Sequelae of intrinsic foreign-body contamination during selective renal angiography in rabbits.

Winding, Ole; Gronvall, John A.; Faarup, Poul; Hegedüs, V

doi:10.1148/radiology.134.2.7352209

Cited by 12 publications

(1 citation statement)

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“…Examples include phlebitis (3, 10 -13), pulmonary emboli (14 -16), pulmonary granulomas (3,11,17), immune system dysfunction (3,18), pulmonary dysfunction (13,15), infarction (15,19), and death (14, 20 -22). The patient risk associated with the injection of drugs containing particulate matter depends on a number of factors, including the route of administration used, the particle size and shape, the number of particles injected, the particle composition, and the patient population.…”

Section: Clinical Effects Of Injected Particulate Mattermentioning

confidence: 99%

Particulate Matter in Injectable Drug Products

Langille

2013

PDA Journal of Pharmaceutical Science and Technology

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Clinicians have had concerns about particulate matter contamination of injectable drug products since the development of the earliest intravenous therapeutics. All parenteral products contain particulate matter, and particulate matter contamination still has the potential to cause harm to patients. With tens of millions of doses of injectable drug products administered in the United States each year, it is critical to understand the types and sources of particulate matter that contaminate injectable drug products, the possible effects of injected particulate matter on patients, and the current state of regulations and standards related to particulate matter in injectable drug products. Today, the goal of manufacturers, regulators, and standards-setting organizations should be to continue to minimize the risk of particle-induced sequelae, especially in high-risk patients, without trading unnecessary manufacturing burden for minimal safety gains.

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Section: Clinical Effects Of Injected Particulate Mattermentioning

confidence: 99%