Package Insert: Information for the User

Cefepima Accord1 gpowder for injectable solution and for infusion EFG

cefepima

Read this package insert carefully before starting to use the medicationbecause it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse,even if they are not listed in this package insert. See section 4.

Cefepima Accord is an antibiotic for adults and children. Its function is to eliminate the bacteria that cause infections. It belongs to the group of medications known asfourth-generation cephalosporins.

In adults and children over 12 years:

• Pneumonia (lung infections)
• Complicated (severe) urinary tract infections
• Complicated (severe) abdominal cavity infections
• Peritonitis (inflammation of the abdominal cavity lining) associated with continuous ambulatory peritoneal dialysis (CAPD) in patients undergoing dialysis

In adults:

• Acute gallbladder infections

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

• Complicated (severe) urinary tract infections
• Pneumonia (lung infections)
• Bacterial meningitis (infections of the membranes covering the brain)

Cefepima is also used in adults and children over 2 months

• To treat fever of unknown cause in patients with low defenses (if suspected to be caused by a bacterial infection in patients withmoderate-severe or severe neutropenia). If necessary, another antibiotic should also be administered
• To treat the presence of bacteria in the blood (bacteremia).

Do not use CefepimaAccord:

• If you are allergic to cefepima or any of the other ingredients in this medication (listed in section 6)
• If you have ever had a severe allergic reaction (hypersensitivity) to any type of beta-lactam antibiotic (penicillins, monobactam, and carbapenem).
• If you have high levels of acid in your blood (acidosis).

Inform your doctor if this is your case. If so, do not use Cefepima.

Be especially careful with Cefepima Accord

Inform your doctor or healthcare professional:

• If you have ever had anallergic reactionto cefepima, other beta-lactam antibiotics, or another medication. If you develop an allergic reaction during treatment with cefepima, contact your doctorimmediately, it may be serious. In this case, your doctor will stop treatment immediately.
• If you have ever hadasthmaor are prone to allergies.
• If you havekidney problems, the dose of cefepima may need to be adjusted.
• If you havesevere and persistent diarrheaduring treatment. This may be a sign of inflammation of the large intestine and should be treated urgently.
• If you believe you have developed anew infectionwhile using Cefepima continuously. This may be due to an infection caused by microorganisms not sensitive to cefepima and may require stopping treatment.
• If you undergoblood or urine tests, it is essential to inform your doctor that you are using Cefepima. This medication may alter the results of some tests.

Children

Special dosing guidelines apply to infants and children (see section 3).

Older patientsIn older patients, the dose will be carefully selected and in relation to renal function, as it increases the likelihood of reduced renal function (see section 3).

Other medications and Cefepime Accord

Inform your doctor or pharmacist if you are using, have used recently, or may need to use other medications.

Particularly, inform your doctor if you take the following:

• Other antibiotics, particularly aminoglycosides (such as gentamicin) or diuretics (such as furosemide), as in these cases, renal function should be monitored.
• Medications used to prevent blood clotting (anticoagulants of coumarin, such as warfarin), as their effects may be intensified.
• Determined 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 or pharmacist before using this medication.
• There is no experience of its use during pregnancy, so caution should be exercised when prescribing Cefepima Accord to pregnant women. Inform your doctor if you become pregnant during treatment with Cefepima Accord.
• Cefepima is excreted in breast milk in very low amounts, so caution should be exercised when administering to a breastfeeding woman.
• There are no data on the use of cefepima and human fertility

Driving and operating machinery

No studies have been conducted on the effects of this medication on the ability to drive and operate machinery. However, possible adverse reactions such as altered consciousness, dizziness, confusion, or hallucinations may impair the ability to drive and operate machinery.

Administration:

Cefepima Accord is usually administered by a doctor or nurse. It can be administered through a drip (intravenous infusion), directly into a vein, or by deep injection into a large muscle in the buttock (intramuscular).

Usual Dose:

The correct dose of Cefepima Accord will be decided by your doctor and will depend on: the severity and type of infection, if you are taking other antibiotics, your weight and age, and 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).

Infants (over 2 months) and Children up to 40 kg (approximately 12 years)

For every kilogram the infant or child weighs, 50 mg of cefepima will be administered every 12 hours. In cases of severe infections, such as meningitis, this dose will be administered every 8 hours.

Infants (1 - 2 months)

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

Patients with Kidney Problems

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

• Consult your doctorif this is your case.

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

Using More Cefepima Accord than Prescribed

In the event of a severe overdose, especially in patients with renal insufficiency, hemodialysis may help remove cefepima from the body (peritoneal dialysis is not useful). Accidental overdose has occurred with high-dose administration to patients with renal insufficiency.

If you have any additional questions about the use of this medication, ask your doctor, pharmacist, or nurse.

Missing a Dose of Cefepima Accord

If you think you have missed a dose of CefepimaAccord, inform your doctor immediately.

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.,

Conditions to watch for

Some people who use cefepima may experience severe allergic reactions or potentially serious skin reactions. The symptoms of these reactions are:

• Severe allergic reaction. The signs arehives, swelling, sometimes on the face or mouth, which causesdifficulty breathing.
• Skin eruptions, which may presentblistersand appear to besmall pinpricks(a dark central point surrounded by a lighter area and a dark ring around the edge).
• Widespread hiveswithblistersandskin peeling. (These may be signs ofStevens-Johnson syndromeor atoxic epidermal necrolysis).
• Fungal infections: in rare cases, medicines like Cefepima Accord can cause the proliferation of yeast-like fungi (Candida) in the body that can lead to fungal infections (such as candidiasis). This side effect is more likely to occur if you use Cefepima Accord for a long time.

Immediately contact a doctor or nurse if you notice any of these symptoms.

Very common side effects that may appear in blood tests:

These may affectmore than 1 in 10 people:

• Positive Coombs test

Common side effects

This may affectup to 1 in 10 people:

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

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 number of white blood cells (eosinophilia)
• Low levels of red blood cells (anemia)

Uncommon side effects

This may affectup to 1 in 100 people:

• Colitis (inflammation of the colon), which causes diarrhea, usually with blood and mucus, and abdominal pain
• Fungal infections in the mouth or vagina (candidiasis)
• Elevated temperature (fever)
• Redness of the skin, urticaria, itching (pruritus)
• Discomfort (nausea), vomiting
• Headache

Inform your doctorif you notice any of these symptoms.

Uncommon side effects that may appear in blood tests:

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

Rare side effects

This may affectup to 1 in 1000 people:

• Allergic reactions
• Fungal infections (candidiasis)
• Convulsions, dizziness, alteration of taste, sensation of sharp pain or numbness of the skin
• Difficulty breathing
• Abdominal pain, constipation
• Chills
• Deep skin swelling
• Joint pain
• Tinnitus

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
• Digestive problems
• Renal problems
• Bleeding

Side effects that may appear in blood tests:

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

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a side effect that does not appear in this leaflet. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side 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 usethis medicationafter the expiration date that appears on the box and on the label after the abbreviation CAD. The expiration date is the last day of the month indicated.

Do not store above30°C. Store in the cardboard box to protect it from light.

The storage conditions for the reconstituted/diluted solutions of the medication can be seen at the end of the prospectus “This information is intended solely for healthcare professionals”.

Medications should not be thrown down the drains or in the trash.Ask your pharmacist how to dispose of the packaging and the medications that you no longer need. In this way, you will help to protect the environment.

Composition ofCefepimeAccord

The active ingredient is cefepime as cefepime dihydrochloride monohydrate (1.19g)

The other component is L-arginine (to adjust the pH)

Appearance of the product and contents of the container

Cefepime Accord is a white to pale yellow powder for injectable solution and for infusion conditioned in closed glass vials with a rubber stopper and a flip-off cap. The vials are conditioned in carton boxes.

Presentation: 1 and 50 vials.

Not all presentations may be marketed

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Accord Healthcare S.L.U.

World Trade Center. Moll de Barcelona, s/n,

Edifici Est, 6th floor.

08039, Barcelona

Spain

Responsible manufacturer

LABORATORIO FARMACEUTICO CT.S.r.l.

Via Dante Alighieri, 71

18038 Sanremo (IM)

Italy

This medicinal product is authorized in the member states of the European Economic Area with the following names:Portugal:Cefepime Accord 1g powder for solution for injection/for infusion

Spain: Cefepime Accord1 gpowder for injectable solution and for infusion EFG

Date of the last review of this leaflet: October 2022

The detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

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This information is intended solely for healthcare professionals:

After reconstitution, the solution is clear, colorless to amber and particle-free.

Storage conditions after reconstitution:

The following chemical and physical stability has been demonstrated in use:

• Cefepime 1 g reconstituted with lidocaine 1% may be used up to 12 hours when stored at 2– 5°C
• Cefepime 1 g reconstituted with water for injection and sodium chloride 0.9% may be used up to 24 hours when stored at 2-8°C.

From a microbiological point of view, the product must be used immediately. If not used immediately, the storage times in use and the conditions before use are the responsibility of the user.

Storage conditions after dilution:

The following chemical and physical stability has been demonstrated in use:

• Cefepime 1 g diluted with water for injection with dextrose 10% may be used up to 12 hours when stored at 25°C.

All other diluted solutions for infusion or solutions for intramuscular administration must be used immediately.

Intramuscular administration:

In the preparation of the injectable solution for intramuscular administration, water for injection 3 ml or lidocaine hydrochloride 0.5% or 1% solution must be used as a solvent.

Use of lidocaine:

In the event that a lidocaine solution is used as a solvent, cefepime solutions must only be used for intramuscular injection. Before use, the contraindications of lidocaine, warnings and other relevant information detailed in the lidocaine technical data sheet must be considered.

Lidocaine solution must never be administered intravenously.

Intramuscular injection with lidocaine as a solvent is indicated for children over 30 months.

Intravenous administration:

Cefepime Accord 1 g must be reconstituted with 10 ml of water for injection or dextrose 5% or sodium chloride 0.9% solution. The resulting solution must be injected directly into a vein (3 to 5 minutes) or into the cannula of an infusion system while the patient receives a compatible intravenous fluid.

The following table contains reconstitution instructions:

Intravenous infusion

After reconstitution, Cefepime Accord 1 g may be administered through the tubing of the infusion system or directly into the infusion fluid. The solution must be administered over a period of approximately 30 minutes.

Cefepime Accord is compatible with the following solutions: sodium chloride 0.9% (with or without dextrose 5%), dextrose 5%, Ringer's lactate solution (with or without dextrose 5%), sodium lactate M/6 for concentrations of 1 to 40 mg/ml

Cefepime Accord may be administered simultaneously with other antibiotics or other medications, provided that the same syringe, the same infusion vial or the same injection site is not used. Cefepime solutions are compatible with amikacin, ampicillin, clindamycin, heparin, potassium chloride, theophylline.

Like other cephalosporins, after reconstitution the solution may turn yellow. However, this is not a sign of loss of efficacy. Only a particle-free solution should be used.