Cefepime tzf

Package leaflet: Information for the user

Cefepime TZF, 1 g, powder for solution for injection / infusion
Cefepimum
Please read all of this leaflet carefully before this medicine is administered, because it contains
important information for you.

• 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 leaflet:

1. What Cefepime TZF is and what it is used for
2. What you need to know before you are given 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 antibiotics called cephalosporins. This type of antibiotic works in a similar way to penicillin.
Cefepime TZF is administered intravenously either as an injection or by infusion.
Indications
Cefepime TZF is used to treat the following infections caused by microorganisms sensitive to cefepime.
Adults:

• Bacteraemia (presence of bacteria in the blood) associated with or potentially related to one of the infections listed below
• Severe pneumonia
• Severe urinary tract infections
• Intra-abdominal infections, including peritonitis, possibly in combination with another antibiotic
• Infections of the gallbladder and biliary tract
• Empirical treatment of febrile episodes of unknown origin in patients with compromised immunity (empirical treatment of febrile episodes in patients with moderate or severe neutropenia), possibly in combination with another antibiotic

Children:

• Bacteraemia (presence of bacteria in the blood) associated with or potentially related to one of the infections listed below
• Severe pneumonia
• Severe urinary tract infections
• Bacterial meningitis
• Empirical treatment of febrile episodes of unknown origin in patients with compromised immunity (empirical treatment of febrile episodes in patients with moderate or severe neutropenia), possibly 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 to other antibiotics with a similar chemical structure (beta-lactam antibiotics, such as penicillins, monobactams or carbapenems).

Special caution is required when using Cefepime TZF in the following cases

• if the patient has impaired kidney function, which may reduce the elimination of cefepime;
• if the patient has allergies (e.g. hay fever, urticaria) or has previously experienced an allergic reaction to beta-lactam antibiotics (penicillins, monobactams or carbapenems) or other drugs. If an allergic reaction occurs during treatment with cefepime, contact a doctor immediately, as this may have serious consequences. In such a case, the doctor will discontinue treatment immediately.
• if the patient has previously suffered from asthma or has a tendency towards allergic reactions;
• if the patient is undergoing blood or urine tests, inform the doctor that the patient is taking Cefepime TZF, as this medicine may affect the results of certain tests;
• if the patient develops severe, persistent diarrhoea during treatment with Cefepime TZF, inform the doctor immediately, so that the doctor can check whether inflammation of the intestinal mucosa has occurred due to antibiotic use and, if necessary, initiate appropriate treatment.

During treatment with Cefepime TZF, secondary infections caused by other microorganisms (e.g. mucosal candidiasis with redness and white coating) may occur. These infections will be appropriately treated by the physician.

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

Elderly patients
Dosage in elderly patients should be carefully adjusted, taking into account renal function, as these patients have a higher likelihood of impaired kidney function (see section 3).

Cefepime TZF and other medicines
Inform the doctor or pharmacist about all medicines currently being taken, recently taken, or planned to be taken, including those available without a prescription.
In particular, inform the doctor if the patient is taking bacteriostatic antibiotics simultaneously, as they may affect the action of Cefepime TZF.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.

Pregnancy
Cefepime TZF should not be used during pregnancy unless, in the opinion of the doctor, it is absolutely necessary.

Breastfeeding
Cefepime passes into human milk; therefore, Cefepime TZF should be used during breastfeeding only after careful consideration by the doctor of the benefit-risk ratio.

Driving and operating machinery
No studies have been conducted on the effect of Cefepime TZF on the ability to drive vehicles or operate machinery. During treatment with cefepime, adverse effects such as disturbances in consciousness, dizziness, confusion or hallucinations (see section 4) may occur, which could adversely affect the ability to drive vehicles or operate machinery. Therefore, patients should not drive or operate machinery while taking Cefepime TZF.

3. How to use Cefepime TZF

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

The duration of treatment is usually 7 to 10 days. Generally, Cefepime TZF should not be administered for less than 7 days or longer than 14 days.
In the case of empirical treatment of febrile episodes in patients with neutropenia, the duration of treatment is usually 7 days or until resolution of neutropenia.
Children aged 1 month to 12 years and (or) with body weight of 40 kg or less

In children aged 1 to 2 months, a dosage of 30 mg/kg body weight every 12 or 8 hours is sufficient. Children in this age group should be under constant monitoring during administration of cefepime.
For children with body weight above 40 kg, dosing should follow adult recommendations (see table). For children older than 12 years with body weight below 40 kg, dosing should follow recommendations for younger patients with body weight less than or equal to 40 kg. Pediatric dosing must not exceed the maximum adult dose (2 g every 8 hours).

Dosing in patients with renal function impairment
Adults and children with body weight above 40 kg (approximately 12 years of age)
Dosage adjustment is necessary in patients with impaired renal function to compensate for slower renal elimination. The initial dose in patients with mild or moderate renal impairment is the same as in patients with normal renal function, i.e., 2 g of cefepime.
Subsequent dosing (maintenance doses) is presented in the table below

Patients on dialysis
The following dosage is recommended:

• 1 g of cefepime on the first day of treatment, followed by 0.5 g of cefepime daily for all infections, except in patients with febrile neutropenia. In the latter case, the dose is 1 g per day.

Cefepime should be administered, whenever possible, at the same time each day, and on dialysis days, after completion of dialysis.
For patients with renal function impairment undergoing continuous ambulatory peritoneal dialysis, the following dosage is recommended:

• 1 g of cefepime every 48 hours for severe infections (sepsis, pneumonia, complicated urinary tract infections, gallbladder and biliary tract infections);
• 2 g of cefepime every 48 hours for very severe infections (intra-abdominal infections, including peritonitis, empirical treatment of febrile neutropenia).

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

Infants aged 1 – 2 months

Patients with liver function disorders
Dose adjustment is not necessary in patients with liver function disorders.

Elderly patients
Due to the increased risk of kidney function impairment, caution should be exercised when determining the dose in elderly patients and kidney function should be monitored. If kidney function impairment occurs, the physician will adjust the dosing regimen.

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

Use of a higher than recommended dose of Cefepime TZF
If the patient thinks they have received too high a dose of the medicine, medical advice must be sought immediately, as adverse reactions may possibly occur with greater severity.

Missed dose of Cefepime TZF
If the patient thinks they have missed a dose of the medicine, they should inform their doctor without delay.

Discontinuation of treatment with Cefepime TZF
If treatment with Cefepime TZF is discontinued, the underlying disease may worsen.

If there are any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Immediately inform a doctor if the patient experiences any of the following serious adverse reactions:

• severe allergic reaction presenting with sudden and worsening shortness of breath, swelling around the head and other parts of the body, skin rash, circulatory disturbances, and low blood pressure
• severe, widespread inflammatory redness of the skin with blister formation accompanied by fever – these may be symptoms of toxic epidermal necrolysis [Lyell's syndrome] or Stevens-Johnson syndrome
• persistent diarrhoea ranging from mild to severe, accompanied by abdominal pain and fever (pseudomembranous colitis), which may occur during antibiotic treatment or even up to two months after completion of treatment
• occurrence of disturbances in consciousness with disorientation, hallucinations, body stiffness, loss of consciousness, muscle tremors, and seizures.

The following adverse reactions have also been observed during treatment with Cefepime TZF.

Very common adverse reactions (occurring in more than 1 in 10 patients):

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

Common adverse reactions (occurring in less than 1 in 10 patients):

• prolonged blood clotting time (prolonged prothrombin time and activated partial thromboplastin time), reduced number of red blood cells (anaemia), increased number of certain types of white blood cells (eosinophilia)
• inflammation of the vein at the injection site
• diarrhoea
• increased blood test results (alanine aminotransferase activity, aspartate aminotransferase activity, alkaline phosphatase, bilirubin concentration) indicating impaired liver function
• rash
• irritation, pain, inflammation at the injection or infusion site

Uncommon adverse reactions (occurring in less than 1 in 100 patients):

• fungal infections of the mouth with white coating, vaginal inflammation
• reduced number of certain types of blood cells (thrombocytopenia, leukopenia, neutropenia)
• headache
• inflammation of the large intestine with abdominal pain (colitis), nausea, vomiting
• skin redness (erythema)
• erythema, urticaria, itching

Rare adverse reactions (occurring in less than 1 in 1,000 patients):

• non-specific fungal infections
• allergic reaction
• seizures, sensory disturbances such as tingling and numbness (paraesthesia), taste disturbances, dizziness
• vasodilation
• tinnitus
• dyspnoea
• abdominal pain, constipation
• fluid retention in tissues (oedema)
• joint pain
• genital itching
• chills

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

• marked decrease in red blood cells (anaemia), marked decrease in white blood cells (agranulocytosis), reduction in all types of blood cells (aplastic anaemia), leading to increased risk of bleeding, bruising, and infections
• false positive urine glucose test
• confusion, hallucinations
• coma, stupor, non-inflammatory brain disease (encephalopathy), disturbances in consciousness, muscle twitching
• bleeding
• gastrointestinal disorders
• inflammatory skin redness (erythema multiforme)
• kidney function disorders (renal failure, toxic nephropathy)

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: +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 provide more information on the safety of this medicine.

5. How to store Cefepime TZF

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

6. Contents of the pack and other information

What Cefepime TZF contains:
The active substance is: cefepime (in the form of cefepime hydrochloride monohydrate)
Each vial contains 1 g of cefepime (in the form of cefepime hydrochloride monohydrate).
The other ingredient is: L-Arginine

What Cefepime TZF looks like and contents of the pack
White to slightly yellowish powder.
The pH of the prepared solution is 4.0 to 6.0.

Pack
1 vial in a cardboard box.

Marketing Authorisation Holder and Importer
Tarchomin Pharmaceutical Works "Polfa" Joint Stock Company
A. Fleminga Street 2
03-176 Warsaw
Telephone number: 22 811-18-14

For further information on this medicinal product, please contact the Marketing Authorisation Holder.

Information intended exclusively for healthcare professionals

After opening the vial and preparing the solution
Solutions of cefepime should be used immediately after preparation.
Preparation and administration methods of solutions
Before administration, the appearance of the solution should be inspected. The solution may be administered only if it is
clear and practically free from particles visible to the naked eye.
Solutions may range in color from yellow to yellowish-brown. This does not adversely affect the
therapeutic efficacy of the medicinal product Cefepime TZF.
The contents of the vial are intended for single use only. Any unused portion of the prepared solution must be discarded.
Methods of solution preparation
Preparation of solution for intramuscular injection
Cefepime TZF product should be dissolved in 2.4 mL of one of the diluents listed in the table below. The resulting solution should be administered by deep intramuscular injection into a large muscle (e.g., the upper outer quadrant of the gluteus maximus).
Doses exceeding 1 g should be administered at two separate injection sites.
Cefepime TZF may be dissolved in 0.5% or 1% lidocaine hydrochloride solution; however, addition of a local anesthetic is generally not necessary, as intramuscular injection of the drug is painless or causes only minimal discomfort.
Volumes and diluents (and approximate concentrations) used for preparation of solutions for intramuscular injection

Preparation of the intravenous injection solution
The contents of the vial should be dissolved in the appropriate amount of solvent indicated in the table below.
The prepared solution should be administered slowly over 3 to 5 minutes directly into the vein or via an infusion set
when the patient is simultaneously receiving another compatible intravenous infusion solution.

Preparation of the intravenous infusion solution
To prepare the intravenous infusion, cefepime solution should be prepared in the same manner as for intravenous injection.
The appropriate volume of the prepared solution should be added to an infusion container containing a compatible infusion fluid.
The intravenous infusion should last approximately 30 minutes.

Volumes and solvents (and approximate concentrations) used for the preparation of solutions for intravenous injection and infusion

Preparation of solutions must be carried out under aseptic conditions.
Any unused portions of the medicinal product or waste materials must be disposed of in accordance with local regulations.
Pharmaceutical incompatibilities
Cefepime must not be mixed with other medicinal products or solutions except those mentioned in section 6.6.
The drug shows physicochemical incompatibilities with metronidazole, vancomycin, gentamicin, tobramycin, netilmicin, and aminophylline. If concomitant intravenous administration of any of these drugs is indicated, they must not be mixed with cefepime nor administered through the same intravenous access.