Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS

6.1   List of excipients

Stannous chloride dihydrate
Cysteine hydrochloride monohydrate
Sodium Citrate
Mannitol
6.2   Incompatibilities

This medicinal product must not be mixed with other medicinal products except those mentioned in section 12.

6.3   Shelf life

The expiry date of the product is indicated on the packaging materials.


6.4   Special precautions for storage

Do not store above 25°C. Keep the vials in the outer carton, in order to protect from light.

After reconstitution and radiolabelling, do not store above 25° C and use within 10 hours.
Storage of radiopharmaceuticals should be in accordance with national regulation on radioactive materials.

6.5   Nature and contents of container

15 mL multidose glass vial, type I borosilicate glass sealed with a bromobutyl rubber stopper and an aluminium caps.

Pack size: 5 vials

6.6   Special precautions for disposal
General warnings
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.

Contents of the vial are intended only for use in the preparation of technetium (99mTc) sestamibi and are not to be administered directly to the patient without first undergoing the preparative procedure.

For instructions on extemporary preparation 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 extemporary preparation is not radioactive. However, after sodium pertechnetate (99mTc), 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 or any other biological fluids. Radiation protection precautions in accordance with national regulations must therefore be taken.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.