Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Sodium chloride
Ascorbic acid
Sodium acetate
Sodium hydroxide
Gentisic acid
Acetic acid
Diethylene triamine pentaacetic acid (DTPA)
Water for injections

6.2   Incompatibilities

This medicinal product must not be mixed with other medicinal products except those mentioned in section 4.2.

6.3   Shelf life

72 hours from the date and time of calibration.
The expiry date of the product is indicated on the packaging materials.
6.4   Special precautions for storage

Store below 25°C.

Do not freeze
Store in the original package to protect from ionising radiation (lead shielding).

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

Clear, colourless Type I glass vial, closed with a bromobutyl rubber stopper and aluminium seal.

Each vial contains a volume that ranges from 20.5 to 25.0 mL of solution, corresponding to an activity of 7 400 MBq at date and time of infusion.

The vial is enclosed within a lead container for protective shielding.

6.6   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 instructions on preparation of the medicinal product before administration, see section 10.

If at any time in the preparation of this medicinal product the integrity of the lead container or the 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 follow 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 national regulations must therefore be taken.

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 others living in the same household as individuals undergoing treatment or to the general public depending on the level of activity administered, hence radioprotection rules should be followed (see section 4.4). Suitable precautions in accordance with national 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 of in accordance with local requirements.

Lutetium-177 for Lutathera may be prepared using two different sources of stable nuclides (either lutetium-176 or ytterbium-176) resulting in different waste management. The user must consult the documentation provided before using Lutathera to ensure appropriate waste management.