Wednesday, September 29, 2010

Defect in PegIntron Redipen single dose delivery

Hong Kong: Alert on sealing defect in PegIntron Redipen single dose delivery system

Submitted by editor on September 25, 2010 - 20:30

The Department of Health (DH) was yesterday (September 24) informed by Schering-Plough SOL Limited (Schering-Plough), the registration holder of a drug delivery system PegIntron Redipen, of a sealing defect involving glass cartridges in the system.

PegIntron Redipen is a single-dose delivery system to deliver peginterferon alfa-2b, a prescription drug used for the treatment of hepatitis C.There are 5 registered preparations in Hong Kong: PegIntron Redipen 50mcg per 0.5ml (HK-55115), PegIntron Redipen 80mcg per 0.5ml (HK-55119), PegIntron Redipen 100mcg per 0.5ml (HK-55118), PegIntron Redipen 120mcg per 0.5ml (HK-55117) and PegIntron Redipen 150mcg per 0.5ml (HK-55116).
According to Schering-Plough, the defect is related to individual Redipen device and it may affect the product quality, with possible safety consequence.

Based on available information in hand, it is estimated that the defect occurred with a frequency of about 3 in 20,000.
Records in Schering-Plough showed that the products have been supplied to 10 medical practitioners and three local hospitals.Due to the low prevalence of the defect and no readily available stock replacement, Schering-Plough proposed to send medical representatives to visit all involved doctors and hospitals to inspect their stock before being utilised.Healthcare professionals should only administer the products to patients after Schering-Plough has confirmed that their products are satisfactory.

After risk assessment, DH endorsed the above proposal.Meanwhile, DH is also liaising with leading overseas authorities about the issue and will continue to monitor the wholesaler¦s inspection.

Schering-Plough has set up a hotline, 3791 2987, for public enquiries.
Patients should consult healthcare professionals if in doubt, he said.

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