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Product licence was granted for Hemofil.

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Dr Thomas commented regarding the Kryobulin licence application that despite precautions being taken, "the risk of transmission of serum hepatitis can only be diminished and not completely eliminated.

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Austrian Inspectors conducted an inspection of the manufacturing facilities regarding the Kryobulin licence application.

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Dr Thomas visited Immuno factories in Vienna.

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In a journal article it was reported that the risk of causing hepatitis from blood taken from paid donors was markedly higher than that of blood from unpaid donors.

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"The Gift Relationship" by Richard Titmuss was published, in which it was stated that the risk of catching hepatitis from blood taken from paid donors was higher than that of blood from unpaid donors.

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In a journal article by Alter et al it was stated that the exclusion of commercial and HBAg positive blood donors had resulted in a marked reduction in post-transfusion hepatitis.

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Grady et al "Risk of Posttransfusion Hepatitis in the United States: A Prospective Cooperative Study" reported on the National Transfusion Hepatitis Study in the US, that those cases of hepatitis with which Hepatitis B antigen was associated accounted for around 60 percent of the cases of post-transfusion hepatitis which had occurred.

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Professor J. Garrott Allen of Stanford University Medical Centre concluded in a paper published in 1972 that the risk of serum hepatitis from transfusions derived from prison and Skid Row populations was at least ten times that from the use of volunteer donors.

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At an international forum reported in Vox Sanguinis in 1972, Dr Biggs and Dr Dormandy assessed that patients with haemophilia could be adequately maintained with the use of cryoprecipitate.

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Dr Peter Jones wrote in an article that "cryoprecipitate is now the product of choice in
major surgery, allowing the potent but antigenic animal fractions and expensive human
concentrate to be reserved for major complications, the emergency treatment of
patients with FVIII inhibitors, or, in the case of concentrate, for prophylaxis."

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Dr Carol K Kasper and Shelly An Kipnis concluded in an article on Hepatitis and Clotting-Factor Concentrates that single donor products were preferable for older children and adults who had little exposure to blood products.

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From a report on the progress of the MRC Cryoprecipitate Working Party Survey of the Incidence of Transfusion Jaundice, Haemophilia Centre Directors were aware that larger pools theoretically came with a greater risk of causing "clinical" hepatitis.

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Professor Edward Blackburn wrote on behalf of Haemophilia Centre Directors to the Chief Medical Officer, stating that there was "an urgent need to increase supplies of Factor VIII Concentrate."

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Dr William d'A Maycock's view was that self-sufficiency should be the aim. He stated that insufficient freeze-dried antihaemophilic globulin concentrate was made in the UK, and there was a need to supplement the existing UK supply. However, the facilities for larger scale fractionation that would become available in England and Scotland should eliminate the need to use foreign commercial preparations.

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The US Panel on Review of Blood and Blood Derivatives stated that when it came to prophylactic use of AHF in people with congenital Factor 8 deficiency, its safety had not been well evaluated - "the risks may outweigh the benefits" and "a similar situation applies to recommendations for home therapy either in chronic low dose prophylactic use or for intermittent, episodic home therapy. Antihemophilic Factor (Human) usage is limited because of risk of transmitting viral hepatitis."

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DHSS opened a "call-off" contract with Serological Products Ltd (later known as Immuno Ltd) and Travenol Laboratories (Hyland) for the supply of up to five million international units of Hemofil and Kryobulin to haemophilia centres.

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DHSS confirmed to Abbott that a license would be granted for Antihemophilic Factor (Human) Injection subject to conditions.

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An application to vary the product licence for Hemofil was approved on 13 June 1975, allowing for the use of radioimmunoassay ("RIA") testing for Hepatitis B antigen.

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An application to renew the product licence for Hemofil (product licence 0116/0011) was granted.

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