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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.
Published on:
23 July, 2024
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."
Published on:
23 July, 2024
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.
Published on:
23 July, 2024
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."
Published on:
23 July, 2024
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.
Published on:
23 July, 2024
DHSS confirmed to Abbott that a license would be granted for Antihemophilic Factor (Human) Injection subject to conditions.
Published on:
23 July, 2024
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.
Published on:
23 July, 2024
An application to renew the product licence for Hemofil (product licence 0116/0011) was granted.
Published on:
23 July, 2024
An application for variation of product licence for Kryobulin was submitted.
Published on:
08 October, 2024
An application was made to vary the product licence for Kryobulin, in order to allow for the use of radioimmunoassay (RIA) testing for Hepatitis B antigen.
Published on:
23 July, 2024
In the report regarding the product licence application of the Antihemophilic Factor, it was noted that the donors met the criteria of the regulations and each was tested for syphilis. The medical assessor also added that there had been no
inspection of the manufacturing facilities.
Published on:
23 July, 2024
The report stated donors met the criteria of the regulations and each was tested for syphilis.
Published on:
23 July, 2024
Dr Biggs stated in a letter to Dr Sheila Waiter that Commercial Human Factor 8 should be made available to doctors who treat patients with haemophilia as an interim measure until enough can be made by the NHS.
Published on:
23 July, 2024
In a letter to the Editor of the Lancet, Dr Biggs discussed the shortage of Factor 8 for the treatment of haemophilia patients and how this could be improved with proper financial investment.
Published on:
23 July, 2024
In a journal article, E K Blackburn stated that those who were in charge of patients with haemophilia no longer felt they can tolerate the undertreatment of their patients.
Published on:
23 July, 2024
The licence application for Koate (made by Cutter) was submitted.
Published on:
23 July, 2024
Dr R D Andrews noted in his assessment report, regarding the Koate licence application, that plasma for Koate (made by Cutter) was supplied from 54 different firms under various ownership, including US State prisons, and "suffers from being prepared from multi-centre donations which cannot be properly controlled by inspection."
Published on:
23 July, 2024
Dr R D Andrews mentioned in his assessment report, regarding the Koate licence application, each donation was RIA tested for HBV antigen and that there had been no reports attributing hepatitis to Koate since the introduction in the US in February 1974.
Published on:
23 July, 2024
In early January 1976, CSM (B) recommended the grant of a licence which was subject to conditions. It particularly sought information regarding the pool size, and the reasons for and rate of donor rejection centre by centre.
Published on:
23 July, 2024
The UK product licence for Koate stated that the presence of hepatitis should be assumed.
Published on:
23 July, 2024
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