Zinforo

ceftaroline fosamil

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This is a summary of the European public assessment report (EPAR) for Zinforo. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Zinforo.

What is Zinforo?

Zinforo is a powder that is made up into a solution for infusion (drip) into a vein. It contains the active substance ceftaroline fosamil.

What is Zinforo used for?

Zinforo is an antibiotic. It is used to treat the following infections in adults and children from two months of age:

  • Complicated skin and soft tissue (tissue below the skin) infections. ‘Complicated’ means that the infection is difficult to treat.
  • Community-acquired pneumonia (an infection of the lungs that is caught outside of hospital).

Prescribers should consider official guidance on the appropriate use of antibiotics.

The medicine can only be obtained with a prescription.

How is Zinforo used?

Zinforo is given as an infusion into a vein lasting 60 minutes. In adults and adolescents from 12 to 18 years of age and weighing at least 33 kilograms, the recommended dose is 600 mg every 12 hours. In younger children from two months of age, and in children weighing less than 33 kilograms, the recommended dose depends on the weight of the patient.

Patients with complicated skin and soft tissue infections should be treated for five to 14 days, whereas patients who have community-acquired pneumonia should be treated for five to seven days. In patients with moderately reduced kidney function the doctor may need to reduce the dose.

How does Zinforo work?

The active substance in Zinforo, ceftaroline fosamil, is a type of antibiotic called cephalosporin belonging to the group of ‘beta-lactams’. It works by interfering with the production of complex molecules called ‘peptidoglycans’, which are essential components of bacterial cell walls. It does so by binding and blocking some enzymes called penicillin-binding protein transpeptidases involved in the last steps of bacterial cell wall production. This causes weakness in the bacterial cell walls which then become prone to collapse, ultimately leading to the death of the bacteria.

In experimental studies Zinforo was shown to have activity against certain bacteria against which other antibiotics belonging to the beta-lactam class do not work (methicillin resistant Staphylococcus aureus (MRSA) and penicillin non-susceptible Streptococcus pneumoniae (PNSP)). The full list of bacteria against which Zinforo is active can be found in the summary of product characteristics (also part of the EPAR).

How has Zinforo been studied?

Zinforo has been studied in seven main studies in which it was compared with other antibiotics:

  • two studies involving a total of 1,396 adults compared Zinforo with vancomycin and aztreonam used together to treat complicated skin and soft tissue infections;
  • two studies involving a total of 1,241 adults compared Zinforo with ceftriaxone to treat community-acquired pneumonia;
  • one study in 163 children compared Zinforo with vancomycin or cefazolin, with or without aztreonam, to treat skin and soft tissue infections;
  • one study in 161 children compared Zinforo with ceftriaxone to treat community-acquired pneumonia that required hospital stay;
  • one study in 40 children finally compared Zinforo with ceftriaxone and vancomycin to treat complicated community-acquired pneumonia.

In all of the studies, the main measure of effectiveness was the number of patients whose infection was cured after treatment.

What benefit has Zinforo shown during the studies?

Zinforo was as effective as the other antibiotics in treating both types of infection:

  • In complicated skin and soft tissue infection, one study showed that 86.6% of the patients receiving Zinforo were cured (304 out of 351), compared with 85.6% of the patients receiving the combination of vancomycin and aztreonam (297 out of 347). In the second study, 85.1% of patients receiving Zinforo were cured (291 out of 342) compared with 85.5% of the patients receiving the combination of vancomycin and aztreonam (289 out of 338).
  • In community-acquired pneumonia, one study showed that 83.8% of the patients receiving Zinforo were cured (244 out of 291), compared with 77.7% of the patients receiving ceftriaxone (233 out of 300). In the second study, 81.3% of patients receiving Zinforo were cured (235 out of 289) compared with 75.5% of the patients receiving ceftriaxone (206 out of 273).
What is the risk associated with Zinforo?

The most common side effects with Zinforo (seen in more than 3% of patients) are diarrhoea, headache, nausea (feeling sick), and pruritus (itching), which were generally mild or moderate in severity. For the full list of all side effects reported with Zinforo, see the package leaflet.

Zinforo must not be used in people who are hypersensitive (allergic) to ceftaroline fosamil or any of the other ingredients. Zinforo must also not be used in patients who are hypersensitive to other antibiotics belonging to the cephalosporin class and those who are severely allergic to other beta-lactam antibiotics. For the full list of restrictions, see the package leaflet.

Why has Zinforo been approved?

The CHMP noted that Zinforo was effective in treating complicated skin and soft tissue infections and community-acquired pneumonia and was generally well tolerated in both adults and children. The risk of hypersensitivity was considered to be limited as treatment duration is relatively short. The CHMP noted that Zinforo had shown activity in experimental models against certain bacteria against which other antibiotics belonging to the beta-lactam class do not work such as MRSA. However there were uncertainties about the effects of Zinforo in patients with certain very severe infections. These effects will be investigated in further studies. The CHMP concluded that benefits of Zinforo are greater than its risks and recommended that it be given marketing authorisation.

What measures are being taken to ensure the safe and effective use of Zinforo?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Zinforo have been included in the summary of product characteristics and the package leaflet.

Other information about Zinforo

The European Commission granted a marketing authorisation valid throughout the European Union for Zinforo on 23 August 2012.

For more information about treatment with Zinforo, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Zinforo : EPAR - Summary for the public BG = bălgarski 18/09/2012 30/09/2016
Zinforo : EPAR - Summary for the public ES = español 18/09/2012 30/09/2016
Zinforo : EPAR - Summary for the public CS = čeština 18/09/2012 30/09/2016
Zinforo : EPAR - Summary for the public DA = dansk 18/09/2012 30/09/2016
Zinforo : EPAR - Summary for the public DE = Deutsch 18/09/2012 30/09/2016
Zinforo : EPAR - Summary for the public ET = eesti keel 18/09/2012 30/09/2016
Zinforo : EPAR - Summary for the public EL = elliniká 18/09/2012 30/09/2016
Zinforo : EPAR - Summary for the public EN = English 18/09/2012 30/09/2016
Zinforo : EPAR - Summary for the public FR = français 18/09/2012 30/09/2016
Zinforo : EPAR - Summary for the public IT = italiano 18/09/2012 30/09/2016
Zinforo : EPAR - Summary for the public LV = latviešu valoda 18/09/2012 30/09/2016
Zinforo : EPAR - Summary for the public LT = lietuvių kalba 18/09/2012 30/09/2016
Zinforo : EPAR - Summary for the public HU = magyar 18/09/2012 30/09/2016
Zinforo : EPAR - Summary for the public MT = Malti 18/09/2012 30/09/2016
Zinforo : EPAR - Summary for the public NL = Nederlands 18/09/2012 30/09/2016
Zinforo : EPAR - Summary for the public PL = polski 18/09/2012 30/09/2016
Zinforo : EPAR - Summary for the public PT = português 18/09/2012 30/09/2016
Zinforo : EPAR - Summary for the public RO = română 18/09/2012 30/09/2016
Zinforo : EPAR - Summary for the public SK = slovenčina 18/09/2012 30/09/2016
Zinforo : EPAR - Summary for the public SL = slovenščina 18/09/2012 30/09/2016
Zinforo : EPAR - Summary for the public FI = suomi 18/09/2012 30/09/2016
Zinforo : EPAR - Summary for the public SV = svenska 18/09/2012 30/09/2016
Zinforo : EPAR - Summary for the public HR = Hrvatski 18/09/2012 30/09/2016

This EPAR was last updated on 30/09/2016 .

Authorisation details

Product details

Product details for Zinforo
NameZinforo
Agency product numberEMEA/H/C/002252
Active substance

ceftaroline fosamil

International non-proprietary name (INN) or common name

ceftaroline fosamil

Therapeutic area Community-Acquired InfectionsPneumoniaSkin Diseases, Infectious
Anatomical therapeutic chemical (ATC) code J01DI02
Additional monitoring

This medicine is under additional monitoring. This means that it is being monitored even more intensively than other medicines. For more information, see medicines under additional monitoring.

Publication details

Publication details for Zinforo
Marketing-authorisation holder

AstraZeneca AB

Revision10
Date of issue of marketing authorisation valid throughout the European Union23/08/2012

Contact address:

AstraZeneca AB
151 85 Södertälje
Sweden

Product information

Product information

01/06/2016  Zinforo -EMEA/H/C/002252 -II/0022

Name Language First published Last updated
Zinforo : EPAR - Product Information HR = Hrvatski 18/09/2012 17/06/2016
Zinforo : EPAR - Product Information HR = Hrvatski 18/09/2012 17/06/2016
Zinforo : EPAR - Product Information HR = Hrvatski 18/09/2012 17/06/2016
Zinforo : EPAR - Product Information HR = Hrvatski 18/09/2012 17/06/2016
Zinforo : EPAR - Product Information HR = Hrvatski 18/09/2012 17/06/2016
Zinforo : EPAR - Product Information HR = Hrvatski 18/09/2012 17/06/2016
Zinforo : EPAR - Product Information HR = Hrvatski 18/09/2012 17/06/2016
Zinforo : EPAR - Product Information HR = Hrvatski 18/09/2012 17/06/2016
Zinforo : EPAR - Product Information HR = Hrvatski 18/09/2012 17/06/2016
Zinforo : EPAR - Product Information HR = Hrvatski 18/09/2012 17/06/2016
Zinforo : EPAR - Product Information HR = Hrvatski 18/09/2012 17/06/2016
Zinforo : EPAR - Product Information HR = Hrvatski 18/09/2012 17/06/2016
Zinforo : EPAR - Product Information HR = Hrvatski 18/09/2012 17/06/2016
Zinforo : EPAR - Product Information HR = Hrvatski 18/09/2012 17/06/2016
Zinforo : EPAR - Product Information HR = Hrvatski 18/09/2012 17/06/2016
Zinforo : EPAR - Product Information HR = Hrvatski 18/09/2012 17/06/2016
Zinforo : EPAR - Product Information HR = Hrvatski 18/09/2012 17/06/2016
Zinforo : EPAR - Product Information HR = Hrvatski 18/09/2012 17/06/2016
Zinforo : EPAR - Product Information HR = Hrvatski 18/09/2012 17/06/2016
Zinforo : EPAR - Product Information HR = Hrvatski 18/09/2012 17/06/2016
Zinforo : EPAR - Product Information HR = Hrvatski 18/09/2012 17/06/2016
Zinforo : EPAR - Product Information HR = Hrvatski 18/09/2012 17/06/2016
Zinforo : EPAR - Product Information HR = Hrvatski 18/09/2012 17/06/2016
Zinforo : EPAR - Product Information HR = Hrvatski 18/09/2012 17/06/2016
Zinforo : EPAR - Product Information HR = Hrvatski 18/09/2012 17/06/2016

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Zinforo : EPAR - All Authorised presentations HR = Hrvatski 18/09/2012  
Zinforo : EPAR - All Authorised presentations HR = Hrvatski 18/09/2012  
Zinforo : EPAR - All Authorised presentations HR = Hrvatski 18/09/2012  
Zinforo : EPAR - All Authorised presentations HR = Hrvatski 18/09/2012  
Zinforo : EPAR - All Authorised presentations HR = Hrvatski 18/09/2012  
Zinforo : EPAR - All Authorised presentations HR = Hrvatski 18/09/2012  
Zinforo : EPAR - All Authorised presentations HR = Hrvatski 18/09/2012  
Zinforo : EPAR - All Authorised presentations HR = Hrvatski 18/09/2012  
Zinforo : EPAR - All Authorised presentations HR = Hrvatski 18/09/2012  
Zinforo : EPAR - All Authorised presentations HR = Hrvatski 18/09/2012  
Zinforo : EPAR - All Authorised presentations HR = Hrvatski 18/09/2012  
Zinforo : EPAR - All Authorised presentations HR = Hrvatski 18/09/2012  
Zinforo : EPAR - All Authorised presentations HR = Hrvatski 18/09/2012  
Zinforo : EPAR - All Authorised presentations HR = Hrvatski 18/09/2012  
Zinforo : EPAR - All Authorised presentations HR = Hrvatski 18/09/2012  
Zinforo : EPAR - All Authorised presentations HR = Hrvatski 18/09/2012  
Zinforo : EPAR - All Authorised presentations HR = Hrvatski 18/09/2012  
Zinforo : EPAR - All Authorised presentations HR = Hrvatski 18/09/2012  
Zinforo : EPAR - All Authorised presentations HR = Hrvatski 18/09/2012  
Zinforo : EPAR - All Authorised presentations HR = Hrvatski 18/09/2012  
Zinforo : EPAR - All Authorised presentations HR = Hrvatski 18/09/2012  
Zinforo : EPAR - All Authorised presentations HR = Hrvatski 18/09/2012  

Pharmacotherapeutic group

Antibacterials for systemic use

Therapeutic indication

Zinforo is indicated for the treatment of the following infections in adults and children from the age of 2 months:

  • Complicated skin and soft tissue infections (cSSTI);
  • Community-acquired pneumonia (CAP).

Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Zinforo : EPAR - Public assessment report HR = Hrvatski 18/09/2012  
CHMP summary of positive opinion for Zinforo HR = Hrvatski 22/06/2012  

Authorised

This medicine is approved for use in the European Union