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 you.

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

Contents of the leaflet

1. What Biofuroksym is and what it is used for
2. What you need to know before you use 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. It works by killing the 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 Biofuroksym

When not to use Biofuroksym:

• if the patient is allergic to cephalosporin antibiotics or to any of the other ingredients of Biofuroksym (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, skin peeling, blisters and/or oral mucosal ulcers after treatment with cefuroxime or other antibiotics from the cephalosporin group.

➔ If the patient thinks any of the above apply, they should tell their doctor before
starting treatment with Biofuroksym. The patient must not
take Biofuroksym.
Warnings and precautions
During treatment with Biofuroksym, be alert for symptoms such as allergic reactions and gastrointestinal disturbances (e.g. diarrhoea). This will help reduce the risk of complications (see "Symptoms which require attention" in section 4). If the patient has previously experienced any allergic reactions to other antibiotics such as penicillin, they may also be allergic to Biofuroksym.
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, seek immediate medical advice.
Blood and urine tests
Biofuroksym may affect the results of tests for detecting glucose in blood or urine, as well as a blood test known as the Coombs test. If the patient is to undergo such tests, they should:
➔ inform the person collecting the sample that they are taking Biofuroksym.
Biofuroksym with other medicines
Tell the doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. This includes medicines available without a prescription.
Some medicines may affect the action of Biofuroksym or may increase the risk of adverse effects. These include:

• antibiotics of the group 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 Biofuroksym.

Pregnancy, breastfeeding and fertility
Inform the doctor before taking Biofuroksym:

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

The doctor will assess whether the benefits of using Biofuroksym during pregnancy and breastfeeding outweigh any potential risks to the child.
Driving and operating machinery
The patient should not drive or operate machinery if they do not feel well.
Biofuroksym contains sodium
Biofuroksym, 250 mg
The medicine contains 14 mg of sodium (the main component of table salt) per vial. This corresponds to 0.7% of the maximum recommended daily dietary intake of sodium for adults.
Biofuroksym, 500 mg
The medicine contains 28 mg of sodium (the main component of table salt) per vial. This corresponds to 1.4% of the maximum recommended daily dietary intake of sodium for adults.
Biofuroksym, 750 mg
The medicine contains 42 mg of sodium (the main component of table salt) per vial. This corresponds to 2.1% of the maximum recommended daily dietary intake of sodium for adults.
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 also 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 consideration for 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 (drip) or as an injection directly into a vein or
into a muscle.
Typically used 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 daily dose of 30 to 100 mg of Biofuroksym per kilogram of body weight is given, divided into two or three doses.
Infants (over 3 weeks of age) and children
A daily dose of 30 to 100 mg of Biofuroksym per kilogram of body weight is given, divided into three or four doses.
Adults and adolescents
750 mg to 1.5 g of Biofuroksym two, three, or four times daily. Not 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 their 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 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 appear as small rings (a dark spot in the center surrounded by a lighter ring and a dark 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 excessive growth of yeast (Candida) in the body, leading to fungal infection (e.g. candidiasis). The risk of this adverse reaction is higher if Biofuroksym 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 tests:

• 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 tests:

• 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,
• Inflammation of the kidneys and blood vessels,
• Excessively rapid breakdown of red blood cells (hemolytic anemia),
• Skin rash that may develop into blisters and appear as small rings (a dark spot in the center surrounded by a lighter ring and a dark edge).

➔ If the patient experiences any of the adverse reactions listed above, inform the doctor.

Adverse reactions that may be revealed in blood tests:

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

Reporting of adverse reactions
If any adverse symptoms occur, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at 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 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 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 in use. 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 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, respectively. The vials are closed with a rubber stopper
and sealed with an aluminium cap or an aluminium cap with a flip-off seal, and packed
into 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 medical 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
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 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 infusion solutions listed below, maintaining stability 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 for 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 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 material must 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. The needle should be inserted vertically at a 90° angle into the centrally marked area, as shown in the diagram below: