Cefepim Mip Pharma

Leaflet accompanying the packaging: information for the user

Cefepim MIP Pharma, 1 g, powder for solution for injection/infusion

Cefepim MIP Pharma, 2 g, powder for solution for injection/infusion

Cefepim ( Cefepimum)

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Cefepim MIP Pharma and what is it used for
• 2. Important information before using Cefepim MIP Pharma
• 3. How to use Cefepim MIP Pharma
• 4. Possible side effects
• 5. How to store Cefepim MIP Pharma
• 6. Contents of the packaging and other information

1. What is Cefepim MIP Pharma and what is it used for

Cefepim MIP Pharma is an antibiotic used in adults and children. Its action is based on killing bacteria that cause infections. It belongs to a group of antibiotics called fourth-generation cephalosporins.
Cefepim MIP Pharma is used to treat the following infections:
In adults and children over 12 years, including:
lung infections (pneumonia)
complicated (severe) urinary tract infections
complicated (severe) abdominal infections
peritonitis (inflammation of the lining of the abdominal cavity) associated with dialysis in patients undergoing continuous ambulatory peritoneal dialysis (CAPD)
In adults:
acute cholecystitis
In children aged 2 months to 12 years with a body weight of less than 40 kg, including:
complicated (severe) urinary tract infections
lung infections (pneumonia)
bacterial meningitis
Cefepim is also used in adults and children over 2 months of age:
to treat febrile neutropenia (fever of unknown origin in patients with reduced immunity); if necessary, another antibiotic should be added to the treatment,
to treat bacterial sepsis ( bacteremia).

2. Important information before using Cefepim MIP Pharma

When not to use Cefepim MIP Pharma:

• if the patient is allergic ( hypersensitive) to any cephalosporin antibiotic or to any of the other ingredients of this medicine (listed in section 6)
• if the patient has ever had a severe allergic reaction ( hypersensitivity reaction) to a beta-lactam antibiotic of another type (penicillins, monobactams, carbapenems)
• if the patient has increased blood acidity ( acidosis)
• The patient should inform their doctor before starting to use Cefepim MIP Pharma if they think the above information applies to them. In such a situation, the patient must not be given Cefepim MIP Pharma.

Special warnings and precautions for use

The patient should inform their doctor:

• if they have ever had an allergic reactionto cefepim or any other beta-lactam antibiotic, or to any other medicine; if an allergic reaction occurs during cefepim treatment, the patient should immediatelyconsult a doctor, as the reaction may be severe; in such a situation, the doctor will immediately stop the use of the medicine,
• if they have ever been diagnosed with asthmaor have a tendency to allergies,
• if they have kidney problems; it may be necessary to modify the cefepim dose,
• if a severe and persistent diarrheaoccurs during treatment; this may be a sign of colitis, and medical help may be necessary,
• if the patient suspects that they have developed a new infectionwhile using Cefepim MIP Pharma for a long time; this may be an infection caused by microorganisms that are not sensitive to cefepim, and it may be necessary to stop using the medicine,
• if the doctor prescribes blood or urine testsfor the patient, the patient should tell the doctor that they are using Cefepim MIP Pharma, as this medicine may affect the results of some tests.

Cefepim MIP Pharma and other medicines

If the patient is taking other medicines besides Cefepim MIP Pharma, or has taken them recently, or may take them in the near future, they should inform their doctor or pharmacist. This is important because some medicines cannot be taken with Cefepim MIP Pharma.
The patient should especially inform their doctor about the following medicines:

• other antibiotics, especially aminoglycosides (such as gentamicin) or "diuretic tablets" (diuretics, such as furosemide) - in such cases, kidney function should be monitored;
• medicines that prevent blood clotting (anticoagulant medicines, such as warfarin) - their action may be enhanced;
• certain types of antibiotics (bacteriostatic antibiotics) - they may affect the action of Cefepim MIP Pharma.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
There is no data on the use of cefepim in pregnant women, and it is recommended to avoid using cefepim during pregnancy.
Small amounts of the medicine may pass into breast milk. Cefepim MIP Pharma can be used in breastfeeding women, but the baby should be carefully monitored for any side effects.

Driving and using machines

Cefepim MIP Pharma has no significant effect on the ability to drive and use machines, or its effect is negligible. During treatment, headaches, dizziness, or vision disturbances may occur. If such symptoms occur, the patient should not drive or operate machines.

3. How to use Cefepim MIP Pharma

Method of administration:

Cefepim MIP Pharma is usually administered by a doctor or nurse. It is given as an intravenous infusionor by injectiondirectly into a vein.

Recommended dose:

The dose of Cefepim MIP Pharma will be determined by the doctor and depends on: the severity and type of infection, whether the patient is taking another antibiotic at the same time, the patient's body weight and age, and the patient's kidney function. The duration of treatment is usually 7 to 10 days.

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

The usual dose for adults is 4 g per day, divided into two doses (2 g every 12 hours). In the case of very severe infections, the dose may be increased to 6 g per day (2 g every 8 hours).
Infants (over 2 months) and children with a body weight of up to 40 kg (approximately up to 12 years of age)
The dose is 50 mg of cefepim per kilogram of body weight, administered every 12 hours. In the case of very severe infections or bacterial meningitis, the same dose may be administered every 8 hours.

Infants aged 1 to 2 months

The dose is 30 mg of cefepim per kilogram of body weight, administered every 12 hours (or every 8 hours in the case of very severe infections).

Patients with kidney problems

If the patient has kidney problems, the doctor may reduce the dose of the medicine.

• The patient should inform their doctor if they think the above information applies to them.

If the patient has any further doubts about using this medicine, they should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Cefepim MIP Pharma can cause side effects, although not everybody gets them.

Situations that require attention

A small number of people using Cefepim MIP Pharma may experience an allergic reaction or skin reaction, which can be severe. The symptoms of such reactions are:

• severe allergic reaction- symptoms include swelling and itching rash, sometimes also of the face or lips, which can cause difficulty breathing,
• skin rash, which may be accompanied by blisters, resembling small targets(dark spots in the center, surrounded by a lighter area and a dark border along the edges),
• widespread rash with blistersand peeling of the skin(these may be symptoms of Stevens-Johnson syndromeor toxic epidermal necrolysis),
• fungal infections:in rare cases, taking medicines like Cefepim MIP Pharma may promote the growth of fungi ( Candida) in the body, leading to fungal infections (such as thrush); the likelihood of this side effect is higher when using Cefepim MIP Pharma for a long time.
• If the patient experiences any of these symptoms, they should immediately contact their doctor or nurse.

Very common side effects observed in blood test results:

May occur in more than 1 in 10 people:

• positive Coombs test

Common side effects

May occur in up to 1 in 10 people:

• pain, swelling, or redness along the vein at the injection site
• diarrhea
• rash
• The patient should inform their doctorif any of the above symptoms occur.

Common side effects observed in blood test results:

• increased activity of substances ( enzymes) produced by the liver
• increased bilirubin level (substance produced by the liver)
• change in the number of white blood cells ( eosinophilia)
• decreased number of red blood cells ( anemia)

Uncommon side effects

May occur in up to 1 in 100 people:

• colitis (inflammation of the large intestine) causing diarrhea, usually with blood and mucus, abdominal pain
• oral thrush, vaginal infections
• increased body temperature (fever)
• redness of the skin, hives, itching
• nausea, vomiting
• headache
• The patient should inform their doctorif they experience any of the above symptoms.

Uncommon side effects observed in blood test results:

• decreased number of certain types of blood cells ( leukopenia, neutropenia, thrombocytopenia)
• increased levels of urea and creatinine in the blood.

Rare side effects

May occur in up to 1 in 1000 people:

• allergic reactions
• fungal infections ( candidiasis)
• seizures, dizziness, taste disturbances, tingling or numbness on the skin
• shortness of breath
• abdominal pain, constipation
• chills
• swelling of the deeper skin layers

Other side effects with unknown frequency (including single cases)

• acute allergic reactions
• coma, impaired consciousness or difficulty thinking, confusion and hallucinations
• false positive result of the glucose test in urine
• digestive problems
• kidney problems
• bleeding

Side effects observed in blood test results:

• change in the number of blood cells ( agranulocytosis)
• rapid breakdown of red blood cells ( hemolytic anemia)

Reporting side effects

If side effects occur, including any not listed in the leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: ndl@urpl.gov.pl
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Cefepim MIP Pharma

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the label and carton after: 'Expiry date'. The expiry date refers to the last day of the month.
Store at a temperature below 30°C. Store the vials in the outer packaging to protect from light.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Cefepim MIP Pharma contains

• The active substance of the medicine is cefepim. Each vial contains 1 g or 2 g of cefepim (as cefepime dihydrochloride monohydrate).
• The other ingredient is L-arginine.

What Cefepim MIP Pharma looks like and what the pack contains

Cefepim MIP Pharma, 1 g is available in 15 ml vials of colorless glass (type I), with a bromobutyl rubber stopper, with an aluminum flip-off seal, in a cardboard box
Cefepim MIP Pharma, 2 g is available in 50 ml vials of colorless glass (type I), with a bromobutyl rubber stopper, with an aluminum flip-off seal, in a cardboard box
Pack sizes: Boxes containing 1, 5, or 10 vials. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

MIP Pharma GmbH
Kirkeler Str. 41
66440 Blieskastel, Germany
phone 0049 (0) 6842 9609 0
fax 0049 (0) 6842 9609 355

Date of last revision of the leaflet: 09.05.2019

Information intended only for healthcare professionals:
Preparation of the solution for direct intravenous injection
The contents of the vial should be dissolved in 10 ml of solvent, according to the instructions in the table below.
The prepared solution should be administered slowly over 3 to 5 minutes - either directly into a vein or through an infusion set when the patient is receiving another compatible solution by intravenous infusion.
Preparation of the solution for intravenous infusion
To administer an intravenous infusion, the cefepim solution should be prepared in the same way as described above for direct intravenous injection. The appropriate amount of the prepared solution should be added to an infusion container containing a compatible infusion fluid (recommended final volume: about 40 to 50 ml). The duration of the intravenous infusion should be about 30 minutes.
The following table provides instructions for preparing the solution:

Dosing in patients with renal impairment:
Adults and adolescents with a body weight over 40 kg:
The recommended initial dose in patients with renal impairment is the same as in patients with normal renal function. The following table shows the maintenance dosing guidelines:

Patients on dialysis:
A single loading dose of 1 g on the first day of cefepim therapy, then 500 mg per day on subsequent days, except for patients with febrile neutropenia, who should continue to receive 1 g per day.
Cefepim should be administered after hemodialysis, as close as possible to the same time every day.
For patients on continuous ambulatory peritoneal dialysis (CAPD), the recommended dosing is: 1 g every 48 hours for severe infections or 2 g every 48 hours for very severe infections.
Renal impairment in children:
The recommended initial dose is 30 mg/kg for infants aged 1 to 2 months or 50 mg/kg for children aged 2 months to 12 years. The following table shows the maintenance dosing guidelines: