Prospect: information for the user

Ceftriaxone Sodium 2 g powder for injectable solution and for infusion EFG

Read this prospect carefully before starting to use this medicine, because it contains important information for you.

- Keep this prospect, as you may have to read it again.

- If you have any doubts, consult your doctor or pharmacist.

- This medicine has been prescribed to you and should not be given to other people, even if they have the same symptoms, as it may harm them.

- If you experience adverse effects, consult your doctor or pharmacist, even if they do not appear in this prospect. See section 4.

1. What Ceftriaxone Sodium is and for what it is used.

2. What you need to know before starting to use Ceftriaxone Sodium

3. How to use Ceftriaxone Sodium

4. Possible adverse effects.

5. Storage of Ceftriaxone Sodium.

6. Contents of the package and additional information

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 a fever due to a bacterial infection.

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.

Do not use Ceftriaxone Solution

• 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 this reaction include sudden inflammation of the throat or face that makes it hard to breathe or swallow, sudden swelling of the hands, feet, and ankles, chest pain, or a severe and rapid skin rash.
• if you are allergic to lidocaine and are to receive ceftriaxone by intramuscular injection

Ceftriaxone 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 coloration of the skin or the white of the eye) or is to receive a product containing calcium through a vein.

Warnings and Precautions

Consult your doctor, pharmacist, or nurse before starting to take ceftriaxone:

• 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 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 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, an increase in a type of white blood cell (eosinophilia), and an increase in the size 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 ceftriaxone for a long time, you may need to have blood tests periodically. Ceftriaxone may affect the result of a urine glucose test 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 glucose level (glucemia), do not use certain glucose control systems that may give incorrect glucose values while you are being treated with ceftriaxone. If you use any such system, read the instructions for use and talk to your doctor, pharmacist, or nurse. If necessary, alternative testing methods should be used.

Children

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

• recently received a product containing calcium through a vein or is to receive one.

Other medicines and Ceftriaxone Solution

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

Particularly, inform 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 plan to become pregnant, consult your doctor before using this medicine.

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

Driving and operating machinery

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

Ceftriaxone Solution contains sodium

This medicine contains 165.6 mg of sodium (main component of table salt/for cooking) in each vial. This is equivalent to 8.28% of the maximum daily sodium intake recommended for an adult.

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

• in intravenous infusion or
• directly into a vein or
• into a muscle

A doctor, pharmacist, or nurse prepares ceftriaxone for administration. It should not be mixed or administered simultaneously with other injected products that contain 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 adolescents 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 weighing 50 kg or more should receive the recommended dose for adults.

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 use more Ceftriaxona Sala than you should

If you accidentally 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to use Ceftriaxona Sala

If you forget a dose of this medication, take it as soon as you remember. 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 Sala

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 symptoms may include:

• 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 experience 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, which causes fever, chills, headache, muscle pain, and skin rash that 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).
• Bleeding disorders. The symptoms may include frequent petechiae, as well as joint pain and swelling.
• Headache.
• Dizziness.
• Feeling unwell or sick.
• Itching.
• Pain or burning sensation at the injection site or in the vein where the medicine was administered. Pain at the injection site.
• Elevated body temperature (fever).
• Altered kidney function (increased creatinine in the blood).

Rare (may affect up to 1 in 1000 people)

• Colitis (inflammation of the large intestine). The symptoms 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.
• Edema (inflammation due to fluid accumulation).
• Chills.
• Ceftriaxone treatment, particularly in elderly patients with severe kidney problems or neurological disorders, may rarely 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 (sensation of spinning).
• Pancreatitis (inflammation of the pancreas). The symptoms may include severe abdominal pain that radiates to the back.
• Stomatitis (inflammation of the mucous membrane lining the oral cavity).
• Glossitis (inflammation of the tongue). The symptoms 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 ceftriaxona calcium deposits. You may experience pain while urinating or decreased urine output.
• Falsely positive Coombs test result (a test for detecting certain blood abnormalities).
• Falsely positive galactosemia test result (abnormal accumulation of galactose in the blood).
• Ceftriaxone may interfere with some glucose tests (blood sugar), 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 prospectus. 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.

Keep this medication out of the reach and sight of children.

Store below 25°C. Store in the original packaging to protect it from light.

Before reconstitution: Do not use this medication after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

After reconstitution:The physical and chemical stability in use has been demonstrated up to 8 hours at 25°C and 24 hours in a refrigerator (between 2-8°C)

From a microbiological point of view, unless the opening/reconstitution/dilution method excludes the risk of microbial contamination, the product must be used immediately. If not used immediately, the storage times and conditions of the solution before administration are the responsibility of the user and, normally, should not exceed the times indicated earlier for chemical and physical stability during use, whichever is shorter.

Ceftriaxone Sodium Composition

The active ingredient is ceftriaxone (as ceftriaxone sodium).

Each vial contains 2 g of ceftriaxone (as ceftriaxone sodium).

After reconstitution with 40 ml of an appropriate solution (see Administration Form below), the concentration of the solution is 50 mg of ceftriaxone (as ceftriaxone sodium) per ml.

The powder vial does not contain other components (excipients).

Product Appearance and Packaging

It is presented in a glass vial, closed with a rubber stopper and sealed with a capsule.

It is presented in cardboard boxes containing 1 powder vial or in clinical packaging of 100 powder vials.

Only some package sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Laboratorio Reig Jofre, S.A.

Gran Capitán, 10 – 08970

Sant Joan Despí (Barcelona),

Spain

Last Review Date of this Leaflet: April 2024

This information is intended solely for healthcare professionals

Administration Form

Intramuscular Administration

For intramuscular administration, use commercial presentations that include a lidocaine ampule as a solvent.

Since the solvent used is lidocaine, the resulting solution should never be administered intravenously. Please refer to the Technical Dossier or Summary of Product Characteristics of lidocaine for further information.

Intravenous Administration

Ceftriaxone can be administered in an intravenous infusion of at least 30 minutes (preferred route) or by slow intravenous injection of 5 minutes. Intermittent intravenous injections should be administered over 5 minutes, preferably in large veins. Intravenous doses of 50 mg/kg or more in infants and children up to 12 years of age should be administered by infusion. In neonates, intravenous doses should have a duration of approximately 60 minutes to reduce the risk of bilirubin encephalopathy. Consider intramuscular administration when intravenous administration is not possible or less suitable for the patient. For doses above 2 g, intravenous administration should be used.

Concentrations for intravenous injection: 100 mg/ml

Concentrations for intravenous infusion: 50 mg/ml

Ceftriaxone is contraindicated in neonates (≤ 28 days) requiring (or expected to require) treatment with intravenous solutions containing calcium, including continuous infusions containing calcium, such as parenteral nutrition, due to the risk of ceftriaxone calcium precipitation.

Do not use diluents containing calcium (e.g., Ringer's solution or Hartmann's solution) to reconstitute ceftriaxona vials or for the subsequent dilution of a reconstituted vial for intravenous administration, as a precipitate may form. Ceftriaxone calcium precipitation may also occur if ceftriaxone is mixed with calcium-containing solutions in the same intravenous line. Therefore, do not mix or administer ceftriaxone and calcium-containing solutions simultaneously.

For preoperative prophylaxis of surgical site infections, ceftriaxone should be administered 30-90 minutes before surgery.

Instructions for Use

For post-reconstitution stability of the vial, see section 5.

Ceftriaxone should not be mixed in the same syringe with any medication other than a 1.06% hydrochloride lidocaine solution (for intramuscular use only). See Administration Form.

Lidocaine solutions should not be administered intravenously.

Intravenous injection: dissolve 1 g of ceftriaxone in 10 ml of water for injection. The injection should be administered over 5 minutes, directly into a vein or through an intravenous catheter.

Intravenous infusion: dissolve 2 g of ceftriaxone in 40 ml of one of the following calcium-free solutions: sodium chloride 0.9%, glucose 5%, glucose 10%, glucose 5% in sodium chloride 0.9%, or sterile water for injection. The infusion should be administered over at least 30 minutes.

See sections Posology and Administration Form for further information.

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, do not use diluents containing calcium (e.g., Ringer's solution or Hartmann's solution) to reconstitute ceftriaxone vials or for the subsequent dilution of a reconstituted vial for intravenous administration, as a precipitate may form. Do not mix or administer ceftriaxone and calcium-containing solutions simultaneously, including total parenteral nutrition solutions.

Mixtures of beta-lactam antibacterials (penicillins and cephalosporins) and aminoglycosides may result in substantial mutual inactivation. If administered simultaneously, they should be administered in separate sites. Do not mix them in the same syringe or vial.