FrancophonIA/ELRC3.0 huggingface dataset:
English: Sixty-nine participants attended in person at EMA offices in London (or called in by telephone), including 40 patients and patient representatives, 14 healthcare professionals and academics, 13 representatives from pharmaceutical industry as well as members of the media.
Maltese: Disgħa u sittin parteċipant attendew personalment fl-uffiċċji tal-EMA f'Londra (jew ingħaqdu bittelefon), inkluż 40 pazjent u rappreżentant tal-pazjenti, 14-il professjonista tal-kura tas-saħħa u akkademiċi, 13-il rappreżentant mill-industrija farmaċewtika kif ukoll membri tal-midja.
English: Today, quinolones and fluoroquinolones are used for over 120 indications in the EU, including different types of urinary tract, respiratory, genital, gastrointestinal tract, skin, bone, and joint infections.
Maltese: Illum, il-kinoloni u l-fluworokinoloni jintużaw għal aktar minn 120 indikazzjoni fl-UE, inkluż tipi differenti ta' infezzjonijiet fl-apparat tal-awrina, respiratorji, ġenitali, fil-passaġġ gastrointestinali, talġilda, tal-għadam u tal-ġogi.
English: Elsa Leitão, Germany
Maltese: Elsa Leitão, il-Ġermanja
English: Public hearing held on 13 June 2018
Maltese: Li saret fit-13 ta' Ġunju 2018
English: Markus Hamedinger, Austria
Maltese: Markus Hamedinger, l-Awstrija
English: Send questions on public hearings to: publichearings@ema.europa.eu www.ema.europa.eu
Maltese: Aktar informazzjoni dwar il-ħidma tal-Aġenzija Ewropea għall-Mediċini tista' tinstab fuq is-sit elettroniku tagħha: www.ema.europa.eu
English: Joshua Sutton, UK
Maltese: Joshua Sutton, ir-Renju Unit
English: Speaker 13 (joining via telephone):
Maltese: Kelliem 13 (ingħaqad bit-telefon):
English: General public (patient representatives, carers, families) Speaker 1:
Maltese: Pubbliku ġenerali (rappreżentanti tal-pazjenti, persuni li jindokraw, familji) Kelliem 1:
English: Mary McCarthy, European Union of General Practioners (UEMO) Speaker 18:
Maltese: Mary McCarthy, Unjoni Ewropea tat-Tobba (UEMO) Kelliem 18:
English: On 13 June 2018, the European Medicines Agency (EMA) held a public hearing on quinolone and fluoroquinolone antibiotics to hear the views of patients and the general public on the persistence of side effects reported with this group of medicines.
Maltese: Fit-13 ta' Ġunju 2018, l-Aġenzija Ewropea għall-Mediċini (EMA) organizzat seduta pubblika dwar lantibijotiċi kinolon u fluworokinolon sabiex tisma' l-fehmiet tal-pazjenti u tal-pubbliku ġenerali dwar ilpersistenza ta' effetti sekondarji rrappurtati b'dan il-grupp ta' mediċini.
English: A recurring theme was the lack of knowledge of the possible side effects among doctors.
Maltese: Tema rikorrenti kienet in-nuqqas ta' għarfien tal-effetti sekondarji possibbli fost it-tobba.
English: • Encourage research on how the medicines cause side effects, including genetic research.
Maltese: • Tiġi mħeġġa r-riċerka dwar kif il-mediċini jikkawżaw effetti sekondarji, inkluż riċerka ġenetika.
English: Many other members of the public who could not attend sent submissions in writing, which will all be taken into account during the review.
Maltese: Bosta membri oħra tal-pubbliku li ma setgħux jattendu bagħtu sottomissjonijiet bil-miktub, li kollha ser jiġu kkunsidrati waqt ir-reviżjoni.
English: EMA's Pharmacovigilance Risk Assessment Committee (PRAC) started a review of this class of medicines following reports of serious, long-lasting side effects mainly affecting muscles, tendons, joints and the nervous system.
Maltese: Il-Kumitat dwar il-Valutazzjoni tar-Riskji tal-Farmakoviġilanza (PRAC) tal-EMA beda reviżjoni ta' din ilklassi ta' mediċini wara rapporti ta' effetti sekondarji serji li jdumu li prinċipalment jaffettwaw ilmuskoli, l-għeruq, il-ġogi u s-sistema nervuża.
English: More information on the ongoing review of quinolone and fluoroquinolone antibiotics is available on a dedicated webpage.
Maltese: Aktar informazzjoni dwar ir-reviżjoni li għadha għaddejja tal-antibijotiċi kinolon u fluworokinolon hija disponibbli fuq paġna web dedikata.
English: Miriam van Staveren, The Netherlands Speaker 12 (joining via telephone):
Maltese: Miriam van Staveren, In-Netherlands
English: • In your opinion, what further measures could be taken to optimise the safe use of quinolones and fluoroquinolones?
Maltese: • Fl-opinjoni tiegħek, x'miżuri oħra jistgħu jittieħdu biex jiġi ottimizzat l-użu sigur tal-kinoloni u l fluworokinoloni?
English: • Patients were not given information about risks.
Maltese: • Il-pazjenti ma ngħatawx informazzjoni dwar ir-riskji.
English: Summary of issues raised
Maltese: Sommarju tal-kwistjonijiet li tqajmu
English: Quinolones and fluoroquinolones are synthetic antibiotics used for a wide range of bacterial infections.
Maltese: Il-kinoloni u l-fluworokinoloni huma antibijotiċi sintetiċi li jintużaw għal firxa wiesgħa ta' infezzjonijiet batteriċi.
English: • What is your view of the risks associated with quinolone and fluoroquinolone use?
Maltese: • X'inhi l-fehma tiegħek dwar ir-riskji assoċjati mal-użu tal-kinoloni u l-fluworokinoloni?
English: Patients called for better recognition of patterns of toxicity with quinolones and fluoroquinolones (sometimes referred to as ‘fluoroquinolone-associated disability syndrome').
Maltese: Il-pazjenti talbu rikonoxximent aħjar tat-tendenzi ta' tossiċità bil-kinoloni u l-fluworokinoloni (xi drabi issir referenza għaliha bħala “sindrome ta' diżabilità assoċjat ma' fluworokinolon”).
English: In closing the discussions, Dr Raine praised the courageous testimonies from patients and other participants.
Maltese: Fl-għeluq tad-diskussjonijiet, Dr Raine faħħret it-testimonjanzi kuraġġużi mill-pazjenti u minn parteċipanti oħra.
English: While some doctors were aware of symptoms affecting the Achilles tendon, many did not know of, recognise or report other side effects that could possibly have been linked to quinolones and fluoroquinolones.
Maltese: Filwaqt li xi tobba kienu jafu bis-sintomi li jaffettwaw l-għerq Achilles, bosta ma kinux jafu, ma rrikonoxxewx jew ma rrappurtawx effetti sekondarji oħra li possibbilment setgħu kienu marbuta mal-kinoloni u l-fluworokinoloni.
English: Patients described life-changing symptoms following treatment with quinolone and fluoroquinolone antibiotics, including pain and disability lasting several years, with some patients only experiencing limited improvement over time.
Maltese: Il-pazjenti ddeskrivew sintomi li biddlulhom ħajjithom wara l-kura bl-antibijotiċi kinolon u fluworokinolon, inkluż uġigħ u diżabilità li damu bosta snin, b'xi pazjenti li esperjenzaw biss titjib limitat maż-żmien.
English: • Improve management of patients with side effects (taking account of wide-ranging symptoms).
Maltese: • Jitjieb l-immaniġġjar tal-pazjenti b'effetti sekondarji (filwaqt li jiġu kkunsidrati s-sintomi li jvarjaw ħafna).
English: • Restrict quinolone and fluoroquinolone use to situations where there are no alternatives.
Maltese: • L-użu tal-kinoloni u l-fluworokinoloni jiġi ristrett għal sitwazzjonijiet fejn ma jkun hemm l-ebda alternattiva.
English: Given the seriousness of the side effects, Melanie Carr, Head of EMA's Stakeholders and Communication Division remarked in her welcome address that this public hearing was “particularly important because it allows us to consider your views on the risk associated with these medicines and consider options for regulatory action in a wider public health context”.
Maltese: Barra minn hekk, il-preskrizzjoni ta' dawn il-mediċini għandha tiġi mmonitorjata aħjar u għandhom jiġu indikati twissijiet sabiex il-pazjenti li kellhom dawn l-effetti sekondarji jiġu infurmati biex iwaqqfu l-kura immedjatament u qatt ma jerġgħu jingħataw dawn ilmediċini.
English: Other participants including healthcare professionals and academics called for more research, including genetic research, to establish the precise mechanisms through which the medicines cause these side effects, determine how they affect different populations and quantify the overall magnitude of the risk.
Maltese: Il-pazjenti u l-professjonisti tal-kura tas-saħħa nnutaw il-ħtieġa għal titjib fl-immaniġġjar ta' pazjenti bl-effetti sekondarji u li għarfien espert minn oqsma differenti jinġieb flimkien sabiex jiġu indirizzati ssintomi li jvarjaw ħafna.
English: • Improve communication on quinolone and fluoroquinolone toxicity, including possible risk factors,
Maltese: • Titjieb il-komunikazzjoni dwar tossiċità bil-kinolon u l-fluworokinolon, inkluż fatturi ta' riskju possibbli, u tiżdied aktar informazzjoni fl-informazzjoni dwar il-prodott, inkluż il-fuljett ta' tagħrif.
English: “More than anything we need to restore the chain of trust,” she noted, adding that one of the hardest things for patients with these debilitating symptoms was the lack of recognition of what they are experiencing.
Maltese: “Fuq kollox jeħtieġ li nirrestawraw il-katina ta' fiduċja,” hija nnutat, waqt li żiedet li waħda mill-aktar affarijiet ibsin għall-pazjenti b'dawn is-sintomi ta' indeboliment kien in-nuqqas ta' rikonoxximent ta' x'kienu qegħdin jesperjenzaw.
English: Finally, a representative of a pharmaceutical company that markets this class of antibiotics, acknowledged the need to improve information on the risk of these medicines in their product information, particularly the package leaflets.
Maltese: Finalment, rappreżentant ta' kumpanija farmaċewtika li tqiegħed fis-suq din il-klassi ta' antibijotiċi, irrikonoxxa l-ħtieġa li l-informazzjoni dwar ir-riskju ta' dawn il-mediċini għandha titjieb fl-informazzjoni dwar il-prodott tagħhom, partikolarment il-fuljett ta' tagħrif.
English: • Consider how certain foods affect patients' symptoms, particularly meat treated with quinolones and fluoroquinolones.
Maltese: • Jiġi kkunsidrat kif ċertu ikel jaffettwa s-sintomi tal-pazjenti, partikolarment laħam ikkurat bil kinoloni u l-fluworokinoloni.
English: The hearing was broadcast live and a recording is available on EMA's website.
Maltese: Is-seduta xxandret direttament u hemm reġistrazzjoni disponibbli fuq is-sit web tal-EMA.
English: The final stage of the review procedure is the adoption by the European Commission of a legally binding decision applicable in all EU Member States.
Maltese: adozzjoni mill-Kummissjoni Ewropea ta' deċiżjoni legalment vinkolanti applikabbli fl-Istati Membri kollha tal-UE.
English: 30 October 2014 EMA/698187/2014
Maltese: EMA/698187/2014
English: Tel. +44 (0)20 3660 8427 E-mail: press@ema.europa.eu
Maltese: 3660 8427 E-mail: press@ema.europa.eu
English: Bromocriptine is a dopamine receptor agonist.
Maltese: Bromocriptine huwa agonista tar-riċettur tad-dopamina.
English: Information to patients
Maltese: Informazzjoni lill-pazjenti
English: Bromocriptine medicines have been authorised via national procedures for various indications in the following EU Member States: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Lithuania, Luxemburg, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden and United Kingdom, as well as Norway.
Maltese: Mediċini li fihom bromocriptine ġew awtorizzati permezz ta' proċeduri nazzjonali għal diversi indikazzjonijiet fl-Istati Membri tal-UE li ġejjin: fl-Awstrija, fil-Belġju, fil-Bulgarija, fil-Kroazja, f'Ċipru, fir-Repubblika Ċeka, fid-Danimarka, fl-Estonja, fil-Finlandja, fi Franza, fil-Ġermanja, fil-Greċja, flUngerija, fl-Irlanda, fl-Italja, fil-Litwanja, fil-Lussemburgu, fil-Pajjiżi l-Baxxi, fil-Polonja, fil-Portugall, fir-Rumanija, fis-Slovakkja, fis-Slovenja, fi Spanja, fl-Isvezja u fir-Renju Unit, kif ukoll fin-Norveġja.
English: The review of oral bromocriptine was initiated at the request of France on 17 July 2013, under Article 31 of Directive 2001/83/EC.
Maltese: Ir-reviżjoni ta' bromocriptine mill-ħalq inbdiet fuq talba ta' Franza fis-17 ta' Lulju 2013, skont lArtikolu 31 tad-Direttiva 2001/83/KE.
English: Contact our press officer Monika Benstetter
Maltese: Ikkuntattja lill-uffiċjal tal-istampa tagħna Monika Benstetter
English: 1 The CMDh is a medicines regulatory body representing the European Union (EU) Member States.
Maltese: 1 Is-CMDh huwa korp regolatorju tal-mediċini li jirrappreżenta l-Istati Membri tal-Unjoni Ewropea (UE).
English: However, the absolute number of cases reported post-marketing is low especially given the fact that bromocriptine has been available in the EU since 1973, with a substantial patient exposure; overall incidence rates are estimated to be between 0.005% and 0.04%.
Maltese: Madankollu, l-għadd assolut ta' każijiet irrapportati wara t-tqegħid fis-suq huwa baxx speċjalment minħabba lfatt li bromocriptine ilu disponibbli fl-UE mill-1973, b'espożizzjoni sostanzjali ta' pazjenti; b'mod ġenerali r-rati ta' inċidenza huma stmati li huma bejn 0.005% u 0.04%.
English: The review was triggered by concerns in France over increased reports of rare but potentially serious or fatal side effects, particularly cardiovascular side effects (such as heart attack and stroke), neurological side effects such as seizures (fits) and psychiatric side effects (such as hallucinations and manic episodes).
Maltese: Ir-reviżjoni nbdiet wara tħassib fi Franza dwar żieda fir-rapport ta' effetti sekondarji rari iżda potenzjalment serji jew fatali, partikularment effetti sekondarji kardjovaskulari (bħal attakk tal-qalb u puplesija), effetti sekondarji newroloġiċi bħal aċċessjonijiet (puplesiji) u effetti sekondarji psikjatriċi (bħal alluċinazzjonijiet u episodji manijaċi).
English: On 20 August 2014, the Coordination Group for Mutual Recognition and Decentralised ProceduresHuman (CMDh)1 endorsed by majority recommendations on the use of bromocriptine-containing medicines by mouth to prevent or suppress breast milk production (lactation) after childbirth.
Maltese: Fl-20 ta' Awwissu 2014, il-Grupp ta' Koordinazzjoni għal Proċedura tar-Rikonoxximent Reċiproku u lProċedura Deċentralizzata - Bniedem (CMDh)1 approva b'maġġoranza r-rakkomandazzjonijiet dwar lużu ta' mediċini li fihom bromocriptine mill-ħalq għall-prevenzjoni jew għat-trażżin tal-produzzjoni talħalib tas-sider (treddigħ) wara l-ħlas.
English: Products with strengths of 5 or 10 mg are not indicated for such use.
Maltese: Prodotti b'qawwiet ta' 5 jew 10 mg mhumiex indikati għal dan l-użu.
English: • Bromocriptine should only be used orally in strengths up to 2.5 mg to inhibit lactation when medically indicated, such as in case of intrapartum loss, neonatal death or HIV infection of the mother.
Maltese: • Bromocriptine għandu jintuża biss mill-ħalq f'qawwiet sa 2.5 mg biex irażżan it-treddigħ meta dan ikun medikament indikat, bħal fil-każ ta' telf intrapartum, mewt tat-trabi tat-twelid jew infezzjoni tal-omm bl-HIV.
English: However, the data available were such that conclusions on the efficacy of bromocriptine in mastitis, breast engorgement and painful breast engorgement could not be made.
Maltese: Madankollu, id-dejta disponibbli kienet tali li ma setgħux isiru konklużjonijiet dwar leffikaċja ta' bromocriptine f'mastite, konġestjoni tas-sider u konġestjoni tas-sider bl-uġigħ.
English: • Use is contraindicated for patients with uncontrolled hypertension, hypertensive disorders of pregnancy (including eclampsia, pre-eclampsia or pregnancy-induced hypertension), hypertension post-partum and in the puerperium, a history of coronary artery disease or other severe cardiovascular conditions, or a history of severe psychiatric disorders.
Maltese: • L-użu huwa kontraindikat għal pazjenti bi pressjoni għolja li ma tkunx ikkontrollata, b'disturbi ta' pressjoni għolja tat-tqala (inklużi eklampsja, pre-eklampsja jew pressjoni għolja kkawżata mittqala), bi pressjoni għolja wara l-ħlas u fil-pwerperjum, bi storja ta' mard tal-arterji koronarji jew b'kondizzjonijiet kardjovaskulari severi oħra, jew bi storja ta' disturbi psikjatriċi severi.
English: The CMDh, a body representing EU Member States, is responsible for ensuring harmonised safety standards for medicines authorised via national procedures across the EU.
Maltese: Is-CMDh, korp li jirrappreżenta l-Istati Membri tal-UE, huwa responsabbli biex jiżgura standards armonizzati dwar is-sigurtà għal mediċini awtorizzati permezz ta' proċeduri nazzjonali madwar l-UE.
English: • Bromocriptine should not be used for the routine suppression of lactation, nor for the relief of symptoms of post-partum pain and engorgement, which can be adequately treated with nonpharmacological intervention (such as firm breast support, ice application) and simple analgesics.
Maltese: • Bromocriptine m'għandux jintuża għat-trażżin ta' rutina tat-treddigħ, u lanqas għas-serħan missintomi ta' wġigħ u konġestjoni tas-sider wara l-ħlas, li jistgħu jiġu ttrattati b'mod adegwat permezz ta' interventi mhux farmakoloġiċi (bħas-sapport sod tas-sider, l-applikazzjoni tas-silġ) u analġeżiċi sempliċi.
English: If hypertension, suggestive chest pain, severe, progressive, or unremitting headache (with or without visual disturbance) or evidence of central nervous system toxicity develops, treatment should be discontinued and the patient evaluated promptly.
Maltese: Jekk tiżviluppa pressjoni għolja, uġigħ suġġestiv fis-sider, uġigħ ta' ras qawwija, progressiva, jew li ma tbattix (bi jew mingħajr disturbi fil-vista) jew ikun hemm evidenza ta' tossiċità fis-sistema nervuża ċentrali, il-kura għandha titwaqqaf u l-pazjenta għandha tiġi evalwata fil-pront.
English: The PRAC recommendations were sent to Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), which adopted a final position.
Maltese: Ir-rakkomandazzjonijiet tal-PRAC intbagħtu lill-Grupp ta' Koordinazzjoni għal Proċedura tar-Rikonoxximent Reċiproku u l-Proċedura Deċentralizzata - Bniedem (CMDh), li adotta pożizzjoni finali.
English: The CMDh position followed a review by the EMA's Pharmacovigilance Risk Assessment Committee (PRAC) of available data on the safety and effectiveness of bromocriptine in controlling breast milk production after childbirth, which led to these recommendations.
Maltese: Ir-rakkomandazzjonijiet ta' hawn fuq huma bbażati fuq reviżjoni tal-evidenza disponibbli dwar issigurtà u l-effikaċja ta' bromocriptine mill-ħalq għall-prevenzjoni u t-trażżin tat-treddigħ.
English: Since lactation is a natural process that eventually stops if the infant is not breastfed, and other means of management are available, the French medicines agency (ANSM) asked the EMA to review the medicines and see if the benefits of such use still outweighed the risks.
Maltese: Peress li t-treddigħ huwa proċess naturali li eventwalment jieqaf jekk it-tarbija ma tiġix imreddgħa, u hemm mezzi oħra ta' ġestjoni disponibbli, l-aġenzija talmediċini Franċiża (ANSM) talbet lill-EMA biex tirrevedi l-mediċini u tara jekk il-benefiċċji ta' dan l-użu għadhomx jegħlbu r-riskji.
English: • Blood pressure should be monitored in those who take the medicine (especially on the first day of taking it) so that early signs of problems can be detected, and the medicine stopped.
Maltese: • Il-pressjoni tad-demm għandha tiġi mmonitorjata f'dawk li jieħdu l-mediċina (speċjalment fl-ewwel jum li jeħduha) sabiex ikunu jistgħu jiġu skoperti s-sinjali bikrija ta' problemi, u l-mediċina titwaqqaf.
English: More about the procedure
Maltese: Tel.
English: Bromocriptine is also used to treat other conditions, such as hyperprolactinaemia (high levels of prolactin in the body) and Parkinson's disease; however these uses are not covered by this review.
Maltese: Bromocriptine jintuża wkoll għall-kura ta' kundizzjonijiet oħra, bħall-iperprolaktinemija (livelli għoljin ta' prolaktin fil-ġisem) u l-marda ta' Parkinson; madankollu dawn l-użi mhumiex koperti minn din irreviżjoni.
English: The CMDh agreed that the medicines should only be used for this purpose (in strengths up to 2.5 mg) when there are compelling medical reasons for stopping lactation, such as the need to avoid further distress after loss of the baby during or just after childbirth, or in mothers with HIV infection, who should not breastfeed.
Maltese: Is-CMDh qabel li l-mediċini għandhom jintużaw biss għal dan l-iskop (f'qawwiet sa 2.5 mg) meta jkun hemm raġunijiet mediċi konvinċenti għall-waqfien tat-treddigħ, bħall-ħtieġa li tiġi evitata aktar tbatija wara l-mewt tat-tarbija waqt jew eżatt wara l-ħlas, jew f'ommijiet b'infezzjoni tal-HIV, li m'għandhomx ireddgħu.
English: • Medicines containing bromocriptine are licensed in many EU countries for use by mouth to prevent or stop milk production after childbirth in women who are not breastfeeding.
Maltese: • Mediċini li fihom bromocriptine huma liċenzjati f'bosta pajjiżi tal-UE għall-użu mill-ħalq għallprevenzjoni jew għall-waqfien tal-produzzjoni tal-ħalib wara l-ħlas f'nisa li ma jkunux qed ireddgħu.
English: • On the basis of available safety data, a causal association between use of bromocriptine and serious cardiovascular, neurological or psychiatric events could not be excluded.
Maltese: • Abbażi tad-dejta disponibbli dwar is-sigurtà, ma setgħetx tiġi eskluża assoċjazzjoni kawżali bejn lużu ta' bromocriptine u avvenimenti kardjovaskulari, newroloġiċi jew psikjatriċi serji.
English: • Blood pressure should be carefully monitored especially during the first day of therapy.
Maltese: • Il-pressjoni tad-demm għandha tiġi mmonitorjata bir-reqqa speċjalment matul l-ewwel jum ta' terapija.
English: EMA/25826/2014 EMEA/V/C/002382
Maltese: EMEA/V/C/002382
English: Equisolon is a veterinary medicine that contains the active substance prednisolone.
Maltese: Equisolon huwa mediċina veterinarja li fiha s-sustanza attiva prednisolone.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Equisolon on 12/03/2014.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Equisolon fi 12/03/2014.
English: The active substance in Equisolon, prednisolone, is a corticosteroid, a medicine that acts to reduce the activity of the immune system.
Maltese: Is-sustanza attiva f'Equisolon, prednisolone, hija kortikosterojdi, mediċina li taħdem biex tnaqqas l-attività tas-sistema immuni.
English: It is available as a powder to be given by mouth.
Maltese: Huwa disponibbli bħala trab li tingħata mill-ħalq.
English: The most common side effects (seen in more than 1 in 10 horses) with Equisolon are suppression of production of cortisol (a natural corticosteroid important in the body's response to stress), and an increase in the level of triglycerides (a type of fat) in the blood.
Maltese: L-effetti sekondarji l-aktar komuni (li dehru f'aktar minn żiemel 1 minn kull 10) b'Equisolon huma trażżin tal-produzzjoni ta' kortisol (kortikosterojdi importanti fir-rispons naturali tal-ġisem għallistress), u żieda fil-livell tat-trigliċeridi (tip ta' xaħam) fid-demm.
English: If you want more information on the basis of the CVMP recommendations, read the scientific discussion (also part of the EPAR).
Maltese: Jekk tixtieq iktar informazzjoni relatata mar-rakkomandazzjonijiet tas-CVMP, aqra d-Diskussjoni Xjentifika (parti wkoll mill-EPAR).
English: What is Equisolon?
Maltese: X'inhu Equisolon?
English: In horses with RAO, the immune system (the body's natural defences) over-reacts to triggering substances (antigens) that are present in dust that the horse breathes in.
Maltese: Fiż-żwiemel b'RAO, is-sistema immuni (id-difiżi naturali tal-ġisem) tirreaġixxi ż-żejjed għal sustanzi (antiġeni) preżenti fit-trab li ż-żiemel jieħu man-nifs.
English: Equisolon should be mixed with a small amount of food and given by mouth at a dose of 1 mg prednisolone per kg bodyweight once a day.
Maltese: Equisolon għandu jitħallat ma' ammont żgħir ta' ikel u jingħata mill-ħalq f'doża ta' 1 mg ta' prednisolone għal kull kg talpiż tal-ġisem darba kuljum.
English: Treatment with prednisolone at the recommended dose of 1 mg per kg bodyweight over ten days in combination with environmental control resulted in significant improvements in fluid in the airways and clinical signs associated with RAO.
Maltese: Kura bi prednisolone fid-doża rakkomandata ta' 1 mg għal kull kg tal-piż tal-ġisem fuq għaxart ijiem flimkien ma' kontroll ambjentali wasslet għal titjib sinifikanti fil-fluwidu fil-passaġġi tal-arja u s-sinjali kliniċi assoċjati ma' RAO.