Daptomycin Hospira
Authorised
This medicine is authorised for use in the European Union
daptomycin
MedicineHumanAuthorised
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'.
Daptomycin Hospira is given by infusion (drip) into a vein.
In adults, for skin or soft tissue infections without bacteraemia, Daptomycin Hospira is given at a dose of 4 mg/kg body weight once a day. For endocarditis and for skin or soft tissue infection with bacteraemia, the dose is 6 mg/kg once a day. Daptomycin Hospira is given into a vein as an infusion lasting 30 minutes or as an injection lasting 2 minutes.
In children, the dose of Daptomycin Hospira for skin or soft tissue infection without bacteraemia depends on the child’s age and ranges between 5 and 10 mg/kg body weight once a day. Higher doses (between 7 and 12 mg/kg once a day) are used if the skin or soft tissue infection is associated with bacteraemia. Daptomycin Hospira is given by infusion lasting 60 minutes in children aged 1 to 6 years and 30 minutes in those aged above 7 years.
The duration of treatment with Daptomycin Hospira depends on the risk of complications and official recommendations.
The medicine can only be obtained with a prescription. For more information about using Daptomycin Hospira, see the package leaflet or contact your doctor or pharmacist.
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 surrounding the bacterial cell and upsetting the essential functions that keep the cell alive.
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, so the active substance is delivered straight into the bloodstream.
Because Daptomycin Hospira is a generic medicine, its benefits and risks are taken as being the same as the reference medicine’s.
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.
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. In addition, the company will also provide a leaflet for laboratories explaining how to test to see if an infection is likely to respond to the medicine.
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.
Daptomycin Hospira received a marketing authorisation valid throughout the EU on 22 March 2017.
Product information
Latest procedure affecting product information: IB/0020
25/03/2022
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Daptomycin Hospira
- 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
Pharmacotherapeutic group
Antibacterials for systemic useTherapeutic 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.
News on Daptomycin Hospira
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