The warning label on Kryobulin by Immuno Ltd stated that despite the precautions taken in the selection and testing of donors and donations, the risk of transmitting hepatitis could not be entirely excluded. Read more about The warning label on Kryobulin by Immuno Ltd stated that despite the precautions taken in the selection and testing of donors and donations, the risk of transmitting hepatitis could not be entirely excluded.
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. Read more about 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.
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. Read more about 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.
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. Read more about 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.
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. Read more about 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.
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. Read more about 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.
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. Read more about 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.
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. Read more about 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.
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." Read more about 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."
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. Read more about 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.