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

Each sterile, non-pyrogenic, lyophilized Tilmanocept Powder vial contains:

Tilmanocept 250mcg; Trehalose, Dihydrate 20 mg; Glycine 0.5 mg; Sodium Ascorbate 0.5 mg; Stannous Chloride, Dihydrate 0.075 mg

The Tilmanocept Powder vials are sealed under nitrogen at the time of manufacturer, and contain no preservatives.

DILUENT for Lymphoseek contains:

Each vial contains 4.5 mL sterile, non-pyrogenic, aqueous solution of:

Potassium Phosphate 0.04% w/v; Sodium Phosphate-7H2 O 0.11% w/v; Sodium Chloride 0.50% w/v; Phenol 0.40% w/v

Rx Only

For Customer Service call: 1-800-476-5270

Web site: www.lymphoseek.com

WARNING: Radiopharmaceuticals should be used by persons who are qualified by specific training in the safe use and handling of radionuclides and whose experience and training have been approved by the appropriate governmental agency authorized to license the use of nuclides.

 
(click image for full-size original) KIT FOR THE PREPARATION OF LYMPHOSEEK (TECHNETIUM TC 99M TILMANOCEPT) tilmanocept kit 
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52579-1600
 
Packaging
# Item Code Package Description Multilevel Packaging
1  NDC:52579-1600-5 1 KIT in 1 CARTON contains a KIT
1   1 KIT in 1 KIT This package is contained within the CARTON (52579-1600-5)
 
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1  5 VIAL  5 
Part 2  5 VIAL  5 
 
Part 1 of 2
LYMPHOSEEK tilmanocept injection, powder, lyophilized, for solution 
Product Information
Item Code (Source) NDC:52579-1695
Route of Administration INTRADERMAL, SUBCUTANEOUS DEA Schedule 
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TECHNETIUM TC-99M TILMANOCEPT (TECHNETIUM TC-99M TILMANOCEPT)  TILMANOCEPT 250 ug
Inactive Ingredients
Ingredient Name Strength
TREHALOSE DIHYDRATE  20 mg
GLYCINE  0.5 mg
SODIUM ASCORBATE  0.5 mg
STANNOUS CHLORIDE  0.075 mg
SODIUM HYDROXIDE  
HYDROCHLORIC ACID  
NITROGEN  
Packaging
# Item Code Package Description Multilevel Packaging
1  NDC:52579-1695-1 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL None
Marketing Information 
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA202207 03/13/2013 
Part 2 of 2
STERILE BUFFERED SALINE DILUENT diluent injection, solution 
Product Information
Item Code (Source) NDC:52579-1649
Route of Administration INTRADERMAL, SUBCUTANEOUS DEA Schedule 
Inactive Ingredients
Ingredient Name Strength
POTASSIUM PHOSPHATE, UNSPECIFIED FORM  
SODIUM PHOSPHATE, DIBAS