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IMPORTANT SAFETY INFORMATION

WARNING: SERIOUS CARDIOPULMONARY REACTIONS

Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following perflutren-containing microsphere administration. 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 [see Warnings and Precautions (5.1)].

DEFINITY® Vial for (Perflutren Lipid Microsphere) Injectable Suspension

INDICATIONS

DEFINITY® is indicated, after activation, for use in adult and pediatric patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border.

CONTRAINDICATIONS

DEFINITY® is contraindicated in patients with known or suspected hypersensitivity to perflutren lipid microsphere or its components, such as polyethylene glycol (PEG) [see Warnings and Precautions (5.2) and Description (11)].

IMPORTANT SAFETY INFORMATION

WARNING: SERIOUS CARDIOPULMONARY REACTIONS

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 [see Warnings and Precautions (5.1)].

In postmarketing use, rare but serious cardiopulmonary or hypersensitivity reactions have been reported during or shortly following perflutren and PEG-containing microsphere administration [see Adverse Reactions (6)]. The risk for these reactions may be increased among patients with unstable cardiopulmonary conditions and/or with pre-existing PEG hypersensitivity [see Adverse Reactions (6.2)]. It is not always possible to reliably establish a causal relationship to drug exposure due to the presence of underlying conditions.

Patients with sickle cell disease may be at higher risk of painful crisis and DEFINITY® should be administered with caution.

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

Customer Service 1.800.299.3431

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INDICATIONS

IMPORTANT SAFETY INFORMATION

WARNING: SERIOUS CARDIOPULMONARY REACTIONS

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