Form:DrugProjectForm: Difference between revisions
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Gerald Chi (talk | contribs) mNo edit summary |
Gerald Chi (talk | contribs) mNo edit summary |
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=Overview Statement= | =Overview Statement= | ||
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* '''Step 1: Check the "Warnings" section from the FDA label'''<BR> | * '''Step 1: Check the "Warnings" section from the FDA label'''<BR> | ||
* '''Step 2: Select "Yes" from the drop-down menu if there is a Black Box Warning'''</SMALL> | * '''Step 2: Select "Yes" from the drop-down menu if there is a Black Box Warning'''</SMALL> | ||
| valign=top |{{{field|hasBlackBoxWarning|input type=dropdown|values=,Yes}}} | | valign=top | {{{field|hasBlackBoxWarning|input type=dropdown|values=,Yes}}} | ||
|- | |- | ||
| valign=top | Please list the most common adverse reactions associated with the drug:<BR><SMALL> | | valign=top | Please list the most common adverse reactions associated with the drug:<BR><SMALL> | ||
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|- | |- | ||
| valign=top | Please enter the '''body''' of the Black Box Warning | | valign=top | Please enter the '''body''' of the Black Box Warning | ||
| valign=top |{{{field|blackBoxWarningBody|input type=textarea|editor|size=35|default=''{{fontcolor|#FF0000|Condition Name:}}'' (Content)}}} | | valign=top | {{{field|blackBoxWarningBody|input type=textarea|editor|size=35|default=''{{fontcolor|#FF0000|Condition Name:}}'' (Content)}}} | ||
|} | |} | ||
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{| | {| | ||
| style="width: 50%;" valign=top | Please enter the FDA-Labeled Indications and Dosing Information for Adults | | style="width: 50%;" valign=top | Please enter the FDA-Labeled Indications and Dosing Information for '''Adults'''<BR><SMALL> | ||
| valign=top |{{{field|fdaLIADAdult|input type=textarea|editor|size=35|default= | * '''Step 1: Check the "Dosage And Administration" section from the FDA label'''<BR> | ||
* '''Step 2: Insert the dosing information for each indication'''</SMALL> | |||
| valign=top | {{{field|fdaLIADAdult|input type=textarea|editor|size=35|default= | |||
'''Condition 1''' | |||
* Dosing Information | * Dosing Information | ||
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:: (Dosage)}}} | :: (Dosage)}}} | ||
|- | |- | ||
| valign=top | Please enter any established Off-Label Use and Dosage for '''Adults''' | |||
|- | |- | ||
| valign=top | Guideline-Supported Off-Label Use | |||
|{{{field|offLabelAdultGuideSupport|input type=textarea|size=35|editor}}} | | valign=top | {{{field|offLabelAdultGuideSupport|input type=textarea|size=35|editor|default= | ||
'''Condition 1''' | |||
* Developed by: (Organization) | |||
* Class of Recommendation: (Class) (Link) | |||
* Strength of Evidence: (Category A/B/C) (Link) | |||
* Dosing Information/Recommendation | |||
:* (Dosage)}}} | |||
|- | |- | ||
| valign=top | Non–Guideline-Supported Off-Label Use | |||
|{{{field|offLabelAdultNoGuideSupport|input type=textarea|size=35|editor}}} | | valign=top | {{{field|offLabelAdultNoGuideSupport|input type=textarea|size=35|editor|default= | ||
'''Condition 1''' | |||
* Dosing Information | |||
:* There is limited information about ''Off-Label Non–Guideline-Supported Use'' of {{PAGENAME}} in adult patients.}}} | |||
|} | |} | ||
=Pediatric Indications and Dosage= | =Pediatric Indications and Dosage= | ||
{| | {| | ||
| style="width: 50%;" valign=top | Please enter the FDA-Labeled Indications and Dosage Information for '''Children'''<BR><SMALL> | |||
| {{{field|fdaLIADPed|input type=textarea|size=35| | * '''Step 1: Check the "Dosage And Administration" section from the FDA label'''<BR> | ||
* '''Step 2: Insert the dosing information for each indication'''</SMALL> | |||
| valign=top | {{{field|fdaLIADPed|input type=textarea|editor|size=35|default= | |||
'''Condition 1''' | |||
* Dosing Information | |||
:: (Dosage)}}} | |||
|- | |- | ||
| valign=top | Please enter any established Off-Label Use and Dosage for '''Children''' | |||
|- | |- | ||
| valign=top | Guideline-Supported Off-Label Use | |||
|{{{field|offLabelPedGuideSupport|input type=textarea|size=35|editor}}} | | valign=top | {{{field|offLabelPedGuideSupport|input type=textarea|size=35|editor|default= | ||
'''Condition 1''' | |||
* Developed by: (Organization) | |||
* Class of Recommendation: (Class) (Link) | |||
* Strength of Evidence: (Category A/B/C) (Link) | |||
* Dosing Information/Recommendation | |||
:* (Dosage)}}} | |||
|- | |- | ||
| valign=top | Non-Guideline-Supported Off-Label Use | |||
|{{{field|offLabelPedNoGuideSupport|input type=textarea|size=35|editor}}} | | valign=top | {{{field|offLabelPedNoGuideSupport|input type=textarea|size=35|editor|default= | ||
'''Condition 1''' | |||
* Dosing Information | |||
:* There is limited information about ''Off-Label Non–Guideline-Supported Use'' of {{PAGENAME}} in pediatric patients.}}} | |||
|} | |} | ||
=Contraindications= | =Contraindications= | ||
{| | {| | ||
| style="width: 50%;" valign=top | Please enter the FDA reported contraindications:<BR><SMALL> | |||
| {{{field|contraindications|input type=textarea|size=35|editor}}} | * '''Step 1: Check the "Contraindications" section from the FDA label'''<BR> | ||
* '''Step 2: Arrange the contents into bullet points'''</SMALL> | |||
| valign=top | {{{field|contraindications|input type=textarea|size=35|editor|default= | |||
* Condition 1 | |||
* Condition 2 | |||
* Condition 3 | |||
* Condition 4 | |||
* Condition 5 | |||
}}} | |||
|} | |} | ||
=Warnings= | =Warnings= | ||
{| | {| | ||
| style="width: 50%;" valign=top | Please enter the FDA reported warnings associated with the drug:<BR><SMALL> | |||
| {{{field|warnings|input type=textarea|size=35|editor}}} | * '''Step 1: Check the "Warnings" section from the FDA label'''<BR> | ||
* '''Step 2: Arrange the contents into bullet points'''</SMALL> | |||
| valign=top | {{{field|warnings|input type=textarea|size=35|editor|default= | |||
'''Conidition 1''' | |||
(Description) | |||
}}} | |||
|} | |} | ||
=Adverse Reactions= | =Adverse Reactions= | ||
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|{{{field|overdose|input type=textarea|size=35|editor}}} | |{{{field|overdose|input type=textarea|size=35|editor}}} | ||
|} | |} | ||
=Pharmacology= | =Pharmacology= | ||
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Pill Shape: | Pill Shape: | ||
{{{field|pillShape|input type=dropdown| values=Round,Oval,Square,Rectangular,Triangular,Capsule,Pentagon,Hexagon,Diamond,Gear,DoubleCircle,Clover,TearDrop,Octagon,SemiCircle,Bullet,Trapezoid,FreeForm}}} | {{{field|pillShape|input type=dropdown| values=Round,Oval,Square,Rectangular,Triangular,Capsule,Pentagon,Hexagon,Diamond,Gear,DoubleCircle,Clover,TearDrop,Octagon,SemiCircle,Bullet,Trapezoid,FreeForm}}} | ||
Pill Size (in mm): | Pill Size (in mm): | ||
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{{{field|pillScore|input type=dropdown|values=1,2,3,4,5,6,7,8,9,10}}} | {{{field|pillScore|input type=dropdown|values=1,2,3,4,5,6,7,8,9,10}}} | ||
{{{end template}}} | {{{end template}}} | ||
=Add Images of the Package= | =Add Images of the Package= | ||
Revision as of 21:17, 1 May 2014