FrancophonIA/ELRC3.0 huggingface dataset:
English: Most events were mild, with Grade 3 or 4 events reported in 0.7 % (2/274) of patients.
Maltese: Ħafna avvenimenti kienu ħfief, b'avvenimenti ta' Grad 3 jew 4 li ġew irrappurtati f'0.7 % (2/274) tal-pazjenti.
English: Median, months (95 % CI)
Maltese: Medjana, xhur (95 % CI)
English: Severity of adverse reactiona
Maltese: Severità tar-reazzjoni avversa
English: The median time to onset of the first event of RPED (all grades) was 1.5 month (range 0.03 to 17.5 months).
Maltese: Iż-żmien medjan għall-bidu tal-ewwel avveniment ta' RPED (il-gradi kollha) kien 1.5 xhur (medda 0.03 sa 17.5 xhur).
English: Cerebral haemorrhage occurred in 1.5 % (4/274) of patients with fatal outcome in 3 patients.
Maltese: Emorraġija ċerebrali seħħet f'1.5 % (4/274) tal-pazjenti b'riżultat fatali fi 3 pazjenti.
English: After oral administration, binimetinib is rapidly absorbed with a median Tmax of 1.5 hours.
Maltese: Wara għoti orali, binimetinib jiġi assorbit malajr b'Tmax medjan ta' 1.5 sigħat.
English: Inhibition of P-gp or BCRP is unlikely to result in a clinically important increase in binimetinib concentrations as binimetinib exhibits moderate to high passive permeability.
Maltese: BCRP aktarx ma tirriżultax f'żieda klinikament importanti fil-konċentrazzjonijiet ta' binimetinib peress li binimetinib jinibixxi permeabbiltà passiva moderata sa għolja.
English: Pruritus*
Maltese: Rimettar *
English: Uveitis including iridocyclitis and iritis have been reported in patients treated with binimetinib in combination with encorafenib (see section 4.8).
Maltese: F'pazjenti kkurati b'binimetinib flimkien ma' encorafenib, ġew irrappurtati uveiti inkluż iridoċiklite u irite (ara sezzjoni 4.8).
English: The effects of renal impairment on the pharmacokinetics of binimetinib in combination with encorafenib have not been evaluated clinically.
Maltese: L-effetti tal-indeboliment renali fuq il-farmakokinetika ta' binimetinib flimkien ma' encorafenib ma ġewx evalwati klinikament.
English: Blood creatine phosphokinase increased
Maltese: Modifikazzjoni fid-doża
English: Cutaneous malignancies
Maltese: Malinni tal-ġilda
English: Common (may affect up to 1 in 10 people) - some types of skin tumours such as skin papilloma and basal cell carcinoma - allergic reaction that may include swelling of the face and difficulty breathing - changes in the way things taste - inflammation of the eye (uveitis) - inflammation of the colon (colitis) - redness, chapping or cracking of the skin - inflammation of the fatty layer under the skin, symptoms include tender skin nodules - skin rash with a flat discoloured area or raised bumps like acne (dermatitis acneiform) - redness, skin peeling or blisters on hand and feet (palmar plantar erythrodysesthesia or hand and foot syndrome) - kidney failure - abnormal kidney test results (creatinine elevations) - abnormal blood test results for liver function (blood alkaline phosphatase) - abnormal blood test results for pancreas function (amylase, lipase) - increased skin sensitivity to sunlight
Maltese: - ħmura jew qsim tal-ġilda - infjammazzjoni tas-saff tax-xaħam taħt il-ġilda, sintomi jinkludu noduli tal-ġilda sensittivi - raxx tal-ġilda b'parti ċatta b'telf ta' kulur jew boċċi mqabbżin bħall-akne (dermatite acneiforme) - ħmura, tqaxxir tal-ġilda jew infafet fuq l-idejn u s-saqajn (eritrodiżesteżija palmari plantari jew sindrome tal-idejn u tas-saqajn)
English: Administration of a single 45 mg dose of binimetinib with a high-fat, high-calorie meal decreased the maximum binimetinib concentration (Cmax) by 17 %, while the area under the concentration-time curve (AUC) was unchanged.
Maltese: L-għoti ta' doża waħda ta' 45 mg ta' binimetinib ma' ikla b'ħafna xaħam u ħafna kaloriji naqqas il-konċentrazzjoni massima ta' binimetinib (Cmax) bi 17 %, filwaqt li l-erja taħt il-kurva talkonċentrazzjoni-ħin (AUC) ma nbidlitx.
English: The expiry date refers to the last day of that month.
Maltese: Din id-dejta turi li l-effikaċja tal-kombinazzjoni tkun inqas f'dawn il-pazjenti.
English: • stomach (abdominal) pain
Maltese: • emboli tad-demm
English: The safety of binimetinib (45 mg orally twice daily) in combination with encorafenib (450 mg orally once daily) (hereafter referred to as Combo 450) was evaluated in 274 patients with BRAF V600 mutant unresectable or metastatic melanoma, based on two Phase II studies (CMEK162X2110 and CLGX818X2109) and one Phase III study (CMEK162B2301, Part 1) (hereafter referred to as the pooled Combo 450 population).
Maltese: Is-sigurtà ta' binimetinib (45 mg oralment darbtejn kuljum) flimkien ma' encorafenib (450 mg oralment darba kuljum) (minn hawn 'il quddiem issir referenza għalih bħala Combo 450) ġiet evalwata f'274 pazjent b'melanoma li ma tistax titneħħa jew metastatika mutanti BRAF V600, abbażi ta' żewġ studji ta' Fażi
English: In Study CMEK162B2301-Part 2, in the Combo 300 arm, nausea was observed in 27.2% (70/257) of patients and was Grade 3 in 1.6% (4/257) of patients.
Maltese: Fl-Istudju CMEK162B2301-Parti 2, fil-fergħa Combo 300, nawsja ġiet osservata f'27.2% (70/257) talpazjenti u kienet ta' Grad 3 f'1.6% (4/257) tal-pazjenti.
English: Binimetinib undergoes minimal renal elimination.
Maltese: Binimetinib jgħaddi minn eliminazzjoni mill-kliewi minima.
English: ENCO 300
Maltese: ANNESS III
English: Based on a population pharmacokinetic analysis, age or body weight do not have a clinically important effect on the systemic exposure of binimetinib.
Maltese: Abbażi ta' analiżi tal-farmakokinetika tal-popolazzjoni, l-età jew il-piż tal-ġisem m'għandhomx effett klinikament importanti fuq l-esponiment sistemiku ta' binimetinib.
English: CuSCC was reported when binimetinib was used in combination with encorafenib (see section 4.8 of encorafenib SmPC).
Maltese: encorafenib (ara sezzjoni 4.8 tal-SmPC ta' encorafenib).
English: • Retinal vein occlusion (RVO) Binimetinib should be permanently discontinued.
Maltese: • Okklużjoni tal-vina tar-retina (RVO, retinal vein occlusion)
English: Vascular disorders
Maltese: Tromboemboliżmu venużf
English: Each film-coated tablet contains 15 mg binimetinib.
Maltese: Kull pillola miksija b'rita fiha 15 mg binimetinib.
English: Haemorrhages, including major haemorrhagic events, can occur when binimetinib is administered (see section 4.8).
Maltese: Meta jingħata binimetinib, jistgħu jseħħu emorraġiji, inkluż avvenimenti emorraġiċi maġġuri (ara sezzjoni 4.8).
English: Facial paresis was reported when binimetinib was used in combination with encorafenib (see section 4.8 of encorafenib SmPC).
Maltese: Pareżi tal-wiċċ ġie rrappurtat meta binimetinib intuża flimkien ma' encorafenib (ara sezzjoni 4.8 talSmPC ta' encorafenib).
English: Effect of UGT1A1 inducers or inhibitors on binimetinib Binimetinib is primarily metabolised through UGT1A1 mediated glucuronidation.
Maltese: Interazzjonijiet tal-prodott mediċinali Effett ta' indutturi jew inibituri ta' UGT1A1 fuq binimetinib
English: Constipation occurred in 24.1 % (66/274) of patients and was Grade 1 or 2.
Maltese: L-istitikezza seħħet f'24.1 % (66/274) tal-pazjenti u kienet ta' Grad 1 jew 2.
English: Following a single oral dose of 45 mg [14C] binimetinib in healthy subjects, at least 50 % of the binimetinib dose was absorbed.
Maltese: Wara doża orali waħda ta' 45 mg [14C] binimetinib f'individwi b'saħħithom, ġie assorbit tal-inqas 50 % tad-doża ta' binimetinib.
English: Standard genotixicity studies with binimetinib were negative.
Maltese: Studji standard dwar l-effett tossiku fuq ilġeni b'binimetinib kienu negattivi.
English: Usually, these skin cancers (see also section 2) are confined to a small area and can be removed with surgery and treatment with Mektovi (and encorafenib) can continue without interruption.
Maltese: Normalment, dawn ilkanċers tal-ġilda (ara wkoll sezzjoni 2) ikunu konfinati għal erja żgħira u jistgħu jitneħħew b'kirurġija u l-kura b'Mektovi (u encorafenib) tista' tkompli mingħajr interruzzjoni.
English: In cell free system, binimetinib inhibits MEK1 and MEK2 with the half maximal inhibitory concentration (IC50)'s in the 12-46 nM. MEK proteins are upstream regulators of the extracellular signal-related kinase (ERK) pathway, which promotes cellular proliferation.
Maltese: Binimetinib huwa inibitur riversibbli mhux kompetittiv ATP tal-attività ta' kinażi ta' kinażi 1 regolat b'sinjal ekstraċellulari attivat b'mitoġenu (MEK1) u MEK2. F'sistema mingħajr ċelluli, binimetinib jinibixxi MEK1 u MEK2 bil-konċentrazzjoni inibitorja massima bin-nofs (IC50) fil-12-46 nM.
English: Most patients had metastatic disease (95 %) and were Stage IVM1c (64 %); 27 % of patients had elevated baseline serum lactate dehydrogenase (LDH), and 45% of patients had at least 3 organs with tumour involvement at baseline and 3.5 % had brain metastases.
Maltese: Ħafna mill-pazjenti kellhom marda metastatika (95 %) u kienu fi Stadju IVM1c (64 %); 27 % tal-pazjenti kellhom lattatdeidroġenażi (LDH, lactate dehydrogenase) fis-seru fil-linja bażi miżjuda, u 45 % tal-pazjenti kellhom tal-inqas 3 organi b'involviment tat-tumur fil-linja bażi u 3.5 % kellhom metastażijiet tal moħħ. 27 pazjent (5 %) kienu rċivew inibituri tal-punt ta' kontroll preċedenti (kontra PD1/PDL1 jew ipilimumab) (8 pazjenti fil-fergħa Combo 450 (4 %); 7 pazjenti fil-fergħa vemurafenib (4 %);
English: The median time to first occurrence of LVD (any grade) was 4.4 months (range 0.03 to 21.3 months) in patients who developed an LVEF below 50 %.
Maltese: Iż-żmien medjan għall-bidu tal-ewwel okkorrenza ta' LVD (kwalunkwe grad) kien 4.4 xhur (0.03 sa 21.3 xhur) f'pazjenti li żviluppaw LVEF taħt 50 %.
English: If during treatment patient develops uveitis, see section 4.2 of encorafenib SmPC for guidance.
Maltese: Jekk waqt il-kura pazjent jiżviluppa uveite, ara sezzjoni 4.2 tal-SmPC ta' encorafenib għal gwida.
English: Erythema*
Maltese: Sturdament*
English: Rhabdomyolysis was reported in 0.4 % (1/274) of patients treated with encorafenib in combination with binimetinib.
Maltese: Ir-rabdomijoliżi ġiet irrappurtata f'0.4 % (1/274) tal-pazjenti kkurati b'encorafenib flimkien ma'
English: New primary malignancies, cutaneous and non-cutaneous, have been observed in patients treated with BRAF inhibitors and can occur when binimetinib is administered in combination with encorafenib (see section 4.8).
Maltese: Ġew osservati malinni primarji ġodda, tal-ġilda u mhux tal-ġilda, f'pazjenti kkurati b'inibituri ta' BRAF u jistgħu jseħħu meta binimetinib jingħata flimkien ma' encorafenib (ara sezzjoni 4.8).
English: Hypertension led to dose interruption or adjustment in 2.9 % of patients.
Maltese: L-ipertensjoni wasslet għal interruzzjoni jew aġġustament fid-doża fi 2.9 % tal-pazjenti.
English: Talk to your doctor immediately if you get muscle pain, cramps, stiffness, spasm, dark urine.
Maltese: Kellem lit-tabib tiegħek immedjatament jekk ikollok uġigħ fil-muskoli, bugħawwieġ, ebusija, spażmu, awrina skura.
English: The median time to onset of the first event was 2.7 months (range: 0.5 to 17.5 months).
Maltese: Iż-żmien medjan għall-bidu tal-ewwel avveniment kien 2.7 xhur (medda: 0.5 sa 17.5 xhur).
English: The safety of encorafenib (300 mg orally once daily) in combination with binimetinib (45 mg orally twice daily) was evaluated in 257 patients with BRAF V600 mutant unresectable or metastatic melanoma (hereafter referred to as the Combo 300 population), based on the Phase III study (CMEK162B2301, Part 2).
Maltese: Is-sigurtà ta' encorafenib (300 mg oralment darba kuljum) flimkien ma' binimetinib (45 mg oralment darbtejn kuljum) ġiet evalwata f'257 pazjent b'melanoma li ma tistax titneħħa jew metastatika mutanti
English: Dysgeusia
Maltese: Nawsja
English: Muscle problems: Mektovi can cause breakdown of muscles (rhabdomyolysis) which can lead to kidney damage and can be fatal; signs and symptoms can include:
Maltese: Problemi fil-muskoli: Mektovi jista' jikkawża kollass tal-muskolu (rabdomijoliżi) li jista' jwassal għal ħsara fil-kliewi u li jista' jkun fatali; is-sinjali u s-sintomi jistgħu jinkludu:
English: Mutations in the BRAF gene can produce proteins that cause the melanoma to grow.
Maltese: Mutazzjonijiet fil-ġene BRAF jistgħu jipproduċu proteini li jwasslu għal tkabbir tal-melanoma.
English: CK elevation and rhabdomyolysis
Maltese: Id-DOR medjana għal risposti kkonfermati skont il
English: • Lung or breathing problems: This medicine may cause lung or breathing problems including inflammation of the lungs (pneumonitis or interstitial lung disease); signs and symptoms can include: cough, shortness of breath or fatigue.
Maltese: • Problemi fil-pulmun jew fin-nifs: Din il-mediċina tista' tikkawża problemi fil-pulmun jew finnifs inkluż infjammazzjoni tal-pulmun (pulmonite jew mard interstizjali tal-pulmun); is-sinjali u s-sintomi jistgħu jinkludu: sogħla, qtugħ ta' nifs jew għeja.
English: • Binimetinib should be permanently discontinued.
Maltese: • Binimetinib għandu jitwaqqaf b'mod permanenti.
English: CK and creatinine levels should be monitored monthly during the first 6 months of treatment and as clinically indicated.
Maltese: Il-livelli ta' CK u tal-kreatinina għandhom jiġu mmonitorjati kull xahar waqt l-ewwel 6 xhur ta' kura u kif indikat klinikament.
English: Diarrhoea led to dose discontinuation in 0.4 % of patients and to dose interruption or dose modification in 4.4 % of patients.
Maltese: Id-dijarea wasslet għat-twaqqif tad-doża f'0.4 % tal-pazjenti u għal interruzzjoni fid-doża jew modifikazzjoni fid-doża f'4.4 % tal-pazjenti.
English: Following a single oral dose of 45 mg [14C] binimetinib in healthy subjects, approximately
Maltese: Wara doża orali waħda ta' 45 mg [14C] binimetinib f'individwi b'saħħithom, il-passaġġi ta'
English: Abdominal pain*
Maltese: Uġigħ addominali*
English: The median time to definitive 10 % deterioration in the FACT-M score was not reached in the Combo 450 arm and was 22.1 months (95 % CI: 15.2, NE) in the vemurafenib arm with a HR for the difference of 0.46 (95 % CI: 0.29, 0.72).
Maltese: 2, NE) fil-fergħa ta' vemurafenib b'HR għad-differenza ta' 0.46 (95 % CI 0.29, 0.72).
English: PFS
Maltese: St.
English: The most common adverse reactions (>25%) occurring in patients treated with encorafenib 300 mg administered with binimetinib were fatigue, nausea and diarrhoea.
Maltese: Ir-reazzjonijiet avversi l-aktar komuni (> 25 %) li seħħew f'pazjenti kkurati b'encorafenib 300 mg mogħti ma' binimetinib kienu għeja, nawsja u dijarea.
English: Dose interruption or dose modification was reported in 0.4 % (1/274) of patients.
Maltese: L-interruzzjoni fid-doża jew il-modifikazzjoni fid-doża ġiet irrappurtata f'0.4 % (1/274) tal-pazjenti.
English: Haemorrhagee
Maltese: Użu orali
English: Further information on Zelboraf 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: Zelboraf is available as tablets (240 mg).
Maltese: Zelboraf jiġi bħala pilloli (240 mg).
English: This overview was last updated in 02-2018.
Maltese: Din il-ħarsa ġenerali ġiet aġġornata l-aħħar fi: 02-2018.
English: Other information about Zelboraf
Maltese: Informazzjoni oħra dwar Zelboraf
English: Zelboraf received a marketing authorisation valid throughout the EU on 17 February 2012.
Maltese: Zelboraf irċieva awtorizzazzjoni għat-tqegħid fis-suq valida fl-EU fis-17 ta' Frar 2012.
English: The active substance in Zelboraf, vemurafenib, is an inhibitor of BRAF, a protein involved in stimulating cell division.
Maltese: Is-sustanza attiva f'Zelboraf, vemurafenib, hija inibitur ta' BRAF, proteina li tistimula d-diviżjoni ċellulari.
English: The most common side effects with Zelboraf (which may affect more than 3 in 10 patients) include arthralgia (joint pain), tiredness, rash, photosensitivity reaction (sunburn-like reactions following exposure to light), nausea and vomiting (feeling sick and being sick), alopecia (hair loss), diarrhoea, headache, pruritus (itching), skin papilloma (warts) and hyperkeratosis (thickening and toughening of the skin).
Maltese: L-effetti sekondarji l-aktar komuni b'Zelboraf (li jistgħu jaffettwaw aktar minn 3 minn kull 10) jinkludu artralġja (uġigħ fil-ġogi), għeja, raxx, reazzjoni għal fotosensittività (reazzjonijiet bħal ħruq mix-xemx wara esponiment għad-dawl), nawsja u rimettar (tħossok u tkun ma tiflaħx), alopeċja (telf taxxagħar), dijarea, uġigħ ta' ras, prurite (ħakk), papilloma tal-ġilda (felul) u iperkeratożi (tħaxxin u taħrix tal-ġilda).
English: The most common serious side effects include another type of skin cancer called ‘cutaneous squamous cell carcinoma', which is commonly treated by local surgery, keratoacanthoma (benign skin tumour), rash, arthralgia and change in liver test results (increased gamma-glutamyltransferase [GGT]).
Maltese: L-effetti sekondarji serji l-aktar komuni jinkludu tip ieħor ta' kanċer tal-ġilda msejjaħ "karċinoma taċ-ċelloli skwamużi tal-ġilda", li normalment jiġi kkurat permezz ta' kirurġija lokali, keratoakantoma (tumur tal-ġilda beninn), raxx, artralġja u bidla fir-riżultati tat-test tal-fwied (żieda filgamma-glutamyltransferase [GGT]).
English: Zelboraf was compared with the cancer medicine dacarbazine in a main study involving 675 patients with melanoma containing the BRAF V600 mutation whose tumours had spread or could not be surgically removed.
Maltese: Zelboraf tqabbel mal-mediċina kontra l-kanċer dacarbazine fi studju ewlieni li involva 675 pazjent b'melanoma li fiha l-mutazzjoni BRAF V600 li t-tumuri tagħhom kienu nfirxu jew li ma setgħux jitneħħew b'kirurġija.
English: As for all medicines, data on the use of Zelboraf are continuously monitored.
Maltese: Bħal għall-mediċini kollha, id-data dwar l-użu ta' Zelboraf hija ssorveljata kontinwament.
English: What are the risks associated with Zelboraf?
Maltese: X'inhuma r-riskji assoċjati ma' Zelboraf?
English: The study showed that patients taking Zelboraf lived on average for 13.2 months compared with 9.9 months for patients on dacarbazine, and it took on average 5.3 months for the disease to worsen in the Zelboraf group compared with 1.6 months in the dacarbazine group.
Maltese: L-istudju wera li pazjenti li kienu qed jieħdu Zelboraf għexu medja ta' 13.2 xhur meta mqabbla ma' 9.9 xhur għal pazjenti fuq dacarbazine, u l-marda ħadet medja ta' 5.3 xhur biex taqleb għall-agħar fil-grupp b'Zelboraf meta mqabbel ma' 1.6 xhur fil-grupp b'dacarbazine.
English: The recommended dose is 960 mg (four tablets) twice daily.
Maltese: Id-doża rakkomandata hija 960 mg (erba' pilloli) darbtejn kuljum.
English: Zelboraf contains the active substance vemurafenib.
Maltese: Zelboraf fih is-sustanza attiva vemurafenib.
English: Zelboraf is a cancer medicine used to treat adults with melanoma (a type of skin cancer) that has spread to other parts of the body or cannot be surgically removed.
Maltese: Zelboraf huwa mediċina kontra l-kanċer li tintuża biex tikkura adulti b'melanoma (tip ta' kanċer talġilda) li nfirxet għal partijiet oħrajn tal-ġisem u ma tistax titneħħa b'kirurġija.
English: How does Zelboraf work?
Maltese: Kif jaħdem Zelboraf?
English: Zelboraf is only for patients whose melanoma tumour cells have a specific mutation (genetic change) called ‘BRAF V600'.
Maltese: Zelboraf huwa biss għal pazjenti li ċ-ċelloli tat-tumur tal-melanoma tagħhom għandhom mutazzjoni speċifika (bidla ġenetika) imsejħa "BRAF V600".
English: What measures are being taken to ensure the safe and effective use of Zelboraf?
Maltese: X'miżuri qegħdin jitteħdu biex jiġi żgurat l-użu sigur u effettiv ta' Zelboraf?
English: For the full list of side effects and restrictions with Zelboraf, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u restrizzjonijiet bi Zelboraf, ara l-fuljett ta' tagħrif.
English: The Agency considered the side effects to be manageable and included recommendations for doctors to help reduce the risks in the product information.
Maltese: L-Aġenzija kkunsidrat li leffetti sekondarji jistgħu jiġu mmaniġġjati u inkludiet rakkomandazzjonijiet għat-tobba biex tgħinhom inaqqsu r-riskji fl-informazzjoni dwar il-prodott.
English: The main measures of effectiveness were how long the patients lived (overall survival) and how long they lived without their disease getting worse (progression-free survival).
Maltese: Il-kejl prinċipali taleffikaċja kien kemm damu jgħixu l-pazjenti (sopravivenza globali) u kemm damu jgħixu mingħajr ma l-marda tagħhom qalbet għall-agħar (sopravivenza mingħajr progressjoni).
English: Why is Zelboraf authorised in the EU?
Maltese: Għaliex Zelboraf ġie awtorizzat fl-UE?
English: Side effects reported with Zelboraf are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati bi Zelboraf huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: In melanoma tumours with the BRAF V600 mutation, an abnormal form of BRAF is present which plays a role in the development of the cancer by allowing uncontrolled division of the tumour cells.
Maltese: Fit-tumuri tal-melanoma bil-mutazzjoni BRAF V600, ikun hemm forma anormali ta' BRAF bi rwol importanti fl-iżvilupp tal-kanċer, minħabba li tippermetti diviżjoni mhux ikkontrollata taċ-ċelloli tat-tumur.
English: The preliminary review was concluded on 8th of February 2018.
Maltese: Ir-rieżami preliminari ġie konkluż fit-8 ta' Frar 2018.
English: Esmya (ulipristal acetate, 5 mg) is a centrally authorised medicinal product indicated for pre-operative treatment as well as intermittent treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age.
Maltese: Esmya (ulipristal acetate, 5 mg) huwa prodott mediċinali awtorizzat skont il-proċedura ċentralizzata indikata għall-kura ta' qabel l-operazzjoni kif ukoll għal kura intermittenti ta' sintomi moderati sa severi ta' fibrojdi fl-utru f'nisa adulti ta' età riproduttiva.
English: • The PRAC considered the procedure under Article 20 of Regulation (EC) No 726/2004 resulting from pharmacovigilance data for Esmya (Ulipristal acetate), in particular the need for provisional measures in accordance with Article 20(3) of Regulation (EC) N0 726/2004.
Maltese: • Il-PRAC ikkunsidra l-proċedura skont l-Artikolu 20 tar-Regolament (KE) Nru 726/2004 bħala riżultat ta' data dwar il-farmakoviġilanza għal Esmya (Ulipristal acetate), b'mod partikolari lħtieġa għal miżuri proviżorji skont l-Artikolu 20(3) tar-Regolament (KE) Nru 726/2004.
English: Three out of those four cases of serious liver injury were reported to the competent authorities before November 2017.
Maltese: Tliet każijiet minn dawk l-erbgħa ta' ħsara serja fil-fwied ġew irrappurtati lill-awtoritajiet kompetenti qabel Novembru 2017.
English: Given the estimated exposure to Esmya of approximately 175,000 patient years, the number of cases of subacute severe liver impairment leading to liver transplantation with Esmya is higher than expected (4 transplantation cases among 175,000 patient years - a total of 7 cases with severe liver impairment among 175,000 patient years; although causality is uncertain for some of these cases).
Maltese: Minħabba l-esponiment stmat għal Esmya ta' madwar 175,000 sena tal-pazjent, in-numru ta' każijiet ta' indeboliment tal-fwied sever subakut li wassal għal trapjant tal-fwied b'Esmya huwa ogħla minn dak mistenni (4 każijiet ta' trapjant fost 175,000 sena tal-pazjent - total ta' 7 każijiet b'indeboliment talfwied sever fost 175,000 sena tal-pazjent; għalkemm il-kawżalità hija inċerta għal xi każijiet minn dawn).
English: The clinical efficacy of ulipristal acetate in the pre-operative treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age was based on short-term studies demonstrating the ability of the active substance to reduce fibroid-related bleeding, anaemia and fibroid size if administered in a daily dose of 5 mg for up to three months.
Maltese: L-effikaċja klinika ta' ulipristal acetate fil-kura ta' qabel l-operazzjoni ta' sintomi moderati sa severi ta' fibrojdi fl-utru f'nisa adulti ta' età riproduttiva ġiet ibbażata fuq studji ta' perjodu qasir li juru l-ħila tassustanza attiva li tnaqqas il-fsada relatata mal-fibrojdu, l-anemija u d-daqs tal-fibrojdu jekk tingħata f'doża ta' kuljum ta' 5 mg sa tliet xhur.