FrancophonIA/ELRC3.0 huggingface dataset:
English: When it is given with other cancer medicines, the dose is always 200 mg every three weeks.
Maltese: Meta jingħata ma' mediċini oħra kontra lkanċer, id-doża dejjem hija ta' 200 mg kull tliet ġimgħat.
English: Recombinant lipidated fHbp (factor H binding protein) Produced in Escherichia coli cells by recombinant DNA technology Adsorbed on aluminium phosphate (0.25 milligram aluminium per dose)
Maltese: fHbp lipidat rikombinanti (irbit ta' proteina ta' fattur H) Prodott f'ċelloli Escherichia coli minn teknoloġija ta' DNA rikombinanti Adsorbit fuq fosfat tal-aluminju (0.25 milligramma ta' aluminju kull doża)
English: Neisseria meningitidis serogroup B fHbp subfamily A
Maltese: Neisseria meningitidis serogrupp B fHbp tas-sottofamilja A
English: --1 1 dose (0.5 ml) contains:
Maltese: 1 Doża waħda (0.5 ml) fiha:
English: Neisseria meningitidis serogroup B fHbp subfamily B
Maltese: Neisseria meningitidis serogrupp B fHbp tas-sottofamilja B
English: The most common side effects with Litak (seen in more than 1 patient in 10) are infections, pancytopenia or myelosuppression (low blood cell counts), purpura (bruising), immunosuppression (a weakened immune system), decreased appetite, headache, dizziness, abnormal breath and chest sounds, cough, nausea (feeling sick), vomiting, constipation, diarrhoea, rash, localised exanthema (skin eruptions), diaphoresis (excessive sweating), injection site reactions (pain and inflammation at the site of injection), fever, fatigue (tiredness), chills and asthenia (weakness).
Maltese: L-iktar effetti sekondarji komuni ta' Litak (li dehru f'bejn pazjent wieħed u għaxra minn kull mija) huma l-infezzjonijiet, panċitopenija jew mjelosuppressjoni (għadd baxx ta' ċelloli tad-demm), tbenġil, immunosuppressjoni (sistema immunitarja mdgħajfa), tnaqqis fl-aptit, uġigħ ta' ras, sturdament, nifs u ħsejjes tan-nifs anormali, sogħla, nawżea (dardir), remettar, stitikezza, dijarrea, raxx, eżantema lokalizzata (disturbi ta' raxx fil-ġilda), djaforeżi (għaraq eċċessiv), reazzjonijiet fis-sit tal-injezzjoni (uġigħ u infjammazzjoni fis-sit tal-injezzjoni), deni, għeja kbira, tertir tal-bard u astenija (dgħufija).
English: Cladribine is an ‘analogue' of purine (a substance that has a similar chemical structure to purine).
Maltese: Cladribine huwa ‘analogu' ta' purine (sustanza li għandha struttura kimika simili għal purine).
English: In the main study, 97% of the patients had either complete or partial remission (60 out of 62), and 76% had complete remission (47 out of 62).
Maltese: Fl-istudju ewlieni, 97% tal-pazjenti kellhom remissjoni kompleta jew parzjali (60 minn 62), u 76% kellhom remissjoni kompleta (47 minn 62).
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) LITAK EPAR summary for the public
Maltese: RAPPORT PUBBLIKU EWROPEW TA' VALUTAZZJONI (EPAR) LITAK Sommarju tal-EPAR għall-pubbliku
English: The European Commission granted a marketing authorisation valid throughout the EU for Litak to Lipomed GmbH on 14 April 2004.
Maltese: Il-Kummissjoni Ewropea tat l-awtorizzazzjoni għat-tqegħid fis-suq għal Litak valida fl-Unjoni Ewropea kollha lil Lipomed GmbH fl-14 ta' April 2004.
English: Other information about Litak:
Maltese: Tagħrif ieħor dwar Litak:
English: It belongs to the group of anticancer medicines called ‘antimetabolites'.
Maltese: Tifforma parti mill-grupp ta' mediċini ta' kontra l-kanċer magħrufa bħala ‘antimetaboliti'.
English: The summary of opinion of the Committee for Orphan Medicinal Products for Litak is available here.
Maltese: Is-sommarju tal-opinjoni tal-Kumitat għall-Prodotti Mediċinali Orfni għal Litak huwa disponibbli minn hawnhekk.
English: The recommended dose is 0.14 mg per kilogram body weight, once a day for five days.
Maltese: Id-doża rakkomandata hija ta' 0.14 mg għal kull kilogramma li jiżen il-pazjent, darba kuljum għal ħamest ijiem.
English: Cladribine has been in use in anticancer medicines since the 1980s and it has been available as an intravenous infusion (drip into a vein) in some European Union (EU) Member States since 1993.
Maltese: Cladribine ilu jintuża bħala mediċina ta' kontra l-kanċer mis-snin tmenin u ilu disponibbli bħala infużjoni intravenuża (dripp fil-vina) f'xi Stati Membri tal-Unjoni Ewropea (UE) mill-1993.
English: Purine is one of the fundamental chemicals that make up DNA.
Maltese: Purine huwa wieħed mis-sustanzi kimiċi fundamentali li jiffurmaw id-DNA.
English: Litak is a solution for injection that contains the active substance cladribine.
Maltese: Litak huwa soluzzjoni għall-injezzjoni li fiha s-sustanza attiva cladribine.
English: The marketing authorisation was renewed on 14 April 2009.
Maltese: L-awtorizzazzjoni għat-tqegħid fis-suq ġiet imġedda fl-14 ta' April 2009.
English: What is the risk associated with Litak?
Maltese: X'inhu r-riskju assoċjat ma' Litak?
English: Why has Litak been approved?
Maltese: Għaliex ġie approvat Litak?
English: The active substance in Litak, cladribine, is a cytotoxic, a medicine that kills cells that are dividing, such as cancer cells.
Maltese: Is-sustanza attiva f'Litak, cladribine, hija ċitotossika, mediċina li toqtol iċ-ċelloli li jkunu qed jinqasmu, bħaċ-ċelloli tal-kanċer.
English: What is Litak?
Maltese: Kif jaħdem Litak?
English: In the body, cladribine is converted within lymphocytes into a chemical called CdATP, which interferes with the production of new DNA.
Maltese: Filġisem, cladribine jinbidel fil-linfoċiti stess biex isir sustanza kimika magħrufa bħala CdATP, li jinterferixxi mal-produzzjoni ta' DNA ġdid.
English: Because the number of patients with hairy cell leukaemia is low, the disease is considered ‘rare', and Litak was designated an ‘orphan medicine' (a medicine used in rare diseases) on 18 September 2001.
Maltese: Billi l-għadd ta' pazjenti bil-lewċemija fiċ-ċelloli bix-xagħar huwa wieħed żgħir, il-marda hija kkunsidrata ‘rari', u Litak ġie kklassifikat bħala ‘mediċina orfni' (mediċina għal mardiet rari) fit-18 ta' Settembru 2001.
English: Because cladribine has been used for a number of years, the company presented data from the published literature.
Maltese: Billi cladribine ilu jintuża għal għadd ta' snin, il-kumpanija ppreżentat dejta mil-letteratura ppubblikata.
English: How does Litak work?
Maltese: Kif ġie studjat Litak?
English: Litak has been examined in one main study involving 63 adults with hairy cell leukaemia.
Maltese: Litak ġie eżaminat fi studju wieħed ewlieni bis-sehem ta' 63 adult bil-lewċemija taċċelloli bix-xagħar.
English: For the full list of all side effects reported with Litak, see the Package Leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji rrappurtati ma' Litak, ara l-Fuljett ta' Tagħrif.
English: Litak is used to treat adults with hairy cell leukaemia, a cancer of blood in which too many B-lymphocytes (a type of white blood cell) are produced.
Maltese: Litak jintuża fit-trattament ta' adulti li jkollhom lewċemija fiċ-ċelloli bix-xagħar, kanċer tad-demm li fih jiġu prodotti ħafna linfoċiti-B (tip ta' ċelloli tad-demm bojod).
English: The term ‘hairy cell' refers to the hair-like projections that can be seen on the surface of the lymphocytes when they are examined under a microscope.
Maltese: It-terminu ‘ċelloli bix-xagħar' jirreferi għal projezzjonijiet qishom xagħar li jidhru fuq l-uċuh tal-linfoċiti meta dawn jiġu eżaminati taħt mikroskopju.
English: Patients can inject themselves once they have been trained appropriately.
Maltese: Dan ma jħallix liċ-ċelloli jinqasmu, u b'hekk inaqqas ilprogressjoni tal-lewċemija.
English: Litak must not be used during pregnancy or breast-feeding, in patients less than 18 years of age, in patients with moderate to severe kidney or liver disease or in combination with other medicines that reduce the production of blood cells.
Maltese: Litak m'għandux jintuża waqt it-tqala jew waqt it-treddigħ, f'pazjenti ta' inqas minn 18-il sena, f'pazjenti b'mard moderat jew sever tal-kliewi jew tal-fwied jew flimkien ma' mediċini oħra li jnaqqsu l-produzzjoni ta' ċelloli tad-demm.
English: It should be used with caution in patients over 65 years of age, with frequent monitoring of blood counts, the liver and the kidneys.
Maltese: Għandu jintuża b'kawtela f'pazjenti ta' iktar minn 65 sena, b'monitoraġġ frekwenti tal-valuri tad-demm, tal-fwied u tal-kliewi.
English: Bipolar disorder
Maltese: Disturb bipolari
English: With respect to quality aspects,
Maltese: Fir-rigward tal-aspetti tal-kwalità,
English: London, 23 July 2008 Doc.
Maltese: Londra, 23 ta' Lulju 2008 Dok. Ref.
English: Ref. EMEA/CHMP/212114/2008
Maltese: EMEA/476663/2008
English: Lamictal and associated names, 25 mg, 50 mg, 100 mg, 200 mg tablet and 2 mg, 5 mg, 25 mg, 50 mg, 100 mg, 200 mg, dispersible / chewable tablet, is an antiepileptic drug, used for the treatment of epilepsy and Bipolar Disorder.
Maltese: Lamictal u ismijiet assoċjati, pilloli ta' 25 mg, 50 mg, 100 mg, 200 mg u pilloli li jdubu / li jintmagħdu ta' 2 mg, 5 mg, 25 mg, 50 mg, 100 mg, 200 mg, huwa mediċina antiepilettika, użata għat-trattament tal-epilessija u ta' Disturbi Bipolari.
English: Adults 18 years and above
Maltese: Adulti ta' 18-il sena u ‘l fuq
English: On 1 March 2007, GlaxoSmithKline Research & Development Limited presented to the EMEA a referral under Article 30 of Directive 2001/83/EC, as amended, in order to harmonise the nationally authorised Summaries of Product Characteristics (SPC), Labelling and Package Leaflet including quality aspects of the medicinal product Lamictal and associated names.
Maltese: Fl-1 ta' Marzu 2007, GlaxoSmithKline Research & Development Limited ippreżenta referenza skont l-Artikolu 30 tad-Direttiva 2001/83/KE, kif emendata, lill-EMEA, sabiex jiġu armonizzati s-Sommarji tal-Karatteristiċi tal-Prodott (SPC), it-Tikketta u l-Fuljett ta' Tagħrif awtorizzati fuq livell nazzjonali inkluż l-aspetti ta' kwalità tal-prodott mediċinali Lamictal u ismijiet assoċjati.
English: The Marketing Authorisation Holder provided supplementary information on 16 October 2007.
Maltese: Id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq ipprovda tagħrif supplimentari fis-16 ta' Ottubru 2007.
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 30 REFERRAL FOR Lamictal and associated names International Non-Proprietary Name (INN): lamotrigine
Maltese: GĦALL-UŻU MILL-BNIEDEM (CHMP) OPINJONI WARA REFERENZA SKONT L-ARTIKOLU 30 GĦAL Lamictal u ismijiet assoċjati Denominazzjoni Komuni Internazzjonali (DKI): lamotrigine
English: The procedure started on 29 March 2007.
Maltese: Il-proċedura nbdiet fid-29 ta' Marzu 2007.
English: The excipients used in the formulations of the drug product and manufacturing processes are standard for the proposed pharmaceutical forms.
Maltese: Is-sustanzi mhux attivi użati fil-formolazzjonijiet tal-prodott mediċinali u l-proċessi ta' manifattura huma standard għall-forom farmaċewtiċi proposti.
English: Lamictal is indicated as adjunctive therapy in the treatment of epilepsy, for partial seizures and generalised seizures including tonic-clonic seizures and the seizures associated with Lennox-Gastaut Syndrome.
Maltese: Lamictal huwa indikat bħala terapija aġġuntiva fit-trattament tal-epilessija, għal attakki ta' puplesija parzjali u attakki ta' puplesija ġeneralizzati inkluż attakki ta' puplesija toniċi-kloniċi u attakki ta' puplesija assoċjati mas-Sindrome ta' Lennox-Gastaut.
English: Adults and children above 12 years
Maltese: Adulti u tfal ta' ‘l fuq minn 12-il sena
English: Lamictal is indicated for the prevention of mood episodes in patients with bipolar disorder, predominantly by preventing depressive episodes.
Maltese: Lamictal huwa indikat għall-prevenzjoni ta' episodji ta' burdati f'pazjenti b'disturb bipolari, l-iktar billi jimpedixxi episodji dipressivi.
English: Lamictal is indicated for use as adjunctive or monotherapy in the treatment of epilepsy, for partial seizures and generalised seizures, including tonic-clonic seizures and the seizures associated with Lennox-Gastaut Syndrome.
Maltese: Lamictal huwa indikat sabiex jintuża bħala terapija aġġuntiva jew bħala monoterapija fit-trattament tal-epilessija, għal attakki ta' puplesija parzjali u attakki ta' puplesija ġeneralizzati inkluż attakki ta' puplesija toniċi-kloniċi u attakki ta' puplesija assoċjati mas-Sindrome ta' Lennox-Gastaut.
English: Children 2 to 12 years
Maltese: Tfal ta' bejn sentejn u 12-il sena
English: The CHMP gave a positive opinion on 24 April 2008 recommending the harmonisation of the SPC, Labelling and Package Leaflet including quality aspects for Lamictal and associated names.
Maltese: Is-CHMP ta opinjoni pożittiva fl-24 ta' April 2008, u rrakkomanda l-armonizzazzjoni tal-SPC, itTikketta u l-Fuljett ta' Tagħrif inkluż l-aspetti ta' kwalità għal Lamictal u ismijiet assoċjati.
English: After epileptic control has been achieved during adjunctive therapy, concomitant antiepileptic drugs (AEDs) may be withdrawn and patients continued on Lamictal monotherapy.
Maltese: Wara li jkun inkiseb kontroll epilettiku matul terapija aġġuntiva, mediċini antiepilettiċi konkomittanti (AEDs) jistgħu jiġu rtirati u l-pazjenti jistgħu jitkomplew fuq monoterapija b'Lamictal.
English: The basis for referral was that there were divergences in the Summaries of Product Characteristics (SPC) including quality aspects of Lamictal and associated names approved across EU Member States, with respect to the indication,
Maltese: Il-bażi għar-referenza kienet li kien hemm diverġenzi fis-Sommarji tal-Karatteristiċi tal-Prodott (SPC) inkluż l-aspetti tal-kwalità ta' Lamictal u l-ismijiet assoċjati approvati madwar l-Istati Membri tal-UE, fir-rigward tal-indikazzjoni.
English: The drug substance and the drug product have been appropriately described and generally satisfactory documentation has been provided.
Maltese: Is-sustanza mediċinali u l-prodott mediċinali ġew deskritti b'mod xieraq u b'mod ġenerali, ġiet ipprovduta dokumentazzjoni sodisfaċenti.
English: Further information on Evant can be found on the Agency's website: ema.europa.eu/Find medicine/veterinary/EPAR/evant.
Maltese: Aktar informazzjoni dwar Evant tinstab fis-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/veterinary/EPAR/evant.
English: Other information about Evant
Maltese: Informazzjoni oħra dwar Evant
English: Evant is a vaccine.
Maltese: Evant huwa vaċċin.
English: Evant is a veterinary vaccine used to protect chickens against coccidiosis caused by the coccidia parasites Eimeria acervulina, Eimeria maxima, Eimeria mitis, Eimeria praecox and Eimeria tenella.
Maltese: Evant huwa vaċċin veterinarju użat biex jipproteġi t-tiġieġ kontra koċċidjożi kkawżat mill-parassiti coccidia Eimeria acervulina, Eimeria brunetti, Eimeria maxima, Eimeria necatrix u Eimeria tenella.
English: Evant received a marketing authorisation valid throughout the EU on 5 February 2019.
Maltese: Evant ingħata awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fil-5 ta' Frar 2019.
English: Evant (avian coccidiosis vaccine, live) EMA/893808/2018
Maltese: EMA/893808/2018
English: This overview was last updated in December 2018.
Maltese: Din il-ħarsa ġenerali ġiet aġġornata l-aħħar f'Diċembru 2018.
English: What are the risks associated with Evant?
Maltese: X'inhuma r-riskji assoċjati ma' Evant?
English: This will help protect against coccidiosis.
Maltese: Dan jgħin jipproteġi kontra l-koċċidjożi.
English: The vaccine contains live attenuated (weakened) oocysts of Eimeria acervulina, Eimeria maxima, Eimeria mitis, Eimeria praecox and Eimeria tenella.
Maltese: Il-vaċċin fih ooċisti (imdgħajfa) attenwati ħajjin ta' Eimeria acervulina, Eimeria brunetti, Eimeria maxima, Eimeria necatrix u Eimeria tenella.
English: How is Evant used?
Maltese: Kif jaħdem Evant?
English: In the future if the animals are exposed to the same Eimeria species the immune system will be able to respond more quickly.
Maltese: Jekk fil-futur lannimali jkunu esposti għall-istess speċijiet Eimeria, is-sistema immunitarja tkun kapaċi tirreaġixxi aktar malajr.
English: The vaccine solvent contains the adjuvant montanide IMS to enhance the immune response.
Maltese: Is-solvent tal-vaċċin fih ukoll l-aġġuvant montanide IMS sabiex itejjeb ir-rispons immunitarju.
English: The studies showed Evant reduced damage to the gut and oocysts in the faeces for each Eimeria species and that it reduced diarrhoea caused by Emeria acervulina, Eimeria maxima and Eimeria tenella.
Maltese: L-istudji wrew li Evant naqqas il-ħsara fl-imsaren u l-ooċisti flippurgar għal kull speċi Eimeria u li naqqas id-dijarea kkawżata minn Emeria acervulina, Eimeria maxima u Eimeria tenella.
English: Infected birds shed disease spores (oocysts) in their faeces that can spread the infection.
Maltese: Għasafar infettati jwaqqgħu spori tal-mard (ooċisti) flippurgar tagħhom li jistgħu jferrxu l-infezzjoni.
English: It is available as tablets containing 75 mg and 100 mg eluxadoline.
Maltese: Jiġi bħala pilloli li fihom 75 mg u 100 mg eluxadoline.
English: In the second study symptoms improved in 33% (125 out of 382) of patients taking Truberzi 100 mg twice a day compared with 20% (77 out of 382) of patients taking placebo.
Maltese: Fit-tieni studju ssintomi tjiebu fi 33% (125 minn 382) ta' pazjenti li jieħdu Truberzi 100 mg darbtejn kuljum imqabbla ma' 20% (77 minn 382) ta' pazjenti li jieħdu l-plaċebo.
English: Truberzi must not be given to patients treated with a class of medicines known as potent OATP1B1 inhibitors (such as ciclosporin, a medicine that works on the immune system).
Maltese: Truberzi ma jistax jingħata lil pazjenti kkurati bi klassi ta' mediċini magħrufa bħala inibituri OATP1B1 potenti (bħal ciclosporin, mediċina li taħdem fuq is-sistema tal-immunità).
English: This is a summary of the European public assessment report (EPAR) for Truberzi.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Truberzi.
English: In the first study effectiveness was shown in 29% (125 out of 426) of patients taking Truberzi 100 mg twice a day compared with 19% (81 out of 427) in patients taking placebo.
Maltese: Fl-ewwel studju l-effettività ġiet murija f'29% (125 minn 426) tal-pazjenti li jieħdu Truberzi 100 mg darbtejn kuljum imqabbla ma' 19% (81 minn 427) fil-pazjenti li jieħdu l-plaċebo.
English: Eluxadoline, the active substance in Truberzi, is an opioid receptor agonist.
Maltese: Eluxadoline, is-sustanza attiva fi Truberzi, huwa agonist tar-riċettur opjojd.
English: Why is Truberzi approved?
Maltese: Għaliex ġie approvat Truberzi?
English: Truberzi contains the active substance eluxadoline.
Maltese: Truberzi fih is-sustanza attiva eluxadoline.
English: What are the risks associated with Truberzi?
Maltese: X'inhuma r-riskji assoċjati ma' Truberzi?
English: Truberzi was evaluated in two main studies involving over 2,400 patients with irritable bowel syndrome with diarrhoea.
Maltese: Truberzi ġie evalwat f'żewġ studji ewlenin li jinvolvu ‘l fuq minn 2,400 pazjent bis-sindromu talimsaren irritabbli bid-dijarea.
English: It is used for the treatment of adults who have irritable bowel syndrome with diarrhoea.
Maltese: Huwa użat għall-kura ta' adulti li għandhom sindromu tal-imsaren irritabbli bid-dijarea.
English: Serious side effects include pancreatitis (inflammation of the pancreas) and sphincter of Oddi spasm (a painful condition in which bile and digestive juices are blocked from flowing into the gut).
Maltese: Effetti sekondarji serji jinkludu pankreatite (infjamazzjoni talfrixa) u l-ispażmu fl-isfinkter ta' Oddi (kundizzjoni ta' uġigħ li fiha l-likwidu tal-marrara u l-likwidi taddiġestjoni jiġu mblukkati milli jiċċirkolaw fil-musrana).
English: Other information about Truberzi
Maltese: Informazzjoni oħra dwar Truberzi:
English: Irritable bowel syndrome is a long-term disorder of the gut with pain or discomfort in the abdomen (belly), bloating and altered bowel habit.
Maltese: Is-sindromu tal-imsaren irritabbli hija disturb fit-tul talmusrana b'uġigħ jew skumdità fl-addome (żaqq), infieħ u funzjoni alterata tal-musrana.
English: Truberzi is a medicine that acts on the digestive system.
Maltese: Truberzi huwa mediċina li taħdem fuq is-sistema diġestiva.
English: The full EPAR for Truberzi 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 Għal aktar informazzjoni rigward il-kura bi Truberzi, aqra l-fuljett ta' tagħrif (parti wkoll mill-EPAR) jew ikkuntattja lit-tabib jew lill-ispiżjar tiegħek.
English: Truberzi must not be given to patients with liver disorders, those at risk of pancreatitis (such as those who have had problems with their pancreas or who drink alcohol excessively), patients whose gall bladders have been removed or who have disorders affecting secretion of bile into the gut, and those who have had severe or long-term constipation or blocked bowel.
Maltese: Truberzi ma jistax jingħata lil pazjenti b'disturbi fil-fwied, dawk li huma f'riskju ta' pankreatite (bħal dawk li kellhom problemi bil-frixa tagħhom jew li jixorbu l-alkoħol b'mod eċċessiv), pazjenti li l-marrara tagħhom tneħħiet jew li għandhom disturbi li jaffettwaw is-sekrezzjoni tal-likwidu tal-marrara filmusrana, u dawk li għandhom jew kellhom stitikezza severa jew fit-tul jew musrana mblokkata.
English: Because eluxadoline is not absorbed into the blood and distributed around the body, its effects are largely confined to the gut.
Maltese: Peress li eluxadoline mhuwiex assorbit fid-demm u distribut madwar il-ġisem, l-effetti tiegħu huma l-aktar limitati għall-musrana.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) considered that the benefits of Truberzi are modest but there is an unmet need for treatments of irritable bowel syndrome with diarrhoea.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) tal-Aġenzija kkonsidra li l-benefiċċji ta' Truberzi huma modesti imma hemm ħtieġa mhux sodisfatta għal trattamenti tas-sindromu talmusrana irritabbli bid-dijarea.
English: In both studies Truberzi was compared with placebo (a dummy treatment) over 26 weeks of treatment during which patients kept a daily record of their irritable bowel syndrome symptoms.
Maltese: Fiż-żewġ studji Truberzi ġie mqabbel ma' plaċebo (kura finta) fuq 26 ġimgħa ta' kura li fihom il-pazjenti żammu rekord tas-sintomi tagħhom tas-sindromu tal-imsaren irritabbli.
English: In patients who get troublesome side effects, the dose can be reduced to 75 mg each morning and evening.
Maltese: F'pazjenti li jesperjenzaw effetti sekondarji inkwetanti, id-doża tista' titnaqqas għal 75 mg kull filgħodu u filgħaxija.
English: What measures are being taken to ensure the safe and effective use of Truberzi?
Maltese: X'miżuri qed jitteħdu biex jassiguraw l-użu sigur u effikaċi ta' Truberzi?
English: For the full list of all side effects of Truberzi, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u restrizzjonijiet kollha ta' Truberzi, ara l-fuljett ta' tagħrif.
English: How does Truberzi work?
Maltese: Kif jintuża Truberzi?
English: It is not intended to provide practical advice on how to use Truberzi.
Maltese: Dan mhux maħsub biex jipprovdi konsultazzjoni prattika dwar l-użu ta' Truberzi.
English: Effectiveness was measured as an improvement of over 30% in abdominal pain combined with an absence of very loose stool.
Maltese: L-effettività ġiet imkejla bħala titjib ta' ‘l fuq minn 30% f'uġigħ addominali meta mqabbel ma' nuqqas ta' ppurgar maħlul.
English: Side effects were mainly limited to the digestive system and mostly mild.
Maltese: L-effetti sekondarji kienu prinċipalment limitati għas-sistema diġestiva u fil-biċċa l-kbira moderati.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/18/226/001
Maltese: EU/2/18/226/001
English: Dextran-40
Maltese: Dekstran-40
English: Use a 20G needle.
Maltese: Uża labra ta' 20G.
English: Incompatibilities:
Maltese: Inkompatibilitajiet maġġuri:
English: Adenosine
Maltese: Adenożina
English: Industrial Ventorro del Cano
Maltese: Industrial Ventorro del Cano Alcorcón
English: Trolox (6-hydroxyl-2,5,7,8- tetramethylchroman-2-carboxylic acid) Water for injections
Maltese: Trolox (6-idrossil-2,5,7,8- tetrametilkroman-2-aċidu karbossiliku)