1 syringe x 0.5 mL
 0.5 mL 2.5 mL
5 syringes x 0.2 mL or
4 syringes x 0.25 mL or

2 syringes x 0.5 mL
 1 mL 5 mL
Each Lymphoseek vial, once reconstituted and radiolabeled, would contain sufficient amount to provide doses for up to four patients when prepared according to the instructions. The radiolabeled Lymphoseek is to be used within 6 hours of its preparation. Discard the unused radiolabeled Lymphoseek.
Once the Reconstituted Vial Volume is established, use the following steps to prepare radiolabeled Lymphoseek:

a.Prior to radiolabeling, inspect the Tilmanocept Powder vial for any damage. Do not use if vial integrity appears compromised.
b.For radiolabeling, use Technetium Tc 99m pertechnetate, sodium injection solution from a technetium Tc 99m generator within 8 hours of its elution.
c.Do not vent the Tilmanocept Powder vial prior to or during radiolabeling.
d.Using a sterile syringe, aseptically draw approximately 92.5 MBq (2.5 mCi) of Technetium Tc 99m pertechnetate sodium injection solution in either about 0.35 mL volume (for 0.5 mL Reconstituted Vial Volume) or about 0.7 mL volume (for 2.5 mL or 5 mL Reconstituted Vial Volume). Assay the syringe for technetium Tc 99m activity in a dose calibrator.
e.Prior to reconstitution, write the radioactivity amount, the Reconstituted Vial Volume, date and time, expiration time and lot number in the space provided on the radioactive product vial label and affix it to the Tilmanocept Powder vial. Place the vial in a radiation shield and sanitize the septum with alcohol wipe.
f.Aseptically add Technetium Tc 99m pertechnetate, sodium injection solution (from step d above) to the Tilmanocept Powder vial. Without withdrawing the needle, remove an equal volume of headspace gas. Do not vent.
g.Remove the needle, gently shake the vial to mix the contents, and then let it stand at room temperature for at least 15 minutes.
h.Aseptically add the supplied DILUENT for Lymphoseek to the radiolabeled product in the Tilmanocept Powder vial to bring the volume to the Reconstituted Vial Volume of 0.5 mL, 2.5 mL, or 5 mL prior to filling the patient dose in syringe(s). To normalize pressure, withdraw an equal volume of headspace gas.
i.Assay the reconstituted vial for total radioactivity using a dose calibrator. Write the technetium Tc 99m activity concentration, total volume, assay time and date, expiration time, and lot number on the shield label supplied with the Kit. Affix the label to the shield.
j.Determine the radiochemical purity of the reconstituted product as described in 2.4. Do not use if the radiochemical purity is less than 90%.
k.Withdraw the required volume of the reconstituted product into the required number of syringes. Assay the syringe(s) in a dose calibrator. Write the radioactivity amount, date and time of assay, volume, and expiration time (this is not to exceed 6 hours from preparation time) on the supplied syringe label and affix it to the syringe(s).
l.Store the reconstituted product at room temperature in a shield. Use within the expiry time on the label.
Route of Administration and Injection Method:

The route of administration depends on the type of cancer and the planned injection technique. Inject Lymphoseek into a patient at least 15 minutes prior to intraoperative lymphatic mapping; do not delay mapping more than 15 hours after Lymphoseek injection. Table 2 shows the route of administration options.

Table 2. Lymphoseek Admin