FrancophonIA/ELRC3.0 huggingface dataset:
English: Sildenafil should be used with caution in patients with anatomical deformation of the penis (such as angulation, cavernosal fibrosis or Peyronie's disease), or in patients who have conditions which may predispose them to priapism (such as sickle cell anaemia, multiple myeloma or leukaemia).
Maltese: Sildenafil għandu jintuża b'kawtela f'pazjenti b'deformazzjoni anatomika tal-pene (bħal angulazzjoni, fibrosi fil-korpus kavernożum jew il-marda ta' Peyronie), jew f'pazjenti li għandhom kundizzjonijiet li jagħmluhom predisposti għal prijapiżmu (bħal anemija tas-sickle cell, majeloma multipla jew lewkimja).
English: Not known
Maltese: Mhux magħruf
English: CYP3A4 inducers seemed to have a substantial impact on the pharmacokinetics of sildenafil in pulmonary arterial hypertension patients, which was confirmed in the in vivo interaction study with CYP3A4 inducer bosentan.
Maltese: Indutturi ta' CYP3A4 dehru li għandhom impatt sostanzjali fuq il-farmakokinetiċi ta' sildenafil f'pazjenti bi pressjoni arterjali għolja fil-pulmun, u dan ġie kkonfermat fi studju in vivo ta' linterazzjoni ma' l-induttur ta' CYP3A4 bosentan.
English: The primary endpoint was the placebo-corrected percentage change in peak VO2 from baseline to week 16 assessed by CPET testing in the combined dose groups (Table 2).
Maltese: Il-punt tat-tmiem primarju kien il-perċentwali tal-bidla ikkoreġuta tal-plaċebo fil-punt l-aktar għoli ta' VO2 mil-linja bażi sa ġimgħa 16 evalwat mit-test ta' CPET fil-gruppi li qed jingħataw dożi kkombinati (Tabella 2).
English: In the two placebo-controlled studies adverse events were generally mild to moderate in severity.
Maltese: Fiż-żewġ studji ikkontrollati bi plaċebo effetti negattivi kienu ġeneralment ta' serjetà ħafifa għal moderata.
English: Healthy elderly volunteers (65 years or over) had a reduced clearance of sildenafil, resulting in approximately 90% higher plasma concentrations of sildenafil and the active N-desmethyl metabolite compared to those seen in healthy younger volunteers (18-45 years).
Maltese: Voluntiera anzjani b'saħħithom (65 sena jew iżjed) kellhom tneħħija mnaqqsa ta' sildenafil, li jirriżulta f'bejn wieħed u ieħor 90 % tal-konċentrazzjonijiet ogħla fil-plażma ta' sildenafil u lmetabolu attiv N-desmethly mqabbel ma' dawk li nstabu f'voluntiera żagħżagħ b'saħħithom (18-45 sena).
English: By sildenafil treatment group, median duration of sildenafil treatment was 1696 days (excluding the 5 subjects who received placebo in double-blind and were not treated in the long-term extension study).
Maltese: Skont il-grupp ta' trattament b'sildenafil, it-tul medjan tat-trattament b'sildenafil kien 1,696 jum (li jeskludi l-5 individwi li rċivew plaċebo fl-istudju double-blind u li ma ġewx ikkurati fl-istudju ta' estensjoni fit- tul).
English: Renal insufficiency
Maltese: GĦAMLA KWALITATTIVA
English: The postulated mechanism for this change in colour discrimination is related to inhibition of PDE6, which is involved in the phototransduction cascade of the retina.
Maltese: Il-mekkaniżmu maħsub għal din il-bidla fid-diskriminazzjoni tal-kulur jinvolvi l-inibizzjoni ta' PDE6, li huwa nvolut fil-phototransduction cascade tar-retina.
English: At 24 hours, the plasma levels of sildenafil were still approximately 200 ng/ml, compared to approximately 5 ng/ml when sildenafil was administered alone.
Maltese: F'24 siegħa, l-livelli tal-plażma ta' sildenafil kienu għadhom bejn wieħed u ieħor 200 ng/ml, imqabblin ma' bejn wieħed u ieħor 5 ng/ml meta sildenafil ingħata waħdu.
English: Paediatric population (1 year to 17 years)
Maltese: Użufil-popolazzjonipedjatrika(Età ta'bejnsenau17-ilsena)
English: Granpidam 20 mg film-coated tablets sildenafil
Maltese: Granpidam 20 mg pilloli miksijin b'rita
English: The following serious adverse events have been reported commonly (may affect up to 1 in 10 people); pneumonia, heart failure, right heart failure, heart related shock, high blood pressure in the lungs, chest pain, fainting, respiratory infection, bronchitis, viral infection in the stomach and intestines, urinary tract infections and tooth cavities.
Maltese: L-avvenimenti avversi serji li ġejjin kienu rrapurtati b'mod komuni (jistgħu jaffetwaw sa1 minn kull 10 pazjenti): pnewmonja, insuffiċjenza tal-qalb, insuffiċjenza tal-qalb fin-naħa tal-lemin, xokk relatat mal-qalb, pressjoni tad-demm għolja fil-pulmun, uġiħ fis-sider, ħass ħażin, infezzjoni respiratorja, bronkite, infezzjoni virali fl-istonku u fl-imsaren, infezzjonijiet fit-tratt urinarju u tħassir tas-snien.
English: Veno-occlusive disease
Maltese: IL-PRODOTT MEDIĊINALI
English: The efficacy and safety of sildenafil co-administered with other treatments for pulmonary arterial hypertension (e.g. ambrisentan, iloprost) has not been studied in controlled clinical trials.
Maltese: L-effikaċja u s-sigurta' ta' sildenafil amministrat flimkien ma' trattamenti oħra għall-pressjoni arterjali għolja tal-pulmun (eż. ambrisentan, iloprost) ma ġietx studjata fi studji kliniċi kkontrollati.
English: Invented name Strength Pharmaceutical Form Route of administration Packaging
Maltese: Numru ta' l-EU Isem ivvintat Qawwa Għamla Farmaċewtika
English: Package size
Maltese: Mnejn jinġħata Il-Pakkett
English: Strength Pharmaceutical Form
Maltese: Qawwa Għamla farmaċewtikaMnejn jingħata
English: Clinical safety
Maltese: Sigurtà klinika
English: Dihydroergotamine mesilate (dihydroergotamine - DHE) is a semi-synthetic derivative of ergotamine.
Maltese: Dihydroergotamine mesilate (dihydroergotamine - DHE) huwa derivattiv semi-sintetiku tal-ergotamina.
English: (PAOD Stage II)
Maltese: ta' Stadju II)
English: In some published literature, they are considered as aetiology of retroperitoneal fibrosis (P. Meier et al, La fibrose rétropéritonéale, une maladie inflammatoire méconnue.
Maltese: F'xi letteratura ppubblikata, huma meqjusa bħala etjoloġija ta' fibrożi retroperitoneali (P. Meier et al, La fibrose rétropéritonéale, une maladie inflammatoire méconnue.
English: • Acute retinopathies of vascular origin
Maltese: • Retinopatiji akuti ta' oriġini vaskulari
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 ġejjin li fihom derivati tal-ergotina: dihydroergocryptine/kafeina, dihydroergocristine, dihydroergotamine, dihydroergotoxine u nicergoline.
English: • Ancillary treatment of Raynaud's syndrome
Maltese: • Kura anċillari tas-sindromu ta' Raynaud
English: One case was confounded by medical history and in 25 cases co-suspected drugs were reported: benfluorex (4 cases), dexflenfuramine (4 cases), pergolide (1 case), beta blockers (9 cases), fenofibrate (2 cases) and ergot derivative drug (8 cases).
Maltese: Każ wieħed kien imfixkel minn storja medika u f'25 każ kienu rrapportati mediċini ko-suspettati: benfluorex (4 każijiet), dexflenfuramine (4 każijiet), pergolide (każ 1), imblokkaturi beta (9 każijiet), fenofibrate (2 każijiet) u mediċina b'derivattiv talergotina (8 każijiet).
English: After 4 months of treatment, the attack frequency decreased by 2.0 ± 1.6 (-60.0%) with dihydroergotamine versus 1.7 ± 1.5 (-48.8%) with placebo (p = 0.014 for the relative variations).
Maltese: Wara 4 xhur ta' kura, il-frekwenza tal-attakki naqset b'2.0 ± 1.6 (-60.0%) b'dihydroergotamine kontra 1.7 ± 1.5 (-48.8%) bi plaċebo (p = 0.014 għall-varjazzjonijiet relattivi).
English: Under-notification can be suspected given that:
Maltese: Jista' jkun hemm suspett ta' nuqqas ta' rapportar minħabba li:
English: The CHMP considered the MAHs' proposals for risk minimisation measures.
Maltese: Is-CHMP ikkunsidra l-proposti tal-MAHs għal miżuri ta' minimizzazzjoni tar-riskji.
English: • Orthostatic hypotension
Maltese: • Pressjoni baxxa ortostatika
English: The frequency of attacks of migraine (the primary efficacy criteria) was not statistically significant (dihydroergotamine group (-1.84 ± 1.55) vs. placebo group (-1.67 ± 1.49) (p=0.220)).
Maltese: Il-frekwenza tal-attakki ta' emigranja (il-kriterju primarju tal-effikaċja) ma kinitx statistikament sinifikanti (il-grupp li ħa dihydroergotamine (-1.84 ± 1.55) kontra l-grupp li ħa lplaċebo (-1.67 ± 1.49) (p=0.220)).
English: Therefore, in accordance with Article 116 of Directive 2001/83/EC the CHMP recommends:
Maltese: Għalhekk, skont l-Artikolu 116 tad-Direttiva 2001/83/KE s-CHMP jirrakkomanda:
English: A post-hoc analysis was performed in the sub-group of patients (n=288) with functional handicap and quality of life (QOL) decrease (defined by Migraine Specific Quality of Life, MSQ<80).
Maltese: Saret analiżi post-hoc fis-sottogrupp ta' pazjenti (n=288) b'diżabilità funzjonali u tnaqqis fil-kwalità talħajja (QOL) (definit mill-Kwalità tal-Ħajja Speċifika għall-Emigranja, MSQ<80).
English: • Ancillary treatment of intermittent claudication in symptomatic peripheral arterial occlusive disease
Maltese: • Kura anċillari ta' klawdikazzjoni intermittenti f'mard okklużiv sintomatiku tal-arterji periferali (PAOD
English: However, a total of 134 cases of ergostim or symptoms potentially related to ergotism have been reported by the MAHs.
Maltese: Madankollu, il-MAHs irrapportaw total ta' 134 każ ta' ergotiżmu jew sintomi potenzjalment relatati mal-ergotiżmu.
English: Benefit -risk balance
Maltese: Bilanċ bejn il-benefiċċju u r-riskju
English: As expected, fibrosis occurred mostly in female patients (68%) after long time of treatment with dihydroergotamine (9.1 years on average) and the most frequent type of fibrosis reaction reported was retroperitoneal (36%), followed by cardiac (30%) and pleural (18%).
Maltese: Kif mistenni, il-fibrożi seħħet l-aktar f'pazjenti nisa (68%) wara żmien twil ta' kura b'dihydroergotamine (medja ta' 9.1 snin) u l-aktar tip frekwenti ta' reazzjoni ta' fibrożi rapportata kien retroperitoneali (36%), segwit minn dik kardijaka (30%) u plewrali (18%).
English: Only one study, Thulesius (1986), demonstrated a significant decrease of immediate drop in blood pressure after standing up with 10mg per day dihydroergotamine compared to placebo, in patients with hypotension induced by treatment with psychotropic drugs and it became available after the initial marketing authorisation was granted.
Maltese: Studju wieħed biss, Thulesius (1986), wera tnaqqis sinifikanti ta' tnaqqis immedjat fil-pressjoni taddemm wara qawmien bil-wieqfa b'10mg kuljum ta' dihydroergotamine meta mqabbel ma' plaċebo, f'pazjenti bi pressjoni baxxa minħabba kura b'mediċini psikotropiċi u sar disponibbli wara li ngħatat lawtorizzazzjoni inizjali għat-tqegħid fis-suq.
English: • Symptomatic treatment of veno-lymphatic insufficiency
Maltese: • Kura sintomatika ta' insuffiċjenza veno-limfatika
English: • Ancillary treatment of visual acuity decrease and visual field disturbances presumably of vascular origin
Maltese: • Kura anċillari ta' tnaqqis fl-akutezza viżwali u disturbi fil-vista preżumibbilment ta' oriġini vaskulari
English: Overall, 8 cases of fibrotic adverse reactions from a French survey conducted in 2011 and 50 cases among the 75 cases reported by the MAHs have been considered as potentially related to dihydroergotamine including 24 with no confounding factor.
Maltese: B'mod globali, 8 każijiet ta' reazzjonijiet avversi fibrotiċi minn stħarriġ Franċiż li sar fl-2011 u 50 każ minn fost il-75 każ irrapportati mill-MAHs kienu meqjusa bħala potenzjalment relatati ma' dihydroergotamine fosthom 24 bl-ebda fattur li jfixkel.
English: The CHMP has considered the totality of the available data on the safety and efficacy of dihydroergotamine.
Maltese: Is-CHMP ikkunsidra t-totalità tad-dejta disponibbli dwar is-sigurtà u l-effikaċja ta' dihydroergotamine.
English: For the percentage of responders (61.1% in the dihydroergotamine group vs. 55.9% in the placebo group) the difference was not statistically significant.
Maltese: Għall-perċentwal tal-persuni li rrispondew (61.1% fil-grupp li ħa dihydroergotamine kontra 55.9% fil-grupp ħa l-plaċebo), id-differenza ma kinitx statistikament sinifikanti.
English: • Symptomatic treatment of chronic pathological cognitive and neurosensorial impairment in elderly
Maltese: • Kura sintomatika ta' indeboliment konjittiv u newrosensorjali patoloġiku kroniku fl-anzjani
English: For all products the concomitant use of CYP3A inhibitors is contraindicated with dihydroergotamine (section 4.5) and for others the concomitant use of vasonconstrictive agent is also contraindicated.
Maltese: Għall-prodotti kollha, l-użu konkomitanti ta' inibituri ta' CYP3A huwa kontraindikat ma' dihydroergotamine (sezzjoni 4.5) u għal oħrajn, l-użu konkomitanti ta' sustanzi vażokostriġġenti huwa wkoll kontraindikat.
English: Systolic blood pressure of the placebo and the dihydroergotamine group differed already at baseline.
Maltese: Il-pressjoni sistolika tad-demm tal-grupp talplaċebo u ta' dihydroergotamine kienu diġà differenti fil-linja bażi.
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: Il-MAHs ippreżentaw ukoll il-perspettivi u s-sommarji kritiċi tagħhom tar-rapporti spontanji kollha ta' reazzjonijiet fibrotiċi (kardijaċi bi jew mingħajr pressjoni għolja tal-arterji pulmonari, pulmonari, plewrali, peritoneali, retroperitoneali, eċċ.) u ergotiżmu bilprodotti mediċinali tagħhom li fihom derivati tal-ergotina.
English: (excluding Alzheimer's disease and other dementia)
Maltese: (minbarra l-marda ta' Alzheimer u tipi oħra ta' dimenzja)
English: Overall summary of the scientific evaluation of dihydroergotamine containing medicinal products (see Annex I)
Maltese: Sommarju ġenerali tal-evalwazzjoni xjentifika tal-prodotti mediċinali li fihom dihydroergotamine (ara Anness I)
English: − Symptomatic treatment of veno-lymphatic insufficiency.
Maltese: Kura sintomatika ta' insuffiċjenza veno-limfatika.
English: • The Committee considered the procedure under Article 31 of Directive 2001/83/EC for ergot derivatives containing medicinal products in the concerned indications.
Maltese: • Il-Kumitat ikkunsidra l-proċedura skont l-Artikolu 31 tad-Direttiva 2001/83/KE għal prodotti mediċinali li fihom derivati tal-ergotina fl-indikazzjonijiet ikkonċernati.
English: Symptoms of ergotism are listed in the sections 4.8, 4.9 of all the SmPCs and ergotism is identified in section 4.4 as a consequence of a prolonged use of dihydroergotamine or high dosage.
Maltese: Is-sintomi tal-ergotiżmu huma elenkati fis-sezzjonijiet 4.8, 4.9 tal-SmPCs kollha u l-ergotiżmu ġie identifikat fis-sezzjoni 4.4 bħala konsegwenza tal-użu fit-tul ta' dihydroergotamine jew doża għolja.
English: The literature data indicate a possible efficacy of oral dihydroergotamine in migraine prophylaxis, but definite scientific proof remains weak.
Maltese: Id-dejta mil-letteratura tindika l-effikaċja possibbli ta' dihydroergotamine orali fil-profilassi talemigranja, imma provi xjentifiċi definittivi jibqgħu dgħajfa.
English: − Orthostatic hypotension.
Maltese: Pressjoni baxxa ortostatika.
English: The open label study (Wenzel-E et al, 1989) that became available after the granting of the initial marketing authorisation discusses the use of dihydroergotamine in venous insufficiency.
Maltese: L-istudju b'tikketta miftuħa (Wenzel-E et al, 1989) li sar disponibbli wara l-għoti tal-awtorizzazzjoni inizjali għat-tqegħid fis-suq jiddiskuti l-użu ta' dihydroergotamine fl-insuffiċjenza tal-vini.
English: For the indication “symptomatic treatment of veno-lymphatic insufficiency” very few studies have been conducted.
Maltese: Għall-indikazzjoni “kura sintomatika ta' insuffiċjenza veno-limfatika” ftit saru studji.
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 plawżibbli ħafna li d-derivati talergotina li jaġixxu bħala agonisti tar-riċettur ta' 5-HT2B jistgħu jinduċu mard “serotonerġiku" tal-valvi simili għal dak ikkawżat minn tumuri karċinojdi jew leżjonijiet fibrotiċi ta' tessuti oħra, wieħed għandu jiftakar li xi derivati tal-ergotina mhumiex agonisti tar-riċettur ta' 5-HT2B.
English: In addition, patients were included if they displayed a reduction of systolic blood pressure of more than 10 mmHg, which does not comply with the established definition of orthostatic hypotension (at least 20 mm Hg below baseline).
Maltese: Barra minn hekk, il-pazjenti kienu inklużi jekk urew tnaqqis fil-pressjoni sistolika taddemm ta' aktar minn 10 mmHg, li mhuwiex konformi mad-definizzjoni stabbilita ta' pressjoni baxxa ortostatika (mill-inqas 20 mm Hg taħt il-linja bażi).
English: Some of them assessed the injection route or doses higher than recommended (up to 42mg daily, instead of 10mg daily).
Maltese: Xi wħud minnhom ivvalutaw mnejn ingħatat linjezzjoni jew dożi ogħla milli rakkomandat (sa 42mg kuljum, minflok 10mg kuljum).
English: Almost all cases were serious (93% of the cases where seriousness was reported) and treatment with dihydroergotamine was discontinued in 91% of the cases (for which information is available) and in 57% of these cases, the outcome has been reported as improved or recovered.
Maltese: Kważi l-każijiet kollha kienu serji (93% tal-każijiet fejn il-gravità kienet irrapportata) u l-kura b'dihydroergotamine twaqqfet f'91% tal-każijiet (li għalihom hemm informazzjoni disponibbli) u f'57% ta' dawn il-każijiet, l-eżitu kien irrapportat bħala li tjieb jew irkupra.
English: The CHMP also noted the position of several MAHs that there is not enough evidence to support an indication of oral dihydroergotamine in orthostatic hypotension.
Maltese: Is-CHMP innota wkoll il-pożizzjoni ta' bosta MAHs li ma hemmx biżżejjed evidenza biex tappoġġa indikazzjoni ta' dihydroergotamine orali fil-pressjoni baxxa ortostatika.
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 ta' farmakoviġilanza li saret fl-2011, notifiki spontanji ġodda rrapportati b'uħud minn dawk il-prodotti identifikaw każijiet serji ta' fibrożi u ergotiżmu u Franza ħasset li dan it-tħassib għas-sigurtà mhuwiex megħlub mill-evidenza limitata ta' effikaċja.
English: The Committee concluded that the benefit-risk balance of dihydroergotamine containing products for oral use is not favourable pursuant to Article 116 of Directive 2001/83/EC for prophylaxis of migraine, for orthostatic hypotension and for symptomatic treatment of veno-lymphatic insufficiency.
Maltese: Il-Kumitat ikkonkluda li skont l-Artikolu 116 tad-Direttiva 2001/83/KE, il-bilanċ bejn il-benefiċċju u rriskju tal-prodotti li fihom dihydroergotamine għall-użu orali mhuwiex favorevoli għall-profilassi talemigranja, għall-pressjoni baxxa ortostatika u għall-kura sintomatika ta' insuffiċjenza veno-limfatika.
English: The studies presented are old and of poor methodological quality: uncontrolled, open designed, with a low number of patients (n=12 in Wenzel, 1989, the most recent study).
Maltese: L-istudji ppreżentati huma qodma u ta' kwalità metodoloġika fqira: mhux ikkontrollati, b'disinn miftuħ, b'għadd baxx ta' pazjenti (n=12 f'Wenzel, 1989, l-aktar studju riċenti).
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: Fejn kien possibbli kienet ipprovduta reviżjoni tad-dejta l-oħra kollha disponibbli (jiġifieri dejta mil-letteratura, dejta pre-klinika, u dejta klinika oħra fosthom studji epidemjoloġiċi) li kienet rilevanti għall-valutazzjoni tar-riskju ta' fibrożi.
English: Ergot derivatives are recognised as being capable of inducing fibrosis, in particular heart valve fibrosis.
Maltese: Id-derivati tal-ergotina huma rikonoxxuti li kapaċi jinduċu fibrożi, b'mod partikolari fibrożi tal-valvi talqalb.
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 għar-riċetturi serotoninerġiċi bid-derivati differenti tal-ergotina u d-dożi terapewtiċi użati jistgħu jispjegaw id-differenzi osservati fir-rati ta' notifika għarreazzjonijiet fibrotiċi.
English: Although significant reduction in venous capacity, capillary flow of erythrocytes and peak flow of reactive hyperemia were demonstrated, due to a very small study group, the uncontrolled design and other methodological limitations, the CHMP could not draw any conclusion on the efficacy of dihydroergotamine.
Maltese: Għalkemm intwera tnaqqis sinifikanti fil-kapaċità venuża, fil-fluss kapillari tal-eritroċiti u l-fluss massimu ta' iperimja reattiva, minħabba l-grupp żgħir ħafna tal-istudju, id-disinn mhux ikkontrollat u limitazzjonijiet metodoloġiċi oħra, is-CHMP ma seta' jiġbed l-ebda konklużjoni dwar l-effikaċja ta' dihydroergotamine.
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 serotoninerġiċi, b'mod partikolari r-riċetturi ta' 5-HT2B minn derivati tal-ergotina ġiet deskritta b'mod estensiv fil-letteratura.
English: The design of this study was considered acceptable by the CHMP (i.e. controlled, randomised, double-blind) but the size of the study was considered small (n=58).
Maltese: Id-disinn ta' dan l-istudju kien meqjus bħala aċċettabbli mis-CHMP (jiġifieri ikkontrollat, aleatorju, bi blindaġġ doppju) imma d-daqs tal-istudju kien meqjus żgħir (n=58).
English: In the only recent, large study with appropriate design (double-blind, placebo-controlled, 5-month treatment study) (PROMISE study) that became available after the granting of the initial marketing authorisation, the evidence for efficacy of dihydroergotamine in the prevention of migraine has not been demonstrated as there was no statistically significant difference between dihydroergotamine and placebo.
Maltese: Fl-uniku studju kbir, reċenti, b'disinn xieraq (studju fuq 5 xhur, bi blindaġġ doppju, ikkontrollat bi plaċebo, dwar il-kura) (l-istudju PROMISE) li sar disponibbli wara l-għoti tal-awtorizzazzjoni inizjali għat-tqegħid fis-suq, ma ntwerietx l-evidenza għall-effikaċja ta' dihydroergotamine fil-prevenzjoni talemigranja peress li ma kienx hemm differenza statistikament sinifikanti bejn dihydroergotamine u lplaċebo.
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 tarriċetturi ta' 5-HT2A u 5-HT1B u anke effett plawżibbli fuq it-trasportatur tas-serotonin.
English: The marketing authorisation holders (MAHs) submitted all available efficacy data from clinical trials and observational studies, including data that became available since the granting of the initial marketing authorisation.
Maltese: Id-detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq (MAHs) ippreżentaw id-dejta kollha disponibbli dwar l-effikaċja minn provi kliniċi u studji ta' osservazzjoni, inkluża dejta li saret disponibbli wara l-għoti tal-awtorizzazzjoni inizjali għat-tqegħid fis-suq.