Biofuroksim

Package Leaflet: Information for the User

Biofuroxym

250 mg, 500 mg, 750 mg

Powder for solution or suspension for injection
Cefuroxime

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

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

Table of Contents of the Package Leaflet

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

1. What is Biofuroxym and what is it used for

Biofuroxym is an antibiotic used in adults and children. The medicine works by killing bacteria that cause infections. It belongs to a group of medicines called cephalosporins.

Biofuroxym is used to treat infections of:

• the lungs or chest,
• the urinary system,
• the skin and soft tissues,
• the abdomen.

Biofuroxym is also used:

• to prevent infections during surgery.

2. Important information before using Biofuroxym

When not to use Biofuroxym:

• if you are allergic to cephalosporin antibioticsor any of the other ingredients of Biofuroxym (listed in section 6);
• if you have ever had a severe allergic reaction (hypersensitivity) to any other type of beta-lactam antibiotic (penicillins, monobactams or carbapenems);
• if you have ever had a severe skin rash or blistering of the skin, or mouth ulcers after taking cefuroxime or other cephalosporin antibiotics.

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If you think any of these apply to you, tell your doctor before taking Biofuroxym. You should not take Biofuroxym.

Warnings and precautions

While taking Biofuroxym, pay attention to whether you experience any symptoms such as allergic reactions and stomach or gut disorders (e.g. diarrhea). This will reduce the risk of complications (see "Symptoms to watch out for" in section 4). If you have had an allergic reaction to other antibiotics, such as penicillin, you may also be allergic to Biofuroxym.
Severe skin reactions have been reported with cefuroxime, such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS). If you notice any of the symptoms of severe skin reactions described in section 4, seek medical attention immediately.

Blood and urine tests

Biofuroxym may affect the results of tests for sugar in the urine or blood, or a blood test called the Coombs test. If you are going to have these tests, you should:
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tell the person taking the samplethat you are taking Biofuroxym.

Biofuroxym and other medicines

Tell your doctor about all the medicines you are taking now or have recently taken, including those that are available without a prescription.
Some medicines may affect the action of Biofuroxym or increase the risk of side effects. These include:

• aminoglycoside antibiotics,
• diuretics (water tablets), e.g. furosemide,
• probenecid,
• oral anticoagulants (blood thinners). ➔ If this applies to you, tell your doctor. Your doctor may need to monitor your kidney function while you are taking Biofuroxym.

Pregnancy, breastfeeding, and fertility

Tell your doctor before taking Biofuroxym:

• if you are pregnant, think you may be pregnant, or plan to become pregnant,
• if you are breastfeeding.

Your doctor will assess whether the benefits of taking Biofuroxym during pregnancy and breastfeeding outweigh the risks to the baby.

Driving and using machines

Do not drive or operate machinery if you do not feel well.

Biofuroxym contains sodium

Biofuroxym, 250 mg
The medicine contains 14 mg of sodium (a major component of common salt) per vial. This corresponds to 0.7% of the maximum recommended daily intake of sodium in the diet for adults.
Biofuroxym, 500 mg
The medicine contains 28 mg of sodium (a major component of common salt) per vial. This corresponds to 1.4% of the maximum recommended daily intake of sodium in the diet for adults.
Biofuroxym, 750 mg
The medicine contains 42 mg of sodium (a major component of common salt) per vial. This corresponds to 2.1% of the maximum recommended daily intake of sodium in the diet for adults.
Preparation of the medicine for administration - see section "Information intended for healthcare professionals only" at the end of the package leaflet. When calculating the total sodium content in the prepared dilution, consider the sodium from the diluent. For accurate information on the sodium content in the solution used for dilution, refer to the patient information leaflet of the diluent used.
Consider this for patients controlling their sodium intake.

3. How to use Biofuroxym

Biofuroxym is usually given by a doctor or nurse. It can be given by drip (intravenous infusion)or as an injectiondirectly into a vein or muscle.

Usual dose

Your doctor will decide the correct dose of Biofuroxym for you, taking into account the severity and type of infection, any other antibiotics you are taking, your 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 Biofuroxym 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 Biofuroxym is given over 24 hours, divided into three or four doses.

Adults and adolescents

From 750 mg to 1.5 g of Biofuroxym, two, three, or four times a day. No more than 6 g per day.

Patients with kidney problems

If you have kidney problems, your doctor may change the dose of Biofuroxym.
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If this applies to you, tell your doctor.

4. Possible side effects

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

Symptoms to watch out for

A small number of people taking Biofuroxym have reported an allergic reaction or potentially severe skin reaction. Their symptoms may be:

• Widespread rash, high fever, and swollen lymph nodes(DRESS or hypersensitivity syndrome).
• Chest painassociated with an allergic reaction, which can be a sign of a heart attack (Kounis syndrome).

Severe allergic reaction. Symptoms include: raised, itchy rash, swelling, sometimes of the face or mouth, which can make breathing difficult.

• Rash on the skin, which can develop into blisteringand look like small rings(a dark spot in the center surrounded by a lighter border with a dark ring around the edge).
• Widespread skin changes, with blistering and peeling skin. (This may be a sign of Stevens-Johnson syndrome or toxic epidermal necrolysis, also known as Lyell's disease).
• Fungal infections. Medicines like Biofuroxym 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 Biofuroxym is used for a long time.

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If you experience any of the above symptoms, seek medical attention immediately.

Common side effects(occurring in less than 1 in 10 patients):

• Pain at the injection site, swelling, and redness along the vein.
• If you experience any of these side effects, tell your doctor.

Common side effects that may appear in blood test results:

• 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(occurring in less than 1 in 100 patients):

• Skin rash, hives,
• Diarrhea, nausea, abdominal pain. ➔ If you experience any of these side effects, tell your doctor.

Uncommon side effects that may appear in blood test results:

• Decrease in the number of white blood cells (leukopenia),
• Increased 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 frequency cannot be estimated from the available data (the frequency cannot be determined from the available data):

• Fungal infection,
• High fever,
• Allergic reactions (hypersensitivity),
• Colitis (inflammation of the large intestine), causing diarrhea, usually with blood and mucus, abdominal pain,
• Kidney inflammation and blood vessel inflammation,
• Too rapid breakdown of red blood cells (hemolytic anemia),
• 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).

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If you experience any of the above side effects, tell your doctor.
Side effects that may appear in blood test results:

• Decrease in the number of platelets (cells involved in blood clotting - thrombocytopenia),
• Increased levels of urea and creatinine in the blood.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. 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
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 the medicine.

5. How to store Biofuroxym

Keep the medicine out of the sight and reach of children.
Store the medicine at a temperature below 25°C, away from light.
After reconstitution, the solution remains stable for 24 hours at a temperature between 2°C and 8°C.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
The notation on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot means the batch number.
Medicines should 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 Biofuroxym contains

• The active substance is cefuroxime. Each vial contains 250 mg, 500 mg, or 750 mg of cefuroxime (as sodium salt). The medicine does not contain any excipients.

What Biofuroxym looks like and contents of the pack

The medicine is a white or almost white, crystalline powder in a glass vial containing 250 mg, 500 mg, or 750 mg of powder. The vials are closed with a rubber stopper and protected with an aluminum cap or an aluminum cap with a hood, and packaged in cardboard boxes.
The pack contains 1 or 10 vials.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Pharmaceutical Works POLPHARMA S.A.
ul. Pelplińska 19
83-200 Starogard Gdański
phone: +48 22 364 61 01

Manufacturer

Pharmaceutical Works POLPHARMA S.A.
ul. Pelplińska 19
83-200 Starogard Gdański
Pharmaceutical Works POLPHARMA S.A.
Production Plant in Duchnice
ul. Ożarowska 28/30
05-850 Ożarów Mazowiecki

Date of last revision of the package leaflet: ----------------------------------------------------------------------------------------------------------------------

Information intended for healthcare professionals only:

Instructions for reconstitution

Table 1. Volumes of water to be added and concentrations of the solution useful when partial doses are to be used.

** The resulting volume of the cefuroxime solution in the solvent increases due to the phase shift coefficient of the active substance, resulting in the presented concentrations (mg/ml).
Compatibility
Cefuroxime sodium (5 mg/ml) in 5% w/v or 10% w/v xylitol injection solution can be stored for up to 24 hours at 25°C.
Cefuroxime sodium is compatible with aqueous solutions containing no more than 1% lidocaine hydrochloride.
Cefuroxime sodium is compatible with the following infusion solutions, with which its action is maintained for 24 hours at room temperature:
0.9% w/v sodium chloride solution
5% glucose solution for injection
0.18% w/v sodium chloride solution with 4% glucose solution for injection
5% glucose solution and 0.9% sodium chloride solution for injection
5% glucose solution and 0.45% sodium chloride solution for injection
5% glucose solution and 0.225% sodium chloride solution for injection
10% glucose solution for injection
10% invert sugar solution in water for injection
Ringer's solution for injection
Lactated Ringer's solution for injection
Sodium lactate solution for injection (M/6)
Multicomponent sodium lactate solution for injection (Hartmann's solution).
The stability of cefuroxime sodium in 0.9% sodium chloride solution for injection and in 5% glucose solution for injection is not affected by the presence of sodium hydrocortisone phosphate.
Cefuroxime sodium also shows compatibility for 24 hours at room temperature if added to an intravenous infusion solution containing:
heparin (10 or 50 units/ml) in 0.9% sodium chloride solution for injection;
potassium chloride (10 or 40 mEq/l) in 0.9% sodium chloride solution for injection.
Any unused product or waste material should be disposed of in accordance with local regulations.
Preparation of the solution for rapid injection
Puncture the stopper with a needle and inject the recommended volume of solvent into the vial. To puncture the stopper, use a needle with a diameter not greater than 0.8 mm. Insert the needle into the center of the stopper at a 90° angle, as shown in the following diagram: