PPROSPECTUS: INFORMATION FOR THE USER

Ceftriaxone Normon 1.000 mg powder and solution for injectable intramuscular solution EFG

Ceftriaxone

Read this prospectus carefully before starting to use this medicine, 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 or pharmacist.
• This medicine has been prescribed for you and should not be given to others, 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 prospectus. See section 4.

This medication is an antibiotic that belongs to the group known as cephalosporins.

Ceftriaxona is indicated for the treatment of severe infections such as:

• bacterial meningitis,
• abdominal infections (such as peritonitis and biliary tract infections),
• bone and joint infections, complicated skin and soft tissue infections,
• complicated urinary tract infections including pyelonephritis (kidney infection),
• respiratory infections,
• genital infections (including gonorrhea) and,
• stages II and III of Lyme disease (infection caused by tick bite).

Ceftriaxona is also indicated to prevent infections before or after surgery.

Do not use Ceftriaxona Normon

• if you are allergic (hypersensitive) to the active ingredient or to cephalosporins, penicillins, or any other beta-lactam antibiotics, or to any of the other components of this medication.
• in newborns with jaundice (yellow discoloration of the skin due to excess bilirubin) or hypoproteinemia (deficiency of a blood protein called albumin), or in premature babies due to the risk of developing hyperbilirubinemic encephalopathy (a disease that can cause brain damage due to bilirubin accumulation and be fatal).
• Ceftriaxona should not be mixed or administered simultaneously with solutions or products containing calcium, even if used through different infusion routes, as precipitates may form.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Ceftriaxona Normon:

• If you have had any allergic reaction to ceftriaxona or to any penicillin or have suffered from severe allergies or asthma, as ceftriaxona could cause allergic reactions that, in some cases, may be fatal (anaphylaxis). If this occurs, contact a doctor immediately or go to the nearest hospital.
• If you experience intense and prolonged diarrhea during or after use of this medication, it may be due to a type of colitis (pseudomembranous colitis) that can be severe. In this case, your doctor will discontinue ceftriaxona administration and initiate appropriate treatment. Inform your doctor if you have suffered from gastrointestinal diseases, particularly colitis.
• If you are undergoing prolonged treatment with ceftriaxona, other infections (superinfections) may appear due to overgrowth of certain organisms such as enterococci or Candida.
• When undergoing prolonged treatment, your doctor should perform periodic blood tests.
• If, due to ceftriaxona calcium sedimentation, signs and symptoms of biliary tract disease appear, accompanied by alterations in biliary tract ultrasound. The risk of these alterations may increase in treatments lasting more than 14 days, in patients with renal failure, dehydration, or total parenteral nutrition, as well as in very young children. In case of occurrence, the medication with ceftriaxona should be discontinued.
• Before starting treatment with Ceftriaxona Normon, if you have severe liver or kidney disease, as you may need a dose adjustment or if you are at risk of developing pancreatitis (inflammation of the pancreas).
• If you are to undergo any diagnostic tests (including blood, urine, skin tests using allergens, etc.), inform your doctor that you are using this medication, as it may alter the results.

-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, symptoms similar to the flu, increased levels of liver enzymes observed in blood tests, and an increase in a type of white blood cell (eosinophilia) and an increase in lymph node size (signs of severe skin reactions, see also section 4 “Possible adverse effects”).

-If you have liver or kidney problems (see section 4).

Children and adolescents

Children over 12 years old, and with a weight ≥50 kg, the same dose as adults, see section 3.

Children under 12 years old,

• Newborns (up to 14 days): 20-50 mg/kg of body weight, administered in a single dose, with no differences between full-term and premature babies. Do not exceed the dose of 50 mg/kg of body weight.
• Newborns (15-28 days), infants (28 days to 23 months), and children (2 to 12 years): a single daily dose of 20-80 mg/kg of body weight

Other medications and Ceftriaxona Normon

Inform your doctor or pharmacist if you are using or have recently used other medications, even those purchased without a prescription.

Your doctor will exercise special caution during the simultaneous use of ceftriaxona with:

• Probenecid (a medication used to treat gout)
• Other antibiotics (medications used to treat infections).
• Hormonal contraceptives. It is recommended to take additional precautions during treatment and in the month following.

Pregnancy and lactation

Consult your doctor or pharmacist before using any medication.

If you are pregnant or believe you may be pregnant, inform your doctor before using this medication, and he will decide whether it is advisable to use it. The consumption of medications during pregnancy can be hazardous to the embryo or fetus and should be monitored by your doctor.

Driving and operating machines

No adverse effects on your ability to drive vehicles or operate tools or machines have been demonstrated, but it should be noted that Ceftriaxona Normon may occasionally cause dizziness.

Ceftriaxona Normon contains sodium

This medicationcontains 83.24 mg of sodium (main component of table salt/for cooking) in each vial. This corresponds to 4.14% of the maximum daily sodium intake recommended for an adult.

It contains 1.03 mmol (23.78 mg) of sodium per ml of reconstituted solution.

Ceftriaxone is administered byintramuscular route.

For intramuscular administration, the contents of the vial must be dissolved in 3.5 ml of the solvent from the accompanying ampoule.

This medication must be administered by a healthcare professional.

In case of doubt, consult your doctor or pharmacist again.

Depending on your disease, age, weight, and response to treatment with this medication, your doctor will prescribe the most suitable dose and treatment duration.

Do not modify the dose on your own. If you estimate that the effect of this medication is too strong or too weak, inform your doctor or pharmacist.

You will continue to receive this medication for at least 2 to 3 days after recovering from your illness or to prevent infections for some days after your surgical operation.

Follow exactly the administration instructions for the medication contained in this leaflet or those indicated by your doctor or pharmacist. In case of doubt, ask yourdoctor or pharmacist

Adults, children over 12 years old, and ≥ 50 kg:1 to 2 g of ceftriaxone every 24 hours, which means 1-2 g/day; in severe cases, the dose can be increased to 4 g/day.

Gonococcal disease (uncomplicated genital infection):asingle intramuscular dose of 250 mg is recommended.

Stages II and III of Lyme disease:a dose of 50 mg/kg of body weight is recommended, up to a maximum of 2 grams per day, once a day for 14 days.

Prevention of diseases before and after operations:1 to 2 g of ceftriaxone administered 30-90 minutes before the intervention.

Patients with renal or hepatic impairment:In the case of patients with impaired renal function, it is not necessary to reduce the dose of Ceftriaxone Normon, as long as liver function remains normal. Only in cases of creatinine clearance <10

Patients on dialysis:No additional supplementary dose is required after dialysis, however, serum concentrations will be monitored to determine if dose adjustments are necessary, as the elimination rate in these patients may be reduced.

Geriatric patients:In the case of elderly patients, the recommended adult doses do not need to be modified.

Children under 12 years old

Newborns (up to 14 days): 20 to 50 mg/kg of body weight, administered in a single dose, with no differences between term and preterm babies. Do not exceed the dose of 50 mg/kg of body weight.

Newborns (15-28 days), infants (28 days to 23 months), and children (2 to 12 years): a single daily dose of 20-80 mg/kg of body weight.

Bacterial meningitis in newborns (15-28 days), infants (28 days to 23 months), and children (2 to 12 years):initiate treatment with doses of 100 mg/kg (not exceeding 4 g) once a day. As soon as the causal germ is identified and its sensitivity is determined, the dose may be adjusted accordingly.

Depending on the dosing, there are other presentations more suitable for the different posological regimens.

If you use more Ceftriaxone Normon than you should

In case of overdose by this administration route, it may lead to convulsions and gastrointestinal disturbances.

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 used.

Information for the healthcare professional

Immediately interrupt treatment with ceftriaxone and implement the necessary therapeutic and supportive measures.

There is no specific antidote. It is not eliminated by dialysis.

If you forgot to use Ceftriaxona Normon

Do not use a double dose to compensate for the missed doses.

If you interrupt treatment with Ceftriaxona Normon

Do not discontinue treatment before completing it, as the desired effect will not be achieved. It is very important to treat infections for the recommended time, otherwise it may worsen.

If you have any other doubts about the use of this product, ask your doctor or pharmacist.

Ceftriaxone should not be mixed or administered simultaneously with solutions or products containing calcium, even if they are used through different routes of infusion.

Cases of reactions that have caused the death of newborns and premature infants due to the formation of calcium ceftriaxone precipitates in the lungs and kidneys of these patients have been described. In some cases, the infusion routes and administration times of ceftriaxone and calcium-containing solutions were different.

Like all medications, Ceftriaxone may have adverse effects, although not all people may experience them.

Frequent adverse effects (may affect up to 1 in 10 people):

Diarrhea, nausea, stomatitis (inflammation of the mucous membrane of the mouth) and glossitis (inflammation of the tongue).

Less frequent adverse effects (may affect up to 1 in 100 people):

Exanthema (skin eruption), allergic dermatitis (inflammation of the skin), rash (exanthema), edema (accumulation of fluid in tissues) and erythema multiforme.

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

Vulvovaginitis (bacterial infections of the female genital tract), anemia (decrease in hemoglobin concentration in blood), leukocytopenia (decrease in the number of leukocytes in blood), granulocytopenia (decrease in the number of granulocytes in blood), thrombocytopenia (decrease in the number of platelets in blood), eosinophilia (increase in a certain group of white blood cells), anaphylactic or anaphylactoid reactions, urticaria (generalized itching of the skin), headache, dizziness, symptomatic precipitation of ceftriaxone calcium in the gallbladder and increase in hepatic enzymes (parameters detected in blood tests), oliguria (decrease in urine production), increase in serum creatinine (parameter detected in blood tests), fever, chills and phlebitis (inflammation of veins) that may be even less frequent if applied through a slow injection over a period of 2-4 minutes.

Very rare adverse effects (may affect up to 1 in 10,000 people):

Bleeding disorders, agranulocytosis (decrease or absence of white blood cells in blood) especially after 10 days of treatment or high doses, pseudomembranous colitis (acute and severe diarrhea caused by bacterial overinfection), pancreatitis, gastrointestinal hemorrhage, Stevens-Johnson syndrome, toxic epidermal necrolysis or Lyell syndrome (skin destruction with epidermal detachment that begins with the formation of blisters but without inflammation), renal precipitation of ceftriaxone sodium in pediatric patients, hematuria (presence of blood in urine).

Adverse effects of unknown frequency (frequency cannot be estimated from available data)

Severe skin reactions. If you have areactionsevere skin eruption, inform your doctor immediately.

The symptoms may include:

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

- A combination of any of the following symptoms: generalized skin eruption, high body temperature, elevated liver enzyme values, blood abnormalities (eosinophilia), lymph node enlargement and involvement of other body organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome).

- Jarisch-Herxheimer reaction that produces fever, chills, headache, muscle pain and skin eruption that is usually self-limiting. This occurs shortly after starting ceftriaxone treatment for infections caused by spirochetes such as Lyme disease.

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

Problems with the gallbladder or liver, which may cause pain, nausea, vomiting, yellow skin discoloration, itching, dark urine and clay-colored stools.

Reporting of adverse effects

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

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

Keep out of reach and sight of children.

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

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

After reconstitution: Reconstituted solutions maintain their chemical and physical stability for 6 hours at 25°C and for 24 hours in a refrigerator (2°C-8°C).

From a microbiological point of view, the product must be used immediately. If not used immediately, storage conditions and time, before use, are the responsibility of the professional and should not exceed 24 hours stored between 2 and 8°C, unless reconstitution has taken place in controlled and validated aseptic conditions.

Medicines should not be disposed of through drains or in the trash. Deposit the packaging and medicines you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Ceftriaxone Normon Composition

The active ingredient is ceftriaxone (as ceftriaxone sodium). Each vial of powder contains 1,000 mg of ceftriaxone (as ceftriaxone sodium).

The ampoule of solvent contains 35 mg of lidocaine hydrochloride monohydrate.

Once reconstituted with the 3.5 ml of lidocaine hydrochloride monohydrate solvent contained in the ampoule, the concentration of the solution is 285.71 mg of ceftriaxone (as ceftriaxone sodium) per ml

The other components (excipients) are:

Ampoule of solvent: water for injection preparations.

Product appearance and packaging contents

It is presented in a glass vial, closed with a rubber stopper and sealed with a flip-off capsule, and 1 ampoule of solvent.

Packaging of 1 and 100 vials

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer responsible

Laboratorios Normon, S.A.

Ronda de Valdecarrizo, 6 – 28760

Tres Cantos – Madrid (SPAIN)

This leaflet has been revised in:December 2023

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

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This information is intended solely for healthcare professionals

This medicine is reconstituted before use. The reconstituted solution is for single use. Discard any remaining solution.

The reconstituted solution is clear and yellow or slightly yellowish.

Incompatibilities

Solutions containing ceftriaxone should not be mixed or have other agents added. In particular, diluents containing calcium (e.g., Ringer's solution, Hartmann's solution) should not be used to reconstitute ceftriaxone vials or to dilute reconstituted vials for IV administration, as it may form precipitates. Ceftriaxone should not be mixed or administered simultaneously with solutions containing calcium

Ceftriaxone is incompatible with amsacrine, vancomycin, fluconazole, and aminoglycosides

Administration form

Only forintramuscular administration.

To administer intramuscularly, the contents of the vial are dissolved in 3.5 ml of the solvent ampoule that accompanies it (a solution of lidocaine hydrochloride monohydrate 35mg/3.5ml), or in the case of administering 2 g of ceftriaxone per day by intramuscular administration, 2 vials of 1 g of ceftriaxone reconstituted with 2 ampoules of lidocaine hydrochloride monohydrate solution 35mg/3.5ml should be used.

Once reconstituted with the 3.5 ml of solvent, the concentration of the solution is 285.71 mg of ceftriaxone (as ceftriaxone sodium) per ml.

The solution should be examined before injecting it for the presence of particles or turbidity. If particles are observed, the solution should be discarded. Then, inject into a relatively large muscle. Do not inject more than 1 gram in the same place. For doses above 2 g, intravenous administration should be used.

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 in other solutions different from those mentioned above.