Cefepime Noridem

Package leaflet: Information for the patient

Cefepime Noridem 1 g powder for injectable solution/for infusion
Cefepime Noridem 2 g powder for injectable solution/for infusion
Cefepime
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

1. What Cefepime Noridem is and what it is used for
2. What you need to know before using Cefepime Noridem
3. How to use Cefepime Noridem
4. Possible side effects
5. How to store Cefepime Noridem
6. Contents of the pack and other information

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

Cefepime Noridem is an antibiotic used in adults and children. It works by killing the bacteria responsible for infections. It belongs to a group of medicines called fourth-generation cephalosporins.
In adults and children over 12 years of age, including:

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

In adults:

• Acute gallbladder infections

In children from 2 months up to 12 years of age and with body weight below 40 kg, including:

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

Cefepime is also used in adults and children over 2 months of age:

• To treat an episode of fever of unknown origin in patients with reduced resistance (if fever is suspected to be due to a bacterial infection in patients with neutropenia of moderate to severe degree). If necessary, it should be administered in combination with another antibiotic.
• To treat blood infections (bacteremia).

2. What you need to know before using Cefepime Noridem

Do not use Cefepime Noridem if:

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

Inform your doctor before starting treatment with Cefepime Noridem if you think this applies to you.
In such cases, Cefepime Noridem must not be administered to you.
Warnings and precautions
Talk to your doctor before taking Cefepime Noridem:

• if you have ever had an allergic reaction to cefepime or to other beta-lactam antibiotics or other medicines. If you develop an allergic reaction during treatment with cefepime, you must contact your doctor immediately, as it could be serious. In this case, your doctor will immediately stop the treatment.
• if you have ever suffered from asthma or have a tendency towards allergies.
• if you have kidney problems, a dose adjustment of cefepime may be necessary.
• if you develop severe and persistent diarrhoea during treatment. This may be a sign of inflammation of the large intestine and requires urgent medical attention.
• if you suspect you have developed a new infection during prolonged use of Cefepime Noridem. This may be an infection caused by microorganisms not sensitive to cefepime, and discontinuation of treatment may be necessary.
• if you are due to have blood or urine tests, it is important that you inform your doctor that you are taking Cefepime Noridem. This medicine may alter the results of certain tests.

Other medicines and Cefepime Noridem
Inform 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 (e.g. furosemide); in these cases, your kidney function should be monitored.
• certain types of antibiotics (bacteriostatic antibiotics), as they may affect the effectiveness of cefepime.

Pregnancy, breastfeeding and fertility
If you are pregnant, breastfeeding, suspect you may be pregnant, or are planning to become pregnant, ask your doctor for advice before taking this medicine.
There is no information available on the use of this medicine during pregnancy; it is preferable to avoid using cefepime during pregnancy.
Small amounts of this medicine may pass into breast milk. However, cefepime may still be administered while breastfeeding. Nevertheless, you must monitor the breastfed infant for the development of adverse effects.
Driving and using machines
Cefepime does not affect, or has only a negligible effect on, the ability to drive vehicles or operate machinery.
While taking this medicine, you may experience headache, dizziness, or visual disturbances. Do not drive or operate machinery if you do not feel well.

3. How to use Cefepime Noridem

Method of administration:
Cefepime Noridem is generally administered by a doctor or nurse. It can be given as an intravenous infusion (IV infusion) or as an injection directly into a vein.
Recommended dose:
The correct dose of Cefepime Noridem for you will be determined by your doctor and will depend on: the severity and type of infection, whether you are taking any other antibiotics; your body weight and age; and kidney function. The usual duration of treatment is 7–10 days.
Adults and adolescents weighing more than 40 kg (from approximately 12 years of age)
The usual dose for adults is 4 g per day, divided into two doses (2 g every 12 hours). In severe infections, the dose may be increased up to 6 g per day (2 g every 8 hours).
Young children (from 2 months) and children up to 40 kg (approximately 12 years)
For each kg of body weight of the young child or child, 50 mg of cefepime will be administered every 12 hours. In case of severe infections, such as meningitis, this dose will be given every 8 hours.
Infants (from 1 to less than 2 months)
For each kg of body weight of the infant, 30 mg of cefepime will be administered every 12 hours (or every 8 hours in case of severe infections).
Patients with renal impairment
If you have kidney problems, your doctor may adjust your dose.
Inform your doctor if this applies to you.
If you have any doubts about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

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

Conditions to be aware of
A small number of people using Cefepime Noridem experience an allergic reaction or a potentially serious skin reaction. Symptoms of these reactions include:

• Severe allergic reaction. Signs include raised, itchy rash, swelling, sometimes of the face or mouth, causing difficulty breathing.
• Skin rash which may present with blisters resembling small targets (a dark spot in the centre surrounded by a pale area with a black ring around the edge).
• Widespread rash with blisters and skin peeling. (These may be signs of Stevens-Johnson syndrome or toxic epidermal necrolysis).
• Fungal infections: Rarely, medicines such as Cefepime Noridem may cause excessive growth of yeast (Candida) in the body, leading to fungal infections (such as candidiasis). These side effects are more likely if you are taking Cefepime Noridem for a prolonged period.

Contact a doctor or nurse immediately if you experience any of these symptoms.

Very common side effects that may be detected by blood tests:
These may affect more than 1 in 10 people:

• positive Coombs test

Common side effects
These may affect up to 1 in 10 people:

• pain at the injection site, swelling and redness along the vein
• diarrhoea
• rash

Tell your doctor if any of these side effects concern you.

Common side effects that may be detected by blood tests:

• increased levels of substances (enzymes) produced by the liver
• increased bilirubin (a substance produced by the liver)
• changes in white blood cell count (eosinophilia)
• low levels of red blood cells (anaemia)

Uncommon side effects
These may affect up to 1 in 100 people:

• inflammation of the colon (large intestine), causing diarrhoea, usually with blood and mucus, and stomach pain
• fungal infections in the mouth, vaginal infections
• high temperature (fever)
• skin redness, urticaria, itching
• nausea, vomiting
• headache

Tell your doctor if you experience any of these symptoms.

Uncommon side effects that may be detected by blood tests:

• low levels of certain blood cells (leucopenia, neutropenia, thrombocytopenia)
• increased levels of blood urea nitrogen and serum creatinine in the blood.

Rare side effects
These may affect up to 1 in 1,000 people:

• allergic reactions
• fungal infections (candidiasis)
• seizures, dizziness, altered taste sensation, tingling or numbness of the skin
• shortness of breath
• abdominal pain, constipation
• tremors

Other side effects with unknown frequency (including single case reports)

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

Side effects that may be detected by blood tests:

• changes in blood cell counts (agranulocytosis)
• red blood cells destroyed too quickly (haemolytic anaemia).

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at: www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Cefepime Noridem

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the vial.
The expiry date refers to the last day of that month.
Before opening: store below 25°C. Keep the vials in the outer packaging to protect the medicine from light.
Stability period of the reconstituted solution
When Cefepime Noridem powder has been dissolved, it should be administered immediately. Otherwise, the solution is generally not stored for more than 24 hours at 2–8°C.
Do not use Cefepime Noridem if you notice that the solution is cloudy or discoloured.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Cefepime Noridem contains

• The active substance is cefepime. Each vial contains cefepime dihydrochloride monohydrate equivalent to 1 g or 2 g of cefepime.
• The other excipient is L-arginine.

Description of the appearance of Cefepime Noridem and contents of the pack
Fine white to pale yellow powder in a glass vial. After reconstitution, the solution is clear and yellowish-brown in colour.
Glass vials (Type III) closed with rubber stoppers and sealed with aluminium caps with a pull-off plastic cap.
The medicine is available in packs of 1, 10 or 50 vials.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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
T: +30 210 8161802, F: +30 2108161587

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Netherlands Cefepime Noridem 1 g, powder for solution for injection/infusion
Cefepime Noridem 2 g, powder for solution for injection/infusion
France CEFEPIME NORIDEM 1 g, poudre pour solution injectable/pour perfusion
CEFEPIME NORIDEM 2 g, poudre pour solution injectable/pour perfusion
Belgium Cefepime Noridem 1 g, poudre pour solution injectable/pour perfusion / Poeder voor oplossing voor injectie/infusie / Pulver zur Herstellung einer Injektions-/Infusionslösung
Cefepime Noridem 2 g, poudre pour solution injectable/pour perfusion / Poeder voor oplossing voor injectie/infusie / Pulver zur Herstellung einer Injektions-/Infusionslösung
Luxembourg Cefepime Noridem 1 g, poudre pour solution injectable/pour perfusion
Cefepime Noridem 2 g, poudre pour solution injectable/pour perfusion
Czech Republic Cefepim Noridem
Slovakia Cefepim Noridem
Slovakia Cefepim Noridem 1 g prášok na injekčný/infúzny roztok
Cefepim Noridem 2 g prášok na injekčný/infúzny roztok
Austria Cefepim Noridem 1 g pulver zur Herstellung einer Injektions-/Infusionslösung
Cefepim Noridem 2 g pulver zur Herstellung einer Injektions-/Infusionslösung
Germany Cefepim Noridem 1 g pulver zur Herstellung einer Injektions-/Infusionslösung
Cefepim Noridem 2 g pulver zur Herstellung einer Injektions-/Infusionslösung
Hungary Cefepim Noridem 1 g por oldatos injekcióhoz vagy infúzióhoz
Cefepim Noridem 2 g por oldatos injekcióhoz vagy infúzióhoz
Italy Cefepime Noridem
Cefepime Noridem
Spain Cefepima Noridem 1 g polvo para solución inyectable y para perfusión EFG
Cefepima Noridem 2 g polvo para solución inyectable y para perfusión EFG
Portugal Cefepima Noridem
Cefepima Noridem
Cyprus Cefepime Noridem 1 g κόνις για ενέσιμο διάλυμα/ διάλυμα προς έγχυση
Cefepime Noridem 2 g κόνις για ενέσιμο διάλυμα/ διάλυμα προς έγχυση

The following information is intended for healthcare professionals only:
Instructions for use and handling
Preparation of solution for intravenous injection
The contents of the vial are dissolved in 10 mL of solvent as indicated in the table below. The reconstituted solution is injected slowly over a period of 3–5 minutes – either directly into a vein or directly into the cannula of an infusion system while the patient is receiving an infusion with a compatible intravenous solution.

Preparation of solution for intravenous infusion
For intravenous infusion, reconstitute the 1 g or 2 g cefepime solution as described above for direct intravenous administration; then add the required amount of the reconstituted solution to a container with compatible intravenous fluids. The prepared solution should be administered over approximately 30 minutes.

The following table provides reconstitution instructions:
Route of Solvent to be Approximate final Approximate
administration / added (mL) volume (mL) concentration of
quantity cefepime (mg/mL)
IV
1 g vial 10 11.4 90
2 g vial 10 12.8 160

Compatibility with intravenous fluids:
Cefepime Noridem is compatible, at concentrations from 1 to 40 mg/mL, with one of the following intravenous fluids:

• 0.9% sodium chloride solution,
• 5% glucose solution,
• water for injections

Reconstitution/dilution must be performed under aseptic conditions. Add the recommended volume of reconstituting solution and gently shake until the contents of the vial are completely dissolved.
For single use only. Any unused solution remaining must be discarded.
Note: parenteral medicinal products should be visually inspected for particulate matter prior to administration. If particles are present in the solution, it must not be used.

Storage after reconstitution
Stability after reconstitution
Reconstituted solutions should be used immediately.
Chemical and physical stability of the diluted preparation 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 standpoint, the product should be used immediately.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and should not exceed 24 hours at a temperature between 2°C and 8°C.
Do not use Cefepime Noridem if the solution appears cloudy or discoloured.
Unused solution must be discarded.
Do not dispose of medicines via wastewater. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

Dosing in patients with renal impairment:
Adults and adolescents weighing more than 40 kg:
The recommended initial dose for patients with renal impairment is the same as for patients with normal renal function. The following table provides the maintenance dose:

Patients on dialysis:
A loading dose of 1 g on the first day of treatment with cefepime, followed by 500 mg daily,
except for febrile neutropenia, for which the recommended dose is 1 g daily. On dialysis days, cefepime
should be administered after dialysis. If possible, cefepime should be given at the same time each day.
For patients undergoing CAPD, the following dosage is recommended: 1 g every 48 hours in case of severe
infections or 2 g every 48 hours in case of very severe infections.
Impaired renal function in children:
An initial dose of 30 mg/kg is recommended for children aged 1 month to less than 2 months or
50 mg/kg for patients aged 2 months to 12 years. The following table provides the maintenance dose: