Zavicefta 2 g/0,5 g polvo para concentrado para solucion para perfusion

Label: information for the user

Zavicefta 2 g/0.5 g powder for concentrate for solution for infusion

ceftazidima/avibactam

Read this label carefully before starting to use this medicine, because it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or nurse.
• If you experience any adverse effects, consult your doctor or nurse, even if they are not listed in this label. See section 4.

1. What Zavicefta is and for what it is used

2. What you need to know before starting to use Zavicefta

3. How to use Zavicefta

4. Possible adverse effects

1. Storage of Zavicefta

6. Contents of the pack and additional information

What is Zavicefta

Zavicefta is an antibiotic that contains the active principles ceftazidima and avibactam.

• Ceftazidima belongs to the group of antibiotics known as “cephalosporins”. It is able to destroy many types of bacteria.
• Avibactam is a “beta-lactamase inhibitor” that helps ceftazidima to destroy some bacteria that it cannot destroy on its own.

What is Zavicefta used for

Zavicefta is indicated in adults and pediatric patients from birth to treat:

• infections of the stomach and intestine (abdomen)
• urinary tract infections or kidney infections known as “urinary tract infections”
• a lung infection known as “pneumonia”
• infections caused by bacteria that cannot be destroyed with other antibiotics

Zavicefta is indicated in adults to treat blood infections associated with abdominal, urinary tract, or pneumonia infections.

How Zavicefta works

Zavicefta works by eliminating certain types of bacteria that can cause severe infections.

Do not use Zavicefta if

• you are allergic to ceftazidime, avibactam, or any of the other components of this medication (listed in section 6)
• you are allergic to other cephalosporins
• you have ever had a severe allergic reaction to other antibiotics belonging to the penicillin or carbapenem groups

Do not use Zavicefta if any of the above applies to you. If you are unsure, consult your doctor or nurse before using Zavicefta.

Warnings and precautions

Consult your doctor or nurse before starting to use Zavicefta if:

• you have ever had an allergic reaction (including only a skin rash) to antibiotics belonging to the penicillin or carbapenem groups
• you have kidney problems - your doctor may need to give you a lower dose to ensure you are not taking too much medication. This could cause symptoms such as seizures (see sectionUsing more Zavicefta than you should)

If any of the above applies to you (or you are unsure), consult your doctor or nurse before using Zavicefta.

Consult your doctor or nurse if you experience diarrhea during your treatment.

Other infections

There is a small chance that you may contract a different infection caused by another bacterium during or after treatment with Zavicefta. This includes candidiasis (fungal infections of the mouth or genital area).

Laboratory tests

Inform your doctor that you are undergoing treatment with Zavicefta if you are to undergo any laboratory tests. This is because you may develop an abnormal response to a laboratory test called the "Coombs test" or "DAGT". This test detects antibodies that may act against red blood cells.

Zavicefta may also affect the results of some urine tests for sugar. Inform the person taking the sample that you have been administered Zavicefta.

Other medications and Zavicefta

Inform your doctor or nurse if you are using, have used recently, or may need to use any other medication.

Inform your doctor before using Zavicefta if you are taking any of the following medications:

• a type of antibiotic called chloramphenicol
• a type of antibiotic called aminoglycoside, such as gentamicin, tobramycin
• a diuretic called furosemide
• a medication for gout called probenecid

Consult your doctor before using Zavicefta if any of the above applies to you.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before using this medication.

Driving and operating machinery

Zavicefta may make you feel dizzy. This may affect your ability to drive or operate machinery.

Zavicefta contains sodium

This medication contains approximately 146mg of sodium (main component of table salt/for cooking) in each vial. This is equivalent to 7.3% of the recommended daily maximum sodium intake for an adult.

Consult your doctor or pharmacist if you need 3or more vials per day for a prolonged period, especially if you have been advised to follow a low-sodium diet.

Zavicefta will be administered by a doctor or nurse.

How much to use

The recommended dose for adults isone vial (2g of ceftazidime and 0.5g of avibactam) every 8hours. The doctor will calculate the dose for pediatric patients from birth based on the child's weight and age.

It is administered through an intravenous infusion, which usually takes approximately 2 hours.

The treatment duration is generally 5 to 14 days, depending on the type of infection you have and how you respond to the treatment.

Patients with kidney problems

If you have kidney problems, your doctor may reduce your dose. This is because Zavicefta is eliminated from your body through your kidneys.

If you use more Zavicefta than you should

Zavicefta will be administered by a doctor or nurse, so it is unlikely that you will receive an incorrect dose. However, if you experience any adverse effects or think you may have received too much Zavicefta, inform your doctor or nurse immediately. If you take too much Zavicefta, it may affect your brain and cause seizures or coma.

If you forgot to use Zavicefta

If you think you have not received a dose, inform your doctor or nurse immediately.

If you have any other questions about the use of this medication, ask your doctor or nurse.

Like all medicines, this medicine can cause side effects, although not everyone will experience them. With this medicine, the following side effects may occur:

Severe side effects

Inform your doctor immediately if you experience any of the following severe side effects - you may need urgent medical treatment:

• Severe allergic reactions - signs may include sudden swelling of the lips, face, throat, or tongue, severe skin rash, or other severe skin reactions, difficulty swallowing or breathing, or sudden chest pain (which may be a sign of Kounis syndrome). These reactions can be potentially fatal.
• Diarrhea that worsens or does not stop, or stools that contain blood or mucus - this can occur during or after stopping treatment with Zavicefta. In this situation, do not take medications that slow down or stop intestinal movement.

Inform your doctor immediately if you experience any of the severe side effects mentioned above.

Other side effects

Inform your doctor or nurse if you experience any of the following side effects:

Very common:(may affect more than 1 in 10 people)

• Abnormal results in a laboratory test called "DAGT" or "Coombs test". This test detects antibodies that may act against your red blood cells. This may cause anemia (which may make you feel tired) and jaundice (yellowing of the skin and eyes)

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

• Fungal infections, including infections in the mouth and vagina
• Change in the number of some types of blood cells (called "eosinophils" and "thrombocytes") – which is observed in blood tests
• Headache
• Dizziness
• Nausea or vomiting
• Abdominal pain
• Diarrhea
• Increased levels of some enzymes produced by the liver – which is observed in blood tests
• Itchy, raised patches ("hives")
• Itching
• Redness, pain, or swelling at the injection site of Zavicefta
• Fever

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

• Increased number of a type of blood cell (called "lymphocytes") which is observed in blood tests
• Decreased number of some types of blood cells (called "leukocytes") – which is observed in blood tests
• Tickling or numbness
• Bad taste in the mouth
• Increased levels of some substances in the blood (called "creatinine" and "urea"). These substances indicate how well your kidneys are functioning.

Rare:(may affect up to 1 in 10,000 people)

• Swelling of a part of the kidney that causes a decrease in its normal functioning

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

• Significant decrease in the type of white blood cells in the blood that fight infection, which is observed in blood tests
• Significant decrease in the number of red blood cells (hemolytic anemia), which is observed in blood tests
• Severe allergic reaction (seesevere side effects, above)
• Yellowing of the white of the eyes or skin (jaundice)
• Sudden appearance of a severe rash or blistering or peeling of the skin, possibly accompanied by high fever or joint pain (these may be signs of more serious medical conditions such as toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, or a condition known as DRESS, Drug Reaction with Eosinophilia and Systemic Symptoms)
• Swelling under the skin, especially on the lips and around the eyes

Inform your doctor or nurse if you experience any of the side effects mentioned above.

Reporting side effects

If you experience any type of side effect, consult your doctor or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from light.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. In this way, you will help protect the environment.

Composition of Zavicefta

• The active ingredients are ceftazidime and avibactam. Each vial contains pentahydrate of ceftazidime equivalent to 2 g of ceftazidime and sodium avibactam equivalent to 0.5 g of avibactam.
• The other excipients are anhydrous sodium carbonate (see section “Zavicefta contains sodium”).

Appearance of the product and contents of the pack

Zavicefta is a yellowish white powder for concentrate for solution for infusion contained in a vial. It is marketed in boxes containing 10 vials.

Marketing authorisation holder

Pfizer Ireland Pharmaceuticals Unlimited Company

Operations Support Group

Ringaskiddy, County Cork

Ireland

Responsible person

ACS Dobfar,S.p.A.

Via Alessandro Fleming 2

Verona 37135

Italy

Further information on this medicinal product can be obtained by contacting the local representative of the marketing authorisation holder:

Last update of this leaflet: 02/2025.

Other sources of information

The detailed information on this medicinal product is available on the website of the European Medicines Agency:https://www.ema.europa.eu

----------------------------------------------------------------------------------------------------------------

This information is intended for healthcare professionals only:

Important: Please consult the Summary of Product Characteristics before prescribing.

The compatibility of Zavicefta with other medicinal products has not been established. Zavicefta should not be mixed or added to solutions containing other medicinal products.

The powder must be reconstituted with water for injection and the resulting concentrate must then be diluted immediately before use. The reconstituted solution is a pale yellow solution free of particles.

Mix gently to reconstitute and check that the contents have completely dissolved. Parenteral medicines must be visually inspected to exclude the presence of particles before administration.

Bags for infusion

If the intravenous solution is prepared with the diluents listed in section 6.6 (with a ceftazidime concentration of 8 mg/ml), it has been demonstrated to have chemical and physical stability in use (from the initial puncture of the vial) for a period of up to 12 hours at 2°C – 8°C, followed by up to 4 hours at no more than 25°C.

If the intravenous solution is prepared with the diluents listed in section 6.6 (with a ceftazidime concentration of > 8 mg/ml to 40 mg/ml), it has been demonstrated to have chemical and physical stability in use (from the initial puncture of the vial) for a period of up to 4 hours at no more than 25°C.

Syringes for infusion

If the intravenous solution is prepared with the diluents listed in section 6.6 (with a ceftazidime concentration of ≥ 8 mg/ml to 40 mg/ml), it has been demonstrated to have chemical and physical stability in use (from the initial puncture of the vial) for a period of up to 6 hours at no more than 25°C.

From a microbiological point of view, the medicinal product must be used immediately, unless the reconstitution/dilution has been performed in controlled and validated aseptic conditions. If not used immediately, it is the responsibility of the user to determine the periods and conditions of storage prior to use and not to exceed those mentioned above.

Zavicefta (ceftazidime/avibactam) is a combination product; each vial contains 2 g of ceftazidime and 0.5 g of avibactam in a fixed ratio of 4:1. The dosage recommendations are based solely on the ceftazidime component.

To prepare and administer the solution, standard aseptic techniques must be used. Pediatric doses can be prepared in an infusion bag or an infusion syringe of suitable size.

The resulting solution must be administered over 120 minutes.

Each vial is for single use only.

The disposal of unused medicinal product and all materials that have been in contact with it will be in accordance with local regulations.

The total time interval between the start of reconstitution and the completion of preparation of the intravenous infusion should not exceed 30 minutes.

Instructions for preparing doses for adults and pediatric patients in INFUSION BAG or INFUSION SYRINGE:

NOTE: The following procedure describes the steps for preparing an infusion solution with a final concentration of 8-40 mg/ml of ceftazidime. All calculations must be completed before starting these steps.

• For pediatric patients aged 3 to 12 months:Prepare the following steps for preparing a solution for infusion with a final concentration of 20 mg/ml (sufficient for most situations).
• For pediatric patients from birth (including premature) to <3 months:,prepare the following steps for preparing a solution for infusion with a final concentration of 10 mg/ml (sufficient for most situations).

1. Prepare thereconstituted solution(167.3 mg/mlof ceftazidime):

1. Insert the needle of the syringe through the stopper of the vial and inject 10 ml of sterile water for injection.
2. Withdraw the needle and shake the vial until a clear solution is obtained.
3. Insert a needle to release the gas through the stopper of the vialafterthe product has dissolved to release the internal pressure (this is important to preserve the sterility of the product).

1. Prepare thefinal solutionfor infusion to a final concentration of20 mg/mlof ceftazidime:

1. Prepare additional dilutions of the reconstituted solution by transferring a calculated volume of the reconstituted solution to an infusion syringe.
2. Consult the tables below to confirm the calculations. The values shown are approximate, as it may be necessary to round to the nearest graduation mark on a syringe of suitable size. Note that the tables DO NOT include all possible calculated doses, but can be used to estimate the approximate volume to verify the calculation.

Preparation of Zavicefta (final concentration of 20 mg/ml of ceftazidime) for pediatric patients aged 3 to 12 months with a creatinine clearance (CrCL) of > 50 ml/min/1.73 m2

1Based solely on the ceftazidime component.

Preparation of Zavicefta (final concentration of 20 mg/ml of ceftazidime) for pediatric patients aged 3 to 12 months with a creatinine clearance (CrCL) of 31-50 ml/min/1.73 m2

1Based solely on the ceftazidime component.

Preparation of Zavicefta (final concentration of 20 mg/ml of ceftazidime) for pediatric patients aged 3 to 12 months with a creatinine clearance (CrCL) of 16-30 ml/min/1.73 m2

1Based solely on the ceftazidime component.

Pediatric patients from birth (including premature) to <3 months:

NOTE: The following procedure describes the steps for preparing a mother solution for infusion with a final concentration of 10 mg/ml of ceftazidime suitable for administration of doses less than 250 mg to pediatric patients from birth (including premature) to <3 months. Alternative concentrations can be prepared, but must have a final concentration range of 8 to 40 mg/ml of ceftazidime.

1. Prepare thereconstituted solution(167.3 mg/mlof ceftazidime):

1. Insert the needle of the syringe through the stopper of the vial and inject 10 ml of sterile water for injection.
2. Withdraw the needle and shake the vial until a clear solution is obtained.
3. Insert a needle to release the gas through the stopper of the vialafterthe product has dissolved to release the internal pressure (this is important to preserve the sterility of the product).

1. Prepare themother solution finalfor infusion to a final concentration of10 mg/mlof ceftazidime:

1. Prepare additional dilutions of the reconstituted solution by transferring 3 ml of the reconstituted solution to an infusion bag or syringe that contains 47 ml of diluent (sodium chloride 9 mg/ml [0.9%] solution for injection or dextrose 50 mg/ml [5%] solution for injection) to obtain a final volume of 50 ml.
2. Mix well (e.g. invert the infusion bag or, using a syringe connector, pass the solution gently back and forth at least 5 times between 2 syringes).
3. Transfer a suitable volume of10 mg/mlof mother solution of ceftazidime to an infusion syringe. Consult the table below to confirm the calculations. The values shown are approximate, as it may be necessary to round to the nearest graduation mark on a syringe of