Cefuroxime Tzf

Leaflet attached to the packaging: patient information

Cefuroxime TZF, 750 mg, powder for solution for injection / infusion

Cefuroxime TZF, 1500 mg, powder for solution for injection / infusion

Cefuroxime

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult a doctor or pharmacist.
• 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.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Cefuroxime TZF and what is it used for

Cefuroxime TZF is an antibiotic used in adults and children. The medicine works by killing bacteria sensitive to cefuroxime that cause infections. It belongs to a group of medicines called cephalosporins.

Cefuroxime TZF is used to treat infections of:

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

Cefuroxime TZF is also used:

• to prevent infections during surgery.

The doctor may check what type of bacteria caused the patient's infection and check during treatment whether the bacteria are sensitive to Cefuroxime TZF.

2. Important information before using Cefuroxime TZF

When not to use Cefuroxime TZF:

• if the patient has been found to be allergic to cephalosporin antibioticsor any of the other ingredients of Cefuroxime TZF (listed in section 6);
• if the patient has ever had a severe allergic reaction (hypersensitivity) to any other type of beta-lactam antibiotic (penicillins, monobactams, or carbapenems);
• if the patient has ever had a severe skin rash or skin peeling, blisters, and (or) ulcers of the mouth after treatment with cefuroxime or other cephalosporin antibiotics.

If the patient thinks any of the above applies to them, they should tell their doctor beforestarting to use Cefuroxime TZF. The patient must not take Cefuroxime TZF.

Warnings and precautions

Before starting to use Cefuroxime TZF, the patient should discuss it with their doctor, pharmacist, or nurse.
During treatment with Cefuroxime TZF, the patient should be aware of symptoms such as allergic reactions, skin rashes, stomach and intestine problems (e.g., diarrhea), or fungal infections.
This will reduce the risk of complications (see "Symptoms to watch out for"in section 4).
If the patient has had any allergic reactions to other antibiotics, such as penicillin, they may also be allergic to Cefuroxime TZF.
Severe skin reactions, such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with cefuroxime treatment. If the patient notices any symptoms of severe skin reactions described in section 4, they should contact their doctor immediately.

Blood and urine tests

Cefuroxime TZF may affect the results of tests for sugar in the urine or blood and a blood test called the Coombs test. If the patient is to have these tests, they should:
tell the person taking the test samplesthat they are taking Cefuroxime TZF.

Cefuroxime TZF and other medicines

The patient should tell their doctor about all medicines they are taking now or have recently taken, as well as any medicines they plan to take. This includes medicines that are available without a prescription.
Some medicines may affect the action of Cefuroxime TZF or increase the risk of side effects. These include:

• aminoglycoside antibiotics
• diuretic tablets(e.g., furosemide)
• probenecid
• oral anticoagulants(blood thinners). If this applies to the patient, they should tell their doctor. During treatment with Cefuroxime TZF, the patient may need to have additional kidney function tests.

Oral contraceptives

Cefuroxime TZF may reduce the effectiveness of oral contraceptives. If the patient is taking oral contraceptives while using Cefuroxime TZF, they should also use mechanical methods of contraception(e.g., condoms). The patient should consult their doctor for advice.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before using this medicine.
The doctor will assess whether the benefits to the patient of using Cefuroxime TZF during pregnancy and breastfeeding outweigh the risks to the baby.

Driving and using machines

The patient should not drive or use machines if they do not feel well.

Cefuroxime TZF contains sodium

Cefuroxime TZF, 750 mg, powder for solution for injection / infusion
The medicine contains 40.65 mg of sodium (the main ingredient of common salt) per vial.
This is equivalent to 2.03% of the maximum recommended daily intake of sodium in the diet for adults.
This should be taken into account for patients on a controlled sodium diet.
Considering the dosing schedule presented in section 3, the maximum amount of sodium that can be administered to the patient in the maximum daily dose is 325.2 mg, which is equivalent to 16.26% of the WHO-recommended maximum 2 g daily intake of sodium for adults.
Cefuroxime TZF, 1500 mg, powder for solution for injection / infusion
The medicine contains 81.3 mg of sodium (the main ingredient of common salt) per vial.
This is equivalent to 4.06% of the maximum recommended daily intake of sodium in the diet for adults.
This should be taken into account for patients on a controlled sodium diet.
Considering the dosing schedule presented in section 3, the maximum amount of sodium that can be administered to the patient in the maximum daily dose is 325.2 mg, which is equivalent to 16.26% of the WHO-recommended maximum 2 g daily intake of sodium for adults.

3. How to use Cefuroxime TZF

This medicine should always be used exactly as prescribed by the doctor. If the patient is unsure, they should consult their doctor.
Cefuroxime TZF is usually given by a doctor or nurse.It can be given as an intravenous infusionor as an injectiondirectly into a vein or into a muscle.

Usual dose

The doctor will decide on the suitable dose of Cefuroxime TZF for the patient, taking into account the severity and type of infection, any other antibiotics the patient is taking, their body weight, age, and kidney function.

Newborns and infants (0-3 weeks old)

For every kilogram of the infant's body weight, a dose of 30 to 100 mg of Cefuroxime TZF is given over 24 hours, divided into two or three doses.

Infants (over 3 weeks old) and children

For every kilogram of the infant's or child's body weight, a dose of 30 to 100 mg of Cefuroxime TZF is given over 24 hours, divided into three or four doses.

Adults and adolescents

750 mg to 1.5 g of Cefuroxime TZF, two, three, or four times a day.
No more than 6 g per day.

Patients with kidney problems

If the patient has kidney problems, the doctor may change the dose of Cefuroxime TZF.

• If this applies to the patient, they should tell their doctor.

4. Possible side effects

Like all medicines, Cefuroxime TZF can cause side effects, although not everybody gets them.

Symptoms to watch out for

• A small number of people taking Cefuroxime TZF have reported a severe allergic reaction or potentially severe skin reaction. The symptoms may be:
• Severe allergic reaction. Symptoms include: raised, itchy rash, swelling, sometimes of the face or lips, which can make breathing difficult.
• Skin rash, which can develop into blistersand look like small targets(a dark spot in the center surrounded by a lighter border with a dark ring around the edge).
• Widespread skin changes, with blisters and peeling skin. (This may be a sign of Stevens-Johnson syndrome or toxic epidermal necrolysis, also known as Lyell's disease).
• Widespread rash, high fever, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
• Chest pain associated with an allergic reaction, which can be a sign of a heart attack caused by an allergy (Kounis syndrome).

Other problems to watch out for while taking Cefuroxime TZF

• Fungal infections. Medicines like Cefuroxime TZF can rarely cause an overgrowth of yeast (Candida) in the body, leading to a fungal infection (e.g., thrush). The risk of this side effect is higher if Cefuroxime TZF is used for a long time.
• Severe diarrhea (pseudomembranous colitis). Medicines like Cefuroxime TZF can cause inflammation of the colon (large intestine), leading to severe diarrhea, usually with blood and mucus, abdominal pain, and fever.

If the patient experiences any of these symptoms, they should contact their doctor or nurse immediately. Common side effects (may affect up to 1 in 10 people):

• pain, swelling, and redness at the injection site. If the patient experiences any of these side effects, they should tell their doctor.

Common side effects that may show up in blood tests:

• increased activity of substances (enzymes) produced in the liver
• change in the number of white blood cells (neutropenia or eosinophilia)
• decrease in the number of red blood cells (anemia)

Uncommon side effects(may affect up to 1 in 100 people):

• skin rash, hives, itching
• diarrhea, nausea, abdominal pain

If the patient experiences any of these side effects, they should tell their doctor.

Uncommon side effects(may affect up to 1 in 100 people) that may show up in blood tests:

• decrease in the number of white blood cells (leukopenia)
• increase in bilirubin levels (a substance produced by the liver)
• positive Coombs test result

Other side effects

Other side effects occur in a very small number of patients, but the exact frequency is unknown:

• fungal infection
• high fever
• allergic reactions (hypersensitivity)
• inflammation of the colon (large intestine), leading to diarrhea, usually with blood and mucus, abdominal pain
• inflammation of the kidneys and blood vessels
• rapid breakdown of red blood cells (hemolytic anemia)
• skin rash, which can develop into blisters and look like small targets (a dark spot in the center surrounded by a lighter border with a dark ring around the edge). If the patient experiences any of these side effects, they should tell their doctor.

Side effects that may show up in blood tests:

• decrease in the number of platelets (cells involved in blood clotting - thrombocytopenia)
• increase in urea and creatinine levels in the blood.

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to 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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Cefuroxime TZF

The medicine should be stored out of sight and reach of children.
Store in a temperature below 25°C. Store the vial in the outer packaging to protect it from light.
Do not use this medicine after the expiry date (EXP) stated on the label and packaging.
The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the packaging and other information

What Cefuroxime TZF contains

The active substance of the medicine is cefuroxime (as cefuroxime sodium).
1 vial contains 750 mg or 1500 mg of cefuroxime.
Cefuroxime TZF contains sodium (see section 2).
The medicine does not contain any other ingredients.

What Cefuroxime TZF looks like and contents of the pack

White to cream-colored powder.
After adding the appropriate amount of water for injection, a clear solution or suspension with a light yellow to amber color is formed.
Packaging: one vial in a cardboard box.

Marketing authorization holder and importer

Tarchomińskie Zakłady Farmaceutyczne "Polfa" Spółka Akcyjna
ul. A. Fleminga 2
03-176 Warsaw
Phone number: 22 811-18-14
In order to obtain more detailed information on this medicine, the patient should contact the marketing authorization holder.

Date of last revision of the leaflet:

Information intended for healthcare professionals only

Please refer to the Summary of Product Characteristics

Cefuroxime TZF, 750 mg, powder for solution for injection / infusion
Cefuroxime TZF, 1500 mg, powder for solution for injection / infusion
Before administration, the appearance of the solution and suspension should be checked. After adding the appropriate amount of water for injection, a clear solution or suspension with a light yellow to amber color is formed. The intravenous injection solution and infusion solution can only be administered if they are clear and practically free from visible particles.
Instructions for dissolution

... (rest of the translation remains the same)