KIT FOR THE PREPARATION OF TECHNETIUM TC99M SESTAMIBI- technetium tc-99m sestamibi injection

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Sun Pharmaceutical Industries, Inc.

INN (International Name):

TECHNETIUM TC-99M SESTAMIBI

Sammensetning:

TECHNETIUM TC-99M SESTAMIBI 1 mg in 10 mL

Administreringsrute:

INTRAVENOUS

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Myocardial Imaging: 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 agent’s 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: Technetium Tc 99m Sestamibi 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. Technetium Tc 99m Sestamibi is not indicated for breast cancer scree

Produkt oppsummering:

Kit for the Preparation of Technetium Tc 99m Sestamibi for Injection is supplied as a lyophilized mixture in10 mL vials in a kit of five (5) (NDC #45567-0555-1) or a kit of thirty (30) (NDC #45567-0555-2), 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 5.4–5.7. The contents of the vial are lyophilized and stored under nitrogen. Store at 20-25°C (68-77°F)[See USP] before and after reconstitution. Kit for the Preparation of Technetium Tc 99m Sestamibi Injection contains no preservatives. Included in each five (5) vial kit is one (1) package insert, six (6) vial shield labels and six (6) radiation warning labels. Included in each thirty (30) vial kit is one (1) package insert, thirty-six (36) vial shield labels and thirty-six (36) radiation warning labels. This reagent kit for preparation of a radiopharmaceutical is approved for use by persons licensed pursuant to Section 120.547 Code of Massachusetts Regulation 105, or under equivalent license of the U.S. Nuclear Regulatory Commission of an Agreement State.

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

KIT FOR THE PREPARATION OF TECHNETIUM TC99M SESTAMIBI- TECHNETIUM
TC-99M
SESTAMIBI INJECTION
SUN PHARMACEUTICAL INDUSTRIES, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE KIT
FOR THE PREPARATION OF TECHNETIUM TC
99M SESTAMIBI FOR INJECTION SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR KIT FOR THE PREPARATION
OF TECHNETIUM TC 99M SESTAMIBI FOR INJECTION.
KIT FOR THE PREPARATION OF TECHNETIUM TC 99M SESTAMIBI FOR INJECTION
KIT FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1990
INDICATIONS AND USAGE
Technetium Tc 99m Sestamibi, is a myocardial perfusion agent indicated
for:
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
The following adverse reactions have been reported in ≤ 0.5% of
patients: signs and symptoms consistent with seizure
occurring shortly after administration of the agent; transient
arthritis; angioedema, arrhythmia, dizziness, syncope,
abdominal pain, vomiting, and severe hypersensitivity characterized by
dyspnea, hypotension, bradycardia, asthenia, and
vomiting within two hours after a second injection of Technetium Tc
99m Sestamibi. A few cases of flushing, edema,
injection site inflammation, dry mouth, fever, pruritis, rash,
urticaria and fatigue have also been attributed to administration
of the agent (6).
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT SUN PHARMACEUTICAL
INDUSTRIES, INC.AT 1-800-221-7554
OR 781-275-7120 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.(6)
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)
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 370-1110
MBq (10-30 mCi) (2).
For