FrancophonIA/ELRC3.0 huggingface dataset:
English: Pravafenix is used in adults at high risk of heart disease whose ‘low-density-lipoprotein' (LDL or ‘bad') cholesterol is already being controlled with pravastatin alone but who still need to improve their cholesterol levels and to reduce their levels of triglycerides (a type of fat).
Maltese: Pravafenix jintuża f'adulti li għandhom riskju għoli ta' mard tal-qalb, li l-kolesterol ‘lipoproteina ta' densità baxxa' (LDL jew ‘ħażin') tagħhom diġà qiegħed jiġi kkontrollat bi pravastatin waħdu iżda li xorta jeħtieġu li jtejbu l-livelli tal-kolesterol tagħhom u li jnaqqsu l-livelli tagħhom ta' trigliċeridi (tip ta' xaħam).
English: The active substances in Pravafenix, pravastatin and fenofibrate, work in different ways and their actions have a complementary effect.
Maltese: Is-sustanzi attivi fi Pravafenix, pravastatin u fenofibrate, jaħdmu b'modi differenti u l-azzjonijiet tagħhom għandhom effett kumplimentari.
English: The company carried out one main study, in which Pravafenix was compared with pravastatin alone in 248 patients at high risk of heart disease who had abnormal levels of cholesterol and triglyceride fats.
Maltese: Il-kumpanija wettqet studju prinċipali wieħed, li fih, Pravafenix tqabbel ma' pravastatin waħdu f'248 pazjent b'riskju għoli ta' mard tal-qalb li kellhom livelli anormali ta' kolesterol u xaħmijiet trigliċeridi.
English: Pravafenix is a medicine that contains the active substances pravastatin and fenofibrate.
Maltese: Pravafenix huwa mediċina li fiha s-sustanzi attivi pravastatin u fenofibrate.
English: What is Pravafenix?
Maltese: Kif jintuża Pravafenix?
English: It must also not be used in patients with gall bladder disease, chronic or acute pancreatitis (inflammation of the pancreas) or a history of myopathy (muscle disorders) or rhabdomyolysis (breakdown of muscle fibres) following treatment with a statin or a fibrate.
Maltese: Lanqas ma għandu jintuża f'pazjenti b'marda talmarrara, pankreatite kronika jew akuta (infjammazzjoni tal-frixa) jew storja ta' mijopatija (disturbi talmuskoli) jew rhabdomyolysis (tkissir tal-fibri tal-muskoli) wara kura bi statin jew fibrat.
English: Pravafenix must not be used in patients aged below 18 years or in patients with severe liver problems, moderate to severe kidney problems, photo allergy or phototoxic reactions (allergic reaction or skin damage due to light exposure) during treatment with fibrates or ketoprofen.
Maltese: Pravafenix ma għandux jintuża f'pazjenti li għandhom anqas minn 18-il sena jew f'pazjenti bi probemi serji fil-fwied, problemi moderati għal serji fil-kliewi, allerġija għaddawl jew reazzjonijiet foto-tossiċi (reazzjoni allerġika jew ħsara għall-ġilda minħabba espożizzjoni għad-dawl) matul kura b'fibrates jew ketoprofen.
English: What is the risk associated with Pravafenix?
Maltese: X'inhu r-riskju assoċjat ma' Pravafenix?
English: The Committee also noted that the benefits of Pravafenix were mainly in patients who had high levels of triglyceride fats and low levels of HDL cholesterol.
Maltese: Il-Kumitat innota wkoll li l-benefiċċji ta' Pravafenix kienu prinċipalment f'pazjenti li kellhom livelli għoljin ta' xaħmijiet trigliċeridi u livelli baxxi ta' kolesterol HDL.
English: The CHMP looked at newly published data on the benefits of the combination of statins and fenofibrate.
Maltese: Is-CHMP ħares lejn id-dejta li għadha kif ġiet ippubblikata dwar il-benefiċċji tal-kombinazzjoni ta' statins u fenofibrate.
English: The cholesterol drawn out of the blood in this way is the LDL, or ‘bad' cholesterol.
Maltese: Il-kolesterol li jinġibed mid-demm b'dan il-mod huwa LDL, jew ilkolesterol ‘il-ħażin'.
English: How has Pravafenix been studied?
Maltese: Kif ġie studjat Pravafenix?
English: Before starting treatment with Pravafenix, the doctor should first investigate all possible causes of the patient's abnormal cholesterol and triglycerides levels and place the patient on a suitable diet.
Maltese: Qabel tinbeda l-kura bi Pravafenix, it-tabib għandu l-ewwel jinvestiga l-kawżi kollha possibbli tal-livelli mhux normali tal-kolesterol u tat-trigliċeridi tal-pazjent u jġiegħel lill-pazjent isegwi dieta adegwata.
English: Ref. EMEA/263700/2008
Maltese: EMEA/263700/2008
English: London, 16 October 2009 Doc.
Maltese: Londra, 16 ta' Ottubru 2009 Dok. Ref.
English: 1 Procedure under Article 107 of Directive 2001/83/EC, as amended.
Maltese: 1 Proċedura skont l-Artikolu 107 tad-Direttiva 2001/83/KE, kif emendata.
English: Nimesulide is available as branded and generic medicines in the following Member States: Austria, Bulgaria, the Czech Republic, Cyprus, France, Greece, Hungary, Italy, Latvia, Lithuania, Malta, Poland, Portugal, Romania, Slovakia and Slovenia.
Maltese: L-Awstrija, il-Bulgarija, irRepubblika Ċeka, Ċipru, Franza, il-Greċja, l-Ungerija, l-Italja, il-Latvja, il-Litwanja, Malta, il-Polonja, ilPortugall, ir-Rumanija, is-Slovakkja u s-Slovenja.
English: This should be carried out in a separate ‘Article 31' referral procedure.
Maltese: Din għandha ssir fi proċedura ta' referenza ‘Artikolu 31' separata.
English: What are the conclusions of the review?
Maltese: X'inhuma l-konklużjonijiet tar-reviżjoni?
English: What is nimesulide?
Maltese: X'inhi nimesulide?
English: Nimesulide is a non-selective non-steroidal anti-inflammatory drug (NSAID).
Maltese: Nimesulide hija mediċina anti-infjammatorja mhux sterojdali mhux selettiva (NSAID).
English: Products containing nimesulide have been available since 1985 and are authorised in a number of Member States2.
Maltese: Prodotti li fihom nimesulide ilhom disponibbli sa mill-1985 u huma awtorizzati f'għadd ta' Stati Membri2.
English: Which data has the CHMP reviewed?
Maltese: Liema dejta irreveda s-CHMP?
English: It is used to treat acute (short-term) pain, and the symptoms of painful osteoarthritis (swelling in the joints) and primary dysmenorrhoea (period pains).
Maltese: Tintuża biex tikkura uġigħ akut (perjodu ta' żmien qasir), u s-sintomi ta' osteoartrite b'uġigħ (nefħa fil-ġogi) u dismenorrea primarja (uġigħ tal-period).
English: The review of the liver-related safety of ‘systemic formulations' of medicines containing nimesulide has been completed.
Maltese: Ir-reviżjoni tas-sigurtà relatata mal-fwied ta' ‘formulazzjonijiet sistemiċi' ta' mediċini li fihom nimesulide ntemmet.
English: Why was nimesulide reviewed?
Maltese: Għaliex ġiet riveduta nimesulide?
English: The European Commission noted that, in some Members States, nimesulide was restricted to second-line treatment.
Maltese: IlKummissjoni Ewropea innotat li, f'xi Stati Membri, nimesulide kienet ristretta għal trattament tal-linja sekondarja.
English: Questions and answers on the outcome of the review of nimesulide-containing medicines1
Maltese: Mistoqsijiet u tweġibiet dwar ir-riżultat tar-reviżjoni ta' mediċini li fihom nimesulide1
English: In the latest review, the CHMP has looked at all the reports of side effects affecting the liver in patients taking nimesulide reported since April 2007, including those from Ireland.
Maltese: Fl-aħħar reviżjoni, is-CHMP ħares lejn ir-rapporti kollha tal-effetti sekondarji li jaffetwaw il-fwied f'pazjenti li jieħdu nimesulide li ġew irrapportati minn April 2007, inklużi dawk mill-Irlanda.
English: The review was an article 107 procedure triggered by the decision of Ireland's medicines regulatory authority in May 2007 to suspend the marketing authorisation for systemic nimesulide-containing medicines, mainly because of liver problems.
Maltese: Ir-reviżjoni kienet proċedura ta' Artikolu 107 li nbdiet bid-deċiżjoni tal-awtorità regolatorja tal-mediċini talIrlanda f'Mejju 2007 biex tissospendi l-awtorizzazzjoni għat-tqegħid fis-suq għal mediċini sistemiċi li fihom nimesulide, l-iktar minħabba problemi fil-fwied.
English: This type of referral is used when it is of ‘Community interest' (for the benefit of all Member States) to have a common view on the benefit-risk balance of a medicine.
Maltese: Din it-tip ta' referenza tintuża meta tkun ta' ‘interess għall-Komunità' (għall-benefiċċju talIstati Membri kollha) sabiex ikun hemm ħarsa komuni lejn il-bilanċ benefiċċju-riskju ta' mediċina.
English: The simulation took the impact of patients switching to alternative painkiller medicines into account.
Maltese: Issimulazzjoni ikkunsidrat l-impatt tal-pazjenti li jaqilbu għal mediċini kontra l-uġigħ alternattivi.
English: However, it recommended that some restrictions should be placed on the way these medicines are prescribed, including limiting the pack size to 30 doses, and that the information provided to doctors and patients be amended to limit the risk of liver injury
Maltese: Madankollu, irrakkomanda li għandhom jitpoġġew xi restrizzjonijiet fuq il-mod kif dawn il-mediċini jingħataw b'riċetta ta' tabib, inkluż li d-daqs tal-pakkett ikun limitat għal 30 doża, u li l-informazzjoni pprovduta lit-tobba u lillpazjenti tiġi emendata biex ikun limitat ir-riskju ta' korriment tal-fwied
English: The European Commission endorsed the CHMP opinion with a further restriction to limit the use of these medicines to ‘second-line' (used when at least one other medicine has failed).
Maltese: Il-Kummissjoni Ewropea approvat l-opinjoni tas-CHMP b'restrizzjoni oħra li jkun limitat l-użu ta' dawk il-mediċini għal ‘linja sekondarja' (użati meta għallinqas mediċina waħda ma tkunx irnexxiet).
English: This process involves a consultation step with the Standing Committee for Medicinal Products for Human Use, a body of representatives from Member States.
Maltese: Dan il-proċess jinvolvi pass ta' konsultazzjoni mal-Kumitat Permanenti għall-Prodotti Mediċinali għall-Użu mill-Bniedem, korp ta' rappreżentanti mill-Istati Membri.
English: The European Commission issued a decision on 16 October 2009.
Maltese: Il-Kummissjoni ħarġet deċiżjoni fis-16 ta' Ottubru 2009.
English: The Standing Committee could not reached an agreement, and, on 8 February 2008, the European Commission therefore asked the CHMP to further consider its opinion, taking new data on the risk of liver problems into account, in particularly new data supplied by Ireland, and looking at ways of minimising the risk associated with nimesulide.
Maltese: IlKumitat Permanenti ma setax jasal ftehim, u għalhekk, fit-8 ta' Frar 2008, il-Kummissjoni Ewropea talbet lis-CHMP biex jikkunsidra aktar l-opinjoni tiegħu, billi jikkunsidra dejta ġdida dwar ir-riskju ta' problemi fil-fwied, b'mod partikolari dejta ġdida pprovduta mill-Irlanda, u jħares lejn modi kif jiġi minimizzat ir-riskju assoċjat ma' nimesulide.
English: Based on the additional information reviewed, the CHMP has not changed its conclusions from September 2007, namely that the benefits of systemic formulations of nimesulide still outweigh their risks, provided that the use of these medicines is restricted to ensure that the risk of patients developing liver problems is kept to a minimum.
Maltese: Fuq il-bażi tal-informazzjoni addizjonali riveduta, is-CHMP ma biddilx il-konklużjonijiet tiegħu minn Settembru 2007, jiġifieri li l-benefiċċji ta' formulazzjonijiet sistemiċi ta' nimesulide xorta huma akbar mir-riskji tagħhom, sakemm l-użu ta' dawn il-mediċini huwa ristrett sabiex jiżgura li r-riskju talpazjenti li jkunu qed jiżviluppaw problemi tal-fwied jinżamm l-inqas possibbli.
English: This suggested that the measures recommended in September 2007, including the changes to the prescribing information, were appropriate to reduce the risk of liver problems associated with nimesulide.
Maltese: Dan issuġġerixxa li l-miżuri rrakkmandati f'Settembru 2007, inklużi t-tibdiliet fl-informazzjoni għall-preskrizzjoni, kienu adegwati biex inaqqsu r-riskju ta' problemi tal-fweid assoċjati ma' nimesulide.
English: Nimesulide was reviewed by the CHMP in 2007 because of concerns with liver injury.
Maltese: Sa Diċembru 2007, kienet disponibbli wkoll fil-Belġju.
English: The CHMP noted that the only additional measures taken by Member States were changes to the prescription status or reimbursement levels for nimesulide-containing medicines.
Maltese: Is-CHMP innota li l-uniċi miżuri addizjonali li ħadu l-Istati Membri kienu tibdiliet fl-istat talpreskrizzjoni jew livelli ta' rimbors għal mediċini li fihom nimesulide.
English: This review should look at all of the potential risks of the medicine, especially the risk of side effects affecting the stomach and the gut, which were outside the scope of the original Article 107 procedure.
Maltese: Din ir-reviżjoni għandha tħares lejn ir-riskji potenzjali kollha tal-mediċini, b'mod speċjali l-effetti sekondarji li jaffettwaw l-istonku u l-imsaren, li kienu barra mill-għan talproċedura oriġinali tal-Artikolu 107.
English: The Committee has also reviewed the results of an Italian ‘simulation study', carried out by the Italian medicines regulatory authority.
Maltese: IlKumitat irreveda wkoll ir-riżultati minn ‘studju ta' simulazzjoni' Taljan, magħmul mill-awtorità regolatorja Taljana tal-mediċini.
English: This study used existing reports of the rate of side effects with all NSAIDs to simulate the possible effect that a suspension of nimesulide would have on the rates of side effects affecting the stomach and gut.
Maltese: Dan l-istudju għamel użu minn rapporti eżistenti tar-rata tal-effetti sekondarji bl-NSAIDs kollha sabiex għamel simulazzjoni tal-effetti possibbli li jista' jkollha sospensjoni ta' nimesulide fuq ir-rati tal-effetti sekondarji li jaffettwaw l-istonku u l-imsaren.
English: The CHMP opinion adopted in September 2007 was transmitted to the European Commission so that it could issue a final decision.
Maltese: L-opinjoni tas-CHMP adottata f'Settembru 2007 ġiet trasmessa lill-Kummissjoni Ewropea sabiex tkun tista' toħroġ deċiżjoni finali.
English: The Committed has also looked at whether Member States took additional measures to those proposed by the CHMP in September 2007, in order to minimise the risk of liver problems in patients using nimesulide-containing medicines.
Maltese: Il-Kumitat ħares ukoll lejn jekk l-Istati Membri ħadux miżuri addizjonali ma' dawk proposti misCHMP f'Settembru 2007, sabiex jiminimizzaw ir-riskju ta' problemi fil-fwied f'pazjenti li jużaw mediċini li fihom nimesulide.
English: 3 The details on the actions taken by the EMEA and of their outcome can be found in the question-and-answer document published in September 2007.
Maltese: 3 Id-dettalji dwar l-azzjonijiet meħudin mill-EMEA u r-riżultati tagħhom jistgħu jinstabu fid-dokument mistoqsija u tweġiba ippubblikat f'Settembru 2007.
English: However, the CHMP further concluded that the benefits and risks of nimesulide should be assessed in a wider context.
Maltese: Madankollu, is-CHMP ikkonkluda wkoll li l-benefiċċji u r-riskji ta' nimesulide għandhom jiġu evalwati f'kuntest usa'.
English: ©EMEA 2007
Maltese: 10 kunjetti©EMEA
English: Packaging Content
Maltese: Daqs tal pakkett
English: Further information on EndolucinBeta can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about EndolucinBeta
Maltese: Informazzjoni oħra dwar EndolucinBeta
English: The most common side effects with EndolucinBeta (which may affect more than 1 in 10 people) are anaemia (low red blood cell counts), thrombocytopenia (low blood platelet counts), leucopenia (low white blood cell counts), lymphopenia (low levels of lymphocytes, a particular type of white blood cell), nausea (feeling sick), vomiting and mild and temporary hair loss.
Maltese: L-effetti sekondarji l-aktar komuni b'EndolucinBeta (li jistgħu jaffettwaw aktar minn persuna 1 minn kull 10) huma anemija (għadd baxx ta' ċelloli ħomor tad-demm), tromboċitopenja (għadd baxx ta' pjastrini tad-demm), lewkopenija (għadd baxx ta' ċelloli bojod tad-demm), limfopenija (livelli baxxi ta' limfoċiti, tip partikolari ta' ċellola bajda tad-demm), nawsja (tħossok ma tiflaħx), rimettar u telf ta' xagħar ħafif u temporanju.
English: As with all radiolabelling materials for medicines, there are risks linked to radiation exposure from EndolucinBeta.
Maltese: Fir-rigward ta' kull materjal ta' radjutikkettar għall-mediċini, hemm riskji relatati mal-esponiment ta' radjazzjoni minn EndolucinBeta.
English: What are the risks associated with EndolucinBeta?
Maltese: X'inhuma r-riskji assoċjati ma' EndolucinBeta?
English: EndolucinBeta received a marketing authorisation valid throughout the EU on 6 July 2016.
Maltese: EndolucinBeta rċieva awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fis-6 ta' Lulju 2016.
English: Several published studies have established the usefulness of lutetium (177Lu) in radiolabelling medicines for diagnosing and treating neuroendocrine tumours.
Maltese: Diversi studji ppubblikati stabbilixxew l-utilità ta' lutetium (177Lu) fir-radjutikkettar ta' mediċini għaddijanjożi u għall-kura ta' tumuri newroendokrinali.
English: The active substance in EndolucinBeta, lutetium (177Lu) chloride, is a radioactive compound that mainly releases beta radiation, with small amounts of gamma radiation.
Maltese: Is-sustanza attiva f'EndolucinBeta, il-lutetium (177Lu) chloride, hija kompost radjuattiv li prinċipalment jirrilaxxa radjazzjoni beta, b'ammonti żgħar ta' radjazzjoni gamma.
English: How is EndolucinBeta used?
Maltese: EndolucinBeta?
English: As for all medicines, data on the use of EndolucinBeta are continuously monitored.
Maltese: Bħal għall-mediċini kollha, id-data dwar l-użu ta' EndolucinBeta hija ssorveljata kontinwament.
English: EndolucinBeta contains the radioactive compound lutetium (177Lu) chloride and is used for radiolabelling other medicines.
Maltese: EndolucinBeta fih il-kompost radjuattiv lutetium (177Lu) chloride u jintuża għar-radjutikkettar ta' mediċini oħrajn.
English: These tumours affect hormonesecreting cells in many parts of the body, including the pancreas, intestine, stomach and lungs.
Maltese: Dawn it-tumuri jaffettwaw iċ-ċelloli li jsaffu l-ormoni f'bosta partijiet tal-ġisem, inkluż il-frixa, l-imsaren, l-istonku u l-pulmun.
English: EndolucinBeta is to be used to radiolabel medicines that have been specifically developed for use with lutetium (177Lu) chloride.
Maltese: EndolucinBeta (lutetium (177Lu) chloride)
English: The radiolabelled medicine is then given to the patient according to the instructions in that medicine's product information.
Maltese: Imbagħad il-mediċina radjutikkettata tingħata lill-pazjent skont l-istruzzjonijiet fl-informazzjoni dwar ilprodott ta' dik il-mediċina.
English: Information on how to minimise the risks is included in the product information for EndolucinBeta.
Maltese: Informazzjoni dwar kif għandhom jitnaqqsu r-riskji hija inkluża fl-informazzjoni dwar il-prodott għal EndolucinBeta.
English: EndolucinBeta itself is radioactive, and as with any other radioactive product, its use may carry a risk of developing cancer and defects that are passed on to children.
Maltese: EndolucinBeta nnifsu huwa radjuattiv, u bħal kull prodott radjuattiv ieħor, l-użu tiegħu jista' jġib miegħu riskju li jiġi żviluppat kanċer u difetti ereditarji.
English: Radiolabelling with EndolucinBeta takes place in a laboratory.
Maltese: Ir-radjutikkettar b'EndolucinBeta isir f'laboratorju.
English: Radiolabelling is a technique for tagging (or labelling) medicines with radioactive compounds so they can carry radioactivity to where it is needed in the body, for example, the site of a tumour.
Maltese: Ir-radjutikkettar hija teknika għall-immarkar (jew it-tikkettar) ta' mediċini b'komposti radjuattivi biex b'hekk ikunu jistgħu jġorru r-radjuattività għal fejn tkun meħtieġa fil-ġisem, pereżempju, is-sit ta' tumur.
English: The doctor will ensure that the expected benefit to the patients of using EndolucinBeta outweigh the risks linked to the radioactivity.
Maltese: It-tabib sejjer jiżgura li l-benefiċċju mistenni għall-pazjenti li jużaw EndolucinBeta jkun akbar mir-riskji relatati mar-radjuattività.
English: An overview of EndolucinBeta and why it is authorised in the EU
Maltese: Ħarsa ġenerali lejn EndolucinBeta u għalfejn huwa awtorizzat fl-UE
English: Information on restrictions that apply specifically to medicines radiolabelled with EndolucinBeta can be found in the package leaflets of those medicines.
Maltese: Informazzjoni dwar ir-restrizzjonijiet li japplikaw speċifikament għall-mediċini radjutikkettati b'EndolucinBeta tinstab fil-fuljetti ta' tagħrif ta' dawk il-mediċini.
English: Why is EndolucinBeta authorised in the EU?
Maltese: Għaliex EndolucinBeta ġie awtorizzat fl-UE?
English: Parcelas 1 y 2 La Almunia de Doña Godina 50100 Zaragoza
Maltese: Parcelas 1 y 2 La Almunia de Doña Godina 50100
English: GE Healthcare Ltd The Grove Centre White Lion Road Amersham HP7 9LL UK
Maltese: GE Healthcare Ltd The Grove Centre White Lion Road Amersham HP7 9LL
English: Date of first authorisation: 22 May 2017
Maltese: Data tal-ewwel awtorizzazzjoni: 22 Mejju 2017
English: Fluciclovine is not metabolised in vivo.
Maltese: Fluciclovine ma jiġix metabolizzat in vivo.
English: Advanced Accelerator Applications 3 rue Charles Lauer 92210 Saint Cloud France
Maltese: Advanced Accelerator Applications 3 rue Charles Lauer 92210 Saint Cloud Franza
English: Exp: ToC + 10h
Maltese: JIS: ToC + 10h
English: Exp: ToC + 8h
Maltese: JIS: ToC + 8h
English: Norsk medisinsk syklotronsenter AS, 0372 Oslo, Norway.
Maltese: Norsk medisinsk syklotronsenter AS, 0372 Oslo, In-Norveġja.
English: Seibersdorf Labor GmbH Grundstück Nr. 482/2 EZ 98 KG 2444 Seibersdorf AUSTRIA
Maltese: Seibersdorf Labor GmbH Grundstück Nr. 482/2 EZ 98 KG 2444
English: Typical total scan time is between 20-30 minutes.
Maltese: Il-ħin tal-iskenjar totali tipiku huwa ta' bejn 20-30 minuta.
English: For patient preparation, see section 4.4.
Maltese: Għal preparazzjoni tal-pazjent, ara sezzjoni 4.4.
English: Blue Earth Diagnostics Ireland Ltd, 6th Floor, 2 Grand Canal Square, Dublin 2, Ιreland
Maltese: Blue Earth Diagnostics Ireland Ltd, 6th Floor, 2 Grand Canal Square, Dublin 2, Irlanda
English: GE Healthcare Ltd, Amersham HP7 9LL, UK Advanced Accelerator Applications, 50100, La Almunia-Zaragoza, Spain Advanced Accelerator Applications, 407014, Meldola (FC), Italy Advanced Accelerator Applications, 92210 Saint Cloud, France
Maltese: GE Healthcare Ltd, Amersham HP7 9LL, Ir-Renju Unit Advanced Accelerator Applications, 50100, Zaragoza, Spanja Advanced Accelerator Applications, 407014, Meldola (FC), Italja Advanced Accelerator Applications, 92210 Saint Cloud, Franza
English: DATE OF REVISION OF THE TEXT 11.
Maltese: DATA TA' REVIŻJONI TAT-TEST 11.
English: True positive (%) False positive (%) True negative (%) False negative (%) Sensitivity [95% CI] Specificity [95% CI]
Maltese: Negattiv veru (%) Negattiv falz (%) Sensittività [95% CI]
English: Volume: {xx.x} mL
Maltese: {xx.x} mL
English: Meldola (FC) Italy
Maltese: Meldola (FC)
English: Seibersdorf Labor GmbH, 2444 Seibersdorf, Austria.
Maltese: Seibersdorf Labor GmbH, 2444
English: Using the findings of other relevant imaging modalities and clinical follow-up as reference standard in the recruited population, patient-based sensitivity and specificity of fluciclovine (18F) PET-CT for detection of prostate/prostate bed recurrences were 94.7% (89/94) (95%CI: 88.0-98.3%) and 54.8% (17/31) (95%CI:36-72.7%), respectively.
Maltese: referenza fil-popolazzjoni reklutata , is-sensittività u l-ispeċifiċità ta' PET-CT bi fluciclovine (18F) għall-iskoperta ta' rikorrenzi fil-prostata/bed tal-prostata bbażata fuq il-pazjent kienu ta' 94.7% (89/94) (95% CI: 88.0-98.3%) u ta' 54.8% (17/31) (95% CI:36-72.7%), rispettivament.
English: - The active substance is fluciclovine (18F).
Maltese: - Is-sustanza attiva hi fluciclovine (18F).
English: MedDRA system organ class
Maltese: Sistema tal-klassifika tal-organi ta' MedDRA
English: Seibersdorf Labor GmbH, 2444 Seibersdorf, Austria Norsk medisinsk syklotronsenter AS, 0372 Oslo, Norway Advanced Accelerator Applications, 13005 Marseille, France Nucleis SA, 4000 Liège, Belgium
Maltese: Seibersdorf, L-Awstrija Norsk medisinsk syklotronsenter AS, 0372 Oslo, In-Norveġja Advanced Accelerator Applications, 13005 Marseille, Franza Nucleis SA, 4000 Liège, Belġju