Afronis

General warning Radiopharmaceuticals should be received, used and administered only by authorised persons in designated clinical settings.‍‍‍‍‍‍​​​‍​​​​​​ Its receipt, storage, use, transfer and disposal are subject to the regulations and/or appropriate licences of the competent official organisation. Radiopharmaceuticals should be prepared in a manner which satisfies both radiation safety and pharmaceutical quality requirements. Appropriate aseptic precautions should be taken. Contents of the vial are intended only for use in the preparation of technetium ( 99mTc) exametazime injection and are not to be administered directly to the patient without first undergoing the preparative procedure. For instructions on reconstitution of the medicinal product before administration, see section 12. If at any time in the preparation of this product the integrity of this vial is compromised it should not be used. Administration procedures should be carried out in a way to minimise risk of contamination of the medicinal product and irradiation of the operators. Adequate shielding is mandatory. The content of the kit before reconstitution is not radioactive. However, after sodium pertechnetate ( 99m Tc), Ph.Eur. is added, adequate shielding of the final preparation must be maintained. The administration of radiopharmaceuticals creates risks for other persons from external radiation or contamination from spill of urine, vomiting etc. Radiation protection precautions in accordance with national regulations must therefore be taken. After use, all materials associated with the preparation and administration of radiopharmaceuticals, including any unused product and its container, should be decontaminated or treated as radioactive waste and disposed of in accordance with local requirements.