Cefepime Panpharma

Leaflet accompanying the packaging: information for the user

Cefepime Panpharma, 1 g, powder for solution for injection or infusion

Cefepime (in the form of Cefepime dihydrochloride monohydrate)

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

• Keep this leaflet, you may need to read it again.
• Ask your doctor, pharmacist or nurse if you have any further questions.
• 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 any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, pharmacist or nurse.

Table of contents of the leaflet:

• 1. What is Cefepime Panpharma and what is it 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. Contents of the packaging and other information

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

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

Adults

• Sepsis (blood infection).
• Severe pneumonia.
• Complicated urinary tract infections.
• Abdominal infections, including peritonitis, in combination with another antibiotic if necessary.
• Infections of the gallbladder and bile ducts.
• Treatment of febrile conditions of unknown origin in patients with impaired immune system function [empirical treatment of febrile episodes in patients with moderate or severe neutropenia (i.e., a condition in which the number of white blood cells in the blood is decreased and accompanied by fever)] in combination with another antibiotic if necessary.

Children

• Sepsis (blood infection).
• Severe pneumonia.
• Complicated urinary tract infections.
• Bacterial meningitis.
• Treatment of febrile conditions of unknown origin in patients with impaired immune system function [empirical treatment of febrile episodes in patients with moderate or severe neutropenia (i.e., a condition in which the number of white blood cells in the blood is decreased and accompanied by fever)] in combination with another antibiotic if necessary.

2. Important information before using Cefepime Panpharma

When not to use Cefepime Panpharma

• If the patient is allergic to cefepime, any other cephalosporin antibiotic, or any of the other ingredients of this medicine (listed in section 6).
• If the patient has ever had an immediate and/or severe hypersensitivity reaction to penicillin or any other beta-lactam antibiotic with a similar chemical structure.

Warnings and precautions

Before starting treatment with Cefepime Panpharma, consult your doctor, pharmacist or nurse.

When to be particularly careful when using Cefepime Panpharma

• If the patient has kidney disease (e.g., if impaired renal function has been detected), as the elimination of this medicine from the body may be impaired.
• If the patient has an allergy (e.g., to hay fever, hives) or if the patient has ever had an allergic reaction to medicines. If any hypersensitivity reaction occurs, administration of Cefepime Panpharma should be discontinued and appropriate treatment should be initiated.
• If persistent diarrhea occurs during or after treatment with this medicine. In this case, the doctor should be informed immediately so that they can determine if the diarrhea is caused by antibiotic-associated colitis; it may be necessary to discontinue the use of this medicine.

The use of Cefepime Panpharma may lead to the development of secondary infections caused by other microorganisms (e.g., fungal infections of the mucous membranes, which are characterized by redness of the mucous membranes or the appearance of a white coating on them). These secondary infections will be treated appropriately by the doctor.

Children

In the case of infants and children, special dosing guidelines apply (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 function, as this group of patients is more likely to develop kidney disease (see section 3, "How to use Cefepime Panpharma").

Other medicines and Cefepime Panpharma

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 obtained without a prescription.

Pregnancy and breastfeeding

If you are pregnant, breastfeeding, or think you may be pregnant, or if you are planning to become pregnant, consult your doctor or pharmacist before using this medicine. Do not use this medicine during pregnancy unless it is absolutely necessary and has been clearly prescribed by your doctor. Cefepime may pass into breast milk, so this medicine should be used with caution during breastfeeding and after consulting your doctor. Before taking any medicine, consult your doctor or pharmacist for advice.

Driving and using machines

Do not drive or operate machinery while taking medicines like Cefepime Panpharma, as the patient may experience impaired consciousness or dizziness.

3. How to use Cefepime Panpharma

This medicine should always be taken as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.

Dosing in patients with normal renal function

Adults and children weighing at least 40 kg (in children, this corresponds to approximately 12 years of age)
The treatment usually lasts 7 to 10 days. Cefepime Panpharma should not be used for less than 7 days or more than 14 days in one treatment cycle.
In the case of febrile episodes in patients with impaired immune system function (neutropenia), treatment should last 7 days or until the neutropenia improves.

Dose size of Cefepime Panpharma [mg/kg body weight] / interval between doses / duration of treatment

In the case of children from 1 to 2 months of age, a dose of 30 mg/kg body weight every 12 or 8 hours is sufficient. Children in this age group should be closely monitored during treatment with this medicine. In children weighing more than 40 kg, the dose recommended for adults should be used (see table). In children over 12 years of age and weighing less than 40 kg, the dose recommended for younger patients weighing 40 kg should be used. The dose used in children should not exceed the maximum dose for adults (2.0 g every 8 hours).

Dosing in patients with impaired renal function

Adults and children weighing at least 40 kg (in children, this corresponds to approximately 12 years of age)
Cefepime Panpharma is eliminated from the body mainly through the kidneys. If the patient has kidney disease (e.g., if impaired renal function has been detected), the doctor will reduce the dose of this medicine to adapt it to the slowed elimination of the medicine from the body through the kidneys. The first dose of Cefepime Panpharma in patients with mild or moderate renal impairment is the same as in patients with normal renal function, i.e., 2.0 g. The recommended maintenance doses are given in the table below.

Patients undergoing dialysis

If the patient requires dialysis (hemodialysis), they 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 in subsequent days of treatment for all types of infections, except for febrile conditions in patients with impaired immune system function (neutropenia), in which case the dose is 1.0 g per day.

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

• 1.0 g of Cefepime Panpharma every 48 hours in the case of severe 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 in the case of very severe infections[abdominal infections, including peritonitis, febrile conditions in patients with impaired immune system function (neutropenia)].

Children from 1 month of age, weighing no more than 40 kg (approximately 12 years of age)
A single dose of 50 mg/kg body weight in children from 2 months to 12 years of age and a single dose of 30 mg/kg body weight in children from 1 to 2 months of age corresponds to a dose of 2.0 g in adults. Therefore, it is recommended to use the same extension of the interval between doses and/or the same reduction in dosing as in adults, according to the tables below.

Liver function disorders

No dose modification 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 function, as this group of patients is more likely to develop kidney disease.

Using more than the recommended dose of Cefepime Panpharma

Immediately contact a doctor or other healthcare professional, as the patient may experience more severe side effects.

Missing a dose of Cefepime Panpharma

Immediately contact a doctor or other healthcare professional.

Stopping treatment with Cefepime Panpharma

Do not stop treatment with this medicine without consulting your doctor. The disease may worsen if treatment with Cefepime Panpharma is stopped before the end of the recommended treatment period. If you have any further questions about using this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine 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 shortness of breath, swelling in the face or other parts of the body, skin rash, circulatory disorders, and a drop in blood pressure.
• Sudden appearance of skin rash, blisters, or peeling of the skin, accompanied by fever.
• Persistent diarrhea, 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 classification is 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: the frequency of these side effects is unknown

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

• Positive Coombs test result (a test for the presence of certain antibodies).

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

• Prolonged blood clotting time (prolonged prothrombin time or kaolin-cephalin time),
• Anemia,
• Increased number of certain blood cells (eosinophilia),
• Phlebitis at the injection site,
• Diarrhea,
• Skin rash,
• Reaction at the injection site,
• Pain and inflammatory reaction 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 number of certain blood cells (thrombocytopenia, leukopenia, neutropenia),
• Headache,
• Colitis,
• Nausea,
• Vomiting,
• Redness of the skin (erythema),
• Urticaria,
• Itching of the skin,
• Increased urea levels in the blood,
• Increased creatinine levels in the serum,
• Fever,
• Inflammatory reaction around the injection site.

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

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

Otherside effects (the frequency of these side effects is unknown)

• Decreased number of certain blood cells [aplastic anemia, hemolytic anemia, agranulocytosis, and resulting increased risk of bleeding, bruising, and infections],
• Life-threatening shock caused by an allergic reaction (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 redness of the skin with blisters and fever (Stevens-Johnson syndrome, see introduction to the section on side effects),
• Inflammatory redness of the skin (erythema multiforme),
• Kidney failure,
• Kidney damage (nephrotoxicity).

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 "national reporting system":
Department for Monitoring of Adverse Reactions to 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 medicine.

5. How to store Cefepime Panpharma

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

6. Contents of the packaging and other information

What Cefepime Panpharma contains

• The active substance of this medicine is cefepime dihydrochloride monohydrate. Each vial of Cefepime Panpharma 1 g contains 1 g of cefepime (in the form of cefepime dihydrochloride monohydrate).
• The other ingredient is L-arginine.

What Cefepime Panpharma looks like and what the packaging contains

Cefepime Panpharma 1 g is a pale yellow powder for solution for injection or infusion in a glass vial (type II) with a capacity of 20 ml, with a chlorobutyl rubber stopper, an aluminum seal, and a 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 for marketing in the Member States of the European Economic Area under the following names:

Date of last revision of the leaflet: 05.08.2020

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Information intended for healthcare professionals only:

Resistance datafor cefepime - see the technical information for the medicinal product Cefepime Panpharma.

How to use:

Preparation and administration of the ready-to-use solution:
Cefepime Panpharma powder for solution for injection or infusion should be dissolved in:
a)
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 concentration of cefepime in the vial, are given in the table below.

Solutions reconstituted with water for injection are physically and chemically 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 physically and chemically stable for 4 hours at room temperature (15-25°C). From a microbiological point of view, the product should be used immediately. If the product is not used immediately, the user is responsible for the storage time after reconstitution and the storage conditions, but the storage time after opening should not normally exceed 24 hours at 2-8°C, unless the product has been reconstituted in controlled and validated aseptic conditions.
Warning!
Ready-to-use solutions that have been prepared correctly may have a yellow to yellow-brown color. This does not affect the efficacy of the medicinal product Cefepime Panpharma. The contents of the vial are intended for single use only. Any remaining solution should be discarded.