Descriptions:
| Term | description type | Language/acceptability | Language/acceptability | Case significance |
|---|---|---|---|---|
| Product containing precisely [substance][number][Unit of measure ]/[1] each [dose form] (clinical drug) | FSN | us:P | gb:P | ci |
| [substance] [Unit of measure ] [dose form] | SYN | us:P | gb:P | ci |
Concept model:
| Attribute cardinality | Attribute | Value | role group number | role group cardinality |
|---|---|---|---|---|
| 0 | N/A | |||
| 1..1 | 0 | 1..1 | ||
| 1..1 | 0 | 1..1 | ||
| 1..1 | 0 | 1..1 | ||
| 0..1 | 0 | 0..1 | ||
| 0..1 | 0 | 0..1 | ||
| 1..1 | 1..* | 1..* | ||
| 1..1 | 1..* | |||
| 1..1 | 1..* | |||
| 1..1 | 1..* | |||
| 1..1 | 1..* | |||
| 0..1 | 1..* |
Definition status:
900000000000073002 |Defined (core metadata concept)|
Rules for description generation:
- Apply General rules for generating descriptions for templates
- 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.
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).
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)
DRUGS-276 - Getting issue details... STATUS