Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in labeling: Patients with Pulmonary Hypertension [ see Warnings and Precautions ( 5.1 ) ] .
Hypersensitivity Reactions [ see Warnings and Precautions ( 5.2 ) ] .
The following adverse reactions associated with the use of technetium Tc 99m albumin aggregated products including PULMOTECH MAA have been identified in clinical studies or postmarketing reports.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Cardiovascular Disorders : Deaths in patients with severe pulmonary hypertension Immune System Disorders : Hypersensitivity reactions such as anaphylaxis, impairment of cardiac and circulatory functions in the form of changes in respiration, pulse, and blood pressure, chest pain, and syncope, urticaria, reddening of the face, sweating, and nausea Skin and Subcutaneous Tissue Disorders : Injection site reactions The following adverse reactions have been reported: Death in patients with severe pulmonary hypertension, anaphylaxis, impairment of cardiac and circulatory functions in the form of changes in respiration, pulse, and blood pressure, chest pain, and possible syncope, urticaria, reddening of the face, sweating, nausea, and injection site reaction.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact CURIUM US LLC at 1-866-789-2211 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
5 WARNINGS AND PRECAUTIONS Patients with P ulmonary H ypertension : Administer the lowest number of particles possible and have emergency resuscitation equipment available.
( 5.1 ) Hypersensitivity Reactions : Have emergency resuscitation equipment and trained personnel available.
Interrupt the administration if a reaction occurs during administration.
Monitor patients.
( 5.2 ) Risk of Temporary Impediment to Blood Flow in Patients with Right-to-Left Heart Shunts : Administer the lowest possible number of particles.
Like all medications, Pulmotech Maa can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: