PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - DILUENT

Diluent Label

NDC 65857-401-45

DILUENT for Lymphoseek

For diluting radiolabeled Lymphoseek only

Not for direct administration

See package insert for preparation and
administration instructions.

Single Dose Vial - Discard unused portion.

Rx Only 23001105-C04

Contents: 4.5 mL non-pyrogenic, aqueous
solution of 0.04% w/v Potassium Phosphate,
0.11% w/v Sodium Phosphate (Heptahydrate),
0.50% w/v Sodium Chloride and 0.40% w/v
Phenol.

Store in the original packaging at 20° to 25°C
(68° to 77°F), excursions permitted to 15° to
30°C (59° to 86°F) [See USP Controlled Room Temperature].

Distributed by:
Cardinal Health 414, LLC
Dublin, OH 43017

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INDICATIONS & USAGE SECTION

Highlight: Lymphoseek is a radioactive diagnostic agent indicated with or without scintigraphic imaging for:

•

Lymphatic mapping using a handheld gamma counter to locate lymph nodes draining a primary tumor site in adult and pediatric patients age one month and older with solid tumors for which this procedure is a component of intraoperative management. (1)

•

Guiding sentinel lymph node biopsy using a handheld gamma counter in patients with clinically node negative squamous cell carcinoma of the oral cavity, breast cancer or melanoma. (1)

1 INDICATIONS AND USAGE

Lymphoseek is a radioactive diagnostic agent indicated with or without scintigraphic imaging for:

•

Lymphatic mapping using a handheld gamma counter to locate lymph nodes draining a primary tumor site in adult and pediatric patients age one month and older with solid tumors for which this procedure is a component of intraoperative management.

•

Guiding sentinel lymph node biopsy using a handheld gamma counter in patients with clinically node negative squamous cell carcinoma of the oral cavity, breast cancer or melanoma.

DOSAGE FORMS & STRENGTHS SECTION

Highlight: For Injection: The Lymphoseek kit contains five vials each containing 250 mcg tilmanocept, and is packaged either with or without five DILUENT for Lymphoseek vials each containing 4.5 mL of sterile buffered saline with phenol. After radiolabeling with technetium Tc 99m and dilution, Lymphoseek contains approximately 92.5 MBq (2.5 mCi) and 250 mcg of technetium Tc 99m tilmanocept in 0.5 mL to 5 mL total volume for injection. (3)

3 DOSAGE FORMS AND STRENGTHS

For Injection: Lymphoseek (kit for preparation of technetium Tc 99m tilmanocept injection) is supplied as five vials each containing 250 mcg tilmanocept, and is packaged either with or without five DILUENT for Lymphoseek vials each containing 4.5 mL of sterile buffered saline with phenol. After radiolabeling with technetium Tc 99m, Lymphoseek contains approximately 92.5 MBq (2.5 mCi) and 250 mcg technetium Tc 99m tilmanocept in 0.5 mL to 5 mL total volume.

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CONTRAINDICATIONS SECTION

Highlight: None. (4)

4 CONTRAINDICATIONS

None.

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INFORMATION FOR PATIENTS SECTION

17 PATIENT COUNSELING INFORMATION

•

Advise patients to seek medical attention for reactions following injection of Lymphoseek such as difficulty breathing, skin rash, or other allergy manifestations.

•

Inform nursing women to pump and discard breast milk for at least 24 hours following administration of Lymphoseek injection [see Use in Specific Populations (8.2)].

Distributed by:

Cardinal Health 414, LLC
Dublin, OH 43017

Lymphoseek is a registered trademark of Cardinal Health 414, LLC.

Patent: www.lymphoseek.com/patent- information

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