BIOFUROKSYM 250 mg Powder

Contents of the leaflet

1. Leaflet attached to the packaging: information for the user
2. Biofuroxym
3. 250 mg, 500 mg, 750 mg
   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 Biofuroxym and what is it used for
   1. Biofuroxym is used to treat infections:
5. Important information before using Biofuroxym
   1. When not to use Biofuroxym:
   2. Warnings and precautions
   3. Blood and urine tests
   4. Biofuroxym and other medicines
   5. Pregnancy, breastfeeding, and fertility
   6. Driving and using machines
   7. Biofuroxym contains sodium
6. How to use Biofuroxym
   1. Usual dose
   2. Newborns and infants (0-3 weeks old)
   3. Infants (over 3 weeks old) and children
   4. Adults and adolescents
   5. Patients with kidney disease
7. Possible side effects
   1. Symptoms to watch out for
   2. If the patient experiences any of the above symptoms, they should immediately contact their doctor or nurse.
   3. Other side effects
   4. Reporting side effects
8. How to store Biofuroxym
9. Contents of the packaging and other information
   1. What Biofuroxym contains
   2. What Biofuroxym looks like and what the packaging contains
   3. Marketing authorization holder and manufacturer
   4. Marketing authorization holder
   5. Manufacturer
   6. Date of last update of the leaflet: ----------------------------------------------------------------------------------------------------------------------
   7. Information intended exclusively for medical professionals:
   8. Instructions for reconstitution

Leaflet attached to the packaging: information for the user

Biofuroxym

250 mg, 500 mg, 750 mg

powder for solution or suspension for injection
Cefuroxime

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a 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 the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or nurse. See section 4.

Table of contents of the 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 packaging 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,
• of the urinary tract,
• of the skin and soft tissues,
• of the abdomen.

Biofuroxym is also used:

• to prevent infections during surgery.

2. Important information before using Biofuroxym

When not to use Biofuroxym:

• if the patient is allergic to cephalosporin antibioticsor any of the other ingredients of Biofuroxym (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, blisters, and (or) ulcers of the mouth after treatment with cefuroxime or other cephalosporin antibiotics.

➔
If the patient thinks that any of the above applies to them, they should tell their doctorbefore starting to use Biofuroxym. The patient must not take Biofuroxym.

Warnings and precautions

During treatment with Biofuroxym, attention should be paid to whether symptoms such as allergic reactions and gastrointestinal disorders (e.g. diarrhea) occur. 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 Biofuroxym.
Severe skin reactions, such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with cefuroxime. If any of the symptoms associated with severe skin reactions described in section 4 are noticed, the patient should immediately consult a doctor.

Blood and urine tests

Biofuroxym may affect the results of tests for sugar in urine or blood and a blood test called the Coombs test. If the patient is to have such tests, they should:
➔
tell the person taking the test samplesthat they are taking Biofuroxym.

Biofuroxym 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 affect the action of Biofuroxym or increase the risk of side effects. These include:

• aminoglycoside antibiotics,
• diuretic tablets(e.g. furosemide),
• probenecid,
• oral anticoagulants(anticoagulants). ➔ If this applies to the patient, they should tell their doctor. During treatment with Biofuroxym, it may be necessary to monitor the patient's kidney function.

Pregnancy, breastfeeding, and fertility

The patient should inform their doctor before taking Biofuroxym:

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

The doctor will assess whether the benefits of using Biofuroxym during pregnancy and breastfeeding outweigh the risks to the child.

Driving and using machines

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

Biofuroxym contains sodium

Biofuroxym, 250 mg
The medicine contains 14 mg of sodium (the main 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 (the main 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 (the main 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 the section: "Information intended exclusively for medical professionals" at the end of the leaflet. When calculating the total sodium content in the prepared dilution of the medicine, the sodium from the diluent should be taken into account. To obtain accurate information about the sodium content in the solution used to dilute the medicine, the patient should consult the patient information leaflet for the diluent used.
This should be taken into account in patients controlling their sodium intake.

3. How to use Biofuroxym

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

Usual dose

The doctor will decide on the appropriate dose of Biofuroxym 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 Biofuroxym is administered per day, 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 administered per day, 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 disease

If the patient has kidney disease, the doctor may change the dosage of Biofuroxym.
➔
If this applies to the patient, they should tell their doctor.

4. Possible side effects

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

Symptoms to watch out for

In a small number of people taking Biofuroxym, an allergic reaction or potentially severe skin reaction has been reported. The symptoms may be:

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

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

• Rash on the skin, which may 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).
• Widespread skin changes, with blistering peeling skin. (This may be a sign of Stevens-Johnson syndrome or toxic epidermal necrolysis - 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.

➔

If the patient experiences any of the above symptoms, they should immediately contact their doctor or nurse.

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

• pain at the injection site, 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 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 the patient experiences any of these side effects, they should tell their doctor.

Uncommon side effects that may appear in blood test results:

• 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 (the frequency cannot be determined from the available data):

• fungal infection,
• 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 rings (a dark spot in the center surrounded by a lighter border with a dark ring around the edge).

➔
If the patient experiences any of the above side effects, they should tell their doctor.
Side effects that may appear in blood test results:

• 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 side effects occur, including any side effects not listed in this leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the 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 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, out of the 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 inscription 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. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Biofuroxym contains

• The active substance of the medicine 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 what the packaging contains

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 packed in cardboard boxes.
The packaging contains 1 or 10 vials.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

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

Manufacturer

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

Date of last update of the leaflet: ----------------------------------------------------------------------------------------------------------------------

Information intended exclusively for medical professionals:

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 up to 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)
Multi-component 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 phosphate hydrocortisone salt.
Cefuroxime sodium is also compatible 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, a needle with a diameter of no more than 0.8 mm should be used. The needle should be inserted at a 90° angle, in the centrally marked field, as shown in the following diagram: