Cefepime Panpharma

Package Leaflet: Information for the User

Cefepime Panpharma, 2 g, Powder for Solution for Injection or Infusion

Cefepime (as Cefepime Dihydrochloride Monohydrate)

Read the Package Leaflet Carefully Before Using the Medication, as it Contains Important Information for the Patient.

• Keep this package leaflet, you may need to read it again.
• Ask your doctor, pharmacist, or nurse if you have any further questions.
• This medication 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, tell your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this package leaflet.

Package Leaflet Contents:

• 1. What Cefepime Panpharma is and what it is used for
• 2. Important information before using Cefepime Panpharma
• 3. How to use Cefepime Panpharma
• 4. Possible side effects
• 5. How to store Cefepime Panpharma
• 6. Package contents and other information

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

Cefepime Panpharma is an antibiotic in the form of a powder for solution for injection or infusion. The active substance of this medication, cefepime, belongs to a group of antibiotics called cephalosporins, which are similar to penicillins. This medication is used to treat infections caused by bacteria that are sensitive to cefepime.

Adults

• Sepsis (blood infection).
• Severe pneumonia.
• Complicated urinary tract infections.
• Intra-abdominal infections, including peritonitis, in combination with another antibiotic if necessary.
• Infections of the gallbladder and bile ducts.
• Treatment of febrile episodes of unknown origin in patients with impaired immune system function (empirical treatment of febrile episodes in patients with moderate or severe neutropenia) in combination with another antibiotic if necessary.

Children

• Sepsis (blood infection).
• Severe pneumonia.
• Complicated urinary tract infections.
• Bacterial meningitis.
• Treatment of febrile episodes of unknown origin in patients with impaired immune system function (empirical treatment of febrile episodes in patients with moderate or severe neutropenia) in combination with another antibiotic if necessary.

2. Important information before using Cefepime Panpharma

When not to use Cefepime Panpharma

• If you are allergic to cefepime, any other cephalosporin antibiotic, or any of the other ingredients of this medication (listed in section 6).
• If you have ever had a severe and/or immediate allergic reaction to penicillin or any other beta-lactam antibiotic.

Warnings and precautions

Before using Cefepime Panpharma, tell your doctor, pharmacist, or nurse.

When to be cautious when using Cefepime Panpharma

• If you have kidney disease (e.g., impaired renal function), as the elimination of this medication may be impaired.
• If you have an allergy (e.g., hay fever, hives) or have ever had an allergic reaction to medications. If an allergic reaction occurs, discontinue Cefepime Panpharma and initiate appropriate treatment.
• If you experience persistent diarrhea during or after treatment with this medication. Inform your doctor immediately, as this may be a sign of antibiotic-associated colitis.

Using Cefepime Panpharma may lead to the development of secondary infections caused by other microorganisms (e.g., fungal infections of the mucous membranes, which may be characterized by redness or a white coating). These secondary infections will be treated by your doctor.

Children

Special dosing instructions apply to infants and children (see section 3, "How to use Cefepime Panpharma").

Elderly patients

Dosing in elderly patients should be carefully selected, taking into account the degree of renal impairment, as this group of patients is more likely to develop kidney disease (see section 3, "How to use Cefepime Panpharma").

Other medications and Cefepime Panpharma

Tell your doctor or pharmacist about all medications you are currently taking or have recently taken, including those obtained without a prescription.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medication. Do not use this medication during pregnancy unless it is absolutely necessary and has been explicitly recommended by your doctor. Cefepime may pass into breast milk, and this medication should be used with caution during breastfeeding, after consulting your doctor.

Driving and using machines

Do not drive or operate machinery while using medications like Cefepime Panpharma, as you may experience impaired consciousness or dizziness.

3. How to use Cefepime Panpharma

Always use this medication exactly as your doctor or pharmacist has told you. If you are unsure, ask your doctor or pharmacist.

Dosing in patients with normal kidney function

Adults and children weighing at least 40 kg (approximately 12 years of age)
The usual treatment duration is 7 to 10 days. Cefepime Panpharma should not be used for less than 7 days or more than 14 days in a single treatment cycle.
In patients with febrile neutropenia, treatment should last 7 days or until neutropenia resolves.

Dose and administration

Dosing in patients with impaired kidney function

Adults and children weighing at least 40 kg (approximately 12 years of age)
Cefepime Panpharma is primarily eliminated by the kidneys. If you have kidney disease (e.g., impaired renal function), your doctor will reduce the dose to adjust for the slowed elimination of the medication from the body. The first dose of Cefepime Panpharma in patients with mild or moderate kidney impairment is the same as in patients with normal kidney function, i.e., 2.0 g.

Patients on dialysis

If you require dialysis (hemodialysis), you will receive a lower dose:

• 1.0 g of Cefepime Panpharma on the first day of treatment, and then 0.5 g of Cefepime Panpharma per day on subsequent days of treatment for all types of infections, except for febrile episodes in patients with impaired immune system function (neutropenia), in which case the dose is 1.0 g per day.

Whenever possible, Cefepime Panpharma should be administered at the same time of day, and on dialysis days, it should be administered after dialysis.
For patients with impaired kidney function undergoing continuous ambulatory peritoneal dialysis, the following dosing is recommended:

• 1.0 g of Cefepime Panpharma every 48 hours for critical infections[sepsis (blood infection), pneumonia, complicated urinary tract infections, infections of the gallbladder and bile ducts].
• 2.0 g of Cefepime Panpharma every 48 hours for severe infections[intra-abdominal infections, including peritonitis, febrile episodes in patients with impaired immune system function (neutropenia)].

Children weighing less than 40 kg (approximately 12 years of age)
A single dose of 50 mg/kg in children aged 2 months to 12 years and a single dose of 30 mg/kg in children aged 1 to 2 months corresponds to a dose of 2.0 g in adults. Therefore, the same prolongation of the dosing interval and/or reduction in dose as in adults is recommended, according to the tables below.

Infants aged 1 to 2 months

Liver function impairment
No dose adjustment is necessary in patients with impaired liver function.
Elderly patients
Dosing in elderly patients should be carefully selected, taking into account the degree of renal impairment, as this group of patients is more likely to develop kidney disease.

Overdose of Cefepime Panpharma

Contact your doctor or other healthcare professional immediately, as you may experience more severe side effects.

Missed dose of Cefepime Panpharma

Contact your doctor or other healthcare professional immediately.

Stopping Cefepime Panpharma treatment

Do not stop using this medication without consulting your doctor. Your condition may worsen if you stop using Cefepime Panpharma before the end of the recommended treatment period.
If you have any further questions about using this medication, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medications, Cefepime Panpharma can cause side effects, although not everybody gets them.

Inform your doctor immediately

if you experience any of the following symptoms:

• Severe allergic reaction with sudden and severe difficulty breathing, swelling of the face or other parts of the body, skin rash, disturbances in circulation, and a drop in blood pressure.
• Sudden appearance of skin rash, blisters, or peeling of the skin, accompanied by fever.
• Persistent diarrhea, ranging from mild to severe, with abdominal pain and fever, which may occur even two months after the end of antibiotic therapy.
• Impaired consciousness with disorientation, hallucinations, stiffness, fainting, muscle tremors, and painful muscle spasms.

When evaluating side effects, the following frequency categories are used:

• Very common: occurring in more than 1 in 10 patients
• Common: occurring in 1 to 10 in 100 patients
• Uncommon: occurring in 1 to 10 in 1,000 patients
• Rare: occurring in 1 to 10 in 10,000 patients
• Very rare: occurring in less than 1 in 10,000 patients
• Other: frequency cannot be estimated from available data

Very commonside effects (occurring in more than 1 in 10 patients)

• Positive Coombs test result.

Commonside effects (occurring in 1 to 10 in 100 patients)

• Prolonged blood clotting time (prothrombin time or activated partial thromboplastin time),
• Anemia,
• Increased eosinophil count,
• Phlebitis at the injection site,
• Diarrhea,
• Rash,
• Reaction at the injection site,
• Pain and inflammation at the injection site,
• Increased levels of certain substances in the blood (alanine aminotransferase, aspartate aminotransferase, bilirubin, alkaline phosphatase).

Uncommonside effects (occurring in 1 to 10 in 1,000 patients)

• Fungal infections of the mouth with a white coating,
• Vaginitis,
• Decreased platelet count, white blood cell count, or neutrophil count,
• Headache,
• Colitis with abdominal pain,
• Nausea,
• Vomiting,
• Redness of the skin (erythema),
• Hives,
• Itching,
• Increased urea levels in the blood,
• Increased creatinine levels in the blood,
• Fever,
• Inflammation at the injection site.

Rareside effects (occurring in 1 to 10 in 10,000 patients)

• Fungal infections (candidiasis),
• Allergic reactions,
• Seizures,
• Numbness or tingling (paresthesia),
• Taste disturbances,
• Dizziness,
• Vasodilation,
• Shortness of breath,
• Abdominal pain,
• Constipation,
• Fluid retention (edema),
• Joint pain,
• Genital itching,
• Chills,
• Ringing in the ears (tinnitus).

Otherside effects (frequency cannot be estimated from available data)

• Decreased blood cell count [aplastic anemia, hemolytic anemia, agranulocytosis, and resulting increased risk of bleeding, bruising, and infections],
• Life-threatening allergic shock (see introduction to the section on side effects),
• False-positive glucose test result in urine,
• Disorientation,
• Hallucinations,
• Coma,
• Numbness,
• Non-inflammatory brain disease (encephalopathy),
• Impaired consciousness,
• Muscle tremors,
• Bleeding,
• Gastrointestinal disorders,
• Necrosis of skin cells (toxic epidermal necrolysis),
• Severe inflammatory skin rash with blisters and fever (Stevens-Johnson syndrome, see introduction to the section on side effects),
• Inflammatory skin rash (erythema multiforme),
• Kidney failure,
• Kidney damage (nephrotoxicity).

Reporting side effects

If you experience any side effects, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the "national reporting system":
Department of Medicinal Product Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
PL-02 222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting side effects will help to gather more information on the safety of this medication.

5. How to store Cefepime Panpharma

Keep this medication out of the sight and reach of children.
Do not use this medication after the expiration date stated on the packaging and container after the "EXP" date. The expiration date refers to the last day of the month.
Store in the original packaging to protect from light.
Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medications no longer needed. This will help protect the environment.

6. Package contents and other information

What Cefepime Panpharma contains

• The active substance is cefepime dihydrochloride monohydrate. Each vial of Cefepime Panpharma 2 g contains 2 g of cefepime (as cefepime dihydrochloride monohydrate).
• The other ingredient is L-arginine.

What Cefepime Panpharma looks like and contents of the pack

Cefepime Panpharma 2 g is a pale yellow powder for solution for injection or infusion in a glass vial (type II) with a capacity of 50 ml, with a rubber stopper, aluminum seal, and polypropylene flip-off cap. The vials are packaged in cardboard boxes.
Pack size: 10 vials.

Marketing authorization holder and manufacturer

PANMEDICA

406 BUREAUX DE LA COLLINE
92213 SAINT-CLOUD CEDEX
FRANCE

Manufacturer

LDP-LABORATORIOS TORLAN S.A.

CTRA DE BARCELONA, 135-B
08290 CERDANYOLA DEL VALLES
BARCELONA
SPAIN

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of the package leaflet: 05.08.2020

---------------------------------------------------------------------------------------------------------------------------

Information intended for healthcare professionals only:

Resistance dataon cefepime – see the summary of product characteristics for Cefepime Panpharma.

Administration:

Preparation and administration of the ready-to-use solution:
Cefepime Panpharma powder for solution for injection or infusion should be reconstituted:
a)
in water for injection
or in one of the solutions listed in point b) below, intended for intravenous administration
b)
0.9% sodium chloride solution
0.9% sodium chloride solution with 5% glucose solution
5% or 10% glucose solution
Ringer's solution with lactate
Ringer's solution with lactate and 5% glucose solution
1/6-molar sodium lactate solution
The volume of the solvent to be added to each vial, as well as the cefepime concentration in the vial, are shown in the table below.

Solutions reconstituted with water for injection are stable for 18 hours at room temperature (15-25°C) and for 2 days if stored in the refrigerator (2-8°C).
Solutions reconstituted with other solvents (0.9% sodium chloride solution, 0.9% sodium chloride solution with 5% glucose solution, 5% or 10% glucose solution, Ringer's solution with lactate, Ringer's solution with lactate and 5% glucose solution, 1/6-molar sodium lactate solution) are stable for 4 hours at room temperature (15-25°C).
From a microbiological point of view, the product should be used immediately. If not used immediately, the responsibility for the storage time after reconstitution and storage conditions lies with the user, and the storage time after opening should not normally exceed 24 hours at 2-8°C, unless reconstitution has been carried out in controlled and validated aseptic conditions.
Caution!
Ready-to-use solutions prepared correctly may have a yellow to yellow-brown color. This does not affect the efficacy of Cefepime Panpharma. The contents of the vial are for single use only. Any remaining solution should be discarded.