ZINFORO 600 MG POWDER FOR CONCENTRATE FOR PERFUSION SOLUTION

Introduction

Package Leaflet:information for the user

Zinforo600mg powder for concentrate for solution for infusion

ceftaroline fosamil

Read all of this leaflet carefully before you start 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 or nurse.
• If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Zinforo and what is it used for
2. What you need to know before you use Zinforo
3. How to use Zinforo
4. Possible side effects
5. Storage of Zinforo
6. Contents of the pack and other information

1. What is Zinforo and what is it used for

What is Zinforo

Zinforo is an antibiotic medicine that contains the active substance ceftaroline fosamil. It belongs to a group of medicines called “cephalosporin antibiotics”.

What is Zinforo used for

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

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

How Zinforo works

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

2. What you need to know before you use Zinforo

Do not use Zinforo

• if you are allergic to ceftaroline fosamil or any of the other ingredients of this medicine (listed in section 6)
• 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 not sure, talk to your doctor or nurse before using Zinforo.

Warnings and precautions

Talk to your doctor or nurse before starting Zinforo:

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

You may get another infection caused by another bacterium during or after treatment with Zinforo.

You may develop signs and symptoms of severe skin reactions such as fever, joint pain, skin rash, scaly red rash, skin bumps containing pus, blisters, or peeling of the skin, circular red patches often with blisters in the center on the trunk, ulcers in the mouth, throat, nose, genitals, and eyes. If this happens, talk to your doctor or nurse immediately.

Lab tests

You may develop an abnormal response to a lab test (called Coombs test) that detects certain antibodies that can 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 not sure), talk to your doctor or nurse before using Zinforo.

Other medicines and Zinforo

Tell your doctor or nurse if you are using, have recently used, or might use any other medicines.

Pregnancy and breastfeeding

If you are pregnant, talk to your doctor before using Zinforo. Do not use this medicine during pregnancy unless your doctor has told you to.

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.

Driving and using machines

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

3. How to use Zinforo

Zinforo will be given to you by a doctor or nurse.

How much to use

The 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 recommended dose for children depends on the child's age and weight and is given every 8 or 12 hours. It is given through a drip into a vein over 5 to 60 minutes if you receive the standard dose or 120 minutes if you receive a higher dose.

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

Patients with kidney problems

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

If you use more Zinforo than you should

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

If you miss a dose of Zinforo

If you think you have missed a dose, tell your doctor or nurse immediately.

If you have any other questions about using this medicine, ask your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may happen with this medicine:

Tell your doctor immediately if you get any of these symptoms, as you may need urgent medical treatment:

• Sudden swelling of your face, lips, tongue, or throat; a severe rash; and problems swallowing or breathing. These can be signs of a severe allergic reaction (anaphylaxis) and can be life-threatening;
• Diarrhea that becomes severe or doesn't stop, or stools that contain blood or mucus during or after stopping treatment with Zinforo. In this situation, do not take medicines that stop or slow down bowel movements.

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

• Changes in a blood test called “Coombs test” commonly seen in patients taking this type of antibiotic. This test detects certain antibodies that can act against your red blood cells.

Common (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

• Anemia
• Raised itchy rash (urticaria)
• An increase in creatinine levels in the blood. Creatinine indicates how well your kidneys are working
• Bleeding or bruising more than usual. This may be due to a decrease in platelet count 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 cells in the blood (leucopenia and neutropenia).
• Changes in your mental state, such as confusion, reduced level of consciousness, abnormal movements, or seizures (encephalopathy): these have occurred in people when the dose given 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 get a fever, symptoms similar to flu, sore throat, or other infections that could be serious.
• An increase in the number of certain white blood cells in the blood (eosinophilia).

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

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

Sudden chest pain, which may be a sign of a potentially serious allergic reaction, called Kounis syndrome, which has been seen with other medicines of the same type. If this happens, talk to a doctor or nurse immediately.

Reporting of side effects

If you experience any side effects, talk to your doctor or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Zinforo

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

Do not use this medicine after the expiry date which is stated on the carton. The expiry date is the last day of the month stated.

Store below 30°C.

Keep in the original packaging to protect from light.

Medicines should not be disposed of via wastewater or household waste. The hospital will dispose of all waste materials safely. This will help protect the environment.

6. Contents of the pack and other information

What Zinforo contains

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

Appearance and packaging

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

Marketing authorisation holder

Pfizer Ireland Pharmaceuticals Unlimited Company

Operations Support Group

Ringaskiddy, County Cork

Ireland

Manufacturer

ACS Dobfar S.p.A.

Via A. Fleming 2

37135 Verona

Italy

You can request more information about this medicine from the local representative of the marketing authorisation holder:

Date of last revision of this leaflet: 01/2025.

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: https://www.ema.europa.eu.

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This information is intended only for healthcare professionals:

Important: Consult the summary of product characteristics before prescribing.

Aseptic technique must be used to prepare the infusion solution. The contents of the Zinforo vial should be reconstituted with 20 ml of water for injections. The following are the instructions for reconstituting the Zinforo vial:

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

The 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 the contents have dissolved completely. Parenteral drugs should be inspected visually for particles before administration.

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

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

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

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

Each vial is for single use only.

Disposal of unused medicine and all materials that have come into contact with it should be done in accordance with local regulations.