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Titolo:
Intravenous immunoglobulin: regulatory perspectives on use and supply
Autore:
Farrugia, A; Poulis, P;
Titolo Testata:
TRANSFUSION MEDICINE
fascicolo: 2, volume: 11, anno: 2001,
pagine: 63 - 74
SICI:
0958-7578(200104)11:2<63:IIRPOU>2.0.ZU;2-I
Fonte:
ISI
Lingua:
ENG
Soggetto:
HEPATITIS-C VIRUS; NON-B-HEPATITIS; IMMUNE GLOBULIN THERAPY; NON-A; NEUROLOGIC DISORDERS; GAMMA-GLOBULIN; DRUG-THERAPY; INFECTION; OUTBREAK; SAFETY;
Keywords:
fractionation; immunoglobulins; intravenous; plasma; safety; supply; therapy;
Tipo documento:
Review
Natura:
Periodico
Settore Disciplinare:
Life Sciences
Citazioni:
83
Recensione:
Indirizzi per estratti:
Indirizzo: Farrugia, A TGA Labs, Blood Prod Grp, POB 100, Woden, ACT 2606, Australia TGA Labs POB 100 Woden ACT Australia 2606 ACT 2606, Australia
Citazione:
A. Farrugia e P. Poulis, "Intravenous immunoglobulin: regulatory perspectives on use and supply", TRANSFUS M, 11(2), 2001, pp. 63-74

Abstract

Technological advancements in the fractionation of plasma in the early 1970s led to the production of immunoglobulin preparations which could be administered intravenously. The ability to deliver larger doses than was possible with intramuscular products was accompanied by clinical studies demonstrating the efficacy of immunoglobulin treatment in a number of autoimmune and inflammatory conditions. This has led to a continuing increase in the usage of this product such that, currently, it is considered to be the drivingforce for plasma procurement. In recent years, difficulties have been experienced in the supply of this product in various markets. While intravenous immunoglobulins (IVIG) have undoubted clinical superiority over intramuscular products for the majority of indications, their use should be tempered with caution. Early clinical studies revealed that the risk of viral transmission from these products was higher than that of the traditional intramuscular presentation. This has had a profound impact on blood transfusion science as it has provided a major impetus for nucleic acid testing (NAT) for viral agents in blood donations. Perhaps less widely appreciated are the pressures which may be felt in blood services as the traditional drivers for plasma procurement - factor wr and albumin - become secondary to MG. This review discusses the factors affecting the supply and safety of IVIG and the implications of recent global regulatory decisions on the delivery of this product and other therapeutic products derived from human plasma.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 01/04/20 alle ore 11:47:42