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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] [number] [Unit of measure ] [dose form]SYNus:Pgb:Pci


Concept model:

Definition status:  

900000000000073002 |Defined (core metadata concept)|

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 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:                                                                                                                                                                                                                                                                                                                                                       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:

        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 ``PT show value as '/actuation'    Example:

        Budesonide 200 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


DRUGS-276 - Getting issue details... STATUS

DRUGS-645 - Getting issue details... STATUS

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