600 mg powder for concentrate for infusion, solution
ceftaroline fosamilum (ceftaroline fosamilum)
What Zinforo is and what it is used for
What Zinforo is
Zinforo is an antibiotic medicine containing the active substance ceftarolinefosamil. 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 the following diseases:
- infection in the skin and the tissues under the skin
- an infection in the lungs called pneumonia or pneumonia
How Zinforo works
Zinforo works by killing certain bacteria that can cause serious infections.
What you need to know before using Zinforo
Do not use Zinforo
- if you are allergic to ceftarolinefosamil or any of the other ingredients of this medicine (listed in section 6)
- if you are allergic to other cephalosporin antibiotics
- if you have previously had severe allergic reactions to other antibiotics such as penicillin or carbapenems
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 need to prescribe a lower dose )
- if you have ever had seizures (convulsions)
- if you have ever had mild allergic reactions to other antibiotics such as penicillin or carbapenems
- if you have ever had severe diarrhea while taking antibiotics
You may get an infection caused by another bacteria during or after treatment with Zinforo.
You may develop signs and symptoms of serious skin reactions such as fever, joint pain, rash, red scaly skin, blisters, blisters or peeling skin, red round spots on the upper body, often with blisters in the middle, sores in the mouth, throat, nose, genitals or eyes. If this happens, talk to your doctor or nurse immediately.
Laboratory test
You may show an abnormal result on a laboratory test (so-called Coomb’s test) which checks for the presence of certain antibodies that can affect your red blood cells. If the level of red blood cells drops, the doctor can check to see if these antibodies have caused it.
If any of the above applies to you (or if you are not sure), you should consult a doctor or nurse before using Zinforo.
Other medicines and Zinforo
Tell the doctor or nurse if you are using, have recently used, or might be using other medicines.
Pregnancy and breastfeeding
If you are pregnant, tell your doctor before using Zinforo. Do not use the medicine during pregnancy unless your doctor tells you to.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor before using this medicine.
Driving ability and use of machinery
Zinforo can cause side effects, such as dizziness. This may affect your ability to drive and use machines.
How to use Zinforo
Zinforo is given to you by a doctor or nurse.
Dosage
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 given as a drip into a vein over 5 to 60 minutes if you receive the usual dose one or 120 minutes if you receive the increased dose one.
A treatment 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, the doctor may lower the dose, as Zinforo is excreted from the body via the kidneys.
If you use too much Zinforo
If you think you have been given too much Zinforo, tell the doctor or nurse immediately.
If you missed a dose of Zinforo
If you think you have missed a dose, tell the doctor or nurse immediately.
If you have any further questions about this medicine, ask your doctor or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may occur with this medicine:
Tell your doctor immediately if you get these symptoms because you may need emergency medical attention:
- Sudden swelling of the lips, face, throat, or tongue; severe skin rash and trouble swallowing or breathing. This can be a sign of a severe allergic reaction ( anaphylaxis ) which can be life-threatening
- Diarrhea that becomes severe or prolonged, or stools that contain blood or mucus during or after treatment with Zinforo. In this situation, you should not take medicines that stop or calm bowel activity.
Very common ( may affect more than 1 in 10 people )
- Changes in a blood test called the Coombs test, which is commonly seen in patients receiving this type of antibiotic. This test checks for the presence of certain antibodies that can affect your red blood cells.
Common ( may affect up to 1 in 10 people )
- Fever
- Headache
- Dizziness
- Itching, skin rash
- Diarrhea, abdominal pain
- Nausea and vomiting
- More enzymes are produced by the liver (seen in blood samples)
- Pain and irritation in the veins
- Redness, pain, or swelling at the injection site
Uncommon ( may affect up to 1 in 100 people )
- Blood deficiency ( anemia )
- Raised, itchy rash ( hives )
- An increase in the creatinine level in the blood. Creatinine shows how well your kidneys are working.
- More bleeding or bruising than usual. This may be because the level of platelets in the blood has dropped.
- Changes in tests show how well your blood clots.
- Decreased total number of white blood cells or certain white blood cells in the blood ( leukopenia and neutropenia )
- Changes related to your mental state, e.g. confusion, reduced level of consciousness, abnormal movements, or seizures ( encephalopathy ) – these have occurred in people when the dose they have received is too high, especially 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, flu-like symptoms, sore throat, or other infection that can be serious.
- An increase in the number of certain white blood cells in the blood ( eosinophilia ).
Has been reported (occurring in an unknown number of users)
- A type of lung disease in which the number of eosinophils (a type of white blood cell ) increases in the lungs ( eosinophilic pneumonia ).
How to store Zinforo
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the packaging. The expiration date is the last day of the specified month.
Store at a maximum of 30 °C.
Store in the original packaging. Light sensitive.
Medicines must not be thrown into the drain or among the household waste. The hospital disposes of all waste material safely. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- Each vial contains 600 mg of ceftaroline family.
- Another ingredient is arginine.
Appearance and package sizes of the medicine
Zinforo is a white-yellow to light-yellow powder to concentrate for infusion, solution in a vial. It is available in packs of 10 vials.
Marketing Authorisation Holder
Pfizer Ireland Pharmaceuticals
Operations Support Group
Ringaskiddy, County Cork
Ireland
Manufacturer
ACS Dobfar SpA
Nucleo Industriale S. Atto
64100 Teramo
Italy
ACS Dobfar SpA
Via A. Fleming 2
37135 Verona
Italy
Contact the representative of the Marketing Authorization Holder if you would like to know more about this medicine:
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