CEFEPIMA KABI 2g POWDER FOR INJECTABLE SOLUTION AND FOR INFUSION

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

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

(cefepima)

Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.

Keep this leaflet, as you may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

1. What Cefepima Kabi is and what it is used for
2. What you need to know before you use Cefepima Kabi
3. How to use Cefepima Kabi
4. Possible side effects
5. Storage of Cefepima Kabi
6. Contents of the pack and other information

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

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 certain types of bacteria, which means it is only suitable for treating certain types of infections.

Cefepima Kabi can treat many classes of infections:

In adults and children over 12 years, including:

• complicated (severe) infections of the bladder and kidneys (urinary tract infections)
• lung infections (pneumonia)
• complicated (severe) infections in the abdominal cavity
• inflammation of the membrane surrounding the abdominal cavity (peritonitis) associated with dialysis in patients undergoing continuous ambulatory peritoneal dialysis (CAPD)

In children from 2 months to 12 years and with a body weight ≤ 40 kg, including:

• complicated (severe) infections of the bladder and kidneys (urinary tract infections)
• lung infections (pneumonia)

Cefepima can be used in adults and children over 2 months in the treatment of a bloodstream invasion by bacteria (bacteremia) that causes or is suspected to have caused any of the aforementioned infections.

Cefepima can be used in adults and children over 2 months in the treatment of neutropenic patients (patients with low defenses) with fever that is suspected to be due to a bacterial infection.

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 components of this medication (listed in section 6)

??any other antibiotic of the cephalosporin type

• if you have ever had an acute 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 careful with Cefepima Kabi

Tell your doctor before starting treatment with Cefepima Kabi

• if you have ever had an allergic reaction to cefepima or other beta-lactam antibiotics or any medication. If you develop an allergic reaction during treatment with Cefepima, you should contact your doctor immediately, as it could be serious. In that case, the doctor will stop treatment immediately.
• if you have ever had asthma or an allergic tendency.
• if you have kidney problems, the dose of Cefepima Kabi may need to be adjusted.
• if you develop severe and persistent diarrhea during treatment. This can 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 may be an infection by microorganisms not sensitive to cefepima and may require interruption of treatment.
• if you need to have blood or urine tests, it is essential that you inform your doctor that you are using Cefepima Kabi. This medication can alter the results of some tests.

Other medications and Cefepima Kabi

Tell your doctor or pharmacist if you are using, have recently used, or may need to take other medications. This is important because some medications should not be taken or 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.
• medications used to prevent blood clotting (cumulative anticoagulants, such as warfarin), their action could 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 about the use of this medication during pregnancy, it is preferable to avoid the use of cefepima during pregnancy.

Small amounts of this medication may pass into breast milk. You can be given cefepima during breastfeeding, although you should monitor for any adverse effects in the breastfed 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 using machines

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

3. How to use Cefepima Kabi

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

The usual dose

• in adults and adolescents (over 12 years) is 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
• the usual duration of therapyis 7 to 10 days.
• the maximum dose for children over 2 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, 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 medication 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 treatment with Cefepima Kabi

Even if you feel better after the first doses, complete the treatment with this medication. If you stop 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.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone gets them.

The following side effects are important and will require immediate action if you experience them. You should stop takingCefepima Kabi and visit your doctor immediatelyif you experience the following symptoms:

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

• Acute allergic reaction (called anaphylaxis) associated with difficulty breathing or sudden choking, swelling of the face or body, rash, fainting (loss of consciousness) (may affect up to 1 in 1,000 people).

Also, the following side effects have been reported:

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

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

• Allergic reactions such as skin rash
• Diarrhea
• Breathing difficulties
• Pain, swelling, and irritation of the injection-perfusion area (phlebitis) and vein inflammation (thrombophlebitis)
• Alteration of blood count, including low red blood cell count (anemia) and changes in the number of white blood cells
• Alteration of special laboratory values indicating liver failure

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

• Vaginal inflammation
• Irritated skin, hives
• Headache, fever
• Nausea and vomiting
• Mouth sores
• Increased results of some blood tests (urea and creatinine) indicating kidney function
• Alterations of blood count (changes in the number of some white blood cells and platelets)
• Inflammation of the perfusion area

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

• Disorder of perception (paresthesia), confusion, dizziness, epileptic seizure, altered appetite
• Breathing difficulties
• Mouth sores
• Abdominal pain, constipation
• Expansion of blood vessels
• Chills

Unknown(frequency cannot be estimated from available data)

• Potentially fatal allergic reaction (anaphylactic shock)
• Alteration of blood count, acute decrease in the number of red blood cells (anemia) or white blood cells (agranulocytosis)
• Brain dysfunction, including an 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 glucose in urine test

Reporting of side effects

If you experience any side effects, talk to your doctor or nurse, even if it is possible side effects not listed in this leaflet. You can also report them directly through 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 medication.

5. Storage of Cefepima Kabi

Keep this medication out of 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 above 25°C.

Keep 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 observe that the solution is cloudy and discolored; it should be completely transparent and between colorless and amber.

You should discard any unused solution.

.

"Medicines should not be thrown away through wastewater or household waste. Place the packaging and medications you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment."

6. Contents of the pack and other 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 2 g powder for solution for injection or infusion contains 2 g of cefepima (as 2378.5 mg of cefepima dihydrochloride monohydrate).

Appearance of the product and contents of the pack

Cefepima Kabi powder is usually mixed with water for injectable preparations or with other suitable liquids to prepare a clear intravenous solution (intravenous) 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 medication 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 solution for injection or infusion EFG

Poland:Cefepim Kabi

Portugal: Cefepima Kabi

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

This leaflet was last revised in July 2015

"Detailed and updated information on this medication 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 only for doctors 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 (from colorless to amber) without affecting the product's potency.

Storage conditions

Before opening:

Do not store 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°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 should not normally exceed 24 hours at 2-8°C, 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 direct intravenous administration, reconstitute Cefepima Kabi with sterile water for injectable preparations, 5% dextrose injection, or 0.9% sodium chloride, for the volumes shown in the following table, "Preparation of cefepima solutions". The resulting solution should be injected directly into the vein over an interval of 3 to 5 minutes or injected into the tube of a medication administration device while the patient is receiving a compatible IV fluid.

For intravenous infusion, reconstitute 2 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

Elimination

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