GSK UK has written to health care professionals to highlight that the rotavirus vaccine [Rotarix] should be administered
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■ GSK UK has written to health care professionals to highlight that the rotavirus vaccine [Rotarix] should be administered orally. The company points out that unlike most other vaccines, Rotarix is given orally, with an applicator that resembles a syringe. GSK says it has received 20 reports worldwide describing the wrong route of administration of Rotarix (the vaccine was injected intramuscularly or subcutaneously). The company says there have been 6 non-serious adverse events reported from outside the EU in association with the improper route of administration of Rotarix. These reports described reactions that were mild, such as local erythema. All reactions were reported on the day of vaccination and did not persist beyond 24 hours. GSK is reinforcing the product information and labelling of Rotarix accordingly. GlaxoSmithKline. Important information regarding correct route of administration of oral vaccine (Rotarix TM). Company Communication : [1 801013748 page], Oct 2006. Available from: URL: http://www.mhra.gov.uk
0114-9954/10/1127-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved
Reactions 11 Nov 2006 No. 1127
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