Ceftriaxone kabi

Package leaflet: Information for the patient

Ceftriaxone Kabi, 2 g, powder for solution for infusion
Ceftriaxonum
Please read the entire leaflet carefully before use, as it contains
important information for the patient.
­ Keep this leaflet, so that you can read it again if necessary.
­ If you have any questions, please consult your doctor, pharmacist, or nurse.
­ This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
­ If any adverse reactions occur in the patient, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
Table of contents of the leaflet

1. What Ceftriaxone Kabi is and what it is 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. Contents of the pack and other information

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

Ceftriaxone Kabi 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.
Ceftriaxone Kabi is used to treat infections of:
­ the brain (meningitis);
­ the lungs;
­ the middle ear;
­ the abdomen and abdominal lining (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 adult patients and children, including newborns from day 15 of life;
­ 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 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 the hands, feet and ankles (ankle joints), chest pain, and rapidly developing severe rash;
• if the patient is allergic to lidocaine and is to receive Ceftriaxone Kabi by intramuscular injection.

Do not use Ceftriaxone Kabi in young children 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 is to receive an intravenous medicine containing calcium.

Warnings and precautions

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

• the patient has recently received or is about to receive medications containing calcium;
• the patient has recently had diarrhoea after antibiotic treatment;
• the patient 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 diseases 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 severe skin reactions, see also section 4 "Possible side effects").

Blood or urine tests

If the patient is receiving Ceftriaxone Kabi 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 Ceftriaxone Kabi.
  If the patient has diabetes or needs to monitor blood glucose levels, do not use test methods that may incorrectly measure blood glucose levels during ceftriaxone treatment. If the patient monitors blood glucose, check the instructions and inform the doctor, pharmacist or nurse. Alternative testing methods should be used if necessary.

Children

Before giving Ceftriaxone Kabi to a child, talk to the doctor, pharmacist or nurse if:

• the child has recently received or is about to receive intravenous medication containing calcium.

Ceftriaxone Kabi with other medicines

Tell your doctor or pharmacist if the patient is taking, has recently taken or might take any other medicines.
In particular, inform your doctor or pharmacist if the patient is taking any of the following medicines:

• an aminoglycoside antibiotic;
• an antibiotic called chloramphenicol (used to treat infections, particularly eye infections).

Pregnancy, breastfeeding and fertility

If the patient is pregnant or breastfeeding, thinks 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 Ceftriaxone Kabi for the mother and the potential risk to the unborn or breastfed child.

Driving and using machines

Ceftriaxone Kabi may cause dizziness. If dizziness occurs, do not drive, operate tools or machinery. Inform the doctor if such symptoms occur.

Ceftriaxone Kabi contains sodium

This medicine contains 164.6 mg of sodium (the main component of table salt) per vial. This corresponds to 8.2% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to use Ceftriaxone Kabi

Ceftriaxone Kabi 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 Kabi is prepared by a doctor, pharmacist, or nurse and must not be mixed or co-administered with solutions containing calcium.
Typically used dose
The doctor will decide what dose of Ceftriaxone Kabi 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 Ceftriaxone Kabi 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 administer 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 from day 15 of life up to 12 years of age with body weight below 50 kg:
- 50 mg to 80 mg of Ceftriaxone Kabi per kg of the child's body weight, once daily, depending on the severity and type of infection. In case of severe infection, the doctor may administer a higher dose up to 100 mg per kg of the child's body weight, 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 Ceftriaxone Kabi per kg of the child's 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 child's 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 Ceftriaxone Kabi 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 Ceftriaxone Kabi
If a dose higher than prescribed is accidentally administered, contact a doctor or the nearest hospital immediately.
Missed dose of Ceftriaxone Kabi
If a dose of Ceftriaxone Kabi is 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 Ceftriaxone Kabi
Do not stop using Ceftriaxone Kabi unless instructed by a doctor. If you have any further questions about the use of this medicine, consult 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 during treatment with this medicine:
Severe allergic reactions (frequency unknown – cannot be estimated from the available data)
If you experience 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 associated with an allergic reaction, which may be a symptom of an allergy-induced heart attack (Kounis syndrome).

Severe skin reactions (frequency unknown – cannot be estimated from the available data)
If you experience a severe skin reaction, tell 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 fever, 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 Ceftriaxone Kabi for infections caused by spirochetes, such as Lyme disease.

Other side effects:
Common (may affect up to 1 in 10 patients)
­ abnormalities in white blood cells (e.g. decreased white blood cell count and increased eosinophils) and platelets (decreased platelet count);
­ loose stools or diarrhoea;
­ changes in blood test results assessing liver function;
­ rash.

Uncommon (may affect up to 1 in 100 patients)
­ 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 Ceftriaxone Kabi was administered, pain at injection site;
­ high temperature (fever);
­ abnormal kidney function test results (increased blood creatinine levels).

Rare (may affect up to 1 in 1000 patients)
­ 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;
­ blood or sugar in the urine;
­ oedema (fluid retention);
­ chills;
­ treatment with ceftriaxone — especially in elderly patients with serious kidney or nervous system disorders — may rarely cause reduced level of consciousness, abnormal movements, restlessness, and seizures.

Frequency not known (cannot be estimated from the available data)
­ secondary infection that is resistant to previously used antibiotics;
­ a type of anaemia in which red blood cells are destroyed (haemolytic anaemia);
­ marked decrease in white blood cells (agranulocytosis);
­ seizures;
­ severe dizziness (sensation of spinning);
­ inflammation of the pancreas; 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;
­ gallbladder and/or liver-related problems, which may cause pain, nausea, vomiting, yellowing of the skin, 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 when passing urine or production of a small amount of urine;
­ false positive Coombs test result (a test detecting certain blood disorders);
­ false positive galactosemia test result (abnormal accumulation of galactose sugar in the body);
­ Ceftriaxone Kabi may affect the results of certain blood glucose tests – please consult your doctor about this.

Reporting of side effects
If any side effects occur, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects 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
Side effects can also be reported to the marketing authorisation holder.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Ceftriaxone Kabi

Keep the medicine 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 stated month.
Store the vial in the 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 wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack 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 range from colourless to pale yellow.
One pack of Ceftriaxone Kabi, powder for solution for infusion, contains 5, 7 or 10 glass vials with powder, stoppered with a butyl rubber closure and sealed with an aluminium cap. 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
Manufacturer
Labesfal, Laboratorios Almiro, S.A.
Zona Industrial do Lagedo
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
tel.: +48 22 345 67 89
This medicinal product is authorised in the European Economic Area countries 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 powder for solution for infusion
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 powder for infusion solution, solution
Poland Ceftriaxone Kabi
Portugal CEFTRIAXONA KABI
Slovakia Ceftriaxon Kabi 2 g
Sweden Ceftriaxon Fresenius Kabi 2 g, powder for infusion solution, solution
Hungary Ceftriaxon Kabi 2 g por oldatos infúzióhoz
Italy Ceftriaxone FKI

Information intended exclusively for medical professionals:

Ceftriaxone Kabi, 2 g, powder for solution for infusion
Please refer to the Summary of Product Characteristics (SmPC).
Administration method
Ceftriaxone Kabi 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 given
into a large vein. Intravenous doses of 50 mg/kg body weight or higher in infants and children under 12
years of age should be administered by intravenous infusion. In neonates, intravenous doses should be
administered 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 appropriate
depth into a relatively large muscle. Do not administer more than 1 g at a single site. Intramuscular
administration should be considered only when intravenous administration is not feasible or less
appropriate for the individual patient. Doses of 2 g should be administered intravenously.
When lidocaine solution is used as a solvent, the resulting solution must never be administered
intravenously (see section 4.3 of the SmPC). The information provided in the lidocaine Summary of
Product Characteristics should be taken into account.
Ceftriaxone is contraindicated in neonates (age ≤28 days) who require (or are expected to require)
intravenous 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 precipitate formation, diluents containing calcium (e.g. Ringer's solution or Hartmann's
solution) must not be used to dissolve 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
with calcium-containing solutions (see sections 4.3, 4.4 and 6.2 of the SmPC).
For preoperative prevention of surgical site infections, ceftriaxone should be administered 30–90 minutes
before surgery.
Instructions for use
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;
• 5% (50 mg/ml) glucose solution.

Intravenous infusion

The infusion should be administered over at least 30 minutes.
The solution should be inspected after preparation. Only clear solutions, without visible solid particles, should be used. The reconstituted solution is intended for single use only, and any unused portion of the solution should be discarded.
Any unused medicinal product or waste material should be disposed of in accordance with local regulations.
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 reconstituting ceftriaxone or for further dilution of the reconstituted powder for intravenous administration, as precipitation may occur. Do not mix ceftriaxone or administer 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 point of view, the medicinal product should be used immediately. If not used immediately, the responsibility for storage conditions and duration lies with the user. The solution should not be stored for longer than 24 hours at 2°C to 8°C, unless reconstitution has been carried out under controlled and validated aseptic conditions.
Special precautions during storage
Store the vial in the outer packaging to protect from light.
Storage conditions for the prepared solution, see section “Prepared solution”.