国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
TECHNETIUM TC-99M SESTAMIBI (UNII: 971Z4W1S09) (TECHNETIUM TC-99M SESTAMIBI - UNII:971Z4W1S09)
Sun Pharmaceutical Industries, Inc.
TECHNETIUM TC-99M SESTAMIBI
TECHNETIUM TC-99M SESTAMIBI 1 mg in 10 mL
INTRAVENOUS
PRESCRIPTION DRUG
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
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.
Abbreviated New Drug Application
KIT FOR THE PREPARATION OF TECHNETIUM TC99M SESTAMIBI- TECHNETIUM TC-99M SESTAMIBI INJECTION SUN PHARMACEUTICAL INDUSTRIES, 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 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: • • DOSAGE AND ADMINISTRATION • • DOSAGE FORMS AND STRENGTHS • CONTRAINDICATIONS • WARNINGS AND PRECAUTIONS • • • • • 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 阅读完整的文件