Cefuroxime dali pharma

Package leaflet: Information for the patient

Cefuroxime Dali Pharma, 750 mg, powder for solution for injection/infusion
Cefuroxime Dali Pharma, 1500 mg, powder for solution for injection/infusion
Cefuroximum
Please read this leaflet carefully before using this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or nurse. See section 4.

Table of contents of the leaflet

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

1. What Cefuroxime Dali Pharma is and what it is used for
Cefuroxime Dali Pharma is an antibiotic used in adults, adolescents, and children. It works by killing bacteria causing infections that are sensitive to cefuroxime (as the sodium salt). It belongs to a group of medicines called cephalosporins.
Cefuroxime Dali Pharma is used to treat infections of:

• the lungs or chest
• the urinary tract
• the skin and soft tissues
• the abdomen

Cefuroxime Dali Pharma is also used:

• to prevent infections during surgery.

Your doctor may test which type of bacteria caused your infection and may check during treatment whether the bacteria are sensitive to cefuroxime.

2. Important information before using Cefuroxime Dali Pharma

Do not use Cefuroxime Dali Pharma:

• if you are allergic to cefuroxime sodium or to any other cephalosporin antibiotics, or to any of the other ingredients of this medicine (listed in section 6).
• if you have ever had a severe allergic reaction (hypersensitivity) to any other beta-lactam antibiotics (e.g. penicillins, monobactams, or carbapenems).
• if you have ever developed a severe skin rash, skin peeling, blisters, and/or mouth ulcers after treatment with cefuroxime or other cephalosporin antibiotics.

If you think any of the above apply to you, you must tell your doctor before starting treatment with Cefuroxime Dali Pharma. You must not take Cefuroxime Dali Pharma.

Warnings and precautions
Talk to your doctor before using Cefuroxime Dali Pharma.
While being treated with Cefuroxime Dali Pharma, watch for symptoms such as allergic reactions, skin rashes, gastrointestinal disturbances (e.g. diarrhoea), or fungal infections. This will help reduce the risk of complications (see “Symptoms to be aware of” in section 4). If you have ever had allergic reactions to other beta-lactam antibiotics such as penicillins, carbapenems, or monobactams, you may also be allergic to Cefuroxime Dali Pharma.
Serious skin reactions have occurred with cefuroxime treatment, such as:
Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS). If you notice any of the symptoms related to severe skin reactions described in section 4, seek immediate medical advice.

Overgrowth of resistant microorganisms
Treatment with Cefuroxime Dali Pharma may lead to overgrowth of yeasts (Candida) in the body, which may result in fungal infections. This side effect may also lead to overgrowth of other resistant microorganisms (e.g. Enterococci and Clostridioides difficile), which may necessitate discontinuation of treatment. This side effect is more likely if Cefuroxime Dali Pharma is used for a prolonged period.

Severe diarrhoea (pseudomembranous colitis)
Medicines such as Cefuroxime Dali Pharma may cause inflammation of the colon (large intestine), resulting in severe diarrhoea, usually with blood and mucus, abdominal pain, and fever. Your doctor may consider stopping cefuroxime and starting appropriate treatment against Clostridioides difficile if you develop diarrhoea during or after treatment with Cefuroxime Dali Pharma. Do not take anti-peristaltic medicinal products.

Kidney problems
Use with caution in patients with kidney disease. Your doctor will decide the appropriate dose of Cefuroxime Dali Pharma based on your kidney function. See („Patients with kidney disease”) in section 3.

Administration into the anterior chamber of the eye
Cefuroxime Dali Pharma is not intended for administration into the anterior chamber of the eye. Injection into the anterior chamber of the eye may cause serious reactions such as macular oedema, retinal oedema, retinal detachment, retinal toxicity, visual disturbances, decreased visual acuity, blurred vision, corneal opacity, and corneal oedema.

Blood and urine tests
Cefuroxime Dali Pharma may affect the results of tests for glucose in blood or urine and the blood test known as the Coombs test. If you are to have such tests, you should:

• tell the person taking the samples that you are taking Cefuroxime Dali Pharma.

Cefuroxime Dali Pharma and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take, including those available without a prescription.
Some other medicines may affect the action of Cefuroxime Dali Pharma or increase the risk of side effects. These include:

• antibiotics known as aminoglycosides
• diuretic tablets (water tablets), e.g. furosemide
• probenecid
• oral anticoagulants (blood thinners)

If any of the above apply to you, you must tell your doctor.
Additional monitoring of kidney function may be required during treatment with Cefuroxime Dali Pharma.

Oral contraceptives
Cefuroxime Dali Pharma may reduce the effectiveness of oral contraceptives. If you are taking oral contraceptives while being treated with Cefuroxime Dali Pharma, you should use additional mechanical methods of contraception (e.g. condoms). Please consult your doctor for advice.

Pregnancy, breastfeeding, and fertility
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor before using this medicine.
Your doctor will assess whether the benefits of using Cefuroxime Dali Pharma during pregnancy or breastfeeding outweigh the risks to the baby.

Driving and using machines
No studies on the effect of cefuroxime on the ability to drive and use machines have been conducted. However, based on known side effects (e.g. swelling and redness along the vein, skin rash, pain at injection site), Cefuroxime Dali Pharma is unlikely to affect the ability to drive and use machines. You should not drive or operate machinery if you do not feel well.

Cefuroxime Dali Pharma contains sodium
Cefuroxime Dali Pharma, 750 mg, powder for solution for injection/infusion
This medicine contains 40.6 mg of sodium (the main component of table salt) in each vial. This corresponds to 2.03% of the maximum recommended daily dietary sodium intake for adults. This should be taken into account in patients who are controlling their dietary sodium intake.
Cefuroxime Dali Pharma, 1500 mg, powder for solution for injection/infusion
This medicine contains 81.2 mg of sodium (the main component of table salt) in each vial. This corresponds to 4.06% of the maximum recommended daily dietary sodium intake for adults. This should be taken into account in patients who are controlling their dietary sodium intake.

3. How to use Cefuroxime Dali Pharma

Cefuroxime Dali Pharma is usually administered by a doctor or nurse. It may be
given as an intravenous infusion (IV infusion) or as an injection administered directly into a vein or
intramuscularly.
Typical dosage
The doctor will determine the appropriate dose of Cefuroxime Dali Pharma for the patient, taking into account
the severity and type of infection, whether the patient is taking any other antibiotics, body weight, age, and kidney function.
Newborns and infants (aged 0–3 weeks)
A daily dose of 30 to 100 mg of Cefuroxime Dali Pharma per kilogram of body weight is given, divided into two or three doses.
Infants and young children older than 3 weeks of age, and children or adolescents with body weight below 40 kg
A daily dose of 30 to 100 mg of Cefuroxime Dali Pharma per kilogram of body weight is given, divided into three or four doses.
Adults, adolescents, and children with body weight of 40 kg or more
750 to 1500 mg of Cefuroxime Dali Pharma two, three, or four times daily. Not more than 6 g per day.
Patients with impaired kidney function
If the patient has impaired kidney function, the doctor may decide that a dosage adjustment is necessary.
If this applies to the patient, they should inform the doctor.
Use of a higher than recommended dose of Cefuroxime Dali Pharma
If the patient believes they have received more than the recommended dose of Cefuroxime Dali Pharma, they should
immediately inform the doctor or nurse. Symptoms of overdose may include encephalopathy, seizures, and coma. The risk is higher in patients with impaired kidney function.
Missed dose of Cefuroxime Dali Pharma
If the patient thinks they may have missed a dose of Cefuroxime Dali Pharma, they should contact the doctor or nurse immediately.
Do not administer a double dose to make up for a missed dose.
Stopping treatment with Cefuroxime Dali Pharma
Stopping treatment too early may worsen treatment outcomes or lead to a recurrence that is more difficult to treat. Follow the doctor's instructions.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.
Instructions for preparing the medicine for use are located at the end of the package leaflet under the section “Information intended exclusively for healthcare professionals”.

4. Possible adverse reactions

Like all medicines, Cefuroxime Dali Pharma may cause adverse reactions, although not everyone experiences them.

Symptoms to be aware of

In a small number of patients taking Cefuroxime Dali Pharma, an allergic reaction or potentially severe skin reaction has been reported. Symptoms may include:

• Severe allergic reaction. Symptoms include: raised, itchy rash, swelling, sometimes of the face or lips, which may make breathing difficult.
• Skin rash, which may develop into blisters and appear as target-like lesions (a dark spot in the centre surrounded by a lighter ring and a dark circle around the edge).
• Widespread skin lesions with blisters and peeling skin (this may be a sign of Stevens-Johnson syndrome or toxic epidermal necrolysis).
• Widespread rash, high fever, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
• Chest pain associated with an allergic reaction, which may be a symptom of an allergy-induced heart attack (Kounis syndrome).

Other symptoms to be aware of during treatment with Cefuroxime Dali Pharma

• Fungal infections. Medicines such as Cefuroxime Dali Pharma may rarely cause overgrowth of yeast (Candida) in the body, leading to fungal infection (e.g. thrush). The risk of this adverse reaction is higher if Cefuroxime Dali Pharma is used for a prolonged period.
• Severe diarrhoea (pseudomembranous colitis). Medicines such as Cefuroxime Dali Pharma may cause inflammation of the colon (large intestine), resulting in severe diarrhoea, usually with blood and mucus, abdominal pain, and fever.

If the patient experiences any of these symptoms, seek immediate medical advice from a doctor or nurse.

Common adverse reactions (may occur in not more than 1 in 10 patients):

• pain at the injection site, swelling and redness along the vein.

If the patient experiences any of these adverse reactions, inform the doctor.

Common adverse reactions that may be revealed in blood tests:

• increased activity of substances (enzymes) produced in the liver
• changes in white blood cell count (neutropenia or eosinophilia)
• decreased number of red blood cells (anaemia)

Uncommon adverse reactions (may occur in not more than 1 in 100 patients):

• skin rash, urticaria
• diarrhoea, nausea, abdominal pain

If the patient experiences any of these adverse reactions, inform the doctor.

Uncommon adverse reactions that may be revealed in blood tests:

• decreased number of white blood cells (leukopenia)
• increased bilirubin levels (a substance produced by the liver)
• positive Coombs test

Other adverse reactions

Other adverse reactions occur in a very small number of patients, but the exact frequency is unknown (frequency cannot be estimated from available data):

• fungal infections
• high temperature (fever)
• allergic reactions (hypersensitivity)
• inflammation of the colon (large intestine), causing diarrhoea, usually with blood and mucus, abdominal pain
• inflammation of the kidneys and blood vessels
• excessive breakdown of red blood cells (haemolytic anaemia)
• skin rash, which may develop into blisters and appear as target-like lesions (a dark spot in the centre surrounded by a lighter ring and a dark circle around the edge)

If the patient experiences any of these adverse reactions, inform the doctor.

Adverse reactions that may be revealed in blood tests:

• decreased number of platelets (cells involved in blood clotting – thrombocytopenia)
• increased blood urea nitrogen and serum creatinine levels.

Reporting of adverse reactions

If any adverse reactions occur, including any not listed in this leaflet, inform a doctor or nurse. Adverse reactions can be reported directly to: Department of Monitoring of Adverse Drug Reactions, 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.
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Cefuroxime Dali Pharma

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date (EXP) stated on the outer carton and on the vial label. The expiry date refers to the last day of the stated month.
The abbreviation 'Lot' on the packaging indicates the batch number.
Unopened (powder for solution for injection or infusion): Do not store above 25°C. Store vials in the outer packaging to protect from light.
Reconstituted solution: Chemical and physical in-use stability has been demonstrated for no longer than 6 hours when stored at 25°C, or no longer than 24 hours when stored between 2°C and 8°C. From a microbiological point of view, unless the method of opening/reconstitution/dilution excludes the risk of microbiological contamination, the product should be used immediately. If the product is not used immediately, the responsibility for storage conditions and duration prior to use lies with the user, and such storage should generally not exceed the times mentioned above for chemical and physical in-use stability.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Cefuroxime Dali Pharma contains
The active substance is cefuroxime in the form of cefuroxime sodium.
One vial contains 750 mg.
One vial contains 1500 mg of cefuroxime.
The medicinal product does not contain any excipients.

What Cefuroxime Dali Pharma looks like and contents of the pack
The medicinal product is a white or almost white powder for solution for injection/infusion.
After adding an appropriate volume of water or another suitable solvent, a whitish suspension is formed for intramuscular administration or a yellowish solution for intravenous administration.

Cefuroxime Dali Pharma, 750 mg, powder for solution for injection or infusion: 10 mL colourless and transparent vial made of type II glass or 15 mL colourless and transparent vial made of type III glass, with a bromobutyl rubber stopper and an aluminium flip-off cap (green for the 10 mL vial made of type II glass and grey for the 15 mL vial made of type III glass).

Cefuroxime Dali Pharma, 1500 mg, powder for solution for injection or infusion: 10 mL colourless and transparent vial made of type II glass or 15 mL colourless and transparent vial made of type III glass, with a bromobutyl rubber stopper and an aluminium flip-off cap (blue for the 10 mL vial made of type II glass and red for the 15 mL vial made of type III glass).

Pack: 10 vials in a carton.

Marketing Authorisation Holder
Dali Pharma GmbH
Brehmstraße 56,
40239 Düsseldorf
Germany
email: [email protected]

Importer
Health-Med Sp. z o.o. sp. j.
ul. Chełmska 30/34
00-725 Warszawa
Poland

This medicinal product is authorised in the European Economic Area countries under the following names:
Malta Cefuroxime Dali Pharma, 750 mg, powder for solution for injection or infusion
Cefuroxime Dali Pharma, 1500 mg, powder for solution for injection or infusion
Poland Cefuroxime Dali Pharma

Information intended solely for healthcare professionals:

Cefuroxime Dali Pharma, 750 mg, powder for solution for injection/infusion
Cefuroxime Dali Pharma, 1500 mg, powder for solution for injection/infusion
Cefuroximum
This is a fragment of the Summary of Product Characteristics, intended to assist in the administration of
Cefuroxime Dali Pharma. When determining the appropriateness of using the medicinal product in a specific patient, the prescribing physician should consult the SmPC.
Method of administration
Cefuroxime Dali Pharma should be administered by intravenous injection over 3 to 5 minutes, directly into a vein or by intermittent infusion or continuous infusion lasting 30 to 60 minutes, or by deep intramuscular injection.
Intramuscular injections should be administered deeply into relatively large muscles. Do not inject more than 750 mg at a single site. Doses exceeding 1500 mg should be administered intravenously.
Reconstitution instructions
The solution should only be used if it is clear and free from particles.
Volumes of water added and concentrations of the solution/suspension are provided for situations where partial doses are required.

*The prepared solution should be added to 50 or 100 mL of a compatible infusion fluid (information
regarding compatibility – see below).
** The final volume of cefuroxime solution in the solvent increases due to the phase displacement factor of the active substance, resulting in the concentrations [mg/mL] stated above.
Compatibility
From a microbiological standpoint, unless the method of opening/reconstitution/dilution excludes the risk of microbiological contamination, the product should be used immediately. If the product is not used immediately, the user is responsible for the storage time and conditions prior to use, which generally should not exceed the times indicated above for chemical and physical stability during use.
1500 mg of sodium cefuroxime is compatible with 1 g of azlocillin solution (in 15 mL solution) or 5 g of azlocillin (in 50 mL solution) for up to 24 hours at 4°C or 6 hours at temperatures below 25°C.
Sodium cefuroxime (5 mg/mL) in 10% w/v xylitol solution for injection can be stored for up to 24 hours at 25°C.
Sodium cefuroxime is compatible with aqueous solutions containing not more than 1% lidocaine hydrochloride for up to 24 hours at 4°C or 6 hours at temperatures below 25°C.
Sodium cefuroxime is compatible with the following infusion fluids. Stability is maintained for up to 24 hours at 4°C or 6 hours at temperatures below 25°C with:
0.9% w/v sodium chloride solution (BP)
5% glucose solution for injection (BP)
0.18% w/v sodium chloride with 4% glucose solution for injection (BP)
5% glucose and 0.9% w/v sodium chloride solution for injection (BP)
10% glucose solution for injection
10% invert sugar solution in water for injection
Ringer's solution for injection (USP)
Sodium lactate Ringer's solution for injection (USP)
Sodium lactate solution for injection (M/6)
Any unused portions of the medicinal product or waste materials should be disposed of in accordance with local regulations.