CEFEPIMA NORIDEM 2 g POWDER FOR INJECTABLE SOLUTION AND FOR INFUSION

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

Do not use Cefepima Noridem:

• if you are allergic to cefepima (hypersensitive), to any cephalosporin antibiotic, 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 other type of beta-lactam antibiotic (penicillins, monobactams, and carbapenems).
• if you have high blood acidity (acidosis).

If you think you are in any of these situations, inform your doctor before starting treatment with cefepima. In that case, cefepima should not be administered to you.

Warnings and precautions

Consult your doctor before starting to use Cefepima Noridem:

• If you have ever had an allergic reactionto cefepima or another antibiotic belonging to the beta-lactam class or to any other medicine. If you experience an allergic reaction during treatment with cefepima, contact your doctor immediately, as it could be severe. In this case, the doctor will interrupt the treatment immediately.
• If you have ever had asthmaor tend to have allergies.
• If you have kidney problems, it may be necessary to adjust the dose of cefepima.
• If you suffer from acute and persistent diarrheaduring treatment. It could be an inflammation of the large intestine and requires urgent medical attention.
• If you suspect that you have acquired a new infectionduring prolonged use of cefepima. This could be due to an infection caused by microorganisms that are not sensitive to cefepima and may require interruption of treatment.
• If you are going to have blood or urine tests, it is essential to inform the doctor that you are using cefepima. This medicine can alter the results of some tests.

Other medicines and Cefepima Noridem

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

In particular, inform your doctor if you are taking any of the following medicines:

• Other antibiotics, especially aminoglycosides (such as gentamicin) or diuretics (such as furosemide). In these cases, kidney function should be monitored.
• Certain types of antibiotics (bacteriostatic antibiotics), as they may affect the functioning of cefepima.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.

There are limited or no data on the use of cefepima in pregnant women, so cefepima is not recommended during pregnancy.

Cefepima is excreted in breast milk in small amounts. However, you can be given cefepima while breastfeeding. Nevertheless, you should observe your breastfed baby for any adverse effects.

Driving and using machines

The influence of cefepima on the ability to drive and use machines is negligible or nil. You may experience headache, feel dizzy, or have changes in vision while taking this medicine. If you do not feel well, do not drive or use machines.

3. How to use Cefepima Noridem

Administration:

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

Usual dose:

The correct dose of cefepima for you will be decided by your doctor and depends on: the severity and type of infection, whether or not you are taking other antibiotics, your weight and age, and how well your kidneys are working. The usual duration of treatment is 7-10 days.

Adults and adolescents over 40kg (approx. over 12years of age)

The usual dose for adults is 4 g per day, divided into two doses (2 g every 12 hours). In very severe infections, the dose can be increased to 6 g per day (2 g every 8 hours).

Infants (from 2months) and children up to 40kg (approx. 12years)

For every kilogram of body weight of the infant or child, 50 mg of cefepima will be administered every 12 hours. In the case of very severe infections, and for example, to treat meningitis, this dose can be administered every 8 hours.

Infants (from 1 to less than 2months)

For every kilogram of body weight of the infant, 30 mg of cefepima will be administered every 12 hours (or every 8 hours in the case of very severe infections).

Patients with kidney problems

It may be necessary for your doctor to change the dose if you have kidney problems.

Talk to your doctor if you are in this situation.

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.

Diseases that require special attention

A small number of people using cefepima experience a severe allergic reaction or skin reaction that can be life-threatening. The symptoms of these reactions include:

• Severe allergic reaction. The signs include itchy rash, swelling, sometimes on the face or mouth, causing difficulty breathing.
• Skin rashthat can form blistersand appears as small targets(dark central spot, surrounded by a paler area, with a dark ring around the edge).
• A widespread rash, accompanied by blistersand skin peeling. (These symptoms can be signs of Stevens-Johnson syndromeor toxic epidermal necrolysis).
• Fungal infections:in rare cases, medicines like cefepima can cause the overgrowth of yeast (Candida) in the body, which can cause fungal infections (such as candidiasis). This side effect is more likely if you take cefepima for a prolonged period.

If you experience any of these symptoms, contact your doctor or nurse immediately.

Very common side effects that may appear in blood tests are:

May affect more than 1 in 10people:

• positive Coombs test

Common side effects

May affect up to 1 in 10people:

• pain at the injection site, swelling, and redness around a vein
• diarrhea
• skin rash

If you are concerned about any of these symptoms, tell your doctor.

Common side effects that may appear in blood tests are:

• increase in substances (enzymes) produced by the liver
• increase in bilirubin (a substance produced by the liver)
• changes in white blood cell counts (eosinophilia)
• low red blood cell count (anemia)

Uncommon side effects

May affect up to 1 in 100people:

• inflammation of the colon (large intestine), which causes diarrhea, usually accompanied by blood and mucus, stomach pain
• fungal infections in the mouth, vaginal infections
• high temperature (fever)
• redness of the skin, urticarial rash (hives), itching (pruritus)
• feeling sick (nausea), vomiting
• headache

If you experience any of these symptoms, tell your doctor.

Uncommon side effects that may appear in blood tests are:

• low levels of certain blood cells (leukopenia, neutropenia, thrombocytopenia)
• increase in urea or creatinine levels in the blood.

Rare side effects

May affect up to 1 in 1,000people:

• allergic reactions
• fungal infections (candidiasis)
• seizures, dizziness, altered sense of taste, sensation of pins and needles or numbness of the skin

• breathing difficulties
• abdominal pain, constipation
• chills

Other side effects of unknown frequency (also isolated cases)

• severe allergic reactions
• coma, reduced level of consciousness or difficulty thinking, confusion, and hallucinations
• false positive glucose test in urine
• digestive problems
• kidney problems
• bleeding

Side effects that may appear in blood tests are:

• changes in blood cell counts (agranulocytosis)
• rapid breakdown of red blood cells (hemolytic anemia)

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects 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. Storage of Cefepima Noridem

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 carton and vial. The expiry date is the last day of the month stated.

Before opening: store below 25°C. Store the vials in the outer packaging to protect from light.

Validity period of the prepared solution

After converting the Cefepima Noridem powder into a solution, it should be administered immediately. Otherwise, the solution will not be stored for more than 24 hours at 2-8°C.

Do not use Cefepima Noridem if you notice that the solution is not transparent or has changed color.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Container Content and Additional Information

Composition of Cefepima Noridem

• The active ingredient is cefepima. Each vial contains cefepima dihydrochloride monohydrate, which is equivalent to 2 g of cefepima.
• The other excipients are L-arginine.

Appearance of the Product and Container Content

Fine white to light yellow powder contained in a glass vial. After dissolution, a clear yellowish-brown solution.

Glass vials (type III), closed with a rubber stopper and sealed with an aluminum cap, with a flip-top plastic cap.

The medication is presented in boxes of 1, 10, or 50 vials.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Noridem Enterprises Limited

Evagorou & Makariou

Mitsi Building 3, Office 115

1065 Nicosia, Cyprus

Manufacturer:

DEMO S.A. PHARMACEUTICAL INDUSTRY

21st Km National Road Athens–Lamia,

14568 Krioneri, Attiki, Greece

phone: (+30) 210.8161802

fax: (+30) 2108161587

This medication is authorized in the member states of the European Economic Area under the following names:

Date of the last revision of this prospectus: March 2025

Detailed information about 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 healthcare professionals:

Instructions for use and handling

Preparation of the solution for IV 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 3-5 minutes, directly into a vein or directly into the cannula of an infusion system, while the patient is receiving an infusion with a compatible IV solution.

Preparation of the solution for IV perfusion

In the case of intravenous perfusion, reconstitute the solution of 2 g of cefepima, as indicated above for direct intravenous administration; and add the necessary amount of the resulting solution to a container with one of the compatible IV liquids. The prepared solution should be administered over a period of approximately 30 minutes.

In the following table, the instructions for reconstitution are shown:

Compatibility with intravenous fluids:

Cefepima Noridem is compatible at concentrations between 1 and 40 mg/ml with one of the following solutions for intravenous perfusion:

• Sodium chloride solution 0.9%
• Glucose solution 5%
• Water for injectable preparations

The reconstitution/dilution of the medication should be performed under sterile conditions. Add the recommended volume of the reconstituted solution and gently shake until the contents of the vial are completely dissolved.

For single use only. Any remaining solution should be discarded.

Note: Parenteral medications should be visually inspected before administration to rule out the presence of particulate matter in suspension. If present, do not use the solution.

Storage after reconstitution

Validity period of the prepared solution

The reconstituted solutions should be used immediately.

The chemical and physical stability of the preparation after dilution has been demonstrated for 7 days when stored at 2°C-8°C or for 24 hours when stored at 23°C-27°C.

From a microbiological point of view, the product should be used immediately.

If not used immediately, the storage times and conditions before use are the responsibility of the user and should not exceed 24 hours at a temperature of 2-8°C.

Do not use Cefepima Noridem if you observe that the solution is not transparent or has changed color.

Any unused remaining solution should be discarded.

Medications should not be thrown down the drain. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Dosage 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 those with normal renal function. In the following table, the recommended maintenance dose is provided:

Patient on dialysis:

A loading dose of 1 g on the first day of treatment with cefepima, followed by 500 mg per day thereafter, unless in the case of febrile neutropenia, for which the recommended dose is 1 g per day. On dialysis days, cefepima should be administered after the dialysis cycle. Cefepima should be administered at the same time every day, if possible.

In patients undergoing CAPD, the following dosing regimen is recommended: 1 g every 48 hours in the case of severe infections or 2 g every 48 hours in the case of very severe infections.

Renal insufficiency in children:

An initial dose of 30 mg/kg is recommended for infants from 1 to less than 2 months or 50 mg/kg for patients between 2 months and 12 years. In the following table, the maintenance dose is provided: