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United States: FDA issues new dosing guidance for children using Valcyte(English Only)
 
The United States Food and Drug Administration (FDA) notifies health care professionals of updated dosing recommendations for Valcyte (valganciclovir) oral tablets and solution used by children and adolescents receiving a kidney or heart transplant. The update is intended to prevent drug overdosing of children with low body weight, low body surface area, and very low serum creatinine. The revised dosing instructions now appear in the product’s label. Valcyte is an antiviral agent and in US, the medication can be used for the prevention of cytomegalovirus (CMV) disease in children from 4 months to 16 years of age who have undergone a kidney or heart transplant and who are at a higher risk of getting the disease.

Please refer to the following website in FDA for details:
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm225887.htm

In Hong Kong, only Valcyte Tablet is registered by Roche Hong Kong Ltd. It is not indicated for use in children and adolescents.


Ends/Thursday, September 16, 2010
Issued at HKT 12:30
 
 
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