By Henrik S. Thomsen, Judith A. W. Webb
This is the 3rd version of a really profitable booklet that initially emerged from the paintings of a committee organize via the ecu Society of Urogenital Radiology in 1994 to contemplate the protection of distinction media used for diagnostic imaging. the recent variation not just absolutely updates the former variation, but additionally contains new chapters on advanced themes comparable to pediatric matters and sensible elements of off-label distinction media use. complete attention is given to the numerous various issues of safety on the subject of iodine-based distinction media, gadolinium-based distinction media, microbubbles for ultrasound, and barium sulfate. The textual content contains chapters on either acute and not on time non-renal adversarial reactions and on renal hostile reactions. the entire questions usually raised in radiological perform are addressed. This publication, offered in a convenient, easy-to-use structure, presents a useful, targeted, and extraordinary resource of information.
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Extra resources for Contrast Media: Safety Issues and ESUR Guidelines
It is not intended to impact on the practice of medicine. European legislation does not require Member States to prohibit the prescription or administration of medicines outside their authorized indications. Medicines prescribed outside the terms of the marketing authorization may be dispensed by pharmacists and administered by nurses or midwives. In addition, the legislation contains a specific exemption which enables Member States to permit the supply of unlicensed medicines for individual patients on the order of their doctor—Article 5 of Directive 2001/83/ EC provides that: ‘‘A Member State may, in accordance with the legislation in force and to fulfil special needs, exclude from the provisions of this Directive medicinal products supplied in response to a bona fide unsolicited order, formulated in accordance with the specifications of an authorized health-care professional and for use by an individual patient under his direct personal responsibility’’.
2012). The frequency of off-label prescriptions in children may be higher than 60–80 % (Bazzano et al. 2009). In the current system, a contrast agent is approved for some indications and then, based on data in the peerreviewed literature, the experience of colleagues, and professional guidelines, many radiologists use the agent offlabel, in the interests of patient care. This off-label use has Off-Label Use of Contrast Media increased over the years. Few severe adverse reactions have occurred, with no difference in adverse reactions between use for approved and unapproved body area indications.
For example, the European Medicines Agency (EMA) may not have given competent authority to the member state concerned, or drugs may still be in development or be undergoing clinical trials. An application for authorization of a drug may have been refused or a drug H. S. Thomsen and J. A. W. ), Contrast Media, Medical Radiology. 1007/174_2013_867, Ó Springer-Verlag Berlin Heidelberg 2014 23 24 may no longer have an authorization. Also, there may not be authorization for particular population groups, such as children or allergic patients.