FrancophonIA/ELRC3.0 huggingface dataset:
English: In a 3-week crossover, randomised, placebo-controlled clinical study Bretaris Genuair was associated with a statistically significant improvement in exercise endurance time in comparison to placebo of 58 seconds (95% CI=9-108; p=0.021; pre-treatment value: 486 seconds).
Maltese: Fi studju kliniku crossover ta' tliet ġimgħat, li fih il-parteċipanti ntgħażlu b'mod każwali, ikkontrollat bi plaċebo, Bretaris Genuair ġie assoċjat ma' titjib statistikament sinfikanti li tejjeb b'mod sinifikanti l-ħin ta' kapaċità li wieħed jissaporti l-eżerċizzju meta mqabbel ma' plaċebo ta' 58 sekonda (95% CI=9-108; p=0.021; valur ta' qabel il-kura: 486 sekonda).
English: In addition, no clinically significant effects of Bretaris Genuair on cardiac rhythm were observed on 24-hour Holter monitoring after 3 months treatment of 336 patients (of whom 164 received Bretaris Genuair 322 µg twice daily).
Maltese: Barra minn hekk, ma ġie osservat l-ebda effett klinikament sinifikanti ta' Bretaris Genuair fuq ir-ritmu kardijaku matul monitoraġġ Holter ta' 24 siegħa wara trattament ta' 3 xhur ta' 336 pazjent (li 164 minnhom irċevew Bretaris Genuair 322 µg darbtejn kuljum).
English: Renal and urinary disorders
Maltese: Indeboliment renali
English: Bretaris Genuair 322 micrograms inhalation powder Aclidinium (aclidinium bromide)
Maltese: Bretaris Genuair 322 mikrogramma trab li jittieħed man-nifs aclidinium (aclidinium bromide)
English: Bretaris Genuair 322 micrograms inhalation powder aclidinium (aclidinium bromide)
Maltese: Bretaris Genuair 322 mikrogramma trab li jittieħed man-nifs Aclidinium (aclidinium bromide)
English: After 6 months treatment, the mean improvement in morning pre-dose (trough) FEV1 compared to placebo was 128 mL (95% CI=85-170; p<0.0001).
Maltese: Wara t-trattament ta' 6 xhur, it-titjib medju fl-FEV1 qabel id-doża (livell minimu) ta' filgħodu meta mqabbel mal-plaċebo kien ta' 128 mL (95% CI=85-170; p<0.0001).
English: Following intravenous administration of 400 µg radiolabelled aclidinium bromide to healthy subjects, approximately 1% of the dose was excreted as unchanged aclidinium bromide in the urine.
Maltese: Wara għoti ġol-vini ta' 400 µg ta' aclidinium bromide radjutikkettat lil individwi b'saħħithom, bejn wieħed u ieħor 1% tad-doża tneħħiet bħala aclidinium bromide mhux mibdul fl-awrina.
English: The following side effects may occur whilst using Bretaris Genuair: Common: may affect up to 1 in 10 people - Headache - Inflammation of the sinuses (sinusitis) - Common cold (nasopharyngitis) - Cough - Diarrhoea - Nausea
Maltese: L-effetti sekondarji li ġejjin jistgħu jseħħu filwaqt li tuża Bretaris Genuair: Komuni: jistgħu jaffettwaw sa 1 minn 10 persuni - Uġigħ ta' ras - Infjammazzjoni tas-sinusijiet (sinusite) - Riħ (nażofarinġite) - Sogħla - Dijarea - Nawsja
English: Aclidinium bromide is a maintenance bronchodilator and should not be used for the relief of acute episodes of bronchospasm, i.e. as a rescue therapy.
Maltese: Aclidinium bromide huwa bronkodilatatur ta' manutenzjoni u m'għandux jintuża sabiex itaffi episodji akuti ta' bronkospażmi, jiġifieri bħala terapija ta' salvataġġ.
English: As aclidinium bromide is metabolised mainly by chemical and enzymatic cleavage in the plasma, hepatic dysfunction is very unlikely to alter its systemic exposure.
Maltese: Minħabba li aclidinium bromide huwa metabolizzat l-aktar minn qasma kimika u enzematika fil-plażma, disfunzjoni epatika hija ferm improbabbli li tibdel l-espożizzjoni sistemika tiegħu.
English: COPD is a long-term disease; therefore, it is recommended that Bretaris Genuair is used every day, twice a day and not only when breathing problems or other symptoms of COPD are experienced.
Maltese: COPD hija marda fit-tul; għaldaqstant, huwa rrakkomandat li Bretaris Genuair jintuża kuljum, darbtejn kuljum u mhux biss meta jinħassu s-sintomi ta' problemi fit-teħid ta' nifs jew sintomi oħrajn ta' COPD.
English: The hydrolysis occurs both chemically (non-enzymatically) and enzymatically by esterases, butyrylcholinesterase being the main human esterase involved in the hydrolysis.
Maltese: L-idrolożi sseħħ kemm b'mod kimiku (mhux b'mod enzimatiku) kif ukoll b'mod enzimatiku b'esterażi, b'butyrylcholinesterase jkun l-esterase ewlieni talbniedem involut fl-idroliżi.
English: Laboratori Guidotti S.p.A. Tel: +39- 050 971011
Maltese: Tel: +39- 050 971011
English: SGRQ
Maltese: GmbH.
English: Pooled efficacy analysis of the 6-month and 3-month placebo controlled studies demonstrated a statistically significant reduction in the rate of moderate to severe exacerbations (requiring treatment with antibiotics or corticosteroids or resulting in hospitalisations) with aclidinium 322 µg twice daily compared to placebo (rate per patient per year: 0.31 vs 0.44 respectively; p=0.0149).
Maltese: Analiżi tal-effikaċja miġbura tal-istudji kkontrollati bi plaċebo ta' 6 xhur u 3 xhur urew tnaqqis statistikament sinifikanti fir-rata ta' taħrix moderat għal sever tal-marda (li kien jeħtieġ kura b'antibijotiċi jew kortikosterojdi jew li rriżulta f'li l-pazjent kellu jiddaħħal l-isptar) b'aclidinium 322 µg darbtejn kuljum meta mqabbal ma' plaċebo (rata kull pazjent kull sena: 0.31 vs 0.44 rispettivament; p=0.0149).
English: Disease-Specific Health Status and Symptomatic Benefits Bretaris Genuair provided clinically meaningful improvements in breathlessness (assessed using the Transition Dyspnoea Index [TDI]) and disease-specific health status (assessed using the St. George's Respiratory Questionnaire [SGRQ]).
Maltese: Stat tas-Saħħa Speċifiku għall-Marda u l-Benefiċċji Sintomatiċi Bretaris Genuair ipprovda titjib klinikament sinifikanti fin-nuqqas ta' nifs (evalwat billi ntuża l-Indiċi ta' Qtugħ ta' nifs ta' Transizzjoni (Transition Dyspnoea Index)
English: Regular use of Bretaris Genuair can help you when you have ongoing shortness of breath related to your disease to help you minimise the effects of the disease on your everyday life and reduce the number of flare-ups (the worsening of your COPD symptoms for several days).
Maltese: Użu regolari ta' Bretaris Genuair jista' jgħinek meta jkollok nuqqas ta' nifs kontinwu relatat mal-marda tiegħek biex jgħinek tnaqqas kemm jista' jkun l-effetti tal-marda fil-ħajja ta' kuljum tiegħek u tnaqqas in-numru ta' feġġ f'daqqa (l-aggravar tas-sintomi tiegħek tas-COPD għal diversi jiem).
English: Effects in nonclinical studies with respect to cardiovascular parameters (increased heart rates in dogs), reproductive toxicity (foetotoxic effects), and fertility (slight decreases in conception rate, number of corpora lutea, and pre- and post-implantation losses) were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.
Maltese: Fi studji li mhumiex kliniċi fir-rigward tal-parametri kardjovaskulari (żieda fir-rata ta' taħbit tal-qalb fil-klieb), it-tossiċità riproduttiva (effetti fetotossiċi), u l-fertilità (tnaqqis żgħir fir-rata ta' konċepiment, numru ta' corpora lutea, u telf ta' qabel u wara l-impjant) l-effetti dehru biss wara esponimenti meqjusa ferm aktar għoljin mill-massimu ta' esponiment fil-bniedem, u dan jindika ftit rilevanza għall-użu kliniku.
English: In addition, Bretaris Genuair showed a statistically significant reduction of 35% in the rate of hospitalisations due to COPD exacerbations while on-treatment during the first year compared with placebo (RR 0.65; 95% CI 0.48 to 0.89; p=0.006).
Maltese: Barra minn hekk, Bretaris Genuair wera tnaqqis statistikament sinifikanti ta' 35 % fir-rata ta' dħul fl-isptar minħabba aggravar ta' COPD waqt it-trattament matul l-ewwel sena meta mqabbel ma' plaċebo (RR 0.65; 95% CI 0.48 sa 0.89; p=0.006).
English: However, single inhaled doses up to 6,000 µg aclidinium bromide have been administered to healthy subjects without systemic anticholinergic adverse reactions.
Maltese: Madankollu, dożi waħedhom meħudin man-nifs sa 6,000 µg ta' aclidinium bromide ngħataw lil individwi b'saħħithom mingħajr reazzjonijiet avversi antikolinerġiċi sistemiċi.
English: 58.7% were male and 90.7% were Caucasian, with a mean postbronchodilator FEV1 of 47.9% of predicted value and a mean CAT (COPD Assessment Test) of 20.7.
Maltese: 9 % tal-valur previst u CAT (Test ta' Valutazzjoni tas-COPD) medju ta' 20.7.
English: 1.5 Release the green button (Figure F).
Maltese: Itlaq il-buttuna l-ħadra (Figura F).
English: Stop taking Bretaris Genuair and seek medical help immediately: - if you get tightness of the chest, coughing, wheezing or breathlessness immediately after using the medicine.
Maltese: Tiħux aktar Bretaris Genuair u fittex għajnuna medika minnufih: - jekk tħoss tagħfis fis-sider, sogħla, tħarħir jew qtugħ ta' nifs dritt wara li tuża l-mediċina.
English: A placebo-controlled trial in 1791 patients with moderate to very severe COPD treated with Bretaris Genuair up to 36 months did not identify other adverse reactions.
Maltese: Prova kkontrollata bil-plaċebo f'1791 pazjent b'COPD moderata għal severa ħafna ttrattati bi Bretaris Genuair sa 36 xahar ma identifikatx reazzjonijiet avversi oħrajn.
English: Carton containing 3 inhalers each with 60 doses.
Maltese: Kartuna li fiha 3 inalaturi, kull wieħed b'60 doża.
English: Clinical efficacy studies showed that Bretaris Genuair provided clinically meaningful improvements in lung function (as measured by the forced expiratory volume in 1 second [FEV1]) over 12 hours following morning and evening administration, which were evident within 30 minutes of the first dose (increases from baseline of 124-133 mL).
Maltese: [FEV1]) fuq 12-il siegħa b'għoti filgħodu u filgħaxija, li kien evidenti fi żmien 30 minuta mill-ewwel doża (żidiet millinja bażi ta' 124-133 mL).
English: The low absolute bioavailability of inhaled aclidinium bromide (<5%) is because aclidinium bromide undergoes extensive systemic and pre-systemic hydrolysis whether deposited in the lung or swallowed.
Maltese: Il-bijodisponibilità assoluta baxxa tal-aclidinium bromide meħud man-nifs (<5%) hija għaliex aclidinium bromide tgħaddi minn idroliżi sistemika u pre-sistemika estensiva sew jekk depożitata filpulmun sew jekk miblugħa.
English: Each delivered dose (the dose leaving the mouthpiece) contains 375 µg aclidinium bromide equivalent to 322 µg of aclidinium.
Maltese: Kull doża fornuta (id-doża li tħalli l-biċċa tal-ħalq) fiha 375 µg ta' aclidinium bromide ekwivalenti għal 322 µg ta' aclidinium.
English: Pharmacotherapeutic group: Drugs for obstructive airway diseases, anticholinergics; ATC Code: R03BB05.
Maltese: Mediċini għal mard ostruttiv tal-passaġġi tal-arja, antikolinerġiċi; Kodiċi ATC:
English: Bretaris Genuair also improved daily symptoms of COPD (dyspnoea, cough and sputum production) and night-time and early morning symptoms.
Maltese: Bretaris Genuair tejjeb ukoll is-sintomi ta' kuljum tas-COPD (produzzjoni ta' qtugħ ta' nifs, sogħla u bżieq) u s-sintomi ta' filgħaxija u ta' kmieni filgħodu.
English: Dizziness
Maltese: Prurite
English: Hypersensitivity
Maltese: Sensittività eċċessiva Rari
English: Other medicines and Bretaris Genuair
Maltese: Mediċini oħra u Bretaris Genuair
English: Bretaris Genuair 322 micrograms inhalation powder
Maltese: Bretaris Genuair 322 mikrogramma trab li jittieħed man-nifs
English: The Bretaris Genuair group showed a statistically significant delay in the time to first moderate or severe exacerbation while on-treatment compared to the placebo group.
Maltese: Il-grupp ta' Bretaris Genuair wera dewmien statistikament sinifikanti fiż-żmien għall-ewwel aggravar moderat jew sever waqt it-trattament meta mqabbel mal-grupp tal-plaċebo.
English: Percentage of Patients who achieved MCID
Maltese: laħqu MCID
English: Dose indicator
Maltese: Indikatur tad-doża
English: No effects on QT interval (corrected using either the Fridericia or Bazett method or individuallycorrected) were observed when aclidinium bromide (200 µg or 800 µg) was administered once daily for 3 days to healthy subjects in a thorough QT study.
Maltese: Ma ġie osservat l-ebda effett fuq l-intervall QT (ikkoreġut bl-użu jew tal-metodu Fridericia jew Bazett jew inkella kkoreġut b'mod individwali) meta aclidinium bromide (200 µg jew 800 µg) ingħata darba kuljum għal tliet ijiem lil individwi b'saħħithom fi studju dettaljat dwar il-QT.
English: Inhaler label
Maltese: Indikatur taddoża
English: Bretaris Genuair Placebo
Maltese: Kif taħżen Bretaris Genuair
English: The safety margins for human systemic exposure with 400 µg twice daily over the no observed adverse effect levels in these studies ranged from 7- to 73-fold.
Maltese: Il-marġini ta' sigurtà għal espożizzjoni sistemika tal-bniedem b'400 µg darbtejn kuljum fuq il-livelli ta' effetti avversi sinifikanti mhux osservati f'dawn l-istudji varjaw minn 17- il darba għal 187 darba.
English: Hepatic impairment No dose adjustments are required for patients with hepatic impairment (see section 5.2).
Maltese: Ma huwa meħtieġ l-ebda aġġustament tad-doża għall-pazjenti b'indeboliment epatiku (ara sezzjoni 5.2).
English: The occurrence of headache, dizziness or blurred vision following administration of aclidinium bromide (see section 4.8) may influence the ability to drive or to use machinery.
Maltese: L-okkorrenza ta' wġigħ ta' ras, sturdament jew vista mċajpra wara li jingħata aclidinium bromide (ara sezzjoni 4.8) tinfluwenza l-ħila li ssuq jew tħaddem magni.
English: High doses of aclidinium bromide may lead to anticholinergic signs and symptoms.
Maltese: Dożi għoljin ta' aclidinium bromide jistgħu jwasslu għal sinjali u sintomi antikolinerġiċi.
English: Excipients with known effect Each delivered dose contains approximately 12 mg lactose (as monohydrate).
Maltese: Eċċipjent(i) b'effett magħruf Kull doża mogħtija fiha madwar 12 mg ta' lactose (bħala monohydrate).
English: 2.7 Make sure the control window is now red (Figure K).
Maltese: 2.7 Kun żgur li t-tieqa ta' kontroll issa hija ħamra (Figura K).
English: Maximal bronchodilation was achieved within 1-3 hours after dosing with mean peak improvements in FEV1 relative to baseline of 227-268 mL at steady-state.
Maltese: Bronkodilatazzjoni massima nkisbet fi żmien siegħa-tliet sigħat wara dożaġġ bl-ogħla titjib medju f'FEV1 fir-rigward tal-linja bażi ta' 227-268 mL fl-istat fiss.
English: Inhaled aclidinium bromide acts locally in the lungs to antagonise M3 receptors of airway smooth muscle and induce bronchodilation.
Maltese: Aclidinium bromide li jittieħed man nifs jaġixxi lokalment fil-pulmun sabiex jantagonizza r-riċetturi M3 tal-muskolu lixx tal-passaġġ talarja u jinduċi l-bronkodilatazzjoni.
English: Hypersensitivity to aclidinium bromide or to the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għal aclidinium bromide jew għal kwalunkwe sustanzi mhux attivi elenkati fissezzjoni 6.1.
English: Maximal bronchodilatory effects were evident from day one and were maintained over the 6-month treatment period.
Maltese: L-effetti bronkodilatatorji massimi kienu evidenti mill-ewwel jum u nżammu matul il-perjodu ta' trattament ta' 6 xhur.
English: Nonclinical in vitro and in vivo studies showed rapid, dose-dependent and long-lasting inhibition by aclidinium of acetylcholine-induced bronchoconstriction.
Maltese: Studji in vitro u in vivo mhux kliniċi wrew inibizzjoni mgħaġġla minn aclidinium, li tiddependi fuq id-doża u li ddum, ta' tidjiq tal-passaġġ tal-arja indott minn acetycholine.
English: The primary safety endpoint was the time to first occurrence of MACE, defined as any of the following adjudicated events: cardiovascular death, non-fatal myocardial infarction (MI), or non-fatal ischemic stroke.
Maltese: Il-punt tat-tmiem tas-sigurtà primarja kien iż-żmien għall-ewwel okkorrenza ta' MACE, definit bħal xi wieħed mill-avvenimenti aġġudikati li ġejjin: mewt kardjovaskulari, infart mijokardijaku (MI) mhux fatali, jew puplesija iskemika mhux fatali.
English: Carton containing 1 inhaler with 60 doses.
Maltese: Kartuna li fiha inalatur 1 b'60 doża.
English: There is no relevant use of Bretaris Genuair in children and adolescents (under 18 years of age) for the indication of COPD.
Maltese: Ma hemm l-ebda użu relevanti ta' Bretaris Genuair fit-tfal u l-adoloxxenti (età taħt it-18-il sena) għallindikazzjoni tas-COPD.
English: Mouthpiece
Maltese: Sturdament
English: The MAH shall perform the pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in the Risk Management Plan presented in Module 1.8.2. of the Marketing Authorisation and any subsequent updates of the RMP agreed by the Committee for Medicinal Products for Human Use (CHMP).
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq (MAH) għandu jwettaq l-attivitajiet ta' farmakovigilanza kif deskrit fil-Pjan ta' Farmakoviġilanza, kif inhu maqbul fil-RMP ppreżentat f'Modulu 1.8.2 tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u kwalunkwe aġġornament sussegwenti talRMP kif maqbul mill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP).
English: 1.2 Look at the control window (should be red, Figure C).
Maltese: 1.2 Ħares lejn it-tieqa ta' kontroll (għandha tkun ħamra, Figura C).
English: Following inhalation of 200 µg and 400 µg of aclidinium bromide by healthy subjects or COPD patients, the urinary excretion of unchanged aclidinium was very low at about 0.1% of the administered dose, indicating that renal clearance plays a minor role in the total aclidinium clearance from plasma.
Maltese: Il-livelli fil-plażma tal-metabolit tal-aċidu huma bejn wieħed u ieħor 100 darba akbar minn dawk tal-metaboli tal-alkoħol u s-sustanza attiva mhux mibdula ta' wara t-teħid man-nifs.
English: A. Menarini Pharma GmbH.
Maltese: IL-PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
English: UAB “BERLIN-CHEMIE MENARINI BALTIC” Tel: +370 52 691 947
Maltese: Berlin-Chemie/Menarini Polska Sp. z o.o. Tel.: +48 22 566 21 00
English: Nonclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, and toxicity to reproduction and development.
Maltese: Tagħrif mhux kliniku ibbażat fuq studji konvenzjonali ta' sigurtà farmakoloġika, effett tossiku minn dożi ripetuti, effett tossiku fuq il-ġeni, riskju ta' kanċer, u effett tossiku fuq is-sistema riproduttiva u l-iżvilupp, ma juri l-ebda periklu speċjali għall-bnedmin.
English: RED
Maltese: RA
English: Studies in rats have shown slight reductions in fertility only at dose levels much higher than the maximum human exposure to aclidinium bromide (see section 5.3).
Maltese: Studji f'annimali urew tossiċità tal-fetu biss f'livelli ta' doża ferm ogħla mill-espożizzjoni massima tal-bniedem għal aclidinium bromide (ara sezzjoni 5.3).
English: Invented name Strength Pharmaceutical Form Route of administration Packaging
Maltese: Qawwa Għamla farmaċewtika
English: • Updated information on adverse reactions.
Maltese: • Informazzjoni aġġornata dwar ir-reazzjonijiet avversi.
English: A total of 81 (18%) patients on the phase 2 study (n=449) have experienced serious vascular occlusive events and overall, a total of 101 patients (23%) have experienced vascular occlusive events (serious and non-serious).
Maltese: Total ta' 81 (18%) pazjent fl-istudju tal-fażi 2 (n=449) esperjenzaw avvenimenti okklużivi vaskulari serji u b'mod globali, total ta' 101 pazjent (23%) esperjenzaw avvenimenti okklużivi vaskulari (serji u mhux serji).
English: Serious cardiac failure events have occurred in a total of 23 patients (5.1%).
Maltese: Seħħew avvenimenti ta' insuffiċjenza tal-qalb serji f'total ta' 23 pazjent (5.1%).
English: The incidence of arterial thrombotic events (per 100 patient years) remains relatively constant.
Maltese: L-inċidenza ta' avvenimenti trombotiċi arterjali (għal kull 100 sena ta' pazjent) jibqa' relattivament kostanti.
English: Ponatinib is a tyrosine kinase inhibitor (TKI), designed with the purpose of inhibiting the kinase activity of native BCR-ABL, and all mutant variants, including ‘gatekeeper' T315I.
Maltese: Ponatinib huwa inibitur tat-tirożina kinażi (TKI), maħsub bil-għan li jinibixxi l-attività ta' kinażi ta' BCR-ABL nattiv, u l-varjanti tal-mutanti kollha, inkluż l-'għassies' T315I.
English: Nevertheless the Committee agreed that it is important to reflect these data in the product information.
Maltese: Madankollu, il-Kummissjoni qablet li huwa importanti li din id-dejta tiġi riflessa fl-informazzjoni dwar il-prodott.
English: An additional risk minimisation activity was required by the PRAC.
Maltese: Il-PRAC kien jeħtieġ attività addizzjonali ta' minimizzazzjoni tar-riskju.
English: These included further consideration of the PK-PD profile of ponatinib to determine the optimal dosing in all patient populations and indications (including recommendations for initial dose and dose reductions), further assessment of the nature, severity and frequency of all treatment-emergent vascular occlusive adverse events (and possible sequelae), and heart failure, exploration of the potential mechanisms of action leading to vascular occlusive events and consideration of the possibilities for further risk minimisation measures.
Maltese: Dawn kienu jinkludu aktar konsiderazzjoni tal-profil PK-PD ta' ponatinib sabiex jiġi ddeterminat l-aħjar dożaġġ filpopolazzjonijiet ta' pazjenti u l-indikazzjonijiet kollha (inkluż ir-rakkomandazzjonijiet għad-doża inizjali u t-tnaqqis fid-doża), il-valutazzjoni ulterjuri tan-natura, is-severità u l-frekwenza talavvenimenti avversi okklużivi vaskulari li ħarġu mill-kura (u l-konsegwenzi possibbli), u linsuffiċjenza tal-qalb, l-esplorazzjoni tal-mekkaniżmi potenzjali ta' azzjoni li jwasslu għal avvenimenti okklużivi vaskulari u l-konsiderazzjoni tal-possibbiltajiet għal aktar miżuri ta' minimizzazzjoni tar-riskju.
English: • Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation.
Maltese: • lewkimja limfoblastika akuta pożittiva għall-kromożoma ta' Philadelphia (Ph+ ALL) li huma reżistenti għal dasatanib; li huma intolleranti għal dasatinib u li għalihom, kura sussegwenti b'imatinib mhijiex klinikament xierqa; jew li għandhom il-mutazzjoni T315I.
English: The Marketing Authorisation was granted by the European Commission on 1 July 2013 for the following indications in adult patients:
Maltese: Il-Kummissjoni Ewropea tat Awtorizzazzjoni għat-Tqegħid fis-Suq fl-1 ta' Lulju 2014 għallindikazzjonijiet li ġejjin fil-pazjenti adulti:
English: The overall safety profile for ponatinib is generally consistent with that considered at the time of marketing authorisation, with the notable addition of the risk of vascular occlusive events.
Maltese: Il-profil tas-sigurtà globali għal ponatinib huwa ġeneralment konsistenti ma' dak ikkunsidrat fi żmien l-awtorizzazzjoni għat-tqegħid fis-suq, biż-żieda importanti tar-riskju ta' avvenimenti okklużivi vaskulari.
English: • chronic phase, accelerated phase, or blast phase chronic myeloid leukaemia (CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation and
Maltese: • lewkimja majelojde kronika (CML) f'fażi kronika, fażi aċċellerata, jew fażi blast li huma reżistenti għal dasatanib jew nilotinib; li huma intolleranti għal dasatinib jew nilotinib u li għalihom kura sussegwenti b'imatinib mhijiex klinikament xierqa; jew li għandhom ilmutazzjoni T315I u
English: • The PRAC took note of the serious risk of vascular occlusive events associated with Iclusig, which is likely to be dose-related.
Maltese: • Il-PRAC ħa nota tar-riskju serju ta' avvenimenti okklużivi vaskulari assoċjati ma' Iclusig, li x'aktarx ikun relatat mad-doża.
English: The possible role of anti-platelet, anti-coagulant or lipid lowering drugs in reducing the risk of vascular occlusive events remains uncertain.
Maltese: Ir-rwol possibbli ta' mediċini anti-plejtlits, anti-koagulanti, jew li jnaqqsu l-lipidi fit-tnaqqis tarriskju ta' avvenimenti okklużivi vaskulari jibqa' inċert.