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FUZEON: avoiding injection-site reactions.


On January 31 the FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
 announced that the FUZEON (enfuvirtide) package insert package insert Pharmacology A synopsis of key physicochemical, pharmacologic, clinical efficacy, and clinical safety properties of a prescription drug, bundled therewith, intended to be highly readable and helpful to clinicians looking for specific  had been changed to include precautions to avoid injection-site reactions injection-site reactions

apart from those caused by infection at the site there is a characteristic reaction in dogs and cats which is a germinal center created by the strong antigenic stimulus provided by the injection.
, either using a needle, or the Biojector(r) 2000 needlefree injection system. For example, here is one place where changes were made (this is from the new version):

"Patients and caregivers should be instructed on the preferred anatomical sites for administration (upper arm, abdomen, anterior thigh). FUZEON should not be injected near any anatomical areas where large nerves course close to the skin, such as near the elbow, knee, groin or the inferior of medial sections of the buttocks buttocks /butĀ·tocks/ (butĀ“oks) the two fleshy prominences formed by the gluteal muscles on the lower part of the back. , skin abnormalities, including directly over a blood vessel blood vessel
n.
An elastic tubular channel, such as an artery, a vein, a sinus, or a capillary, through which the blood circulates.


blood vessel(s),
n the network of muscular tubes that carry blood.
, into moles, scar tissue, bruises, of near the navel, surgical scars, tattoos or bum sites."

The changes are at: http://www.fda.gov/oashi/aids/listserve/listserve2007.html#013007 And the complete revised prescribing information is at: http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=2705
COPYRIGHT 2006 John S. James
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2006, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:AIDS Treatment News
Date:Nov 1, 2006
Words:156
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