Cefepime accord

Package leaflet: Information for the user

Cefepime Accord, 1 g, powder for solution for injection/infusion
Cefepimum
Please read this leaflet carefully before using this medicine because it contains
important information for you.
­ Keep this leaflet, as you may need to read it again.
­ If you have any further questions, please ask your doctor, pharmacist, or nurse.
­ This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
­ If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor. See section 4.
Contents of the leaflet

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

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

Cefepime Accord is an antibiotic used in adults and children. It works by killing bacteria that cause infections. It belongs to a group of antibiotics called fourth-generation cephalosporins.
Cefepime Accord is used to treat the following infections:
In adults and adolescents aged over 12 years:

• lung infections (pneumonia),
• complicated (severe) urinary tract infections,
• complicated (severe) intra-abdominal infections,
• peritoneal membrane inflammation (peritonitis) associated with dialysis in patients undergoing continuous ambulatory peritoneal dialysis (CAPD).

In adults:

• acute gallbladder infection (acute cholecystitis).

In children aged 2 months to 12 years with body weight below 40 kg:

• complicated (severe) urinary tract infections,
• lung infections (pneumonia),
• infections of the membranes surrounding the brain (bacterial meningitis).

Cefepime is also used in adults and children aged over 2 months:
for the treatment of febrile episodes of unknown origin in patients with decreased immunity (when bacterial infection is suspected in patients with moderate to severe neutropenia). Combination therapy with another antibiotic is recommended if necessary,
for the treatment of bloodstream bacterial infection (bacteraemia).

2. Important information before using Cefepime Accord

When not to use Cefepime Accord

• if the patient is allergic to cefepime or to any of the other ingredients of this medicine (listed in section 6);
• if the patient has ever experienced a severe allergic reaction (hypersensitivity reaction) to another type of beta-lactam antibiotic (penicillins, monobactams, carbapenems);
• if the patient has increased blood acidity (acidosis).

The patient should inform the doctor before starting Cefepime Accord if they think
the above information applies to them. In such a case, the patient must not be given Cefepime Accord.
Warnings and precautions
The patient should inform the doctor or healthcare professional:

• if they have ever had an allergic reaction to cefepime or any other beta-lactam antibiotic, or to any other medicine; if an allergic reaction occurs during treatment with cefepime, the patient should seek medical advice immediately, as the reaction may be severe; in such a case, the doctor will immediately discontinue the medicine;
• if they have ever been diagnosed with asthma or a tendency to allergies;
• if they have kidney function disorders; in such cases, the dose of cefepime may need to be adjusted;
• if they develop severe and persistent diarrhoea during treatment; this may be a sign of inflammation of the large intestine, and prompt medical attention may be required;
• if they suspect they have developed a new infection during prolonged treatment with Cefepime Accord; this may be an infection caused by microorganisms resistant to cefepime, and discontinuation of the medicine may be necessary;
• if the doctor prescribes blood or urine tests, the patient should inform the doctor that they are taking Cefepime Accord, as this medicine may affect the results of certain tests.

Children
Special dosage guidelines apply to infants and children (see section 3).
Elderly patients
Dosage in elderly patients should be carefully adjusted, taking into account renal function, as these patients have a higher likelihood of impaired kidney function (see section 3).
Cefepime Accord and other medicines
The patient should tell their doctor or pharmacist about all medicines they are currently taking, have recently taken, or plan to take.
In particular, the patient should inform the doctor if they are taking:

• other antibiotics, especially aminoglycosides (such as gentamicin) or "water pills" (diuretics, such as Furosemide) – in such cases, kidney function should be monitored;
• medicines that prevent blood clotting (anticoagulants, coumarin derivatives such as warfarin)
  • their effect may be enhanced;
• certain types of antibiotics (bacteriostatic antibiotics) – these may affect the action of cefepime.

Pregnancy, breastfeeding and fertility

• If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.

• Particular caution should be exercised when prescribing Cefepime Accord to pregnant women due to the lack of data on its use in this patient group. If the patient becomes pregnant while taking Cefepime Accord, she should inform her doctor.

• Cefepime passes into human milk in very small amounts; therefore, caution should be exercised when administering it to breastfeeding women.

• There are no data on the effect of cefepime on human fertility.

Driving and operating machinery
Studies on the effect of cefepime on the ability to drive vehicles and operate machinery have not been conducted. However, possible adverse effects such as altered consciousness, dizziness, confusion, or hallucinations may affect the ability to drive and operate machinery.

3. How to use Cefepime Accord

Method of administration:
Cefepime Accord is usually administered by a doctor or nurse. It is given as an
intravenous infusion (drip) or as an injection directly into a vein, or as a deep
injection into the large buttock muscle (intramuscularly).
Recommended dose:
The dose of Cefepime Accord will be determined by the doctor and depends on: severity and type of infection,
concomitant use of other antibiotics by the patient, body weight and age, and kidney function
of the patient. The duration of treatment is usually 7 to 10 days.
Adults and adolescents with body weight above 40 kg (approximately over 12 years of age)
The usual dose in adults is 4 g per day, divided into two doses (2 g every 12 hours).
In cases of very severe infections, the dose may be increased to 6 g per day (2 g every 8 hours).
Infants (over 2 months of age) and children with body weight up to 40 kg (approximately up to 12 years of age)
A dose of 50 mg of cefepime per kilogram of body weight of the child is administered every 12 hours.
In cases of very severe infections, or for example bacterial meningitis, the same dose may be given every 8 hours.
Infants from 1 month up to but less than 2 months of age
A dose of 30 mg of cefepime per kilogram of body weight of the infant is administered every
12 hours (or every 8 hours in cases of very severe infections).
Patients with impaired kidney function
If the patient has impaired kidney function, the doctor may adjust the dose of the medicine.
Patients should inform their doctor if they believe this applies to them.
If you have any further questions about the use of this medicine, consult your
doctor, pharmacist, or nurse.
Use of a higher than recommended dose of Cefepime Accord
In cases of severe overdose, especially in patients with impaired kidney function,
haemodialysis may be helpful in removing cefepime from the body (peritoneal dialysis is not beneficial).
Unintentional overdose has occurred when patients with impaired kidney function received cefepime in high doses.
If you have any further questions about the use of this medicine, consult your
doctor, pharmacist, or nurse.
Missed dose of Cefepime Accord
If the patient thinks a dose of Cefepime Accord has been missed, this should be reported to the doctor.
If you have any further questions about the use of this medicine, consult your
doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Situations to be aware of
A small number of people taking Cefepime Accord have shown an allergic reaction or skin reaction, which
can be severe. Signs of such reactions include:

• Severe allergic reaction – signs include raised and itchy rash, swelling, sometimes of the face or lips, which may cause difficulty in breathing,
• Skin rash, which may be accompanied by blisters, appearing as small target-like lesions (dark spots in the centre, surrounded by a lighter area and a dark ring along the edge),
• Widespread rash with blisters and peeling of the skin (these may be symptoms of Stevens-Johnson syndrome or toxic epidermal necrolysis [Lyell's syndrome]),
• Fungal infections: in rare cases, taking medicines such as Cefepime Accord may encourage the growth of yeast (Candida) in the body, which may lead to fungal infections (such as thrush); the likelihood of this adverse effect is higher when Cefepime Accord is taken for a prolonged period. If any of these symptoms occur, the patient should contact a doctor or nurse immediately.

Very common adverse effects observed in blood test results:
May occur in more than 1 in 10 people:

• Positive Coombs test

Common adverse effects
May occur in no more than 1 in 10 people:

• Pain, swelling or redness along the vein
• Diarrhoea
• Rash
  Inform the doctor if any of the above symptoms affect the patient.

Common adverse effects observed in blood test results:

• Increased activity of substances (enzymes) produced by the liver
• Elevated bilirubin levels (a substance produced by the liver)
• Change in white blood cell count (eosinophilia)
• Reduced number of red blood cells (anaemia)

Uncommon adverse effects
May occur in no more than 1 in 100 people:

• Colitis (inflammation of the large intestine) causing diarrhoea, usually with blood and mucus, abdominal pain
• Oral thrush, vaginal infections
• Increased body temperature (fever)
• Skin redness, urticaria (hives), itching
• Nausea, vomiting
• Headache
  Inform the doctor if the patient observes any of the above symptoms.

Uncommon adverse effects observed in blood test results:

• Reduced number of certain types of blood cells (leukopenia, neutropenia, thrombocytopenia)
• Increased blood urea nitrogen and creatinine levels.

Rare adverse effects
May occur in no more than 1 in 1000 people:

• Allergic reactions
• Fungal infections (candidiasis)
• Seizures, dizziness, taste disturbances, skin tingling and numbness
• Shortness of breath
• Abdominal pain, constipation
• Chills
• Swelling of deeper skin layers
• Joint pain
• Tinnitus

Other adverse effects with unknown frequency (including isolated cases)

• Severe allergic reactions
• Coma, disturbances of consciousness or difficulty thinking, confusion and hallucinations
• False positive urine glucose test result
• Digestive problems
• Kidney function disorders
• Bleeding

Adverse effects observed in blood test results:

• Change in blood cell count (agranulocytosis)
• Excessive breakdown of red blood cells (haemolytic anaemia)

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform a doctor, pharmacist or nurse. Adverse effects
can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Cefepime Accord

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and label after EXP. The expiry date refers to the last day of the stated month.
Do not store above 30 °C. Keep in the original packaging to protect from light.
Storage of solutions: see section “Information intended exclusively for medical or healthcare personnel” at the end of this leaflet.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Cefepime Accord contains

• The active substance is cefepime in the form of cefepime hydrochloride monohydrate (1.19 g).
• The other ingredient is L-arginine (used to adjust pH).

What Cefepime Accord looks like and contents of the pack
Cefepime Accord is a white to pale yellow powder for solution for injection/infusion, contained in 17 ml vials made of colourless type III glass, with a chlorobutyl rubber stopper type I, and an aluminium flip-off cap, packed in a cardboard box.
Pack sizes: 1, 5, 10 or 50 vials
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Accord Healthcare Polska Sp. z o.o.
Taśmowa Street 7
02-677 Warsaw
Tel: +48 22 577 28 00
Manufacturer
Laboratorio Farmaceutico CT S.r.l.
Via Dante Alighieri, 71
18038 Sanremo
Italy
This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Information intended exclusively for healthcare professionals:

After reconstitution, the solution is clear, colourless to amber, and free of particulate matter.
Storage conditions after reconstitution:
Chemical and physical stability of the product has been demonstrated as follows:
Cefepime Accord 1 g reconstituted with 1% lidocaine can be used for up to 12 hours if stored at 2–5°C.
Cefepime Accord 1 g dissolved in water for injections and 0.9% sodium chloride can be used for up to 24 hours if stored at 2–8°C.
Cefepime Accord 2 g dissolved in water for injections and 0.9% sodium chloride can be used for up to 12 hours if stored at 2–8°C.
From a microbiological point of view, the product should be used immediately. If the solution is not used immediately, the person administering the medicinal product is responsible for the storage time and conditions after opening.
Storage conditions after dilution:
Chemical and physical stability of the product has been demonstrated as follows:
Cefepime Accord 1 g diluted with water for injections and 10% dextrose can be used for up to 12 hours if stored at 25°C.
All other diluted infusion solutions or solutions for intramuscular administration should be used immediately.
Intramuscular administration:
To prepare a solution for injection for intramuscular administration, use as solvent 3 ml of water for injections or 0.5% or 1% lidocaine hydrochloride solution.
Use of lidocaine:
When using lidocaine solution as solvent, cefepime solutions must be used exclusively for intramuscular injections. Before use, consider contraindications, warnings, and other important information specified in the lidocaine product characteristics.
Lidocaine solution must never be administered intravenously.
In children above 30 months of age, intramuscular injection using lidocaine as solvent is recommended.
Intravenous administration:
Cefepime Accord 1 g should be dissolved in 10 ml of water for injections or in 5% dextrose solution or 0.9% sodium chloride solution. The resulting solution should be injected directly into the vein (over 3 to 5 minutes) or into the infusion line when the patient is receiving a compatible intravenous fluid.
The table below provides instructions for reconstitution:

Intravenous infusion
Reconstituted Cefepime Accord 1 g may be administered via an infusion line or directly into the infusion fluid. The solution should be administered over approximately 30 minutes.
Cefepime is compatible with the following solutions: 0.9% sodium chloride solution (with or without 5% dextrose solution), 5% Ringer's solution with lactate (with or without 5% dextrose solution), and M/6 sodium lactate at concentrations from 1 to 40 mg/ml.
Cefepime Accord may be administered simultaneously with other antibiotics or other medicinal products, 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, and theophylline.
As with other cephalosporins, after reconstitution the solution may turn yellow, which does not affect the efficacy of the medicinal product. Only solutions free from particulate matter should be used.