Drug – bio-affecting and body treating compositions – In vivo diagnosis or in vivo testing – Diagnostic or test agent produces visible change on skin
Reexamination Certificate
2001-10-05
2004-12-21
Saunders, David (Department: 1644)
Drug, bio-affecting and body treating compositions
In vivo diagnosis or in vivo testing
Diagnostic or test agent produces visible change on skin
C424S009800, C427S002120
Reexamination Certificate
active
06833128
ABSTRACT:
FIELD
A method for monitoring local reactions associated with injection sites and kit for performance of the method are disclosed. More specifically, a simple visual method for monitoring local reactions associated with injection sites, which can be utilized even in non-medical environments, and a kit for use in performing the method are disclosed. The disclosed method and kit can be used, for example, to monitor local reactions associated with a subject's vaccine injection site, and help determine whether the local reaction observed is within normal ranges. Use of the method can reduce unnecessary return medical visits due to overreaction to normal local reactions at vaccine injection sites, as well as provide assurance that a subject's local reaction is within the normal range. In cases where the local reaction exceeds the normal range, the method can provide guidance on seeking additional medical advice and/or attention.
BACKGROUND
In the United States, approximately 74 million vaccine or immunization shots are expected to be administered in 2000 as protection against various diseases. Due largely to the trend in combination immunizations, the number of immunization shots is expected to decrease to about 66 million in 2004. Many of these vaccinations will be directed at young children, especially infants. In many cases, such immunizations cause local reactions such as, for example, redness, swelling, erythema, and the like. Although such local reactions are common and generally are not medically significant (e.g., are not predictive of serious problems), many parents, especially first-time parents, become concerned when they observe such redness or swelling. Moreover, such parents often have difficulty determining whether a child's reaction to the shot is within normal limits or parameters and, thus, become needlessly concerned. Such concern, in addition to being worrisome, can also result in unnecessary clinical attention (such as doctor visits) and medical expenses.
It would be desirable, therefore, to provide a simple method to monitor local reactions due to an injection, in order to determine whether the local reaction is within normal parameters.
SUMMARY
A method is disclosed for monitoring local reactions associated with injection sites. The method provides a simple visual method for monitoring local reactions associated with injection sites, which can even be utilized by laypersons (such as parents or guardians) in non-medical environments. A kit is also provided for performing the method. The method can be used with human subjects, but could also be used with animal subjects such as horses or dogs. The disclosed method can be used, for example, by a parent to monitor local reactions associated with a child's vaccine injection site, and help determine whether a local reaction is within normal ranges. Use of the method can reduce unnecessary medical visits due to overreaction to normal local reactions at injection sites, as well as provide assurance that a local reaction is within the normal range. In cases where the local reaction exceeds the normal range, the method can provide guidance on seeking additional medical advice and/or attention.
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Klarquist & Sparkman, LLP
Saunders David
The United States of America as represented by the Department of
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