TECHNETIUM TC 99M SESTAMIBI injection

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE (UNII: N6OU7HJ70P) (TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE - UNII:N6OU7HJ70P)

Հասանելի է:

Curium US LLC

INN (Միջազգային անվանումը):

TETRAKISCOPPER TETRAFLUOROBORATE COPPER TETRAFLUOROBORATE - UNII:N6OU7HJ70P)

Կազմը:

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

Կառավարման երթուղին:

INTRAVENOUS

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Թերապեւտիկ ցուցումներ:

Myocardial Imaging: Kit for the Preparation of Technetium Tc99m 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 Tc99m 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: Kit for the Preparation of Technetium Tc99m 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 fo

Ապրանքի ամփոփագիր:

Kit for the Preparation of Technetium Tc99m Sestamibi Injection is supplied as a 10 mL vial in kits of five (5) (NDC # 69945-092-20) or a carton of thirty (30) (NDC # 69945-092-40), 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 5.6-5.7. The contents of the vial are lyophilized and stored under nitrogen. Store at 15-25°C (59-77°F) before and after reconstitution. Protect from light prior to reconstitution. Technetium Tc99m Sestamibi contains no preservatives. Included in each five (5) vial kit is one (1) package insert and five (5) radioassay information labels with radiation warning symbol.  Included in each thirty (30) vial carton is one (1) package insert and thirty (30) radioassay information labels with radiation warning symbol. This reagent kit is approved by the U.S. Nuclear Regulatory Commission for distribution to persons licensed to use by-product material identified in §35.200 to 10 CFR Part 35, to persons who have a similar authorization issued by an Agreement State, and, outside the United States, to persons authorized by the appropriate authority.

Լիազորման կարգավիճակը:

Abbreviated New Drug Application

Ապրանքի հատկությունները

TECHNETIUM TC 99M SESTAMIBI- TECHNETIUM TC 99M SESTAMIBI INJECTION
CURIUM US LLC
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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 TC99M SESTAMIBI INJECTION SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING
INFORMATION FOR KIT FOR THE PREPARATION OF TECHNETIUM TC99M SESTAMIBI
INJECTION.
KIT FOR THE PREPARATION OF TECHNETIUM TC99M SESTAMIBI INJECTION
INITIAL U.S. APPROVAL: DECEMBER, 1990
INDICATIONS AND USAGE
Technetium Tc99m Sestamibi is a myocardial perfusion agent indicated
for: (1)
detecting coronary artery disease by localizing myocardial ischemia
(reversible defects) and infarction
(non-reversible defects)
evaluating myocardial function and developing information for use in
patient management decisions
DOSAGE AND ADMINISTRATION
For Myocardial Imaging: The suggested dose range for I.V.
administration of Technetium Tc99m
Sestamibi in a single dose to be employed in the average patient (70
Kg) is 370-1110 MBq (10-30
mCi).
For Breast Imaging: The recommended dose range for I.V. administration
of Technetium Tc99m
Sestamibi is a single dose of 740-1110 MBq (20-30 mCi).
DOSAGE FORMS AND STRENGTHS
Kit for the Preparation of Technetium Tc99m Sestamibi Injection is
supplied as a lyophilized mixture in a 10
mL vial. (3)
CONTRAINDICATIONS
None known.
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.
Technetium Tc99m Sestamibi has been rarely associated with acute
severe allergic and anaphylactic
events of angioedema and generalized urticaria. In some patients the
allergic symptoms developed on
the second injection during Technetium Tc99m Sestamibi imaging.
Caution should be exercised and emergency equipment should be
available when administering
Technetium Tc99m Sestamibi.
Before administering Technetium Tc99m Sestamibi patients should be
asked about th