Partial seizures occurred in the same period as the IS only in patients with symptomatic infantile plasms, whose outcomewas very poor;

It may be used for the manufacture of medicinal products derived from human blood and human plasma or used in the preparation of pooled platelets, or pooled, leucocyte-depleted platelets.

(vi) characterisation of the plasma pool.

(ii) testing of blood/plasma donations and pools for infectious agents, including information on test methods and, in the case of plasma pools, validation data on the tests used.

When samples of serum or plasma are pooled, the number of samples included in each pool shall be such that the OIE weak positive standard serum shall be detected as positive when diluted in negative sera or plasma by the number of samples making up the pool.

(ii) information on centres or establishments in which testing of donations and plasma pools is carried out, including inspection and approval status.

Seed materials, cell banks, pools of serum or plasma and other materials of biological origin and, whenever possible, the materials from which they are derived shall be tested for adventitious agents.

To this end the concept of a plasma master file (PMF) should be introduced, in particular in order to allow the pooling of national expertise and through the coordination by the EMEA of a single evaluation.

Where ELISA tests are used for certification purposes pooling of samples of serum or plasma must be carried out in such a way that the test results can be undoubtedly related to the individual animal included in the pool.

This upper limit shall be determined by the national reference laboratory, taking into account that the test must be adequate to detect evidence of infection in a single animal of the group of animals, of which samples of serum or plasma have been pooled.

characterisation of the plasma pool.

Dried human plasma prepared from pools of more than two donations

It is usually prepared from pooled plasma from not fewer than 1,000 donors.

It is usually prepared from pooled plasma from not fewer than 1000 donations.

It is obtained from pooled liquid human plasma from not less than 1 000 donors.

and the testing of each donation and pools of plasma for signs of virus/infections.

testing of blood/plasma donations and pools for infectious agents, including information on test methods and, in the case of plasma pools, validation data on the tests used.

Plasma pools used in the preparation of fibrinogen should contain as few donations as possible.

CYP2D6 extensive/ poor metabolisers Plasma concentrations of venlafaxine are higher in CYP2D6 poor metabolisers than extensive metabolisers.

Haemoglobin dissociates in plasma and is progressively incorporated in the protein pool of the organism.

High levels of plasma 3-OMD have been associated with poor response to levodopa in Parkinson’ s disease patients.

These include careful selection of blood and plasma donors to make sure those at risk of carrying infections are excluded, and the testing of each donation and pools of plasma for signs of virus/ infections.

These include careful selection of blood and plasma donors to make sure those at risk of carrying infections are excluded, and the testing of each donation and pools of plasma for signs of viruses/infections.

These include ● careful selection of blood and plasma donors to make sure those at risk of carrying infections are excluded, and ● the testing of each donation and pools of plasma for signs of virus/infections.

Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific na

It may be used for the manufacture of medicinal products derived from human blood and human plasma or used in the preparation of pooled platelets, or pooled, leucocyte-depleted platelets.

information on centres or establishments in which testing of donations and plasma pools is carried out, including inspection and approval status.

Unless the plasma is pooled and frozen within 48 hours of collecting the blood, the sterility of each unit shall be tested by culturing not less than 10 ml.

Based on its high molecular weight, poor aqueous solubility, and extensive erythrocyte and plasma protein binding, it is anticipated that tacrolimus will not be dialysable.

Based on the poor aqueous solubility and high erythrocyte and plasma protein binding of Rapamune, it is anticipated that Rapamune will not be dialysable to any significant extent.

The CHMP noted that UMAN BIG is manufactured from large pools of human plasma, through a consolidated and validated industrial process and that the conformity of UMAN BIG to Ph. Eur.

In CYP2D6 poor metabolisers, concomitant use of potent inhibitors of CYP3A4 may result in higher plasma concentrations of aripiprazole compared to that in CYP2D6 extensive metabolizers.

Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/ removal of virus.

Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/ removal of viruses.

Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection, and the inclusion of effective manufacturing steps for the inactivation/ removal of viruses.

Seed materials, cell banks, pools of serum or plasma and other materials of biological origin and, whenever possible, the source materials from which they are derived shall be tested for adventitious agents.

Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include careful selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/ removal of viruses.

Sunitinib and its primary active metabolite were the major drug-related compounds identified in plasma, urine and faeces, representing 91.5 %, 86.4 % and 73.8 % of radioactivity in pooled samples, respectively.

However in conscious dogs, the active metabolite had no effect on the QT interval and QTc interval at plasma exposures at least 33-fold higher than mean peak free plasma concentration in human subjects who are extensive metabolisers and 21-fold higher than measured in subjects who are poor CYP2D6 metabolisers after fesoterodine 8 mg once daily.

To minimize the risk of transmitting serum hepatitis, plasma should be prepared from pools which should contain not more than 12 donations, or by any other method that has been shown to diminish the risk in comparable manner.

However, when combined with a CYP3A4 inhibitor, patients who are poor metabolisers of CYP2C9 are at risk of increases in bosentan plasma concentrations that may be of higher magnitude, thus leading to potential harmful adverse events.

Information on safety with respect to transmissible agents Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the 5 inactivation/removal of viruses.

It is expected that in CYP2C19 poor metabolisers or in patients receiving concomitantly strong CYP2C19 inhibitors (see section 4.5), nelfinavir plasma levels would be elevated whereas levels of tert-butyl hydroxy nelfinavir would be negligible or non-measurable.

UMAN BIG is manufactured from large pools of human plasma, through a consolidated and validated industrial process that ensures compliance with Ph. Eur. requirements, as well as reproducibility of quality characteristics, hence consistency of the biological response.

A lower initial dose of 12.5 mg may be appropriate when clinical factors warrant dose adjustment, such as in patients with hepatic or renal impairment, for certain drug interactions that increase risperidone plasma concentrations (see section 4.5), or in patients who have a history of poor tolerability to psychotropic medications.

The objective of this Agreement is to enable each of the Contracting Parties, by pooling their research efforts in the field of controlled thermonuclear fusion and plasma physics, to derive maximum benefit from the resources assigned to their respective research programmes by avoiding unnecessary duplication, and thus to hasten the attainment of the common objective of such research, namely the production of electricity at competitive prices by utilization of controlled thermonuclear fusion reactions.