Daptomycin Hospira
daptomycin
Table of contents
Overview
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.
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) |
|
| Anatomical therapeutic chemical (ATC) code |
J01XX09
|
Generic |
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 |
5
|
| Date of issue of marketing authorisation valid throughout the European Union |
22/03/2017
|
| Contact address | |
Product information
09/04/2019 Daptomycin Hospira - EMEA/H/C/004310 - N/0010
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
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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.