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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 descendants of 736542009 <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

The attribute value should represent the manufactured dose form

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 groupExpression 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)

Use one of the following patterns for the PT.  Align naming 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 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

Exception:

• The following units of measure should not be abbreviated in descriptions; they should always be spelled out:
  • international unit
  • microequivalent
  • microliter
  • microgram
  • microliter (with GB spelling microlitre)
  • million unit
  • nanogram
  • picogram
  • unit

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).