Biofazolin

Package leaflet: Information for the patient

Biofazolin, 1 g, powder for solution for injection
Cefazolinum
Please read this leaflet carefully before using this medicine, as it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further 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 someone else even if their symptoms are the same as yours.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or nurse. See section 4.

Table of contents

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

1. What Biofazolin is and what it is used for

Biofazolin contains the antibiotic cefazolin, which belongs to the group of first-generation cephalosporins.
After reconstitution and appropriate dilution, the medicine is administered intramuscularly or intravenously (by injection or infusion).
Indications
Biofazolin is used in the treatment of serious infections caused by susceptible bacteria:

• respiratory tract infections*,
• urinary and genital tract infections,
• skin and soft tissue infections,
• biliary tract infections,
• bone and joint infections,
• sepsis,
• endocarditis. *Biofazolin is effective in eliminating streptococcal bacteria from the nose and throat.

Penicillin is the drug of choice for the treatment and prevention of infections caused by streptococci, including the prevention of rheumatic fever.
There are no data confirming the efficacy of Biofazolin in the late prevention of rheumatic fever.
Before starting treatment, your doctor will recommend performing a culture and determining bacterial sensitivity to cefazolin.
Biofazolin is used for prophylaxis of perioperative infections in patients undergoing surgical procedures with an increased risk of infection, e.g. cholecystectomy in high-risk patients (especially over 70 years of age, patients with acute cholecystitis, congestive jaundice, or gallstones), or in gynecological procedures such as adnexectomy or hysterectomy, or in patients in whom infection at the surgical site would be particularly dangerous (e.g. in cardiac surgery, orthopedic surgery, especially prosthetic joint implantation).

2. Information before using Biofazolin

When not to use Biofazolin

• if the patient is allergic to cefazolin or any other cephalosporin antibiotic.

Warnings and precautions
Before starting treatment with Biofazolin, discuss this with your doctor or nurse.
If the patient is allergic, especially to certain antibiotics (penicillins and cephalosporins), this should be
reported to the doctor.
Patients who are allergic to penicillins may also be allergic to cephalosporins (so-called cross-allergy).
A severe allergic reaction may occur after administration of Biofazolin.
Particular caution is required in patients who have experienced allergic reactions after penicillin
administration, especially anaphylactic shock (an immediate severe allergic reaction
characterized by rash, swelling, itching, hives, shortness of breath).
During treatment with cefazolin, symptoms of allergic reactions have been reported, including
difficulty breathing and chest pain. If any of these symptoms occur, cefazolin should be
discontinued immediately and medical advice should be sought immediately from a doctor or
emergency department.
If the patient experiences concerning allergic symptoms, inform the doctor.
It may be necessary to discontinue treatment with Biofazolin and initiate appropriate therapy.
In case of a severe allergic reaction, adrenaline and other anti-shock medications may be required
(circulatory support drugs, corticosteroids, and antihistamines).
If the patient develops diarrhoea, inform the doctor.
Very rarely, during or after completion of treatment, pseudomembranous colitis may occur,
characterized by diarrhoea, which may appear even some time after discontinuation of the
antibiotic.
In mild cases of diarrhoea, the doctor may recommend only discontinuing the drug; in more severe
cases, rehydration and electrolyte replacement will be required. The doctor may prescribe oral
metronidazole or vancomycin. Medications that inhibit peristalsis or have constipating effects should
not be administered.
Use of Biofazolin, like other antibiotics, may lead to fungal infections (candidiasis) of the oral cavity
and genital organs, or overgrowth of resistant bacteria. The doctor will then recommend appropriate
treatment.
Use of Biofazolin in patients with impaired kidney function
If the patient has kidney disease, this should be reported to the doctor before administering
Biofazolin, as dose adjustment may be necessary. The doctor will determine the dosing regimen
according to kidney function; see: Dosage in patients with renal impairment.
Biofazolin and other medicines
Inform the doctor about all medicines currently used or recently taken, as well as any medicines the
patient plans to use.
Concomitant use of potent diuretics, such as furosemide, with cefazolin may have adverse effects
on the kidneys.
Concomitant use of cefazolin with anticoagulant drugs may prolong blood clotting time and increase
the risk of bleeding.
Probenecid delays renal excretion of cefazolin.
Effect on laboratory test results
Use of cefazolin may cause:

• false-positive results in urine glucose tests performed by the reduction method,
• false-positive results in antiglobulin tests (Coombs test).

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become
pregnant, she should consult a doctor before using this medicine.
If the patient is pregnant or suspects she may be pregnant, this medicine should be used only if the
doctor considers it absolutely necessary.
Caution should be exercised during breastfeeding, as cefazolin passes into human milk in very small
amounts and may cause diarrhoea, fungal infection (candidiasis), or allergy in the breastfed infant.
Driving and operating machinery
Biofazolin does not affect the ability to drive or operate machinery.
Biofazolin contains sodium
The medicine contains 52.8 mg of sodium (the main component of table salt) per vial (per 1 g of product).
This corresponds to 2.64% of the maximum recommended daily dietary sodium intake for adults.
The sodium content from the diluent should be taken into account when calculating the total sodium
content in the prepared diluted solution [see below: information intended exclusively for healthcare professionals (information on solution preparation)]. For accurate information on the sodium content in the solution used to dilute the medicine, refer to the package leaflet of the diluent used.

3. How to use the medicine Biofazolin

This medicine should always be used as directed by your doctor. If in doubt, consult your doctor or nurse.
Biofazolin is administered intravenously as an injection lasting 3 to 5 minutes or as an infusion lasting 20 to 30 minutes, or intramuscularly.
Adults
Cefazolin is usually given in doses ranging from 500 mg to 1.5 g, administered every 6, 8, or 12 hours, depending on the severity of the infection.

* In very severe and life-threatening infections, the dose may be increased up to 12 g per day.
Children
25 to 50 mg/kg body weight per day in divided doses every 6 or 8 hours.
In severe infections, the dose may be increased to 100 mg/kg b.w. per day in divided doses.
Cefazolin is not recommended for use in premature infants and newborns during the first month of life, as there are no data confirming the safety of the antibiotic in this patient group.
Dosing for surgical prophylaxis
Usually, 1 g of cefazolin is administered 30 to 60 minutes before surgery,
and an additional 500 mg or 1 g during surgical procedures lasting longer than 2 hours.
For procedures with a high risk of infection, 500 mg or 1 g is given every 6 or 8 hours
for 24 hours after surgery.
In special cases (e.g., after joint prosthesis implantation, cardiac surgery), the antibiotic is administered for 3 to 5 days.
Dosing in patients with renal impairment
After the initial dose, appropriate for the type and severity of infection, subsequent dosing should be adjusted according to the degree of renal impairment.
Adults

Children

Overdose of Biofazolin
Patients with renal insufficiency are particularly susceptible to overdose; in these patients, the drug may easily accumulate in the body due to poor excretion. After an overdose, headache, dizziness, drowsiness, sensory disturbances may occur, and in the most severe cases, seizures.
Excessive accumulation of the drug in the body may lead to increased levels of creatinine, blood urea nitrogen, liver enzymes, and bilirubin, as well as cause changes in blood composition (thrombocytosis, eosinophilia, leukopenia), reduced blood coagulation (prolonged prothrombin time), and a false-positive Coombs test result.
If an overdose is suspected, inform your doctor immediately; the doctor will initiate appropriate symptomatic treatment.
In the event of seizures, discontinuation of the drug is recommended, along with administration of anticonvulsant medications and ensuring adequate respiratory ventilation. Circulatory parameters, blood gas analysis, and electrolyte levels should be monitored.
Hemodialysis and hemoperfusion remove the drug from the body.

Missed dose of Biofazolin
The drug should be administered according to the physician's instructions.
If an intravenous injection or infusion was not given at the scheduled time, the missed dose should be administered as soon as possible. However, if the time for the next dose is approaching, the missed dose should not be given. Continue treatment at the previously established times.
Do not administer a double dose to make up for a missed dose.
If you have any further doubts regarding the use of this medicinal product, consult your doctor or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Based on available data, the frequency of occurrence of adverse reactions cannot be determined.
You should contact your doctor or nurse immediately if any of the following occur:

• anaphylaxis (immediate severe allergic reaction characterized by rash, swelling, itching, hives, shortness of breath);
• chest pain, which may indicate a potentially severe allergic reaction known as Kounis syndrome;
• Stevens-Johnson syndrome (severe skin reaction characterized by blisters on mucous membranes of the mouth and genital organs, fever, and joint pain);
• pseudomembranous colitis (inflammation of the colon which may cause watery diarrhoea, possibly containing blood), during or after treatment with cefazolin;
• hepatitis, cholestatic jaundice.

Other adverse reactions:

• oral candidiasis;
• drug fever;
• loss of appetite, diarrhoea, nausea and vomiting;
• rash;
• increased blood urea concentration without clinical signs of renal failure; isolated cases of interstitial nephritis and other renal function disorders have been reported in seriously ill patients receiving multiple medications;
• genital and anal itching, vaginal inflammation, fungal genital infections;
• pain and induration at the intramuscular injection site, phlebitis following intravenous administration.

Adverse reactions that may be revealed by laboratory tests:

• eosinophilia (increased number of white blood cells in blood smear), neutropenia (reduced number of granulocytes), leukopenia (reduced number of white blood cells), thrombocytopenia (reduced number of platelets);
• increased liver enzyme activity (AspAT, AlAT, alkaline phosphatase), increased blood urea concentration without clinical signs of renal failure.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or nurse. 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 4921 301
Fax: +48 22 4921 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 Biofazolin

Store below 30°C. Protect from light.
The prepared solution can be stored for 24 hours in the refrigerator, i.e. at a temperature from 2°C to 8°C.
Keep this medicine out of the sight and reach of children.
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 "EXP" indicates the expiry date, and following "Lot" indicates the batch number.

6. Contents of the pack and other information

What Biofazolin contains

• The active substance is cefazolin. Each vial contains 1 g of cefazolin (as the sodium salt). Biofazolin contains sodium – see section 2, "Biofazolin contains sodium". The medicine does not contain excipients.

What Biofazolin looks like and contents of the pack
Biofazolin is available as a powder for solution for injection in a glass vial. The powder is white or almost white.
The glass vial is closed with a rubber stopper and sealed with an aluminium cap or an aluminium cap with a flip-off seal, and packed in a cardboard box.
Biofazolin is available in vials containing 1 g.
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:

Biofazolin, 1 g, powder for solution for injection
Cefazolinum
Preparation of injection and infusion solutions
Biofazolin is administered intravenously by injection over 3 to 5 minutes or by intravenous infusion lasting 20 to 30 minutes, or intramuscularly.
Preparation of injection solution
Puncture the stopper with a needle and inject the recommended volume of solvent into the vial. To puncture the stopper, use a needle with a diameter no greater than 0.8 mm (21 G in Gauge [G] scale). The needle should be inserted vertically at a 90° angle into the centrally marked area, as shown in the diagram below:

Before administration, check that the solution is clear and free from insoluble particles.
Intravenous injection (over 3 to 5 minutes)
Dissolve the contents of the vial in at least 10 mL of water for injections.
The medication must be injected very slowly, over no less than 3 minutes.
Intravenous infusion (over 20 to 30 minutes)
After initial reconstitution, cefazolin should be further diluted with 50 mL or 100 mL of one of the following solutions:
0.9% sodium chloride solution,
5% glucose solution,
10% glucose solution,
5% glucose solution with 0.9% sodium chloride solution,
5% glucose solution with 0.45% sodium chloride solution,
5% glucose solution with 0.2% sodium chloride solution,
Ringer's solution,
Ringer's solution with sodium lactate,
5% glucose solution with Ringer's solution with sodium lactate.
Intramuscular injection
The drug should be administered deeply into a large muscle mass. Intramuscular administration of cefazolin rarely causes pain.
Add the appropriate amount of solvent to the vial and shake until the contents are completely dissolved. The solution may have a pale yellow color.

Pharmaceutical incompatibilities
Cefazolin solutions should not be mixed with aminoglycoside antibiotics or with other drugs in the same syringe or infusion set.