Ertapenem SUN
ertapenem
Table of contents
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.
-
List item
Ertapenem SUN : EPAR - Medicine Overview (PDF/167.1 KB)
First published: 30/09/2022
EMEA/H/C/005815 -
-
List item
Ertapenem SUN : EPAR - Risk Management Plan summary (PDF/212.12 KB)
First published: 30/09/2022
Authorisation details
| Product details | |
|---|---|
| Name |
Ertapenem SUN
|
| Agency product number |
EMEA/H/C/005815
|
| Active substance |
ertapenem sodium
|
| International non-proprietary name (INN) or common name |
ertapenem
|
| Therapeutic area (MeSH) |
Bacterial Infections
|
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 |
SUN Pharmaceutical Industries (Europe) B.V.
|
| Date of issue of marketing authorisation valid throughout the European Union |
15/07/2022
|
| Contact address |
Polarisavenue 87
2132JH Hoofddorp The Netherlands |
Product information
19/05/2022 Ertapenem SUN - EMEA/H/C/005815 -
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).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
Therapeutic 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.