By Henrik S. Thomsen, Judith A. W. Webb
This is the 3rd variation of a really profitable booklet that initially emerged from the paintings of a committee organize through the ecu Society of Urogenital Radiology in 1994 to think about the security of distinction media used for diagnostic imaging. the recent version not just totally updates the former variation, but additionally contains new chapters on advanced issues equivalent to pediatric concerns and functional elements of off-label distinction media use. entire attention is given to the various various issues of safety in terms of iodine-based distinction media, gadolinium-based distinction media, microbubbles for ultrasound, and barium sulfate. The textual content comprises chapters on either acute and behind schedule non-renal adversarial reactions and on renal adversarial reactions. all the questions often raised in radiological perform are addressed. This booklet, provided in a convenient, easy-to-use layout, presents a useful, certain, and remarkable resource of information.
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Extra info for Contrast Media: Safety Issues and ESUR Guidelines
Health care professionals play a key role in safety surveillance, as they are frontline observers if serious and unexpected adverse reactions1 occur. They are obliged to report their observations and suspicions to the regulatory authorities, which can then react in an appropriate and timely manner. Even before the administration of a medicinal product to the patient, the health care professionals play a crucial role. Before administration of any medicinal product to patients—whether for therapeutic, preventive, or diagnostic purposes—a careful risk/benefit assessment should always be undertaken.
General Principles of Evaluation 3 The principles used for the evaluation of medicinal products with respect to quality, pharmacology, toxicology, pharmacokinetics, and safety also apply to diagnostic agents. However, since contrast agents are used to diagnose and monitor diseases or conditions and not for treatment, the clinical development programs have to be adapted accordingly. As for other medicinal products, the balance between benefits and risks should be taken into account when granting a marketing authorization.
European medicines legislation does not apply to the following: • Medicines prepared in a pharmacy in accordance with a medical prescription for an individual patient (the ‘‘magistral formula’’). • Medicines prepared in a pharmacy in accordance with the prescriptions of a pharmacopoeia and intended to be supplied directly to the patients served by the pharmacy (the ‘‘officinal formula’’). • Medicines for research and development trials [covered by the Directive 2001/20/EC on good clinical practice in the conduct of clinical trials for human use (‘‘the Clinical Trials Directive’’)].
Contrast Media: Safety Issues and ESUR Guidelines by Henrik S. Thomsen, Judith A. W. Webb