CEFTRIAXONE Fresenius Kabi 1 g POWDER AND SOLVENT FOR INTRAMUSCULAR 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 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 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

Consult your doctor, pharmacist, or nurse before starting treatment with Ceftriaxone Fresenius Kabi if:

• You have recently taken or may need 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 enlargement of the 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 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

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

• They have recently taken or may need 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, consult 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 it may pose 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 by 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 correct 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 and children over 12 years

• 1 - 2 g given once daily. In severe cases, the daily dose may be increased up to 4 g given once daily, depending on the severity and type of infection. If you have a 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 with body weight 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. If you have a 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 with a body weight of 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 body weight of the baby.

Patients with liver or kidney impairment:

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

If you use more Ceftriaxone Fresenius Kabi than you should

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

If you forget to use Ceftriaxone Fresenius Kabi

If you miss an injection, you should have it 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 a missed dose.

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 medicine, 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 may 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 peeling of the skin, 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), enlargement of the lymph nodes, and involvement of other organs of 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 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 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 previously prescribed antibiotic treatment.
• Anemia in which red blood cells are destroyed (hemolytic anemia).
• Severe decrease in white blood cell count (agranulocytosis).
• Convulsions.
• Dizziness (vertigo, a feeling that everything is spinning).
• Inflammation of the pancreas (pancreatitis). Symptoms include severe stomach pain that spreads to the back.
• Inflammation of the mucous membrane lining of the mouth (stomatitis).
• Inflammation of the tongue (glossitis). Symptoms include swelling, redness, and pain of the tongue.
• Problems with the gallbladder or liver, which can cause pain, nausea, vomiting, yellowing of the skin, itching, 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 urinating 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.

Intramuscular injection of ceftriaxone reconstituted without lidocaine is painful.

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 Medicines Monitoring System for Human Use (Website: www.notificaRAM.es) By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Ceftriaxone Fresenius Kabi

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of the month shown.

Do not store above 25°C.

Store the vial in the outer packaging 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. These measures will help protect the environment.

6. Container Content and Additional Information

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 1% lidocaine hydrochloride solution in each ampoule.

Once the vial content is reconstituted with 3.5 ml of the ampoule solvent, the solution contains 285.7 mg of ceftriaxone per ml.

Appearance of the Product and Container Content

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

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

It is presented in boxes of 1 vial, 10 vials, or 100 vials (clinical packaging). Not all packaging 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:

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

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

Date of the 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:

Ceftriaxone Fresenius Kabi1 gpowder and solvent for intramuscular injectable solution EFG

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

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 (see sections 4.2, 4.3, 4.4, and 4.8 of the Summary of Product Characteristics and section 6 of the leaflet).

For intramuscular administration, the content of the Ceftriaxone Fresenius Kabi 1g vial is dissolved in 3.5 ml of the accompanying ampoule solvent (1% lidocaine hydrochloride solution). Then, inject deeply into a large muscle mass, performing a prior aspiration to avoid accidental injection into a blood vessel.

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

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, weight, and 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 germs, the dose may be increased up 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 germs, 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 full-term and premature 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 with a weight of >50 kg: the same dose as for adults will be used.

Bacterial meningitis in infants and children

Treatment will be initiated with a dose of 100 mg/kg (not exceeding 4 g) once daily. As soon as the causal germ 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), the dose of ceftriaxone should not exceed 2 g daily.< p>

In cases of severe 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 if necessary.

In dialyzed patients, it is not necessary to administer an additional supplementary dose after the dialysis session; in any case, the patient's clinical situation will 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 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 if necessary.

Duration of therapy:

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