CEFTRIAXONE NORMON 2.000 mg POWDER FOR SOLUTION FOR INFUSION

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

Do not use Ceftriaxone Normon

• if you are allergic (hypersensitive) to the active ingredient or to cephalosporins, penicillins, or other beta-lactam antibiotics, or to any of the other components of this medication.
• in newborns with jaundice (yellowing of the skin due to excess bilirubin) or hypoalbuminemia (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 different infusion routes are used, as precipitates may form.

Warnings and precautions

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

• If you have had any allergic reaction to ceftriaxone or any penicillin or have suffered from severe allergies or asthma, as ceftriaxone may cause allergic reactions that can be fatal (anaphylaxis). If this happens, contact a doctor or go to the nearest hospital immediately.
• If you experience severe and prolonged diarrhea during or after using this medication, it may be due to a type of colitis (pseudomembranous colitis) that can be severe. In this case, your doctor will suspend the administration of ceftriaxone and initiate appropriate treatment. Inform your doctor if you have had 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 will 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. If this occurs, the medication with ceftriaxone should be suspended.
• Before starting treatment with Ceftriaxone 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 going to undergo any diagnostic tests (including blood tests, urine tests, skin tests that use 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, flu-like symptoms, increased liver enzyme levels 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 weighing ≥ 50 kg: the same dose as adults, see section 3 below.

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 full-term and premature babies. 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): single daily dose of 20-80 mg/kg of body weight.

Other medications and Ceftriaxone Normon

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

Your doctor will be particularly careful during the simultaneous use of ceftriaxone with:

• Probenecid (a medication used to treat gout).
• Other antibiotics (medications used for 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 pregnant, inform your doctor before using this medication, and they will decide whether to use it. The use of medications during pregnancy can be hazardous to the embryo or fetus and should be monitored by your doctor.

Driving and using machines

It has not been demonstrated that the use of Ceftriaxone Normon can affect your ability to drive vehicles or operate tools or machines, but it should be taken into account that ceftriaxone can occasionally cause dizziness.

Ceftriaxone Normon contains sodium

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

3. How to use Ceftriaxone Normon

Ceftriaxone is administered intravenously.

Follow the administration instructions for this medication exactly as 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 think 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 a few days after your surgery.

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

Adults, children over 12 years old, and weighing ≥ 50 kg:1 to 2 grams of ceftriaxone every 24 hours, which means 1-2 grams/day; in severe cases, the dose may be increased to 4 grams/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 up to a maximum of 2 grams daily is recommended, administered once a day for 14 days.

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

Patients with renal or hepatic impairment:In cases of patients with altered 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 ml min, the dose of ceftriaxone should not exceed 2 grams daily.< p>

Patients on dialysis:no additional supplementary dose is necessary 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.

Elderly patients:In the case of elderly patients, it is not necessary to modify the recommended doses for adults.

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 full-term and premature babies. 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): 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):treatment will be initiated with a dose of 100 mg/kg (not exceeding 4 grams) 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 dosage, there are other presentations more suitable for the different dosing regimens.

If you use more Ceftriaxone Normon than you should

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

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 healthcare professionals

Immediately interrupt treatment with ceftriaxone and initiate appropriate therapeutic and supportive measures.

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

If you forget to use Ceftriaxone Normon

Do not use a double dose to make up for forgotten doses.

If you interrupt treatment with Ceftriaxone Normon

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

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

4. Possible adverse effects

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

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

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

Infections and infestations

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

Blood and lymphatic system disorders

• Rare (may affect up to 1 in 1,000 people): anemia (decrease in hemoglobin concentration in blood), leukopenia (decrease in white blood cell count), granulocytopenia (decrease in granulocyte count), thrombocytopenia (decrease in platelet count), and eosinophilia (increase in a certain type of white blood cell).
• 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 after high doses.

Immune system disorders

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

The symptoms may include:

• Jarisch-Herxheimer reaction, which produces fever, chills, headache, muscle pain, and skin rash, usually self-limiting. This occurs shortly after starting treatment with ceftriaxone 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

• Frequent (may affect up to 1 in 10 people): diarrhea, nausea, stomatitis (inflammation of the mouth mucosa), and glossitis (inflammation of the tongue).
• Very rare (may affect up to 1 in 10,000 people): pseudomembranous colitis (severe diarrhea caused by a superinfection by a bacterium), pancreatitis, gastrointestinal bleeding.

Hepatobiliary disorders

• Rare (may affect up to 1 in 1,000 people): symptomatic precipitation of ceftriaxone calcium in the gallbladder and increased liver enzymes (parameters detected in blood tests).
• Frequency not known (frequency cannot be estimated from available data): gallbladder or liver problems, which can cause pain, nausea, vomiting, yellowing of the skin, itching, abnormal 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 (skin inflammation), rash (exanthema), edema (fluid accumulation in tissues), and erythema multiforme.
• Frequency not known (frequency cannot be estimated from available data): severe skin reactions.

If you experience a severe skin rash, inform a 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 SJS and TEN).
• A combination of any of the following symptoms: widespread skin rash, high body temperature, elevated liver enzyme levels, blood abnormalities (eosinophilia), increased lymph node size, and involvement of other body organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or hypersensitivity syndrome to medications).

Renal and urinary disorders

• Rare (may affect up to 1 in 1,000 people): oliguria (decreased urine production), increased serum creatinine (parameter detected in blood tests).
• Very rare (may affect up to 1 in 10,000 people): renal precipitation of ceftriaxone sodium 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 the veins), which may be even less frequent if administered through a slow injection over a period of 2-4 minutes.

Treatment with ceftriaxone, particularly in elderly patients with severe kidney or nervous system problems, can rarely cause decreased consciousness, abnormal movements, agitation, and convulsions.

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 not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications (Website: www.notificaRAM.es)

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

5. Storage of Ceftriaxone Normon

Keep out of the reach and sight of children.

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

Before reconstitution: Do not use Ceftriaxone Normon after the expiration date stated on the packaging after "CAD". The expiration date is the last day of the indicated month.

After reconstitution/dilution: The reconstituted and diluted solutions in mini-bags or burettes for infusion maintain their chemical and physical stability for 6 hours at 25°C and for 24 hours in the refrigerator (2°C-8°C).

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

From a microbiological point of view, the product should be used immediately. If not used immediately, the 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 the reconstitution took place in controlled and validated aseptic conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of packaging and medicines that are no longer needed. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Ceftriaxone Normon

The active ingredient is ceftriaxone (as ceftriaxone sodium).

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

Appearance of the Product and Package Contents

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

Packages of 1 and 50 vials

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760

Tres Cantos – Madrid (SPAIN)

This leaflet was revised in: September 2021

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

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

This information is intended only for healthcare professionals

This medication is reconstituted before use. The reconstituted solution is for single use. Discard any leftover solution.

The reconstituted solution is clear and yellow or slightly yellowish.

Incompatibilities

Solutions containing ceftriaxone should not be mixed or added to other agents. 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 when administered intravenously, as they 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 Method

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

It will 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% hydroxyethyl starch in 5% glucose, or sterile water for injectable preparations. Then, the reconstituted solution will be transferred to the final distribution vehicle (mini-bags or burettes for infusion) to reach a total volume of 50 ml.

The solution should be examined before injection for any particles or turbidity. If foreign particles are observed, the solution should be discarded.

The dose and administration schedule used depend 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 indicated above.