Cefepime Tzf

Package Leaflet: Information for the User

Cefepime TZF, 1 g, powder for solution for injection/infusion

Cefepime

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

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

Contents of the package leaflet:

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

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

Cefepime TZF contains the active substance cefepime, which belongs to a group of cephalosporins. This type of antibiotic works similarly to penicillin.
The medicine is administered intravenously by injection or infusion.

Indications for use

Cefepime TZF is used to treat the following infections caused by bacteria susceptible to cefepime.
Adults:

• Bacteremia (presence of bacteria in the blood) co-existing with one of the following infections or potentially related to it
• Severe pneumonia
• Severe urinary tract infections
• Infections in the abdominal cavity, including peritonitis, if necessary in combination with another antibiotic
• Infections of the gallbladder and bile ducts
• Empirical treatment of febrile episodes of unknown origin in patients with impaired immunity (empirical treatment of febrile episodes in patients with moderate or severe neutropenia), if necessary in combination with another antibiotic

Children:

• Bacteremia (presence of bacteria in the blood) co-existing with one of the following infections or potentially related to it
• Severe pneumonia
• Severe urinary tract infections
• Bacterial meningitis
• Empirical treatment of febrile episodes of unknown origin in patients with impaired immunity (empirical treatment of febrile episodes in patients with moderate or severe neutropenia), if necessary in combination with another antibiotic

2. Important information before using Cefepime TZF

When not to use Cefepime TZF

• If the patient is allergic to cefepime or any of the other ingredients of this medicine (listed in section 6).
• If the patient has ever had an allergic reaction (hypersensitivity reaction) to cephalosporin antibiotics or other antibiotics with a similar chemical structure (beta-lactam antibiotics, such as penicillins, monobactams, or carbapenems).

In the following cases, special caution is required when using Cefepime TZF

• if the patient has impaired renal function, which may lead to reduced excretion of cefepime;
• if the patient is allergic (e.g., hay fever, urticaria) and has had an allergic reaction to beta-lactam antibiotics (penicillins, monobactams, or carbapenems) or other medicines. If an allergic reaction occurs during cefepime treatment, the patient should contact their doctor immediately, as this may have serious consequences. In such cases, the doctor will discontinue treatment immediately.
• if the patient has a history of asthma or is prone to allergic reactions;
• if the patient is undergoing blood or urine tests, they should inform their doctor that they are taking Cefepime TZF, as this medicine may affect the results of some tests.
• if the patient experiences severe, persistent diarrhea while taking Cefepime TZF, they should inform their doctor so that they can check if the antibiotic has caused colitis and take appropriate treatment.

During treatment with Cefepime TZF, secondary infections caused by other microorganisms (e.g., oral thrush with redness and white patches) may occur. These infections will be treated by the doctor.

Children

Special dosage guidelines apply to infants and children (see section 3).

Elderly patients

Dosage in elderly patients should be carefully selected, taking into account renal function, as these patients are more likely to have impaired renal function (see section 3).

Cefepime TZF and other medicines

Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take, including those available without a prescription.
In particular, tell your doctor if you are taking bacteriostatic antibiotics at the same time, as they may affect the action of Cefepime TZF.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Cefepime TZF should not be used during pregnancy unless your doctor considers it absolutely necessary.
Breastfeeding
Cefepime passes into breast milk, so Cefepime TZF should only be used during breastfeeding after careful consideration by your doctor of the benefit-risk ratio.

Driving and using machines

No studies have been conducted on the effect of Cefepime TZF on the ability to drive and use machines. During cefepime treatment, side effects such as impaired consciousness, dizziness, confusion, or hallucinations (see section 4) may occur, which may have a negative impact on the ability to drive and use machines, so you should not drive or use machines while taking Cefepime TZF.

3. How to use Cefepime TZF

Cefepime TZF is usually administered by a doctor or nurse.
It is given by intramuscular injection or intravenous infusion or by direct injection into a vein.
The dosage is determined by the doctor based on the type and severity of the infection, the patient's age, weight, and renal function.
Dosage for patients with normal renal function
Adults and adolescents over 40 kg (over 12 years old)

Treatment duration is usually 7 to 10 days. Cefepime TZF should not be administered for less than 7 days and more than 14 days.
In the case of empirical treatment of febrile episodes in patients with neutropenia, the treatment duration is usually 7 days or until neutropenia resolves.
Children from 1 month to 12 years old and (or) weighing 40 kg or less

In children from 1 to 2 months old, a dose of 30 mg/kg body weight every 12 or 8 hours is sufficient. During cefepime administration in this age group, patients should be under constant supervision.
In children over 40 kg, the dosage recommended for adults (see table) is used. In children over 12 years old and weighing less than 40 kg, the dosage recommendations for younger patients weighing 40 kg or less should be followed. The dosage in children should not exceed the maximum adult dose (2 g every 8 hours).
Dosage in patients with renal impairment
Adults and children over 40 kg (approximately 12 years old)
In patients with renal impairment, dosage adjustment is necessary to compensate for slower renal excretion. The first dose for patients with mild or moderate renal impairment is the same as for patients with normal renal function, i.e., 2 g of cefepime.
Subsequent dosing (maintenance doses) is presented in the following table

Dialysis patients
The following dosage is recommended:

• 1 g of cefepime on the first day of treatment, then 0.5 g of cefepime per day, for all infections, except for patients with febrile neutropenia, in which case the dose is 1 g per day.

Cefepime should be administered as close as possible to the same time every day, and on dialysis days, after dialysis.
In patients with renal impairment undergoing continuous ambulatory peritoneal dialysis, the following dosage is recommended:

• 1 g of cefepime every 48 hours for severe infections (septicemia, pneumonia, complicated urinary tract infections, infections of the gallbladder and bile ducts);
• 2 g of cefepime every 48 hours for very severe infections (infections in the abdominal cavity, including peritonitis, empirical treatment of febrile neutropenia).

Children from 1 month old and weighing up to 40 kg (approximately 12 years old)
A single dose of 50 mg/kg body weight in children over 2 months old to 12 years old and a single dose of 30 mg/kg body weight in children from 1 to 2 months old corresponds to a dose of 2 g in adults. Therefore, in children, a similar extension of the dosing interval and/or reduction of the dose is recommended, as in adults, according to the following tables.
Children from 2 months old and weighing up to 40 kg (approximately 12 years old)

Infants from 1 to 2 months old

Patients with impaired liver function
No dose adjustment is necessary in patients with impaired liver function.
Elderly patients
Due to the increased risk of renal impairment, elderly patients should be cautious when selecting the dose and monitoring renal function. If renal impairment occurs, the doctor will adjust the dosage of the medicine.

Method of administration

Further information on the method of administration can be found at the end of the leaflet, in the section "Information intended for healthcare professionals only".

Use of a higher than recommended dose of Cefepime TZF

If you think you have received too much of the medicine, contact your doctor immediately, as you may experience more severe side effects.

Missed dose of Cefepime TZF

If you think you have missed a dose of the medicine, tell your doctor immediately.

Discontinuation of Cefepime TZF

If you stop using Cefepime TZF, your underlying condition may worsen.
If you have any further questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Cefepime TZF can cause side effects, although not everybody gets them.
You should immediatelyinform your doctor if you experience any of the following severe side effects:

• severe allergic reaction with sudden, worsening shortness of breath, swelling around the head and other parts of the body, skin rash, circulatory disorders, decreased blood pressure
• severe, widespread inflammatory redness of the skin with blistering and fever - these may be symptoms of toxic epidermal necrolysis (Lyell's syndrome) or Stevens-Johnson syndrome
• persistent diarrhea of mild to severe intensity, with abdominal pain and fever (pseudomembranous colitis), which may occur during antibiotic treatment or up to two months after its completion
• impaired consciousness with disorientation, hallucinations, stiffness, loss of consciousness, muscle tremors, and seizures.

During treatment with Cefepime TZF, the following side effects have also been observed.

Very common side effects (more than 1 in 10 patients):

• false-positive Coombs test (method for detecting antibodies)

Common side effects (less than 1 in 10 patients):

• prolonged blood clotting time (prolonged prothrombin time and thromboplastin time), decreased red blood cell count (anemia), increased white blood cell count (eosinophilia),
• phlebitis at the injection site,
• diarrhea,
• increased liver function test results (alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, bilirubin) indicating liver function disorders,
• rash,
• irritation, pain, inflammation at the injection or infusion site.

Uncommon side effects (less than 1 in 100 patients):

• fungal infections of the mouth with white patches, vaginal inflammation,
• decreased platelet count (thrombocytopenia), decreased white blood cell count (leukopenia, neutropenia),
• headache,
• colitis with abdominal pain (pseudomembranous colitis), nausea, vomiting,
• skin redness (erythema),
• erythema, urticaria, itching,
• increased urea and creatinine levels in the blood,
• fever, phlebitis at the infusion site

Rare side effects (less than 1 in 1,000 patients):

• non-specific fungal infections,
• allergic reaction,
• seizures, sensory disturbances, such as tingling and numbness (paresthesia), taste disorders, dizziness,
• vasodilation,
• tinnitus,
• shortness of breath,
• abdominal pain, constipation,
• fluid retention (edema),
• joint pain,
• genital itching,
• chills.

Frequency not known (frequency cannot be estimated from available data):

• significant decrease in red blood cell count (anemia), significant decrease in white blood cell count (agranulocytosis), decrease in all blood cell types (aplastic anemia) and increased risk of bleeding, bruising, and infections,
• false-positive glucose test result in urine,
• confusion, hallucinations (delirium),
• coma, stupor, non-inflammatory brain disease (encephalopathy), impaired consciousness, muscle tremors,
• bleeding,
• gastrointestinal disorders,
• inflammatory skin redness (erythema multiforme),
• renal function disorders (renal failure, toxic nephropathy).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Cefepime TZF

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date (EXP) stated on the label and carton.
The expiry date refers to the last day of the month.
Store below 30°C. Store the vial in the outer carton to protect from light.
Instructions for storage and preparation of the solution can be found at the end of the leaflet, in the subsection "Information intended for healthcare professionals only".
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Cefepime TZF contains:

The active substance is: cefepime (as cefepime dihydrochloride monohydrate)
One vial contains 1 g of cefepime (as cefepime dihydrochloride monohydrate).
The other ingredient is: L-Arginine

What Cefepime TZF looks like and contents of the pack

White to light yellow powder.
The pH of the prepared solution is 4.0 to 6.0.

Packaging

1 vial in a cardboard box.

Marketing authorization holder and importer

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

Date of last revision of the leaflet: ----------------------------------------------------------------------------------------------------------------------------------

Information intended for healthcare professionals only

After opening the vial and preparing the solution
Cefepime solutions should be used immediately after preparation.

Method of preparation and administration of solutions

Before administration, the appearance of the solution should be checked. The solution can only be administered if it is clear and practically free from visible particles.
Solutions may have a yellow to yellow-brown color. This does not affect the efficacy of Cefepime TZF.
The contents of the vial are intended for single use. Any remaining prepared solution should be discarded.
Method of preparation of solutions
Preparation of solution for intramuscular injection
Cefepime TZF should be dissolved in 2.4 ml of one of the solvents listed in the following table. The prepared solution should be injected deeply into a large muscle (e.g., the upper outer quadrant of the gluteus maximus).
Doses exceeding 1 g should be injected into two different sites.
Cefepime TZF can be dissolved in 0.5% or 1% lidocaine hydrochloride solution, but the addition of a local anesthetic is usually not necessary, as intramuscular injection of the medicine is painless or causes minimal pain.
Amounts and solvents (and approximate concentrations) used to prepare solutions for intramuscular injection

Preparation of solution for intravenous injection
The contents of the vial should be dissolved in an appropriate amount of solvent listed in the following table.
The prepared solution should be administered slowly over 3 to 5 minutes directly into a vein or through an infusion set when the patient is receiving another compatible solution by intravenous infusion.
Preparation of solution for intravenous infusion
To administer an intravenous infusion, cefepime solution should be prepared in the same way as for intravenous injection. The appropriate amount of prepared solution should be added to an infusion container containing a compatible infusion fluid. The duration of intravenous infusion should be approximately 30 minutes.
Amounts and solvents (and approximate concentrations) used to prepare solutions for intravenous injection and infusion

Solution preparation must be carried out under aseptic conditions.
Any unused product or waste materials should be disposed of in accordance with local regulations.

Incompatibilities

Cefepime should not be mixed with other medicinal products or solutions, except those listed in section 6.6.
Cefepime is incompatible with metronidazole, vancomycin, gentamicin, tobramycin, netilmicin, and aminophylline. If concomitant intravenous administration of any of these drugs is indicated, they should not be mixed with cefepime or administered through the same intravenous access.