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Patient Confidentiality and Privacy |
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Registry is very concerned with protection of patient
confidentiality and privacy. This Registry was established
with the collaboration of FDA as a post-marketing
commitment and has received IRB (Institutional Review
Board) approval for its protocol. The Registry is
an extension of safety surveillance of ribavirin
exposures in pregnancy. |
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Who May Provide Information to the Registry |
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Registry collects information from patients and
health care providers, i.e., |
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From pregnant patients who have received ribavirin
while pregnant or during 6 months after treatment
has stopped, or who were exposed to ribavirin through
their male sexual partner treated with ribavirin
while she was pregnant or during 6 months after
he had stopped treatment |
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From male sexual partners who have been treated
with ribavirin and whose pregnant partner was exposed
while he was on treatment or during the 6 months
after treatment was stopped |
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From providers who prescribed ribavirin, obstetric
providers, or genetic counselors who become aware
of a pregnancy exposure to ribavirin |
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Pediatric providers who can provide information
on the live born infant following an in-utero exposure
to ribavirin |
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How Can Information be Provided |
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Information can be provided by phone or the data
forms may be completed. |
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