Pharmaceutical particulars : מידע רוקחי

6. PHARMACEUTICAL PARTICULARS
6.1.   List of excipients
• Column system:
Aluminiumoxide.
• Bag of solution for elution:
Sodium chloride, sodium nitrate, water for injection.
• Elution vials: Nitrogen under reduced pressure.

6.2.   Incompatibilities
This medicinal product must not be mixed with other medicinal products except for those indicated in section 12.

6.3.   Shelf life
Generator: 21 days from manufacturing date.
The calibration date and the expiry date are stated on the label.
Sodium pertechnetate (99mTc) eluate: After elution, use within 10 hours up to 10 withdrawals.
This medicinal product does not require any special storage conditions.

6.4.   Special precautions for storage
Generator: This medicinal product does not require any special storage conditions.
Eluate: For storage conditions after elution of the medicinal product, see section 6.3.
Vacuum vials: Do not store above 25°C.
Storage of radiopharmaceuticals should be in accordance with national regulation on radioactive materials.

6.5.   Nature and contents of container
Tekcis generator is delivered in a type A transport container. It comprises:
• a 250 mL soft polypropylene bag containing the elution solution (1). It is connected by a stainless steel needle (2) to the top of the chromatographic column;
• a glass chromatographic column (3) closed at both ends by silicone stoppers filled with sintered stainless steel frits (4). This column contains alumina onto which molybdenum-99 is adsorbed.
• an outlet needle (5) connected to the bottom of the column, while the other end of the needle (6) can be connected to an elution vial to elute the column or a protective vial (STE-ELU) to maintain sterility between two elutions.
The alumina column and needle are protected by cylindro-conical lead or tungsten shielding (7). Generators up to 25 GBq of technetium (99mTc) are protected by lead shielding and that 50 GBq generators are protected by tungsten shielding.
The entire system is placed in a moulded plastic parallelepiped shell (23 x 21 x 14 cm) (8-9).
The elution needle emerges from the upper part of the plastic shell, protected by a transport cap or protective vial (STE-ELU).
A safety valve (10), closed during transport, is situated next to the elution needle.

Accessories supplied with the generator:
• a bag of 7 sterile, pyrogen-free, partial-vacuum elution vials (TC-ELU-5) (11) allowing the elution of 5 mL to 6 mL.
• a sterile elution needle protective vial (STE-ELU).
Each elution vial or protective vial is a 15 mL, colourless, European Pharmacopoeia type I glass vial closed by a rubber stopper and sealed by an aluminium cap.
• An elution container (12) is provided with the first shipment.
Other accessories available:
• kits containing 7 x 15 mL vials: o    partial vacuum vials allowing elution of 5 to 6 mL;
o    partial vacuum vials allowing elution of 9 to 11 mL;
o    vacuum vials allowing elution of 14 to 16 mL.
• additional lead shielding adapted to the Tekcis generator: PROTECT ELU.
Packsize :
99m
Tc activity                 2       4     6     8     10    12     16   20   25    50   GBq (Maximal eluable activity at calibration date, 12h CET)
99
Mo activity                  2.5     5     7     9.5   12    14.5   19   24   30   60    GBq (at calibration date, 12h CET)


Diagram of the Tekcis generator in elution mode

12

9                                                                            11 

10
6



2


3

1                                                                            4 

5
7
1   bag of elution solution         cylindro-conical lead or tungsten   8 7 shielding
2   connection needle               lower plastic shell                      8
3   glass chromatography column     upper plastic shell                      9 4   silicone stopper + sintered     safety valve                             10 stainless steel frits
5   stainless steel outlet needle   elution vial                             11 
6   elution needle                  elution container                        12 

6.6.   Special precautions for disposal and other handling
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.

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 minimize risk of contamination of the medicinal product and irradiation of the operators. Adequate shielding is mandatory.

The administration of radiopharmaceuticals creates risks for other persons from external radiation or contamination from spills of urine, vomiting, etc. Radiation protection precautions in accordance with national regulations must therefore be taken.
The residual activity of the generator must be estimated before disposal.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.