Daptomycin Hospira

daptomycin

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An overview of Daptomycin Hospira and why it is authorised in the EU

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

  • complicated infections of the skin and the ‘soft tissues’ below the skin. ‘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). 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.

Daptomycin Hospira contains the active substance daptomycin. It 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. The medicine 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.

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 authorised 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 authorised in the EU?

The European Medicines Agency concluded that, in accordance with EU requirements, Daptomycin Hospira has been shown to be comparable to Cubicin. Therefore, the Agency’s view was that, as for Cubicin, the benefit of Daptomycin Hospira outweighs the identified risk and it can be authorised for use in the EU.

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

The company that markets Daptomycin Hospira will provide all doctors who are expected to use this medicine with a dosage card to ensure the safe 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 also been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Daptomycin Hospira are continuously monitored. Side effects reported with Daptomycin Hospira are carefully evaluated and any necessary action taken to protect patients.

Other information about Daptomycin Hospira

Daptomycin Hospira received a marketing authorisation valid throughout the EU on 22 March 2017.

Name Language First published Last updated
Daptomycin Hospira : EPAR - Medicine overview BG = bălgarski 2017-04-24 2018-04-18
Daptomycin Hospira : EPAR - Medicine overview ES = español 2017-04-24 2018-04-18
Daptomycin Hospira : EPAR - Medicine overview CS = čeština 2017-04-24 2018-04-18
Daptomycin Hospira : EPAR - Medicine overview DA = dansk 2017-04-24 2018-04-18
Daptomycin Hospira : EPAR - Medicine overview DE = Deutsch 2017-04-24 2018-04-18
Daptomycin Hospira : EPAR - Medicine overview ET = eesti keel 2017-04-24 2018-04-18
Daptomycin Hospira : EPAR - Medicine overview EL = elliniká 2017-04-24 2018-04-18
Daptomycin Hospira : EPAR - Medicine overview EN = English 2017-04-24 2018-04-18
Daptomycin Hospira : EPAR - Medicine overview FR = français 2017-04-24 2018-04-18
Daptomycin Hospira : EPAR - Medicine overview IT = italiano 2017-04-24 2018-04-18
Daptomycin Hospira : EPAR - Medicine overview LV = latviešu valoda 2017-04-24 2018-04-18
Daptomycin Hospira : EPAR - Medicine overview LT = lietuvių kalba 2017-04-24 2018-04-18
Daptomycin Hospira : EPAR - Medicine overview HU = magyar 2017-04-24 2018-04-18
Daptomycin Hospira : EPAR - Medicine overview MT = Malti 2017-04-24 2018-04-18
Daptomycin Hospira : EPAR - Medicine overview NL = Nederlands 2017-04-24 2018-04-18
Daptomycin Hospira : EPAR - Medicine overview PL = polski 2017-04-24 2018-04-18
Daptomycin Hospira : EPAR - Medicine overview PT = português 2017-04-24 2018-04-18
Daptomycin Hospira : EPAR - Medicine overview RO = română 2017-04-24 2018-04-18
Daptomycin Hospira : EPAR - Medicine overview SK = slovenčina 2017-04-24 2018-04-18
Daptomycin Hospira : EPAR - Medicine overview SL = slovenščina 2017-04-24 2018-04-18
Daptomycin Hospira : EPAR - Medicine overview FI = suomi 2017-04-24 2018-04-18
Daptomycin Hospira : EPAR - Medicine overview SV = svenska 2017-04-24 2018-04-18
Daptomycin Hospira : EPAR - Medicine overview HR = Hrvatski 2017-04-24 2018-04-18

This EPAR was last updated on 18/04/2018 .

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

Revision2
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

13/04/2018  Daptomycin Hospira -EMEA/H/C/004310 -IB/0007

Name Language First published Last updated
Daptomycin Hospira : EPAR - Product Information HR = Hrvatski 2017-04-24 2018-04-18
Daptomycin Hospira : EPAR - Product Information HR = Hrvatski 2017-04-24 2018-04-18
Daptomycin Hospira : EPAR - Product Information HR = Hrvatski 2017-04-24 2018-04-18
Daptomycin Hospira : EPAR - Product Information HR = Hrvatski 2017-04-24 2018-04-18
Daptomycin Hospira : EPAR - Product Information HR = Hrvatski 2017-04-24 2018-04-18
Daptomycin Hospira : EPAR - Product Information HR = Hrvatski 2017-04-24 2018-04-18
Daptomycin Hospira : EPAR - Product Information HR = Hrvatski 2017-04-24 2018-04-18
Daptomycin Hospira : EPAR - Product Information HR = Hrvatski 2017-04-24 2018-04-18
Daptomycin Hospira : EPAR - Product Information HR = Hrvatski 2017-04-24 2018-04-18
Daptomycin Hospira : EPAR - Product Information HR = Hrvatski 2017-04-24 2018-04-18
Daptomycin Hospira : EPAR - Product Information HR = Hrvatski 2017-04-24 2018-04-18
Daptomycin Hospira : EPAR - Product Information HR = Hrvatski 2017-04-24 2018-04-18
Daptomycin Hospira : EPAR - Product Information HR = Hrvatski 2017-04-24 2018-04-18
Daptomycin Hospira : EPAR - Product Information HR = Hrvatski 2017-04-24 2018-04-18
Daptomycin Hospira : EPAR - Product Information HR = Hrvatski 2017-04-24 2018-04-18
Daptomycin Hospira : EPAR - Product Information HR = Hrvatski 2017-04-24 2018-04-18
Daptomycin Hospira : EPAR - Product Information HR = Hrvatski 2017-04-24 2018-04-18
Daptomycin Hospira : EPAR - Product Information HR = Hrvatski 2017-04-24 2018-04-18
Daptomycin Hospira : EPAR - Product Information HR = Hrvatski 2017-04-24 2018-04-18
Daptomycin Hospira : EPAR - Product Information HR = Hrvatski 2017-04-24 2018-04-18
Daptomycin Hospira : EPAR - Product Information HR = Hrvatski 2017-04-24 2018-04-18
Daptomycin Hospira : EPAR - Product Information HR = Hrvatski 2017-04-24 2018-04-18
Daptomycin Hospira : EPAR - Product Information HR = Hrvatski 2017-04-24 2018-04-18
Daptomycin Hospira : EPAR - Product Information HR = Hrvatski 2017-04-24 2018-04-18
Daptomycin Hospira : EPAR - Product Information HR = Hrvatski 2017-04-24 2018-04-18

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 in adults (see sections 4.4 and 5.1):

  • Adult 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
Daptomycin Hospira : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 2018-02-26 2018-04-18

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

More information on Daptomycin Hospira