Kit for the preparation of Lymphoseek (technetium Tc 99m tilmanocept) Injection is distributed by Navidea Biopharmaceuticals, Inc., Dublin, OH 43017

Lymphoseek is a registered trademark of Navidea Biopharmaceuticals, Inc.

Revision date: 02/2013

6-D001712C

Package/Label -- Principal Display Panel -- Vial Container (Part 1 -- 250mcg Tilmanocept Powder Vial)NDC 52579-1695-1

Tilmanocept Powder for preparation of Lymphoseek (technetium Tc 99m tilmanocept) Injection

250 mcg Tilmanocept per Vial

Administer only after radiolabeling with technetium Tc 99m.

See insert for content, preparation and administration instructions.

Store at controlled room temperature, 20°C -- 25°C (68°F -- 77°F).

Distributed by:

Navidea Biopharmaceuticals, Inc.

Dublin, OH 43017

Sterile Rx Only

6-L001642E

 
(click image for full-size original) Package/Label -- Principal Display Panel -- Vial Container (Part 2 -- 4.5 mL DILUENT Vial)NDC 52579-1649-1

DILUENT for Lymphoseek

For diluting radiolabeled Lymphoseek only

Not for direct administration

See package insert for preparation and administration instructions.

Sing Use Vial -- Discard unused portion.

RX Only
Contents: 4.5 mL non-pyrogenic, aqueous solution of 0.04% w/v Potassium Phosphate, 0.11% w/v Sodium Phosphate (Heptahydrate), 0.5% w/v Sodium Chloride and 0.40% w/v Phenol.

Store at controlled room temperature, 20°C -- 25°C (68°F -- 77°F), in original package, excursions permitted to 15°C to 30°C (59°F to 86°F).

Distributed by:

Navidea Biopharmaceuticals, Inc.

Dublin, OH 43017

23001105-N02

 
(click image for full-size original) Package/Label -- Principal Display Panel -- Radioassay Information Label (Product and Syringe)CAUTION RADIOACTIVE MATERIAL

Rx Only

Lymphoseek® (technetium Tc 99m tilmanocept) Injection

Store at controlled room temperature, 20°C -- 25°C (68°F -- 77°F).

MBq (mCi) Tc 99m/mL

Volume (mL)

Time/Date

Expiration Time Lot No.

6-L001694C

 
(click image for full-size original) Package/Label -- Principal Display Panel -- Radioassay Information Label (Shield)CAUTION RADIOACTIVE MATERIAL

Rx Only

Shield Label

Lymphoseek (technetium Tc 99m tilmanocept) Injection

Contents:

Technetium Tc 99m

pertechnetate, sodium

Tilmanocept 50 mcg

Trehalose, Dihydrate 4 mg

Glycine 0.1 mg

Sodium Ascorbate 0.1 mg

Stannous Chloride, Dihydrate 0.015 mg

Buffered Saline with phenol q.s.
Store at controlled room temperature,

20°C -- 25°C (68°F -- 77°F).

Discard Unused Portion

MBq (mCi) Tc 99m/mL

Volume (mL)

Time/Date

Expiration Time Lot No.

6-L001592D

 
(click image for full-size original) Package/Label -- Principal Display Panel -- 5 Vial BoxNDC: 52579-1600-5

Kit for the Preparation of Lymphoseek® (technetium Tc 99m tilmanocept) Injection

250 mcg Tilmanocept per Vial

Contents:

◦Five vials of Tilmanocept Powder, 250 mcg NDC 52579-1695-1
◦Five v