflammation of the throat or face that makes it difficult to breathe or swallow, sudden swelling of the hands, feet, and ankles, chest pain, or a severe and rapid skin eruption.

if you are allergic to lidocaína and are to receive ceftriaxona by intramuscular injection.

Ceftriaxona LDP Torlan should not be administered to babies if:

?the baby is premature.

?the baby is a newborn (up to 28 days old) and has certain blood problems or jaundice (yellow discoloration of the skin or white of the eye) or is to be administered a product containing calcium through a vein.

Warnings and precautions

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

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

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

?if you have had problems with your liver or kidneys (see section 4).

?if you have gallstones or kidney stones.

?if you have had other diseases, for example, hemolytic anemia (decrease in 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 enlargement of lymph nodes (signs of severe skin reactions, see also section 4 "Possible side effects")

If you need a blood or urine test

If you are to receive ceftriaxona for a long time, you may need to have blood tests periodically. Ceftriaxona may affect the results of a urine glucose test and a blood test called the Coombs test. If you are having tests:

• inform the person taking the sample that you have received ceftriaxona.

If you are diabetic or need to control your blood glucose level (glucemia), do not use certain glucose control systems that may provide incorrect glucose values while you are being treated with ceftriaxona. If you use such a system, consult the user instructions and talk to your doctor, pharmacist, or nurse. If necessary, alternative testing methods should be used.

Children

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

?recently received a product containing calcium through a vein or is to be administered one.

Other medications and Ceftriaxona LDP Torlan

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

Particularly, inform your doctor or pharmacist if you are taking any of the following medications:

?an antibiotic called aminoglucósido.

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

Pregnancy, breastfeeding, and fertility

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

Your doctor will evaluate the expected benefits of ceftriaxona treatment against the risks to your baby.

Driving and operating machines

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

Ceftriaxona LDP Torlan contains sodium

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

Typically, a doctor or nurse administers ceftriaxone. It can be administered:

?in intravenous infusion or

?in direct injection into a vein or

?in a muscle

A healthcare professional prepares ceftriaxone for administration. It should not be mixed or administered simultaneously with other injected products containing calcium.

Recommended dose

Your doctor will decide on 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 state 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 12 years of age or older 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 greater than 2 g, it may be administered as a single daily dose or as two separate doses.

Newborns, infants, and children 15 days to 12 years of age with a weight less than 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 per day, up to a maximum of 4 g per day. If your daily dose is greater than 2 g, it may be administered as a single daily dose 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 child'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 impaired kidney or liver function, you may receive a different dose than recommended. Your doctor will decide how much ceftriaxone you need and will closely monitor you according to the severity of the liver or kidney disease.

If you take more Ceftriaxona LDP Torlan than you should

If you mistakenly receive a dose greater than prescribed, 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 medication and the amount ingested.

If you forget to use Ceftriaxona LDP Torlan

If you forget a dose of this medication, take it as soon as possible. However, if it is almost time for the next injection, skip the missed dose. Do not receive a double dose (two injections at once) to compensate for a missed dose.

If you interrupt treatment with Ceftriaxona LDP Torlan

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

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

Severe side effects

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

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

The signs may be:

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

?Sudden inflammation of the hands, feet, and ankles.

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

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

If you have a severe skin reaction, inform your 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 SSJy NET).

?A combination of any of the following symptoms: generalized skin rash, high body temperature, elevated liver enzyme values, blood abnormalities (eosinophilia), enlarged lymph nodes, and organ damage (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome).

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

Other possible side 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 platelet counts (decreased thrombocyte count).

?Loose stools or diarrhea.

?Changes in liver function test results.

?Skin rash.

Rare (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 petechiae, as well as joint pain and swelling.

?Headache.

?Dizziness.

?Feeling unwell or sick.

?Itching (pruritus).

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

?Elevated body temperature (fever).

?Altered kidney function (increased serum creatinine).

Very rare (may affect up to 1 in 1,000 people)

?Colitis (inflammation of the large intestine). The signs may include diarrhea, often with blood and mucus, abdominal pain, and fever.

?Difficulty breathing (bronchospasm).

?Rash (urticaria) that may cover a large area of the body, with itching and swelling.

?Blood or sugar in the urine.

?Swelling (edema).

?Chills.

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

Unknown frequency (cannot be estimated from available data)

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

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

?Agranulocytosis (severe decrease in white blood cells).

?Seizures.

?Dizziness (vertigo).

?Pancreatitis (inflammation of the pancreas). The signs may include severe abdominal 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 of the tongue.

?Biliary or liver problems, which may cause pain, nausea, vomiting, yellowing of the skin, itching, dark-colored urine, and clay-colored stools.

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

?Renal disorders caused by ceftriaxone calcium deposits. You may experience pain while urinating or have a decreased urine output.

?Falsely positive Coombs test result (a test for detecting some blood abnormalities).

?Falsely positive galactosemia test result (an abnormal accumulation of galactose in the blood).

?Ceftriaxone may interfere with some glucose tests (blood sugar tests), consult your doctor.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: www.notificaRAM.es.

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

• The storage of ceftriaxone is the responsibility of your doctor or pharmacist, who will also be in charge of properly disposing of any unused ceftriaxone. Keep this medication out of the sight and reach of children.
• Do not use this medication after the expiration date that appears on the box or vial. The expiration date is the last day of the month indicated.
• This medication does not require special temperature conditions for storage.

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 a 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) from 2 to 8°C, unless reconstitution, dilution, etc. have taken place in validated aseptic conditions.

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

Medicines should not be disposed of through the drains or in the trash. Deposit the containers and unused medicines at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and unused medicines. In this way, you will help protect the environment.

Ceftriaxone LDP Torlan Composition

The active ingredient of Ceftriaxone LDP Torlan 1g powder for injectable solution and for infusion 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.

Appearance of the product and contents of the package

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

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

HOLDER OF THE COMMERCIALIZATION AUTHORIZATION AND RESPONSIBLE FOR MANUFACTURING

LDP- Laboratorios TORLAN, S.A.

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

Last review date of this prospectus: May 2024

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

----------------------------------------------------------------------------------------------------------------

This information is intended solely for healthcare professionals:

INFORMATION FOR HEALTHCARE PROFESSIONALS

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

Ceftriaxone (in the form of ceftriaxone sodium)

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

Instructions for use

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

The reconstituted solution is clear and yellow or slightly yellowish. During the storage of pre-prepared solutions, a change 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 injectable solution. The injection of the reconstituted vial should be slow but uninterrupted for approximately 3-5 minutes directly into a vein or through an intravenous cannula.

For intramuscular administration:It is recommended to dissolve the contents of the Ceftriaxone LDP Torlan1 g vial in 3.5 ml of 1% lidocaine solution. Since direct intramuscular injection may cause pain, the use of a local anesthetic such as lidocaine allows for increased local tolerance. The injection should be rapid and uninterrupted.

Lidocaine solutions should not be administered intravenously.

For intravenous infusion:It is recommended to dissolve the contents of the Ceftriaxone LDP Torlan1 g vial 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 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 with other solutions different from those mentioned above (see Incompatibilities section below).

The solution should be examined before injecting it to see if it contains particles or turbidity. If 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 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 to dilute 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 performed with the same syringe or in the same infusion solution.

.