Prospect: Information for the User

Cefepima NORMON1 g powder and solvent for injectable solutionand for infusion EFG

Read this prospect thoroughly before starting to use the medication.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to you and should not be given to other people, even if they have the same symptoms, as it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if they do not appear in this prospect. See section 4

Cefepima NORMON is an antibiotic administered by infusion (with a drip) or intravenous injection, in special cases by deep muscle injection (intramuscular).

Cefepima belongs to the group of antibiotics called "cephalosporins". These antibiotics are quite similar to penicillin.

Cefepima NORMON is effective against certain types of bacteria that are sensitive to the active substance cefepima.

It is suitable for the treatment of infections in adults such as:

• lung infections (pneumonia),
• kidney and bladder infections (urinary tract),
• skin and subcutaneous tissue infections,
• fever in patients with severe or moderate reduction of certain white blood cells,
• abdominal infections (peritonitis, biliary tract infections)

Cefepima may also be used to help prevent infections after abdominal surgery.

It is suitable for treatment in children of infections such as:

• severe lung infections (pneumonia),
• severe bladder and kidney infections (urinary tract),
• skin and subcutaneous tissue infections,
• fever in patients with moderate or severe reduction of certain white blood cells,
• brain infections (bacterial meningitis).

Do not use Cefepima NORMON:

• If you are allergic (hypersensitive) to cefepime or arginine.
• If you are allergic (hypersensitive) to any other cephalosporin or other type of antibiotic.
• If you have ever had a severe allergic reaction to any penicillin or to any other beta-lactam antibiotic, because this could mean that you may also be allergic to cefepime.
• If you have ever had other types of allergic reactions, asthma, hay fever, or the appearance of hives (urticaria).
• If you have high levels of potassium in your blood.
• If you have high levels of acidity in your blood.

In case of doubt, ask your doctor or pharmacist.

Warnings and precautions

Consult your doctor or pharmacist before starting to use cefepime if:

• You have ever had an allergic reaction to penicillin or other medications in the family of penicillins (beta-lactam antibiotics),
• You have kidney problems,
• You have ever had intestinal problems with diarrhea, called colitis, or any serious problem in the intestines.

Your doctor may want to change the treatment or give you a special warning.

Use of Cefepima NORMON with other medications

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

This is important because some medications should not be taken with Cefepima NORMON.

Especially, inform your doctor if:

• You are using medications that can affect the functioning of the kidneys, such as aminoglycoside antibiotics or medications that increase the amount of urine or the need to urinate (diuretics).
• You have diabetes:Inform your doctor if you have diabetes and regularly analyze your blood sugar levels. Cefepime may alter the results of blood sugar tests (non-enzymatic). Other tests may be used to control diabetes while you are being treated with this medication.
• You have blood tests:This medication may alter the results of some blood tests (such as the Coombs test). It is essential to inform your doctor that you are being treated with cefepime when you go for blood tests.

Pregnancyandbreastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.
Cefepime will only be administered if the expected benefit for the mother is greater than the unknown risks for the fetus.

Do not breastfeed while using this medication because small amounts of it pass into the milk and therefore to the infant.

Consult your doctor or pharmacist before using any medication.

Driving and operating machines

No studies have been conducted to know the effects on the ability to drive and operate machines. However, side effects may occur that may affect the ability to drive or operate machines (see section 4).

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Cefepima is usually administered by a doctor or nurse. In case of doubt, consult your doctor or pharmacist again.

It is administered:

• By injectionintravenously(over 3-5 minutes) or through a drip (over 30 minutes) into a vein (perfusion)orby deep injection into the buttock (intramuscular).

The dose of Cefepimawill be determined by your doctor based on your age, weight, severity of the infection, and the degree of kidney function. Your doctor will explain this to you.

• The usual dose in adults is2 to 4 grams(g) daily. In severe infections, the dose may be increased up to 6 g daily.
• Children or people with kidney problems may need lower doses. This will be decided by your doctor.

If you use more Cefepima NORMON than you should:

Since a doctor or nurse will administer Cefepima, it is unlikely that you will receive an incorrect dose. However, if you experience side effects or think you have received too much, inform 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 forgot to use Cefepima NORMON

If you think you have not received a dose of Cefepima, inform your doctor immediately.

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

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

You must inform your doctor immediately if you notice any of the following:

Rare side effects (may affect up to 1 in 100 people)

• Intestinal inflammation (colitis or antibiotic-associated colitis), causing severe, prolonged watery diarrhea with abdominal cramps and fever.

Very rare side effects (may affect up to 1 in 1,000 people)

• Severe allergic reactions (sudden onset of sneezing, difficulty breathing or dizziness, swelling of the eyelids, face, lips or throat)
• Seizures (epileptic crises).

Side effects of unknown frequency

• Destruction and inability to form red blood cells, which may cause weakness, bruising, frequent infections, pale skin, fatigue, difficulty breathing, and dark urine.
• Absence of white blood cells, which may cause sudden high fever, severe sore throat, and mouth ulcers.
• Severe and rapid allergic reaction, with constriction of the airways that may prevent breathing.
• Coma, decreased consciousness, or difficulty thinking.
• Diverse conditions affecting the brain, symptoms of which may cause paralysis of part or all of the body, stiffness in the neck, speech and eye movement abnormalities.
• Sudden muscle contraction.
• Peeling and blisters on the skin, mouth, eyes, and genitals.
• Renal insufficiency, causing a significant decrease in urine production.

Other possible side effects:

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

• False positive result in a test for red blood cell status (Coombs test).

Common side effects(may affect up to 1 in 10 people)

• Low red blood cell count, increased levels of certain types of white blood cells, changes in blood coagulation parameters.
• Intravenous administration may cause inflammation of blood vessels.
• Diarhea.
• Increased levels of certain liver enzymes, high levels of bilirubin in the blood.
• Rash.
• Reactions at the injection or infusion site, pain, and inflammation at the injection site.

Rare side effects (may affect 1 in 100 people)

• Oral candidiasis (yeast infection), vaginal infections.
• Severe blood disorders, including changes in the number of certain white blood cells and platelets (symptoms may include fatigue, new infections, bruising, and easy bleeding).
• Headache, sensation of dizziness (nausea) and dizziness (vomiting).
• Urticaria, redness, and itching of the skin.
• Anomalous results in kidney function tests.
• Fever.

Very rare side effects (may affect 1 in 1,000 people)

• Tickling or numbness in the hands or feet.
• Decreased consciousness or difficulty thinking, dizziness.
• Alteration of taste.
• Widening of blood vessels.
• Difficulty breathing.
• Abdominal pain (stomach), constipation.
• Itching in the genital organs.
• Tremors.

Side effects of unknown frequency

• False positives in urine glucose tests
• Confusion, hallucinations, drowsiness, altered consciousness.
• Bleeding
• Gastrointestinal discomfort.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is not listed in this leaflet. You can alsoreport them directly through the Spanish System for Pharmacovigilance of Medicines for human use: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 use this medication afterthe expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C. Store in the cardboard box to protect it from light.

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

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Cefepima NORMON

Each vial contains1 g of cefepima (as cefepima dihydrochloride monohydrate)

The other component (excipient) is L-arginine

Each ampoule contains water for injection

Appearance of the product and contents of the package

Cefepima NORMONis a white or almost white powder for injection and for infusion conditioned in closed glass vials with a rubber stopper and a flip-off cap.

The vials are conditioned in carton boxes.

Presentations: 1 and 50 vials.

Only some sizes of packaging may be commercially available

Holder of the marketing authorization and responsible for manufacturing

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Date of the last review of this leaflet: May 2014

The detailed and updated information on this medicine 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 only formedical professionals or healthcare professionals:

Cefepima NORMON 1 g powder and diluent for injection and infusion EFG

This is an extract from the Product Characteristics Summary to help administer Cefepima NORMON. To determine the suitability of its use in a particular patient, the doctor must be familiar with the Product Characteristics Summary.

For intravenous injection, slow/infusion and intramuscular injection.

INCOMPATIBILITIES WITH DILUENTS AND OTHER MEDICINES

Cefepima NORMONshould notbe mixed with the following antibiotics: metronidazole, vancomycin, gentamicin, tobramycin sulfate, and netilmicin sulfate, because they may cause physical or chemical incompatibilities. If concomitant treatment is indicated, these antibiotics should be administered separately.

INSTRUCTIONS FOR USE, HANDLING AND DISPOSAL

Should be used aseptic techniques to reconstitute the solution. The reconstituted solution should be administered immediately after preparation.

Inspect the vial before using it. It should be used only if the solution is free of particles.

Use only transparent solutions.

As with other cephalosporins, cefepima solutions may acquire a yellow to amber color, depending on the storage conditions. However, this has no negative effect on the product's efficacy.

The disposal of unused medication and all materials that have come into contact with it will be carried out in accordance with local regulations.

Administration method:

Intravenous administration:

To administer IV direct injection, the contents of the ampoule are dissolved in 5 or 10 ml of water for injection, 5% glucose solution for infusion or 0.9% sodium chloride solution for infusion, as indicated in the following table. Reconstitution should be carried out with immediate and vigorous agitation until the product is completely dissolved after adding the volume of diluent with which the vial is reconstituted, avoiding the diffusion of the diluent in the powder without it dissolving.The prepared solution is injected slowly over 3 to 5 minutes or directly into a vein or through a cannula of an infusion system while the patient is receiving an IV infusion with a compatible IV solution.

To administer IV infusions, the powder is dissolved as described for direct IV injections. An appropriate amount of the prepared solution is added to an IV infusion bag containing a compatible IV solution.

Cefepima NORMON, once reconstituted, is compatible with the following IV infusion solutions:Water for injection, 0.9% sodium chloride solution, 5% glucose solution for infusion, 10% glucose solution for infusion, 1/6M sodium lactate solution for infusion, 5% glucose and 0.9% sodium chloride solution for infusion, Ringer lactate solution and glucose 5% for infusion, and Ringer lactate solution for infusion.The reconstituted and diluted solutions should be administered immediately after preparation.

Intramuscular administration

Cefepima NORMON should be prepared with one of the following solutions:Water for injection, 0.9% sodium chloride solution, 5% glucose solution for infusion.Although Cefepima NORMON can be prepared with 0.5% or 1% lidocaine solution, this is not generally necessary, as IM administration does not cause pain or only mild pain. The reconstituted product with lidocaine should be administered immediately after preparation.

Dosage:

Adults and adolescents with a body weight of more than 40 kg (approximately over 12 years):

• The recommended doses for adults and adolescents with a body weight of more than 40 kg with normal renal function are presented in the following table:

• For prophylaxis in intra-abdominal surgery, a single dose of 2 g is administered by infusion over 30 minutes, 60 minutes before the intervention, followed by 500 mg of metronidazole. The dose of metronidazole should be reconstituted and administered according to the official Product Characteristics Summary. Due to the incompatibility between cefepima and metronidazole, these two active substances should not be administered together. Before administering metronidazole, it is recommended to empty the infusion tube with a compatible fluid. If the intervention lasts more than 12 hours, the infusion should be repeated after 12 hours.

Pediatric population:

Pneumonia, urinary tract infections, skin and soft tissue infections: 50 mg/kg every 12 hours for 10 days. For severe infections, the dose can be administered every 8 hours.

• Bacterial meningitis and empirical treatment of febrile neutropenia: 50 mg/kg every 8 hours for 7-10 days.
• The experience is limited in children under 2 months. The recommended dose is 30 mg/kg every 12 hours or every 8 hours. These patients should be carefully monitored when they are administered Cefepima NORMON.
• The pediatric doses should not exceed the maximum daily dose for adults (2 g every 8 hours).
• The experience with intramuscular administration in pediatric patients is limited.

Geriatric patients:

No dose adjustment is required, except in cases of renal insufficiency.

Adults with liver insufficiency:

No dose adjustment is required in patients with liver insufficiency

Adults with renal insufficiency:

The initial recommended dose in patients with renal insufficiency (except in cases of dialysis, see below) is the same as that of patients with normal renal function.The following table shows the maintenance dosing for adult patients with renal dysfunction:

Patients undergoing dialysis:

The recommended dose is 1 g of cefepima on the first day of treatment, followed by 500 mg/day in all infections, except febrile neutropenia. Cefepima should be administered after hemodialysis on dialysis days. When possible, cefepima should be administered at the same time every day.

In cases of continuous ambulatory peritoneal dialysis, cefepima can be administered at the same doses recommended for patients with normal renal function, but only with intervals of 48 hours.

Children with renal insufficiency:

Maintenance dosing in children between 2 months and 12 years with renal insufficiency:

Treatment duration:

Generally, treatment should be continued for a few more days after the fever has subsided and the pathological symptoms have resolved.The treatment duration is usually 7 to 10 days; however, a longer treatment may be necessary in more severe infections. For empirical treatment of febrile neutropenia, the treatment duration is usually 7 days or until neutropenia is resolved.