Descriptions:
| Term | description type | Language/acceptability | Language/acceptability | Case significance |
|---|---|---|---|---|
| Product containing precisely [substance][number][Unit of measure ]/1 each [dose form] (clinical drug) | FSN | us:P | gb:P | ci |
| [substance] [number] [Unit of measure ] [dose form] | SYN | us:P | gb:P | ci |
Concept model:
| Role group cardinality | Attribute cardinality | Attribute in role group cardinality | Attribute | Value |
|---|---|---|---|---|
| 1..* | ||||
| 0..0 | 1..1 | |||
| 0..0 | 1..1 | |||
| 0..0 | 1..1 | int(>#0..) | ||
| 0..0 | 0..1 | int(>#0..) | ||
| 0..0 | 0..1 | int(>#0..) | ||
| 1..* | 1..1 | 1..1 | ||
| 1..1 | 1..1 | |||
| 1..1 | 1..1 | dec(>#0..) | ||
| 1..1 | 1..1 | |||
| 1..1 | 1..1 | dec(>#0..) | ||
| 1..1 | 1..1 |
Definition status:
900000000000073002 |Defined (core metadata concept)|
Applies To:
<< 763158003 |Medicinal product (product)| : 411116001 |Has manufactured dose form (attribute)| = < 736542009 |Pharmaceutical dose form (dose form)| , 763032000 |Has unit of presentation (attribute)| = < 732935002 |Unit of presentation (unit of presentation)| , 1142139005 |Count of base of active ingredient (attribute)| = *
Template Language
[[~1..1]] 411116001 |Has manufactured dose form (attribute)| = [[ +id( < 736542009 |Pharmaceutical dose form (dose form)| ) @form]],
[[~1..1]] 763032000 |Has unit of presentation (attribute)| = [[ +id( < 732935002 |Unit of presentation (unit of presentation)| ) @presentation]],
[[~1..1]] 1142139005 |Count of base of active ingredient (attribute)| = [[ int(>#0..) @baseCount]],
[[~0..1]] 766954007 |Count of base and modification pair (attribute)| = [[ int(>#0..) @baseModCount]],
[[~0..1]] 766953001 |Count of active ingredient (attribute)| = [[ int(>#0..) @ingredCount]],
[[~1..*]] {
[[~1..1]] 762949000 |Has precise active ingredient (attribute)| = [[ +id( < 105590001 |Substance (substance)| ) @ingred]],
[[~1..1]] 732943007 |Has basis of strength substance (attribute)| = [[ +id( < 105590001 |Substance (substance)| ) @boss]],
[[~1..1]] 732944001 |Has presentation strength numerator value (attribute)| = [[ dec(>#0..) @presStrenNumVal]],
[[~1..1]] 732945000 |Has presentation strength numerator unit (attribute)| = [[ +id( < 767524001 |Unit of measure (qualifier value)| ) @presStrenNumUnit]],
[[~1..1]] 732946004 |Has presentation strength denominator value (attribute)| = [[ dec(>#0..) ]],
[[~1..1]] 732947008 |Has presentation strength denominator unit (attribute)| = [[ +id( < 767524001 |Unit of measure (qualifier value)| ) @presStrenDenomUnit]]}
Rules for description generation:
- Apply General rules for generating descriptions for templates
For multiple ingredients, the BoSS substance ingredients in each description need to be in alphabetical order
For multiple ingredients, for FSN add 'and [substance][number][Unit of measure ]' after the first [substance][number][Unit of measure ] for each |Has basis of strength substance (attribute)| Example: 413382007 |Product containing precisely abacavir 600 milligram and lamivudine 300 milligram/1 each conventional release oral tablet (clinical drug)|.
For multiple ingredients PT - add ' [substance][number][Unit of measure ] and' at the beginning of the PT Example; Abacavir 600 mg and lamivudine 300 mg oral tablet
- PT uses Preferred Terms in values; Example where BoSS = Precise active ingredient:<BoSS substance PT> <Presentation strength numerator value PT> <Presentation strength numerator unit PT> <Manufactured dose form value PT>
Example; Abacavir 300 mg oral tablet FSN Exceptions: a. If substance value for Precise active ingredient <> BoSS add (as [substance]) to text string as illustrated below. The substance value in parentheses uses the substance value for the Precise active ingredient (PAA) and not the BoSS, which is the first substance value in the description:
Product containing precisely [BoSS substance] (as [PAA substance]) [number] [Unit of measure ]/1 each [dose form] (clinical drug)Example:
Product containing precisely doxazosin (as doxazosin mesilate) 4 milligram/1 each conventional release oral tablet (clinical drug)b. Where Manufactured dose form value is NOT < 421378002 |Basic dose form with solid state of matter (basic dose form)| then include a value for Presentation strength denominator unit and remove “each” from text string:
Product containing precisely [substance][number][Unit of measure ]/1 [Unit of presentation] [dose form] (clinical drug)
Examples:
- Product containing precisely aztreonam 500 milligram/1 vial powder for conventional release solution for injection (clinical drug)
- Product containing precisely budesonide 200 microgram/1 actuation conventional release powder for inhalation (clinical drug)
- PT Exceptions:
a. Where BoSS <> Precise active ingredient:
The substance value in parentheses uses the substance value for the Precise active ingredient and not the BoSS, which is the first substance value in the description:
[substance] (as [substance]) [number][Unit of measure ] [dose form]
Example:Showing also US and GB dialect spelling variations in PT:
US PT: Doxazosin (as doxazosin mesylate) 4 mg oral tablet (GB Acceptable)
GB PT: Doxazosin (as doxazosin mesilate) 4 mg oral tablet (US Acceptable)
b. Where the concept Has unit of presentation (unit of presentation) has value = Actuation (unit of presentation) then for FSN show value as '/1 actuation' Example:
770274000 |Product containing precisely beclometasone dipropionate 200 microgram/1 actuation pressurized conventional release solution for inhalation (clinical drug)|
Example PT: Aclidinium bromide 375 microgram/actuation powder for inhalation
7. The following units of measure should not be abbreviated in descriptions; they should always be spelled out: international unit, microgram, million unit, nanogram, picogram, unit
JIRA tickets:
DRUGS-276 - Getting issue details... STATUS
DRUGS-645 - Getting issue details... STATUS
INFRA-3212 - Getting issue details... STATUS