FrancophonIA/ELRC3.0 huggingface dataset:
English: Bluetongue virus inactivated, serotype 8:
Maltese: Virus inattivat tal-Bluetongue, serotip 8:
English: *(Cycling value (Ct) ≥ 36 by a validated RT-PCR method, indicating no presence of viral genome) Onset of immunity:
Maltese: *(Valur ta' ċiklaġġ (Ct) ≥ 36 b'metodu RT-PCR ivvalidat, li jindika li m' hemm ebda preżenza ta' genome virali) Bidu tal-immunità:
English: BTV 8 antigen ……… 106.5 CCID50/ml.
Maltese: Antiġen ta' BTV8 ............... 106.5
English: BLUEVAC BTV8 suspension for injection for cattle and sheep
Maltese: VETERINARJU BLUEVAC BTV8 suspensjoni għal injezzjoni għal frat u nagħaġ
English: According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council as amended, a Member State may, in accordance with its national legislation, prohibit the manufacture, import, possession, sale, supply and/or use of immunological veterinary medicinal products on the whole or part of its territory if it is established that:
Maltese: Skont l-Artikolu 71 tad-Direttiva 2001/82/KE tal-Parlament Ewropew u tal-Kunsill, kif emendata, Stat Membru jista', skont il-liġijiet nazzjonal tiegħu, jipprojbixxi l-manifattura, l-importazzjoni, il-pussess, il bejgħ, il-forniment u/jew l-użu ta' prodotti mediċinali veterinarji immunoloġiċi fit-territorju sħiħ tiegħu jew parti minnu jekk jiġi stabbilit illi:
English: Sheep
Maltese: UŻU
English: NAME OF THE VETERINARY MEDICINAL PRODUCT
Maltese: Kodiċijiet veterinarji
English: In this category of animals the vaccine should be used only according to the benefit-risk assessment by the responsible veterinarian and/or National competent authorities on the current vaccination policies against bluetongue virus (BTV).
Maltese: F'din il-kategorija ta' annimali, il-vaċċin għandu jintuża biss skont il-valutazzjoni ta' benefiċċju/riskju minn veterinarju responsabbli u/jew mill-Awtoritajiet Kompetenti nazzjonali dwar il-politika attwali ta' tilqim kontra lVirus tal-Bluetongue (BTV).
English: For the active immunisation of cattle from 2.5 months of age to prevent viraemia* caused by bluetongue virus serotype 8.
Maltese: Għat-tilqim attiv ta' frat minn età ta' 2.5 xahar biex tkun impeduta viremija* kkawżata minn virus talbluetongue serotip 8.
English: Batch: {number}
Maltese: {numru}
English: An average increase in body temperature varying between 0.5 and 1.0 ºC is a common reaction observed in sheep and cattle.
Maltese: Żieda medja fit-temperatura tal-ġisem li tvarja bejn 0.5 u 1.0 ºC hija reazzjoni komuni osservata fin nagħaġ u l-frat.
English: 100 ml 252 ml
Maltese: Flixkun ta' 100 ml u 252 ml
English: Box of 1 bottle of 52 ml Box of 1 bottle of 100 ml Box of 1 bottle of 252 ml.
Maltese: flixkun 1 ta' 52 ml flixkun 1 ta' 100 ml flixkun 1 ta' 252 ml
English: It lasts not longer than 24 to 48 hours.
Maltese: Din iddum mhux aktar minn 24 sa 48 siegħa.
English: *(Cycling value (Ct) ≥ 36 by a validated RT-PCR method, indicating no presence of viral genome)
Maltese: *(Valur ta' ċiklaġġ (Ct) ≥ 36 b'metodu RT-PCR ivvalidat, li jindika li ma hemm ebda preżenza ta'
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu).
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediku veterinarju tinstab fuq il-websajt tal-Aġenzija Ewropea għall-Mediċini (http://www.ema.europa.eu/)
English: Each ml of vaccine contains: Bluetongue virus inactivated, serotype 8
Maltese: Kull ml tal-vaċċin fih: Virus tal-bluetongue mhux attivat, serotip 8
English: Pharmacotherapeutic group: bluetongue virus vaccine, inactivated.
Maltese: Vaċċin tal-virus tal-bluetongue, inattivat
English: Painless swellings occur occasionally with a size up to 2 cm in sheep and up to 4.5 cm in cattle after a double dose.
Maltese: Xi drabi jista' jkun hemm nefħa mingħajr uġigħ ta' daqs sa 2 cm fin nagħaġ u sa 4.5 cm fil-frat wara doża doppja.
English: Detailed information on this product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Maltese: Informazzjoni dettaljata dwar dan il-prodott tinstab fuq il-websajt tal-Aġenzija Ewropea għall-Mediċini (http://www.ema.europa.eu/)
English: No information is available on the use of the vaccine in seropositive bovines, including those with maternally derived antibodies.
Maltese: M'hemm l-ebda informazzjoni disponibbli dwar l-użu tal-vaċċin f´bhejjem seropożittivi, inkluż dawk b'antikorpi li ġejjin mill-omm.
English: Suspension for injection White or pinkish-white.
Maltese: suspensjoni għal injezzjoni għal frat u nagħaġ
English: CZ Veterinaria, S.A. La Relva s/n 36400 Porriño Spanien
Maltese: CZ Veterinaria, S.A. La Relva s/n 36400
English: CZ Veterinaria, S.A. La Relva s/n, 36400 Porriño SPAIN
Maltese: CZ Veterinaria, S.A. La Relva s/n, 36400
English: Any revaccination scheme should be agreed by the competent authority or by the responsible veterinarian, taking into account the local epidemiological situation.
Maltese: Kull skema ta' tilqim mill-ġdid għandu jsir qbil fuqha mill-Awtorità Kompetenti jew mill-veterinarju responsabbli, filwaqt li tiġi kkunsidrata s-sitwazzjoni epidemjoloġika lokali.
English: Occasionally, the presence of maternally derived antibodies in ovines of minimum recommended age might interfere with the protection induced by the vaccine.
Maltese: F'ċerti każijiet, il-preżenza ta' antikorpi dderivati mill-omm f'ovini ta' età minima rrakkomandata jistgħu jinterferixxu mal-protezzjoni pprovduta mit-tilqima.
English: A. LABELLING
Maltese: IT-TEST
English: Cardboard box with 1 bottle containing either 126 sheep doses or 63 cattle doses (252 ml).
Maltese: Kaxxa tal-kartun bi flixkun wieħed li fih jew 126 doża għan-nagħaġ jew 63 doża għall-frat (252 ml)
English: CZ Veterinaria, S.A. 36400 Porriño SPAIN
Maltese: 36400 Porriño SPANJA
English: a) the administration of the product to animals will interfere with the implementation of a national programmes for the diagnosis, control and/or eradication of animal diseases, or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals.
Maltese: a) l-għotja tal-prodott lill-annimali tinterferixxi mal-implimentazzjoni ta' programm nazzjonali għad djanjosi, il-kontroll jew l-eradikazzjoni tal-mard tal-annimali, jew tikkawża diffikultajiet fiċ ċertifikazzjoni tal-assenza tal-kontaminazzjoni f'annimali ħajjin jew fl-ikel jew prodotti oħrajn li jiġu minn annimali kkurati;
English: CZ Veterinaria, S.A. La Relva s/n 36400 Porriño España
Maltese: CZ Veterinaria, S.A. La Relva s/n P.O. Box 16 36400
English: For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder.
Maltese: Mediċina veterinarja li ma ġietx użata jew materjal ta' skart minn tali prodotti mediċinali veterinarji għandhom jintremew skont ir-rekwiżiti lokali.
English: For the active immunisation of sheep from 2.5 months of age to prevent viraemia* and to reduce clinical signs caused by bluetongue virus serotype 8.
Maltese: Għat-tilqim attiv tan-nagħaġ minn età ta' 2.5 xahar biex tkun impeduta viremija* u biex jitnaqqsu s-sinjali kliniċi kkawżati minn virus tal-bluetongue serotip 8. *(Valur ta' ċiklaġġ (Ct) ≥ 36 b'metodu RT-PCR ivvalidat, li jindika li ma hemm ebda preżenza ta' genom virali) Bidu tal-immunità:
English: Cattle
Maltese: Frat
English: Oral solution bottle (HDPE) 180 ml
Maltese: Soluzzjoni orali flixkun (HDPE) 180 ml
English: 1 bottle + 1 syringe
Maltese: 1 flixkun + 1 siringa
English: Strength Pharmaceutical form Route of administration
Maltese: Għamla farmaċewtika
English: Jatros Gastroenterol, 1993” (Study S2)”, and
Maltese: Jatros Gastroenterol, 1993” (Studju S2)”, u
English: Data, however, were not controlled.
Maltese: Madankollu, id-data ma kinitx ikkontrollata.
English: Supplementary Integrated Clinical Study Report Final PAZ 9527-5-S2”, of the study conducted in 1988 in Germany entitled “Schaffstein, W. and Burkard, I.: Symbioflor 2 - Eine therapeutische Alternative zur Behandlung des irritablen Kolons.
Maltese: Rapport ta' Studju Kliniku Integrat Supplimentari Finali PAZ 9527-5-S2”, tal-istudju li sar fl-1988 fil-Ġermanja bl-isem ta' “Schaffstein, W. and Burkard, I.: Symbioflor 2 - Eine therapeutische Alternative zur Behandlung des irritablen Kolons.
English: • Regulation of the immune system, gastrointestinal disorders, irritable bowel syndrome (DE).
Maltese: • Regolazzjoni tas-sistema immunitarja, distubi gastrointestinali, sindrome tal-musrana irritabbli (DE).
English: • To regulate the immune system (immune-regulation): functional disturbances of the gastrointestinal system (HU).
Maltese: • Sabiex jirregola s-sistema immunitarja (regolazzjoni tal-immunità): disturbi funzjonali tas-sistema gastrointestinali (HU).
English: • Functional disturbances of the gastrointestinal tract and irritable bowel syndrome (Colon irritable) (AT).
Maltese: • Disturbi funzjonali tal-apparat gastrointestinali u sindrome tal-musrana irritabbli (Irritabbli għallkolon) (AT).
English: • The CHMP considered the procedure under Article 31 of Directive 2001/83/EC for Symbioflor 2 (Escherichia coli bacteria (cells and autolysate)) and associated names (Symbioflor 2);
Maltese: • Is-CHMP ikkunsidra l-proċedura skont l-Artikolu 31 tad-Direttiva 2001/83/KE għal Symbioflor 2 (batterja Escherichia coli (ċelluli u awtoliżat) u l-ismijiet assoċjati (Symbioflor 2);
English: Indication in the treatment of functional gastrointestinal disorders
Maltese: Indikazzjoni fil-kura ta' disturbi gastrointestinali funzjonali
English: The marketing authorisations were granted in Austria in 2000 (renewed on 12 February 2014) and in 2003 in Hungary (HU) respectively.
Maltese: L-awtorizzazzjonijiet għat-tqegħid fis-suq fl-Awstrija ngħataw fl-2000 (iġġeddu fit-12 ta' Frar 2014) u fl-Ungerija fl-2003 (HU) rispettivament.
English: “Functional gastrointestinal disorders” defines a heterogeneous group of individual diseases, ranging from functional oesophageal, gastric, intestinal, biliary, pancreatic to functional anorectal disorders, with a wide range of different underlying pathophysiologies and symptomatic entities that require different treatment modalities.
Maltese: “Disturbi gastrointestinali funzjonali” tiddefinixxi grupp eteroġeneu ta' mard individwali, li jvarja minn disturbi esofogali, gastriċi, intestinali, biljari, pankreatiċi funzjonali sa disturbi anorettali funzjonali, b'firxa wiesgħa ta' patofiżjoloġiji sottostanti u entitajiet sintomatiċi differenti li jeħtieġu modalitajiet ta' kura differenti.
English: Indication in the treatment of irritable bowel syndrome
Maltese: Indikazzjoni fil-kura ta' sindrome tal-musrana irritabbli
English: Symbioflor 2 has been marketed in Germany since 1954 and in Austria since 1975.
Maltese: Symbioflor 2 ilu mqiegħed fis-suq filĠermanja mill-1954 u fl-Awstrija mill-1975.
English: • A 2005 re-analysis of a 1988 study “Efficacy and tolerability of Symbioflor2: A randomised, multicentre, double-blind, placebo-controlled trial in 298 patients with irritable bowel syndrome treated continuously for 8 weeks with Symbioflor 2 (clinical phase IV).
Maltese: • Analiżi mill-ġdid fl-2005 ta' studju li sar fl-1988 “L-effikaċja u t-tollerabbiltà ta' Symbioflor 2: Prova randomizzata, multiċentrika, double-blind, ikkontrollata bil-plaċebo f'298 pazjent b'sindrome talmusrana irritabbli kkurati kontinwament għal 8 ġimgat b'Symbioflor 2 (fażi klinika IV).
English: On 30 March 2016 Germany triggered a referral under Article 31 of Directive 2001/83/EC, and requested the CHMP to assess the benefit-risk balance of Symbioflor 2 in the claimed indications ("functional gastrointestinal disorders'', "irritable bowel syndrome") and to issue an opinion on whether the relevant marketing authorisations should be maintained, varied, suspended or revoked.
Maltese: Fit-30 ta' Marzu 2016, il-Ġermanja tat bidu għal riferiment skont l-Artikolu 31 tadDirettiva 2001/83/KE, u talbet lis-CHMP jivvaluta l-bilanċ bejn il-benefiċċju u r-riskju ta' Symbioflor 2 fl-indikazzjonijiet iddikjarati (“disturbi gastrointestinali funzjonali”, “sindrome tal-musrana irritabbli”) u biex tinħareġ opinjoni dwar jekk l-awtorizzazzjonijiet għat-tqegħid fis-suq rilevanti għandhomx jinżammu, jiġu varjati, jiġu sospiżi jew jiġu revokati.
English: In the clinical development program, there were respectively 50 adverse drug reactions reported in the Symbioflor 2 group, and 44 in the placebo group for Study S2 in 79 patients.
Maltese: Fil-programm ta' żvilupp kliniku, hemm 50 reazzjoni avversa għal mediċini rispettivament irrappurtati fil-grupp ta ' Symbioflor 2, u 44 fil-grupp tal-plaċebo għall-Istudju S2 f'79 pazjent.
English: Symbioflor 2 (Escherichia coli bacteria (cells and autolysate)) and associated names (Symbioflor 2) is a probiotic containing living Escherichia coli bacteria, which exist in normal gut flora in humans.
Maltese: Symbioflor 2 (batterja Escherichia coli (ċelluli u awtoliżat)) u l-ismijiet assoċjati (Symbioflor 2) huwa probijotiku li fih batterja Escherichia coli ħajja, li teżisti fil-flora tal-imsaren normali fil-bnedmin.
English: Symbioflor 2 is composed of 10 different isolates of Escherichia coli which are partly autolysed and partly presented as living bacteria.
Maltese: Symbioflor 2 huwa magħmul minn 10 iżolati differenti ta' Escherichia coli li huma parzjalment awtoliżati u parzjalent preżenti bħala batterja ħajja.
English: Finally, the CHMP noted that the total number of reports was low, and as per the Weber effect, a decline in reporting of adverse events is likely over time.
Maltese: Finalment, is-CHMP innota li n-numru totali ta' rapporti kien baxx, u skont l-effett ta' Weber, huwa probabbli li maż-żmien ikun hemm tnaqqis fir-rappurtar ta' avvenimenti avversi.
English: Symbioflor 2 is currently used for the indications:
Maltese: Bħalissa Symbioflor 2 qed jintuża għall-indikazzjonijiet:
English: Symbioflor 2 is available in the European Union (EU) in Austria (AT), Germany (DE) and Hungary (HU) as a medicine not subject to prescription or over-the-counter (OTC).
Maltese: Symbioflor 2 huwa disponibbli fl-Unjoni Ewropea (UE) fl-Awstrija (AT), fil-Ġermanja (DE) u fl-Ungerija (HU) bħala mediċina mhux bir-riċetta ta' tabib jew li tinxtara mingħajr riċetta ta' tabib (OTC, over-the-counter).
English: • Acknowledging the limitations of the established efficacy profile of Symbioflor 2, the CHMP requested the MAH to conduct a well-designed and adequately powered multi-centre, double blind, randomised, placebo controlled post approval efficacy study allowing for relevant subpopulation analyses to confirm the efficacy of Symbioflor 2 in the treatment of IBS in general versus subtypes of the disease such as IBS C and IBS D, gender, disease severity and address the sustainability of efficacy to confirm the efficacy of Symbioflor 2 in IBS;
Maltese: • Filwaqt li jiġu rikonoxxuti l-limitazzjonijiet tal-profil tal-effikaċja stabbilit ta' Symbioflor 2, is-CHMP talab lill-MAH biex iwettaq studju dwar l-effikaċja mfassal tajjeb u b'mod adegwat ibbażat fuq diversi ċentri, double-blind, randomizzat, ikkontrollat bil-plaċebo ta' wara l-approvazzjoni li jippermmetti lill-analiżijiet tas-sottopopolazzjoni rilevanti biex jikkonfermaw l-effikaċja ta' Symbioflor 2 fil-kura tal-IBS inġenerali kontra sottotipi tal-marda bħal IBS C u IBS D, sess, severità tal-marda u jindirizzaw is-sostenibbiltà tal-effikaċja biex jikkonfermaw l-effikaċja ta' Symbioflor 2 fl-IBS.
English: • An observational non-interventional study in 203 children and adolescents conducted between 2007 and 2008 in Germany “Efficacy and tolerability of Symbioflor 2 in children with Irritable Bowel Syndrome”.
Maltese: • Studju ta' bla intervent ta' osservazzjoni f'203 itfal u adoloxxenti li sar bejn l-2007 u l-2008 filĠermanja “L-effikaċja u t-tollerabbiltà ta' Symbioflor 2 fi tfal b'Sindrome tal-Musrana Irritabbli”.
English: • The CHMP reviewed all available data from clinical studies, published literature, post-marketing experience, including responses and communications submitted by the MAH in writing, on the efficacy and safety of Symbioflor 2 in their proposed indications and sought as well views of the ad hoc expert group on Symbioflor 2;
Maltese: • Is-CHMP irrieżamina d-data kollha disponibbli minn studji kliniċi, letteratura ppubblikata, esperjenza ta' wara t-tqegħid fis-suq, inkluż risponsi u komunikazzjonijiet ippreżentati mill-MAH bil-miktub, dwar l-effikaċja u s-sigurtà ta' Symbioflor 2 fl-indikazzjonijiet proposti tagħhom u fittex ukoll fehmiet tal-grupp ta' esperti ad hoc dwar Symbioflor 2;
English: • The CHMP considered that “functional gastrointestinal disorders” is a heterogeneous group of individual diseases with a wide range of different underlying pathophysiologies and symptoms that require different treatment modalities.
Maltese: • Is-CHMP ikkunsidra li “disturbi gastrointestinali funzjonali” huwa grupp eteroġeneu ta' mard individwali b'firxa wiesgħa ta' patofiżjoloġiji sottostanti u entitajiet sintomatiċi differenti li jeħtieġu modalitajiet ta' kura differenti.
English: The CHMP acknowledged the deletion of the indication “functional gastrointestinal disorders” during this procedure.
Maltese: Is-CHMP irrikonoxxa t-tneħħija tal-indikazzjoni “disturbi gastrointestinali funzjonali” matul din il-proċedura.
English: In 2005, based on the evaluation of the available evidence at that time in the claimed indications ("functional gastrointestinal disorders'', "irritable bowel syndrome"), the application was refused by the German National Competent Authority on the ground that a positive benefit-risk had not been adequately established.
Maltese: Fl-2005, abbażi tal-valutazzjoni tal-evidenza disponibbli dak iż-żmien fl-indikazzjonijiet iddikjarati (“disturbi gastrointestinali funzjonali”, “sindrome tal-musrana irritabbli”), l-Awtorità Nazzjonali Kompetenti Ġermaniża rrifjutat l-applikazzjoni għar-raġuni li ma kienx ġie stabbilit b'mod adegwat benefiċċju u riskju pożittiv.
English: The findings were consistent across age and gender subgroups.
Maltese: Is-sejbiet kienu konsistenti fis-sottogruppi taletà u tas-sess.
English: It is therefore unlikely that post-marketing data will provide significant further information on the safety profile of Symbioflor 2 in the treatment of IBS.
Maltese: Għalhekk mhuwiex probabbli li ddata ta' wara t-tqegħid fis-suq se tipprovdi aktar informazzjoni sinifikanti dwar il-profil tas-sigurtà ta' Symbioflor 2 fil-kura tal-IBS.
English: The evaluations presented in the Study Report of Study S2 (1989), based on a primary endpoint of “global evaluation” of efficacy by the investigator at the end of the trial, showed that Symbioflor 2 administered over an 8-week period had better outcomes than placebo on most of the evaluated endpoints.
Maltese: Il-valutazzjonijiet ippreżentati fir-Rapport ta' Studju tal-Istudju S2 (1989), abbażi ta' punt ta' tmiem ta' “valutazzjoni globali” tal-effikaċja mill-investigatur fit-tmiem tal-prova, urew li Symbioflor 2 mogħti fuq perjodu ta' 8 ġimgħat kellu riżultati aħjar mill-plaċebo f'ħafna mill-punti ta' tmiem ivvalutati.
English: This relatively benign safety profile was confirmed by post-marketing data.
Maltese: Ilprofil tas-sigurtà relattivament beninn ġie kkonfermat minn data ta' wara t-tqegħid fis-suq.
English: In the re-evaluation report of Study S2 (2005), the endpoints were redefined, combining parameters of a patient-centred assessment of spontaneous symptoms with endpoints based on physical examination by the physician.
Maltese: Fir-rapport ta' valutazzjoni mill-ġdid tal-Istudju S2 (2005), il-punti ta' tmiem ġew definiti mill-ġdid, waqt li kkombinaw parametri ta' valutazzjoni ffukata fuq il-pazjent ta' sintomi spontanji b'punti ta' tmiem ibbażati fuq eżami fiżiku mit-tabib.
English: Proof of the efficacy of Symbioflor 2 in this patient population would have required a prospective, double-blinded, randomized and placebo-controlled trial as per the guideline CPMP/EWP/785/97 in force at the time of the conduct of the study.
Maltese: Prova tal-effikaċja ta' Symbioflor 2 f'din ilpopolazzjoni ta' pazjenti tkun teħtieġ prova prospettiva, double-blinded, randomizzata u kkontrollata bil-plaċebo skont il-linja gwida CPMP/EWP/785/97 li kienet fis-seħħ fiż-żmien meta sar l-istudju.
English: In 2005, rather than conducting a new study in line with the “Note for guidance on statistical principles for clinical trials” (CPMP/ICH/363/96) then in force, the MAH decided to perform a post-hoc reevaluation of Study S2, i.e. establishing the definition of the primary hypothesis, the corresponding evaluation plan and the statistical analysis methods in full knowledge of the results.
Maltese: Fl-2005, minflok għamel studju ġdid f'konformità man-”Nota għal gwida dwar prinċipji statistiċi għal provi kliniċi” (CPMP/ICH/363/96) li dak iż-żmien kienet fis-seħħ, l-MAH iddeċieda li jwettaq valutazzjoni mill-ġdid post-hoc tal-Istudju S2, jiġifieri, li jistabbilixxi d-definizzjoni tal-ipoteżi primarja, il-pjan ta' valutazzjoni korrispondenti u l-metodi ta' analiżi statistika f'għarfien sħiħ tar-riżultati.
English: From post-marketing experience, only 18 adverse reactions have been reported to Eudravigilance for Symbioflor 2, covering both the treatment of IBS and other functional gastrointestinal disorders despite significant exposure over several decades of marketing and the pharmacovigilance system put in place by the MAH since the early 2000.
Maltese: Minn esperjenza ta' wara t-tqegħid fis-suq, ġew irrappurtati biss 18-il reazzjoni avversa lill-Eudravigilance għal Symbioflor 2, li jkopru kemm il-kura tal-IBS kif ukoll disturbi gastrointestinali funzjonali oħra minkejja esponiment sinifikanti mifrux fuq diversi deċennji ta' tqegħid fis-suq u s-sistema ta' farmakoviġilanza mdaħħla fis-seħħ mill-MAH sa mill-bidu tal-2000.
English: Although Study S2 was conducted before requirements of the current IBS guideline “Guideline on the evaluation of medicinal products for the treatment of irritable bowel syndrome” (CPMP/EWP/785/97) or the previous CHMP point to consider on IBS came into force, the original protocol of Study S2 neither defined a primary endpoint nor planned for a statistical analysis.
Maltese: Għalkemm l-Istudju S2 sar qabel ir-rekwiżiti tal-linja gwida tal-IBS attwali “Linja gwida dwar ilvalutazzjoni ta' prodotti mediċinali għall-kura ta' sindrome tal-musrana irritabbli” (CPMP/EWP/785/97) jew il-punt tas-CHMP preċedenti biex jikkunsidra dwar IBS daħlu fis-seħħ, il-protokoll oriġinai talIstudju S2 la ddefinixxa punt ta' tmiem primarju u lanqas ma ppjana analiżi statistika.
English: Furthermore, the CHMP requested that the MAH conduct a well-designed and adequately powered multi-centre, double blind, randomised, placebo controlled post approval efficacy study allowing for relevant subpopulation analyses to assess the efficacy of Symbioflor 2 in the treatment of IBS in general versus subtypes of the disease such as IBS C and IBS D, gender, disease severity and address the sustainability of efficacy to confirm the efficacy of Symbioflor 2 in IBS.
Maltese: Barra minn hekk, is-CHMP talab li l-MAH iwettaq studju dwar l-effikaċja mfassal tajjeb u b'mod adegwat ibbażat fuq diversi ċentri, double-blind, randomizzat, ikkontrollati bil-plaċebo ta' wara lapprovazzjoni li jippermetti lill-analiżijiet tas-sottopopolazzjoni rilevanti biex jivvalutaw l-effikaċja ta' Symbioflor 2 fil-kura tal-IBS b'mod ġenerali kontra sottotipi tal-marda bħal IBS C u IBS D, sess, severità tal-marda u jindirizzaw is-sostenibbiltà tal-effikaċja biex jikkonfermaw l-effikaċja ta' Symbioflor 2 fl-IBS.
English: • Considering available safety data from the clinical trial and post-marketing experience with Symbioflor 2, the CHMP came to the conclusion that the demonstrated risks were overall low.
Maltese: • Meta tiġi kkunsidrata data ta sigurtà disponibbli mill-prova klinika u mill-esperjenza ta wara ttqegħid fis-suq b'Symbioflor 2, is-CHMP wasal għall-konklużjoni li r-riskji murija huma globalment baxxi.