Примери за използване на Solutions for infusion на Английски и техните преводи на Български
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Studies have shown that Zinforo solutions for infusion are stable for up to 6 hours at room temperature.
The conduct of this study will be a condition to the marketing authorisations for HES solutions for infusion.
The PRAC also contraindicated the use of HES solutions for infusion in patients with sepsis or who are critically ill.
Therefore the CMDh recommends the variation to the terms of the marketing authorisations for HES solutions for infusion.
Studies have shown that Zavicefta solutions for infusion are stable for up to 12 hours at room temperature.
The accreditation would require that relevant healthcare professionals receive training on the safe use of HES solutions for infusion.
It was also considered that HES solutions for infusion are used for the treatment of life-threatening medical conditions.
Impact on the clinical practice of potential suspension of MA for HES solutions for infusion.
HES containing solutions for infusion were indicated mainly for the treatment and prophylaxis of hypovolaemia and hypovolemic shock.
In addition, a significant decrease of the usage of HES solutions for infusion was noted in most EU Member States.
HES solutions for infusion are authorised worldwide for the treatment of hypovolaemia associated with various conditions.
A new unit compliant with the highest standards was installed for the production of solutions for infusion in 2000 at the Adlershof site.
Use of HES solutions for infusion should be restricted to the initial phase of volume resuscitation with a maximum time interval of 24 hours.
It is available as a concentrate(4 mg/5 ml) to be made up intoa solution for infusion(drip) into a vein, and as solutions for infusion(4 mg/100 ml and 5 mg/100 ml).
Because of the risk of kidney injury and mortality, HES solutions for infusion are contraindicated in patients with sepsis or in critically ill patients.
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 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.
It will allow targeting HCPs in charge of the administration of the medicinal product who have an important role in ensuring adherence to the adequate use of HES solutions for infusion.
Hydroxyethyl starch(HES) solutions for infusion include products with starch derived from potato or corn with different molecular weights and substitution ratios.
Patients in the approved indication may become critically ill orseptic shortly after receiving HES solutions for infusion and these patients cannot be identified prospectively.
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.
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…).
A review of HES solutions for infusion was initiated on 29 November 2012 at the request of the German medicines agency, under Article 31 of Directive 2001/83/EC.
The CMDh took into consideration the revised PRAC recommendation to suspend the marketing authorisations for solutions for infusion adopted at May PRAC plenary meeting.
Because of the risk of kidney injury and death, HES solutions for infusion must not be used in patients with blood infection or kidneys problems or in critically ill patients.
PRAC confirmed that the available information, including more recent submitted clinical data, do not change the established risk of increased mortality andrenal failure related to the use of HES solutions for infusion in these patients.
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.
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.
From a microbiological point of view,when administered with solutions for infusion the medicinal product should be used immediately after dilution by aseptic technique.
Hydroxyethyl starch(HES) solutions for infusion contain starch with different molecular weights(mainly 130kD; 200kD) and substitution ratio(the number of hydroxyethyl groups per glucose molecule).