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201–250/250
obseg delovanja
201 Prevajalska redakcija
RS
EMEA
Do najnižje koncentracije z opaznim učinkom (the lowest observable effect level - LOEL) za miopatijo je pri podganah in psih prišlo pri izpostavljenostih, ki so bile 0, 8 do 2, 3- kratniki terapevtskih koncentracij pri človeku pri odmerjanju 6 mg/ kg za bolnike z normalnim delovanjem ledvic.
11 The lowest observable effect level (LOEL) for myopathy in rats and dogs occurred at exposure levels of 0.8 to 2.3-fold the human therapeutic levels at 6 mg/ kg for patients with normal renal function.
202 Prevajalska redakcija
RS
EMEA
V primerjavi s placebom je bil Emselex v odmerkih 7, 5 mg in 15 mg povezan s statistično značilnim izboljšanjem nekaterih vidikov kakovosti življenja, izmerjenih s Kingsovim zdravstvenim vprašalnikom. Obsegali so vpliv inkontinence, omejitve delovanja, socialne omejitve in merila izraženosti.
Emselex 7.5 mg and 15 mg were associated with statistically significant improvements over placebo in some aspects of quality of life as measured by the Kings Health Questionnaire including incontinence impact, role limitations, social limitations and severity measures.
203 Prevajalska redakcija
izobraževanje
CELEX: 31998Y0822(01)
Pri ocenjevanju interesa Skupnosti Komisija preuči "…pomen domnevne kršitve v zvezi z delovanjem skupnega trga, možnost ugotavljanja obstoja kršitve in obseg preiskave, potrebne, da se, pod najboljšimi možnimi pogoji, izpolni njena naloga zagotavljanja izpolnjevanja členov 85 in 86…" [35]
In evaluating the Community interest, the Commission examines '... the significance of the alleged infringement as regards the functioning of the common market, the probability of establishing the existence of the infringement and the scope of the investigation required in order to fulfil, under the best possible conditions, its task of ensuring that Articles 85 and 86 are complied with...` (35).
204 Prevajalska redakcija
izobraževanje
CELEX: 31994R3290
Do obsega, ki je potreben za pravilno delovanje skupne ureditve trga za goveje in telečje meso, lahko Svet na predlog Komisije po glasovalnem postopku iz člena 43(2) Pogodbe v posebnih primerih v celoti ali delno prepove uporabo postopkov aktivnega in pasivnega oplemenitenja za proizvode iz člena 1.
To the extent necessary for the proper working of the common organization of the market in beef and veal, the Council, acting in accordance with the voting procedure laid down in Article 43 (2) of the Treaty on a proposal from the Commission, may, in special cases, prohibit in whole or in part the use of inward or outward processing arrangements in respect of products listed in Article 1.
205 Prevajalska redakcija
izobraževanje
CELEX: 31994R3290
Do obsega, ki je potreben za pravilno delovanje skupne ureditve trga za prašičje meso, lahko Svet na predlog Komisije po glasovalnem postopku iz člena 43(2) Pogodbe v posebnih primerih v celoti ali delno prepove uporabo postopka aktivnega oplemenitenja za proizvode iz člena 1 za proizvodnjo proizvodov iz tega člena.
To the extent necessary for the proper working of the common organization of the market in pigmeat, the Council, acting in accordance with the voting procedure laid down in Article 43 (2) of the Treaty on a proposal from the Commission, may, in special cases, prohibit in whole or in part the use of inward processing arrangements in respect of products listed in Article 1 which are intended for the manufacture of products listed in that Article.
206 Prevajalska redakcija
izobraževanje
CELEX: 31994R3290
Do obsega, ki je potreben za pravilno delovanje skupne ureditve trga za jajca in te uredbe, lahko Svet na predlog Komisije po glasovalnem postopku iz člena 43(2) Pogodbe v posebnih primerih v celoti ali delno prepove uporabo postopka aktivnega oplemenitenja za proizvode iz člena 1 za proizvodnjo proizvodov iz tega člena.
To the extent necessary for the proper working of the common organization of the market in eggs and this Regulation, the Council, acting in accordance with the voting procedure laid down in Article 43 (2) of the Treaty on a proposal from the Commission, may, in special cases, prohibit in whole or in part the use of inward processing arrangements in respect of products listed in Article 1 which are intended for the manufacture of products listed in that Article.
207 Prevajalska redakcija
izobraževanje
CELEX: 21996A0520(01)
Izmenjave informacij o pomembnih mednarodnih problemih v zvezi z jedrsko energijo, kakor so pospeševanje razvoja na področju mednarodnega varovanja in neširjenja v obsegu obojestranskega interesa in pristojnosti, vključno s sodelovanjem z IAEA pri zadevah varovanja ter vzajemnega delovanja med jedrsko energijo in okoljem;
Exchange of information on major international questions related to nuclear energy, such as promotion of development in the field of international nuclear safeguards and non-proliferation within areas of mutual interest and competence, including collaboration with the IAEA on safeguards matters and on the interaction between nuclear energy and the environment;
208 Prevajalska redakcija
izobraževanje
CELEX: 32000R1901
"Celovit industrijski obrat" pomeni kombinacijo strojev, aparatov, naprav, opreme, instrumentov in materialov, v nadaljevanju "sestavni deli", ki spadajo v različne tarifne podštevilke klasifikacije Harmoniziranega sistema in ki so namenjeni za skupno delovanje kot obsežna enota za proizvodnjo blaga ali ponujanje storitev.
"Complete industrial plant" means a combination of machines, apparatus, appliances, equipment, instruments and materials, hereinafter referred to as "component parts", which fall under various headings of the Harmonised System classification and which are designed to function together as a large-scale unit to produce goods or provide services.
209 Prevajalska redakcija
RS
EMEA
Glede učinkov na periferne živce je določanje še varnih odmerkov temeljilo na primerjavi med 8- kratno (pri podganah) oziroma 6- kratno (pri psih) vrednostjo Cmax pri odmerku brez opaženih učinkov (No Observed Effect Level - NOEL) in med Cmax pri odmerjanju 6 mg/ kg enkrat dnevno pri bolnikih z normalnim delovanjem ledvic.
Safety margins for peripheral nerve effects in rats and dogs are 8- and 6-fold, respectively, based on comparison of Cmax values at the No Observed Effect Level (NOEL) with the Cmax achieved on dosing with 6 mg/ kg once daily in patients with normal renal function.
210 Prevajalska redakcija
izobraževanje
CELEX: 31993L0001
ker so glede na obseg in učinke predlaganega delovanja ukrepi Skupnosti, predvideni v tej direktivi, ne le potrebni, ampak tudi nepogrešljivi za uresničenje navedenih ciljev, ker teh ciljev države članice ne morejo doseči posamič in ker je njihovo uresničenje na ravni Skupnosti pravzaprav že predvideno z Direktivo 76/116/EGS;
Whereas, in view of the scope and effects of the proposed action, the Community measures provided for by this Directive are not only necessary but also indispensable for the attainment of the stated objectives, whereas these objectives cannot be achieved by Member States individually, and whereas their attainment at Community level is, in fact, already provided for by Directive 76/116/EEC;
211 Prevajalska redakcija
izobraževanje
CELEX: 31995L0008
ker so glede na obseg in učinke predlaganega delovanja ukrepi Skupnosti, predvideni v tej direktivi, ne le potrebni, ampak tudi nepogrešljivi za uresničenje navedenih ciljev, ker teh ciljev države članice ne morejo doseči posamič in ker je njihovo uresničenje na ravni Skupnosti pravzaprav že predvideno z Direktivo 76/116/EGS;
Whereas, in view of the scope and effects of the proposed action, the Community measures provided for by this Directive are not only necessary but also indispensable for the attainment of the stated objectives, whereas these objectives cannot be achieved by Member States individually and whereas their attainment at Community level is, in fact, already provided for by Directive 76/116/EEC;
212 Prevajalska redakcija
izobraževanje
CELEX: 31994R3290
Do obsega, ki je potreben za pravilno delovanje skupne ureditve trga za perutninsko meso, lahko na predlog Komisije Svet po glasovalnem postopku iz člena 43(2) Pogodbe v posebnih primerih v celoti ali delno prepove uporabo postopkov aktivnega in pasivnega oplemenitenja za proizvode iz člena 1(1) za proizvodnjo proizvodov iz člena 1(1).
To the extent necessary for the proper working of the common organization of the market in poultrymeat, the Council, acting in accordance with the voting procedure laid down in Article 43 (2) of the Treaty on a proposal from the Commission, may, in special cases, prohibit in whole or in part the use of inward or outward processing arrangements in respect of products listed in Article 1 (1) which are intended for the manufacture of products listed in Article 1 (1).
213 Prevajalska redakcija
izobraževanje
CELEX: 31994R3290
Do obsega, ki je potreben za pravilno delovanje skupne ureditve trga za mleko in mlečne izdelke, lahko Svet na predlog Komisije po glasovalnem postopku iz člena 43(2) Pogodbe v posebnih primerih v celoti ali delno prepove uporabo postopka aktivnega oplemenitenja za proizvode iz člena 1 za proizvodnjo blaga iz tega člena ali blaga iz Priloge.
To the extent necessary for the proper working of the common organization of the market in milk and milk products, the Council, acting in accordance with the voting procedure laid down in Article 43 (2) of the Treaty on a proposal from the Commission, may, in special cases, prohibit in whole or in part the use of inward processing arrangements in respect of products listed in Article 1 which are intended for the manufacture of products listed in that Article or of goods listed in the Annex.
214 Prevajalska redakcija
izobraževanje
CELEX: 32002L0024
Ker izboljšanja delovanja sistema ES-homologacije vozil ni mogoče doseči v zadostni meri na ravni posameznih držav članic,marveč jih je zaradi obsega in učinka predloženih ukrepov lažje doseči na ravni Skupnosti, lahko Skupnost sprejme ukrepe skladno z načelom subsidiarnosti, določenim v členu 5 Pogodbe o ustanovitvi Evropske skupnosti.
Since the objectives of improving the functioning of the system of Community vehicle approval according to type cannot be sufficiently achieved by the Member States individually and can therefore, given the scale and the impact of the measures proposed, be better achieved at Community level, the Community may adopt measures in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty.
215 Prevajalska redakcija
izobraževanje
CELEX: 32002D0836
SRS bo okrepil svoje sodelovanje z mednarodnimi ustvarjalnimi enotami in svetovalci na najvišji ravni z delovanjem v skladu z obstoječimi uspešnimi izkušnjami (npr. mreža evropskega znanstvenega in tehnološkega observatorija, skupina ekonomistov na visoki ravni) in s prizadevanji za ustanovitev mednarodne mreže za sodelovanje pri predvidevanjih.
The JRC will strengthen its working relationships with international think-tanks and top level advisors, by following up existing successful experiences (e.g. the European Science and Technology Observatory network, the High-Level Economists Group) and by pursuing the establishment of an International foresight cooperation framework.
216 Prevajalska redakcija
izobraževanje
CELEX: 31992R0593
ker je treba glede na obseg uradom zaupanih nalog in njihovo pomembnost pri pravilnem in enotnem izvajanju pravil Skupnosti v sektorju sprejeti določbe za novo petletno obdobje udeležbe Skupnosti pri pokrivanju stroškov uradov, tako pa omogočiti uradu pravilno in učinkovito delovanje in ohranjanje njegove upravne samostojnosti, predvidene s pravili,
whereas, in view of the extent of the tasks entrusted to agencies and of their importance for the correct and uniform application of Community rules in the sector, provision should be made, for a new period of five years, for a Community contribution to the agencies' expenditure enabling them to function effectively and regularly while maintaining the administrative autonomy envisaged by the rules,
217 Prevajalska redakcija
izobraževanje
CELEX: 31998L0007
ker je primerno brez odlašanja raziskati, do kakšnega obsega je nadaljnja stopnja usklajevanja stroškovnih elementov potrošniških kreditov potrebna, da bi evropskemu potrošniku omogočili boljšo primerjavo med dejanskimi odstotki obresti, ki jih ponujajo institucije v različnih državah članicah, in s tem zagotovili usklajeno delovanje notranjega trga,
Whereas it is appropriate to study without delay to what extent a further degree of harmonization of the cost elements of consumer credit is necessary in order to put the European consumer in a position to make a better comparison between the actual percentage rates of charges offered by institutions in the various Member States, thereby ensuring harmonious functioning of the internal market,
218 Prevajalska redakcija
izobraževanje
CELEX: 31998D2119
ker lahko v skladu z načelom subsidiarnosti vsak nov ukrep, sprejet na področju, ki ne sodi v izključno pristojnost Skupnosti tako kot epidemiološko spremljanje in obvladovanje nalezljivih bolezni, Skupnost sprejme le, če se lahko cilji zaradi obsega ali učinkov predlaganega delovanja lažje dosežejo na ravni Skupnosti kot v posameznih državah članicah;
Whereas, in accordance with the principle of subsidiarity, any new measure taken in an area which does not fall within the exclusive competence of the Community, such as the epidemiological surveillance and control of communicable diseases, may be taken by the Community only if, by reason of the scale or effects of the proposed action, the objectives of the proposed action can be better achieved by the Community than by the Member States;
219 Prevajalska redakcija
izobraževanje
CELEX: 31998L0079
posebne analitične značilnosti delovanja (npr. občutljivost, specifičnost, natančnost, ponovljivost, reproduktivnost, meje zaznavanja in obseg meritev, vključno z informacijami, potrebnimi za nadzor znanih pomembnih medsebojnih vplivov (interferenc)), omejitve metode in informacije kako naj uporabnik uporabi razpoložljive referenčne merilne postopke in materiale,
the specific analytical performance characteristics (e.g. sensitivity, specificity, accuracy, repeatability, reproducibility, limits of detection and measurement range, including information needed for the control of known relevant interferences), limitations of the method and information about the use of available reference measurement procedures and materials by the user,
220 Prevajalska redakcija
izobraževanje
CELEX: 32004L0023
Ker države članice ne morejo v zadostnem obsegu doseči ciljev te direktive, in sicer postavitve visokih standardov kakovosti in varnosti za človeška tkiva in celice v celotni Skupnosti, in ker se ti cilji torej zaradi obsega delovanja lažje dosežejo na ravni Skupnosti, lahko Skupnost sprejme ukrepe skladno z načelom subsidiarnosti, kakor je določeno v členu 5 Pogodbe.
Since the objective of this Directive, namely to set high standards of quality and safety for human tissues and cells throughout the Community, cannot be sufficiently achieved by the Member States and can therefore, by reason of scale and effects, be better achieved at Community level, the Community may adopt measures in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty.
221 Prevajalska redakcija
izobraževanje
CELEX: 32003L0098
Pregled zadeva zlasti področje uporabe in vpliv te direktive, vključno z obsegom povečanja ponovne uporabe dokumentov javnega sektorja, učinke načel, ki se uporabljajo za obračunavanje in ponovno uporabo uradnih besedil, ki so zakonodajne in upravne narave, kakor tudi nadaljnje možnosti izboljšanja pravilnega delovanja notranjega trga in razvoj industrije evropske vsebine.
The review shall in particular address the scope and impact of this Directive, including the extent of the increase in re-use of public sector documents, the effects of the principles applied to charging and the re-use of official texts of a legislative and administrative nature, as well as further possibilities of improving the proper functioning of the internal market and the development of the European content industry.
222 Prevajalska redakcija
izobraževanje
CELEX: 32001L0037
Poročilu se priložijo vsi predlogi za spremembe in dopolnila k tej direktivi, za katero Komisija meni, da jo je treba prilagajati razvojnim dosežkom na področju tobačnih izdelkov v obsegu, ki je potreben za vzpostavitev in delovanje notranjega trga, ter upoštevati vse nove okoliščine na podlagi znanstvenih dejstev in razvojnih dosežkov na mednarodno dogovorjenih standardih za izdelke.
That report shall be accompanied by any proposals for amendments to this Directive which the Commission deems necessary to adapt it to developments in the field of tobacco products, to the extent necessary for the establishment and operation of the internal market, and to take into account any new development based on scientific facts and developments on internationally agreed product standards.
223 Prevajalska redakcija
izobraževanje
CELEX: 31978L0632
uporablja se prvi stavek točke 5.1.5 (to se pravi sila v velikosti 37,8 daN, ki povzroči, da se element umakne nazaj ali odtrga), zatem pa še točka 5.1.4 v primeru, da je prišlo do umika nazaj v takem obsegu, da je ostala izboklina v velikosti med 3,2 in 9,5 mm, ali, v primeru, da je prišlo do odtrganja, zadnja dva stavka točke 5.1.5 (površino preseka je treba izmeriti pred delovanjem sile).
the first sentence of point 5.1.5 (i.e. a force of 37 78 daN for retraction or detachment) is applied and then point 5.1.4 in case of retraction up to a protrusion between 3 72 and 9 75 mm or, in the case of detachment, the two last sentences of point 5.1.5 (the cross-section area is measured before the force is applied).
224 Prevajalska redakcija
RS
EMEA
Pregled učinkovitosti delovanja Agencije je v tem trenutku še posebej pomemben, saj se Agencija spopada z izzivi, ki izhajajo iz vedno večje zahtevnosti in količine njenih dejavnosti, iz vedno večjega obsega odgovornosti, iz povečanih pričakovanj zainteresiranih strani, iz izzivov, ki jih predstavlja prihod novih in bolj zapletenih tehnologij, in nadaljnje globalizacije farmacevtskega sektorja.
Reviewing the efficiency of the Agency’ s operations is particularly important at this time, as it faces challenges resulting from the increased complexity and volume of its activities, from its wider scope of responsibilities, from the heightened expectations of its stakeholders, from challenges posed by the advent of new and more complex technologies, and from the continuing globalisation of the pharmaceutical sector.
225 Prevajalska redakcija
izobraževanje
CELEX: 31998Y0822(01)
Sporočilo Komisije z dne 27. novembra 1996 o merilih za ocenjevanje nacionalnih programov za izračunavanje stroškov in financiranje univerzalne storitve in smernice za delovanje takšnih programov bo pomembno za določanje obsega, do katerega se lahko uporabijo obveznosti univerzalne storitve za utemeljitev dodatnih stroškov, povezanih z delitvijo neto stroškov pri uporabi univerzalne storitve (COM(96) 608).
The Commission Communication of 27 November 1996 on Assessment Criteria for National Schemes for the Costing and Financing of Universal Service and Guidelines for the Operation of such Schemes will be relevant for the determination of the extent to which the universal service obligation can be used to justify additional charges related to the sharing of the net cost in the provision of universal service (COM(96) 608).
226 Prevajalska redakcija
izobraževanje
CELEX: 32004R0138
SNR 93 navaja, da bi bilo treba določiti izboljšave osnovnih sredstev glede na obseg sprememb značilnosti osnovnih sredstev, to je glede na večje spremembe velikosti, oblike, delovanja, zmogljivosti ali pričakovane življenjske dobe, ali glede na dejstvo, da izboljšave niso take spremembe, ki bi potekale redno pri drugih osnovnih sredstvih iste vrste kot del rednih programov vzdrževanja in popravil (prim. SNR 93, 10.49).
The SNA 93 specifies that improvements made to fixed assets should be determined either by the magnitude of the changes in the characteristics of the fixed assets - i.e. by major changes in their size, shape, performance, capacity or anticipated service life - or by the fact that improvements are not the kinds of changes that are observed to take place routinely in other fixed assets of the same kind, as part of ordinary maintenance and repair programmes (cf. SNA 93, 10.49).
227 Prevajalska redakcija
RS
EMEA
Druga poglavja povzetka glavnih značilnosti zdravila Naslednja poglavja povzetka glavnih značilnosti zdravila so bila prav tako predmet obsežnega usklajevanja v tem napotitvenem postopku, in sicer poglavje 4. 4 Posebna opozorila in previdnostni ukrepi, 4. 5 Medsebojno delovanje, 4. 6 Nosečnost in dojenje, 4. 8 Neželeni učinki, 4. 9 Preveliko odmerjanje, 5. 1 Farmakodinamične lastnosti in 5. 2 Farmakokinetične lastnosti.
Other Sections of the SPC The following sections of the SPC were also subject to extensive harmonisation during this referral procedure, namely sections 4.4 Special warnings and precautions, 4.5 Interactions, 4.6 Pregnancy and lactation, 4.8 Undesirable effects, 4.9 Overdose, 5.1 Pharmacodynamic properties, and 5.2 Pharmacokinetic properties.
228 Prevajalska redakcija
izobraževanje
CELEX: 22002A1217(02)
Svet v obsegu, ki se mu zdi potreben, spodbuja študije o ekonomiki proizvodnje in distribucije kakava, vključno z gibanji in projekcijami, vplivom vladnih ukrepov v državah izvoznicah in uvoznicah na proizvodnjo in porabo kakava, možnostmi za povečanje porabe kakava pri tradicionalnih in morebitnih novih oblikah uporabe ter učinki delovanja tega sporazuma na izvoznike in uvoznike kakava, vključno z njihovimi pogoji menjave.
The Council shall, to the extent it considers necessary, promote studies of the economics of cocoa production and distribution, including trends and projections, the impact of governmental measures in exporting and importing countries on the production and consumption of cocoa, the opportunities for expansion of cocoa consumption for traditional and possible new uses, and the effects of the operation of this Agreement on exporters and importers of cocoa, including their terms of trade.
229 Prevajalska redakcija
izobraževanje
CELEX: 32003R1267
V poročilu Monetarnega odbora o statističnih zahtevah v Ekonomski in monetarni uniji (EMU), ki ga je Ekonomsko-finančni svet sprejel 18. januarja 1999, je poudarjeno, da sta za pravilno delovanje EMU in enotnega trga poglavitnega pomena učinkovit nadzor in koordinacija ekonomskih politik, kar zahteva obsežen sistem statističnih informacij, ki daje oblikovalcem politik potrebne podatke, na katerih temeljijo njihove odločitve.
The report of the Monetary Committee on statistical requirements in the Economic and Monetary Union (EMU), endorsed by the Ecofin Council of 18 January 1999, underlined that, for the proper functioning of the EMU and the single market, effective surveillance and coordination of economic policies are of major importance and that this requires a comprehensive statistical information system providing policy makers with the necessary data on which to base their decisions.
230 Prevajalska redakcija
RS
EMEA
Mehanizem delovanja Paroksetin je močan in selektiven zaviralec prevzema 5- hidroksitriptamina (5- HT, serotonin). Domnevno je njegovo antidepresivno delovanje in učinkovitost pri zdravljenju obsesivno - kompulzivne motnje, socialne anksiozne motnje/ socialne fobije, generalizirane anksiozne motnje, posttravmatske stresne motnje in panične motnje povezano z njegovim specifičnim zaviranjem prevzema serotonina v možganskih nevronih.
Mechanism of Action Paroxetine is a potent and selective inhibitor of 5-hydroxytryptamine (5-HT, serotonin) uptake and its antidepressant action and effectiveness in the treatment of OCD, Social Anxiety disorder/ Social Phobia, General Anxiety Disorder, Post-traumatic Stress Disorder and Panic Disorder is thought to be related to its specific inhibition of 5-HT uptake in brain neurones.
231 Prevajalska redakcija
RS
EMEA
V študiji zmanjševanja proteinurije z zdravilom Diovan (Diovan Reduction of Proteinuria - DROP) so naprej preučevali učinkovitost valsartana pri zmanjšanju izločanja albumina z urinom pri 391 hipertenzivnih bolnikih (s krvnim tlakom 150/ 88 mmHg), s sladkorno boleznijo tipa 2, z albuminurijo (v povprečju 102 µg/ min; v obsegu 20- 700 µg/ min) in z ohranjenim delovanjem ledvic (s povprečno koncentracijo kreatinina v serumu 80 µmol/ l).
The Diovan Reduction of Proteinuria (DROP) study further examined the efficacy of valsartan in reducing UAE in 391 hypertensive patients (BP=150/ 88 mmHg) with type 2 diabetes, albuminuria (mean=102 µg/ min; 20-700 µg/ min) and preserved renal function (mean serum creatinine = 80 µmol/ l).
232 Prevajalska redakcija
izobraževanje
CELEX: 32004L0012
Ker ciljev predlaganega ukrepa, in sicer usklajevanje nacionalnih ciljnih deležev recikliranja odpadne embalaže, pri čemer se upoštevajo razmere v posamezni državi članici, in zagotavljanje dodatnih pojasnil o definicijah, države članice ne morejo doseči v zadostni meri ter se torej zaradi obsega delovanja lažje dosežejo na ravni Skupnosti, lahko Skupnost v skladu z načelom subsidiarnosti, določenim v členu 5 Pogodbe, sprejme ukrepe.
Since the objectives of the proposed action, namely to harmonise national targets for the recycling of packaging waste, taking into account individual circumstances of each Member State, and to provide further clarification on definitions, cannot be sufficiently achieved by the Member States and can therefore, by reason of the scale of the action, be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty.
233 Prevajalska redakcija
RS
EMEA
Pri magnetnoresonančnem slikanju lobanje se lahko, če močan klinični sum na lezijo ne izgine kljub enkratnem odmerku kontrastnega sredstva ali kadar lahko natančnejša informacija o številu, velikosti ali obsegu lezij vpliva na obravnavanje ali zdravljenje bolnika, pri osebah z normalnim delovanjem ledvic v 30 minutah po prvem injiciranju uporabi druga bolusna injekcija z odmerkom 0, 1 mmol/ kg, ker lahko poveča diagnostični izkoristek pregleda.
In cranial MRI, if a strong clinical suspicion of a lesion persists despite a single dose contrast- enhanced MRI or when more accurate information on the number, size or extent of lesions might influence management or therapy of the patient, in subjects with normal renal function, a second bolus injection of 100 micromol/ kg may be administered within 30 minutes of the first injection as it may increase the diagnostic yield of the examination.
234 Prevajalska redakcija
izobraževanje
CELEX: 21994A1223(20)
Glede na njihovo obveznost iz tega dogovora glede notifikacije v kar največjem mogočem obsegu njihovo sprejetje trgovinskih ukrepov, ki vplivajo na delovanje GATT 1994, pri čemer takšna notifikacija ne posega v stališča glede doslednosti ukrepov ali njihovo relevantnost za pravice in obveznosti v okviru večstranskih trgovinskih sporazumov in, kjer je to primerno, plurilateralnih trgovinskih sporazumov, se članice strinjajo, da se bodo primerno ravnale po priloženem seznamu ukrepov.
With regard to their undertaking therein to notify, to the maximum extent possible, their adoption of trade measures affecting the operation of GATT 1994, such notification itself being without prejudice to views on the consistency of measures with or their relevance to rights and obligations under the Multilateral Trade Agreements and, where applicable, the Plurilateral Trade Agreements, Members agree to be guided, as appropriate, by the annexed list of measures.
235 Prevajalska redakcija
izobraževanje
CELEX: 31967L0548
ker se glede na obseg tega področja in številne podrobne ukrepe, ki bodo potrebni za približanje vseh predpisov v zvezi z nevarnimi snovmi, zdi smotrno najprej obravnavati približevanje zakonov in drugih predpisov v zvezi z razvrščanjem, pakiranjem in označevanjem nevarnih snovi ter v poznejših direktivah obravnavati približevanje predpisov v zvezi z uporabo teh nevarnih snovi in pripravkov, če se ugotovi, da razlike med temi predpisi neposredno vplivajo na vzpostavitev in delovanje skupnega trga;
Whereas in view of the extent of this field and the many detailed measures which will be required for the approximation of all the provisions relating to dangerous substances, it would appear advisable to deal first with the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances and to deal in later directives with the approximation of the provisions relating to the use of those dangerous substances and preparations if it is established that the differences between such provisions directly affect the establishment or functioning of the common market;
236 Prevajalska redakcija
izobraževanje
CELEX: 31997R0515
Če se je tretja država pravno zavezala, da zagotovi pomoč, potrebno za pridobitev vseh dokazov o nepravilnostih postopkov, ki se zdijo, da so v nasprotju s carinsko ali kmetijsko zakonodajo, ali za določitev obsega dejanj, za katere je bilo ugotovljeno, da so v nasprotju s tema zakonodajama, se ji lahko informacije, pridobljene z uporabo te uredbe, sporočijo v okviru usklajenega delovanja s soglasjem pristojnih organov, ki so jih zagotovili ter ob upoštevanju njihovih notranjih predpisov o posredovanju osebnih podatkov tretjim državam.
Provided the third country concerned has given a legal undertaking to provide the assistance required to gather proof of the irregular nature of operations which appear to constitute breaches of customs or agricultural legislation or to determine the scope of operations which have been found to constitute breaches of that legislation, information obtained under this Regulation may be communicated to that third country as part of a concerted action, subject to the agreement of the competent authorities supplying the information, in accordance with their internal provisions concerning the communication of personal data to third countries.
237 Prevajalska redakcija
izobraževanje
CELEX: 32004L0067
Ker cilja te direktive, in sicer zagotavljati ustrezno raven zanesljivosti oskrbe s plinom, zlasti v primerih večjih motenj oskrbe, in hkrati prispevati k pravilnemu delovanju notranjega trga s plinom, v vseh okoliščinah države članice ne morejo doseči v dovolj veliki meri, zlasti glede na vedno večjo medsebojno odvisnost držav članic glede zanesljivosti oskrbe s plinom, ter je torej ta cilj zaradi obsega in učinkov delovanja laže doseči na ravni Skupnosti, lahko Skupnost sprejme ukrepe v skladu z načelom subsidiarnosti, določenim v členu 5 Pogodbe.
Since the objective of this Directive, namely ensuring an adequate level for the security of gas supply, in particular in the event of a major supply disruption, whilst contributing to the proper functioning of the internal gas market, cannot, in all circumstances, be sufficiently achieved by the Member States, particularly in light of the increasing interdependency of the Member States regarding security of gas supply, and can therefore, by reason of the scale and effects of the action, be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty.
238 Prevajalska redakcija
RS
EMEA
Nevtropenija Potrebna je previdnost pri bolnikih, ki imajo iz kateregakoli vzroka nizko število levkocitov in/ ali nevtrofilcev, in pri bolnikih, ki prejemajo zdravila, za katera je znano, da povzro ajo nevtropenijo. To velja tudi za bolnike, pri katerih se je v preteklosti pojavilo z zdravili povzro eno zavrto delovanje kostnega mozga ali so prejemali zdravila, toksi na za kostni mozeg, pri bolnikih z zavrtim delovanjem kostnega mozga zaradi so asne bolezni, obsevanja ali kemoterapije ter pri bolnikih s hipereozinofilnimi stanji ali mieloproliferativno boleznijo.
Neutropenia Caution should be exercised in patients with low leukocyte and/ or neutrophil counts for any reason, in patients receiving medicines known to cause neutropenia, in patients with a history of drug-induced bone marrow depression/ toxicity, in patients with bone marrow depression caused by concomitant illness, radiation therapy or chemotherapy and in patients with hypereosinophilic conditions or with myeloproliferative disease.
239 Prevajalska redakcija
RS
EMEA
Nevtropenija Potrebna je previdnost pri bolnikih, ki imajo iz kateregakoli vzroka nizko število levkocitov in/ ali nevtrofilcev, in pri bolnikih, ki prejemajo zdravila, za katera je znano, da povzročajo nevtropenijo. To velja tudi za bolnike, pri katerih se je v preteklosti pojavilo z zdravili povzročeno zavrto delovanje kostnega mozga ali so prejemali zdravila, toksična za kostni mozeg, pri bolnikih z zavrtim delovanjem kostnega mozga zaradi sočasne bolezni, obsevanja ali kemoterapije ter pri bolnikih s hipereozinofilnimi stanji ali mieloproliferativno boleznijo.
4 Caution should be exercised in patients with low leukocyte and/ or neutrophil counts for any reason, in patients receiving medicines known to cause neutropenia, in patients with a history of drug-induced bone marrow depression/ toxicity, in patients with bone marrow depression caused by concomitant illness, radiation therapy or chemotherapy and in patients with hypereosinophilic conditions or with myeloproliferative disease.
240 Prevajalska redakcija
RS
EMEA
74 Nevtropenija Potrebna je previdnost pri bolnikih, ki imajo iz kateregakoli vzroka nizko število levkocitov in/ ali nevtrofilcev, in pri bolnikih, ki prejemajo zdravila, za katera je znano, da povzročajo nevtropenijo. To velja tudi za bolnike, pri katerih se je v preteklosti pojavilo z zdravili povzročeno zavrto delovanje kostnega mozga ali so prejemali zdravila, toksična za kostni mozeg, pri bolnikih z zavrtim delovanjem kostnega mozga zaradi sočasne bolezni, obsevanja ali kemoterapije ter pri bolnikih s hipereozinofilnimi stanji ali mieloproliferativno boleznijo.
74 Caution should be exercised in patients with low leukocyte and/ or neutrophil counts for any reason, in patients receiving medicines known to cause neutropenia, in patients with a history of drug-induced bone marrow depression/ toxicity, in patients with bone marrow depression caused by concomitant illness, radiation therapy or chemotherapy and in patients with hypereosinophilic conditions or with myeloproliferative disease.
241 Prevajalska redakcija
RS
EMEA
Pogosti  težave s srcem: srčni infarkt, * angina pektoris (bolečine v prsih)  težave z želodcem: siljenje na bruhanje, zgaga, divertikel (težava z želodcem ali črevesom, ki lahko boli ali se okuži), bruhanje, * sindrom razdražljivega črevesa (lahko obsega bolečine v trebuhu, drisko, prebavne težave, vetrove)  ledvični kamni (ki lahko povzročijo bolečine v trebuhu ali hrbtu, kri v urinu), težave pri odvajanju urina, zvišan kreatinin (preiskava krvi, povezana z delovanjem ledvic − težko dihanje − spazmi mišic − edemi (zastajanje vode, ki lahko povzroči otekanje) − povečanje ali vnetje prostate, zvišanje za prostato specifičnega antigena (laboratorijska preiskava) − različne vrste okužb − povečanje telesne mase
Common − Heart problems: heart attack*, angina (chest pain) − Stomach problems: nausea, heartburn, diverticulum (a problem with the stomach or intestine that can become painful or infected), vomiting*, irritable bowel syndrome (can include stomach ache, diarrhoea, indigestion, wind) − Kidney stones (which may lead to stomach or back pain, blood in urine), difficulty passing urine, increased creatinine (blood test result related to kidney function) − Difficulty breathing − Muscle spasms − Oedema (water retention that can cause swelling) − Enlarged or inflamed prostate, prostate specific antigen increased (lab test) − Infections of various types − Weight gain
242 Prevajalska redakcija
RS
EMEA
Redko (pri več kot 1 od 10, 000 bolnikov, vendar manj kot pri 1 od 1000 bolnikov): • visok tlak v očeh, vnetje obarvanega dela očesa, obsežno vnetje očesa; • kožni rak, rak limfnega sistema, maligni melanom; • bolezni ščitnice; • beljakovine v urinu; • zmanjšanje števila krvnih ploščic (kar poveča tveganje krvavitev ali podplutb), zmanjšanje števila krvnih celic (kar lahko povzroči šibkost, podplutbe ali poveča verjetnost okužb); • bolečina v prsih, srce neha črpati kri, zožitve v srčnih arterijah, tekočina v okolici srca, ki lahko povzroči hudo bolečino v prsih, težave s srcem, ki lahko povzročijo kratko sapo ali otekanje gležnjev, občutek hitrega bitja srca; • izguba sluha, zvonjenje v ušesih; • vnetje trebušne slinavke, ki povzroči hude bolečine v trebuhu in hrbtu, vnetje, ki povzroči bolečine v trebuhu in drisko, zapora črevesa, ki lahko povzroči slabost v želodcu in bruhanje, vnetje, ki povzroči bolečine pri požiranju, težave z želodcem, vnetje želodca, ki povzroči bolečine v trebuhu, občutek siljenja na bruhanje in bruhanje; • obsežna okvara jeter, trebušni simptomi (npr. bruhanje, težave z želodcem, zaprtje), preveč maščobe v jetrih, kar lahko povzroči nelagodje v trebuhu, utrujenost in slabo počutje, žolčni kamni, ki lahko povzročijo hudo bolečino in zvišano telesno temperaturo, spremembe krvnih preiskav, ki kažejo delovanje jeter; • vnetje, ki povzroči povišano telesno temperaturo, izpuščaj na koži, bolečino v sklepih; • vnetje debelega črevesa, ki povzroči povišano telesno temperaturo, bolečine in krče v trebuhu, zaprtje; • uničenje kože in globokih tkiv zaradi okužbe;
• skin cancer; cancer, cancer that affects the lymph system, malignant melanoma; • thyroid disorders; • protein in urine; • reduction in blood platelets which increases risk of bleeding or bruising, reduction in blood cells which can cause weakness, bruising or make infections more likely; • chest pain, heart stops pumping, blockages in the arteries of the heart, fluid around the heart that can cause severe chest pain, heart problems that can cause shortness of breath or ankle swelling, sensation of heart beating rapidly; • hearing loss, buzzing; • inflammation of the pancreas which causes severe pain in the abdomen and back, inflammation that causes abdominal pain and diarrhoea, blockages of the intestine that cause nausea and vomiting, inflammation that causes pain on swallowing, indigestion, inflammation of the stomach which causes pain in the abdomen, nausea and vomiting; • extensive injury to the liver, abdominal symptoms (such as vomiting, indigestion, constipation), excess fat in the liver which can cause abdominal discomfort, fatigue and feeling unwell, stones in the gallbladder that can cause sever pain and fever, blood test shows changes in the way the liver is working; • inflammation that causes fever, skin rash, joint pain; • inflammation of the large intestine that causes fever, abdominal pain and cramping, constipation, • skin and deep tissue destruction caused by infection; • high blood level of calcium that is usually without symptoms but could cause abdominal pain, depression, weakness and kidney stones, low blood calcium that can cause tingling in the fingers and toes and muscle cramping; • abnormal muscle breakdown which can lead to kidney problems; • swelling in the back of the throat, fluid around the lungs that may cause shortness of breath, pain upon taking a deep breath; • inflammation of abdominal fat causing painful skin nodules; • a sac in the wall of a major artery, blockage of a heart valve usually without symptoms but may cause shortness of breath with exercise, chest pain and fainting, inflammation and clot of a vein, blockage of a blood vessel, sensation of heart beating rapidly; • multiple sclerosis, facial muscle weakness or paralysis.
243 Prevajalska redakcija
RS
EMEA
Redko (pri več kot 1 od 10, 000 bolnikov, vendar manj kot pri 1 od 1000 bolnikov): • visok tlak v očeh, vnetje obarvanega dela očesa, obsežno vnetje očesa; • kožni rak, rak limfnega sistema, maligni melanom; • bolezni ščitnice; • beljakovine v urinu; • zmanjšanje števila krvnih ploščic (kar poveča tveganje krvavitev ali podplutb), zmanjšanje števila krvnih celic (kar lahko povzroči šibkost, podplutbe ali poveča verjetnost okužb); • bolečina v prsih, srce neha črpati kri, zožitve v srčnih arterijah, tekočina v okolici srca, ki lahko povzroči hudo bolečino v prsih, težave s srcem, ki lahko povzročijo kratko sapo ali otekanje gležnjev, občutek hitrega bitja srca; • izguba sluha, zvonjenje v ušesih; • vnetje trebušne slinavke, ki povzroči hude bolečine v trebuhu in hrbtu, vnetje, ki povzroči bolečine v trebuhu in drisko, zapora črevesa, ki lahko povzroči slabost v želodcu in bruhanje, vnetje, ki povzroči bolečine pri požiranju, težave z želodcem, vnetje želodca, ki povzroči bolečine v trebuhu, občutek siljenja na bruhanje in bruhanje; • obsežna okvara jeter, trebušni simptomi (npr. bruhanje, težave z želodcem, zaprtje), preveč maščobe v jetrih, kar lahko povzroči nelagodje v trebuhu, utrujenost in slabo počutje, žolčni kamni, ki lahko povzročijo hudo bolečino in zvišano telesno temperaturo, spremembe krvnih preiskav, ki kažejo delovanje jeter; • vnetje, ki povzroči povišano telesno temperaturo, izpuščaj na koži, bolečino v sklepih; • vnetje debelega črevesa, ki povzroči povišano telesno temperaturo, bolečine in krče v trebuhu, zaprtje; • uničenje kože in globokih tkiv zaradi okužbe; • visok nivo kalcija v krvi, ki je ponavadi brez simptomov, vendar lahko povzroči bolečine v trebuhu, depresijo, slabost in ledvične kamne, nizek nivo kalcija v krvi, ki lahko povzroči mravljinčenje v prstih rok in nog ter mišične krče; • nenormalna razgradnja mišic, ki lahko povzroči težave z ledvicami; • otekost v zadnjem delu žrela, tekočina okrog pljuč, ki lahko povzroči kratko sapo, bolečina pri globokem vdihu; • vnetje trebušnega maščevja, ki povzroči boleče vozličke; • razširitev v steni večje arterije, zožitev srčne zaklopke, ki je po navadi brez simptomov, a lahko povzroči kratko sapo med telesno dejavnostjo, bolečine v prsih in omedlevico, vnetje in krvni strdek v veni, zamašitev žile, občutek hitrega bitja srca; • multipla skleroza, šibkost ali ohromelost mišic obraza; • Guillain- Barréjev sindrom (mišična oslabelost, nenormalna občutenja, ščemenje v rokah in zgornjem delu telesa); • predrtje črevesa; • jetrnovranični limfom celic T.
Rare (in more than 1 in 10,000 patients but less than 1 in 1000 patients) • high pressure within the eyes, inflammation of the colored part of the eye, extensive inflammation of the eye; • skin cancer, cancer, cancer that affects the lymph system, malignant melanoma; • thyroid disorders; • protein in urine; •. reduction in blood platelets which increases risk of bleeding or bruising, reduction in blood cells which can cause weakness, bruising or make infections more likely; • chest pain, heart stops pumping, blockages in the arteries of the heart, fluid around the heart that can cause severe chest pain, heart problems that can cause shortness of breath or ankle swelling, sensation of heart beating rapidly; • hearing loss, buzzing; • inflammation of the pancreas which causes severe pain in the abdomen and back, inflammation that causes abdominal pain and diarrhoea, blockages of the intestine that cause nausea and vomiting, inflammation that causes pain on swallowing, indigestion, inflammation of the stomach which causes pain in the abdomen, nausea and vomiting; • extensive injury to the liver, abdominal symptoms (such as vomiting, indigestion, constipation), excess fat in the liver which can cause abdominal discomfort, fatigue and feeling unwell, stones in the gallbladder that can cause severe pain and fever, blood test shows changes in the way the liver is working; • inflammation that causes fever, skin rash, joint pain; • inflammation of the large intestine that causes fever, abdominal pain and cramping, constipation; • skin and deep tissue destruction caused by infection; • high blood level of calcium that is usually without symptoms but could cause abdominal pain, depression, weakness and kidney stones, low blood calcium that can cause tingling in the fingers and toes and muscle cramping; • abnormal muscle breakdown which can lead to kidney problems; • swelling in the back of the throat, fluid around the lungs that may cause shortness of breath, pain upon taking a deep breath; • inflammation of abdominal fat causing painful skin nodules; • a sac in the wall of a major artery, blockage of a heart valve usually without symptoms but may cause shortness of breath with exercise, chest pain and fainting, inflammation and clot of a vein, blockage of a blood vessel, sensation of heart beating rapidly; • multiple sclerosis, facial muscle weakness or paralysis.
244 Prevod
promet
CELEX: 31996R1292
Delovanje iz obsega te uredbe je izvzeto od taks, dajatev in carin.
Operations under this Regulation shall be exempt from taxes, duties and customs charges.
245 Prevod
promet
CELEX: 31996R1257
Delovanje iz obsega te uredbe je izvzeto od davkov, dajatev, taks in carin.
The operations covered by this Regulation shall be exempt from taxes, charges, duties and customs duties.
246 Prevod
promet
CELEX: 31996R1257
Ta pomoč obsega tudi delovanje v zvezi s pripravami na nevarnosti ali preprečevanjem nesreč ali primerljivimi izjemnimi razmerami.
Such aid shall also comprise operations to prepare for risks or prevent disasters or comparable exceptional circumstances.
247 Prevod
promet
CELEX: 22001A0517(01)
Mejne vrednosti, izražene kot mg/m 3, se nanašajo na normalne pogoje (prostornina pri 273,15 K, 101,3 kPa, suh plin) in se izračunajo kot povprečna vrednost odmerkov na uro, obsegajoč več ur delovanja, praviloma 24 ur.
Limit values, expressed as mg/m 3, refer to standard conditions (volume at 273,15 K, 101,3 kPa, dry gas) and are calculated as an average value of one-hour measurements, covering several hours of operation, as a rule 24 hours.
248 Prevod
promet
CELEX: 32002D0601
bi razširitev geografskega obsega programa Tempus III na sredozemske države nečlanice in na ozemlja, ki jih navaja Uredba (ES) št. 1488/96, omogočila delovanje na podlagi preskušenih prednosti tega programa, doseganje ekonomije obsega in razširitev regionalnega sodelovanja na področje širše Evro-sredozemske regije.
Enlarging the geographical scope of the Tempus III programme to the Mediterranean non-member countries and territories referred to in Regulation (EC) No 1488/ 96 would make it possible to build on the proven strengths of that programme, achieve economies of scale and favour regional cooperation around the wider Euro-Mediterranean region.
249 Prevod
promet
CELEX: 31996R1257
odobri celotne načrte, katerih namen je zagotoviti jasen okvir za delovanje v dani državi ali regiji, kjer sta obseg in zapletenost humanitarne krize taka, da kažeta, da se bo slednja verjetno nadaljevala, ter proračun za te načrte.
approve global plans intended to provide a coherent framework for action in a given country or region where the scale and complexity of the humanitarian crisis is such that it seems likely to continue, and the budgets for those plans.
250 Prevod
finance
CELEX: 31999L0002
ker razlike med nacionalnimi predpisi v zvezi s obsevanjem živil z ionizirajočim sevanjem in pogoji uporabe sevanja ovirajo prosti pretok živil in lahko ustvarijo pogoje nelojalne konkurence, s čimer neposredno vplivajo na delovanje notranjega trga;
(1) Whereas differences between national laws relating to the treatment of foodstuffs by ionising radiation and its conditions of use hinder the free movement of foodstuffs and may create conditions of unequal competition, thereby directly affecting the operation of the internal market;
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