Special Warning : אזהרת שימוש

4.4       Special warnings and precautions for use

Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have occurred in patients receiving beta-lactam antibiotics. Before therapy with Doribax is started, careful inquiry should be made concerning a previous history of hypersensitivity reactions to other active substances in this class or to beta-lactam antibiotics. Doribax should be used with caution in patients with such a history.
Should a hypersensitivity reaction to Doribax occur, it should be discontinued immediately and appropriate measures taken. Serious acute hypersensitivity (anaphylactic) reactions require immediate emergency treatment.

Seizures have infrequently been reported during treatment with other carbapenems.

Pseudomembranous colitis due to Clostridium difficile has been reported with Doribax as with nearly all anti-bacterial agents and may range in severity from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhoea during or subsequent to the administration of Doribax (see section 4.8).

Administration of doripenem, like other antibiotics, has been associated with emergence and selection of strains with reduced susceptibility. Patients should be carefully monitored during therapy. If superinfection occurs, appropriate measures should be taken. Prolonged use of Doribax should be avoided.

The concomitant use of doripenem and valproic acid/sodium valproate is not recommended (see section 4.5).


When Doribax was used investigationally via inhalation, pneumonitis occurred. Therefore, Doribax should not be administered by this route.

Description of the patient population treated in clinical studies

In two clinical trials of patients with complicated intra-abdominal infections (N=962) the most common anatomical site of infection in microbiologically-evaluable Doribax-treated patients was the appendix (62%). Of these, 51% had generalised peritonitis at baseline. Other sources of infection Doribax PI_09 2014
included colon perforation (20%), complicated cholecystitis (5%) and infections at other sites (14%).
Eleven percent had an APACHE II score of >10, 9.5% had post-operative infections, 27% had single or multiple intra-abdominal abscesses and 4% had concurrent bacteraemia at baseline.

In two clinical trials of patients with complicated urinary tract infections (N=1179), 52% of microbiologically-evaluable Doribax-treated patients had complicated lower urinary tract infections and 48% had pyelonephritis, of which 16% were complicated. Overall, 54% of patients had a persistent complication, 9% had concurrent bacteraemia and 23% were infected with a levofloxacin resistant uropathogen at baseline.

The experience in patients who are severely immunocompromised, receiving immunosuppressive therapy, and patients with severe neutropenia is limited since this population was excluded from phase 3 trials.

Effects on Driving

4.7    Effects on ability to drive and use machines

No studies on the effects of Doribax on the ability to drive and use machines have been performed.
Based on reported adverse drug reactions, it is not anticipated that Doribax will affect the ability to drive and use machines.



Doribax PI_09 2014