The wording of the warning label on Armour's Factorate was done in a roundabout way; unlike the more direct approach of some other manufacturers such as Cutter, Armour's said that "Despite careful selection of donors, it may contain causative agents of viral hepatitis." Read more about The wording of the warning label on Armour's Factorate was done in a roundabout way; unlike the more direct approach of some other manufacturers such as Cutter, Armour's said that "Despite careful selection of donors, it may contain causative agents of viral hepatitis."
The warning label on Armour's Factorate package insert stated that radioimmunoassay testing for Hepatitis B surface antigen had been done, however that since no completely reliable laboratory test was yet available to detect all potentially infectious plasma donations, the risk of transmitting viral hepatitis was still present. Read more about The warning label on Armour's Factorate package insert stated that radioimmunoassay testing for Hepatitis B surface antigen had been done, however that since no completely reliable laboratory test was yet available to detect all potentially infectious plasma donations, the risk of transmitting viral hepatitis was still present.
Cutter laboratories included a warning on Koate label which stated that "Koate concentrate is a purified dried fraction of pooled plasma obtained from many paid donors. The presence of hepatitis virus should be assumed and the hazard of administering Koate concentrate should be weighed against the medical consequence of withholding it." Read more about Cutter laboratories included a warning on Koate label which stated that "Koate concentrate is a purified dried fraction of pooled plasma obtained from many paid donors. The presence of hepatitis virus should be assumed and the hazard of administering Koate concentrate should be weighed against the medical consequence of withholding it."
Hyland Laboratories product information leaflet for Hemofil contained the warning that although the lot had been reconstituted for use and found non reactive for HBsAg using RIA techniques the product should continue to be considered to carry a risk with respect to hepatitis. Read more about Hyland Laboratories product information leaflet for Hemofil contained the warning that although the lot had been reconstituted for use and found non reactive for HBsAg using RIA techniques the product should continue to be considered to carry a risk with respect to hepatitis.
A study by Kasper and Kipnis reviewed the incidence of clinical hepatitis in people with haemophilia and concluded that older children and adults who had little exposure to blood products were at a high risk of developing hepatitis after the introduction of clotting factor concentrates. Read more about A study by Kasper and Kipnis reviewed the incidence of clinical hepatitis in people with haemophilia and concluded that older children and adults who had little exposure to blood products were at a high risk of developing hepatitis after the introduction of clotting factor concentrates.
Alpha's application for the renewal of its license of heat treated profilate contained the warning that viral hepatitis may be transmitted by the product. Read more about Alpha's application for the renewal of its license of heat treated profilate contained the warning that viral hepatitis may be transmitted by the product.
Abbott Laboratories data sheet for Profilate repeated the warning on the 1976 label that the benefits of administration must be weighed against the risk of viral hepatitis. Read more about Abbott Laboratories data sheet for Profilate repeated the warning on the 1976 label that the benefits of administration must be weighed against the risk of viral hepatitis.
Alpha/Abbott Laboratories data sheet and warning label for Profilate later included the statement that present methods of testing plasma were not sensitive enough to detect all units of infective plasma and that whenever possible single donor products were preferable. Read more about Alpha/Abbott Laboratories data sheet and warning label for Profilate later included the statement that present methods of testing plasma were not sensitive enough to detect all units of infective plasma and that whenever possible single donor products were preferable.
The initial product label for Profilate by Alpha/Abbott Laboratories included a warning which stated that "Patients with mild deficiencies who consequently have not received multiple transfusions of blood, or blood products, are at greatest risk. Under such circumstances, the benefits of Profilate administration must be weighed carefully against the risk of viral hepatitis" Read more about The initial product label for Profilate by Alpha/Abbott Laboratories included a warning which stated that "Patients with mild deficiencies who consequently have not received multiple transfusions of blood, or blood products, are at greatest risk. Under such circumstances, the benefits of Profilate administration must be weighed carefully against the risk of viral hepatitis"
Abbott Laboratories Ltd information pages for Antihemophilic Factor (Human) included the warning that "This product is prepared from units of human plasma which have been tested and found nonreactive for Hepatitis Associated Antigen. However, it is recognized that presently available methods are not sensitive enough to detect all units of potential infectious plasma and the risk of transmitting hepatitis is still present." Read more about Abbott Laboratories Ltd information pages for Antihemophilic Factor (Human) included the warning that "This product is prepared from units of human plasma which have been tested and found nonreactive for Hepatitis Associated Antigen. However, it is recognized that presently available methods are not sensitive enough to detect all units of potential infectious plasma and the risk of transmitting hepatitis is still present."