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Fil-każ ta' espożizzjoni waqt it-tqala, ma teżistix biżżejjed informazzjoni klinika biex ikun eskluż xi effett teratoġeniku tal-FSH rikombinanti. | In case of exposure during pregnancy, clinical data are not sufficient to exclude a teratogenic effect of recombinant hFSH. |
Ministru tal-Akkomodazzjoni Rurali u l-Faċilitajiet Soċjali (ex-Speaker tal-Parlament), imwieled fil-15.9.1946. | Minister of Rural Housing and Social Amenities (former Speaker of Parliament), born 15.9.1946. |
Dħul fis-seħħ | Entry into force |
X'INHU LANTUS OPTISET U GĦALXIEX JINTUŻA | WHAT LANTUS IS AND WHAT IT IS USED FOR |
Għaldaqstant, ir-Regolament (UE) Nru 185/2010 għandu jiġi emendat skont dan. | Regulation (EU) No 185/2010 should therefore be amended accordingly. |
Biċċiet u vireg, tal-ħadid jew tal-azzar mhux illigat, mhux maħduma aktar minbarra rrumblati sħan, miġbuda sħun jew estrużi sħun, ta' uċuħ rettangolari tal-"KEFA" (minbarra kwadri) (minbarra li fihom għafsiet, kustilji, skanalaturi jew deformazzjonijiet oħra prodotti matul il-proċess tal-irrumblar, biċċiet u vireg mibruma wara li kienu rrumblati u li jistgħu jinħadmu mill-magni) | Bars and rods, of iron or non-alloy steel, not further worked than hot-rolled, hot-drawn or hot-extruded, of rectangular"ECSC" (excl. square) cross-section (excl. containing indentations, ribs, grooves or other deformations produced during the rolling process, bars and rods twisted after rolling and free-cutting steel) |
Tagħrif ieħor dwar CellCept: | Other information about CellCept: |
ĠU L 193, 23.7.2005, p. 9; MT: ĠU L 352M, 31.12.2008, p. 239. | OJ L 193, 23.7.2005, p. 9. |
Kif mifitehem f'Singapor qegħdin naħdmu fuq negozjati dettaljati rigward l-eliminazzjoni ta' dazji fuq ċertu xorb spirituż. | As agreed in Singapore we have engaged in detailed negotiations regarding the elimination of duties on certain spirituous beverages. |
Mhux inqas minn € 86,8, iżda inqas minn € 88,6 | Not less than € 86,8 but less than € 88,6 |
Billi: | Whereas: |
10. | 10. |
Bidliet fid-doża waqt il-fażi ta' manutenzjoni tal-kura m'għandhomx jsiru aktar spiss minn kull ġimgħatejn. | Dose changes in the maintenance phase of treatment should not be made more frequently than every two weeks. |
Id-Detentur ta' l-Awtorizzazzjoni għat-tqegħid fis-suq | Marketing Authorisation Holder |
Levetiracetam jgħati protezzjoni kontra aċċessjonijiet kemm tat-tip parzjali kif ukoll tat-tip primarji ġeneralizzati f'firxa wiesgħa ta'mudelli f'annimali. | Levetiracetam induces seizure protection in a broad range of animal models of partial and primary generalised seizures without having a pro-convulsant effect. |
Il-Ġurnal Uffiċjali tar-Repubblika Franċiża tat-8 ta' Lulju 1990. | Official Journal of the French Republic of 8 July 1990. |
Għandha tissottometti immedjatament, fuq talba sempliċi mill-Kummissjoni, informazzjoni dwar il-miżuri li diġà ttieħdu u li huma ppjanati li jikkonformaw ma' din id-Deċiżjoni. | It shall immediately submit, on simple request by the Commission, information on the measures already taken and planned to comply with this Decision. |
Fi studji kliniċi l-IARs normalment kienu kkontrollati bit-tnaqqis tar-rata ta' l-infużjoni u bil-kura tal-pazjent minn qabel bl-antistamini u/ jew antipiretiċi (paracetamol jew ibuprofen), u dan għamilha possibbli li l-pazjent seta' jkompli jirċievi l-kura. | In clinical studies IARs were usually manageable by slowing the rate of infusion and by (pre-) treating the patient with antihistamines and/ or antipyretics (paracetamol or ibuprofen), thus enabling the patient to continue treatment. |
Amlodipine jeżerċita effett antianġinali permezz tat-twessiegħ ta' l-arterjoli periperali kif ukoll permezz ta' tnaqqis ta' afterload kardijaku, mingħajr ma jirriżulta f'takikardja riflessiva, u b'riżultat t'hekk, il-konsum ta' l-enerġija u d-domanda għall-ossiġnu tal-muskolu kardijaku jonqsu. | Amlodipine exerts antianginal effect through the dilation of peripheral arterioles as well as through reduction of cardiac afterload, without resulting in reflex tachycardia, and accordingly, energy consumption and oxygen demand of cardiac muscle decrease. |
Makaw skarlat | Scarlet macaw |
Wara li ngħata l-bidu għall-investigazzjoni, il-kumpaniji kollha li kkooperaw qablu li jirrilaxxaw ismijiethom fil-kapaċità tagħhom bħala kooperaturi, iżda mhux, fejn applikabbli, fil-kapaċità tagħhom bħala kwerelanti. | After initiation, all cooperating companies agreed to release their names in their capacity as co-operators but not, where applicable, in their capacity as complainants. |
Dawn għandhom ikunu fil-forma ta' tranżazzjonijiet finanzjarji (kontanti), ħlief għad-diprezzament. | These must be in the form of financial (cash) transactions, with the exception of depreciation. |
Fl-opinjoni tagħha, l-EFSA qieset il-mistoqsijiet speċifiċi kollha u t-tħassib li tqajjem mill-Istati Membri fil-kuntest tal-konsultazzjoni tal-awtoritajiet kompetenti nazzjonali kif stipulat fl-Artikoli 6(4) u 18(4) ta' dak ir-Regolament. | In its opinion, EFSA considered all the specific questions and concerns raised by the Member States in the context of the consultation of the national competent authorities as provided for by Article 6(4) and Article 18(4) of that Regulation. |
Jekk jogħġbok aqra sew l-istruzzjonijiet u segwihom pass wara pass. | Please read the instructions carefully and follow them step by step. |
Huwa mistenni li l-livelli ta'voriconazole jerġgħu lura għal-livelli normali fil-ġimgħa li ma jitteħdux pilloli. | It is expected that the voriconazole levels will return to standard levels during the pill-free week. |
Jekk tibla' bi żball, fittex parir ta' tabib immedjatament u uri il-fuljett tal-pakkett jew it-tikketta lit-tabib. | In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician. |
2 Doża ta' manteniment Id-doża effettiva hija ta' bejn 3 u 6 mg darbtejn kuljum; biex jinkiseb il-benefiċċju massimu mill-kura, il-pazjenti għandhom jinżammu fuq l-aktar doża għolja li jittoleraw. | Maintenance dose The effective dose is 3 to 6 mg twice a day; to achieve maximum therapeutic benefit patients should be maintained on their highest well tolerated dose. |
) (magħruf ukoll bħala Qaddour, Qaddur) | ) (a.k.a. Qaddour, Qaddur) |
Din il-pressjoni għolja tista' twassal għall-marda li tissejjaħ glawkoma. | This pressure can lead to an illness called glaucoma. |
Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) iddeċieda li, meta jintuża flimkien ma'dexamethasone, il-benefiċċji ta' Revlimid huma ogħla mir-riskji tiegħu fit-trattament ta'pazjenti li jbatu minn mjeloma multipla li kienu sottoposti qabel għal terapija ta' l-inqas darba. | The Committee for Medicinal Products for Human Use (CHMP) decided that, in combination with dexamethasone, Revlimid' s benefits are greater than its risks for the treatment of multiple myeloma patients who have received at least one prior therapy. |
“Artikolu 6 | 6 |
Tel: + 39 (0) 45 9218 111 | Tel: + 39 (0)45 9218 111 |
L-awtorità kompetenti tista' tawtorizza t-trasport, l-użu u r-rimi ta' kampjuni ta' riċerka u dijanjostiċi taħt kondizzjonijiet li jiżguraw il-kontroll tar-riskji għas-saħħa pubblika u tal-annimali. | The competent authority may authorise the transport, use and disposal of research and diagnostic samples under conditions which ensure the control of the risks to public and animal health. |
Fittex għal parir mediku minnufih jekk inti għandek xi sinjali jew sintomi bħal ta'deni persistenti, uġigħ fil-griżmejn, tbenġil, fsada jew sfurija. | Seek medical advice immediately if you have any signs or symptoms such as persistent fever, sore throat, bruising, bleeding or paleness. |
[Pazjenti b'endokardite, ostjomajelite jew meninġite b'Candida, jew dawk b'infezzjoni minħabba C. krusei, kienu speċifikament esklużi mill-istudju]. | [Patients with Candida endocarditis, osteomyelitis or meningitis, or those with infection due to C. krusei, were specifically excluded from the study]. |
Il-prodotti tad-demm; | blood products; |
2. | 2. |
Ir-riċirkolazzjoni tal-gass tal-egżost (EGR): iva/le [1] Aqta' barra dak li ma japplikax. | Exhaust gas recirculation (EGR): yes/no [1] Strike out what does not apply. |
Id-detentur ta' l-awtorizzazzjoni għat-tqegħid fis-suq | Marketing Authorisation Holder |
Fil-każ li l-istudju attwarju ma jkunx lest, ir-rati ta' sostituzzjoni jonqsu, b'effett mill-1 ta' Jannar 2012 biex jiġu evitati d-defiċits.”. | In case the actuarial study is not ready, replacement rates are reduced, starting from 1 January 2012, to avoid deficits.'. |
Qawwa ta' l-emorraġija / Tip ta' proċedura kirurġika Emorraġija | Frequency of doses (hours)/ |
Żomm is-siringa bil-kunjett rasu' l isfel u iġbed lura l-planġer sabiex iddaħħal is-soluzzjoni kollha fis-siringa. | Hold the syringe with the vial upside down and pull the plunger to draw all the solution into the syringe. |
iffissar tar-rata inizjali ta' aktar minn sena u sa (u tinkludi) ħames snin, | over one and up to (and including) five years initial rate fixation, |
It-trasferimenti relatati mal-FEG għandhom isiru skont l-Artikolu 27 tar-Regolament Finanzjarju. | Transfers related to the EGF shall be made in accordance with Article 27 of the Financial Regulation. |
Il-produzzjoni ta' l-istatistiċi għandha tirrispetta l-imparzjalità, l-affidabilità, l-oġġettività, l-indipendenza xjentifika, l-effikaċja fl-infiq u l-kunfidenzjalità dwar l-istatistika ta' l-informazzjoni. | The production of statistics shall conform to impartiality, reliability, objectivity, scientific independence, cost-effectiveness and statistical confidentiality. |
12. 375 mg/ 22. 5 cm² li terħi 75 µg fentanyl fis-siegħa | 12.375 mg/ 22.5 cm² which release 75 µg fentanyl per hour |
Hija responsabbli mill-operazzjoni tal-kanali tat-televiżjoni tas-Sirja proprjetà tal-Istat, tnejn terrestri u wieħed bis-satellita, kif ukoll stazzjonijiet tar-radju tal-gvern. | It is responsible for operating Syria's state-owned television channels, two terrestrial and one satellite, as well as government radio stations. |
L-elementi tad-dejta msemmija fil-punt 3 għandhom jiġu trażmessi mit-trasponder permezz tal-protokoll tal-Mod S biss jekk il-proċess taċ-ċertifikazzjoni tal-inġenju tal-ajru u tat-tagħmir ikopri t-trażmissjoni ta' dawn l-elementi tad-dejta permezz tal-protokoll tal-Mod S. | The data items referred to in point 3 shall only be transmitted by the transponder via the Mode S protocol if the aircraft and equipment certification process covers the transmission of these data items via the Mode S protocol. |
Indeboliment epatiku: | Hepatic impairment: |
Għodod għat-tħin tat-tip bil-manku biex jinħadem metall (esklużi bil-parti li taħdem ta' karburi tal-metall magħqudha f'materjal solidu bis-sħana) | Shank type milling tools for working metal (excluding with working part of sintered metal carbide) |
B. | B. |
Magyarország Alcon Hungária Gyógyszerkereskedelmi Kft. + 36- 1- 463- 9080 | Magyarorszag Alcon Hungária Gyógyszerkereskedelmi Kft. + 36-1-463-9080 |
Riċevibbli | Receivables |
Għalkemm hemm l-eliminazzjoni ta' radioattività fl-awrina wara t-tehid ta' etanercept immarkat b'sustanza radju- attiva f'pazjenti u f'voluntiera, ma gietx osservata żieda fil-konċentrazzjonijiet ta' etanercept f'pazjenti b'insuffiċjenza renali jew epatika akuta. | 205 Although there is elimination of radioactivity in urine after administration of radiolabelled etanercept to patients and volunteers, increased etanercept concentrations were not observed in patients with acute renal or hepatic failure. |
ĠU L 248, 16.9.2002, p. 1. | OJ L 248, 16.9.2002, p. 1. |
Barra minn hekk, kawżi oħra ta' anemija, bħal defiċjenza ta' vitamina B12 jew ta' folate, għandhom jiġu esklużi qabel ma tinbeda terapija b'epoetin alfa. | In addition, other causes of anaemia, such as vitamin B12 or folate deficiency, should be excluded before instituting therapy with epoetin alfa. |
Is-Sistema ta' Informazzjoni tal-Kummissjoni għall-Pjan SET (SETIS) ser tiġi mmobilizzata biex tiżviluppa, flimkien mal-partijiet interessati, indikaturi ewlenin tal-prestazzjoni (KPIs) li jimmonitorjaw il-progress tal-implimentazzjoni. | The Commission's Information System for the SET Plan (SETIS) will be mobilised to develop, together with stakeholders, key performance indicators (KPIs) to monitor the progress of implementation. |
Novartis Europharm Limited Wimblehurst Road Horsham West Sussex, RH12 5AB Ir-Renju Unit | Novartis Europharm Limited Wimblehurst Road Horsham West Sussex, RH12 5AB United Kingdom |
4. | 4. |
Dan ser jestendi l-appoġġ tekniku lill-istati Afrikani li ma setgħux jiġu inklużi fl-ewwel proġett kif ukoll lill-istati magħżulin fir-Reġjun tal-Amerika Latina u l-Karibew (ir-Reġjun LAC). | It will extend the technical support to the African States that could not be included in the first project as well as to selected states in the Latin American and Caribbean Region (LAC Region). |
- Jekk ikollok aktar mistoqsijiet, staqsi lit-tabib jew lill-ispiżjar tiegħek. | - If you have any further questions, ask your doctor or pharmacist. |
Skont l-Artikolu 2(7)(b) tar-Regolament bażiku, f'investigazzjonijiet ta' antidumping li jikkonċernaw importazzjonijiet li joriġinaw mir-RPĊ il-valur normali għandu jiġi ddeterminat skont l-Artikolu 2(1) sa (6) tar-Regolament Bażiku għal dawk il-produtturi esportaturi li jkunu wrew li jissodisfaw il-kriterji stabbiliti fl-Artikolu 2(7)(c) tar-Regolament bażiku, jiġifieri fejn jintwera minn dawn il-produtturi esportaturi li l-kundizzjonijiet ta' ekonomija tas-suq huma prevalenti fir-rigward tal-manifattura u l-bejgħ tal-prodott simili. | Pursuant to Article 2(7)(b) of the basic Regulation, in anti-dumping investigations concerning imports originating in the PRC, normal value shall be determined in accordance with Article 2(1) to (6) of the basic Regulation for those exporting producers which have shown that they meet the criteria laid down in Article 2(7)(c) of the basic Regulation, i.e. where it is demonstrated by such exporting producers that market economy conditions prevail in respect of the manufacture and sale of the like product. |
Id-data ta' skadenza tirreferi g all-a ar urnata ta' dak ix-xahar. | The expiry date refers to the last day of that month. |
XX/ SSSS | MM/ YYYY |
Id-deċiżjoni biex it-terapija tkun estiża għal sena ta' trattament għandha tkun ibbażata fuq fatturi pronostiċi (eż., ġenotip, età > 40 sena, sess maskil, fibrożi li tgħaqad). | The decision to extend therapy to one year of treatment should be based on prognostic factors (e.g., genotype, age > 40 years, male gender, bridging fibrosis). |
Immirat, billi jiffoka fuq politiki u setturi ewlenin kruċjali sabiex jiġu indirizzati l-isfidi tas-soċjetà, titjieb it-tmexxija industrijali u l-kompetittività, jiġi appoġġat it-tkabbir sostenibbli, b'livell baxx ta' karbonju, u inklużiv, u jiġu pprovduti prodotti ambjentali u prodotti pubbliċi oħrajn. | Targeted, focusing on policies and key sectors crucial for tackling societal challenges, enhancing industrial leadership and competitiveness, supporting sustainable, low-carbon, inclusive growth, and providing environmental and other public goods. |
0Imwieled/imwielda f'dan il-pajjiż | in this country |
Kif taħżen Arixtra 6. | How to store Arixtra 6. |
Il-kontenut tal-kunjett għandu jintuża minnufih la darba ttaqqab it-tapp tal-lastku. | The contents of a vial should be used immediately after piercing the rubber stopper. |
Informazzjoni rigward | Information regarding |
Ma hemm l-ebda antidotu speċifiku għal doża eċċessiva ta' SUTENT u t-trattament għal doża eċċessiva għandu jikkonsisti minn miżuri t'appoġġ ġenerali. | There is no specific antidote for overdosage with SUTENT and treatment of overdose should consist of general supportive measures. |
Suffejra kolestatika, żieda fl-AST u l-ALT, purpura, raxx u ħakk. | Cholestatic jaundice, AST and ALT increase, purpura, rash and pruritus. |
Sensittività eċċessiva, reazzjoni anafilattika | Hypersensitivity, anaphylactic reaction |
Il-bokkla għandha tkun iddisinjata b'tali mod li tipprekludi kwalunkwe possibbiltà ta' użu mhux korrett. | The buckle shall be so designed as to preclude any possibility of incorrect use. |
INCRELEX għandu jiġi mogħti permezz ta' siringi u labar ta' l-injezzjoni li jintremew wara l-użu. | INCRELEX should be administered using sterile disposable syringes and injection needles. |
Varjetà ta' referenza (tip/grad) għall-kwotazzjoni fil-borża | Reference variety (type/grade) for exchange quotation |
Dejjem ħu Velmetia eżattament kif qallek it-tabib tiegħek. | Always take Velmetia exactly as your doctor has told you. |
Ísland VISTOR HF Sími: + 354 535 7000 | Ísland VISTOR HF Sími: + 354 535 7000 |
Żmien li l-prodott jibqa' tajjeb wara li jiġi miżjud ma' l-ikel imnixxef u ppreparat minn qabel: | Shelf-life after incorporation into pelleted feed: |
Addittiv | Additive |
Mhux aktar minn 1 % | Not more than 1 % |
Kampjun issiġillat kampjun issiġillat b'tali mod li ma jkun possibbli l-ebda aċċess għall-kampjun mingħajr ma jitkisser jew jitneħħa s-siġill, | Sealed sample a sample sealed in such a manner as to prevent any access to the sample without breaking or removing the seal. |
“Il-massa totali effettiva tal-vettura” (Mt) tfisser il-massa mhux okkupata u mhux mgħobbija tal-vettura (Mk) magħduda mal-porzjon (k = 0.5), tal-massa totali tal-okkupanti (Mm), meqjusa li tkun magħquda riġidament mal-vettura. | effective vehicle mass' (Mt) means the unladen kerb mass of the vehicle (Mk) combined with the portion (k = 0,5), of the total occupant mass (Mm), considered to be rigidly attached to the vehicle. |
Herpes simplex | Herpes simplex |
• infezzjonijiet fl-apparat respiratorju • infezzjonijiet fil-widnejn jew fis-sinus fit-tul jew li jerġgħu jitfaċċaw • infezzjonijiet fl-apparat urinarju • infezzjonijiet fit-testikoli • infezzjonijiet fl-organi ġenitali fin-nisa • infezzjonijiet fl-apparat gastro- intestinali u intra- addominali • infezzjonijiet fil-ġilda u fit-tessut l-artab • infezzjonijiet fl-għadam u l-ġogi • biex jikkuraw infezzjonijiet f'pazjenti b'għadd ta' ċelluli bojod tad-demm baxx ħafna (newtropenija) • biex jipprevjenu infezzjonijiet f'pazjenti b'għadd ta' ċelluli bojod tad-demm baxx ħafna (newtropenija) • biex jipprevjenu infezzjonijiet ikkawżati mill-batterja Neisseria meningitidis • esponiment għal teħid man-nifs ta' antraċe | • respiratory tract infections • long lasting or recurring ear or sinus infections • urinary tract infections • infections of the testicles • genital organ infections in women • gastro-intestinal tract infections and intra-abdominal infections • skin and soft tissue infections • bone and joint infections • to treat infections in patients with a very low white blood cell count (neutropenia) • to prevent infections in patients with a very low white blood cell count (neutropenia) • to prevent infections due to the bacterium Neisseria meningitidis • anthrax inhalation exposure |
CHORDATA (KORDATI) | CHORDATA (CHORDATES) |
Operatur bil-kodiċi TAIL NB:N4009L | Operator using TAIL NB:N4009L |
Meta jkun hemm bżonn ta' aġġustament fid-doża, dan għandu jsir fi stadji ta' 25 IU/ kg 3 darbiet fil-ġimgħa b'intervalli ta' mill-anqas 4 ġimgħat sakemm tintlaħaq il-mira mixtieqa. | When a dose adjustment is necessary, this should be done in steps of 25 IU/ kg 3 times per week at intervals of at least 4 weeks until the desired goal is achieved. |
Tista' tagħmlilhom | It may harm them, even |
Artikolu 112 | Article 112 |
Sabiex jiġi garantit li l-miżuri previsti f'dan ir-Regolament ikunu effettivi, jeħtieġ li dan ir-Regolament jidħol fis-seħħ minnufih, | In order to ensure that the measures provided for in this Regulation are effective, this Regulation must enter into force immediately, |
Prandin 2 mg pilloli Repaglinide | Prandin 2 mg tablets Repaglinide |
Teл.: + 359 800 12 400 | Teл.: + 359 800 12 400 |
Kull membru tal-Assoċjazzjoni tal-Melton Mowbray Pork Pie għandu jirċievi n-numru ta' Ċertifikazzjoni tiegħu pprovdut mill-korp ta' spezzjoni u li għandu jintwera fuq l-imballaġġ u fuq kwalunkwe materjal tal-post tal-bejgħ meta jinbiegħu l-Melton Mowbray Pork Pies. | Each member of the Melton Mowbray Pork Pie Association will receive their own Certification number provided by the inspection body to display on packaging and any other point of sale material when selling Melton Mowbray Pork Pies. |
ĠU Edizzjoni Speċjali bil-Malti, Kapitolu 1, Vol. 3, pp. 16 - 18. | OJ L 318, 27.11.1998, p. 1. |
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. |
Artikolu 16 | Article 16 |
Magħmul fi Brussell, l-4 ta' Frar 2013. | Done at Brussels, 4 February 2013. |
kuljum). | of 1,200 mg each day). |
Dan l-istudju wera li PegIntron kien superjuri għal interferon alfa- 2b (Tabella 5). | This study showed that Peg Intron was superior to interferon alfa-2b (Table 5). |