Daptomycin Hospira

RSS

daptomycin

Authorised
This medicine is authorised for use in the European Union.

Overview

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

  • complicated infections of the skin and ‘soft tissue’ below the skin in patients from 1 year of age. ‘Complicated’ means that the infection is difficult to treat, because it has spread to the deep tissues below the skin, treatment with surgery might be needed, or the patient has other conditions that might affect how well treatment works;
  • right-sided infective endocarditis (infection of the lining or the valves of the right side of the heart) caused by the bacterium Staphylococcus aureus ( 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 aureus. It is used in adults, when the bacteraemia is associated with either of the two infections above, or in adolescents and children from 1 year of age when the bacteraemia is associated with complicated infections of the skin and soft tissue.

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

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. For more information on generic medicines, see 'Related content'.

This EPAR was last updated on 08/01/2020

Authorisation details

Product details
Name
Daptomycin Hospira
Agency product number
EMEA/H/C/004310
Active substance
daptomycin
International non-proprietary name (INN) or common name
daptomycin
Therapeutic area (MeSH)
  • Soft Tissue Infections
  • Skin Diseases, Bacterial
Anatomical therapeutic chemical (ATC) code
J01XX09
GenericGeneric

This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

Publication details
Marketing-authorisation holder
Pfizer Europe MA EEIG
Revision
7
Date of issue of marketing authorisation valid throughout the European Union
22/03/2017
Contact address

Boulevard de la Plaine 17
1050 Bruxelles
Belgium

Product information

02/12/2019 Daptomycin Hospira - EMEA/H/C/004310 - N/0012

Contents

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Pharmacotherapeutic group

Antibacterials for systemic use

Therapeutic indication

Daptomycin is indicated for the treatment of the following infections.

  • 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 isrecommended that the decision to use daptomycin should take into account the antibacterial susceptibility of the organism and should be based on expert advice.
  • Adult and paediatric (1 to 17 years of age) patients with Staphylococcus aureus bacteraemia (SAB).

In adults, use in bacteraemia should be associated with RIE or with cSSTI, while in paediatric patients, use in bacteraemia should be associated with cSSTI.

Daptomycin is active against Gram positive bacteria only. 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

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