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| Note | ||
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Pre-filled pens or cartridges are discrete dose forms as they can be counted. In the International edition of SNOMED CT, clinical drugs presenting in pre-filled pens or cartridges are modeled with normalized concentration strength. Example of pre-filled pen:
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When the manufacturer describes their product characteristics to indicate that two separate ingredients are present in their formulation, then both ingredients must be modeled separately.
For example,
- The summary of product characteristics for a manufactured product for a sachet of 100mg sodium valproate prolonged-release granules contains Sodium valproate 66.66mg and Valproic acid 29.03mg that must be separately modeled as |Product containing precisely sodium valproate 66.66 milligram and valproic acid 29.03 milligram/1 sachet prolonged-release oral granules (clinical drug)|
When a product has a metered delivery, the strength is "per actuation" not as a concentration.
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| Warning |
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Lyophilized dose forms are out of scope for the international edition of SNOMED CT. |
Modeling
| Stated parent | concept763158003 |Medicinal product (product) | |
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| Semantic tag | (clinical drug) | |
| Definition status | Defined
900000000000073002 |Sufficiently defined by necessary conditions definition status (core metadata concept)|
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Attribute: Has manufactured dose form | Range: <736542009 |Pharmaceutical dose form (dose form)
Cardinality: 1..1 Powder and granules for oral suspension, solution, etc. may be modeled using concentration strength and the administrable dose form (e.g. 1145409004 |Product containing precisely amoxicillin 25 milligram/1 milliliter and clavulanic acid (as clavulanate potassium) 6.25 milligram/1 milliliter conventional release oral suspension (clinical drug)|) | |
Attribute: Has unit of presentation | Range: <732935002 |Unit of presentation (unit of presentation)| Cardinality: 1..1 | |
Attribute: Count of base of active ingredient (attribute) | Concrete Type: Integer Range: >#0.. Cardinality: 1..1 | |
| Relationship group | One relationship group containing one instance of each of the following attributes is required for each precise active ingredient. | |
| Range: <105590001 |Substance (substance)| excluding concepts representing structural groupers, dispositions, or combined substances Cardinality: 1..1 per relationship group Note:
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| Range: <105590001 |Substance (substance)| excluding concepts representing structural groupers, dispositions, or combined substances Cardinality: 1..1 per relationship group | |
| Concrete Type: Decimal Range: >#0.. Cardinality: 1..1 per relationship group | |
| Range: <767524001 |Unit of measure (qualifier value)| Cardinality: 1..1 per relationship group | |
| Concrete Type: Decimal Range: >#0.. Cardinality: 1..1 per relationship group For this pattern, the attribute value is 1. Note: the The denominator strength value is required for concepts in the the International Release even if the value = 1, because including denominators for only some concepts negatively affects the classification results. | |
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Naming
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Use one of the following patterns for the FSN and PT.
| FSN | Where Precise active ingredient = BoSS and Unit of presentation = discrete solid dose form (e.g. capsule, lozenge, pessary, suppository, tablet):
For example,
Where Precise active ingredient is not = BoSS and Unit of presentation = discrete solid dose form (e.g. capsule, lozenge, pessary, suppository, tablet):
For example,
Where Precise active ingredient = BoSS and Unit of presentation = other discrete dose form (e.g. actuation, vial, sachet)
For example,
Where Precise active ingredient is not = BoSS and Unit of presentation = other discrete dose form (e.g. actuation, vial, sachet)
For example,
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| Preferred Term | Use one of the following patterns for the PT. Where BoSS = Precise active ingredient:
For example,
Where BoSS is not = Precise active ingredient:
For example,
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| Synonyms | Synonyms matching the FSN are not required. |
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The following illustrates the inferred view for 783301004 |Product containing precisely abacavir (as abacavir sulfate) 600 milligram and lamivudine 300 milligram/1 each conventional release oral tablet (clinical drug)|:
Sodium valproate and Valproic acid
When a manufacturer SPC label indicates that two separate ingredients, sodium valproate and valproic acid, are present in the formulation, and thus, one of the substances is a modification of the other, then each ingredient must be modeled separately within its own role group.
Two ungrouped attributes are also required:
- |Count of active ingredient| with the total number of active ingredients
- |Count of base of active ingredient| with the total number of base active ingredients
For example,
- The summary of product characteristics for a manufactured product for a sachet of 100 mg sodium valproate prolonged-release granules contains Sodium valproate 66.66 mg and Valproic acid 29.03 mg, that must be separately modeled as |Product containing precisely sodium valproate 66.66 milligram and valproic acid 29.03 milligram/1 sachet prolonged-release oral granules (clinical drug)|
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