CEFTRIAXONE Fresenius Kabi 1 g POWDER FOR INTRAVENOUS INJECTION SOLUTION

2. What you need to know before you use Ceftriaxone Fresenius Kabi

Do not use Ceftriaxone Fresenius Kabi:

• If you are allergic to ceftriaxone or any of the other ingredients of this medicine (listed in section 6).
• If you have had a severe or immediate 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 breathing or swallowing difficult, sudden swelling of the hands, feet, and ankles, chest pain, and a severe skin rash that develops quickly.
• If you are allergic to lidocaine and are to be given Ceftriaxone Fresenius Kabi as an intramuscular injection.

Ceftriaxone Fresenius Kabi must not be used in babies if:

• The baby is premature.

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

Warnings and precautions

Tell your doctor, pharmacist, or nurse before you start using Ceftriaxone Fresenius Kabi if:

• You have recently taken or may have to take products containing calcium.
• You have recently had diarrhea after using 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 skin and weakness or shortness of breath).
• You need to 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, 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 are to have a blood or urine test

If you have been prescribed Ceftriaxone Fresenius Kabi for a long period, you will need to have regular blood tests.

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

If you are having tests:

• Tell the person taking the sample that you have been given Ceftriaxone Fresenius Kabi.

If you are diabetic or need to monitor your blood glucose levels, you should not use certain blood glucose monitoring systems that may give incorrect results while you are taking ceftriaxone. If you use such systems, you should check the instructions for use and consult your doctor, pharmacist, or nurse. Alternative methods should be used if necessary.

Children

Ask your doctor or pharmacist or nurse before Ceftriaxone Fresenius Kabi is given to your child if:

• They have recently taken or may have to take a product intravenously that contains calcium.

Other medicines and Ceftriaxone Fresenius Kabi

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

In particular, tell your doctor or pharmacist if you are using any of the following medicines:

• 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 are planning to have a baby, ask your doctor for advice before taking this medicine.

Your doctor will decide whether to treat you with Ceftriaxone Fresenius Kabi and the risk to your baby.

Driving and using machines

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

Ceftriaxone Fresenius Kabi contains sodium

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

3. How to use Ceftriaxone Fresenius Kabi

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

Usual dose

Your doctor will decide the right dose of Ceftriaxone Fresenius Kabi for you. The dose will depend on the severity and type of infection; whether you are taking other antibiotics; your weight and age; how well your kidneys and liver are working. 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 years and weighing 50 kg or more:

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

Newborns, infants, and children from 15 days to 12 years and weighing less than 50 kg:

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

Newborns (0-14 days)

• 20-50 mg of Ceftriaxone Fresenius Kabi per kg of body weight once daily, depending on the severity and type of infection.
• The maximum daily dose must not exceed 50 mg per kg of the baby's body weight.

Patients with liver or kidney problems:

You will be given a different dose than usual. Your doctor will decide 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 than the prescribed dose, tell your doctor or go to the nearest hospital.

If you forget to use Ceftriaxone Fresenius Kabi

If you miss an injection, it should be given as soon as possible. However, if it is almost time for your next injection, skip the missed injection. Do not have a double dose (two injections at the same time) to make up for missed doses.

If you stop using Ceftriaxone Fresenius Kabi

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

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

4. Possible side effects

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

Severe allergic reactions (frequency not known, cannot be estimated from the available data)

If you have a severe allergic reaction, tell your doctor immediately.

Symptoms may include:

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

Severe skin reactions (frequency not known, cannot be estimated from the available data)

If you have a severe skin reaction, tell your doctor immediately.

Symptoms may include:

• A severe rash that develops quickly, with blisters or skin peeling, and possibly blisters in the mouth (Stevens-Johnson syndrome and toxic epidermal necrolysis, also known as SJS and TEN, respectively).
• A combination of any of the following symptoms: widespread rash, high body temperature, elevated liver enzyme values, blood abnormalities (eosinophilia), enlarged lymph nodes, and involvement of other organs (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 rash, usually self-limiting. This occurs shortly after starting treatment with ceftriaxone for infections with spirochetes, such as Lyme disease.

Other possible symptoms:

Common (may affect up to 1 in 10 people)

• Abnormalities with white blood cells (such as decreased leukocytes and increased eosinophils) and platelets (decreased thrombocytes).
• Loose stools or diarrhea.
• Changes in blood test results for liver function.
• Rash.

Uncommon (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).
• Blood clotting disorders. Symptoms may include bruising and pain or swelling of the joints.
• Headache.
• Dizziness.
• Discomfort or nausea.
• Itching (pruritus).
• Pain or burning in the vein where Ceftriaxone Fresenius Kabi was given. Pain at the injection site.
• High temperature (fever).
• Abnormal kidney function test (elevated serum creatinine).

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

• Inflammation of the large intestine (colon). Symptoms include diarrhea, usually with blood and mucus, stomach pain, and fever.
• Breathing difficulties (bronchospasm).
• Hives that may cover much of the body, with itching and swelling.
• Blood or sugar in the urine.
• Swelling (edema).
• Chills.
• Treatment with ceftriaxone, particularly in elderly patients with severe kidney problems or nervous system problems, can rarely cause decreased consciousness, abnormal movements, agitation, and convulsions.

Frequency not known (cannot be estimated from the available data)

• Secondary infection that may not respond to the previously prescribed antibiotic treatment.
• Anemia where red blood cells are destroyed (hemolytic anemia).
• Severe decrease in white blood cell count (agranulocytosis).
• Convulsions.
• Dizziness (vertigo, a feeling that everything is spinning).
• Pancreatitis (inflammation of the pancreas). Symptoms include severe stomach pain that spreads to the back.
• Stomatitis (inflammation of the mucous membrane lining of the mouth).
• Glossitis (inflammation of the tongue). Symptoms include swelling, redness, and pain in the tongue.
• Problems with the gallbladder or liver, which can cause pain, nausea, vomiting, yellowing of the skin, itching, abnormally dark urine, and clay-colored stools.
• A neurological condition that can occur in newborns with severe jaundice (kernicterus).
• Kidney problems caused by ceftriaxone-calcium deposits. There may be pain when passing water (urine) or a decrease in urine output.
• False-positive result in the Coombs test (a test performed for certain blood problems).
• False-positive result in galactosemia (abnormal accumulation of galactose).
• Ceftriaxone Fresenius Kabi may interfere with some blood glucose tests – please consult your doctor.

Reporting of side effects:

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is not listed in this leaflet. You can also report side effects 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. Storing Ceftriaxone Fresenius Kabi

Keep out of the sight and reach of children.

Do not use Ceftriaxone Fresenius Kabi after the expiry date stated on the carton after EXP. The expiry date refers to the last day of the month shown.

Do not store above 25°C.

Keep the vial in the outer carton to protect it from light.

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

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

6. Container Contents and Additional Information

Composition of Ceftriaxone Fresenius Kabi

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

Product Appearance and Container Contents

The solutions may vary from colorless to pale yellow.

Ceftriaxone Fresenius Kabi powder for injection and infusion is presented in containers containing 1, 10, or 100 glass vials of powder, closed with a rubber stopper. Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Fresenius Kabi España, S.A.U.

Torre Mapfre-Vila Olímpica

Marina 16-18, 08005 – Barcelona

Spain

Manufacturer

LABESFAL – Laboratórios Almiro S.A.

Lagedo, 3465-157 Santiago de Besteiros

Portugal

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

AustriaCeftriaxone Kabi 1 g Powder for Solution for Injection/Infusion

BelgiumCeftriaxone Fresenius Kabi 1g Powder for Solution for Injection/Infusion

Czech RepublicCeftriaxone Kabi 1g, Powder for Injection/Infusion Solution

DenmarkCeftriaxone Fresenius Kabi

EstoniaCeftriaxone Kabi 1 g

FinlandCeftriaxone Fresenius Kabi 1 g Injection/Infusion Dry Substance, for Solution

GermanyCeftriaxone Kabi 1 g

GreeceCeftriaxone Kabi 1g, Powder for Injectable Solution/Infusion

HungaryCeftriaxone Kabi 1 g Powder for Injection/Infusion

LuxembourgCeftriaxone Kabi 1 g Powder for Solution for Injection/Infusion

LithuaniaCeftriaxone Kabi 1 g Powder for Injection/Infusion Solution

LatviaCeftriaxone Kabi 1 g Powder for Injection/Infusion Solution Preparation

NetherlandsCeftriaxone Fresenius Kabi 1g Powder for Solution for Injection/Infusion

NorwayCeftriaxone Fresenius Kabi 1 g Powder for Injection/Infusion Solution

PolandCeftriaxone Kabi 1 g

PortugalCeftriaxone Fresenius Kabi

SlovakiaCeftriaxone Kabi 1 g

SwedenCeftriaxone Fresenius Kabi 1 g, Powder for Injection/Infusion Solution

Date of Last Revision of this Leaflet:July 2022

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

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This information is intended only for healthcare professionals:

Intravenous Administration:

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 precipitation may occur.

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 summary of product characteristics and section 6 of the package leaflet).

Direct intravenous injection should be administered over 2-4 minutes. Administration of doses greater than 50 mg/kg should be performed by infusion. Intravenous infusion should be administered over at least 30 minutes.

For intravenous administration, the contents of the Ceftriaxone Fresenius Kabi 1g vial are dissolved in 10 ml of solvent (water for injections). The solution should be examined before injection for 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.

Adults and Children Over 12 Years: The usual dose is 1-2 g of ceftriaxone administered once daily (every 24 hours). In severe cases or infections caused by moderately sensitive microorganisms, the dose may be increased to a maximum of 4 g once daily.

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 daily for 14 days.

Perioperative prophylaxis

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

Combination therapy:

In infections caused by gram-negative microorganisms, combination with aminoglycosides may be necessary, especially in severe or life-threatening infections.

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 preterm infants. The dose should not exceed 50 mg/kg of body weight.

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

Children weighing >50 kg: the same adult dose should be used.

Bacterial meningitis in infants and children

Treatment should be initiated with a dose of 100 mg/kg (not exceeding 4 g) once daily. As soon as the causative microorganism is identified and its sensitivity is determined, the dose may be adjusted accordingly.

Elderly:The recommended doses for adults do not need to be modified, provided there is no impairment of renal and/or hepatic function.

Patients with Renal Impairment:

In patients with impaired renal function, the dose does not need to be reduced, provided hepatic function remains normal. Only in cases of preterminal renal failure (creatinine clearance <10 ml min) should the dose of ceftriaxone not exceed 2 g daily.< p>

In cases of severe concomitant renal and hepatic dysfunction, the dose of ceftriaxone should not exceed 2 g daily, unless plasma concentrations are determined at regular intervals, adjusting the dose as necessary.

In dialyzed patients, it is not necessary to administer an additional supplementary dose after the dialysis session; however, the patient's clinical situation should be monitored to adjust the dose if necessary.

Patients with Hepatic Impairment:

In cases of hepatic impairment, the dose does not need to be reduced if renal function is intact. In cases of severe concomitant renal and hepatic dysfunction, the dose of ceftriaxone should not exceed 2 g daily, unless plasma concentrations are determined at regular intervals, adjusting the dose as necessary.

Duration of Therapy:

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