CEFEPIMA KABI 1g POWDER FOR INJECTABLE SOLUTION AND FOR INFUSION

2. What you need to know before you use Cefepima Kabi

Do not use Cefepima Kabi:

• if you are allergic (hypersensitive) to:

? cefepima or any of the other ingredients of this medicine (listed in section 6)

? any other cephalosporin-type 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 are not sure, ask your doctor.

Tell your doctor before using Cefepima Kabi:

• if you have ever had an allergic reaction to cefepima or other beta-lactam antibiotics or any other medicine. If you develop an allergic reaction during treatment with Cefepima, you should contact your doctor immediately, as it could be severe. In this case, your doctor will stop treatment immediately.
• if you have ever had asthma or an allergic tendency.
• if you have kidney problems, your doctor may need to adjust the dose of Cefepima Kabi.
• if you develop severe and persistent diarrhea during treatment. This could be a sign of inflammation of the large intestine and requires urgent medical attention.
• if you suspect you have developed a new infection during prolonged use of Cefepima Kabi. This could be an infection caused by microorganisms that are not sensitive to cefepima and may require discontinuation of treatment.
• if you need to have a blood or urine test, it is important that you inform your doctor that you are using Cefepima Kabi. This medicine may affect the results of some tests.

Other medicines and Cefepima Kabi

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. This is important because some medicines should not be used with cefepima.

In particular, tell your doctor if you are taking:

• any other antibiotic, especially aminoglycosides (such as gentamicin) or diuretics (such as furosemide); in these cases, kidney function should be monitored.
• medicines used to prevent blood clotting (anticoagulants such as warfarin), their effect may be enhanced.
• certain types of antibiotics (bacteriostatic antibiotics) may interfere with the action of cefepima.

Pregnancy and breastfeeding

Tell your doctor if you are pregnant or think you may be pregnant before receiving treatment with Cefepima Kabi. Since there is no information on the use of this medicine during pregnancy, it is preferable to avoid using cefepima during pregnancy.

Small amounts of this medicine may pass into breast milk. You can be given cefepima while breastfeeding, although you should monitor your baby for any side effects.

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 taking any medicine.

Driving and using machines

While taking this medicine, you may have headaches, seizures, dizziness, confusion, or an altered state of consciousness. In this case, do not drive or use any machine or tool.

3. How to use Cefepima Kabi

Cefepima Kabi is usually given by a doctor or nurse. The 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 kidney function. Your doctor will explain it to you.

Cefepima Kabi is usually given 2 to 3 times a day.

The usual dose is:

• in adults and adolescents (over 12 years) 4 to 6 grams per day,
• in infants and children (from 2 months to 12 years) the dose is 100 to 150 milligrams per kilogram of body weight per day

If you use more Cefepima Kabi than you should

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

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

If you forget to use Cefepima Kabi

If you think you have missed an injection or infusion, talk to your doctor.

If you stop using Cefepima Kabi

Even if you feel better after the first doses, follow the complete treatment with this medicine. If you stop treatment with this medicine too soon, your infection may not be cured.

If you have any further questions on the use of this medicine, ask your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects are important and may require immediate action if you experience them. You should stop using Cefepima Kabiand see your doctor immediatelyif you experience any of the following symptoms:

• A severe inflammation of the large intestine, called pseudomembranous colitis (or antibiotic-associated colitis), which causes severe, watery diarrhea with abdominal cramps and fever (may affect up to 1 in 100 people).

• A severe allergic reaction (anaphylaxis) associated with difficulty breathing or sudden shortness of breath, swelling of the face or body, rash, fainting (may affect up to 1 in 1,000 people).

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

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

Other side effects have also been reported:

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

• False positive result for the test for antibodies that destroy red blood cells

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

• Allergic reactions such as skin rash
• Diarrhea
• Pain, swelling, and irritation at the injection/infusion site (phlebitis) and inflammation of the vein (thrombophlebitis)

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

• Vaginal inflammation
• Irritated skin, hives
• Headache, fever
• Nausea and vomiting
• Mouth ulcers
• Increased results of some blood tests (urea and creatinine) indicating kidney function
• Changes in blood cell counts (changes in the number of some white blood cells and platelets)

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

• Disorders of perception (paresthesia), confusion, dizziness, epileptic seizure, altered appetite
• Breathing difficulties
• Mouth ulcers
• Abdominal pain, constipation
• Enlargement of blood vessels
• Chills

Not known(frequency cannot be estimated from the available data)

• Potentially life-threatening allergic reaction (anaphylactic shock)
• Changes in blood cell counts, sudden decrease in the number of red blood cells (anemia) or white blood cells (agranulocytosis)
• Brain dysfunction, including altered state of consciousness (stupor, coma), confusion, hallucinations, muscle movements (myoclonus)
• Kidney failure (kidney failure, 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 side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Cefepima Kabi

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

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

Do not store above 25°C.

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

Once the solution with Cefepima Kabi powder is prepared, it should be used immediately. Do not use Cefepima Kabi if you notice that the solution is cloudy or discolored; it should be completely clear and colorless to pale yellow.

Any unused solution should be discarded.

"Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment."

6. Container Content and Additional Information

Composition of Cefepima Kabi

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

Each vial of Cefepima Kabi 1 g powder for solution for injection or infusion contains 1 g of cefepima (as 1189.2 mg of cefepima dihydrochloride monohydrate).

Appearance of the Product and Container Content

Cefepima Kabi powder is normally mixed with water for injectable preparations

or with other suitable liquids to prepare a clear injectable solution for intravenous (IV) administration

or an infusion (drip) in a vein (intravenous infusion).

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

suitable fluids for infusion.

Marketing Authorization Holder

FRESENIUS KABI ESPAÑA, S.A.U.

C/Marina 16-18

08005 – Barcelona (Spain)

Manufacturer

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 under the following names:

Belgium, Netherlands:Cefepim Fresenius Kabi 1 g, powder for solution for injection or infusion;

Bulgaria:Cefepima Kabi 1 g powder for solution for injection or infusion; Cefepima Kabi 2 g powder for solution for injection or infusion

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

Spain:Cefepima Kabi 1g powder for solution for injection or infusion 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 last revised in July 2015

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

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This information is intended solely for healthcare professionals:

Before administration, it is recommended to inspect the parenteral solutions

to verify that they are free of particles.

The solution may change color after storage (from colorless to yellow

amber) without affecting the product's potency.

Storage Conditions

Prior to opening:

Do not store at a temperature above 25°C.

Keep 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 2 hours at 25 ºC.

From a microbiological point of view, the dilution should be used immediately. If not used immediately, the storage time and conditions before use are the responsibility of the user and should not normally exceed 24 hours at 2 - 8 ºC, unless the reconstitution has been 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 directintravenous administration, reconstitute Cefepima Kabi with sterile water for

injectable preparations, 5% dextrose injection, or 0.9% sodium chloride injection,

for the volumes shown in the following table, “Preparation of cefepima solutions”. The resulting solution should be injected directly into a vein over an

interval of 3 to 5 minutes or should be injected into the tubing of an infusion set while the patient is receiving a compatible IV fluid.

For infusion, reconstitute 1 g of cefepima solution as indicated above for direct intravenous 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

Disposal

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