CEFEPIME 1 g Powder

Contents of the leaflet

1. Leaflet accompanying the packaging: information for the user
2. Cefepime Accord, 1 g, powder for solution for injection/infusion
   1. Read the leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
3. What Cefepime Accord is and what it is used for
4. Important information before using Cefepime Accord
   1. When not to use Cefepime Accord
   2. Warnings and precautions
   3. Children
   4. Older people
   5. Cefepime Accord and other medicines
   6. Pregnancy, breastfeeding, and fertility
   7. Driving and using machines
5. How to use Cefepime Accord
   1. Method of administration:
   2. Recommended dose:
   3. Adults and adolescents over 12 years of age (approximately over 40 kg body weight)
   4. Infants (over 2 months of age) and children weighing up to 40 kg (approximately up to 12 years of age)
   5. Infants from 1 to less than 2 months of age
   6. Patients with kidney problems
   7. Using more than the recommended dose of Cefepime Accord
   8. Missing a dose of Cefepime Accord
6. Possible side effects
   1. Situations to watch out for
   2. If you experience any of these symptoms, you should immediately contact your doctor or nurse.
   3. Very common side effects observed in blood tests:
   4. Common side effects
   5. Uncommon side effects
   6. Rare side effects
   7. Other side effects with unknown frequency (including single cases)
   8. Reporting side effects
7. How to store Cefepime Accord
8. Contents of the packaging and other information
   1. What Cefepime Accord contains
   2. What Cefepime Accord looks like and what the pack contains
   3. Marketing authorization holder
   4. Manufacturer
   5. This medicinal product is authorized in the Member States of the European Economic Area under the following names:
   6. Date of last revision of the leaflet: June 2024
   7. Information intended for healthcare professionals only:

Leaflet accompanying the packaging: information for the user

Cefepime Accord, 1 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, so you can read it again if you need to.
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If you have any doubts, consult your doctor, pharmacist, or nurse.
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This medicine has been prescribed to a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
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If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor. See section 4.

Table of contents of the leaflet

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

1. What Cefepime Accord is and what it is 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 and weighing less than 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, if it is suspected that the fever is caused by a bacterial infection); concomitant use with another antibiotic is recommended if necessary,
to treat bacterial sepsis.

2. Important information before using 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 another type of beta-lactam antibiotic (penicillins, monobactams, carbapenems);
• if the patient has increased blood acidity (acidosis).

Tell your doctor before starting to use Cefepime Accord if you think any of the above applies to you. In such a case, you must not use Cefepime Accord.

Warnings and precautions

Tell your doctor or healthcare professional:

• if the patient has ever had an allergic reactionto cefepime or any other beta-lactam antibiotic, or to any other medicine; if an allergic reaction occurs during treatment with cefepime, you should immediatelyconsult a doctor, as this reaction may be severe; in such a case, the doctor will immediately stop the use of the medicine;
• if the patient has ever been diagnosed with asthmaor has a tendency to allergies;
• if the patient has kidney problems; the dose of cefepime may need to be adjusted;
• if a severe and persistent diarrheaoccurs during treatment; this may be a sign of colitis and prompt medical attention may be necessary;
• if the patient suspects that they have developed a new infectionduring long-term use of Cefepime Accord; this may be an infection caused by bacteria that are resistant to cefepime and it may be necessary to stop using the medicine;
• if the doctor orders blood or urine tests, the patient should tell the doctor that they are using Cefepime Accord, as this medicine may affect the results of some tests.

Children

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

Older people

Dosage in older people should be carefully selected, taking into account kidney function, as these patients are more likely to have reduced kidney function (see section 3).

Cefepime Accord and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.
In particular, tell your doctor if you are taking:

• 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 effect may be enhanced;
• certain types of antibiotics (bacteriostatic antibiotics) - may affect the action of cefepime.

Pregnancy, breastfeeding, and fertility

• If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using 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 you become pregnant while using Cefepime Accord, tell your doctor.
• Cefepime passes into breast milk in very small amounts, so caution should be exercised when using it in breastfeeding women.

There is no data on the effect of cefepime on human fertility.

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 consciousness, dizziness, confusion, or hallucinations may affect the ability to drive and use machines.

3. How to use Cefepime Accord

Method of administration:

Cefepime Accord is usually administered by a doctor or nurse. It is given as an intravenous infusionor by injectiondirectly into a vein or by deep intramuscular injection into the gluteal muscle.

Recommended dose:

The dose of Cefepime Accord will be determined by your doctor and depends on: the severity and type of infection, whether you are taking another antibiotic at the same time, your weight and age, and your kidney function. The duration of treatment is usually 7 to 10 days.

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

The usual dose for 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 weighing up to 40 kg (approximately up to 12 years of age)

A dose of 50 mg of cefepime per kilogram of body weightis 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 weightis used, administered every 12 hours (or every 8 hours in the case of very severe infections).

Patients with kidney problems

If you have kidney problems, your doctor may adjust the dose of the medicine.
Tell your doctor if you think any of the above applies to you.
If you have any further doubts about using this medicine, consult your doctor, pharmacist, or nurse.

Using more than the recommended dose of Cefepime Accord

In cases of severe overdose, especially in patients with kidney problems, hemodialysis may be helpful in removing cefepime from the body (peritoneal dialysis is not beneficial). Unintentional overdose has occurred when patients with kidney problems received cefepime in high doses.
If you have any further doubts about using the medicine, consult your doctor, pharmacist, or nurse.

Missing a dose of Cefepime Accord

If you think you have missed a dose of Cefepime Accord, tell your doctor.
If you have any further doubts about using the medicine, consult your 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 using Cefepime Accord may experience an allergic reaction or skin reaction, which can be severe. The symptoms of such reactions are:

• severe allergic reaction- signs 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 edges),
• widespread rash with blistersand peeling of the skin(these may be symptoms of Stevens-Johnson syndrome or toxic epidermal necrolysis),
• 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 using Cefepime Accord for a long period.

If you experience any of these symptoms, you should immediately contact your doctor or nurse.

Very common side effects observed in blood tests:

May occur more often than in 1 in 10 people:

• positive Coombs test

Common side effects

May occur less often than in 1 in 10 people:

• pain, swelling, or redness along the vein
• diarrhea
• rash Tell your doctorif you experience any of the above.

Common side effects observed in blood tests:

• increased activity of substances (enzymes) produced by the liver
• increased bilirubin level (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 in 1 in 100 people:

• colitis (inflammation of the large intestine) causing diarrhea, usually with blood and mucus, abdominal pain
• oral thrush, vaginal infections
• increased body temperature (fever)
• redness of the skin, hives, itching
• nausea, vomiting
• headache Tell your doctorif you experience any of the above.

Uncommon side effects observed in blood tests:

• 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 in 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 skin layers
• joint pain
• ringing in the ears

Other side effects with unknown frequency (including single cases)

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

Side effects observed in blood tests:

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

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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 the medicine.

5. How to store Cefepime Accord

Keep the medicine 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. 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 Accord contains

• The active substance of the medicine is cefepime in the form of cefepime dihydrochloride monohydrate (1.19 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, in 17 ml vials made of colorless type III glass, with a chlorobutyl rubber stopper type I, and 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 solid particles.
Storage conditions after reconstitution:
The chemical and physical stability of the product has been demonstrated as follows:
Cefepime Accord 1 g reconstituted with 1% lidocaine can be used for 12 hours if stored at 2-5°C.
Cefepime Accord 1 g dissolved in water for injection and 0.9% sodium chloride can be used for 24 hours if stored at 2-8°C.
Cefepime Accord 2 g dissolved 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 person administering the medicine is responsible for the storage conditions after opening.
Storage conditions after dilution:
The chemical and physical stability of the product has been demonstrated as follows:
Cefepime Accord 1 g diluted with water for injection and 10% dextrose can be used for 12 hours if stored at 25°C.
All other diluted infusion solutions or solutions for intramuscular administration should be used immediately.
Intramuscular administration:
To prepare a solution for intramuscular injection, 3 ml of water for injection or 0.5% or 1% lidocaine hydrochloride solution should be used as a solvent.
Use of lidocaine:
If a lidocaine solution is used as a solvent, cefepime solutions should only be used for intramuscular injections. Before use, consider the contraindications, warnings, and other important information listed in the Lidocaine Product Characteristics.
Lidocaine solution should never be administered intravenously.
In children over 30 months of age, intramuscular injection of lidocaine as a solvent is recommended.
Intravenous administration:
Cefepime Accord 1 g should be dissolved in 10 ml of water for injection or in 5% dextrose solution or 0.9% sodium chloride. The resulting solution should be injected directly into a vein (over 3 to 5 minutes) or into a cannula of the infusion system, when the patient is receiving a compatible intravenous fluid.
The following table contains instructions for reconstitution:
Intravenous infusion

Cefepime Accord 1 g reconstituted can be administered through a drip infusion 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% dextrose), 5% Ringer's solution with lactate (with or without 5% dextrose), lactated Ringer's solution 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, vial, 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 without solid particles should be used.