Prospecto:information for the user

Zinforo600mg powder for concentrate for solution for infusion

ceftarolina fosamil

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

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or nurse.
• If you experience adverse effects, consult your doctor or nurse, even if they are not listed in this prospect. See section4.

1.What Zinforo is and for what it is used

2.What you need to knowbeforestarting touse Zinforo

3.How to use Zinforo

4.Possible adverse effects

5.Storage of Zinforo

6.Contents of the package and additional information

What is Zinforo

Zinforo is an antibiotic medication that contains the active ingredient ceftarolina fosamil. It belongs to a group of medications called “cephalosporin antibiotics”.

What is Zinforo used for

Zinforo is used to treat children (from birth) and adults with:

• skin and tissue infections below the skin
• a lung infection called “pneumonia”

How Zinforo works

Zinforo works by destroying certain bacteria that can cause serious infections.

Do not use Zinforo

• If you are allergic to cefiderocol or any of the other ingredients in this medication (listed in section6)
• If you are allergic to cephalosporins (a class of antibiotics)
• If you have had severe allergic reactions to other antibiotics such as penicillin or carbapenem.

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

Warnings and precautions

Consult your doctor or nurse before starting to use Zinforo:

• If you have kidney problems (your doctor may need to prescribe a lower dose)
• If you have ever had seizures (epileptic attacks or convulsions)
• If you have ever had mild allergic reactions to other antibiotics such as penicillin or carbapenem
• If you have had severe diarrhea when taking antibiotics in the past.

You may develop another infection caused by another bacteria during or after treatment with Zinforo.

You may develop signs and symptoms ofsevere skin reactionssuch as, for example, fever, joint pain, skin rash, scaly red rash, skin bumps containing pus, blisters or skin peeling, circular red patches often with central blisters on the trunk, mouth, throat, nose, genitals, and eyes. If this happens, consult your doctor or nurse immediately.

Laboratory tests

You may develop an abnormal response to a laboratory test (called Coombs test) that detects certain antibodies that may act against red blood cells. If your red blood cell count decreases, your doctor may check if these antibodies have caused this decrease in red blood cells.

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

Other medications and Zinforo

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

Pregnancy and breastfeeding

If you are pregnant, consult your doctor before using Zinforo. Do not use this medication during pregnancy unless your doctor has instructed you to.

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

Driving and operating machinery

Zinforo may cause side effects such as dizziness. This may affect your ability to drive or operate machinery.

Zinforo will be administered by a doctor or nurse.

How much to use

The usual recommended dose for adults is 600 mg every 12 hours.Your doctor may increase your dose to 600 mg every 8 hours for some infections.The usual recommended dose for children depends on the child's age and weight and is administered every 8 or 12 hours.It is administered through a vein infusion over 5 to 60 minutes if receiving the usual dose or 120 minutes if receiving a higher dose.

A typical treatment course usually lasts from 5 to 14 days for skin infections and from 5 to 7 days for pneumonia.

Patients with kidney problems

If you have kidney problems, your doctor may reduce your dose, as Zinforo is eliminated from your body through your kidneys.

If you use more Zinforo than you should

If you think you may have been given too much Zinforo, inform your doctor or nurse immediately.

If you did not receive a dose of Zinforo

If you think you did not receive 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 may cause side effects, although not everyone will experience them. With this medicine, the following side effects may occur:

Inform your doctor immediately if you experience these symptoms, as you may need urgent medical treatment:

• Sudden swelling of the lips, face, throat, or tongue; a severe rash; and difficulty swallowing or breathing. These may be signs of a severe allergic reaction (anaphylaxis) and may be life-threatening;
• Diarrhea that becomes severe or does not stop, or stools that contain blood or mucus during or after stopping treatment with Zinforo. In this situation, do not take medications that slow down or stop intestinal movement.

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

• Changes in a blood test called the "Coombs test" observed frequently in patients receiving this type of antibiotic. This test detects certain antibodies that may act against their red blood cells.

Common (may affect up to 1 in 10 people)

• Fever
• Headache
• Dizziness
• Itching, skin rash
• Diarrhea, stomach pain
• Nausea or vomiting
• Increased production of liver enzymes (detected in blood tests)
• Vein pain and irritation
• Redness, pain, or swelling at the injection site.

Uncommon (may affect up to 1 in 100 people)

• Anemia
• Itchy, palpable rash (urticaria)
• An increase in the level of creatinine in the blood. Creatinine indicates how well your kidneys are functioning
• Bleeding or hematoma that is more severe than usual. This may be due to a decrease in platelet levels in the blood
• Changes in tests that determine how your blood clots
• A decrease in the total number of white blood cells, or a certain type of white blood cell in the blood (leucopenia and neutropenia).
• Changes in your mental state, such as confusion, reduced consciousness, abnormal movements, or seizures (encephalopathy): these have occurred in people when the dose administered is too high, especially in people with kidney problems.

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

• A significant decrease in the number of certain white blood cells in the blood (agranulocytosis). You may have a fever, symptoms similar to the flu, sore throat, or another infection that could be severe.
• An increase in the number of certain white blood cells in the blood (eosinophilia).

Frequency not known (cannot be estimated from available data)

• A type of lung disease where eosinophils (a type of white blood cell) appear in the lungs in greater numbers (eosinophilic pneumonia).

Sudden chest pain, which may be a sign of a potentially severe allergic reaction, which has been observed with other medications of the same type called Kounis syndrome. If this occurs, consult a doctor or nurse immediately.

Reporting of side effects

If you experienceany type of side effect, consult your doctor or nurse, even if it is apossibleside effect that does not appear in this prospectus.You can also report them directly through thenational notification system included in theAppendix V.By reporting side effects, you can contribute to providing more information about the safety of this medicine.

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

Do not usethis medicationafter the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

Store below 30°C.

Store in the original packaging to protect it from light.

Medicines should not be disposed of through drains or in the trash. The hospital will dispose of all waste materials safely. By doing so, you will help protect the environment.

Composition of Zinforo

• Each vial contains 600 mg of ceftaroline fosamil.
• The other component is arginine.

Appearance of the product and contents of the pack

Zinforo is a pale yellow to yellowish white powder for concentrate for solution for infusion in a vial. It is available in packs containing 10 vials.

Marketing Authorization Holder

Pfizer Ireland Pharmaceuticals Unlimited Company

Operations Support Group

Ringaskiddy, County Cork

Ireland

Responsible for manufacturing

ACS Dobfar S.p.A.

Via A. Fleming 2

37135 Verona

Italy

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

Last update of this leaflet: 01/2025.

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.

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This information is intended for healthcare professionals only:

Important: Consult the SmPC before prescribing.

The solution for infusion should be prepared using aseptic technique. The contents of the Zinforo vial should be reconstituted with 20 ml of water for injection to prepare the infusion solution. The following instructions summarize the reconstitution of the Zinforo vial:

The reconstituted solution should be further diluted to prepare the infusion solution for Zinforo. A 250 ml, 100 ml, or 50 ml infusion bag may be used to prepare the infusion, based on the patient's required volume. Appropriate diluents for infusion include: sodium chloride 9 mg/ml (0.9%) injection, dextrose 50 mg/ml (5%) injection, sodium chloride 4.5 mg/ml and dextrose 25 mg/ml injection (0.45% sodium chloride and 2.5% dextrose), or Lactate Ringer solution. The resulting solution should be administered according to the selected dose over 5 to 60 minutes for the standard dose or 120 minutes for the high dose in 50 ml, 100 ml, or 250 ml infusion volumes.

Infusion volumes for pediatric patients will vary according to the child's weight. The concentration of the infusion solution during preparation and administration should not exceed 12 mg/ml of ceftaroline fosamil.

The reconstitution time is less than 2 minutes. Mix slowly to reconstitute and check to ensure that the contents have dissolved completely. Parenteral medications should be visually inspected for particles before administration.

The color of the Zinforo infusion solutions varies from transparent, pale yellow to dark yellow depending on the concentration and storage conditions. It is free of particles. When stored as recommended, the product's potency is not affected.

Chemical and physical stability has been demonstrated in use for up to 12 hours at 2°C to 8°C and 6 hours at 25°C.

From a microbiological point of view, the medicinal product should be used immediately unless the method of opening/reconstitution/dilution excludes the risk of microbial contamination. If not used immediately, the storage conditions and shelf life before use are the responsibility of the user.

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

Each vial is for single use only.

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