CEFEPIMA NORMON 2 g POWDER AND SOLVENT FOR INJECTION AND INFUSION SOLUTION

Introduction

Package Leaflet: Information for the User

Cefepime NORMON 2 g powder and solvent for solution for injection and infusionand for infusionEFG

Read all of this leaflet carefully before you start using this medicine.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you, do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• 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 Cefepime NORMON is and what it is used for
2. Before you use Cefepime NORMON
3. How to use Cefepime NORMON
4. Possible side effects
5. Storing Cefepime NORMON
6. Package contents and further information

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

Cefepime NORMON is an antibiotic that is administered by infusion (drip) or by intravenous injection.

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

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

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 decrease in certain white blood cells,
• abdominal infections (peritonitis, biliary infections)

It can also be used to help prevent infections after abdominal surgery.

It is suitable for the treatment of infections in children 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 decrease in certain white blood cells,
• brain infections (bacterial meningitis).

2. Before you use Cefepime NORMON

Do not use Cefepime 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 other beta-lactam antibiotic, as this may indicate that you are also allergic to cefepime.
• If you have ever had any other type of allergic reactions, asthma, hay fever, or hives (urticaria).
• If you have high potassium levels in your blood.
• If you have high acidity levels in your blood.

In case of doubt, consult 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 medicines in the penicillin family (beta-lactam antibiotics),
• you have kidney problems,
• you have ever had intestinal problems with diarrhea, called colitis, or any severe problem in the intestines.

If you experience any of these situations, your doctor may want to change the treatment or give you special warnings.

Using Cefepime NORMON with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

This is important because some medicines should not be taken with Cefepime NORMON. In particular, tell your doctor if:

• You are using medicines that may affect kidney function, such as aminoglycoside antibioticsor drugs that increase urine production or the need to urinate (diuretics).
• You have diabetes:Inform your doctor if you have diabetes and regularly check your urine sugar levels. Cefepime may alter the results of urine sugar tests (non-enzymatic). Other tests can be used to monitor diabetes during treatment with this medicine.
• You have blood tests:This medicine may alter the results of some blood tests (such as the Coombs test). It is essential that you inform your doctor that you are being treated with cefepime when you have blood tests.

Pregnancyandbreast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine. Cefepime will only be administered if the expected benefit to the mother is greater than the unknown risks to the fetus.

Do not breastfeed if you are using this medicine because small amounts of it pass into breast milk and therefore to the infant.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

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

3. How to use Cefepime NORMON

Follow exactly the administration instructions for this medicine as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Cefepime is usually administered by a doctor or nurse. If in doubt, consult your doctor or pharmacist again.

It is administered:

By intravenous injection (over 3-5 minutes) or through a drip (over 30 minutes) into a vein (infusion)

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

• The usual dose in adults is 2 to 4 grams (g) daily. In severe infections, the dose may be increased 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 Cefepime NORMON than you should:

Since it will be a doctor or nurse who administers Cefepime, it is unlikely that you will receive an incorrect dose. However, if you experience side effects or think you have received too much, 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 medicine and the amount ingested.

If you forget to use Cefepime NORMON

If you think you have not received a dose of Cefepime, tell your doctor immediately.

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

4. Possible side effects

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

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

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

• Inflammation of the intestines (colitis or antibiotic-associated colitis), causing severe, prolonged watery diarrhea with stomach cramps and fever.

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

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

Side effects of unknown frequency

• Destruction and inability to form red blood cells, which can cause weakness, bruising, frequent infections, pale skin, fatigue, difficulty breathing, and dark urine.
• Absence of white blood cells, which can cause high fever, severe sore throat, and ulcers in the mouth.
• A severe and rapid allergic reaction, with constriction of the airways, which can prevent breathing.
• Coma, decreased consciousness, or difficulty thinking.
• Various conditions that affect the brain, symptoms of which can 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.
• Kidney failure, 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 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 white blood cell count, changes in blood coagulation parameters.

• Intravenous administration may cause inflammation of the blood vessels.
• Diarrhea.
• Increased levels of certain liver enzymes, high bilirubin levels in the blood.
• Rash.
• Reactions at the injection or infusion site, pain, and inflammation at the injection site.

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

• Oral candidiasis (fungal infection), vaginal infections.
• Severe blood disorders, including changes in the number of certain white blood cells and platelets (symptoms may include fatigue, new infections, and formation of bruises and easy bleeding).
• Headache, feeling of dizziness (nausea) and dizziness (vomiting).
• Skin rash (urticaria), redness, and itching of the skin.
• Abnormal results in kidney function tests.
• Fever.

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

• Numbness or tingling in the hands or feet.
• Decreased consciousness or difficulty thinking, dizziness.
• Alteration of taste.
• Vasodilation.
• Difficulty breathing.
• Stomach pain (abdomen), constipation.
• Itching in the genital area.
• Tremors.

Side effects of unknown frequency

• False positives in urine glucose tests.
• Confusion, hallucinations, drowsiness, altered consciousness.
• Bleeding.
• Digestive disorders.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Cefepime NORMON

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

Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date is the last day of the month indicated.

Do not store above 30°C. Store in the carton to protect from light.

The storage conditions for the reconstituted/diluted solutions of the medicine can be found at the end of the leaflet "This information is intended only for healthcare professionals".

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the SIGRE collection point at the pharmacy. If in doubt, consult your pharmacist on how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Container Content and Additional Information

Composition of Cefepima NORMON

Each vial contains 2 g of cefepima (as cefepima dihydrochloride monohydrate)

The other component (excipient) is L-arginine

Each ampoule contains water for injectable preparations

Appearance of the Product and Container Content

Cefepima NORMON is a white or almost white powder for injectable solution and perfusion, packaged in glass vials closed with an elastomer stopper and a flip-off cap.

The vials are packaged in cardboard boxes.

Presentation: 1 and 50 vials.

Only some package sizes may be commercialized

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

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

Date of the last revision of this prospectus: May 2014

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 medical professionals or healthcare professionals:

Cefepima NORMON 2 g powder and solvent for injectable solution and perfusion EFG

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

For slow intravenous injection/perfusion.

INCOMPATIBILITIES WITH DILUENTS AND OTHER MEDICINES

Cefepima NORMON solutions must notbe mixed with the following antibiotics: metronidazole, vancomycin, gentamicin, tobramycin sulfate, and netilmicin sulfate, as physical or chemical incompatibilities may occur. If concomitant treatment is indicated, these antibiotics must be administered separately.

INSTRUCTIONS FOR USE, HANDLING, AND DISPOSAL

Aseptic techniques must be used to reconstitute the solution. The reconstituted solution must be administered immediately after preparation.

Inspect the vial before use. It must only be used if the solution is free of particles.

Only use transparent solutions.

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

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

Method of Administration:

Intravenous Administration:

For direct IV injection, the contents of the ampoule are dissolved in 5 or 10 ml of water for injectable preparations, 5% glucose solution for perfusion, or 9 mg/ml (0.9%) sodium chloride solution for perfusion, as indicated in the following table. Reconstitution must be carried out with immediate and vigorous agitation until the product is completely dissolved after adding the volume of solvent used to reconstitute the vial, avoiding diffusion of the solvent into the powder without dissolving it. The prepared solution is injected slowly over 3 to 5 minutes or directly into a vein or through a cannula of an IV perfusion system while the patient is receiving an IV perfusion with a compatible solution.

For IV perfusions, the powder is dissolved as described for direct IV injections. An appropriate amount of the prepared solution is added to an IV perfusion container containing a compatible IV perfusion solution.

Cefepima NORMON, once reconstituted, is compatible with the following perfusion solutions: water for injectable preparations, 9 mg/ml (0.9%) sodium chloride solution for perfusion, 5% glucose solution for perfusion, 10% glucose solution for perfusion, 1/6M sodium lactate solution for perfusion, 5% glucose and 9 mg/ml (0.9%) sodium chloride solution for perfusion, Ringer's lactate solution, and 5% glucose and Ringer's lactate solution for perfusion. Reconstituted and diluted solutions must be administered immediately after preparation.

Posology:

Adults and Adolescents with a Body Weight Over 40 kg (Approximately Over 12 Years):

• The recommended doses for adults and adolescents with a body weight over 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 perfusion over 30 minutes, 60 minutes before the intervention, followed by the administration of 500 mg of metronidazole. The metronidazole dose must be reconstituted and administered according to the official Summary of Product Characteristics. Due to the incompatibility between Cefepima and metronidazole, these two active substances must not be administered together. Before perfusing metronidazole, it is recommended that the perfusion tube be flushed with a compatible fluid. If the intervention lasts more than 12 hours, the perfusion 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 may be administered every 8 hours.

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

Elderly Patients:

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

Hepatic Insufficiency in Adults:

No dose adjustment is required in patients with hepatic insufficiency.

Renal Insufficiency in Adults:

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

Dialyzed Patients:

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. On dialysis days, cefepima must be administered after hemodialysis. Whenever possible, cefepima should be administered at the same time every day.

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

Children with Renal Insufficiency:

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

Duration of Treatment:

In general, treatment should always be continued for a few days after the reduction of fever and the resolution of pathological symptoms. The duration of treatment is usually 7 to 10 days; however, longer treatment may be necessary for more severe infections. For the empirical treatment of febrile neutropenia, the duration of treatment is generally 7 days or until the resolution of neutropenia.