FrancophonIA/ELRC3.0 huggingface dataset:
English: Two 12-week paediatric studies have been performed in which 265 children aged 6-11 years were treated with a maintenance dose of budesonide/formoterol (2 inhalations of
Maltese: Saru żewġ studji pedjatriċi ta' 12-il ġimgħa li fihom, 265 tifel u tifla ta' bejn 6 u 11-il sena ġew ikkurati b'doża ta' manteniment ta' budesonide/formoterol (2 inalazzjonijiet ta'
English: • Medicines for a fast or uneven heartbeat (such as quinidine, disopyramide, procinamide and terfanidine).
Maltese: Il-kura konkomitanti ma' quinidine, disopyramide, procainamide, phenothiazines, antistamini
English: Animal reproduction studies with formoterol have shown a somewhat reduced fertility in male rats at high systemic exposure (see section 5.3).
Maltese: Studji dwar ir riproduzzjoni fl-annimali b'formoterol urew fertilità xi ftit imnaqqsa f'firien irġiel b'esponiment sistemiku għoli (ara sezzjoni 5.3).
English: BiResp Spiromax 320 micrograms/9 micrograms inhalation powder
Maltese: BiResp Spiromax 320 mikrogramma/9 mikrogrammi trab li jittieħed man-nifs
English: Study 6 months
Maltese: Studju 6 xhur
English: • Use within 6 months of removing from the foil wrapping.
Maltese: • TIĦUX aktar minn 6 inalazzjonijiet f'ħin wieħed.
English: BiResp Spiromax 320 micrograms/9 micrograms inhalation powder budesonide/formoterol fumarate dihydrate
Maltese: BiResp Spiromax 320 mikrogramma/9 mikrogrammi trab li jittieħed man-nifs budesonide/ formoterol fumarate dihydrate
English: 160/4.5 µg bd + formoterol 4.5 µg as needed
Maltese: Budesonide/Formoterol Furmarate Dihydrate 160/4.5 µg bd + formoterol 4.5 µg kif meħtieġ
English: BiResp Spiromax is indicated for use in adults 18 years of age and older only.
Maltese: BiResp Spiromax huwa indikat għall-użu f'persuni adulti minn 18-il sena 'l fuq biss.
English: For BiResp Spiromax there are two treatment approaches:
Maltese: Għal BiResp Spiromax hemm żewġ approċċi differenti ta' kura:
English: BiResp Spiromax 160 micrograms /4.5 micrograms inhalation powder budesonide / formoterol fumarate dihydrate
Maltese: BiResp Spiromax 160 mikrogramma/4.5 mikrogrammi trab li jittieħed man-nifs budesonide/ formoterol fumarate dihydrate
English: Treatment groups
Maltese: Gruppi ta' kura
English: Budesonide and formoterol have not been observed to interact with any other medicinal products used in the treatment of asthma.
Maltese: Budesonide u formoterol ma kienu osservati li jinteraġixxu mal-ebda prodott mediċinali ieħor użat fil kura tal-ażma.
English: BiResp Spiromax should be discontinued immediately, the patient should be assessed and an alternative therapy is instituted if necessary (see section
Maltese: BiResp Spiromax għandu jitwaqqaf immedjatament, il-pazjent għandu jiġi valutat u jekk ikun meħtieġ, tinbeda terapija alternattiva (ara sezzjoni 4.4).
English: In Study 735, lung function, symptom control, and reliever use were similar in all treatment groups.
Maltese: Fl-Istudju 735, il-funzjoni tal-pulmun, il-kontroll tas-sintomi, u l-użu tas-sustanzata' solljiev kienu simili fil-gruppi kollha ta' kura.
English: BiResp Spiromax maintenance therapy
Maltese: Jekk tuża BiResp Spiromax aktar milli suppost
English: In 2 other studies with patients seeking medical attention due to acute asthma symptoms, budesonide/formoterol provided rapid and effective relief of bronchoconstriction similar to salbutamol and formoterol.
Maltese: budesonide/formoterol ipprovda solljiev rapidu u effettiv tal-bronkokostrizzjoni simili għal salbutamol u formoterol.
English: Once asthma symptoms are controlled, consideration may be given to gradually reducing the dose of BiResp Spiromax.
Maltese: Ladarba s-sintomi tal-ażma jiġu kkontrollati, għandu jiġi kkunsidrat it-tnaqqis gradwali tad-doża ta' BiResp Spiromax.
English: The safety and efficacy of BiResp Spiromax in children, 12 years and younger and adolescents, 13 to 17 years of age has not yet been established.
Maltese: Is-sigurtà u l-effikaċja ta' BiResp Spiromax fit-tfal, sa 12-il sena u l-adolexxenti, minn 13 sa 17-il sena ma ġewx determinati s'issa.
English: How to store BiResp Spiromax
Maltese: X' fih BiResp Spiromax
English: • Use BiResp Spiromax every day.
Maltese: • Uża BiResp Spiromax kuljum.
English: (A) Using BiResp Spiromax and a separate ‘reliever inhaler'
Maltese: (A) Użu ta' BiResp Spiromax u inalatur ta' solljiev separat
English: • cataract (clouding of the lens in the eye)
Maltese: • glawkoma (żieda fil-pressjoni tal-għajn)
English: A total daily dose of more than 8 inhalations is not normally needed; however, a total daily dose of up to 12 inhalations could be used for a limited period.
Maltese: Ġeneralment mhijiex meħtieġa doża totali ta' kuljum ta' aktar minn 8 inalazzjonijiet; madankollu tista' tintuża doża totali ta' kuljum sa 12-il inalazzjoni għal perjodu limitat.
English: BiResp Spiromax is an inhalation powder.
Maltese: Tużax BiResp Spiromax biex tittratta dawn is-sintomi tal-ażma.
English: BiResp Spiromax contains formoterol and budesonide, which have different modes of action and show additive effects in terms of reduction of asthma exacerbations.
Maltese: BiResp Spiromax fih formoterol u budesonide, li għandhom modi ta' azzjoni differenti u juru effetti addittivi f'termini tat-tnaqqis fit-taħrix tal-ażma.
English: This helps to prevent asthma symptoms from occurring.
Maltese: Tista' tkun indikata kura sintomatika u ta' sostenn.
English: BiResp Spiromax 160 micrograms / 4.5 micrograms inhalation powder
Maltese: BiResp Spiromax 160 mikrogramma/4.5 mikrogrammi trab li jittieħed man-nifs.
English: BiResp Spiromax 160 micrograms / 4.5 micrograms inhalation powder budesonide/ formoterol fumarate dihydrate Inhalation use.
Maltese: BiResp Spiromax 160 mikrogramma/4.5 mikrogrammi, trab li jittieħed man-nifs budesonide/formoterol fumarate dihydrate
English: BiResp Spiromax 320 micrograms/9 micrograms inhalation powder budesonide/formoterol fumarate dihydrate Inhalation use.
Maltese: BiResp Spiromax 320 mikrogramma/9 mikrogrammi, trab li jittieħed man-nifs budesonide/formoterol fumarate dihydrate
English: Limited data about this interaction for high-dose inhaled budesonide indicates that marked increases in plasma levels (on average four fold) may occur if itraconazole, 200 mg once daily, is administered concomitantly with inhaled budesonide (single dose of 1000 micrograms).
Maltese: Dejta limitata dwar din l-interazzjoni għal budesonide ta' doża għolja li jittieħed man-nifs tindika li jista' jkun hemm żidiet qawwija fil-livelli fil-plażma (medja ta' erba' darbiet aktar) jekk itraconazole, 200 mg darba kuljum, jingħata fl-istess ħin ma' budesonide li jittieħed man-nifs (doża waħda ta'
English: BiResp Spiromax 160 mcg/4.5 mcg inhalation powder budesonide/formoterol fumarate dihydrate Inhalation use.
Maltese: BiResp Spiromax 160 μg/4.5 μg trab li jittieħed man-nifs budesonide/formoterol fumarate dihydrate
English: BiResp Spiromax pharmacokinetic profile
Maltese: Kif għandek tuża BiResp Spiromax
English: • If you have been prescribed BiResp Spiromax and a separate reliever inhaler, read the section called (A)
Maltese: • Jekk ingħatajt BiResp Spiromax u inalatur ta' solljiev separat, aqra s-sezzjoni msejħa ‘(A) Użu ta' BiResp Spiromax u inalatur ta' solljiev separat'.
English: • If you get asthma symptoms such as sudden attacks of breathlessness and wheezing, take 1 inhalation and wait a few minutes.
Maltese: • Jekk jiġuk is-sintomi tal-ażma, bħal attakki f'daqqa ta' qtugħ ta' nifs u tħarħir, ħu inalazzjoni waħda u stenna ftit minuti.
English: In patients using potent CYP3A4 inhibitors, a budesonide/formoterol fumarate fixed-dose combination is not recommended.
Maltese: F' pazjenti li jkunu qegħdin jużaw inibituri qawwija ta' CYP3A4, mhijiex rakkomandata terapija b'kombinazzjoni ta' doża fissa ta'
English: In studies, mean lung deposition of budesonide after inhalation via the powder inhaler ranged from 32% to 44% of the delivered dose.
Maltese: Fl-istudji, id depożitu medju ta' budesonide fil-pulmuni wara t-teħid man-nifs permezz tal-inalatur tat-trab kien ivarja minn 32% sa 44% tad-doża mogħtija.
English: BiResp Spiromax maintenance therapy: BiResp Spiromax is taken as regular maintenance treatment with a separate rapid-acting bronchodilator reliever inhaler.
Maltese: Il-qawwiet aktar baxxi ta' BiResp Spiromax huma disponibbli għar-reġim tat-terapija ta' manteniment u ta' solljiev.
English: Preparing your new BiResp Spiromax
Maltese: Profil farmakokinetiku ta' BiResp Spiromax
English: Cushing´s syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract and glaucoma.
Maltese: soppressjoni adrenali, dewmien fit-tkabbir tat-tfal u adolexxenti, tnaqqis fid-densità minerali tal għadam, katarretti u glawkoma.
English: • you have severe liver problems.
Maltese: • Taħbita tal-qalb mgħaġġla.
English: How to use BiResp Spiromax 4.
Maltese: Uża BiResp Spiromax tiegħek kuljum.
English: Do not use BiResp Spiromax 320/9 micrograms as a ‘reliever inhaler'.
Maltese: Tużax BiResp Spiromax 320/9 mikrogrammi bħala inalatur ta' solljiev.
English: Symptoms of adrenal gland suppression could be tiredness, weakness, stomach problems, including nausea, vomiting, pain and diarrhoea, darkening of the skin and weight loss.
Maltese: Sintomi ta' soppressjoni tal glandola adrenali jistgħu jkunu għeja, dgħjufija, problemi fl-istonku inklużi dardir, rimettar, uġigħ u dijarea, il-ġilda tiskura u telf ta' piż.
English: INSTRUCTIONS ON USE
Maltese: Avven imenti
English: Some medicines may increase the effects of BiResp Spiromax and your doctor may wish to monitor you carefully if you are taking these medicines (including some medicines for HIV: ritonavir, cobicistat).
Maltese: Xi mediċini jistgħu jżidu l-effetti ta' BiResp Spiromax u t-tabib tiegħek għandu mnejn ikun irid jimmonitorjak b'attenzjoni jekk tkun qed tieħu dawn il-mediċini (inklużi xi mediċini għall-HIV:
English: 3 inhalers each containing 60 doses.
Maltese: 2 inalaturi u kull inalatur fih 60 doża. 3 inalaturi u kull inalatur fih 60 doża.
English: 3 inhalers each containing 120 doses.
Maltese: 2 inalaturi u kull inalatur fih 120 doża. 3 inalaturi u kull inalatur fih 120 doża.
English: In usual practice when control of symptoms is achieved with the twice daily dose regimen with a lower strength product, titration to a lower effective dose could include once daily dosing when, in the opinion of the prescriber, a long-acting bronchodilator is required to maintain control rather than treatment with an inhaled corticosteroid alone.
Maltese: taħrix ripetut, li jkollhom sintomi sinifikanti minkejja terapija regolari bi bronkodilaturi li jaħdmu fit tul.
English: Pregnancy
Maltese: INALATUR
English: Pharmaceutical Form
Maltese: European Medicines Agency Veterinary Medicines
English: EU/2/99/011/001 Locatim >2.8log10 /ml bovine concentrated lactoserum
Maltese: Kemm irid jgħaddi ħin qabel ma l-annimal ikun jista' jinqatel u l-laħam tiegħu jintuża għallkonsum mill-bniedem (withdrawal period)?
English: 60 ml
Maltese: Paġna 2/2
English: Type III glass bottles
Maltese: Tagħrif ieħor dwar Locatim:
English: Strength
Maltese: ©EMEA 2007
English: Packaging Content Package sizeWithdrawal period
Maltese: Dan id-dokument huwa sommarju tar-Rapport tal-Valutazzjoni Pubblika Ewropew.
English: Oral solution Neonatal calves less than 12 hours of age
Maltese: Locatim hu soluzzjoni orali prodotta mill-kolostru li tingħata lill-għoġġiela fl-ewwel 12-il siegħa mit-twelid.
English: EU/1/15/1047/001 BLINCYTO
Maltese: EU/1/15/1047/001
English: Powder: 38.5 mcg Solution: 10 mL
Maltese: 38.5 mcg Soluzzjoni: 10 mL
English: 1 vial (powder) + 1 vial (solution)
Maltese: 1 kunjett ( trab ) + 1 kunjett (soluzzjoni )
English: 38.5 mcg Powder for concentrate and solution for solution for infusion
Maltese: BLINCYTO 38.5 mcg trab għallkonċentrat u soluzzjoni għal soluzzjoni għallinfużjoni.
English: Pack size
Maltese: Trab:
English: Intravenous use Powder: vial (glass)
Maltese: Trab: kunjett (ħġieġ ) Soluzzjoni: kunjett (ħġieġ )
English: What is Saroten?
Maltese: 'inhu Saroten?
English: • the treatment of serious depression (major depressive disorder)
Maltese: ' depressjoni serja (disturb depressiv maġġuri)
English: It contains the active substance amitriptyline.
Maltese: Fih is-sustanza attiva amitriptilina.
English: • treatment to prevent chronic tension-type headache (CTTH)
Maltese: -tip tensjoni kronika (CTTH)
English: The companies that market these medicines include Bayer GmbH and Lundbeck A/S.
Maltese: Il-kumpaniji li jqiegħdu dawn il-mediċini fis-suq huma Bayer GmbH u Lundbeck A/S.
English: The European Commission issued a decision on this opinion on 08/05/2017.
Maltese: Il-Kummissjoni Ewropea ħarġet deċiżjoni dwar din l-opinjoni fl-08/05/2017.
English: On 17 December 2015, the Greek medicines regulator, the National Organization for Medicines (EOF), referred the matter to the CHMP in order to harmonise the marketing authorisations for Saroten and associated names in the EU.
Maltese: 2015, ir-regolatur tal-mediċini Grieg, l-Organizzazzjoni Nazzjonali għall-Mediċini (EOF), irreferiet il-kwistjoni lis-CHMP sabiex jiġu armonizzati l-awtorizzazzjonijiet għat-tqegħid fis-suq għal Saroten u ismijiet assoċjati fl-UE.
English: Saroten and associated names (such as Redomex and Sarotex) is marketed in Austria, Belgium, Cyprus, Denmark, Estonia, Germany, Greece, Luxembourg, the Netherlands and Sweden, and also in Norway.
Maltese: -Danimarka, fl-Estonja, fil-Ġermanja, fil-Greċja, fil-Lussemburgu, fin-Netherlands u flIżvezja u anki fin-Norveġja.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for amitriptyline in the European Union (EU).
Maltese: ġenzija kkonkluda li he armonizzazzjoni tal-informazzjoni tal-preskrizzjoni għal amitriptyline fl-Unjoni Ewropea (UE).
English: The CHMP harmonised other sections of the SmPC including the warnings and precautions relating to treatment (4.4), and recommendations not to use the medicine during pregnancy and to consider the risks and benefits of use during breast feeding (4.6).
Maltese: Ic-CHMP armonizza sezzjonijiet oħrajn tas-SmPC inklużi t-twissijiet u l-prekawzjonijiet relatati malkura (4.4), u r-rakkomandazzjonijiet biex din il-mediċina ma tintużax waqt it-tqala u biex jiġu kkunsidrati r-riskji u l-benefiċċji tal-użu waqt it-treddigħ (4.6). Emendi oħrajn kienu jinkludu linformazzjoni dwar l-interazzjonijiet ma
English: Saroten is authorised in the EU via national procedures.
Maltese: Saroten huwa awtorizzat fl-UE permezz ta onali.
English: 4.3 Contra-indications
Maltese: 4.3 Kontraindikazzjonijiet Saroten ma g
English: Amitriptyline is also available in EU countries as generic amitriptyline.
Maltese: -UE bħala amitriptyline ġeneriku.
English: Use is not permitted in children less than 6 years of age.
Maltese: L-użu mhuwiex permess fi tfal li għandhom inqas minn 6 snin.
English: Saroten is available as modified-release capsules, tablets (including modifiedrelease tablets), and as a solution for injection.
Maltese: Saroten ji ġi bħala kapsuli ta modifikat), u bħala soluzzjoni għall-injezzjoni.
English: 4.1 Therapeutic indications The CHMP agreed that Saroten and associated names could be used in adults for:
Maltese: Is-CHMP qabel li Saroten u l-ismijiet assoċjati jistgħu jintużaw fl-adulti:
English: It should only be prescribed by a specialist doctor and should only be used when physical causes of the problem (including conditions such as spina bifida) have been ruled out and when other treatments, including other medicines used for this problem, have not worked.
Maltese: Din għandha tiġi preskritta biss minn tabib speċjalizzat u għandha tintuża biss meta l-kawżi fiżiċi tal-problema (inklużi kondizzjonijiet bħal spina bifida) ikunu ġew eliminati u meta kuri oħrajn, inklużi mediċini oħrajn użati għal din il-problema, ma jkunux ħadmu.
English: Treatment is usually by mouth and the dose depends on the condition to be treated; as the strengths of the different tablets and capsules can vary, it is important to choose one that allows the right dose to be given.
Maltese: Il-kura normalment tittieħed mill-ħalq u d-doża tiddependi mill-kundizzjoni li trid tiġi kkurata; peress li l-qawwiet tal-pilloli u l-kapsuli differenti jistgħu jvarjaw, huwa importanti li tintgħażel waħda li tippermetti li tingħata ddoża t-tajba.
English: On 23 February 2017, the European Medicines Agency completed a review of Saroten.
Maltese: Fit-23 ta ' Frar 2017, l-Aġenzija Ewropea għall-Medi ċini temmet rieżami ta' Saro
English: Questions and answers on Saroten and associated names (amitriptyline)
Maltese: Saroten u ismijiet assoċjati (bħal Redomex u Sarotex) jiġi kkummerċjalizzat fl-Awstrija, fil-Belġju,
English: • treatment to prevent migraine.
Maltese: • għall-kura għall-prevenzjoni tal-emigranja.
English: The CHMP harmonised the doses to be used in the approved indications.
Maltese: Is-CHMP armonizza d-dożi li għandhom jintużaw fl-indikazzjonijiet approvati.
English: Saroten is a medicine used to treat a variety of conditions in the EU, including depression and various depressive states, a number of disorders associated with chronic (long-term) pain including the prevention of migraine or recurring headaches, and for the treatment of nocturnal enuresis (bedwetting) in children.
Maltese: Saroten huwa medi ċina użata biex tikkura varjetà ta' kundizzjon diversi stati depressivi o
English: While harmonising the use of Saroten in neuropathic pain and prevention of CTTH and migraine, the CHMP considered that Saroten should not be used for other forms of chronic pain.
Maltese: ' ċerti mediċini oxidase (MAOIs) fl-istess ħin ma ġimagħtejn) qabel titwaqqaf waħda minn dawn il-mediċini u jinbeda Saroten, jew bil-maqlub.
English: Annex IV Scientific conclusions radium Ra223 dichloride
Maltese: radium Ra223 dichloride
English: The PRAC concluded that the risks observed were unlikely to be due to bias.
Maltese: Il-PRAC ikkonkluda li r-riskji osservati x'aktarx li ma kinux dovuti għal preġudizzju.
English: Xofigo (radium Ra223 dichloride, also radium-223 herein) is a centrally authorised product indicated for the treatment of adults with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastases.
Maltese: Xofigo (radium Ra223 dichloride, ukoll radium-223 hawnhekk) huwa prodott awtorizzat ċentralment indikat għat-trattament ta' adulti b'kanċer tal-prostata reżistenti għall-kastrazzjoni, metastasi sintomatika tal-għadam u l-ebda metastasi vixxerali magħrufa.
English: Analyses of uncleaned preliminary data of a clinical trial evaluating Xofigo in combination with abiraterone acetate and prednisone/prednisolone in a patient population with asymptomatic or mildly symptomatic prostate cancer (ERA 223), found that the incidences of treatment emergent fractures and deaths were increased in the treatment arm (radium-223 dichloride plus abiraterone acetate and prednisone/prednisolone) compared to the control arm (placebo plus abiraterone acetate and prednisone/prednisolone).
Maltese: Analiżi ta' data preliminari mhux imnaddfa ta' prova klinika li evalwat Xofigo flimkien ma' abiraterone acetate u prednisone/prednisolone f'pazjenti b'kanċer tal-prostata mhux sintomatiku jew ftit sintomatiku (ERA 223), sabet li l-inċidenzi ta' fratturi u mwiet emerġenti ta' trattament kienu miżjudin fil-fergħa ta' trattament (radium-223 dichloride flimkien ma' abiraterone acetate u prednisone/prednisolone) meta mqabbla mal-fergħa ta' kontroll (plaċebo flimkien ma' abiraterone acetate u prednisone/prednisolone).
English: • The PRAC considered the procedure under Article 20 of Regulation (EC) No 726/2004 resulting from pharmacovigilance data, in particular regarding the need for provisional measures in accordance with Article 20(3) of Regulation (EC) No 726/2004 for Xofigo (radium Ra223 dichloride) and taking into account the grounds set out in Articles 116 of Directive 2001/83/EC.
Maltese: • Il-PRAC ikkunsidra l-proċedura skont l-Artikolu 20 tar-Regolament (KE) Nru 726/2004 bħala riżultat ta' data dwar il-farmakoviġilanza, b'mod partikolari rigward il-ħtieġa għal miżuri provviżorji skont l-Artikolu 20(3) tar-Regolament (KE) Nru 726/2004 għal Xofigo (radium Ra223 dichloride) filwaqt li qies ir-raġunijiet stabbiliti fl-Artikoli 116 tad-Direttiva 2001/83/KE.
English: The Committee, as a consequence, recommends the variation to the terms of the marketing authorisation for Xofigo (radium Ra223 dichloride).
Maltese: Bħala konsegwenza, il-Kumitat jirrakkomanda l-varjazzjoni għat-termini talawtorizzazzjoni għat-tqegħid fis-suq għal Xofigo (radium Ra223 dichloride).
English: Scientific conclusions
Maltese: Anness IV
English: Interim results of the REASSURE study report also a significant concomitant use with enzalutamide in clinical practice (22%).
Maltese: Ir-riżultati interim tal-istudju REASSURE jirrappurtaw ukoll użu sinifikanti konkomitanti ma' enzalutamide fil-prattika klinika (22%).
English: Whilst the exact extent of use of radium-223 in combination with abiraterone acetate and prednisolone/prednisone in clinical practice is not known, interim data from an observational study (REASSURE) reported that 5% of patients were treated with this combination.
Maltese: Filwaqt li l-firxa eżatta ta' użu ta' radium-223 flimkien ma' abiraterone acetate u prednisolone/prednisone fil-prattika klinika mhix magħrufa, data interim minn studju osservatorju (REASSURE) irrapportat li 5% tal-pazjenti kienu kkurati b'din il-kombinazzjoni.
English: Whilst at this stage it is not excluded that the concurrent administration of radium-223 + abiraterone + prednisolone/prednisone is critical to the subsequent increased risks of fractures and death, it cannot be excluded either that the risks observed could apply to other effective androgen receptor antagonists.
Maltese: Filwaqt li f'dan l-istadju mhuwiex eskluż li l-għoti simultanju ta' radium-223 + abiraterone + prednisolone/prednisone huwa kritiku għar-riskji miżjuda sussegwenti ta' fratturi u mewt, ma jistax jiġi eskluż li r-riskji osservati jistgħu japplikaw għal riċetturi tal-androġeni effettivi oħra.
English: • The PRAC reviewed the preliminary data analyses of Study ERA 223 that suggested an increased risk of fracture and mortality when radium Ra223 dichloride treatment, compared to placebo, is initiated concurrently with abiraterone acetate and prednisone/prednisolone treatment.
Maltese: • Il-PRAC irreveda l-analiżi tad-data preliminari ta' Studju ERA 223 li ssuġġerixxa riskju akbar ta' ksur u mortalità meta kura b'radium Ra223 dichloride, meta mqabbla ma' plaċebo, tinbeda flistess ħin ma' abiraterone acetate u ma' kura ta' prednisone/prednisolone.
English: The PRAC considered preliminary data analyses from a randomized, placebo-controlled multicentre phase III study (15396/ERA-223) in chemotherapy-naïve patients with asymptomatic or mildly symptomatic castration resistant prostate cancer with bone metastases (CRPC).
Maltese: III b'aktar minn ċentru wieħed (15396 / ERA-223) ikkontrollat bi plaċebo f'pazjenti li qatt ma ħadu l-kemoterapija qabel, b'kanċer mhux sintomatiku jew ftit sintomatiku tal-prostata reżistenti għall-kastrazzjoni b'metastasi flgħadam (CRPC, castration resistant prostate cancer).
English: • In addition, in the absence of definite evidence that the results observed were specific to the combination with abiraterone acetate and prednisone/prednisolone, the PRAC considered that healthcare professionals and patients should be warned that the safety and efficacy of radium Ra223 dichloride in combination with second-generation androgen receptor antagonists including enzalutamide have not been established.
Maltese: • Barra minn hekk, fin-nuqqas ta' evidenza definita li r-riżultati osservati kienu speċifiċi għallkombinazzjoni ma' abiraterone acetate u prednisone/prednisolone, il-PRAC qies li lprofessjonisti tal-kura tas-saħħa u l-pazjenti għandhom jiġu mwissija li s-sigurtà u l-effikaċja tad-radium Ra223 dichloride flimkien ma' antagonisti ta' riċetturi ta' androġeni tat-tieni ġenerazzjoni inkluż enzalutamide ma ġewx stabbiliti.