CEFEPIMA MIP 1 g POWDER FOR INJECTABLE SOLUTION AND FOR INFUSION

Introduction

Package Leaflet: Information for the User

Cefepima MIP 1 g Powder for Solution for Injection and Infusion EFG

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

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

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

Cefepima MIP is an antibiotic for adults and children. Its function is to eliminate the bacteria that cause infections. It belongs to the group of medicines called fourth-generation cephalosporins.

In adults and children over 12 years:

• Lung infections (pneumonia)
• Complicated (severe) urinary tract infections
• Complicated (severe) abdominal cavity infections
• Inflammation of the lining of the abdominal cavity (peritonitis) associated with continuous ambulatory peritoneal dialysis (CAPD) in patients undergoing peritoneal dialysis

In adults:

• Acute gallbladder infections

In children between 2 months and 12 years and with a body weight below 40 kg, it is used to treat:

• Complicated (severe) urinary tract infections
• Lung infections (pneumonia)
• Bacterial meningitis (infection of the membranes covering the brain)

Cefepima is also used in adults and children over 2 months

• to treat fever of unknown origin in patients with low defenses (if it is suspected that the fever is caused by a bacterial infection in patients with moderate to severe neutropeniaor severe neutropenia). If necessary, another antibiotic should also be administered
• to treat the presence of bacteria in the blood (bacteremia).

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

Do not use Cefepima MIP:

• if you are allergic (hypersensitive) to cephalosporin antibiotics or to any of the other components of this medicine (listed in section 6).
• if you have ever had a severe allergic reaction (hypersensitivity) to any type of beta-lactam antibiotic (penicillins, monobactams, and carbapenems).
• if you have high levels of acid in the blood (acidosis).

• Before using Cefepima MIP, inform your doctor if this applies to you. If so, you should not use Cefepima MIP.

Be careful with Cefepima MIP

Tell your doctor or healthcare professional:

• If you have ever had an allergic reactionto cefepima, 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 may be serious. In this case, the doctor will discontinue treatment immediately.
• If you have ever had asthmaor are prone to allergies.
• If you have kidney problems, it may be necessary to adjust the dose of cefepima.
• If you experience severe and persistent diarrheaduring treatment. This can be a sign of inflammation of the large intestine and should be treated urgently.
• If you think you have developed a new infectionduring continuous use of Cefepima MIP. This may be due to an infection caused by microorganisms that are not sensitive to cefepima, and it may be necessary to discontinue treatment.
• If you undergo a blood or urine test, it is essential to inform the doctor that you are using Cefepima MIP. This medicine may alter the results of some tests.

Using Cefepima MIP with other medicines

Are you currently using any other medicines, have you used them recently, or might you use them in the near future? In that case, inform your doctor or pharmacist. This is important because some medicines cannot be taken or used with cefepima.

In particular, inform your doctor if you are taking:

• other antibiotics, especially aminoglycosides (such as gentamicin) or water pills (diuretics, such as furosemide), as kidney function should be monitored in these cases.
• medicines used to prevent blood clotting (coumarin anticoagulants, such as warfarin), as their effects may be enhanced.
• certain types of antibiotics (bacteriostatic antibiotics), as they may interfere with the functioning of cefepima.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

There is no information on the use of this medicine during pregnancy; it is preferable to avoid using cefepima during pregnancy.

Small amounts of the medicine may pass into breast milk. However, you can use cefepima even if you are breastfeeding. Nevertheless, you should observe whether the breastfed baby develops any side effects.

Driving and using machines

Cefepima MIP does not affect or has negligible effects on the ability to drive and use machines. You may experience headache, dizziness, or visual disturbances during the use of this medicine.

Do not drive or use machines if you do not feel well.

3. How to use Cefepima MIP

Administration:

Cefepima MIP is usually administered by a doctor or nurse. It can be administered with a drip(intravenous infusion) or as an injectiondirectly into a vein.

Usual dose:

The correct dose of Cefepima MIP will be decided by your doctor and will depend on: the severity and type of infection, whether you are taking other antibiotics, your weight and age, and your kidney function. The usual duration of treatment is 7 to 10 days.

Adults and adolescents over 40 kg (approximately over 12 years)

The usual dose in adults is 4 g per day divided into two doses (2 g every 12 hours). In cases of severe infection, the dose may be up to 6 g per day (2 g every 8 hours).

Babies (over 2 months) and children up to 40 kg (approximately 12 years)

For every kilogram the baby or child weighs, they will be administered 50 mg of cefepima every 12 hours. In cases of severe infections and, for example, meningitis, this dose will be administered every 8 hours.

Babies (1-2 months)

For every kilogram the baby weighs, they will be administered 30 mg of cefepima every 12 hours (or every 8 hours in cases of severe infections).

Patients with kidney problems

If you have kidney problems, your doctor may modify the dose.

• Consult your doctorif this applies to you.

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

4. Possible side effects

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

Conditions you should be aware of

Some people using cefepima experience allergic reactions or potentially severe skin reactions. The symptoms of these reactions are:

• Severe allergic reaction. The signs are raised and itchy rash, swelling, sometimes on the face or mouth, causing difficulty breathing.
• Skin rash, which can have blisteringand looks like small targets(a dark center surrounded by a lighter area and with a dark ring around the edge).
• Widespread rashwith blisteringand skin peeling. (These can be signs of Stevens-Johnson syndromeor toxic epidermal necrolysis).
• Fungal infections: in rare cases, medicines like Cefepima MIP can cause the proliferation of yeast-like fungi (Candida) in the body, leading to fungal infections (such as candidiasis). This side effect is more likely if you use Cefepima MIP for a long time.

• Contact a doctor or nurse immediatelyif you notice any of these symptoms.

Very common side effects that may appear in blood tests:

These can affect more than 1 in 10 people:

Positive Coombs test

Common side effects

These can affect up to 1 in 10 people:

• Pain at the injection site, swelling, and redness along the vein
• Diarrhea
• Skin rash

• Consult your doctorif you notice any of these side effects.

Common side effects that may appear in blood tests:

• Increased levels of substances (enzymes) produced by the liver
• Increased levels of bilirubin (a substance produced by the liver)
• Changes in the count of white blood cells (eosinophilia)
• Low levels of red blood cells (anemia)

Uncommon side effects

These can affect up to 1 in 100 people:

• Inflammation of the colon (large intestine), which causes diarrhea, usually with blood and mucus, and stomach pain
• Fungal infections in the mouth or vagina (candidiasis)
• High temperature (fever)
• Redness of the skin, hives, itching (pruritus)
• Discomfort (nausea), vomiting
• Headache

• Tell your doctorif you notice any of these symptoms.

Uncommon side effects that may appear in blood tests:

• Low levels of blood cells (leukopenia, neutropenia, thrombocytopenia)
• Increased levels of urea and serum creatinine in the blood.

Rare side effects

These can affect up to 1 in 1,000 people:

• Allergic reactions
• Fungal infections (candidiasis)
• Seizures, dizziness, alteration of the sense of taste, sensation of sharp pain or numbness of the skin
• Difficulty breathing
• Abdominal pain, constipation
• Chills
• Swelling of the deeper layers of the skin

Other side effects of unknown frequency (and individual cases known)

• Severe allergic reactions
• Coma, decreased consciousness or difficulty thinking, confusion, and hallucinations
• False positives in urine glucose tests
• Gastrointestinal problems
• Kidney problems
• Bleeding

Side effects that may appear in blood tests:

• Changes in the count of blood cells (agranulocytosis)
• Rapid destruction of red blood cells (hemolytic anemia)

Reporting 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 System of Pharmacovigilance of Medicines for Human Use: www.notificaRAM.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Cefepima MIP

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 packaging and on the label after "EXP". The expiry date is the last day of the month shown.

Store below 30°C. Store in the outer packaging to protect from light.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Container Contents and Additional Information

Composition of Cefepima MIP

• The active ingredient is cefepima (as monohydrate dichlorohydrate). Each vial contains 1 g of cefepima (as monohydrate dichlorohydrate).
• The other component is arginine.

Appearance of Cefepima MIP and Container Contents

Cefepima MIP 1 g is available in 15 ml glass vials with a rubber stopper and a "flip-off" seal.

Package sizes: Packages of 1, 5, or 10 glass vials. Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

MIP Pharma GmbH

Kirkeler Str. 41

66440 Blieskastel, Germany

Tel.: 0049 (0) 6842 9609 0

Fax: 0049 (0) 6842 9609 355

Date of Last Revision of this Leaflet: January 2019.

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/

This information is intended only for healthcare professionals:

Preparation of the Solution for Direct Intravenous Injection

The contents of the vial are dissolved in 10 ml of solvent as indicated in the following table. The prepared solution is injected slowly over a period of 3 to 5 minutes directly into a vein or into the cannula of an infusion system if the patient is receiving an infusion with a compatible intravenous solution.

Preparation of the Solution for Intravenous Infusion

For intravenous infusion, the cefepima solution of 1 g is reconstituted as indicated above for intravenous administration and the required amount of the prepared solution is added to a container with a compatible intravenous infusion solution (recommended final volume: 40-50 ml). The prepared solution should be administered over a period of approximately 30 minutes.

The following table contains the instructions for reconstitution:

Compatibility with Intravenous Solutions

The following solvents are suitable for preparing the solution:

• Water for preparation of injectables
• Glucose solution 50 mg/ml (5%)
• Sodium chloride solution 9 mg/ml (0.9%)

Reconstitution/dilution must be performed under aseptic conditions. Add the recommended volume of the solution to be reconstituted and gently shake until the contents of the vial are completely dissolved.

As with other cephalosporins, cefepima solutions may have a yellow or amber color depending on storage conditions. However, this does not have a negative influence on the effect of the product.

Inspect the vial before use. It will only be used if the solution does not contain particles. Use only clear solutions.

The product is for single use. Any remaining solution must be discarded. Disposal of unused product and all materials that have come into contact with it will be carried out in accordance with local regulations.

Storage after Reconstitution

Validity Period of the Prepared Solution

The chemical and physical stability of the prepared solution has been verified for 2 hours at 25°C and for 24 hours at 2-8°C. From a microbiological point of view, the prepared solution must be used immediately. If not, the user will be responsible for the storage time and conditions before use.

Dose in Patients with Renal Insufficiency:

Adults and Adolescents over 40 kg:

The recommended initial dose for patients with renal insufficiency is the same as for patients with normal renal function. The following table indicates the maintenance dose:

Patients on Dialysis:

A loading dose of 1 g on the first day of treatment with cefepima and then 500 mg per day, except in cases of febrile neutropenia, for which the recommended dose is 1 g per day.

On dialysis days, cefepima should be administered after the dialysis session. If possible, cefepima should be administered at the same time every day.

For patients on CAPD, the following dose is recommended: 1 g every 48 hours in case of severe infections or 2 g every 48 hours in case of very severe infections.

Renal Insufficiency in Children:

An initial dose of 30 mg/kg is recommended for infants from 1 to 2 months and 50 mg/kg for patients from 2 months to 12 years of age. The following table indicates the maintenance dose: