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51–56/56
host control
51 Prevajalska redakcija
RS
EMEA
In a placebo-controlled trial in 1287 patients ≤ 24 months of age with haemodynamically significant congenital heart disease (639 Synagis; 648 placebo), 5 monthly doses of 15 mg/ kg Synagis reduced the incidence of RSV hospitalisations by 45 % (p = 0.003) (congenital heart disease study).
V preskušanju, ki je bilo kontrolirano s placebom in je zajelo 1. 287 bolnikov, starih ≤ 24 mesecev in s hemodinamsko pomembno prirojeno boleznijo srca (639 jih je dobivalo Synagis, 648 placebo), je 5 mesečnih odmerkov Synagisa 15 mg/ kg zmanjšalo incidenco hospitalizacij zaradi RSV za 45 % (p = 0, 003) (raziskava prirojenih bolezni srca).
52 Prevajalska redakcija
izobraževanje
CELEX: 32002L0065
This Directive aims to achieve the objectives set forth above without prejudice to Community or national law governing freedom to provide services or, where applicable, host Member State control and/or authorisation or supervision systems in the Member States where this is compatible with Community legislation.
Namen te direktive je doseči prej navedene cilje brez poseganja v zakonodajo Skupnosti ali nacionalno zakonodajo, ki ureja svobodo opravljanja storitev, ali kadar je to primerno, v nadzor in/ali pristojnost države članice gostiteljice ali v sisteme nadzora držav članic, če je to združljivo z zakonodajo Skupnosti.
53 Prevajalska redakcija
RS
EMEA
In each of two randomised, placebo-controlled trials, PROWESS and ADDRESS (see section 5.1), 28- day and in-hospital mortality were higher in patients treated with drotrecogin alfa (activated) compared to placebo for the sub-population of patients with single organ dysfunction and recent surgery (n=98 in PROWESS and n=636 in ADDRESS).
V vsakem od dveh randomiziranih s placebom kontroliranih preskušanj, PROWESS in ADDRESS (glejte poglavje 5. 1), sta bili 28- dnevna umrljivost in umrljivost v času hospitalizacije višji pri bolnikih, zdravljenih z drotrekoginom alfa (aktiviranim), v primerjavi s placebom, pri podskupini bolnikov z okvarjenim delovanjem enega organa in nedavnim operacijskim posegom (n = 98 v preskušanju PROWESS in n = 636 v preskušanju ADDRESS).
54 Prevajalska redakcija
izobraževanje
the on-going activities of the Host Party, supported by the EU and the International Community, to strengthen the rule of law, particularly to promote reform of the criminal justice system, and to take further action to prevent and control organised crime and develop policing standards in accordance with internationally recognised standards,
potekajočih dejavnosti države gostiteljice, ki jih podpirata EU in mednarodna skupnost, za okrepitev vladavine prava zlasti s pospeševanjem reforme kazenskega pravosodnega sistema in za sprejemanje nadaljnjih ukrepov za preprečevanje in nadzor nad organiziranim kriminalom ter oblikovanje policijskih standardov v skladu z mednarodno priznanimi standardi;
55 Prevajalska redakcija
izobraževanje
CELEX: 32000L0012
The competent host Member State authorities can, without prejudice to their powers of proper control, continue either, in an emergency, on their own initiative or following the initiative of the competent home Member State authorities, to verify that the activities of a credit institution established within their territories comply with the relevant laws and with the principles of sound administrative and accounting procedures and adequate internal control.
Pristojni organi države članice gostiteljice brez poseganja v pooblastila za izvajanje lastne kontrole v nujnih primerih ali na lastno pobudo ali na pobudo pristojnih organov matične države članice lahko še naprej preverjajo, ali so dejavnosti kreditne institucije, ustanovljene na njihovem ozemlju, v skladu z ustrezno zakonodajo in načeli dobro premišljenih administrativnih in računovodskih postopkov ter ustreznimi notranjimi kontrolami.
56 Prevajalska redakcija
RS
EMEA
In a 12-month, placebo-controlled study in paediatric patients 2 to 5 years of age with mild asthma and episodic exacerbations, montelukast 4 mg once daily significantly (p≤ 0.001) reduced the yearly rate of asthma exacerbation episodes (EE) compared with placebo (1.60 EE vs. 2.34 EE, respectively), [ EE defined as ≥ 3 consecutive days with daytime symptoms requiring β -agonist use, or corticosteroids (oral or inhaled), or hospitalization for asthma ].
23 V 12- mesečni, s placebom kontrolirani študiji pri pediatričnih bolnikih, starih 2 do 5 let, z blago astmo in epizodnimi poslabšanji je montelukast v odmerku 4 mg enkrat na dan v primerjavi s placebom pomebno (p≤0, 001) zmanjšal letni delež epizod poslabšanja (EP) astme (1, 60 EP proti 2, 34 EP); [ EP je definirana kot ≥ 3 zaporedni dnevi z dnevnimi simptomi, zaradi katerih je potrebna uporaba agonistov beta ali kortikosteroidov (peroralnih ali inhalacijskih) ali bolnišnično zdravljenje astme ].
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host control