Torisel 30 mg concentrate and diluent for solution for infusion – information about the observed deviation at revalidation of the cleaning procedure
06.08.2012
Pfizer Croatia d.o.o. company has informed HALMED that a deviation at the revalidation of the cleaning procedure in the manufacturing site Ben Venue laboratories, OHIO, USA has been observed, which means that a presence of residual substances from the filling and cleaning procedure carried out in this manufacturing site has been notified.
Bearing in mind that until July 2010 in the aforementioned manufacturing site the diluent of the medicinal product Torisel 30 mg concentrate and diluent for solution for transfusion (temsirolimus) was produced, it cannot be excluded that the batches of the aforementioned product AG48/1X and AGBV/1F that had been released on the Croatian market as well as a larger number of other batches released in other countries, are not impacted by this deviation.
The manufacturer has carried out an initial risk assessment and based on calculations, determined that quantities of residual substances that may be potentially found in batches manufactured in this manufacturing site, may be far lower than quantities of residuals in medicinal products set out in regulatory guidelines.
Torisel is indicated as a first line treatment of patients with the advanced carcinoma of kidney cells in which there are at least three out of six prognostic risk factors and for treatment of adult patients with relapsed refractory lymphoma of mantle cells. Torisel is administered through intravenous infusion under medical supervision in health care settings.
HALMED has not received any report on quality defects or adverse reaction to Torisel. HALMED will continue to monitor the safe use of the medicinal product Torisel and inform the public about any new information.
We remind healthcare professionals that they should report any adverse reaction to HALMED, as well as quality defect. Patients who have developed any adverse reaction to medicinal product may report it directly to HALMED via form or on-line application, with recommendation regarding any adverse reaction they discover to consult with their doctor or pharmacist about the continuation of their therapy.
