PATIENT INFORMATION LEAFLET

CEFEPIMA KABI 1 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.

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".

Antibiotics are used to treat bacterial infections and do not work for viral infections such as the flu or a cold.

It is essential to follow the instructions regarding the dose, administration interval, and treatment duration indicated by your doctor.

Do not store or reuse this medication. If there is any leftover antibiotic after treatment, return it to the pharmacy for proper disposal. Do not dispose of the medication through the drain or in the trash.

No 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 cephalosporin-type antibiotic

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

denominated

If you have any doubts, ask your doctor.

Inform your doctor before starting to use Cefepima Kabi

• if you have ever had asevere allergic reactionto cefepime or to other antibiotics of the beta-lactam type or to any medication. If you have developed an allergic reaction during treatment with Cefepima, you must contact your doctor

immediately, as it could be serious. In that case, your doctor will suspend the treatment immediately.

• if you have ever suffered fromasthmaor a tendency to be allergic.
• if you havekidney problems, it may be necessary to adjust the dose of Cefepima Kabi.
• if you developsevere and persistent diarrheaduring treatment. This may be a sign of an inflamed large intestine and requires urgent medical intervention.

sign of an inflamed large intestine and requires urgent medical intervention.

• if you suspect that you have developed anew infectionduring prolonged use of Cefepima Kabi. This may be an infection caused by microorganisms that are not sensitive to cefepime and may require discontinuation of treatment.

Cefepima Kabi. This may be an infection caused by microorganisms that are not sensitive to cefepime and may require discontinuation of 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 alter the results of some tests.

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.

medications should not be taken or used with cefepime.

In particular, inform your doctor if you take:

• any other antibiotic, especially aminoglycosides (such as gentamicin) or

diuretics (such as furosemide); in these cases, kidney function should be monitored.

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

action may be reinforced.

• 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 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.

best to avoid using cefepime during pregnancy.

Small amounts of this medication may pass into breast milk. Cefepime may be administered during breastfeeding, but you should monitor for any adverse effects in the infant.

infant.

If you are pregnant or breastfeeding, 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 that case, do not drive or operate any machinery.

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

by slow injection into a vein (intravenous) or

• by 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 how well your kidneys are functioning. 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 six 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, speak with 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 shouldinterrupt the administrationof Cefepima Kabi and visit your doctorimmediatelyif 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).

Also, the following side effects have 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

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

- Alteration of blood count, including low red blood cell count (anemia) and changes in white blood cell count

- Alteration of laboratory values 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

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

- Inflammation of the infusion area

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

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

- Respiratory difficulties

- Ulcers

- Abdominal pain, constipation

- Vasodilation

- Chills

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

- Potential fatal allergic reaction (anaphylactic shock)

- Alteration of blood count, 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 for 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 turbid 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. Dispose of the

packaging and medicines that you do not need at the SIGRE collection point

of the pharmacy. In

case of doubt, ask your pharmacist how to dispose of the packaging and medicines

that you do not need. In this way, 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 1 g powder for injectable solution or for infusion contains 1 g of cefepime (as 1189.2 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 injectable solution in

vein (intravenous) or a perfusion (infusion) in vein (intravenous perfusion).

Once prepared, the doctor may mix the cefepima Kabi solution with other

appropriate fluids for perfusion.

Marketing Authorization Holder

FRESENIUS KABI ESPAÑA, S.A.U.

C/Marina 16-18

08005 – Barcelona (Spain)

Responsible 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 1 g, powder for solution for injection

or infusion;

Bulgaria:Cefepima Kabi 1 g powder for injectable solution or for perfusion; Cefepima

Kabi 2 g in powder for injectable solution or perfusion

Cyprus, Greece:Cefepima Kabi 1 g, κ?νις για δι?λυμα προς ?νεση ? ?γχυση;

Spain:Cefepima Kabi 1g powder for injectable solution or for perfusion EFG;

Poland:Cefepim Kabi

Portugal: Cefepima Kabi

Romania:CEFEPIME KABI 1 g, pulbere pentru solutie injectabila sau perfuzabila;

Slovenia:Cefepim Kabi 1 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 of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/”

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This information is intended solely for medical professionals or healthcare 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) 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 during 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%), lactate

sodium 6M.

Instructions for Reconstitution, Dilution, and Administration

For intravenousdirectadministration, reconstitute cefepima Kabi with sterile injectable preparation water, 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.

Forintravenous perfusion, reconstitute 1 g of 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 perfusion time should be 30 minutes.

Preparation of cefepima solutions

Elimination

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