Descriptions:
| Term | description type | Language/acceptability | Language/acceptability | Case Significance |
|---|---|---|---|---|
| Product containing precisely [substance][number][Numerator Unit of measure ]/[1][Denominator Unit of measure ] [dose form] (clinical drug) | FSN | us:P | gb:P | ci |
| [substance] [number] [Numerator Unit of measure ]/ [Denominator Unit of measure ] [dose form] (clinical drug) | SYN | us:P | gb:P | ci |
Concept model:
| Role group cardinality | Attribute cardinality | Attribute in role group cardinality | Attribute | Value |
|---|---|---|---|---|
| 0..0 | 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 | dec(>#0..) | |||
| 1..1 | ||||
| 1..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)|
, {
733725009 |Has concentration strength numerator unit (attribute)|
= <
767524001 |Unit of measure (qualifier value)|
}
Template Language
[[~1..1]] 411116001 |Has manufactured dose form (attribute)| = [[ +id( < 736542009 |Pharmaceutical dose form (dose form)| ) @form]],
[[~1..1]] 1142139005 |Count of base of active ingredient (attribute)| = [[ int(>#0..) @baseCount]],
[[~0..1]] 1142141006 |Count of base and modification pair (attribute)| = [[ int(>#0..) @baseModCount]],
[[~0..1]] 1142140007 |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]] 1142138002 |Has concentration strength numerator value (attribute)| = [[ dec(>#0..) @concentStrenNumVal]],
[[~1..1]] 733725009 |Has concentration strength numerator unit (attribute)| = [[ +id( < 767524001 |Unit of measure (qualifier value)| ) @concentStrenNumUnit]],
[[~1..1]] 1142137007 |Has concentration strength denominator value (attribute)| = #1,
[[~1..1]] 733722007 |Has concentration strength denominator unit (attribute)| = [[ +id( < 767524001 |Unit of measure (qualifier value)| ) @concentStrenDenomUnit]]}
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 the FSN; align terming and case sensitivity with the FSN for the concepts that are selected as the attribute values, excluding the semantic tag e.g. Product containing precisely clotrimazole 10 milligram/1 gram conventional release cutaneous cream (clinical drug)
- For the PT; align terming and case sensitivity with the PT for the concepts that are selected as the attribute values e.g. Clotrimazole 10 mg/g cutaneous cream
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:
Product containing precisely lopinavir 80 milligram/1 milliliter and ritonavir 20 milligram/1 milliliter conventional release oral solution (clinical drug)For multiple ingredients PT - add ' [substance][number][Unit of measure ] and' at the beginning of the PT Example; Lopinavir 80 mg/mL and ritonavir 20 mg/mL oral solution
FSN Exceptions: 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: Single ingredient example = Product containing precisely <BoSS FSN> (as <Precise active ingredient FSN>) <Concentration strength numerator value FSN> <Concentration strength numerator unit FSN>/<Concentration strength denominator value FSN> <Concentration strength denominator unit FSN> <Manufactured dose form FSN> (clinical drug)
Examples:
Product containing precisely amikacin (as amikacin sulfate) 250 milligram/1 milliliter conventional release solution for injection (clinical drug)
Product containing precisely mupirocin (as mupirocin calcium) 20 milligram/1 gram conventional release nasal ointment (clinical drug)
PT Exceptions:
Where BoSS <> Precise active ingredient: Single ingredient example<BoSS PT> (as <Precise active ingredient PT>) <Concentration strength numerator value PT> <Concentration strength numerator unit PT>/<Concentration strength denominator value PT> <Concentration strength denominator unit PT> <Manufactured dose form PT>
Example:
Amikacin (as amikacin sulfate) 250 mg/mL solution for injection
Mupirocin (as mupirocin calcium) 20 mg/g nasal ointment
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
DRUGS-548 - Getting issue details... STATUS
DRUGS-646 - Getting issue details... STATUS