CEFTRIAXONE NORMON 1000 mg POWDER AND SOLUTION FOR INTRAMUSCULAR INJECTION

Introduction

PROSPECT: INFORMATION FOR THE USER

Ceftriaxone Normon 1,000 mg powder and solution for intramuscular injectable solution EFG

Ceftriaxone

Read the entire prospectus carefully before starting to use this medication, 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 medication has been prescribed to 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 are not listed in this prospectus. See section 4.

Contents of the prospectus:

1. What Ceftriaxone Normon is and what it is used for.
2. What you need to know before starting to use Ceftriaxone Normon
3. How to use Ceftriaxone Normon
4. Possible adverse effects
5. Storage of Ceftriaxone Normon
6. Package contents and additional information

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

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

Ceftriaxone 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 is also indicated for preventing infections before or after surgery.

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 antibiotics called β-lactamics 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 perfusion 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 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 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, without 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 Normon can occasionally cause dizziness.

Ceftriaxone Normon contains sodium

This medication contains 83.24 mg of sodium (main component of table salt) per vial. This is equivalent to 4.14% of the maximum recommended daily sodium intake for an adult.

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

3. How to use Ceftriaxone Normon

Ceftriaxone is administered intramuscularly.

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

This medication should 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.

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 the medication 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 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, 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 per day.< p>

Patients on dialysis:no additional supplemental 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, without 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 the healthcare professional

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 perfusion 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 perfusion routes and administration times of ceftriaxone and calcium-containing solutions were different.

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

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

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

Uncommon adverse effects (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.

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

Vulvovaginitis (infections of the female genital tract caused by bacteria), anemia (decrease in hemoglobin concentration in blood), leukopenia (decrease in white blood cell count), granulocytopenia (decrease in granulocyte count), thrombocytopenia (decrease in platelet count), eosinophilia (increase in a certain type of white blood cell), anaphylactic (allergic) or anaphylactoid reactions, urticaria (generalized itching of the skin), headache, dizziness, symptomatic precipitation of ceftriaxone calcium in the gallbladder, and increased liver enzymes (parameters detected in blood tests), oliguria (decreased urine production), increased serum creatinine (parameter detected in blood tests), fever, chills, and phlebitis (inflammation of the veins) that can be even less frequent if administered through a slow injection over a period of 2-4 minutes.

Very rare adverse effects (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, pseudomembranous colitis (severe and acute diarrhea caused by a superinfection by a bacterium), pancreatitis, gastrointestinal bleeding, Stevens-Johnson syndrome, toxic epidermal necrolysis, or Lyell syndrome (skin destruction with epidermal detachment that starts with blister formation 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 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 values, blood abnormalities (eosinophilia), increased lymph node size, and involvement of other organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome).
• 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.

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

Problems with the gallbladder or liver, which can cause pain, nausea, vomiting, yellowing of the skin, itching, abnormal urine, and clay-colored stools.

Reporting adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is 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 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 month indicated.

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 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 has taken place in controlled and validated aseptic conditions.

Medications should not be thrown away through the sewers or in the trash. Deposit the packaging and medications you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Container Contents and Additional Information

Composition of Ceftriaxone Normon

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

The solvent ampoule contains 35 mg of lidocaine hydrochloride monohydrate.

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

The other components (excipients) are:

Solvent ampoule: water for injectable preparations.

Appearance of the Product and Container Contents

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

Packaging of 1 and 100 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:December 2023

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

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This information is intended only for healthcare professionals

This medication 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 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

For intramuscular use only.

For intramuscular administration, the vial contents are dissolved in 3.5 ml of solvent from the accompanying ampoule (a solution of lidocaine hydrochloride monohydrate 35mg/3.5ml), or in the case of administering 2 g of ceftriaxone per day intramuscularly, 2 vials of 1 g of ceftriaxone reconstituted with 2 ampoules of lidocaine hydrochloride monohydrate 35mg/3.5ml solution 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 injection for particles or turbidity. If foreign particles are observed, the solution should be discarded. Then, inject into a relatively large muscle. Do not administer more than 1 gram in the same location. For doses greater than 2 g, intravenous administration should be used.

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.