Ceftriaxon kabi 1 g

Package leaflet: Information for the patient

Ceftriaxon Kabi 1 g, powder for solution for injection/infusion
Ceftriaxonum
Please read all of this leaflet carefully before using this medicine, because it contains
important information for you.
­ Keep this leaflet. You may need to read it again.
­ If you have any further questions, ask your doctor, pharmacist, or nurse.
­ This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them, even if their symptoms are the same.
­ If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

1. What Ceftriaxon Kabi 1 g is and what it is used for
2. Important information before using Ceftriaxon Kabi 1 g
3. How to use Ceftriaxon Kabi 1 g
4. Possible side effects
5. How to store Ceftriaxon Kabi 1 g
6. Contents of the pack and other information

1. What Ceftriaxon Kabi 1 g is and what it is used for

Ceftriaxon Kabi 1 g is an antibiotic used in adult patients and children (including newborns). It works by killing bacteria that cause infections. It belongs to a group of medicines called cephalosporins.

Ceftriaxon Kabi 1 g is used to treat infections of:
­ 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.

This medicine may also be used:
­ to treat certain sexually transmitted infections (gonorrhoea and syphilis);
­ to treat patients with low white blood cell counts (neutropenia) who have fever due to bacterial infection;
­ to treat chest infections in adult patients with chronic bronchitis;
­ to treat Lyme disease (a tick-borne illness) in adults and children, including newborns from day 15 of life;
­ to prevent infections during surgery.

2. Important information before using Ceftriaxon Kabi 1 g

When not to use Ceftriaxon Kabi 1 g:
­ if the patient is allergic to ceftriaxone or to any of the other ingredients of this medicine
(listed in section 6);
­ if the patient has previously experienced 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 hands,
feet and ankles, chest pain, and rapidly developing severe rash;
­ if the patient is allergic to lidocaine and Ceftriaxon Kabi 1 g is to be administered by intramuscular injection.

Do not use Ceftriaxon Kabi 1 g in newborns and premature infants if:
­ the child is a premature infant;
­ the child is a newborn (up to 28 days of age) and has certain blood disorders or jaundice (yellowing of the skin and/or whites of the eyes), or if the child is to receive intravenous medication containing calcium.

Warnings and precautions
Before starting treatment with Ceftriaxon Kabi 1 g, discuss with your doctor, pharmacist or nurse if:
­ the patient has recently received or is about to receive medications containing calcium;
­ the patient has recently had diarrhoea after antibiotic treatment; has ever had intestinal problems, particularly colitis (inflammation of the large intestine);
­ the patient has liver or kidney problems (see section 4);
­ the patient has gallstones or kidney stones;
­ the patient has other medical conditions such as haemolytic anaemia (reduced number of red blood cells causing paleness, weakness or shortness of breath);
­ the patient is on a low-sodium diet;
­ the patient currently has or has ever had any of the following symptoms:
rash, redness of the skin, blisters around the lips, eyes or mouth, skin peeling, high fever, flu-like symptoms, increased liver enzyme activity observed in blood tests, increased number of a certain type of white blood cells (eosinophilia), and swollen lymph nodes (symptoms of serious skin reactions, see also section 4 “Possible side effects”).

Blood or urine tests
If the patient is receiving Ceftriaxon Kabi 1 g for a prolonged period, regular blood tests may be necessary. The medicine may affect the results of urine glucose tests and blood tests known as the Coombs test. If the patient is undergoing such tests:
­ inform the person collecting the sample that the patient is receiving Ceftriaxon Kabi 1 g.
If the patient has diabetes or needs to monitor blood glucose levels, do not use test methods that may give falsely elevated glucose readings during ceftriaxone treatment. If the patient monitors blood glucose, they should check the instructions and inform their doctor, pharmacist or nurse. Alternative testing methods should be used if necessary.

Children
Before giving Ceftriaxon Kabi 1 g to a child, discuss with a doctor, pharmacist or nurse if:
­ the child has recently received or is about to receive intravenous medication containing calcium.

Ceftriaxon Kabi 1 g and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken or might take in the future.
In particular, inform your doctor or pharmacist if the patient is taking any of the following medicines:
­ an antibiotic from the aminoglycoside group;
­ an antibiotic called chloramphenicol (used to treat infections, particularly eye infections).

Pregnancy, breastfeeding and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor before using this medicine.
The doctor will assess the benefits of using Ceftriaxon Kabi 1 g for the mother and the potential risk to the baby.

Driving and operating machinery
Ceftriaxon Kabi 1 g may cause dizziness. If dizziness occurs, do not drive, operate tools or machinery. Inform the doctor if such symptoms occur.

Ceftriaxon Kabi 1 g contains sodium
This medicine contains 82.3 mg of sodium (the main component of table salt) per vial. This corresponds to 4.1% of the maximum recommended daily dietary sodium intake for adults.

3. How to use Ceftriaxon Kabi 1 g

Ceftriaxone is usually administered by a doctor or nurse. It is given as an intravenous infusion (drip) or
by direct injection into a vein or into a muscle. Ceftriaxone is prepared by a doctor, pharmacist,
or nurse and must not be mixed or administered simultaneously with calcium-containing solutions.

Typically used dose
The doctor will decide what dose of Ceftriaxon Kabi 1 g is appropriate for the individual patient. The dose
depends on the severity and type of infection, whether the patient is taking other antibiotics, the patient's age and body weight, and liver and kidney function. The number of days or weeks during which the patient
will receive Ceftriaxon Kabi 1 g depends on the type of infection.

Adult patients, elderly patients, and children aged 12 years and older with body weight
greater than or equal to 50 kilograms (kg):
­ 1 g to 2 g once daily, depending on the severity and type of infection. In case of severe
infection, the doctor may use a higher dose (up to 4 g once daily). If the daily dose exceeds 2 g,
the medicine may be given as a single dose or in two separate doses.

Newborns, infants, and children aged 15 days to 12 years with body weight below 50 kg:
­ 50 mg to 80 mg of Ceftriaxon Kabi 1 g per kg of body weight per day, once daily,
depending on the severity and type of infection. In case of severe infection, the doctor
may use a higher dose up to 100 mg per kg of body weight per day, with a maximum of 4 g once daily.
If the daily dose exceeds 2 g, the medicine may be given as a single daily dose or in two separate doses.
­ Children with body weight of 50 kg or more should receive the standard adult dose.

Newborns aged 0–14 days:
­ 20 mg to 50 mg of Ceftriaxon Kabi 1 g per kg of body weight per day, once daily,
depending on the severity and type of infection.
­ The maximum daily dose must not exceed 50 mg per kg of body weight.

Patients with impaired liver or kidney function
The patient may receive a dose different from the usual. The doctor will determine the appropriate dose of
Ceftriaxon Kabi 1 g for the individual patient and will closely monitor the patient's condition depending on the severity of liver or kidney disease.

Use of a higher than recommended dose of Ceftriaxon Kabi 1 g
If a dose higher than prescribed is accidentally administered, contact a doctor or the nearest hospital immediately.

Missed administration of Ceftriaxon Kabi 1 g
If a dose has been missed, it should be administered as soon as possible. However, if it is almost time for the next dose, the missed dose should not be given. Do not use a double dose (two injections at the same time) to make up for a missed dose.

Stopping treatment with Ceftriaxon Kabi 1 g
Do not stop using Ceftriaxon Kabi 1 g unless instructed by the doctor. If you have any further questions about the use of this medicine, consult your doctor or nurse.

4. Possible adverse reactions

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

Severe allergic reactions (frequency unknown – cannot be estimated from available data)
If a severe allergic reaction occurs, 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, or ankles;
­ chest pain associated with an allergic reaction, which may be a sign of an allergy-induced heart attack (Kounis syndrome).

Severe skin reactions (frequency unknown – cannot be estimated from available data)
If a severe skin reaction occurs, inform your doctor immediately.
Symptoms of such a reaction may include:
­ rapidly developing 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, abnormal blood test results (eosinophilia), swollen lymph nodes, and involvement of other organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS syndrome 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 Ceftriaxon Kabi 1 g for infections caused by spirochetes, such as Lyme disease.

Other possible adverse reactions:

Common (may affect up to 1 in 10 people)
­ abnormalities in white blood cells (e.g. decreased number of leukocytes and increased number of eosinophils) and platelets (decreased number of platelets);
­ loose stools or diarrhoea;
­ changes in blood test results assessing liver function;
­ rash.

Uncommon (may affect up to 1 in 100 people)
­ fungal infections (e.g. candidiasis);
­ decreased number of white blood cells (granulocytopenia);
­ decreased number of red blood cells (anaemia);
­ problems with blood clotting; symptoms may include easy bruising, joint pain, and swelling;
­ headache;
­ dizziness;
­ nausea or vomiting;
­ itching (pruritus);
­ pain or burning along the vein into which Ceftriaxon Kabi 1 g was administered, pain at the injection site;
­ high temperature (fever);
­ abnormal kidney function test result (increased blood creatinine concentration).

Rare (may affect up to 1 in 1,000 people)
­ inflammation of the large intestine (colitis); symptoms include diarrhoea, usually with blood and mucus, abdominal pain, and fever;
­ breathing difficulties (bronchospasm);
­ raised rash (urticaria), which may affect large areas of the body, itching, and swelling;
­ presence of blood or glucose in urine;
­ oedema (fluid retention);
­ chills;
­ treatment with ceftriaxone — especially in elderly patients with severe renal or nervous system disorders — may rarely cause reduced level of consciousness, abnormal movements, agitation, and seizures.

Frequency unknown (cannot be estimated from available data)
­ secondary infection resistant to previously used antibiotics;
­ a certain type of anaemia involving destruction of red blood cells (haemolytic anaemia);
­ marked decrease in white blood cells (agranulocytosis);
­ seizures;
­ severe dizziness (sensation of spinning);
­ pancreatitis; symptoms include severe abdominal pain radiating to the back;
­ inflammation of the mucous membrane of the mouth;
­ inflammation of the tongue; symptoms include swelling, redness, and pain of the tongue;
­ disorders related to the gallbladder and/or liver, which may cause pain, nausea, vomiting, jaundice, itching, very dark urine, and pale stools;
­ a nervous system disorder that may occur in newborns with severe jaundice (kernicterus);
­ kidney problems caused by deposition of calcium-ceftriaxone salts; symptoms may include pain during urination or production of small amounts of urine;
­ falsely positive Coombs test result (a test detecting certain blood disorders);
­ falsely positive galactosemia test result (abnormal accumulation of galactose sugar in the body);
­ Ceftriaxon Kabi 1 g may affect the results of certain blood glucose tests — please consult your doctor about this.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Ceftriaxon Kabi 1 g

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the container. The expiry date refers to the last day of the stated month.
Store the vial in its outer packaging to protect it from light.
The ceftriaxone solution prepared after dissolving the powder should be used immediately. However, this solution may be stored for up to 12 hours at 25°C or for up to 2 days at a temperature of 2°C to 8°C.
Do not use this medicine if cloudiness is visible; the solution should be completely clear. Any unused portion of the solution must be discarded.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to properly dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What Ceftriaxon Kabi 1 g contains
The active substance is ceftriaxone. Each vial contains 1 g of ceftriaxone in the form of ceftriaxone sodium.

What Ceftriaxon Kabi 1 g looks like and contents of the pack
Solutions may be colourless to pale yellow.
One pack of Ceftriaxon Kabi 1 g, powder for solution for injection/infusion, contains either 5 or 10 glass vials with powder, closed with butyl rubber stoppers and aluminium seals. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw
Poland

Manufacturer
Labesfal, Laboratorios Almiro, S.A. (Fresenius Kabi Group)
3465-157 Santiago de Besteiros
Portugal

For further information, please contact the Marketing Authorisation Holder:
Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw
Poland
Tel.: +48 22 345 67 89

This medicinal product is authorised for sale in the European Economic Area under the following names:
Austria Ceftriaxon Kabi 1 g Pulver zur Herstellung einer Injektions-/Infusionslösung
Belgium Ceftriaxone Fresenius Kabi 1g poeder voor oplossing voor injectie/infusie
Czech Republic Ceftriaxon Kabi 1g, prášek pro injekční/infuzní roztok
Denmark Ceftriaxon Fresenius Kabi
Estonia Ceftriaxone Kabi 1 g
Finland Ceftriaxon Fresenius Kabi 1 g injektio-/infuusiokuiva-aine, liuosta varten
Greece Ceftriaxone Kabi 1g, κόνις για ενέσιμο διάλυμα/διάλυμα προς έγχυση
Netherlands Ceftriaxone Fresenius Kabi 1g poeder voor oplossing voor injectie/infusie
Lithuania Ceftriaxone Kabi 1 g milteliai injekciniam / infuziniam tirpalui
Luxembourg Ceftriaxon Kabi 1 g Pulver zur Herstellung einer Injektions-/Infusionslösung
Latvia Ceftriaxone Kabi 1 g pulveris injekciju/infūziju šķīduma pagatavošanai
Germany Ceftriaxon Kabi 1 g
Norway Ceftriaxon Fresenius Kabi 1 g pulver til injeksjons-/infusjonsvæske, oppløsning
Poland Ceftriaxon Kabi 1 g
Portugal CEFTRIAXONA KABI
Slovakia Ceftriaxon Kabi 1 g
Sweden Ceftriaxon Fresenius Kabi 1 g, pulver till injektions-/ infusionsvätska, lösning
Hungary Ceftriaxon Kabi 1 g por oldatos injekcióhoz / infúzióhoz

Information intended exclusively for medical professionals:

Ceftriaxon Kabi 1 g, powder for solution for injection/infusion
Please refer to the Summary of Product Characteristics (SmPC).
Administration route
Ceftriaxon Kabi 1 g may be administered by intravenous infusion lasting at least 30 minutes (recommended
route of administration), or by slow intravenous injection over 5 minutes, or by deep intramuscular injection.
Intermittent intravenous injection lasting longer than 5 minutes should preferably be administered into a large vein.
In infants and children under 12 years of age, intravenous doses of 50 mg/kg body weight or higher should be given
by intravenous infusion. In neonates, intravenous doses should be administered over a period longer than 60 minutes
to reduce the potential risk of developing bilirubin encephalopathy (see sections 4.3 and 4.4 of the SmPC).
Intramuscular injections should be administered deeply into a relatively large muscle mass. Do not administer more than 1 g at a single injection site. Intramuscular administration should be considered when intravenous administration is not feasible or less appropriate for the individual patient. Doses of 2 g or higher must be administered intravenously.
When using lidocaine solution as a solvent, the resulting solution must never be administered intravenously (see section 4.3 of the SmPC). The information provided in the lidocaine product characteristics should be taken into account.
Ceftriaxone is contraindicated in neonates (age ≤28 days) who require (or are expected to require) intravenous therapy with calcium-containing solutions, including continuous infusions containing calcium, such as parenteral nutrition solutions, due to the risk of precipitation of ceftriaxone-calcium salt (see section 4.3 of the SmPC).
Due to the risk of precipitation, diluents containing calcium (e.g., Ringer's solution or Hartmann's solution) must not be used to reconstitute ceftriaxone or to further dilute the prepared solution for intravenous administration. Ceftriaxone-calcium salt may also precipitate if ceftriaxone is mixed with calcium-containing solutions in the same infusion system. Therefore, ceftriaxone must not be mixed or co-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 prior to surgery.
Instructions for use
Ceftriaxone must not be mixed in the same syringe with any other medicinal product except 1% lidocaine hydrochloride solution (for intramuscular injection only).
The reconstituted solution should be shaken for at least 60 seconds to ensure complete dissolution of ceftriaxone.
Compatibility of ceftriaxone has been demonstrated with the following solutions:

• 0.9% (9 mg/mL) sodium chloride solution;
• 1% (10 mg/mL) lidocaine hydrochloride solution;
• 5% (50 mg/mL) glucose solution;
• water for injections.

Only the solvents listed in the tables below should be used to prepare solutions for administration by the specified route.
Intramuscular injections

The prepared solution should be administered by deep intramuscular injection into the gluteal muscle.
Lidocaine solution must not be administered intravenously.
Intravenous injections

The prepared solution should be administered over at least 5 minutes, directly into a vein or
via an intravenous infusion set.
The prepared injection solutions are pale yellow in color, which does not impair the efficacy
or tolerability of Ceftriaxon Kabi 1 g.
Intravenous infusion

The preparation of the ready-to-use solution for infusion should be carried out in two steps to achieve the appropriate volume of infusion solution:

1. Ceftriaxon Kabi 1 g, powder for solution for infusion, should be dissolved in the vial with 10 ml of one of the compatible infusion solutions. This solution should then be transferred to a suitable infusion bag. Controlled and validated aseptic conditions must be maintained.
2. The prepared solution should be further diluted with 9.5 ml of diluent to obtain a final volume of 20 ml and a concentration of 50 mg/ml.

The infusion should be administered over at least 30 minutes.
To ensure that the entire dose of Ceftriaxon Kabi 1 g has been administered, it is recommended to flush the infusion line with one of the compatible diluents at the end of the infusion.
The solution should be visually inspected after preparation. Only clear, particle-free solutions should be used. The medicinal product is intended for single use only after reconstitution, and any unused portion of the solution must be discarded.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Pharmaceutical incompatibilities
According to literature data, ceftriaxone is incompatible with amsacrine, vancomycin, fluconazole, aminoglycoside antibiotics, and labetalol.
Do not mix this medicinal product with other medicinal products, except those mentioned in section "Instructions for use".
In particular, do not use calcium-containing diluents (e.g. Ringer's solution, Hartmann's solution) for dissolving ceftriaxone or for further dilution of the reconstituted powder for intravenous administration, as precipitation may occur. Do not mix ceftriaxone or co-administer it simultaneously with calcium-containing solutions, including total parenteral nutrition solutions.

Prepared solution
Chemical and physical stability of the solution has been demonstrated for 12 hours at 25°C and for 2 days at 2°C to 8°C. From a microbiological standpoint, the product should be used immediately. If not used immediately, the user is responsible for ensuring the storage duration and conditions. The solution should not be stored for longer than 24 hours at 2°C to 8°C, unless the solution was prepared under controlled and validated aseptic conditions.

Special precautions during storage
Store the vial in the outer packaging to protect from light.
For storage conditions of the prepared solution, see section "Prepared solution".