Characteristics of the medicinal product
INVANZ is a bottle containing a white powder to be dissolved before use to make up a solution for infusion (drip into a vein). INVANZ contains the active ingredient ertapenem.
Therapeutic indications
INVANZ is an antibiotic used to treat infections such as abdominal infections, community-acquired pneumonia (the term "community-acquired" [CAP] means that the infection has been contracted outside the hospital), gynecological infections, foot infections in the diabetic patients. INVANZ can be used in adults and children (from 3 months of age).
INVANZ is prescribed when the antibiotic is likely to neutralize the bacteria responsible for infections. Before using INVANZ, the doctor must consult an official guide on the correct use of antibiotics.
The medicine can only be obtained with a prescription.
Method of use
In adults and adolescents the dosage of INVANZ is 1 gram given once a day. In children (aged 3 months to 12 years) the medicine is given twice a day and the dosage changes according to the weight of the child (15 mg / kg body weight). Infusion should be performed within 30 minutes. INVANZ therapy lasts 3 to 14 days, depending on the type and severity of the infection. If conditions improve, you can switch to an oral antibiotic. INVANZ cannot be used in patients with severe kidney problems, including dialysis patients.
Mechanisms of action
The active substance of INVANZ, the œpenpenem, is an antibiotic belonging to the group of so-called "carbapenems". It works by binding to certain proteins on the surface of bacterial cells, thereby interfering with the vital functions of cells and neutralizing bacteria. The summary of product characteristics includes the list of bacteria to which INVANZ is active.
Studies carried out
The effects of INVANZ were first tested in experimental models before being studied in humans.
The use of INVANZ in the treatment of infections in adults has been compared with that of other antibiotics: it has been 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), gynecological (412 patients) and in infections of the skin and soft tissues (infections of the skin and tissues immediately below the skin: 540 patients; diabetic foot infections: 576 patients). The studies carried out on children concerned the same kind of infections and the medicines used for the comparison were ceftriaxone (CAP: 389 children) and ticarcillin / clavulanate (intra-abdominal infections: 105 children). The aim of the studies was generally to examine whether the infection was resolved in the days following the treatment (cure test: 7 to 28 days after treatment, depending on the type of infection).
Benefits found following the studies
INVANZ was as effective as ceftriaxone or piperacillin / tazobactam in abdominal infections, community-acquired pneumonia, gynecological infections and diabetic foot infections: ie the same treatment rates were obtained with both INVANZ and the medicine used for comparison (between 87% and 94% for INVANZ compared to 83-92% for comparative medicines). However, the data presented were not sufficient to justify the use of INVANZ in the treatment of urinary tract infections and skin and soft tissue infections, except for diabetic foot ulcers. In children the efficacy of the medicine was comparable to that of the comparator medicines and to the efficacy observed in adults.
Associated risks
The main side effects of INVANZ (seen in between 1 and 10 patients in 100) are headache, diarrhea, nausea, vomiting, erythema (including diaper rash in children), itching and disorders (including pain) at the injection site of medicine. INVANZ also affects the results of some blood tests. For the full list of all side effects reported with INVANZ, see the Package Leaflet.
INVANZ should not be used in people who may be hypersensitive (allergic) to alertenem or to any of the excipients, or to other antibiotics in the same group (carbapenem). Use should also be avoided in patients who are severely allergic to other types of antibiotics such as penicillins or cephalosporins.
Grounds for approval
The Committee for Medicinal Products for Human Use (CHMP) concluded that INVANZ has shown (despite the limited number of severe cases treated during the trials) to be effective in the treatment of abdominal infections, community-acquired pneumonia, gynecological infections and diabetic foot infections. The CHMP also concluded that the medicine is effective in children. The CHMP decided that INVANZ's benefits are greater than its risks and therefore recommended that it be given marketing authorization.
Further information
On 18 April 2002, the European Commission granted a marketing authorization valid throughout the European Union for INVANZ to Merck Sharp & Dohme Limited.
The full version of the EPAR is available here.
Last update of this summary: March 2006
