BIOFUROKSYM 1.5 g Powder

Contents of the leaflet

1. Leaflet accompanying the packaging: information for the user
2. Biofuroxym
3. 5 g, powder for solution for injection
   1. Please read carefully the contents of the leaflet 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 these symptoms, they should 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 healthcare professionals:
   8. Instructions for reconstitution

Leaflet accompanying the packaging: information for the user

Biofuroxym

1.5 g, powder for solution for injection

Cefuroxime

Please read carefully the contents of the leaflet before using the medicine, as it contains important information for the patient.

• Please keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should 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 their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform 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 peeling of the skin, blisters, and (or) ulcers of the mouth after treatment with cefuroxime or other cephalosporin antibiotics.

➔
If the patient thinks they are affected by the above circumstances, they should tell their doctor
beforestarting 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 observed, 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 the 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(blood thinners). ➔ If this applies to the patient, they should tell their doctor. During treatment with Biofuroxym, it may be necessary to perform additional monitoring of 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 baby.

Driving and using machines

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

Biofuroxym contains sodium

The medicine contains 83 mg of sodium (the main component of common salt) in each vial. This corresponds to 4.15% of the maximum recommended daily intake of sodium in the diet for adults.
Preparation of the medicine for administration - see section: "Information intended exclusively for healthcare 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. For accurate information on the sodium content in the solution used to dilute the medicine, the patient information leaflet of the diluent used should be consulted.
This should be taken into account for 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 injectiongiven directly into a vein or
into a 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, the patient's use of any other antibiotics, 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 given 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 given 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 a potentially severe skin reaction has been reported. Their symptoms may be the following.

• Widespread rash, high fever, and swollen lymph nodes(DRESS or hypersensitivity syndrome).
• Chest painassociated with an allergic reaction, which may be a sign of an allergic myocardial infarction (Kounis syndrome).
• Severe allergic reaction. Symptoms include: raised, itchy rash, swelling, sometimes of the face or lips, 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 changeswith blisters and 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 these symptoms, they should 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 be detected 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(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 be detected 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 (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 and blood vessel inflammation,
• 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 be detected 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 side effects occur, including any side effects not listed in this leaflet, the patient should inform 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.
By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Biofuroxym

Store the medicine out of sight and reach of children.
The medicine should be stored at a temperature below 25°C, without access to 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 1.5 g 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 1.5 g of powder. The vials are closed with a rubber stopper and secured 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

Polpharma S.A.
Pelplińska 19, 83-200 Starogard Gdański
phone: +48 22 364 61 01

Manufacturer

Polpharma S.A.
Pelplińska 19, 83-200 Starogard Gdański
Polpharma S.A.
Duchnice Production Plant
Ożarowska 28/30, 05-850 Ożarów Mazowiecki

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

Information intended exclusively for healthcare 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 reconstituted solution should be added to 50 or 100 ml of a compatible infusion fluid (information on compatibility - see below).
** 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).
In accordance with the principles of proper procedure, the solution should be used immediately after preparation.
The solution of the medicine remains stable for 24 hours at a temperature between 2°C and 8°C.
Deepening of the color intensity of the antibiotic solution during storage does not affect its therapeutic value.
Compatibility
1.5 g of cefuroxime sodium dissolved in 15 ml of water for injections can be added to a solution of metronidazole (500 mg/100 ml) - the action of both components is maintained for 24 hours at a temperature below 25°C.
1.5 g of cefuroxime sodium is compatible with 1 g of azlocillin (in 15 ml of solution) or 5 g of azlocillin (in 50 ml of solution) for 24 hours at 4°C or for 6 hours at a temperature below 25°C.
Cefuroxime sodium (5 mg/ml) in 5% w/v or 10% w/v xylitol solution for injection can be stored for 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 the 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 phosphate hydrocortisone.
Cefuroxime sodium also shows compatibility for 24 hours at room temperature if it is 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 not greater than 0.8 mm should be used. The needle should be inserted into the center of the stopper at an angle of 90°, as shown in the following diagram: