Pharmaceutical particulars : מידע רוקחי

6.       PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Disodium phosphate anhydrous
Maize starch
Silica, colloidal anhydrous
Sodium thiosulphate, pentahydrate
Sodium hydroxide
Water for injections
Capsule:         Gelatin
Titanium dioxide (E171)
Acetic acid
Yellow iron oxide (E172)
Sodium laurilsulfate
6.2 Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

6.3 Shelf Life
The shelf life for this product is 14 days from the activity reference date stated on the label.

6.4 Special precautions for storage
Store below 25oC. Do not freeze.
Store in the original package to prevent from external radiation exposure in accordance with national regulations on radioactive materials.

6.5 Nature and contents of container
Each capsule is contained within a polycarbonate cup with a charcoal disc to absorb iodine-131. This cup is enclosed within a lead shield.

Pack sizes: 37-740 MBq in 37 MBq steps, 50 – 1000 MBq in 50 MBq steps, 0.925-5.55 GBq in 185 MBq steps and 1000 – 5500 MBq in 100 MBq steps. Each pack contains a single capsule.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling
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 local competent official organisation.
Radiopharmaceuticals should be prepared in a manner which satisfies both radiation safety and pharmaceutical quality requirements.

Precautions to be taken before handling or administration of the medicinal product The administration of sodium iodide (131I) for therapy is likely to result in a relatively high radiation dose to most patients and may result in significant environmental hazard and creates risks for other persons from external radiation or contamination from spill of urine, vomiting, etc. 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. Suitable precautions in accordance with national regulations should therefore be taken concerning the activity eliminated by the patients in order to avoid any contaminations.
Administration procedures should be carried out in a way to minimize risk of contamination of the medicinal product and irradiation of the operators. Adequate shielding is mandatory.
When opening the container personnel should be aware that free radioactivity may be registered on monitors. This activity is due to Xe-131m which is formed for 1.17 % in the decay of I-131. Though visible on monitors this does not pose a relevant risk for personnel.
The effective dose rate by inhalation of the Xe-131m formed is 0.1% of the dose rate at 1 m from a lead-shielded capsule.

Precautions and activity data
1.3% of iodine (131I) decays via xenon (131mXe) (half-life 12 days) and a small amount of xenon (131mXe) activity may be present in the packaging as a result of diffusion. It is therefore recommended that the transport container be opened in a ventilated enclosure and that, after removal of the capsule, the packaging materials are allowed to stand overnight before disposal to permit the release of absorbed xenon (131mXe).
In addition, there can be limited leakage of volatile iodine-131 activity from the capsule.
The activity of a capsule at 12h00 GMT from calibration date can be calculated from the table 1.

Table 1
Day                 Coefficient           Day                   Coefficient -6                  1,677                 5                     0,650 -5                  1,539                 6                     0,596 -4                  1,412                 7                     0,547 -3                  1,295                 8                     0,502 -2                  1,188                 9                     0,460 -1                  1,090                 10                    0,422 0                   1,000                 11                    0,387 1                   0,917                 12                    0,355 2                   0,842                 13                    0,326
3                   0,772                 14                    0,299 4                   0,708
Any unused product or waste material should be disposed of in accordance with local requirements.