Food and Drug Regulations

C.03.209 A package insert shall be included in every kit and shall show

• (a) the proper name and the brand name, if any, of the kit and a description of its use;

• (b) a list of the contents of the kit;

• (c) the name and address of the distributor referred to in paragraph C.01A.003(b) of the kit;

• (d) identification of the radionuclides that can be used to prepare the radiopharmaceutical;

• (e) directions for preparing the radiopharmaceutical and a statement of the storage requirements for the prepared radiopharmaceutical;

• (f) a statement of the duration of the useful life of the prepared radiopharmaceutical;

• (g) a description of the biological actions of the prepared radiopharmaceutical;

• (h) indications and contraindications in respect of the prepared radiopharmaceutical;

• (i) warnings and precautions in respect of the components and the prepared radiopharmaceutical;

• (j) the adverse reactions, if any, associated with the prepared radiopharmaceutical;

• (k) where applicable, the pharmacology and toxicology of the prepared radiopharmaceutical or a statement that such information is available on request;

• (l) the radiation dosimetry in respect of the prepared radiopharmaceutical;

• (m) a statement of the recommended use for the prepared radiopharmaceutical and the recommended radioactivity to be administered for that use;

• (n) a statement of the route of administration of the prepared radiopharmaceutical; and

• (o) a recommendation that the radiochemical purity and radioactivity content of the prepared radiopharmaceutical be checked prior to administration.