Cefuroxime tzf

Package leaflet: Information for the patient

Cefuroxime TZF, 750 mg, powder for solution for injection / infusion
Cefuroxime TZF, 1500 mg, powder for solution for injection / infusion
Cefuroximum
Please read this leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Cefuroxime TZF is and what it is 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 pack and other information

1. What Cefuroxime TZF is and what it is 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,
• of the urinary tract,
• of the skin and soft tissues,
• of the abdomen.

Cefuroxime TZF is also used:

• to prevent infections during surgery.

Your doctor may test which type of bacteria caused the infection and may monitor 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 a known allergy to cephalosporin antibiotics or to any of the other ingredients of Cefuroxime TZF (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 cephalosporin antibiotics.

If the patient believes any of the above apply, they should inform their doctor before
starting treatment with Cefuroxime TZF. The patient must not take Cefuroxime TZF.
Warnings and precautions
Before starting treatment with Cefuroxime TZF, discuss this with your doctor, pharmacist or
nurse.
During treatment with Cefuroxime TZF, be alert for symptoms such as allergic reactions, skin rashes, gastrointestinal disturbances (e.g. diarrhoea) or fungal infections.
This will help reduce the risk of complications (see “Symptoms to be aware of” in section 4).
If the patient has previously experienced allergic reactions to other antibiotics such as penicillin, they may also be allergic to Cefuroxime TZF.
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, contact a doctor immediately.
Blood and urine tests
Cefuroxime TZF may affect the results of tests for glucose in blood or urine and may cause a positive Coombs test. If the patient is to undergo such tests, they should:
inform the person collecting the sample that they are taking Cefuroxime TZF.
Cefuroxime TZF and other medicines
Tell the doctor about all medicines the patient is currently taking or has recently taken, including medicines obtained without a prescription, as well as any medicines the patient plans to take.
Some medicines may affect the action of Cefuroxime TZF or may increase the risk of adverse effects. These include:

• antibiotics of a group called 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 required during treatment with Cefuroxime TZF.

Oral contraceptives
Cefuroxime TZF may reduce the effectiveness of oral contraceptives. If a patient is taking oral contraceptives during treatment with Cefuroxime TZF, additional mechanical methods of contraception (e.g. condoms) should be used. Consult a doctor for advice.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor before using this medicine.
The doctor will assess whether the benefits of using Cefuroxime TZF during pregnancy or breastfeeding outweigh any potential risks to the child.
Driving and operating machinery
Patients should not drive or operate machinery 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 component of table salt) in each vial.
This corresponds to 2.03% of the maximum recommended daily dietary sodium intake for adults.
This should be taken into account in patients who are monitoring their dietary sodium intake.
Considering the dosing regimen described in section 3, the maximum amount of sodium that may be administered to a patient at the maximum daily dose is 325.2 mg, which corresponds to 16.26% of the WHO recommended maximum daily dietary sodium intake of 2 g for adults.
Cefuroxime TZF 1500 mg, powder for solution for injection / infusion
The medicine contains 81.3 mg of sodium (the main component of table salt) in each vial.
This corresponds to 4.06% of the maximum recommended daily dietary sodium intake for adults.
This should be taken into account in patients who are monitoring their dietary sodium intake.
Considering the dosing regimen described in section 3, the maximum amount of sodium that may be administered to a patient at the maximum daily dose is 325.2 mg, which corresponds to 16.26% of the WHO recommended maximum daily dietary sodium intake of 2 g for adults.

3. How to use Cefuroxime TZF

This medicine should always be used exactly as your doctor has told you. If you are unsure,
you should consult your doctor.
Cefuroxime TZF 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.
Typical dose
Your doctor will decide the appropriate dose of Cefuroxime TZF for you, taking into account the severity and
type of infection, whether you are taking any other antibiotics, your body weight, age, and kidney function.
Newborns and infants (aged 0–3 weeks)
For each kilogram of the infant's body weight, a daily dose of 30 to 100 mg of Cefuroxime TZF is given,
divided into two or three doses.
Infants (over 3 weeks of age) and children
For each kilogram of the infant's or child's body weight, a daily dose of 30 to 100 mg of Cefuroxime TZF is given,
divided into three or four doses.
Adults and adolescents
750 mg to 1.5 g of Cefuroxime TZF 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 the 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 patients taking Cefuroxime TZF, severe allergic reactions or potentially serious skin reactions have been reported. Symptoms may include:
• Severe allergic reaction. Symptoms include: raised, itchy rash, swelling, sometimes of the face or lips, which may make breathing difficult.
• Skin rash, which may develop into blisters and appear as target-like lesions (a dark spot in the centre surrounded by a lighter ring and a dark ring around the 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 syndrome).
• Extensive 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-induced heart attack (Kounis syndrome).

Other symptoms to watch for during treatment with Cefuroxime TZF

• Fungal infections. Medicines such as Cefuroxime TZF may rarely cause overgrowth of yeasts (Candida) in the body, which may lead to fungal infection (e.g. thrush). The risk of this adverse reaction is higher if Cefuroxime TZF is used for a prolonged period.
• Severe diarrhoea (pseudomembranous colitis). Medicines such as Cefuroxime TZF may cause inflammation of the colon (large intestine), leading to severe diarrhoea, usually with blood and mucus, abdominal pain and fever.

If any of these symptoms occur in the patient, contact a
doctor or nurse immediately.
Common adverse reactions (may occur in up to 1 in 10 patients):

• pain at injection site, swelling and redness along the vein. If any of these adverse reactions occur in the patient, inform the doctor.

Common adverse reactions that may be revealed by blood tests:

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

Uncommon adverse reactions (may occur in up to 1 in 100 patients):

• skin rash, urticaria, itching
• diarrhoea, nausea, abdominal pain

If any of these adverse reactions occur in the patient, inform the
doctor.
Uncommon adverse reactions (may occur in up to 1 in 100 patients) that may be revealed by blood tests:

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

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

• fungal infection
• high temperature (fever)
• allergic reactions (hypersensitivity)
• inflammation of the colon (large intestine), causing diarrhoea, usually with blood and mucus, abdominal pain
• inflammation of the kidneys and blood vessels
• excessive breakdown of red blood cells (haemolytic anaemia)
• skin rash, which may develop into blisters and appear as target-like lesions (a dark spot in the centre surrounded by a lighter ring and a dark ring around the edge). If any of these adverse reactions occur in the patient, inform the doctor.

Adverse reactions that may be revealed by blood tests:

• decrease in platelets (cells involved in blood clotting - thrombocytopenia)
• increased blood urea nitrogen and serum creatinine levels.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration 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 authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Cefuroxime TZF

Keep this medicine out of the sight and reach of children.
Store below 25 °C. Keep the vial in the outer packaging to protect 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 stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Cefuroxime TZF contains
The active substance is cefuroxime (in the form of cefuroxime sodium).
Each 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
A white to creamy powder.
After adding the appropriate volume of water for injection, a clear solution or suspension is formed, ranging in colour from pale yellow to amber.

Pack: one vial in a cardboard box.

Marketing Authorisation Holder and Importer
Tarchomińskie Zakłady Farmaceutyczne „Polfa” Spółka Akcyjna
ul. A. Fleminga 2
03-176 Warszawa
Telephone number: 22 811-18-14

For further information about this medicine, please contact the Marketing Authorisation Holder.

Information intended solely for healthcare professionals

The Summary of Product Characteristics must be consulted
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 inspected. After adding the appropriate volume of water for injection, a clear solution or suspension ranging in color from light yellow to amber is formed. Intravenous injection and infusion solutions may only be administered if they are clear and practically free from visible particles.

Instructions for reconstitution
Table 1. Volumes of water to be added and resulting concentrations, useful when partial doses are required.

| Vial size | Route of administration | Formulation | Volume of water to add | Approximate concentration of cefuroxime ** | |---------------|-----------------------------|------------------|----------------------------|-----------------------------------------------| | 750 mg | Intramuscular | Suspension | 3 mL | 216 mg/mL | | | Intravenous injection | Solution | At least 6 mL | 116 mg/mL | | | Intravenous infusion | Solution | At least 6 mL | 116 mg/mL | | 1500 mg | Intramuscular | Suspension | 6 mL | 216 mg/mL | | | Intravenous injection | Solution | At least 15 mL | 94 mg/mL | | | Intravenous infusion | Solution | 15 mL* | 94 mg/mL |

* The reconstituted solution should be added to 50 or 100 mL of a compatible infusion fluid (compatibility information – see below).
** The final volume of the cefuroxime solution increases due to the phase displacement factor of the active substance, resulting in the concentrations (mg/mL) shown above.

The reconstituted cefuroxime solution maintains physicochemical stability depending on the solvent used and its volume (Table 2).
From a microbiological standpoint, the medicinal product should be used immediately. If not used immediately, the user is responsible for the storage conditions and duration.

Table 2. Stability of cefuroxime solutions depending on the solvent used and its volume.

Ringer's lactate solution for injection
Metronidazole solution
0.18% w/v sodium chloride solution with 4% glucose solution for injection
5% glucose and 0.9% sodium chloride solution for injection
5% glucose and 0.45% sodium chloride solution for injection
5% glucose and 0.225% sodium chloride solution for injection
Sodium lactate compound solution for injection (Hartmann's solution)
7.5 mL/15 mL 100 mg/mL Water for Injection 5 48
0.9% sodium chloride solution
5% glucose solution
10% glucose solution
Ringer's solution for injection
Ringer's lactate solution for injection
Metronidazole solution
0.18% w/v sodium chloride solution with 4% glucose solution for injection
5% glucose and 0.9% sodium chloride solution for injection
5% glucose and 0.45% sodium chloride solution for injection
5% glucose and 0.225% sodium chloride solution for injection
Sodium lactate compound solution for injection (Hartmann's solution)
Heparin (10 IU/mL) in 0.9% sodium chloride solution for injection
Heparin (50 IU/mL) in 0.9% sodium chloride solution for injection
1% lidocaine solution (for intramuscular injection only)
150 mL/300 mL 5 mg/mL 5% xylitol solution - 5

Fluids for the preparation of solutions for injection:
Water for Injection
0.9% sodium chloride solution
5% glucose solution
10% glucose solution
Ringer's solution for injection
Ringer's lactate solution for injection
Metronidazole solution
5% xylitol solution
0.18% w/v sodium chloride solution with 4% glucose solution for injection
5% glucose and 0.9% sodium chloride solution for injection
5% glucose and 0.45% sodium chloride solution for injection
5% glucose and 0.225% sodium chloride solution for injection
Sodium lactate compound solution for injection (Hartmann's solution)
1% lidocaine solution (for intramuscular injection only)
Heparin (10 IU/mL) in 0.9% sodium chloride solution for injection
Heparin (50 IU/mL) in 0.9% sodium chloride solution for injection

Fluids for the preparation of infusion solutions:
Water for Injection
0.9% sodium chloride solution
10% glucose solution
Ringer's lactate solution for injection
Metronidazole solution
5% xylitol solution

Administration method
Cefuroxime TZF should be administered by intravenous injection over 3 to 5 minutes, directly into a vein, or by intermittent infusion or continuous infusion lasting 30 to 60 minutes, or by deep intramuscular injection.
Intramuscular injections should be administered deeply into relatively large muscles. No more than 750 mg should be injected at a single site. Doses greater than 1.5 g should be administered intravenously.

Pharmaceutical incompatibilities
Cefuroxime solutions should not be mixed (e.g., in the same syringe) with aminoglycoside solutions. Cefuroxime and aminoglycoside solutions should not be mixed in the same syringe or infusion container due to the risk of mutual inactivation. If concomitant administration of these drugs is necessary, they should be administered at different sites. Cefuroxime solutions are most stable within a pH range of 5–7; therefore, fluids with a pH higher than 7.5 (e.g., sodium bicarbonate solution) should not be used as solvents.