Tarfazolin

LEAFLET INCLUDED IN THE PACKAGE: INFORMATION FOR THE PATIENT

TARFAZOLIN, 1 g, powder for solution for injection and infusion

Cefazolin

You should read the leaflet carefully before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• You should consult a doctor or pharmacist if you have any doubts.
• 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 as yours.
• If any of the side effects get worse or if you notice any not listed in the leaflet, you should tell your doctor.

Table of contents of the leaflet

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

1. WHAT IS TARFAZOLIN AND WHAT IS IT USED FOR

Tarfazolin contains the active substance cefazolin. Cefazolin is an antibiotic from the group of so-called cefalosporins - antibiotics similar to penicillin.

Indications for use

Tarfazolin is indicated for the treatment of the following infections caused by microorganisms sensitive to cefazolin.

• Respiratory tract infections
• Urinary tract infections
• Skin and soft tissue infections
• Bone and joint infections
• Biliary tract infections
• Septicaemia
• Endocarditis
• In the prevention of postoperative infections in patients at increased risk of infection, e.g. cholecystectomy in high-risk patients (especially after 70 years of age, patients with acute cholecystitis, with obstructive jaundice, with stones) or after appendectomy, hysterectomy or caesarean section, or in patients where infection at the surgical site would be particularly dangerous (e.g. in cardiac surgery, orthopaedic surgery, especially endoprosthesis implantation).

2. IMPORTANT INFORMATION BEFORE USING THE MEDICINE TARFAZOLIN

When not to use the medicine Tarfazolin

If the patient is allergic (hypersensitive) to cefazolin or other cefalosporin antibiotics.

Warnings and precautions

• Patients allergic to penicillins may also be allergic to cefalosporins.
• If the patient has had an allergic reaction to penicillins or other beta-lactam antibiotics in the past, they should inform their doctor before starting the medicine. Particular caution will be required.
• If the patient experiences an allergic reaction, characterized by sudden onset of wheezing, difficulty breathing, swelling of the eyelids, face or lips, rash or itching, they should stop taking the medicine and contact their doctor immediately.

The patient should also inform their doctor if:

• a rash occurs in the patient while taking the medicine - the doctor may decide to change the medicine;
• the patient has factors that may cause a deficiency of vitamin K or bleeding disorders for other reasons (such as parenteral nutrition, liver and kidney dysfunction, haemophilia, thrombocytopenia);
• the patient has impaired kidney function - the doctor will adjust the dosage of the medicine according to the degree of kidney failure;
• the patient experiences severe and persistent diarrhoea while taking or after completing the course of Tarfazolin. The patient should not take anti-diarrheal medications that slow down intestinal peristalsis;
• a new infection (e.g. thrush) occurs in the patient while taking Tarfazolin; the doctor may then decide to discontinue the medicine.

Other medicines and Tarfazolin

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.
In particular, the patient should inform their doctor if they are taking:

• probenecid (a medicine used for gout and other conditions);
• aminoglycoside antibiotics (e.g. streptomycin, tobramycin, gentamicin).

Effect on laboratory test results
Tarfazolin may affect some tests, such as tests that measure the amount of glucose (sugar) in the urine and tests that measure certain substances in the blood (Coombs test).

Pregnancy and breastfeeding

In pregnancy and during breastfeeding, or if the patient thinks they may be pregnant, or if they plan to become pregnant, they should consult their doctor or pharmacist before using this medicine.
The patient should avoid using Tarfazolin during pregnancy, unless the doctor considers it necessary.
The medicine is excreted in small amounts in breast milk, and therefore it should be used with caution in breastfeeding women.

Driving and using machines

There is no data on the effect of the medicine on the ability to drive and use machines.

3. HOW TO USE TARFAZOLIN

The patient does not use this medicine on their own.
The medicine will be administered to the patient by a qualified person, i.e. a doctor or nurse.
Tarfazolin can be administered by intramuscular or intravenous injection or by intravenous infusion.

Adults

Tarfazolin is usually administered in doses of 500 mg to 1500 mg every 6, 8 or 12 hours, depending on the severity of the infection.
The maximum daily dose of cefazolin is 12 g.

Children

Usually, 25 mg to 50 mg/kg body weight per day is administered in divided doses every 6 or 8 hours. In severe infections, the dose can be increased to 100 mg/kg body weight per day.
If the patient feels that the effect of the medicine is too strong or too weak
they should consult their doctor.

Duration of treatment

The duration of treatment will be determined by the doctor, depending on the severity and type of infection. The patient should follow the doctor's instructions.

Method of administration and preparation of solutions

Detailed information is provided at the end of the leaflet in the section intended for healthcare professionals - "Information intended exclusively for healthcare professionals".

Using a higher dose of Tarfazolin than recommended

It is unlikely that the patient will be given a dose higher than recommended. The patient should contact their doctor, pharmacist or nurse as soon as possible if they think they have been given a higher dose than recommended. Overdose of the medicine may lead to increased side effects, including irritation of the central nervous system and seizures.
If the patient is in doubt about the method of administration of the medicine, they should consult their doctor, pharmacist or nurse.

Missing a dose of Tarfazolin

If a dose of the medicine is missed at a fixed, specified time, the medicine should be administered as soon as possible, if the time to administer the next dose is long enough, or the regular administration of the medicine should be continued.
A double dose should not be used to make up for a missed dose.

Stopping the use of Tarfazolin

It is important to use the medicine according to the recommended treatment cycle. The patient should not stop the treatment because they feel better. If the treatment cycle is stopped too early, the infection may return.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Tarfazolin can cause the following side effects, although not everybody gets them.

Severe side effects

• Sudden wheezing, swelling of the lips, face or body, rash, fainting or difficulty swallowing (severe allergic reaction)

A widespread rash on the skin, which may include blisters and peeling of the skin, especially around the mouth, nose, eyes and genitals

• Severe diarrhoea, lasting for a long time or containing blood, accompanied by abdominal pain and fever. This may be a sign of severe colitis (pseudomembranous colitis), which can occur after using antibiotics.
• If any of these symptoms occur, the patient should contact their doctor immediately.

The patient should stop using Tarfazolin.

Other side effects that the patient should inform their doctor about if they occur
Uncommon (in 1 to 10 in 100 patients)
redness, pain at the injection site.
Rare (in 1 to 10 in 1,000 patients)
oral thrush
diarrhoea, nausea, vomiting, loss of appetite, abdominal pain
thrombophlebitis after intravenous administration
Very rare (less than 1 in 10,000 patients)
jaundice, dark urine and fatigue - may be a sign of liver problems
Frequency not known(cannot be estimated from available data)
genital thrush
increased or decreased number of certain blood cells
rash
transient increase in activity of certain liver enzymes
If the patient experiences any side effects, including those not listed in the leaflet, they should consult their doctor, nurse or pharmacist.

5. HOW TO STORE TARFAZOLIN

The medicine should be stored out of sight and reach of children.
Store in a temperature below 25

• C. Store in the original package to protect from light.

Do not use this medicine after the expiry date (EXP) stated on the package. The expiry date refers to the last day of the month.
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 PACKAGE AND OTHER INFORMATION

What Tarfazolin contains

The active substance of the medicine is cefazolin (in the form of cefazolin sodium).
Each vial contains 1 g of cefazolin.
The medicine does not contain any other ingredients.

What Tarfazolin looks like and what the package contains

Crystalline, white or almost white powder.
Package:One vial in a cardboard box.

Responsible entity and manufacturer

Tarchomińskie Zakłady Farmaceutyczne "Polfa" Spółka Akcyjna
ul. A. Fleminga 2
03-176 Warszawa
Phone number: 22 811-18-14
To obtain more detailed information, the patient should contact the representative of the responsible entity.

Date of last update of the leaflet:

The following information is intended exclusively for healthcare professionals or healthcare workers

To obtain additional information, see the Summary of Product Characteristics.

Instructions for preparing the medicine for use and method of administration

Any unused product or waste should be disposed of in accordance with local regulations.

Preparation of solutions Intramuscular injections

The contents of the 1 g vial should be dissolved in approximately 3 ml of water for injections. Shake gently before use.
Inject deeply into large muscle areas.

Solutions prepared for intramuscular injections should be used immediately after preparation. Intravenous injections

The contents of the 1 g vial should be dissolved in at least 10 ml of water for injections. Shake gently before use.
Inject slowly over 3 to 5 minutes.
Intravenous infusions
The solution prepared as for intravenous injections should be diluted in 50 to 100 ml of 5% or 10% glucose solution, Ringer's solution or 0.9% sodium chloride solution and infused into large veins.

Solutions prepared for injections and infusions remain stable for 24 hours at a temperature of 2

C (refrigerator).

A change in the colour of the solution to yellow (straw-like) does not affect the activity or properties of the preparation.
Cefazolin should not be mixed in the same syringe with other medicines.

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