FrancophonIA/ELRC3.0 huggingface dataset:
English: The CHMP acknowledged that there are no alternative treatments for Niemann Pick type C disease, but it was concerned that a benefit of Zavesca in the treatment of the neurological symptoms of Niemann Pick type C disease had not been sufficiently demonstrated.
Maltese: Is-CHMP għaraf li ma hemmx trattamenti alternattivi għall-marda Niemann Pick tat-tip C, iżda kien imħasseb li ma kienx intwera xi benefiċċju ta' Zavesca b'mod suffiċjenti.
English: It is used for the treatment of mild to moderate type 1 Gaucher disease.
Maltese: Tintuża fit-trattament tal-marda ta' Gaucher tat-tip 1 minn ħafifa għal moderata.
English: The effectiveness of Zavesca has been studied in one main study involving 29 patients aged 12 years and over with Niemann Pick type C disease.
Maltese: L-effikaċja ta' Zavesca ġiet studjata fi studju wieħed ewlieni bis-sehem ta' 29 pazjent ta' 12-il sena jew iktar bil-marda Niemann Pick tat-tip C.
English: What is happening for Zavesca for the treatment of type 1 Gaucher disease?
Maltese: X'inhu jiġri b'Zavesca għat-trattament tal-marda ta' Gaucher tat-tip 1?
English: How is Zavesca expected to work?
Maltese: Kif huwa mistenni li taħdem Zavesca?
English: The effects of Zavesca were first tested in experimental models before being studied in humans.
Maltese: L-effetti ta' Zavesca għall-ewwel ġew ittestjati f'mudelli sperimentali qabel ma ġew studjati fuq ilbniedem.
English: Based on the review of the data and the company's response to the CHMP's list of questions, at the time of the withdrawal, the CHMP had given a negative opinion and did not recommend the approval of Zavesca for the treatment of neurological manifestations in patients with Niemann Pick type C disease.
Maltese: Abbażi ta' l-analiżi tad-dejta u t-tweġiba mogħtija mill-kumpanija għal-lista ta' mistoqsijiet tal-CHMP fi żmien l-irtar, is-CHMP kien ta opinjoni negattiva u ma rrakkomandax li tingħata l-awtorizzazzjoni għat-tqegħid fis-suq għal Zavesca għat-trattament ta' manifestazzjonijiet newroloġiċi f'pazjenti bilmarda Niemann Pick tat-tip C.
English: Zavesca was also linked to side effects affecting the stomach and gut, as well as cases of weight loss and thrombocytopenia (low blood platelet counts).
Maltese: Zavesca kienet relatata wkoll ma' l-effetti sekondarji li jaffettwaw l-istonku u l-imsaren, kif ukoll każijiet ta' telf ta' piż u tromboċitopenija (għadd baxx ta' platelets).
English: This is expected to reduce the symptoms of the disease.
Maltese: Dan mistenni jnaqqas is-sintomi tal-marda.
English: In patients with this disease, a fatty substance called glucosylceramide builds up in different parts of the body, such as the spleen, liver, and bones.
Maltese: F'pazjeti b'din il-marda, sustanza xaħmija magħrufa bħala glukosilċeramide (glucosylceramide) takkumula f'partijiet differenti tal-ġisem, bħall-milsa, il-fwied, u l-għadam.
English: The disease can result in dementia and is usually fatal before the patient has reached adulthood.
Maltese: Il-marda tista' twassal għad-demenza u ġeneralmant tkun fatali qabel ma l-pazjent isir adult.
English: Tygacil tigecycline
Maltese: Tygacil tigeċiklina
English: The full EPAR for Tygacil 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 summary was last updated in 05-2015.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar fi 05-2015.
English: This document is a summary of the European Public Assessment Report (EPAR) for Tygacil.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Tygacil.
English: It contains the active substance tigecycline.
Maltese: Fih is-sustanza attiva tigeċiklina.
English: An additional study compared Tygacil with the antibiotic ertapenem in 813 diabetic patients with moderate to severe foot infections.
Maltese: Studju addizzjonali qabbel Tygacil mal-antibijotiku ertapenem fi 813-il pazjent dijabetiku b'infezzjonijiet fis-saqajn minn moderati sa serji.
English: In adults, the recommended dose of Tygacil is a starting dose of 100 mg, followed by 50 mg every 12 hours for five to 14 days.
Maltese: Fl-adulti d-doża rakkomandata ta' Tygacil hija doża inizjali ta' 100 mg, segwita b'50 mg kull 12-il siegħa tul minn ħamest ijiem sa 14-il jum.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Tygacil on 24 April 2006.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Tygacil fl-24 ta' April 2006.
English: In children above eight years of age, treatment is only given after consulting with a doctor with appropriate experience in the management of infectious diseases, and should be given as an infusion over a period of 60 minutes.
Maltese: Fit-tfal minn tmien snin 'il fuq, il-kura tingħata biss wara konsultazzjoni ma' tabib b'esperjenza xierqa fl-amministrazzjoni ta' mard infettiv, u għandha tingħata bħala infużjoni f'perjodu ta' 60 minuta.
English: Each infusion should last between 30 and 60 minutes.
Maltese: Kull infużjoni għandha ddum bejn 30 u 60 minuta.
English: The active substance in Tygacil, tigecycline, belongs to a group of antibiotics called ‘glycylcyclines'.
Maltese: Is-sustanza attiva f'Tygacil, it-tigeċiklina, tagħmel parti minn grupp ta' antibijotiċi msejjaħ ‘gliċilċiklini'.
English: In the study looking at diabetic foot infections, Tygacil was less effective than ertapenem: 78% of the patients receiving Tygacil were cured, compared with 83% of those receiving ertapenem.
Maltese: Fl-istudju dwar l-infezzjonijiet dijabetiċi fis-saqajn, Tygacil kien anqas effikaċi mill-ertapenem: 78% tal-pazjenti li ngħataw Tygacil fiequ, apparagun ma' 83% ta' dawk li ngħataw l-ertapenem.
English: In two of these studies, Tygacil was compared with the combination of vancomycin and aztreonam in 1,129 patients with complicated skin and soft tissue infections (not including infected diabetic foot ulcers).
Maltese: Fi tnejn minn dawn l-istudji, Tygacil tqabbel mat-taħlita tal-vankomiċina u l-ażtreonam f'1,129 pazjent b'infezzjonijiet ikkumplikati fil-ġilda u fit-tessut artab (li ma jinkludux ulċeri dijabetiċi tas-saqajn infettati).
English: Why has Tygacil been approved?
Maltese: Għaliex ġie approvat Tygacil?
English: What is the risk associated with Tygacil?
Maltese: X'inhu r-riskju assoċjat ma' Tygacil?
English: The list of bacteria against which Tygacil is active can be found in the summary of product characteristics (also part of the EPAR).
Maltese: Il-lista ta' batterji li kontrihom Tygacil huwa attiv tinstab fissommarju tal-karatteristiċi tal-prodott (parti wkoll mill-EPAR).
English: In the other two studies, Tygacil was compared with imipenem/cilastatin (a combination of two medicines used together as an antibiotic) in 1,568 patients with complicated infections in the abdomen.
Maltese: Fiż-żewġ studji l-oħrajn, Tygacil tqabbel mal-imipenem/iċ-ċilastatina (taħlita ta' żewġ mediċini użati flimikien bħala antibijotiku) f'1,568 pazjent b'infezzjonijiet ikkumplikati fiż-żaqq.
English: In the studies of skin and soft tissue infections, around 86% of the patients receiving Tygacil were cured, compared with around 89% of those receiving vancomycin and aztreonam.
Maltese: Fl-istudji fuq linfezzjonijiet fil-ġilda u fit-tessut artab, madwar 86% tal-pazjenti li ngħataw Tygacil fiequ, apparagun ma' madwar 89% ta' dawk li ngħataw il-vankomiċina u l-ażtreonam.
English: In children from 12 to 18 years a dose of 50 mg is given every 12 hours for a period of 5 to 14 days.
Maltese: Fit-tfal ta' bejn 12 u 18-il sena doża ta' 50 mg tingħata kull 12-il siegħa għal perjodu ta' bejn 5 u 14-il jum.
English: In the studies of abdominal infection, around 86% of the patients receiving either Tygacil or imipenem/cilastatin were cured.
Maltese: Fl-istudji fuq l-infezzjoni fiż-żaqq, madwar 86% tal-pazjenti li ngħataw Tygacil jew l-imipenem/iċ-ċilastatina fiequ.
English: Treatment lasts from 5 to 14 days.
Maltese: Il-kura ddum minn 5 sa 14-il jum.
English: Although there are few data in children, studies suggest that Tygacil can be a treatment alternative for complicated skin and soft tissue or abdominal infections, with bacteria resistant to other antibiotics.
Maltese: Minkejja li hemm ftit data fit-tfal, l-istudji wrew li Tygacil jista' jkun kura alternattiva għal ġilda kkumplikata u t-tessut artab jew infezzjonijiet addominali, b'batterja reżistenti għal antibijotiċi oħra.
English: Patients allergic to tetracycline antibiotics may also be allergic to Tygacil.
Maltese: Il-pazjenti allerġiċi għall-antibijotiċi tetraċiklini jistgħu jkunu wkoll allerġiċi għal Tygacil.
English: The CHMP decided that Tygacil's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' Tygacil huma akbar mir-riskji tiegħu u għaldaqstant irrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: Tygacil is used to treat adults and children older than eight years with complicated infections of the skin and soft tissue (the tissue below the skin), but not foot infections in people with diabetes.
Maltese: Tygacil jintuża għall-kura ta' adulti u tfal ikbar minn tmien snin b'infezzjonijiet ikkumplikati tal-ġilda u t-tessut artab (it-tessut taħt il-ġilda), iżda mhux infezzjonijiet fis-saqajn f'persuni dijabetiċi).
English: In the four main studies, Tygacil was as effective as the comparator antibiotics.
Maltese: Fl-erba' studji prinċipali, Tygacil kien effikaċi daqs l-antibijotiċi kumparattivi.
English: In children from 8 to 12 years old a dose of 1.2 mg per kilogram body weight is given by infusion into a vein every twelve hours, up to a maximum dose of 50 mg every 12 hours.
Maltese: infużjoni fil-vina kull tnax-il siegħa, sa doża massima ta' 50 mg kull 12-il siegħa.
English: EMEA/H/C/792
Maltese: EMEA/H/C/792 RAPPORT TAL-VALUTAZZJONI
English: It is available as round, yellow tablets (2.5, 5, 7.5, 10, 15 and 20 mg) and as round, yellow ‘orodispersible' tablets (5, 7.5, 10, 15 and 20 mg).
Maltese: Huwa disponibbli bħala pilloli tondi, sofor (2.5, 5, 7.5, 10, 15 u 20 mg) u bħala pilloli ‘orodispersibbli' tondi u sofor (5, 7.5, 10, 15 u 20 mg).
English: This summary was last updated in 09-2008.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar fi: 09-2008.
English: Zalasta is a ‘generic medicine'.
Maltese: Zalasta huwa ‘mediċina ġenerika'.
English: The active substance in Zalasta, olanzapine, is an antipsychotic medicine.
Maltese: Is-sustanza attiva f''Zalasta, olanzapine, hija mediċina antipsikotika.
English: Zalasta is a medicine containing the active substance olanzapine.
Maltese: Zalasta huwa mediċina li fiha s-sustanza attiva olanzapine.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) ZALASTA EPAR summary for the public
Maltese: PUBBLIKA EWROPEW (EPAR) ZALASTA
English: The European Commission granted a marketing authorisation valid throughout the EU for Zalasta to KRKA, d.d., Novo mesto on 27 September 2007.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Zalasta lil KRKA, d.d., Novo mesto fit-27 ta' Settembru 2007.
English: The recommended starting dose of Zalasta depends on the disease being treated: 10 mg per day is used in schizophrenia and in the prevention of manic episodes, and 15 mg per day in the treatment of manic episodes, unless it is used with other medicines, in which case the starting dose can be 10 mg per day.
Maltese: Id-doża tal-bidu rrakomandata ta' Zalasta tiddependi mill-marda li tkun qed tiġi ttrattata: doża ta' 10 mg kuljum tintuża għall-iskiżofrenija u fil-prevenzjoni ta' każijiet manijaċi, u 15-il mg kuljum fittrattament ta' episodji manijaċi, sakemm ma tintużax ma' mediċini oħra, f'liema każ id-doża tal-bidu tista' tkun ta' 10 mg kuljum.
English: Why has Zalasta been approved?
Maltese: Għaliex ġie approvat Zalasta?
English: This means that Zalasta is similar to ‘reference medicines' already authorised in the European Union (EU) called Zyprexa and Zyprexa Velotab.
Maltese: Dan ifisser li Zalasta huwa simili għall-‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) li jisimhom Zyprexa u Zyprexa Velotab.
English: It is thought that olanzapine's beneficial effect is due to it blocking receptors for the neurotransmitters 5-hydroxytryptamine (also called serotonin) and dopamine.
Maltese: Hu maħsub li l-effett benefiku ta' olanzapine huwa dovut għall-imblokkar tar-riċetturi għan-newrotrażmettituri 5-idrossitripamina (5-hydroxytrypamine) (imsejħa wkoll serotonina) u dopamina.
English: If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
Maltese: Jekk tixtieq aktar informazzjoni abbażi tar-rakkomandazzjonijiet tas CHMP, aqra d-Diskussjoni Xjentifika (ukoll parti mill-EPAR).
English: Zalasta is also used to treat moderate to severe manic episodes (extremely high mood) in adults.
Maltese: Zalasta jintuża wkoll fittrattament ta' każijiet moderati jew severi tal-manija (burdata tajba b'mod estrem) fl-adulti.
English: For more information on generic medicines, see the question-and-answer document here.
Maltese: Għal aktar informazzjoni dwar il-mediċina ġenerika, ara d-dokument ta' mistoqsija u tweġiba tagħhom hawn.
English: Because Zalasta is a generic medicine, studies have been limited to tests to demonstrate that it is bioequivalent to the reference medicines (i.e. that the medicines produce the same levels of the active substance in the body).
Maltese: Minħabba li Zalasta huwa mediċina ġenerika, l-istudji ġew illimitati għall-testijiet biex jintwera illi huwa bijoekwivalenti għall-mediċini ta' referenza (jiġifieri li l-mediċini jipproduċu l-istess livelli ta' sustanza attiva fil-ġisem).
English: What is Zalasta?
Maltese: Kif jaħdem Zalasta?
English: Schizophrenia is a mental illness that has a number of symptoms including disorganised thinking and speech, hallucinations (hearing or seeing things that are not there), suspiciousness and delusions (mistaken beliefs).
Maltese: L-iskizofrenija hija marda mentali li għandha numru ta' sintomi, inkluż disturbi fil-ħsieb u fid-diskors, alluċinazzjonijiet (il-pazjent jisma' jew jara affarijiet li ma jeżistux), suspetti u delirji (ħsibijiet żbaljati).
English: It is known as an ‘atypical' antipsychotic because it is different from the older antipsychotic medicines that have been available since the 1950s.
Maltese: Hija magħrufa bħala antipsikotiku 'atipiku' minħabba li hija differenti mill-mediċini antipsikotiċi iktar antiki li ilhom disponibbli mill-ħamsinijiet.
English: Therefore, the CHMP's view was that, as for Zyprexa and Zyprexa Velotab, the benefit outweighs the identified risk.
Maltese: Għaldaqstant, il-fehma tas-CHMP kienet li, bħal f'Zyprexa u Zyprexa Velotab, il-benefiċċju jegħleb r-riskju identifikat.
English: How has Zalasta been studied?
Maltese: Kif ġie studjat Zalasta?
English: Other information about Zalasta:
Maltese: Tagħrif ieħor dwar Zalasta:
English: How does Zalasta work?
Maltese: Għal xiex jintuża Zalasta?
English: The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Zalasta has been shown to have comparable quality and to be bioequivalent to Zyprexa and Zyprexa Velotab.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) ikkunsidra li, b'mod konformi mal-ħtiġijiet ta' l-UE, ġie muri li Zalasta għandu kwalità komparabbli ma' u li hu bijoekwivlent għallZyprexa u Zyprexa Velotab.
English: What are the benefit and risk of Zalasta?
Maltese: X'inhu il-benefiċċju u r-riskju ta' Zalasta?
English: Since these neurotransmitters are involved in schizophrenia and bipolar disorder, olanzapine helps to normalise the activity of the brain, reducing the symptoms of these diseases.
Maltese: Billi dawn in-newrotrażmettituri għandhom sehem fliskiżofrenija u fid-disturbi bipolari, olanzapine jgħin fin-normalizzazzjoni ta' l-attività tal-moħħ, u b'hekk inaqqas is-sintomi ta' dawn il-mardiet.
English: Because Zalasta is a generic medicine and is bioequivalent to the reference medicines, its benefit and risk are taken as being the same as those of the reference medicines.
Maltese: Minħabba li Zalasta huwa mediċina ġenerika u huwa bijoekwivalenti għall-mediċini ta' referenza, ilbenefiċċju u r-riskju tiegħu huma meqjusa li huma l-istess bħal dawk tal-mediċini ta' referenza.
English: This disrupts signals transmitted between brain cells by ‘neurotransmitters', chemicals that allow nerve cells to communicate with each other.
Maltese: Dan ifixkel is-sinjali trażmessi bejn iċ-ċelloli tal-moħħ permezz tan-'newrotrasmettituri', sustanzi kimiċi li jippermettu liċċelloli tal-moħħ jikkomunikaw ma' xulxin.
English: It can also be used to prevent the recurrence of these episodes (when symptoms come back) in adults with bipolar disorder (a mental illness causing alternating periods of high mood and depression) who have responded to an initial course of treatment.
Maltese: Jista' wkoll jintuża sabiex jipprevjeni li dawn l-episodji jerġgħu ifeġġu (meta jerġa' jitfaċċaw is-sintomi) f'adulti b'disturbi bipolari (marda mentali b'perjodi li jalternaw bejn burdata tajba ħafna u depressjoni) u li jkunu rrispondew għal kors inizjali ta' trattament.
English: EMA/72796/2014 EMEA/H/C/000474
Maltese: EMEA/H/C/000474
English: The full EPAR for Ventavis 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: The recommended dose is 2.5 or 5 micrograms.
Maltese: Id-doża rakkomandata hija ta' 2.5 jew 5 mikrogrammi.
English: Ventavis is a medicine that contains the active substance iloprost.
Maltese: Ventavis huwa mediċina li fiha s-sustanza attiva iloprost.
English: EPAR summary for the public
Maltese: Sommarju tal-EPAR għall-pubbliku iloprost
English: This is a summary of the European public assessment report (EPAR) for Ventavis.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Ventavis.
English: Ventavis was significantly more effective than placebo: 17% of the patients taking Ventavis responded to treatment (17 out of 101), compared with 5% of the patients taking placebo (5 out of 102).
Maltese: Ventavis wera b'mod sinifikanti li huwa aktar effettiv mill-plaċebo: 17% tal-pazjenti li kienu qed jieħdu Ventavis rrispondew għall-kura (17 minn 101), meta mqabbla ma' 5% tal-pazjenti li kienu qed jieħdu lplaċebo (5 minn 102).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Ventavis on 16 September 2003.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Ventavis valida fl-Unjoni Ewropea kollha fis-16 ta' Settembru 2003.
English: The most common side effects with Ventavis (seen in more than 1 patient in 10) are headache, vasodilation (blood vessels becoming wider causing flushing or reddening of the face), bleeding episodes, chest pain and discomfort, peripheral oedema (swelling, especially of the ankles and feet), nausea (feeling sick), pain in the jaw and contraction of the jaw muscles, and cough.
Maltese: L-effetti sekondarji l-aktar komuni b'Ventavis (li dehru f'iktar minn pazjent 1 minn kull 10) huma wġigħ ta' ras, vasodilazzjoni (meta l-vini u l-arterji jitwessgħu u jikkawżaw ħmura fil-wiċċ), fsada, uġigħ fissider u skumdità, edema periferika (nefħa, l-iżjed fl-għekiesi u fis-saqajn), nawżja (tħossok ma tiflaħx), uġigħ fix-xedaq u kontrazzjoni tal-muskoli tax-xedaq, u sogħla.
English: Other information about Ventavis
Maltese: Informazzjoni oħra dwar Ventavis
English: Ventavis is an inhaled formulation of iloprost, a substance that is very similar to prostacyclin, a naturally occurring molecule that causes blood vessels to dilate (expand).
Maltese: Ventavis huwa formulazzjoni inalata ta' iloprost, sustanza li hija simili ħafna għal prostaċiklin, molekula li hija prodotta b'mod naturali li tikkaġuna l-ftuħ (espansjoni) tal-vini u l-arterji tad-demm.
English: Ventavis was originally authorised under ‘exceptional circumstances' because, as the disease is rare, limited information was available at the time of approval.
Maltese: Ventavis kien oriġinarjament awtorizzat taħt “ċirkostanzi ta' eċċezzjoni”, għaliex, minħabba li l-marda hija rari, kien hemm disponibbli informazzjoni limitata fi żmien l-approvazzjoni.
English: As the company had supplied the additional information requested at the time of authorisation, the ‘exceptional circumstances' ended on 26 August
Maltese: Peress li l-kumpanija pprovdiet l-informazzjoni addizzjonali mitluba, iċ-‘ċirkostanzi ta' eċċezzjoni' ntemmu fis-26 ta' Awwissu
English: What is Ventavis?
Maltese: X'inhu Ventavis?
English: Ventavis has been compared with placebo (a dummy treatment) in one study involving 203 adults with stable class III or IV pulmonary hypertension that was either primary or caused by another condition.
Maltese: Ventavis tqabbel ma' plaċebo (trattament finta) fi studju wieħed li kien jinvolvi 203 adulti li jbatu minn ipertensjoni fil-pulmun tal-klassi stabbli
English: The medicine must be given using a type of nebuliser known as a ‘dosimetric' nebuliser, which stops automatically when the correct dose has been delivered.
Maltese: Il-mediċina trid tingħata bl-użu ta' tip ta' nebulizzatur magħruf bħala nebulizzatur ‘dosimetriku', li jieqaf awtomatikament meta d-doża korretta tkun ingħatat.
English: A risk management plan has been developed to ensure that Ventavis is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Ventavis jintuża bl-aktar mod sigur possibbli.
English: Why has Ventavis been approved?
Maltese: Għaliex ġie approvat Ventavis?
English: Ventavis is used for the treatment of adult patients with class III primary pulmonary hypertension to improve exercise capacity (the ability to carry out physical activity) and symptoms.
Maltese: Ventavis jintuża fil-kura ta' pazjenti adulti b'ipertensjoni primarja fil-pulmun tal-klassi
English: A ‘response' was defined as a combination of a 10% improvement in exercise capacity (measured by looking at how far the patient could walk in six minutes) and an improvement of the patient's condition (the severity of the disease going down by at least one class), without a worsening of pulmonary hypertension or death.
Maltese: Il-kejl ewlieni tal-effikaċja kien in-numru ta' pazjenti li wrew reazzjoni għall-kura wara 12-il ġimgħa. ‘Reazzjoni' kienet definita bħala taħlita ta' 10% titjib fil-kapaċità tal-eżerċizzju (imkejla permezz ta' kemm il-pazjent seta' jimxi 'l bogħod f'sitt minuti), u titjib fil-kondizzjoni tal-pazjent (il-gravità li lmarda taqleb għall-agħar b'mhux inqas minn klassi waħda), mingħajr ma l-ipertensjoni fil-pulmun tiggrava jew ikun hemm mewt.
English: Pulmonary hypertension is a debilitating disease where there is severe constriction (narrowing) of the blood vessels of the lungs that causes high blood pressure in the vessels taking blood from the right side of the heart to the lungs.
Maltese: L-ipertensjoni fil-pulmun hija marda ta' indeboliment meta jkun hemm restrizzjoni (tidjiq) gravi flarterji u l-vini tad-demm tal-pulmuni li tikkaġuna pressjoni għolja tad-demm fl-arterji u fil-vini li jieħdu d-demm min-naħa tal-lemin tal-qalb għal pulmuni.
English: The dose should be reduced to 2.5 micrograms again if the patient cannot tolerate the higher dose.
Maltese: 2.5 mikrogrammi jekk il-pazjent ma jkunx jista' jittollera d-doża ogħla.
English: The medicine can only be obtained with a prescription.
Maltese: Il-mediċina tingħata bejn sitta u disa' darbiet kuljum.