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.
- SOR/79-236, s. 4
- SOR/93-202, s. 19
- SOR/97-12, s. 58
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