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Trattament speċifiku | Specific treatment |
F'pazjenti li għandhom dijabete ta' tip 2 u jbatu minn pressjoni għolja, il-kura mogħtija fil-bidu hija ta' 150 mg ta' irbesartan darba kuljum u tiġi titrata għal 300 mg darba kuljum bħala l-aħjar doża ta' manteniment ippreferuta għall-kura tal-mard renali. | In hypertensive type 2 diabetic patients, therapy should be initiated at 150 mg irbesartan once daily and titrated up to 300 mg once daily as the preferred maintenance dose for treatment of renal disease. |
Il-frekwenzi huma definiti bħala komuni ħafna (≥ 1/ 10), komuni (≥ 1/ 100 sa < 1/ 10) u mhux komuni (≥1/ 1000 sa < 1/ 100). | Frequencies are defined as very common (≥ 1/ 10), common (≥ 1/ 100 to < 1/ 10) and uncommon (≥ 1/ 1000 to < 1/ 100). |
Il-Kummissjoni tikkonkludi li l-holding ta' 24 % tikkostitwixxi f'dawn iċ-ċirkostanzi holding importanti, anke meta jitqies id-daqs tal-intrapriża ta' IFB u s-sitwazzjoni finanzjarja tagħha qabel ir-ristrutturazzjoni. | The Commission concludes that, under these circumstances, and in view of the size of the IFB business and its disastrous financial situation prior to its restructuring, a shareholding of 24 % constitutes a significant shareholding. |
Zonegran għandu jintuża bl-attenzjoni f'pazjenti li jkunu qed jiġu kkurati fl-istess ħin bl-inibituri ta' carbonic anhydrase bħal topiramate, għax hemm huma informazzjoni insuffiċjenti biex tiġi eskluża interazzjoni farmakodinamika (ara Sezzjoni 4. 5). | Zonegran should be used with caution in patients being treated concomitantly with carbonic anhydrase inhibitors such as topiramate, as there are insufficient data to rule out a pharmacodynamic interaction (see Section 4.5). |
Fi studji kliniċf' pazjenti b'psikożdovuta għ mediċ (agonist ta'dopamine) assoċ mal-marda ta' | In clinical trials in patients with drug-induced (dopamine agonist) psychosis associated with Parkinson' s disease, worsening of Parkinsonian symptomatology and ha llucinations were reported very commonly and more frequently than with placebo. |
Ktejjeb ta' tagħrif dwar l-integrazzjoni | Handbook on Integration |
Digoxin: | Digoxin: |
Nederland Danmark UCB Pharma B. V. | Nederland UCB Pharma B.V. |
Artikolu 1 | Article 1 |
Għal dan l-iskop għandu jikkoopera ma » l-istituzzjonijiet jew korpi tal-Komunità u ma » lawtoritajiet kompetenti ta » l-Istati Membri jew pajjiżi terzi u ma » organizzazzjonijiet internazzjonali. | For these purposes it shall cooperate with the Community institutions or bodies and with the competent authorities of the Member States or third countries and with international organizations. |
Viċi President | Vice-President |
Fl-Artikolu 3, il-paragrafu 3 jinbidel b'li ġej: | in Article 3, paragraph 3 is replaced by the following: |
F703C: l-erja mhux misjuba | F703C: area not found |
9. | 9 ANNEX II |
Teħel is-serje jekk d– | Fail the series if d– |
(μg/ 0. 5ml) | Once Weekly (ml) |
L-informazzjoni għandha tiġi pprovduta għaż-żoni tal-offerti kollha f'dawk l-Istati Membri biss b'alimentazzjoni ta' aktar minn 1 % ta' ġenerazzjoni ta' enerġija mir-riħ jew mix-xemx fis-sena jew għal dawk iż-żoni tal-offerti b'alimentazzjoni ta' aktar minn 5 % ta' ġenerazzjoni ta' enerġija mir-riħ jew mix-xemx fis-sena. | The information shall be provided for all bidding zones only in Member States with more than 1 % feed-in of wind or solar power generation per year or for bidding zones with more than 5 % feed-in of wind or solar power generation per year. |
Din il-munita turi ġenzjana, bħala parti mis-serje tal-fjuri, li tissimbolizza impenn lejn l-ambjent u r-rwol ta » l-Awstrija fl-iżvilupp tal-politika ambjentali tal-Komunità. | This coin features a gentian, as part of a floral series, symbolising a duty to the environment and the part Austria is playing in the development of a Community environmental policy. back to top |
H- 1123 Budapest Tel.: +36 1 457- 8500 | H-1123 Budapest Tel.: +36 1 457-8500 |
14. | 14. |
ma' l-aċċess | thrombosis |
14. | 14. |
Karvea jipprevjeni li angiotensin- II tingħaqad ma' dawn ir-riċetturi, u jwassal il-vini tad-demm biex jirrilassaw u b'hekk il-pressjoni tinżel. | Karvea prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax and the blood pressure to lower. |
Fejn jintwera biss valur wieħed għall-integrità min-nirien ta' fruntiera bejn żewġ spazji, dak il-valur għandu japplika fil-każijiet kollha. | Where a single value is shown for the fire integrity of a boundary between two spaces, that value shall apply in all cases. |
ratiopharm GmbH Graf- Arco- Str. | ratiopharm GmbH Graf-Arco-Str. |
klejms taħt self ta' titoli kontra kollateral fi flus: il-kontroparti ta' flus kontanti mħallsa bi skambju ma' titoli mislufin mill-FVC. | claims under securities borrowing against cash collateral: counterpart of cash paid in exchange for securities borrowed by the FVC |
• tnaqqis fit-tul ta' ħajja u żjieda fl-imwiet attribwiti ma' progressjoni tal-mard f' 4 xhur f' pazjenti b' kanċer metastastiku fis-sider, li qed jirċievu l-kimoterapija, meta ngħatalhom biex jintlaħaq targit ta' emoglobina ta' 12- 14 g/ dl (7. 5 – 8. 7 mmol/ l) | • shortened overall survival and increased deaths attributed to disease progression at 4 months in patients with metastatic breast cancer receiving chemotherapy when administered to target a haemoglobin of 12-14 g/ dl (7.5-8.7 mmol/ l) |
Artikolu 1 | Article 1 |
Sid il-vettura | Vehicle owner |
Epatite Ċ Kronika: | Chronic Hepatitis C: |
dettalji dwar: | details of: |
Inġenju tal-ajru li qed itir, jew li qed jopera fuq l-art jew fuq l-ilma, għandu jagħti d-dritta lil inġenju tal-ajr li jkun qiegħed nieżel jew li jkun qiegħed fl-istadji finali ta' avviċinament lejn l-art. | An aircraft in flight, or operating on the ground or water, shall give way to aircraft landing or in the final stages of an approach to land. |
Sors: Statistika ta' esportazzjoni mill-Istati Uniti u tweġibiet għall-kwestjonarju tal-esportaturi mill-Istati Uniti li ħadu sehem fil-kampjun | Source: US export statistics and questionnaire replies of the sampled dumping US exporters. |
Operatur bil-kodiċi TAIL NB:J8SLU | Operator using TAIL NB:J8SLU |
Għal kimiċi fejn testijiet preċedenti ta' tossiċità għal doża ripetuta għal 28 jum u/jew għal 90 jum ikunu indikaw il-potenzjal li jikkawżaw effetti immunotossiċi, investigazzjonijiet ulterjuri ta' dan il-punt ta' tmiem ikunu jistgħu jsiru b'mod fakultattiv fit-tmiem. | For chemicals where previous repeated dose 28-day and/or 90-day toxicity tests indicated the potential to cause immunotoxic effects, further investigations of this endpoint may optionally be conducted at termination. |
Artikolu 16 | Article 16 |
L-Artikolu 308d tar-Regolament tal-Kummissjoni (KEE) Nru 2454/93 [5] għandu japplika. | Article 308d of Commission Regulation (EEC) No 2454/93 [5] shall apply. |
Meta Agenerase jingħata flimkien, jistà jkun hemm żieda konsiderevoli fil-konċentrazzjoni fil-plażma ta' inibitur ta' PDE5 u effetti mhux mixtieqa bħal pressjoni baxxa, bdil fil-vista u prijapiżmu. | Co- administration with Agenerase may substantially increase PDE5 inhibitor plasma concentrations and associated adverse events, including hypotension, visual changes and priapism (see section 4.4). |
Żvilupp rurali ffinanzjat mit-Taqsima talGaranziji ta' l-EAGGF — Perjodu ta' Programmar mill-2000 sa l-2006 | Rural development financed by the EAGGF Guarantee Section — Programming period 2000 to 2006 |
Kif taħżen Focetria 6. | OTHER |
Sustanzi mhux attivi: protamine sulphate, metacresol, phenol, zinc chloride, sodium dihydrogen phosphate dihydrate, glycerol, sodium hydroxide, hydrochloric acid (għall- aġġustament tal-pH), ilma għall-injezzjonijiet. | Excipients: protamine sulphate, metacresol, phenol, zinc chloride, sodium dihydrogen phosphate dihydrate, glycerol, sodium hydroxide, hydrochloric acid (for pH adjustment), water for injections. |
Jekk il-kunjett ma jkunx f'kundizzjoni perfetta meta tirċivih, erġa' agħtih lura lil min tahulek. ► Jekk ma jkunx inħażen kif suppost jew jekk ġie ffriżat (ara 6 Kif taħżen Actraphane) ► Jekk ma jkunx abjad u opak b'mod uniformi meta jerġa'jiġi ffurmat f'suspensjoni. | If it isn' t in perfect condition when you get the vial, return the vial to your supplier ► If it hasn' t been stored correctly or been frozen (see 6 How to store Actraphane) ► If it' s not uniformly white and cloudy when it' s resuspended. |
9140 Boskijiet tal-fagu subalpini medjo-Ewropej b'Acer u Rumex arifolius | 9140 Medio-European subalpine beech woods with Acer and Rumex arifolius |
Jekk titla' fuq sellum dejjem ikun hemm il-possibbiltà li jaqa' u jweġġa'. | Climbing a ladder always includes the possibility of falling off and injuring oneself. |
ĠU L 145, 10.6.2009, p. 1. | OJ L 145, 10.6.2009, p. 1. |
KARTUNA TA' BARRA TAL-PAKKETT B'ĦAFNA (BIL- KAXXA ĊELESTI) | OUTER CARTON OF MULTIPACK (WITH BLUE BOX) |
Artikolu 2 | Article 2 |
Bonds u noti 2.2.1.1. | Bonds and notes 2.2.1.1. |
Żejt tal-kreożot, distillat li jaħli f'temperatura għolja; żejt tal-ħasil | Creosote oil, high-boiling distillate; Wash oil |
“ANNESS | 'ANNEX |
- ketoconazole, mediċina li tintuża biex tikkura infezzjonijiet tal-fungu. | - ketoconazole, a medicine used to treat fungal infections. |
Għaldaqstant huwa xieraq li l-Istati Membri jivvalutaw dawk ix-xenarji ta' użu jew esponiment u dawk ir-riskji għall-kompartimenti u l-popolazzjonijiet li għadhom ma ġewx indirizzati b'mod rappreżentattiv fil-valutazzjoni tar-riskju li saret fil-livell tal-UE, u li, meta jkunu qed jagħtu l-awtorizzazzjonijiet tal-prodotti, jiżguraw li jittieħdu miżuri xierqa jew li jiġu imposti kundizzjonijiet speċifiċi sabiex ir-riskji identifikati jittaffew għal livelli aċċettabbli. | It is therefore appropriate that Member States assess those uses or exposure scenarios and those risks to the compartments and populations that have not been representatively addressed in the EU level risk assessment and, when granting product authorisations, ensure that appropriate measures are taken or specific conditions imposed in order to reduce the identified risks to acceptable levels. |
METODU U MOD( I) TA'AMMINISTRAZZJONI | METHOD AND ROUTE(S) OF ADMINISTRATION |
Informazzjoni dettaljata dwar din il-mediċina tinsab fuq il-website ta' l-Aġenzija Ewropeja dwar il-Mediċini (EMEA) http: // www. emea. europa. eu /. __ | Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu. |
li jistabbilixxi regoli għall-implimentazzjoni tar-Regolament tal-Kunsill (KE) Nru 1234/2007 fir-rigward tan-notifiki tal-Istati Membri lill-Kummissjoni fis-settur tal-ħalib u l-prodotti tal-ħalib | laying down rules for the implementation of Council Regulation (EC) No 1234/2007 as regards Member States' notifications to the Commission in the milk and milk products sector |
Aktar minn hekk, mil-lat tekniku, il-logħob tal-każinos offrut onlajn u f'postijiet tradizzjonali jidher li huwa komparabbli f'termini ta' pjattaformi teknoloġiċi, formats u parametri. | Moreover, from a technical point of view, casino games offered online and in land-based premises appear to be comparable in terms of the technological platforms, formats and parameters. |
Qabel il-15 ta' Awwissu 2010, l-Istati Membri għandhom jittrażmettu lill-Kummissjoni l-informazzjoni li ġejja billi jużaw il-mudelli stabbiliti fl-Annessi I.A and I.B: | Before 15 August 2010, the Member States shall transmit to the Commission the following information using the models set out in the Annexes I.A and I.B: |
Ammont tal-prezz rappreżentattiv għal kull 100 kg nett tal-prodott ikkonċernat | Representative price per 100 kg net of the product concerned |
Analażi sistematika saret fuq 9000 pazjent bil-kancer li pparteċipaw f' 57 studji kliniċi. | A systematic review has also been performed involving more than 9000 cancer patients participating in 57 clinical trials. |
Pjanċi tal-landa, folji u strixxi oħra tal-landa, ikluż azzar miksi bi kromju bmod elettrolitiku | Tinplate, other tinned sheet and strip, including electrolytically chromium coated steel (ECCS) |
Ġell | Gel |
Il-frekwenza ta' dawn l-effetti sekondarji mniżżla hawn taħt hija definita' bl-użu ta' din is-sistema li ġejja: • komuni ħafna (taffetwa iktar minn pazjent 1 f'10) • komuni (taffetwa pazjent 1 sa 10 f'100) • mhux komuni (taffetwa pazjent 1 sa 10 f'1, 000) • rari (taffetwa pazjent 1 sa 10 f'10, 000) • rari ħafna (taffetwa inqas minn pazjent 1 f'10, 000) • mhux magħruf (ma tistax tittieħed stima mid-data disponibbli). | 21 The frequency of possible side effects listed below is defined using the following system: • very common (affects more than 1 user in 10) • common (affects 1 to 10 users in 100) • uncommon (affects 1 to 10 users in 1,000) • rare (affects 1 to 10 users in 10,000) • very rare (affects less than 1 user in 10,000) • not known (frequency cannot be estimated from the available data) |
Il-produtturi li jixtiequ jiksbu eżenzjoni għandhom iressqu talba sostnuta b'evidenza xierqa fil-limitu taż-żmien indikat fl-Artikolu 3(3) ta' dan ir-Regolament. | Producers wishing to obtain an exemption should submit a request duly supported by evidence within the time limit indicated in Article 3(3) of this Regulation. |
L-abbozz tal-minuti għandu jitfassal misSegretarjat Ġenerali fi żmien ħmistax-il jum u ppreżentat lill-Kunsill jew lill-Coreper għall-approvazzjoni. | The draft minutes shall be drawn up by the General Secretariat within 15 days and submitted to the Council or to Coreper for approval. |
il-prodotti msemmijin f'(a), (b) jew (ċ) fuq maħlulin fl-ilma; | the products mentioned in (a), (b) or (c) above dissolved in water; |
• nuqqas sinifikattiv ta' rispons għal mediċini wżati biex jikkuraw l-anemija; jew | • significant lack of response to drugs used to treat anaemia; or |
180 mcg | Treatment difference 95%CI |
27 Is-soluzzjoni rikostitwita m'għandha ebda preservattiv. | 27 The reconstituted solution contains no preservative. |
Il-valur tal-kollateral għandu jkun il-valur tas-suq jew il-valur tas-self ipotekarju mnaqqas kif xieraq sabiex jirrefletti r-riżultati tal-monitoraġġ meħtieġ skont l-Artikolu 208(3) u sabiex jikkunsidra kwalunkwe pretensjoni preċedenti fuq il-proprjetà. | The value of the collateral shall be the market value or mortgage lending value reduced as appropriate to reflect the results of the monitoring required under Article 208(3) and to take account of any prior claims on the property. |
Fajber tal-ħġieġ miksi bil-fluworokarbonju (PTFE), jew | Fluorocarbon (PTFE) coated glass fibre, or |
Fi tmien pazjenti li ħadu 40 mg darbtejn kuljum waqt li kienu sajma, l-AUC0- 12h fi stat stabbli kien 1284±227 ng⋅h/ ml (18%) (medja ± SD [% CV]), Cmax kien 536±146 ng/ ml (27%), u Cmin kien 9±8 ng/ ml (89%). | In eight patients receiving 40 mg twice daily in the fasted state, steady-state AUC0-12h was 1284±227 ng⋅ h/ ml (18%) (mean ± SD [% CV]), Cmax was 536±146 ng/ ml (27%), and Cmin was 9±8 ng/ ml (89%). |
għall-kura ta' l-ażma), | treat asthma), |
BASTIMENTI ĠODDA TAL-KLASSI B, Ċ U D TAT-TUL TA' 24 METRU JEW AKTAR: | NEW CLASS B, C AND D SHIPS OF 24 METRES IN LENGTH AND OVER: |
lil hinn mil-livell “normali” ta' madwar EUR 2 biljun – u b'mod partikolari bit-tisħiħ tassettur tal-SMEs filpajjiż, li fl2009 ammontaw għal EUR 1.5 biljun f'self lil banek intermedjarji. | of EUR 500m/year beyond the “normal” level of some EUR 2bn – and in particular by strengthening the SME sector in the country, which in 2009 accounted for EUR 1.5bn in loans to intermediary banks. |
ĠU L 324, 29.11.2002, p. 1. | OJ L 324, 29.11.2002, p. 1. |
5. | 62 5. |
Aċċessjonijiet INVEGA għandu jintuża b'mod kawt ma' pazjenti bi storja ta' aċċessjonijiet jew kondizzjonijiet oħra li għandhom il-potenzjal li jkabbru l-possibiltà ta' aċċessjoni. | Seizures INVEGA should be used cautiously in patients with a history of seizures or other conditions that potentially lower the seizure threshold. |
Bi proporzjoni ta' kollaġen/proteina ta' mhux aktar minn 0,35 [16] u li fih bil-piż il-perċentwali li ġejjin ta' laħmijiet tal-bovini (eskluż il-ġewwieni u x-xaħam): | With a collagen/protein ratio of no more than 0,35 [16] and containing by weight the following percentages of bovine meats (excluding offal and fat): |
75 Bħal kull mediċina oħra, Levemir jista' jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd. | Like all medicines, Levemir can cause side effects, although not everybody gets them. |
Stabbilit għall-kwalità standard kif iddefinita fl-Anness IV, il-punt II, tar-Regolament (KE) Nru 1234/2007. | For the standard quality defined in point II of Annex IV to Regulation (EC) No 1234/2007. |
L-utenti | Users |
ANNESS 4 | ANNEX 4 |
Wara li kkunsidrat it-Trattat li jistabbilixxi l-Komunità Ewropea, | Having regard to the Treaty establishing the European Community, |
35 TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA | 32 PARTICULARS TO APPEAR ON THE OUTER PACKAGING |
folja (PVC/ PE/ PCTFE/ alu) | blister (PVC/ PE/ PCTFE/ alu) |
Il-qawwa ta' sistema xjentifika u teknoloġika Ewropea tiddependi mill-kapaċità tagħha li tiġbor it-talent u l-ideat kull fejn jeżistu. | The strength of the European science and technology system depends on its capacity to harness talent and ideas from wherever they exist. |
Deheb u ammonti riċevibbli f'deheb | Gold and gold receivables |
Fsada patoloġika attiva. | Active pathological bleeding. |
Data ta' l-aħħar tiġdid: | Date of latest renewal: |
Dik is-somma, madankollu, m'għandhiex tkun aktar minn parti minn kull tnax tal-approprjazzjonijiet previsti fl-istess kapitolu tal-abbozz tal-baġit. | That sum shall not, however, exceed one twelfth of the appropriations provided for in the same chapter of the draft budget. |
Istruzzjonijiet iddettaljati dwar l-użu huma pprovduti fil-fuljett ta' tagħrif. | Detailed instructions for use are provided in the package leaflet. |
Prodotti tad-dulċiera, kejkijiet, ħlewwiet u gallettini | Bread, pastry, cakes, confectionery, biscuits and other baker's wares |
Aktar ġrajjiet avversi kienu innotati b' docetaxel bħala monoterapija (55. 4%) meta mqabbel ma' paclitaxel (23%). | More grade 3/ 4 adverse events were observed for docetaxel monotherapy (55.4%) compared to paclitaxel (23.0%). |
Τηλ: +357 - 22 76 62 76 | Τηλ: +357 - 22 76 62 76 |
Azithromycin/ Efavirenz (600 mg doża waħda/ 400 mg darba kuljum) | therapeutic areas (dose) |
Data tat-twelid/Post tat-twelid: 8.10.1987, Vukovar, Kroazja | Date of birth/Place of birth: 8.10.1987, Vukovar, Croatia |
Deċiżjoni bħal din tista' tittieħed biss jekk it-total tal-ispejjeż li jkunu saru diġà u dawk li aktarx isiru jaqbeż l-ammont li għandu jiġi rkuprat jew jekk jirriżulta li l-irkupru mhux possibbli li jsir minħabba insolvenza, irreġistrata u rrikonoxxuta skont il-liġi nazzjonali, tad-debitur jew tal-persuni legalment responsabbli għall-irregolarità. | Such a decision may only be taken if the costs already and likely to be incurred total more than the amount to be recovered or if the recovery proves impossible owing to the insolvency, recorded and recognised under national law, of the debtor or the persons legally responsible for the irregularity. |
Din id-Deċiżjoni hija indirizzata lir-Repubblika Portugiża. | This Decision is addressed to the Portuguese Republic. |
KIF TINGĦATA L-INJEZZJONI | HOW TO USE DYNASTAT |