PATIENT INFORMATION LEAFLET

Ceftriaxone NORMON 500 mg powder and solvent for solution for injection and infusion EFG

Ceftriaxone

Read this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you and you should not give it to others, even if they have the same symptoms, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

Ceftriaxona Normon 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 Normon is also indicated to prevent infections before or after a surgical operation.

No 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 (deficit 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).
• Ceftriaxone 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 ceftriaxone or to any penicillin or have suffered from severe allergies or asthma, as ceftriaxone could cause you allergic reactions that, in some cases, could be fatal (anaphylaxis). If this occurs, contact a doctor immediately or go to the nearest hospital.
• If you present intense and prolonged diarrhea during or after the use of this medication, it may be due to a type of colitis (pseudomembranous colitis) that can be serious. In this case, your doctor will suspend the administration of ceftriaxone and initiate an appropriate treatment. Inform your doctor if you have suffered from gastrointestinal diseases, particularly colitis.
• If you are undergoing prolonged treatment with ceftriaxone, other infections (superinfections) may appear due to the overgrowth of certain organisms such as enterococci or Candida.
• When undergoing prolonged treatments, your doctor should perform periodic blood tests.
• If, due to the sedimentation of ceftriaxone calcium, signs and symptoms of gallbladder disease appear, accompanied by alterations in gallbladder 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 ceftriaxone should be suspended.
• Before starting treatment with Ceftriaxona Normon, if you have severe liver or kidney disease, as you may need a dose adjustment or if you have a risk of developing pancreatitis (inflammation of the pancreas).
• If you are to undergo any diagnostic test (including blood tests, urine tests, 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 the size of lymph nodes (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 to50 mg/kg of weight, administered in a single dose, without differences between full-term and premature babies. Do not exceed the dose of 50 mg/kg of 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 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 take special care during the simultaneous use of ceftriaxone with:

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

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

If you are pregnant or think you may be, 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

It has not been demonstrated that the use of Ceftriaxona Normon can affect your ability to drive vehicles or operate tools or machines, but it should be noted that Ceftriaxona Normon may occasionally cause dizziness.

Ceftriaxona Normon contains sodium

This medicationcontains 41.6 mg of sodium (main component of table salt/for cooking) in each vial. This corresponds to 2.08% of the maximum daily sodium intake recommended for an adult.

It contains 0.36 mmol (8.32 mg) of sodium per ml of reconstituted solution.

Ceftriaxone is administered byintravenous route.

Your doctor will administer this medication through direct intravenous injection, in 2-4 minutes. Administration of doses greater than 50 mg/kg should be performed through infusion.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. 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.

Never modify the dose on your own. If you estimate that the action of this medication is too strong or weak, inform your doctor or pharmacist.

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

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

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

Gonococcal disease (uncomplicated genital infection):A single 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

Newborns (up to 14 days): 20 to 50 mg/kg of body weight, administered in a single dose, with no differences between term and premature infants. The dose should not exceed 50 mg/kg of body weight.

Newborns (15-28 days), infants (28 days to 23 months), and children (2 to 12 years): a daily single 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):Treatment will be initiated 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 different posological regimens.

If you use more Ceftriaxone Normon than you should

In case of overdose through 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.

No specific antidote exists. It is not eliminated by dialysis.

If you forgot to use Ceftriaxone Normon

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

If you interrupt treatment with Ceftriaxone 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 children 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 medicines, Ceftriaxone Normon may cause side effects, although not everyone gets them.

Infections and infestations

• Rare (may affect up to 1 in 1,000 people): vulvovaginitis (bacterial infections of the female genital tract).

Blood and lymphatic system disorders

• Rare (may affect up to 1 in 1,000 people): anemia (decrease in hemoglobin concentration in blood), leucopenia (decrease in the number of white blood cells), granulocytopenia (decrease in the number of granulocytes in blood), thrombocytopenia (decrease in the number of platelets in blood), and eosinophilia (increase in a certain group of white blood cells).
• Very rare (may affect up to 1 in 10,000 people): coagulation disorders, agranulocytosis (decrease or absence of white blood cells in the blood), especially after 10 days of treatment or high doses.

Immune system disorders

• Rare (may affect up to 1 in 1,000 people): anaphylactic or anaphylactoid reactions and urticaria (generalized skin itching).
• Frequency not known (the frequency cannot be estimated from available data): severe skin reactions. If you have a severe skin reaction, inform your doctor immediately.

The symptoms may include:

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

Nervous system disorders

• Rare (may affect up to 1 in 1,000 people): headache and dizziness.

Gastrointestinal disorders

• Common (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).
• Very rare (may affect up to 1 in 10,000 people): pseudomembranous colitis (acute and severe diarrhea caused by bacterial overinfection), pancreatitis, gastrointestinal hemorrhage.

Hepatobiliary disorders

• Rare (may affect up to 1 in 1,000 people): symptomatic precipitation of ceftriaxone calcium in the gallbladder and increase in liver enzymes (parameters detected in blood tests).
• Frequency not known (the frequency cannot be estimated from available data): problems with the gallbladder or liver, which may cause pain, nausea, vomiting, yellowing of the skin, itching, dark urine, and clay-colored stools.

Skin and subcutaneous tissue disorders

• Uncommon (may affect up to 1 in 100 people): exanthema (skin rash), allergic dermatitis (inflammation of the skin), rash, edema (accumulation of fluid in tissues), and erythema multiforme.
• Frequency not known (the frequency cannot be estimated from available data): severe skin reactions. 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 SSJ and NET).

- A combination of any of the following symptoms: generalized skin rash, 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).

Renal and urinary disorders

• Rare (may affect up to 1 in 1,000 people): oliguria (decrease in urine production), increase in serum creatinine (parameter detected in blood tests).
• Very rare (may affect up to 1 in 10,000 people): ceftriaxone sodium precipitation in pediatric patients, hematuria (presence of blood in urine).

General disorders and administration site conditions

• Rare (may affect up to 1 in 1,000 people): fever and chills, phlebitis (inflammation of veins) that may be even less frequent if applied through a slow injection over a period of 2-4 minutes).

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

Reporting of 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 the Pharmacovigilance of Medicinal Products for Human Use (Website:www.notificaRAM.es) By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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. Dispose of 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 packaging and medicines you no longer need. This will help protect the environment.

Ceftriaxone Normon Composition

The active ingredient is ceftriaxone (as ceftriaxone sodium).

Each vial contains 500 mg of ceftriaxone (as ceftriaxone sodium). Once reconstituted with the 5 ml of solvent contained in the ampoule, the concentration of the solution is 100 mg of ceftriaxone (as ceftriaxone sodium) per ml

The powder vial has no other components (excipients).

The solvent ampoule contains 5 ml of water for injection.

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 a glass solvent ampoule.

It is presented in cardboard boxes containing 1 powder vial and 1 solvent ampoule.

Marketing Authorization Holder and Responsible Manufacturer

Laboratorios Normon, S.A.

Ronda de Valdecarrizo, 6 – 28760

Tres Cantos – Madrid (SPAIN)

This leaflet has been revised in:February 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

Intravenous route

Administration by direct intravenous injection will be performed in 2-4 minutes. Administration of doses greater than 50 mg/kg should be performed by infusion.

To administer intravenously, the contents of the vial are dissolved in 5 ml of solvent from the ampoule that accompanies it (5 ml of water for injection).

Once reconstituted with the 5 ml of solvent, the concentration of the solution is 100 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.

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.