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December 19, 2011 - Importance of Visual Inspection of Dilution Agent Torisel
Following on from
previous reports about Ben Venue Laboratories (BVL), the
company Pfizer B.V. has sent a letter to doctors and pharmacists.
It is important to inspect the contents of the vial with dilution
agent – present in the packaging temserolimus (Torisel) – closely
before use. This will allow timely detection of possible
contamination with particulate matter. The dilution agent should
not contain any particles that are visible to the naked eye.
This was written in a
letter – a so-called Direct Healthcare Professional
Communication (DHPC) – from the company Pfizer B.V. This letter
with important safety information was sent to oncologists,
haematologists, urologists and pharmacists in consultation with the
Medicines Evaluation Board (MEB) and the Healthcare
Inspectorate.
Temserolimus is used in the treatment of advanced kidney cell
cancer and mantle cell lymphoma if the lymphoma has returned after
previous treatment or has not responded to other forms of
treatment.
The recognition and analysis of adverse events during the entire
life cycle of a medicine is called medicine monitoring or
pharmacovigilance. This is a key task of the MEB. In the event of
urgent and/or important safety issues, medical professionals are
informed by means of a
Direct Healthcare Professional Communication.
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