FrancophonIA/ELRC3.0 huggingface dataset:
English: Duloxetine is used under different trademarks in several indications (treatment of diabetic neuropathic pain, major depressive disorder, generalised anxiety disorder and stress urinary incontinence).
Maltese: Duloxetine huwa użat taħt trejdmarks differenti f'ħafna indikazzjonijiet (kura ta' uġigħ newropatiku tad-dijabete, disturb depressiv maġġuri, disturb ta' ansjetà ġeneralizzata u l-inkontinenza ta' l-urina minħabba sforz).
English: Overall, Xeristar's efficacy has been demonstrated at daily doses between 60 and 120 mg in a total of five out of seven randomised, double-blind, placebo-controlled, fixed dose acute studies in adult outpatients with major depressive disorder.
Maltese: B'mod ġenerali , l-effikaċja ta' Xeristar ġiet ipprovata f'dożaġġi ta' kuljum ta' bejn 60 u 120 mg f'total ta' ħamsa minn seba' studji li saru f'sitwazzjonijiet akuti, b'doża fissa, randomised, double-blind u kkontrollati bil-plaċebo f'pazjenti li mhumiex residenti ġo sptar u li għandhom mard depressiv maġġuri.
English: Sodium lauryl sulfate Titanium dioxide (E171) Indigo carmine (E132) Yellow iron oxide (E172) Edible white ink
Maltese: Indigo carmine (E132) Iron oxide isfar (E172) Inkjostru abjad li jista' jittiekel
English: In an open label long-term uncontrolled study, the pain reduction in patients responding to 8-weeks of acute treatment of Xeristar 60 mg once daily was maintained for a further 6-months as measured by change on the Brief Pain Inventory (BPI) 24-hour average pain item.
Maltese: ġimgħat ta' kura akuta b'Xeristar 60 mg darba kuljum ġie mantnut għal 6 xhur oħra kif imkejjel mit tibdil f'dik il-parti tal-Brief Pain Inventory (BPI) tal-uġigħ medju fuq 24 siegħa.
English: Dizziness Lethargy Tremor Paraesthesia
Maltese: ANNESS I SOMMARJU TAL-KARATTERISTIĊI
English: The concomitant use of Xeristar with selective, reversible MAOIs, like moclobemide, is not recommended (see section 4.4).
Maltese: Mhux irrakkomandat l-użu fl-istess ħin ta' Xeristar ma' MAOIs riversibbli u selettivi bħal moclobemide (ara sezzjoni 4.4).
English: EU/1/04/297/001 (28 hard gastro-resistant capsules) EU/1/04/297/006 (7 hard gastro-resistant capsules)
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/04/297/001 (28 kapsula gastro-reżistenti iebsa) EU/1/04/297/006 (7 kapsuli gastro-reżistenti ibsin)
English: At least 30% reported pain reduction was recorded in approximately 65% of duloxetine treated patients versus 40% for placebo.
Maltese: Kważi 65% talpazjenti kkurati b'duloxetine kontra l-40% ta' dawk fuq plaċebo rreġistraw tnaqqis ta' mill-inqas 30%
English: Cutaneous vasculitis
Maltese: Fih is-sucrose
English: Generalised anxiety disorder
Maltese: Disturbi fis-sistema nervuża
English: Xeristar 60 mg once daily demonstrated a statistically significant superiority compared to placebo (p=0.004) on the primary outcome measure, the prevention of depressive relapse, as measured by time to relapse.
Maltese: Xeristar 60 mg darba kuljum wera superjorità statistikament sinifikanti meta mqabbel ma' plaċebo (p=0.004) f'daq li għandu x'jaqsam ir-riżultat primarju, il-prevenzjoni ta' rikaduta depressiva, ikkalkulata permezz taż-żmien li għadda sar-rikaduta.
English: How to take Xeristar
Maltese: X'fih Xeristar
English: Gender: Pharmacokinetic differences have been identified between males and females (apparent plasma clearance is approximately 50% lower in females).
Maltese: Differenzi farmakokinetiċi kienu identifikati bejn l-irġiel u n-nisa (it-tneħħija apparenti millplażma huwa bejn wieħed u ieħor 50% inqas fin-nisa).
English: Fertility
Maltese: Vertiġini
English: Chest pain7
Maltese: Ħalq xott
English: Neither duloxetine (30-120 mg) nor the active control arm (fluoxetine 20-40 mg) statistically separated from placebo on change from baseline to endpoint in the Children´s Depression Rating Scale-Revised (CDRS-R) total score.
Maltese: Bħala bidla mil-linja bażi sar-riżultat finali, la duloxetine (30-120 mg) u lanqas il-fergħa ta' kontroll attiv (fluoxetine 20-40
English: Each capsule contains 30 or 60 mg of duloxetine (as hydrochloride).
Maltese: Kull kapsula fiha 30 jew 60 mg ta' duloxetine (bħala hydrochloride).
English: In a relapse prevention study, patients responding to 12-weeks of acute treatment with open-label Xeristar 60 mg once daily were randomised to either Xeristar 60 mg once daily or placebo for a further 6-months.
Maltese: Fiż-żewġ studji, Xeristar 60 mg darba kuljum u 60 mg darbtejn kuljum naqqsu b'mod sinifikanti luġigħ meta mqabbla ma' plaċebo.
English: • inflammation of the blood vessels in the skin (cutaneous vasculitis)
Maltese: • Infjammazzjoni tal-arterji u tal-vini fil-ġilda (vaskulite kutanea) Rappurtar tal-effetti sekondarji
English: The efficacy of Xeristar at the recommended dose of 60 mg once a day was demonstrated in three out of three randomised, double-blind, placebo-controlled, fixed dose acute studies in adult outpatients with major depressive disorder.
Maltese: L-effikaċja ta' Xeristar fid-doża rakkomandata ta' 60 mg darba kuljum ġiet ppruvata fit-tlieta minn tliet studji li saru f'sitwazzjonijiet akuti, b'doża fissa, randomised, double-blind u kkontrollati bil-plaċebo f'pazjenti li mhumiex residenti ġo sptar u li għandhom mard depressiv maġġuri.
English: Orgasm abnormal Abnormal dreams ideation5,7
Maltese: Imġiba suwiċidali5,7
English: Caution is advisable if Xeristar is used concomitantly with serotonergic agents like SSRIs, SNRIs, tricyclic antidepressants like clomipramine or amitriptyline, MAOIs like moclobemide or linezolid, St John's wort (Hypericum perforatum) or triptans, tramadol, pethidine and tryptophan (see section 4.4).
Maltese: John's wort (Hypericum perforatum) jew triptans, tramadol, pethidine u tryptophan (ara sezzjoni 4.4).
English: Current available data are described in sections 4.8, 5.1 and 5.2.
Maltese: It-tagħrif li hemm disponibbli s'issa huwa deskritt f'sezzjonijiet 4.8, 5.1 u 5
English: Xeristar is a hard gastro-resistant capsule.
Maltese: GĦAMLA FARMAĊEWTIKA Kapsula gastro-reżistenti iebsa.
English: The effect of Xeristar 60 mg once a day in elderly depressed patients (≥65 years) was specifically examined in a study that showed a statistically significant difference in the reduction of the HAMD17 score for duloxetine-treated patients compared to placebo.
Maltese: L-effett ta' Xeristar 60 mg darba kuljum, f'pazjenti anzjani b'depressjoni (> 65 sena) ġie speċifikament eżaminat f'studju li wera differenza statistikament sinifikanti fit-tnaqqis tal-punteġġ ta'
English: Xeristar with food, drink and alcohol
Maltese: XERISTAR mal-ikel, max-xorb u mal-alkoħol
English: Constipation Diarrhoea Abdominal pain Vomiting Dyspepsia Flatulence
Maltese: Żieda fil-creatine phosphokinase fiddemm
English: The safety and efficacy of duloxetine for the treatment of generalised anxiety disorder in paediatric patients aged 7-17 years have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' duloxetine fil-kura ta' disturb ta' ansjetà ġeneralizzata f'pazjenti pedjatriċi b'etajiet bejn 7-17-il sena ma ġewx stabbiliti.
English: Store in the original package to protect from moisture.
Maltese: Żomm fil-pakkett oriġinali sabiex tilqa' mill-umdità.
English: Capsule shell: gelatin, sodium lauryl sulfate, titanium dioxide (E171), indigo carmine (E132), yellow iron oxide (E172) (60 mg only) and edible green ink (30 mg) or edible white ink (60 mg).
Maltese: iron oxide isfar (E172) (għas-60 mg biss) u inkjostru aħdar li jittiekel (30 mg) jew inkjostru abjad li jittiekel (60 mg).
English: Your doctor will tell you if you should be taking Xeristar.
Maltese: It-tabib se jgħidlek jekk għandekx tieħu Xeristar.
English: Duloxetine had no effect on male fertility, and effects in females were only evident at doses that caused maternal toxicity.
Maltese: Duloxetine ma kellu ebda effett fuq il-fertilità tar-raġel u effetti fin-nisa kienu evidenti biss b'dożi li kkawżaw tossiċità materna.
English: Appetite
Maltese: Apatija
English: Other psychiatric conditions for which Xeristar is prescribed can also be associated with an increased risk of suicide-related events.
Maltese: Hija esperjenza klinika ġenerali li r-riskju ta' suwiċidju jista' jiżdied fl-istadji bikrijin ta' fejqan.
English: • Make sure your midwife and/or doctor knows you are on Xeristar.
Maltese: • Kun ċert li l-qabla u/jew it-tabib/a jafu li qiegħda fuq Xeristar.
English: Paediatric population: Pharmacokinetics of duloxetine in paediatric patients aged 7 to 17 years with major depressive disorder following oral administration of 20 to 120 mg once daily dosing regimen was characterized using population modelling analyses based on data from 3 studies.
Maltese: Il-farmakokinetika ta' duloxetine, wara l-għoti mill-ħalq b'skeda ta' dożaġġ ta' 20 sa 120 mg darba kuljum f'pazjenti pedjiatriċi b'etajiet minn 7 sa 17-il sena b'disturb depressiv maġġuri, ġiet ikkaratterizzata bl-użu ta' analiżi ta' mudelli ta' popolazzjoni bbażati fuq tagħrif minn
English: Adverse reactions may be more common during concomitant use of Xeristar and herbal preparations containing St John's wort (Hypericum perforatum).
Maltese: John's wort (Hypericum perforatum).
English: Each capsule contains 30 mg of duloxetine (as hydrochloride).
Maltese: Xeristar 30 mg Kull kapsula fiha 30 mg ta' duloxetine (bħala hydrochloride)
English: Dizziness, sensory disturbances (including paraesthesia or electric shock-like sensations, particularly in the head), sleep disturbances (including insomnia and intense dreams), fatigue, somnolence, agitation or anxiety, nausea and/or vomiting, tremor, headache, myalgia, irritability, diarrhoea, hyperhydrosis and vertigo are the most commonly reported reactions.
Maltese: Sturdament, disturbi tas-sensi (fosthom parastizja jew sensazzjonijiet li jixbħu dak ta' xokk elettriku, speċjalment fir-ras), disturbi fl-irqad, (fosthom insomnja u ħolm intens), għeja, ħedla ta' rqad,
English: Further information on Soliris can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Soliris.
Maltese: ema.europa.eu/medicines/human/EPAR/Soliris.
English: Myasthenia gravis
Maltese: Mijastenija gravi
English: Soliris contains the active substance eculizumab.
Maltese: Soliris fih is-sustanza attiva l-ekuliżumab.
English: This overview was last updated in 09-2019.
Maltese: Din il-ħarsa ġenerali ġiet aġġornata l-aħħar f'09-2019.
English: Other information about Soliris
Maltese: Informazzjoni oħra dwar Soliris
English: Further information on the orphan designations can be found on the European Medicines Agency's website (PNH: 17 October 2003; aHUS: 24 July 2009; myasthenia gravis: 29 July 2014; NMOSD: 24 April 2019).
Maltese: Aktar informazzjoni dwar id-denominazzjonijiet orfni tista' tinstab fuq is-sit web talAġenzija Ewropea għall-Mediċini (PNH: 17 ta' Ottubru 2003; aHUS: 24 ta' Lulju 2009; mijastenija gravi: 29 ta' Lulju 2014;
English: Soliris led to a reduction of 4.7 points on the scale whereas placebo led to 2.8 point reduction after 26 weeks.
Maltese: Soliris wassal għal tnaqqis ta' 4.7 punti fuq l-iskala waqt li l-plaċebo wassal għal tnaqqis ta' 2.8 punti wara 26 ġimgħa.
English: In addition, 76% achieved haematological normalisation (levels of platelets and LDH within normal levels).
Maltese: Barra minn hekk, 76 % kisbu “normalizzazzjoni ematoloġika” (livelli tal-pjastrini u ta' LDH fi ħdan livelli normali).
English: What are the risks associated with Soliris?
Maltese: X'inhuma r-riskji assoċjati ma' Soliris?
English: Soliris received a marketing authorisation valid throughout the EU on 20 June 2007.
Maltese: Soliris ingħata awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fl-20 ta' Ġunju 2007.
English: Soliris is a medicine used to treat adults and children with paroxysmal nocturnal haemoglobinuria (PNH) and atypical haemolytic uraemic syndrome (aHUS).
Maltese: Soliris huwa mediċina li tintuża biex tikkura lill-adulti u lit-tfal b'emoglobinurija notturna parossismali (PNH - paroxysmal nocturnal haemoglobinuria) u b'sindrome uremiku emolitiku atipiku (aHUSatypical haemolytic uraemic syndrome).
English: For aHUS, Soliris was studied in three main studies involving 67 patients.
Maltese: Għall-aHUS, Soliris ġie studjat fi tliet studji ewlenin li involvew 67 pazjent.
English: The active substance in Soliris, eculizumab, is a monoclonal antibody (a type of protein) that has been designed to attach to the C5 complement protein, which is a part of the body's defence system called the ‘complement system'.
Maltese: Is-sustanza attiva f'Soliris, l-ekuliżumab, hija antikorp monoklonali (tip ta' proteina) li ġiet iddisinjata biex teħel mal-proteina C5 tal-komplement, li hija parti mis-sistema ta' difiża tal-ġisem imsejħa s“sistema tal-komplement”.
English: After around 22 months on average, 3% of patients treated with Soliris had had a relapse, whereas 43% of patients treated with placebo had already had a relapse after around 9 months on average.
Maltese: Wara madwar medja ta' 22 xahar, 3 % tal-pazjenti kkurati b'Soliris kellhom rikaduta, filwaqt li 43 % tal-pazjenti kkurati bil-plaċebo kien diġà kellhom rikaduta wara madwar medja ta' 9 xhur.
English: A reduction in the score by 2 points indicates a clinically significant improvement of the patient's condition.
Maltese: Tnaqqis fil-punteġġ b'2 punti jindika titjib klinikament sinifikanti tal-kondizzjoni tal-pazjent.
English: The second study, involving 20 patients with aHUS who were already receiving plasma exchange or infusion, resulted in 80% of the patients no longer requiring plasma exchange, infusion or dialysis and 90% of the patients achieving haematological normalisation after treatment with Soliris.
Maltese: It-tieni studju, li involva 20 pazjent bl-aHUS li kienu diġà qed jirċievu skambju plażmiku jew infużjoni, irriżulta fi 80 % tal-pazjenti li ma kinux għadhom jeħtieġu skambju plażmiku, infużjoni jew dijaliżi u 90 % tal-pazjenti li kisbu normalizzazzjoni ematoloġika wara l-kura b'Soliris.
English: Treatment increased platelet counts to normal levels in 83% of the patients, while the platelet count rose to normal levels in 77% (10 out of 13 patients) who initially had low platelet counts.
Maltese: Il-kura żiedet l-għadd tal-pjastrini għal livelli normali fi 83 % tal-pazjenti, waqt li l-għadd tal-pjastrini għola għal livelli normali f'77 % (10 minn 13-il pazjent) li fil-bidu kellhom għadd tal-pjastrini baxx.
English: For myasthenia gravis, Soliris was compared with placebo in one main study involving 126 adults with myasthenia gravis who had previously received standard treatment which had failed.
Maltese: Għall-mijastenija gravi, Soliris tqabbel mal-plaċebo fi studju ewlieni wieħed li involva 126 adult b'mijastenija gravi li preċedentement kienu rċevew kura standard li ma kinitx irnexxiet.
English: PNH results in anaemia (low red blood cell counts), thrombosis (blood clots in the blood vessels), pancytopenia (low counts of blood cells) and dark urine, while aHUS results in anaemia, thrombocytopenia (a decrease in the number of platelets, components that help the blood to clot) and kidney failure.
Maltese: Il-marda PNH tirriżulta fl-anemija (għadd baxx ta' ċelloli ħomor tad-demm), fit-trombożi (emboli tad-demm fil-vażijiet), fil-panċitopenija (għadd baxx taċ-ċelloli tad-demm) u fl-urina skura, filwaqt li l-marda aHUS tirriżulta fl-anemija, fit-tromboċitopenija (tnaqqis fl-għadd tal-pjastrini, li huma komponenti li jgħinu d-demm jagħqad) u insuffiċjenza renali.
English: The safety profile was similar for all the diseases and was considered acceptable.
Maltese: Il-profil tas-sigurtà kien simili għall-mard kollu u tqies aċċettabbli.
English: For PNH, Soliris was compared with placebo (a dummy treatment) in one main study involving 87 adults with PNH who had had at least four blood transfusions for anaemia in the previous year.
Maltese: Għall-PNH, Soliris tqabbel mal-plaċebo (kura finta) fi studju ewlieni wieħed li involva 87 adult bil-PNH li kienu ħadu tal-inqas erba' trasfużjonijiet tad-demm għall-anemija fis-sena preċedenti.
English: Treatment with Soliris increased platelet counts in 82% of the patients, and platelet counts rose to normal levels in 87% (13 out of 15 patients) who had low platelet counts at the start.
Maltese: Il-kura b'Soliris żiedet l-għadd tal-pjastrini fi 82 % tal-pazjenti, u l-għadd tal-pjastrini għola għal livelli normali f'87 % (13 minn 15-il pazjent) li fil-bidu kellhom għadd tal-pjastrini baxx.
English: Because of the increased risk of developing meningococcal sepsis, Soliris must not be given to people who have an infection caused by Neisseria meningitides; it must also not be given to patients who have not been vaccinated against this bacterium, unless they have the vaccination and take appropriate antibiotics to reduce the risk of infection for two weeks after vaccination.
Maltese: Minħabba riskju miżjud ta' żvilupp ta' sepsi meningokokkali, Soliris m'għandux jingħata lil nies li għandhom infezzjoni kkawżata minn Neisseria meningitidis; dan m'għandux jingħata lanqas lil pazjenti li ma tlaqqmux kontra dan il-batterju, sakemm dawn ma jieħdux it-tilqima u jieħdu l-antibijotiċi xierqa biex inaqqsu r-riskju ta' infezzjoni għal ġimagħtejn wara t-tilqima.
English: As for all medicines, data on the use of Soliris are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Soliris hija ssorveljata kontinwament.
English: For NMOSD, Soliris was compared with placebo in one main study involving 143 adults with NMOSD whose disease was relapsing.
Maltese: Għall-NMOSD, Soliris tqabbel mal-plaċebo fi studju ewlieni wieħed li involva 143 adult bl-NMOSD li lmarda tagħhom kienet rikaduta.
English: These diseases are rare, and Soliris was designated an ‘orphan medicine' (a medicine used in rare diseases).
Maltese: Dawn il-kundizzjonijiet huma rari, u Soliris ġie denominat bħala “mediċina orfni” (mediċina li tintuża f'mard rari).
English: For the full list of side effects and restrictions with Soliris, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet b'Soliris, ara l-fuljett ta' tagħrif.
English: Soliris is also used to treat adults with neuromyelitis optica spectrum disorder (NMOSD), a disease where the immune system damages nerve cells causing problems mostly with the optic (eye) nerve and the spinal cord.
Maltese: Soliris jintuża wkoll biex jikkura l-adulti b'disturb tal-ispettru ottiku newromijeliti (NMOSDneuromyelitis optica spectrum disorder), marda fejn is-sistema immunitarja tagħmel il-ħsara liċ-ċelloli tan-nerf u dan jikkawża l-problemi l-aktar fin-nerf ottiku (tal-għajnejn) u fis-sinsla tad-dahar.
English: In patients with PNH, aHUS, myasthenia gravis and NMOSD, the complement proteins are over-active and damage the patients' own cells.
Maltese: F'pazjenti bil-PNH u bl-aHUS, bil-mijastenija gravi u bl-NMOSD, il-proteini tal-komplement huma attivati żżejjed u jagħmlu ħsara liċ-ċelloli tal-pazjenti stess.
English: The most common side effect with Soliris (which may affect more than 1 in 10 people) is headache.
Maltese: L-effett sekondarju l-aktar komuni b'Soliris (li jista' jaffettwa aktar minn persuna waħda minn kull 10) huwa wġigħ ta' ras.
English: The third study involved 30 patients with aHUS who had received at least one dose of Soliris.
Maltese: It-tielet studju involva 30 pazjent bl-aHUS li kienu rċevew tal-inqas doża waħda ta' Soliris.
English: How is Soliris used?
Maltese: Kif jintuża Soliris?
English: EMA/818458/2015 EMEA/H/C/000639
Maltese: EMA/H/C/000639
English: This summary was last updated in 01-2016.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'01-2016.
English: The full EPAR for Rotarix 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: It is available in three forms:
Maltese: Jiġi fi tliet forom:
English: Other information about Rotarix:
Maltese: Informazzjoni oħra dwar Rotarix:
English: Rotarix rotavirus vaccine, live
Maltese: Rotarix vaċċin rotavirus, ħaj
English: In the main study, the number of cases of severe rotavirus gastroenteritis was lower following vaccination with Rotarix: 0.1% of the babies vaccinated with Rotarix in whom effectiveness was assessed developed severe rotavirus gastroenteritis (12 out of over 9,000) compared with 0.9% of the babies who received placebo (77 out of almost 9,000).
Maltese: Mit-trabi li ngħataw il-vaċċin Rotarix u li fihom saret valutazzjoni tal-effikaċja tiegħu kien hemm 0.1% li żviluppaw gastroenterite severa (12 minn iktar minn 9,000), meta mqabbla ma' 0.9% tat-trabi li ngħataw il-plaċebo (77 minn kważi 9,000).
English: This document is a summary of the European Public Assessment Report (EPAR) for Rotarix.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Rotarix.
English: • a powder and solvent that are made up into an oral suspension in an oral applicator;
Maltese: • trab u solvent li jintgħamlu f'sospensjoni orali f'applikatur orali;
English: Rotarix contains a live attenuated (weakened) form of the human rotavirus (RIX4414 strain).
Maltese: Rotarix fih forma mdgħajfa iżda ħajja tar-rotavirus uman (razza RIX4414).
English: PCV-1 is not known to cause any disease.
Maltese: Il-PCV-1 mhux magħruf li jikkawża kwalunkwe mard.
English: Overall, the clinical studies of Rotarix involved over 75,000 babies and took place in various countries worldwide.
Maltese: B'mod ġenerali, l-istudji kliniċi ta' Rotarix involvew iżjed minn 75,000 tarbija u saru f'diversi pajjiżi fiddinja kollha.
English: What is Rotarix?
Maltese: X'inhuwa Rotarix?
English: The most common side effects with Rotarix (seen in between 1 and 10 patients in 100) are diarrhoea and irritability.
Maltese: L-effetti sekondarji l-aktar komuni b'Rotarix (li dehru f'bejn pazjent wieħed u 10 minn kull 100) huma d-dijarrea u irritabbiltà.
English: • an oral suspension in a squeezable tube.
Maltese: • sospensjoni orali f'tubu li jingħasar.
English: A further study looked at the safety of Rotarix and its ability to stimulate the production of antibodies in 1,009 babies born up to 13 weeks prematurely.
Maltese: Studju ieħor stħarreġ is-sigurtà ta' Rotarix u l-ħila tiegħu li jistimula l-produzzjoni ta' antikorpi f'1,009 trabi li twieldu sa 13-il ġimgħa qabel iż-żmien.
English: Four additional studies were carried out in over 3,000 infants, to confirm that the ready-for-use forms of the vaccine were as safe and as effective as the powder and solvent formulation in stimulating the production of antibodies against rotavirus.
Maltese: Saru wkoll erba' studji addizzjonali f'aktar minn 3,000 tarbija, sabiex ikun ikkonfermat li l-forom talvaċċin imħejjija bil-lest għall-użu kinux siguri u effikaċi daqs il-formulazzjoni tat-trab u s-solvent biex jistimulaw il-produzzjoni ta' antikorpi kontra r-rotavirus.
English: What is the risk associated with Rotarix?
Maltese: X'inhuwa r-riskju assoċjat ma' Rotarix?
English: Why has Rotarix been approved?
Maltese: Għaliex ġie approvat Rotarix?
English: Rotarix is used in babies aged from 6 to 24 weeks to protect against gastroenteritis (diarrhoea and vomiting) caused by rotavirus infections.
Maltese: Rotarix jintuża fi trabi li jkollhom bejn 6 ġimgħat sa 24 ġimgħa għall-protezzjoni kontra l-gastroenterite (dijarrea u remettar) ikkawwżati minn infezzjonijiet tar-rotavirus.
English: Rotarix was more effective than placebo in preventing severe gastroenteritis due to rotavirus.
Maltese: Rotarix kien aktar effettiv mill-plaċebo fil-prevenzjoni tal-gastroenterite severa kkaġunata mirrotavirus.
English: The main study compared Rotarix with placebo (a dummy vaccine) in over 63,000 babies who were born at full term (after a pregnancy of at least 36 weeks).
Maltese: L-istudju prinċipali qabbel lil Rotarix ma' plaċebo (vaċċin finta) f'iktar minn 63,000 tarbija li twieldu f'terminu sħiħ (wara tqala ta' mill-inqas 36 ġimgħa).
English: • an oral suspension in a prefilled oral applicator;
Maltese: • sospensjoni orali f'applikatur orali mimli minn qabel;
English: A risk management plan has been developed to ensure that Rotarix is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Rotarix jintuża bl-aktar mod sigur possibbli.