Prospect: Information for the User

Ceftriaxone Fresenius Kabi 1 g Powder and Diluent for Injectable Solution Intramuscular EFG

ceftriaxone

Read the entire prospect carefully before starting to use the medication, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only to you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they do not appear in this prospect. See section 4.

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

Ceftriaxone Fresenius Kabiis 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 can be used in the following cases:

• to treat specific sexually transmitted infections (gonorrhea and syphilis).
• to treat patients with low white blood cell count (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 recently taken or may need to take products containing calcium.
• You have recently had diarrhea 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 conditions, such as hemolytic anemia (reduction in the number of red blood cells that can cause pale yellow skin and cause weakness or shortness of breath).
• 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 lymph node size (signs of severe skin reactions, see also section 4 “Possible side effects”).

If you need to have blood or urine tests

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 having tests:

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

If you are diabetic or need to 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 Ceftriaxona Fresenius Kabi is administered to your child if:

• They have recently taken or may need 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 need 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 plan to become pregnant, consult your doctor before using this medication.

Your doctor will decide whether it is advisable 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 daily recommended 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 and children over 12 years

• 1 - 2 g administered once a day. In severe cases, the daily dose may be increased to 4 g once a day depending on the severity and type of infection. In the case of a severe infection, your doctor will administer a higher dose (up to 4 g once a day). If your daily dose is more 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 kg

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

Patients with liver or kidney 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 a missed dose.

If you interrupt treatment with Ceftriaxone Fresenius Kabi

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

If you have any other questions about the use of this medication, 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 skin peeling, 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 treatment with ceftriaxona 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-colored urine, and clay-colored stools.
• Neurological disorder that may occur in newborns with severe jaundice (kernicterus).
• Renal problems caused by ceftriaxona calcium deposits. There may be 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.

The intramuscular injection of reconstituted ceftriaxona without lidocaine is painful.

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 this medication out of the sight and reach of children.

Do not use this medication 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 a refrigerator (2-8°C).

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

Composition of Ceftriaxone Fresenius Kabi

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

The other components (excipients) are: 3.5 ml of lidocaine hydrochloride solution at 1% in each ampoule.

Once the contents of the vial are reconstituted with 3.5 ml of the ampoule's solvent, the solution contains 285.7 mg of ceftriaxone per ml.

Appearance of the product and contents of the package

Ceftriaxone Fresenius Kabi is a white or yellowish crystalline powder for injection solution.

Ceftriaxone Fresenius Kabi 1 g is available in transparent glass vials of 15 ml closed with a rubber stopper.

It is presented in boxes of 1 vial, 10 vials, or 100 vials (clinical packaging).It is possible that not all package sizes are commercially available.

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:

ItalyCEFTRIAXONE KABI 1g/3.5 ml powder and solvent for solution for injection for intramuscular use

PortugalCeftriaxona Fresenius 1000 mg/3.5 ml pó and solvent for solution injectable (IM)

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:

Ceftriaxone Fresenius Kabi1 gpowder and solvent for injectable solution intramuscular EFG

Ceftriaxone Fresenius Kabi powder and solvent for injectable solution for intramuscular use should be administered by intramuscular injection and never by intravenous injection. In children under 2 years, this route of administration should not be used.

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 when administered by 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).

To administer intramuscularly, dissolve the contents of the Ceftriaxone Fresenius Kabi 1 g vial in 3.5 ml of the solvent from the accompanying ampoule (1% lidocaine hydrochloride solution). Then, inject deeply into a large muscle mass, performing a prior aspiration to avoid inadvertently injecting into a blood vessel.

If more than 1 g needs to be administered, the dose should be divided into two different muscle masses.

Examine the solution before injecting it for the presence of particles or turbidity. If particles are observed, discard the solution.

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 is recommended to administer a dose of 50 mg/Kg of 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 procedure. 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 newborns. 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 over 50 kg:the same dose as for adults will be used.

Bacterial meningitis in infants and children

Initiate treatment 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 if liver function remains normal. Only in cases of pre-terminal renal failure (creatinine clearance <10

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

In patients undergoing dialysis, no additional dose is required after dialysis; however, the patient's clinical situation should be monitored, and adjustments to the dose may be necessary.

Patients with hepatic impairment:

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