Page History

Descriptions:

Concept model:

116680003|Is a (attribute)|

3763158003763158003 |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)|

int(>#0..)

1142141006 |

Count of base and modification pair (attribute)|

int(>#0..)

1142140007 |Count of active ingredient (attribute)|

int(>#0..)

762949000 |Has precise active ingredient (attribute)|

<105590001 |Substance (substance)|

732943007|Has basis of strength substance (attribute)|

<105590001 |Substance (substance)|

1142135004 |Has presentation strength numerator value (attribute)|

<260299005|Number (qualifier value)|

dec(>#0..)

732945000|Has presentation strength numerator unit (attribute)|

<767524001 |

Unit 

of 

measure (qualifier value)|

1142136003 |Has presentation strength denominator value (attribute)|

38112003|1 (qualifier value)|

#1

732947008|Has presentation strength denominator unit (attribute)|

< 767524001 |Unit of 

measure (

qualifier 

value)|

Definition status:  

900000000000073002|Defined (core metadata concept)|

Rules for description generation:

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

763158003 |Medicinal product (product)| : 
[[~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]] 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]] 1142135004 |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]] 1142136003 |Has presentation strength denominator value (attribute)| = #1, 
[[~1..1]] 732947008 |Has presentation strength denominator unit (attribute)| = [[ +id( < 767524001 |Unit of measure (qualifier value)|) @presStrenDenomUnit]]}

Rules for description generation:

1. Apply General rules for generating descriptions for templates

2. For multiple ingredients, the BoSS substance ingredients in each description need to be in alphabetical order 

3. 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

4. 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
   
   

5. 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

6. Remove the semantic tags, (substance) (unit of presentation) (dose form) and (qualifier value)      
7. 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) 

8. Align case sensitivity with substance term  

9. FSN = Product containing precisely [substance][number][SI unit FSN MINUS /actuation]/[1] each [dose form] (clinical drug)[substance] 

10. PT = [SI unit PT MINUS /actuation] [dose form]

11. If BOSS differs from precise active ingredient 
    FSN Product containing precisely [substance](as[substance]) [number][SI unit of mass]/[1] each [dose form] (clinical drug) e.g 

    Example:   
    Product containing precisely doxazosin (as doxazosin mesilate) 8 4 milligram/1 each prolonged-conventional release oral tablet (clinical drug)PT [substance] 

    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)
      
      
12. 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])  [SI unit of mass PT[number][Unit of measure ] [dose form] e.g. US with GB language Acceptability: Doxazosin        
    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

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