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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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Dr Maycock in a draft letter stated that the warning on the Hemofil labels overstated the risks since August 1975 the concentrates were being made from RIA tested plasma. However, that until concentrate prepared from UK plasma was available the benefits attached to Hemofil outweighed the risk.

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Dr Maycock in a draft letter stated that the warning on the Hemofil labels overstated the risks and was chosen to afford Travenol maximum protection given that plasma and concentrate were tested in a proper manner by RIA.

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Dr Maycock's draft letter stated that there was always the problem of non-B hepatitis which he said American authorities thought accounted for 90% of transfusion associated hepatitis and which opened a "new vista of complications."

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In the draft product licence application for Kryobulin on the manufacture and composition it stated that any donor who had a pathological transaminase level or positive Australia antigen test was excluded from the donor program but despite this the risk of transmission of homologous serum hepatitis could only be diminished not eliminated.

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Under the heading "side effects" Kryobulin's draft product licence application stated that despite the precautions taken in the selection of donors, the risk of transmission of homologous serum hepatitis could not entirely be excluded when administering human coagulation factors.

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Immuno in a draft application for its product license stated that their product was prepared from the pooled plasma of healthy donors, and that donors were tested at each donation for their GPT level and the absence of AU/SH/HA antigens.

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Dr Dane stated in a letter that they did not consider the warning about homologous serum hepatitis on the leaflet of Kryobulin to be adequate, particularly when the product had been shown to contain HBsAg.

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Norman Berry stated that he was surprised at Dr Dane's letter about the warning label because they had submitted the warning phrase on the labels to the Committee on Safety of Medicines as part of their product licence application and it had been accepted.

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In a letter to Mr Berry Dr Dane stated that their comments on the warning on Kryobulin leaflets was a personal observation, and that they were aware that their views and those of several of their colleagues did not coincide with those of the Committee on Safety of Medicines.

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A memo from J A Holgate shows that the DHSS considered Dr Dane's comments about the warning labels on Kyrobulin and stated he hoped they could disprove and show they would never release a batch known to be positive and rely on the warning label.

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