Ceftriaxone Fresenius Kabi 1 g powder and solvent for intramuscular injection solution EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Ceftriaxone Fresenius Kabi 1 g powder and solvent for injectable solution for intramuscular injection EFG

ceftriaxone

Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if these are adverse effects not listed in this leaflet. See section 4.

Contents of this leaflet

1. What Ceftriaxone Fresenius Kabi is and what it is used for
2. What you need to know before using Ceftriaxone Fresenius Kabi
3. How to use Ceftriaxone Fresenius Kabi
4. Possible side effects
5. How to store Ceftriaxone Fresenius Kabi
6. Contents of the pack and other information

1. What Ceftriaxone Fresenius Kabi is and what it is used for

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

Antibiotics are used to treat bacterial infections and are not effective against viral infections such as flu or the common cold.

It is important that you follow your doctor's instructions regarding dose, frequency, and duration of treatment.

Do not store or reuse this medicine. If you have any antibiotic left after completing your treatment, return it to the pharmacy for proper disposal. Do not dispose of medicines via wastewater or household waste.

Ceftriaxone Fresenius Kabi is indicated for the treatment of 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 (gonorrhoea and syphilis).
• to treat patients with a low white blood cell count (neutropenia) who have fever due to a bacterial infection.
• to treat chest infections in adults with chronic bronchitis.
• to treat Lyme disease (caused by tick bite) in adults and children, including newborns from 15 days of age.
• to prevent infections during surgical procedures.

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

Do not use Ceftriaxone Fresenius Kabi:

• If you are allergic to ceftriaxone or to 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 rapidly.
• If you are allergic to lidocaine and Ceftriaxone Fresenius Kabi is to be administered by 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 disorders or jaundice (yellowing of the skin or whites of the eyes), or needs to be treated intravenously with a product containing calcium.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before using Ceftriaxone Fresenius Kabi if:

• You have recently taken or may need to take products containing calcium.
• You have recently experienced diarrhea after taking an antibiotic. If you have ever had gastrointestinal problems, particularly colitis (inflammation of the intestine).
• You have liver or kidney problems (see section 4).
• You have gallstones or kidney stones.
• You have other medical conditions, such as hemolytic anemia (a reduction in the number of red blood cells that may cause pale yellow skin, weakness, or shortness of breath).
• You are on a low-sodium diet.
• You are experiencing or have experienced a combination of any of the following symptoms: rash, skin redness, blistering of the lips, eyes, and mouth, skin peeling, high fever, flu-like symptoms, increased liver enzyme levels seen in blood tests, an increase in a type of white blood cell (eosinophilia), and swollen lymph nodes (signs of serious skin reactions; see also section 4 “Possible side effects”).

If you need to have blood or urine tests

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

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

If you are undergoing tests:

• Inform the person collecting the sample that you have been administered 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 inaccurate blood glucose readings while you are receiving ceftriaxone. If you use such systems, you should review the user instructions and consult your doctor, pharmacist, or nurse. Alternative methods should be used if necessary.

Children

Talk to your doctor, pharmacist, or nurse before Ceftriaxone Fresenius Kabi is administered to your child if:

• He/She has recently received or may need to receive an intravenous product containing calcium.

Other medicines and Ceftriaxone Fresenius Kabi

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

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

• An antibiotic called an 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 medicine.

Your doctor will decide whether treatment with Ceftriaxone Fresenius Kabi is appropriate and assess any potential risk to your baby.

Driving and using machines

Ceftriaxone Fresenius Kabi may cause dizziness. If you feel dizzy, do not drive or operate any tools or machinery. 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 table/cooking salt) per vial. This corresponds to 4.1% of the maximum daily recommended intake of sodium for an adult.

3. How to use Ceftriaxone Fresenius Kabi

Ceftriaxone Fresenius Kabi is normally administered 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 administered together with injections containing calcium.

Recommended dose

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

Adults and children over 12 years

• 1 - 2 g administered once daily. In severe cases, the daily dose may be increased up to 4 g as a single dose, depending on the severity and type of infection. In case of a severe infection, your doctor will administer a higher dose (up to 4 g once daily). If your daily dose exceeds 2 g, it will be given once daily 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 daily, depending on the severity and type of infection. In case of a 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 daily. If your daily dose exceeds 2 g, it will be given once daily or in two separate doses.
• Children weighing 50 kg or more will receive 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 should not exceed 50 mg per kg of the infant's body weight.

Patients with hepatic or renal impairment:

You will be given a different dose than the usual. Your doctor will determine the dose of Ceftriaxone Fresenius Kabi you require and will monitor you closely depending on the severity of your 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 immediately.

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 dose. Do not receive a double dose (two injections at once) to make up for a missed dose.

If you stop using Ceftriaxone Fresenius Kabi

Do not stop treatment with Ceftriaxone Fresenius Kabi unless instructed by your doctor.

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

4. Possible adverse effects

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

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

If you experience a severe allergic reaction, inform 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 a heart attack caused by an allergy (Kounis syndrome).

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

If you develop a severe skin rash, inform your doctor immediately.

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 SJS and TEN, respectively).
• A combination of any of the following symptoms: widespread skin rash, high body temperature, elevated liver enzyme levels, 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 causing fever, chills, headache, muscle pain, and skin rash, which is usually self-limiting. This occurs shortly after starting ceftriaxone treatment for spirochete infections such as Lyme disease.

Other possible symptoms:

Frequent (may affect up to 1 in 10 people)

• Abnormalities in 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).
• Coagulation disorders. Symptoms may include tendency to bruise and joint pain and swelling.
• Headache.
• Dizziness.
• Malaise or nausea.
• Pruritus (itching).
• Pain or burning sensation in the vein where Ceftriaxone Fresenius Kabi was administered. Pain at the injection site.
• Elevated temperature (fever).
• Abnormal kidney function test (increased 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.
• Difficulty breathing (bronchospasm).
• Hives that may cover most of the body, with itching and swelling.
• Blood or sugar in the urine.
• Edema (fluid accumulation).
• Chills.
• Treatment with ceftriaxone, particularly in elderly patients with severe kidney problems or nervous system disorders, may rarely cause decreased consciousness, abnormal movements, agitation, and seizures.

Frequency not known (cannot be estimated from 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).
• Seizures.
• Vertigo (sensation that everything is spinning).
• Inflammation of the pancreas (pancreatitis). Symptoms include severe stomach pain radiating to the back.
• Inflammation of the lining of the mouth mucosa (stomatitis).
• Inflammation of the tongue (glossitis). Symptoms include swelling, redness, and pain of the tongue.
• Problems with the gallbladder or liver, which may cause pain, nausea, vomiting, yellowing of the skin, itching, abnormally dark urine, and clay-colored stools.
• Neurological condition that may occur in neonates with severe jaundice (kernicterus).
• Kidney problems caused by deposits of calcium-ceftriaxone. There may be pain when passing water (urine) or reduced urine output.
• False positive result in the Coombs test (a test performed for certain blood disorders).
• False positive result in galactosemia (abnormal accumulation of galactose).
• Ceftriaxone Fresenius Kabi may interfere with certain blood glucose tests – please consult your doctor.

Intramuscular injection of reconstituted ceftriaxone without lidocaine is painful.

Reporting of adverse effects:

If you experience any adverse effects, talk to your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines (Website: www.notificaRAM.es). By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ceftriaxone Fresenius Kabi

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 25°C.

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

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

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ceftriaxone Fresenius Kabi

The active substance 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 contents are reconstituted with 3.5 ml of solvent from the accompanying ampoule, the solution contains 285.7 mg of ceftriaxone per ml.

Appearance of the product and contents of the pack

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

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

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

Italy CEFTRIAXONE KABI 1g/3,5 ml powder and solvent for injectable solution for intramuscular use

Portugal Ceftriaxona Fresenius 1000 mg/3,5 ml powder and solvent for injectable solution (IM)

Date of latest revision of this leaflet: July 2022

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

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This information is intended for healthcare professionals only:

Ceftriaxone Fresenius Kabi 1 g powder and solvent for intramuscular injectable solution EFG

Ceftriaxone Fresenius Kabi powder and solvent for intramuscular injectable solution must be administered by intramuscular route and never by intravenous route. This route of administration should not be used in children under 2 years of age.

Solutions containing ceftriaxone must not be mixed or combined with other agents. In particular, diluents containing calcium (e.g., Ringer's solution, Hartmann's solution) must not be used to reconstitute ceftriaxone vials or to dilute reconstituted vials when administration by IV route is intended, as precipitates may form.

Ceftriaxone must 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 patient information leaflet).

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

If more than 1 g is required, the dose should be divided and administered into two separate muscle masses.

The solution should be inspected before injection for the presence of particles or turbidity. If foreign particles are observed, the solution must be discarded.

The dose and dosing regimen 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 organisms, the dose may be increased up to a maximum of 4 g once daily.

Stage II and III Lyme disease

A dose of 50 mg/kg body weight (up to a maximum of 2 g daily) once daily for 14 days is recommended.

Perioperative prophylaxis

A single dose of 1–2 g, administered 30–90 minutes before surgery. In colorectal surgery, another antibiotic with appropriate spectrum against anaerobes should be added.

Combination therapy:

In infections caused by Gram-negative organisms, combination with aminoglycosides may be necessary, especially in severe infections or those posing a life-threatening risk.

Neonates and children under 12 years:

Neonates (up to 14 days): 20 to 50 mg/kg body weight administered as a single dose, with no difference between full-term and preterm neonates. The dose of 50 mg/kg body weight must not be exceeded.

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

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

Bacterial meningitis in infants and children

Treatment should be initiated with a dose of 100 mg/kg (without exceeding 4 g) once daily. As soon as the causative organism is identified and its sensitivity determined, the dose may be adjusted accordingly.

Elderly: Doses recommended for adults do not need to be modified provided renal and/or hepatic function is not impaired.

Patients with renal impairment:

In patients with impaired renal function, dose reduction is not necessary as long as hepatic function remains normal. Only in cases of pre-terminal renal failure (creatinine clearance <10 ml/min) should the ceftriaxone dose not exceed 2 g daily.

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

In dialyzed patients, no supplementary dose is required after dialysis; however, the patient's clinical status should be monitored to determine if dose adjustments are needed.

Patients with hepatic impairment:

In cases of hepatic deterioration, dose reduction is not necessary if renal function is intact. In cases of concomitant severe renal and hepatic dysfunction, the ceftriaxone dose should not exceed 2 g daily unless plasma concentrations are regularly monitored and the dose adjusted as necessary.

Duration of therapy:

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