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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. 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 BoSS substance ingredients in each description needs to be in alphabetical order 

  4. For multiple ingredients, for FSN add 'and [substance][number][Unit of measure ]' after the first [substance][number][Unit of measure ] where there are multiple |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  Abacavir 600 mg and lamivudine 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:

Where BoSS = Precise active ingredient:

<BoSS PT> <Presentation strength numerator value PT> <Presentation strength numerator unit PT> <Manufactured dose form PT>
Example:

Abacavir 300 mg oral tablet
Abacavir 600 mg and lamivudine 300 mg oral tablet
Atropine sulfate 600 microgram oral tablet
Codeine sulfate 15 mg oral tablet
Aztreonam 500 mg powder for solution for injection vial
Budesonide 200 microgram/actuation powder for inhalation
Buserelin (as buserelin acetate) 100 microgram/actuation nasal spray
Where BoSS <> Precise active ingredient:

<BoSS PT> (as <Precise active ingredient PT>) <Presentation strength numerator value PT> <Presentation strength numerator unit PT> <Manufactured dose form PT>
Example:

US PT: Doxazosin (as doxazosin mesylate) 4 mg oral tablet
GB PT: Doxazosin (as doxazosin mesylate) 4 mg oral tablet
US/GB PT: Disopyramide (as disopyramide phosphate) 150 mg prolonged-release oral tablet
US PT: Floxacillin (as floxacillin sodium) 250 mg powder for solution for injection vial
GB PT: Flucloxacillin (as flucloxacillin sodium) 250 mg powder for solution for injection vial
Exception:

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

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