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151 Prevajalska redakcija
izobraževanje
CELEX: 31991R2351
whereas Commission Regulation (EEC) No 2220/85 of 22 July 1985 laying down common detailed rules for the application of the system of securities for agricultural products (6), as mended by Regulation (EEC) No 3745/89 (7), should be applied for the lodging and the release of that specific security;
ker bi za položitev in sprostitev navedene posebne varščine morali uporabiti določbe Uredbe Komisije (EGS) št. 2220/85 z dne 22. julija 1985 o skupnih podrobnih pravilih za uporabo sistema varščin pri kmetijskih proizvodih [6], spremenjene z Uredbo (EGS) št. 3745/89 [7];
152 Prevajalska redakcija
izobraževanje
CELEX: 32001R0245
a list of all sale/purchase contracts, processing commitments and processing contracts as referred to in Article 5 for that marketing year, broken down into flax and hemp and mentioning the farmer's identification number under the integrated administration and control system and the parcels concerned, and
seznam kupoprodajnih pogodb, obvez za predelavo in pogodb o predelavi iz člena 5 za tekoče poslovno leto, ločeno za lan in konopljo, in navesti identifikacijsko številko kmeta, dodeljeno v okviru z integriranega upravnega in kontrolnega sistema ter zadevna zemljišča in
153 Prevajalska redakcija
izobraževanje
CELEX: 32002D0834
Studying the brain and combating diseases of the nervous system: The objectives are to use genome information to understand better the functioning and dysfunctioning of the brain, in order to gain new insight into mental processes, to combat neurological disorders and diseases, and to improve brain repair.
Preučevanje možganov in preprečevanje bolezni živčnega sistema: Cilji so uporaba genomskih informacij za boljše razumevanje delovanja in nepravilnega delovanja možganov za pridobivanje novega vpogleda v duševne procese, preprečevanje nevroloških motenj in bolezni ter izboljšanje obnove delovanja možganov.
154 Prevajalska redakcija
RS
EMEA
The efficacy of Forsteo in men and women (N=428) receiving sustained systemic glucocorticoid therapy (equivalent to 5 mg or greater of prednisone for at least 3 months) was demonstrated in the 18- month primary phase of a 36 month, randomised, double-blind, comparator-controlled study (alendronate 10 mg/ day).
Učinkovitost FORSTEA pri moških in ženskah (N=428), ki so prejemali podaljšano sistemsko glukokortikoidno terapijo (kar ustreza 5 mg ali več prednizona v najmanj 3 mesecih) so dokazali v 18 - mesečni začetni fazi 36- mesečne, randomizirane, dvojno slepe, s primerjavo kontrolirane študije (alendronat 10 mg/ dan).
155 Prevajalska redakcija
izobraževanje
CELEX: 32000D0428
The simultaneous inoculation of a porcine cell line and one of the above-mentioned tissue culture systems (preferably primary bovine thyroid cells) is a useful guide as to whether vesicular samples contain swine vesicular disease virus or foot and mouth disease virus, as the former will only grow in cells of porcine origin.
Hkratna nasaditev materiala na prašičje celične linije in eno od prej navedenih tkivnih kultur (najbolj priporočljivo na primarne ščitnične celice goveda) je uporabna pri določanju, ali vzorci vsebujejo virus vezikularne bolezni prašičev ali virus slinavke in parkljevke, ker virus vezikularne bolezni prašičev raste le v celicah prašičev.
156 Prevajalska redakcija
RS
EMEA
The CHMP considered that the safety data submitted indicates that the local and systemic AEs observed during clinical studies were as expected in terms of types and rates for a polysaccharide- protein conjugate vaccine and showed similar reactogenicity to other mono-component MenC and Hib vaccines in various clinical studies.
CHMP je menil, da predloženi podatki o varnosti kažejo, da so bili lokalni in sistemski neželeni učinki, ki so jih opazili med kliničnimi študijami, pričakovani glede na tipe in razmerja za cepivo konjugiranega polisaharida- proteina in da je cepivo pokazalo podobne sposobnosti sproženja imunske reakcije kot druga enokomponentna cepiva proti MenC in Hib v različnih kliničnih študijah.
157 Prevajalska redakcija
izobraževanje
CELEX: 31980R1475
Having regard to the provisions mentioned in the citations of Commission Regulations: - (EEC) No 193/75 of 17 January 1975 laying down common detailed rules for the application of the system of import and export licences and advance-fixing certificates for agricultural products (1), as last amended by Regulation (EEC) No 2971/79 (2),
(EGS) št. 193/75 z dne 17. januarja 1975 o določitvi skupnih podrobnih pravil za uporabo sistema uvoznih in izvoznih dovoljenj in potrdil o vnaprejšnji določitvi za kmetijske proizvode1, kakor je bila nazadnje spremenjena z Uredbo (EGS) št. 2971/792,
158 Prevajalska redakcija
izobraževanje
CELEX: 32003L0055
Any party having a complaint against a transmission, LNG or distribution system operator with respect to the issues mentioned in paragraphs 1, 2 and 4 and in Article 19 may refer the complaint to the regulatory authority which, acting as dispute settlement authority, shall issue a decision within two months after receipt of the complaint.
Stranka, ki se želi pritožiti zoper upravljavca prenosnih, UZP ali distribucijskih sistemov glede vprašanj v odstavkih 1, 2, in 4 ter v členu 19, lahko pošlje pritožbo regulativnemu organu, ki v vlogi organa za poravnavo sporov v dveh mesecih po prejemu pritožbe izda svoj sklep.
159 Prevajalska redakcija
izobraževanje
CELEX: 32004L0083
Protection is generally provided when the actors mentioned in paragraph 1 take reasonable steps to prevent the persecution or suffering of serious harm, inter alia , by operating an effective legal system for the detection, prosecution and punishment of acts constituting persecution or serious harm, and the applicant has access to such protection.
Zaščita se načelno nudi, kadar subjekti iz odstavka 1 sprejmejo razumne ukrepe za preprečitev preganjanja ali resne škode, med drugim z vodenjem učinkovitega pravnega sistema za odkrivanje, pregon in kaznovanje dejanj, ki pomenijo preganjanje ali resno škodo, prosilec pa ima dostop do takšne zaščite.
160 Prevajalska redakcija
izobraževanje
CELEX: 31992R3046
In connection with trade between the Community as constituted on 31 December 1985 and Spain or Portugal, and between those two last-mentioned Member States, the Intrastat system shall also apply to goods still liable to certain customs duties and charges having equivalent effect or which remain subject to other measures laid down by the Act of Accession.
V zvezi s trgovino med Skupnostjo, kakršna je bila osnovana 31. decembra 1985, in Španijo ali Portugalsko ter med tema državama članicama se uporablja sistem Intrastat tudi za blago zavezano plačilu carin ali dajatev z enakovrednim učinkom ali ki je predmet drugih ukrepov iz Akta o pristopu.
161 Prevajalska redakcija
RS
EMEA
Stocrin is also associated with nervous system symptoms, such as dizziness, insomnia (difficulty sleeping), somnolence (sleepiness), impaired concentration and abnormal dreaming, and with psychiatric disorders, including severe depression, suicidal thoughts, suicide attempts and aggressive behaviour, especially in patients with a history of mental illness.
Zdravilo Stocrin je povezano tudi s simptomi živčnega sistema, kot so omotica, nespečnost, zaspanost, motnje koncentracije in nenormalne sanje, ter s psihiatričnimi motnjami, kot so huda depresija, samomorilno razmišljanje, poskusi samomora in agresivno obnašanje, zlasti pri bolnikih, ki so v preteklosti že imeli duševne motnje.
162 Prevajalska redakcija
RS
EMEA
Sustiva is also associated with nervous system symptoms, such as dizziness, insomnia (difficulty sleeping), somnolence (sleepiness), impaired concentration and abnormal dreaming, and with psychiatric disorders, including severe depression, suicidal thoughts, suicide attempts and aggressive behaviour, especially in patients with a history of mental illness.
Zdravilo Sustiva je povezano tudi s simptomi živčnega sistema, kot so omotica, nespečnost, zaspanost, motnje koncentracije in nenormalne sanje, ter s psihiatričnimi motnjami, kot so huda depresija, samomorilno razmišljanje, poskusi samomora in agresivno obnašanje, zlasti pri bolnikih, ki so v preteklosti že imeli duševne motnje.
163 Prevajalska redakcija
izobraževanje
CELEX: 32004R0851
1.The Centre shall in the fields within its mission establish, in cooperation with the Member States, procedures for systematically searching for, collecting, collating and analysing information and data with a view to the identification of emerging health threats which may have mental as well as physical health consequences and which could affect the Community.
Center na področjih svojega delovanja v sodelovanju z državami članicami vzpostavi postopke za sistematično iskanje, zbiranje, združevanje in analizo informacij in podatkov z namenom ugotavljanja nastajajočih nevarnosti za zdravje, ki lahko imajo tako duševne kot telesne zdravstvene posledice in ki lahko prizadenejo Skupnost.
164 Prevajalska redakcija
izobraževanje
CELEX: 31997D0265
For the purposes of Article 12 of Regulation (EEC) No 1836/93 the Commission hereby recognises that the international standard ISO 14001:1996 and the European standard EN ISO 14001:1996, establishing specification for environmental management systems, contain requirements corresponding to those of the above mentioned Regulation, as specified in the Annex to this Decision.
Za namene člena 12 Uredbe (EGS) št. 1836/93 Komisija tu priznava, da mednarodni standard ISO 14001:1996 in evropski standard EN ISO 14001:1996, ki določata specifikacijo za sisteme okoljskega upravljanja, vsebujeta zahteve, ki ustrezajo v Prilogi določenim zahtevam iz navedene uredbe.
165 Prevajalska redakcija
RS
EMEA
Rebetol should not be used in: • pregnant women, • women who are breast-feeding, • patients with severe heart disease, • patients with a severe medical condition, including kidney failure and severe liver disease. • patients with certain blood disorder that affect haemoglobin, • patients with a history of certain disorders of the immune system, or are taking medicine that suppress the immune system, • children and adolescents with a history of severe mental illness, particularly severe depression, suicidal thoughts or suicide attempts.
Zdravilo Rebetol se ne sme uporabljati pri: • nosečnicah, • doječih ženskah, • bolnikih s hudo srčno boleznijo, • bolnikih z resnim zdravstvenim stanjem, vključno z ledvično odpovedjo in hudo jetrno boleznijo. • bolnikih s katero od krvnih motenj, ki vpliva na hemoglobin, • bolnikih z anamnezo motenj imunskega sistema ali ki jemljejo zdravilo za zaviranje delovanja imunskega sistema, • otrocih in mladostnikih z anamnezo hude duševne bolezni, še posebej hude depresije, samomorilnih misli ali poskusa samomora.
166 Prevajalska redakcija
RS
EMEA
body ’ s own cells or tissues, such as systemic lupus, rheumatoid arthritis, inflammatory bowel disease or psoriasis). • If you are taking any other medicines mentioned under “ Taking other medicines ” or if you are to have an operation or special X-ray investigation requiring an injection, talk to your doctor. • If you have an infection your doctor will closely monitor you.
telesne celice ali tkiva, kot je na primer sistemski lupus, revmatoidni artritis, vnetne črevesne bolezni ali psoriaza). • Če jemljete katero koli drugo zdravilo, navedeno v poglavju „ Jemanje drugih zdravil “, ali če boste v kratkem operirani ali boste imeli rentgensko preiskavo na način, ki zahteva injiciranje, se o tem pogovorite z zdravnikom. • Če imate okužbo, vas bo zdravnik pozorno spremljal.
167 Prevajalska redakcija
izobraževanje
CELEX: 32000D0273
This means that it is necessary to decide whether, for a given product, the existence of a factory production control system under the responsibility of the manufacturer is a necessary and sufficient condition for an attestation of conformity, or whether, for reasons related to compliance with the criteria mentioned in Article 13(4), the intervention of an approved certification body is required.
To pomeni, da je treba odločiti, ali je za nek proizvod ali družino proizvodov obstoj sistema kontrole proizvodnje, za katerega je odgovoren proizvajalec, potreben in zadosten pogoj za potrditev skladnosti ali pa je zaradi izpolnjevanja meril iz člena 13(4) potrebno vključiti priglašen certifikacijski organ.
168 Prevajalska redakcija
izobraževanje
CELEX: 31977L0541
IN THE CASE OF RESTRAINT SYSTEMS , TWO SAMPLES , WHICH MAY INCLUDE TWO OF THE SAMPLES OF BELTS MENTIONED IN 2.1.2.2 , AND , AT THE MANUFACTURER'S CHOICE , EITHER A VEHICLE REPRESENTATIVE OF THE VEHICLE TYPE TO BE APPROVED , OR THE PART OR PARTS OF THE VEHICLE CONSIDERED ESSENTIAL BY THE TECHNICAL SERVICE CONDUCTING APPROVAL TESTS FOR TESTING THE RESTRAINT SYSTEM , SHALL BE SUBMITTED BY THE APPLICANT TO THE SERVICE.
Pri sistemih za zadrževanje potnikov mora vložnik tehnični službi izročiti dva vzorca, ki lahko vključujeta dva vzorca pasov iz točke 2.1.2.2 in, po izbiri proizvajalca, eno vzorčno vozilo tistega tipa, ki mu je treba podeliti homologacijo, ali pa del ali dele vozila, ki jih tehnična služba, ki opravlja homologacijske preskuse, smatra za bistvene.
169 Prevajalska redakcija
RS
EMEA
In one of these trials, a randomized, multicenter study, 882 infants were assigned in a 3:1 ratio to receive either PROCOMVAX or Merck Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (Merck PRP-OMPC Vaccine) plus Merck Hepatitis B (Recombinant) Vaccine at 2, 4, and 12-15 months of age, with the children monitored daily for five days after each injection for local reactions and systemic complaints.
V eni od teh raziskav, ki je bila randomizirana in multicentrična, so 882 dojenčkov v razmerju 3: 1 razvrstili tako, da so prejemali PROCOMVAX ali pa Merckovo konjugirano cepivo proti hemofilusu b (meningokokni beljakovinski konjugat) (cepivo Merck PRP - OMPC) in Merckovo (rekombinantno) cepivo proti hepatitisu B. Otroke so cepili v starosti 2., 4. in od 12. do 15. meseca in jih glede lokalnih reakcij in sistemskih težav spremljali pet dni po vsaki injekciji.
170 Prevajalska redakcija
izobraževanje
CELEX: 32001D0019
This means that it is necessary to decide whether, for a given product or family of products, the existence of a factory production control system under the responsibility of the manufacturer is a necessary and sufficient condition for an attestation of conformity, or whether, for reasons related to compliance with the criteria mentioned in Article 13(4), the intervention of an approved certification body is required.
To pomeni, da je nujno odločiti, ali je za dani proizvod ali družino proizvodov obstoj sistema kontrole proizvodnje, za katerega je odgovoren proizvajalec, potreben in zadosten pogoj za potrditev skladnosti ali pa je za izpolnjevanje meril iz člena 13(4) treba vključiti odobren certifikacijski organ.
171 Prevajalska redakcija
izobraževanje
CELEX: 32000D0245
this means that it is necessary to decide whether, for a given product or family of products, the existence of a factory production control system under the responsibility of the manuafacturer is a necessary and sufficient condition for an attestation of conformity, or whether, for reasons related to compliance with the criteria mentioned in Article 13(4), the intervention of an approved certification body is required.
to pomeni, da je treba odločiti, ali je za nek proizvod ali družino proizvodov obstoj sistema kontrole proizvodnje, za katerega je odgovoren proizvajalec, potreben in zadosten pogoj za potrditev skladnosti ali pa je zaradi izpolnjevanja meril iz člena 13(4) potrebno vključiti priglašen certifikacijski organ.
172 Prevajalska redakcija
izobraževanje
CELEX: 32004R0796
2.For the purpose of the identification of the payment entitlements referred to in paragraph 1(c), the pre-printed forms distributed to the farmer in accordance with Article 22 (2) of Regulation (EC) No 1782/2003 shall mention the identification of the payment entitlements in accordance with the identification and registration system provided for in Article 7 broken down by set-aside entitlements and other entitlements.
Za namene identifikacije pravic do plačil iz odstavka 1(c) je na vnaprej natisnjenih obrazcih, ki jih dobi kmet v skladu s členom 22(2) Uredbe (ES) št. 1782/2003, navedena identifikacija pravic do plačil v skladu s sistemom identifikacije in registracije, predvidenim v členu 7, razdeljenim na pravice do prahe in druge pravice.
173 Prevajalska redakcija
izobraževanje
CELEX: 31996D0577
whereas this means that it is necessary to decide whether, for a given product or family of products, the existence of a factory production control system under the responsibility of the manufacture is a necessary and sufficient condition for attestation of conformity, or whether, for reasons related to compliance with the criteria mentioned in Article 13 (4), the intervention of an approved certification body is required;
ker to pomeni, da je treba odločiti, ali je za neki proizvod ali družino proizvodov obstoj sistema kontrole proizvodnje, za katerega je odgovoren proizvajalec, potreben in zadosten pogoj za potrditev skladnosti ali pa je zaradi izpolnjevanja meril, navedenih v členu 13(4), potrebno vključiti priglašen certifikacijski organ;
174 Prevajalska redakcija
izobraževanje
CELEX: 32003L0054
Any party having a complaint against a transmission or distribution system operator with respect to the issues mentioned in paragraphs 1, 2 and 4 may refer the complaint to the regulatory authority which, acting as dispute settlement authority, shall issue a decision within two months after receipt of the complaint. This period may be extended by two months where additional information is sought by the regulatory authority.
Vsaka stran, ki se želi pritožiti zoper upravljavca prenosnih ali distribucijskih omrežij glede vprašanj v odstavkih 1, 2, in 4 lahko pošlje pritožbo regulatornemu organu, ki v vlogi organa za poravnavo sporov v dveh mesecih po prejemu pritožbe izda svoj sklep.To obdobje se lahko podaljša za dva meseca, če regulatorni organ želi pridobiti dodatne informacije.
175 Prevajalska redakcija
izobraževanje
CELEX: 31999D0469
whereas this means that it is necessary to decide whether, for a given product or family of products, the existence of a factory production control system under the responsability of the manufacturer is a necessary and sufficient condition for an attestation of conformity, or whether, for reasons related to compliance with the criteria mentioned in Article 13(4), the intervention of an approved certification body is required;
ker to pomeni, da je treba odločiti, ali je za nek proizvod ali družino proizvodov obstoj sistema kontrole proizvodnje, za katerega je odgovoren proizvajalec, potreben in zadosten pogoj za potrditev skladnosti ali pa je zaradi izpolnjevanja meril iz člena 13(4) treba vključiti priglašen certifikacijski organ;
176 Prevajalska redakcija
izobraževanje
CELEX: 31999D0470
whereas this means that it is necessary to decide whether, for a given product or family of products, the existence of a factory-production control system under the responsability of the manufacturer is a necessary and sufficient condition for an attestation of conformity, or whether, for reasons related to compliance with the criteria mentioned in Article 13(4), the intervention of an approved certification body is required;
ker to pomeni, da je treba odločiti, ali je za neki proizvod ali družino proizvodov obstoj sistema kontrole proizvodnje, za katerega je odgovoren proizvajalec, potreben in zadosten pogoj za potrditev skladnosti, ali pa je zaradi izpolnjevanja meril iz člena 13(4) potrebno vključiti priglašen certifikacijski organ;
177 Prevajalska redakcija
izobraževanje
CELEX: 32003D0728
Whereas this means that it is necessary to decide whether, for a given product or family of products, the existence of a factory production control system under the responsibility of the manufacturer is a necessary and sufficient condition for an attestation of conformity, or whether, for reasons related to compliance with the criteria mentioned in Article 13(4), the intervention of an approved certification body is required.
To pomeni, da se je treba odločiti, ali je za določen proizvod ali družino proizvodov obstoj sistema kontrole proizvodnje, za katerega je odgovoren proizvajalec, potreben in zadosten pogoj za potrjevanje skladnosti ali pa je zaradi izpolnjevanja meril iz člena 13(4) potrebna intervencija odobrenega certifikacijskega organa.
178 Prevajalska redakcija
izobraževanje
CELEX: 31991L0422
'2.7 In the case of motor vehicles authorized to draw trailers of category O3 or O4 fitted with compressed air braking systems, in addition to the above mentioned requirements, the prescriptions in item 2.2.1.18.4.1 of Annex I shall be verified by conducting the following test: (a) by measuring the pressure at the extremity of a pipe 2,5 m long with an internal diameter of 13 mm which shall be joined to the coupling head of the supply line;
"2.7 Pri vozilih, ki lahko vlečejo priklopno vozilo kategorije O3 ali O4, opremljeno s pnevmatskim zavornim sistemom, se zahteve iz točke 2.2.1.18.4.1 Priloge I poleg zgoraj navedenih zahtev preverjajo z naslednjim preskusom: (a) z merjenjem tlaka na koncu 2,5-metrske cevi z notranjim premerom 13 mm, ki se priključi na spojno glavo napajalnega voda;
179 Prevajalska redakcija
izobraževanje
CELEX: 31997D0161
whereas this means that it is necessary to decide whether, for a given product or family of products, the existence of a factory production control system under the responsibility of the manufacturer is a necessary and sufficient condition for an attestation of conformity, or whether, for reasons related to compliance with the criteria mentioned in Article 13 (4), the intervention of an approved certification body is required for that purpose;
ker to pomeni, da se je treba odločiti, ali je za posamezen proizvod ali družino proizvodov obstoj sistema kontrole proizvodnje pod odgovornostjo proizvajalca potreben in zadosten pogoj za potrjevanje skladnosti ali pa je zaradi razlogov glede izpolnjevanja meril iz člena 13(4) za ta namen potrebna udeležba odobrenega certifikacijskega organa;
180 Prevajalska redakcija
izobraževanje
CELEX: 32003L0055
Any party having a complaint against a transmission, LNG or distribution system operator with respect to the issues mentioned in paragraphs 1, 2 and 4 and in Article 19 may refer the complaint to the regulatory authority which, acting as dispute settlement authority, shall issue a decision within two months after receipt of the complaint. This period may be extended by two months where additional information is sought by the regulatory authorities.
Prizadeta stranka, ki ima pravico vložiti pritožbo na sklep o metodologijah za izračun, sprejet skladno z odstavki 2, 3 in 4, ali če za regulativni organ velja obveznost posvetovanja glede predlaganih metodologij za izračun, lahko najpozneje v dveh mesecih po objavi sklepa ali njegovega predloga ali v krajšem roku, če to predvidijo države članice, vloži pritožbo v ponoven pregled.
181 Prevajalska redakcija
RS
EMEA
Other side effects reported with Keppra are: • nervous system disorders: paraesthesia (tingling); • psychiatric disorders: abnormal behaviour, anger, anxiety, confusion, hallucination, mental disorder, suicide, suicide attempt and suicidal ideation; • digestive disorders: pancreatitis, hepatic failure, hepatitis, liver function test abnormal; • nutrition disorders: weight loss; • skin disorders: hair loss; • blood disorders: decreased number of red blood cells, and/ or white blood cells.
Ostali neželeni učinki, o katerih so poročali pri Keppri so: • bolezni živčevja: parestezija (mravljinčenje) • psihiatrične motnje: nenormalno vedenje, jeza, tesnoba, zmedenost, halucinacije, duševne motnje, samomor, poskus samomora in razmišljanje o samomoru; • bolezni prebavil: vnetje trebušne slinavke, odpoved jeter, hepatitis, nenormalne vrednosti testov jetrnih funkcij • prehranske motnje: zmanjšanje telesne mase • bolezni kože: izguba las • bolezni krvi: zmanjšano število rdečih krvnih celic in/ ali belih krvnih celic
182 Prevajalska redakcija
izobraževanje
CELEX: 31993R3665
The Information Sheet INF 7 referred to in paragraph 1 shall be used where the compensating products obtained from inward processing operations under the drawback system are transferred, without a repayment claim being lodged, to an office of discharge not mentioned in the authorization and are assigned there, either in the unaltered state or after further duly authorized processing, to one of the customs-approved treatments or uses permitting repayment or remission, in accordance with Article 128 (1) of the code.
Informativni list INF 7 iz odstavka 1 se uporabi, kadar so pridobljeni proizvodi, dobljeni po operacijah aktivnega oplemenitenja po sistemu povračil, preneseni, ne da bi bil vložen zahtevek za poplačilo, na urad zaključka, ki ni omenjen v dovoljenju, in so tja dodeljeni v nespremenjenem stanju ali po nadaljnjem pravilno dovoljenem oplemenitenju za eno od carinsko dovoljenih rab ali uporab, ki dovoljujejo povračilo ali odpustitev v skladu s členom 128 (1) zakonika.
183 Prevajalska redakcija
izobraževanje
CELEX: 32002R0471
Subject to the measures in force in the Community relating to double-checking systems and to prior and retrospective Community surveillance of textile products on importation into the Community, binding tariff information issued by the customs authorities of Member States which does not conform to the provisions mentioned under item Nos 1, 3, 4 and 5 in the table of the Annex to this Regulation can continue to be invoked for a period of 60 days, under the provisions of Article 12(6) of Regulation (EEC) No 2913/92.
V skladu z določbami člena 12(6) Uredbe (EGS) št. 2913/92 in ob upoštevanju veljavnih ukrepov v Skupnosti v zvezi s sistemom dvojne kontrole ter predhodnega in naknadnega nadzora Skupnosti nad tekstilnimi izdelki pri uvozu v Skupnost se lahko še 60 dni sklicuje na zavezujoče tarifne informacije, ki jih izdajajo carinski organi držav članic in ki niso v skladu z določbami, navedenimi v točkah 1, 3, 4 in 5 tabele v Prilogi k tej uredbi.
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haemorrhage (incl. cases of muscle haemorrhage), post-operative gastrointestinal tract haemorrhage (incl. anaemia, and gingival bleeding, rectal haemorrhage, wound haememesis), haematuria (incl. blood haemorrhage) urine present), genital tract haemorrhage (incl. menorrhagia), hypotension (incl. blood pressure decreased, procedural hypotension), nose bleed General disorders and administration site conditions Localised oedema, peripheral oedema, feeling unwell (incl. fatigue, asthenia), fever Immune system disorders
posegih (vključno z redkimi primeri krvavitev v mišice), anemijo po krvavitev v prebavilih (vključno s kirurškem posegu krvavitvijo iz dlesni, krvavitvijo iz in krvavitev iz danke, hematemezo), hematurija (tudi kri rane) v seču), krvavitev iz spolovil (vključno z menoragijo), hipotenzija (tudi znižanje krvnega tlaka, hipotenzija pri posegu), krvavitev iz nosu Splošne težave in spremembe na mestu aplikacije lokalizirani edemi, periferni edemi, slabo počutje (vključno z utrujenostjo, astenijo), zvišana telesna temperatura
185 Prevajalska redakcija
izobraževanje
CELEX: 31996L0092
The Commission shall review the application of this Directive and submit a report on the experience gained on the functioning of the internal market in electricity and the implementation of the general rules mentioned in Article 3 in order to allow the European Parliament and the Council, in the light of experience gained, to consider, in due time, the possibility of a further opening of the market which would be effective nine years after the entry into force of the Directive taking into account the coexistence of systems referred to in Articles 17 and 18.
Komisija pregleda uporabo te direktive in predloži poročilo o pridobljenih izkušnjah pri delovanju notranjega trga z električno energijo in o izvajanju splošnih pravil iz člena 3 z namenom, da omogoči Evropskemu parlamentu in Svetu, da v luči pridobljenih izkušenj v primernem času preučita možnosti nadaljnjega odpiranja trga, ki naj bi se ga izvedlo devet let po začetku veljavnosti te direktive, ob upoštevanju hkratnega obstoja sistemov iz členov 17 in 18.
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izobraževanje
CELEX: 32000D0447
The Commission is required to select, between the two procedures under Article 13(3) of Directive 89/106/EEC for attesting the conformity of a product, the "least onerous possible procedure consistent with safety", This means that it is necessary to decide whether, for a given product or family of products, the existence of a factory production control system under the responsability of the manufacturer is a necessary and sufficient condition for an attestation of conformity, or whether, for reasons related to compliance with the criteria mentioned in Article 13(4), the intervention of an approved certification body is required.
Komisija mora med dvema postopkoma potrjevanja skladnosti proizvoda po členu 13(3) Direktive 89/106/EGS izbrati "najmanj zahteven postopek, ki je skladen z varnostnimi zahtevami". To pomeni, da je treba odločiti, ali je za neki proizvod ali družino proizvodov obstoj sistema kontrole proizvodnje, za katerega je odgovoren proizvajalec, potreben in zadosten pogoj za potrditev skladnosti ali pa je zaradi izpolnjevanja meril iz člena 13(4) potrebno vključiti priglašen certifikacijski organ.
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Viral infection (e. g. influenza, herpes virus infection) Uncommon: Sepsis, tuberculosis, abscess, bacterial infection, fungal infection, cellulitis, candidiasis Unknown: Opportunistic infections (such as atypical mycobacterial infection, pneumocystosis, histoplasmosis, coccidioidomycosis, cryptococcosis, aspergillosis and listeriosis), hepatitis B reactivation, salmonellosis Neoplasms benign, malignant and unspecified (including cysts and polyps) Unknown: Hepatosplenic T-cell lymphoma (primarily in adolescents and young adults with Crohn’ s disease and ulcerative colitis), lymphoma (including non-Hodgkin’ s lymphoma and Hodgkin’ s disease) Blood and lymphatic system disorders Uncommon: Neutropenia, leukopenia, thrombocytopenia, anaemia, lymphopenia, lymphadenopathy, lymphocytosis Unknown: Agranulocytosis, thrombotic thrombocytopenic purpura, pancytopenia, haemolytic anaemia, idiopathic thrombocytopenic purpura Immune system disorders Common: Serum sickness-like reaction Uncommon: Anaphylactic reaction, lupus-like syndrome, allergic respiratory symptom Unknown: Anaphylactic shock, serum sickness, vasculitis Psychiatric disorders Uncommon: Depression, amnesia, agitation, confusion, insomnia, somnolence, nervousness, apathy Nervous system disorders Common: Headache, vertigo, dizziness Uncommon: Central nervous system demyelinating disorders (multiple sclerosis-like disease) Rare: Meningitis Unknown: Peripheral demyelinating disorders (such as Guillain-Barré syndrome, chronic inflammatory demyelinating polyneuropathy and multifocal motor neuropathy), central nervous system demyelinating disorders (such as optic neuritis), transverse myelitis, seizure, neuropathy, hypoaesthesia, paraesthesia Eye disorders Uncommon: Endophthalmitis, keratitis, conjunctivitis, periorbital oedema, hordeolum Cardiac disorders
Infekcijske in parazitske bolezni pogosti: virusne okužbe (npr. gripa ali herpesne okužbe) občasni: sepsa, tuberkuloza, absces, bakterijske okužbe, glivične okužbe, celulitis, kandidiaza neznana: oportunistične okužbe (npr. atipična mikobakterijska okužba, pnevmocistoza, histoplazmoza, kokcidioidomikoza, kriptokokoza, aspergiloza in listerioza), reaktivacija hepatitisa B, salmoneloza Benigne, maligne in neopredeljene neoplazme (vključno s cistami in polipi) neznana: hepatosplenični limfom T celic (primarno pri mladostnikih in mlajših odraslih s Crohnovo boleznijo in ulceroznim kolitisom), limfom (vključno z neHodgkinovim limfomom in Hodgkinovo boleznijo) Bolezni krvi in limfatičnega sistema občasni: nevtropenija, levkopenija, trombocitopenija, anemija, limfopenija, limfadenopatija, limfocitoza neznana: agranulocitoza, trombotična trombocitopenična purpura, pancitopenija, hemolitična anemija, idiopatska trombocitopenična purpura Bolezni imunskega sistema pogosti: reakcije, podobne serumski bolezni občasni: anafilaktične reakcije, lupusu podoben sindrom, alergijski simptomi v dihalih neznana: anafilaktični šok, serumska bolezen, vaskulitis Psihiatrične motnje občasni: depresija, amnezija, vznemirjenost, zmedenost, nespečnost, zaspanost, živčnost, apatija Bolezni živčevja pogosti: glavobol, vrtoglavica, omotica občasni: demielinizirajoče motnje osrednjega živčevja (bolezen, podobna multipli sklerozi) redki: meningitis
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29 Immune System Disorders Drug hypersensitivity Metabolism and Nutrition Disorders Anorexia, Polydipsia Psychiatric Disorders Confusional state, Listless, Anorgasmia, Blunted affect Nervous System Disorders Unresponsive to stimuli, Loss of consciousness, Neuroleptic malignant syndrome, Diabetic coma, Cerebrovascular accident, Depressed level of consciousness, Cerebral ischemia, Cerebrovascular disorder, Transient ischemic attack, Dysarthria, Disturbance in attention, Balance disorder, Speech disorder, Coordination abnormal, Movement disorder Eye Disorders Ocular hyperemia, Eye discharge, Eye swelling, Dry eye, Lacrimation increased, Photophobia, Visual acuity reduced, Eye rolling, Glaucoma Ear and Labyrinth Disorders Tinnitus Vascular Disorders Flushing Respiratory, Thoracic, and Mediastinal Disorders Wheezing, Pneumonia aspiration, Pulmonary congestion, Respiratory disorder, Rales, Epistaxis, Respiratory tract congestion, Hyperventilation, Dysphonia Gastrointestinal Disorders Dysphagia, Faecal incontinence, Faecaloma, Lip swelling, Cheilitis Skin and Subcutaneous Tissue Disorders Skin lesion, Skin disorder, Skin discoloration, Seborrheic dermatitis, Hyperkeratosis, Dandruff, Erythema Musculoskeletal, Connective Tissue, and Bone Disorders Rhabdomyolysis, Joint swelling, Posture abnormal, Joint stiffness Renal and Urinary Disorders Enuresis, Dysuria, Pollakiuria Reproductive System and Breast Disorders Ejaculation disorder, Vaginal discharge, Menstrual disorder General Disorders and Administration Site Conditions Generalised oedema, Face oedema, Gait disturbance, Thirst, Chills, Peripheral coldness, Drug withdrawal syndrome
29 Infekcijske in parazitske bolezni Vnetje tonzil, celulitis, otitis media, okožbe oči, akaroza, okužba dihal, onihomikoze, kronični otitis media Bolezni krvi in limfatičnega sistema Granulocitopenija Bolezni imunskega sistema Preobčutljivost na zdravila Presnovne in prehranske motnje Anoreksija, polidipsija Psihiatrične motnje Stanje zmedenosti, ravnodušnost, anorgazmija, otopela čustva Bolezni živčevja Nedovzetnost za dražljaje, izguba zavesti, nevroleptični maligni sindrom, diabetična koma, cerebrovaskularni dogodki, potlačen nivo zavesti, cerebralna ishemija, cerebrovaskularne motnje, tranzitorna ishemična ataka, disartrija, motnje pozornosti, motnje ravnotežja, motnje govora, motnje koordinacije, motnje pri gibanju Očesne bolezni Očesna hiperemija, izcedek iz očesa, otekanje oči, suho oko, povečano solzenje, fotofobija, zmanjšana ostrina vida, zavijanje oči, glavkom Ušesne bolezni, vključno z motnjami labirinta Tinitus Žilne bolezni Zardevanje Bolezni dihal, prsnega koša in mediastinalnega prostora Sopenje, aspiracijska pljučnica, pljučna kongestija, respiratorne motnje, žvižgi v pljučih, epistaksa, kongestija dihal, hiperventilacija, hripavost Bolezni prebavil Disfagija, inkontinenca blata, fekalom, oteklina ustnice, heilitis Bolezni kože in podkožja Kožne rane, bolezni kože, razbarvanje kože, seboroični dermatitis, hiperkeratoza, prhljaj, eritem Bolezni mišično- skeletnega sistema in vezivnega tkiva Rabdomioliza, otekanje sklepov, nenormalna telesna drža, okorelost sklepov Bolezni sečil Enureza,, disurija, polakiurija Motnje reprodukcije in dojk Motnje ejakulacije, izcedek iz nožnice, motnje menstrualnega ciklusa Splošne težave in spremembe na mestu aplikacije Generaliziran edem, edem obraza, motnje v telesni drži, žeja, mrazenje, hladne okončine, odtegnitveni sindrom,
189 Prevajalska redakcija
izobraževanje
CELEX: 32002R0471
For the goods listed under item Nos 1, 3, 4 and 5 of the table in the Annex to this Regulation, it is appropriate that, subject to the measures in force in the Community relating to double-checking systems and to prior and retrospective Community surveillance of textile products on importation into the Community, binding tariff information which is issued by the customs authorities of Member States in respect of the classification of goods in the Combined Nomenclature and which does not conform to the provisions mentioned under item Nos 1, 3, 4 and 5 in the table of the Annex to this Regulation, can continue to be invoked for a period of 60 days by the holder under the provisions in Article 12(6) of Council Regulation (EEC) No 2913/92 of 12 October 1992 establishing the Community Customs Code(3), as last amended by European Parliament and Council Regulation (EC) No 2700/2000(4)l.
Primerno, da se lahko imetnik blaga v skladu z določbami iz člena 12(6) Uredbe Sveta (EGS) št. 2913/92 z dne 12. oktobra 1992 o uvedbi carinskega zakonika Skupnosti [3], kakor je bila nazadnje spremenjena z Uredbo Evropskega parlamenta in Sveta (ES) št. 2700/2000 [4], ob upoštevanju veljavnih ukrepov v Skupnosti v zvezi s sistemom dvojne kontrole ter predhodnega in naknadnega nadzora Skupnosti nad tekstilnimi izdelki pri uvozu v Skupnost, za blago, navedeno v točkah št. 1, 3, 4 in 5 tabele v Prilogi k tej uredbi še 60 dni sklicuje na zavezujoče tarifne informacije, ki jih izdajajo carinski organi držav članic glede uvrstitve blaga v kombinirano nomenklaturo in ki niso v skladu z določbami, navedenimi v točkah 1, 3, 4 in 5 preglednice v Prilogi k tej uredbi.
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It is especially important to mention these: other medicines to treat HIV infection sildenafil (used by men to treat impotence (erectile dysfunction)) 154 oral contraceptives (" the Pill ") any medicines used to treat diseases related to the acid in the stomach (e. g. antacids, H2- blockers and proton pump inhibitors) medicines to lower blood pressure, to slow heart rate, or to correct heart rhythm simvastatin, lovastatin, and atorvastatin (used to lower blood cholesterol) nevirapine and efavirenz (used to treat HIV) cyclosporin, tacrolimus, and sirolimus (medicines to decrease the effects of body 's immune system) certain antibiotics (rifabutin, clarithromycin) ketoconazole, itraconazole, and voriconazole (antifungals) warfarin (anticoagulant, used to reduce the blood clots) irinotecan (used to treat cancer) sedative agents (e. g. midazolam administered by injection) buprenorphine (used to treat opioid addiction and pain).
Posebno pomembno je omeniti naslednje: druga zdravila za zdravljenje okužbe z virusom HIV, sildenafil (zdravilo za zdravljenje moške impotence (erektilna disfunkcija)), peroralni kontraceptivi, vsa zdravila, ki jih uporabljamo za zdravljenje bolezni, povezanih z želodčno kislino (npr. antacidi, antagonisti histaminskih receptorjev H2 in zaviralci protonske črpalke), zdravila za znižanje zvišanega krvnega tlaka, za upočasnitev srčnega utripa ali za uravnavanje srčnega ritma, simvastatin, lovastatin in atorvastatin (znižujejo holesterol v krvi), nevirapin in efavirenz (zdravila za zdravljenje okužbe z virusom HIV), ciklosporin, takrolimus in sirolimus (zdravila, ki zavirajo imunski sistem), nekateri antibiotiki (rifampicin, klaritromicin), ketokonazol, itrakonazol in vorikonazol (antimikotiki), varfarin (antikoagulant za preprečevanje krvnih strdkov), irinotekan (zdravilo za zdravljenje raka) pomirjevala (npr. midazolam, ki ga uporabljamo v obliki injekcij) buprenorfin (uporabljamo ga za zdravljenje zasvojenosti z opioidi in lajšanje bolečine).
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Uncommon (in more than 1 in 1000 patients but less than 1 in 100patients): • serious infections (including tuberculosis, histoplasmosis and sepsis [blood poisoning]), joint infection; • skin infections, skin warts, superficial fungal infections; • anaemia, low white blood cell and platelet counts, lymphopaenia (low immune cell counts); • swelling of the lymph nodes; • systemic lupus erythematosus; • allergic reactions, (including seasonal and medicines allergy); • increased lipid and uric acidvalues, appetite disorders; • anxiety, depression, feeling sleepy and difficulty sleeping, shaking; • taste disturbances; • vision disturbances, eye inflammation or infection; • ear discomfort; • sensation of heart beatingirregularly, high blood pressure, flushing; • asthma, shortness of breath, hoarseness; • abdominal symptoms (such as vomiting, constipation), rectal bleeding; • skin disorders (such as psoriasis, eczema or infections)itchy rash, slow wound healing, bruising, hair loss; • muscle weakness; • urinary disturbances (such as blood in urine, increased urinary frequency); • increased menstrual bleeding; • flu-like symptoms, chest pain, swelling of the feet; • accidental injury, impaired healing.
Občasno (pri več kot 1 od 1000 bolnikov, vendar manj kot pri 1 od 100 bolnikov): • resne okužbe (vključno s tuberkulozo, histoplazmozo in sepso [ zastrupitev krvi ]), okužba sklepa; • okužba kože, bradavice na koži, povrhnje glivične okužbe; • anemija, zmanjšanje števila belih krvnih celic in krvnih ploščic, limfopenija (zmanjšano število imunskih celic v krvi); • oteklost bezgavk; �� sistemski lupus eritematosus; • alergijske reakcije (vključno s sezonskimi alergijami in alergijami na zdravila); • zvišani lipidi in sečna kislina, motnje apetita; • tesnobnost, depresija, zaspanost in težave s spanjem, tresenje; • motnje okusa; • motnje vida, vnetje ali okužba očesa; • neprijeten občutek v ušesu; • občutek neenakomernega bitja srca, visok krvni pritisk, zardevanje; • astma, hitra zadihanost, hripavost; • trebušni simptomi (npr. bruhanje, zaprtje), krvavitve v danko; • bolezni kože (npr. luskavica, ekcem ali okužbe), srbeč izpuščaj, počasno celjenje ran, podplutbe, izpadanje las in dlak; • mišična šibkost; • motnje na sečilih (npr. kri v urinu, pogostejše uriniranje); • močnejše menstruacijske krvavitve; • simptomi podobni gripi, bolečine v prsih, otekanje stopal; • naključna poškodba, slabše celjenje.
192 Prevod
izobraževanje
CELEX: 32002R2342
That annual report shall also mention any systemic problems detected by the specialised panel set up pursuant to Article 66(4) of the Financial Regulation.
V tem letnem poročilu tudi navede kakršne koli sistematične težave, ki jih je odkrila posebna komisija, ustanovljena na podlagi člena 66(4) Finančne uredbe.
193 Prevod
promet
CELEX: 31996R1292
Whereas, given the different responsibilities of men and women for the food security of households, systematic account should be taken of their different roles when drawing up programmes aimed at achieving food security;
ker je treba, glede na različne vloge moških in žensk pri varnosti preskrbe s hrano v gospodinjstvih, sistematično upoštevati njihove različne vloge, kadar se oblikujejo programi, namenjeni doseganju varnosti preskrbe s hrano;
194 Prevod
promet
CELEX: 21994A1231(24)
In conformity with Article 26 (1), Bulgaria confirms that the export taxes mentioned in Annex IX, should they be introduced, shall not have a more restrictive effect than the system of non-automatic licences and export ceilings.
Skladno s členom 26(1) Bolgarija potrjuje, da izvozne dajatve, navedene v Prilogi IX, v primeru njihove uvedbe nimajo bolj omejevalnih učinkov kakor sistem neavtomatskega izdajanja dovoljenj in izvozni plafoni.
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