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Supply Updates

DEFINITY® Vial for (Perflutren Lipid Microsphere) Injectable Suspension:

Please visit DEFINITYimaging.com for the latest supply updates.

 

TechneLite® (Technetium Tc99m Generators):

Please visit TechneLite.com for the latest molybdenum 99 (Mo-99) supply updates.

 

Important Safety Information for DEFINITY®:

INDICATIONS

Activated DEFINITY® (Perflutren Lipid Microsphere) Injectable Suspension is indicated for use in patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border.

CONTRAINDICATIONS

Do not administer DEFINITY® to patients with known or suspected right-to-left, bi-directional or transient right-to-left cardiac shunts, by intra-arterial injection, or to patients with known hypersensitivity to perflutren.

IMPORTANT SAFETY INFORMATION

WARNING:  Serious Cardiopulmonary Reactions

Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following perflutren-containing microsphere administration [See WARNINGS AND PRECAUTIONS (5.1)].  Most serious reactions occur within 30 minutes of administration.

  • Assess all patients for the presence of any condition that precludes DEFINITY® administration [See CONTRAINDICATIONS (4)].

  • Always have resuscitation equipment and trained personnel readily available.


In post marketing use, rare but serious cardiopulmonary or anaphylactoid reactions have been reported during or shortly following perflutren-containing microsphere administration [See ADVERSE REACTIONS (6)]. The risk for these reactions may be increased among patients with unstable cardiopulmonary conditions [See Postmarketing Experience (6.2)]. It is not always possible to reliably establish a causal relationship to drug exposure due to the presence of underlying cardiopulmonary disease.

Please see full Prescribing Information, including boxed WARNING regarding serious cardiopulmonary reactions.

 

Important Safety Information for TechneLite®:
INDICATIONS AND USAGE:
Sodium Pertechnetate Tc 99m Injection is used IN ADULTS as an agent for: Brain Imaging (including cerebral radionuclide angiography), Thyroid Imaging, Salivary Gland Imaging, Placenta Localization, Blood Pool Imaging (including radionuclide angiography), Urinary Bladder Imaging (direct isotopic cystography) for the detection of vesico-ureteral reflux, Nasolacrimal Drainage System Imaging.

Sodium Pertechnetate Tc 99m Injection is used IN CHILDREN as an agent for: Brain Imaging (including cerebral radionuclide angiography), Thyroid Imaging, Blood Pool Imaging, Urinary Bladder Imaging (direct isotopic cystography) for the detection of vesico-ureteral reflux. 

CONTRAINDICATIONS: None known.

Important Safety Information: 
Allergic reactions including anaphylaxis have been reported infrequently following the administration of Sodium Pertechnetate Tc99m Injection.

WARNINGS:
Radiation risks associated with the use of Sodium Pertechnetate
Tc 99m Injection are greater in children than in adults and, in general, the younger the
child, the greater the risk owing to greater absorbed radiation doses and longer life expectancy.
These greater risks should be taken firmly into account in all benefit-risk assessments involving children.

PRECAUTIONS:
Since the eluate does not contain an antimicrobial agent, it should not be used after 12
hours from the time of TECHNELITE®, Technetium Tc 99m Generator elution. After the termination of the nasolacrimal imaging procedure, blowing the nose and washing the eyes with sterile distilled water or an isotonic sodium chloride solution will further minimize the radiation dose. As in the use of any radioactive material, care should be taken to minimize radiation exposure to patients and occupational workers. Radiopharmaceuticals should be used only by physicians who are qualified by training and experience and who are licensed in the safe handling of radionuclides.

Please See Full Prescribing Information


© 2014 Lantheus Medical Imaging, Inc.