FrancophonIA/ELRC3.0 huggingface dataset:
English: • The study was designed to assess the effect of adding nicotinic acid / laropiprant to statins on a composite endpoint of major vascular events, which included the combination of coronary death, non-fatal heart attack, stroke and revascularisation.
Maltese: • L-istudju kien iddisinjat biex jevalwa l-effett taż-żieda tal-aċidu nikotiniku / laropiprant ma' statins fuq endpoint kompost ta' avvenimenti vaskulari maġġuri, li kienu jinkludu l-kombinazzjoni ta' mewt koronarja, attakk tal-qalb mhux fatali, puplesija u rivaskularizzazzjoni.
English: On 17 January 2013, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) confirmed the recommendation to suspend the marketing authorisations of Tredaptive, Pelzont and Trevaclyn (nicotinic acid / laropiprant) used to treat adults with dyslipidaemia (abnormally high blood levels of fats such as triglycerides and cholesterol).
Maltese: Fis-17 ta' Jannar 2013, il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) tal-Aġenzija Ewropea għall-Mediċini kkonferma r-rakkomandazzjoni biex l-awtorizzazzjonijiet għat-tqegħid fis-suq ta' Tredaptive, Pelzont u Trevaclyn (aċidu nikotiniku / laropiprant) li jintużaw fil-kura ta' adulti b'dislipidemija (livelli abnormalment għoljin ta' xaħam fid-demm bħal trigliċeridi u kolesterol) jiġu sospiżi.
English: Nicotinic acid is a naturally occurring substance used in low doses as a vitamin (known as niacin or vitamin B3).
Maltese: L-aċidu nikotiniku huwa sustanza li sseħħ b'mod naturali li f'dożi baxxi tintuża bħala vitamina (magħrufa bħala niacin jew vitamina
English: • Treatment with nicotinic acid / laropiprant together with a statin did not result in a statistically significant reduction in major vascular events such as heart attack and stroke compared with statin therapy alone.
Maltese: • Kura b'aċidu nikotiniku / laropiprant flimkien ma' statin ma wasslitx għal tnaqqis statistikament sinifikanti f'avvenimenti vaskulari maġġuri bħal attakk tal-qalb u puplesija meta mqabbla ma' terapija bi statin waħdu.
English: The CHMP opinion was sent to the European Commission, which endorsed it and issued a final legally binding decision on 22 March 2013.
Maltese: L-opinjoni tas-CHMP intbagħtet lill-Kummissjoni Ewropea, li qablet magħha u ħarġet deċiżjoni finali legalment vinkolanti fit-22 ta' Marzu 2013.
English: As taking Tredaptive, Pelzont and Trevaclyn together with a statin has no additional benefit in reducing the risk of major vascular events compared with statin therapy alone and taking into account the increased risk of serious side effects, the CHMP recommended the suspension of these medicines.
Maltese: Peress li t-teħid ta' Tredaptive, Pelzont u Trevaclyn flimkien ma' statin ma għandu l-ebda benefiċċju addizzjonali fit-tnaqqis tar-riskju ta' avvenimenti vaskulari maġġuri meta mqabbel ma' terapija bi statin waħdu u b'kunsiderazzjoni taż-żieda fir-riskju ta' effetti sekondarji serji, is-CHMP irrakkomanda s-sospensjoni ta' dawn il-mediċini.
English: • Tredaptive, Pelzont and Trevaclyn are identical medicines authorised throughout the EU on 3 July 2008 for the treatment of dyslipidaemia in combination with a statin when statin treatment alone is not sufficient, or alone in patients unable to take statins.
Maltese: • Tredaptive, Pelzont u Trevaclyn huma mediċini identiċi awtorizzati madwar l-UE fit-3 ta' Lulju 2008 għall-kura tad-dislipidemija f'kombinazzjoni ma' statin meta l-kura bi statin waħdu ma tkunx biżżejjed, jew weħidhom f'pazjenti li ma jistgħux jieħdu statins.
English: The PRAC recommendations were sent to the Committee for Medicinal Products for Human Use (CHMP), responsible for all questions concerning medicines for human use, which adopted the Agency's final opinion.
Maltese: Ir-rakkomandazzjonijiet tal-PRAC intbagħtu lill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP), responsabbli għall-kwistjonijiet kollha dwar il-mediċini għall-użu mill-bniedem, li adotta l-opinjoni finali tal-Aġenzija.
English: The results of the study, which are still preliminary, indicated that taking nicotinic acid / laropiprant together with a statin has no significant additional benefit in reducing the risk of major vascular events such as heart attack and stroke, compared with statin therapy alone.
Maltese: Ir-riżultati tal-istudju, li għadhom preliminari, indikaw li t-teħid tal-aċidu nikotiniku / laropiprant flimkien ma' statin ma għandu l-ebda effett benefiku addizzjonali fit-tnaqqis tar-riskju ta' avvenimenti vaskulari maġġuri bħal attakk tal-qalb u puplesija, meta mqabbel ma' terapija bi statin waħdu.
English: The Agency's recommendations are based on the new data from the HPS2-THRIVE study:
Maltese: Ir-rakkomandazzjonijiet tal-Aġenzija huma bbażati fuq dejta ġdida mill-istudju HPS2-THRIVE:
English: Laropiprant has no effect on cholesterol but it reduces flushing, by blocking the receptors for a substance called ‘prostaglandin D2' which is released when nicotinic acid is taken and which dilates (widens) the blood vessels in the skin.
Maltese: Laropiprant ma għandu l-ebda effett fuq il-kolesterol iżda jnaqqas il-fwawar, billi jimblokka r-riċetturi għal sustanza magħrufa bħala ‘prostaglandin D2' li tintreħa meta jittieħed l-aċidu nikotiniku u li twessa' l-arterji tad-demm fil-ġilda.
English: The CHMP opinion was based on a recommendation by the Pharmacovigilance Risk Assessment Committee (PRAC) to suspend these medicines.
Maltese: L-opinjoni tas-CHMP kienet ibbażata fuq rakkomandazzjoni mill-Kumitat dwar il-Valutazzjoni tar-Riskji tal-Farmakoviġilanza (PRAC) biex dawn il-mediċini jiġu sospiżi.
English: • A review of these data was first conducted by the Pharmacovigilance Risk Assessment Committee (PRAC).
Maltese: • Reviżjoni ta' din id-dejta kienet l-ewwel saret mill-Kumitat dwar il-Valutazzjoni tar-Riskji talFarmakoviġilanza (PRAC).
English: • The Agency recommended the suspension of Tredaptive, Pelzont or Trevaclyn following the review of new evidence which indicated that the benefits of these medicines no longer outweigh their risks for patients.
Maltese: • L-Aġenzija rrakkomandat is-sospensjoni ta' Tredaptive, Pelzont jew Trevaclyn wara r-reviżjoni ta' evidenza ġdida li indikat li l-benefiċċji ta' dawn il-mediċini m'għadhomx jegħlbu r-riskji tagħhom għall-pazjenti.
English: Rösch & Handel Scheringgasse 2/Objekt 2 1140 Vienna
Maltese: Rösch & Handel Scheringgasse 2/Objekt 2 1140
English: SANOFI AVENTIS France 1-13, boulevard Romain Rolland
Maltese: AVENTIS France 1-13, boulevard Romain Rolland
English: Nicergolin tablet
Maltese: Nicergolin pillola
English: Ergotop 10 mgTabletten tablet
Maltese: Ergotop 10 mgTabletten pillola
English: Pfizer Italia srl Via Isonzo, 71 04100 Latina Italy
Maltese: Pfizer Italia srl Via Isonzo, 71 04100 Latina
English: Largo Umberto Boccioni, 1 21040 Origgio - Varese Italy
Maltese: Largo Umberto Boccioni, 1 21040
English: NICERGOLINA SANDOZ 30 mg tablet
Maltese: NICERGOLINA SANDOZ 30 mg pillola
English: SERMION 5 mg, poudre pour solution pour perfusion powder for solution for infusion intravenous use
Maltese: SERMION 5 mg, poudre pour solution pour perfusion trab għal soluzzjoni għal infużjoni użu għal ġol-vini
English: Latina Italy
Maltese: Milano Italy
English: Kwizda Pharma GmbH Effingergasse 21 1160 Vienna Austria
Maltese: Kwizda Pharma GmbH Effingergasse 21
English: 10 mg/ml powder and solvent per oral solution
Maltese: 10 mg/ml trab u solvent għal soluzzjoni orali
English: S.C. SLAVIA PHARM S.R.L.
Maltese: S.C. LABORMED PHARMA S.A. Bd.
English: Borgo San Michele SS 156 Km
Maltese: Pfizer Italia S.r.l. Borgo San Michele SS 156 Km
English: Sandoz d.d., Verovškova 57, 1000 Ljubljana, Slovenia capsules, hard oral use
Maltese: Sandoz d.d., Verovškova 57, 1000 Ljubljana, Slovenia kapsuli, ibsin
English: 4 mg/4 ml powder and solvent for solution for injection intramuscular and intravenous use
Maltese: 4 mg/4 ml trab u solvent għal soluzzjoni għal injezzjoni użu għal ġolmuskoli u użu għal ġol-vini
English: Sandoz d.d., Verovškova 57, 1000 Ljubljana, Slovenia film-coated tablets oral use
Maltese: Sandoz d.d., Verovškova 57, 1000 Ljubljana, Slovenia pilloli miksija b'rita użu orali
English: Modifiedrelease capsule, hard
Maltese: Kapsula li terħi lmediċina b'mod modifikat, iebsa
English: Latvia
Maltese: Latina
English: Pfizer Italia S.r.l., Via Isonzo 71, 04100 Latina, Italy film-coated tablets oral use
Maltese: Pfizer Italia S.r.l., Via Isonzo 71, 04100
English: Pfizer, spol.
Maltese: Ir-Repubbika Ċeka Pfizer, spol.
English: Luxembourg film-coated tablets oral use
Maltese: Luxembourg pilloli miksija b'rita użu orali
English: Annex I List of the names, pharmaceutical form(s), strength(s) of the medicinal product(s), route(s) of administration, marketing authorisation holder(s) in the member states
Maltese: Lista' ta' ismijiet, għamla/għamla farmaċewtika/għamliet farmaċewtiċi, qawwa tal-prodott(i) mediċinali, mnejn jingħata, detentur(i) talawtorizzazzjoni għat-tqegħid fis-suq fl-Istati Membri
English: Nicergolin powder and solvent for solution for injection intramuscular use intravenous use
Maltese: Nicergolin trab u solvent għal soluzzjoni għal injezzjoni użu għal ġolmuskoli u użu għal ġol-vini
English: 25 October 2013 EMA/565019/2013
Maltese: 23 ta' Ottubru 2013 EMA/565019/2013
English: The medicines included in the EU review are: fenoterol, hexoprenaline, isoxsuprine, ritodrine, salbutamol and terbutaline, which have been authorised for tocolytic treatment (to suppress labour contractions).
Maltese: Il-mediċini inklużi fir-reviżjoni tal-UE huma: fenoterol, hexoprenaline, isoxsuprine, ritodrine, salbutamol u terbutaline, li ġew awtorizzati għal kura tokolitika (biex irażżnu lkontrazzjonijiet tal-ħlas).
English: The review of short-acting beta-agonists was initiated in November 2012 at the request of the Hungarian medicines agency, under Article 31 of Directive 2001/83/EC.
Maltese: Ir-reviżjoni ta' agonisti beta li jaħdmu fuq perjodu qasir inbdiet f'Novembru 2012 fuq talba tal-aġenzija tal-mediċini Ungeriża, skont l-Artikolu 31 tad-Direttiva 2001/83/KE.
English: The reviewed data originated from clinical studies, post-marketing reports and the published literature.
Maltese: Id-dejta riveduta oriġinat minn studji kliniċi, rapporti wara t-tqegħid fis-suq u l-letteratura ppubblikata.
English: Information to healthcare professionals
Maltese: Informazzjoni lill-professjonisti tas-saħħa
English: These recommendations follow a review of available cardiovascular safety data on the medicines fenoterol, hexoprenaline, isoxsuprine, ritodrine, salbutamol and terbutaline when used in obstetric indications.
Maltese: Dawn ir-rakkomandazzjonijiet ġejjin wara reviżjoni tad-dejta disponibbli dwar is-sigurtà kardjovaskulari dwar il-mediċini fenoterol, hexoprenaline, isoxsuprine, ritodrine, salbutamol u terbutaline meta jintużaw f'indikazzjonijiet ostetriċi.
English: They are available as tablets, oral solutions, solutions for injection or infusion, and suppositories.
Maltese: Huma disponibbli bħala pilloli, soluzzjonijiet orali, soluzzjonijiet għal injezzjoni jew infużjoni, u suppożitorji.
English: Oral and suppository formulations which are only authorised in obstetric indications will have their marketing authorisations revoked and shall be removed from the market by the Marketing Authorisation Holders by 25th November 2013 at the latest.
Maltese: Il-formulazzjonijiet orali u s-suppożitorji li huma awtorizzati biss f'indikazzjonijiet ostetriċi se jkollhom l-awtorizzazzjonijiet għat-tqegħid fis-suq tagħhom revokati u sejrin jitneħħew mis-suq mid-Detenturi tal-Awtorizzazzjoni għat-Tqegħid fis-Suq sa mhux aktar tard mill-25 ta' Novembru 2013.
English: Short-acting beta-agonists work by stimulating a receptor on the surface of cells called the ‘beta-2 adrenergic receptor', which brings about smooth muscle relaxation.
Maltese: Agonisti beta li jaħdmu fuq perjodu qasir jaħdmu billi jistimulaw riċettur fuq is-superfiċje ta' ċelloli magħrufin bħala r-‘riċettur beta-2 adrenerġiku', li jikkawża l-muskoli l-lixxi sabiex jirrilassaw.
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 lill-Istati Membri tal-UE, huwa responsabbli biex jiżgura standards armonizzati tas-sigurtà għal mediċini awtorizzati permezz ta' proċeduri nazzjonali madwar l-UE.
English: The medicines are called ‘short acting' because they work quickly, usually having an effect in less than five minutes, which lasts for several hours.
Maltese: Il-mediċini huma msejħa ‘li jaġixxu fuq perjodu qasir' għaliex jaħdmu malajr, u normalment ikollhom effett f'anqas minn ħames minuti, liema effett idum għal bosta sigħat.
English: These recommendations follow a review by the European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC), which looked into the known risk of cardiovascular side effects (problems affecting the heart and blood vessels) with high doses of short-acting beta-agonists when used as tocolytics (medicines that suppress labour contractions).
Maltese: Dawn ir-rakkomandazzjonijiet ġejjin wara reviżjoni mill-Kumitat għall-Valutazzjoni tar-Riskji talFarmakoviġilanza (PRAC) tal-Aġenzija Ewropea għall-Mediċini, li investiga r-riskju magħruf ta' effetti kardjovaskulari sekondarji (problemi li jaffettwaw il-qalb u l-vażi tad-demm) b'dożi għoljin ta' agonisti beta li jaħdmu fuq perjodu qasir meta użati bħala tokolitiċi (mediċini li jrażżnu l-kontrazzjonijiet talħlas).
English: • Parenteral short-acting beta-agonists are effective in the short-term and they can still be used in all authorised obstetric indications (inhibition of premature labour, external cephalic version, emergency use in specified conditions).
Maltese: • Agonisti beta li jaħdmu fuq perjodu qasir li jingħataw b'mod parenterali huma effettivi fuq perjodu qasir u jistgħu jibqgħu jintużaw fl-indikazzjonijiet ostetriċi awtorizzati kollha (trażżin ta' ħlas prematur, verżjoni cephalic esterna, użu f'emerġenza f'kundizzjonijiet speċifikati).
English: The Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh)1 has endorsed by consensus new recommendations to restrict the use of medicines called ‘short-acting beta-agonists'.
Maltese: Il-Grupp ta' Koordinazzjoni għar-Rikonoxximent Reċiproku u l-Proċeduri DeċentralizzatiUman (CMDh)1 approva b'kunsens rakkomandazzjonijiet ġodda biex l-użu ta' mediċini magħrufin bħala ‘agonisti beta li jaħdmu fuq perjodu qasir' jiġi ristrett.
English: • High-dose short-acting beta-agonists are associated with a risk of serious adverse cardiovascular events to both the mother and the fetus, particularly when used for a prolonged period of time.
Maltese: • Dożi għoljin ta' agonisti beta li jaħdmu fuq perjodu qasir huma assoċjati ma' riskju ta' avvenimenti kardjovaskulari avversi serji kemm għall-omm u l-fetu, b'mod partikolari meta jintużaw għal perjodu twil.
English: It proposed revising their prescribing information, with reinforced warnings on the cardiovascular risks.
Maltese: Ippropona li ssir reviżjoni talinformazzjoni tal-preskrizzjoni tagħhom, bi twissijiet msaħħa dwar ir-riskji kardjovaskulari.
English: However, their use should be limited to pregnant women between 22 and 37 weeks of gestation and women receiving these medicines should be kept under specialist supervision for the duration of treatment, which is limited to a maximum of 48 hours.
Maltese: Madankollu, lużu tagħhom għandu jkun limitat għal nisa tqal bejn it-22 u s-37 ġimgħa ta' tqala u n-nisa li jkunu qed jirċievu dawn il-mediċini għandhom jinżammu taħt superviżjoni speċjalizzata għat-tul tal-kura, li hija limitata għal massimu ta' 48 siegħa.
English: As short-acting beta-agonists are all authorised nationally, the PRAC recommendations were sent to Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh).
Maltese: Peress li agonisti beta li jaħdmu fuq perjodu qasir huma kollha awtorizzati fuq livell nazzjonali, ir-rakkomandazzjonijiet tal-PRAC intbagħtu lill-Grupp ta' Koordinazzjoni għarRikonoxximent Reċiproku u l-Proċeduri Deċentralizzati - Uman (CMDh).
English: • These medicines can still be given intravenously (into a vein) to suppress premature labour, but their use is limited to a maximum of 48 hours, and only in women between the 22nd and the 37th weeks of pregnancy.
Maltese: • Dawn il-mediċini xorta jistgħu jingħataw ġol-vina biex irażżnu l-ħlas prematur, iżda l-użu tagħhom huwa limitat għal massimu ta' 48 siegħa, u biss fuq nisa bejn it-22 u s-37 ġimgħa ta' tqala.
English: Short-acting beta-agonists have been authorised by national procedures in several European Union (EU) Member States, and have been marketed for many years under various trade names.
Maltese: Agonisti beta li jaħdmu fuq perjodu qasir ġew awtorizzati permezz ta' proċeduri nazzjonali f'bosta Stati Membri tal-Unjoni Ewropea (UE), u ilhom imqiegħda fis-suq għal bosta snin taħt diversi ismijiet kummerċjali.
English: • Because of a risk of problems affecting the heart and circulation to both the mother and unborn baby with high-dose short-acting beta-agonists, these medicines must not be used by mouth or as suppositories to suppress premature labour in pregnant women.
Maltese: • Jekk tingħata dawn il-mediċini għal ħlas prematur b'dan il-mod, it-tabib tiegħek se jimmonitorja lilek u lit-tarbija tiegħek waqt il-kura u jwaqqaf il-kura jekk ikun hemm xi sinjali ta' problemi filqalb.
English: Therefore, the PRAC concluded that the benefits of injectable forms of these medicines continue to outweigh their risks when used under specific conditions: these medicines should only be used to suppress premature labour for up to 48 hours, between the 22nd and the 37th weeks of pregnancy and under specialist supervision with continuous monitoring of the mother and the unborn baby.
Maltese: Għalhekk, il-PRAC ikkonkluda li l-benefiċċji tal-forom injettabbli ta' dawn ilmediċini jkomplu jegħlbu r-riskji tagħhom meta jintużaw taħt kondizzjonijiet speċifiċi: dawn il-mediċini għandhom jintużaw biss biex irażżnu l-ħlas prematur sa 48 siegħa, bejn it-22 u s-37 ġimgħa tat-tqala u taħt superviżjoni speċjalizzata b'monitoraġġ kontinwu tal-omm u t-tarbija li għadha ma twelditx.
English: EMA/193648/2014 EMEA/H/C/000223
Maltese: EMEA/H/C/000223
English: It contains the active substance emedastine (0.5 mg/ml).
Maltese: Fih is-sustanza attiva emedastina (0.5 mg/ml).
English: Emadine emedastine
Maltese: Emadine emedastina
English: The full EPAR for Emadine can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Similar reductions in redness scores were seen, falling from 4.5 to 3.7 after five minutes and 2.7 after two hours.
Maltese: Deher ukoll tnaqqis simili filpunteġġi li jirriflettu l-ħmura, li naqsu minn 4.5 għal 3.7 wara ħames minuti u 2.7 wara sagħtejn.
English: The active substance in Emadine, emedastine, is an antihistamine.
Maltese: Is-sustanza attiva f'Emadine, l-emedastina, hija antiistamina.
English: This is a summary of the European public assessment report (EPAR) for Emadine.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Emadine.
English: For redness, the scores fell from around 2.7 to 0.5 for Emadine and to 1.1 for levocabastine.
Maltese: Għall-ħmura, il-punteġġi naqsu minn madwar 2.7 għal 0.5 għal Emadine u għal 1.1 għal levocabastine.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Emadine on 27 January 1999.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Emadine valida fl-Unjoni Ewropea kollha fis-27 ta' Jannar 1999.
English: The company also presented the results of studies in which patients received Emadine, levocabastine or placebo (a dummy treatment) before being subjected to an ‘allergen challenge'.
Maltese: Il-kumpanija ppreżentat ukoll ir-riżultati ta' studji li fihom il-pazjenti ngħataw Emadine, levocabastine jew plaċebo (trattament finta) qabel ma ġew soġġetti għal ‘sfida allerġenika'.
English: The most common side effects with Emadine (which may affect between 1 and 2 patients in 100) are eye pain, eye pruritus (itchy eye) and conjunctival hyperaemia (increased blood flow to the eye, leading to redness).
Maltese: L-effetti sekondarji l-aktar komuni b'Emadine ( li jistgħu jaffettwaw bejn pazjent 1 u 2 minn 100) huma wġigħ fl-għajn, prurite fl-għajn (irritazzjoni fl-għajn) u iperemija konġuntivali (żieda fil-provvista tad-demm għall-għajn, li twassal għal ħmura).
English: Emadine is used to treat the symptoms of seasonal allergic conjunctivitis (inflammation of the eyes caused by pollen in patients with hayfever).
Maltese: Emadine jintuża fit-trattament ta' sintomi tal-konġuntivite allerġika staġjonali (infjammazzjoni talgħajnejn ikkawżata mill-polline f'pazjenti bir-riħ tal-ħuxlief).
English: In the long term, the itching scores fell from an average of around 3.9 on the first day, falling to 0.8 for Emadine and 2.0 for levocabastine after six weeks.
Maltese: Filperjodu twil, il-punteġġi li jirriflettu l-ħakk naqsu minn medja ta' madwar 3.9 fl-ewwel jum, fejn naqsu għal 0.8 għal Emadine u 2.0 għal levocabastine wara sitt ġimgħat.
English: Emadine was as effective as levocabastine in reducing symptoms of seasonal conjunctivitis.
Maltese: Emadine kien effettiv daqs levocabastine fit-tnaqqis tas-sintomi ta' konġuntivite staġjonali.
English: In both groups of patients, itching scores fell from around 5.1 at the start of the study, to around 3.8 after five minutes and around 2.7 after two hours.
Maltese: Fiż-żewġ gruppi ta' pazjenti, il-punteġġi li jirriflettu l-ħakk naqsu minn madwar 5.1 fil-bidu tal-istudju, għal madwar 3.8 wara ħames minuti u għal madwar 2.7 wara sagħtejn.
English: Emadine has been compared with levocabastine (another antihistamine) in one main study involving 222 patients with seasonal conjunctivitis aged four years and over.
Maltese: Emadine tqabbel ma' levocabastine (antiistamina oħra) fi studju ewlieni li fih ħadu sehem 222 pazjent ta' erba' snin jew iktar bil-konġuntivite staġjonali.
English: Similar results were seen in adults and in children.
Maltese: Dehru riżultati simili fl-adulti u fit-tfal.
English: The bottle form of Emadine contains benzalkonium chloride, which is known to discolour soft contact lenses.
Maltese: Il-forma ta' Emadine fil-flixkun ikun fiha l-klorur benzalkonju, li hu magħruf li jibdel il-kulur ta' lentijiet tal-kuntatt rotob.
English: Emadine is not recommended for patients older than 65 years or in patients who have problems with their liver or kidneys.
Maltese: Emadine mhux rakkomandat għal pazjenti ta' iktar minn 65 sena jew f'pazjenti li jkollhom problemi filfwied jew fil-kliewi.
English: What is the risk associated with Emadine?
Maltese: Għal xiex jintuża Emadine?
English: Why has Emadine been approved?
Maltese: Għaliex ġie approvat Emadine?
English: What is Emadine?
Maltese: X'inhu Emadine?
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Emadine's benefits are greater than its risks for the symptomatic treatment of seasonal allergic conjunctivitis.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) iddeċieda li l-benefiċċji ta' Emadine fit-trattament sintomatiku tal-konġuntivite allerġika staġjonali huma ikbar mir-riskji tiegħu.
English: These symptoms include itching, redness and swelling.
Maltese: Dawn is-sintomi jinkludu ħakk, ħmura u nefħa.
English: How has Emadine been studied?
Maltese: Kif ġie studjat Emadine?
English: For the full list of all side effects and restrictions with Emadine, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet kollha b'Emadine, ara l-fuljett ta' tagħrif.