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Descriptions:

Termdescription typeLanguage/acceptabilityLanguage/acceptabilityCase significance
Product containing precisely [substance][number][SI unit of mass]/[1] each [dose form] (clinical drug)FSNus:Pgb:Pci
[substance] [SI unit of mass] [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
766952006411116001 |CountHas ofmanufactured base of active ingredientdose form (attribute)|



Scg expression
<260299005<736542009 |NumberPharmaceutical dose form (qualifierdose valueform)|
01..1
1..1
Scg expression
763032000766952006 |HasCount of unitbase of active presentationingredient (attribute)|
Scg expression
<732935002<260299005 | Unit of presentationNumber (unitqualifier of presentationvalue) |
01..1
1..1
Scg expression
411116001763032000 |Has manufacturedunit doseof formpresentation (attribute)|
Scg expression
<736542009<732935002 |Pharmaceutical Unit doseof formpresentation (doseunit of formpresentation)| 
01..1
1..1
Scg expression
762949000 |Has precise active ingredient (attribute)|
Scg expression
<105590001 |Substance (substance)|
11..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
<258681007 |International System of Units unit of mass (qualifier value)|
1
1..1
Scg expression
732946004|Has presentation strength denominator value (attribute)|
Scg expression
38112003|1 (qualifier value)|
1
1..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) 
  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. Remove the semantic tags, (substance) (unit of presentation) (dose form) and (qualifier value) 
  5. For clinical drug PT SI Unit of mass uses the PT which is an abbreviation e.g. mg   
  6. A Preferred Term (PT) for both US and GB dialect as per the substance concept terming must be added where there are US and GB spelling variations (language acceptability P/A) 
  7. Align case sensitivity with substance term  

  8. If BOSS differs from precise active ingredient BoSS <> Precise active ingredient:

    FSN Product containing precisely [substance](as[substance]) [number][SI unit of mass]/[1] each [dose form] (clinical drug) e.g Product containing precisely doxazosin (as doxazosin mesilate) 8 milligram/1 each prolonged-release oral tablet (clinical drug)

    PT [substance] (as[substance]) [SI unit of mass PT] [dose form] e.g. US with GB language Acceptability:

     Doxazosin (as doxazosin mesylate) 8 mg prolonged-release oral tabletPreferred
    Doxazosin (as doxazosin mesilate) 8 mg prolonged-release oral tabletAcceptable
  9. Exceptions:use Use of 'actuation' - 
    Product containing precisely budesonide 200 microgram/actuation conventional release powder for inhalation (clinical drug)
  10. Use of 'vial powder':•Product containing precisely aztreonam 500 milligram/1 vial powder for conventional release solution for injection (clinical drug)JIRA ticket for implementation:

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