FrancophonIA/ELRC3.0 huggingface dataset:
English: However, it may decline a request to speak at the public hearing if the outline of the planned intervention addresses a matter that is not prima facie related to the subject matter of the public hearing.
Maltese: Madankollu, tista' tiċħad talba sabiex titkellem f'seduta ta' smigħ pubbliku jekk is-sinopsi tal-intervent ippjanat jindirizza kwistjoni li mhijiex prima facie relatata mas-suġġett tas-seduta ta' smigħ pubbliku.
English: The information submitted to the Agency will be made public for all participants who make an intervention at the public hearing, with the exception of any personal contact details.2
Maltese: Is-seduti ta' smigħ pubbliċi huma miftuħin għall-membri kollha tal-pubbliku.
English: • Feasibility to hold a public hearing in light of the urgency of the matter.
Maltese: • Il-fattibilità li ssir seduta ta' smigħ pubbliku fid-dawl tal-urġenza tal-kwistjoni.
English: The PRAC Chair concludes the public hearing and explains the next steps of the procedure.
Maltese: Il-President tal-PRAC jikkonkludi s-seduta ta' smigħ pubbliku u jispjega l-passi li jmiss tal-proċedura.
English: The full EPAR for Cinryze 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: C1 inhibitor (human)
Maltese: Inibitur ta' C1 (uman)
English: Other information about Cinryze
Maltese: Informazzjoni oħra dwar Cinryze
English: Cinryze contains the active substance C1 inhibitor (human).
Maltese: Cinryze fih is-sustanza attiva inibitur ta' C1 (uman).
English: This is a summary of the European public assessment report (EPAR) for Cinryze.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Cinryze.
English: The active substance in Cinryze, human C1 inhibitor, is a protein extracted from human blood.
Maltese: Is-sustanza attiva f'Cinryze, l-inibitur ta' C1 uman, hija proteina estratta mid-demm uman.
English: The C1 inhibitor protein is required to control the ‘complement' and ‘contact' systems, collections of proteins in the blood that fight against infection and cause inflammation.
Maltese: Il-proteina inibitur ta' C1 hija meħtieġa biex tikkontrolla s-sistemi ‘kumplementari' u tal-‘kuntatt', kollezzjonijiet ta' proteini fid-demm li jiġġieldu kontra l-infezzjoni u jikkawżaw l-infjammazzjoni.
English: Why has Cinryze been approved?
Maltese: Għaliex ġie approvat Cinryze?
English: The dose is reduced to 500 Units in children aged 2 to 11 years weighing 10 to 25 kg.
Maltese: Id-doża titnaqqas għal 500 unità fit- tfal ta' bejn 2 u 11-il sena li jiżnu bejn 10 u 25 kg.
English: Over 50% of patients receiving Cinryze had started having improvements 2 hours into treatment, compared with 33% of patients given placebo.
Maltese: Aktar minn 50% tal-pazjenti li kienu qegħdin jirċievu Cinryze kien beda jkollhom titjib sagħtejn wara l-kura, meta mqabbla ma' 33% tal-pazjenti li kienu ngħataw il-plaċebo.
English: Patients with low levels of this protein have excessive activity of these two systems, which leads to the symptoms of angioedema.
Maltese: Ilpazjenti b'livelli baxxi ta' din il-proteina għandhom attività eċċessiva ta' dawn iż-żewġ sistemi, li twassal għas-sintomi tal-anġjoedema.
English: Cinryze is a medicine used to treat angioedema (swelling) attacks in adults, adolescents and children over 2 years with hereditary angioedema.
Maltese: Cinryze hija mediċina li tintuża fil-kura tal-attakki tal-anġjodema (nefħa) fl-adulti, l-adoloxxenti u tfal minn 2 'il fuq li jkollhom anġjoedema ereditarja.
English: The average number of attacks experienced in patients treated with Cinryze was 6.1 over the 12-week period compared with 12.7 for patients on placebo.
Maltese: In-numru medju ta' attakki esperjenzati minn pazjenti li rċevew kura b'Cinryze kien ta' 6.1 fuq perjodu ta' 12-il ġimgħa meta mqabbla ma' 12.7 għall-pazjenti fuq il-plaċebo.
English: For prevention before a medical, dental or surgical procedure in adults, adolescents and children over 2 years and weighing more than 25 kg, Cinryze is given as 1,000 Units within the 24 hours before the procedure.
Maltese: Għall-prevenzjoni qabel intervent mediku, dentali jew kirurġiku fl-adulti, l-adoloxxenti u t-tfal minn sentejn 'il fuq u li jiżnu iktar minn 25 kg, Cinryze jingħata bħala 1000 unità fi żmien 24 siegħa qabel ilproċedura.
English: Based on the evidence from the studies, the CHMP concluded that Cinryze's benefits are greater than its risks and recommended that it be approved for use in the EU.
Maltese: Skont l-evidenza mill-istudji, is-CHMP ikkonkluda li l-benefiċċji ta' Cinryze huma akbar mir-riskji tiegħu u rrakkomanda li jkun approvat għall-użu fl-UE.
English: The second study, involving 24 patients from the first study, looked at the number of attacks over 12week periods when patients were given Cinryze or placebo as prevention.
Maltese: It-tieni studju, li involva 24 pazjent mill-ewwel studju, ħares lejn in-numru ta' attakki fuq perjodu ta' 12-il ġimgħa meta l-pazjenti kienu ngħataw Cinryze jew plaċebo bħala prevenzjoni.
English: Cinryze is also used for routine prevention in adults, adolescents and children from 6 years of age who have severe and frequent angioedema attacks for which prevention with oral medicines is not adequate or in patients whose attacks are not adequately treated.
Maltese: Cinryze jintuża wkoll għall-prevenzjoni ta' rutina fl-adulti, fl-adoloxxenti u fit-tfal minn 6 snin 'il fuq li jkollhom attakki tal-anġjoedema severi u frekwenti li għalihom il-prevenzjoni permezz ta' mediċini orali mhijiex adegwata jew f'pazjenti li l-attakki tagħhom mhumiex ikkurati b'mod adegwat.
English: The only common side effect seen in studies with Cinryze (seen in between 1 and 10 patients in 100) is rash, which is not serious and typically involves the arms, chest, abdomen or the injection site.
Maltese: L-uniku effett sekondarju komuni li deher fl-istudji b'Cinryze (li deher f'bejn 1 u 10 pazjenti minn kull 100) huwa raxx, li mhuwiex serju u normalment jinvolvi d-dirgħajn, is-sider, l-addome jew is-sit talinjezzjoni.
English: For the full list of all side effects and restrictions with Cinryze, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet kollha b'Cinryze, ara l-fuljett ta' tagħrif.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Cinryze on 15 June 2011.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Cinryze valida madwar l-Unjoni Ewropea fil-15 ta' Ġunju 2011.
English: What are the risks associated with Cinryze?
Maltese: X'inhuma r-riskji assoċjati ma' Cinryze?
English: The dose is reduced to 500 Units in children aged 2 to 11 years weighing 10 to 25 kg. For routine prevention in adults and adolescents, Cinryze is given as 1,000 Units every 3 or 4 days.
Maltese: Għall-prevenzjoni ta' rutina fl-adulti u l-adoloxxenti, Cinryze jingħata bħala 1,000 unità kull 3 jew 4 ijiem.
English: The company that makes Cinryze will ensure that healthcare professionals in all Member States who are expected to prescribe Cinryze are provided with an educational pack instructing them to ensure that caregivers and patients who will give the medicine at home are properly trained.
Maltese: Il-kumpanija li tagħmel Cinryze sejra tiżgura li l-professjonisti tal-kura tas-saħħa fl-Istati Membri kollha li huma mistennija li jippreskrivu Cinryze jiġu pprovduti b'pakkett edukattiv li javżahom biex jiżguraw li l-pazjenti u dawk li jieħdu ħsiebhom li sejrin jagħtu l-mediċina d-dar ikunu mħarrġa sew.
English: In the first study, Cinryze or placebo (a dummy treatment) were used to treat angioedema attacks in 71 patients.
Maltese: Fl-ewwel studju, Cinryze jew il-plaċebo (kura finta) intużaw fil-kura ta' attakki ta' anġjoedema f'71 pazjent.
English: The average number of attacks during 12 weeks of treatment with Cinryze was reduced compared with the period before Cinryze and the attacks were less severe, did not last as long and required less treatment.
Maltese: In-numru medju ta' attakki matul 12-il ġimgħa ta' kura b'Cinryze tnaqqas meta mqabbel mal-perjodu qabel Cinryze u lattakki kienu inqas severi, ma damux daqshekk u ħtieġu inqas kura.
English: In the second study, Cinryze was given as prevention to 6 children with hereditary angioedema.
Maltese: Fit-tieni studju, Cinryze ingħata bħala prevenzjoni lil sitt itfal b'anġjodema ereditarja.
English: How is Cinryze used?
Maltese: Kif jintuża Cinryze?
English: For treatment of angioedema attacks in adults, adolescents and children over 2 years and weighing more than 25 kg, the patient is given 1,000 Units at the first sign of an angioedema attack.
Maltese: Għall-kura tal-attakki tal-aġjodema fl-adulti, l-adoloxxenti u t-tfal minn sentejn 'il fuq u li jiżnu iktar minn 25 kg, il-pazjent jingħata 1,000 unità fl-ewwel sinjal ta' attakk tal-anġjodema.
English: The company provided data on the use of Cinryze in 91 adults and children with hereditary angioedema to prevent attacks when undergoing a medical, surgical or dental procedure.
Maltese: Il-kumpanija pprovdiet ukoll data dwar l-użu ta' Cinryze f'91 adult u tfal b'anġjodema ereditarja biex jipprevjeni attakki waqt intervent mediku, kirurġiku jew dentali. Cinryze kien ukoll effettiv filprevenzjoni ta' attakki attivati permezz ta' dawn il-proċeduri, bi 98% tal-interventi li ma jattivawx attakk fi żmien 72 siegħa.
English: Cinryze was more effective than placebo in treating and preventing attacks of angioedema in two main studies involving patients with hereditary angioedema, most of whom were adults.
Maltese: Fl-ewwel studju, Cinryze intuża wkoll biex jikkura l-attakki tal-anġjodema f'disat itfal b'anġjodema ereditarja.
English: It is also used to prevent angioedema attacks that can be triggered by medical, dental or surgical procedures.
Maltese: Jintuża fil-prevenzjoni tal-attakki tal-anġjoedema li jistgħu jiġu attivati permezz ta' interventi mediċi, dentali jew kirurġiċi.
English: Treatment should be started under the supervision of a doctor experienced in treating hereditary angioedema.
Maltese: Il-kura għandha tinbeda u tkun taħt is-superviżjoni ta' tabib b'esperjenza fil-kura tal-anġjoedema ereditarja.
English: A second dose of 1,000 Units may be given if the patient has not responded adequately after one hour, or sooner for attacks in the larynx (voice box) or if the start of the treatment had been delayed.
Maltese: It-tieni doża ta' 1,000 unità tista' tingħata jekk il-pazjent ma rrispondiex b'mod adegwat wara siegħa, jew aktar malajr għal attakki fil-larinġi (kaxxa vokali) jew jekk il-bidu tal-kura kien ġie ttardjat.
English: Route of administration
Maltese: Metodu ta' Amministrazzjoni
English: Meat and offal: cattle: 22 days.
Maltese: Laħam u interjuri: 22 ġurnata
English: Subcutaneous use Vial (glass) 500 ml
Maltese: Użu taħt il-ġilda Kunjett (hġieġ)
English: Cattle
Maltese: Baqar
English: Target species
Maltese: Speċi
English: Packaging Content Package size
Maltese: Ippakkjar Kontenut Daqs tal-Ippakk jar
English: EMA/296055/2010 EMEA/V/C/002232
Maltese: EMEA/V/C/002232
English: Canine vaccine against Leishmania infantum adjuvanted
Maltese: Vaċċin għall-klieb kontra Leishmania infantum adjuvat
English: Leishmania infantum is a parasite that causes leishmaniosis.
Maltese: Leishmania infantum huwa parassita li jikkawża leishmaniosis.
English: CaniLeish contains an ‘adjuvant' (a highly purified fraction of Quillaja saponaria) to enhance the immune response.
Maltese: CaniLeish fih ‘adjuvant' (frazzjoni ppurifikata ħafna ta' Quillaja saponaria) biex isaħħaħ ir-rispons immunitarju.
English: After vaccination transient antibodies against leishmania detected by immunofluorescence antibody test (IFAT) may appear but do not reflect an active infection.
Maltese: Wara t-tilqim jistgħu jidhru antikorpi tranżitorji kontra leishmania li jinstabu permezz ta' test antikorpi immunofluworixxenti (IFAT) iżda ma jirriflettux infezzjoni attiva.
English: CaniLeish is to be used only in ‘leishmania-negative' dogs.
Maltese: CaniLeish għandu jintuża biss fi klieb ‘negattivi għal leishmania'.
English: This summary was last updated on 14/03/2011.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar fi 14/03/2011.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for CaniLeish to Virbac S.A. on 14/03/2011.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida madwar l-Unjoni Ewropea għal CaniLeish lil Virbac S.A. fil-14/03/2011.
English: Other temporary signs commonly seen following vaccination can also occur such as hyperthermia (raised body temperature), apathy (lack of vitality) and digestive disorders lasting one to six days.
Maltese: Jista' jkun hemm ukoll sinjali temporanji oħrajn li normalment jintwerew wara t-tilqim bħal ipertermija (temperatura għolja tal-ġisem), apatija (nuqqas ta' vitalità) u disturbi diġestivi li jdumu minn jum sa sitt ijiem.
English: If you want more information on the basis of the CVMP recommendations, read the Scientific Discussion (also part of the EPAR).
Maltese: Jekk trid aktar informazzjoni abbażi tar-rakkomandazzjonijiet tas-CVMP, aqra dDiskussjoni Xjentifika (parti wkoll mill-EPAR).
English: The CVMP concluded that the benefits of CaniLeish outweigh the risks for the active immunisation of leishmania-negative dogs from six months of age to reduce the risk to develop an active infection and clinical disease after contact with Leishmania infantum and recommended that CaniLeish be given a marketing authorisation.
Maltese: Is-CVMP ikkonkluda li l-benefiċċji ta' CaniLeish huma akbar mir-riskji għat-tilqim attiv ta' klieb negattivi għal leishmania minn sitt xhur 'il fuq biex jitnaqqas ir-riskju li jiżviluppaw infezzjoni attiva u mard kliniku wara kuntatt ma' Leishmania infantum u rrakkomanda li CaniLeish jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: Why has CaniLeish been approved?
Maltese: Għaliex ġie approvat CaniLeish?
English: What is CaniLeish?
Maltese: X'inhu CaniLeish?
English: CaniLeish is a vaccine.
Maltese: CaniLeish huwa vaċċin.
English: It contains Leishmania infantum excreted secreted proteins (ESP).
Maltese: Huwa fih proteini mnixxija u mneħħija (ESP) ta' Leishmania infantum.
English: After injection, some dogs can have moderate and temporary local reactions, such as swelling, nodule (hardening), pain on palpation or erythema (reddening).
Maltese: Wara l-injezzjoni, xi klieb jista' jkollhom reazzjonijiet lokali moderati u temporanji, bħal nefħa, noduli (għebusija), uġigħ ma' palpitazzjoni (meta tintmiss) jew eritema (ħmura).
English: The safety of the vaccine was studied in two main laboratory safety studies carried out in leishmania-free dogs (overdose and single and repeated administration) and one field trial.
Maltese: Is-sigurtà tal-vaċċin ġiet studjata f'żewġ studji ta' sigurtà prinċipali fil-laboratorju li twettqu fi klieb mingħajr leishmania (mod kif jingħata b'doża eċċessiva u singola u ripetuta) u prova waħda fil-post.
English: The efficacy of vaccination in dogs already infected was not investigated and therefore cannot be recommended.
Maltese: L-effikaċja tat-tilqima fil-klieb li jkunu diġà infettati ma ġietx investigata u għaldaqstant ma tistax tkun rakkomandata.
English: CaniLeish is used to vaccinate dogs from six months of age to reduce the risk of developing an active infection and clinical disease after contact with Leishmania infantum.
Maltese: CaniLeish jintuża għat-tilqim tal-klieb minn sitt xhur 'il fuq biex jitnaqqas ir-riskju li jiżviluppaw infezzjoni attiva u mard kliniku wara kuntatt m'a' Leishmania infantum.
English: A number of laboratory trials where dogs were submitted to experimental infection were also presented.
Maltese: Ġew ippreżentati numru ta' provi fil-laboratorju fejn il-klieb kienu sottoposti għal infezzjoni esperimentali.
English: What is the risk associated with CaniLeish?
Maltese: Għalxiex jintuża CaniLeish?
English: How has CaniLeish been studied?
Maltese: Kif ġie studjat CaniLeish?
English: The parasite is transmitted from an infected dog to a non-infected dog by the bites of sand flies.
Maltese: Il-parassita tiġi trasmessa minn kelb infettat lil kelb mhux infettat bil-gdim tannemus.
English: Other information about CaniLeish:
Maltese: Tagħrif ieħor dwar CaniLeish:
English: In the future, if the animals are exposed to Leishmania infantum parasite, the immune system will be able to respond more quickly.
Maltese: Kemm-il darba fil-ġejjieni l-annimali jkunu esposti għall-parassita Leishmania infantum, is-sistema immunitarja tkun kapaċi tirreaġixxi aktar malajr.
English: The benefit of the vaccination was assessed in zones with a high risk of infection where it has been shown in leishmania free dogs to decrease the risk of developing an active infection and a symptomatic disease after contact with the parasite.
Maltese: Il-benefiċċju tat-tilqim ġien vvalutat f'żoni b'riskju għoli ta' infezzjoni fejn intwera li fi klieb mingħajr leishmania jnaqqas ir-riskju li jiżviluppaw infezzjoni attiva u marda sintomatika wara kuntatt mal-parassita.
English: The efficacy of the vaccine was studied in one main field trial that lasted for two years involving vaccinated and control dogs submitted to natural exposure to infection in zones where there is a high risk of infection.
Maltese: L-effikaċja tal-vaċċin ġiet studjata fi prova waħda prinċipali fil-post li damet sentejn li ħadu sehem fiha klieb imlaqqmin u kkontrollati sottoposti għal esponiment naturali għal infezzjoni f'żoni fejn hemm riskju għoli ta' infezzjoni.
English: Allergic-type reactions are uncommon and if a dog shows signs of an allergic reaction, they should be given appropriate symptomatic treatment.
Maltese: Mhumiex komuni reazzjonijiet tat-tip allerġiċi u jekk kelb juri sinjali ta' reazzjoni allerġika, għandhom jingħataw kura sintomika adatta.
English: CaniLeish is a vaccine that contains a number of proteins that are released from the Leishmania infantum parasite during its growth.
Maltese: CaniLeish huwa vaċċin li fih numru ta' proteini li jiġu rilaxxati mill-parassita Leishmania infantum waqt li jkun jikber.
English: Infected dogs play a central role in the accidental transmission of parasites to humans.
Maltese: Klieb infettati għandhom rwol prinċipali fit-trasmissjoni aċċidentali ta' parassiti lill-bnedmin.
English: 10 November 2017 EMA/727596/2017 EMEA/H/C/004165
Maltese: 10 ta' Novembru 2017 EMA/727596/2017 EMEA/H/C/004165
English: Withdrawal of the marketing authorisation application for Plivensia (sirukumab) EMA/727596/2017
Maltese: (sirukumab) EMA/727596/2017
English: What is Plivensia?
Maltese: X'inhu Plivensia?
English: Plivensia is a medicine that contains the active substance sirukumab.
Maltese: Plivensia huwa mediċina li fiha s-sustanza attiva sirukumab.
English: The active substance in Plivensia, sirukumab, is a monoclonal antibody, a type of protein which has been designed to block a molecule called interleukin-6.
Maltese: Is-sustanza attiva f'Plivensia, is-sirukumab, hija antikorp molekulari, tip ta' proteina li tfasslet apposta biex timblokka riċettur fil-ġisem imsejjaħ interleukin-6.
English: The main measure of effectiveness was a reduction in symptoms of 20% or more, based on a standard rating score (ACR-20), after 16 weeks of treatment.
Maltese: Il-kejl ewlieni għall-effikaċja kien tnaqqis fis-sintomi ta' 20% jew iktar, skont punteġġ tal-klassifikazzjoni standard (ACR-20) wara 16-il ġimgħa ta' kura.
English: The company presented data from three main studies involving over 3,000 patients.
Maltese: Il-kumpanija ppreżentat data minn tliet studji ewlenin li involvew 'il fuq minn 3000 pazjent.
English: On 26 October 2017, Janssen-Cilag International NV officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Plivensia, for the treatment of rheumatoid arthritis.
Maltese: Fis 26 ta' Ottubru 2017, Janssen-Cilag International NV għarrfet uffiċjalment lill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) bl-intenzjoni li tirtira l-applikazzjoni tagħha għallawtorizzazzjoni għat-tqegħid fis-suq għal Plivensia, għall-kura ta' artrite rewmatojde.
English: It was to be available as a solution for injection in pre-filled pens and syringes (50 mg).
Maltese: Dan kellu jiġi bħala soluzzjoni għallinjezzjoni f'pinen u f'siringi mimlijin għal-lest (50 mg).
English: The third study compared Plivensia with adalimumab (a monoclonal antibody targeting a chemical messenger called tumour necrosis factor - TNF) in patients who could not take methotrexate or whose condition had not responded adequately to methotrexate; the study looked at the improvement in how patients' joints worked (based on a standard rating score called DAS28-ESR) after 24 weeks of treatment.
Maltese: It-tielet studju qabbel Plivensia ma' adalimumab (antikorp monoklinali li jimmira messaġġier kimiku msejjaħ fattur ta' nekrożi ta' tumur - TNF) f'pazjenti li ma setgħux jieħdu methotrexate jew li lkundizzjoni tagħhom ma rrispondietx b'mod adegwat għal methotrexate; l-istudju ħares lejn it-titjib filmod li jaħdmu l-ġogi tal-pazjenti (skont punteġġ tal-klassifikazzjoni msejjaħ DAS28-ESR) wara 24 ġimgħa ta' kura.
English: What was Plivensia expected to be used for?
Maltese: Għal xiex kien mistenni li jintuża Plivensia?
English: By blocking interleukin-6, sirukumab reduces inflammation and other symptoms associated with rheumatoid arthritis.
Maltese: Billi jimblokka interleukin-6, is-sirukumab inaqqas l-infjammazzjoni u sintomi oħra assoċjati mal-artrite rewmatojde.
English: Withdrawal of the marketing authorisation application for Plivensia (sirukumab)
Maltese: L-irtirar tal-applikazzjoni għall-awtorizzazzjoni għattqegħid fis-suq għal Plivensia (sirukumab)
English: Two studies compared Plivensia with placebo (a dummy treatment) in patients with moderate to severe rheumatoid arthritis for whom treatment with a DMARD or with an anti-TNF agent (another type of medicine for rheumatoid arthritis) had not worked well enough or had led to troublesome side effects.
Maltese: Żewġ studji qabblu Plivensia ma' plaċebo (kura finta) f'pazjenti b'artrite rewmatojde moderata sa severa li għalihom il-kura b'DMARD jew b'aġenti anti-TNF (tip ta' mediċina oħra għall-artrite rewmatojde) ma ħadmux tajjeb biżżejjed jew wasslu għal effetti sekondarji inkwetanti.
English: Plivensia was expected to be used in adults with moderate to severe rheumatoid arthritis, a disease that causes inflammation of the joints.
Maltese: Plivensia kien mistenni li jintuża f'adulti b'artrite rewmatojde moderata sa severa, marda li tikkawża infjammazzjoni tal-ġogi.
English: Interleukin-6 is involved in causing inflammation and is found at high levels in the joints of patients with rheumatoid arthritis.
Maltese: Interleukin-6 huwa involut fl-ikkawżar ta' infjammazzjoni u jinsab f'livelli għoljin fil-ġogi ta' pazjenti li jbatu minn artrite rewmatojde.
English: In its letter notifying the Agency of the withdrawal of the application, the company stated that, given the need for additional clinical data and the fact that other treatments blocking the action of interleukin-6 are available, it wishes to prioritise other programs in its portfolio.
Maltese: Fl-ittra tagħha biex tinnotifika lill-Aġenzija bl-irtirar tal-applikazzjoni, il-kumpanija ddikjarat li, minħabba l-bżonn għal data klinika addizzjonali u l-fatt li hemm disponibbli kuri oħra li jimblukkaw lazzjoni ta' interleukin-6, hi tixtieq tipprijoritizza programmi oħra fil-portafoll tagħha.
English: The medicine was to be used in patients when treatment with one or more medicines known as disease-modifying anti-rheumatic drugs (DMARDs) had not worked well enough or had led to troublesome side effects.
Maltese: Il-mediċina kellha tintuża f'pazjenti meta kura b'mediċina waħda jew aktar magħrufin bħala mediċini antirewmatiċi li jimmodifikaw il-marda (DMARDs) ma jkunux ħadmu jew kienu wasslu għal effetti sekondarji inkwetanti.
English: 3641 RT Mijdrecht Nederland
Maltese: 3641 RT Mijdrecht Olanda
English: Streptococcus Groups A, B, C, G
Maltese: Streptococcus Gruppi A, B, C, G
English: 1123 Budapest Hungary
Maltese: 1123 Budapest Ungerija