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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 need to be in alphabetical order 

  4. 'and [substance]' needs to be added at the beginning for FSN for multiple |Has basis of strength substance (attribute)| 

  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:

Use the following pattern for the PT; align terming and case sensitivity with the PT for the concepts that are selected as the attribute values. For multiple ingredient drug products, the BoSS must be in alphabetical order and separated by the word “and”.

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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