Ceftriaxone Kabi

Leaflet attached to the packaging: patient information

Ceftriaxone Kabi, 2 g, powder for solution for infusion

Ceftriaxone

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

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Keep this leaflet, so you can read it again if you need to.
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If you have any doubts, consult your doctor, pharmacist, or nurse.
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This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
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If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Ceftriaxone Kabi and what is it used for
• 2. Important information before using Ceftriaxone Kabi
• 3. How to use Ceftriaxone Kabi
• 4. Possible side effects
• 5. How to store Ceftriaxone Kabi
• 6. Package contents and other information

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

Ceftriaxone Kabi is an antibiotic used in adult patients and children (including newborns). Its action is to kill bacteria that cause infections. It belongs to a group of medicines called cephalosporins.
Ceftriaxone Kabi is used to treat infections of the:
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brain (meningitis);
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lungs;
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middle ear;
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abdomen and abdominal wall (peritonitis);
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urinary tract and kidneys;
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bones and joints;
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skin and soft tissues;
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blood;
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heart.
This medicine can be used:
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to treat certain sexually transmitted infections (gonorrhea and syphilis);
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to treat patients with a low white blood cell count (neutropenia) who have a fever caused by a bacterial infection;
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to treat chest infections in adult patients with chronic bronchitis;
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to treat Lyme disease (a disease transmitted by ticks) in adult patients and children, including newborns from the 15th day of life;
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to prevent infections during surgery.

2. Important information before using Ceftriaxone Kabi

When not to use Ceftriaxone Kabi:

• if the patient is allergic to ceftriaxone or any of the other ingredients of this medicine (listed in section 6); ­ if the patient has had a sudden or severe allergic reaction to penicillin or similar antibiotics (such as cephalosporins, carbapenems, or monobactams). Symptoms of such a reaction include: sudden swelling of the throat or face, which may make breathing or swallowing difficult, sudden swelling of the hands, feet, and ankles, chest pain, and a rapidly spreading severe rash; ­ if the patient is allergic to lidocaine and is to receive Ceftriaxone Kabi by intramuscular injection.

Ceftriaxone Kabi must not be used in newborn babies if:

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the baby is premature;
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the baby is a newborn (up to 28 days old) and has certain blood disorders or jaundice (yellowing of the skin and/or eyes) or is to receive a calcium-containing intravenous solution.

Warnings and precautions

Before starting treatment with Ceftriaxone Kabi, the patient should discuss it with their doctor, pharmacist, or nurse if:
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the patient has recently received or is about to receive calcium-containing medicines;
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the patient has recently had diarrhea after antibiotic treatment. The patient has had intestinal problems, particularly colitis (inflammation of the large intestine);
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the patient has liver or kidney problems (see section 4);
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the patient has kidney stones or gallstones;
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the patient has other diseases, such as hemolytic anemia (reduced red blood cell count, which can cause pallor and weakness or shortness of breath);
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the patient is on a low-sodium diet;
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the patient has or has had any of the following symptoms: rash, redness of the skin, blisters around the mouth, eyes, or genital area, peeling skin, high fever, flu-like symptoms, increased liver enzyme activity in blood tests, and increased white blood cell count (eosinophilia) and swollen lymph nodes (symptoms of severe skin reactions, see also section 4 "Possible side effects").

Blood or urine tests

If the patient is receiving Ceftriaxone Kabi for a long time, regular blood tests may be necessary. The medicine may affect the results of urine sugar tests and a blood test called the Coombs test. If the patient is having tests:
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they should tell the person taking the sample that they are taking Ceftriaxone Kabi.
If the patient has diabetes or needs to control their blood sugar levels, they should not use tests that may give false results for blood sugar levels while taking ceftriaxone. If the patient is monitoring their blood sugar levels, they should check the instructions and tell their doctor, pharmacist, or nurse. They should use alternative methods of testing if necessary.

Children

Before giving Ceftriaxone Kabi to a child, the doctor, pharmacist, or nurse should be consulted if:
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the child has recently received or is about to receive a calcium-containing intravenous solution.

Ceftriaxone Kabi and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or might take.
In particular, the patient should tell their doctor or pharmacist if they are taking any of the following medicines:
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an aminoglycoside antibiotic;
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an antibiotic called chloramphenicol (used to treat infections, especially eye infections).

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should ask their doctor for advice before taking this medicine.
The doctor will assess the benefits of using Ceftriaxone Kabi for the mother and the risk for the baby.

Driving and using machines

Ceftriaxone Kabi may cause dizziness. If the patient experiences dizziness, they should not drive or use any tools or machines. They should tell their doctor if they experience such symptoms.

Ceftriaxone Kabi contains sodium

This medicine contains 164.6 mg of sodium (the main component of common salt) per vial, which is 8.2% of the maximum recommended daily intake of sodium for adults.

3. How to use Ceftriaxone Kabi

Ceftriaxone Kabi is usually given by a doctor or nurse. It is given as an intravenous infusion or by injection directly into a vein or muscle. Ceftriaxone Kabi is prepared by a doctor, pharmacist, or nurse and should not be mixed or given at the same time as solutions containing calcium.

Usual dose

The doctor will decide what dose of Ceftriaxone Kabi is suitable for the patient. The dose depends on the severity and type of infection, whether the patient is taking other antibiotics, the patient's age and weight, and the patient's liver and kidney function. The number of days or weeks the patient will receive Ceftriaxone Kabi depends on the type of infection.

Adult patients, elderly patients, and children over 12 years old with a body weight of 50 kg or more:

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1 g to 2 g, once a day, depending on the severity and type of infection. For severe infections, the doctor will use a higher dose (up to 4 g once a day). If the daily dose is more than 2 g, the medicine can be given in one dose or in two separate doses.

Newborns, infants, and children from 15 days to 12 years old with a body weight below 50 kg:

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50 mg to 80 mg of Ceftriaxone Kabi per kg of body weight, once a day, depending on the severity and type of infection. For severe infections, the doctor will use a higher dose of up to 100 mg per kg of body weight, up to a maximum of 4 g once a day. If the daily dose is more than 2 g, the medicine can be given in one dose per day or in two separate doses.
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Children with a body weight of 50 kg or more should receive the usual adult dose.

Newborns from 0 to 14 days old:

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

Patients with liver or kidney problems

The patient may receive a different dose than usual. The doctor will determine what dose of Ceftriaxone Kabi is suitable for the patient and will closely monitor their condition, depending on the severity of the liver and kidney disease.

Using more Ceftriaxone Kabi than prescribed

If the patient accidentally receives a higher dose than prescribed by their doctor, they should contact their doctor or the nearest hospital immediately.

Missing a dose of Ceftriaxone Kabi

If the patient misses an injection, they should receive it as soon as possible. However, if it is almost time for the next injection, they should not take the missed dose. They should not take a double dose (two injections at the same time) to make up for the missed dose.

Stopping treatment with Ceftriaxone Kabi

The patient should not stop using Ceftriaxone Kabi unless their doctor tells them to. If the patient has any further questions about their treatment, they should ask their doctor or nurse.

4. Possible side effects

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

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

If the patient experiences a severe allergic reaction, they should tell their doctor immediately.
Symptoms may include:
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sudden swelling of the face, throat, lips, or mouth; this may make breathing or swallowing difficult;
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sudden swelling of the hands, feet, and ankles;
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chest pain associated with an allergic reaction, which may be a sign of a heart attack caused by an allergy (Kounis syndrome).

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

If the patient experiences a severe skin reaction, they should tell their doctor immediately.
Symptoms of such a reaction may include:

• rapidly spreading severe rash, with blisters or peeling of the skin and possible blisters in the mouth (Stevens-Johnson syndrome and toxic epidermal necrolysis, also known as SJS and TEN);
• any of the following symptoms: spreading rash, high body temperature, increased liver enzyme activity, blood test abnormalities (eosinophilia), and swollen lymph nodes (symptoms of severe skin reactions, also known as DRESS or drug hypersensitivity syndrome);
• Jarisch-Herxheimer reaction causing fever, chills, headache, muscle pain, and skin rash, usually self-limiting; this reaction occurs shortly after starting treatment with Ceftriaxone Kabi for infections caused by spirochetes, such as Lyme disease.

Other side effects:

Common (may affect up to 1 in 10 people)

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blood abnormalities (e.g., decreased white blood cell count and increased eosinophil count) and platelet abnormalities (decreased platelet count);
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loose stools or diarrhea;
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changes in liver function tests;
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rash.

Uncommon (may affect up to 1 in 100 people)

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fungal infections (e.g., thrush);
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decreased white blood cell count (granulocytopenia);
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decreased red blood cell count (anemia);
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blood clotting problems; symptoms may include easy bruising and pain or swelling of the joints;
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headache;
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dizziness;
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nausea or vomiting;
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itching (pruritus);
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pain or burning along the vein into which Ceftriaxone Kabi was given, pain at the injection site;
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high temperature (fever);
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abnormal kidney function test (increased creatinine level in the blood).

Rare (may affect up to 1 in 1000 people)

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inflammation of the large intestine (colitis); symptoms include diarrhea, usually with blood and mucus, abdominal pain, and fever;
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breathing difficulties (bronchospasm);
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hives (urticaria), which may spread across the body, itching, and swelling; this can be a sign of an allergic reaction;
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blood or sugar in the urine;
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swelling (fluid retention);
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chills;
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Ceftriaxone Kabi may rarely cause decreased consciousness, abnormal movements, agitation, and seizures, especially in elderly patients with severe kidney or neurological disorders.

Frequency not known (cannot be estimated from available data)

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secondary infection that cannot be treated with previously used antibiotics;
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a certain type of anemia where red blood cells are destroyed (hemolytic anemia);
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significant decrease in white blood cell count (agranulocytosis);
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seizures;
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severe dizziness (vertigo);
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pancreatitis; symptoms include severe abdominal pain that radiates to the back;
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inflammation of the mouth lining;
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inflammation of the tongue; symptoms include swelling, redness, and pain of the tongue;
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problems with the gallbladder and/or liver, which can cause pain, nausea, vomiting, yellowing of the skin, itching, dark urine, and clay-colored stools;
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a neurological disorder that can occur in newborns with severe jaundice (kernicterus);
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kidney problems caused by the deposition of calcium ceftriaxone; symptoms may include pain when urinating or decreased urine production;
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false positive Coombs test (a test that detects certain blood disorders);
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false positive test for galactosemia (a disorder that causes the accumulation of a sugar called galactose in the body);
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Ceftriaxone Kabi may affect the results of some glucose tests - the patient should check with their doctor.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
tel.: +48 22 49 21 301
fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Ceftriaxone Kabi

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Store the vial in the outer packaging to protect it from light.
The ceftriaxone solution prepared after reconstitution should be used immediately. However, the solution can be stored for 12 hours at 25°C or for 2 days at 2-8°C.
Do not use this medicine if it is cloudy, the solution should be completely clear. Any unused solution should be discarded.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer need. This will help protect the environment.

6. Package contents and other information

What Ceftriaxone Kabi contains

The active substance is ceftriaxone. Each vial contains 2 g of ceftriaxone in the form of ceftriaxone sodium.

What Ceftriaxone Kabi looks like and contents of the pack

Solutions may be colorless to pale yellow.
Ceftriaxone Kabi powder for solution for infusion is available in packs of 5, 7, or 10 glass vials with powder, closed with a butyl rubber stopper and an aluminum seal. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw

Manufacturer

Labesfal, Laboratorios Almiro, S.A.
Zona Industrial do Lagedo
3465-157 Santiago de Besteiros
Portugal
To obtain more detailed information, the patient should contact the marketing authorization holder:
Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw
tel.: +48 22 345 67 89

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

Austria
Ceftriaxon Kabi 2g Pulver zur Herstellung einer Infusionslösung
Belgium
Ceftriaxone Fresenius Kabi 2g powder for solution for infusion
Czech Republic
Ceftriaxon Kabi 2g, prášek pro přípravu infuzního roztoku
Denmark
Ceftriaxon Fresenius Kabi
Estonia
Ceftriaxone Kabi 2 g
Finland
Ceftriaxon Fresenius Kabi 2 g infuusiokuiva-aine, liuosta varten
Greece
Ceftriaxone Kabi 2g, κόνις για διάλυμα προς έγχυση
Netherlands
Ceftriaxone Fresenius Kabi 2g poeder voor oplossing voor infusie
Lithuania
Ceftriaxone Kabi 2 g milteliai infuziniam tirpalui
Luxembourg
Ceftriaxon Kabi 2 g Pulver zur Herstellung einer Infusionslösung
Latvia
Ceftriaxone Kabi 2 g pulveris infūziju šķīduma pagatavošanai
Germany
Ceftriaxon Kabi 2 g Pulver zur Herstellung einer Infusionslösung
Norway
Ceftriaxone Fresenius Kabi 2 g pulver til infusjonsvæske, oppløsning
Poland
Ceftriaxone Kabi
Portugal
CEFTRIAXONA KABI
Slovakia
Ceftriaxon Kabi 2 g
Sweden
Ceftriaxon Fresenius Kabi 2 g, pulver till infusionsvätska, lösning
Hungary
Ceftriaxon Kabi 2 g por oldatos infúzióhoz
Italy
Ceftriaxone FKI
Date of last revision of the leaflet:02.05.2024
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Information intended for healthcare professionals only:

Ceftriaxone Kabi, 2 g, powder for solution for infusion

See the Summary of Product Characteristics (SmPC).

Method of administration

Ceftriaxone Kabi can be administered by intravenous infusion over at least 30 minutes (recommended administration method) or by slow intravenous injection over 5 minutes, or by deep intramuscular injection. Intravenous bolus injection over a longer period than 5 minutes should be performed preferably in a large vein. In infants and children under 12 years old, intravenous doses of 50 mg/kg or more should be given by intravenous infusion. In newborns, intravenous doses should be given over a period longer than 60 minutes to reduce the potential risk of bilirubin encephalopathy (see sections 4.3 and 4.4 of the SmPC). Intramuscular injections should be administered at a suitable depth in a relatively large muscle. Do not administer more than 1 g per injection site. Intramuscular administration should be considered when intravenous administration is not possible or is less appropriate for the patient. Doses over 2 g should be administered intravenously.
In the case of using a lidocaine solution as a solvent, the resulting solution should never be administered intravenously (see section 4.3 of the SmPC). The information provided in the Summary of Product Characteristics of lidocaine should be taken into account.
Ceftriaxone is contraindicated in newborns (≤28 days) who require (or are expected to require) calcium-containing intravenous solutions, including continuous calcium-containing infusions such as parenteral nutrition, due to the risk of precipitation of calcium ceftriaxone (see section 4.3 of the SmPC).
Due to the risk of precipitation, calcium-containing diluents (e.g., Ringer's solution or Hartmann's solution) should not be used to reconstitute ceftriaxone or further dilute the reconstituted solution for intravenous administration. Ceftriaxone should not be mixed or administered simultaneously with calcium-containing solutions (see sections 4.3, 4.4, and 6.2 of the SmPC).
For preoperative prophylaxis of surgical site infections, ceftriaxone should be administered 30-90 minutes before the surgical procedure.

Instructions for use

The reconstituted solution should be shaken for at least 60 seconds to ensure complete dissolution of ceftriaxone.
Ceftriaxone has been shown to be compatible with the following solutions:

• 0.9% (9 mg/ml) sodium chloride solution;
• 5% (50 mg/ml) glucose solution.

Intravenous infusion
The infusion should be administered over at least 30 minutes.

The solution should be inspected after reconstitution. Only a clear solution without visible particles should be used. The reconstituted solution is for single use only, and any unused solution should be discarded.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Incompatibilities

According to the literature, ceftriaxone is incompatible with amsacrine, vancomycin, fluconazole, aminoglycoside antibiotics, and labetalol.
Do not mix the medicine with other medicines, except those mentioned in the "Instructions for use" section.
In particular, do not use calcium-containing diluents (e.g., Ringer's solution or Hartmann's solution) to reconstitute ceftriaxone or further dilute the reconstituted solution for intravenous administration, as precipitation may occur. Do not mix ceftriaxone with calcium-containing solutions or administer them simultaneously (see sections 4.3, 4.4, and 6.2 of the SmPC).
Ceftriaxone should not be mixed with or administered simultaneously with calcium-containing solutions, including total parenteral nutrition solutions.

Reconstituted solution

The chemical and physical stability of the solution has been demonstrated for 12 hours at 25°C and for 2 days at 2-8°C. From a microbiological point of view, the product should be used immediately. If not used immediately, the responsibility for the storage conditions and duration lies with the user. The solution should not be stored for more than 24 hours at 2-8°C, unless it has been prepared in controlled and validated aseptic conditions.

Special precautions for storage

Store the vial in the outer packaging to protect it from light.
Storage conditions for the reconstituted solution, see the "Reconstituted solution" section.