FrancophonIA/ELRC3.0 huggingface dataset:
English: Xefo is not recommended for use in children and adolescents below age 18 due to lack of data
Maltese: Xefo mhuwiex rakkomandat għal użu fuq tfal u adoloxxenti taħt l-età ta' 18-il sena minħabba nuqqas ta' tagħrif
English: EMA/240374/2015 EMEA/V/C/003764
Maltese: EMEA/V/C/003764
English: The active substance in Sileo, dexmedetomidine hydrochloride, is a type of sedative medicine called an alpha-2 adrenoceptor agonist.
Maltese: Is-sustanza attiva f'Sileo, dexmedetomidine hydrochloride, hija tip ta' mediċina sedattiva msejħa agonist adrenoċettur alfa-2.
English: 72% (64 of 89) of the Sileo-treated dogs were scored excellent or good for behaviour compared to 37% (34 of 93) of the group given dummy treatment.
Maltese: 72% (64 minn 89) tal-klieb ikkurati b'Sileo ngħataw punteġġ eċċellenti jew tajjeb għal imġiba meta mqabbel ma' 37% (34 minn 93) tal-grupp li ngħata kura finta.
English: Sileo is a veterinary medicine that contains dexmedetomidine hydrochloride.
Maltese: Sileo huwa mediċina veterinarja li fiha dexmedetomidine hydrochloride.
English: Impermeable disposable gloves should be worn when handling Sileo.
Maltese: Għaliex ġie appruvat Sileo?
English: What is the risk associated with Sileo?
Maltese: X'riskji huma assoċjati ma' Sileo?
English: The effectiveness of Sileo was investigated in a field study involving dogs exposed to fireworks noise at New Year's Eve. Sileo was given to 89 dogs and 93 dogs received a dummy treatment.
Maltese: Sileo ngħata lil 89 kelb u 93 kelb irċevew kura finta.
English: What is Sileo?
Maltese: X'inhu Sileo?
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Sileo on 10 June 2015.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida madwar l-Unjoni Ewropea għal Sileo fi 10/06/2015.
English: Sedation, vomiting and urinary incontinence may also occur in less than 10 in 100 dogs.
Maltese: Sedazzjoni, rimettar u inkontinenza urinarja jistgħu jseħħu wkoll f'inqas minn 10 klieb minn kull 100 kelb.
English: It is available as an oromucosal gel (a gel applied to the lining of the mouth).
Maltese: Jiġi bħala ġel oromukużali (ġel applikat mal-kisja tal-ħalq).
English: Typical signs of anxiety and fear in dogs include panting, trembling, pacing, seeking people, hiding or trying to escape, refusal to eat and inappropriate urination or defaecation.
Maltese: Sinjali tipiċi tal-ansejtà u l-biża' fil-klieb jinkludu tleħħiġ, rogħda, li jkunu fuq ix-xwiek, li jfittxu n-nies, li jinħbew jew li jippruvaw jaħarbu, li jirrifjutaw li jieklu u li jgħaddu l-awrina jew li jippurgaw mhux kif suppost.
English: Short-lived paleness of the lining of the mouth and gums at the application site may occur in less than 10 in 100 dogs due to a temporary localised narrowing of the blood vessels.
Maltese: Jista' jkun hemm sfurija li tgħaddi malajr tal-kisja tal-ħalq u l-ħanek fis-sit tal-applikazzjoni f'anqas minn 10 minn kull 100 kelb minħabba tidjiq lokalizzat temporanju tal-vini u l-arterji.
English: How has Sileo been studied?
Maltese: Kif ġie studjat Sileo?
English: The CVMP concluded that the benefits of Sileo exceed the risks for the approved indication and recommended that Sileo be given a marketing authorisation.
Maltese: Is-CVMP ikkonkluda li l-benefiċċji ta' Sileo huma akbar mir-riskji għall-indikazzjoni approvata u rrakkomanda li Sileo jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: If the noise continues and the dog shows signs of anxiety and fear again, further doses can be given at intervals of two hours, up to a total of 5 times during each event.
Maltese: Jekk il-ħoss ikompli u l-kelb jerġa' juri sinjali ta' ansjetà u biża', jistgħu jingħataw dożi oħrajn f'intervalli ta' sagħtejn, sa total ta' 5 darbiet matul kull avveniment.
English: Pregnant women should avoid contact with the product as uterine contractions and reduced blood pressure of the unborn baby may occur after exposure to dexmedetomidine.
Maltese: Nisa tqal għandhom jevitaw kuntatt mal-prodott peress li jistgħu jseħħu kontrazzjonijiet tal-utru u pressjoni tad-demm mnaqqsa fit-tarbija mhux imwielda wara esponiment għal dexmedetomidine.
English: How does Sileo work?
Maltese: Għal xiex jintuża Sileo?
English: Sileo must not be used in dogs with severe disorders of the heart and blood vessels, with severe disease such as kidney or liver failure or in dogs if unexpectedly sedated from a previous dose.
Maltese: Sileo għandu jintuża fi klieb b'disturbi severi tal-qalb u l-vini u l-arterji, b'mard sever bħal insuffiċjenza tal-fwied u l-kliewi jew fi klieb jekk jitħeddlu b'mod mhux mistenni minn doża preċedenti.
English: This is a summary of the European public assessment report.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni.
English: If Sileo is accidentally ingested or if there is prolonged contact with the eyes, lips or the inside of the mouth or nostrils medical advice should be sought immediately and the package leaflet or the label shown to the doctor.
Maltese: Peress li noradrenalina hija involuta fiżżamma tal-attenzjoni u l-interess, it-tnaqqis tar-rilaxx tagħha jnaqqas is-severità ta' ansjetà akuta u biża' assoċjati mal-ħsejjes.
English: Score good for behaviour indicated only mild and short-lived signs of fear and anxiety shown by the dog whilst score excellent for behaviour indicated no signs shown.
Maltese: Punteġġ tajjeb għall-imġiba indika biss sinjali ħfief u li għaddew malajr ta' biża' u ansjetà murija mill-kelb filwaqt li punteġġ eċċellenti għallimġiba ma indika ebda sinjal muri.
English: For a full list of all restrictions and side-effects reported with Sileo, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrappurtati b'Sileo, ara l-fuljett ta' tagħrif.
English: Immediate packaging Pack size blister (PVC/PE/PVDC/alu) 294 (3x98) tablets (multipack)
Maltese: Il-pakkett li jmiss malprodott
English: Strength Pharmaceutical form Route of administration
Maltese: Isem (ivvintat) Qawwa Għamla farmaċewtika Mnejn għandu jingħata
English: Iclusig is available as tablets (15 mg, 30 mg and 45 mg).
Maltese: Iclusig jiġi bħala pilloli (15 mg, 30 mg u 45 mg).
English: Further information on the orphan designations can be found here: ema.europa.eu/Find medicine/Human medicines/Rare disease designation (CML; ALL).
Maltese: ema.europa.eu/Find medicine/Human medicines/Rare disease designation (CML; ALL).
English: Further information on Iclusig can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: Aktar informazzjoni fuq Iclusig tinstab fis-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The most common serious side effects with Iclusig (which may affect more than 2 in 100 people) are pneumonia (infection of the lungs), pancreatitis (inflammation of the pancreas), pyrexia (fever), abdominal pain (stomach ache), myocardial infarction (heart attack), atrial fibrillation (irregular rapid contractions of the upper chambers of the heart), peripheral arterial occlusive disease (problem with blood flow in the arteries), anaemia (low red blood cell counts), angina pectoris (pains to the chest, jaw and back due to problems with blood flow to the heart), decreased blood levels of platelets (components that help the blood to clot), febrile neutropenia (low white blood cell counts with fever), hypertension (high blood pressure), coronary artery disease (heart disease caused by the obstruction of the blood vessels that supply the heart muscle), cardiac failure (when the heart does not work as well as it should), cerebrovascular accident (stroke), sepsis (blood poisoning), cellulitis (inflammation of the deep skin tissue), acute kidney injury (kidney damage), urinary tract infection (infection of the structures that carry urine) and increased levels of lipase (an enzyme).
Maltese: L-effetti sekondarji serji l-aktar komuni b'Iclusig (li jistgħu jaffettwaw aktar minn 2 persuni minn kull 100 persuna) huma pulmonite (infezzjoni fil-pulmun), pankreatite (infjammazzjoni tal-frixa), deni, uġigħ addominali (uġigħ ta' stonku), infart mijokardiku (attakk tal-qalb), fibrilazzjoni atrijali (kontrazzjonijiet rapidi irregolari tal-kompartimenti ta' fuq tal-qalb), mard okklużiv arterjali periferali (problema bil-fluss tad-demm fl-arterji), anemija (għadd baxx ta' ċelloli ħomor tad-demm), angina pectoris (uġigħ fis-sider, fix-xedaq u fid-dahar minħabba problemi bi fluss tad-demm lejn il-qalb), livelli mnaqqsa ta' pjastrini fid-demm (komponenti li jgħinu d-demm jagħqad), newtropenija bid-deni (għadd baxx ta' ċelloli bojod tad-demm bid-deni), ipertensjoni (pressjoni tad-demm għolja), mard tal-arterji koronarji (mard tal-qalb ikkawżat mill-imblokkar tal-vażi li jfornu l-muskolu tal-qalb), insuffiċjenza kardijaka (meta l-qalb ma taħdimx tajjeb kemm suppost), aċċident ċerebrovaskulari (puplesija), sepsi (avvelenament tad-demm), ċellulite (infjammazzjoni tat-tessut tal-ġilda fil-fond), ħsara fil-kliewi akuta (ħsara fil-kliewi), infezzjoni fl-apparat tal-awrina (infezzjoni tal-istrutturi li jmexxu l-awrina) u livelli miżjud ta' lipażi (enżima).
English: Iclusig received a marketing authorisation valid throughout the EU on 1 July 2013.
Maltese: Iclusig irċieva awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fl-1 ta' Lulju 2013.
English: Other information about Iclusig
Maltese: Informazzjoni oħra dwar Iclusig
English: Ponatinib acts by blocking a tyrosine kinase called Bcr-Abl.
Maltese: Ponatinib taġixxi billi timblokka l-kinażi tat-tirożina msejħa Bcr-Abl.
English: As for all medicines, data on the use of Iclusig are continuously monitored.
Maltese: Bħal għall-mediċini kollha, id-data dwar l-użu ta' Iclusig hija ssorveljata kontinwament.
English: • among the patients with Ph+ ALL, around 41% (13 out of 32) had a major haematological response.
Maltese: • fost il-pazjenti b'Ph+ ALL, madwar 41 % (13 minn 32) kellhom rispons ematoloġiku maġġuri.
English: Iclusig is a cancer medicine that contains the active substance ponatinib.
Maltese: Iclusig huwa mediċina kontra l-kanċer li fiha s-sustanza attiva ponatinib.
English: Iclusig has been investigated in one main study involving 449 patients with CML or Ph+ ALL and who were intolerant or resistant to treatment with dasatinib or nilotinib, or had the T315I mutation.
Maltese: Iclusig ġie investigat fi studju ewlieni wieħed li involva 449 pazjent b'CML jew Ph+ ALL u li kienu intolleranti jew reżistenti għal kura b'dasatinib jew nilotinib, jew li kellhom il-mutazzjoni T315I.
English: Venous thromboembolic reactions (problems due to blood clots in the veins) occurred in 6% of patients.
Maltese: Reazzjonijiet tromboemboliċi vaskulari (problemi minħabba emboli tad-demm fil-vini) seħħu f'6 % ta' pazjenti.
English: What are the risks associated with Iclusig?
Maltese: X'inhuma r-riskji assoċjati ma' Iclusig?
English: Arterial occlusive adverse events (clots or blockages in the arteries) occurred in 25% of patients, with serious adverse events occurring in 20% of patients.
Maltese: Avvenimenti negattivi okklużivi arterjali (emboli jew imblokkar fl-arterji) seħħu f'25 % ta' pazjenti, b'avvenimenti negattivi li seħħu f'20 % tal-pazjenti.
English: • among the patients with CML in the chronic phase, around 54% (144 out of 267) had a major cytogenetic response;
Maltese: • fost il-pazjenti b'CML fil-fażi kronika, madwar 54 % (144 minn 267) kellhom rispons ċitoġenetiku
English: The active substance in Iclusig, ponatinib, belongs to a group of medicines called ‘tyrosine kinase inhibitors'.
Maltese: Is-sustanza attiva f'Iclusig, il-ponatinib, tagħmel parti minn grupp ta' mediċini msejħa "inibituri kinażi tat-tirożina".
English: These diseases are rare, and Iclusig was designated an ‘orphan medicine' (a medicine used in rare diseases) on 2 February 2010.
Maltese: Dan il-mard huwa rari, u Iclusig ġie denominat bħala "mediċina orfni" (mediċina li tintuża f'mard rari) fit-2 ta' Frar 2010.
English: The recommended starting dose is 45 mg once per day.
Maltese: Id-doża inizjali rakkomandata hija ta' 45 mg darba kuljum.
English: How does Iclusig work?
Maltese: Kif jaħdem Iclusig?
English: • chronic myeloid leukaemia (CML) in its different stages known as chronic, accelerated and blast phases;
Maltese: • lewkimja majelojde kronika (CML) fl-istadji differenti tagħha magħrufa bħala fażijiet kroniċi, mgħaġġla u blastiċi;
English: It is also used in patients who have a genetic mutation called ‘T315I mutation' which makes them resistant to treatment with imatinib, dasatinib or nilotinib.
Maltese: Jintuża wkoll f'pazjenti li jkollhom mutazzjoni ġenetika msejħa “mutazzjoni T315I” li tagħmilhom reżistenti għal kura b'imatinib, dasatinib jew nilotinib.
English: Serious venous occlusive adverse events (clots or blockages in the veins) occurred in 5% of patients.
Maltese: Avvenimenti negattivi okklużivi vaskulari serji (emboli jew imblokkar fil-vini) seħħu f'5 % ta' pazjenti.
English: By blocking Bcr-Abl, Iclusig helps to control the growth and spread of leukaemia cells.
Maltese: Billi jimblokka Bcr-Abl, Iclusig jgħin biex jikkontrolla t-tkabbir u t-tixrid taċ-ċelloli tal-lewkimja.
English: • among the patients with CML in the blast phase, around 31% (19 out of 62) had a major haematological response;
Maltese: • fost il-pazjenti b'CML fil-fażi blastika, madwar 31 % (19 minn 62) kellhom rispons ematoloġiku
English: Iclusig was shown to be an effective treatment for those patients with CML or Ph+ ALL who have limited treatment options.
Maltese: Iclusig intwera li huwa kura effettiva għal dawk il-pazjenti b'CML jew Ph+ ALL li jkollhom għażliet limitati ta' kura.
English: • among the patients with CML in the accelerated phase, around 58% (48 out of 83) had a major haematological response;
Maltese: • fost il-pazjenti b'CML fil-fażi mgħaġġla, madwar 58 % (48 minn 83) kellhom rispons ematoloġiku
English: • acute lymphoblastic leukaemia (ALL) in patients who are ‘Philadelphia-chromosome positive' (Ph+).
Maltese: • lewkimja limfoblastika akuta (ALL) f'pazjenti li huma "pożittivi għall-kromosoma ta' Philadelphia" (Ph+). Ph+ tfisser li xi wħud mill-ġeni tal-pazjent ikunu rranġaw lilhom infushom biex jiffurmaw kromosoma speċjali msejħa l-kromosoma ta' Philadelphia li twassal għall-iżvilupp tal-lewkimja.
English: What benefits of Iclusig have been shown in studies?
Maltese: X'inhuma l-benefiċċji ta' Iclusig li ħarġu mill-istudji?
English: The risk of problems (including heart attacks and strokes) resulting from blood clots or blockages in arteries or veins could be reduced by checking for and treating contributory conditions such as high blood pressure and raised cholesterol both before and during treatment.
Maltese: Ir-riskju ta' problemi (inklużi attakki talqalb u puplesiji) li jirriżultaw minn emboli tad-demm jew imblokkar fl-arterji jew fil-vini jista' jitnaqqas billi jiġu kkontrollati u kkurati l-kondizzjonijiet kontributorji bħall-pressjoni tad-demm għolja u lkolesterol għoli kemm qabel kif ukoll matul il-kura.
English: These compounds act by blocking enzymes known as tyrosine kinases.
Maltese: Aktar informazzjoni dwar id-denominazzjoni orfni tista' tinstab hawn:
English: Also, the company will conduct a study in order to determine the best starting dose of Iclusig and to assess the safety and effectiveness of Iclusig following dose reduction in patients with chronic phase CML who achieve major cytogenetic response.
Maltese: Barra dan, il-kumpanija se tagħmel studju sabiex tiġi determinata l-aħjar doża inizjali ta' Iclusig u jiġu vvalutati s-sigurtà u l-effikaċja ta' Iclusig wara tnaqqis tad-doża f'pazjenti b'CML fil-fażi kronika li jiksbu rispons ċitoġeniku maġġuri.
English: For the full list of side effects and restrictions with Iclusig, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrappurtati b'Iclusig, ara l-fuljett ta' tagħrif.
English: Regarding its safety, the side effects with Iclusig were largely similar to those of other tyrosine kinase inhibitors and mostly manageable with dose reduction or dose delay.
Maltese: Fir-rigward tas-sigurtà tiegħu, l-effetti sekondarji b'Iclusig kienu ġeneralment simili għal inibituri oħrajn ta' kinażi tat-tirożina u ħafna minnhom setgħu jiġu mmaniġġjati bi tnaqqis fid-doża jew ittardjar tad-doża.
English: What measures are being taken to ensure the safe and effective use of Iclusig?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Iclusig?
English: It is used to treat adults with the following types of leukaemia (cancer of the white blood cells):
Maltese: Dan jintuża biex jikkura adulti bit-tipi ta' lewkimja li ġejjin (kanċer taċ-ċelloli bojod tad-demm):
English: The usual dose is one infusion of 4 mg over at least 15 minutes.
Maltese: Id-doża normali hija infużjoni waħda ta' 4 mg fuq perjodu ta' mill-inqas 15-il minuta.
English: Further information on Zoledronic Acid Accord can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/zoledronic-acid-accord.
Maltese: ema.europa.eu/medicines/human/EPAR/zoledronic-acid-accord.
English: The medicine is given as an infusion (drip) into a vein.
Maltese: Il-mediċina tingħata bħala infużjoni (dripp) ġol-vina.
English: Zoledronic Acid Accord received a marketing authorisation valid throughout the EU on 16 January
Maltese: Zoledronic Acid Accord irċieva awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fis16 ta' Jannar 2014.
English: The active substance in Zoledronic Acid Accord, zoledronic acid, is a bisphosphonate.
Maltese: Is-sustanza attiva f'Zoledronic Acid Accord, l-aċidu żoledroniku, hija bisfosfonat.
English: It is not recommended for patients with severely reduced kidney function.
Maltese: Mhuwiex rakommandat għal pazjenti b'funzjoni tal-kliewi mnaqqsa severament.
English: Zoledronic Acid Accord contains the active substance zoledronic acid and is a ‘generic medicine'.
Maltese: Zoledronic Acid Accord fih is-sustanza attiva aċidu żoledroniku u huwa "mediċina ġenerika".
English: Other information about Zoledronic Acid Accord
Maltese: Informazzjoni oħra dwar Zoledronic Acid Accord
English: The company that markets Zoledronic Acid Accord will provide a card to inform patients receiving Zoledronic Acid Accord about the risk of osteonecrosis of the jaw and to instruct them to contact their doctor if they get symptoms.
Maltese: Il-kumpanija li tqiegħed Zoledronic Acid Accord fis-suq ser tipprovdi kard biex tinforma lill-pazjenti li jirċievu Zoledronic Acid Accord dwar ir-riskji tal-osteonekrożi fix-xedaq u biex tgħidilhom jikkuntattjaw lit-tabib tagħhom jekk jesperjenzaw xi sintomi.
English: This includes fractures (breaks in the bone), spinal compression (when the spinal cord is compressed by the bone), bone disorders needing radiotherapy (treatment with radiation) or surgery, and hypercalcaemia (high levels of calcium in the blood).
Maltese: Dan jinkludi fratturi (ksur fl-għadam), kompressjoni fl-ispina tad-dahar (meta l-ispina tad-dahar tkun kompressa mill-għadam), disturbi flgħadam li jeħtieġu r-radjuterapija (kura bir-radjazzjoni) jew intervent kirurġiku, u iperkalċemija (livelli għoljin ta' kalċju fid-demm).
English: Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Zometa, and do not need to be repeated for Zoledronic Acid Accord.
Maltese: Studji dwar il-benefiċċji u r-riskji tas-sustanza attiva fl-użijiet approvati diġà twettqu bil-mediċina ta' referenza, Zometa, u m'għandhomx għalfejn jiġu ripetuti għal Zoledronic Acid Accord.
English: How is Zoledronic Acid Accord used?
Maltese: Zoledronic Acid Accord?
English: There was no need for ‘bioequivalence' studies to investigate whether Zoledronic Acid Accord is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood.
Maltese: Ma kienx hemm bżonn ta' studji ta' “bijoekwivalenza” biex jiġi investigat jekk Zoledronic Acid Accord jiġix assorbit b'mod simili bħall-mediċina ta' referenza biex jipproduċi l-istess livell tas-sustanza attiva fid-demm.
English: As for all medicines, data on the use of Zoledronic Acid Accord are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Zoledronic Acid Accord hija ssorveljata kontinwament.
English: Because Zoledronic Acid Accord is a generic medicine, its benefits and risks are taken as being the same as the reference medicines'.
Maltese: Billi Zoledronic Acid Accord huwa mediċina ġenerika, il-benefiċċji u r-riskji tiegħu huma meqjusa listess bħal dawk tal-mediċina ta' referenza.
English: Zoledronic Acid Accord is a medicine used to prevent bone complications in adults with advanced cancer that is affecting the bone.
Maltese: Zoledronic Acid Accord huwa mediċina li tintuża għall-prevenzjoni ta' kumplikazzjonijiet fl-għadam f'adulti b'kanċer avvanzat li jkun qed jaffettwa l-għadam.
English: This means that Zoledronic Acid Accord contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the European Union (EU) called Zometa.
Maltese: Dan ifisser li Zoledronic Acid Accord fih l-istess sustanza attiva u jaħdem bl-istess mod bħal “mediċina ta' referenza” diġà awtorizzata fl-Unjoni Ewropea (UE) msejħa Zometa.
English: Zoledronic Acid Accord (zoledronic acid)
Maltese: Kif jintuża Zoledronic Acid Accord?
English: When used to prevent bone complications, the infusion can be repeated every three to four weeks, and patients should also take supplements of calcium and vitamin D. A lower dose is recommended for patients with bone metastases (when cancer has spread to the bone) if they have mild to moderately reduced kidney function.
Maltese: Hija rakkomandata doża iktar baxxa għall-pazjenti li jkollhom metastasi flgħadam (meta l-kanċer ikun infirex mal-għadam) jekk ikollhom tnaqqis ħafif sa moderat fil-funzjoni tal-kliewi.
English: Other information about Vepured:
Maltese: Informazzjoni oħra dwar Vepured:
English: The full EPAR for Vepured can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: Protection starts 21 days after vaccination and lasts for 112 days.
Maltese: Il-protezzjoni tibda 21 jum wara t-tilqim u ddum 112-il jum.
English: Why is Vepured approved?
Maltese: Għal xiex ġie approvat Vepured?
English: A field study involving 2- to 3-day-old piglets, 1,173 of which were vaccinated with Vepured and 1,048 piglets given a dummy injection, showed that Vepured prevented death of virtually all the piglets from oedema disease over a 115 day period and there was a significant reduction in signs of the disease which included difficulty breathing, oedema (fluid retention) and signs related to the nervous system.
Maltese: Qasam ta' studju li involva qżieqeż ta' jumejn sa tlett ijiem, u li 1,173 minnhom tlaqqmu b'Vepured u 1,048 qażquż li ngħataw injezzjoni finta, wera li virtwalment Vepured impedixxa l-mewt tal-qżieqeż kollha mill-marda oedema matul perjodu ta' 115-il jum u kien hemm tnaqqis sinifikanti fis-sinjali tal-marda li inkludew diffikultà fin-nifs, oedema (ritenzjoni tal-fluwidu) u sinjali relatati mas-sistema nervuża.
English: E. coli verotoxoid vaccine (inactivated recombinant)
Maltese: Vaċċin verotoxoid E.coli(rikombinant inattivat)
English: This is a summary of the European public assessment report (EPAR) for Vepured.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Vepured.
English: This summary was last updated in June 2017.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'Ġunju 2017.
English: Vepured contains adjuvants (aluminium hydroxide and DEAE-dextran) to enhance the immune response.
Maltese: Vepured fih ukoll aġġuvanti (l-idrossidu tal-aluminju u DEAE-dextran) li jtejbu r-rispons immunitarju.