TECHNETIUM TC 99M SESTAMIBI injection, powder, for solution

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

TECHNETIUM TC-99M SESTAMIBI (UNII: 971Z4W1S09) (TECHNETIUM TC-99M SESTAMIBI - UNII:971Z4W1S09)

Disponibil de la:

Jubilant Draximage (USA) Inc.

INN (nume internaţional):

TECHNETIUM TC-99M SESTAMIBI

Compoziție:

TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE 1 mg in 1 mL

Calea de administrare:

INTRAVENOUS

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

Myocardial Imaging: Kit for the preparation of Technetium Tc 99m Sestamibi Injection is a myocardial perfusion agent that is indicated for detecting coronary artery disease by localizing myocardial ischemia (reversible defects) and infarction (non-reversible defects), in evaluating myocardial function and developing information for use in patient management decisions. Technetium Tc 99m Sestamibi evaluation of myocardial ischemia can be accomplished with rest and cardiovascular stress techniques (e.g., exercise or pharmacologic stress in accordance with the pharmacologic stress agents labeling). It is usually not possible to determine the age of a myocardial infarction or to differentiate a recent myocardial infarction from ischemia. Breast Imaging: Kit for the preparation of Technetium Tc 99m Sestamibi Injection is indicated for planar imaging as a second line diagnostic drug after mammography to assist in the evaluation of breast lesions in patients with an abnormal mammogram or a palpable breast mass. Kit f

Rezumat produs:

Kit for the Preparation of Technetium Tc 99m Sestamibi Injection is supplied as a 10 mL vial in kits of five (5) (NDC # 45548-141-05), ten (10) (NDC # 45548-141-10) and thirty (30) (NDC # 45548-141-30), sterile and non pyrogenic. The patient dose should be measured by a suitable radioactivity calibration system immediately prior to patient administration. Radiochemical purity should be checked prior to patient administration. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Prior to lyophilization the pH is between 5.6 and 5.8. The contents of the vial are lyophilized and stored under nitrogen. Store at 15 °C to 25 °C (59 °F to 77 °F) before and after reconstitution. Kit for Preparation of Technetium Tc 99m Sestamibi Injection contains no preservatives. Included in each kit of five (5) vials, ten (10) vials and thirty (30) vials, is a package insert and a sufficient number of vial shield labels and radiation warning labels. This reagent kit 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.

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

TECHNETIUM TC 99M SESTAMIBI- TECHNETIUM TC 99M SESTAMIBI INJECTION,
POWDER, FOR SOLUTION
JUBILANT DRAXIMAGE (USA) INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE KIT
FOR THE PREPARATION OF
TECHNETIUM TC 99M SESTAMIBI INJECTION SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING
INFORMATION FOR KIT FOR THE PREPARATION OF TECHNETIUM TC 99M SESTAMIBI
INJECTION.KIT FOR THE
PREPARATION OF TECHNETIUM TC 99M SESTAMIBI INJECTION
(TETRAKIS(1-ISOCYANO-2-METHOXY-2-
METHYL-PROPANE)-COPPER(1) TETRAFLUOROBORATE) INJECTION, POWDER,
LYOPHILIZED, FOR SOLUTION
FOR
INTRAVENOUS USE.
INITIAL U.S. APPROVAL: DECEMBER 1990
INDICATIONS AND USAGE
Technetium Tc 99m Sestamibi, is a myocardial perfusion agent indicated
for:
detecting coronary artery disease by localizing myocardial ischemia
(reversible defects) and infarction
(non-reversible defects) (1)
evaluating myocardial function and developing information for use in
patient management decisions (1)
DOSAGE AND ADMINISTRATION
FOR MYOCARDIAL IMAGING: The suggested dose range for I.V.
administration of Technetium Tc 99m
Sestamibi in a single dose to be employed in the average patient (70
kg) is 370 to 1110 MBq (10 to 30
mCi) (2).
FOR BREAST IMAGING: The recommended dose range for I.V. administration
of Technetium Tc 99m
Sestamibi is a single dose of 740 to 1110 MBq (20 to 30 mCi) (2).
DOSAGE FORMS AND STRENGTHS
Kit for the Preparation of Technetium Tc 99m Sestamibi Injection is
supplied as a lyophilized sterile and
non-pyrogenic mixture in a 10 mL vial in kits of five (5) (NDC #
45548-141-05), ten (10) (NDC # 45548-
141-10) and thirty (30) (NDC # 45548-141-30) (3).
CONTRAINDICATIONS
None known (4).
WARNINGS AND PRECAUTIONS
Pharmacologic induction of cardiovascular stress may be associated
with serious adverse events such
as myocardial infarction, arrhythmia, hypotension, bronchoconstriction
and cerebrovascular events
(5.1).
Technetium Tc 99m Sestamibi has been rarely associated with acute
severe allergic and anaphylactic
even