Примери за използване на HES solutions на Английски и техните преводи на Български
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HES solutions are contraindicated in severe coagulopathy.
The conduct of this study will be a condition to the marketing authorisations for HES solutions for infusion.
HES solutions for infusion are contraindicated in severe coagulopathy.
The PRAC also contraindicated the use of HES solutions for infusion in patients with sepsis or who are critically ill.
HES solutions should not be used for fluid maintenance.
Therefore the CMDh recommends the variation to the terms of the marketing authorisations for HES solutions for infusion.
HES solutions should be discontinued at the first sign of coagulopathy.
Healthcare professionals have been informed in writing of the outcome of the review andthe changes to the use of HES solutions.
HES solutions should be used at the lowest effective dose for the shortest period of time.
Impact on the clinical practice of potential suspension of MA for HES solutions for infusion.
HES solutions are now contraindicated in patients with renal impairment or renal replacement therapy.
The accreditation would require that relevant healthcare professionals receive training on the safe use of HES solutions for infusion.
HES solutions for infusion are used to replace fluids in the body after acute(sudden) blood loss.
Because of the risk of kidney injury and mortality, HES solutions for infusion are contraindicated in patients with sepsis or in critically ill patients.
HES solutions for infusion are contraindicated in patients with renal impairment or undergoing renal replacement therapy.
The PRAC also noted the overall exposure to HES solutions for infusion in the EU, estimated to about 1.5 to 2 million patients per year since 2014.
HES solutions may continue to be used to treat hypovolaemia(low blood volume) caused by acute(sudden) blood loss.
Because of the risk of kidney injury and mortality, HES solutions must no longer be used in patients with sepsis, burn injuries or critically ill patients.
However, new evidence was considered in the parallel Article 107i procedure andthis was the basis for the PRAC's final recommendation on the use of HES solutions.
Use of HES solutions for infusion should be restricted to the initial phase of volume resuscitation with a maximum time interval of 24 hours.
In view of the seriousness of the risks related to the use of HES solutions for infusion outside the terms of the MA, the CMDh considered this measure as proportionate.
HES solutions should only be used for the treatment of hypovolaemia due to acute blood loss when crystalloids alone are not considered sufficient.
The MAH should deliver the training on the appropriate use of HES solutions for infusion to relevant HCPs on a regular basis, as agreed with the national competent authorities.
The MAH should manage the accreditation of the hospitals/ centres,ensuring that all relevant HCPs intended to prescribe/ administer HES solutions for infusion have been adequately trained.
The review of HES solutions for infusion was initiated on 17 October 2017 at the request of the Swedish Medical Products Agency, under Article 107i of Directive 2001/83/EC.
Patients in the approved indication may become critically ill orseptic shortly after receiving HES solutions for infusion and these patients cannot be identified prospectively.
Most of the arguments refer to the use of HES solutions for infusion outside the terms of the MA or to claimed benefits that are not clinically significant or supported by robust data.
The training materials should be distributed to all relevant HCPs intended to prescribe/administer HES solutions for infusion(e.g. anaesthiologists, intensive care physicians, nurses…).
HES solutions for infusion are used to replace plasma volume following acute(sudden) blood loss, where treatment with alternative products known as‘crystalloids' alone is not considered sufficient.
In view of the above, the PRAC concluded that pursuant to Article 116 of Directive 2001/83/EC the risks related to the use of HES outweigh their benefits andthus the benefit-risk balance of HES solutions for infusion is no longer favourable.