FrancophonIA/ELRC3.0 huggingface dataset:
English: Aseptically reconstitute each Empliciti vial with a syringe of adequate size and an 18 gauge or smaller needle as shown in Table 1.
Maltese: B'mod asettiku irrikostitwixxi kull kunjett ta' Empliciti b'siringa ta' daqs xieraq u labra ta' 18 gauge jew iżgħar kif muri fit-Tabella 1.
English: Infusion reaction Infusion reactions have been reported in patients receiving elotuzumab (see section 4.8).
Maltese: Reazzjoni għall-infużjoni Ġew irrapportati reazzjonijiet għall-infużjoni f'pazjenti li qed jirċievu elotuzumab (ara sezzjoni 4.8).
English: p-valuec Complete Response (CR + sCR)d n (%)
Maltese: b n (%) [95% CI] valur pc Rispons Sħiħ (CR + sCR)d n (%)
English: Studies to evaluate the effect of elotuzumab on fertility have not been performed.
Maltese: Ma twettqux studji biex jiġi evalwat l-effett ta' elotuzumab fuq il-fertilità.
English: How to use Empliciti
Maltese: Jekk tingħata wisq Empliciti
English: Hypoaesthesia 25 4.9 Mood altered 23 4.5 Hypersensitivity 10 2.0
Maltese: Dejta dwar l-effikaċja u s-sigurtà ta' Empliciti f'pazjenti ≥ 85 sena hija limitata ħafna.
English: Lymphopeniab 10 21.0 Pneumoniac
Maltese: IL-PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
English: In 2013, an urgent union procedure under Article 107i of Directive 2001/83/EC (EMEA/H/A-107i/1363) was initiated further to the increased reporting of hepatotoxicity reactions in association with flupirtine.
Maltese: Fl-2013, inbdiet proċedura tal-unjoni urġenti skont l-Artikolu 107i tad-Direttiva 2001/83/KE (EMEA/H/A-107i/1363) wara r-rappurtar miżjud ta' reazzjonijiet ta' epatotossiċità b'assoċjazzjoni ma' flupirtine.
English: • The PRAC reviewed all newly available safety and efficacy data, including information provided by the marketing authorisation holders on cases of liver injury, results of observational studies, data available in EudraVigilance and the scientific literature, in the context of the data reviewed in the previous procedure EMEA/H/A-107i/1363 and in relation to the risk of hepatotoxicity associated to flupirtine-containing medicinal products.
Maltese: • Il-PRAC irreveda d-data kollha dwar is-sigurtà u l-effikaċja li għadha kif ġiet disponibbli, inkluża informazzjoni pprovduta mid-detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq dwar każijiet ta' ħsara fil-fwied, riżultati tal-istudji ta' osservazzjoni, data disponibbli f'EudraVigilance u lletteratura xjentifika, fil-kuntest tad-dejta riveduta fil-proċedura preċedenti EMEA/H/A107i/1363 u fir-rigward tar-riskju ta' epatotossiċità assoċjata mal-prodotti mediċinali li fihom flupirtine.
English: The PRAC adopted a recommendation on 8 February 2018 which was then considered by the CMDh, in accordance with Article 107k of Directive 2001/83/EC.
Maltese: Il-PRAC adotta rakkomandazzjoni, fit-8 ta' Frar 2018 li dak iż-żmien ġiet ikkunsidrata mis-CMDh, skont l-Artikolu 107k tad-Direttiva 2001/83/KE.
English: Flupirtine is a ‘selective neuronal potassium channel opener' that acts by opening Kv7 potassium channels leading to functional N-methyl-D-aspartate receptor antagonism.
Maltese: Flupirtine huwa “aġent li jiftaħ il-kanal tal-potassju newronali selettiv” li jaġixxi billi jiftaħ il-kanali talpotassju Kv7 li jwassal għal antagoniżmu tar-riċettur ta' N-methyl-D-aspartate funzjonali.
English: • The PRAC considered the procedure under Article 31 of Directive 2001/83/EC resulting from pharmacovigilance data for flupirtine-containing medicinal products (see Annex I).
Maltese: • Il-PRAC ikkunsidra l-proċedura skont l-Artikolu 31 tad-Direttiva 2001/83/KE li tirriżulta middata tal-farmakoviġilanza għall-prodotti mediċinali li fihom flupirtine (ara Anness I).
English: Additionally a facilitatory effect on gamma-aminobutyric acid A receptors has been described.
Maltese: Barra minn hekk, ġie deskritt effett faċilitatorju fuq riċetturi ta' aċidu gamma-aminobutirriku A.
English: In 2013, as a result of an urgent Union procedure under Article 107i of Directive 2001/83/EC (EMEA/H/A-107i/1363), the marketing authorisations (MAs) for flupirtine-containing medicinal products were varied to impose restrictions and risk minimisations measures implemented in view of the risk of liver injury.
Maltese: Fl-2013, bħala riżultat ta' proċedura tal-Unjoni urġenti skont l-Artikolu 107i tad-Direttiva 2001/83/KE (EMEA/H/A-107i/1363), l-awtorizzazzjonijiet għat-tqegħid fis-suq (MAs) għall-prodotti mediċinali li fihom flupirtine ġew varjati biex jimponu restrizzjonijiet u miżuri tal-imminimizzar tar-riskju implimentati fid-dawl tar-riskju ta' ħsara fil-fwied.
English: Data from spontaneous reports and the literature confirm the risk of unpredictable and potentially fatal liver injury associated to the use of flupirtine-containing medicinal products.
Maltese: Data minn rapporti spontanji u mil-letteratura tikkonferma r-riskju ta' ħsara fil-fwied mhux prevista u potenzjalment fatali assoċjata mal-użu ta' prodotti mediċinali li fihom flupirtine.
English: The PRAC considered all newly available safety and efficacy data, including information provided by the marketing authorisation holders on cases of liver injury, results of the above mentioned observational studies (DUS and PASS), data available in EudraVigilance and the scientific literature, in the context of the data reviewed in the previous Article 107i procedure.
Maltese: Il-PRAC ikkunsidra d-data kollha dwar is-sigurtà u l-effikaċja li għadha kif ġiet disponibbli, inkluża informazzjoni pprovduta mid-detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq dwar każijiet ta' ħsara fil-fwied, riżultati tal-istudji ta' osservazzjoni msemmija hawn fuq (DUS u PASS), data disponibbli f'EudraVigilance u l-letteratura xjentifika, fil-kuntest tad-data riveduta fil-proċedura preċedenti skont lArtikolu 107i.
English: • The PRAC concluded that the safety data confirm that the use of flupirtine-containing medicinal products is associated with a risk of unpredictable and potentially fatal liver injury.
Maltese: • Il-PRAC ikkonkluda li d-data ta' sigurtà tikkonferma li l-użu ta' prodotti mediċinali li fihom flupirtine huwa assoċjat ma' riskju ta' ħsara fil-fwied mhux prevista u potenzjalment fatali.
English: Furthermore, the individual case reports of hepatobiliary toxicity show a substantial proportion of cases with noncompliance with the safety restrictions.
Maltese: Barra minn hekk, ir-rapporti tal-każijiet individwali ta' tossiċità epatobiljari juru proporzjon sostanzjali ta' każijiet b'nuqqas ta' konformità mar-restrizzjonijiet tas-sigurtà.
English: However, considering the failure of the previous measures, the absence of risk factors sensitive enough to predict the risk of hepatotoxicity, the clinical setting where these medicinal products are used, the PRAC could not identify further measures that would ensure effective minimisation of the risk of hepatotoxicity associated to the use of flupirtine-containing medicinal products.
Maltese: Madankollu, meta jiġi kkunsidrat il-falliment tal-miżuri preċedenti, in-nuqqas ta' fatturi ta' riskju sensittivi biżżejjed biex jipprevedu r-riskju ta' epatotossiċità, l-ambjent kliniku fejn jintużaw dawn ilprodotti mediċinali, il-PRAC ma setax jidentifika jekk miżuri ulterjuri jiżgurawx imminimizzar effettiv tar-riskju ta' epatotossiċità assoċjata mal-użu ta' prodotti mediċinali li fihom flupirtine.
English: • The PRAC considered that there is no new significant information on the demonstrated efficacy of flupirtine in the management of acute (nociceptive) pain (mild, moderate and severe).
Maltese: • Il-PRAC ikkunsidra li m'hemm l-ebda informazzjoni sinifikanti ġdida dwar l-effikaċja murija ta' flupirtine fil-ġestjoni ta' uġigħ (noċiċettiv) akut (ħafif, moderat u sever).
English: In addition, cases of drug induced liver injury (DILI), including serious cases, continued to be received in EudraVigilance (EV) with flupirtine-containing medicinal products reported as suspected or interacting products.
Maltese: Barra minn hekk, baqgħu jiġu rċevuti f'EudraVigilance (EV) każijiet ta' ħsara fil-fwied indotta mill-mediċina (DILI) bi prodotti mediċinali li fihom flupirtine rrappurtati bħala prodotti suspettati jew li jinteraġixxu.
English: The PRAC is of the opinion that the results of the newly available studies support the efficacy of flupirtine in the management of acute (nociceptive) pain (mild, moderate and severe) previously demonstrated in clinical trials.
Maltese: Il-PRAC huwa tal-opinjoni li r-riżultati tal-istudji li jkunu għadhom kif ġew disponibbli jappoġġjaw leffikaċja ta' flupirtine fil-ġestjoni ta' uġigħ (noċiċettiv) akut (ħafif, moderat u sever) li ntwera preċedentement fil-provi kliniċi.
English: In 2017, results of observational studies imposed as an outcome of this urgent union procedure indicated a low degree of compliance with the authorised terms of use of flupirtinecontaining medicinal products and more specifically, with the above-mentioned restrictions and risk minimisations measures.
Maltese: Fl-2017, riżultati ta' studji ta' osservazzjoni imposti bħala eżitu ta' din il-proċedura tal-unjoni urġenti indikaw grad baxx ta' konformità mat-termini għallużu awtorizzati tal-prodotti mediċinali li fihom flupirtine, u b'mod aktar speċifiku, mar-restrizzjonijiet u l-miżuri tal-imminimizzar tar-riskju msemmija hawn fuq.
English: On 19 October 2017, the BfArM therefore triggered a referral under Article 31 of Directive 2001/83/EC resulting from pharmacovigilance data, and requested the PRAC to assess the impact of the above concerns on the benefit-risk balance of flupirtine-containing medicinal products and to issue a recommendation on whether the relevant marketing authorisations should be maintained, varied, suspended or revoked.
Maltese: Għalhekk, fid-19 ta' Ottubru 2017, BfArM tat bidu għal referenza skont l-Artikolu 31 tadDirettiva 2001/83/KE bħala riżultat ta' dejta tal-farmakoviġilanza, u talbet lill-PRAC biex jivvaluta limpatt tat-tħassib imsemmi hawn fuq, fuq il-bilanċ bejn il-benefiċċju u r-riskju tal-prodotti mediċinali li fihom flupirtine u biex joħroġ rakkomandazzjoni dwar jekk l-awtorizzazzjonijiet għat-tqegħid fis-suq rilevanti għandhomx jinżammu, jiġu varjati, sospiżi jew revokati.
English: • The PRAC discussed further risk minimisation proposals and concluded that no feasible measures would ensure effective minimisation of the hepatotoxicity risk to an acceptable level and that therefore this risk outweighs the benefits of flupirtine in the treatment of acute pain, when treatment with other analgesics is contraindicated.
Maltese: • Il-PRAC iddiskuta proposti tal-imminimizzar tar-riskju ulterjuri u kkonkluda li l-ebda miżura affidabbli ma tiżgura mminimizzar effettiv tar-riskju ta' epatotossiċità għal livell aċċettabbli u li għalhekk dan ir-riskju huwa akbar mill-benefiċċji ta' flupirtine fil-kura ta' uġigħ akut, meta tiġi kontraindikata kura ma' analġeżiċi oħra.
English: PRAC considered that the newly available safety data, confirmed the known risk of unpredictable and potentially fatal liver injury.
Maltese: Il-PRAC iddiskuta jekk imminimizzar tar-riskju ulterjuri jnaqqasx biżżejjed ir-riskju ta' epatotossiċità.
English: • Considering the new reports of liver injury, together with the results of observational studies, indicating a very low compliance to the measures recommended in 2013 to minimise the risk of hepatotoxicity, the PRAC concluded that these measures have not been effective in adequately minimising the risk of hepatotoxicity.
Maltese: • Meta jiġu kkunsidrati r-rapporti ġodda ta' ħsara fil-fwied, flimkien mar-riżultati tal-istudji ta' osservazzjoni, li jindikaw konformità baxxa ħafna mal-miżuri rrakkomandati fl-2013 għallimminimizzar tar-riskju ta' epatotossiċità, il-PRAC ikkonkluda li dawn il-miżuri ma kinux effettivi biex jimminimizzaw b'mod adegwat ir-riskju ta' epatotossiċità.
English: Cases of drug induced liver injury (DILI), including cases of acute liver failure, cases necessitating a liver transplant and cases with a fatal outcome have been received since the previous review.
Maltese: Sa mir-reviżjoni preċedenti, ġew irċevuti każijiet ta' ħsara fil-fwied indotta mill-mediċina (DILI), inklużi każijiet ta' insuffiċjenza akuta tal-fwied, każijiet li jeħtieġu trapjant u każijiet b'riżultat fatali.
English: Therefore, pursuant to Article 116 of Directive 2001/83/EC, the CMDh recommends the revocation of the marketing authorisations for flupirtine-containing medicinal products.
Maltese: Għalhekk, skont l-Artikolu 116 tad-Direttiva 2001/83/KE, is-CMDh jirrakkomanda r-revoka talawtorizzazzjonijiet għat-tqegħid fis-suq għall-prodotti mediċinali li fihom flupirtine.
English: Based on the review of all data available at the time, the PRAC concluded that flupirtine is associated with an increased risk of hepatotoxicity.
Maltese: Abbażi tar-reviżjoni tad-data kollha disponibbli dak iż-żmien, il-PRAC ikkonkluda li flupirtine huwa assoċjat ma' riskju miżjud ta' epatotossiċità.
English: In view of the recent study results and as cases of liver injury continue to be reported, the German national competent authority (BfArM) considered that the impact of the risk of liver injury on the benefit-risk balance of these medicinal products and the adequacy of the related risk minimisation measures, should be reviewed.
Maltese: Minkejja l-limitazzjonijiet tagħhom, is-sitt studji ta' osservazzjoni mwettqa wrew b'mod konsistenti nuqqas sostanzjali ta' konformità mal-miżuri meħtieġa sabiex jiġi mminimizzat ir-riskju ta' epatotossiċità.
English: The PRAC concluded that while the use of flupirtine-containing products has decreased, the measures implemented have been ineffective to minimise the hepatotoxicity risk to an acceptable level.
Maltese: Il-PRAC ikkonkluda li filwaqt li l-użu tal-prodotti li fihom flupirtine naqas, il-miżuri implimentati ma kinux effettivi biex jimminimizzaw ir-riskju ta' epatotossiċità għal livell aċċettabbli.
English: • Prescription of a supratherapeutic dose (MedDRA term: drug toxicity)
Maltese: • Preskrizzjoni ta' doża supra-terapewtika (terminu MedDRA: tossiċità tad-droga)
English: The MAH, in agreement with the competent authorities in the Member States, shall implement, prior to the launch, an educational programme for physicians aiming to provide educational material on correct diagnosis and therapeutic managements of the treatment of inborn errors in primary bile acid synthesis due to 3β-Hydroxy-Δ5-C27-steroid oxidoreductase deficiency or Δ4-3Oxosteroid-5β-reductase deficiency and to inform on expected and potential risks associated with the treatment.
Maltese: Il-MAH bi ftehim mal-awtoritajiet kompetenti fl-Istati Membri għandu jimplimenta qabel it-tnedija, programm edukattiv għal tobba li jridu jipprovdu materjal edukattiv dwar id-dijanjożi korretta u lġestjonijiet terapewtiċi tal-kura ta' żbalji innati fis-sintesi tal-bila aċidika primarja minħabba nnuqqas ta' 3β-Hydroxy-Δ5-C27-fl-assenza ta' ossieoreduttaż tal-isterjode jew Δ4-3-Ossjosterojd-5βreduttaż u sabiex jinforma dwar riskji mistennija u potenzjali assoċjati mat-trattament.
English: • Risk of gallstones
Maltese: • Riskju ta' kalkoli
English: 100 tablets (2 x 50)
Maltese: 100 pillola (2 X 50)
English: bottle (HDPE) without outer carton 180 tablets
Maltese: Flixkun (HDPE) mingħajr il-kartuna ta' barra
English: The full EPAR for Aivlosin can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: Aivlosin is an antibiotic.
Maltese: Aivlosin huwa antibijotiku.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom orali jitħallat f'għalf tal-majjali minn sid il-majjali u jintuża għall-kura ta' majjali individwali.
English: Other information about Aivlosin:
Maltese: Informazzjoni oħra dwar Aivlosin:
English: Aivlosin tylvalosin
Maltese: Aivlosin tilvalożin
English: This is a summary of the European public assessment report (EPAR) for Aivlosin.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Aivlosin.
English: The European Commission granted a marketing authorisation valid throughout the EU for Aivlosin on 9 September 2004.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha għal Aivlosin fid-9 ta' Settembru 2004.
English: Why is Aivlosin approved?
Maltese: Għaliex ġie approvat Aivlosin?
English: The active substance of Aivlosin is tylvalosin (previous name: acetylisovaleryltylosin), an antibiotic of the macrolide group.
Maltese: Is-sustanza attiva ta' Aivlosin hija t-tilvalożin (isem preċedenti: aċetiliżovaleriltilożin), antibijotiku li jagħmel parti mill-grupp tal-makrolidi.
English: In chickens and pheasants, it is used for treatment or metaphylaxis of lung infections caused by a bacterium Mycoplasma gallisepticum.
Maltese: Fit-tiġieġ u l-faġani, jintuża għall-kura jew għall-metafilassi ta' infezzjonijiet tal-pulmun ikkawżati millbatterju Mycoplasma gallisepticum.
English: When mixing Aivlosin into feed or drinking water or handling the medicated feed or water, direct contact with eyes, skin and mouth should be avoided and protective equipment should be worn, e.g. overalls, gloves and face masks (respirator).
Maltese: Meta Aivlosin jitħallat mal-għalf jew mal-ilma tax-xorb jew meta jkun se jintmess għalf jew ilma medikati, jenħtieġ li jiġi evitat il-kuntatt dirett mal-għajnejn, mal-ġilda u mal-ħalq u jenħtieġ li jintlibes apparat protettiv, bħal ġagagi, ingwanti, u maskri tal-wiċċ (respiraturi) .
English: The antimicrobial effectiveness of tylvalosin against bacteria causing diseases was investigated in the laboratory.
Maltese: L-effikaċja antimikrobika tat-tilvalożin kontra l-batterji li jikkawżaw il-mard ġiet investigata fillaboratorji.
English: These included a dose confirmation study in turkey poults (young turkeys) artificially infected with a lung virus (avian pneumovirus) and Ornithobacterium rhinotracheale, to simulate a complicated infection.
Maltese: Dawn kienu jinkludu studju dwar il-konferma tad-doża fi frieħ ta' dundjan (dundjani żgħar) infettati b'mod artifiċjali b'virus tal-pulmun (pnewmovirus avjan) u Ornithobacterium rhinotracheale, biex tiġi simulata infezzjoni kkumplikata.
English: What is the risk associated with Aivlosin?
Maltese: X'inhu r-riskju assoċjat ma' Aivlosin?
English: The effectiveness of Aivlosin was similar to that of other medicines of the same class already authorised for this disease in chickens.
Maltese: L-effikaċja ta' Aivlosin kienet simili għal dik ta' mediċini oħra tal-istess klassi diġà awtorizzati għal din il-marda fit-tiġieġ.
English: Metaphylaxis refers to the simultaneous treatment of both diseased animals and clinically healthy animals in close contact with them.
Maltese: Metafilassi tirreferi għall-kura simultanja ta' annimali morda u annimali klinikament b'saħħithom li jkunu f'kuntatt mill-qrib magħhom.
English: In turkeys, it is used to treat lung infections caused by a bacterium, Ornithobacterium rhinotracheale, which can cause illness when it is complicated by other viral and bacterial infections.
Maltese: Fid-dundjani, jintuża għall-kura ta' infezzjonijiet tal-pulmun ikkawżati mill-batterju Ornithobacterium rhinotracheale li jista' jikkawża mard meta jkun ikkumplikat b'infezzjonijiet virali u batteriċi oħra.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Aivlosin's benefits are greater that its risks and recommended that it be approved for use in the EU.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu Veterinarju (CVMP) tal-Aġenzija kkonkluda li l-benefiċċji ta' Aivlosin huma akbar mir-riskji tiegħu u rrakkomanda li jkun approvat għall-użu fl-UE.
English: In pigs, it is used to treat or for metaphylaxis of a number of infectious diseases that are caused by bacteria that affect the lungs (i.e. swine enzootic pneumonia) or the intestinal tract (swine dysentery or porcine proliferative enteropathy).
Maltese: Fil-majjali, jintuża biex jikkura jew għall-metafilassi ta' għadd ta' mard li jittieħed li huwa kkawżat minn batterji li jaffettwaw il-pulmuni (jiġifieri pulmonite enzootika tal-majjali) jew l-apparat intestinali (dissenterija tal-majjali jew enteropatija proliferattiva tal-porċini).
English: Aivlosin is available as a premix for medicated feeding stuff and as an oral powder for pigs, and as granules for use in drinking water for pigs, chickens, turkeys and pheasants.
Maltese: Is-suċċess tal-kura b'Aivlosin kien simili għall-effikaċja ta' mediċini oħra tal-istess klassi awtorizzati għal mard bħal dan fil-majjali.
English: The number of patients could be considered sufficient in 4 studies (146, 203, 155 and 324 patients) and small in 2 studies (50 and 49 patients).
Maltese: L-għadd ta' pazjenti seta' jitqies suffiċjenti f'4 studji (146, 203, 155 u 324 pazjent) u żgħir f'2 studji (50 u 49 pazjent).
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: Regarding ergotism, there were several cases reported in the French Pharmacovigilance database where dihydroergocryptine/caffeine was the suspected drug for symptoms related to ergotism.
Maltese: Fir-rigward tal-ergotiżmu, kien hemm bosta każijiet irrapportati fid-database Franċiża ta' Farmakoviġilanza fejn dihydroergocryptine/kafeina kien il-mediċina suspettata għal sintomi relatati mal-ergotiżmu.
English: The CHMP has considered the totality of the available data on the safety and efficacy of dihydroergocryptine/caffeine.
Maltese: Is-CHMP ikkunsidra t-totalità tad-dejta disponibbli dwar is-sigurtà u l-effikaċja ta' dihydroergocryptine/kafeina.
English: Is not favourable for ancillary treatment of Raynaud's syndrome.
Maltese: Kura anċillari tas-sindromu ta' Raynaud.
English: The studies mainly assessed functional symptoms, capillaroscopic parameters and plethysmographic parameters whose clinical relevance was considered questionable by the CHMP.
Maltese: L-istudji evalwaw prinċipalment sintomi funzjonali, parametri kapillaroskopiċi u parametri pletismografiċi li rrilevanza klinika tagħhom kienet meqjusa dubjuża mis-CHMP.
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 tagħhom u sommarji kritiċi tar-rapporti spontanji kollha ta' reazzjonijiet fibrotiċi (kardijaċi bi jew mingħajr pressjoni għolja tal-arterji pulmonari, pulmonari, plewrali, peritoneali, retroperitoneali, eċċ) u ergotiżmu bil-prodotti mediċinali tagħhom li fihom derivati tal-ergotina.
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-kamp viżiv preżumibbilment ta' oriġini vaskulari
English: Data provided during a referral under Article 31 in 2007-2008 (EMEA/H/A-31/881) including dihydroergocryptine showed that several cases of fibrosis either pulmonary or cardiac or retroperitoneal were suspected to be associated to the treatment with dihydroergocryptine use for Parkinson's disease treatment (involving dosage five times higher).
Maltese: Dejta pprovduta matul riferiment skont l-Artikolu 31 fl-2007-2008 (EMEA/H/A-31/881) li kien jinkudi dihydroergocryptine wriet li bosta każijiet ta' fibrożi jew pulmonari jew kardijaċi jew retroperitonali kienu ssuspettati li kienu marbuta mal-kura bl-użu ta' dihydroergocryptine għall-kura tal-marda ta' Parkinson (li tinvolvi dożi ħames darbiet ogħla).