is may include upper respiratory tract
infection, ear infection, fever, and runny nose. In children born with
heart problems, Synagis was associated with reports of low blood oxygen
levels and abnormal heart rhythms. Synagis should not be used in patients
with a history of a severe prior reaction to Synagis or its components.
Side effects, such as, skin reactions around the area where the shot was
given (like redness, swelling, warmth, or discomfort) can also occur.
The pivotal trial for Synagis was called the IMpact trial and comprised
a total of 1,502 children who were randomized (500 placebo, 1,002 Synagis)
in a double-blind, placebo-controlled protocol where 1,486 children
completed the study's follow-up.
In the IMpact trial, monthly prophylaxis with Synagis via intramuscular
injections was associated with a 55-percent reduction in hospitalization as
a result of RSV (p=<0.001). Reductions were observed in both children with
bronchopulmonary dysplasia (38 percent reduction) and premature children
without BPD (78 percent reduction). Approximately 50 percent of the
children in the analysis had BPD.
For full prescribing information for Synagis, see the company's website
at: http://www.medimmune.com/products/synagis/index.asp.
About MedImmune
MedImmune strives to provide better medicines to patients, new medical
options for physicians and rewarding careers to employees. Dedicated to
advancing science and medicine to help people live better lives, the
company is focused on infection, oncology, respiratory disease and
inflammation, cardiovascular/gastrointestinal disease, and neuroscience.
With approximately 3,000 employees worldwide and headquarters in Maryland,
MedImmune is wholly owned by AstraZeneca plc (LSE: AZN.L, NYSE: AZN). For
more information, visit MedImmune's website at http://www.medimmune.com
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SOURCE MedImmune Copyright©2008 PR Newswire. All rights reserved | |
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