KIT FOR THE PREPARATION OF LYMPHOSEEK (TECHNETIUM TC 99M TILMANOCEPT)- tilmanocept kit

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

TECHNETIUM TC-99M TILMANOCEPT (UNII: 8IHI69PQTC) (TECHNETIUM TC-99M TILMANOCEPT - UNII:8IHI69PQTC)

Tilgjengelig fra:

Cardinal Health 414, LLC

INN (International Name):

TECHNETIUM TC-99M TILMANOCEPT

Sammensetning:

TILMANOCEPT 250 ug

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Lymphoseek is a radioactive diagnostic agent indicated with or without scintigraphic imaging for: None. There are no available data on Lymphoseek use in pregnant women. Additionally, animal reproduction studies have not been conducted with technetium Tc 99m tilmanocept. However, all radiopharmaceuticals, including Lymphoseek, have a potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose. If considering Lymphoseek administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes based on the radiation dose from the drug and the gestational timing of exposure. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies are 2 to 4% and 15

Produkt oppsummering:

The Lymphoseek (kit for the preparation of technetium Tc 99m tilmanocept injection) (NDC 65857-425-05) includes: The Lymphoseek (kit for the preparation of technetium Tc 99m tilmanocept injection) (NDC 65857-450-05) includes: Storage Store Lymphoseek (kit for the preparation of technetium Tc 99m tilmanocept injection) 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]. Store radiolabeled Lymphoseek in radiation shielding at room temperature.  Use radiolabeled Lymphoseek within 6 hours of preparation. Discard unused portion. Handling This Lymphoseek (kit for the preparation of 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.

Autorisasjon status:

New Drug Application

Preparatomtale

KIT FOR THE PREPARATION OF LYMPHOSEEK (TECHNETIUM TC 99M
TILMANOCEPT)- TILMANOCEPT
CARDINAL HEALTH 414, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LYMPHOSEEK SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR LYMPHOSEEK.
LYMPHOSEEK (KIT FOR THE PREPARATION OF TECHNETIUM TC 99M TILMANOCEPT
INJECTION) FOR,
SUBCUTANEOUS, INTRADERMAL, SUBAREOLAR, OR PERITUMORAL USE
INITIAL U.S. APPROVAL: 2013
INDICATIONS AND USAGE
Lymphoseek is a radioactive diagnostic agent indicated with or without
scintigraphic imaging for:
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
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)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
Hypersensitivity: Ask patients about prior reactions to drugs,
especially dextran or modified forms of
dextran. Observe for hypersensitivity signs and symptoms following
Lymphoseek injection. Have
resuscitation equipment and trained personnel immediately available.
(5.1)
ADVERSE REACTIONS
The most common adverse reactions (incidence < 1%) are injection site
irritation and/or pain. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT CARDINAL HEALTH AT
1-800-618-2768 OR
WWW.LYMPHOSEEK.COM OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH
USE IN SPECIFIC POPULATIONS
Lactation. To decrease radiation exposure to the breastfed child,
advise a lactating woman to pump and
discard breast milk after the administration of Lymphoseek for 24
hours. (8.2)
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 9/2023
Lymphatic mapping using a handheld gamma counter to locate lymph node