Cefepime mip pharma

Package leaflet: 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
Cefepime (Cefepimum)
Please read all of 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 further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of the leaflet

1. What Cefepim MIP Pharma is and what it is used for
2. Before you use 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 pack and other information

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

Cefepim MIP Pharma is an antibiotic used in adults and children. It works by killing bacteria that cause infections. It belongs to a group of antibiotics called cephalosporins of the fourth generation.
Cefepim MIP Pharma is used to treat the following infections:
In adults and children over 12 years of age, including:

• lung infections (pneumonia)
• complicated (severe) urinary tract infections
• complicated (severe) intra-abdominal infections
• peritonitis (inflammation of the abdominal lining) associated with dialysis in patients undergoing continuous ambulatory peritoneal dialysis (CAPD)
  In adults:
• acute cholecystitis (acute gallbladder infection)
  In children aged 2 months to 12 years with body weight 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:
• for treating febrile episodes of unknown origin in patients with decreased immunity (when bacterial infection is suspected in patients with moderate to severe neutropenia); another antibiotic may need to be added to the treatment if necessary,
• for treating bloodstream bacterial infection (bacteremia).

2. Before you use Cefepim MIP Pharma
Do not use Cefepim MIP Pharma:

• if you are allergic (hypersensitive) to any cephalosporin antibiotic or to any of the other ingredients of this medicine (listed in section 6)
• if you have ever had a severe allergic reaction (hypersensitivity reaction) to another type of beta-lactam antibiotic (penicillins, monobactams, carbapenems)
• if you have increased blood acidity (acidosis)
  • Inform your doctor before starting Cefepim MIP Pharma if you think any of the above applies to you. In such a case, you must not be given Cefepim MIP Pharma.

Take special care with Cefepim MIP Pharma
Tell your doctor:

• if you 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, you must immediately consult your doctor, as the reaction may be severe; in such a case, your doctor will immediately discontinue the medicine,
• if you have ever been diagnosed with asthma or have a tendency towards allergies,
• if you have kidney function disorders; your dose of cefepime may need to be adjusted,
• if you develop severe and persistent diarrhoea during treatment; this may be a sign of colitis and you may need urgent medical attention,
• if you suspect you have developed a new infection during prolonged treatment with Cefepim MIP Pharma; this may be an infection caused by microorganisms resistant to cefepime, and treatment may need to be discontinued,
• if your doctor has ordered blood or urine tests, you should inform your doctor that you are taking Cefepim MIP Pharma, as this medicine may affect the results of certain tests.

Cefepim MIP Pharma and other medicines
If you are taking, have recently taken, or might take any other medicines, you must inform your doctor or pharmacist. This is important because some medicines should not be taken together with Cefepim MIP Pharma.
Tell your doctor especially about the following medicines:

• other antibiotics, particularly aminoglycosides (such as gentamicin) or "water tablets" (diuretics, such as Furosemide) – in such cases, kidney function should be monitored;
• anticoagulant medicines (coumarin derivatives such as warfarin) – their effect may be enhanced;
• certain types of antibiotics (bacteriostatic antibiotics) – they may affect the action of Cefepim MIP Pharma.

Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, you should consult your doctor or pharmacist before using this medicine.
There are no data on the use of cefepime in pregnant women; the use of cefepime during pregnancy is not recommended.
Small amounts of the medicine may pass into breast milk. Cefepime may be used in breastfeeding women, but the infant should be carefully monitored for any adverse effects.
Driving and using machines
Cefepim MIP Pharma has no effect or negligible effect on the ability to drive and use machines. Headache, dizziness or visual disturbances may occur during treatment. If such symptoms occur, do not drive or operate machinery.

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 infusion (drip) or by injection directly 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 simultaneously receiving another antibiotic, body weight and age, and the patient's kidney function.
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 the child's body weight 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 aged 1 to 2 months
A dose of 30 mg of cefepime per kilogram of infant's body weight is administered every 12 hours
(or every 8 hours in case of very severe infections).
Patients with impaired kidney function
If the patient has impaired kidney function, the doctor may reduce the dose of the medicine.

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

If you have any further doubts regarding the use of this medicine, consult your
doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, Cefepim MIP Pharma can cause adverse reactions, although not everyone will experience them.

Situations to be aware of
A small number of people taking Cefepim MIP Pharma may experience an allergic reaction or skin reaction, which may be severe. Symptoms of such reactions include:

• Severe allergic reaction – signs include raised, itchy rash and 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 center, surrounded by a lighter area and a dark ring along the edges),
• Extensive rash with blisters and skin peeling (which may be symptoms of Stevens-Johnson syndrome or toxic epidermal necrolysis),
• Fungal infections: in rare cases, taking medicines such as Cefepim MIP Pharma may promote the growth of yeast (Candida) in the body, leading to fungal infections (such as thrush); the likelihood of this adverse reaction is higher when Cefepim MIP Pharma is taken for a prolonged period.
• If any of these symptoms occur, the patient should contact their doctor or nurse immediately.

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

• Positive Coombs test

Common adverse reactions
May occur in up to 1 in 10 people:

• Pain, swelling, or redness along the vein at the injection site
• Diarrhea
• Rash
  • Inform the doctor if the patient experiences any of the above symptoms.

Common adverse reactions observed in blood test results:

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

Uncommon adverse reactions
May occur in up to 1 in 100 people:

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

Uncommon adverse reactions 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 reactions
May occur in up to 1 in 1000 people:

• Allergic reactions
• Fungal infections (candidiasis)
• Seizures, dizziness, taste disturbances, skin tingling or prickling sensations
• Shortness of breath
• Abdominal pain, constipation
• Chills
• Swelling of deeper skin layers

Other adverse reactions with unknown frequency (including isolated cases)

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

Adverse reactions observed in blood test results:

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

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of 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
e-mail: [email protected]
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Cefepim MIP Pharma

Keep this medicine out of the 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 specified month.
Store below 30°C. Keep vials in the outer packaging to protect from light.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.

6. Contents of the pack and other information

What Cefepim MIP Pharma contains

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

What Cefepim MIP Pharma looks like and contents of the pack
Cefepim MIP Pharma, 1 g is available in 15 ml vials made of colourless glass (type I), with a bromobutyl rubber stopper and an aluminium "flip-off" cap, packed in a cardboard box.
Cefepim MIP Pharma, 2 g is available in 50 ml vials made of colourless glass (type I), with a bromobutyl rubber stopper and an aluminium "flip-off" cap, packed in a cardboard box.
Pack sizes: Boxes containing 1, 5 or 10 vials. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer/Importer
MIP Pharma GmbH
Kirkeler Str. 41
66440 Blieskastel, Germany
tel +49 (0) 6842 9609 0
fax +49 (0) 6842 9609 355

Information intended exclusively for medical professionals:

Preparation of 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 the vein or via
an intravenous infusion set when the patient is simultaneously receiving another compatible intravenous solution.

Preparation of solution for intravenous infusion
To prepare for intravenous infusion, cefepime solution of 1 g or 2 g should be prepared in the same manner as described above for direct intravenous injection. The appropriate volume of the prepared solution should then be added to an infusion container containing a compatible infusion fluid (recommended final volume: approximately 40 to 50 ml). The intravenous infusion should be administered over approximately 30 minutes.

The table below provides instructions for solution preparation:

Compatibility with intravenous fluids
The following solvents may be used for the preparation of the solution:

• water for injections,
• glucose solution 50 mg/ml (5%),
• sodium chloride solution 9 mg/ml (0.9%).

Preparation of the solution should be carried out under aseptic conditions. Add the recommended volume of solvent and gently shake the vial until the contents are completely dissolved.
Cefepime solutions, like other cephalosporins, may turn from yellow to amber in color, depending on storage conditions. However, this does not negatively affect the medicinal product's efficacy.
The vial should be inspected before use. The product may only be used if the solution does not contain visible solid particles. Only clear solutions should be administered.
For single use only. Any unused portion of the solution after use must be discarded.
Any unused medicinal product or waste material should be disposed of in accordance with local regulations.
Storage after reconstitution
Stability period of the prepared solution
The prepared solution is chemically and physically stable for 2 hours at 25°C and for 24 hours at 2 to 8°C. From a microbiological standpoint, the solution should be used immediately after preparation. If not used immediately, the responsibility for storage conditions and duration after opening lies with the person administering the medicinal product.
Dosing in patients with renal impairment:
Adults and adolescents with body weight greater than 40 kg:
The recommended initial dose in patients with impaired renal function is the same as in patients with normal renal function. The following table provides guidelines for maintenance dosing:

Patients undergoing dialysis:
One loading dose of 1 g on the first day of cefepime therapy, followed by 500 mg daily on subsequent days, except for patients with febrile neutropenia, in whom a daily dose of 1 g is recommended.
On dialysis days, cefepime should be administered after hemodialysis, preferably at the same time each day.
For patients undergoing continuous ambulatory peritoneal dialysis (CAPD), the following dosing regimen is recommended: 1 g every 48 hours for severe infections or 2 g every 48 hours for very severe infections.
Renal function impairment in children:
The recommended initial dose is 30 mg/kg body weight for infants aged 1 to 2 months or 50 mg/kg body weight for children aged 2 months to 12 years. The following table presents the maintenance dosing regimen: