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ADOTTAT DAN IR-REGOLAMENT:
HAS ADOPTED THIS REGULATION:
Paragun tas-selfiet tal-Bank […] u tal-ARP lill-Crist
Comparison of […] Bank and IDA loans to Crist
Jista' jinħtieġ li jiżdied it-trattament ta' kontra il-pressjoni tad-demm.
It may be necessary to add or increase anti-hypertensive treatment.
Ir-Regolament tal-Kunsill (UE) Nru 57/2011 tat-18 ta' Jannar 2011 li jiffissa għall-2011 l-opportunitajiet tas-sajd għal ċerti stokkijiet tal-ħut u gruppi ta' stokkijiet tal-ħut, applikabbli fl-ilmijiet tal-UE u, għal bastimenti tal-UE, f'ċerti ilmijiet mhux tal-UE [2] jistabbilixxi kwoti għall-2011.
Council Regulation (EU) No 57/2011 of 18 January 2011 fixing for 2011 the fishing opportunities for certain fish stocks and groups of fish stocks, applicable in EU waters and, for EU vessels, in certain non-EU waters [2], lays down quotas for 2011.
144
154 144
L-effett anti- emetiku jdum għal ta' l-anqas 12- il siegħa, u b'hekk għall-konvenjenza, il-kura tista' tiġi amministrata il-lejl ta' qabel vjaġġ kmieni filgħodu.
The anti-emetic effect persists for at least 12 hours, which for convenience may allow administration the night before early morning travel.
1 - Fl-istudju ta' CML ta' fażi kronika, il-punt aħħari primarju kien l-MCyR f'pazjenti reżistenti għal imatinib.
1- In the study of chronic phase CML, the primary endpoint was MCyR in imatinib-resistant patients.
Dan it-test jintuża biex jiġi ddeterminat jekk bozza bil-filament hijiex konformi mar-rekwiżiti, billi jiġi ċċekkjat jekk:
This test is used to determine, by checking whether:
- tqalligħ, dijarea
- nausea, diarrhoea
li jistabbilixxi l-valuri fissi tal-importazzjoni għad-determinazzjoni tal-prezz ta' dħul ta' ċertu frott u ħaxix
establishing the standard import values for determining the entry price of certain fruit and vegetables
tinżamm il-konformità mal-kundizzjonijiet u r-restrizzjonijiet tal-punt 21.A.711(e) assoċjati mal-permess għat-titjir;
compliance with the conditions and restrictions of point 21.A.711(e) associated with the permit to fly;
L-Armenja
Armenia
Fejn ir-rekwiżiti stipulati fil-punti (2)(d) jew (2)(e) jintlaħqu, il-pjanti speċifikati għandhom, barra minn dan, jilħqu wieħed mir-rekwiżiti li ġejjin:
Where the requirements set out in point (2)(d) or (2)(e) are met, the specified plants shall, in addition, satisfy one of the following requirements:
Aħżen fil-pakkett oriġinali.
Store in the original package.
Lietuva UAB sanofi- aventis Lietuva Tel: +370 5 2755224
Lietuva UAB sanofi-aventis Lietuva Tel: +370 5 2755224
CPA 22.22.14: Damiġġjani, fliexken, fliexken bl-għonq dejjaq (flasks) u oġġetti simili, tal-plastik
CPA 22.22.14: Carboys, bottles, flasks and similar articles of plastics
Qabel l-użu: aħżen fi friġġ (2°C - 8°C).
Before use: store in a refrigerator (2°C - 8°C).
Skont il-“prinċipju tas-sjieda tad-dejta” li jinsab fl-Artikolu 34(2) tar-Regolament SIS II u 49(2) tad-Deċiżjoni tas-SIS II, it-trażmissjoni ta' informazzjoni supplimentari lil pajjiżi terzi tista' ssir biss mill-Istat Membru “sid” tad-dejta.
In accordance with the'data ownership principle' contained in Article 34(2) of the SIS II Regulation and Article 49(2) of the SIS II Decision, transmission of supplementary information to third countries can only be performed by the Member State'owner' of the data.
Tismin
Fattening
SANOFI PASTEUR MSD SNC 8, rue Jonas Salk F- 69007 Lyon Franza
SANOFI PASTEUR MSD SNC 8, rue Jonas Salk F-69007 Lyon France
5.5.2.5. jinxtegħlu u jintfew fl-istess ħin.
come on and go off simultaneously;
Deskrizzjoni ċara ta' dan l-immarkar speċjali għandha tiġi kkomunikata lill-Kummissjoni sal-1 ta' Jannar 2014.”.
A clear description of this special mark shall be communicated to the Commission by 1 January 2014.'.
fil-każ ta' prodott li jkun fih il-piridaben bħala l-unika sustanza attiva, fejn meħtieġ, jemendaw jew jirtiraw l-awtorizzazzjoni sa mhux iktar tard mit-30 ta' April 2015; jew
in the case of a product containing pyridaben as the only active substance, where necessary, amend or withdraw the authorisation by 30 April 2015 at the latest; or
Wara li kkunsidra t-Trattat dwar il-Funzjonament tal-Unjoni Ewropea,
Having regard to the Treaty on the Functioning of the European Union,
Il-Kumitat ta' Ġestjoni għall-Organizzazzjoni Komuni tas-Swieq Agrikoli ma tax opinjoni tiegħu fil-limitu tażżmien stabbilit mill-president tiegħu,
The Management Committee for the Common Organisation of Agricultural Markets has not delivered an opinion within the time limit set by its Chair,
IU meħtieġa = piż tal-ġisem (kg) x żjieda mixtieqa tal-fattur VIII (% tan-normal) x 0. 5
Required IU = body weight (kg) x desired factor VIII rise (% of normal) x 0.5
MUDELL TAD-DOKUMENT TA' INFORMAZZJONI
MODEL INFORMATION DOCUMENT
Il-fini tal-akkreditament ta' tali SKI għndu jkun maqbul bejn l-awtorità kontraenti u l-ASN/ASM rilevanti.
The scope of accreditation of such CIS shall be agreed between the contracting authority and the relevant NSA/DSA.
ambra, meerschaum, ambra agglomerata u meerschaum agglomerat, ġett u sostituti minerali għall-ġett.
amber, meerschaum, agglomerated amber and agglomerated meerschaum, jet and mineral substitutes for jet.
Infjammazzjoni tal-pulmun (bronkite); tħossok imdejjaq (dipressjoni); diffikultà biex torqod (insomnja); indeboliment fil-vista; diffikultà biex tieħu n-nifs; uġigħ addominali, stitikezza, gass żejjed (dispepsja), tħossok imdardar; funzjoni anormali tal-fwied; nefħa malajr tal-ġilda u tal-mukuża (anġjoedima), ħmura tal-ġilda (eritema); reazzjonijiet allerġiċi bħal ħakk jew raxx; żieda fl-għaraq, ħorriqija (urtikarja); uġigħ fil-ġogi (artralġja) u uġigħ fl-estremitajiet, bugħawwieġ fil-muskoli; mard qisu influwenza; uġigħ; żieda fil-livelli tal-uric acid, livelli baxxi ta' sodium, żieda fil-livelli tal-krejatinina, enzimi epatiċi jew creatine phosphokinase fid-demm.
Inflammation of the lung (bronchitis); feeling sad (depression); difficulty falling asleep (insomnia); impaired vision; difficulty breathing; abdominal pain, constipation, bloating (dyspepsia), feeling sick; abnormal liver function; rapid swelling of the skin and mucosa (angioedema), redness of the skin (erythema); allergic reactions such as itching or rash; increased sweating, hives (urticaria); joint pain (arthralgia) and pain in extremities, muscle cramps; flu-like-illness; pain; increased levels of uric acid, low levels of sodium, increased levels of creatinine, hepatic enzymes or creatine phosphokinase in the blood.
Numru tal-approvazzjoni
Approval number
L-insulina li hemm f'Insulin Human Winthrop Comb 25 hija magħmula bi proċess bijoteknoloġiku u hija identika għall-insulina li jagħmel il-ġisem innifsu (“ insulina umana ”).
The insulin contained in Insulin Human Winthrop Comb 25 is made by a biotechnology process and is identical with the body's own insulin.
Ir-reazzjonijiet avversi huma elenkati hawn taħt, skond il-klassi ta' l-organi tas-sistema tal-ġisem u skond il-frekwenza.
The adverse reactions are listed below, by system organ class and by frequency.
Titjib fil-ħakk ta' aktar minn 50% deher f'55% tal-pazjenti kkurati b'desloratadine imqabbla ma' 19% kkurati bi plaċebo.
An improvement in pruritus of more than 50% was observed in 55% of patients treated with desloratadine compared with 19% of patients treated with placebo.
3.
3.
Qalba tal-pillola:
Tablet core:
Disfunzjoni tat-tirojde l-iktar bħala ipotirojdiżmu jew ipertirojdiżmu
Thyroid dysfunction most often presenting as hypothyroidism or hyperthyroidism
Grupp Nru
Group No
PREKAWZJONIJIET SPE JALI G AR-RIMI TA' PRODOTTI MEDI INALI MHUX U ATI JEW SKART MINN DAWN IL-PRODOTTI MEDI INALI, JEKK HEMM B ONN
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
jew [II.2.5.4. oriġinaw minn stabbiliment, fejn fir-rigward tal-brucellożi (B. melitensis) l-annimali suxxettibbli kollha kienu ħielsa minn kwalunkwe sinjali kliniċi jew kwalunkwe sinjali ta' din il-marda għall-aħħar 12-il xahar, l-ebda annimali ovini u kaprini ma tlaqqmu kontra din il-marda, ħlief dawk imlaqqma minn tilqima Rev. 1 aktar minn sentejn ilu, u l-annimali ovini u kaprini kollha b'età akbar minn sitt xhur ġew suġġetti għal mill-inqas żewġ testijiet (3), li saru b'riżultati negattivi fuq kampjuni meħuda fi… (data) u fi… (data) b'mill-inqas sitt xhur bejniethom, b'tal-aħħar ikunu fi żmien 30 jum mill-ġbir tal-ova (1)/embrijuni (1),]
or [II.2.5.4. originate from a holding, where in respect of brucellosis (B. melitensis) all susceptible animals have been free from any clinical or any signs of this disease for the last 12 months, none of the ovine and caprine animals have been vaccinated against this disease, save those vaccinated with Rev. 1 vaccine more than two years ago, and all ovine and caprine animals over six months of age have been subjected to at least two tests (3), carried out with negative results on samples taken on… (date) and on… (date) at least six months apart, the latter being within 30 days prior to collection of the ova (1)/embryos (1),]
l-ewwel sentenza hi sostitwita b'li ġej:
the first sentence is replaced by the following:
162 Effetti mhux mixtieqa f'pazjenti pedjatriċi bi psorjasi tal-plakka
Undesirable effects in paediatric patients with plaque psoriasis
Numru tal-Artikolu
Article No.
utilitajiet
utilities
Faqqiegħ ikkultivat (Faqqiegħ komuni, oyster mushroom, shiitake, fungus mycelium (partijiet veġetattivi))
Cultivated fungi (Common mushroom, oyster mushroom, shiitake, fungus mycelium (vegetative parts))
Sjuwts tal-iskijjar (minbarra maħduma bil-labar jew bil-ganċ)
Ski suits (excl. knitted or crocheted)
Għal aktar informazzjoni ara l-fuljett ta' tagħrif.
See the package leaflet for further information.
għall-protezzjoni tal-ilma ta' taħt l-art, meta s-sustanza attiva tkun applikata f'reġjuni b'ħamrija u/jew kundizzjonijiet ta' klima vulnerabbli;
the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions;
“preparat ta' laħam tat-tjur” tfisser laħam tat-tjur, inkluż laħam tat-tjur li sar biċċiet, li żdidulu oġġetti tal-ikel, ħwawar jew addittivi jew li għadda minn proċessi li ma kinux suffiċjenti biex ibiddlu l-istruttura tal-fibra muskolari interna tal-laħam;
preparation" means poultrymeat including poultrymeat that has been reduced to fragments, which has had foodstuffs, seasonings or additives added to it or which has undergone processes insufficient to modify the internal muscle fibre structure of the meat;
Ipprovdi s-saħħa alkoħolika (perċentwal bil-volum ta' 20 °C) jekk applikabbli skont il-lista tal-Kodiċijiet 11 tal-Anness II.
Provide the alcoholic strength (percentage by volume at 20 °C) if applicable in accordance with Code list 11 of Annex II.
Dan ir-Regolament jidħol fis-seħħ fl-1 ta' Jannar 2014.
This Regulation shall enter into force on 1 January 2014.
Komuni (> 1%, < 10%) Komuni (> 1%, < 10%)
Common (> 1%,< 10%) Common (> 1%,< 10%)
Skalaturi u trasportaturi pnewmatiċi (ħlief għal użu fl-agrikultura, għal materjali bil-kwantità)
Pneumatic elevators and conveyors (excluding for agricultural use, for bulk materials)
1mg/ ml
1mg/ ml
il-preżentata ta' dokumenti u prodotti oħra ta' xiehda;
the production of documents and items of evidence;
Puplesija kkawżata mis-sħana li teħtieġ kura fl-isptar kienet iddijanjostikata f'xi każijiet.
Heat stroke requiring hospital treatment was diagnosed in some cases.
120 pilloli miksijin b'rita 180 pillola miksija b'rita 360 pillola miksija b'rita
120 film-coated tablets 180 film-coated tablets 360 film-coated tablets
ANNESS
ANNEX
Artikolu 1
Article 1
wara li kkunsidra r-Rapport tal-Kumitat għall-Kontroll tal-Baġit u l-opinjoni tal-Kumitat għall-Ambjent, is-Saħħa Pubblika u s-Sikurezza tal-Ikel (A6-0125/2008),
having regard to the report of the Committee on Budgetary Control and the opinion of the Committee on Environment, Public Health and Food Safety (A6-0125/2008),
Minerali u konċentrati tal-kobalt
Cobalt ores and concentrates
8 °C (± 2 °C) fejn tali leġiżlazzjoni jew gwida ma teżistix.
8 °C (± 2 °C) where no such legislation or guidance exists.
Dan il-Protokoll preċedenti skada fil-31 ta' Mejju 2010.
The former Protocol expired on 31 May 2010.
Qabel tieħu xi mediċina staqsi lit-tabib tiegħek jekk tistax teffettwalek il-livell tiegħek taz-zokkor fid-demm, u x'għandek tagħmel, jekk meħtieġ.
Before taking a medicine ask your doctor if it can affect your blood sugar level, and what action, if any, you need to take.
Uġigħ addominali u dijarea Rari ħafna:
Abdominal pain and diarrhoea Very rare:
L-insulina li hemm f'Insuman Comb 25 hija magħmula bi proċess bijoteknoloġiku u hija identika għall-insulina li jagħmel il-ġisem innifsu.
The insulin contained in Insuman Comb 25 is made by a biotechnology process and is identical with the body's own insulin.
Intensità tad-dawl mitfugħ
Intensity of light emitted
l-azzjonijiet meħuda sabiex is-sħab imsemmija fl-Artikolu 5 jiġu involuti fit-tħejjija tal-programm operazzjonali, u r-rwol ta' dawk is-sħab fl-implimentazzjoni, il-monitoraġġ u l-evalwazzjoni tal-programm operazzjonali.
the actions taken to involve the relevant partners referred to in Article 5 in the preparation of the operational programme, and the role of those partners in the implementation, monitoring and evaluation of the operational programme.
ml ta' solvent
Subcutaneous use
L-aġġustamenti annwali ma għandhomx jaqbżu l-ammonti massimi li ġejjin (prezzijiet tal-2011) għas-snin 2018-2020 meta mqabbla mal-limitu massimu tal-pagament oriġinali tas-sena rilevanti:
The annual adjustments shall not exceed the following maximum amounts (in 2011 prices) for the years 2018-2020 as compared to the original payment ceiling of the relevant years:
M'għandekx tgħaddiha lil persuni oħra.
Do not pass it on to others.
Għar-raġunijiet stabbiliti hawn fuq, fl-investigazzjoni tagħha l-Kummissjoni kkonkludiet li l-iskema ta' għajnuna li tikkonċerna lil CalMac tikkostitwixxi għajnuna eżistenti [54] u tat bidu lill-proċedura ta' kooperazzjoni prevista skont l-Artikolu 17 tar-Regolament Proċedurali b'mod parallel mal-proċedura ta' investigazzjoni formali.
For the reasons set out above, the Commission has concluded in the course of its investigation that the aid scheme concerning CalMac constitutes an existing aid [54] and initiated the co-operation procedure provided for pursuant to Article 17 of the Procedural Regulation in parallel to the formal investigation procedure.
Tagħmir li jitfa' ż-żerriegħa, tagħmir li jiżra' u tagħmir li jħawwel għall-użu fl-agrikoltura, ortikoltura jew forestrija
Seeders, planters and transplanters for use in agriculture, horticulture and forestry
Il-kontenitur m'g andux jimtela mill-did.
The container must not be refilled.
2.
2.
Huma għandhom jagħmlu kull sforz biex jassistu lir-RSUE fl-implimentazzjoni tal-mandat.
They shall make every effort to assist the EUSR in the implementation of the mandate.
Metodu 2 qed jiġi sostitwiti b'dan li ġej:
Methods 2 are replaced as follows:
13.
13.
Pazjenti li kellhom rispons kliniku (tnaqqis f' CDAI ≥ 70) f'ġimgħa 4 ġew isseparati minn ma' l-oħrajn u ġew analizzati separatement minn dawk li ma kellhomx rispons kliniku
response (decrease in CDAI ≥ 70) at week 4 were stratified and analysed separately from those not in clinical response at week 4.
Mirtazapine Remeron SolTab
Remeron SolTab Remeron SolTab
Jekk ir-reazzjonijiet avversi jippersistu, id-doża ta' kuljum għandha tiġi mnaqqsa temporanjament għal dik id-doża preċedenti li kienet ittollerata sew.
If adverse reactions persist, the daily dose should be temporarily reduced to the previous well-tolerated dose or the treatment may be discontinued.
180 Għid lit-tabib tiegħek minnufih jekk qed jgħaddulek ħsibijiet jew aptit li tweġġa'lilek innifsek.
Tell your doctor immediately if you are having any thoughts or feelings about hurting yourself.
Direttur Ġenerali għall-Affarijiet Marittimi u s-Sajd
Director-General for Maritime Affairs and Fisheries
Żomm fejn ma jintlaħaqx u ma jidhirx mit-tfal.
Keep out of the reach and sight of children.
L-interess tal-fornituri
Interest of suppliers
ADOTTAT DAN IR-REGOLAMENT:
HAS ADOPTED THIS REGULATION:
Nuqqas ta' osservanza tal-iskadenzi għall-ħlasijiet.
Non-respect of payment deadlines
It-tubu fih ringiela waħda jew aktar karattri jew linji rranġati f'ringieli, kull karattru jew linja jikkonsisti/tikkonsisti f'elementi fosforexxenti jew fluworexxenti.
The tube contains one or more rows of characters or lines arranged in rows, each character or line consisting of fluorescent or phosphorescent elements.
NUMRU TAL-LOTT
BATCH NUMBER
Bħalma jiġri b'interferon alfa- 2b, pazjenti li għandhom passat ta' insuffiċjenza tal-qalb konġestiva, attakk tal-qalb kif ukoll/ jew li kellhom jew għandhom problemi arritmiċi u li qed jingħataw terapija b'ViraferonPeg jeħtieġu sorveljanza mill-qrib.
As with interferon alfa-2b, patients with a history of congestive heart failure, myocardial infarction and/or previous or current arrhythmic disorders, receiving ViraferonPeg therapy require close monitoring.
tat-12 ta' Frar 2014
of 12 February 2014
M'hemm bżonn ta' aġġustament fid-doża għall-ebda wieħed minn dawn il-prodotti mediċinali.
No dosage adjustment is necessary for any of these medicinal products.
it-tjur, flieles ta' jum jew bajd għat-tfaqqis deskritti hawn fuq huma konformi mad-dispożizzjonijiet tad-Deċiżjoni(jiet) tal-Kummissjoni…/…/UE li tikkonċerna garanziji addizzjonali fir-rigward ta'… (indika l-mard(a)) u skont l-Artikolu 16 jew 17 tad-Direttiva tal-Kunsill 2009/158/KE.
the poultry, day-old chicks or hatching eggs described above comply with the provisions of Commission Decision(s)…/…/EU concerning additional guarantees with regard to… (indicate disease(s)) and in accordance with Article 16 or 17 of Council Directive 2009/158/EC.
Fil-prinċipju, “rivalutazzjonijiet tal-prezz u tar-rata tal-kambju” tinkludi wkoll tibdiliet fil-valutazzjoni li jirriżultaw minn tranżazzjonijiet fl-attiv/passiv, jiġifieri qligħ/telf realizzat; madankollu, hemm prattiċi nazzjonali diverġenti f'dan ir-rigward.
In principle,'price and exchange rate revaluations' also contain valuation changes that result from transactions in assets/liabilities, i.e. realised gains/losses; however, there are different national practices in this respect.
Stigma tal-fjuri
Flower stigma
Kategoriji li għandhom jiġu trażmessi
Categories to be transmitted
il-punt 1.1.3 huwa sostitwit b'dan li ġej:
point 1.1.3 is replaced by the following:
Post tat-twelid: Provinċja ta' Faryab, Afganistan.
Place of birth: Faryab province, Afghanistan.
4. 3 Kontra- indikazzjonijiet
4.3 Contraindications
Enterobacteriaceae
Enterobacteriaceae