Zinforo
ceftaroline fosamil
ceftaroline fosamil
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 Zinforo is and what it is used for
What you need to know before you use Zinforo
How to use Zinforo
Possible side effects
How to store Zinforo
Contents of the pack and other information
Zinforo is an antibiotic medicine that contains the active substance ceftaroline fosamil. It belongs to a group of medicines called ‘cephalosporin antibiotics.’
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’
Zinforo works by killing certain bacteria, which can cause serious infections.
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.
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
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.
Tell your doctor or nurse if you are using, have recently used or might use any other medicines.
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.
Zinforo may cause side effects such as dizziness. This may impair your ability to drive or operate machinery.
Zinforo will be given to you by a doctor or nurse.
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.
If you have kidney problems your doctor may lower your dose because Zinforo is removed from your body by the kidneys.
If you think you have been given too much Zinforo, tell your doctor or nurse straight away.
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.
Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may happen with this medicine:
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.
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.
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.
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, ora 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.
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).
A form of lung disease where eosinophils (a form of white blood cell) appear in the lung in increased numbers (eosinophilic pneumonia).
If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via thenationalreportingsystemlistedin Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
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.
Each vial contains 600 mg of ceftaroline fosamil.
The other ingredient is arginine.
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.
Pfizer Ireland Pharmaceuticals Operations Support Group Ringaskiddy, County Cork Ireland
ACS Dobfar S.p.A. Nucleo Industriale S. Atto 64100 Teramo
Italy
ACS Dobfar S.p.A. Via A. Fleming 2 37135 Verona
Italy
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
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Tel: +420-283-004-111
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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 (mg) | Volume of diluent to be added (mL) | Approximate ceftaroline concentration (mg/mL) | Amount to be withdrawn |
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.