FrancophonIA/ELRC3.0 huggingface dataset:
English: The Agency concluded that Sylvant has shown beneficial effect by reducing tumour size and symptoms in patients with multicentric Castleman's disease, and that this positive effect seems to be maintained over time.
Maltese: L-Aġenzija kkonkludiet li Sylvant wera effett benefiku billi naqqas id-daqs u s-sintomi tat-tumur f'pazjenti b'mard multiċentriku ta' Castleman, u li dan l-effett pożittiv jidher li jinżamm fuq perjodu ta' żmien.
English: Multicentric means that the disease affects several lymph nodes as well as other organs in the body.
Maltese: Multiċentriku jfisser li l-marda taffettwa bosta nodi limfatiċi kif ukoll organi oħrajn fil-ġisem.
English: The company that markets Sylvant is required to set up a patient registry to provide further data on long-term safety.
Maltese: Il-kumpanija li tikkummerċjalizza Sylvant hija meħtieġa li twaqqaf reġistru ta' pazjenti biex tipprovdi aktar informazzjoni dwar is-sigurtà fuq perjodu fit-tul.
English: Sylvant can only be obtained with a prescription and treatment should be given by qualified healthcare professionals and under appropriate medical supervision.
Maltese: Sylvant jista' jinkiseb biss b'riċetta ta' tabib u l-kura għandha tingħata minn professjonisti fil-qasam tal-kura tas-saħħa kwalifikati u taħt superviżjoni medika xierqa.
English: By attaching to IL-6, siltuximab blocks its activity and stops abnormal cell growth, thus reducing the size of the lymph nodes and the symptoms of the disease.
Maltese: Meta teħel ma' IL-6, is-siltussimab timblokka l-attività tagħha u twaqqaf tkabbir anormali taċ-ċelluli, b'hekk tnaqqas id-daqs tanl-nodi limfatiċi u s-sintomi tal-marda.
English: For the full list of side effects and restrictions of Sylvant, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet kollha ta' Sylvant, ara l-fuljett ta' tagħrif.
English: What measures are being taken to ensure the safe and effective use of Sylvant?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Sylvant?
English: Patients with Castleman's disease produce too much IL-6 and this is thought to contribute to the abnormal growth of certain cells in the lymph nodes.
Maltese: Il-pazjenti bil-marda ta' Castleman jipproduċu wisq IL-6 u dan hu maħsub li jikkontribwixxi għat-tkabbir anormali ta' ċerti ċelluli fin-nodi limfatiċi.
English: Side effects of Sylvant were considered acceptable but further long-term data are to be collected.
Maltese: L-effetti sekondarji ta' Sylvant kienu kkunsidrati bħala aċċettabbli iżda għandha tinġabar aktar data fuq perjodu fit-tul.
English: The full EPAR for Alkindi 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: Alkindi is a ‘hybrid medicine'.
Maltese: Alkindi huwa “mediċina ibrida”.
English: Alkindi hydrocortisone
Maltese: Alkindi idrokortiżon
English: Other information about Alkindi
Maltese: Informazzjoni oħra dwar Alkindi
English: This is a summary of the European public assessment report (EPAR) for Alkindi.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Alkindi.
English: Alkindi contains the active substance hydrocortisone.
Maltese: Alkindi fih is-sustanza attiva idrokortiżon.
English: The capsules are opened and the granules are placed in the child's mouth.
Maltese: Alkindi huwa disponibbli bħala kapsuli li fihom granuli.
English: Why is Alkindi approved?
Maltese: Għaliex ġie approvat Alkindi?
English: Alkindi produces similar levels of hydrocortisone in the blood to a reference medicine already authorised in the EU.
Maltese: Alkindi jipproduċi livelli simili ta' idrokortiżon fid-demm bħal mediċina ta' referenza li diġà hija awtorizzata fl-UE.
English: This means that it is similar to a ‘reference medicine' containing the same active substance (in this case Hydrocortisone Tablets Auden Mckenzie), but Alkindi is available in a different form (granules instead of tablets) and has been developed for children only.
Maltese: Dan ifisser li huwa simili għal "mediċina ta' referenza" li fiha l-istess sustanza attiva (f'dan il-każ, Pilloli tal-Idrokortiżon Auden Mckenzie), iżda Alkindi huwa disponibbli f'forma differenti (granuli minflok pilloli) u ġie żviluppat għat-tfal biss.
English: A lack of the hormone causes several symptoms, including weight loss, muscle weakness, tiredness and low blood pressure.
Maltese: Nuqqas tal-ormon jikkawża diversi sintomi, inklużi telf fil-piż, dgħufija tal-muskoli, għeja u pressjoni tad-demm baxxa.
English: What are the risks associated with Alkindi?
Maltese: X'inhuma r-riskji assoċjati ma' Alkindi?
English: The active substance in Alkindi, hydrocortisone, is the same as cortisol, the main steroid hormone released by the body's adrenal gland.
Maltese: Is-sustanza attiva f'Alkindi, l-idrokortiżon, hija l-istess bħall-kortiżol, l-ormon tal-isterojde ewlieni li jinħareġ mill-glandola adrenali tal-ġisem.
English: Alkindi is a medicine for children (from birth to up to 18 years of age) whose adrenal glands cannot make enough of a hormone called cortisol.
Maltese: Alkindi huwa mediċina għat-tfal (mit-twelid sa 18-il sena) li l-glandoli adrenali tagħhom ma jistgħux jipproduċu biżżejjed ormon bl-isem ta' kortiżol.
English: Alkindi must not be used in patients with hypersensitivity (allergy) to the active substance or to any of the ingredients of Alkindi.
Maltese: Alkindi ma għandux jintuża f'pazjenti b'sensittività eċċessiva (allerġija) għas-sustanza attiva jew għal kwalunkwe wieħed mill-ingredjenti ta' Alkindi.
English: The dose is chosen to be lowest possible that controls the child's symptoms.
Maltese: Id-doża tintgħażel sabiex tkun l-inqas waħda possibbli li tikkontrolla s-sintomi tat-tfal.
English: Studies on the benefits and risks of the active substance have already been carried out with the reference medicine and do not need to be repeated for Alkindi.
Maltese: Diġà saru studji dwar il-benefiċċji u r-riskji tas-sustanza attiva bil-mediċina ta' referenza u m'għandhomx għalfejn jiġu ripetuti għal Alkindi.
English: What measures are being taken to ensure the safe and effective use of Alkindi?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Alkindi?
English: No side effects were reported in studies with Alkindi, but some side effects have been reported with other hydrocortisone medicines.
Maltese: Fl-istudji b'Alkindi ma ġie rrapportat l-ebda effett sekondarju, iżda xi effetti sekondarji ġew irrapportati bil-mediċini l-oħrajn tal-idrokortiżon.
English: The company also carried out studies to show that it is ‘bioequivalent' to the reference medicine.
Maltese: Il-kumpanija għamlet studji biex turi li hija “bijoekwivalenti” għall-mediċina ta' referenza.
English: How does Alkindi work?
Maltese: Kif jintuża Alkindi?
English: For the full list of side effects see the package leaflet.
Maltese: Għal-lista sħiħa ta' effetti sekondarji, ara l-fuljett ta' tagħrif.
English: The onset of protection is from 4 days onwards.
Maltese: Il-bidu tal-protezzjoni huwa minn 4 ijiem 'l hemm.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) VAXXITEK HVT+IBD EPAR summary for the public
Maltese: EMEA/V/C/065 RAPPORT TA' VALUTAZZJONI PUBBLIKA EWROPEA (EPAR) VAXXITEK HVT+IBD Sommarju ta' l-EPAR għall-pubbliku
English: Zero days.
Maltese: Xejn ġranet.
English: The benefit-risk balance may be found in module 6 of this EPAR.
Maltese: Il-bilanċ bejn ir-riskju-benefiċċju jista' jinstab f'modulu 6 ta' dan l-EPAR.
English: Vaxxitek HVT+IBD is a recombinant vaccine intended for use against Infectious Bursal Disease (also known as Gumboro Disease) and Marek's Disease in chickens.
Maltese: Vaxxitek HVT+IBD huwa vaċċin rekombinanti intenzjonat għal użu kontra l-Marda Burżali Infettiva (magħrufa ukoll bħala Marda Gumboro) u l-Marda ta' Marek fit-tiġieġ.
English: The onset of protection is from 2 weeks onwards and the protection extends to 9 weeks.
Maltese: Il-bidu tal-protezzjoni huwa minn ġimagħtejn 'l hemm u l-protezzjoni testendi sa 9 ġimgħat.
English: Vaxxitek HVT + IBD contains vaccine strains which induce an active immunity and a serological response (detected antibodies) against the two diseases.
Maltese: Vaxxitek HVT + IBD fih razez tal-vaċċin li jinduċu immunità attiva u reazzjoni seroloġika (antikorpi osservati) kontra ż-żewġ mardiet.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Vaxxitek HVT+IBD exceed the risks of its use in chickens and recommended that Vaxxitek HVT+IBD be given a marketing authorisation.
Maltese: Il-Kumitat għal Prodotti Mediċinali għal Użu Veterinarju (CVMP) ikkonkluda li l-benefiċċji ta' Vaxxitek HVT+IBD jaqbżu r-riskji ta' l-użu tiegħu fit-tiġieġ u jirrikmanda li Vaxxitek HVT+IBD jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: The product appears to show no interference with antibodies derived from the mother bird and can be safely administered to day-old chickens and chicks in the egg without presenting any apparent safety problem or inducing an immunosuppressive effect.
Maltese: Il-prodott jidher li ma jurix interferenza ma' antikorpi mill-għasfura omm u jista' jiġi amministrat b'mod sikur lill-flieles ta' età ta' ġurnata u flieles fil-bajda mingħajr ma jippreżenta problemi ta' sigurtà li jidhru jew li jinduċu effett immunosoppressiv.
English: Vaxxitek HVT+IBD is also used to reduce mortality, clinical signs and effects of Marek's disease, a herpes virus infection of chickens.
Maltese: Vaxxitek HVT+IBD jintuża wkoll biex inaqqas il-mortalità u l-effetti tal-Marda ta' Marek, infezzjoni ta' virus herpes tat-tiġieġ.
English: The safety for non-susceptible bird species (pheasants, ducks, partridges, quails and pigeons) and for mammalian species (mice and guinea-pigs) was also demonstrated.
Maltese: Is-sigurtà ntweriet ukoll għal speċi ta' għasafar mhux suxxettibbli (faġani, papri, perniċi, summien u ħamiem) u għal speċi ta' mammiferi (ġrieden u fniek ta' l-Indi).
English: What is Vaxxitek HVT+IBD?
Maltese: X'inhu Vaxxitek HVT+IBD?
English: Other information about Vaxxitek HVT+IBD:
Maltese: Tagħrif ieħor dwar Vaxxitek HVT+IBD:
English: No information is available on the safety and efficacy from the concurrent use with any other vaccine, except Merial attenuated vaccines against Marek's disease, Newcastle disease and Infectious bronchitis.
Maltese: Merial kontra l-marda ta' Marek, marda Newcastle u bronkite infettiva.
English: The studies demonstrated that Vaxxitek HVT+IBD is effective in the active immunisation of chickens and chicks in the egg against Infectious Bursal disease.
Maltese: L-istudji urew li Vaxxitek HVT+IBD huwa effettiv fit-tilqim attiv tat-tiġieġ u flieles fil-bajda kontra lMarda Burżali Infettiva.
English: A single vaccination is sufficient to provide protection during the risk period.
Maltese: Tilqima waħda hija biżżejjed biex tipprovdi protezzjoni waqt il-perijodu ta' riskju.
English: Why has Vaxxitek HVT+IBD been approved?
Maltese: Għal x'hiex ġie approvat Vaxxitek HVT+IBD?
English: What is the risk associated with Vaxxitek HVT+IBD?
Maltese: X'inhu r-riskju assoċjat ma' Vaxxitek HVT+IBD?
English: The full EPAR for Pritor 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: Pritor is a medicine that contains the active substance telmisartan.
Maltese: Pritor huwa mediċina li fiha s-sustanza attiva telmisartan.
English: Various doses of Pritor were compared with placebo (a dummy treatment) and with other medicines for hypertension (atenolol, lisinopril, enalapril and amlodipine).
Maltese: Diversi dożi differenti ta' Pritor tqabblu ma' plaċebo (kura finta) jew ma' mediċini oħra għall-ipertensjoni (atenolol, lisinopril, enalapril u amlodipina).
English: However, the following side effects are seen in between 1 and 10 patients in 1,000: upper respiratory tract infection (colds) including inflammation of the throat and sinuses, urinary tract infection (infection of the structures that carry urine) including bladder infection, anaemia (low red blood cell counts), hyperkalaemia (high blood potassium levels), depression, insomnia (difficulty sleeping), syncope (fainting), vertigo (a spinning sensation), bradycardia (slow heart rate), hypotension (low blood pressure), dyspnoea (difficulty breathing), cough, abdominal pain (stomach ache), diarrhoea, dyspepsia (heartburn), flatulence (gas), vomiting, hyperhidrosis (excessive sweating), pruritus (itching), rash, myalgia (muscle pain), back pain, muscle spasms, renal impairment
Maltese: Madakollu, l-effetti sekondarji li ġejjin dehru f'bejn 1 u 10 pazjenti f'1,000: infezzjonijiet fil-parti ta' fuq tan-nifs (irjiħat) fosthom infjammazzjoni tal-griżmejn u s-sinus, infezzjoni fl-apparat urinarju (infezzjoni fl-istrutturi li jġorru l-awrina) fosthom l-infezzjoni filbużżieqa tal-awrina, anemija (tnaqqis fil-għadd ta' ċelloli ħomor tad-demm), iperkalemija (livelli għoja ta' potassju fid-demm), dipressjoni, insonnja (diffikultà fl-irqad), sinkope (tħossok ħażin), mejt
English: Other information about Pritor
Maltese: Informazzjoni oħra dwar Pritor
English: This is a summary of the European public assessment report (EPAR) for Pritor.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Pritor.
English: For the prevention of cardiovascular problems, 80 mg Pritor once a day has been studied in one main study involving almost 26,000 patients aged 55 years or over who had heart or artery disease, had had a stroke, or had diabetes and were at high risk of cardiovascular problems.
Maltese: Għall-prevenzjoni ta' problemi kardjovaskulari, id-doża ta' 80 mg ta' Pritor darba kuljum ġiet studjata fi studju li involva kważi 26,000 pazjent minn 55 sena 'l fuq li kellhom mard fil-qalb jew fl-arterji, puplesija, jew kellhom id-diabete u kien f'riskju għoli ta' problemi kardjovaskulari.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Pritor on 11 December 1998.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq fl-Unjoni Ewropea kollha għal Pritor fil-11 ta' Diċembru 1998.
English: For the treatment of essential hypertension, the usual recommended dose of Pritor is 40 mg once a day, but some patients may benefit from using 20 mg once a day.
Maltese: Għall-kura tal-ipertensjoni essenzjali, normalment id-doża rakkomandata ta' Pritor hija 40 mg darba kuljum, iżda xi pazjenti jistgħu jibbenefikaw mill-użu ta' doża ta' 20 mg darba kuljum.
English: For the treatment of essential hypertension, Pritor has been studied in 2,647 patients who took Pritor either alone or in combination with hydrochlorothiazide.
Maltese: Għall-kura tal-ipertensjoni essenzjali, Pritor ġie studjat f'2,647 pazjent li ħadu Pritor waħdu jew inkella flimkien mal-idroklorotijażide.
English: What is the risk associated with Pritor?
Maltese: X'inhu r-riskju assoċjat ma' Pritor?
English: If the target blood pressure is not reached, the dose can be increased to 80 mg, or another medicine for hypertension can be added, such as hydrochlorothiazide.
Maltese: Jekk il-pressjoni tad-demm fil-mira ma tintlaħaqx, id-doża tista' tiżdied għal 80 mg, jew tista' tiżdied mediċina oħra għall-ipertensjoni, bħal hydrochlorothiazide.
English: Pritor was compared with ramipril (another medicine to prevent cardiovascular problems), and with the combination of both medicines.
Maltese: Pritor tqabbel ma' ramipril (mediċina oħra li tipprevjeni problemi kardjovaskulari), kif ukoll mat-taħlita taż-żewġ mediċini.
English: What is Pritor?
Maltese: X'inhu Pritor?
English: Hypotension may be more common in patients receiving Pritor to prevent cardiovascular problems.
Maltese: L-ipotensjoni tista' tkun iżjed komuni f'pazjenti li jkunu qed jingħataw Pritor għall-prevenzjoni ta' problemi kardjovaskulari.
English: The active substance in Pritor, telmisartan, is an ‘angiotensin II receptor antagonist', which means that it blocks the action of a hormone in the body called angiotensin II.
Maltese: Is-sustanza attiva f'Pritor, it-telmisartan, hija “antagonista tar-riċettur ta' anġjotensina
English: It also allows the heart to pump blood more easily, which can help to reduce the risk of future cardiovascular problems.
Maltese: Tippermetti wkoll lill-qalb sabiex tippompja d-demm aktar faċilment, li jista' jgħin sabiex jitnaqqas ir-riskju ta' problemi kardjovaskulari futuri.
English: Why has Pritor been approved?
Maltese: Għaliex ġie approvat Pritor?
English: In the prevention of cardiovascular problems, Pritor had a similar effect to ramipril, with around 17% of patients dying, being admitted to hospital because of cardiovascular problems, or having a heart attack or stroke.
Maltese: Għall-prevenzjoni ta' problemi kardjovaskulari, Pritor kellu effett simili għal ramipril, b'madwar 17% tal-pazjenti mietu, iddaħlu l-isptar minħabba problemi kardjovaskulari, jew kellhom attakk tal-qalb jew puplesija.
English: How does Pritor work?
Maltese: X'benefiċċju wera Pritor waqt l-istudji?
English: How has Pritor been studied?
Maltese: Kif ġie studjat Pritor?
English: By blocking the receptors to which angiotensin II normally attaches, telmisartan stops the hormone having an effect, allowing the blood pressure to drop, reducing the risks associated with high blood pressure, such as having a heart attack or stroke.
Maltese: Billi timblokka r-riċetturi li normalment anġjotensina II teħel magħhom, it-telmisartan twaqqaf l-ormon milli jkollu effett, u dan iwassal għal tnaqqis fil-pressjoni tad-demm, u b'hekk tnaqqas ir-riskju assoċjat ma' pressjoni tad-demm għolja, bħalma huma l-attakk tal-qalb u l-puplesija.
English: Side effects with Pritor are not common.
Maltese: L-effetti sekondarji bi Pritor m'humiex komuni.
English: A risk management plan has been developed to ensure that Pritor is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Pritor jintuża bl-aktar mod sigur possibbli.
English: (reduced kidney function) including sudden kidney failure, chest pain, asthenia (weakness) and increased blood levels of creatinine (a marker of muscle breakdown).
Maltese: (vertiġini, sens ta' tidwir), bradikardija (taħbit tal-qalb mhux mgħaġġel), ipotensjoni (pressjoni taddemm baxxa), dispnea (diffikultà fin-nifs), sogħla, uġigħ addominali (uġigħ fl-istonku), dijarrea, dispepsija (ħruq ta' stonku), flatulenza (gass), remettar, iperidrożi (għaraq eċċessiv), prurite (ħakk), raxx, mijalġija (uġigħ fil-muskoli), uġigħ fid-dahar, spażmi tal-muskolu, indeboliment renali (problemi fil-kliewi) inkluża l-insuffiċjenza tal-kliewi, uġigħ fis-sider, astenja (djgħufija) u livelli għola ta' kreatina fid-demm (marker tal-kataboliżmu - diżintegrazzjoni tal-muskoli).
English: For the full list of all side effects reported with Pritor, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji rrappurtati bi Pritor, ara l-fuljett ta' tagħrif.
English: In the treatment of essential hypertension, Pritor was more effective than placebo at reducing diastolic blood pressure and had similar effects to the other medicines for hypertension.
Maltese: Għall-kura tal-ipertensjoni essenzjali, Pritor irriżulta aktar effikaċi mill-plaċebo biex inaqqas il-pressjoni tad-demm dijastolika u kellu effetti simili għal mediċini oħra għall-ipertensjoni.
English: The CHMP decided that Pritor's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' Pritor huma akbar mir-riskji tiegħu u rrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: 24 January 2014
Maltese: 24 ta' Jannar 2014
English: What is Winfuran?
Maltese: X'inhu Winfuran?
English: Winfuran is a medicine that contains the active substance nalfurafine.
Maltese: Winfuran huwa mediċina li fiha s-sustanza attiva nalfurafine.
English: Withdrawal of the marketing authorisation application for Winfuran (nalfurafine) EMA/33514/2014
Maltese: (nalfurafine) EMA/33514/2014
English: Winfuran was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 11 September 2002 for uraemic pruritus.
Maltese: Winfuran kien ikklassifikat bħala ‘mediċina orfni' (mediċina li tintuża f'mard rari) fil11 ta' Settembru 2002 għal ħakk uremiku.
English: On 17 January 2014, Toray International U.K. Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Winfuran, intended for the treatment of severe uraemic pruritus (a form of itching) in patients with end-stage kidney disease on dialysis.
Maltese: Fis-17 ta' Jannar 2014, Toray International U.K. Limited għarrfet uffiċjalment lill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) bl-intenzjoni li tirtira l-applikazzjoni tagħha għallawtorizzazzjoni għat-tqegħid fis-suq għal Winfuran, maħsub għall-kura ta' ħakk uremiku sever (forma ta' ħakk) f'pazjenti b'mard tal-kliewi fl-aħħar stadju li qegħdin fuq dijalisi.
English: The effects of Winfuran were compared with placebo (a dummy treatment) in one main study involving 339 patients with uraemic pruritus who were on regular dialysis.
Maltese: L-effetti ta' Winfuran tqabblu ma' plaċebo (kura finta) fi studju ewlieni li fih ħadu sehem 339 pazjent b'ħakk uremiku li kienu fuq dijalisi regolari.
English: Although an additional analysis showed a modest benefit in a subpopulation of patients with a severe form of uraemic pruritus, the CHMP considered that the clinical relevance had not been shown.
Maltese: Għalkemm analiżi addizzjonali wriet benefiċċju modest f'subpopolazzjoni ta' pazjenti b'forma severa ta' ħakk uremiku, is-CHMP qies li r-rilevanza klinika ma kinitx intweriet.
English: What was Winfuran expected to be used for?
Maltese: Għalxiex kien mistenni li jintuża Winfuran?
English: Withdrawal of the marketing authorisation application for Winfuran (nalfurafine)
Maltese: L-irtirar tal-applikazzjoni għall-awtorizzazzjoni għat tqegħid fis-suq għal Winfuran (nalfurafine)
English: Winfuran activates different opioid receptors, called kappa receptors, which block the activity of the mu-opioid receptors and therefore relieve the itching in patients with uraemic pruritus.
Maltese: Winfuran jattiva riċetturi opjojdi differenti, imsejħa riċetturi Kappa, li jimblokkaw l-attività tar-riċetturi mu-opjojdi u b'hekk ittaffi l-ħakk f'pazjenti b'ħakk uremiku.
English: Winfuran was to be used in patients with end-stage renal disease (when the kidneys have stopped working completely) and who are on dialysis (a technique for removing waste products from the blood).
Maltese: Winfuran kellu jintuża f'pazjenti b'mard tal-kliewi fl-aħħar stadju (meta l-kliewi jkunu waqfu jaħdmu kompletament) u li jkunu fuq dijalisi (teknika għat-tneħħija ta' prodotti ta' skart mid-demm).
English: The effects of Winfuran were first tested in experimental models before being studied in humans.
Maltese: L-effetti ta' Winfuran ġew l-ewwel ittestjati f'mudelli sperimentali qabel ma ġew studjati fil-bniedem.
English: The main measure of effectiveness was the change in symptoms such as itching intensity and sleep disturbance after 4 weeks of treatment based on a standard scoring system.
Maltese: Il-kejl ewlieni tal-effikaċja kien il-bidla fis-sintomi bħallintensità tal-ħakk u disturbi fl-irqad wara 4 ġimgħat ta' kura abbażi ta' sistema standard ta' punteġġi.
English: Based on the review of the data, at the time of the withdrawal, the CHMP had given a negative opinion, recommending that the marketing authorisation be refused for Winfuran for the treatment of severe uraemic pruritus.
Maltese: Fuq il-bażi tar-reviżjoni tad-dejta, fiż-żmien tal-irtirar, is-CHMP kien ta opinjoni negattiva, li tirrakkomanda li l-awtorizzazzjoni għat-tqegħid fis-suq għal Winfuran tiġi rifjutata għall-kura ta' ħakk uremiku sever.
English: Olysio is available as 150 mg capsules.
Maltese: Olysio jiġi bħala kapsuli ta' 150 mg.