Daptomycin Hospira

daptomycin

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This is a summary of the European public assessment report (EPAR) for Daptomycin Hospira. 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 Daptomycin Hospira.

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

What is Daptomycin Hospira and what is it used for?

Daptomycin Hospira is an antibiotic medicine used to treat the following bacterial infections:

  • complicated infections of the skin and the ‘soft tissues’ below the skin in adults and children from 1 to 17 years of age. ‘Complicated’ means that the infection is difficult to treat, because it has spread to the deep tissues below the skin, because treatment with surgery might be needed, or because the patient has other conditions that might affect the treatment;
  • right-sided infective endocarditis (infection of the lining or the valves of the right side of the heart) caused by the bacterium Staphylococcus aureus (S. aureus) in adults. The decision to treat this infection with Daptomycin Hospira should be based on the likelihood that the medicine will work against the infection and on advice from an expert;
  • bacteraemia (infection of the blood) caused by S. aureus, associated with either of the two infections above, in adults.

Daptomycin Hospira contains the active substance daptomycin.

Daptomycin Hospira is a ‘generic medicine’. This means that Daptomycin Hospira contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the European Union (EU) called Cubicin.

How is Daptomycin Hospira used?

Daptomycin Hospira is available as a powder that is made up into a solution for injection or infusion (drip) into a vein. In adults, Daptomycin Hospira is given by a doctor or a nurse either as an infusion lasting 30 minutes or as an injection lasting two minutes. For skin or soft tissue infections without bacteraemia, Daptomycin Hospira is given at a dose of 4 mg per kilogram body weight once every 24 hours for 7 to 14 days or until the infection has cleared up. For endocarditis and for skin or soft tissue infection with bacteraemia, the dose is 6 mg/kg once every 24 hours.

In children aged 7 to 17 years with complicated skin or soft tissue infections, Daptomycin Hospira is given as an infusion lasting 30 minutes and in children aged 1 to 6 years the infusion should last 60 minutes. The dose changes with the child’s age and varies between 5 to 10 mg/kg once every 24 hours for up to 14 days.

The duration of treatment depends on the risk of complications and official recommendations. Depending on the infection being treated and whether a patient has more than one infection, other antibiotics may be given during treatment with Daptomycin Hospira.

The medicine can only be obtained with a prescription. For more information, see the package leaflet.

How does Daptomycin Hospira work?

The active substance in Daptomycin Hospira, daptomycin, is an antibiotic that belongs to the group ‘lipopeptides’. It can stop the growth of certain types of bacteria by attaching to the membrane around each bacterial cell and upsetting the essential functions that keep the cell alive. A list of bacteria against which Daptomycin Hospira is active can be found in the summary of product characteristics (also part of the EPAR).

How has Daptomycin Hospira been studied?

Studies on the benefits and risks of the active substance in the approved uses have already been carried out with the reference medicine, Cubicin, and do not need to be repeated for Daptomycin Hospira.

As for every medicine, the company provided studies on the quality of Daptomycin Hospira. There was no need for ‘bioequivalence’ studies to investigate whether Daptomycin Hospira is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood. This is because Daptomycin Hospira is given into a vein either by infusion or by injection, so the active substance is delivered straight into the bloodstream.

What are the benefits and risks of Daptomycin Hospira?

Because Daptomycin Hospira is a generic medicine, its benefits and risks are taken as being the same as the reference medicine’s.

Why is Daptomycin Hospira approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Daptomycin Hospira has been shown to be comparable to Cubicin. Therefore, the CHMP’s view was that, as for Cubicin, the benefit outweighs the identified risk. The Committee recommended that Daptomycin Hospira be approved for use in the EU.

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

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

Other information about Daptomycin Hospira

The European Commission granted a marketing authorisation valid throughout the European Union for Daptomycin Hospira on 22 March 2017.

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

Name Language First published Last updated
Daptomycin Hospira : EPAR - Summary for the public BG = bălgarski 2017-04-24  
Daptomycin Hospira : EPAR - Summary for the public ES = español 2017-04-24  
Daptomycin Hospira : EPAR - Summary for the public CS = čeština 2017-04-24  
Daptomycin Hospira : EPAR - Summary for the public DA = dansk 2017-04-24  
Daptomycin Hospira : EPAR - Summary for the public DE = Deutsch 2017-04-24  
Daptomycin Hospira : EPAR - Summary for the public ET = eesti keel 2017-04-24  
Daptomycin Hospira : EPAR - Summary for the public EL = elliniká 2017-04-24  
Daptomycin Hospira : EPAR - Summary for the public EN = English 2017-04-24  
Daptomycin Hospira : EPAR - Summary for the public FR = français 2017-04-24  
Daptomycin Hospira : EPAR - Summary for the public IT = italiano 2017-04-24  
Daptomycin Hospira : EPAR - Summary for the public LV = latviešu valoda 2017-04-24  
Daptomycin Hospira : EPAR - Summary for the public LT = lietuvių kalba 2017-04-24  
Daptomycin Hospira : EPAR - Summary for the public HU = magyar 2017-04-24  
Daptomycin Hospira : EPAR - Summary for the public MT = Malti 2017-04-24  
Daptomycin Hospira : EPAR - Summary for the public NL = Nederlands 2017-04-24  
Daptomycin Hospira : EPAR - Summary for the public PL = polski 2017-04-24  
Daptomycin Hospira : EPAR - Summary for the public PT = português 2017-04-24  
Daptomycin Hospira : EPAR - Summary for the public RO = română 2017-04-24  
Daptomycin Hospira : EPAR - Summary for the public SK = slovenčina 2017-04-24  
Daptomycin Hospira : EPAR - Summary for the public SL = slovenščina 2017-04-24  
Daptomycin Hospira : EPAR - Summary for the public FI = suomi 2017-04-24  
Daptomycin Hospira : EPAR - Summary for the public SV = svenska 2017-04-24  
Daptomycin Hospira : EPAR - Summary for the public HR = Hrvatski 2017-04-24  

This EPAR was last updated on 24/04/2017 .

Authorisation details

Product details

Product details for Daptomycin Hospira
NameDaptomycin Hospira
Agency product numberEMEA/H/C/004310
Active substance

daptomycin

International non-proprietary name (INN) or common name

daptomycin

Therapeutic area Soft Tissue InfectionsSkin Diseases, Bacterial
Anatomical therapeutic chemical (ATC) code J01XX09
Generic

A generic medicine is a medicine which is similar to a medicine that has already been authorised (the 'reference medicine'). A generic medicine contains the same quantity of active substance(s) as the reference medicine. Generic and reference medicines are used at the same dose to treat the same disease, and they are equally safe and effective.

Publication details

Publication details for Daptomycin Hospira
Marketing-authorisation holder

Hospira UK Limited

Revision0
Date of issue of marketing authorisation valid throughout the European Union22/03/2017

Contact address:

Hospira UK Limited
Horizon Honey Lane 
Maidenhead 
Hurley SL6 6RJ 
United Kingdom

Product information

Product information

22/03/2017  Daptomycin Hospira -EMEA/H/C/004310 --

Name Language First published Last updated
Daptomycin Hospira : EPAR - Product Information HR = Hrvatski 2017-04-24  
Daptomycin Hospira : EPAR - Product Information HR = Hrvatski 2017-04-24  
Daptomycin Hospira : EPAR - Product Information HR = Hrvatski 2017-04-24  
Daptomycin Hospira : EPAR - Product Information HR = Hrvatski 2017-04-24  
Daptomycin Hospira : EPAR - Product Information HR = Hrvatski 2017-04-24  
Daptomycin Hospira : EPAR - Product Information HR = Hrvatski 2017-04-24  
Daptomycin Hospira : EPAR - Product Information HR = Hrvatski 2017-04-24  
Daptomycin Hospira : EPAR - Product Information HR = Hrvatski 2017-04-24  
Daptomycin Hospira : EPAR - Product Information HR = Hrvatski 2017-04-24  
Daptomycin Hospira : EPAR - Product Information HR = Hrvatski 2017-04-24  
Daptomycin Hospira : EPAR - Product Information HR = Hrvatski 2017-04-24  
Daptomycin Hospira : EPAR - Product Information HR = Hrvatski 2017-04-24  
Daptomycin Hospira : EPAR - Product Information HR = Hrvatski 2017-04-24  
Daptomycin Hospira : EPAR - Product Information HR = Hrvatski 2017-04-24  
Daptomycin Hospira : EPAR - Product Information HR = Hrvatski 2017-04-24  
Daptomycin Hospira : EPAR - Product Information HR = Hrvatski 2017-04-24  
Daptomycin Hospira : EPAR - Product Information HR = Hrvatski 2017-04-24  
Daptomycin Hospira : EPAR - Product Information HR = Hrvatski 2017-04-24  
Daptomycin Hospira : EPAR - Product Information HR = Hrvatski 2017-04-24  
Daptomycin Hospira : EPAR - Product Information HR = Hrvatski 2017-04-24  
Daptomycin Hospira : EPAR - Product Information HR = Hrvatski 2017-04-24  
Daptomycin Hospira : EPAR - Product Information HR = Hrvatski 2017-04-24  
Daptomycin Hospira : EPAR - Product Information HR = Hrvatski 2017-04-24  
Daptomycin Hospira : EPAR - Product Information HR = Hrvatski 2017-04-24  
Daptomycin Hospira : EPAR - Product Information HR = Hrvatski 2017-04-24  

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
Daptomycin Hospira : EPAR - All Authorised presentations HR = Hrvatski 2017-04-24  
Daptomycin Hospira : EPAR - All Authorised presentations HR = Hrvatski 2017-04-24  
Daptomycin Hospira : EPAR - All Authorised presentations HR = Hrvatski 2017-04-24  
Daptomycin Hospira : EPAR - All Authorised presentations HR = Hrvatski 2017-04-24  
Daptomycin Hospira : EPAR - All Authorised presentations HR = Hrvatski 2017-04-24  
Daptomycin Hospira : EPAR - All Authorised presentations HR = Hrvatski 2017-04-24  
Daptomycin Hospira : EPAR - All Authorised presentations HR = Hrvatski 2017-04-24  
Daptomycin Hospira : EPAR - All Authorised presentations HR = Hrvatski 2017-04-24  
Daptomycin Hospira : EPAR - All Authorised presentations HR = Hrvatski 2017-04-24  
Daptomycin Hospira : EPAR - All Authorised presentations HR = Hrvatski 2017-04-24  
Daptomycin Hospira : EPAR - All Authorised presentations HR = Hrvatski 2017-04-24  
Daptomycin Hospira : EPAR - All Authorised presentations HR = Hrvatski 2017-04-24  
Daptomycin Hospira : EPAR - All Authorised presentations HR = Hrvatski 2017-04-24  
Daptomycin Hospira : EPAR - All Authorised presentations HR = Hrvatski 2017-04-24  
Daptomycin Hospira : EPAR - All Authorised presentations HR = Hrvatski 2017-04-24  
Daptomycin Hospira : EPAR - All Authorised presentations HR = Hrvatski 2017-04-24  
Daptomycin Hospira : EPAR - All Authorised presentations HR = Hrvatski 2017-04-24  
Daptomycin Hospira : EPAR - All Authorised presentations HR = Hrvatski 2017-04-24  
Daptomycin Hospira : EPAR - All Authorised presentations HR = Hrvatski 2017-04-24  
Daptomycin Hospira : EPAR - All Authorised presentations HR = Hrvatski 2017-04-24  
Daptomycin Hospira : EPAR - All Authorised presentations HR = Hrvatski 2017-04-24  
Daptomycin Hospira : EPAR - All Authorised presentations HR = Hrvatski 2017-04-24  
Daptomycin Hospira : EPAR - All Authorised presentations HR = Hrvatski 2017-04-24  
Daptomycin Hospira : EPAR - All Authorised presentations HR = Hrvatski 2017-04-24  
Daptomycin Hospira : EPAR - All Authorised presentations HR = Hrvatski 2017-04-24  

Pharmacotherapeutic group

Antibacterials for systemic use

Therapeutic indication

Daptomycin is indicated for the treatment of the following infections (see sections 4.4 and 5.1):

  • Adult and paediatric (1 to 17 years of age) patients with complicated skin and soft-tissue infections (cSSTI).
  • Adult patients with right-sided infective endocarditis (RIE) due to Staphylococcus aureus. It is recommended that the decision to use daptomycin should take into account the antibacterial susceptibility of the organism and should be based on expert advice. (see sections 4.4 and 5.1).
  • Adult patients with Staphylococcus aureus bacteraemia (SAB) when associated with RIE or with cSSTI.

Daptomycin is active against Gram positive bacteria only (see section 5.1). In mixed infections where Gram negative and/or certain types of anaerobic bacteria are suspected, daptomycin should be co-administered with appropriate antibacterial agent(s).

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

Initial marketing-authorisation documents

Name Language First published Last updated
Daptomycin Hospira : EPAR - Public assessment report HR = Hrvatski 2017-04-24  
CHMP summary of positive opinion for Daptomycin Hospira HR = Hrvatski 2017-01-27  

Authorised

This medicine is approved for use in the European Union