Cefuroxime Dali Pharma

PATIENT INFORMATION LEAFLET

Leaflet attached to the packaging: patient information

Cefuroxime Dali Pharma, 750 mg, powder for solution for injection or infusion

Cefuroxime Dali Pharma, 1500 mg, powder for solution for injection or infusion

infusion
Cefuroxime

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or nurse.
• 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.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or nurse. See section 4.

Table of contents of the leaflet

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

1. What is Cefuroxime Dali Pharma and what is it used for

Cefuroxime Dali Pharma is an antibiotic used in adults, adolescents, and children. The medicine works by killing bacteria that cause infections sensitive to cefuroxime (in the form of cefuroxime sodium). It belongs to a group of medicines called cephalosporins.

Cefuroxime Dali Pharma is used to treat infections:

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

Cefuroxime Dali Pharma is also used:

• to prevent infections during surgery.

The doctor may check what type of bacteria caused the patient's infection and check during treatment if the bacteria are sensitive to cefuroxime.

2. Important information before taking Cefuroxime Dali Pharma

When not to take Cefuroxime Dali Pharma:

• if the patient is allergic to cefuroxime sodium or cephalosporin antibioticsor any of the other ingredients of Cefuroxime Dali Pharma (listed in section 6).
• if the patient has ever had a severe allergic reaction (hypersensitivity) to any other type of beta-lactam antibiotic (penicillins, monobactams, or carbapenems).
• if the patient has ever had a severe skin rash or skin peeling and blistering and (or) mouth sores after taking cefuroxime or other cephalosporin antibiotics.

If the patient thinks any of the above applies to them, they should tell their doctor
beforetaking Cefuroxime Dali Pharma. The patient must not take Cefuroxime Dali Pharma.

Warnings and precautions

Before taking Cefuroxime Dali Pharma, the patient should discuss it with their doctor.
During treatment with Cefuroxime Dali Pharma, the patient should be aware of the following symptoms: allergic reactions, skin rashes, stomach and intestine problems (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 beta-lactam antibiotics, such as penicillin, carbapenems, monobactams, they may also be allergic to Cefuroxime Dali Pharma.
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 symptoms related to severe skin reactions described in section 4, they should seek medical advice immediately.

Overgrowth of non-susceptible microorganisms

Taking Cefuroxime Dali Pharma may cause an overgrowth of yeast ( Candida) in the body, leading to fungal infections. This side effect may also result in an overgrowth of other non-susceptible microorganisms (e.g., Enterococciand Clostridioides difficile), which may require discontinuation of treatment. The risk of this side effect is higher if Cefuroxime Dali Pharma is taken for a longer period.

Severe diarrhea (pseudomembranous colitis)

Medicines like Cefuroxime Dali Pharma may cause inflammation of the colon (large intestine), leading to severe diarrhea, usually with blood and mucus, abdominal pain, and fever. The doctor will consider stopping cefuroxime and treating the patient for Clostridioides difficileif they develop diarrhea during or after taking Cefuroxime Dali Pharma. The patient should not take medicines that slow down bowel movements.

Kidney problems

Caution is advised in patients with kidney disease. The doctor will decide on the appropriate dose of Cefuroxime Dali Pharma based on the patient's kidney function. See („Patients with kidney problems”) in section 3.

Administration into the anterior chamber of the eye

Cefuroxime Dali Pharma is not intended for use in the anterior chamber of the eye. Administration of Cefuroxime Dali Pharma into the anterior chamber of the eye may cause serious reactions such as corneal edema, retinal edema, retinal detachment, retinal toxicity, vision disturbances, blurred vision, and corneal clouding.

Blood and urine tests

Cefuroxime Dali Pharma 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 going to have these tests, they should:

• tell the person taking the samplethat they are taking Cefuroxime Dali Pharma.

Cefuroxime Dali Pharma and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or might take. This includes medicines that are available without a prescription.
Some other medicines may affect the action of Cefuroxime Dali Pharma or increase the risk of side effects. These include:

• aminoglycoside antibiotics
• diuretics(e.g., furosemide)
• probenecid
• oral anticoagulants(blood thinners)

If any of the above applies to the patient, they should tell their doctor.
During treatment with Cefuroxime Dali Pharma, the patient may need to have additional kidney function tests.

Oral contraceptives

Cefuroxime Dali Pharma may reduce the effectiveness of oral contraceptives. If the patient is taking oral contraceptives while taking Cefuroxime Dali Pharma, they should also use mechanical methods of contraception(e.g., condoms). The patient should consult their doctor for advice.

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 whether the benefits of taking Cefuroxime Dali Pharma during pregnancy and breastfeeding outweigh the risks to the baby.

Driving and using machines

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

Cefuroxime Dali Pharma contains sodium

Cefuroxime Dali Pharma, 750 mg, powder for solution for injection or infusion
This medicine contains 40.6 mg of sodium (the main ingredient of common salt) per vial. This is equivalent to 2.03% of the maximum recommended daily intake of sodium in the diet for adults.
Cefuroxime Dali Pharma, 1500 mg, powder for solution for injection or infusion
This medicine contains 81.2 mg of sodium (the main ingredient of common salt) per vial. This is equivalent to 4.06% of the maximum recommended daily intake of sodium in the diet for adults.
Patients on a controlled sodium diet should be aware of this.

3. How to take Cefuroxime Dali Pharma

Cefuroxime Dali Pharma is usually given by a doctor or nurse.It can be given as an intravenous infusionor as an injectiondirectly into a vein or into a muscle.

Usual dose

The doctor will decide on the appropriate dose of Cefuroxime Dali Pharma based on the severity and type of infection, the patient's other antibiotic use, 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 Cefuroxime Dali Pharma is given per day, divided into two or three doses.

Infants and young children over 3 weeks old and children or adolescents weighing less than 40 kg

For every kilogram of the infant's or child's body weight, a dose of 30 to 100 mg of Cefuroxime Dali Pharma is given per day, divided into three or four doses.

Adults, adolescents, and children weighing 40 kg or more

750 to 1500 mg of Cefuroxime Dali Pharma two, three, or four times a day. No more than 6 g per day.

Patients with kidney problems

If the patient has kidney problems, the doctor may decide to adjust the dose of Cefuroxime Dali Pharma.
If this applies to the patient, they should tell their doctor.

Taking more than the recommended dose of Cefuroxime Dali Pharma

If the patient thinks they have taken more than the recommended dose of Cefuroxime Dali Pharma, they should immediately inform their doctor or nurse. Symptoms of overdose may occur, such as encephalopathy, seizures, and coma. The risk is higher in patients with impaired kidney function.

Missing a dose of Cefuroxime Dali Pharma

If the patient thinks they may have missed a dose of Cefuroxime Dali Pharma, they should contact their doctor or nurse immediately. The patient should not take a double dose to make up for the missed dose.

Stopping treatment with Cefuroxime Dali Pharma

Stopping treatment too early may worsen the outcome or lead to a relapse that is harder to treat. The patient should follow their doctor's instructions.
If the patient has any further questions about taking this medicine, they should ask their doctor or pharmacist.
The instructions for preparing the medicine are at the end of the leaflet in the section “Information for healthcare professionals only”.

4. Possible side effects

Like all medicines, Cefuroxime Dali Pharma can cause side effects, although not everybody gets them.

Symptoms to watch out for

A small number of people taking Cefuroxime Dali Pharma have reported an allergic reaction or a potentially severe skin reaction. The symptoms may be:

• Severe allergic reaction.Symptoms include: raised, itchy rash, swelling, sometimes of the face or mouth, which may make breathing difficult.
• Skin rash,which may develop into blistersand look like small targets(dark spot in the center surrounded by a lighter ring with a dark ring around the edge).
• Widespread skin changes, with blisters and peeling skin(may be a sign of Stevens-Johnson syndrome or toxic epidermal necrolysis).
• Widespread rash, high fever, swollen lymph nodes(DRESS syndrome or drug hypersensitivity syndrome),
• Chest painassociated with an allergic reaction, which may be a sign of a heart attack caused by an allergy (Kounis syndrome).

Other symptoms to watch out for while taking Cefuroxime Dali Pharma

• Fungal infections.Medicines like Cefuroxime Dali Pharma can rarely cause an overgrowth of yeast ( Candida) in the body, leading to fungal infections (e.g., thrush). The risk of this side effect is higher if Cefuroxime Dali Pharma is taken for a longer period.
• Severe diarrhea (pseudomembranous colitis).Medicines like Cefuroxime Dali Pharma can cause inflammation of the colon (large intestine), leading to severe diarrhea, usually with blood and mucus, abdominal pain, and fever.

If the patient experiences any of these symptoms, they should contact their doctor or nurse immediately. Common side effects (may affect up to 1 in 10 people):

• pain, swelling, and redness along the vein.

If the patient experiences any of these side effects, they should tell their doctor.
Common side effects that may be seen in blood tests:

• increased activity of substances (enzymes) produced in the liver
• change in the number of white blood cells (neutropenia or eosinophilia)
• decrease in the number of red blood cells (anemia)

Uncommon side effects (may affect up to 1 in 100 people):

• skin rash, hives
• diarrhea, nausea, abdominal pain

If the patient experiences any of these side effects, they should tell their doctor.
Uncommon side effects that may be seen in blood tests:

• decrease in the number of white blood cells (leukopenia)
• increase in bilirubin levels (a substance produced by the liver)
• positive Coombs test result

Other side effects

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

• fungal infections
• high fever
• allergic reactions (hypersensitivity)
• inflammation of the colon (large intestine), causing diarrhea, usually with blood and mucus, abdominal pain
• inflammation of the kidneys and blood vessels
• rapid breakdown of red blood cells (hemolytic anemia)
• skin rash, which may develop into blisters and look like small targets (dark spot in the center surrounded by a lighter ring with a dark ring around the edge)

If the patient experiences any of these side effects, they should tell their doctor.
Side effects that may be seen in blood tests:

• decrease in the number of platelets (cells involved in blood clotting - thrombocytopenia)
• increase in urea and creatinine levels in the blood.

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or nurse. Side effects can be reported directly to: Department of Drug Safety, 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 authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Cefuroxime Dali Pharma

The medicine should be kept out of the sight and reach of children.
Do not take this medicine after the expiry date (EXP) stated on the outer carton and vial label. The expiry date refers to the last day of the month.
The abbreviation ‘Lot’ on the packaging means batch number.
Unopened (powder for solution for injection or infusion): Do not store above 25°C. Store the vials in the outer carton to protect from light.
Reconstituted solution: The chemical and physical stability of the reconstituted solution has been demonstrated for 6 hours at 25°C or 24 hours at 2-8°C. From a microbiological point of view, unless the method of opening/reconstitution/dilution precludes the risk of microbial contamination, the product should be used immediately. If the product is not used immediately, the user is responsible for the storage conditions prior to use, and these should normally not exceed the times stated above for chemical and physical stability during use.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Cefuroxime Dali Pharma contains

The active substance of Cefuroxime Dali Pharma is cefuroxime in the form of cefuroxime sodium.
1 vial contains 750 mg.
1 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 or infusion.
After adding the appropriate amount of water or other suitable solvent, a white suspension for intramuscular injection or a yellowish solution for intravenous injection is produced.
Cefuroxime Dali Pharma, 750 mg, powder for solution for injection or infusion: 10 mL colorless and clear vial made of type II or type III glass, with a bromobutyl rubber stopper and a flip-off aluminum cap (green for the 10 mL type II glass vial and gray for the 15 mL type III glass vial).
Cefuroxime Dali Pharma, 1500 mg, powder for solution for injection or infusion: 10 mL colorless and clear vial made of type II or type III glass, with a bromobutyl rubber stopper and a flip-off aluminum cap (blue for the 10 mL type II glass vial and red for the 15 mL type III glass vial).
The pack contains 10 vials in a carton.

Marketing authorization 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 Warsaw
Poland

This medicinal product is authorized in the Member States of the European Economic Area 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
Date of last revision of the leaflet:November 2024
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Information intended for healthcare professionals only:

Cefuroxime Dali Pharma, 750 mg, powder for solution for injection or infusion

Cefuroxime Dali Pharma, 1500 mg, powder for solution for injection or infusion

Cefuroxime

This is an excerpt from the Summary of Product Characteristics, which is intended to assist with the administration of Cefuroxime Dali Pharma. When determining the suitability of the medicine for a particular patient, the prescribing doctor should consult the Summary of Product Characteristics.

Method of administration

Cefuroxime Dali Pharma should be administered by intravenous injection over 3 to 5 minutes, directly into a vein or by intravenous infusion over 30 to 60 minutes, or by continuous infusion, or by deep intramuscular injection.
Intramuscular injections should be administered deep into a relatively large muscle. No more than 750 mg should be injected into one site. Doses greater than 1500 mg should be administered intravenously.

Instructions for dissolution

The solution should only be used if it is clear and free of particles.
Volumes of water added and concentrations of solution/suspension useful when partial doses are needed.

*The reconstituted solution should be added to 50 or 100 mL of compatible infusion fluid (information on compatibility - see below)
** The resulting volume of cefuroxime solution in solvent increases due to the phase shift coefficient of the active substance, resulting in the presented concentrations [mg/ml].
Compatibility
From a microbiological point of view, unless the method of opening/reconstitution/dilution precludes the risk of microbial contamination, the product should be used immediately. If the product is not used immediately, the user is responsible for the storage conditions prior to use, and these should normally not exceed the times stated above for chemical and physical stability during use.
1500 mg of cefuroxime sodium is compatible with 1 g of azlocillin solution (in 15 mL of solution) or 5 g of azlocillin (in 50 mL of solution) for 24 hours at 4°C or 6 hours below 25°C.
Cefuroxime sodium (5 mg/mL) in a 10% w/v xylitol injection solution can be stored for 24 hours at 25°C.
Cefuroxime sodium is compatible with aqueous solutions containing no more than 1% lidocaine hydrochloride for 24 hours at 4°C or 6 hours below 25°C.
Cefuroxime sodium is compatible with the following infusion fluids. The activity is maintained for 24 hours at 4°C or 6 hours below 25°C with:
0.9% w/v sodium chloride solution (BP)
5% glucose solution for injection (BP)
0.18% w/v sodium chloride solution with 4% glucose solution for injection (BP)
5% glucose solution 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)
Lactated Ringer's solution for injection (USP)
Sodium lactate solution for injection (M/6)
Any unused product or waste material should be disposed of in accordance with local requirements.