Basic Information
Ertapenem SUN
Regulatory Information
EMEA/H/C/005815
July 15, 2022
May 19, 2022
2
April 3, 2024
Company Information
the netherlands
Polarisavenue 87 2132JH Hoofddorp
Sun Pharmaceutical Industries (Europe) B.V.
Drug Classification
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### 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.
Overview Summary
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](https://www.ema.europa.eu/en/documents/medicine-qa/questions-answers-generic-medicines_en.pdf). Ertapenem SUN contains the active substance ertapenem.