PATIENT INFORMATION LEAFLET

CEFEPIMA KABI 2 g powder for injection and for IV infusion EFG

(cefepima)

Read this leaflet carefully before you start using the medicine,

because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1.What Cefepima Kabi is and what it is used for

2.What you need to know before you start using Cefepima Kabi

3.How to use Cefepima Kabi

4.Possible side effects

5.Storage of Cefepima Kabi

6.Contents of the pack and additional information

Cefepima Kabi is an antibiotic used to treat infections in different parts of the body caused by bacteria. It belongs to a group of antibiotics called "fourth-generation cephalosporins."

Cefepima only acts against some types of bacteria, meaning it is only suitable for treating some types of infections.

Cefepima Kabi can treat many types of infections:

In adults and children over 12 years, including:

• Severe urinary tract infections (infections of the urinary tract)
• Pneumonia
• Severe abdominal cavity infections
• Peritonitis associated with continuous ambulatory peritoneal dialysis (CAPD) in patients undergoing dialysis

In children from two months to 12 years and with a body weight ≤ 40 kg, including:

• Severe urinary tract infections (infections of the urinary tract)
• Pneumonia

Cefepima can be used in adults and children over two months for the treatment of bacteremia caused by or suspected to be caused by any of the infections mentioned above.

Cefepima can be used in adults and children over two months for the treatment of neutropenic patients (patients with low defenses) with fever suspected to be due to a bacterial infection.

Do not use Cefepima Kabi:

-if you are allergic (hypersensitive) to:

??cefepime or any of the other components of this medication (listed in section 6)

??any other type of cephalosporin antibiotic

-if you have ever had a severe allergic reaction to other beta-lactam antibiotics (such as penicillin, also known as monobactams and carbapenems)

If you have any doubts, ask your doctor.

Be especially careful with Cefepima Kabi

Inform your doctor before starting to use Cefepima Kabi

-if you have ever had anallergic reactionto cefepime or to other beta-lactam antibiotics or to any medication. If you have developed an allergic reaction during treatment with Cefepima, you must contact your doctorimmediately, as it could be severe. In this case, your doctor will stop the treatment immediately.

-if you have ever hadasthmaor a tendency to be allergic.

-if you havekidney problems, your doctor may need to adjust the dose of Cefepima Kabi.

-if you developsevere and persistent diarrheaduring treatment. This may be a sign of an inflammation of the large intestine and requires urgent medical attention.

-if you suspect that you have developed anew infectionwhile using Cefepima Kabi for a long time. This may be an infection caused by microorganisms that are not sensitive to cefepime and may require stopping treatment.

-if you need to haveblood or urine tests,it is essential to inform your doctor that you are using Cefepima Kabi. This medication may affect the results of some tests.

Other medications and Cefepima Kabi

Inform your doctor or pharmacist if you are using, have used recently, or may need to take other medications. This is important because some medications should not be taken or used with cefepime.

Particularly, inform your doctor if you take:

-any other antibiotic, especially aminoglycosides (such as gentamicin) or diuretics (such as furosemide); in these cases, your kidney function should be monitored.

-medications used to prevent blood clotting (anticoagulant coumarins, such as warfarin), their action may be enhanced.

-certain types of antibiotics (bacteriostatic antibiotics) may interfere with the action of cefepime.

Pregnancy and breastfeeding

Inform your doctor if you are pregnant or think you may be pregnant before receiving treatment with Cefepima Kabi. Since there is no information about the use of this medication during pregnancy, it is best to avoid using cefepime during pregnancy.

Small amounts of this medication may pass into breast milk. You can be given cefepime during breastfeeding, but you should monitor if any adverse effects appear in the infant.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using any medication

Driving and operating machinery

While taking this medication, you may experience headaches, convulsions, dizziness, confusion, or altered consciousness. In this case, do not drive or operate any machinery.

Cefepima Kabi is usually administered by a doctor or nurse. Its administration can be:

-slow injection into a vein (intravenous) or

-infusion (drip) into a vein (intravenous infusion).

The dose depends on the type and severity of the infection. The dose also depends on age, weight, and kidney function. Your doctor will explain this to you.

Cefepima Kabi is usually administered two to three times a day.

Usual dose

• in adults and adolescents (over 12 years) is 4 to 6 grams per day,
• in babies and children (from two months to 12 years) the dose is 100 to 150 milligrams per kilogram of body weight per day
• theusual duration of therapyis 7 to 10 days.
• the maximum dose for children over two months and adults is 6 grams per day.

If you use more Cefepima Kabi than you should

If you think you have received more Cefepima Kabi than you should, inform your doctor immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to use Cefepima Kabi

If you think you have forgotten a dose or infusion, talk to your doctor.

If you interrupt the treatment with Cefepima Kabi

Although you may feel better after the first few doses, continue the complete treatment with this medication. If you interrupt the treatment with this medication too soon, it is possible that your infection will not be cured.

If you have any other questions about the use of this medication, ask your doctor.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

The following side effects are serious and will require immediate action if you experience them. You shouldstop administering Cefepima Kabi and visit your doctorimmediately if you experience the following symptoms:

- Inflammation of the large intestine, known as pseudomembranous colitis (or antibiotic-associated colitis); causes a persistent watery diarrhea with abdominal cramps and fever (can affect up to 1 in 100 people).

- Acute allergic reaction (known as anaphylaxis) associated with difficulty breathing or sudden choking, facial or body swelling, rash, fainting (loss of consciousness) (can affect up to 1 in 1,000 people).

- Mild to moderate skin rash with erosions and blisters (erythema multiforme) (the frequency cannot be estimated from the available data).

- Sudden onset of a rash and acute inflammation with blistering or peeling of the skin, associated with high fever and painful joints (Stevens-Johnson syndrome) affects 1-10 people per 10,000).

The following side effects have also been described:

Very common(can affect more than 1 in 10 people).

- False positive result in the test for antibodies that cause the destruction of red blood cells

Common(can affect up to 1 in 10 people).

- Allergic reactions such as skin rash

- Diarrhea

- Respiratory difficulties

- Pain, swelling, and irritation of the intravenous injection site (phlebitis) and vein inflammation (thrombophlebitis)

- Blood count alteration, including low red blood cell count (anemia) and changes in white blood cell count

- Laboratory value alteration indicating liver insufficiency

Uncommon(can affect up to 1 in 100 people).

- Vaginal inflammation

- Irritated skin, urticaria

- Headache, fever

- Nausea and vomiting

- Oral ulcers

- Increase in some blood test results (urea and creatinine) indicating kidney function

- Blood count alteration (changes in the number of some white blood cells and platelets)

- Inflammation of the perfusion area

Rare(can affect up to 1 in 1,000 people).

- Sensory disturbance (paresthesia), confusion, dizziness, seizure, altered appetite

- Respiratory difficulties

- Ulcers

- Abdominal pain, constipation

- Vasodilation

- Chills

Unknown(the frequency cannot be calculated from the available data)

- Potentially fatal allergic reaction (anaphylactic shock)

- Blood count alteration, acute decrease in red blood cell count (anemia) or white blood cell count (agranulocytosis)

- Cerebral dysfunction, including altered consciousness (stupor, coma), confusion, hallucinations, muscle movements (myoclonus)

- Renal insufficiency (renal insufficiency, toxic nephropathy)

- Functional disorder of the stomach and intestine

- Bleeding from damaged blood vessels (hemorrhage)

- False positive result for the glucose test in urine

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or nurse, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging, after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C.

Store the vial in the outer packaging to protect it from light.

Once the solution with Cefepima Kabi powder has been prepared, it must be used immediately. Do not use Cefepima Kabi if you observe that the solution is cloudy and discolored; it must be completely transparent and between colorless and amber.

You must discard any unused solution.

.

“Medicines should not be thrown down the drains or in the trash. Deposit the packaging and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medicines. By doing so, you will help protect the environment.”

Cefepima Kabi Composition

The active ingredient is cefepime in the form of cefepime dihydrochloride monohydrate.The other ingredient is L-arginine.

Each vial of cefepima Kabi 2 g powder for injectable solution or for infusion contains 2 g of cefepime (as 2378.5 mg of cefepime dihydrochloride monohydrate).

Product Appearance and Packaging Contents

Cefepima Kabi powder is normally mixed with water to prepare injectable solutions or with other appropriate liquids to prepare a transparent intravenous (IV) solution or an intravenous infusion (IV).

Once prepared, the physician may mix the Cefepima Kabi solution with other appropriate fluids for infusion.

Marketing Authorization Holder

FRESENIUS KABI ESPAÑA, S.A.U.

C/Marina 16-18

08005 – Barcelona (Spain)

Responsible Person for Manufacturing

LABESFAL - Laboratorios Almiro S.A.

FRESENIUS KABI GROUP

3465-157 Santiago de Besteiros

PORTUGAL

This medicinal product is authorized in the member states of the European Economic Area with the following names:

Belgium, Netherlands:Cefepim Fresenius Kabi 2 g, powder for solution for injection

or infusion;

Cyprus, Greece:Cefepima Kabi 2 g, κ?νις για δι?λυμα προς ?νεση ? ?γχυση

Spain:Cefepima Kabi 2 g powder for injectable solution or for infusion EFG

Poland:Cefepim Kabi

Portugal:Cefepima Kabi

Slovenia:Cefepim Kabi 2 g prašek za raztopino za injiciranje ali infundiranje

This leaflet was revised in July 2015

“Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/”

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This information is intended solely for medical professionals:

Before administration, it is recommended to inspect parenteral solutions to verify that they are free of particles.

The solution may change color after storage (colorless to amber yellow) without affecting the potency of the product.

Storage Conditions

Before opening:

Do not store at a temperature above 25°C.

Store the vial in the outer packaging to protect it from light.

After reconstitution/dilution:

Cefepima solutions should be used immediately after reconstitution.

Chemical and physical stability has been demonstrated for use over two hours at 25°C.

From a microbiological point of view, the dilution should be used immediately. If not used immediately, the time and storage conditions before use are the responsibility of the user and generally should not exceed 24 hours at 2-8°C, unless the reconstitution was prepared in controlled and validated aseptic conditions.

Compatibilities

Cefepima is compatible with the following diluents and solutions: sodium chloride 0.9%

(with or without dextrose 5%), dextrose 10%, Ringer's solution (with or without dextrose 5%), sodium lactate 6M.

Instructions for Reconstitution, Dilution, and Administration

For intravenous direct administration, reconstitute Cefepima Kabi with sterile water for injections, dextrose injection 5%, or sodium chloride injection 0.9%,

for the volumes shown in the following table, “Preparation of cefepima solutions”. The resulting solution should be injected directly into the vein over a period of 3 to 5 minutes or injected into the tubing of a device for administering medications while the patient receives a compatible IV fluid.

For intravenous infusion, reconstitute2 gof cefepima solution, as indicated above for intravenous direct administration; and add an appropriate amount of the resulting solution to a container with a compatible IV fluid. The infusion time should be 30 minutes.

Preparation of cefepima solutions

Elimination

Unused products and waste should be disposed of in accordance with local regulations.