CEFUROXIM 750 mg Powder

Contents of the leaflet

1. Leaflet accompanying the packaging: information for the user
2. Cefuroxim Kabi, 750 mg, powder for solution for injection or infusion
3. Cefuroxim Kabi, 1500 mg, powder for solution for injection or infusion
   1. Read the leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
4. What is Cefuroxim Kabi and what is it used for
   1. Cefuroxim Kabi is used to treat infections:
5. Important information before using Cefuroxim Kabi
   1. When not to use Cefuroxim Kabi:
   2. Warnings and precautions
   3. Blood and urine tests
   4. Cefuroxim Kabi and other medicines
   5. Pregnancy, breastfeeding, and fertility
   6. Driving and using machines
   7. Cefuroxim Kabi contains sodium.
6. How to use Cefuroxim Kabi
   1. Usual dose
   2. Newborns and infants (0-3 weeks old)
   3. Infants (over 3 weeks old) and children
   4. Adult patients and adolescents
   5. Patients with kidney problems
7. Possible side effects
   1. Symptoms to watch out for
   2. Other symptoms to watch out for while taking Cefuroxim Kabi
   3. If the patient experiences any of these symptoms, they should contact their doctor, pharmacist, or nurse immediately.
   4. Common side effects
   5. Uncommon side effects
   6. Other side effects
   7. Reporting side effects
8. How to store Cefuroxim Kabi
9. Contents of the packaging and other information
   1. What Cefuroxim Kabi contains
   2. What Cefuroxim Kabi looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer
   5. This medicinal product is authorized in the Member States of the European Economic Area under the following names:
   6. Instructions for reconstitution

Leaflet accompanying the packaging: information for the user

Cefuroxim Kabi, 750 mg, powder for solution for injection or infusion

Cefuroxim Kabi, 1500 mg, powder for solution for injection or infusion

Cefuroxime

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

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Keep this leaflet, so that you can read it again if necessary.
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In case of any doubts, consult a doctor or pharmacist.
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If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or nurse.
See section 4.

Table of contents of the leaflet

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

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

Cefuroxim Kabi is an antibiotic used in adults and children. Its action involves killing bacteria that cause infections. It belongs to a group of medicines called cephalosporins.

Cefuroxim Kabi is used to treat infections:

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of the lungs or chest;
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of the urinary system;
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of the skin and soft tissues;
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of the abdomen.
Cefuroxim Kabi is also used:
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to prevent infections during surgery.
The doctor may examine what type of bacteria caused the infection in the patient and check during treatment whether the bacteria are sensitive to Cefuroxim Kabi.

2. Important information before using Cefuroxim Kabi

When not to use Cefuroxim Kabi:

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or any of the other ingredients of Cefuroxim Kabi (listed in section 6);
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If the patient thinks that any of the above circumstances apply to them, they should tell their doctorbefore starting to use Cefuroxim Kabi. The patient must not take Cefuroxim Kabi.

Warnings and precautions

Before starting to use Cefuroxim Kabi, the patient should consult their doctor, pharmacist, or nurse. During treatment with Cefuroxim Kabi, the patient should be aware of any symptoms such as allergic reactions, skin rashes, stomach and intestinal disorders (e.g., diarrhea), or fungal infections. This will reduce the risk of complications (see “Symptoms to watch out for”in section 4). If the patient has had any allergic reactions to other antibiotics, such as penicillin, they may also be allergic to Cefuroxim Kabi.
Severe skin side effects have been reported with cefuroxime, such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS). If the patient notices any of the symptoms associated with severe skin reactions described in section 4, they should seek medical advice immediately.

Blood and urine tests

Cefuroxim Kabi may affect the results of tests that detect sugar in the urine or blood and a blood test called the Coombs test. If the patient is to have these tests, they should:
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tell the person taking the test samplesthat they are taking Cefuroxim Kabi.

Cefuroxim Kabi and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. This includes medicines that are available without a prescription.
Some medicines may interact with Cefuroxim Kabi or increase the risk of side effects. These include:
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aminoglycoside antibiotics;
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diuretic tablets(e.g., furosemide);
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probenecid;
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oral anticoagulants(blood thinners).
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If this applies to the patient, they should tell their doctor. During treatment with Cefuroxim Kabi, the patient may need to have additional kidney function tests.

Pregnancy, breastfeeding, and fertility

The patient should inform their doctor before taking Cefuroxim Kabi:
­­The doctor will assess whether the benefits of using Cefuroxim Kabi for the patient outweigh the risks to the baby.

Driving and using machines

The patient should not drive or operate machinery if they do not feel well.

Cefuroxim Kabi contains sodium.

Cefuroxim Kabi, 750 mg: this medicine contains 40.63 mg of sodium (the main component of common salt) per vial. This is equivalent to 2% of the maximum recommended daily intake of sodium in the diet for adults.
Cefuroxim Kabi, 1500 mg: this medicine contains 81.26 mg of sodium (the main component of common salt) per vial. This is equivalent to 4.1% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to use Cefuroxim Kabi

Cefuroxim Kabi is usually administered by a doctor or nurse.It can be given as an intravenous infusionor as an injectiondirectly into a vein or muscle.

Usual dose

The doctor will decide on the appropriate dose of Cefuroxim Kabi for the patient, taking into account the severity and type of infection, any other antibiotics the patient is taking, their body weight, age, and kidney function.

Newborns and infants (0-3 weeks old)

For every kilogram of the infant's body weight, a dose of 30 to 100 mg of Cefuroxim Kabi is given over 24 hours, divided into two or three doses.

Infants (over 3 weeks old) and children

For every kilogram of the infant's or child's body weight, a dose of 30 to 100 mg of Cefuroxim Kabi is given over 24 hours, divided into three or four doses.

Adult patients and adolescents

750 mg to 1.5 g of Cefuroxim Kabi, two to four times a day. Maximum dose: 6 g per day.

Patients with kidney problems

If the patient has kidney problems, the doctor may change the dose of Cefuroxim Kabi.
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If this applies to the patient, they should tell their doctor.

4. Possible side effects

Like all medicines, Cefuroxim Kabi can cause side effects, although not everybody gets them.

Symptoms to watch out for

A small number of patients taking Cefuroxim Kabi have reported an allergic reaction or a potentially severe skin reaction. The symptoms may be:
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severe allergic reaction. Symptoms include: raised, itchy rash, swelling, sometimes of the face or mouth, which can make breathing difficult.
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skin rash, which can develop into blistersand look like small rings(a dark spot in the center, surrounded by a lighter border, with a dark ring around the edge).
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widespread skin changeswith blisters and peeling skin(this may be a sign of Stevens-Johnson syndrome or toxic epidermal necrolysis).
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widespread rash, high fever, and swollen lymph nodes(DRESS syndrome or drug hypersensitivity syndrome).
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chest pain associated with an allergic reaction, which can be a sign of a heart attack caused by an allergy (Kounis syndrome).

Other symptoms to watch out for while taking Cefuroxim Kabi

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Fungal infections. Medicines like Cefuroxim Kabi can rarely cause an overgrowth of yeast (Candida) in the body, leading to a fungal infection (e.g., thrush). The risk of this side effect is higher if Cefuroxim Kabi is used for a long time.
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Severe diarrhea (pseudomembranous colitis). Medicines like Cefuroxim Kabi can cause inflammation of the colon (large intestine), leading to severe diarrhea, usually with blood and mucus, abdominal pain, and fever.
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If the patient experiences any of these symptoms, they should contact their doctor, pharmacist, or nurse immediately.

Common side effects

May occur in more than 1 in 10 patients:
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pain at the injection site, swelling, and redness along the vein.
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If the patient experiences any of these side effects, they should tell their doctor.
Common side effects that may be seen in blood test results:
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increased activity of substances (enzymes) produced by the liver;
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change in the number of white blood cells (neutropenia or eosinophilia);
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decrease in the number of red blood cells (anemia).

Uncommon side effects

May occur in more than 1 in 100 patients:
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skin rash, itchy, raised rash (hives);
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diarrhea, nausea, abdominal pain.
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If the patient experiences any of these side effects, they should tell their doctor.
Uncommon side effects that may be seen in blood test results:
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decrease in the number of white blood cells (leukopenia);
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increase in bilirubin levels in the blood;
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positive Coombs test result.

Other side effects

Other side effects occur in a very small number of patients, but the exact frequency is unknown:
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fungal infection;
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high fever;
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allergic reactions;
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inflammation of the colon (large intestine), leading to diarrhea, usually with blood and mucus, abdominal pain;
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inflammation of the kidneys and blood vessels;
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rapid breakdown of red blood cells (hemolytic anemia);
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skin rash, which can develop into blisters and look like small rings (a dark spot in the center, surrounded by a lighter border, with a dark ring around the edge) (erythema multiforme).
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If the patient experiences any of these side effects, they should tell their doctor.
Side effects that may be seen in blood test results:
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decrease in the number of platelets (cells involved in blood clotting – thrombocytopenia);
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increase in urea and creatinine levels in the blood.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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 the medicine.

5. How to store Cefuroxim 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 after EXP.
The expiry date refers to the last day of the month.
Do not store above 25°C. Store the vial in the carton to protect from light.
The reconstituted suspension or solution of Cefuroxim Kabi should be used immediately.
If not used immediately, the reconstituted suspension or solution should be stored in the refrigerator (at 2°C to 8°C) and used within 5 hours.
Do not use this medicine if visible signs of deterioration are observed, such as solid particles or discoloration.
Dispose of any unused medicine or waste material in accordance with local requirements.
Medicines should not be disposed of via wastewater or household waste. The doctor or nurse will dispose of any unused medicines.
This will help protect the environment.

6. Contents of the packaging and other information

What Cefuroxim Kabi contains

Cefuroxim Kabi, 750 mg: the active substance is cefuroxime. Each vial contains 750 mg of cefuroxime in the form of cefuroxime sodium (789 mg).
Cefuroxim Kabi, 1500 mg: the active substance is cefuroxime. Each vial contains 1500 mg of cefuroxime in the form of cefuroxime sodium (1578 mg).

What Cefuroxim Kabi looks like and contents of the pack

Cefuroxim Kabi is a powder that is usually mixed with water for injections to produce a clear solution for injection or intravenous infusion or a suspension for intramuscular injection. After reconstitution, the doctor may mix the cefuroxime solution with other compatible infusion fluids. The solutions and suspensions may have different colors: from colorless to yellow, depending on the concentration, diluent used, and storage conditions.
Cefuroxim Kabi, 750 mg, powder for solution for injection or infusion, is available in packs containing 1 or 10 glass vials with powder, closed with a bromobutyl rubber stopper and an aluminum seal with a blue plastic flip-off cap.
Cefuroxim Kabi, 1500 mg, powder for solution for injection or infusion, is available in packs containing 1 or 10 glass vials with powder, closed with a bromobutyl rubber stopper and an aluminum seal with a red plastic flip-off cap.
Not all pack sizes may be marketed.

Marketing authorization holder

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

Manufacturer

Labesfal – Laboratórios Almiro S.A.
Lagedo, 3465-157 Santiago de Besteiros
Portugal
To obtain more detailed information, please 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:

Cefuroxim Fresenius Kabi 750 mg, poeder voor oplossing voor injectie of infusie,
poudre pour solution injectable ou pour perfusion, Pulver zur Herstellung einer Injektionslösung/Infusionslösung
Cefuroxim Fresenius Kabi 1500 mg poeder voor oplossing voor injectie of infusie,
poudre pour solution injectable ou pour perfusion, Pulver zur Herstellung einer Injektionslösung/Infusionslösung
Belgium
Czech Republic
Cefuroxim Kabi 750 mg
Cefuroxim Kabi 1500 mg
Denmark
Cefuroxim Fresenius Kabi 750 mg
Cefuroxim Fresenius Kabi 1.5 g
France
CEFUROXIME KABI 750 mg, poudre pour solution injectable ou pour perfusion
Greece
CefuroximeKabi, κόνις για παρασκευή διαλύματος για ένεση/έγχυση, 750 mg
Cefuroxime Kabi κόνις για παρασκευή διαλύματος για ένεση/έγχυση, 1500 mg
Netherlands
Cefuroxim Fresenius Kabi 750 mg poeder voor oplossing voor injectie/infusie
Cefuroxim Fresenius Kabi 1500 mg poeder voor oplossing voor injectie/infusie
Ireland
Cefuroxime 750 mg powder for solution for injection/infusion
Cefuroxime 1.5 g powder for solution for injection/infusion
Norway
Cefuroxim Fresenius Kabi 750 mg
Cefuroxim Fresenius Kabi 1.5 g
Poland
Cefuroxim Kabi
Slovakia
Cefuroxim Kabi 750 mg
Cefuroxim Kabi 1500 mg
Sweden
Cefuroxim Fresenius Kabi 750 mg pulver till injektions-/infusionsvätska, lösning
Cefuroxim Fresenius Kabi 1500 mg pulver till injektions-/infusionsvätska, lösning
Hungary
Cefuroxim Kabi 750 mg por oldatos injekcióhoz vagy infúzióhoz
Cefuroxim Kabi 1500 mg por oldatos injekcióhoz vagy infúzióhoz
United Kingdom
Cefuroxime 750 mg powder for solution for injection/infusion
Cefuroxime 1.5 g powder for solution for injection/infusion
Date of last revision of the leaflet:15.05.2023
Information intended for healthcare professionals only:

Instructions for reconstitution

Volumes of water to be added and concentrations of solution or suspension useful when partial doses are to be used

As with all parenteral medicines, the reconstituted solution or suspension should be inspected before administration for any visible particles or discoloration.
Intramuscular injection: after adding the appropriate amount of solvent for intramuscular injection, a suspension is formed.
Intravenous injection (bolus) or intravenous infusion: the solution should only be used if it is clear and free of solid particles.
Solutions and suspensions may have different colors: from colorless to yellow, depending on the concentration, diluent used, and storage conditions.
Preparation of solution for intravenous infusion
Cefuroxim Kabi should be reconstituted according to the following instructions for dilution of solution for intravenous injection (see above table).
Before administration of the medicine in intravenous infusion, the resulting solution should be diluted in 50-100 mL of one of the following compatible infusion fluids.
Cefuroxime sodium is compatible with the following infusion fluids. Its activity is maintained for 5 hours, at a temperature of 2°C to 8°C:

• water for injections;
• 0.9% sodium chloride solution;
• 5% glucose solution.

Cefuroxime should be administered intravenously over 3 to 5 minutes.
Cefuroxime should be administered as an intravenous infusion over 30 to 60 minutes.
For single use only.
Any unused medicine or waste material should be disposed of in accordance with local requirements.
Chemical and physical stability has been demonstrated after reconstitution, during storage for 5 hours at 2°C to 8°C.
From a microbiological point of view, the medicine should be used immediately. If the solution is not used immediately after reconstitution, the storage times and conditions before use are the responsibility of the user.
Special precautions for storage
Do not store above 25°C.
Store the vial in the outer packaging to protect from light.