Zavicefta

ceftazidime / avibactam

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This is a summary of the European public assessment report (EPAR) for Zavicefta. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Zavicefta.

For practical information about using Zavicefta, patients should read the package leaflet or contact their doctor or pharmacist.

What is Zavicefta and what is it used for?

Zavicefta is an antibiotic used in adults to treat the following infections:

  • complicated (difficult to treat) infections of the tissues and organs within the belly (intra-abdominal infections);
  • complicated (difficult to treat) infections of the urinary tract (structures that carry urine), including pyelonephritis (kidney infection);
  • infections of the lungs that are caught in hospital (hospital-acquired pneumonia), including ventilator-associated pneumonia (pneumonia caught from a ventilator, which is a machine that helps a patient to breathe);
  • infections caused by Gram-negative bacteria (types of bacteria) when other treatments might not work.

Zavicefta contains the active substances ceftazidime and avibactam.

How is Zavicefta used?

Zavicefta is available as a powder to be made up into a solution for infusion (drip) into a vein. The infusion is given over two hours, three times daily. Treatment usually lasts between 5 and 14 days, depending on the type of infection.

Doses may need to be reduced and/or given less often in patients with severely reduced kidney function.

Zavicefta can only be obtained with a prescription, and prescribers should take into account official guidance on the use of antibiotics.

For further information, see the package leaflet.

How does Zavicefta work?

The active substances in Zavicefta are ceftazidime and avibactam. Ceftazidime is an antibiotic called a cephalosporin, which belongs to the wider group ‘beta-lactams’. It works by interfering with the production of certain molecules that bacteria need to build their protective cell walls. This causes weakness in the bacterial cell walls which then become prone to collapse, ultimately leading to the death of the bacteria.

Avibactam blocks the action of bacterial enzymes called beta-lactamases. These enzymes enable bacteria to break down beta-lactam antibiotics such as ceftazidime, making them resistant to the antibiotic’s action. By blocking the action of these enzymes, avibactam allows ceftazidime to act against bacteria that would otherwise be resistant.

What benefits of Zavicefta have been shown in studies?

The benefits of Zavicefta have been shown in four main studies. In two studies, the effects of the combination of Zavicefta and metronidazole (another antibiotic) were compared with those of the antibiotic meropenem in 1490 patients with complicated intra-abdominal infection. Both studies showed that Zavicefta in combination with metronidazole was at least as effective as meropenem at curing the infection. In the first study, one of the patient groups studied showed 92% of patients (376 out of 410) treated with Zavicefta and metronidazole were cured, compared with 93% (385 out of 416) of patients treated with meropenem. In the second study, 94% of patients (166 out of 177) treated with Zavicefta and metronidazole were cured, compared with 94% (173 out of 184) of patients treated with meropenem.

A third study looked at 332 patients with complicated intra-abdominal or urinary tract infections caused by Gram-negative bacteria that were resistant to ceftazidime (could not be killed by ceftazidime). Zavicefta alone (for urinary tract infection) or in combination with metronidazole (for intra-abdominal infection) provided similar results to a number of alternative antibiotics in curing the infection: 91% of patients (140 out of 154) were cured after treatment with Zavicefta compared with 91% (135 out of 148) after treatment with the best alternative antibiotic. In addition, disease-causing bacteria were eliminated in 82% (126 out of 154) of patients after treatment with Zavicefta compared with 63% (94 out of 148) after treatment with the best alternative antibiotic. Due to the design of this study, this evidence of Zavicefta’s benefits is not as strong as for the other studies; however these results support Zavicefta’s activity when combined with the other studies.

In a fourth study, 1,020 patients with complicated urinary tract infections (including pyelonephritis) caused by Gram-negative bacteria were treated with Zavicefta or the antibiotic doripenem. One of the main measures of effectiveness was based on eliminating the disease-causing bacteria. Zavicefta was at least as effective as doripenem: 77% of patients (304 out of 393) treated with Zavicefta showed a response compared with 71% of patients (296 out of 417) treated with doripenem.

What are the risks associated with Zavicefta?

The most common side effects with Zavicefta (which affected more than 5 in 100 people) are nausea (feeling sick), diarrhoea and a positive result in a Coombs test (a sign of the development of antibodies that attack red blood cells). For the full list of all side effects with Zavicefta, see the package leaflet.

Zavicefta must not be used in patients who are hypersensitive (allergic) to the active substances in Zavicefta or any of the other ingredients, or in those who are hypersensitive to other cephalosporin antibiotics or have ever had a severe allergic reaction to another beta-lactam antibiotic.

Why is Zavicefta approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Zavicefta’s benefits are greater than its risks and recommended that it be approved for use in the EU. The CHMP considered that the studies on Zavicefta show that is effective at treating complicated intra-abdominal and urinary tract infections. A study of Zavicefta in patients with hospital-acquired pneumonia has not yet been completed. However, the CHMP considered that the data already available supported Zavicefta’s activity in hospital-acquired pneumonia and for the treatment of infections due to aerobic Gram-negative organisms in adult patients when other treatments might not work. Regarding Zavicefta’s safety profile, side effects were those that can be expected for ceftazidime and a beta-lactamase inhibitor.

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

meropenem (another antibiotic) for the treatment of hospital-acquired pneumonia.

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

Other information about Zavicefta

The European Commission granted a marketing authorisation valid throughout the European Union for Zavicefta on 24 June 2016.

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

Name Language First published Last updated
Zavicefta : EPAR - Summary for the public BG = bălgarski 2016-07-14  
Zavicefta : EPAR - Summary for the public ES = español 2016-07-14  
Zavicefta : EPAR - Summary for the public CS = čeština 2016-07-14  
Zavicefta : EPAR - Summary for the public DA = dansk 2016-07-14  
Zavicefta : EPAR - Summary for the public DE = Deutsch 2016-07-14  
Zavicefta : EPAR - Summary for the public ET = eesti keel 2016-07-14  
Zavicefta : EPAR - Summary for the public EL = elliniká 2016-07-14  
Zavicefta : EPAR - Summary for the public EN = English 2016-07-14  
Zavicefta : EPAR - Summary for the public FR = français 2016-07-14  
Zavicefta : EPAR - Summary for the public IT = italiano 2016-07-14  
Zavicefta : EPAR - Summary for the public LV = latviešu valoda 2016-07-14  
Zavicefta : EPAR - Summary for the public LT = lietuvių kalba 2016-07-14  
Zavicefta : EPAR - Summary for the public HU = magyar 2016-07-14  
Zavicefta : EPAR - Summary for the public MT = Malti 2016-07-14  
Zavicefta : EPAR - Summary for the public NL = Nederlands 2016-07-14  
Zavicefta : EPAR - Summary for the public PL = polski 2016-07-14  
Zavicefta : EPAR - Summary for the public PT = português 2016-07-14  
Zavicefta : EPAR - Summary for the public RO = română 2016-07-14  
Zavicefta : EPAR - Summary for the public SK = slovenčina 2016-07-14  
Zavicefta : EPAR - Summary for the public SL = slovenščina 2016-07-14  
Zavicefta : EPAR - Summary for the public FI = suomi 2016-07-14  
Zavicefta : EPAR - Summary for the public SV = svenska 2016-07-14  
Zavicefta : EPAR - Summary for the public HR = Hrvatski 2016-07-14  

This EPAR was last updated on 29/09/2017 .

Authorisation details

Product details

Product details for Zavicefta
NameZavicefta
Agency product numberEMEA/H/C/004027
Active substance

ceftazidime / avibactam

International non-proprietary name (INN) or common name

ceftazidime / avibactam

Therapeutic area Soft Tissue InfectionsGram-Negative Bacterial InfectionsPneumoniaPneumonia, BacterialDiseasesUrinary Tract Infections
Anatomical therapeutic chemical (ATC) code J01
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 Zavicefta
Marketing-authorisation holder

Pfizer Ireland Pharmaceuticals

Revision2
Date of issue of marketing authorisation valid throughout the European Union24/06/2016

Contact address:

Pfizer Ireland Pharmaceuticals
Operations Services Group
Ringaskiddy, County Cork
Ireland

Product information

Product information

19/07/2017  Zavicefta -EMEA/H/C/004027 -T/0006

Name Language First published Last updated
Zavicefta : EPAR - Product Information HR = Hrvatski 2016-07-14 2017-09-29
Zavicefta : EPAR - Product Information HR = Hrvatski 2016-07-14 2017-09-29
Zavicefta : EPAR - Product Information HR = Hrvatski 2016-07-14 2017-09-29
Zavicefta : EPAR - Product Information HR = Hrvatski 2016-07-14 2017-09-29
Zavicefta : EPAR - Product Information HR = Hrvatski 2016-07-14 2017-09-29
Zavicefta : EPAR - Product Information HR = Hrvatski 2016-07-14 2017-09-29
Zavicefta : EPAR - Product Information HR = Hrvatski 2016-07-14 2017-09-29
Zavicefta : EPAR - Product Information HR = Hrvatski 2016-07-14 2017-09-29
Zavicefta : EPAR - Product Information HR = Hrvatski 2016-07-14 2017-09-29
Zavicefta : EPAR - Product Information HR = Hrvatski 2016-07-14 2017-09-29
Zavicefta : EPAR - Product Information HR = Hrvatski 2016-07-14 2017-09-29
Zavicefta : EPAR - Product Information HR = Hrvatski 2016-07-14 2017-09-29
Zavicefta : EPAR - Product Information HR = Hrvatski 2016-07-14 2017-09-29
Zavicefta : EPAR - Product Information HR = Hrvatski 2016-07-14 2017-09-29
Zavicefta : EPAR - Product Information HR = Hrvatski 2016-07-14 2017-09-29
Zavicefta : EPAR - Product Information HR = Hrvatski 2016-07-14 2017-09-29
Zavicefta : EPAR - Product Information HR = Hrvatski 2016-07-14 2017-09-29
Zavicefta : EPAR - Product Information HR = Hrvatski 2016-07-14 2017-09-29
Zavicefta : EPAR - Product Information HR = Hrvatski 2016-07-14 2017-09-29
Zavicefta : EPAR - Product Information HR = Hrvatski 2016-07-14 2017-09-29
Zavicefta : EPAR - Product Information HR = Hrvatski 2016-07-14 2017-09-29
Zavicefta : EPAR - Product Information HR = Hrvatski 2016-07-14 2017-09-29
Zavicefta : EPAR - Product Information HR = Hrvatski 2016-07-14 2017-09-29
Zavicefta : EPAR - Product Information HR = Hrvatski 2016-07-14 2017-09-29
Zavicefta : EPAR - Product Information HR = Hrvatski 2016-07-14 2017-09-29

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
Zavicefta : EPAR - All Authorised presentations HR = Hrvatski 2016-07-14  
Zavicefta : EPAR - All Authorised presentations HR = Hrvatski 2016-07-14  
Zavicefta : EPAR - All Authorised presentations HR = Hrvatski 2016-07-14  
Zavicefta : EPAR - All Authorised presentations HR = Hrvatski 2016-07-14  
Zavicefta : EPAR - All Authorised presentations HR = Hrvatski 2016-07-14  
Zavicefta : EPAR - All Authorised presentations HR = Hrvatski 2016-07-14  
Zavicefta : EPAR - All Authorised presentations HR = Hrvatski 2016-07-14  
Zavicefta : EPAR - All Authorised presentations HR = Hrvatski 2016-07-14  
Zavicefta : EPAR - All Authorised presentations HR = Hrvatski 2016-07-14  
Zavicefta : EPAR - All Authorised presentations HR = Hrvatski 2016-07-14  
Zavicefta : EPAR - All Authorised presentations HR = Hrvatski 2016-07-14  
Zavicefta : EPAR - All Authorised presentations HR = Hrvatski 2016-07-14  
Zavicefta : EPAR - All Authorised presentations HR = Hrvatski 2016-07-14  
Zavicefta : EPAR - All Authorised presentations HR = Hrvatski 2016-07-14  
Zavicefta : EPAR - All Authorised presentations HR = Hrvatski 2016-07-14  
Zavicefta : EPAR - All Authorised presentations HR = Hrvatski 2016-07-14  
Zavicefta : EPAR - All Authorised presentations HR = Hrvatski 2016-07-14  
Zavicefta : EPAR - All Authorised presentations HR = Hrvatski 2016-07-14  
Zavicefta : EPAR - All Authorised presentations HR = Hrvatski 2016-07-14  
Zavicefta : EPAR - All Authorised presentations HR = Hrvatski 2016-07-14  
Zavicefta : EPAR - All Authorised presentations HR = Hrvatski 2016-07-14  
Zavicefta : EPAR - All Authorised presentations HR = Hrvatski 2016-07-14  
Zavicefta : EPAR - All Authorised presentations HR = Hrvatski 2016-07-14  
Zavicefta : EPAR - All Authorised presentations HR = Hrvatski 2016-07-14  
Zavicefta : EPAR - All Authorised presentations HR = Hrvatski 2016-07-14  

Pharmacotherapeutic group

Antibacterials for systemic use

Therapeutic indication

Zavicefta is indicated for the treatment of the following infections in adults:

  • Complicated intra-abdominal Infection (cIAI)
  • Complicated urinary tract infection (cUTI), including pyelonephritis
  • Hospital-acquired pneumonia (HAP), including ventilator-associated pneumonia (VAP)

Zavicefta is also indicated for the treatment of infections due to aerobic Gram-negative organisms in adult patients with limited treatment options.

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

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Zavicefta : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 2017-04-06 2017-09-29

Initial marketing-authorisation documents

Name Language First published Last updated
Zavicefta : EPAR - Public assessment report HR = Hrvatski 2016-07-14  
CHMP summary of opinion for Zavicefta HR = Hrvatski 2016-04-29  

Authorised

This medicine is approved for use in the European Union