Page History

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116680003|Is a (attribute)|

3763158003|Medicinal product (product)

411116001 |Has manufactured dose form (attribute)|

<736542009 |Pharmaceutical dose form (dose form)|

766952006 |Count of base of active ingredient (attribute)|

<260299005 |Number (qualifier value)|

766954007|Count of base and modification pair (attribute)| 

<260299005 |Number (qualifier value)|

766953001|Count of active ingredient (attribute)|

<260299005 |Number (qualifier value)|

762949000 |Has precise active ingredient (attribute)|

<105590001 |Substance (substance)|

732943007|Has basis of strength substance (attribute)|

<105590001 |Substance (substance)|

733724008 |Has concentration strength numerator value (attribute)|

<260299005|Number (qualifier value)|

733725009 |Has concentration strength numerator unit (attribute)|

<767524001 |Unit of measure (qualifier value)

733723002 |Has concentration strength denominator value (attribute)|

38112003|1 (qualifier value)|

733722007 |Has concentration strength denominator unit (attribute)|

< 732935002 |Unit of presentation (unit of presentation)|

Definition status:  

900000000000073002|Defined (core metadata concept)|

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1. Apply General rules for generating descriptions for templates

2. For multiple ingredients, the BoSS substance ingredients in each description need to be in alphabetical order 

3. For the FSN; align terming and case sensitivity with the FSN for the concepts that are selected as the attribute values, excluding the semantic tag e.g. Product containing precisely clotrimazole 10 milligram/1 gram conventional release cutaneous cream (clinical drug)
4. For the PT; align terming and case sensitivity with the PT for the concepts that are selected as the attribute values e.g. Clotrimazole 10 mg/g cutaneous cream

5. For multiple ingredients, for FSN add 'and [substance][number][Unit of measure ]' after the first [substance][number][Unit of measure ] for each  |Has basis of strength substance (attribute)| Example: 
   Product containing precisely lopinavir 80 milligram/1 milliliter and ritonavir 20 milligram/1 milliliter conventional release oral solution (clinical drug)

6. For multiple ingredients PT - add ' [substance][number][Unit of measure ] and' at the beginning of the PT Example;  Lopinavir 80 mg/mL and ritonavir 20 mg/mL oral solution

7. FSN Exceptions: a. If If substance value for Precise active ingredient  <> BoSS add (as [substance]) to text string as illustrated below. The substance value in parentheses uses the substance value for the Precise active ingredient (PAA) and not the BoSS, which is the first substance value in the description:
   Product containing precisely [BoSS substance] (as [PAA 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] Single ingredient example                                                                                                                                                                                                                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)

   Examples:

   • Product containing precisely

     aztreonam 500

     amikacin (as amikacin sulfate) 250 milligram/1

     vial powder for

     milliliter conventional release solution for injection (clinical drug)
     Product containing precisely

     budesonide 200 microgram

     mupirocin (as mupirocin calcium) 20 milligram/1

     actuation

     gram conventional release

     powder for inhalation

     nasal ointment (clinical drug)

   PT

    PT Exceptions:                                                                                                                                                                                                                                                                                                                                                   
   

   a. Where

   Where BoSS <> Precise active ingredient:

   
   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:
          [substance] (as [substance]) [number][Unit of measure ] [dose form]        
   Example:Showing also US and GB dialect spelling variations in PT:

        US PT: Doxazosin (as doxazosin mesylate) 4 mg oral tablet (GB Acceptable)
        GB PT: Doxazosin (as doxazosin mesilate) 4 mg oral tablet (US Acceptable)

        b.  Where the concept  Has unit of presentation (unit of presentation) has value =  Actuation (unit of presentation) then for FSN show value as '/1 actuation'    Example:

770274000 |Product containing precisely beclometasone dipropionate 200 microgram/1 actuation pressurized conventional release solution for inhalation (clinical drug)|

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1. Single ingredient example

   <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>

   Example:

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

7. The following units of measure should not be abbreviated in descriptions; they should always be spelled out: international unit, microgram, million unit, nanogram, picogram, unit

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