Ceftriaxone Normon 2,000 mg powder for solution for infusion EFG

Ceftriaxone is indicated in the treatment of infections:

• of the brain (meningitis);
• of the lungs;
• of the middle ear;
• of the abdomen and abdominal wall (peritonitis);
• of the urinary tract and kidneys;
• of the bones and joints;
• of the skin and soft tissues;
• of the blood;
• of the heart.

This medicine may be administered:

• to treat specific sexually transmitted infections (gonorrhoea 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 (infection caused by tick bite) in adults and children, including newborns from 15 days of age;
• to prevent infections during surgical procedures.

2. What you need to know before using Ceftriaxone Normon

Do not use Ceftriaxone Normon

• If you are allergic to ceftriaxone or to 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 an allergic reaction include sudden swelling of the throat or face causing difficulty breathing or swallowing, sudden swelling of hands, feet, and ankles, chest pain, or a rapid and severe skin rash.
• If you are allergic to lidocaine and need to receive ceftriaxone by intramuscular injection.

Ceftriaxone Normon must not be used in newborns in the following cases:

• Premature infants.
• Newborns (up to 28 days of age) with jaundice (yellowing of the skin or whites of the eyes), or if an intravenous product containing calcium is to be administered.

Warnings and precautions

Talk to your doctor or pharmacist before starting Ceftriaxone Normon:

• If you have recently used or are about to use products containing calcium.
• If you have recently had diarrhoea after taking an antibiotic. If you have intestinal problems, particularly colitis (inflammation of the intestine).
• If you have liver or kidney problems (see section 4).
• If you have gallstones or kidney stones.
• If you suffer from other diseases, such as haemolytic anaemia (reduction in red blood cells, which may cause yellowing of the skin, weakness, and difficulty breathing).
• If you are on a low-sodium diet.
• If you experience or have experienced a combination of any of the following symptoms: skin rash, skin redness, blistering of lips, eyes, and mouth, skin peeling, high fever, flu-like symptoms, increased liver enzyme levels shown in blood tests, an increase in a type of white blood cells (eosinophilia), and swollen lymph nodes (signs of serious skin reactions; see also section 4 "Possible side effects").

If you are to undergo blood or urine tests

When using this medicine for prolonged periods, periodic blood tests may be necessary. Ceftriaxone may interfere with urine glucose tests and with a blood test known as the Coombs test. If you are to undergo any testing:

• Inform the person taking your sample that you are taking this medicine.

If you are diabetic or need to monitor your blood glucose levels, do not use certain blood glucose monitoring systems, as the readings may be inaccurate due to ceftriaxone use. If you use such systems, consult the instructions for use and inform your doctor, pharmacist, or nurse. Alternative methods may be used if necessary.

Children

Talk to your doctor, pharmacist, or nurse before administering ceftriaxone to your child if:

• They have received or are about to receive an intravenous product containing calcium.

Other medicines and Ceftriaxone Normon

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

Your doctor will exercise special caution when using ceftriaxone together with:

• A type of antibiotic called aminoglycosides.
• An antibiotic called chloramphenicol (used to treat infections, particularly of the eye).

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 benefits of treatment with ceftriaxone against the potential risks to the fetus.

Driving and using machines

Ceftriaxone may cause dizziness. If you feel dizzy or experience vertigo, do not drive or operate tools or machinery. If you have these symptoms, inform your doctor.

Ceftriaxone Normon contains sodium

Each vial contains 166.48 mg of sodium (the main component of table/cooking salt) per vial. This corresponds to 8.32% of the maximum recommended daily sodium intake for an adult.

3. How to use Ceftriaxone Normon

Ceftriaxone is usually administered by a doctor or nurse. It may be given by intravenous infusion or by direct injection into a vein or into a muscle. Ceftriaxone is prepared by a doctor, pharmacist, or nurse and should never be mixed with injections containing calcium, nor should it be administered simultaneously with such injections.

Usual dose

Your doctor will determine the correct dose of ceftriaxone for you. The dose will depend on the severity and type of infection, whether you are receiving treatment with other antibiotics, your body weight and age, as well as kidney and liver function. The number of days or weeks during which you will receive ceftriaxone depends on the type of infection you have.

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

• 1 to 2 g once daily, depending on the severity and type of infection. In severe cases, your doctor may increase the dose (up to 4 g once daily). If the daily dose exceeds 2 g, it may be given as a single dose once daily or divided into two separate doses.

Neonates, 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 kilogram of body weight once daily, depending on the severity and type of infection. In case of severe infection, the doctor may increase the dose up to 100 mg per kilogram of body weight, up to a maximum of 4 g per day. If the daily dose exceeds 2 g, it may be given as a single dose once daily or divided into two separate doses.
• Children weighing 50 kg or more should receive the usual adult dose.

Neonates (0–14 days):

• 20 to 50 mg of ceftriaxone per kilogram of body weight once daily, depending on the severity and type of infection.
• The maximum daily dose should not exceed 50 mg per kg of the infant's body weight.

Patients with hepatic or renal impairment

You may receive a different dose than the usual dose. Your doctor will determine the appropriate dose of ceftriaxone for you and will monitor you based on the severity of your liver or kidney disorder.

If you are given more Ceftriaxone Normon than you should

If you accidentally receive a higher dose than prescribed, contact your doctor or nearest hospital immediately.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and amount used.

If you forget to use Ceftriaxone Normon

If you miss an injection, you should receive it as soon as possible. However, if the time for the next injection is approaching, do not take the missed injection. Do not take a double dose (two injections at the same time) to make up for a missed dose.

If you stop treatment with Ceftriaxone Normon

Do not stop treatment with ceftriaxone unless your doctor has instructed you to do so.

If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, Ceftriaxone Normon may produce adverse effects, although not everyone experiences them.

The possible adverse effects associated with the use of this medicine are listed below:

Treatment with ceftriaxone, particularly in elderly patients with severe kidney or nervous system disorders, may in rare cases lead to decreased consciousness, abnormal movements, agitation, and seizures.

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

If you experience a severe allergic reaction, consult 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 the hands, feet, and ankles.
• Chest pain occurring in the context of allergic reactions, which may be a symptom of an allergy-induced heart attack (Kounis syndrome).

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

If you experience a severe allergic reaction, consult your doctor immediately. Signs may include:

• A severe rash that develops rapidly, with blisters or skin peeling, and sometimes mouth blisters (Stevens-Johnson syndrome [SJS] and toxic epidermal necrolysis [TEN]).
• A combination of any of the following symptoms: widespread skin rash, high body temperature, increased liver enzyme levels observed in blood tests, abnormalities in blood count (eosinophilia), enlarged lymph nodes, and involvement of other organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS syndrome or systemic drug hypersensitivity syndrome with eosinophilia).
• Jarisch-Herxheimer reaction causing fever, chills, headache, muscle pain, and skin rash, which usually resolve spontaneously. These effects occur shortly after starting ceftriaxone treatment for spirochete infections, such as Lyme disease.

Other possible adverse effects:

Frequent (may affect up to 1 in 10 people)

• Abnormalities in white blood cells (such as decreased leukocytes and increased eosinophils) and platelets (decreased thrombocytes).
• Soft stools or diarrhoea.
• Abnormal liver function test results in blood analysis.
• Skin rash.

Uncommon (may affect up to 1 in 100 people)

• Fungal infection (e.g., candida or genital fungal infections).
• Decreased number of white blood cells (granulocytopenia).
• Decreased number of red blood cells (anaemia).
• Blood clotting disorders. Signs may include easy bruising, as well as joint pain and swelling.
• Headache.
• Dizziness.
• Nausea or vomiting.
• Pruritus (itching).
• Pain or burning sensation at the site of ceftriaxone administration. Blisters, bruising, intense redness or rash, burning sensation, pain, irritation, itching, hardening of the skin, or inflammation at the injection site.
• High temperature (fever).
• Abnormal kidney test results in blood analysis (increased serum creatinine).

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

• Inflammation of the large intestine (colon). Signs may include diarrhoea, usually with blood and mucus, stomach pain, and fever.
• Difficulty breathing (bronchospasm).
• Rash (urticaria) that may affect large areas of the body, with itching and swelling.
• Blood or glucose in the urine.
• Oedema (fluid accumulation).
• Chills.
• Infections at the injection site.

Frequency not known (frequency cannot be estimated from available data)

• A secondary infection that may not respond to previously prescribed antibiotics.
• A form of anaemia in which red blood cells are destroyed (haemolytic anaemia).
• Marked decrease in certain white blood cells (agranulocytosis).
• Seizures.
• Vertigo (spinning sensation).
• Inflammation of the pancreas (pancreatitis). Signs may include severe stomach pain radiating to the back.
• Inflammation of the oral mucosa (stomatitis).
• Inflammation of the tongue (glossitis). Signs may include swelling, redness, and pain in the tongue.
• Gallbladder or liver disorders that may cause pain, nausea, vomiting, yellowing of the skin, itching, darkening of the urine, and clay-coloured stools.
• Neurological disease that may cause severe jaundice in neonates (nuclear jaundice).
• Kidney disorders due to calcium-ceftriaxone deposits, which may cause pain when urinating or reduced urine output.
• False positive Coombs test result (a test that detects certain blood disorders).
• False positive result for galactosaemia (abnormal accumulation of the sugar galactose).

Ceftriaxone may alter the results of certain types of blood glucose tests. Please consult your doctor.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines (www.notificaRAM.es).

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ceftriaxone Normon

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

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

Do not use Ceftriaxone Normon after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month indicated.

Reconstituted solutions diluted in infusion minibags or burettes remain chemically and physically stable for 6 hours at 25°C and for 24 hours under refrigeration (2°C–8°C).

The reconstituted product in the vial should be immediately transferred to the final distribution vehicle (infusion minibags or burettes).

From a microbiological standpoint, the product should be used immediately. If not used immediately, the storage time and conditions prior to use are the responsibility of the user and should not exceed 24 hours at 2°C–8°C, unless reconstitution has taken place under controlled, validated aseptic conditions.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their containers to your pharmacy’s SIGRE collection point. If in doubt, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ceftriaxone Normon

The active substance is ceftriaxone.

Each vial contains 2,000 mg of ceftriaxone (as sodium ceftriaxone).

Appearance of the product and contents of the container

Ceftriaxone Normon consists of a powder for solution for infusion.

The powder is almost white or yellowish in colour.

It is supplied in a glass vial, closed with a rubber stopper and sealed with an aluminium flip-off cap.

Pack sizes of 1 and 50 vials.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Laboratorios Normon, S.A.
Ronda de Valdecarrizo, 6 – 28760
Tres Cantos – Madrid (Spain)

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Spain: Ceftriaxone Normon 2,000 mg powder for solution for infusion EFG

Iceland: Ceftriaxona Normon 2000 mg innrennslisstofn, lausn

Date of the most recent review of this summary: March 2026

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

This information is intended for healthcare professionals only

Please refer to the product's summary of characteristics or package insert for complete prescribing information.

Solutions containing ceftriaxone must not be mixed or combined with other agents. In particular, diluents containing calcium (e.g., Ringer's solution, Hartmann's solution) must not be used to reconstitute ceftriaxone vials or to dilute reconstituted vials when administered intravenously, as precipitates may form. Ceftriaxone must not be mixed or co-administered with calcium-containing solutions.

According to available medical literature, ceftriaxone is incompatible with amsacrine, vancomycin, fluconazole, and aminoglycosides.

Instructions for use

Intravenous infusion. It must be administered over at least 30 minutes.

The powder should be dissolved in 10 ml of one of the following calcium-free infusion solutions: 0.9% sodium chloride, 0.45% sodium chloride + 2.5% glucose, 5% glucose, 10% glucose, 6% dextran in 5% glucose, 6–10% hydroxyethyl starch perfusions, or sterile water for injections. The reconstituted solution should then be transferred into the final infusion vehicle (mini-bags or infusion burettes) to achieve a total volume of 50 ml.

The solution must be inspected visually for particulate matter or cloudiness prior to administration. If foreign particles are observed, the solution must be discarded.

The dose and administration regimen used depend on the patient's age and weight, as well as the severity of the infection.

The solution must not be mixed with solutions containing other antibiotics or with solutions other than those specified above.