Invanz

ertapenem

This is a summary of the European public assessment report (EPAR) for Invanz. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Invanz.

What is Invanz?

Invanz is a medicine that contains the active substance ertapenem. It is available as a vial containing a powder which is dissolved before use to make up a solution for infusion (drip into a vein).

What is Invanz used for?

Invanz is an antibiotic. It is used in adults and children from the age of 3 months to treat the following infections:

• infections within the abdomen;
• community-acquired pneumonia (infection of the lungs – community-acquired means that the infection has been caught outside of hospital);
• gynaecological infections;
• foot infections in diabetes patients.

Invanz is used when the bacteria that cause the infection are likely to be killed by the antibiotic. Before using Invanz, doctors should consider official guidance on the appropriate use of antibiotics.

The medicine can only be obtained with a prescription.

How is Invanz used?

When given to adults and adolescents, Invanz is given at a dose of 1 g once a day. For younger patients (3 months to 12 years), it is given twice a day, and the dose is based on the weight of the patient (15 mg per kilogram body weight) but must not exceed 1 g per day. The infusion should last 30 minutes. The treatment lasts between three and 14 days, depending on the type and the severity of the infection. Once the infection has improved, the patient’s treatment can be switched to an oral antibiotic.

How does Invanz work?

The active substance in Invanz, ertapenem, is an antibiotic that belongs to the group known as ‘carbapenems’. It acts by attaching to certain types of proteins on the surface of the bacteria cells. This upsets the essential functions that keep the cell alive, and kills the bacteria. The list of bacteria against which Invanz is active can be found in the summary of product characteristics (also part of the EPAR).

How has Invanz been studied?

For the treatment of infections in adults, Invanz was compared with ceftriaxone in community-acquired pneumonia (866 patients) and urinary tract infections (592 patients), and with a combination of piperacillin and tazobactam in abdominal infections (655 patients), gynaecological infections (412 patients) and skin and soft tissues infections (infections of the skin and the tissues just below the skin, 540 patients; and diabetic foot infections, 576 patients). In studies in children, Invanz was compared with ceftriaxone (community-acquired pneumonia, 389 children) and ticarcillin/clavulanate (intra-abdominal infections, 105 children). The studies examined if the infection was cured in the days following treatment (7 to 28 days after treatment depending on the type of infection).

What benefit has Invanz shown during the studies?

Invanz was as effective as ceftriaxone or piperacillin/tazobactam for the treatment of abdominal infections, community-acquired pneumonia, gynaecological infections and diabetic foot infections: the same cure rates were reached for both Invanz and the comparator medicine (between 87 and 94% for Invanz, against 83 to 92% for the comparators). However, the data presented were not sufficient to support the use of Invanz in the treatment of urinary tract infections and skin and soft tissue infections, except diabetic foot ulcers. In children, its effectiveness was comparable to that of the comparators, and to the effectiveness seen in adults.

What is the risk associated with Invanz?

The most common side effects with Invanz (seen between 1 and 10 patients in 100) are headache, diarrhoea, nausea (feeling sick), vomiting, rash (including nappy rash in children), itching, problems at the site where the medicine was infused (including pain and inflammation of the vein). Invanz also has an effect on some blood tests. For the full list of all side effects reported with Invanz, see the package leaflet.

Invanz must not be used in people who are hypersensitive (allergic) to ertapenem or any of the other ingredients, or to other antibiotics of the same group (carbapenems). Its use must also be avoided in patients who are severely allergic to other types of antibiotics, such as penicillins or cephalosporins.

Why has Invanz been approved?

The CHMP concluded that the Invanz had shown its effectiveness, albeit with a limited number of severe cases treated during the studies in the treatment of abdominal infections, community-acquired pneumonia, gynaecological infections and diabetic foot infections. The Committee concluded that it also was effective in children. The Committee decided that Invanz’s benefits are greater than its risks and recommended that it be given marketing authorisation.

Other information about Invanz

The European Commission granted a marketing authorisation valid throughout the European Union for Invanz on 18 April 2002.

For more information about treatment with Invanz, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This EPAR was last updated on 08/03/2012 .

More detail is available in the summary of product characteristics

Product details

Publication details

Product information

01/02/2012  Invanz -EMEA/H/C/000389 -N/0039

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

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Antibacterials for systemic use

Therapeutic indication

Treatment
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 section 4.4 and section 5.1

• Intra-abdominal infections
• Community acquired pneumonia
• Acute gynaecological infections
• Diabetic foot infections of the skin and soft tissue (see section 4.4)

Changes since initial authorisation of medicine

Initial marketing-authorisation documents