SPC for Radiopharmaceutical Products

The authorized sequence of topics for the presentation of product information (package leaflet) according to Guideline III/9163/89, reissued 10/25/1993 are listed in Table [Pg.160]

2 Qualitative and Quantitative Composition 2.1 Active Substance(s) 2.2 Physical Characteristics [Pg.160]

4 Clinical Particulars 4.1 Clinical Indications 4.2 Posology and Method of Administration 4.3 Contraindications 4.4 Special Warnings and Special Precautions for Use 4.5 Interactions with Other Medicaments 4.6 Pregnancy and Lactation 4.7 Effects on the Ability to Drive and Use Machines 4.8 Undesirable Effects 4.9 Overdose [Pg.160]

5 Pharmacological Properties 5.1 Pharmacodynamic Properties 5.2 Pharmacokinetics Properties 5.3 Preclinical Safety Data 5.4 Radiation Dosimetry [Pg.160]

6 Pharmaceutical Particulars 6.1 List of Excipient(s) 6.2 Incompatibilities 6.3 Shelf-life 6.4 Special Precautions for Storage 6.5 Nature of Contents of Container 6.6 Instructions for Use/Handling (Labeling and QC Methods) 6.7 Holder of the Marketing Authorization [Pg.160]

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