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Kit for the preparation of Lymphoseek (technetium Tc 99m tilmanocept)

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Overview

What is Kit for the preparation of Lymphoseek (technetium Tc 99m tilmanocept)?

Chemical Characteristics

The active ingredient in Lymphoseek, a radioactive diagnostic agent, is technetium Tc 99m tilmanocept. Technetium Tc 99m binds to the diethylenetriaminepentaacetic acid (DTPA) moieties of the tilmanocept molecule.

Lymphoseek (technetium Tc 99m tilmanocept) injection is supplied as a Kit which contains five Tilmanocept Powder vials. Each Tilmanocept Powder vial contains the non-radioactive ingredients needed to produce technetium Tc 99m tilmanocept. The vial contains a sterile, non-pyrogenic, white to off-white lyophilized powder (under nitrogen) that consists of a mixture of 250 mcg tilmanocept, 20 mg trehalose dihydrate, 0.5 mg glycine, 0.5 mg sodium ascorbate, and 0.075 mg stannous chloride dihydrate.

The DILUENT for Lymphoseek contains 4.5 mL sterile buffered saline consisting of 0.04% (w/v) potassium phosphate, 0.11% (w/v) sodium phosphate (heptahydrate), 0.5% (w/v) sodium chloride, and 0.4% (w/v) phenol.

Physical Characteristics

Technetium Tc 99m decays by isomeric transition with a physical half-life of approximately 6 hours. The principal photon that is useful for detection and imaging studies is listed in .

External Radiation

The linear mass energy absorption attenuation coefficient for Tc 99m is 18.9 cm. The first half-value layer is 0.037 cm of lead (Pb). The use of a 0.25 cm thick standard radiation lead shield will attenuate the radiation emitted by millicurie amounts of technetium Tc 99m by a factor of about 100. A range of values for the relative attenuation of the radiation of technetium Tc 99m that results with various thicknesses of lead shielding are displayed in .

To correct for physical decay of the radionuclide, the fractions that remain at selected intervals after the time of calibration are shown in . 



What does Kit for the preparation of Lymphoseek (technetium Tc 99m tilmanocept) look like?



What are the available doses of Kit for the preparation of Lymphoseek (technetium Tc 99m tilmanocept)?

The Kit for preparation of Lymphoseek contains five Tilmanocept Powder 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. ()

What should I talk to my health care provider before I take Kit for the preparation of Lymphoseek (technetium Tc 99m tilmanocept)?

How should I use Kit for the preparation of Lymphoseek (technetium Tc 99m tilmanocept)?

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

Lymphoseek is a radioactive drug and should be handled with appropriate safety measures to minimize radiation exposure .  Use waterproof gloves, effective radiation shielding, and appropriate safety measures when preparing and handling Lymphoseek.

Radiopharmaceuticals should be used by or under the control of physicians who are qualified by specific training and experience 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 radionuclides.


What interacts with Kit for the preparation of Lymphoseek (technetium Tc 99m tilmanocept)?

Sorry No Records found


What are the warnings of Kit for the preparation of Lymphoseek (technetium Tc 99m tilmanocept)?

Sorry No Records found


What are the precautions of Kit for the preparation of Lymphoseek (technetium Tc 99m tilmanocept)?

Sorry No Records found


What are the side effects of Kit for the preparation of Lymphoseek (technetium Tc 99m tilmanocept)?

Sorry No records found


What should I look out for while using Kit for the preparation of Lymphoseek (technetium Tc 99m tilmanocept)?

None.


What might happen if I take too much Kit for the preparation of Lymphoseek (technetium Tc 99m tilmanocept)?

Sorry No Records found


How should I store and handle Kit for the preparation of Lymphoseek (technetium Tc 99m tilmanocept)?

The Kit for the preparation of Lymphoseek (technetium Tc 99m tilmanocept) injection (NDC 65857-425-05) includes:The Kit for the preparation of Lymphoseek (technetium Tc 99m tilmanocept) injection (NDC 65857-450-05) includes:StorageStore Kit for the preparation of Lymphoseek (technetium Tc 99m tilmanocept) injection in the original packaging at USP controlled room temperature 20°C - 25°C (68°F - 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). Store radiolabeled Lymphoseek in radiation shielding at room temperature.  Use radiolabeled Lymphoseek within 6 hours of preparation. HandlingThis Kit for the preparation of Lymphoseek (technetium Tc 99m tilmanocept) injection is approved for distribution to persons licensed by the U.S. Nuclear Regulatory Commission to use by product material identified in 10 CFR 35.200 or under an equivalent license issued by an Agreement State.The Kit for the preparation of Lymphoseek (technetium Tc 99m tilmanocept) injection (NDC 65857-425-05) includes:The Kit for the preparation of Lymphoseek (technetium Tc 99m tilmanocept) injection (NDC 65857-450-05) includes:StorageStore Kit for the preparation of Lymphoseek (technetium Tc 99m tilmanocept) injection in the original packaging at USP controlled room temperature 20°C - 25°C (68°F - 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). Store radiolabeled Lymphoseek in radiation shielding at room temperature.  Use radiolabeled Lymphoseek within 6 hours of preparation. HandlingThis Kit for the preparation of Lymphoseek (technetium Tc 99m tilmanocept) injection is approved for distribution to persons licensed by the U.S. Nuclear Regulatory Commission to use by product material identified in 10 CFR 35.200 or under an equivalent license issued by an Agreement State.The Kit for the preparation of Lymphoseek (technetium Tc 99m tilmanocept) injection (NDC 65857-425-05) includes:The Kit for the preparation of Lymphoseek (technetium Tc 99m tilmanocept) injection (NDC 65857-450-05) includes:StorageStore Kit for the preparation of Lymphoseek (technetium Tc 99m tilmanocept) injection in the original packaging at USP controlled room temperature 20°C - 25°C (68°F - 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). Store radiolabeled Lymphoseek in radiation shielding at room temperature.  Use radiolabeled Lymphoseek within 6 hours of preparation. HandlingThis Kit for the preparation of Lymphoseek (technetium Tc 99m tilmanocept) injection is approved for distribution to persons licensed by the U.S. Nuclear Regulatory Commission to use by product material identified in 10 CFR 35.200 or under an equivalent license issued by an Agreement State.The Kit for the preparation of Lymphoseek (technetium Tc 99m tilmanocept) injection (NDC 65857-425-05) includes:The Kit for the preparation of Lymphoseek (technetium Tc 99m tilmanocept) injection (NDC 65857-450-05) includes:StorageStore Kit for the preparation of Lymphoseek (technetium Tc 99m tilmanocept) injection in the original packaging at USP controlled room temperature 20°C - 25°C (68°F - 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). Store radiolabeled Lymphoseek in radiation shielding at room temperature.  Use radiolabeled Lymphoseek within 6 hours of preparation. HandlingThis Kit for the preparation of Lymphoseek (technetium Tc 99m tilmanocept) injection is approved for distribution to persons licensed by the U.S. Nuclear Regulatory Commission to use by product material identified in 10 CFR 35.200 or under an equivalent license issued by an Agreement State.The Kit for the preparation of Lymphoseek (technetium Tc 99m tilmanocept) injection (NDC 65857-425-05) includes:The Kit for the preparation of Lymphoseek (technetium Tc 99m tilmanocept) injection (NDC 65857-450-05) includes:StorageStore Kit for the preparation of Lymphoseek (technetium Tc 99m tilmanocept) injection in the original packaging at USP controlled room temperature 20°C - 25°C (68°F - 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). Store radiolabeled Lymphoseek in radiation shielding at room temperature.  Use radiolabeled Lymphoseek within 6 hours of preparation. HandlingThis Kit for the preparation of Lymphoseek (technetium Tc 99m tilmanocept) injection is approved for distribution to persons licensed by the U.S. Nuclear Regulatory Commission to use by product material identified in 10 CFR 35.200 or under an equivalent license issued by an Agreement State.The Kit for the preparation of Lymphoseek (technetium Tc 99m tilmanocept) injection (NDC 65857-425-05) includes:The Kit for the preparation of Lymphoseek (technetium Tc 99m tilmanocept) injection (NDC 65857-450-05) includes:StorageStore Kit for the preparation of Lymphoseek (technetium Tc 99m tilmanocept) injection in the original packaging at USP controlled room temperature 20°C - 25°C (68°F - 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). Store radiolabeled Lymphoseek in radiation shielding at room temperature.  Use radiolabeled Lymphoseek within 6 hours of preparation. HandlingThis Kit for the preparation of Lymphoseek (technetium Tc 99m tilmanocept) injection is approved for distribution to persons licensed by the U.S. Nuclear Regulatory Commission to use by product material identified in 10 CFR 35.200 or under an equivalent license issued by an Agreement State.The Kit for the preparation of Lymphoseek (technetium Tc 99m tilmanocept) injection (NDC 65857-425-05) includes:The Kit for the preparation of Lymphoseek (technetium Tc 99m tilmanocept) injection (NDC 65857-450-05) includes:StorageStore Kit for the preparation of Lymphoseek (technetium Tc 99m tilmanocept) injection in the original packaging at USP controlled room temperature 20°C - 25°C (68°F - 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). Store radiolabeled Lymphoseek in radiation shielding at room temperature.  Use radiolabeled Lymphoseek within 6 hours of preparation. HandlingThis Kit for the preparation of Lymphoseek (technetium Tc 99m tilmanocept) injection is approved for distribution to persons licensed by the U.S. Nuclear Regulatory Commission to use by product material identified in 10 CFR 35.200 or under an equivalent license issued by an Agreement State.


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Lymphoseek (technetium Tc 99m tilmanocept) is a radioactive diagnostic agent.  It accumulates in lymphatic tissue and selectively binds to mannose binding receptors (CD206) located on the surface of macrophages and dendritic cells. Technetium Tc 99m tilmanocept is a macromolecule consisting of multiple units of diethylenetriaminepentaacetic acid (DTPA) and mannose, each covalently attached to a 10 kDa dextran backbone.  The mannose acts as a ligand for the receptor, and the DTPA serves as a chelating agent for labeling with technetium Tc 99m.

Non-Clinical Toxicology
None.

Lymphoseek may pose a risk of hypersensitivity reactions due to its chemical similarity to dextran .  Serious hypersensitivity reactions have been associated with dextran and modified forms of dextran (such as iron dextran drugs).

Before administering Lymphoseek, ask patients about prior hypersensitivity reactions to drugs, especially to dextran and modified forms of dextran.  Have resuscitation equipment and trained personnel immediately available at the time of Lymphoseek administration.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

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Tips

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Interactions

Interactions

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