Prospect: Information for the User

Ceftriaxone Fresenius Kabi 1 g Powder for Injectable Intravenous Solution EFG

ceftriaxone

Ceftriaxone Fresenius Kabiis an antibiotic administered to adults and children (including newborns). It acts by killing bacteria that cause infections.It belongs to a group of antibiotics called cephalosporins.

Ceftriaxone Fresenius Kabi is indicated for treating infections related to:

• the brain (meningitis).
• the lungs.
• the middle ear.
• the abdomen and abdominal wall (peritonitis).
• the urinary tract and kidneys.
• bones and joints.
• the skin and soft tissues.
• the blood.
• the heart.

It may be used in the following cases:

• to treat specific sexually transmitted infections (gonorrhea and syphilis).
• to treat patients with low white blood cell counts (neutropenia) who have fever during a bacterial infection.
• to treat chronic bronchitis in adults.
• to treat Lyme disease (caused by tick bite) in adults and children, including newborns from 15 days of age.
• to prevent infections during surgery.

Do not use Ceftriaxona Fresenius Kabi:

• If you are allergic to ceftriaxone or any of the other components of this medication (listed in section 6).
• If you have had an immediate or severe allergic reaction to penicillins or similar antibiotics (such as cephalosporins, carbapenems, or monobactams). Symptoms include sudden swelling of the throat or face that may make it difficult to breathe or swallow, sudden swelling of the hands, feet, and ankles, chest pain, and a severe skin rash that develops rapidly.
• If you are allergic to lidocaine and Ceftriaxona Fresenius Kabi must be administered as an intramuscular injection.

Ceftriaxona Fresenius Kabi should not be used in babies if:

• The baby is premature.

• The baby is a newborn (up to 28 days old) and has certain blood problems or jaundice (yellowing of the skin or white of the eyes) or must be treated intravenously with a product containing calcium.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Ceftriaxona Fresenius Kabi if:

• You have taken recently or may have to take products containing calcium.
• You have had diarrhea recently after taking an antibiotic. If you have ever had problems with your gastrointestinal system, particularly colitis (inflammation of the intestine).
• You have liver or kidney problems (see section 4).
• You have gallstones or kidney stones.
• You have other diseases, such as hemolytic anemia (reduction in the number of red blood cells that can cause pale yellow skin and cause weakness or dyspnea).
• You must follow a low-sodium diet.
• 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, elevated 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 side effects").

If you are to have a blood or urine test

If you have been prescribed Ceftriaxona Fresenius Kabi for a long period of time, you will need to have blood tests periodically.

Ceftriaxona Fresenius Kabi may affect the results of urine tests for glucose and blood tests in the Coombs test.

If you are undergoing tests:

• Inform the person taking the sample that you have been administered Ceftriaxona Fresenius Kabi.

If you are diabetic or must control your blood glucose levels, do not use certain blood glucose control systems that may measure your blood glucose levels incorrectly while using ceftriaxone. If you use such systems, review the usage instructions and consult with your doctor, pharmacist, or nurse. Alternative methods should be used if necessary.

Children

Consult your doctor or pharmacist or nurse before administering Ceftriaxona Fresenius Kabi to your child if:

• They have taken recently or may have to take an intravenous product containing calcium.

Other medications and Ceftriaxona Fresenius Kabi

Inform your doctor or pharmacist if you are using, have used recently, or may have to use any other medication.

Particularly, consult your doctor or pharmacist if you are using any of the following medications:

• A type of antibiotic called aminoglycoside.
• An antibiotic called Chloramphenicol (used to treat infections, particularly of the eyes).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor before using this medication.

Your doctor will decide whether to treat you with Ceftriaxona Fresenius Kabi and the risk it may pose to your baby.

Driving and operating machinery

Ceftriaxona Fresenius Kabi may cause dizziness. If you feel dizzy, do not drive or use any tools or machinery. Consult your doctor if you experience these symptoms.

Ceftriaxona Fresenius Kabi contains sodium

This medication contains 82.3 mg of sodium (main component of table salt/for cooking) in each vial. This is equivalent to 4.1% of the maximum recommended daily sodium intake for an adult.

Ceftriaxone Fresenius Kabi is usually administered by a doctor or nurse. It can be administered through a drip (intravenous infusion) or through an intravenous or intramuscular injection. Ceftriaxone Fresenius Kabi is prepared by a doctor, pharmacist, or nurse and cannot be mixed or administered with other injections that contain calcium.

Usual dose

Your doctor will decide on the appropriate dose of Ceftriaxone Fresenius Kabi for you.The dose will depend on the severity and type of infection; if you are taking other antibiotics; your weight and age; how well your kidneys and liver are functioning. The number of days or weeks you will be treated with Ceftriaxone Fresenius Kabi will depend on the type of infection you have.

Adults, elderly, and children over 12 yearsand ≥ 50 kg:

• 1 - 2 g administered once a day depending on the severity and type of infection. In case of severe infection, your doctor will administer a higher dose (up to 4 g once a day). If your daily dose is greater than 2 g, it will be administered once a day or in two separate doses.

Newborns, infants, and children from 15 days to 12 years with <50

• 50 - 80 mg of Ceftriaxone Fresenius Kabi per kg of body weight once a day, depending on the severity and type of infection. In case of severe infection, your doctor will administer a higher dose, up to 100 mg per kg of body weight up to a maximum of 4 g once a day. If your daily dose is greater than 2 g, it will be administered once a day or in two separate doses.
• Children with a weight of 50 kg or more will be administered the usual adult dose.

Newborns (0-14 days)

• 20 - 50 mg of Ceftriaxone Fresenius Kabi per kg of body weight once a day depending on the severity and type of infection.
• The maximum daily dose should not exceed 50 mg per kg of body weight of the infant.

Patients with liver or renal impairment:

You will be administered a different dose than the usual one. Your doctor will decide on the dose you need of Ceftriaxone Fresenius Kabi and will monitor you closely depending on the severity of the liver and kidney disease.

If you use more Ceftriaxone Fresenius Kabi than you should

If you accidentally receive more doses than prescribed, inform your doctor or go to the nearest hospital.

If you forget to use Ceftriaxone Fresenius Kabi

If you forget an injection, administer it as soon as possible. However, if it is almost time for your next injection, omit the missed injection.Do not receive a double dose(two injections at once)to compensate for the missed doses.

If you interrupt treatment with Ceftriaxone Fresenius Kabi

Do not stop taking Ceftriaxone Fresenius Kabi unless your doctor tells you to.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.The following side effects may occur with this medicine:

Severe allergic reactions (unknown, cannot be estimated from available data)

Inform your doctor immediately if you experience a severe allergic reaction.

The symptoms may include:

• Sudden swelling of the face, throat, lips, or mouth, which may make it difficult to breathe or swallow.
• Sudden swelling of the hands, feet, and ankles.
• Chest pain in the context of allergic reactions, which may be a symptom of an allergic-induced heart attack (Kounis syndrome).

Severe skin reactions (unknown, cannot be estimated from available data)

Inform your doctor immediately if you experience a severe skin reaction.

The symptoms may include:

• A severe rash that develops rapidly, with blisters or peeling of the skin and possibly blisters in the mouth (Stevens-Johnson syndrome and toxic epidermal necrolysis, also known as SSJ and NET, respectively).
• A combination of any of the following symptoms: generalized skin rash, high body temperature, elevated liver enzyme values, blood abnormalities (eosinophilia), enlarged lymph nodes, and involvement of other organs in the body (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome).
• Jarisch-Herxheimer reaction, which causes fever, chills, headache, muscle pain, and skin rash, which is usually self-limiting. This occurs shortly after starting ceftriaxona treatment for infections caused by spirochetes such as Lyme disease.

Other possible symptoms:

Frequent (may affect up to 1 in 10 people)

• Abnormalities with white blood cells (such as a decrease in leukocytes and an increase in eosinophils) and platelets (decrease in thrombocytes).
• Loose stools or diarrhea.
• Changes in liver function test results.
• Rash.

Rare (may affect up to 1 in 100 people)

• Fungal infections (e.g., candidiasis).
• Decreased white blood cell count (granulocytopenia).
• Decreased red blood cell count (anemia).
• Bleeding disorders. Symptoms may include a tendency to bruise and joint pain and swelling.
• Headache.
• Dizziness.
• Uncomfortable or nausea.
• Itching.
• Pain or burning at the vein where Ceftriaxona Fresenius Kabi has been administered. Pain at the injection site.
• Elevated body temperature (fever).
• Abnormal kidney function test results (increased serum creatinine).

Rare (may affect up to 1 in 1000 people)

• Colitis, which may cause diarrhea, usually with blood and mucus, abdominal pain, and fever.
• Difficulty breathing (bronchospasm).
• Urticaria that may cover most of the body, with itching and swelling.
• Blood or sugar in the urine.
• Edema (fluid accumulation).
• Chills.
• The treatment with ceftriaxona, particularly in elderly patients with severe kidney problems or neurological problems, rarely may cause decreased consciousness, abnormal movements, agitation, and seizures.

Frequency unknown (cannot be estimated from available data)

• Second infection that may not respond to the previously prescribed antibiotic treatment.
• Anemia in which red blood cells are destroyed (hemolytic anemia).
• Severe decrease in white blood cell count (agranulocytosis).
• Seizures.
• Dizziness (sensation of spinning).
• Pancreatitis, which may cause severe abdominal pain that radiates to the back.
• Stomatitis, which may cause inflammation of the mucous membrane in the mouth.
• Glossitis, which may cause inflammation of the tongue, with swelling, redness, and pain.
• Problems with the gallbladder or liver, which may cause pain, nausea, vomiting, yellowing of the skin, itching, dark urine, and clay-colored stools.
• Neurological disorder that may occur in newborns with severe jaundice (kernicterus).
• Renal problems caused by ceftriaxona calcium deposits. You may experience pain with urination or decreased urine output.
• Falsely positive Coombs test result (test performed for certain blood disorders).
• Falsely positive galactosemia test result (abnormal accumulation of galactose).
• Ceftriaxona Fresenius Kabi may interfere with some blood glucose tests – please consult your doctor.

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 Pharmacovigilance of Medicines for Human Use (Website:www.notificaRAM.es).Reporting side effects may help provide more information about the safety of this medicine.

Keep out of reach and sight of children.

Do not use Ceftriaxone Fresenius Kabi after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C.

Store the vial in the outer packaging to protect it from light.

The reconstituted solution maintains its stability for 8 hours at 25 °C and 24 hours in the refrigerator (2 - 8 °C).

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of packaging and medicines that you no longer need. In this way, you will help protect the environment.

Composition of Ceftriaxone Fresenius Kabi

The active ingredient is ceftriaxone sodium equivalent to 1.0 g of ceftriaxone.

Appearance of the product and contents of the package

The solutions may vary from colorless to pale yellow.

Ceftriaxone Fresenius Kabi powder for injectable solution and for infusion is presented in containers that contain 1, 10, or 100 glass vials of powder, closed with a rubber stopper. It is possible that not all package sizes are marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Fresenius Kabi España, S.A.U.

Torre Mapfre-Vila Olímpica

Marina 16-18, 08005 – Barcelona

Spain

Responsible for manufacturing

LABESFAL – Laboratórios Almiro S.A.

Lagedo, 3465-157 Santiago de Besteiros

Portugal

This medicine is authorized in the member states of the European Economic Area with the following names:

AustriaCeftriaxon Kabi 1 g Powder for the preparation of an injection/infusion solution

BelgiumCeftriaxone Fresenius Kabi 1g powder for solution for injection/infusion

Czech RepublicCeftriaxon Kabi 1g, powder for injection/infusion solution

DenmarkCeftriaxon Fresenius Kabi

EstoniaCeftriaxone Kabi1 g

FinlandCeftriaxon Fresenius Kabi 1 g injection/infusion powder, for solution

GermanyCeftriaxon Kabi 1 g

GreeceCeftriaxone Kabi 1g, κ?νις for intravenous solution/dilution for infusion

HungaryCeftriaxon Kabi 1 g for parenteral solution for injection/infusion

LuxembourgCeftriaxon Kabi 1 g Powder for the preparation of an injection/infusion solution

LithuaniaCeftriaxone Kabi 1 g powder for injection/infusion solution

LatviaCeftriaxone Kabi 1 g powder for injection/infusion solution

NetherlandsCeftriaxone Fresenius Kabi 1g powder for solution for injection/infusion

NorwayCeftriaxon Fresenius Kabi 1 g powder for injection/infusion solution, for solution

PolandaCeftriaxon Kabi 1 g

PortugalCeftriaxona Fresenius Kabi

SlovakiaCeftriaxon Kabi 1 g

SwedenCeftriaxon Fresenius Kabi 1 g, powder for injection/infusion solution, for solution

Last review date of this leaflet:July 2022

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

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This information is intended solely for healthcare professionals:

Intravenous administration:

The 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 the ceftriaxone vials or to dilute the reconstituted vials when administered IV, as it may form precipitates.

Ceftriaxone should not be mixed or administered simultaneously with solutions containing calcium (see sections 4.2, 4.3, 4.4, and 4.8 of the technical data sheet and section 6 of the leaflet).

Intravenous administration should be performed in 2-4 minutes. Administration of doses exceeding 50 mg/kg should be performed by infusion. IV infusion should be administered in at least 30 minutes.

To administer intravenously, the contents of the Ceftriaxone Fresenius Kabi 1g vial should be dissolved in 10 ml of solvent (water for injection). 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.

Adults and children over 12 years: the usual dose is 1-2 g of ceftriaxone administered once a day (every 24 hours). In severe cases or infections caused by moderately sensitive bacteria, the dose may be increased to a maximum of 4 g once a day.

Stages II and III of Lyme disease

It isrecommended to administer a dose of 50 mg/Kgof body weight, up to a maximum of 2 grams per day, once a day for 14 days.

Perioperative prophylaxis

A single dose of 1-2 g, 30-90 minutes before the intervention. In colorectal surgery, another antibiotic with adequate spectrum against anaerobes should be associated.

Combined therapy:

In infections caused by gram-negative bacteria, it may be necessary to associate with aminoglycosides, especially in severe cases or with vital risk.

Newborns and 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.

Infants and children (from 15 days to 12 years):single daily dose of 20-80 mg/kg of body weight.

Children with a weight of >50 kg: the adult dose will be used.

Bacterial meningitis in infants and children

The treatment will be initiated with doses of 100 mg/kg (without 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.

Older adults:No dose adjustment is required for adults, unless there is renal and/or hepatic dysfunction.

Patients with renal impairment:

In patients with impaired renal function, no dose reduction is necessary, as long as liver function remains normal. Only in cases of pre-terminal renal failure (creatinine clearance <10

In cases of renal and hepatic dysfunction, the ceftriaxone dose should not exceed 2 g per day, unless plasma concentrations are regularly determined and adjusted as necessary.

In patients undergoing dialysis, no additional dose is necessary after the dialysis session; in any case, the patient's clinical situation will be monitored, and adjustments to the dose may be necessary.

Patients with hepatic impairment:

In cases of hepatic dysfunction, no dose reduction is necessary, as long as renal function is intact. In cases of renal and hepatic dysfunction, the ceftriaxone dose should not exceed 2 g per day, unless plasma concentrations are regularly determined and adjusted as necessary.

Duration of therapy:

Varies with the severity of the disease. In general, ceftriaxone administration should be maintained for a minimum of 48 to 72 hours after clinical improvement, or until microbiological eradication is achieved.