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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 concept | 763158003 |Medicinal product (product) |
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| Semantic tag | (clinical drug) |
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| Definition status | Defined - Exception:
- 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 a definition status of Primitive.
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Attribute: Has manufactured dose form | Range: <736542009 |Pharmaceutical dose form (dose form) - While the allowed range for this attribute is broader, the CD-precise discrete dose form concepts should only use <736542009 |Pharmaceutical dose form (dose form)|, excluding grouper concepts based on intended site (e.g. 740596000 |Cutaneous dose form (dose form)|, 385268001 |Oral 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)|) |
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Attribute: Has unit of presentation | Range: <732935002 |Unit of presentation (unit of presentation)| Cardinality: 1..1 |
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Attribute: Count of base of active ingredient (attribute) | Concrete Type: Integer Range: >#0.. Cardinality: 1..1 |
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| Relationship group | One relationship group containing one instance of each of the following attributes is required for each precise active ingredient. |
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- Has precise active ingredient
| Range: <105590001 |Substance (substance)| excluding concepts representing structural groupers, dispositions, or combined substances Cardinality: 1..1 per relationship group Note: - The PAI cannot be modeled as a substance hydrate or solvate unless the BoSS is expressed as a hydrate or solvate.
- Concepts containing pancreatic enzymes are modeled based on the discrete enzymes; because of variability between real clinical drugs, synonyms representing a total amount in a particular product will not be included in the International Release.
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- Has basis of strength substance
| Range: <105590001 |Substance (substance)| excluding concepts representing structural groupers, dispositions, or combined substances Cardinality: 1..1 per relationship group |
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- Has presentation strength numerator value
| Concrete Type: Decimal Range: >#0.. Cardinality: 1..1 per relationship group |
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- Has presentation strength numerator unit
| Range: <767524001 |Unit of measure (qualifier value)| Cardinality: 1..1 per relationship group |
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- Has presentation strength denominator value
| Concrete Type: Decimal Range: >#0.. Cardinality: 1..1 per relationship group For this pattern, the attribute value is 1. The denominator strength value is required for concepts in the International Release even if the value = 1, because including denominators for only some concepts negatively affects the classification results. |
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- Has presentation strength denominator unit
| - Range: <767524001 |Unit of measure (qualifier value)|
- While the allowed range for this attribute is broader, the CD-precise concepts representing discrete dose forms should only use <732935002 |Unit of presentation (unit of presentation).
- Cardinality: 1..1 per relationship group
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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): - Product containing precisely <BoSS FSN> <Presentation strength numerator value FSN> <Presentation strength numerator unit FSN>/<Presentation strength denominator value FSN> each <Manufactured dose form FSN> (clinical drug)
For example, - Product containing precisely abacavir 300 milligram/1 each conventional release oral tablet (clinical drug)
- Product containing precisely abacavir 600 milligram and lamivudine 300 milligram/1 each conventional release oral tablet (clinical drug)
- Product containing precisely atropine sulfate 600 microgram/1 each conventional release oral tablet (clinical drug)
- Product containing precisely codeine sulfate 15 milligram/1 each conventional release oral tablet (clinical drug)
Where Precise active ingredient is not = BoSS and Unit of presentation = discrete solid dose form (e.g. capsule, lozenge, pessary, suppository, tablet): - Product containing precisely <BoSS FSN> (as <Precise active ingredient FSN>) <Presentation strength numerator value FSN> <Presentation strength numerator unit FSN>/<Presentation strength denominator value FSN> each <Manufactured dose form FSN> (clinical drug)
For example, - Product containing precisely doxazosin (as doxazosin mesilate) 4 milligram/1 each conventional release oral tablet (clinical drug)
- Product containing precisely disopyramide (as disopyramide phosphate) 150 milligram/1 each prolonged-release oral tablet (clinical drug)
Where Precise active ingredient = BoSS and Unit of presentation = other discrete dose form (e.g. actuation, vial, sachet) - Product containing precisely <BoSS FSN> <Presentation strength numerator value FSN> <Presentation strength numerator unit FSN>/Presentation strength denominator value FSN> <Presentation strength denominator unit FSN> Manufactured dose form FSN> (clinical drug)
For example, - 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)
Where Precise active ingredient is not = BoSS and Unit of presentation = other discrete dose form (e.g. actuation, vial, sachet) - Product containing precisely <BoSS FSN> (as <Precise active ingredient FSN>) <Presentation strength numerator value FSN> <Presentation strength numerator unit FSN>/<Presentation strength denominator value FSN> <Presentation strength denominator unit FSN> Manufactured dose form FSN> (clinical drug)
For example, - Product containing precisely flucloxacillin (as flucloxacillin sodium) 250 milligram/1 vial powder for conventional release solution for injection (clinical drug)
- Product containing precisely buserelin (as buserelin acetate) 100 microgram/1 actuation conventional release nasal spray (clinical drug)
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| Preferred Term | Use one of the following patterns for the PT. | Where BoSS = Precise active ingredient: - <BoSS PT> <Presentation strength numerator value PT> <Presentation strength numerator unit PT> <Manufactured dose form PT> <Has unit of presentation PT>
For example, Where BoSS is not = Precise active ingredient: - <BoSS PT> (as <Precise active ingredient PT>) <Presentation strength numerator value PT> <Presentation strength numerator unit PT> <Manufactured dose form PT> <Has unit of presentation PT>
For 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
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| Synonyms | Synonyms matching the FSN are not required. |
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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.
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