Package leaflet: Information for the user
Zinforo ® 600 mg 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.
What is in this leaflet
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 that contains 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:
• infections of the skin and the tissues below the skin
• an infection of the lungs called ‘pneumonia’
How Zinforo works
Zinforo works by killing certain bacteria, which 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 other cephalosporin antibiotics
• If you have had previous severe allergic reactions to other antibiotics like 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 using Zinforo:
• If you have kidney problems (your doctor may have to prescribe a lower dose)
• If you have ever had fits (seizures or convulsions)
• If you have ever had any non-severe allergic reactions to other antibiotics like penicillin or
carbapenem
• If you have had severe diarrhoea whilst taking antibiotics in the past
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You may get another infection caused by another bacteria during or following treatment with Zinforo.
You may develop signs and symptoms of severe skin reactions such as fever, joint pain, skin rash, red
scaly rash, skin bumps that contain pus, blisters or peeling of skin, red circular patches often with
central blisters on the trunk, ulcers of mouth, throat, nose, genitals and eyes. If this happens talk to
your doctor or nurse immediately.
Lab Test
You may develop an abnormal lab test (called Coombs test) that looks for certain antibodies which
may act against your red blood cells. If the level of your red blood cells fall your doctor may check to
see if these antibodies have caused this.
If any of the above apply 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 breast-feeding
Tell your doctor before using Zinforo if you are pregnant. Do not use this medicine during pregnancy
unless your doctor has told you to.
If you are pregnant or breast-feeding, 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 impair your ability to drive or operate
machinery.
3. How to use Zinforo
Zinforo will be given 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 some infections. The usual recommended dose for children depends
on the age and weight of the child and is given every 8 or 12 hours. It is given as a drip into a vein
lasting 5 to 60 minutes if you receive the usual dose or 120 minutes if you receive an increased dose.
A course of treatment usually lasts for 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 lower your dose because Zinforo is removed from your
body by the kidneys.
If you use more Zinforo than you should
If you think you have been given too much Zinforo, tell your doctor or nurse straight away.
If you miss a dose of Zinforo
If you think you have missed a dose, tell your doctor or nurse straight away.
If you have any further questions on the use of this medicine, ask your doctor or nurse.
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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 straight away if you get these symptoms as you may need urgent medical
treatment:
• Sudden swelling of your lips, face, throat or tongue; a severe rash; and, swallowing or breathing
problems. These may be signs of a severe allergic reaction (anaphylaxis) and may be life-
threatening;
• Diarrhoea that becomes severe or does not go away or stool that contains blood or mucus during
or after treatment with Zinforo. In this situation, you should not take medicines that stop or slow
bowel movement.
Very common (may affect more than 1 in 10 people)
• Changes in a blood test called a ‘Coombs test’ commonly seen in patients receiving this type of
antibiotic. This test looks for certain antibodies which may act against your red blood cells.
Common (may affect up to 1 in 10 people)
• Fever
• Headache
• Feeling dizzy
• Itching, skin rash
• Diarrhoea, stomach pain
• Feeling sick (nausea) or being sick (vomiting)
• More enzymes produced by your liver (as shown in blood tests)
• Pain and irritation of the veins
• Redness, pain or swelling where the injection was given.
Uncommon (may affect up to 1 in 100 people)
• Anaemia
• Raised itchy rash (hives)
• An increase in the level of creatinine in your blood. Creatinine shows how well your kidneys are
working.
• Bleeding or bruising more than usual. This may be because the level of platelets in your blood
has dropped.
• Changes in tests which measure how well your blood clots.
• A decrease in the total number of white blood cells, or a certain type of white blood cells in your
blood (leucopenia and neutropenia).
• Changes in your mental state such as confusion, reduced level of consciousness, abnormal
movements or fits (encephalopathy) – these have occurred in people when the dose they are
given is too high, particularly 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 your blood
(agranulocytosis). You may experience fever, flu-like symptoms, sore throat, or any other
infection which may be serious.
• An increase in the number of certain white blood cells in your blood (eosinophilia).
Not known (frequency cannot be estimated from the available data)
• A form of lung disease where eosinophils (a form of white blood cell) appear in the lung in
increased numbers (eosinophilic pneumonia).
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Sudden chest pain, which may be a sign of a potentially serious allergic reaction called Kounis
syndrome has been noted with other medicines of the same type. If this happens talk to a doctor or
nurse immediately.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App
Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store 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 container. The expiry date refers
to the last day of that month.
Store below 30°C.
Store in the original package in order to protect from light.
Medicines should not be disposed of via wastewater or household waste. The hospital will dispose of
any waste materials safely. These measures will help to 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.
What Zinforo looks like 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 Authorisation Holder
Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom
Manufacturer(s)
ACS Dobfar S.p.A.
Nucleo Industriale S. Atto
64100 Teramo
Italy
And
ACS Dobfar S.p.A.
Via A. Fleming 2
37135 Verona
Italy
For any information about this medicine, please contact:
Medical Information, Pfizer Ltd, Walton Oaks, Dorking Road, Tadworth, Surrey, KT20 7NS.
Telephone 01304 616161.
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This leaflet was last revised in 03/2024.
Ref: ZI 15_0
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The following information is intended for medical or healthcare professionals only:
Important: Please refer to the Summary of Product Characteristics before prescribing.
Aseptic technique must be followed in preparing the infusion solution. The contents of Zinforo vial
should be reconstituted with 20 mL of sterile water for injections. Instructions for the reconstitution of
Zinforo vial are summarized below:
Dosage strength Volume of diluent Approximate ceftaroline Amount to be
(mg) to be added concentration withdrawn
(mL) (mg/mL)
600 20 30 Total volume
The reconstituted solution must be further diluted to produce Zinforo solution for infusion. A 250 mL,
100 mL or 50 mL infusion bag can be used to prepare the infusion, based on the patient’s volume
requirements. Appropriate infusion diluents 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 dose selected over 5 to 60
minutes for standard dose or 120 minutes for high dose in infusion volumes of 50 mL, 100 mL or
250 mL.
Infusion volumes for paediatric patients will vary according to the weight of the child. The infusion
solution concentration during preparation and administration should not exceed 12 mg/mL ceftaroline
fosamil.
Reconstitution time is less than 2 minutes. Mix gently to reconstitute and check to see that the
contents have dissolved completely. Parenteral drug products should be inspected visually for
particulate matter prior to administration.
The colour of Zinforo infusion solutions ranges from clear, light to dark yellow depending on the
concentration and storage conditions. It is free of any particles. When stored as recommended, the
product potency is not affected.
The chemical and physical in-use stability has been demonstrated for up to 12 hours at 2-8 °C and
6 hours at 25 ºC.
From a microbiological point of view, unless the method of opening/reconstitution/dilution precludes
the risk of microbial contamination the medicinal product should be used immediately. If not used
immediately, in-use storage times and conditions prior to use are the responsibility of the user.
The compatibility of Zinforo with other medicines has not been established. Zinforo should not be
mixed with or physically added to solutions containing other drugs.
Each vial is for single use only.
Any unused product or waste material should be disposed of in accordance with local requirements.
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