Cefepime Solufarma

Leaflet accompanying the packaging: patient information

Cefepime Solufarma, 500 mg, powder for solution for injection/infusion

Cefepime Solufarma, 1000 mg, powder for solution for injection/infusion

Cefepime

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• 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 side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

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

Cefepime Solufarma is indicated for the treatment of adults, adolescents, and children over 2 months of age.
Adults and adolescents
For the treatment of infections caused by susceptible pathogens:

• severe pneumonia;
• complicated urinary tract infections;
• intra-abdominal infections, including peritonitis: combination therapy with additional antibiotics is recommended, taking into account the individual risk for the patient and expected or identified pathogens, if necessary;
• biliary tract infections (gallbladder and bile ducts);
• treatment of patients with bacteremia associated with or suspected to be associated with any of the above infections;
• treatment of patients with moderate (neutrophils ≤1000/mm) or severe (neutrophils ≤500/mm) neutropenia with fever, when a bacterial infection is suspected. In patients with neutropenia with a high risk of severe infections (such as patients after recent bone marrow transplantation, patients with initial hypotension, when there is a suspicion of blood diseases, or severe or prolonged neutropenia), monotherapy with antibacterial agents may be inappropriate.

There is a lack of sufficient data on the use of cefepime in monotherapy in these patients.
Combination therapy with aminoglycosides or glycopeptides is recommended, taking into account the patient's risk profile.
Children
Treatment of infections caused by pathogens susceptible to cefepime:

• severe pneumonia
• complicated urinary tract infections
• bacterial meningitis
• treatment of patients with moderate (neutrophils ≤1000/mm) or severe (neutrophils ≤500/mm) neutropenia with fever, probably caused by a bacterial infection. In patients with neutropenia with a high risk of severe infections (such as patients after recent bone marrow transplantation, patients with initial hypotension, when there is a suspicion of blood diseases, or severe or prolonged neutropenia), monotherapy with antibacterial agents may be inappropriate. However, there is a lack of sufficient data on the use of cefepime in monotherapy in these patients. Combination therapy with aminoglycosides or glycopeptides is recommended, taking into account the individual risk for the patient.

Official guidelines on the proper use of antibacterial agents should be taken into account.

2. Important information before using Cefepime Solufarma

When not to use Cefepime Solufarma

• if the patient is allergic to cefepime or any of the other ingredients of this medicine (listed in section 6), or to beta-lactam antibiotics (such as penicillins, monobactams, and carbapenems).

Warnings and precautions

Before starting treatment with Cefepime Solufarma, the patient should discuss it with their doctor or pharmacist.

• As with any beta-lactam antibiotic, severe and sometimes fatal hypersensitivity reactions have been reported with cefepime.
• Cefepime Solufarma should be used with caution in patients with asthma or a history of allergies. After the first dose, the patient's condition should be closely monitored. If an allergic reaction occurs, treatment with Cefepime Solufarma should be discontinued immediately.
• Severe hypersensitivity reactions may require the administration of epinephrine and other supportive therapies.
• During treatment with almost all antibiotics, including Cefepime Solufarma, the occurrence of diarrhea associated with Clostridium difficile infection (CDAD) has been observed, ranging from mild to life-threatening pseudomembranous colitis. The possibility of CDAD should be considered in all patients who develop diarrhea after antibiotic treatment. A detailed medical history is necessary, as CDAD cases have been reported up to 2 months after the end of antibiotic treatment.
• If the patient has a history of allergic reactions to drugs. Severe and sometimes fatal hypersensitivity reactions have been reported with beta-lactam antibacterial agents. If any allergic reaction occurs, treatment with Cefepime Solufarma should be discontinued and appropriate treatment initiated.
• The use of antibiotics may lead to uncontrolled growth of resistant pathogens; if superinfection occurs during treatment, appropriate measures should be taken.
• Since elderly patients are more likely to have impaired renal function, caution should be exercised when selecting a dose and monitoring renal function.
• Abnormalities in diagnostic tests: Positive Coombs' test results have been reported in patients treated with cefepime, without signs of hemolysis. It can also cause false-positive results in urine glucose testing using the copper reduction method (the enzymatic method should be used).

Cefepime Solufarma and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
The patient should consult their doctor if they are taking:

• aminoglycoside antibiotics or potent diuretics, as they may potentially cause kidney problems. In such cases, the doctor will recommend close monitoring of renal function.
• warfarin and other coumarin derivatives, as their effect may be enhanced by cefepime
• bacteriostatic antibiotics, as they may interfere with the therapeutic effect of beta-lactam antibiotics.

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.
The safety of Cefepime Solufarma during pregnancy has not been established, so it should only be used if absolutely necessary and under close medical supervision.
If the patient is breastfeeding, the doctor will exercise caution when administering Cefepime Solufarma, as small amounts of the medicine may pass into breast milk.
Reproduction studies in animals have not shown any effect on fertility. However, there are no data on the effect of cefepime on human fertility.

Driving and using machines

No studies have been conducted on the effect of the medicine on the ability to drive and use machines. However, possible side effects such as altered consciousness, dizziness, confusion, or hallucinations may affect the ability to perform these activities

3. How to use Cefepime Solufarma

Cefepime Solufarma will be administered intramuscularly or intravenously by a doctor or healthcare professional.
The dose and route of administration usually vary depending on the severity of the infection, renal function, and the patient's overall condition.
In the case of severe, life-threatening infections, especially if septic shock occurs, Cefepime Solufarma will be administered intravenously to the patient.
For direct intravenous administration, the final solution should be injected directly into a vein over 3 to 5 minutes or injected into an administration set while the patient is receiving a compatible diluent intravenously.
For intravenous infusion, the final solution should be administered over approximately 30 minutes.
The following table provides guidelines for cefepime dosing in adults and children over 40 kg with normal renal function.

Infection severity Dose and route of administration Dose interval

Severe infections:
2 g (i.v)
12 hours
Very severe infections (life-threatening):
2 g (i.v)
8 hours
*The duration of treatment is usually 7 to 10 days.
More severe infections may require longer treatment. In empirical treatment of febrile neutropenia, this period should be 7 days or until neutropenia resolves.
For patients weighing ≤ 40 kg, the dosing recommended for children should be used.
Children with normal renal function
The usual recommended dose for children is:

• Pneumonia, urinary tract infections: Children over 2 months and weighing ≤ 40 kg: 50 mg/kg, every 12 hours for 10 days; in more severe infections, an 8-hour dose interval should be maintained.
• Bacterial meningitis and empirical treatment of febrile neutropenia: Children over 2 months and weighing ≤ 40 kg: 50 mg/kg, every 8 hours for 7 to 10 days.

Experience with the use of Cefepime Solufarma in patients under 2 months of age is limited.
Despite experience with a dose of 50 mg/kg, data from pharmacokinetic models in children over 2 months suggest that a dose of 30 mg/kg administered every 12 or 8 hours in children aged 1 to 2 months may be appropriate. Close monitoring of the administration of Cefepime Solufarma to these patients is necessary.
In children and adolescents weighing more than 40 kg, the adult dose can be used. In patients over 12 years of age and weighing ≤ 40 kg, the dosing for younger patients weighing ≤ 40 kg should be used. The pediatric dose should not exceed the adult dose (2 g every 8 hours).
Experience with intramuscular administration in children is limited.
In elderly patients and adults with impaired renal function, patients undergoing dialysis, and children with impaired renal function: the doctor will determine the dose to be administered.

Use/administration of a higher dose of Cefepime Solufarma than recommended

In the event of accidental use/administration of an excessive dose of Cefepime Solufarma, symptoms of overdose may include:

• encephalopathy (a disease characterized by widespread brain tissue damage)
• myoclonus (rapid, involuntary muscle twitching)
• seizures (sudden, involuntary muscle contractions).

In the case of severe overdose, especially in patients with impaired renal function, cefepime can be removed from the body using hemodialysis. Peritoneal dialysis is not effective.
Accidental overdose has occurred during the administration of large doses to patients with impaired renal function.
If there are any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Cefepime Solufarma can cause side effects, although not everybody gets them.
Cefepime Solufarma may cause one or more of the following side effects:
Very common(may affect more than 1 in 10 people):

• positive Coombs' test result (without hemolysis);

Common(may affect up to 1 in 10 people):

• anemia, eosinophilia;
• phlebitis at the injection site;
• diarrhea;
• rash;
• injection site irritation;
• pain and inflammation at the injection site;
• increased levels of certain blood parameters (alanine aminotransferase, aspartate aminotransferase, bilirubin, alkaline phosphatase). Prolonged prothrombin time or partial thromboplastin time (prolonged blood coagulation time).

Uncommon(may affect up to 1 in 100 people):

• oral thrush (fungal infection of the mouth with a white coating);
• vaginitis;
• decreased white blood cell count (thrombocytopenia, leukopenia, neutropenia);
• headache;
• colitis (inflammation of the colon with abdominal pain);
• nausea;
• vomiting;
• redness of the skin;
• hives;
• itching of the skin;
• increased urea levels in the blood;
• increased creatinine levels in the blood;
• fever;
• inflammation at the injection site.

Rare(may affect up to 1 in 1000 people):

• fungal infections;
• allergic reactions;
• seizures;
• sensory disturbances, such as tingling and numbness;
• taste disorders;
• dizziness;
• vasodilation;
• shortness of breath;
• abdominal pain;
• constipation;
• genital itching;
• chills.

Frequency not known(frequency cannot be estimated from the available data):

• aplastic anemia, hemolytic anemia, agranulocytosis;
• anaphylactic shock, angioedema;
• disorientation;
• hallucinations;
• coma;
• apathy;
• encephalopathy;
• altered consciousness;
• myoclonus;
• bleeding;
• gastrointestinal disorders;
• severe skin reactions with discoloration, red spots, purple areas, or blisters;
• renal failure;
• toxic nephropathy;
• false-positive urine glucose test result

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, the patient should tell their doctor or pharmacist or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie
181C PL-02 222
Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Cefepime Solufarma

Store at a temperature below 25°C. Store in the outer packaging to protect from light.
The solution, reconstituted with sterile water for injection or 0.9% sodium chloride solution, shows chemical and physical stability of the solution after reconstitution at 25°C for 12 hours or alternatively at 2°C to 8°C for 3 days.
The solution, reconstituted with 5% dextrose solution, shows chemical and physical stability at 25°C for 12 hours.
No stability study has been conducted using the diluents listed below, so the injection solution should be used immediately after reconstitution, and the infusion solutions should be added to the infusion fluid immediately.
Cefepime Solufarma, 500 mg powder for solution for injection/infusion

• water for injection (solvent)
• Ringer's solution
• 10% dextrose solution
• 1/6 molar sodium lactate solution

Cefepime Solufarma, 1000 mg powder for solution for injection/infusion

• 0.5% lidocaine hydrochloride for injection
• 1% lidocaine hydrochloride for injection
• 10% dextrose solution
• sterile bacteriostatic water for injection with parabens
• sterile bacteriostatic water for injection with benzyl alcohol
• 1/6 molar sodium lactate solution for injection
• 5% glucose and 0.9% sodium chloride for injection
• Ringer's solution with lactates and 5% glucose for injection

From a microbiological point of view, unless the method of opening/reconstitution/dilution precludes the risk of microbial contamination, the product should be used immediately.
If the solution is not used immediately, the user is responsible for the storage conditions and duration.
Store out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month.
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 Cefepime Solufarma contains

Cefepime Solufarma, 500 mg powder for solution for injection/infusion

• the active substance is cefepime dihydrochloride monohydrate, in an amount equivalent to 500 mg of cefepime
• other ingredients: L-arginine

Cefepime Solufarma, 1000 mg powder for solution for injection/infusion

• the active substance is cefepime dihydrochloride monohydrate, in an amount equivalent to 1000 mg of cefepime
• other ingredients: L-arginine

What Cefepime Solufarma looks like and contents of the pack

Cefepime Solufarma, 500 mg, powder for solution for injection/infusion is in a 20 mL glass vial (type I) with a gray protective cap (type 1) with a diameter of 20 mm, made of bromobutyl rubber, with an aluminum flip-off cap and a yellow polypropylene disk in a cardboard box.
Cefepime Solufarma, 1000 mg, powder for solution for injection/infusion is in a 20 mL glass vial (type I) with a gray protective cap (type 1) with a diameter of 20 mm, made of bromobutyl rubber, with an aluminum flip-off cap and a white polypropylene disk in a cardboard box.
Package sizes:1, 5, 10, 50 vials in a cardboard box.
Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Solufarma Produtos Farmacêuticos, Lda.
Av. Bombeiros Voluntários, n.° 146, 1°

• 2765- 201 Estoril Portugal

Manufacturer/Importer

Infosaúde – Instituto de Formação e Inovação em Saúde Unipessoal, Lda
Rua Ferrarias Del- Rei 6, Urbanização de Fábrica Pólvora
2730-269 Barcarena
Portugal

Date of last revision of the leaflet: ------------------------------------------------------------------------------------------------------------------------------

Information intended for healthcare professionals only:

Cefepime Solufarma can be administered intravenously (i.v) or intramuscularly (i.m).
After reconstitution, the solution is colorless to light yellow.
Intravenous administration (i.v)
For direct intravenous administration, Cefepime Solufarma should be dissolved in 10 mL of water for injection, 0.9% sodium chloride solution, or 5% dextrose solution.
The resulting solution can be injected directly into a vein over 3-5 minutes or injected into an administration set while a compatible diluent is administered intravenously to the patient.
The medicine can also be administered through perfusion lines or in continuous intravenous infusion (i.v), while the patient is receiving a compatible fluid intravenously. In the case of infusion, the medicine should be administered over approximately 30 minutes.
Intramuscular administration (i.m)
Cefepime Solufarma 500 mg should be diluted with 1.5 mL of water for injection or 0.5% (or 1%) lidocaine hydrochloride solution.
Cefepime Solufarma 1000 mg should be diluted with 3 mL of water for injection or 0.5% (or 1%) lidocaine hydrochloride solution.
Cefepime Solufarma is compatible with the following solutions: 0.9% sodium chloride solution (with 5% dextrose or without), 5% dextrose, 10% dextrose, Ringer's solution with lactates (with 5% dextrose or without), 1/6 molar sodium lactate solution, to achieve concentrations from 1 to 40 mg/mL.
Cefepime Solufarma can be administered simultaneously with other antibiotics or other medicines, provided they are not mixed in the same syringe with the infusion fluid and not administered at the same injection site.
Any remaining antibiotic solution and all materials used for administration should be disposed of in accordance with local regulations.
Like other cephalosporins, the solution of Cefepime Solufarma may become slightly yellow after reconstitution, but this does not affect the efficacy of cefepime.