Editorial Guideline Release Notes; Version 20180223
A technical correction was made in this release to the Combination Products page. The following was (in italics) in the previous version:
NTP Type Attribute
To indicate that combination products are a different type of medicinal product, rather than use an additional qualifier (such as “combination product”) in the NTP description, combination products will be indicated using a “type” attribute in the NTP class.
The NTP type attribute will be used to indicate only those combination products that contain two or more manufactured items that contain active ingredient substance(s). The NTP Type attribute will not be used on combination products where the second manufactured item is:
a therapeutically inactive diluent
a therapeutically inactive “placebo” (as in the Brevicon 28-day product)
Examples: the combination products shown in normal text below would have the type code applied; those shown in grey would not
clotrimazole 1 % cutaneous cream with clotrimazole 500 mg vaginal tablet
ethinylestradiol 35 microgram oral tablet and norethindrone 500 microgram with lactose oral tablet
conjugated estrogen 625 microgram oral tablet with medroxyprogesterone acetate 2.5 mg oral tablet
amoxicillin (amoxicillin trihydrate) 500 mg oral capsule with clarithromycin 500 mg film coated oral tablet with lansoprazole prolonged release 30 mg oral capsule
budesonide 2 mg dispersible tablet for rectal solution with vehicle for rectal solution
glucagon 1 mg powder for solution for injection with water for injection 1.5 mL
follitropin alfa 33 mcg powder for solution for injection with diluent solution
The words in bold above did not appear in "grey font" on InfoScribe. The following edit has been made to this section as follows to correct this error:
he NTP description, combination products will be indicated using a “type” attribute in the NTP class.
The NTP type attribute will be used to indicate only those combination products that contain two or more manufactured items that contain active ingredient substance(s). The NTP Type attribute will not be used on combination products where the second manufactured item is:
a therapeutically inactive diluent
a therapeutically inactive “placebo” (as in the Brevicon 28-day product)
Examples of the combination products shown below would have the type code applied:
clotrimazole 1 % cutaneous cream with clotrimazole 500 mg vaginal tablet
ethinylestradiol 35 microgram oral tablet and norethindrone 500 microgram with lactose oral tablet
conjugated estrogen 625 microgram oral tablet with medroxyprogesterone acetate 2.5 mg oral tablet
amoxicillin (amoxicillin trihydrate) 500 mg oral capsule with clarithromycin 500 mg film coated oral tablet with lansoprazole prolonged release 30 mg oral capsule
Examples of the combination products shown below would NOT have the type code applied:
budesonide 2 mg dispersible tablet for rectal solution with vehicle for rectal solution
glucagon 1 mg powder for solution for injection with water for injection 1.5 mL
follitropin alfa 33 mcg powder for solution for injection with diluent solution
Acknowledgements
Particular thanks go to the members of the Advisory Group that supported the development of these Guidelines; names and organizations are listed in Appendix A of the Editorial Guidelines themselves
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Copyright information for the Editorial Guidelines
The Editorial Guidelines for the Canadian Clinical Drug Data Set are available for all users to read alongside the actual content of the Canadian Clinical Drug Data Set. They explain the model used in the Canadian Clinical Drug Data Set and how decisions on the population of that model and on the authoring rules for the formal name descriptions.