Примери за използване на To abatacept на Английски и техните преводи на Български
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Do not use ORENCIA If you are allergic(hypersensitive) to abatacept or any of the other ingredients.
Immunogenicity to abatacept following long-term subcutaneous administration was assessed by a new electrochemiluminescence(ECL) assay.
The safety of administering live vaccines to infants exposed to abatacept in utero is unknown.
Study SC-I compared the immunogenicity to abatacept following subcutaneous or intravenous administration as assessed by ELISA assay.
ORENCIA should not be used in patients who may be hypersensitive(allergic) to abatacept or any of the other ingredients.
Do not use ORENCIA if you are allergic to abatacept or any of the other ingredients of this medicine(listed in section 6).
Special caution should be exercised in patients with a history of allergic reactions to abatacept or to any of the excipients.
If a response to abatacept is not present within 6 months of treatment, the continuation of the treatment should be reconsidered(see section 5.1).
In addition, inflammation of the thyroid and pancreas was frequently seen in both juvenile andadult rats exposed to abatacept.
You should not be given ORENCIA if you are allergic to abatacept or any of the other ingredients of this medicine(listed in section 6).
It is not known whether these findings indicate a risk for development of autoimmune diseases in humans exposed in utero to abatacept or belatacept.
Studies in rats exposed to abatacept have shown immune system abnormalities including a low incidence of infections leading to death(juvenile rats).
The rate of progression of structural damage in year 2 was significantly lower than that in year 1 for patients randomised to abatacept(p< 0.0001).
In those patients who initially received infliximab andthen switched to abatacept, the reduction in the mean DAS28 score from baseline was 3.29 at day 729 and 2.48 at day 365.
It is likely that the increased susceptibility to opportunistic infections observed in juvenile rats is associated with the exposure to abatacept before development of memory responses.
If a response to abatacept is not present within 6 months of treatment, the potential benefits of continuing treatment, known and potential risks, and therapeutic alternatives should be considered(see section 5.1).
During the initial double blind 6 months period(short term period),the overall immunogenicity frequency to abatacept was 1.1%(8/725) and 2.3%(16/710)for the subcutaneous and intravenous groups, respectively.
The progression of structural damage was lower in patients receiving continuous abatacept plus methotrexate treatment(for 24 months) compared to patients who initially received methotrexate plus placebo(for 12 months) andwere switched to abatacept plus methotrexate for the next 12 months.
Administration of live vaccines to infants exposed to abatacept in utero is not recommended for 14 weeks following the mother's last exposure to abatacept during pregnancy.
During Period B,the time to disease flare for the patients randomised to placebo was significantly shorter than for those randomised to abatacept(primary endpoint, p=0.0002; log-rank test).
The cumulative immunogenicity frequency to abatacept by the ECL assay with at least one positive sample in the short-term and long-term periods combined was 15.7%(215/1369) while on abatacept, with a mean duration of exposure of 48.8 months, and 17.3%(194/1121) after discontinuation(> 21 days up to 168 days after last dose).
The open label period of the study provided an assessment of the ability of abatacept to maintain efficacy for subjects originally randomised to abatacept andthe efficacy response of those subjects who were switched to abatacept following treatment with infliximab.
Antibodies directed against the whole abatacept molecule or to the CTLA-4 portion of abatacept were assessed by an ECL assay in patients with pJIA following repeated treatment with subcutaneous abatacept.
Antibodies directed against the entire abatacept molecule or to the CTLA-4 portion of abatacept were assessed by ELISA assays in patients with pJIA following repeated treatment with intravenous ORENCIA.
No data are available on the secondary transmission of infection from persons receiving live vaccines to patients receiving abatacept.
The relevance of these findings to the clinical use of abatacept is unknown.
In Study SC-I, abatacept was given subcutaneously to patients after a single loading dose of intravenous abatacept and then every week thereafter.
Abatacept may cross the placenta into the serum of infants born to women treated with abatacept during pregnancy.
Among the patients who entered the open-label 12 month period, 59%(125/213) of patients receiving continuous abatacept plus methotrexate treatment and 48%(92/192)of patients who initially received methotrexate and switched to combination with abatacept had no progression.
Methotrexate, NSAIDs, corticosteroids, andTNF-inhibitors were not found to influence abatacept clearance.