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Kull fdal tal-prodott li ma jkunx intuża jew skart li jibqa' wara l-użu tal-prodott għandu jintrema kif jitolbu l-liġijiet lokali. | Any unused product or waste material should be disposed of in accordance with local requirements. |
Mill-20 ta' Lulju 2015, il-marki tas-swaba' tiegħek jistgħu jiġu mfittxija minn awtoritajiet bħall-pulizija u l-uffiċċju Ewropew tal-pulizija (Europol) li jista' jagħmel rikjesta għall-aċċess għall-bażi tad-dejta tal-Eurodac għal skopijiet ta' prevenzjoni, identifikazzjoni u investigazzjoni ta' reati serji u terroriżmu | As of 20 July 2015, your fingerprints may be searched by authorities such as the police and the European police office (Europol) who may request access to the Eurodac database for the purpose of preventing, detecting and investigating serious crimes and terrorism |
L-Artikolu 162(1) tar-Regolament (KE) Nru 1234/2007 jistipula li d-differenza bejn il-prezzijiet fis-suq dinji tal-prodotti elenkati fil-Parti XVI tal-Anness I għal dak ir-Regolament u l-prezzijiet ta' dawk il-prodotti fis-suq tal-Unjoni, tista' tiġi koperta b'rifużjoni tal-esportazzjoni. | Article 162(1) of Regulation (EC) No 1234/2007 provides that the difference between prices on the world market for the products listed in Part XVI of Annex I to that Regulation and prices for those products on the Union market may be covered by an export refund. |
L-emenda għall-ispeċifikazzjoni, ippubblikata f'Il-Ġurnal Uffiċjali tal-Unjoni Ewropea, li tikkonċerna d-denominazzjoni mniżżla fl-Anness ta' dan ir-Regolament, hija b'dan approvata. | The amendments to the specification published in the Official Journal of the European Union regarding the name contained in the Annex to this Regulation are hereby approved. |
Deċiżjoni tal-Kummissjoni fil-każ C 50/06 tas-27.6.2007, BAWAG (ĠU L 83, 26.3.2008, p. 7, paragrafu 127). | Commission Decision of 27 June 2007 in Case C 50/06 BAWAG (OJ L 83, 26.3.2008, p. 7, paragraph 127). |
Tnaqqis temporanju tal-imposta fuq l-ammont żejjed | Temporary reduction of the surplus levy |
Ir-rilaxx tal-għajnuna makrofinanzjarja tal-Unjoni għandu jiġi ġestit mill-Kummissjoni b'mod konsistenti mal-ftehimiet jew l-arranġamenti milħuqa bejn l-FMI u l-Ukraina u mal-prinċipji u l-objettivi prinċipali tar-riforma ekonomika stabbiliti fl-Aġenda ta' Assoċjazzjoni UE-Ukraina. | The release of the Union macrofinancial assistance shall be managed by the Commission in a manner consistent with the agreements or understandings reached between the IMF and Ukraine and with the key principles and objectives of economic reform set out in the EU-Ukraine Association Agenda. |
Dħul fis-seħħ | Entry into force |
Aħżen fi friġġ (2°C – 8°C). | Form a skin fold by pinching the skin between thumb and forefinger. |
Tiffriżax. | Do not freeze. |
ir-riskju ta' kuntatt ma' mard infettiv u l-mezzi biex jitnaqqsu tali riskji; | risk of contact with infectious diseases and means to reduce such risks; |
L-EDBI serva bħala intermedjarju prinċipali li ttratta l-finanzjament tal-Bank Sepah (sanzjonat mill-UNSCR mill-2007), inklużi ħlasijiet relatati mal-AQM. | EDBI served as a leading intermediary handling Bank Sepah's (sanctioned by UNSC since 2007) financing, including WMD-related payments. |
Klementin | Clementines |
Stat Membru ma għandux jipprojbixxi lill-awtoritajiet kontraenti tiegħu milli jużaw attivitajiet ta' xiri ċentralizzati offruti minn korpi ċentralizzati ta' xiri li jinsabu fi Stat Membru ieħor. | A Member State shall not prohibit its contracting authorities from using centralised purchasing activities offered by central purchasing bodies located in another Member State. |
Dan il-prodott mediċinali m'għandux bżonn prekawzjonijiet speċjali għall-ħażna. | This medicinal product does not require any special storage conditions. |
Ħruq | Burn |
3. | 3. |
L-Anness tar-Regolament (UE) Nru 185/2010 huwa emendat kif ġej: | The Annex to Regulation (EU) No 185/2010 is amended as follows: |
Jekk tinduna b'xi sinjali jew sintomi ta'epatite (deni, tħossok ma tiflaħx, nawsea, remettar, uġigħ addominali, għejja, suffejra) għandek tinforma lit-tabib tiegħek minnufih. | If you notice the signs or symptoms of hepatitis (fever, malaise, nausea, vomiting, abdominal pain, fatigue, jaundice) you should inform your doctor as soon as possible. |
Produzzjoni, kapaċità tal-produzzjoni u użu tal-kapaċità | Production, production capacity and capacity utilisation |
L-Artikoli li ġejjin qegħdin jiddaħħlu: | The following Articles are inserted: |
Somma tar-ringieli minn 1 sa 5a. | Sum of rows 1 to 5a. |
Felden 20 Mg - Kapseln | Felden 20 Mg - Kapseln |
— lArtikolu 5(1) u (2) jikkorrispondi għallArtikolu 4 tal-KEDB; | Article 5(1) and (2) corresponds to Article 4 of the ECHR, |
Sabiex tiġi ċċarata u limitata l-informazzjoni mitluba mill-Kummissjoni relatata mal-ġestjoni ta' qabel ir-rimi tal-iskart radjuattiv u mal-modifikazzjonijiet ta' pjan li dwaru l-Kummissjoni għadha ma ħarġet l-ebda opinjoni, ġew inklużi żewġ annessi ġodda. | To clarify and limit the information required by the Commission pertaining to the predisposal management of radioactive waste and to modifications of a plan on which no opinion has already been issued by the Commission, two new annexes have been included. |
Fil-każ ta' Regolamenti tat-tubi tal-ventilazzjoni II-2/B/9.2.2b u II-2/B/9.3 japplikaw. | In the case of ventilation ducts Regulations II-2/B/9.2.2b and II-2/B/9.3 apply. |
L-Istati Membri għandhom idaħħlu fis-seħħ il-liġijiet, ir-regolamenti u ddispożizzjonijiet amministrattivi neċessarji biex jikkonformaw ma » din id-Direttiva sa mhux aktar tard minn [... | Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by [... |
Il-kundizzjoni tal-ħġieġ | Condition of glass |
Tractocile m'għandux jitħallat ma'prodotti mediċinali oħra fil-borża ta' l-infużjoni. | TRACTOCILE should not be mixed with other medicinal products in the infusion bag. |
Huwa mportanti li tispiċċa l-kors tal-kura anki jekk tibda tħossok aħjar wara ftit ġranet. | It is important that you finish the course of treatment even if you begin to feel better after a few days. |
Il-kopji msemmija fl-ewwel inċiż jistgħu jsiru biss bi qbil mal-awtorità li tirċievi t-talba. | The copies referred to in the first indent may be made only with the consent of the requested authority. |
( 1 ) Linja ta » Gwida BĊE / 2007/2 tas-26 ta » April 2007 fuq Trans-European Automated Real-time Gross settlement Express Transfer system ( TARGET2 ) ( ĠU L 237, 8.9.2007, p. 1 ). | ( 1 ) Guideline ECB / 2007/2 of 26 April 2007 on a Trans-European Automated Real-time Gross settlement Express Transfer system ( TARGET2 ) ( OJ L 237, 8.9.2007, p. 1 ). |
Artikolu 4 | Article 4 |
Niżżel l-ittra tal-Anness għar-Regolament (KE) Nru 338/97 (A, B jew C) li fih jiġu elenkati l-ispeċijiet fid-data tal-ħruġ taċ-ċertifikat. | Enter the letter of the Annex to Regulation (EC) No 338/97 (A, B or C) in which the species is listed at the date of issue of the certificate. |
Rapport Speċjali Nru 16/2009 — It-tmexxija talKummissjoni Ewropea talassistenza ta' qabel l-adeżjoni litTurkija | Special Report No 16/2009 — The European Commission's management of preaccession assistance to Turkey |
Actos ma għandux jintuża fuq persuni li jista'jkollhom sensittività eċċessiva (allerġiċi) għal pioglitazone jew għal xi sustanza oħra, jew f'pazjenti bi problemi fil-fwied, problemi fil-qalb jew b'ketoaċidożi dijabetika (livelli għoljin ta' ketoni [aċidi] fid-demm). | Actos should not be used in people who may be hypersensitive (allergic) to pioglitazone or any of the other ingredients, or in patients with liver problems, heart failure or diabetic ketoacidosis (high levels of ketones [acids] in the blood). |
Każijiet ta' PRCA ġejjin minn antikorpi huma rari ħafna f'pazjenti b' insuffiċjenza renali kronika bl-erythropojetin amministrat minn taħt il-ġilda.. | Cases of antibody-mediated PRCA have been very rarely reported in chronic renal failure patients with erythropoietin administered by the subcutaneous route. |
Artikolu 50 | Article 50 |
Muturi u ġeneraturi DĊ b'enerġija ta' > 37,5 W iżda ≤ 750 W (esklużi muturi li jistartjaw għal magni b'kombustjoni interna) | DC motors and generators of an output > 37.5 W but ≤ 750 W (excluding starter motors for internal combustion engines) |
Kull ħlas ta' kumpens (pereżempju ħlasijiet ta' assigurazzjoni) waqt is-sena ta' kontabbiltà għandu jiżdied ukoll mat-total għall-bejgħ tal-prodotti kkonċernati kull meta jkun jista' jiġi allokat għall-produzzjoni ta' prodotti ta' din ix-xorta. | Any compensation payments (e.g. insurance payments) during the accounting year are to be added to the total for sales of the products concerned wherever they can be allocated to the production of such products. |
Is-sors ta' Tabella 4 ġej mid-dejta statistika disponibbli, inkluż l-Eurostat. | Table 4 was sourced from the available statistical data, including Eurostat. |
Fit-22 ta' Mejju 2006, il-Kunsill approva l-Ftehim ta' Assoċjazzjoni fis-settur tas-sajd bejn il-Komunità Ewropea u r-Renju tal-Marokk [1] (minn hawn'il quddiem “il-Ftehim ta' Assoċjazzjoni”) billi adotta r-Regolament (KE) Nru 764/2006 [2]. | On 22 May 2006 the Council approved the Fisheries Partnership Agreement between the European Community and the Kingdom of Morocco [1] (hereinafter referred to as the'Partnership Agreement') by adopting Regulation (EC) No 764/2006 [2]. |
L-Anness tar-Regolament ta' Implimentazzjoni (UE) Nru 700/2012 huwa emendat skont l-Anness ta' dan ir-Regolament. | The Annex to Implementing Regulation (EU) No 700/2012 is amended in accordance with the Annex to this Regulation. |
Il-kontenut tal-leġiżlazzjoni nazzjonali: Pakketti li jkun fihom oġġetti mill-Grupp ta' Kompatibbiltà B tal-ADR Klassi 1 u pakketti li jkun fihom sustanzi u oġġetti mill-Grupp ta' Kompatibbiltà D tal-ADR Klassi 1 jisgħu jinġarru fuq l-istess vettura ma' oġġetti perikolużi tal-Klassijiet 3, 5.1 jew 8 tal-ADR sakemm (a) dawn il-pakketti tal-Klassi 1 tal-ADR jinġarru f'kontenituri/kompartimenti separati b'disinn approvat u skont il-kundizzjonijiet meħtieġa, mill-awtoritajiet kompetenti, u (b) dawn is-sustanzi tal-Klassijiet 3, 5.1 jew 8 tal-ADR jinġarru f'reċipjenti konformi mar-rekwiżiti tal-awtorità kompetenti fir-rigward tad-disinn, il-kostruzzjoni, l-ittestjar, l-eżaminazzjoni, it-tħaddim u l-użu tagħhom. | Content of the national legislation: Packages containing articles of Compatibility Group B of ADR Class 1 and packages containing substances and articles of Compatibility Group D of ADR Class 1 may be carried on the same vehicle with dangerous goods of ADR Classes 3, 5.1 or 8 provided (a) the said packages of ADR Class 1 are carried in separate containers/compartments of a design approved, and under the conditions required, by the competent authority, and (b) the said substances of ADR Classes 3, 5.1 or 8 are carried in vessels meeting the requirements of the competent authority as regards their design, construction, testing, examination, operation and use. |
Il-Brażil huwa elenkat fil-Grupp Sanitarju D fl-Anness I tad-Deċiżjoni 92/260/KEE u ż-żwiemel irreġistrati intiżi għad-dħul temporanju fl-Unjoni għandhom jikkonformaw mar-rekwiżiti għaċ-ċertifikazzjoni tas-saħħa tal-annimali u dik veterinarja stipulati fil-mudell taċ-ċertifikat tas-saħħa D stipulat fl-Anness II ta' dik id-Deċiżjoni. | Brazil is listed in Sanitary Group D in Annex I to Decision 92/260/EEC and registered horses intended for temporary admission in the Union are to comply with the animal health and veterinary certification requirements set out in the model of health certificate D set out in Annex II to that Decision. |
Studji in vitro juru li l-metaboliżmu ta'voriconazole jista' jiġi mwaqqaf minn delavirdine. | In vitro studies show that the metabolism of voriconazole may be inhibited by delavirdine. |
Id-doża tal-bidu mogħtija taħt il-ġilda jew ġol-vina hija ta' 0. 45 μg/ kg piż tal-ġisem, bħala injezzjoni waħda darba fil-ġimgħa. | The initial dose by subcutaneous or intravenous administration is 0.45 µg/ kg body weight, as a single injection once weekly. |
Parti interessata waħda stqarret li l-ħbula ta' rmiġġ imsemmija hawn fuq ma jaqgħux fid-definizzjoni tal-prodott ikkonċernat billi, minħabba fil-ġonot (iċċumbar) marbuta ma' dawn il-ħbula, prodotti bħal dawn għandhom ikunu ddikjarati bħala “oġġetti ta' ħbula” li jappartjenu lil kodiċi ieħor tan-NM (ara wkoll fil-premessa 23). | One interested party claimed that the mooring ropes referred to above are not falling within the definition of the product concerned as, due to the splices attached to these ropes, such products should be declared as'articles of ropes' which belong to another CN code (see also in recital 23). |
9. | 9. |
It-tabib jista' jirrikmanda doża inqas, speċjalment meta tinbeda il-kura f'ċertu pazjenti bħal dawk fuq l-emodijalisi, u dawk' il fuq minn 75 sena. | The doctor may advise a lower dose, especially when starting treatment in certain patients such as those on haemodialysis, or those over the age of 75 years. |
Opinjoni dwar kif għandhom jiġu rrapurtati s-servizzi transkonfini għall-bilanċ ta » pagamenti u l-istatistika dwar il-qagħda ta » l-investiment internazzjonali ( CON / 2005/23 ) | Opinion on the reporting of cross-border services for balance of payments and international investment position statistics ( CON / 2005/23 ) |
Artikolu 15 | Article 15 |
Rati ta' risponsi sostnuti b'PegIntron + ribavirin (bid- doża ta' ribavirin, ġenotip u viral load) | Sustained response rates with PegIntron + ribavirin (by ribavirin dose, genotype and viral load) |
5. | 5. |
Mhuma indikati l-ebda rekwiżiti kostituzzjonali. | No constitutional requirements indicated. |
26. 5 (152/ 573) | 26.5 (152/ 573) |
Sistema tal-klassifika tal-organi MedDRA | MedDRA system organ class in |
10. | 10. |
Jekk xi wieħed mill-effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li m'humiex imsemmijin f'dan il-fuljett, jekk jogħġbok, għid lit-tabib jew lill-ispiżjar tiegħek. | If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. |
L-ispejjeż ġenerali tar-ristrutturar, inklużi l-ispejjeż tar-ristrutturar qabel l-adeżjoni, laħqu total ta' PLN 450,3 miljun (EUR 106,7 miljun) u primarjament kienu jikkonsistu mir-ristrutturar tal-obbligazzjonijiet taħt id-dritt ċivili (PLN 95,6 miljun u PLN 113,2 miljun rispettivament), l-ispiża tal-organizzazzjoni tas-sistema tad-distribuzzjoni u l-provvista (PLN 151,2 miljun), l-ispiża għall-assigurazzjoni tal-kontinwità tal-provvista (PLN 40,0 miljun) u l-immodernizzar (PLN 30,5 miljun). | The overall restructuring costs, including restructuring costs before accession, totalled PLN 450,3 million (EUR 106,7 million) and consisted mainly of the restructuring of civil-law liabilities (PLN 95,6 million and PLN 113,2 million respectively), the cost of organising the supply and distribution system (PLN 151,2 million), the cost of ensuring continuity of supply (PLN 40,0 million) and modernisation (PLN 30,5 million). |
it-titolu “Il-pubblikazzjonijiet” għandu jiġi ssostitwit bit-titolu “Il-pubblikazzjonijiet u t-tqegħid ta' dokumenti fuq l-internet”; | the heading'Publications' shall be replaced by the heading'Publications and posting of documents on the Internet'; |
Dan ir-Regolament għandu jidħol fis-seħħ fil-jum tal-pubblikazzjoni tiegħu f'Il-Ġurnal Uffiċjali tal-Unjoni Ewropea. | This Regulation shall enter into force on the date of its publication in the Official Journal of the European Union. |
Monofilament, strixxa (tiben artifiċjali u xi ħaġa simili) u imitazzjoni ta' watar magħmula minn materjali tat-tessut artifiċjali | Monofilament, strip (artificial straw and the like) and imitation catgut of artificial textile materials |
Rispons sat- | No |
Artikolu 3 | Article 3 |
Latvija UAB Magnum Veterinarija Smelynes str. | Latvija UAB Magnum Veterinarija Smelynes str. |
Ir-Regolament tal-Kunsill (KE) Nru 510/2006 dwar il-protezzjoni tal-indikazzjonijiet ġeografiċi u d-denominazzjonijiet tal-oriġini għall-prodotti agrikoli u l-oġġetti tal-ikel | Council Regulation (EC) No 510/2006 on the protection of geographical indications and designations of origin for agricultural products and foodstuffs |
Indirizz: (a) White House, Near Saudi Mosque, Clifton, Karachi, il-Pakistan | Address: (a) White House, Near Saudi Mosque, Clifton, Karachi, Pakistan |
Fi studju ta' fażi Ib, la kien hemm effetti sinifikanti ta' gemcitabine fuq il-farmakokinetika ta' erlotinib, u lanqas effetti sinifikanti ta' erlotinib fuq il-farmakokinetika ta' gemcitabine. | In a Phase Ib study, there were no significant effects of gemcitabine on the pharmacokinetics of erlotinib nor were there significant effects of erlotinib on the pharmacokinetics of gemcitabine. |
wisa' minn 3,4 mm sa 3,6 mm; | width 3,4-3,6 mm; |
MOD TA' KIF U MNEJN JING ATA | METHOD AND ROUTE(S) OF ADMINISTRATION |
Ara wkoll ir-ringiela dwar ritonavir hawn isfel. | See also ritonavir row below. |
Li ġej għandu jiġi miżjud qabel l-addattamenti:"u sussegwentament emendata bi: | The following shall be added before the adaptations:"and subsequently amended by: |
Rapport Speċjali Nru 6/2010 – Irriforma tassuq tazzokkor laħqet l-għanijiet prinċipali tagħha? | Special Report No 6/2010 – Has the reform of the sugar market achieved its main objectives? |
Dan ir-Regolament għandu jidħol fis-seħħ fit-tielet jum wara dak tal-pubblikazzjoni tiegħu f'Il-Ġurnal Uffiċjali tal-Unjoni Ewropea. | This Regulation shall enter into force on the third day following that of its publication in the Official Journal of the European Union. |
Artikolu 2 | Article 2 |
Nru tal-grupp | Group No |
Il-prodotti ma għandhomx jintużaw għat-trattament fuq injam li jista' jiġi f'kuntatt dirett mat-tfal, sakemm ma jkunx jista' jintwera fl-applikazzjoni għall-awtorizzazzjoni tal-prodott li r-riskji jistgħu jitnaqqsu għal livell aċċettabbli; | Products shall not be used for treatment of wood with which children may enter in direct contact, unless it can be demonstrated in the application for product authorisation that risks can be reduced to an acceptable level. |
Il-fjuwil jista' jkun fih inibituri tal-ossidazzjoni u diżattivaturi tal-metall li normalment jintużaw sabiex ikunu stabbilizzati l-kurrenti tal-petrol tar-raffineriji, imma m'għandhomx jiżdiedu addittivi tad-deterġenti/dispersivi u żjut solventi. | The fuel may contain oxidation inhibitors and metal deactivators normally used to stabilise refinery gasoline streams, but detergent/dispersive additives and solvent oils shall not be added. |
Pfizer | Pfizer |
Ir-Reġjuni ta' Yambol, Sliven, Shumen u Varna | Regions of Yambol, Sliven, Shumen and Varna |
Strumenti mużikali jew tat-tastieri li l-ħoss tagħhom jiġi prodott, jew irid jiġi amplifikat, permezz tal-elettriku | Musical or keyboard instruments, the sound of which is produced, or must be amplified, electrically |
M14 M15 M16 M17 M18 | M14 M15 M16 M17 M18 |
Artikolu 2 | Article 2 |
Metodu ta' għoti Il-kapsula iebsa għandha timbela sħiħa. | Method of administration The hard capsule should be swallowed whole. |
Informazzjoni dettaljata dwar dan il-prodott tinsab fuq il-website ta' l-Aġenzija Ewropeja dwar il-mediċini (EMEA) http: // www. emea. europa. eu /. | Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/ |
Sa ċertu punt, hu jinibixxi l-aggregazzjoni tat-tromboċiti kkaġunata mill-kollaġen. | To a minor extent it also inhibits collagen-induced thrombocyte aggregation. |
KAPITOLU 1 | CHAPTER 1 |
ISTRUZZJONIJIET DWAR L-UŻU | INSTRUCTIONS ON USE |
Jittieħed mill-ħalq. | Oral use. |
jiżdied il-punt li ġej wara l-punt (a): | the following point is inserted: |
679 703 10 (1. 5) 9 (1. 3) | 703 9 (1.3) |
F'każ li tinjetta b'mod aċċidentali lilek innifsek, fittex parir mediku minnufih u uri l-fuljett tal-pakkett jew it-tikketta lit-tabib. | In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician. |
NUMRU TAL-LOTT TAL-MANIFATTUR | MANUFACTURER' S BATCH NUMBER |
il-perjodu taż-żmien li għandu jitqies għall-istadju tal-użu. | The timespan to be considered for the use stage. |
Jekk lenalidomide jittieħed matul it-tqala, effett teratoġeniku ta' lenalidomide fil-bnedmin hu mistenni. | If lenalidomide is taken during pregnancy, a teratogenic effect of lenalidomide in humans is expected. |
PARTI 1 | PART 1 |
Bieb jew tieqa bil-gwarniċ jew mingħajru huwa kkunsidrat bħala biċċa waħda. | A door or window with or without its frame or threshold is considered as one piece. |
Rari ħafna: | Very rare: |
Il-Bank Ċentrali Ewropew għandu jintrabat legalment ma' terzi, mill-President, jew minn żewġ membri tal-Bord Eżekuttiv jew bil-firem ta' żewġ membri tal-persunal tal-Bank Ċentrali Ewropew li jkunu ġew awtorizzati kif xieraq mill-President biex jiffirmaw f'isem il-Bank Ċentrali Ewropew. | The European Central Bank shall be legally committed to third parties by the President or by two members of the Executive Board or by the signatures of two members of the staff of the European Central Bank who have been duly authorised by the President to sign on behalf of the European Central Bank. |