Biofuroxime

Package leaflet: Information for the user

Biofuroxime
250 mg, 500 mg, 750 mg
powder for solution or suspension for injection
Cefuroximum
Please read all of this leaflet carefully before using this medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult 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 the patient experiences any adverse reactions, including any not listed in this leaflet, inform the doctor or nurse immediately. See section 4.

Table of contents of the leaflet

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

1. What Biofuroxime is and what it is used for

Biofuroxime 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.
Biofuroxime is used to treat infections:

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

Biofuroxime 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 antibiotics or to any of the other ingredients of Biofuroxym (listed in section 6);
• if the patient has ever experienced a severe allergic reaction (hypersensitivity) to any other type of beta-lactam antibiotics (penicillins, monobactams or carbapenems);
• if the patient has ever developed severe skin rash or peeling of the skin, blisters and (or) mouth ulcers after treatment with cefuroxime or other antibiotics from the cephalosporin group.

➔ If the patient believes any of the above apply, they should inform their doctor before starting treatment with Biofuroxym. The patient must not take Biofuroxym.

Warnings and precautions

While being treated with Biofuroxym, be alert for symptoms such as allergic reactions and gastrointestinal disturbances (e.g. diarrhoea). This will help reduce the risk of complications (see "Symptoms to be aware of" in section 4). If the patient has previously experienced any allergic reactions to other antibiotics such as penicillin, they may also be allergic to Biofuroxym.

Severe skin reactions have occurred during treatment with cefuroxime, including: Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS). 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 blood or urine tests for glucose and the blood test known as the Coombs test. If the patient is due to have such tests, they should:

➔ inform the person taking the sample that they are taking Biofuroxym.

Biofuroxym with 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 available without a prescription.

Some medicines may affect the action of Biofuroxym or may increase the risk of adverse effects. These include:

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

➔ If this applies to the patient, they should inform their doctor. Additional monitoring of kidney function may be required during treatment with Biofuroxym.

Pregnancy, breastfeeding and fertility

The patient should inform their doctor before taking Biofuroxym:

• if they are pregnant, suspect 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 operating machinery

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

Biofuroxym contains sodium

Biofuroxym 250 mg
This medicine contains 14 mg of sodium (the main component of table salt) per vial. This corresponds to 0.7% of the maximum recommended daily intake of sodium in the adult diet.

Biofuroxym 500 mg
This medicine contains 28 mg of sodium (the main component of table salt) per vial. This corresponds to 1.4% of the maximum recommended daily intake of sodium in the adult diet.

Biofuroxym 750 mg
This medicine contains 42 mg of sodium (the main component of table salt) per vial. This corresponds to 2.1% of the maximum recommended daily intake of sodium in the adult diet.

Preparation of the medicine for administration – see section: "Information intended exclusively for healthcare professionals" at the end of this leaflet. When calculating the total sodium content in the prepared diluted solution, the sodium originating from the diluent must be taken into account. For accurate information on the sodium content in the solution used to dilute the medicine, refer to the patient leaflet of the diluent used.

This should be taken into account in patients who are monitoring their sodium intake.

3. How to use Biofuroksym

Biofuroksym is usually administered by a doctor or nurse. It may be given as an infusion (intravenous infusion) or as an injection directly into a vein or intramuscularly.
Usual dose
The doctor will decide the appropriate dose of Biofuroksym 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 dose of 30 to 100 mg of Biofuroksym per kilogram of body weight is given daily, divided into two or three doses.
Infants (over 3 weeks of age) and children
A dose of 30 to 100 mg of Biofuroksym per kilogram of body weight is given daily, divided into three or four doses.
Adults and adolescents
750 mg to 1.5 g of Biofuroksym two, three or four times daily. No more than 6 g per day.
Patients with impaired kidney function
If the patient has kidney problems, the doctor may adjust the dosage of the medicine.
➔ If this applies to the patient, they should inform the doctor.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Symptoms to be aware of
In a small number of people taking Biofuroksym, an allergic reaction or potentially severe skin reaction has been reported. Symptoms may include the following:

• Widespread rash, high body temperature and swollen lymph nodes (DRESS syndrome or drug-induced hypersensitivity syndrome).
• Chest pain associated with an allergic reaction, which may be a symptom of an allergy-induced heart attack (Kounis syndrome).
• Severe allergic reaction. Symptoms include: raised, itchy rash, swelling, sometimes of the face or lips, which may make breathing difficult.
• Skin rash that may develop into blisters and look like small rings (a dark spot in the center surrounded by a lighter ring and a dark ring at the edge).
• Widespread skin lesions, with blisters and peeling of the outer layer of skin. (This may be a sign of Stevens-Johnson syndrome or toxic epidermal necrolysis – Lyell's disease).
• Fungal infections. Medicines such as Biofuroksym may rarely cause an overgrowth of yeast (Candida) in the body, which may lead to fungal infection (e.g. candidiasis). The risk of this adverse reaction is higher if Biofuroksym is used for a prolonged period.

➔ If any of the symptoms listed above occur in the patient, contact a doctor or nurse immediately.
Common adverse reactions (occur 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 adverse reactions, inform the doctor.

Common adverse reactions that may be revealed in blood test results:

• Increased activity of substances (enzymes) produced in the liver,
• Changes in white blood cell count (neutropenia or eosinophilia),
• Decreased number of red blood cells (anemia).

Uncommon adverse reactions (occur in less than 1 in 100 patients):

• Skin rash, urticaria,
• Diarrhea, nausea, abdominal pain.
  ➔ If the patient experiences any of these adverse reactions, inform the doctor.

Uncommon adverse reactions that may be revealed in blood test results:

• Decreased number of white blood cells (leukopenia),
• Increased bilirubin concentration (a substance produced by the liver),
• Positive Coombs test result.

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 infection,
• High temperature (fever),
• Allergic reactions (hypersensitivity),
• Colitis (inflammation of the large intestine), causing diarrhea, usually with blood and mucus, and abdominal pain,
• Kidney inflammation and inflammation of blood vessels,
• Excessive breakdown of red blood cells (hemolytic anemia),
• Skin rash that may develop into blisters and look like small rings (a dark spot in the center surrounded by a lighter ring and a dark ring at the edge).

➔ If any of the adverse reactions listed above occur in the patient, inform the doctor.
Adverse reactions that may be revealed in blood test results:

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

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

5. How to store Biofuroksym

Keep this medicine out of sight and reach of children.
Store the medicine below 25 °C, protected 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 stated month.
The label on the packaging shows the expiry date after the abbreviation EXP, and the batch number after the abbreviation Lot.
Medicines must 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 Biofuroksym contains

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

What Biofuroksym 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, respectively. The vials are closed with a rubber stopper
and sealed with an aluminium cap or an aluminium cap with a plastic flip-off seal, and are packed
in cardboard boxes.
The pack contains 1 or 10 vials.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19
83-200 Starogard Gdański
tel. + 48 22 364 61 01

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

Information intended exclusively for healthcare professionals:

Reconstitution instructions
Table 1. Volumes of water to be added and solution concentrations useful when fractional doses are required.

** The reconstituted volume of cefuroxime solution in the solvent increases due to the
phase displacement factor of the active substance, resulting in the stated concentrations
(mg/ml).

Compatibility
Sodium cefuroxime (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.

Sodium cefuroxime is compatible with aqueous solutions containing no more than 1% lidocaine hydrochloride.

Sodium cefuroxime is compatible with the following infusion fluids, with activity maintained for up to 24 hours at room temperature:

• 0.9% w/v sodium chloride solution
• 5% glucose injection solution
• 0.18% w/v sodium chloride with 4% glucose injection solution
• 5% glucose and 0.9% sodium chloride injection solution
• 5% glucose and 0.45% sodium chloride injection solution
• 5% glucose and 0.225% sodium chloride injection solution
• 10% glucose injection solution
• 10% invert sugar solution in water for injection
• Ringer's injection solution
• Sodium lactate Ringer's injection solution
• Sodium lactate injection (M/6)
• Multi-electrolyte sodium lactate injection solution (Hartmann's solution)

The stability of sodium cefuroxime in 0.9% sodium chloride injection solution and 5% glucose injection solution is unaffected by the presence of sodium phosphate hydrocortisone.

Sodium cefuroxime also remains compatible for 24 hours at room temperature when added to intravenous infusion solutions containing:

• Heparin (10 or 50 units/ml) in 0.9% sodium chloride injection solution;
• Potassium chloride (10 or 40 mEq/l) in 0.9% sodium chloride injection solution.

Any unused portions of the medicinal product or waste materials should be disposed of in accordance with local regulations.

Preparation of solution for rapid injection
Pierce the stopper with a needle and inject the recommended volume of solvent into the vial. To pierce the stopper, use a needle with a diameter no greater than 0.8 mm. Insert the needle vertically at a 90° angle into the centrally marked area, as shown in the diagram below: