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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.
Anhydrous
If the When a clinical drug strength has a BoSS specified in the a Summary of Product Characteristics is based on as an anhydrous substance, then the BoSS PAI is represented as the anhydrous unmodified substance, and if supported by the referenced SPC, the PAI is i.e., the substance with an unspecified level of hydration.
For example,
- 1153520006 |Product containing precisely carbidopa anhydrous (as carbidopa) 25 milligram and levodopa 250 milligram/1 each conventional release oral tablet (clinical drug)|
- BoSS = Carbidopa anhydrous PAI = Carbidopa
The SPC states each tablet "contains 27.0 mg carbidopa (equivalent to 25 mg of anhydrous carbidopa) and 250 mg levodopa." The BoSS is anhydrous carbidopa, so the PAI is Carbidopa.
- 1331919008 |Product containing precisely carbidopa anhydrous (as carbidopa) 12.5 milligram and entacapone 200 milligram and levodopa 50 milligram/1 each conventional release oral tablet (clinical drug)|
This SPC states, "Each film-coated tablet contains 50 mg of levodopa, 12.5 mg of carbidopa anhydrous (as 13.5 mg carbidopa monohydrate) and 200 mg of entacapone." The Boss is anhydrous carbidopa, so the PAI is Carbidopa.