Dear Healthcare Professional Letter on new recomendations related to antibiotic profilaxis in patients with a transplanted organ for which perfusion the solution ViaSpan has been used
17.04.2012
Agency for Medicinal Products and Medical Devices (HALMED) has sent out a letter to health care professionals on new recomendations related to the antibiotic profilaxis in patients with a transplaned organ for which perfusion the ViaSpan has been used.
Certain batches of the ViaSpan solution for organ perfusion were withdrawn from the Croatian market in March 2012, what was communicated in a letter (in Croatian) to healtcare professionals sent by the product supplier Pharmaswiss d.o.o. in collaboration with HALMED. In that letter, recomendations to healthcare professionals related to empiric treatment of infections caused by Bacillus stereus were provided .
In April 2012, the Ministry of Health informed HALMED on results of sensitivity testing of the aforesaid pathogene, performed by the British Health Protection Agency (HPA) and forwarded by DG SANCO (Directorate -General for Health and Consumers).
Recomendations to healtcare professionals
In vitro tests performed by HPA on isolates of B. cereus from contaminated lines demonstrate that the bacteria is resistant to penicillin and vancomycin and susceptible to ciprofloxacin, meropenem and gentamicin.
When prescribing the aforementioned medicines, it should be taken into account that:
- gentamicin is usualy not acceptable as monotherapy
- meropenem is higly active in vitro, however there are fears from resistance development (linked to a strain)
- ciprofloxacin is also higly active in vitro, not always a treatment of choice for children, though.
Here you can find the Dear Healtcare Professionals Letter (in Croatian)
HALMED has not received any report of either an adverse drug reaction or infection in patients with a transplanted organ, for which perfusion the solution ViaSpan has been used.
We remind healtcare professionals that they are required to report to HALMED any adverse reaction they observe. Patients who have developed any adverse drug reaction may report it directly to HALMED, however we recomand that patients who observe any adverse reaction, consult their doctor or pharmacist on continuation of their therapy.
