Cefepime Kabi 1 g powder for injection and for infusion EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

CEFEPIME KABI 1 g powder for solution for injection and for intravenous infusion EFG

(cefepime)

Read the entire 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 questions, consult your doctor or pharmacist.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if

they are possible adverse reactions not listed in this leaflet. See section 4.

Leaflet contents:

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

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

Cefepime Kabi is an antibiotic used to treat bacterial infections in different parts of the body. It belongs to a group of antibiotics known as "fourth-generation cephalosporins".

Cefepime only acts against certain types of bacteria, which means that
it is only suitable for treating certain types of infections.

Kabi Cefepime can treat various types of infections:

In adults and children over 12 years of age, including:

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

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

• complicated (severe) bladder and kidney infections (urinary tract infections)
• lung infections (pneumonia)

Cefepime may be used in adults and children over two months of age for the treatment of bacterial invasion of the bloodstream (bacteremia) caused or suspected to be caused by any of the infections mentioned above.

Cefepime may be used in adults and children over two months of age for the treatment of febrile neutropenic patients (patients with low defenses) in whom a bacterial infection is suspected.

2. What you need to know before using Cefepime Kabi

Do not use Cefepime Kabi:

• if you are allergic (hypersensitive) to:

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

  ? any other cephalosporin-type antibiotic

• if you have ever had an acute allergic reaction to other antibiotics of the beta-lactam type (such as penicillins, also referred to as monobactams and carbapenems)

If you have any doubts, ask your doctor.

Inform your doctor before starting to use Cefepime Kabi

• if you have ever had an allergic reaction to cefepime or to other beta-lactam-type antibiotics or to any medicine. If you develop an allergic reaction during treatment with Cefepime Kabi, you must contact your doctor immediately, as it could be serious. In such a case, your doctor will stop the treatment immediately.

• if you have ever suffered from asthma or a tendency towards allergies.

• if you have kidney problems, the dose of Cefepime Kabi may need to be adjusted.

• if you develop severe and persistent diarrhoea during treatment. This may 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 Cefepime Kabi. This could be an infection caused by microorganisms not sensitive to cefepime and may require discontinuation of treatment.

• if you need to have blood or urine tests, it is important that you inform your doctor that you are using Cefepime Kabi. This medicine may alter the results of certain laboratory tests.

Other medicines and Cefepime Kabi

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This is important because some medicines should not be taken or used together with cefepime.

In particular, inform your doctor if you are taking:

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

• medicines used to prevent blood clotting (vitamin K antagonists, such as warfarin); their effect may be enhanced.

• certain types of antibiotics (bacteriostatic antibiotics) which 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 Cefepime Kabi. Since there is no information available on the use of this medicine during pregnancy, it is preferable to avoid using cefepime during pregnancy.

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

If you are pregnant or breastfeeding, think you may be pregnant or are planning to become pregnant, consult your doctor or pharmacist before using any medicine.

Driving and use of machines

While taking this medicine, you may experience headache, seizures, dizziness, confusion, or altered state of consciousness. In such cases, do not drive or operate any machinery or tools.

3. How to use Cefepime Kabi

Cefepime Kabi is normally administered by a doctor or nurse. It may be given:

• 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 your age, body weight, and kidney function. Your doctor will explain this to you.

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

The usual dose is:

• in adults and adolescents (over 12 years of age): 4 to 6 grams per day,
• in infants and children (from 2 months to 12 years of age): 100 to 150 milligrams per kg of body weight per day,
• the usual duration of therapy is 7 to 10 days.
• the maximum dose for children over 2 months of age and adults is six grams per day.

If you use more Cefepime Kabi than you should

If you think you have been given more Cefepime Kabi than you should have, inform your doctor immediately.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number: 91 562 04 20, stating the medication and the amount ingested.

If you forget to use Cefepime Kabi

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

If you stop treatment with Cefepime Kabi

Even if you feel better after the first doses, continue the full course of treatment with this medicine. If you stop treatment with this medicine too early, your infection may not be cured.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

The following side effects are important and will require immediate action if they occur. You must stop administration of Cefepime Kabi and see your doctor immediately if you experience any of the following symptoms:

• Inflammation of the large intestine, called pseudomembranous colitis (or antibiotic-associated colitis); this causes prolonged, watery diarrhoea with abdominal cramps and fever (may affect up to 1 in 100 people).

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

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

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

The following side effects have also been reported:

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

• False positive test for antibodies causing destruction of red blood cells

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

• Allergic reactions such as skin rash
• Diarrhoea
• Pain, swelling, and irritation at the site of intravenous injection/perfusion (phlebitis) and inflammation of the vein (thrombophlebitis)
• Changes in blood count, including low number of red blood cells (anaemia) and changes in the number of white blood cells
• Changes in specific laboratory values indicating liver dysfunction

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

• Inflammation of the vagina
• Irritated skin, urticaria
• Headache, fever
• Nausea and vomiting
• Oral thrush
• Increase in certain blood test results (urea and creatinine) indicating kidney function
• Changes in blood count (changes in number of certain white blood cells and platelets)
• Inflammation at the infusion site

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

• Sensory disturbance (paraesthesia), confusion, dizziness, epileptic seizure, altered appetite

• Breathing difficulties

• Thrush

• Abdominal pain, constipation

• Dilation of blood vessels

• Chills

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

• Potentially life-threatening allergic reaction (anaphylactic shock)
• Changes in blood count, acute decrease in the number of red blood cells (anaemia) or white blood cells (agranulocytosis)
• Brain dysfunction, including altered state of consciousness (stupor, coma), confusion, hallucinations, muscle movements (myoclonus)
• Kidney failure (renal failure, toxic nephropathy)
• Functional disorder of the stomach and intestine
• Bleeding from damaged blood vessels (haemorrhage)
• False positive result for urine glucose test

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Cefepime Kabi

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

Do not use this medicine after the expiry date stated on the container,

following CAD. The expiry date refers to 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 has been prepared with Cefepime Kabi powder, it should be used

immediately. Do not use Cefepime Kabi if the solution appears cloudy or discoloured; the solution should be completely clear and colourless to amber-yellow.

Any unused solution should be discarded.

“Medicines must not be disposed of via wastewater or household waste. Return unused packaging and medicines to the SIGRE point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of packaging and medicines you no longer need. This helps protect the environment.”

6. Pack contents and other information

Composition of Cefepime Kabi

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

Each vial of Cefepime Kabi 1 g powder for injectable solution or for infusion contains 1 g of cefepime (as 1189.2 mg of cefepime dihydrochloride monohydr 1 g powder for injectable solution or for infusion contains 1 g of cefepime (as 1189.2 mg of cefepime dihydrochloride monohydrate).

Appearance of the product and pack contents

Cefepime Kabi powder is normally mixed with water for injections or with other suitable liquids to prepare a clear solution for injection or intravenous infusion (intravenous drip).

Once prepared, the doctor may mix the Cefepime Kabi solution with other suitable infusion fluids.

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, poeder voor oplossing voor injectie of infusie;

Bulgaria: Cefepima Kabi 1 g powder for injectable solution or for perfusion; Cefepima Kabi 2 g powder for injectable solution or for perfusion

Cyprus, Greece: Cefepima Kabi 1 g, κόνις για διάλυμα προς ένεση ή έγχυση;

Spain: Cefepima Kabi 1 g 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 patient information leaflet was last reviewed in July 2015

“Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/”

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This information is intended for healthcare professionals only:

Before administration, parenteral solutions should be inspected visually for particulate matter.

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

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:
Cefepime solutions should be used immediately after reconstitution.
Chemical and physical in-use stability has been demonstrated for 2 hours at 25°C.
From a microbiological standpoint, the solution should be used immediately. If not used immediately, the time and conditions of storage prior to use are the responsibility of the user and should generally not exceed 24 hours at 2–8°C, unless reconstitution was carried out under controlled and validated aseptic conditions.

Compatibility

Cefepime is compatible with the following diluents and solutions: 0.9% sodium chloride (with or without 5% dextrose), 10% dextrose, Ringer's solution (with or without 5% dextrose), 6M sodium lactate.

Instructions for reconstitution, dilution, and administration

For direct intravenous administration, reconstitute Cefepime Kabi with sterile water for injections, 5% dextrose solution, or 0.9% sodium chloride, using the volumes shown in the following table, “Preparation of cefepime solutions”. The resulting solution should be injected directly into the vein over 3 to 5 minutes or administered through an intravenous infusion line while the patient is receiving a compatible IV fluid.

For intravenous infusion, reconstitute 1 g of cefepime solution as described above for direct intravenous administration, and add an appropriate amount of the resulting solution to a container containing a compatible IV fluid. The infusion time should be 30 minutes.

Preparation of cefepime solutions

Disposal

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