Ertapenem SUN
Authorised
This medicine is authorised for use in the European Union
ertapenem
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Ertapenem SUN is an antibiotic. It is used in adults and children over 3 months of age to treat:
- infections within the abdomen;
- community-acquired pneumonia (infection of the lungs caught away from hospital);
- gynaecological infections;
- foot infections in diabetes patients.
Ertapenem SUN is also used in adults to prevent infection after colorectal surgery (surgery in the lower part of the bowel, including the rectum).
Ertapenem SUN is used when the bacteria that cause the infection are likely to be killed by the antibiotic. Before using Ertapenem SUN, doctors should consider official guidance on the appropriate use of antibiotics.
Ertapenem SUN is a ‘generic medicine’. This means that Ertapenem SUN contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU called Invanz. For more information on generic medicines, see the question-and-answer document here.
Ertapenem SUN contains the active substance ertapenem.
Ertapenem SUN is available as a vial containing a powder which is dissolved before use to make up a solution for infusion (drip) into a vein. It is infused over 30 minutes. The medicine can only be obtained with a prescription.
Ertapenem SUN is given at a dose of 1 g once a day in adults and adolescents. For younger patients (3 months to 12 years), a dose of 15 mg per kilogram body weight is given twice a day, up to a total of 1 g per day. Treatment with Ertapenem SUN lasts between 3 and 14 days, depending on the type and the severity of the infection. Once the infection has improved, treatment can be switched to an antibiotic that can be given by mouth.
For preventing infection after colorectal surgery in adults, a single dose of Ertapenem SUN is given within 1 hour before the operation.
For more information about using Ertapenem SUN, see the package leaflet or contact your doctor or pharmacist.
The active substance in Ertapenem SUN, ertapenem, belongs to the group of antibiotics known as ‘carbapenems’. It attaches to certain proteins on the bacteria cells. This upsets the essential functions that keep these cells alive, and so kills the bacteria. Ertapenem SUN can work on a range of different bacteria.
Studies on the benefits and risks of the active substance in the authorised use have already been carried out with the reference medicine, Invanz, and do not need to be repeated for Ertapenem SUN.
As for every medicine, the company provided studies on the quality of Ertapenem SUN. There was no need for ‘bioequivalence’ studies to investigate whether Ertapenem SUN is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood. This is because Ertapenem SUN is given by infusion into a vein, so the active substance is delivered straight into the bloodstream.
Because Ertapenem SUN is a generic medicine and is bioequivalent to the reference 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, Ertapenem SUN has been shown to have comparable quality and to be bioequivalent to Invanz. Therefore, the Agency’s view was that, as for Invanz, the benefits of Ertapenem SUN outweigh the identified risks and it can be authorised for use in the EU.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ertapenem SUN have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Ertapenem SUN are continuously monitored. Suspected side effects reported with Ertapenem SUN are carefully evaluated and any necessary action taken to protect patients.
Ertapenem SUN received a marketing authorisation valid throughout the EU on 15 July 2022
This overview was last updated in 09-2022
Product information
Latest procedure affecting product information:
N/0003
02/04/2024
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
- Ertapenem SUN
- Active substance
- ertapenem sodium
- International non-proprietary name (INN) or common name
- ertapenem
- Therapeutic area (MeSH)
- Bacterial Infections
Pharmacotherapeutic group
ertapenemTherapeutic indication
Treatment
Ertapenem SUN is indicated in paediatric patients (3 months to 17 years of age) and in adults for the treatment of the following infections when caused by bacteria known or very likely to be susceptible to ertapenem and when parenteral therapy is required (see sections 4.4 and 5.1):
- Intra-abdominal infections
- Community acquired pneumonia
- Acute gynaecological infections
- Diabetic foot infections of the skin and soft tissue (see section 4.4)
Prevention
Ertapenem SUN is indicated in adults for the prophylaxis of surgical site infection following elective colorectal surgery (see section 4.4).
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
News on Ertapenem SUN
This page was last updated on