Biofuroxime

Package leaflet: Information for the user

Biofuroksym
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. The medicine may harm another person, even if their symptoms are the same.
• If any adverse reactions occur in the patient, including any adverse reactions not listed in this leaflet, inform the doctor or nurse. See section 4.

Contents of the leaflet

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

1. What Biofuroksym is and what it is used for

Biofuroksym 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.
Biofuroksym is used to treat infections of:

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

Biofuroksym 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 components 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 skin peeling, blisters, and/or oral mucosal 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

During treatment 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 seek immediate medical advice.

Blood and urine tests

Biofuroxym may affect test results for glucose in blood or urine and may give a positive Coombs test. If the patient is due to have such tests, they should:

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

Biofuroxym and other medicines

Inform the doctor about all medicines currently being taken or taken recently, as well as any medicines the patient plans to take, including those available without a prescription.

Some medicines may affect the action of Biofuroxym or 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 necessary during treatment with Biofuroxym.

Pregnancy, breastfeeding, and fertility

Inform the doctor before taking Biofuroxym:

• if the patient is pregnant, suspects she may be pregnant, or is planning to become pregnant,
• if the patient is breastfeeding.

The doctor will assess whether the benefits of using Biofuroxym during pregnancy and breastfeeding outweigh any potential risks to the unborn or breastfed 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 sodium intake 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 sodium intake 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 sodium intake 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 content from the diluent must be taken into account. For accurate information on the sodium content of the solution used to dilute the medicine, refer to the patient leaflet of the diluent used.

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

3. How to use Biofuroksym

Biofuroksym is usually administered by a doctor or nurse. It may be given as an intravenous infusion (IV infusion) or as an injection directly into a vein or into a muscle.
Typical dosage
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 kidney problems
If the patient has impaired kidney function, the doctor may adjust the dosage of the medicine.
➔ If this applies to the patient, they should inform their doctor.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Symptoms to watch for
In a small number of people taking Biofuroxym, 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 hypersensitivity syndrome).
• Chest pain associated with an allergic reaction, which may be a sign of an allergic heart attack (Kounis syndrome).
• 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 blisters and look like small rings (a dark spot in the center surrounded by a lighter ring with a dark edge around the perimeter).
• Widespread skin lesions, with blisters and peeling skin. (This may be a sign of Stevens-Johnson syndrome or toxic epidermal necrolysis - Lyell's disease).
• Fungal infections. Medicines such as Biofuroxym may rarely cause excessive growth of yeast ( Candida ) in the body, which may lead to fungal infection (e.g. candidiasis). The risk of this adverse reaction is higher if Biofuroxym is used for a prolonged period.

➔ If the patient experiences any of the symptoms listed above, 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,
• change 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,
• diarrhoea, 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 levels (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),
• inflammation of the colon (large intestine), causing diarrhoea, usually with blood and mucus, abdominal pain,
• kidney and blood vessel inflammation,
• excessive breakdown of red blood cells (hemolytic anaemia),
• skin rash, which may develop into blisters and look like small rings (a dark spot in the center surrounded by a lighter ring with a dark edge around the perimeter).

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

• decreased number of platelets (blood cells involved in blood clotting - thrombocytopenia),
• increased serum urea nitrogen and creatinine levels.

Reporting of adverse reactions
If any 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 Reactions of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: + 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 the medicine Biofuroxym

Keep the medicine out of the sight and reach of children.
The medicine should be stored at a temperature below 25 °C, protected from light.
After dissolution, 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 marking on the packaging following the abbreviation EXP indicates the expiry date, and following the abbreviation Lot indicates 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 Biofuroksym contains

• The active substance is cefuroxime. Each vial contains 250 mg, 500 mg or 750 mg of cefuroxime (as sodium salt). The medicine contains no excipients.

What Biofuroksym looks like and contents of the pack
Biofuroksym 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 sealed with an aluminium cap or an aluminium cap with a plastic flip-off seal, and packed in cardboard boxes.
Pack sizes contain either 1 or 10 vials.
Not all pack sizes may be marketed.

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 resulting solution concentrations useful when partial doses are required.

** The reconstituted volume of cefuroxime solution in the solvent increases due to the
displacement factor of the active substance, resulting in the concentrations stated below
(mg/ml).
Compatibility
Sodium cefuroxime (5 mg/ml) in 5% w/v or 10% w/v xylitol injection solution may 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 infusion fluids listed below, with stability 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
Ringer's lactate 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 in 5% glucose injection solution is unaffected by the presence of sodium phosphate of 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: