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Author: Admin | 2025-04-28
Cross-contamination during manufacturing should be described (e.g., peanuts, gluten).For biosimilars, include a narrative description of the biosimilar biologic drug that is similar to the narrative in the product monograph of the reference biologic drug. Incorporate changes as necessary where there are descriptive differences between the biosimilar and the reference biologic drug due to, for example, differences in formulation.Presentation: narrative6.1 Physical characteristicsThis subsection applies to radiopharmaceuticals only. Include a brief description of physical characteristics including physical half-life, principle radiation emission data, and physical decay chart (in tabular format). For Generators, the physical characteristics data for both the parent and the daughter radionuclides should be provided. Further and more detailed information (e.g., pH, particle size) should appear in 13 Pharmaceutical Information.Presentation: table6.2 External radiationThis subsection applies to radiopharmaceuticals only. Include a brief description of the external radiation for the radioisotope already present in the final product, or to be used in reconstitution process. Include the specific gamma ray constant for the radioisotope, and the radiation attenuation by lead shielding (in tabular format). For Generators, the physical decay chart for both the parent and the daughter radionuclides should be included.Presentation: table7. Warnings and precautionsInclude clinically significant information about all effects that may pose a hazard to the patient, as well as precautions to be exercised by the healthcare professional, care provider, or by the patient to promote safe and effective use of the drug. Where applicable, genetic polymorphisms should be specified under the appropriate subheading.For blood products, include the following statement:This product is prepared from large pools of human plasma. Thus, there is a possibility it may contain causative agents of viral or other undetermined diseases.For all radiopharmaceutical products, a statement about the special restrictions for use should be provided to complement the information contained in the Serious Warnings and Precautions Box. The
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