FrancophonIA/ELRC3.0 huggingface dataset:
English: The active substance in Zoledronic acid Teva, zoledronic acid, is a bisphosphonate.
Maltese: Is-sustanza attiva f'Zoledronic acid Teva, l-aċidu żoledroniku, hija bisfosfonat.
English: This includes fractures (breaks in the bone), spinal compression (when the spinal cord is compressed by the bone), bone disorders needing radiotherapy (treatment with radiation) or surgery, and hypercalcaemia (high levels of calcium in the blood).
Maltese: Dan jinkludi ksur (ksur fl-għadam), kompressjoni fix-xewka tad-dahar (meta x-xewka tad-dahar tkun kompressata mill-għadam), disturbi fl-għadam li jeħtieġu rradjuterapija (kura bir-radjazzjoni) jew intervent kirurġiku, u iperkalċemija (livelli għoljin ta' kalċju fiddemm).
English: The CHMP concluded that, in accordance with EU requirements, Zoledronic acid Teva has been shown to be comparable to Zometa.
Maltese: Is-CHMP ikkonkluda li skont ir-rekwiżiti tal-UE, Zoledronic acid Teva wera li jista' jitqabbel ma' Zometa.
English: Other information about Zoledronic acid Teva
Maltese: Informazzjoni oħra dwar Zoledronic acid Teva
English: Zoledronic acid Teva is a medicine that contains the active substance zoledronic acid.
Maltese: Zoledronic acid Teva huwa mediċina li fiha s-sustanza attiva aċidu żoledroniku.
English: This means that Zoledronic acid Teva is similar to a ‘reference medicine' already authorised in the European Union (EU) called Zometa.
Maltese: Dan ifisser li Zoledronic acid Teva huwa simili għal ‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) bl-isem Zometa.
English: A risk management plan has been developed to ensure that Zoledronic acid Teva is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Zoledronic acid Teva jintuża bl-aktar mod sigur possibbli.
English: It is not recommended for patients with severe kidney problems.
Maltese: Mhuwiex irrakkomandat lil pazjenti bi problemi serji fil-kliewi.
English: What is Zoledronic acid Teva?
Maltese: X'inhu Zoledronic acid Teva?
English: Because Zoledronic acid Teva is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Billi Zoledronic acid Teva huwa mediċina ġenerika, il-benefiċċji u r-riskji tiegħu jitqiesu li huma l-istess bħal dawk tal-mediċina ta' referenza.
English: Zoledronic acid Teva zoledronic acid
Maltese: Għal xiex jintuża Zoledronic acid Teva?
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Zoledronic acid Teva, including the appropriate precautions to be followed by healthcare professionals and patients.
Maltese: Abbażi ta' dan il-pjan, fis-sommarju tal-karatteristiċi tal-prodott u fil-fuljett ta' tagħrif ġiet inkluża informazzjoni rigward is-sigurtà ta' Zoledronic acid Teva, inklużi l-prekawzjonijiet xierqa li għandhom jiġu segwiti mill-professjonisti tal-kura tas-saħħa u mill-pazjenti.
English: What are the benefits and risks of Zoledronic acid Teva?
Maltese: X'inhuma l-benefiċċji u r-riskji ta' Zoledronic acid Teva?
English: The full EPAR for the reference medicine can also be found on the Agency's website.
Maltese: L-EPAR sħiħ għall-mediċina ta' referenza jista' jinstab ukoll fuq is-sit tal-internet tal-Aġenzija.
English: Therefore, the CHMP's view was that, as for Zometa, the benefit outweighs the identified risk.
Maltese: Għaldaqstant, il-fehma tas-CHMP kienet li, bħal Zometa, il-benefiċċju huwa akbar mir-riskju identifikat.
English: When used to prevent bone complications, the infusion can be repeated every three to four weeks, and patients should also take supplements of calcium and vitamin D. A lower dose is recommended for patients with bone metastases (when cancer has spread to the bone) if they have mild to moderate problems with their kidneys.
Maltese: Hija rakkomandata doża aktar baxxa għall-pazjenti li jkollhom metastażi fl-għadam (meta l-kanċer jinfirex sal-għadam) jekk ikollhom problemi ħfief sa moderati fil-kliewi.
English: It is available as tablets (18 mg).
Maltese: Jiġi bħala pilloli (18 mg).
English: The full EPAR for Selincro 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: As a guide: a bottle of wine (750 ml; 12% alcohol by volume) contains approximately 70 g alcohol and a bottle of beer (330 ml; 5% alcohol by volume) contains approximately 13 g alcohol.
Maltese: Bħala gwida: flixkun inbid (750 ml; 12% alkoħol bil-volum) fih bejn wieħed u ieħor 70 g alkoħol u flixkun birra (330 ml; 5% alkoħol bil-volum) fih madwar 13 g alkoħol.
English: This summary was last updated in 02-2013.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar fi 02-2013.
English: Daily alcohol consumption with Selincro fell from 102 g to 44 g in the first study and from 113 g to 43 g in the second.
Maltese: Il-konsum talalkoħol ta' kuljum b'Selincro naqas minn 102 g għal 44 g fl-ewwel studju u minn 113 g għal 43 g fittieni.
English: This is a summary of the European public assessment report (EPAR) for Selincro.
Maltese: Dan huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Selincro.
English: Selincro was compared with placebo (a dummy treatment) in two main studies involving 1,322 men and women with alcohol dependence.
Maltese: Selincro tqabbel ma' plaċebo (kura finta) f'żewġ studji ewlenin li involvew 1,322 raġel u mara b'dipendenza fuq l-alkoħol.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Selincro on 25 February 2013.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq fl-Unjoni Ewropea kollha għal Selincro fil-25 ta' Frar 2013.
English: Selincro is medicine that contains the active substance nalmefene.
Maltese: Selincro huwa mediċina li fih is-sustanza attiva nalmefene.
English: The most common side effects (seen in more than 1 patient in 10) were nausea (feeling sick), dizziness, insomnia (difficulty sleeping) and headache.
Maltese: L-aktar effetti sekondarji komuni (li dehru f'aktar minn pazjent 1 minn 10) kienu dardir (tħossok ma tiflaħx), sturdament, insomnja (diffikultà fl-irqad) u uġigħ ta' ras.
English: These improvements were better than those seen with placebo by about 2.7 to 3.7 heavy drinking days a month and about 10 to 18 g of alcohol a day.
Maltese: Dan it-titjib kien aħjar minn dak li deher bi plaċebo b'madwar 2.7 għal 3.7 jiem ta' teħid ta' ammont kbir ta' alkoħol fix-xahar u madwar 10 sa 18 g ta' alkoħol kuljum.
English: Selincro does not prevent the intoxicating effects of alcohol.
Maltese: Selincro ma jimpedixxix l-effetti ta' intossifikazzjoni tal-alkoħol.
English: The effects of Selincro were first tested in experimental models before being studied in humans.
Maltese: L-effetti ta' Selincro ġew l-ewwel analizzati fuq mudelli sperimentali qabel ma ġew studjati fil-bniedem.
English: It must also not be used in patients with severe liver or kidney impairment or a recent history of acute alcohol withdrawal syndrome (including hallucinations, seizures (fits) and tremors).
Maltese: Lanqas ma għandu jintuża f'pazjenti b'indeboliment sever tal-fwied jew tal-kliewi jew storja reċenti ta' sindromu ta' rtirar tal-alkoħol akut (inkluż alluċinazzjonijiet, kollassi (palpitazzjonijiet) u rogħda).
English: Why has Selincro been approved?
Maltese: Għaliex ġie approvat Selincro?
English: The CHMP noted that Selincro was shown to be effective in reducing alcohol consumption in men drinking more than 60 g and women drinking more than 40 g a day.
Maltese: Is-CHMP innota li Selincro intwera li huwa effettiv biex inaqqas il-konsum tal-alkoħol f'irġiel li jixorbu aktar minn 60 g u f'nisa li jixorbu aktar minn 40 g kuljum.
English: Selincro is used to help reduce alcohol consumption in adults with alcohol dependence who consume more than 60 g of alcohol per day (for men) or more than 40 g per day (for women).
Maltese: Selincro jintuża sabiex jgħin inaqqas il-konsum tal-alkoħol fl-adulti b'dipendenza fuq l-alkoħol li jikkunsmaw aktar minn 60 g ta' alkoħol kuljum (għall-irġiel) jew aktar minn 40 g kuljum (għan-nisa).
English: Data on the use of Selincro from standard clinical studies are available for a period of six months to one year.
Maltese: Dejta dwar l-użu ta' Selincro minn studji kliniċi standard hija disponibbli għal perjodu ta' sitt xhur sa sena.
English: Selincro was shown to be more effective than placebo in reducing the number of heavy drinking days and daily alcohol consumption.
Maltese: Selincro intwera li huwa aktar effettiv minn plaċebo fit-tnaqqis tan-numru ta' jiem ta' ammont kbir ta' xorb u konsum ta' alkoħol ta' kuljum.
English: In these patients, after six months, the number of heavy drinking days a month with Selincro fell from 23 to 10 in the first study and from 23 to 11 in the second.
Maltese: F'dawn il-pazjenti, wara sitt xhur, in-numru ta' jiem ta' ammonti kbar ta' xorb ta' alkoħol fixxahar b'Selincro naqas minn 23 għal 10 fl-ewwel studju u minn 23 għal 11 fit-tieni.
English: What is Selincro?
Maltese: X'inhu Selincro?
English: How has Selincro been studied?
Maltese: Kif ġie studjat Selincro?
English: Selincro can only be obtained by prescription.
Maltese: Selincro jista' jinkiseb biss bi preskrizzjoni medika.
English: The CHMP decided that Selincro's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' Selincro huma akbar mir-riskji tiegħu u rrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: The active substance in Selincro, nalmefene, attaches to certain opioid receptors in the brain.
Maltese: Is-sustanza attiva f'Selincro, nalmefene, teħel ma' ċerti riċetturi ta' opjojdi fil-moħħ.
English: What is the risk associated with Selincro?
Maltese: X'inhu r-riskju assoċjat ma' Selincro?
English: België/Belgique/Belgien, България, Česká republika, Danmark, Eesti, Ελλάδα, Hrvatska, Ísland, Κύπρος, Latvija, Lietuva, Luxembourg/Luxemburg, Magyarország, Malta, Norge, Polska, Portugal, România, Slovenija, Slovenská republika,
Maltese: België/Belgique/Belgien, България, Česká republika, Danmark, Eesti, Ελλάδα, Hrvatska, Ísland, Κύπρος, Latvija, Lietuva, Luxembourg/Luxemburg, Magyarország, Malta, Norge, Polska, Portugal, România, Slovenija, Slovenská republika, Suomi/Finland, Sverige:
English: Primary Efficacy N=106
Maltese: Primarja N=106
English: Patients, n
Maltese: Pazjenti, n
English: Increases in serum aminotransferases (AST/ALT)
Maltese: Żieda fis-serum aminotransferases (AST/ALT)
English: Grade 4 reactions require treatment modification (see Table 2).
Maltese: Reazzjonijiet ta' Grad 4 jeħtieġu modifika fit-trattament (ara Tabella 2).
English: • The active substance is rucaparib.
Maltese: • Is-sustanza attiva hi rucaparib.
English: Clovis Oncology Ireland Ltd. Regus Dublin Airport Skybridge House - Dublin Airport Swords
Maltese: Regus Dublin Airport Skybridge House - Dublin Airport Swords
English: Almac Pharma Services Limited Seagoe Industrial Estate, Portadown,
Maltese: Almac Pharma Services Limited Seagoe Industrial Estate,
English: Date of first authorisation: 24 May 2018 Date of latest renewal: 13 March 2019
Maltese: Data tal-aħħar tiġdid: 13 Marzu, 2019
English: Breast-feeding (see section 4.6)
Maltese: Treddigħ (Ara sezzjoni 4.6).
English: HRD Groupc
Maltese: Grupp HRDc
English: Rucaparib Placebo
Maltese: Rucaparib Plaċebo
English: Clovis Oncology Spain, S.L.
Maltese: España Clovis Oncology Spain, S.L.
English: Microcrystalline cellulose Sodium starch glycolate (Type A) Colloidal anhydrous silica Magnesium stearate
Maltese: Microcrystalline cellulose Sodium starch glycolate (Tip A) Colloidal anhydrous silica Magnesium stearate
English: Iron oxide yellow (E172)
Maltese: (E553b), u iron oxide yellow (E172).
English: MedDRA system organ class
Maltese: Sistema tal-klassifika tal organi MedDRA
English: Increased alanine aminotransferase, Increased aspartate aminotransferase
Maltese: Żieda f'alanine aminotransferase, Żieda f'aspartate aminotransferase
English: Gastrointestinal toxicities
Maltese: Tossiċitajiet gastrointestinali
English: See section 4 for more information.
Maltese: Ara sezzjoni 4 għal aktar informazzjoni.
English: There are limited clinical data in patients aged 75 or over.
Maltese: Hemm data klinika limitata f'pazjenti li għandhom 75 sena jew aktar.
English: Embryofetal toxicity
Maltese: Tossiċità embrijufetali
English: Brilliant blue FCF aluminium lake (E133) Indigo carmine aluminium lake (E132)
Maltese: Brilliant Blue FCF aluminium lake (E133)
English: For risk mitigation and management, see section 4.4.
Maltese: Għall-mitigazzjoni tar-riskju u mmaniġġjar, ara sezzjoni 4.4.
English: Patients with germline (g)BRCA (n=88, 83.0%) or somatic (s)BRCA (n=18, 17.0%) mutations were included.
Maltese: Pazjenti b'mutazzjonijiet germline (g)BRCA (n=88, 83.0%) jew somatiċi (s)BRCA (n=18, 17.0%) ġew inklużi.
English: Caution is advised when co-administering medicinal products that are CYP3A substrates with a narrow therapeutic index (e.g., alfentanil, astemizole, cisapride, cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, tacrolimus, terfenadine).
Maltese: Il-kawtela hi rakkomandata meta jingħataw fl-istess ħin prodotti mediċinali li huma substrati ta' CYP3A b'indiċi terapewtiku dejjaq (eż., alfentanil, astemizole, cisapride, cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, tacrolimus, terfenadine).
English: Craigavon,
Maltese: Sturdament,
English: CYP1A2 substrates
Maltese: Substrati ta' CYP1A2
English: • Tablet content: Microcrystalline cellulose, sodium starch glycolate (Type A), colloidal anhydrous silica and magnesium stearate.
Maltese: Microcrystalline cellulose, sodium starch glycolate (Type A), colloidal anhydrous silica and magnesium stearate
English: CYP3A substrates
Maltese: Substrati ta' CYP3A
English: Events related to increases in alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were observed in 38% (all grades) and 11% (≥ CTCAE Grade 3) of patients.
Maltese: Avvenimenti relatati ma' żidiet fl-alanine aminotransferase (ALT) u aspartate aminotransferase (AST) kienu osservati fi 38% (il-gradi kollha) u 11 % (≥ CTCAE Grad 3) tal-pazjenti.
English: Increased transaminasesb
Maltese: Żieda fit-transaminasesb
English: K67 P6K2, Ireland
Maltese: K67 P6K2, L-Irlanda
English: At clinical exposures, rucaparib did not inhibit bile salt export pump (BSEP), OATP1B1, OATP1B3, OAT1 and OAT3.
Maltese: F'esponimenti kliniċi, rucaparib ma jinibixxix il-bile salt export pump (BSEP), OATP1B1, OATP1B3, OAT1, OAT3.
English: Due date: Q2
Maltese: Q2
English: The median duration of response was 196 days (95% CI [113 - NA]).
Maltese: It-tul ta' rispons medjan kien ta' 196 jum (95% CI [113 - NA]).
English: • medicines which suppress the immune system - such as ciclosporin, sirolimus or tacrolimus
Maltese: • mediċini li jrażżnu s-sistema immuni - bħal ciclosporin, sirolimus jew tacrolimus
English: • Rubraca is available as either 200 mg, 250 mg or 300 mg tablets.
Maltese: • Rubraca hu disponibbli bħala pilloli jew ta' 200 mg, 250 mg jew ta' 300 mg.
English: The primary efficacy outcome measure of both studies was objective response rate (ORR) as assessed by the investigator according to RECIST version 1.1.
Maltese: objective response rate) kif evalwat mill-investigatur skont RECIST verżjoni 1.1.
English: Kaplan-Meier Curves of Progression-Free Survival in ARIEL3 as Assessed by Investigator: ITT population
Maltese: Kurvi ta' Kaplan-Meier ta' Sopravivenza Mingħajr Progressjoni f'ARIEL3 kif Evalwata mill-Investigatur: Popolazzjoni ITT
English: Following repeated twice daily dosing, the accumulation based on AUC ranged from 3.5 to 6.2 fold.
Maltese: Wara dożi ripetuti darbtejn kuljum, l-akkumulazzjoni bbażata fuq l-AUC varjat minn 3.5 sa 6.2 darbiet.
English: Investigator Assessment
Maltese: Evalwazzjoni mill-Investigatur
English: Cardiac electrophysiology
Maltese: Elettrofiżjoloġija kardijaku
English: Rucaparib was not mutagenic in a bacterial reverse mutation (Ames) assay.
Maltese: Rucaparib ma kienx mutaġeniku f'assaġġ ta' mutazzjoni batterjoloġika invers (Ames).
English: In a population PK analysis, no clinically relevant PK differences were observed among patients with different CYP2D6 phenotypes (including poor metabolizers, n=9; intermediate metabolizers, n=71; normal metabolizers, n=76; and ultra-rapid metabolizers, n=4) or patients with different CYP1A2 phenotypes (including normal metabolizers, n=28; hyperinducers, n=136).
Maltese: F'analiżi ta' PK tal-popolazzjoni ma ġiet osservata l-ebda differenza PK klinikament rilevanti fost pazjenti b'fenotipi differenti ta' CYP2D6 (inklużi metabolizzaturi dgħajfa, n=9; metabolizzaturi medji, n=71; metabolizzaturi normali, n=76; u metabolizzaturi ultrarapidi, n=4) jew pazjenti b'fenotipi differenti ta' CYP1A2 (inklużi metabolizzaturi normali, n=28; iperindutturi,
English: • a low blood-cell count may be a sign of a serious bone marrow problem - such as ‘myelodysplastic syndrome' (MDS) or ‘acute myeloid leukaemia' (AML).
Maltese: • għadd baxx ta' ċelluli tad-demm jista' jkun sinjal ta' problema serja tal-mudullun - bħal ‘sindromu majelodisplastiku' (MDS, myelodysplastic syndrome) jew ‘lewkimja majelojde akuta' (AML, acute myeloid leukaemia).
English: Oxidation, N-demethylation, N-methylation, glucuronidation, and N-formylation were the major metabolic pathways for rucaparib.
Maltese: L-ossidazzjoni, in-N-demethylation, in-Nmethylation, il-glukoronidazzjoni, u n-N-formylation kienu l-passaġġi metaboliċi maġġuri għal rucaparib.
English: Liver transaminase elevations (aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT)) occur early in treatment and are generally transient.
Maltese: Żidiet fit-transaminases tal-fwied (aspartate aminotransferase (AST) u/jew alanine aminotransferase (ALT)) iseħħu kmieni fit-trattament u ġeneralment ikunu temporanji.
English: PFS events, n (%) PFS, median in months (95% CI)
Maltese: Avvenimenti ta' PFS, n (%) PFS, medjana f'xhur (95%
English: Anaemiab, Thrombocytopeniab, Neutropeniab
Maltese: Anemijab, Tromboċitopenijab,
English: The most abundant metabolite was M324, an oxidative deamination product of rucaparib, accounting for 18.6% of the radioactivity in plasma.
Maltese: L-aktar metabolit abbundanti kien M324, prodott ta' demainazzjoni ossidattiva ta' rucaparib, li ammonta għal 18.6 % tar-radjuattività fil-plażma.
English: HDPE bottle, with a polypropylene (PP) induction seal closure, containing 60 tablets.
Maltese: Flixkun tal-HDPE, b'għeluq b'siġill tal-induzzjoni tal-polypropylene (PP), li fih 60 pillola.
English: Enzymes responsible for rucaparib metabolism have not been identified.
Maltese: L-enzimi responsabbli għall-metaboliżmu ta' rucaparib ma ġewx identifikati.
English: Censoring N (%)
Maltese: Iċċensurar N (%)
English: Platinum-sensitive patients had received 2 (n=47, 59.5%), 3 (n=28, 35.4%), or > 3 (n=4, 5.1%) prior lines of platinumbased chemotherapy.
Maltese: Il-pazjenti sensittivi għall-platinum kienu rċivew 2 (n=47, 59.5%), 3 (n=28, 35.4%), jew > 3 (n=4, 5.1%) korsijiet ta' kimoterapija bbażati fuq il-platinum fil-passat.
English: • use a sunscreen and lip balm with a sun protection factor (SPF) of 50 or higher.
Maltese: • Trid tuża sunscreen u lip balm b'fattur għoli ta' protezzjoni kontra x-xemx (SPF, sun protection factor) ta' 50 jew ogħla.
English: Rucaparib accounted for 44.9% and 94.9% of radioactivity in urine and faeces, respectively; while M324 accounted for 50.0% and 5.1% of radioactivity in urine and faeces, respectively.
Maltese: Rucaparib ammonta għal 44.9 % u 94.9 % tar-radjuattività fl awrina u l-ippurgar, rispettivament, filwaqt li M324 ammonta għal 50.0 % u 5.1 % tar-radjuattività fl awrina u l-ippurgar, rispettivament.
English: CYP2C19 substrates
Maltese: Substrati ta' CYP2C19
English: Rubraca contains the active substance rucaparib.
Maltese: Rubraca fih is-sustanza attiva rucaparib.
English: Pregnancy/contraception
Maltese: Tqala/kontraċezzjoni
English: Photosensitivity reaction, Rash
Maltese: Reazzjoni għal fotosensittività, Raxx,
English: Interactions between rucaparib and oral contraceptives have not been studied.
Maltese: Ma ġewx studjati interazzjonijiet bejn rucaparib u kontraċettivi orali.
English: The mean half-life (t1/2) of rucaparib was 25.9 hours.
Maltese: Il medja tal-half-life (t1/2) ta' rucaparib kienet 25.
English: The mean absolute oral bioavailability following a single oral dose of 12 to 120 mg rucaparib was 36%.
Maltese: Il-medja tal-bijodisponibilità orali assoluta wara doża orali waħda ta' 12 sa 120 mg ta' rucaparib kienet 36%.
English: HR (95% CI) p-valueb
Maltese: HR (95% CI) valur pb
English: No significant P-gp inhibition was observed in vivo (section 4.5).
Maltese: Ma ġiet osservata l-ebda inibizzjoni sinifikanti ta' P-gp in vivo (sezzjoni 4.5).
English: In vitro, rucaparib reversibly inhibited CYP1A2, CYP2C19, CYP2C9, and CYP3A, and to a lesser extent CYP2C8, CYP2D6, and UGT1A1.
Maltese: In vitro, rucaparib inibixxa b'mod riversibbli lil CYP1A2, CYP2C19, CYP2C9, u CYP3A, u fi grad inqas lil CYP2C8, CYP2D6, u UGT1A1.
English: IRR- assessment for the ITT population supported the primary endpoint.
Maltese: L-evalwazzjoni tal-IRR għall-popolazzjoni ITT appoġġjat l-end-point primarju.
English: Haematological adverse reactions of all CTCAE Grades of anaemia, thrombocytopenia and neutropenia were reported in 42%, 26% and 16% of patients respectively.
Maltese: Reazzjonijiet avversi ematoloġiċi tal-Gradi CTCAE kollha ta' anemija, tromboċitopenija u newtropenija, ġew irrappurtati fi 42%, 26% u 16% tal-pazjenti, rispettivament.
English: months), and tumour biomarker status (tBRCA, non-BRCA homologous recombination deficiency [nbHRD] and biomarker negative).
Maltese: > 12-il xahar), u status tal-bijomarkatur tat-tumur (tBRCA, defiċjenza ta' rikombinazzjoni omologa mhux BRCA [nbHRD] u negattiv għall-bijomarkatur).
English: In vitro, rucaparib was shown to be a substrate of P-gp and BCRP, but not a substrate of renal uptake transporters OAT1, OAT3, and OCT2, or hepatic transporters OAPT1B1 and OATP1B3.
Maltese: In vitro, intwera li rucaparib hu substrat ta' P-gp u BCRP, iżda mhux substrat tat-trasportaturi talassorbiment renali OAT1, OAT3, u OCT2, jew trasportaturi epatiċi OAPT1B1 u OATP1B3.
English: Interaction of rucaparib with other enzymes and transporter was evaluated in vitro.
Maltese: L-interazzjoni ta' rucaparib ma' enzimi u trasportaturi oħra ġiet evalwata in vitro.
English: • medicines to treat stomach problems - such as cisapride, omeprazole
Maltese: • mediċini għat-trattament ta' problemi fl-istonku - bħal cisapride, omeprazole
English: Frequencies of occurrence of adverse reactions are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1000); very rare
Maltese: Il-frekwenzi talokkorrenza tar-reazzjonijiet avversi huma definiti bħala: komuni ħafna (≥ 1/10); komuni (≥ 1/100 sa < 1/10); mhux komuni (≥ 1/1,000 sa < 1/100); rari (≥ 1/10,000 sa < 1/1000); rari ħafna (< 1/10,000), mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: The adverse reaction frequency is listed by MedDRA System Organ Class (SOC) at the preferred term level.
Maltese: Il-frekwenza tar-reazzjonijiet avversi hi elenkata mis-Sistema tal-Klassifika talOrgani MedDRA (SOC, System Organ Class) fil-livell ta' terminu ippreferut.
English: The proportion of platinum-sensitive patients with gBRCA and sBRCA mutations was comparable to the primary efficacy population at n=66 (83.5%) and n=13 (16.5%) respectively.
Maltese: Il-proporzjon ta' pazjenti sensittivi għall-platinum b'mutazzjonijiet gBRCA u sBRCA kienu komparabbli mal-popolazzjoni tal-effikaċja primarja f'n=66 (83.5%) u n=13 (16.5%) rispettivament.
English: An analysis of progression-free survival (PFS) was also performed.
Maltese: Twettqet ukoll analiżi ta' sopravivenza mingħajr progressjoni (PFS, progression-free survival).