Exblifep 2 g/0.5 g powder for concentrate for solution for infusion
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
EXBLIFEP 2 g/0.5 g powder for concentrate for solution for infusion
cefepime/enmetazobactam
This medicinal product is subject to additional monitoring, which will allow for faster identification of new safety information. You can help by reporting any adverse reactions you may experience. Information on how to report adverse reactions is included at the end of section 4.
Read all of this leaflet carefully before you start using this medicine, as it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, consult your doctor or nurse.
- If you experience any adverse reactions, consult your doctor or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.
Contents of the leaflet
- What EXBLIFEP is and what it is used for
- What you need to know before using EXBLIFEP
- How to use EXBLIFEP
- Possible adverse reactions
- How to store EXBLIFEP
- Contents of the pack and other information
1. What EXBLIFEP is and what it is used for
EXBLIFEP is an antibiotic that contains two active substances:
- cefepime, which belongs to a group of antibiotics known as fourth-generation cephalosporins and which can destroy certain bacteria;
- enmetazobactam, which blocks the action of enzymes called beta-lactamases. These enzymes make bacteria resistant to cefepime by breaking down the antibiotic before it can exert its effect. By inhibiting beta-lactamases, enmetazobactam enables cefepime to be more effective in destroying bacteria.
EXBLIFEP is used in adults to treat:
- complicated (serious) urinary tract infections (bladder and kidneys)
- certain types of pneumonia (a lung infection) occurring during hospitalization
EXBLIFEP is also used to treat bacteremia (the presence of bacteria in the blood) related to or possibly related to one of the infections listed above.
2. What you need to know before using EXBLIFEP
Do not use EXBLIFEP:
- if you are allergic to cefepime, enmetazobactam, or any of the other ingredients of this medicine (listed in section 6).
- if you are allergic to cephalosporins, which are antibiotics used to treat a wide range of infections.
- if you have previously experienced a severe allergic reaction (e.g., severe skin peeling, swelling of the face, hands, feet, lips, tongue, or throat, or difficulty swallowing or breathing) to beta-lactam antibiotics (antibiotics such as penicillins, carbapenems, or monobactams).
Warnings and precautions
Talk to your doctor or pharmacist before starting to use EXBLIFEP if:
- you are allergic to cephalosporins, penicillins, or other antibiotics (see "Do not use EXBLIFEP").
- you have or have had asthma or are prone to allergic reactions. When you first receive this medicine, your doctor will monitor you for any signs of allergy (see section 4).
- you have kidney problems. Your doctor may need to adjust the dose of this medicine.
- you need to have blood or urine tests. This medicine may alter the results of certain tests (see section 4).
Talk to your doctor or pharmacist while using EXBLIFEP if:
- you develop acute and persistent diarrhea during or shortly after treatment. This could be a sign of inflammation of the large intestine and requires urgent medical attention.
- you suspect you have developed an infection during prolonged use of EXBLIFEP. This could be due to microorganisms not sensitive to cefepime, and treatment with EXBLIFEP may need to be discontinued.
Children and adolescents
This medicine must not be given to children under 18 years of age because there is insufficient information on its use in this age group.
Other medicines and EXBLIFEP
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Specifically, inform your doctor if you are taking any of the following medicines:
- other antibiotics, especially aminoglycosides (such as gentamicin) or diuretics (such as furosemide). If you are taking these medicines, your kidney function should be monitored.
- medicines used to prevent blood clotting (vitamin K antagonists such as warfarin). Their effect may be increased when used with EXBLIFEP.
- certain types of antibiotics (bacteriostatic antibiotics). These antibiotics may interfere with the effectiveness of EXBLIFEP.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine.
Your doctor will decide whether you can receive EXBLIFEP during pregnancy.
EXBLIFEP may be excreted in breast milk. If you are breastfeeding, your doctor will decide whether you should discontinue breastfeeding or avoid treatment with EXBLIFEP, taking into account the benefits of breastfeeding for your child and the benefits of treatment for you.
Driving and using machines
This medicine may cause dizziness, which could affect your ability to drive or operate machinery. Do not drive or use machines until this effect has passed.
3. How to use EXBLIFEP
Your doctor or another healthcare professional will administer this medicine to you as an intravenous infusion (drip) into a vein (directly into the bloodstream). Depending on the type of infection you have and your kidney function, the infusion will be given over two or four hours.
The recommended dose is one vial (2 g cefepime and 0.5 g enmetazobactam) every 8 hours.
Treatment usually lasts between 7 and 14 days, depending on the severity and location of the infection, as well as your body's response to treatment.
If you have any kidney problems, your doctor may need to reduce the dose or adjust the frequency of EXBLIFEP administration (see section 2. Warnings and precautions).
If you use more EXBLIFEP than you should
Since this medicine will be administered by a doctor or another healthcare professional, it is unlikely that you will receive too much EXBLIFEP. However, if you have any concerns, inform your doctor, nurse, or pharmacist immediately.
If you forget to use EXBLIFEP
If you think a dose of EXBLIFEP has not been administered, inform your doctor or another healthcare professional immediately.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Contact your doctor immediately if you experience any of the following adverse effects, as you may require urgent medical treatment:
Rare: may affect up to 1 in 1,000 people
- Anaphylactic (allergic) reaction and angioedema. This reaction can be potentially life-threatening.
Signs and symptoms may include sudden swelling of the lips, face, throat, or tongue, severe rash, and difficulty swallowing or breathing.
Frequency not known: frequency cannot be estimated from the available data
- Stevens-Johnson syndrome and toxic epidermal necrolysis. Severe and very intense skin reactions. The skin adverse reaction may appear as a rash, with or without blisters. Skin irritation, sores, or inflammation in the mouth, throat, eyes, nose, and areas around the genitals may occur, as well as fever and flu-like symptoms. Skin rashes may progress to severe, widespread skin lesions (peeling of the epidermis and superficial mucous membranes), which may have potentially life-threatening consequences.
Other adverse effects
Other adverse effects that may occur after treatment with Exblifep include those listed below:
Very common: may affect more than 1 in 10 people
Adverse effects identified through blood tests:
- Positive Coombs test (a blood test to detect antibodies produced by the body that attack its own red blood cells)
Common: may affect up to 1 in 10 people
- Phlebitis at the infusion site (inflammation at the infusion site causing pain, swelling, and redness along a vein)
- Reaction, pain, and inflammation at the infusion site
- Diarrhea
- Skin rash
- Headache
Adverse effects identified through blood tests:
- Increased blood levels of liver enzymes
- Increased blood levels of bilirubin (a substance produced by the liver)
- Increased blood levels of amylase (an enzyme that helps the body digest carbohydrates)
- Increased blood levels of lipase (an enzyme that helps the body digest fats)
- Increased blood levels of lactate dehydrogenase (a marker indicating cellular and tissue damage in the body)
- Changes in white blood cell counts (eosinophilia)
- Low levels of red blood cells (anemia)
- Prolonged blood clotting time (increased time for blood to clot)
Uncommon: may affect up to 1 in 100 people
- Clostridioides difficile-associated diarrhea (CDAD), a painful and severe diarrhea caused by a bacterium called Clostridioides difficile
- Fungal infection in the mouth
- Vaginal infection
- Inflammation of the large intestine causing diarrhea, usually accompanied by blood and mucus
- Dizziness, nausea, vomiting
- Skin redness, urticarial rash (hives), itching
- Fever
- Inflammation at the infusion site
Adverse effects identified through blood tests:
- Low levels of certain blood cells (leukopenia, neutropenia, thrombocytopenia)
- Increased blood levels of urea and creatinine (parameters indicating reduced kidney function)
Rare: may affect up to 1 in 1,000 people
- Difficulty breathing
- Stomach pain, constipation
- Fungal infection
- Seizures (epileptic fits)
- Disturbance of taste sensation
- Tingling or numbness of the skin, muscle cramps
- Itching around the vaginal area
- Allergic dermatitis
- Chills
- Dilation of blood vessels in the body
Frequency not known: frequency cannot be estimated from the available data
- Coma
- Reduced level of consciousness
- Encephalopathy (a brain disorder caused by harmful substances or infection)
- Altered state of consciousness
- Muscle spasms
- Confusion, hallucinations
- False-positive urine glucose test
- Kidney problems (kidney failure or any other physiological change or dysfunction)
- Bleeding
- Erythema multiforme (a skin rash that may form blisters and appears as small target-like lesions [a dark central spot, surrounded by a paler area, with a dark ring around the edge])
Adverse effects identified through blood tests:
- Very low levels of granulocytes, a type of white blood cell (agranulocytosis)
- Rapid breakdown of red blood cells (hemolytic anemia)
- Low levels of red blood cells due to the bone marrow's inability to produce enough cells (aplastic anemia)
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system listed in Annex V. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of EXBLIFEP
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 vial after "EXP". The expiry date refers to the last day of the month indicated.
Unopened vial: Store in a refrigerator (between 2 °C and 8 °C). Keep the vial in the outer packaging to protect it from light.
After reconstitution and dilution: store in a refrigerator (between 2 °C and 8 °C) for a maximum of 6 hours prior to use.
From a microbiological standpoint, the medicine should be used immediately after reconstitution.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.
6. Contents of the pack and other information
Composition of EXBLIFEP
- The active substances are cefepime and enmetazobactam.
- Each vial contains cefepime dihydrochloride monohydrate, equivalent to 2 g of cefepime and 0.5 g of enmetazobactam.
- The other component is L-arginine.
Appearance of the medicinal product and contents of the pack
EXBLIFEP is a powder for concentrate for solution for infusion (powder for concentrate) ranging in colour from white to yellow, contained in 20 ml glass vials with a bromobutyl rubber stopper and a flip-off safety seal.
Pack size: 10 vials.
Marketing Authorisation Holder
Advanz Pharma Limited
Unit 17 Northwood House
Northwood Crescent
Dublin 9
D09 V504
Ireland
(+44) (0)208.588.9131
[email protected]
Manufacturer
Infosaúde - Instituto De Formação E Inovação Em Saúde S.A.
Rua Das Ferrarias Del Rei,
nº6 - Urbanização da Fábrica da Pólvora,
Barcarena,
2730-269,
Portugal
Date of the most recent revision of this leaflet:
Other sources of information
Detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu.
This information is intended for healthcare professionals only:
Preparation of the solution
This medicinal product is for intravenous infusion, and each vial is for single use only.
Aseptic techniques must be followed when preparing the infusion solution.
Preparation of doses
Cefepime/enmetazobactam is compatible with 9 mg/ml sodium chloride (0.9%) injection solution, 5% glucose injection solution, and a combination of glucose and sodium chloride injection solution (containing 2.5% glucose and 0.45% sodium chloride).
EXBLIFEP is supplied as a dry powder contained in a single-dose vial, which must be reconstituted and then diluted prior to intravenous infusion, as described below.
To prepare the required dose for intravenous infusion, reconstitute the vial as indicated in Table 1 below:
- Withdraw 10 ml from a 250 ml infusion bag (compatible injection solution) and use it to reconstitute the cefepime/enmetazobactam vial.
- Gently mix until dissolved. The reconstituted cefepime/enmetazobactam solution will have an approximate concentration of 0.20 g/ml of cefepime and 0.05 g/ml of enmetazobactam. The final volume is approximately 10 ml.
PRECAUTION: THE RECONSTITUTED SOLUTION IS NOT INTENDED FOR DIRECT INJECTION.
Subsequently, the reconstituted solution must be diluted immediately into a 250 ml infusion bag (compatible injection solution) prior to intravenous infusion. To dilute the reconstituted solution, withdraw all or part of the contents of the reconstituted vial and transfer it back into the infusion bag, according to Table 1 below.
- The intravenous infusion of the diluted solution must be completed within 8 hours if stored in the refrigerator (i.e. between 2°C and 8°C); when refrigerated for less than 6 hours, allow it to reach room temperature and then administer at room temperature within a period of 2 or 4 hours.
Table 1. Preparation of cefepime/enmetazobactam doses
Dose of cefepime/enmetazobactam | Number of vials to be reconstituted | Volume to be withdrawn from each reconstituted vial for subsequent dilution | Final volume of the infusion bag |
2.5 g (2 g/0.5 g) | 1 | Entire content (approximately 10 ml) | 250 ml |
1.25 g (1 g/0.25 g) | 1 | 5.0 ml (discard unused content) | 245 ml |
0.625 g (0.5 g/0.125 g) | 1 | 2.5 ml (discard unused content) | 242.5 ml |
Inspect the vial before use. Only use if the solution contains no suspended particles. Use only clear solutions.
Like other cephalosporins, solutions of cefepime/enmetazobactam may develop a yellowish to amber color, depending on storage conditions. However, this does not negatively affect the product's efficacy.
The prepared solution must be administered by intravenous infusion.
Disposal of unused medication and of all materials that have come into contact with it must be carried out in accordance with local regulations.