FrancophonIA/ELRC3.0 huggingface dataset:
English: Whilst the economic and animal health and welfare benefits of vaccination against BVDV type 1 are acknowledged, there are valid alternative BVD vaccines available on the EU market with similar claims to that of Pregsure BVD.
Maltese: Filwaqt li l-benefiċċji ekonomiċi u għas-saħħa u l-benesseri tal-annimali tat-tilqim kontra BVDV tat-tip 1 huma rikonoxxuti, hemm vaċċini tal-BVD alternattivi validi disponibbli fis-suq tal-UE bi pretensjonijiet simili għal dawk ta' Pregsure BVD.
English: It was noted that in Member States where Pregsure BVD was not marketed or in herds where Pregsure BVD had not been used, bovine neonatal pancytopenia appears to be reported as isolated events and may be compatible with so-called idiopathic bovine neonatal pancytopenia.
Maltese: Kien innotat li fl-Istati Membri fejn ma kienx Pregsure BVD ma tpoġġixiex fis-suq jew f'meħliet fejn ma ntużax Pregsure BVD, pancytopenia bovina fl-għoġġiela tat-twelid tidher li ġiet irrapportata bħala avvenimenti iżolati u jista' jkun li hija kompatibbli mal-hekk imsejħa pancytopenia bovina fl-għoġġiela tat-twelid idjopatiċi.
English: From the data evaluated to date, there is evidence to suggest a potential association between vaccination of dams using Pregsure BVD and the occurrence of bovine neonatal pancytopenia in calves.
Maltese: Mid-dejta evalwata sal-lum, hemm evidenza li tissuġġerixxi assoċjazzjoni potenzjali bejn tilqim ta' baqar bl-użu ta' Pregsure BVD u l-inċidenza ta' pancytopenia bovina fl-għoġġiela tat-twelid.
English: Although the definitive aetiology of bovine neonatal pancytopenia is at present unknown, it appears to be a multi-factorial disorder and the possibility that it may be immune-mediated is consistent with available epidemiological data and is becoming a focus of research efforts to identify the causal factor(s) for calves developing bovine neonatal pancytopenia.
Maltese: Għalkemm l-etjoloġija definittiva ta' pancytopenia bovina fl-għoġġiela tat-twelid s'issa mhijiex magħrufa, jidher li hija disordni b'ħafna fatturi u l-possibilità li tista' tkun medjata mill-immunità hija konsistenti mad-dejta epidemjoloġika disponibbli u qed issir punt fokali ta' sforzi fir-riċerka sabiex ikun(u) identifikat(i) ilfattur(i) għal għoġġiela li jiżviluppaw il-pancytopenia bovina fl-għoġġiela tat-twelid.
English: For the suspension to be lifted the marketing authorisation holders should provide the national competent authorities with scientific evidence to demonstrate that the administration of the vaccine to dams, according to the recommendations of the summary of product characteristics, does not lead to an increased risk of bovine neonatal pancytopenia or propose management measures to mitigate this risk and to demonstrate a favourable benefit-risk balance for the product.
Maltese: Barra minn hekk, dejta mhux ippubblikata minn studju li involva rziezet b'kontroll negattiv sabiex jinvestiga l-fatturi ta' amministrazzjoni li potenzjalment huma assoċjati ma' pancytopenia bovina fl-għoġġiela tat-twelid identifikat passat ta' tilqim b'Pregsure BVD fil-livell tal-merħla bħala fattur potenzjali ta' riskju għal pancytopenia bovina fl-għoġġiela tat-twelid.
English: Preliminary epidemiological findings report an association between bovine neonatal pancytopenia calves and a vaccination history, at the herd level, involving Pregsure BVD.
Maltese: Sejbiet epidemjoloġiċi preliminari jirrapportaw assoċjazzjoni bejn pancytopenia bovina fl-għoġġiela tat-twelid u l-istorja tat-tilqim, fuq livell ta' merħla, li involvew Pregsure BVD.
English: In addition to the pharmacovigilance data, the CVMP also took into account epidemiological and experimental studies that provided further evidence to suggest an association between Pregsure BVD and bovine neonatal pancytopenia.
Maltese: Barra mid-dejta ta' farmakoviġilanza, is-CVMP ikkunsidra wkoll studji epidemjoloġiċi u sperimentali li pprovdew evidenza li tissuġġerixxi assoċjazzjoni bejn Pregsure BVD u pancytopenia bovina fl-għoġġiela tat-twelid.
English: • the aetiology of bovine neonatal pancytopenia is unknown and the risk factors associated with the disorder have yet to be determined;
Maltese: • l-etjoloġija tal-pancytopenia bovina fl-għoġġiela tat-twelid mhijiex magħrufa u l-fatturi ta' riskju assoċjati mad-disordni għad iridu jiġu stabbiliti;
English: The possibility of the vaccine triggering the production of allo- or auto-antibodies cannot be excluded and may explain the rapid onset of the disorder in calves that have recently ingested colostrum from vaccinated dams.
Maltese: Il-possibiltà li t-tilqima bdiet il-produzzjoni ta' allojew awto-antikorpi ma tistax tiġi eskluża u tista' tispjega l-fatt li feġġgħet malajr id-disordni flgħoġġiela li jkunu ħadu kolostrum minn baqar imlaqqmin.
English: Belgium Pfizer Animal Health Rue Laid Burniat 1
Maltese: Pfizer Animal Health BV Rivium
English: (PAOD Stage II)
Maltese: Stadju II)
English: The MAH submitted a number of papers with efficacy clinical studies, 2 reviews (the medical letter, 1974, Mc Donald, 1979) and one Cochrane review (2009).
Maltese: L-MAH ippreżenta għadd ta' dokumenti bi studji kliniċi dwar l-effikaċja, 2 reviżjonijiet (l-ittra medika, 1974, Mc Donald, 1979) u reviżjoni waħda ta' Cochrane (2009).
English: • Orthostatic hypotension
Maltese: • Ipotensjoni ortostatika
English: On 18 January 2012, France triggered a referral under Article 31 of Directive 2001/83/EC for the following ergot derivatives containing medicinal products: dihydroergocryptine/caffeine, dihydroergocristine, dihydroergotamine, dihydroergotoxine and nicergoline.
Maltese: Fit-18 ta' Jannar 2012, Franza tat bidu għal riferiment skont l-Artikolu 31 tad-Direttiva 2001/83/KE għall-prodotti mediċinali li ġejjin li fihom derivati tal-ergotina: dihydroergocryptine/caffeine, dihydroergocristine, dihydroergotamine, dihydroergotoxine u nicergoline.
English: Therefore, the CHMP maintained its opinion of 27 June 2013 and therefore, in accordance with Article 116 of Directive 2001/83/EC the CHMP recommends:
Maltese: Għalhekk, is-CHMP żamm l-opinjoni tiegħu tas-27 ta' Ġunju 2013 u għaldaqstant, skont l-Artikolu 116 tad-Direttiva 2001/83/KE is-CHMP jirrakkomanda:
English: More specifically, the CHMP stated that apart from “ergotism” other preferred terms are also related to symptoms of ergotism (i.e paraesthesia, formication, tingling, intestinal/cerebrovascular/peripheral/tongue ischaemia, angina pectoris, coronaropathy, thoracic pain, nausea, vomiting, diarrhoea, abdominal pain, cold sensation, thrombosis, stroke, gangrene, necrosis, vasoconstriction/vasospasm, cyanosis, myalgia, muscular cramps, pain in extremities, vertigo, hypoaesthesia, numbness, headache, confusion, hallucinations).
Maltese: B'mod aktar speċifiku, is-CHMP iddikjara li apparti minn "ergotiżmu" termini ppreferuti oħra huma relatati wkoll ma' sintomi ta' ergotiżmu (jiġifieri parestesija, formikazzjoni, tnemnim, iskemija intestinali/ċerebrovaskulari/periferali/tal-ilsien, anġina pectoris, koronaropatija, uġigħ toraċiku, nawżja, rimettar, dijarea, uġigħ addominali, sensazzjoni ta' kesħa, trombożi, puplesija, kankrena, nekrożi, vażokostrizzjoni/vażospażmu, ċijanożi, mijalġja, bugħawwieġ, uġigħ fl-estremitajiet, vertiġini, ipoestesija, tnemnim, uġigħ ta' ras, konfużjoni, alluċinazzjonijiet).
English: The two comparative studies described by the MAH (Orma, 1958 and Vannas, 1958) were of poor methodological quality; moreover no information is available about the exact design or randomisation in the different groups tested.
Maltese: Iżżewġ studji komparattivi deskritti mill-MAH (Orma, 1958 u Vannas, 1958) kienu ta' kwalità metodoloġika dgħajfa; barra minn hekk ma hemm l-ebda informazzjoni disponibbli dwar id-disinn eżatt jew il-każwalità fil-gruppi differenti ttestjati.
English: The CHMP noted that the incidence of adverse events (i.e. retroperitoneal fibrosis, pulmonary fibrosis, cardiac valvulopathy, ergotism) reported by the MAH with dihydroergotoxine is low.
Maltese: Is-CHMP innota li l-inċidenza ta' avvenimenti avversi (jiġifieri fibrożi retroperitonali, fibrożi pulmonari, valvulopatija kardijaka, ergotiżmu) irrapportati mill-MAH b'dihydroergotoxine hija baxxa.
English: The CHMP took note of the risk minimisation measures proposed by the MAH.
Maltese: Is-CHMP ħa nota tal-miżuri għall-minimizzazzjoni tar-riskji proposti mill-MAH.
English: • Ancillary treatment of intermittent claudication in symptomatic peripheral arterial occlusive disease
Maltese: • Kura anċillari ta' klawdikazzjoni intermittenti f'mard okklussiv arterji periferali sintomatiku (PAOD fi
English: The publications on clinical data are old (from 1971 up to 1995).
Maltese: Il-pubblikazzjonijiet dwar id-dejta klinika huma qodma (mill-1971 sal-1995).
English: − Ancillary treatment of Raynaud's syndrome.
Maltese: − Kura anċillari tas-sindromu ta' Raynaud.
English: However, the presented studies assessed oral dihydroergotoxine in very heterogeneous vein diseases: peripheral and cerebrovascular insufficiency, chronic varicose eczema, ulcus cruris, varicose veins, venous insufficiency, cerebral vascular lesions, thrombophlebitis of the superficial veins, post-thrombophlebitis syndromes.
Maltese: Madankollu, l-istudji ppreżentati vvalutaw dihydroergotoxine orali f'mard eteroġenju ħafna tal-vini: insuffiċjenza periferali u ċerebrovaskulari, ekżema varikuża kronika, ulcus cruris, vini varikużi, insuffiċjenza venuża, leżjonijiet vaskulari ċerebrali, tromboflebite tal-vini superfiċjali, sindromi post-tromboflebite.
English: − Symptomatic treatment of veno-lymphatic insufficiency.
Maltese: − Kura sintomatika ta' insuffiċjenza veno-limfatika.
English: Dihydroergotoxine mesilate is an ergot alkaloid, known also as codergocrine mesilate and ergoloid mesilate, which is composed of equal parts of mesilates of dihydroergocornine, dihydroergocristine, and dihydroergocryptine.
Maltese: • Kura sintomatika ta' insuffiċjenza veno-limfatika Dihydroergotoxine mesilate huwa alkalojdi tal-ergotina, magħruf ukoll bħala codergocrine mesilate u ergoloid mesilate, li huwa magħmul minn partijiet ugwali ta' mesilates ta' dihydroergocornine, dihydroergocristine, u dihydroergocryptine.
English: However, the CHMP also noted that the MAH provided information only for their product (Hydergine) and that underreporting is likely.
Maltese: Madankollu, is-CHMP innota wkoll li l-MAH ipprovda informazzjoni biss għall-prodott tagħhom (Hydergine) u li hemm probabbiltà ta' nuqqas ta' rapportar.
English: It acts as an agonist to dopaminergic and serotonergic receptors and an antagonist for alpha-adrenoreceptors.
Maltese: Jaġixxi bħala agonist għar-riċetturi dopaminerġiċi u serotonerġiċi u antagonist għal adrenoriċetturi alpha.
English: The CHMP has considered the totality of the available data on the safety and efficacy of dihydroergotoxine.
Maltese: Is-CHMP ikkunsidra t-totalità tad-dejta disponibbli dwar is-sigurtà u l-effikaċja of dihydroergotoxine.
English: The CHMP considered the MAHs proposals for risk minimisation measures.
Maltese: Is-CHMP ikkunsidra l-proposti tal-MAHs għal miżuri għall-minimizzazzjoni tar-riskji.
English: The Committee concluded that the benefit-risk balance of dihydroergotoxine containing products is not favourable pursuant to Article 116 of Directive 2001/83/EC for symptomatic treatment of chronic pathological cognitive and neurosensorial impairment in elderly (excluding Alzheimer's disease and other dementia), for ancillary treatment of Raynaud's syndrome, for ancillary treatment of visual acuity decrease and visual field disturbances presumably of vascular origin, for prophylaxis of migraine headache and for symptomatic treatment of veno-lymphatic insufficiency.
Maltese: Il-Kumitat ikkonkluda li skont l-Artikolu 116 tad-Direttiva 2001/83/KE il-bilanċ tal-benefiċċju-riskju ta' prodotti li fihom dihydroergotoxine mhuwiex favorevoli għall-kura sintomatika ta' indeboliment konjittiv u newrosensorjali patoloġiku kroniku fl-anzjani (minbarra l-marda ta' Alzheimer u tipi oħra ta' dimenzja), għall-kura anċillari tas-sindromu ta' Raynaud, għall-kura anċillari ta' tnaqqis fil-preċiżjoni viżiva u disturbi fil-kamp viżiv preżumibbilment ta' oriġini vaskulari, għall-profilassi tal-uġigħ ta' ras tal-emigranja u għall-kura sintomatika ta' insuffiċjenza veno-limfatika.
English: − Is not favourable for ancillary treatment of Raynaud's syndrome.
Maltese: − Mhuwiex favorevoli għall-kura anċillari tas-sindromu ta' Raynaud.
English: Diagnostic and determination of the origin of cognitive impairments are difficult tasks for the modern medicine.
Maltese: Id-dijanjostika u d-determinazzjoni tal-oriġini tal-indeboliment konjittiv huma kompiti diffiċli għallmediċina moderna.
English: For the indication “ancillary treatment of Raynaud's syndrome” the CHMP noted that the indication claimed by the MAH is peripheral vascular disease and that in some Members States the ancillary treatment of Raynaud's syndrome is approved for dihydroergotoxine as part of this more general indication (i.e. “peripheral vascular disease”).
Maltese: Għall-indikazzjoni “kura anċillari tas-sindromu ta' Raynaud” is-CHMP innota li l-indikazzjoni ddikjarata mill-MAH hija marda vaskulari periferali u li f'xi Stati Membri, il-kura anċillari tas-sindromu ta' Raynaud hija approvata għal dihydroergotoxine bħala parti minn din l-indikazzjoni aktar ġenerali (jiġifieri “mard vaskulari periferali”).
English: For the indication “ancillary treatment of visual acuity decrease and visual field disturbances presumably of vascular origin”, seven clinical studies have been submitted.
Maltese: Għall-indikazzjoni “kura anċillari ta' tnaqqis fil-preċiżjoni viżiva u disturbi fil-kamp viżiv preżumibbilment ta' oriġini vaskulari”, ġew ippreżentati seba' studji kliniċi.
English: • Ancillary treatment of visual acuity decrease and visual field disturbances presumably of vascular origin
Maltese: • Kura anċillari ta' tnaqqis fil-preċiżjoni viżiva u disturbi fil-kamp viżiv preżumibbilment ta' oriġini vaskulari
English: In addition, both included a small number of patients (n=48 and n=62), both were short-term studies (1-5 months and 8 months, respectively) which short term duration is considered inappropriate to evaluate the outcome of slow progressing diseases.
Maltese: Barra minn hekk, it-tnejn kienu jinkludu għadd żgħir ta' pazjenti (n=48 u n=62), it-tnejn kienu studji fuq perjodu qasir (1-5 xhur u 8 xhur, rispettivament) u ttul qasir tagħhom mhuwiex meqjus adegwat biex jiġi vvalutat l-eżitu ta' marda li tipprogressa bil-mod.
English: The Cochrane review is not relevant for the assessment as it focuses on dementia and symptoms consistent with dementia.
Maltese: Ir-reviżjoni ta' Cochrane mhijiex rilevanti għall-valutazzjoni peress li tiffoka fuq id-dimenzja u sintomi konsistenti maddimenzja.
English: Ergot derivatives are recognised as being capable of inducing fibrosis, in particular heart valve fibrosis.
Maltese: Derivattivi tal-ergotina huma rikonoxxuti li kapaċi jinduċu fibrożi, b'mod partikulari fibrożi tal-valv talqalb.
English: Overall summary of the scientific evaluation of dihydroergotoxine containing medicinal products (see Annex I)
Maltese: Sommarju ġenerali tal-valutazzjoni xjentifika ta' prodotti mediċinali li fihom dihydroergotoxine (ara Anness I)
English: The relationship between fibrosis and serotoninergic receptor activation, particularly 5-HT2B receptors by ergot derivatives is extensively described in the literature.
Maltese: Ir-relazzjoni bejn il-fibrożi u l-attivazzjoni tar-riċetturi serotonerġiċi, b'mod partikolari riċetturi ta' 5-HT2B minn derivati tal-ergotina ġiet deskritta b'mod estensiv fil-letteratura.
English: Therefore, even if it is highly pharmacologically plausible that ergot derivatives acting as 5HT2B receptor agonists may induce "serotonergic" valve disease similar to that induced by carcinoid tumours or fibrotic lesions of other tissues, it must be remembered that some ergot derivatives are not 5-HT2B receptor agonists.
Maltese: Għalhekk, anke jekk farmakoloġikament huwa ferm plawsibbli li dderivati tal-ergotina li jaġixxu bħala agonisti tar-riċettur ta' 5-HT2B jistgħu jinduċu mard “serotonerġiku" tal-valv simili għal dak ikkawżat minn tumuri karċinojdi jew leżjonijiet fibrotiċi ta' tessuti oħra, għandu jitfakkar li xi derivati tal-ergotina mhumiex agonisti tar-riċettur ta' 5-HT2B.
English: The majority of the papers are not relevant (publications not submitted, studies were open-label, not placebo-controlled and/or with intravenous use of dihydroergotoxine mesilate).
Maltese: Il-maġġoranza ta' dawn id-dokumenti mhumiex rilevanti (pubblikazzjonijiet li ma ġewx sottomessi, l-istudji kienu b'tikketta miftuħa, mhux ikkontrollati bi plaċebo u/jew bl-użu ta' dihydroergotoxine mesilate ġol-vina).
English: Overall, the SAG disagreed with the indication and the target population definitions proposed by the MAH.
Maltese: B'mod ġenerali, is-SAG ma qabilx mal-indikazzjoni u ddefinizzjonijiet tal-popolazzjoni fil-mira proposti mill-MAH.
English: The SAG unanimously agreed that there is no distinct clinical entity for cognitive impairment no dementia (CIND), the diagnostic criteria and definitions have changed over time and this wording does not correspond to a current clinically defined group.
Maltese: Is-SAG qabel unanimament li ma hemm l-ebda entità klinika distinta għal indeboliment konjittiv mingħajr dimenzja (CIND), li l-kriterji u d-definizzjonijiet dijanjostiċi nbidlu mażżmien u li din il-formulazzjoni ma tikkorrispondix għal grupp attwalment definit b'mod kliniku.
English: − Prophylaxis of migraine headache.
Maltese: − Profilassi tal-uġigħ ta' ras tal-emigranja.
English: The data from the reported cases of fibrosis (n=9) are limited in order to draw firm conclusions, however, the capacity of dihydroergotoxine to induce fibrotic reactions, localised in the retroperitoneal, pulmonary and cardiac area cannot be excluded notably based on the absence of any other aetiology for some of the assessed cases and the mechanism of action of ergot derivatives.
Maltese: Id-dejta mill-każijiet ta' fibrożi irrapportati (n=9) hija limitata sabiex jinġibdu konklużjonijiet sodi, madankollu, il-kapaċità ta' dihydroergotoxine li jinduċi reazzjonijiet fibrotiċi, lokalizzati fiż-żona retroperitonali, pulmonari u tal-qalb ma tistax tiġi eskluża speċjalment abbażi tan-nuqqas ta' xi etjoloġija oħra għal xi wħud mill-każijiet ivvalutati u l-mekkaniżmu ta' azzjoni ta' derivattivi talergotina.
English: On the efficacy side for the indication “symptomatic treatment of chronic pathological cognitive and neurosensorial impairment in elderly (excluding Alzheimer's disease and other dementia)”, data were presented by the MAH by sub-areas of the cognitive function diseases: cerebrovascular impairment with arteriosclerosis, cerebrovascular insufficiency and stroke; and other causes with elderly/senile impairment, primary or not otherwise specified impairment, and organic brain syndrome.
Maltese: Mil-lat tal-effikaċja għall-indikazzjoni “kura sintomatika ta' indeboliment konjittiv u newrosensorjali patoloġiku kroniku fl-anzjani (minbarra l-marda ta' Alzheimer u tipi oħra ta' dimenzja)”, l-MAH ippreżentata dejta skont is-sub-oqsma tal-mard tal-funzjoni konjittiva: indeboliment ċerebrovaskulari b'arterjosklerożi, insuffiċjenza ċerebrovaskulari u puplesija; u kawżi oħra b'indeboliment taxxjuħija/senili, indeboliment primarju jew mhux speċifikat b'mod ieħor, u s-sindromu organiku talmoħħ.
English: − Ancillary treatment of visual acuity decrease and visual field disturbances presumably of vascular origin.
Maltese: − Kura anċillari ta' tnaqqis fil-preċiżjoni viżiva u disturbi fil-kamp viżiv preżumibbilment ta' oriġini vaskulari.
English: Dihydroergotoxine modulates synaptic neurotransmitter levels and increases blood flow to the brain; at one time, it was believed that the latter mechanism was the primary mode of action by which dihydroergotoxine exerts clinical effects.
Maltese: Dihydroergotoxine jimmodula l-livelli tannewrotrasmettituri fis-sinapsi u jżid il-fluss tad-demm lill-moħħ; fil-passat, kien maħsub li lmekkaniżmu tal-aħħar kien il-mod primarju ta' azzjoni li permezz tiegħu dihydroergotoxine jeżerċita effetti kliniċi.
English: The risk minimisation measures proposed were not considered by the Committee to effectively reduce the risk for the two highlighted reactions (fibrosis and ergotism) in the broad indication proposed by the MAH.
Maltese: Il-miżuri għall-minimizzazzjoni tar-riskji proposti ma kinux meqjusa mill-Kumitat li b'mod effettiv inaqqsu r-riskju għaż-żewġ reazzjonijiet enfasizzati (fibrożi u ergotiżmu) fl-indikazzjoni wiesgħa proposta mill-MAH.
English: The seriousness of such adverse effects and their possible fatal outcome is underlined.
Maltese: Isserjetà ta' dawn l-effetti avversi u l-eżitu fatali possibbli tagħhom huwa enfasizzat.
English: A review of all other available data (i.e. literature data, pre-clinical data, and other clinical data including epidemiological studies) that were relevant to evaluate the risk of fibrosis was provided where possible.
Maltese: Ir-reviżjoni tad-dejta l-oħra kollha disponibbli (jiġifieri dejta mil-letteratura, dejta pre-klinika, u dejta klinika oħra inkluż studji epidemjoloġiċi) li kienet rilevanti għall-valutazzjoni tar-riskju ta' fibrożi kienet ipprovduta fejn possibbli.
English: The CHMP considered that these studies did not provide robust evidence supporting the efficacy of dihydroergotoxine in the proposed target population.
Maltese: Is-CHMP ikkunsidra li dawn l-istudji ma pprovdewx evidenza robusta li tappoġġa leffikaċja ta' dihydroergotoxine fil-popolazzjoni fil-mira proposta.
English: In addition, the CHMP convened another meeting of the scientific advisory group (SAG) that took place on 16 October 2013.
Maltese: Barra minn hekk, is-CHMP sejjaħ laqgħa oħra tal-grupp xjentifiku konsultattiv (SAG) li saret fis16 ta' Ottubru 2013.
English: The MAHs also submitted their own overviews and critical summaries of all spontaneous reports of fibrotic reactions (cardiac with or without pulmonary arterial hypertension, pulmonary, pleural, peritoneal, retroperitoneal, etc) and ergotism with their ergot derivatives-containing medicinal products.
Maltese: L-MAHs ippreżentaw ukoll il-ħarsiet ġenerali u ssommarji kritiċi tagħhom stess tar-rapporti spontanji kollha ta' reazzjonijiet fibrotiċi (kardijaċi bi jew mingħajr ipertensjoni arterjali pulmonari, pulmonari, plewrali, peritoneali, retroperitonali) u ergotiżmu bil-prodotti mediċinali tagħhom li fihom derivati tal-ergotina.
English: Following a national pharmacovigilance review held in 2011 new spontaneous notifications reported with some of those products identified serious cases of fibrosis and ergotism and France considered that this safety concern is not outweighed by the limited evidence of efficacy.
Maltese: Wara reviżjoni nazzjonali talfarmakoviġilanza li saret fl-2011, notifiki spontanji ġodda rrapportati b'xi wħud minn dawk il-prodotti identifikaw każijiet serji ta' fibrożi u ergotiżmu u Franza kkunsidrat li dan it-tħassib għas-sigurtà mhuwiex megħlub mill-evidenza limitata ta' effikaċja.
English: Therefore, other mechanisms inducing fibrosis cannot be excluded, which suggests a causal link between fibrosis and agonism of 5-HT2A and 5-HT1B receptors and also plausible effect on serotonin transporter.
Maltese: Għalhekk, ma jistgħux jiġu esklużi mekkaniżmi oħra li jinduċu l-fibrożi, li jissuġġerixxi rabta kawżali bejn il-fibrożi u l-agoniżmu ta' riċetturi ta' 5-HT2A u 5-HT1B u anke effett plawsibbli fuq it-trasportatur ta' serotonin.
English: Overall, the varying affinity for serotoninergic receptors with the different ergot derivatives and the therapeutic doses used may explain the differences observed for notification rates for the fibrotic reactions.
Maltese: B'mod ġenerali, l-affinità varjabbli għal riċetturi serotonerġiċi bid-derivati differenti tal-ergotina u d-dożi terapewtiċi użati jistgħu jispjegaw id-differenzi osservati fir-rati ta' notifika għar-reazzjonijiet fibrotiċi.