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Descriptions:

Termdescription typeLanguage/acceptabilityLanguage/acceptabilityCase significance
Product containing precisely [substance][number][Unit of measure ]/[1] each [dose form] (clinical drug)FSNus:Pgb:Pci
[substance] [Unit of measure ] [dose form]SYNus:Pgb:Pci


Concept model:

Attribute cardinalityAttributeValuerole group numberrole group cardinality

Scg expression
116680003|Is a (attribute)|



Scg expression
3763158003|Medicinal product (product)
0N/A
1..1
Scg expression
411116001 |Has manufactured dose form (attribute)|



Scg expression
<736542009 |Pharmaceutical dose form (dose form)|
01..1
1..1
Scg expression
763032000 |Has unit of presentation (attribute)|



Scg expression
<732935002 | Unit of presentation (unit of presentation) 
01..1
1..1
Scg expression
766952006 |Count of base of active ingredient (attribute)|
Scg expression
<260299005 |Number (qualifier value)|
01..1
0..1
Scg expression
766954007|Count of base and modification pair (attribute)| 
Scg expression
<260299005 |Number (qualifier value)|
00..1
0..1
Scg expression
766953001|Count of active ingredient (attribute)|
Scg expression
<260299005 |Number (qualifier value)|
00..1
1..1
Scg expression
762949000 |Has precise active ingredient (attribute)|
Scg expression
<105590001 |Substance (substance)|
1..*1..*
1..1
Scg expression
732943007|Has basis of strength substance (attribute)|
Scg expression
<105590001 |Substance (substance)|
1..*
1..1
Scg expression
732944001|Has presentation strength numerator value (attribute)|
Scg expression
<260299005|Number (qualifier value)|
1..*
1..1
Scg expression
732945000|Has presentation strength numerator unit (attribute)|
Scg expression
<767524001 |Unit of measure (qualifier value)
1..*
1..1
Scg expression
732946004|Has presentation strength denominator value (attribute)|
Scg expression
38112003|1 (qualifier value)|
1..*
0..1
Scg expression
732947008|Has presentation strength denominator unit (attribute)|
Scg expression
732935002 |Unit of presentation (unit of presentation)|
1..*

Definition status:  

Scg expression
900000000000073002|Defined (core metadata concept)|

Rules for description generation:

  1. Apply General rules for generating descriptions for templates
  2. Exceptions:Concepts with product strength that is "not equal to" (e.g. with product strength expressed as a range, greater than, or less than) will have definition status 900000000000074008| Primitive (core metadata concept) and will have the appropriate Medicinal Product Form-only (MPF-only) concept as a stated parent.
  3. For multiple ingredients, the ingredients in each description need to be in alphabetical order e.g. Codeine and paracetamol for FSN but Acetaminophen and codeine (for US PT).

  4. For multiple ingredients...add

  5. FSN Exceptions:

    a. If substance value for Precise active ingredient  <> BoSS add (as [substance]) to text string where indicated below. 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:

    Product containing precisely [substance] (as [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)

  6. PT Exceptions:




Jira
serverIHTSDO JIRA
columnskey,summary,type,created,updated,due,assignee,reporter,priority,status,resolution
serverIdb202d822-d767-33be-b234-fec5accd5d8c
keyDRUGS-276