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A study conducted on the Alpha heat-treated variant Profilate recorded that it was produced from plasma pools of between 5,000 amd 32,000 donors per batch.

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A report included in the initial product licence application for Kryobulin by Serological Products Ltd recorded that the pool size used was 1,000 donors between the ages of 18 and 65, whose plasma was obtained from centres in Austria and West Germany.

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The figure of 1,000 donors appeared on a product label for Kryobulin Red (made with European plasma) in the mid 1970s.

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The figure of 1,000 donors appeared on a draft product label for Prothromplex.

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The draft label provided with the product licence application for heat-treated Kryobulin did not give a donor pool size figure.

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At an NIBSC Infectious Hazards of Blood Products meeting Dr Rodell gave a summary of the commercial pool sizes and stated that one donor probably would not contribute more than four units to a particular pool.

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Hepatitis B tests were not sufficiently sensitive to detect every infected unit for over a decade after screening first became available.

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Dr John Craske's article "An Outbreak of Hepatitis Associated with Intravenous Injection of Factor-VIII Concentrate" was published in The Lancet. It said: "Testing the pooled plasma or the factor-VIII concentrate by the current radioimmunoassay techniques is not a reliable method of excluding hepatitis-B virus. Individual donations should be screened by R.I.A. before being pooled."

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Roderick Murray wrote the article "Viral Hepatitis", published in the Bulletin of the New York Academy of Medicine, which established that increasing pool sizes did not have the effect of dilution (and that any infectious particles would infect the whole pool).

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A report of the Meeting of Blood Products Advisory Committee on the Safety and Purity of Plasma Derivatives records that Dr Rodell warned that one donor infected with AIDS may make several contributions. He suggested that as few as four donors infected with AIDS could infect the whole world supply of factor concentrate.

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Marie Tatt wrote a letter to Elias Greene (and others) about the product licence application for Koate HS and requested that the existing "Warnings" statement (used in US markets) be amended for the UK. She wrote: "we would like to delete the reference to the Fletcher paper and potential transmission of Non-A, Non-B hepatitis".

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Elias Greene sent a fax to Marie Tatt stating that any labelling applied to products in the United States must contain the warning, and that where unlabelled products are sent, the recipient may prepare their own labels.

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The UK subsidiary of Travenol/Baxter was supplied with literature alongside the company's products, and that literature was initially drafted in the US. It was was then reviewed by the UK Regulatory Department to ensure compliance the current product licence requirements.

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A Koate product licence application discussed the addition of a warning about hepatitis.

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In a memo from Edward Cutter to Jack Ryan, Edward Cutter stated that it was advisable to include a warning about AIDs in literature about Factor IX and VIII products.

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In Travenol's licence application for Hemofil the appendix includes a warning that the concentrate should be used when its expected effect is needed in spite of the unknown hepatitis risk associated with its use and special consideration should be given to the use of the concentrate in newborns and infants where a higher morbidity and mortality may be associated with hepatitis.

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In the package leaflet of Hemofil it said that the risk of hepatitis was unknown; this was not as clearcut as the warning on Hemofil bottles which said the risk of transmitting hepatitis was present.

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Peter Jones in reporting on the outcome of a recent meeting of haemophilia centre directors stated that although the product Haemofil was connected to the outbreak of hepatitis at the time, that it was clear all concentrates carried the risk.

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Dr Sheila Waiter stated that it was generally accepted that the benefits of Hemofil outweighed the risks of acquiring hepatitis B but that the statement that every lot of the product was probably contaminated with hepatitis B would be a surprise to clinicians especially as the practice of issuing warning labels was being discontinued by the manufacturer.

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Dr Waiter stated that the risks of Hemofil were being understated or even misrepresented by the manufacturer.

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