Cefepime Accord

Leaflet accompanying the packaging: information for the user

Cefepime Accord, 2 g, powder for solution for injection/infusion

Cefepime

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

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Keep this leaflet, you may need to read it again.
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In case of any doubts, consult a doctor, pharmacist, or nurse.
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This medicine has been prescribed specifically for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
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If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor. See section 4.

Table of contents of the leaflet

• 1. What is Cefepime Accord and what is it used for
• 2. Important information before taking Cefepime Accord
• 3. How to take Cefepime Accord
• 4. Possible side effects
• 5. How to store Cefepime Accord
• 6. Contents of the packaging and other information

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

Cefepime Accord is an antibiotic used in adults and children. Its action is based on killing bacteria that cause infections. It belongs to the group of antibiotics called fourth-generation cephalosporins.
Cefepime Accord is used to treat the following infections:
In adults and adolescents over 12 years of age:

• lung infections (pneumonia),
• complicated (severe) urinary tract infections,
• complicated (severe) abdominal infections,
• peritonitis (inflammation of the lining of the abdominal cavity) associated with dialysis in patients undergoing continuous ambulatory peritoneal dialysis (CAPD).

In adults:

• acute cholecystitis.

In children from 2 months to 12 years of age with a body weight below 40 kg:

• complicated (severe) urinary tract infections,
• lung infections (pneumonia),
• bacterial meningitis.

Cefepime is also used in adults and children over 2 months of age:
to treat febrile neutropenia (fever of unknown origin in patients with reduced immunity); combined therapy with another antibiotic is recommended if necessary,
to treat bacterial sepsis.

2. Important information before taking Cefepime Accord

When not to use Cefepime Accord

• 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 a severe allergic reaction (hypersensitivity reaction) to a beta-lactam antibiotic of a different type (penicillins, monobactams, carbapenems);
• if the patient has increased blood acidity (acidosis).

The patient should inform their doctor before starting to take Cefepime Accord if they think any of the above applies to them. In such a case, the patient must not be given Cefepime Accord.

Warnings and precautions

The patient should inform their doctor or healthcare professional:

• if they have ever had an allergic reaction to cefepime or any other beta-lactam antibiotic, or any other medicine; if an allergic reaction occurs during treatment with cefepime, the patient should immediately consult a doctor, as the reaction may be severe; in such a case, the doctor will immediately stop the use of the medicine;
• if they have ever been diagnosed with asthma or have a tendency to allergies;
• if they have kidney function disorders; the dose of cefepime may need to be modified;
• if they experience severe and persistent diarrhea; this may be a sign of colitis and prompt medical attention may be necessary;
• if they suspect that they have developed a new infection during long-term use of Cefepime Accord; this may be an infection caused by bacteria that are not sensitive to cefepime and discontinuation of the medicine may be necessary;
• if the doctor prescribes blood or urine tests, the patient should tell the doctor that they are taking Cefepime Accord, as the medicine may affect the results of some tests.

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 kidney function, as these patients are more likely to have impaired kidney function (see section 3).

Cefepime Accord and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
The patient should especially inform their doctor about the following medicines:

• other antibiotics, especially aminoglycosides (such as gentamicin) or "diuretic tablets" (diuretics, such as furosemide) - in such cases, kidney function should be monitored;
• blood-thinning medicines (anticoagulants, such as warfarin) - their action may be enhanced;
• certain types of antibiotics (bacteriostatic antibiotics) - they may affect the action of cefepime.

Pregnancy, breastfeeding, and fertility

• If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
• Special caution is recommended when prescribing Cefepime Accord to pregnant women due to the lack of data on the use of the medicine in this group of patients. If the patient becomes pregnant while taking Cefepime Accord, they should inform their doctor.
• Cefepime passes into breast milk in very small amounts, so caution should be exercised when using it in breastfeeding women.

Cefepime has not been shown to affect fertility in humans.

• There is no data on the effect of cefepime on fertility in humans.

Driving and using machines

No studies have been conducted on the effect of cefepime on the ability to drive and use machines. However, possible side effects such as altered state of consciousness, dizziness, confusion, or hallucinations may affect the ability to drive and use machines.

3. How to take Cefepime Accord

Method of administration:

Cefepime Accord is usually administered by a doctor or nurse. It is given as an intravenous infusion or by injection directly into a vein.

Recommended dose:

The dose of Cefepime Accord will be determined by the doctor and depends on: the severity and type of infection, concurrent use of another antibiotic, body weight and age, and the patient's kidney function. The duration of treatment is usually 7 to 10 days.

Adults and adolescents with a body weight over 40 kg (approximately over 12 years of age)

The usual dose in adults is 4 g per day, divided into two doses (2 g every 12 hours).
In the case of very severe infections, the dose may be increased to 6 g per day (2 g every 8 hours).

Infants (over 2 months of age) and children with a body weight up to 40 kg (approximately up to 12 years of age)

A dose of 50 mg of cefepime per kilogram of body weight is used, administered every 12 hours.
In the case of very severe infections or bacterial meningitis, the same dose may be administered every 8 hours.

Infants from 1 to less than 2 months of age

A dose of 30 mg of cefepime per kilogram of body weight is used, administered every 12 hours (or every 8 hours in the case of very severe infections).

Patients with kidney function disorders

If the patient has kidney function disorders, the dose of the medicine may be changed by the doctor.
The patient should inform their doctor if they think the above information applies to them.
In case of any further doubts about the use of this medicine, the patient should consult their doctor, pharmacist, or nurse.

Use of a higher than recommended dose of Cefepime Accord

In cases of severe overdose, especially in patients with kidney function disorders, hemodialysis may be helpful in removing cefepime from the body (use of peritoneal dialysis is not beneficial). Unintentional overdose has occurred when patients with kidney function disorders received cefepime in high doses.
In case of any further doubts about the use of the medicine, the patient should consult their doctor, pharmacist, or nurse.

Missing a dose of Cefepime Accord

If the patient thinks they have not received a dose of Cefepime Accord, they should tell their doctor.
In case of any further doubts about the use of the medicine, the patient should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Cefepime Accord can cause side effects, although not everybody gets them.

Situations to watch out for

A small number of people taking Cefepime Accord may experience an allergic reaction or skin reaction, which can be severe. The symptoms of such reactions are:

• severe allergic reaction- symptoms include raised and itchy rash, swelling, sometimes also of the face or lips, which can cause difficulty breathing,
• skin rash, which may be accompanied by blisters, resembling small targets(dark spots centered, surrounded by a lighter area and a dark border along the edge),
• widespread rash with blistersand peeling of the skin(these may be symptoms of Stevens-Johnson syndrome or toxic epidermal necrolysis [Lyell's syndrome]),
• fungal infections:in rare cases, taking medicines like Cefepime Accord may promote the growth of yeast (Candida) in the body, leading to fungal infections (such as thrush); the likelihood of this side effect is higher when taking Cefepime Accord for a long period.

If the patient experiences any of these symptoms, they should immediately contact their doctor or nurse.

Very common side effects observed in blood test results:

May occur more often than 1 in 10 people:

• positive Coombs test

Common side effects

May occur less often than 1 in 10 people:

• pain, swelling, or redness along the vein
• diarrhea
• rash The patient should inform their doctorif any of the above symptoms occur.

Common side effects observed in blood test results:

• increased activity of substances (enzymes) produced by the liver
• increased bilirubin levels (a substance produced by the liver)
• change in the number of white blood cells (eosinophilia)
• decreased number of red blood cells (anemia)

Uncommon side effects

May occur less often than 1 in 100 people:

• colitis (inflammation of the colon) causing diarrhea, usually with blood and mucus, abdominal pain
• thrush, vaginal infections
• increased body temperature (fever)
• redness of the skin, hives, itching
• nausea, vomiting
• headache The patient should inform their doctorif they experience any of the above symptoms.

Uncommon side effects observed in blood test results:

• decreased number of certain types of blood cells (leukopenia, neutropenia, thrombocytopenia)
• increased levels of urea and creatinine in the blood.

Rare side effects

May occur less often than 1 in 1000 people:

• allergic reactions
• fungal infections (candidiasis)
• seizures, dizziness, taste disorders, tingling and numbness on the skin
• shortness of breath
• abdominal pain, constipation
• chills
• swelling of the deeper layers of the skin
• joint pain
• ringing in the ears

Other side effects with unknown frequency (including single cases)

• severe allergic reactions
• coma, impaired consciousness or difficulty thinking, confusion and hallucinations
• false positive result of the glucose test in urine
• digestive problems
• kidney function disorders
• bleeding

Side effects observed in blood test results:

• change in the number of blood cells (agranulocytosis)
• rapid breakdown of red blood cells (hemolytic anemia)

Reporting side effects

If side effects occur, including those not listed in this leaflet, the patient should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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 the medicine.

5. How to store Cefepime Accord

The medicine should be stored out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and label after EXP. The expiry date refers to the last day of the month.
Do not store above 30°C. Store in the original packaging to protect from light.
Storage of solutions: see the section "Information intended for healthcare professionals only" at the end of the leaflet.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their 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 Accord contains

• The active substance of the medicine is cefepime in the form of cefepime hydrochloride monohydrate (2.38 g).
• The other ingredient is L-arginine (to adjust pH).

What Cefepime Accord looks like and what the pack contains

Cefepime Accord is a white to pale yellow powder for solution for injection/infusion, placed in 17 ml vials made of colorless type III glass, with a chlorobutyl rubber stopper type I, with an aluminum flip-off cap, in a cardboard box.
Pack sizes: 1, 5, 10, or 50 vials
Not all pack sizes may be marketed.

Marketing authorization holder

Accord Healthcare Polska Sp. z o.o.
ul. Taśmowa 7
02-677 Warsaw
Phone: +48 22 577 28 00

Manufacturer

Laboratorio Farmaceutico CT. S.r.l.
Via Dante Alighieri, 71
18038 Sanremo
Italy

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

Date of last revision of the leaflet: June 2024

Information intended for healthcare professionals only:

After reconstitution, the solution is clear, colorless to amber, and free of particulate matter.
Storage conditions after reconstitution:
The chemical and physical stability of the product has been demonstrated as follows:
Cefepime Accord 2 g, after dissolution in water for injection and 0.9% sodium chloride, can be used for 12 hours if stored at 2-8°C.
From a microbiological point of view, the product should be used immediately. If the solution is not used immediately, the responsibility for the storage conditions after opening lies with the healthcare professional.
Storage conditions after dilution:
Diluted solutions for infusion or solutions for intramuscular administration should be used immediately.
Intravenous administration:
Cefepime Accord 2 g should be dissolved in 10 ml of water for injection or in a 5% glucose solution or 0.9% sodium chloride. The resulting solution should be injected directly into a vein (over 3 to 5 minutes) or into the cannula of an infusion system, when the patient is receiving a compatible intravenous fluid.
The following table provides instructions for reconstitution:
Intravenous infusion
Cefepime Accord 2 g, after reconstitution, can be administered through an infusion system or directly into the infusion fluid. The solution should be administered over approximately 30 minutes.
Cefepime is compatible with the following solutions: 0.9% sodium chloride (with or without 5% glucose), 5% Ringer's solution with lactate (with or without 5% glucose), sodium lactate M/6 for concentrations from 1 to 40 mg/ml.
Cefepime Accord can be administered simultaneously with other antibiotics or other medicines, provided that the same syringe, infusion bottle, or injection site is not used. Cefepime solutions are compatible with amikacin, ampicillin, clindamycin, heparin, potassium chloride, and theophylline.
Like other cephalosporins, after reconstitution, the solution may change color to yellow, which does not affect the efficacy of the medicinal product. Only a solution free of particulate matter should be used.