Important Safety Information for PREVENAR(TM)
In clinical studies (n=18,168) in children, the most frequently reported adverse events included injection site reactions, fever (greater than or equal to 38 degrees C/100.4 degrees F), irritability, drowsiness, restless sleep, decreased appetite, vomiting, diarrhea, and rash.
Risks are associated with all vaccines, including PREVENAR(TM). Hypersensitivity to any vaccine component, including diphtheria toxoid, is a contraindication to its use. PREVENAR does not provide 100% protection against vaccine serotypes or protect against nonvaccine serotypes.
As many pathogens other than the pneumococcal serotypes represented in the vaccine may contribute to the burden of pneumonia, protection against all clinical pneumonia is expected to be lower than for invasive pneumococcal disease.
PREVENAR is not indicated for use in adults or in infants younger than 6 weeks of age.
About Wyeth Pharmaceuticals
Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the areas of women's health care, infectious disease, gastrointestinal health, central nervous system, inflammation, transplantation, hemophilia, oncology, vaccines and nutritional products. Wyeth is one of the world's largest research-driven pharmaceutical and health care products companies. It is a leader in the discovery, development, manufacturing and marketing of pharmaceuticals, vaccines, biotechnology products and non-prescription medicines that improve the quality of life for people worldwide. The Company's major divisions include Wyeth Pharmaceuticals, Wyeth Consumer Healthcare and Fort Dodge Animal Health.
The statements in this press release that are not hi
|SOURCE Wyeth Pharmaceuticals|
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