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Kit for the Preparation of Technetium Tc99m Sestamibi for Injection FOR DIAGNOSTIC USE


These highlights do not include all the information needed to use CARDIOLITE®
safely and effectively. See full prescribing information for CARDIOLITE®.
CARDIOLITE®, Kit for the Preparation of Technetium Tc99m Sestamibi for Injection.
Initial U.S. Approval: December, 1990
-----------------------------RECENT MAJOR CHANGES--------------------------------
Use in specifi c populations (8.3) 10/2007
-----------------------------INDICATIONS AND USAGE---------------------------------
CARDIOLITE® is a myocardial perfusion agent indicated for:
• 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
CARDIOLITE® 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
MIRALUMA® is a single dose of 740 - 1110 MBq (20 - 30 mCi).
----------------------------DOSAGE FORMS AND STRENGTHS----------------------------
• CARDIOLITE®, Kit for the Preparation of Technetium Tc99m Sestamibi for Injection
is supplied as a lyophilized mixture in a 5 mL vial.
• 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.
• CARDIOLITE® 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 CARDIOLITE® imaging.
• Caution should be exercised and emergency equipment should be available when
administering CARDIOLITE®.
• Before administering CARDIOLITE® patients should be asked about the possibility of
allergic reactions to either drug.
• The contents of the vial are intended only for use in the preparation of Technetium
Tc99m Sestamibi and are not to be administered directly to the patient without fi rst
undergoing the preparative procedure.