FrancophonIA/ELRC3.0 huggingface dataset:
English: The reduction in pain intensity after 10 minutes was between 1.8 and 2.7 points on an 11-point pain scale for patients who took Instanyl, compared with 1.4 for patients who took placebo.
Maltese: It-tnaqqis fl-intensità tal-uġigħ wara 10 minuti kien bejn 1.8 u 2.7 punti fuq skala ta' wġigħ ta' 11-il punt għall-pazjenti li ħadu Instanyl, meta mqabbla ma' 1.4 għall-pazjenti li ħadu l-plaċebo.
English: The change in pain intensity after 10 minutes was between 2.0 and 2.7 points after receiving doses of Instanyl compared with 1.3 after receiving placebo.
Maltese: Il-probabbiltà ta' intensità fl-uġigħ wara 10 minuti kienet bejn 2.0 u 2.7 punti wara li ngħataw dożi ta' Instanyl meta mqabbla ma' 1.3 wara li ngħata l-plaċebo.
English: What are the risks associated with Instanyl?
Maltese: X'inhuma r-riskji assoċjati ma' Instanyl?
English: Instanyl has been shown to provide rapid relief of pain in patients with cancer.
Maltese: Instanyl intwera li jipprovdi taffija rapida ta' wġigħ f'pazjenti bil-kanċer.
English: As for all medicines, data on the use of Instanyl are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Instanyl hija ssorveljata kontinwament.
English: The active substance in Instanyl, fentanyl, is an opioid.
Maltese: Is-sustanza attiva f'Instanyl, il-fentanil, hija opjojde.
English: Instanyl is a medicine used to treat breakthrough pain in adults with cancer.
Maltese: Instanyl huwa mediċina li tintuża biex tikkura żieda qawwija ta' wġigħ f'adulti bil-kanċer.
English: How is Instanyl used?
Maltese: Kif jaħdem Instanyl?
English: In one main study, 178 adult cancer patients with breakthrough pain took one spray of either Instanyl (50, 100 or 200 microgram) or placebo when they experienced breakthrough pain.
Maltese: Fi studju ewlieni wieħed, 178 pazjent adult bil-kanċer li kellhom żieda qawwija ta' wġigħ ħadu sprej wieħed ta' jew Instanyl (50, 100 jew 200 mikrogramma) jew plaċebo meta esperjenzaw żieda qawwija ta' wġigħ.
English: In Instanyl, fentanyl is contained inside a nasal spray.
Maltese: F'Instanyl, il-fentanil tinsab fi sprej nażali.
English: In a third study, which involved 139 patients and compared Instanyl with ‘transmucosal' fentanyl (absorbed through the lining of the mouth), patients who received Instanyl had faster pain relief than patients who received transmucosal fentanyl .
Maltese: Fit-tielet studju, li kien jinvolvi 139 pazjent u li qabbel Instanyl mal-fentanil “transmukożali” (assorbita mir-rita tal-ħalq), il-pazjenti li ngħataw Instanyl kellhom taffija mill-uġigħ aktar malajr mill-pazjenti li ngħataw il-fentanil transmukożali.
English: Side effects are similar to those of other medicines containing fentanyl, and measures have been put in place to minimise the risk of misuse and overdose.
Maltese: L-effetti sekondarji huma simili għal dawk ta' mediċini oħra li fihom il-fentanil, u ġew implimentati miżuri għall-minimizzazzjoni tarriskju ta' użu ħażin jew użu eċċessiv.
English: What measures are being taken to ensure the safe and effective use of Instanyl?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Instanyl?
English: Instanyl is used in patients who are already using opioids (a group of painkillers that includes morphine and fentanyl) to control long-term cancer pain.
Maltese: Instanyl jintuża f'pazjenti li diġà qegħdin jużaw opjojdi (grupp ta' mediċini li jtaffu l-uġigħ li jinkludu l-morfina u l-fentanil) biex jikkontrollaw l-uġigħ tal-kanċer fit-tul.
English: The highest dose was 200 microgram given as one spray in one nostril and the patients were allowed to take a second spray after 10 minutes if there had been insufficient pain relief.
Maltese: L-ogħla doża kienet 200 mikrogramma li ngħatat bħala sprej wieħed f'minħar wieħed u l-pazjenti setgħu jieħdu t-tieni sprej wara 10 minuti jekk ma kellhomx biżżejjed taffija mill-uġigħ.
English: What benefits of Instanyl have been showed in studies?
Maltese: X'inhuma l-benefiċċji ta' Instanyl li ħarġu mill-istudji?
English: The first dose of Instanyl is 50 micrograms (one spray of the lowest strength) in one nostril; this is increased as necessary until reaching the dose that gives the patient adequate pain relief.
Maltese: L-ewwel doża ta' Instanyl hija ta' 50 mikrogramma (sprej wieħed tal-inqas qawwa) f'minħar wieħed; din tiżdied kif meħtieġ sakemm tintlaħaq id-doża li tagħti lill-pazjent taffija adatta mill-uġigħ.
English: It is available in singledose containers and in multidose containers.
Maltese: Jiġi f'kontenituri b'doża waħda u f'kontenituri b'ħafna dożi.
English: It must not be used in patients treated with medicines containing sodium oxybate (used to treat narcolepsy, a sleep disorder).
Maltese: M'għandu jintuża f'pazjenti kkurati b'mediċini li fihom ossibat tas-sodju (li jintuża għall-kura ta' narkolessija, disturb tal-irqad).
English: Because fentanyl has been in use for many years, the company presented data from the scientific literature, as well as from studies that it had carried out, which showed that Instanyl was more effective than placebo (a dummy treatment) at treating breakthrough pain in cancer patients.
Maltese: Il-kumpanija li tqiegħed Instanyl fis-suq ser tipprovdi wkoll materjal edukattiv li għandu jingħata lillpazjenti, lit-tobba u lill-ispiżjara, fejn jiġi spjegat l-użu korrett u sigur tal-mediċina.
English: Side effects reported with Instanyl are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati b'Instanyl huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: The number of patients who responded to treatment was also higher in the Instanyl group than in the placebo group.
Maltese: Innumru ta' pazjenti li kellhom reazzjoni għall-kura kien ogħla fil-grupp ta' Instanyl milli fil-grupp talplaċebo.
English: Annex IV Conditions for lifting the suspension
Maltese: Anness IV Kundizzjonijiet għat-tneħħija tas-sospensjoni
English: Evidence that the product has been reformulated, that it exhibits an acceptable release profile with the same quality, safety and efficacy profile of the currently authorised formulation but without the clinically significant interaction with alcohol.
Maltese: Evidenza li l-prodott ġie fformulat mill-ġdid, li jesebixxi profil ta' rilaxx aċċettabbli bl-istess profil ta' kwalità, sigurtà u effikaċja tal-formolazzjoni awtorizzata fil-preżent iżda mingħajr l-interazzjoni klinikament sinifikanti mal-alkoħol.
English: Only applicable to products containing a polymethacrylate-triethylcitrate coating as modified-release mechanism
Maltese: Applikabbli biss għal prodotti li fihom kisja ta' polymethacrylate-triethylcitrate bħala mekkaniżmu ta' rilaxx modifikat
English: For the suspension to be lifted the Marketing Authorisation Holders would need to provide the National Competent Authorities with the following:
Maltese: Biex titneħħa s-sospensjoni, id-Detenturi tal-Awtorizzazzjoni għat-Tqegħid fis-Suq iridu jipprovdu lillAwtoritajiet Kompetenti Nazzjonali b'dawn li ġejjin:
English: The new formulation must be approved by the National Competent Authorities of the concerned Member States.
Maltese: Il-formolazzjoni l-ġdida għandha tiġi approvata mill-Awtoritajiet Nazzjonali Kompetenti tal-Istati Membri kkonċernati.
English: EMA/310855/2015 EMEA/V/C/003869
Maltese: EMEA/V/C/003869
English: The full EPAR for Innovax-ILT can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: Innovax-ILT contains live turkey herpesvirus strain HVT/ILT-138.
Maltese: Innovax-ILT fih virus ħerpes tad-dundjan tar-razza HVT/ILT-138.
English: Innovax-ILT is a veterinary vaccine used to protect chickens against infectious laryngotracheitis (ILT) and Marek's disease (MD).
Maltese: Innovax-ILT huwa mediċina veterinarja li tintuża għall-protezzjoni tat-tiġieġ kontra laryngotracheitis infettiva (ILT) u l-marda ta' Marek (MD).
English: This is a summary of the European public assessment report (EPAR) for Innovax-ILT.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Innovax-ILT.
English: The European Commission granted a marketing authorisation valid throughout the EU for Innovax-ILT on 3 July 2015.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Innovax-ILT valida fl-UE kollha fit-3 ta' Lulju 2015.
English: Protection against ILT starts 4 weeks after vaccination and lasts 60 weeks.
Maltese: ILT tibda 4 ġimgħat wara l-vaċċinazzjoni u ddum 60 ġimgħa.
English: Avian infectious laryngotracheitis and Marek's disease vaccine (live recombinant)
Maltese: Vaċċin ta' larynotracheitis infettiva tal-għasafar u tal-marda ta' Marek (ħaj rekombinanti)
English: Why is Innovax-ILT approved?
Maltese: Għaliex ġie approvat Innovax-ILT?
English: The turkey herpesvirus strain HVT/ILT-138 has been modified so that it will produce the glycoproteins gD and gI which form part of the outer coat of the ILT virus.
Maltese: Il-virus ħerpes tad-dundjan tar-razza HVT/ILT-138 ġie mmodifikat sabiex jipproduċi l-glikoproteini gD u gI li jiffurmaw parti mill-kisja ta' barra tal-virus tal-ILT.
English: To evaluate the effects of the vaccine against MD, chickens vaccinated either with Innovax-ILT alone or Innovax-ILT mixed with Nobilis Rismavac (a vaccine which also protects against Marek's disease) were infected with very virulent strains of the MD virus.
Maltese: MD, it-tiġieġ vaċċinati jew b'Innovax-ILT waħdu jew b'Innovax-ILT imħallat ma' Nobilis Rismavac (vaċċin li jipproteġi wkoll kontra l-marda ta' Marek) ġew infettati b'razez virulenti tal-virus tal-MD.
English: MD is another herpesvirus infection of chickens which can cause paralysis of the wings and legs and causes tumours in various organs.
Maltese: MD hija infezzjoni oħra tal-virus ħerpes tat-tiġieġ li tista' tikkawża paraliżi tal-ġwienaħ u s-saqajn u tikkawża tumuri f'diversi organi.
English: Innovax-ILT is a vaccine containing turkey herpesvirus serotype 3, a type of herpesvirus which is closely related to MD virus but does not cause disease in chickens.
Maltese: Innovax-ILT huwa vaċċn li fih il-virus ħerpes tad-dundjan tas-serotip 3, tip ta' virus ħerpes li huwa relatat mill-qrib għall-virus MD iżda ma jikkawżax mard fit-tiġieġ.
English: Other information about Innovax-ILT
Maltese: Informazzjoni oħra dwar Innovax-ILT
English: The disease is caused by a herpesvirus and can be mild (causing watery eyes, nasal discharge and mild inflammation of the windpipe) or severe, causing dyspnoea (difficulty breathing), respiratory depression and coughing up of blood.
Maltese: Il-marda hija kkawżata minn virus ħerpes u tista' tkun ħafifa (li tikkawża għajnejn imdemmgħin, tnixxija mill-imnieħer u infjammazzjoni ħafifa tal-kanal tan-nifs) jew severa, li tikkawża qtugħ ta' nifs (diffikultà fin-nifs), dipressjoni respiratorja u sogħla bid-demm.
English: Chickens showed varying levels of protection after vaccination with either Innovax-ILT alone or Innovax-ILT mixed with Nobilis Rismavac.
Maltese: It-tiġieġ urew livelli varjati ta' protezzjoni wara vaċċinazzjoni b'Innovax-ILT waħdu jew b'Innovax-ILT imħallat ma' Nobilis Rismavac.
English: What are the risks associated with Innovax-ILT?
Maltese: X'inhuma r-riskji assoċjati ma' Innovax-ILT?
English: In a second challenge study the effectiveness of the vaccination with Innovax-ILT alone and InnovaxILT mixed with Nobilis Rismavac was also examined by evaluation of protection after infection under laboratory conditions with the ILT virus.
Maltese: Fit-tieni studju ta' sfida, l-effettività tal-vaċċinazzjoni b'Innovax-ILT waħdu u b'Innovax-ILT imħallat ma' Nobilis Rismavac ġiet eżaminata b'evalwazzjoni tal-protezzjoni wara infezzjoni skont kundizzjonijiet tal-laboratorju bil-virus tal-ILT.
English: Birds infected with MD virus can be carriers and shedders of the virus for life.
Maltese: Għasafar infettati bil-virus MD jistgħu jkunu trasportaturi u xerrieda tal-virus għal tul ħajjithom kollha.
English: How does Innovax-ILT work?
Maltese: Kif jaħdem Innovax-ILT?
English: Protection against MD starts 9 days after vaccination and lasts for life.
Maltese: MD tibda 9 ijiem wara l-vaċċinazzjoni u ddum tul ħajjithom kollha.
English: Chickens were taken from the field trial and challenged (exposed to infection) in the laboratory to demonstrate protection after vaccination.
Maltese: It-tiġieġ ittieħdu mill-prova prattika u ġew sfidati (esposti għall-infezzjoni) fil-laboratorju biex tintwera l-protezzjoni wara l-vaċċinazzjoni.
English: Innovax-ILT is available as a suspension and solvent to be made into a suspension for injection and can only be obtained with a prescription.
Maltese: Innovax-ILT huwa disponibbli bħala sospensjoni u solvent biex jiġu magħmulin f'sospensjoni għal injezzjoni u jista' jinkiseb biss b'riċetta ta' tabib.
English: When Innovax-ILT is given mixed with Nobilis Rismavac protection against MD starts at 5 days after vaccination.
Maltese: Meta Innovax-ILT ġie applikat imħallat ma' Nobilis Rismavac, il-bidu tal-protezzjoni kontra
English: Trobalt retigabine
Maltese: Trobalt retigabina
English: It is available as tablets (50, 100, 200, 300 and 400 mg).
Maltese: Jiġi f'pilloli (50, 100, 200, 300 u 400 mg).
English: The full EPAR for Trobalt 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: This is a summary of the European public assessment report (EPAR) for Trobalt.
Maltese: Dan huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Trobalt.
English: The active substance in Trobalt, retigabine, is an anti-epileptic medicine.
Maltese: Is-sustanza attiva fi Trobalt, ir-retigabina, hija mediċina antiepilettika.
English: Trobalt is a medicine that contains the active substance retigabine.
Maltese: Trobalt huwa mediċina li fiha s-sustanza attiva retigabina.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Trobalt on 28 March 2011.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Trobalt valida fl-Unjoni Ewropea kollha fit-28 ta' Marzu 2011.
English: This will stop further transmission of electrical impulses thereby preventing epileptic seizures.
Maltese: Dan iwaqqaf aktar trasmissjoni ta' impulsi elettriċi u b'hekk jipprevjeni aċċessjonijiet epilettiċi.
English: The recommended maintenance dose is between 600 mg a day and a maximum of 1,200 mg a day.
Maltese: Id-doża ta' manteniment rakkomandata hija bejn 600 mg kuljum u massismu ta' 1,200 mg kuljum.
English: In the second study, seizures were at least halved in 39% (61 out of 158 patients) of the patients on 600 mg Trobalt a day and in 47% (70 out of 149 patients) of the patients on 900 mg a day, compared with 19% (31 out of 164) of the patients on placebo.
Maltese: Fit-tieni studju, l-aċċessjonijiet tnaqqsu mill-anqas bin-nofs f'39% (61 minn 158 pazjent) tal-pazjenti b'600 mg Trobalt kuljum u b'47% (70 minn 149 pazjent) tal-pazjenti b'900 mg kuljum, meta mqabbel ma' 19% (31 minn 164) tal-pazjenti bil-plaċebo.
English: Trobalt has been compared with placebo (a dummy treatment) in three main studies involving a total of 1,244 patients whose seizures were not adequately controlled with other anti-epileptic medicines.
Maltese: Trobalt tqabbel ma' plaċebo (trattament finta) fi tliet studji ewlenin li involvew total ta' 1,244 pazjent li l-aċċessjonijiet tagħhom ma ġewx ikkontrollati b'mod adegwat b'mediċini oħra antiepilettiċi.
English: This compared with a reduction of 13% in the placebo group.
Maltese: Dan tqabbel ma' tnaqqis ta' 13% fil-grupp tal-plaċebo.
English: The company that makes Trobalt must ensure that doctors who are expected to prescribe Trobalt receive an information pack containing important safety information, including information on the risk of pigment changes in the eye and discolouration of the nails, lips and skin, and on the need for a full eye examination at the start of treatment and at least every 6 months during treatment.
Maltese: Il-kumpanija li tipproduċi Trobalt trid tassigura li t-tobba li huma mistennija jippreskrivu Trobalt jingħataw pakkett ta' informazzjoni li fih informazzjoni importanti dwar is-sigurtà, inkluża informazzjoni fuq ir-riskju tal-bidliet fil-pigmentazzjoin fl-għajn u d-diskolorament tad-dwiefer, ix-xufftejn u l-ġilda, u fuq l-importanza ta' eżami tal-għajnejn fil-bidu tal-kura u mill-inqas kull sitt xhur matul il-kura.
English: The CHMP noted that Trobalt is effective at reducing the number of seizures.
Maltese: Is-CHMP innota li Trobalt huwa effettiv fit-tnaqqis tan-numru ta' aċċessjonijiet.
English: In the third study, seizures were at least halved in 56% (66 out of 119 patients) of the patients taking 1,200 mg Trobalt a day, compared with 23% (31 out of 137) of the patients on placebo.
Maltese: Fit-tielet studju, l-aċċessjonijiet tnaqqsu mill-anqas bin-nofs f'56% (66 minn 119-il pazjent) tal-pazjenti li ħadu 1,200 mg Trobalt kuljum, meta mqabbel ma' 23% (31 minn 137) tal-pazjenti bil-plaċebo.
English: Epilepsy is caused by excessive electrical activity in the nerve cells of the brain.
Maltese: L-epilessija tiġi kkawżata millattività elettrika eċċessiva fiċ-ċelloli tan-nervituri tal-moħħ.
English: What is Trobalt?
Maltese: X'inhu Trobalt?
English: The effect of Trobalt at 600 mg a day was inconclusive in this study.
Maltese: Leffett ta' Trobalt b'600 mg kuljum kien inkonklussiv f'dan l-istudju.
English: In the first study, Trobalt at 900 mg a day and 1,200 mg a day was more effective than placebo and reduced the number of seizures per month by 29% and 35% respectively.
Maltese: Fl-ewwel studju, Trobalt b'900 mg kuljum u 1,200 mg kuljum kien aktar effettiv mill-plaċebo u n-numru ta' aċċessjonijiet kull xahar tnaqqsu b'29% u 35% rispettivament.
English: Trobalt is used in combination with other anti-epileptic medicines to treat adults with drug-resistant partial-onset seizures (epileptic fits) that cannot be treated with other combinations of medicines.
Maltese: Trobalt jintuża flimkien ma' mediċini antiepilettiċi oħra fil-kura ta' adulti b'aċċessjonijiet parzjali fil-bidu reżistenti għall-mediċina (attakki ta' epilessija) li ma jistgħux ikunu kkurati b' mediċini oħra.
English: Trobalt at a maintenance dose of 600, 900 or 1,200 mg a day or placebo was taken for 8 weeks in the first study and 12 weeks in the other two studies.
Maltese: Bħala doża ta' manteniment ta' Trobalt 600, 900 jew 1,200 mg kuljum jew plaċebo, Trobalt ingħata għal 8 ġimgħat fl-ewwel studju u għal 12-il ġimgħa fiż-żewġ studji l-oħrajn.
English: What is the risk associated with Trobalt?
Maltese: X'inhu r-riskju assoċjat ma' Trobalt?
English: It is used in epilepsy with or without ‘secondary generalisation' (when the excessive electrical activity reaches the whole brain).
Maltese: Jintuża għall-epilessija bi jew mingħajr 'ġeneralizzazzjoni sekondarja' (meta l-attività eċċessiva elettrika tilħaq il-moħħ kollu).
English: Trobalt acts by keeping the potassium channels open.
Maltese: Trobalt jaġixxi billi jħalli l-kanali talpotassju miftuħin.
English: It will also include information on some less common side effects that have been reported with the medicine, such as problems with passing urine, prolonged QT interval (an alteration of the electrical activity of the heart) and hallucinations (seeing or hearing things that are not there).
Maltese: Din linformazzjoni trid tinkludi wkoll tagħrif fuq effetti sekondarji inqas magħrufa li ġew irrapportati bilmediċina, bħall-problemi biex tagħmel l-awrina, intervall QT imtawwal (altrazzjoni tal-attività elettrika tal-qalb) u alluċinazzjonijiet (tara jew tisma' affarijiet li mhumiex preżenti).
English: How has Trobalt been studied?
Maltese: Kif ġie studjat Trobalt?
English: The most common side effects with Trobalt (seen in more than 1 patient in 10) are dizziness, somnolence (sleepiness), fatigue (tiredness) as well as pigment changes (discolouration) of parts of the eye (including the retina, the light sensitive membrane at the back of the eye) and discolouration of the nails, lips and skin, which have been reported after several years of treatment.
Maltese: L-effetti sekondarji l-aktar komuni bi Trobalt (li dehru f'aktar minn pazjent 1 minn 10) huma l-isturdament, il-ħedla tan-ngħas, l-għeja kif ukoll bidla fil-pigmentazzjoni (diskolorazzjoni)
English: Why has Trobalt been approved?
Maltese: Għaliex ġie approvat Trobalt?
English: For more information on how to use Trobalt, including detailed recommendations for different patients groups, see the summary of product characteristics (also part of the EPAR).
Maltese: Għal aktar informazzjoni dwar kif jintuża Trobalt, inklużi rakkomandazzjonijiet dettaljati għal gruppi ta' pazjenti differenti, ara s-sommarju tal-karatteristiċi tal-prodott (huwa parti wkoll mill-EPAR).
English: What measures are being taken to ensure the safe use of Trobalt?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi assigurat l-użu bla periklu ta' Trobalt?
English: For the full list of all side effects reported with Trobalt, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrapportati bi Trobalt, ara l-Fuljett ta' Tagħrif.
English: The CHMP decided that the benefits of Trobalt are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' Trobalt huma akbar mir-riskji tiegħu u rrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: Lower doses should be used in older patients and in patients with moderate or severe liver or kidney problems.
Maltese: Għandhom jintużaw dożi aktar baxxi f'pazjenti akbar fl-età u f'pazjenti bi problemi moderati jew severi tal-fwied jew tal-kliewi.
English: This is a type of epilepsy where too much electrical activity in one part of the brain causes symptoms such as sudden, jerky movements of one part of the body, distorted hearing, sense of smell or vision, numbness or a sudden sense of fear.
Maltese: Din hija tip ta' epilessija fejn ħafna attività elettrika f'naħa waħda tal-moħħ tikkawża sintomi bħalma huma movimenti għall-għarrieda, mimlija skossi ta' naħa minnhom tal-ġisem, sens ta' smigħ, xamm jew viżta mhux ċar, tgħarix jew sens ta' biża' għall-għarrieda.
English: Treatment with Trobalt starts with one 100 mg tablet three times a day for one week; the dose is then increased weekly by 50 mg per dose according to the patient's response.
Maltese: Il-kura bi Trobalt tibda b'pillola waħda ta' 100 mg tliet darbiet kuljum għal ġimgħa; imbagħad id-doża tiżdied kull ġimgħa b'50 mg kull doża skont ir-rispons tal-pazjent.
English: Veltassa EMA/333696/2017
Maltese: EMA/333696/2017
English: The full EPAR for Veltassa 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: Veltassa contains the active substance patiromer.
Maltese: Veltassa fih is-sustanza attiva patiromer.
English: Veltassa patiromer
Maltese: Veltassa
English: Veltassa is available as sachets (8.4, 16.8 and 25.2 g) of patiromer containing a powder for mixing with water or some fruit juices and taking by mouth.
Maltese: Veltassa jiġi bħala qratas (8.4, 16.8 u 25.2 g) ta' patiromer li fihom trab biex jitħallat mal-ilma jew xi ftit meraq tal-frott u li jittieħdu mill-ħalq.
English: Why is Veltassa approved?
Maltese: Għaliex ġie approvat Veltassa?
English: This summary was last updated in 05/2017.
Maltese: Id-doża massima hija ta' 25.
English: The recommended starting dose is 8.4 g once a day.
Maltese: Id-doża tal-bidu rakkomandata hija ta' 8.4 g darba kuljum.
English: In the first part of the study, 243 patients with hyperkalaemia (with average potassium level of 5.6 mmol/litre) were treated with Veltassa.
Maltese: Fl-ewwel parti tal-istudju, 243 pazjent bl-iperkalimja (b'livell medju ta' potassju ta' 5.6 mmol/litru) ġew ikkurati b'Veltassa.
English: Other information about Veltassa
Maltese: Informazzjoni oħra dwar Veltassa