FrancophonIA/ELRC3.0 huggingface dataset:
English: Further analyses including both arms (DP384/30 (higher dose of EE than Seasonique in the last 7 days of the cycle) and DP3-84/10 (Seasonique)) of the pivotal study PSE-301 and the supportive study PSE-302 did not provide a more reliable estimation of contraceptive efficacy of Seasonique despite the increase in sample size and resulted in a higher PI of 1.67 (95% CI 0.91 - 2.80).
Maltese: (Seasonique)) tal-istudju PSE-301 u l-istudju ta' appoġġ PSE-302 ma pprovdewx stima iktar affidabbli tal-effikaċja ta' kontraċezzjoni ta' Seasonique minkejja ż-żieda fid-daqs tal-kampjun u dan irriżulta f'PI ogħla ta' 1.67 (CI 95 % 0.91 - 2.80).
English: Of note, combined analyses including both arms (DP3-84/30 (higher dose of EE than Seasonique in the last 7 days of the cycle) and DP3-84/10 (Seasonique regimen)) of the pivotal study PSE-301 and the supportive study PSE-302 resulted in a higher PI of 1.67 (95% CI 0.91 - 2.80).
Maltese: (kors Seasonique)) tal-istudju pivotali PSE301 u l-istudju ta' appoġġ PSE-302 irriżultaw f'PI ogħla ta' 1.67 (CI 95 % 0.91 - 2.80).
English: Although, based on women who completed one year of treatment discontinuation due to bleeding/spotting adverse events was more frequent in the Seasonique group (7.4%) than the comparator group (1.1%), the mean total number of days of bleeding/spotting (including scheduled and unscheduled) per patient month was similar, i.e. 4.4 days for both Seasonique and the comparator.
Maltese: Għalkemm, abbażi tan-nisa li temmew sena ta' kura, waqfien minħabba avvenimenti avversi ta' fsada kien aktar frekwenti fil-grupp ta' Seasonique (7.4%) milli fil-grupp tal-komparatur (1.1%), il-medja tan-numru totali ta' ġranet ta' fsada (inklużi ippjanati u mhux ippjanati) għal kull pazjenti kienet simili, jiġifieri 4.4 jiem kemm għal Seasonique kif ukoll għall-komparatur.
English: The absence of a comparator arm was considered justified given that the mechanism of action of this hormonal combination in this dose is well known, that the only differences between Seasonique and existing LNG/EE combination products are the treatment duration (84 days versus 21 days, respectively) and the administration of 10µg EE during the last 7 days of the cycle instead of an hormone free interval (HFI), respectively.
Maltese: LNG/EE eżistenti huma t-tul tal-kura (84 jum meta mqabbel ma' 21 jum, rispettivament) u lamministrazzjoni ta' 10µg ta' EE fl-aħħar 7 ijiem taċ-ċiklu minnflok intervall bla ormoni (HFI), rispettivament.
English: The decentralised procedure was closed on day 210, with most of the Concerned Member States (CMS) agreeing with the conclusions of the RMS except Germany which raised a potential serious risk to public health.
Maltese: Il-proċess deċentralizzat ingħalaq fil-jum 210, b'ħafna mill-Istati Membri (CMS - Concerned Member States) jaqblu mal-konklużjonijiet tal-RMS apparti l-Ġermanja li qajment riskju potenzjali serju għassaħħa pubblika.
English: The results obtained in clinical trials with Seasonique are further supported by post-marketing data.
Maltese: Il-programm ta' żvilupp kliniku għal Seasonique inkluda żewġ provi kliniċi randomizzati ta' fażi
English: Hence the applicant was asked to conduct additional analyses of the bleeding pattern based on three extrapolation rules to include women who prematurely discontinued treatment and to extrapolate those data to the total planned study duration of PSE-302 of one year.
Maltese: Għalhekk l-applikant intalab iwettaq analiżijiet addizzjonali tax-xejra ta' fsada ibbażati fuq tlett regoli ta' estrapolazzjoni sabiex jiġu inklużi nisa li waqqfu l-kura qabel iż-żmien u biex tiġi estrapolata dik id-dejta għat-tul totali tal-istudju ppjanat ta' PSE-302 ta' sena.
English: Dafiro amlodipine / valsartan
Maltese: Dafiro amlodipina / valsartan
English: The full EPAR for Dafiro 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 f'05-2015.
English: It is available as tablets (5 mg amlodipine and 80 mg valsartan; 5 mg amlodipine and 160 mg valsartan; 10 mg amlodipine and 160 mg valsartan).
Maltese: Jiġi bħala pilloli (5 mg amlodipina u 80 mg valsartan; 5 mg amlodipina u 160 mg valsartan; 10 mg amlodipina u 160 mg valsartan).
English: The European Commission granted a marketing authorisation valid throughout the EU for Dafiro on 16 January 2007.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha għal Dafiro fis16 ta' Jannar 2007.
English: This is a summary of the European public assessment report (EPAR) for Dafiro.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Dafiro.
English: The most common side effects with Dafiro (seen in between 1 and 10 patients in 100) are headache, nasopharyngitis (inflammation of the nose and throat), influenza (flu), hypokalaemia (low blood potassium levels), various types of oedema (swelling), fatigue (tiredness), flushing (reddening), asthenia (weakness) and hot flushes.
Maltese: L-effetti sekondarji l-aktar komuni b'Dafiro (li dehru f'bejn pazjent 1 u 10 minn 100) huma wġigħ ta' ras, nasofarinġite (infjammazzjoni tal-imnieħer u tal-gerżuma), influwenza, ipokalemija (livelli baxxi ta' potassju fid-demm), tipi varji ta' edema (nefħa), għeja, ħmura, astenija (debbulizza) u fwawar.
English: In the studies comparing the combination in patients who were already taking either amlodipine or valsartan, the blood pressure in patients taking valsartan alone had fallen by 6.6 mmHg after eight weeks, compared with 9.6 and 11.4 mmHg in the patients adding 5 or 10 mg amlodipine, respectively.
Maltese: Fl-istudji li qabblu lkombinazzjoni fil-pazjenti li diġà kienu qegħdin jieħdu l-amlodipina jew il-valsartan, il-pressjoni taddemm tal-pazjenti li kienu qegħdin jieħdu l-valsartan waħdu niżlitilhom b'6.6 mmHg wara tmien ġimgħat, meta mqabbla ma' 9.6 u 11.4 mmHg fil-pazjenti li żiedu 5 jew 10 mg amlodipina rispettivament.
English: Why has Dafiro been approved?
Maltese: Għaliex ġie approvat Dafiro?
English: Dafiro contains two active substances, amlodipine and valsartan.
Maltese: Dafiro fih żewġ sustanzi attivi, l-amlodipina u l-valsartan.
English: Both are anti-hypertensive medicines that have been available separately in the European Union (EU) since the mid-1990s.
Maltese: It-tnejn huma mediċini antiipertensivi li ilhom disponibbli separatament fl-Unjoni Ewropea (UE) min-nofs is-snin disgħin.
English: What is the risk associated with Dafiro?
Maltese: X'inhu r-riskju assoċjat ma' Dafiro?
English: What is Dafiro?
Maltese: X'inhu Dafiro?
English: The fifth, smaller study compared the combination with lisinopril and hydrochlorothiazide (another combination used to treat hypertension) in 130 patients with severe hypertension.
Maltese: Il-ħames studju, fuq skala iżgħar, qabbel il-kombinazzjoni ma' lisinopril u idroklorotijażide (kombinazzjoni oħra użata għall-kura tal-ipertensjoni) f'130 pazjent b'ipertensjoni gravi.
English: Angiotensin II is a powerful vasoconstrictor (a substance that narrows blood vessels).
Maltese: II hija vażokostrittur qawwi (sustanza li traqqaq l-arterji u l-vini).
English: Patients taking amlodipine alone had a fall of 10.0 mmHg, compared with 11.8 mmHg in the patients adding 160 mg valsartan.
Maltese: 0 mmHg, meta mqabbel ma' 11.8 mmHg fil-pazjenti li żiedu 160 mg valsartan.
English: The patient may need to take separate tablets or capsules before switching to the combination tablet.
Maltese: Ilpazjent jista' jkun meħtieg jieħu pilloli jew kapsuli separati qabel ma jaqleb għall-pillola ta' kombinazzjoni.
English: Two studies (involving almost 3,200 patients) compared amlodipine, valsartan or a combination of both substances with placebo (a dummy treatment).
Maltese: Żewġ studji (li kienu jinvolvu kważi 3,200 pazjent) qabblu l-amlodipina, il-valsartan jew kombinazzjoni taż-żewġ sustanzi ma' plaċebo (kura finta).
English: Five main studies involving nearly 5,200 patients, mostly with mild to moderate hypertension, were carried out.
Maltese: Twettqu ħames studji ewlenin li fihom ħadu sehem 5,200 pazjent, li l-biċċa l-kbira tagħhom kienu jbatu minn ipertensjoni minn ħafifa għal moderata.
English: Dafiro must not be used in patients who have severe liver or bile problems, patients with certain heart problems and patients with severe hypotension (low blood pressure).
Maltese: Dafiro ma għandux jintuża minn pazjenti bi problemi gravi fil-fwied, jew problemi biljari, jew minn pazjenti b'ċerti problemi tal-qalb u minn pazjenti b'ipotensjoni gravi (pressjoni tad-demm baxxa).
English: Dafiro is a medicine that contains two active substances, amlodipine and valsartan.
Maltese: Dafiro huwa mediċina li fiha żewġ sustanzi attivi, l-amlodipina u l-valsartan.
English: It blocks special channels on the surface of cells called calcium channels, through which calcium ions normally enter the cells.
Maltese: Din timblokka l-kanali speċjali fuq il-wiċċ taċ-ċelluli magħrufa bħala kanali tal-kalċju, li minnhom normalment il-joni tal-kalċju jidħlu fiċ-ċelluli.
English: The CHMP decided that Dafiro's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' Dafiro huma akbar mir-riskji tiegħu u rrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: Dafiro must also not be used in combination with aliskiren-containing medicines (also used to treat essential hypertension) in patients with type 2 diabetes or in patients with moderate or severe kidney impairment.
Maltese: Dafiro ma għandux jintuża wkoll flimkien ma' mediċini li fihom l-aliskiren (użati wkoll fil-kura tal-ipertensjoni essenzjali) f'pazjenti bid-dijabete tat-tip 2, jew f'pazjenti li jbatu minn insuffiċjenza moderata jew gravi fil-kliewi.
English: How has Dafiro been studied?
Maltese: Kif ġie studjat Dafiro?
English: Two studies (involving 1,891 patients) compared the combination in patients whose hypertension was not adequately controlled with either 10 mg amlodipine or 160 mg valsartan.
Maltese: Żewġ studji (li kienu jinvolvu 1,891 pazjent) qabblu l-kombinazzjoni f'pazjenti li għalihom ma kienx possibbli li l-ipertensjoni tagħhom tiġi kkontrollata adegwatament b'10 mg amlodipina jew f'160 mg valsartan.
English: Dafiro must not be used in patients who are hypersensitive (allergic) to amlodipine or other medicines in the ‘dihydropyridine derivatives' class, to valsartan, or to any of the other ingredients.
Maltese: Dafiro ma għandux jintuża f'pazjenti li jkunu ipersensittivi (allerġiċi) għall-amlodipina jew mediċini oħra tal-klassi tad-'derivati diidropiridiniċi', għall-valsartan, jew għal kwalunkwe wieħed mill-ingredjenti loħra.
English: By lowering the blood pressure, the risks associated with high blood pressure, such as having a stroke, are reduced.
Maltese: Bit-tnaqqis talpressjoni tad-demm, jitnaqqsu r-riskji assoċjati ma' pressjoni għolja tad-demm, bħall-puplesija.
English: Valsartan is an ‘angiotensin II receptor antagonist', which means that it blocks the action of a hormone in the body called angiotensin II.
Maltese: Il-valsartan hu tip ta' 'antagonist tar-riċetturi tal-anġjotensina
English: The combination of amlodipine and valsartan was more effective at reducing blood pressure than placebo or either valsartan or amlodipine taken alone.
Maltese: Fit-tnaqqis tal-pressjoni tad-demm, il-kombinazzjoni tal-amlodipina u l-valsartan irriżultat aktar effikaċi mill-plaċebo jew mill-valsartan jew l-amlodipina meħudin waħedhom.
English: Approximately 25 µg
Maltese: Madwar 25 µg
English: Conjugate of Haemophilus influenzae type b capsular polysaccharide (PRP)
Maltese: Konjugat ta' Haemophilus influenzae toxoid ta' polysaccharide kapsulari tat-tip b (PRP)
English: 50 (5 X 10) vials + 50 (5 X 10) pre-filled syringes without needles (multipack)
Maltese: 50 (5 X 10) kunjett + 50 (5 X 10) siringa mimlijin għallest mingħajr illabar (pakkett multiplu)
English: Filamentous haemagglutinin, adsorbed
Maltese: Filamentous haemagglutinin, adsorbit
English: Pertactin, adsorbed
Maltese: Pertactin, adsorbit
English: Recombinant hepatitis B surface antigen (S protein), adsorbed
Maltese: Superfiċje tal-epatite B rikombinanti Antiġen (proteina S), adsorbit
English: _ _1 After reconstitution, 1 dose (0.5 ml) contains: Diphtheria toxoid, adsorbed
Maltese: _ _1 Wara r-rikostruzzjoni, doża 1 (0.5 ml) ikun fiha: Toxoid tad-difterite, adsorbit
English: and tetanus toxoid (T), adsorbed (PRP-T)
Maltese: u tat-tetnu (T), adsorbit (PRP-T)
English: 10 vials + 10 pre-filled syringes + 20 needles
Maltese: 10 kunjetti + 10 siringi mimlijin għallest + 20 labra
English: Pertussis toxoid, adsorbed
Maltese: Toxoid tal-pertussis, adsorbit
English: Tetanus toxoid, adsorbed
Maltese: Toxoid tat-tetnu, adsorbit
English: MA (EU) number (Invented)n ame
Maltese: Numru tal-MA Isem (ivvintat)
English: 1 vial + 1 prefilled syringe + 2 needles
Maltese: 10 kunjetti + 10 siringi mimlijin għallest mingħajr illabar kunjett 1 + siringa mimlija għal-lest 1 + 2 labar
English: Lavender oil EMA/HMPC/530968/2012
Maltese: Żejt tal-ispika EMA/HMPC/530968/2012
English: Committee on Herbal Medicinal Products (HMPC)
Maltese: Il-Kumitat għall-Prodotti Mediċinali Erbali (HPMC)
English: What is lavender oil?
Maltese: X'inhu ż-żejt tal-lavandra?
English: Patients with open wounds, skin problems, high fever, severe infections and severe heart and circulation problems should not have full baths with lavender oil.
Maltese: Pazjenti b'feriti miftuħin, problemi tal-ġilda, deni għoli, infezzjonijiet severi u problemi severi tal-qalb u taċ-ċirkolazzjoni ma għandhomx jieħdu banjijiet sħaħ biż-żejt tal-lavandra.
English: Further information on the HMPC assessment of lavender oil, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Maltese: Aktar informazzjoni dwar il-valutazzjoni tal-HMPC tal-mediċini taż-żejt tal-lavandra, inklużi d-dettalji tal-konklużjonijiet tal-Kumitat, tinsab taħt it-tab ‘Id-dokumenti kollha' fis-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: For detailed information on the data assessed by the HMPC, see the HMPC assessment report.
Maltese: Għal informazzjoni dettaljata dwar id-dejta vvalutata mill-HMPC, ara r-rapport ta' valutazzjoni talHMPC.
English: Other information about lavender oil medicines
Maltese: Aktar informazzjoni dwar il-mediċini taż-żejt tal-lavandra
English: What are the risks associated with lavender oil medicines?
Maltese: X'inhuma r-riskji assoċjati mal-mediċini taż-żejt tal-lavandra?
English: Lavender oil is the common name for the essential oil of the plant Lavandula angustifolia Mill.
Maltese: Iż-żejt tal-lavandra huwa l-isem komuni għaż-żejt essenzjali tal-pjanta Lavandula angustifolia Mill.
English: Only few and mild side effects had been reported in studies with lavender oil, including very rare cases of allergic reactions.
Maltese: Xi ftit effetti sekondarji ħfief biss ġew irrapportati fi studji biż-żejt tal-lavandra, inkluż każijiet rari ħafna ta' reazzjonijiet allerġiċi.
English: How are lavender oil medicines approved in the EU?
Maltese: Kif jiġu approvati fl-UE l-mediċini taż-żejt tal-lavandra?
English: Herbal medicines containing lavender oil are usually available in liquid forms to be taken by mouth or as a bath additive.
Maltese: Mediċini erbali li fihom iż-żejt tal-lavandra normalment huma disponibbli f'forom likwidi sabiex jittieħdu mill-ħalq jew bħala addittiv fil-banju.
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of lavender oil.
Maltese: Dan id-dokument huwa sommarju tal-konklużjonijiet xjentifiċi li wasal għalihom il-Kumitat għallProdotti Mediċinali Erbali (HMPC) dwar l-użu mediċinali taż-żejt tal-lavandra.
English: This means that, although there is insufficient evidence from clinical trials, the effectiveness of these herbal medicines is plausible and there is evidence that they have been used safely in this way for at least 30 years (including at least 15 years within the EU).
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom effikaċja ta' dawn il-mediċini erbali hija plawsibbli u hemm evidenza li dawn intużaw b'mod sikur b'dan il-mod għal mill-inqas 30 sena (inkluż għallinqas 15-il sena fi ħdan l-UE).
English: Any applications for the licensing of medicines containing lavender oil have to be submitted to the national authorities responsible for medicinal products, which will assess the application for the herbal medicine and take into account the scientific conclusions of the HMPC.
Maltese: Kwalunkwe applikazzjoni għal-liċenzjar ta' mediċini li fihom iż-żejt tal-lavandra għandha titressaq lillawtoritajiet nazzjonali responsabbli mill-prodotti mediċinali li ser jivvalutaw l-applikazzjoni għallmediċina erbali u jqisu l-konklużjonijiet xjentifiċi tal-HMPC.
English: The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing lavender oil.
Maltese: Il-konklużjonijiet talHMPC jiġu kkunsidrati mill-Istati Membri tal-UE waqt il-valutazzjoni tal-applikazzjonijiet għal-liċenzjar ta' mediċini erbali li fihom iż-żejt tal-lavandra.
English: In its assessment, the HMPC also considered studies with lavender oil in patients with different conditions, including anxiety and sleeping disorders.
Maltese: Fil-valutazzjoni tiegħu, l-HMPC qies ukoll l-istudji biż-żejt tal-lavandra f'pazjenti b'kundizzjonijiet differenti, inkluż b'disturbi tal-ansjeta u tal-irqad.
English: Further information on the risks associated with lavender oil medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Maltese: Aktar informazzjoni dwar ir-riskji assoċjati mal-mediċini taż-żejt tal-lavandra, inklużi l-prekawzjonijiet xierqa għall-użu sigur tagħhom, tinsab fil-monografu taħt it-tab ‘Id-dokumenti kollha' fis-sit elettroniku tal-Aġenzija:
English: EMA/457887/2019 EMEA/H/C/004919
Maltese: EMA/457887/2019 EMA/H/C/004919
English: Further information on Vitrakvi can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/vitrakvi.
Maltese: ema.europa.eu/medicines/human/EPAR/vitrakvi.
English: It contains the active substance larotrectinib.
Maltese: Fih is-sustanza attiva larotreċtinib.
English: Vitrakvi is available as a liquid (20 mg per ml) and capsules (25 and 100 mg) and is taken by mouth.
Maltese: Vitrakvi jiġi bħala likwidu (20 mg għal kull ml) u kapsuli (25 u 100 mg) u jittieħed mill-ħalq.
English: Vitrakvi (larotrectinib) EMA/457887/2019
Maltese: EMA/457887/2019
English: The most common side effects with Vitrakvi (which may affect more than 1 in 5 people) are tiredness, dizziness, constipation, nausea, vomiting, anaemia (low red blood cell counts) and high blood levels of alanine aminotransferase and aspartate aminotransferase (a sign of liver problems).
Maltese: L-effetti sekondarji l-aktar komuni b'Vitrakvi (li jistgħu jaffetwaw aktar minn persuna minn ħamsa) huma għeja, sturdament, konstipazzjoni, dardir, rimettar, anemija (għadd baxx ta' ċelloli ħomor taddemm) u livelli għoljin fid-demm ta' alanina aminotransferażi u aspartataminotransferażi (sinjal ta' problemi tal-fwied).
English: Other information about Vitrakvi
Maltese: Informazzjoni oħra dwar Vitrakvi
English: Most side effects are mild to moderate.
Maltese: Ħafna mill-effetti sekondarji huma ħfief sa moderati.
English: NTRK gene fusion is a rare genetic abnormality that can occur in tumours from different parts of the body such as the lungs, thyroid glands and intestines.
Maltese: NTRK hija anormalità ġenetika rari li tista' sseħħ fit-tumuri minn partijiet differenti tal-ġisem bħall-pulmuni, il-glandoli tat-tirojde u l-intestini.
English: What information is still awaited for Vitrakvi?
Maltese: Liema informazzjoni għadha mistennija għal Vitrakvi?
English: What are the risks associated with Vitrakvi?
Maltese: X'inhuma r-riskji assoċjati ma' Vitrakvi?
English: As for all medicines, data on the use of Vitrakvi are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Vitrakvi hija ssorveljata kontinwament.
English: Vitrakvi (larotrectinib)
Maltese: It-tumuri bil-fużjoni tal-ġeni
English: Tumours with NTRK gene fusion produce an abnormal protein (TRK fusion protein), which causes the uncontrolled growth of cancer cells.
Maltese: NTRK jipproduċu proteina anormali (proteina tal-fużjoni TRK) li tikkawża ttkabbir mhux ikkontrollat ta' ċelloli tal-kanċer.
English: In these studies, 67% of patients who took Vitrakvi had a reduction in the size of their tumours, and the tumours on average shrank to less than half their original size.
Maltese: F'dawn l-istudji, 67 % tal-pazjenti li ħadu Vitrakvi kellhom tnaqqis fid-daqs tat-tumuri tagħhom, u bħala medja, it-tumuri ċkienu għal inqas minnofs id-daqs oriġinali tagħhom.
English: Vitrakvi is a cancer medicine for treating solid tumours with NTRK gene fusion.
Maltese: Vitrakvi huwa mediċina kontra l-kanċer għall-kura ta' tumuri solidi bil-fużjoni tal-ġeni
English: The active substance in Vitrakvi, larotrectinib, blocks the action of this protein, preventing the excessive growth of cancer cells and thereby slowing down the worsening of the cancer.
Maltese: Is-sustanza attiva f'Vitrakvi, il-larotreċtinib, timblokka lazzjoni ta' din il-proteina, u b'hekk tipprevjeni t-tkabbir eċċessiv taċ-ċelloli tal-kanċer u għaldaqstant tnaqqas ir-ritmu li bih il-kanċer imur għall-agħar.
English: Vitrakvi is used in patients whose tumours are advanced, have spread to other parts of the body or are not amenable to surgery, and who have no satisfactory alternative treatments.
Maltese: Vitrakvi jintuża f'pazjenti li t-tumuri tagħhom ikunu avvanzati, ikunu nfirxu ma' partijiet oħra tal-ġisem jew ma jkunux emenabbli għal kirurġija, u li ma jkollhom l-ebda kura alternattiva sodisfaċenti.
English: How is Vitrakvi used?
Maltese: Kif jaħdem Vitrakvi?
English: Why is Vitrakvi authorised in the EU?
Maltese: Għaliex Vitrakvi huwa awtorizzat fl-UE?
English: What measures are being taken to ensure the safe and effective use of Vitrakvi?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Vitrakvi?
English: How does Vitrakvi work?
Maltese: Kif jintuża Vitrakvi?
English: The dose for children is based on their body surface area (weight and height).
Maltese: Barra minn hekk, it-tumuri ċkienu malajr (fi żmien xahrejn).
English: Three ongoing studies in 102 patients with solid tumours with NTRK gene fusion showed that Vitrakvi is effective at reducing the size of patients' tumours.
Maltese: Barra minn hekk, iż-żmien qasir li jittieħed biex it-tumuri jiċkienu huwa importanti biex jitnaqqsu s-sintomi tal-pazjenti.
English: This data will come from the three ongoing studies which aim to confirm the benefits and safety of Vitrakvi and its longer term effect in children.
Maltese: Minħabba li Vitrakvi ngħata awtorizzazzjoni kkundizzjonata, il-kumpanija li tqiegħed Vitrakvi fis-suq se tipprovdi aktar data dwar l-effetti tiegħu.
English: Vitrakvi has been given ‘conditional authorisation'.
Maltese: Vitrakvi ngħata “awtorizzazzjoni kkundizzjonata”.
English: It is available as tablets (20, 40 and 80 mg).
Maltese: Jiġi f'għamla ta' pilloli (20, 40 u 80 mg).