Form:DrugProjectForm: Difference between revisions
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* '''Step 1: Check the "Dosage And Administration" section from the FDA label'''<BR> | * '''Step 1: Check the "Dosage And Administration" section from the FDA label'''<BR> | ||
* '''Step 2: Insert the dosing information for each indication'''</SMALL> | * '''Step 2: Insert the dosing information for each indication'''</SMALL> | ||
| style="width: 50%;" valign=top | {{{field|fdaLIADAdult|input type=textarea|editor|size=35 | | style="width: 50%;" valign=top | {{{field|fdaLIADAdult|input type=textarea|editor|size=35}}} | ||
|- | |- | ||
| style="width: 50%;" valign=top | Please enter established '''off-label use and dosage''' for '''adults''': | | style="width: 50%;" valign=top | Please enter established '''off-label use and dosage''' for '''adults''': | ||
|- | |- | ||
| style="width: 50%;" valign=top | Please enter '''guideline-supported off-label use''' in this field: | | style="width: 50%;" valign=top | Please enter '''guideline-supported off-label use''' in this field: | ||
| style="width: 50%;" valign=top | {{{field|offLabelAdultGuideSupport|input type=textarea|size=35|editor|default= | | style="width: 50%;" valign=top | {{{field|offLabelAdultGuideSupport|input type=textarea|size=35|editor|default=There is limited information about ''Off-Label Guideline-Supported Use'' of {{PAGENAME}} in adult patients.}}} | ||
''' | |||
|- | |- | ||
| style="width: 50%;" valign=top | Please enter '''non–guideline-supported off-label use''' in this field: | | style="width: 50%;" valign=top | Please enter '''non–guideline-supported off-label use''' in this field: | ||
| style="width: 50%;" valign=top | {{{field|offLabelAdultNoGuideSupport|input type=textarea|size=35|editor|default= | | style="width: 50%;" valign=top | {{{field|offLabelAdultNoGuideSupport|input type=textarea|size=35|editor|default=There is limited information about ''Off-Label Non–Guideline-Supported Use'' of {{PAGENAME}} in adult patients.}}} | ||
|} | |} | ||
| Line 268: | Line 247: | ||
* '''Step 1: Check the "Dosage And Administration" section from the FDA label'''<BR> | * '''Step 1: Check the "Dosage And Administration" section from the FDA label'''<BR> | ||
* '''Step 2: Insert the dosing information for each indication'''</SMALL> | * '''Step 2: Insert the dosing information for each indication'''</SMALL> | ||
| style="width: 50%;" valign=top | {{{field|fdaLIADPed|input type=textarea|editor|size=35 | | style="width: 50%;" valign=top | {{{field|fdaLIADPed|input type=textarea|editor|size=35}}} | ||
|- | |- | ||
| style="width: 50%;" valign=top | Please enter established '''off-label use and dosage''' for '''children''': | | style="width: 50%;" valign=top | Please enter established '''off-label use and dosage''' for '''children''': | ||
|- | |- | ||
| style="width: 50%;" valign=top | Please enter '''guideline-supported off-label use''' in this field: | | style="width: 50%;" valign=top | Please enter '''guideline-supported off-label use''' in this field: | ||
| style="width: 50%;" valign=top | {{{field|offLabelPedGuideSupport|input type=textarea|size=35|editor|default= | | style="width: 50%;" valign=top | {{{field|offLabelPedGuideSupport|input type=textarea|size=35|editor|default=There is limited information about ''Off-Label Guideline-Supported Use'' of {{PAGENAME}} in pediatric patients.}}} | ||
''' | |||
|- | |- | ||
| style="width: 50%;" valign=top | Please enter '''non–guideline-supported off-label use''' in this field: | | style="width: 50%;" valign=top | Please enter '''non–guideline-supported off-label use''' in this field: | ||
| style="width: 50%;" valign=top | {{{field|offLabelPedNoGuideSupport|input type=textarea|size=35|editor|default= | | style="width: 50%;" valign=top | {{{field|offLabelPedNoGuideSupport|input type=textarea|size=35|editor|default=There is limited information about ''Off-Label Non–Guideline-Supported Use'' of {{PAGENAME}} in pediatric patients.}}} | ||
|} | |} | ||
=Contraindications= | =Contraindications= | ||
| Line 308: | Line 264: | ||
* '''Step 1: Check the "Contraindications" section from the FDA label'''<BR> | * '''Step 1: Check the "Contraindications" section from the FDA label'''<BR> | ||
* '''Step 2: Arrange the content into bullet points'''</SMALL> | * '''Step 2: Arrange the content into bullet points'''</SMALL> | ||
| style="width: 50%;" valign=top | {{{field|contraindications|input type=textarea|size=35|editor | | style="width: 50%;" valign=top | {{{field|contraindications|input type=textarea|size=35|editor | ||
}}} | }}} | ||
|} | |} | ||
=Warnings= | =Warnings= | ||
| Line 325: | Line 274: | ||
* '''Step 1: Check the "Warnings" section from the FDA label'''<BR> | * '''Step 1: Check the "Warnings" section from the FDA label'''<BR> | ||
* '''Step 2: Arrange the content into bullet points'''</SMALL> | * '''Step 2: Arrange the content into bullet points'''</SMALL> | ||
| style="width: 50%;" valign=top | {{{field|warnings|input type=textarea|size=35|editor | | style="width: 50%;" valign=top | {{{field|warnings|input type=textarea|size=35|editor}}} | ||
}}} | |||
|} | |} | ||
| Line 406: | Line 351: | ||
* '''Step 1: Check the "Drug Interactions" section from the FDA label'''<BR> | * '''Step 1: Check the "Drug Interactions" section from the FDA label'''<BR> | ||
* '''Step 2: Arrange the content into bullet points'''</SMALL> | * '''Step 2: Arrange the content into bullet points'''</SMALL> | ||
| style="width: 50%;" valign=top | {{{field|drugInteractions|input type=textarea|size=35|editor | | style="width: 50%;" valign=top | {{{field|drugInteractions|input type=textarea|size=35|editor}}} | ||
}}} | |||
|} | |} | ||
| Line 564: | Line 500: | ||
{| | {| | ||
| style="width: 50%;" valign=top | Please enter the '''Patient Counseling Information''' here:<BR><SMALL> | | style="width: 50%;" valign=top | Please enter the '''Patient Counseling Information''' here:<BR><SMALL> | ||
| style="width: 50%;" valign=top | {{{field|fdaPatientInfo|input type=textarea|size=35|editor | | style="width: 50%;" valign=top | {{{field|fdaPatientInfo|input type=textarea|size=35|editor}}} | ||
|} | |} | ||
Revision as of 22:06, 20 May 2014