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4. | 4. |
drenaġġ ta' art agrikola jew imsaġġra. | drainage of agricultural or forestry land. |
IL-KUMITAT KONĠUNT TAŻ-ŻEE, | THE EEA JOINT COMMITTEE, |
5. | 5. |
Mhux komuni Disturbi fil-metaboliżmu u n-nutrizzjoni | Metabolism and nutrition disorders |
QABEL MA' TUŻA ORGALUTRAN | BEFORE YOU USE ORGALUTRAN |
L-impatt tar-rifjut tad-deroga l-ġdida mitluba fis-17 ta' April 2013 se jkun minimu. | The impact of a refusal of the new derogation requested on 17 April 2013 would be minimal. |
PORTUGALL | PORTUGAL |
Id-WHO ser tipprovdi għarfien espert tekniku u ġestjoni tal-proġett, iżda mhijiex f'pożizzjoni li tipprovdi fondi għal attivitajiet konġunti f'dan il-kuntest. | The WHO will deliver technical expertise and project management but is not in a position to provide funds to joint activities in this context. |
Id-data tal-approvazzjoni tar-rapport annwali mill-kumitat ta' monitoraġġ | Date of approval of the annual report by the monitoring committee |
Id-Direttiva 64/432/KEE tapplika għall-kummerċ tal-annimali bovini u suwini fl-Unjoni. | Directive 64/432/EEC applies to trade within the Union in bovine animals and swine. |
It-trattament bl-insulina jista' jġiegħel il-ġisem jipproduċi l-antikorpi (sustanzi li jaġġixxu kontra l-insulina). | Insulin treatment can cause the body to produce antibodies to insulin (substances that act against insulin). |
It-tabib tiegħek jista' jnaqqas id-doża ta' Dynastat jew ta' mediċini oħra, jew jista' jkollok bżonn tieħu mediċina oħra. | Your doctor may reduce the dose of Dynastat or other medicines, or you may need to take a different medicine. |
Żomm l-Optiset tiegħek' il bogħod mit-trab u l-ħmieġ. | Protect your OptiSet from dust and dirt. |
Doża ta' Rapinyl tsta' tikkonsisti minn aktar minn pillola waħda. | A dose of Rapinyl may consist of more than one tablet. |
żagarelli tat-tajprajter jew bħalhom, fuq irkiekel jew le jew fi kartriġis (ikklassifikati skond il-materjal li magħmulin minnu, jew f'titlu 9612 jekk bil-linka jew imħejjijin mod ieħor għall-istampar). | typewriter or similar ribbons, whether or not on spools or in cartridges (classified according to their constituent material, or in heading 9612 if inked or otherwise prepared for giving impressions). |
Artikolu 41 | Article 41 |
България sanofi- aventis Bulgaria EOOD Тел: +359 (0) 2 970 53 00 | България sanofi-aventis Bulgaria EOOD Тел.: +359 (0)2 970 53 00 |
4. 2 Pożoloġija u metodu ta' kif għandu jingħata | 4.2 Posology and method of administration |
Din id-Deċiżjoni għandha tidħol fis-seħħ fid-data tal-adozzjoni tagħha. | This Decision shall enter into force on the date of its adoption. |
DOŻA GĦAL KULL SPEĊI, MOD( I) U METODU TA' AMMINISTRAZZJONI | DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION |
Artikolu 88 | Article 88 |
Il-klassifikazzjoni ta' magna awtomatika tal-ipproċessar ta' dejta taħt l-intestatura 8471 hija eskluża hekk kif l-apparat ma jissodisfax il-kundizzjonijiet tan-Nota 5(A) mal-Kapitolu 84. | Classification as an automatic data-processing machine of heading 8471 is excluded as the apparatus does not fulfil the conditions of Note 5(A) to Chapter 84. |
Membru tal-Kummissjoni | Member of the Commission |
aw Id-Dehra ta' EXUBERA u d-daqs tal-pakkett | ris What EXUBERA looks like and contents of the pack |
Għandhom jittieħdu miżuri xierqa biex jiġu llimitati r-riskji għall-ambjent marittimu, minħabba li matul l-evalwazzjoni ġew identifikati riskji mhux aċċettabbli għal dan il-kompartiment. | Appropriate measures should be taken to limit the risks to the marine environment, since unacceptable risks to this compartment have been identified during the evaluation. |
Il-mekkaniżmu tal-formazzjoni tat-tumur u tar-relevanza potenzjali lill-bnedmin mhumiex magħrufa. | The mechanism of tumour formation and the potential relevance for humans are not known. |
Fi studju CD I u studju CD II, f'ġimgħa 4, ġie milħuq riżultat totali li wera titjib li hu statistikament sinifikanti fil-kwestjonarju għall-mard speċifiku dwar il-marda ta' l-infjammazzjoni tal-musrana (IBDQ), u dan f'pazjenti li ġew magħżula b'ordni addoċċ u ngħataw 80/ 40 mg u 160/ 80 mg Humira meta mqabbel mal-plaċebo, u dan deher f'Ġimgħat 26 u 56 fi studju CD III, kif ukoll fil-gruppi tal-kura b'adalimumab meta mqabbla mal-grupp tal-plaċebo. | In CD Study I and CD Study II, statistically significant improvement in the disease-specific inflammatory bowel disease questionnaire (IBDQ) total score was achieved at Week 4 in patients randomised to Humira 80/ 40 mg and 160/ 80 mg compared to placebo and was seen at Weeks 26 and 56 in CD Study III as well among the adalimumab treatment groups compared to the placebo group. |
Artikolu 2 | Article 2 |
Aħsel idejk wara l-użu. | Wash hands after use. |
IL-KUNSILL TAL-UNJONI EWROPEA, | THE COUNCIL OF THE EUROPEAN UNION, |
Idealment, dan il-kampjun għandu mbagħad jinġabar tul il-perjodu kollu ta' espożizzzjoni. | Ideally, this sample should then be collected over the entire exposure period. |
Membru tal-Kamra Inferjuri tal-Parlament, Viċi Kap tal-Kumitat Permanenti dwar il-Liġi, kien Prosekutur tar-Reġjun ta' Mohilev. | Member of the Lower Chamber of the Parliament, Deputy Head of the Permanent Comittee on Law, former Prosecutor of the region of Mohilev. |
Kodici Postali | Postal code |
L-ipergliċemija severa jew il-kitoaċidożi għandhom dejjem ikunu kkurati minn tabib, normalment fi sptar. | Severe hyperglycaemia or ketoacidosis must always be treated by a doctor, normally in a hospital. |
L-esperjenza klinika attwali tindika li t-terapija ta' manteniment b'interferon alfa- 2b ittawwal il-fażi ta' stabbilità; madankollu, l-effetti fuq is-sopravivenza ġenerali ma kinux murija b'mod konklużiv. | Current clinical experience indicates that maintenance therapy with interferon alfa-2b prolongs the plateau phase; however, effects on overall survival have not been conclusively demonstrated. |
Dak il-perijodu għandu jiġi estiż b'xahrejn fuq l-inizjattiva tal-Parlament Ewropew jew tal-Kunsill. | That period shall be extended by two months at the initiative of the European Parliament or of the Council. |
Kodiċi tal-pajjiż terz [1] | Third country code [1] |
Iz-zokkor baxx fid-demm jista'jiġri bħala riżultat t'attività eċċessiva ta' l-insulina relatata mat-teħid ta'l- ikel u l-ħela ta' enerġija. | Hypoglycaemia may occur as a result of an excess of insulin activity relative to food intake and energy expenditure. |
5. | 5. |
“proċedura kontra l-formazzjoni tas-silġ”, fil-każ tal-proċeduri ta' fuq l-art, tfisser proċedura li tipprovdi protezzjoni kontra l-formazzjoni tal-ġlata jew tas-silġ u kontra l-akkumulazzjoni tal-borra fuq l-uċuħ tal-inġenju tal-ajru li jkunu ġew ittrattati għal perjodu taż-żmien limitat (il-ħin taż-żamma); | in the case of ground procedures, means a procedure that provides protection against the formation of frost or ice and accumulation of snow on treated surfaces of the aircraft for a limited period of time (hold-over time); |
TAGĦRIF KLINIKU | CLINICAL PARTICULARS |
L-erja ta' apertura tal-kollettur, Asol | Collector aperture area Asol |
Inibizzjoni ta' CYP3A4 permezz ta''aprepitant tista' tirriżulta f'konċentrazzjonijiet ogħla ta' dawn is-sustanzi attivi fil-plażma, li jistgħu jikkawżaw reazzjonijiet li jheddu l-ħajja. | Inhibition of CYP3A4 by aprepitant could result in elevated plasma concentrations of these active substances, potentially causing serious or life-threatening reactions. |
3/ 3 | 3/ 3 |
Imbagħad aqleb il-flixkun ta' taħt fuq u iġbed il-volum mixtieq. | Then turn bottle up-side down, and withdraw the necessary volume. |
Eesti Novartis Pharma Services Inc. | 123 Eesti Österreich Novartis Pharma Services Inc. |
Id-Deċiżjoni 2011/72/PESK għandha għalhekk tiġi emendata kif meħtieġ, | Decision 2011/72/CFSP should therefore be amended accordingly, |
Żmien ta'Tiżmim: xejn | Withdrawal period: zero days. |
Magyarország Roche (Magyarország) Kft. | Magyarország Roche (Magyarország) Kft. |
Ketoconazole: l-għoti flimkien ta' 62. 5 mg ta' Tracleer darbtejn kuljum għal 6 ijiem flimkien ma' ketoconazole, impeditur qawwi ta' CYP3A4, żied il-konċentrazzjonijiet ta' bosentan fil-plażma b'madwar id-doppju. | Ketoconazole: co-administration of Tracleer 62.5 mg twice daily for 6 days and ketoconazole, a potent CYP3A4 inhibitor, increased the plasma concentrations of bosentan approximately 2-fold. |
Din il-bidla fil-prinċipji kontabilistiċi ma kellhiex impatt fuq l-ammont ta' kapital meħtieġ biex jikkumpensa għall-insuffiċjenza fil-fond tal-pensjonijiet, pjuttost hi tagħti spjegazzjoni għal uħud mill-bidliet li saru fil-kontijiet ta' AS Sporveisbussene bejn l-2003 u l-2004, imsemmija fl-ilment. | This change in accounting principles did not have an impact on the amount of capital needed to offset the underfunding of the pension fund, but rather explains some of the changes in the accounts of AS Sporveisbussene from 2003 to 2004 to which the complaint referred. |
Fil-każ li ssir referenza għal dan il-paragrafu, għandhom japplikaw l-Artikoli 5 u 7 tad-Deċiżjoni 1999/468/KE. | Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply. |
Riċevitur | Recipient |
0 | 0 |
Artikolu 4 | Article 4 |
- id-derivattivi ta' phenothiazine (użati għall-kura ta' disturbi psikjatriċi), | - phenothiazine derivatives (used to treat psychiatric disorders), |
Dawn jistgħu jkunu sintomi ta' allerġija ġeneralizzata għall-insulina, inkluża r-reazzjoni anafilattika, li tista' tkun fatali. | These could be symptoms of generalised allergy to insulin, including anaphylactic reaction, which may be life-threatening. |
Artikolu 3 | Article 3 |
(ml/ min) | (ml/ min) |
Emendi għar-Regolament ta' Implimentazzjoni (UE) Nru 540/2011 | Amendments to Implementing Regulation (EU) No 540/2011 |
10. | 10. |
Fatturi li għandhom jiġu kkonsidrati f'din l-istima għandhom jinkludu t-tip ta' tumur u l-istadju li jkun wasal fih; il-grad tal-anemija; kemm mistennija tgħix persuna; l-ambjent fejn il-pazjent qed jiġi trattat; u l-preferenza tal-pazjent (ara sezzjoni 5. 1). | Factors that should be considered in this assessment should include the type of tumour and its stage; the degree of anaemia; life- expectancy; the environment in which the patient is being treated; and patient preference (see section 5.1). |
Ma jistax jiġi eskluż li inducers oħra (e. ż. phenytoin, carbamazepine, phenobarbital, St John' s wort) jistgħu wkoll ikollhom effett fuq l-esponiment għal rosiglitazone. | It cannot be excluded that other inducers (e. g. phenytoin, carbamazepine, phenobarbital, St John' s wort) may also affect rosiglitazone exposure. |
Meta memantine jingħata flimkien ma' mediċini antispasmodiċi, dantolene jew baclofen, jista' jibdlilhom l-effetti tagħhom u jista' jkun hemm bżonn ta' bidla fid-doża. • L-użu ta' memantine u amantadine għandu jkun evitat, minħabba r-riskju ta' psikożi farmakotossika. | Concomitant administration of memantine with the antispasmodic agents, dantrolene or baclofen, can modify their effects and a dose adjustment may be necessary. • Concomitant use of memantine and amantadine should be avoided, owing to the risk of pharmacotoxic psychosis. |
M'għandekx tgħaddiha lil persuni oħra. | Do not pass it on to others. |
mhux miżjud bi ħlewwa | not sweetened |
Jigi żviluppat grupp ta' persuni li jħarrġu li jmexxu programmi nazzjonali ta' taħriġ u li jxerrdu opportunitajiet ta' taħriġ. | A pool of trainers developed to sustain national training programmes and disseminate training opportunities. |
TAGĦRIF FARMAĊEWTIKU | PHARMACEUTICAL PARTICULARS |
Il-proċedura ġenerali indikata fil-paragrafu 4.7.1 t'hawn fuq għandha tkun segwita għajr għal li s-saqajn għandhom jitqiegħdu kif speċifikat mill-fabbrikant tal-vettura. | The general procedure indicated in paragraph 4.7.1 above shall be followed except that the feet shall be placed as specified by the vehicle manufacturer. |
L-uġigħ muskoloskeletriku normalment ikun ikkontrollat b'analġesiċi standard. | Musculoskeletal pain is usually controlled with standard analgesics. |
4/ 17 8. | 8. |
minflok: | for: |
dwar il-ħruġ ta' liċenzji għall-importazzjoni ta' ross fil-qafas tal-kwoti tariffarji stabbiliti għas-subperjodu minn Ottubru 2011 mir-Regolament (KE) Nru 327/98 | on the issue of licences for importing rice under the tariff quotas opened for the October 2011 subperiod by Regulation (EC) No 327/98 |
Dejjem għandek tuża Fertavid skont il-parir eżatt tat-tabib. | 120 Always use Fertavid exactly as your doctor has told you. |
Iż-żoni tal-vitikultura fid-dipartimenti Bas-Rhin u Haut-Rhin | The wine-growing areas in the departments of Bas-Rhin and Haut-Rhin. |
Iż-żieda fil-livelli ta' angiotensin II fil-plażma li sseħħ meta valsartan jinblokka r-riċetturi AT1 tista' tistimula r-riċettur tas-sottotip AT2, li milli jidher għandu l-effett oppost għal dak tar-riċettur AT1. | The increased plasma levels of angiotensin II following AT1 receptor blockade with valsartan may stimulate the unblocked receptor subtype AT2, which appears to counterbalance the effect of the AT1 receptor. |
Din tinkludi wkoll pjan ta' monitoraġġ għall-effetti ambjentali konformi mal-Anness VII tad-Direttiva 2001/18/KE. | It also includes a monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC. |
Pożoloġija u metodu ta' kif għandu jingħata 4. 2 | 4.2 Posology and method of administration |
Inkluż l-korrezzjonijiet ta' kontabbilità. | Including accounting corrections. |
Wara li kkunsidrat ir-Regolament tal-Kunsill (KE) Nru 1234/2007 tat-22 ta' Ottubru 2007 li jistabbilixxi organizzazzjoni komuni ta' swieq agrikoli u dwar dispożizzjonijiet speċifiċi għal ċerti prodotti agrikoli (Ir-Regolament Waħdieni dwar l-OKS) [1], | Having regard to Council Regulation (EC) No 1234/2007 of 22 October 2007 establishing a common organisation of agricultural markets and on specific provisions for certain agricultural products (Single CMO Regulation) [1], |
J07BC01 | J07BC01 |
L-inċidenza ta' eritema multiforme jew is-sindromu ta' Stevens- Johnson kien ta' bejn wieħed u ieħor 1%. | The incidence of erythema multiforme or Stevens-Johnson syndrome was approximately 0.1%. |
Rappurtar | Reporting |
Ibla' l-pilloli b'ammont suffiċjenti ta' fluwidu (eż. tazza ilma). | Swallow the tablets with a sufficient amount of fluid (e. g. one glass of water). |
dwar l-approvazzjoni mill-Kummissjoni tal-pjanijiet nazzjonali għall-implimentazzjoni tas-sistemi ta' validazzjoni skont l-Artikolu 109(8) tar-Regolament tal-Kunsill (KE) Nru 1224/2009 | on the approval by the Commission of national plans for the implementation of the validation systems in accordance with Article 109(8) of Council Regulation (EC) No 1224/2009 |
Titolu: Sur Raġuni għall-inklużjoni fil-lista: It-Tielet Segretarju, l-Ambaxxata Talibana, Abu Dhabi. | Title: Mr Grounds for listing: Third Secretary, Taliban Embassy, Abu Dhabi. |
Denominazzjoni protetta ta' oriġini u indikazzjoni ġeografika protetta, kif ukoll l-inbid li juża dak l-isem protett f'konformità mal-ispeċifikazzjonijiet ta' prodotti għandhom ikunu protetti kontra: | A protected designation of origin and a protected geographical indication, as well as the wine using that protected name in conformity with the product specifications, shall be protected against: |
Artikoli 115 to 117 | Articles 115 to 117 |
Minn fejn nikseb aktar informazzjoni? | Where do I get more information? |
inklużi f'sistema uffiċjali għall-kontroll tal-lewkożi enżootika bovina, u | included in an official system for the control of enzootic bovine leukosis, and |
Ma kienx hemm evidenza li kien hemm tolleranza farmakoloġika (nuqqas ta' effikaċja) li żviluppat waqt il-kura u l-anqas ta' fenomeni li reġgħu dehru b'aktar qawwa meta l-kura ġiet imwaqqfa f'daqqa waħda. | There was no evidence of pharmacological tolerance (loss of efficacy) developing during treatment nor of rebound phenomena after abrupt treatment discontinuation. |
IL-KUMMISSJONI EWROPEA, | THE EUROPEAN COMMISSION, |
Regolament tal-Kummissjoni (UE) Nru 322/2012 | Commission Regulation (EU) No 322/2012 |
Kull Membru għandu: | Each Member shall: |
L-istruzzjonijiet dettaljati li jakkompanjaw is-sistema ta' l-għoti għandhom ikunu segwiti. | Detailed instruction accompanying the delivery system must be followed. |
jekk tkun hi l-awtorità kompetenti, tieħu tali deċiżjoni hi stess. | if it is the competent authority, take such a decision itself. |
Testijiet tat-trigliċeridi u tal-kolesterol għandhom isiru qabel ma tinbeda t-terapija b'Kaletra u f'intervalli perjodiċi waqt it-trattament. | Triglyceride and cholesterol testing is to be performed prior to initiating Kaletra therapy and at periodic intervals during therapy. |
Lapproprjazzjonijiet annwali għandhom jiġu awtorizzati millawtorità talbaġit fillimiti talqafas finanzjarju. | The annual appropriations shall be authorised by the budgetary authority within the limits of the financial framework. |
Dan ir-Regolament għandu jorbot fl-intier tiegħu u japplika direttament fl-Istati Membri kollha. | This Regulation shall be binding in its entirety and directly applicable in all Member States. |