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763158003 |Medicinal product (product)|

Defined

Exception

900000000000073002 |Sufficiently defined by necessary conditions definition status (core metadata concept)|

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 |Necessary but not sufficient concept definition status (core metadata concept)|are primitive

Range: 736542009 |Pharmaceutical dose form (dose form)|

• • • While the allowed range for this attribute is broader, the CD-precise continuous dose from 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)|)

Concrete Type: Integer

Range: >#0..

Cardinality: 1..1

Range: <105590001 |Substance (substance) excluding concepts representing structural groupers, dispositions, or combined substances

Cardinality: 1..1 per relationship group

• The Precise Active Ingredient (PAI) cannot be modeled as a substance hydrate or solvate unless the BoSS is expressed as a hydrate or solvate.
• Concepts containing pancreatic enzymes will be 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.

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

Expression of product strength in metric units is preferred.

To avoid semantically equivalent concepts, product strength for metric units are normalized as follows:

• • Use milligram if value is <1000; if > then convert to gram
  • Use microgram if value is <1000; if > then convert to milligram
  • Use nanogram if value is <1000; if > then convert to microgram
    
  • Use picogram if value is <1000; if > then convert to nanogram

To avoid semantically equivalent concepts, product strength for units are normalized as follows:

• • Use million unit if value is >1000000 unit

The following units are not allowed unless specifically noted as an exception:

• • 408165007 |Mega u (qualifier value)|

Repeating decimals are rounded to three decimal places (with 5 and above rounded up and 4 and below rounded down).

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 must be 1.

Note: the The denominator strength value is required for concepts in the the International Release even though the value = 1, because including denominators for only some concepts negatively affects the classification results.

Where Precise active ingredient = BoSS:

• Product containing precisely <BoSS FSN> <Concentration strength numerator value FSN> <Concentration strength numerator unit FSN>/<Concentration strength denominator value FSN> <Concentration strength denominator unit FSN> <Manufactured dose form FSN> (clinical drug)

For example,

• • • Product containing precisely amitriptyline hydrochloride 5 milligram/1 milliliter conventional release oral solution (clinical drug)
    • Product containing precisely buprenorphine 70 microgram/1 hour prolonged-release transdermal patch (clinical drug)
    • Product containing precisely clotrimazole 10 milligram/1 gram conventional release cutaneous cream (clinical drug)
    • Product containing precisely zidovudine 10 milligram/1 milliliter conventional release oral solution (clinical drug)
    • Product containing precisely lopinavir 80 milligram/1 milliliter and ritonavir 20 milligram/1 milliliter conventional release oral solution (clinical drug)
      

Where Precise active ingredient is not = BoSS:

• Product containing precisely <BoSS FSN> (as <Precise active ingredient FSN>) <Concentration strength numerator value FSN> <Concentration strength numerator unit FSN>/<Concentration strength denominator value FSN> <Concentration strength denominator unit FSN> <Manufactured dose form FSN> (clinical drug)

For example,

• • • Product containing precisely amikacin (as amikacin sulfate) 250 milligram/1 milliliter conventional release solution for injection (clinical drug)
    • Product containing precisely mupirocin (as mupirocin calcium) 20 milligram/1 gram conventional release nasal ointment (clinical drug)

Where Single ingredient with BoSS = Precise active ingredient:

• <BoSS PT> <Concentration strength numerator value PT> <Concentration strength numerator unit PT>/<Concentration strength denominator value PT> <Concentration strength denominator unit PT> <Manufactured dose form PT>

For example,

• • • Amitriptyline hydrochloride 5 mg/mL oral solution
    • Buprenorphine 70 microgram/hour prolonged-release transdermal patch
    • Clotrimazole 10 mg/g cutaneous cream
    • Zidovudine 10 mg/mL oral solution
    • Lopinavir 80 mg/mL and ritonavir 20 mg/mL oral solution

Where Single ingredient with BoSS is not = Precise active ingredient:

• <BoSS PT> (as <Precise active ingredient PT>) <Concentration strength numerator value PT> <Concentration strength numerator unit PT>/<Concentration strength denominator value PT> <Concentration strength denominator unit PT> <Manufactured dose form PT>

For example,

• • • Amikacin (as amikacin sulfate) 250 mg/mL solution for injection
    • Mupirocin (as mupirocin calcium) 20 mg/g nasal ointment

Synonyms converting metric units to percent or parts per millions may be included for medical gas concepts (e.g. Helium 79% and oxygen 21% gas for inhalation, Helium 790,000 ppm and oxygen 210,000 ppm gas for inhalation).