Special precautions for disposal and other handling: For single use only.
General warning: Radiopharmaceuticals should be received, used and administered only by authorised persons in designated clinical settings. Their 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.
For instruction on preparation of the medicinal product before administration, see Instructions for preparation of radiopharmaceuticals as follows.
If at any time in the preparation of this medicinal product the integrity of this container and 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.
It is necessary to wear waterproof gloves and suitable aseptic techniques when handling the medicinal product.
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 local regulations must therefore be taken.
The surface dose rates and the accumulated dose depend on many factors. Measurements on the location and during work are critical and should be practiced for more precise and instructive determination of overall radiation dose to the staff. Healthcare personnel are advised to limit the time of close contact with patients injected with Lutathera. The use of television monitor systems to monitor the patients is recommended. Given the half-life of 177Lu it is specially recommended to avoid internal contamination. It is necessary to use protective high quality (latex/nitrile) gloves to avoid direct contact with the radiopharmaceutical (vial/syringe). For minimising radiation exposure, always use the principles of time, distance and shielding (reducing the manipulation of the vial and using the material already supplied par the manufacturer).
This preparation is likely to result in a relatively high radiation dose to most patients. The administration of 7,400 MBq may result in significant environmental hazard.
This may be of concern to the immediate family of those individuals undergoing treatment or the general public depending on the level of activity administered, hence radioprotection rules should be followed (Precautions). Suitable precautions in accordance with local regulations should be taken concerning the activity eliminated by the patients in order to avoid any contaminations.
Any unused medicinal product or waste material should be disposed according to local requirements.
Instructions for preparation of radiopharmaceuticals: Quality controls: The solution should be visually inspected for damage and contamination before use, and only clear solutions free of visible particles should be used. The visual inspection of the solution should be performed under a shielded screen for radioprotection purposes. The vial must not be opened.
If at any time in the preparation of this medicinal product the integrity of this vial is compromised, it should not be used.
The amount of radioactivity in the vial must be measured prior to infusion using a suitable radioactivity calibration system in order to confirm that the actual amount of radioactivity to be administered is equal to the planned amount at the infusion time.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements (see Special precautions for disposal and other handling as previously mentioned).
Incompatibilities: This medicinal product must not be mixed with other medicinal products except those mentioned in Dosage & Administration.