Zinforo 600 mg powder for concentrate for solution for infusion

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Zinforo 600 mg powder for concentrate for solution for infusion

ceftaroline fosamil

Read the entire leaflet carefully before you start using this medicine, because 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 not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Zinforo is and what it is used for

What Zinforo is

Zinforo is an antibiotic medicine containing the active substance ceftaroline fosamil. It belongs to a group of medicines called "cephalosporin antibiotics".

What Zinforo is 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 using Zinforo

Do not use Zinforo

• if you are allergic to ceftaroline fosamil or to 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 previously had severe allergic reactions to other antibiotics such as penicillin or carbapenem.

Do not use Zinforo if any of the above apply 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 fits or convulsions)
• If you have previously had a non-severe allergic reaction to other antibiotics such as penicillin or carbapenem
• If you have previously had severe diarrhoea while taking antibiotics.

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

You may develop signs and symptoms of serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS). Seek immediate medical attention if you notice any symptoms related to these serious skin reactions described in section 4.

Laboratory tests

You may develop an abnormal response in a laboratory test (called the Coombs test) that detects certain antibodies that may act against red blood cells. If your red blood cell levels decrease, your doctor may check whether these antibodies have caused the reduction in red blood cells.

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

Other medicines and Zinforo

Inform your doctor or nurse if you are taking, have recently taken, or might need to take any other medicines.

Pregnancy and breast-feeding

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

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine.

Driving and using machines

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

3. How to use Zinforo

Zinforo will be administered to you 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 certain infections. The usual recommended dose for children depends on the child's age and weight, and is given every 8 or 12 hours. It is administered by intravenous infusion over 5 to 60 minutes if receiving the usual dose, or over 120 minutes if receiving a higher dose.

A treatment course usually lasts 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 eliminated from the body through the 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 have missed a dose, inform your doctor or nurse immediately.

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

4. Possible adverse effects

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

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

• Severe skin reactions (frequency not known, cannot be estimated from available data)

• Flat, red skin patches on the chest, target-shaped or circular, often with central blisters, peeling of the skin, and ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).

• Widespread rash, high body temperature, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

• 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 could be life-threatening.

• Diarrhea that becomes severe or does not stop, or stools containing blood or mucus during or after stopping treatment with Zinforo. In this situation, you should not take medicines that stop or slow intestinal movement.

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

• Changes in a blood test called the “Coombs test,” frequently observed in patients receiving this type of antibiotic. This test detects certain antibodies that may 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
• 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)

• Anaemia
• Itchy, raised rash (urticaria)
• Increased levels of creatinine in the blood. Creatinine indicates how well your kidneys are functioning
• Unusual bleeding or bruising. This may be due to a decrease in the level of platelets in the blood
• Changes in tests that assess how your blood clots
• A decrease in the total number of white blood cells, or of certain types of white blood cells in the blood (leucopenia and neutropenia).
• Changes in mental state, such as confusion, reduced level of consciousness, abnormal movements, or seizures (encephalopathy): these have occurred in people when the dose administered was too high, especially in people with kidney problems.

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

• A marked decrease in the number of certain white blood cells in the blood (agranulocytosis). You may develop fever, flu-like symptoms, sore throat, or other infections that could be serious.
• An increase in the number of certain white blood cells (eosinophilia).

Frequency not known (cannot be estimated from available data)

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

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

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse 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 stated on the packaging. The expiry date refers to the last day of the month indicated.

Store below 30 °C.

Keep in the original packaging to protect from light.

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

6. Contents of the pack and other information

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 yellowish-white to light yellow 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

Manufacturer responsible

ACS Dobfar S.p.A.

Nucleo Industriale S. Atto

64100 Teramo

Italy

ACS Dobfar S.p.A.

Via A. Fleming 2

37135 Verona

Italy

More information about this medicinal product is available upon request by contacting the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet:

Other sources of information

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

This information is intended for healthcare professionals only:

Important: Review the summary of product characteristics before prescribing.

An 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 is a summary of the reconstitution instructions for the Zinforo vial:

The reconstituted solution must be further diluted to prepare the Zinforo infusion solution. 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%) 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 Lactated Ringer's 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, using infusion volumes of 50 ml, 100 ml, or 250 ml.

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

Reconstitution time is less than 2 minutes. Gently mix to reconstitute and check that the contents have completely dissolved. Parenteral medicines should be inspected visually for particulate matter prior to administration.

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

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

From a microbiological standpoint, the medicine should be used immediately unless the method of opening/reconstitution/dilution excludes the risk of microbial contamination. If not used immediately, the in-use storage times and conditions prior to use are the responsibility of the user.

Compatibility of Zinforo with other medicinal products has not been established. Zinforo must 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 must be carried out in accordance with local regulations.