MLRS/OPUS-MT-EN-Fixed · Datasets at Hugging Face

mt stringlengths 1 3.29k	en stringlengths 1 3.45k
għal-laħam, li jaqa' taħt il-kodiċijiet tan-Nomenklatura Magħquda (“NM”) elenkati fl-Anness XI.	for meat falling within the Combined Nomenclature ('CN') codes listed in Annex XI.
Artikolu 15	Article 15
Lingwata komuni (Solea solea)	Common sole (Solea solea)
Ġew irrappurtati każijiet ta' dożi eċċessivi b'dożi ta' duloxetine ta' 4800 mg, meta mgħoti waħdu jew flimkien ma' prodotti mediċinali oħra.	Cases of overdoses, alone or in combination with other medicinal products, with duloxetine doses of 4800mg were reported.
b)	(b)
6. 2 Inkompatibilitajiet	The shelf-life of the powder for oral suspension is 2 years.
Injezzjoni fil-vini Id-doża għandha tingħata fuq medda ta' mill-anqas 5 minuti, skond id-doża sħiħa.	In travenous injection The dose should be administered over at least 1-5 minutes, depending on the total dose.
Jista jkollok bżonn terġa' taqrah.	You may need to read it again.
Użu orali Aqra l-fuljett ta' tagħrif qabel l-użu.	Read the package leaflet before use.
TAGĦRIF FARMAĊEWTIKU	PHARMACEUTICAL PARTICULARS
Sabiex tnaqqas ir-riskju ta' effetti sekondarji din id-doża tinkiseb bil-mod bl-iskema ta' kura ta' kuljum kif ġej:	In order to reduce the risk of side effects this dose is achieved gradually by the following daily treatment scheme:
Il-bidliet netti għandhom jintwerew meta mqabbla mas-sitwazzjoni qabel ma tkun saret il-korrezzjoni.	The net changes must be shown as compared with the situation before the correction.
DOKUMENTAZZJONI TAL-APPROVAZZJONI TAT-TIP	TYPE-APPROVAL DOCUMENTATION
Prodott mediċinali jingħata bir-riċetta tat-tabib.	Medicinal product subject to medical prescription.
Attivita` antivirali: il-konċentrazzjoni ħielsa ta' efavirenz li kien hemm bżonn għall-inibizzjoni ta' bejn id-90 u l-95% ta' iżolati wild type jew iżolati tal-laboratorju reżistenti għal zidovudine u iżolati kliniċi in vitro kienet minn 0. 46 sa 6. 8 nM f'razez ta' ċelluli limfoblastojdi, ċelluli periferali mononukleari tad-demm (PBMCs) u kolturi makrofaġi monoċistiċi.	Antiviral activity: the free concentration of efavirenz required for 90 to 95% inhibition of wild type or zidovudine-resistant laboratory and clinical isolates in vitro ranged from 0.46 to 6.8 nM in lymphoblastoid cell lines, peripheral blood mononuclear cells (PBMCs) and macrophage/ monocyte cultures.
L-assoċjazzjoni tal-esportaturi Ċiniżi talbet lill-Kummissjoni “biex tibda mill-ġdid il-proċess kollu tal-għażla u biex tikkuntattja lill-produtturi kollha tal-UE mingħajr ma tirriferi għall-fatt li l-produtturi għandhom ikunu lesti li jkunu parti mill-kampjun” [9].	The association of Chinese exporters requested the Commission'to start the whole selection process anew and contact all EU producers without referring to the fact that the producers must be willing to form part of the sample' [9].
Konklużjoni dwar l-interess tal-Unjoni	Conclusion on Union interest
3.	3.
Din għandha ssir effettiva fil-jum wara l-pubblikazzjoni tad-deċiżjoni f'Il-Ġurnal Uffiċjali tal-Unjoni Ewropea jew f'data aktar tard speċifikata fih.	It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein.
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.
Modulu ta' kamera b'riżoluzzjoni ta' 1280 * 720 P HD, b'żewġ mikrofoni, għall-użu fil-manifattura ta' prodotti taħt l-intestatura 8528 [1]	Camera module with a resolution of 1280 * 720 P HD, with two microphones, for use in the manufacture of products of heading 8528 [1]
TIKKETTA	LABELLING
Tista' tagħmlilhom il-ħsara, anki jekk ikollom l-istess sintomi bħal tiegħek. • 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	- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
Hekk kif il-kwantità globali tilħaq it-80 % tat-tunnellaġġ ta' referenza, tiġi organizzata laqgħa tal-Kumitat Konġunt sabiex jiġu stabbiliti l-modalitajiet tal-pagament kumplimentari dovut lill-Gabon jekk jinqabeż it-tunnellaġġ.	As soon as the overall catch quantity reaches 80 % of the reference tonnage, a meeting of the Joint Committee shall be held in order to establish how Gabon shall receive the additional payment due on account of this possible excess.
Indeboliment renali:	Renal impairment:
Kategorija ta' addittivi teknoloġiċi.	Category of technological additives.
Għalhekk, it-treddiegħ irid jitwaqqaf waqt il-kura u sa mill-inqas 72 siegħa wara li titneħħa il-Fentanyl- ratiopharm (ara sezzjoni 4. 4)	Lactation should therefore be discontinued during treatment and for at least 72 hours after the removal of Fentanyl-ratiopharm (see also section 4.4)
Fi prova separata, 224 pazjent b'ġenotip 2 jew 3 irċevew ViraferonPeg, 1. 5 mikrogrammi/ kg minn taħt il-ġilda, darba fil-ġimgħa, f'kombinazzjoni ma' ribavirin 800 mg- 1, 400 mg p. o. għal 6 xhur (ibbażat fuq il-piż tal-ġisem, tlett pazjenti biss kienu jiżnu > 105 kg, irċevew doża ta' 1, 400 mg) (Tabella 7).	In a separate trial, 224 patients with genotype 2 or 3 received ViraferonPeg, 1.5 microgram/kg subcutaneously, once weekly, in combination with ribavirin 800 mg –1,400 mg p.o. for 6 months (based on body weight, only three patients weighing > 105 kg, received the 1,400 mg dose) (Table 7).
L-Artikolu 46(2) u (3)	Article 46(2) and (3)
Pegasys 180 mcg ribavirin 800 mg, 48 ġ:	Pegasys 180 mcg ribavirin 800 mg, 48 w:
Id-data ta' skadenza tirreferi għall-aħħar ġurnata ta' dak ix-xahar.	The expiry date refers to the last day of that month.
25 % tal-għadd tal-annimali ovini jew kaprini tal-Istat Membru konċernat;	25 % of the ovine and caprine population of the Member State concerned;
It-kura b'Puregon għandha tinbeda taħt is-superviżjoni ta' tabib li għandu esperjenza fil-kura ta' problemi tal-fertilità.	Treatment with Puregon should be initiated under the supervision of a physician experienced in the treatment of fertility problems.
Imballaġġ	Packaging
Il-frekwenza ta' tqallih sever u rimettar kienet 4%.	The incidence of severe nausea and vomiting was 4%.
Il-Kummissjoni għandha temenda d-deċiżjoni li tadotta l-programm, permezz ta' atti ta' implimentazzjoni, sa mhux aktar tard mit-30 ta' Settembru.	The Commission shall amend the decision adopting the programme, by means of implementing acts, not later than 30 September.
Forom ta' kpiepel, tat-tibna jew magħmulin bl-immuntar ta' strixxi ta' xi materjal, la jekk magħfusin għall-forma, lanqas jekk bil-faldi maħdumin, la inforrati, lanqas mirqumin	Hat-shapes, plaited or made by assembling strips of any material, neither blocked to shape, nor with made brims, nor lined, nor trimmed
Referenzi Ġenerali u Links Utli Oħra:	References
Intwera illi interferon alfa- 2b jikkawża l-abort fix-xadini u x'aktarx illi ViraferonPeg ukoll għandu dan l-effett.	ViraferonPeg is likely to also cause this effect.
Itenni li l-Parlament stieden lill-Kummissjoni tivvaluta b'mod oġġettiv u kritiku l-esperjenzi bl-SIF fil-Politika ta' Koeżjoni għall-perjodu ta' programmazzjoni tal-2007-2013, tipprovdi valutazzjoni tar-riskji li tikkunsidra l-Istrumenti ta' Inġinerija Finanzjarja differenti b'mod separat, kif ukoll tqis l-istruttura tar-riskji tal-benefiċjarji tal-SIF, u tirrapporta annwalment lill-Parlament, fiż-żmien dovut qabel il-proċedura ta' kwittanza rispettiva, dwar l-użu tal-SIF fl-Istati Membri, inklużi indikaturi paragunabbli dwar l-effettività, l-effiċjenza u l-ekonomija tal-SIF, u anke dwar kif il-Kummissjoni tikkoordina, tiżgura l-konsistenza u ttaffi r-riskju li jkun hemm elementi doppji bejn l-oqsma ta' politika;	Reiterates that Parliament invited the Commission to evaluate objectively and critically the experiences with FEIs in the Cohesion policy for the programming period 2007-2013, to provide a risk assessment considering different FEIs separately, as well as taking into account the risk structure of beneficiaries of the FEIs, and to report annually to Parliament, in time for the respective discharge procedure, on the use of FEIs in Member States, including comparable indicators on the effectiveness, efficiency and economy of FEIs, and also on how the Commission coordinates, ensures consistency and mitigates the risk of overlapping across the policy areas;
ĠU L 325, 11.12.2007, p. 3.	OJ L 325, 11.12.2007, p. 3.
4. 9 Doża eċċessiva	40 4.9 Overdose
Żjieda fl-għaraq, uġigħ fis-sider, uġigħ fuq in-naħa tal-lemin madwar il-kustilji tiegħek, tnemnim, uġigħ jew sensazzjoni ta' tingiż, bidla fl-attività tal-glandola tat-tirojde (li tista' ġġiegħlek tħossok għajjien jew, anqas komuni, enerġetiku), stonku li mhux f'postu, taħbit mgħaġġel tal-qalb, aġitazzjoni, nervużiżmu, perijodu ta' mestrwali diffiċli jew irregolari.	Increased sweating, chest pain, pain on the right side around your ribs, numbness, pain or tingling feeling, change in thyroid gland activity (which may make you feel tired or, less commonly, energetic), stomach upset, rapid heart rate, agitation, nervousness, difficult or irregular menstrual period.
Tużax KOGENATE Bayer 1000 IU jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal octocog alfa, proteini tal-ġurdien jew għal proteini tal-ħemster jew għal xi wieħed mis-sustanzi l-oħra ta'KOGENATE Bayer 1000 IU.	Do not use KOGENATE Bayer 1000 IU if you are allergic (hypersensitive) to octocog alfa, to mouse or hamster protein or to any of the other ingredients of KOGENATE Bayer 1000 IU.
Lithium: żjidiet riversibbli tal-konċentrazzjonijiet u tossiċità ta' lithium fis-serum ġew irrapportati waqt l-amministrazzjoni konkomitanti ta' lithium ma' inibituri ta' enzimi li jikkonvertu angiotensin.	Lithium: reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin converting enzyme inhibitors.
Trachypithecus geei (I) Gee's golden langur	Delacour's langur
26/02/2010	26/02/2010
Li tiġi stabbilita kapaċità effettiva, indiġena, għall-ġestjoni tal-post tar-reat radjoloġiku u li tiġi identifikata opzjoni tal-forensika nukleari li tkun effiċjenti u kosteffettiva (fejn fattibbli, is-sejbiet għandhom ikunu disponibbli għal pajjiżi oħrajn tar-reġjun rispettiv).	Establishing an effective, indigenous radiological crime scene management capacity and identification of an efficient, cost-effective nuclear forensics option (where feasible, findings to be also made available to other countries of the respective region).
Għall-finijiet tal-Ftehim, it-test tar-Regolament għandu jinqara b'dawn l-adattamenti:	The text of the Regulation shall, for the purposes of this Agreement, be read with the following adaptations:
L-iskop tal-PKS jinkludi l-konservazzjoni tar-riżorsi bijoloġiċi tal-baħar u l-ġestjoni tas-sajd iffukata fuqhom.	The scope of the CFP includes the conservation of marine biological resources and the management of fisheries targeting them.
Użu għal taħt il-gilda.	Subcutaneous use.
Artikolu 45	Article 45
Fekruna mxewka	Spiny turtle
Wara li kkunsidra t-Trattat dwar l-Unjoni Ewropea, u b'mod partikolari l-Artikolu 29 tiegħu,	Having regard to the Treaty on European Union, and in particular Article 29 thereof,
Żomm fejn ma jintlaħaqx u ma jidhirx mit-tfal.	Keep out of the reach and sight of children.
Ir-riżultati tat-test deskritti fil-paragrafu 2.2.1.4 m'għandhomx jeċċedu L, fejn L huwa l-valur ta' limitu preskritt għal kull test tal-approvazzjoni.	The test results described in paragraph 2.2.1.4 shall not exceed L, where L is the limit value prescribed for each approval test.
L-Istati Membri jistgħu jiddeċiedu li ma japplikawx l-Artikolu 10(1), (2) u (3) fejn, fuq deċiżjoni tal-korp amministrattiv jew tat-tmexxija, attiv, ħlief titoli trasferibbli u strumenti tas-suq tal-flus imsemmija fil-paragrafu 1 ta' dan l-Artikolu, huma kontribwiti bħala konsiderazzjoni għajr fi flus li l-valur ġust tagħhom hu derivat minn attiv individwali minn kontijiet statutorji tas-sena finanzjarja ta' qabel sakemm il-kontijiet statutorji kienu soġġetti għal verifika b'mod konformi mad-Direttiva 2006/43/KE tal-Parlament Ewropew u tal-Kunsill tas-17 ta' Mejju 2006 dwar il-verifiki statutorji tal-kontijiet annwali u tal-kontijiet konsolidati [12].It-tieni u ħames subparagrafu tal-paragrafu 2 ta' dan l-Artikolu għandhom japplikaw mutatis mutandis.	Member States may decide not to apply Article 10(1), (2) and (3) where, upon a decision of the administrative or management body, assets other than the transferable securities and money-market instruments referred to in paragraph 1 of this Article are contributed as consideration other than in cash whose fair value is derived by individual asset from the statutory accounts of the previous financial year provided that the statutory accounts have been subject to an audit in accordance with Directive 2006/43/EC of the European Parliament and of the Council of 17 May 2006 on statutory audits of annual accounts and consolidated accounts [12].The second to fifth subparagraphs of paragraph 2 of this Article shall apply mutatis mutandis.
Vilco Ae Pefkon 121 Neo Irakleio 14122 Il-Greċja	Vilco Ae Pefkon 121 Neo Irakleio 14122 Greece
L-amministrazzjoni orali ta' ritonavir (wieħed mill-inibituri l-iktar qawwi ta' CYP3A4) tbaxxi b'żewġ terzi r-rata tat-tneħħija ta' fentanyl mogħti minn ġol-vina, u tirdoppja l-half- life.	Oral administration of ritonavir (one of the most potent CYP3A4 inhibitors) reduced the clearance of intravenous fentanyl by two thirds and doubled the half- life.
Ma ġietx studjata l-interazzjoni	Interaction not studied
Dan il-Pjan ta' Azzjoni kien ikkomplementat bl-Istrateġija tal-UE kontra l-proliferazzjoni tal-Armi tal-Qerda Massiva adottata mill-Kunsill Ewropew fit-12 ta' Diċembru 2003 (l-Istrateġija tal-UE dwar l-AQM).	This Action Plan was complemented by the EU Strategy against proliferation of Weapons of Mass Destruction adopted by the European Council on 12 December 2003 (EU WMD Strategy).
Regolament ta' Implimentazzjoni tal-Kummissjoni (UE) Nru 807/2011	Commission Implementing Regulation (EU) No 807/2011
Il-verżjoni finali ta' dawn il-minuti għandha tiġi ffirmata mill-president u mis-segretarju ġenerali tal-Kumitat.	The final version of such minutes shall be signed by the president and the secretary-general of the Committee.
L-EPAR sħiħ għal Pradaxa jista' jinstab hawnhekk.	The full EPAR for Pradaxa can be found here.
7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.	7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Din id-doża fissa kombinata hija indikata f'pazjenti adulti li għandhom pressjoni għolja li mhiex kontrollata sew b' irbesartan jew b' hydrochlorothiazide waħidhom (ara sezzjoni 5. 1).	This fixed dose combination is indicated in adult patients whose blood pressure is not adequately controlled on irbesartan or hydrochlorothiazide alone (see section 5.1).
Il-qawwa tindika l-kwantità tal-parti minn proteina fil-molekula ta' methoxy polyethylene glycol-epoetin beta mingħajr konsiderazzjoni tal-glikolsilazzjoni.	The strength indicates the quantity of the protein moiety of the methoxy polyethylene glycol-epoetin beta molecule without consideration of the glycosylation.
Pazjenti M'GĦANDHOMX jiu trattati b'porfimer jekk: o ikollhom mard tal-fwied sever o għandhom fistli fit-trakea jew bronki- esofaġeali o ikollhom tmermir suspettat tal-vażi tad-demm ewlenin.	− Caution should be exercised if patients have moderate hepatic disease
Wara li kkunsidra l-Ftehim dwar iż-Żona Ekomika Ewropea [1], kif emendat mill-Protokoll li jaġġusta l-Ftehim dwar iż-Żona Ekonomika Ewropea (il-Ftehim taż-ŻEE), u b'mod partikolari l-Artikolu 98 tiegħu,	Having regard to the Agreement on the European Economic Area [1], as amended by the Protocol adjusting the Agreement on the European Economic Area ('the EEA Agreement'), and in particular Article 98 thereof,
Eżawriment tal-kwota	Quota exhaustion
Billi:	Whereas:
AUC: ↔ Cmax: ↓ 24% (↓ 18 għal ↓ 30) Dawn il-bidliet mhumiex meqjusa bħala klinikament sinifikanti.	(10 mg single dose/ 600 mg once AUC: ↔ daily) Cmax: ↓ 24% (↓ 18 to ↓ 30) These changes are not considered clinically significant.
Iż-żoni ta' vitikultura	Wine growing zones
4. 3 ± 1. 5	3.541
tat-23 ta' Settembru 2010	of 23 September 2010
attiva minn moderata sa severa li kellhom ≥ 18 - il sena.	Patients were permitted to be either disease-modifying, na
Larinġ	Oranges
ADOTTAT DAN IR-REGOLAMENT:	HAS ADOPTED THIS REGULATION:
Evita li tintroduċi xi kontaminazzjoni waqt l-użu.	Avoid introduction of contamination during use.
Drappijiet innitjati jew minsuġa, miksija jew mgħottija fuq naħa waħda b'materjal tal-plastik artifiċjali li fihom ikun hemm inkorporati mikrosferi	Knitted or woven fabrics, coated or covered on one side with artificial plastic material in which are embedded microspheres
Artikolu 12	Article 12
Wara li kkunsidra l-Istatut tas-Sistema Ewropea tal-Banek Ċentrali u tal-Bank Ċentrali Ewropew, b'mod partikolari l-ewwel inċiż tal-Artiklu 3.1, l-Artikolu 12.1, l-Artikolu 14.3 u l-Artikolu 18.2 tiegħu,	Having regard to the Statute of the European System of Central Banks and of the European Central Bank, and in particular the first indent of Article 3.1, Article 12.1, Article 14.3 and Article 18.2 thereof,
NCR SelfServTM 34, NCR SelfServTM 38, NCR SelfServTM 32,	NCR SelfServTM 34, NCR SelfServTM 38, NCR SelfServTM 32,
Opzjonijiet:	Options:
Edima	Oedema
Risperdal	Risperdal
Diskussjoni tal-vantaġġi speċifiċi: użu topiku fl-għajn affettwata, attività antifungali aktar estensiva u/jew anqas irritazzjoni minn aġenti antifungali oħra.	Discussion of the specific advantages: topical use on the affected eye, wider antifungal activity and/or lesser irritation than other antifungal agents.
Billi:	Whereas:
F'iżjed minn żewġ terzi tal-pazjenti, it-tnaqqis fis-serum ta' DNA tal-HBV kien assoċjat man-normalizzazzjoni tal-livelli ta' l-ALT.	In over two thirds of patients suppression of serum HBV DNA was associated with normalisation of ALT levels.
MTIC jkun idrolizzat b'mod spontanju għal 5- amino- imidazole- 4- carboxamide (AIC), intermedju mgħaruf fil-bijosintesi tal-purini u aċidi	MTIC is spontaneously hydrolyzed to 5-amino-imidazole-4- carboxamide (AIC), a known intermediate in purine and nucleic acid biosynthesis, and to methylhydrazine, which is believed to be the active alkylating species.
dejta tat-tranżazzjoni miksuba skont l-Artikolu 25(3) tad-Direttiva 2004/39/KE tal-Parlament Ewropew u tal-Kunsill [3];	transaction data obtained under Article 25(3) of Directive 2004/39/EC of the European Parliament and of the Council [3];
5. 1 Tagħrif farmakodinamiku	5.1 Pharmacodynamic properties
inqas minn 350 mg/kg	less than 350 mg/kg
Jitlob rapport ta' test ulterjuri mis-servizz tekniku responsabbli għat-twettiq tat-testijiet.	Require a further test report from the technical service responsible for conducting the tests.
4.	4.
Valur fiss tal-importazzjoni	Standard import value
Iddritt ta' aċċess għad-dokumenti	Right of access to documents
ribavirin	+ ribavirin
It-termini ta'frekwenza elenkati huma mfissra kif ġej:	The frequency terms listed are defined as follows:
Barra minn hekk, mill-impożizzjoni tad-dażji anti-dumping fl-2006, l-importazzjonijiet Ċiniżi naqsu konsiderevolment minn sehem mis-suq ta' 51 % fil-PI tal-investigazzjoni oriġinali għal bejn 7 % u 15 % tul il-PIR.	Moreover, since the imposition of anti-dumping duties in 2006, the Chinese imports considerably decreased from 51 % market share in the IP of the original investigation to between 7 % and 15 % during the RIP.

għal-laħam, li jaqa' taħt il-kodiċijiet tan-Nomenklatura Magħquda (“NM”) elenkati fl-Anness XI.

for meat falling within the Combined Nomenclature ('CN') codes listed in Annex XI.

Artikolu 15

Article 15

Lingwata komuni (Solea solea)

Common sole (Solea solea)

Ġew irrappurtati każijiet ta' dożi eċċessivi b'dożi ta' duloxetine ta' 4800 mg, meta mgħoti waħdu jew flimkien ma' prodotti mediċinali oħra.

Cases of overdoses, alone or in combination with other medicinal products, with duloxetine doses of 4800mg were reported.

b)

(b)

6. 2 Inkompatibilitajiet

The shelf-life of the powder for oral suspension is 2 years.

Injezzjoni fil-vini Id-doża għandha tingħata fuq medda ta' mill-anqas 5 minuti, skond id-doża sħiħa.

In travenous injection The dose should be administered over at least 1-5 minutes, depending on the total dose.

Jista jkollok bżonn terġa' taqrah.

You may need to read it again.

Użu orali Aqra l-fuljett ta' tagħrif qabel l-użu.

Read the package leaflet before use.

TAGĦRIF FARMAĊEWTIKU

PHARMACEUTICAL PARTICULARS

Sabiex tnaqqas ir-riskju ta' effetti sekondarji din id-doża tinkiseb bil-mod bl-iskema ta' kura ta' kuljum kif ġej:

In order to reduce the risk of side effects this dose is achieved gradually by the following daily treatment scheme:

Il-bidliet netti għandhom jintwerew meta mqabbla mas-sitwazzjoni qabel ma tkun saret il-korrezzjoni.

The net changes must be shown as compared with the situation before the correction.

DOKUMENTAZZJONI TAL-APPROVAZZJONI TAT-TIP

TYPE-APPROVAL DOCUMENTATION

Prodott mediċinali jingħata bir-riċetta tat-tabib.

Medicinal product subject to medical prescription.

Attivita` antivirali: il-konċentrazzjoni ħielsa ta' efavirenz li kien hemm bżonn għall-inibizzjoni ta' bejn id-90 u l-95% ta' iżolati wild type jew iżolati tal-laboratorju reżistenti għal zidovudine u iżolati kliniċi in vitro kienet minn 0. 46 sa 6. 8 nM f'razez ta' ċelluli limfoblastojdi, ċelluli periferali mononukleari tad-demm (PBMCs) u kolturi makrofaġi monoċistiċi.

Antiviral activity: the free concentration of efavirenz required for 90 to 95% inhibition of wild type or zidovudine-resistant laboratory and clinical isolates in vitro ranged from 0.46 to 6.8 nM in lymphoblastoid cell lines, peripheral blood mononuclear cells (PBMCs) and macrophage/ monocyte cultures.

L-assoċjazzjoni tal-esportaturi Ċiniżi talbet lill-Kummissjoni “biex tibda mill-ġdid il-proċess kollu tal-għażla u biex tikkuntattja lill-produtturi kollha tal-UE mingħajr ma tirriferi għall-fatt li l-produtturi għandhom ikunu lesti li jkunu parti mill-kampjun” [9].

The association of Chinese exporters requested the Commission'to start the whole selection process anew and contact all EU producers without referring to the fact that the producers must be willing to form part of the sample' [9].

Konklużjoni dwar l-interess tal-Unjoni

Conclusion on Union interest

3.

Din għandha ssir effettiva fil-jum wara l-pubblikazzjoni tad-deċiżjoni f'Il-Ġurnal Uffiċjali tal-Unjoni Ewropea jew f'data aktar tard speċifikata fih.

It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein.

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.

Modulu ta' kamera b'riżoluzzjoni ta' 1280 * 720 P HD, b'żewġ mikrofoni, għall-użu fil-manifattura ta' prodotti taħt l-intestatura 8528 [1]

Camera module with a resolution of 1280 * 720 P HD, with two microphones, for use in the manufacture of products of heading 8528 [1]

TIKKETTA

LABELLING

Tista' tagħmlilhom il-ħsara, anki jekk ikollom l-istess sintomi bħal tiegħek. • 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

- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,

Hekk kif il-kwantità globali tilħaq it-80 % tat-tunnellaġġ ta' referenza, tiġi organizzata laqgħa tal-Kumitat Konġunt sabiex jiġu stabbiliti l-modalitajiet tal-pagament kumplimentari dovut lill-Gabon jekk jinqabeż it-tunnellaġġ.

As soon as the overall catch quantity reaches 80 % of the reference tonnage, a meeting of the Joint Committee shall be held in order to establish how Gabon shall receive the additional payment due on account of this possible excess.

Indeboliment renali:

Renal impairment:

Kategorija ta' addittivi teknoloġiċi.

Category of technological additives.

Għalhekk, it-treddiegħ irid jitwaqqaf waqt il-kura u sa mill-inqas 72 siegħa wara li titneħħa il-Fentanyl- ratiopharm (ara sezzjoni 4. 4)

Lactation should therefore be discontinued during treatment and for at least 72 hours after the removal of Fentanyl-ratiopharm (see also section 4.4)

Fi prova separata, 224 pazjent b'ġenotip 2 jew 3 irċevew ViraferonPeg, 1. 5 mikrogrammi/ kg minn taħt il-ġilda, darba fil-ġimgħa, f'kombinazzjoni ma' ribavirin 800 mg- 1, 400 mg p. o. għal 6 xhur (ibbażat fuq il-piż tal-ġisem, tlett pazjenti biss kienu jiżnu > 105 kg, irċevew doża ta' 1, 400 mg) (Tabella 7).

In a separate trial, 224 patients with genotype 2 or 3 received ViraferonPeg, 1.5 microgram/kg subcutaneously, once weekly, in combination with ribavirin 800 mg –1,400 mg p.o. for 6 months (based on body weight, only three patients weighing > 105 kg, received the 1,400 mg dose) (Table 7).

L-Artikolu 46(2) u (3)

Article 46(2) and (3)

Pegasys 180 mcg ribavirin 800 mg, 48 ġ:

Pegasys 180 mcg ribavirin 800 mg, 48 w:

Id-data ta' skadenza tirreferi għall-aħħar ġurnata ta' dak ix-xahar.

The expiry date refers to the last day of that month.

25 % tal-għadd tal-annimali ovini jew kaprini tal-Istat Membru konċernat;

25 % of the ovine and caprine population of the Member State concerned;

It-kura b'Puregon għandha tinbeda taħt is-superviżjoni ta' tabib li għandu esperjenza fil-kura ta' problemi tal-fertilità.

Treatment with Puregon should be initiated under the supervision of a physician experienced in the treatment of fertility problems.

Imballaġġ

Packaging

Il-frekwenza ta' tqallih sever u rimettar kienet 4%.

The incidence of severe nausea and vomiting was 4%.

Il-Kummissjoni għandha temenda d-deċiżjoni li tadotta l-programm, permezz ta' atti ta' implimentazzjoni, sa mhux aktar tard mit-30 ta' Settembru.

The Commission shall amend the decision adopting the programme, by means of implementing acts, not later than 30 September.

Forom ta' kpiepel, tat-tibna jew magħmulin bl-immuntar ta' strixxi ta' xi materjal, la jekk magħfusin għall-forma, lanqas jekk bil-faldi maħdumin, la inforrati, lanqas mirqumin

Hat-shapes, plaited or made by assembling strips of any material, neither blocked to shape, nor with made brims, nor lined, nor trimmed

Referenzi Ġenerali u Links Utli Oħra:

References

Intwera illi interferon alfa- 2b jikkawża l-abort fix-xadini u x'aktarx illi ViraferonPeg ukoll għandu dan l-effett.

ViraferonPeg is likely to also cause this effect.

Itenni li l-Parlament stieden lill-Kummissjoni tivvaluta b'mod oġġettiv u kritiku l-esperjenzi bl-SIF fil-Politika ta' Koeżjoni għall-perjodu ta' programmazzjoni tal-2007-2013, tipprovdi valutazzjoni tar-riskji li tikkunsidra l-Istrumenti ta' Inġinerija Finanzjarja differenti b'mod separat, kif ukoll tqis l-istruttura tar-riskji tal-benefiċjarji tal-SIF, u tirrapporta annwalment lill-Parlament, fiż-żmien dovut qabel il-proċedura ta' kwittanza rispettiva, dwar l-użu tal-SIF fl-Istati Membri, inklużi indikaturi paragunabbli dwar l-effettività, l-effiċjenza u l-ekonomija tal-SIF, u anke dwar kif il-Kummissjoni tikkoordina, tiżgura l-konsistenza u ttaffi r-riskju li jkun hemm elementi doppji bejn l-oqsma ta' politika;

Reiterates that Parliament invited the Commission to evaluate objectively and critically the experiences with FEIs in the Cohesion policy for the programming period 2007-2013, to provide a risk assessment considering different FEIs separately, as well as taking into account the risk structure of beneficiaries of the FEIs, and to report annually to Parliament, in time for the respective discharge procedure, on the use of FEIs in Member States, including comparable indicators on the effectiveness, efficiency and economy of FEIs, and also on how the Commission coordinates, ensures consistency and mitigates the risk of overlapping across the policy areas;

ĠU L 325, 11.12.2007, p. 3.

OJ L 325, 11.12.2007, p. 3.

4. 9 Doża eċċessiva

40 4.9 Overdose

Żjieda fl-għaraq, uġigħ fis-sider, uġigħ fuq in-naħa tal-lemin madwar il-kustilji tiegħek, tnemnim, uġigħ jew sensazzjoni ta' tingiż, bidla fl-attività tal-glandola tat-tirojde (li tista' ġġiegħlek tħossok għajjien jew, anqas komuni, enerġetiku), stonku li mhux f'postu, taħbit mgħaġġel tal-qalb, aġitazzjoni, nervużiżmu, perijodu ta' mestrwali diffiċli jew irregolari.

Increased sweating, chest pain, pain on the right side around your ribs, numbness, pain or tingling feeling, change in thyroid gland activity (which may make you feel tired or, less commonly, energetic), stomach upset, rapid heart rate, agitation, nervousness, difficult or irregular menstrual period.

Tużax KOGENATE Bayer 1000 IU jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal octocog alfa, proteini tal-ġurdien jew għal proteini tal-ħemster jew għal xi wieħed mis-sustanzi l-oħra ta'KOGENATE Bayer 1000 IU.

Do not use KOGENATE Bayer 1000 IU if you are allergic (hypersensitive) to octocog alfa, to mouse or hamster protein or to any of the other ingredients of KOGENATE Bayer 1000 IU.

Lithium: żjidiet riversibbli tal-konċentrazzjonijiet u tossiċità ta' lithium fis-serum ġew irrapportati waqt l-amministrazzjoni konkomitanti ta' lithium ma' inibituri ta' enzimi li jikkonvertu angiotensin.

Lithium: reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin converting enzyme inhibitors.

Trachypithecus geei (I) Gee's golden langur

Delacour's langur

26/02/2010

Li tiġi stabbilita kapaċità effettiva, indiġena, għall-ġestjoni tal-post tar-reat radjoloġiku u li tiġi identifikata opzjoni tal-forensika nukleari li tkun effiċjenti u kosteffettiva (fejn fattibbli, is-sejbiet għandhom ikunu disponibbli għal pajjiżi oħrajn tar-reġjun rispettiv).

Establishing an effective, indigenous radiological crime scene management capacity and identification of an efficient, cost-effective nuclear forensics option (where feasible, findings to be also made available to other countries of the respective region).

Għall-finijiet tal-Ftehim, it-test tar-Regolament għandu jinqara b'dawn l-adattamenti:

The text of the Regulation shall, for the purposes of this Agreement, be read with the following adaptations:

L-iskop tal-PKS jinkludi l-konservazzjoni tar-riżorsi bijoloġiċi tal-baħar u l-ġestjoni tas-sajd iffukata fuqhom.

The scope of the CFP includes the conservation of marine biological resources and the management of fisheries targeting them.

Użu għal taħt il-gilda.

Subcutaneous use.

Artikolu 45

Article 45

Fekruna mxewka

Spiny turtle

Wara li kkunsidra t-Trattat dwar l-Unjoni Ewropea, u b'mod partikolari l-Artikolu 29 tiegħu,

Having regard to the Treaty on European Union, and in particular Article 29 thereof,

Żomm fejn ma jintlaħaqx u ma jidhirx mit-tfal.

Keep out of the reach and sight of children.

Ir-riżultati tat-test deskritti fil-paragrafu 2.2.1.4 m'għandhomx jeċċedu L, fejn L huwa l-valur ta' limitu preskritt għal kull test tal-approvazzjoni.

The test results described in paragraph 2.2.1.4 shall not exceed L, where L is the limit value prescribed for each approval test.

L-Istati Membri jistgħu jiddeċiedu li ma japplikawx l-Artikolu 10(1), (2) u (3) fejn, fuq deċiżjoni tal-korp amministrattiv jew tat-tmexxija, attiv, ħlief titoli trasferibbli u strumenti tas-suq tal-flus imsemmija fil-paragrafu 1 ta' dan l-Artikolu, huma kontribwiti bħala konsiderazzjoni għajr fi flus li l-valur ġust tagħhom hu derivat minn attiv individwali minn kontijiet statutorji tas-sena finanzjarja ta' qabel sakemm il-kontijiet statutorji kienu soġġetti għal verifika b'mod konformi mad-Direttiva 2006/43/KE tal-Parlament Ewropew u tal-Kunsill tas-17 ta' Mejju 2006 dwar il-verifiki statutorji tal-kontijiet annwali u tal-kontijiet konsolidati [12].It-tieni u ħames subparagrafu tal-paragrafu 2 ta' dan l-Artikolu għandhom japplikaw mutatis mutandis.

Member States may decide not to apply Article 10(1), (2) and (3) where, upon a decision of the administrative or management body, assets other than the transferable securities and money-market instruments referred to in paragraph 1 of this Article are contributed as consideration other than in cash whose fair value is derived by individual asset from the statutory accounts of the previous financial year provided that the statutory accounts have been subject to an audit in accordance with Directive 2006/43/EC of the European Parliament and of the Council of 17 May 2006 on statutory audits of annual accounts and consolidated accounts [12].The second to fifth subparagraphs of paragraph 2 of this Article shall apply mutatis mutandis.

Vilco Ae Pefkon 121 Neo Irakleio 14122 Il-Greċja

Vilco Ae Pefkon 121 Neo Irakleio 14122 Greece

L-amministrazzjoni orali ta' ritonavir (wieħed mill-inibituri l-iktar qawwi ta' CYP3A4) tbaxxi b'żewġ terzi r-rata tat-tneħħija ta' fentanyl mogħti minn ġol-vina, u tirdoppja l-half- life.

Oral administration of ritonavir (one of the most potent CYP3A4 inhibitors) reduced the clearance of intravenous fentanyl by two thirds and doubled the half- life.

Ma ġietx studjata l-interazzjoni

Interaction not studied

Dan il-Pjan ta' Azzjoni kien ikkomplementat bl-Istrateġija tal-UE kontra l-proliferazzjoni tal-Armi tal-Qerda Massiva adottata mill-Kunsill Ewropew fit-12 ta' Diċembru 2003 (l-Istrateġija tal-UE dwar l-AQM).

This Action Plan was complemented by the EU Strategy against proliferation of Weapons of Mass Destruction adopted by the European Council on 12 December 2003 (EU WMD Strategy).

Regolament ta' Implimentazzjoni tal-Kummissjoni (UE) Nru 807/2011

Commission Implementing Regulation (EU) No 807/2011

Il-verżjoni finali ta' dawn il-minuti għandha tiġi ffirmata mill-president u mis-segretarju ġenerali tal-Kumitat.

The final version of such minutes shall be signed by the president and the secretary-general of the Committee.

L-EPAR sħiħ għal Pradaxa jista' jinstab hawnhekk.

The full EPAR for Pradaxa can be found here.

7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.

Din id-doża fissa kombinata hija indikata f'pazjenti adulti li għandhom pressjoni għolja li mhiex kontrollata sew b' irbesartan jew b' hydrochlorothiazide waħidhom (ara sezzjoni 5. 1).

This fixed dose combination is indicated in adult patients whose blood pressure is not adequately controlled on irbesartan or hydrochlorothiazide alone (see section 5.1).

Il-qawwa tindika l-kwantità tal-parti minn proteina fil-molekula ta' methoxy polyethylene glycol-epoetin beta mingħajr konsiderazzjoni tal-glikolsilazzjoni.

The strength indicates the quantity of the protein moiety of the methoxy polyethylene glycol-epoetin beta molecule without consideration of the glycosylation.

Pazjenti M'GĦANDHOMX jiu trattati b'porfimer jekk: o ikollhom mard tal-fwied sever o għandhom fistli fit-trakea jew bronki- esofaġeali o ikollhom tmermir suspettat tal-vażi tad-demm ewlenin.

− Caution should be exercised if patients have moderate hepatic disease

Wara li kkunsidra l-Ftehim dwar iż-Żona Ekomika Ewropea [1], kif emendat mill-Protokoll li jaġġusta l-Ftehim dwar iż-Żona Ekonomika Ewropea (il-Ftehim taż-ŻEE), u b'mod partikolari l-Artikolu 98 tiegħu,

Having regard to the Agreement on the European Economic Area [1], as amended by the Protocol adjusting the Agreement on the European Economic Area ('the EEA Agreement'), and in particular Article 98 thereof,

Eżawriment tal-kwota

Quota exhaustion

Billi:

Whereas:

AUC: ↔ Cmax: ↓ 24% (↓ 18 għal ↓ 30) Dawn il-bidliet mhumiex meqjusa bħala klinikament sinifikanti.

(10 mg single dose/ 600 mg once AUC: ↔ daily) Cmax: ↓ 24% (↓ 18 to ↓ 30) These changes are not considered clinically significant.

Iż-żoni ta' vitikultura

Wine growing zones

4. 3 ± 1. 5

3.541

tat-23 ta' Settembru 2010

of 23 September 2010

attiva minn moderata sa severa li kellhom ≥ 18 - il sena.

Patients were permitted to be either disease-modifying, na

Larinġ

Oranges

ADOTTAT DAN IR-REGOLAMENT:

HAS ADOPTED THIS REGULATION:

Evita li tintroduċi xi kontaminazzjoni waqt l-użu.

Avoid introduction of contamination during use.

Drappijiet innitjati jew minsuġa, miksija jew mgħottija fuq naħa waħda b'materjal tal-plastik artifiċjali li fihom ikun hemm inkorporati mikrosferi

Knitted or woven fabrics, coated or covered on one side with artificial plastic material in which are embedded microspheres

Artikolu 12

Article 12

Wara li kkunsidra l-Istatut tas-Sistema Ewropea tal-Banek Ċentrali u tal-Bank Ċentrali Ewropew, b'mod partikolari l-ewwel inċiż tal-Artiklu 3.1, l-Artikolu 12.1, l-Artikolu 14.3 u l-Artikolu 18.2 tiegħu,

Having regard to the Statute of the European System of Central Banks and of the European Central Bank, and in particular the first indent of Article 3.1, Article 12.1, Article 14.3 and Article 18.2 thereof,

NCR SelfServTM 34, NCR SelfServTM 38, NCR SelfServTM 32,

Opzjonijiet:

Options:

Edima

Oedema

Risperdal

Diskussjoni tal-vantaġġi speċifiċi: użu topiku fl-għajn affettwata, attività antifungali aktar estensiva u/jew anqas irritazzjoni minn aġenti antifungali oħra.

Discussion of the specific advantages: topical use on the affected eye, wider antifungal activity and/or lesser irritation than other antifungal agents.

Billi:

Whereas:

F'iżjed minn żewġ terzi tal-pazjenti, it-tnaqqis fis-serum ta' DNA tal-HBV kien assoċjat man-normalizzazzjoni tal-livelli ta' l-ALT.

In over two thirds of patients suppression of serum HBV DNA was associated with normalisation of ALT levels.

MTIC jkun idrolizzat b'mod spontanju għal 5- amino- imidazole- 4- carboxamide (AIC), intermedju mgħaruf fil-bijosintesi tal-purini u aċidi

MTIC is spontaneously hydrolyzed to 5-amino-imidazole-4- carboxamide (AIC), a known intermediate in purine and nucleic acid biosynthesis, and to methylhydrazine, which is believed to be the active alkylating species.

dejta tat-tranżazzjoni miksuba skont l-Artikolu 25(3) tad-Direttiva 2004/39/KE tal-Parlament Ewropew u tal-Kunsill [3];

transaction data obtained under Article 25(3) of Directive 2004/39/EC of the European Parliament and of the Council [3];

5. 1 Tagħrif farmakodinamiku

5.1 Pharmacodynamic properties

inqas minn 350 mg/kg

less than 350 mg/kg

Jitlob rapport ta' test ulterjuri mis-servizz tekniku responsabbli għat-twettiq tat-testijiet.

Require a further test report from the technical service responsible for conducting the tests.

4.

Valur fiss tal-importazzjoni

Standard import value

Iddritt ta' aċċess għad-dokumenti

Right of access to documents

ribavirin

+ ribavirin

It-termini ta'frekwenza elenkati huma mfissra kif ġej:

The frequency terms listed are defined as follows:

Barra minn hekk, mill-impożizzjoni tad-dażji anti-dumping fl-2006, l-importazzjonijiet Ċiniżi naqsu konsiderevolment minn sehem mis-suq ta' 51 % fil-PI tal-investigazzjoni oriġinali għal bejn 7 % u 15 % tul il-PIR.

Moreover, since the imposition of anti-dumping duties in 2006, the Chinese imports considerably decreased from 51 % market share in the IP of the original investigation to between 7 % and 15 % during the RIP.