Pharmaceutical particulars : מידע רוקחי

6     PHARMACEUTICAL PARTICULARS
6.1     List of excipients

Sodium D-gluconate
Disodium sulphosalicylate
Stannous chloride dihydrate
Sodium hydrogen carbonate
Nitrogen gas

6.2     Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products except those mentioned in section 11.

6.3     Shelf life

The expiry date of the product is indicated on the packaging materials.
Chemical and physical in-use stability of the reconstituted solution for injection has been demonstrated for 12 hours at 2°C-25°C.

Store the reconstituted product below 25°C. Do not freeze.

6.4     Special precautions for storage
Store in a refrigerator (2°C-8°C). Store in the original package in order to protect from light.

For storage conditions of the reconstituted medicinal product, see section 6.3.

Storage should be in accordance with national regulations for radioactive materials.
6.5     Nature and contents of container

The product is supplied in a 10 ml clear glass vial sealed with a chlorobutyl rubber closure and flip off overseal.

Pack sizes: 2 or 5 vials.

Not all pack sizes may be marketed.
6.6     Special precautions for disposal

The reconstituted product is a clear colourless solution.

General warning
Radiopharmaceuticals should be received, used and administered only by authorized 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) tetrofosmin 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 11.

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 (99mTc), 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 the conditions specified by the local competent authority. Contaminated material must be disposed of as radioactive waste via authorised route.