CEFTRIAXONE NORMON 500 mg POWDER AND SOLVENT FOR SOLUTION FOR INJECTION AND FOR INFUSION

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

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

Ceftriaxone

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information:

1. What Ceftriaxone Normon is and what it is used for.
2. What you need to know before you use Ceftriaxone Normon
3. How to use Ceftriaxone Normon
4. Possible side effects.
5. Storage of Ceftriaxone Normon.
6. Contents of the pack and further information

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

This medicine is an antibiotic that belongs to a group called cephalosporins.

Ceftriaxone 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 gonococcal disease) and,
• stages II and III of Lyme disease (infection caused by a tick bite).

Ceftriaxone Normon is also indicated for the prevention of infections before or after surgical operations.

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

Do not use Ceftriaxone Normon

• if you are allergic (hypersensitive) to the active substance or to cephalosporins, penicillins, or any other antibiotic of the so-called β-lactamics or to any of the other components of this medicine.
• in newborns with jaundice (yellowish skin color 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 immediately or go to the nearest hospital.
• If you experience severe and prolonged diarrhea during or after using this medicine, 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 an overgrowth of some 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. 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 test (including blood tests, urine tests, skin tests that use allergens, etc...), inform your doctor that you are using this medicine, 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 side 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,

• Neonates (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.

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

Other medicines and Ceftriaxone Normon

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

Your doctor will be particularly careful when using ceftriaxone in combination with:

• Probenecid (a medicine used to treat gout).
• Other antibiotics (medicines 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 medicine.

If you are pregnant or think you may be pregnant, inform your doctor before using this medicine, and he will decide whether to use it. The use of medicines 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 you should take into account that ceftriaxone can occasionally cause dizziness.

Ceftriaxone Normon contains sodium

This medicine contains 41.6 mg of sodium (main component of table salt) per vial. This is equivalent to 2.08% of the maximum recommended daily sodium intake for an adult.

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

3. How to use Ceftriaxone Normon

Ceftriaxone is administered intravenously.

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

Follow exactly the administration instructions of this medicine 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 medicine, 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 medicine is too strong or too weak, tell your doctor or pharmacist.

You will continue to receive this medicine for at least 2 to 3 days after you have recovered from your illness or to prevent infections for a few days after your surgical operation.

Follow exactly the administration instructions of the medicine contained in this leaflet 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 infection (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 per day, 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 patients with impaired renal function, it is not necessary to reduce the dose of Ceftriaxone Normon, provided that liver function remains normal. Only in cases of creatinine clearance <10 ml min, the dose of ceftriaxone should not exceed 2 grams per day.< p>

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.

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

Children under 12 years old

Neonates (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.

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

Bacterial meningitis in neonates (15-28 days), infants (from 28 days to 23 months), and children (from 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 seizures 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 medicine and the amount used.

Information for healthcare professionals

Immediately interrupt treatment with ceftriaxone and initiate appropriate therapeutic and support 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 stop using Ceftriaxone Normon

Do not stop treatment before finishing 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 questions about the use of this product, ask your doctor or pharmacist.

4. Possible side 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 salt 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 medicines, Ceftriaxone Normon can cause side effects, although not everybody gets 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 the number of white blood cells in blood), 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 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 (allergic) or anaphylactoid reactions and urticaria (generalized itching of the skin).
• Frequency not known (frequency cannot be estimated from the 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 and acute 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 the available data): problems with the gallbladder or liver, which can cause pain, nausea, vomiting, yellowish skin color, 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 the available data): severe skin reactions. If you experience a severe skin rash, inform a doctor immediately.

• 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 values, 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 drug hypersensitivity syndrome).

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 can be even less frequent if administered by 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 side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines (Website: www.notificaRAM.es) By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Ceftriaxone Normon

Keep out of the reach and sight of children.

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

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

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

From a microbiological point of view, the product should be used immediately. If it is not used immediately, the storage conditions and time before use are the responsibility of the professional and should not exceed 24 hours when 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. Deposit the packaging and any unused medicines at the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Packaging content and additional information

Composition of Ceftriaxone Normon

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 accompanying ampoule (5 ml of water for injectable preparations), 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 injectable preparations.

Appearance of the product and packaging content

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

and a glass solvent ampoule.

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

Marketing authorization holder and manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760

Tres Cantos – Madrid (SPAIN)

This leaflet was last revised in:February 2023

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

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This information is intended for healthcare professionals only

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

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.

For intravenous administration, the contents of the vial are dissolved in 5 ml of solvent from the accompanying ampoule (5 ml of water for injectable preparations).

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 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, weight, and severity of the infection.

The solution should not be mixed with solutions containing other antibiotics or in other solutions different from those mentioned above.