FrancophonIA/ELRC3.0 huggingface dataset:
English: Due to the proteinaceous nature of the product, particle formation may occur in the reconstituted solution and final infusion bags.
Maltese: Minħabba n-natura proteinaceous tal-prodott, jista' jifforma frak fis-soluzzjoni rikostitwita u fil-boroż ta' l-infużjoni finali.
English: Myozyme is used to treat adults, children and adolescents of all ages who have a confirmed diagnosis of Pompe disease.
Maltese: Myozyme jintuża għall-kura ta' persuni adulti, tfal u adolexxenti ta' kull età li jkollhom dijanjosi kkonfermata tal-marda ta' Pompe.
English: At the end of the study (with individual patient treatment durations ranging from 60 to 150 weeks; mean follow-up period of 119 weeks) 14 of 16 patients were alive and 9 of 16 patients were alive and free of invasive ventilatory support.
Maltese: Fit-tmiem tal-istudju (bit-tul tal-kura ta' pazjenti individwali li varja minn 60 sa 150 ġimgħa; il-medja tal-perjodu follow-up kienet ta' 119-il ġimgħa) 14 minn 16-il pazjent kienu ħajjin, u 9 minn 16-il pazjent kienu ħajjin u ħielsa minn sapport ta' ventilazzjoni invażiva.
English: At 104 weeks of treatment, all 13 patients with available data had maintained or improved weight-for-age percentiles (above the 3rd percentile), all 12 patients with available data were above the 3rd percentile for length and all 12 patients with available data were above the 3rd percentile for head circumference.
Maltese: Wara 104 ġimgħat ta' kura, it-13-il pazjent kollha b'dejta disponibbli żammew jew tejbu l-percentiles piż-età (‘il fuq mit-3et percentile), it-12-il pazjent kollha b'dejta disponibbli kienu ‘l fuq mit-3et percentile għat-tul, u t-12-il pazjent kollha b'dejta disponibbli kienu ‘l fuq mit-3et percentile għaċ-ċirkonferenza tar-ras.
English: The infantile-onset form of Pompe disease is characterised by massive deposition of glycogen in the heart, and skeletal muscle always resulting in rapidly progressive cardiomyopathy, generalised muscle weakness and hypotonia.
Maltese: F'pazjenti li fihom il-marda ta' Pompe bdiet fl-infanzja, din tkun ikkaratterizzata minn depożitu massiv ta' glycogen fil-qalb u fil-muskoli skeletriċi, li dejjem jirriżulta f'kardjomijopatija progressiva mgħaġġla, dgħjufija ġeneralizzata fil-muskoli u ipotonija.
English: In clinical studies, the majority of patients developed IgG antibodies to alglucosidase alfa typically within 3 months of treatment.
Maltese: IgG għal alglucosidase alfa, tipikament fi żmien 3 xhur minn meta bdiet il-kura.
English: not known
Maltese: OĦRA TAL
English: Usually, it is characterised by the presence of sufficient residual GAA activity to preclude the development of cardiomyopathy, however some cardiac involvement has been reported in up to approximately 4% of patients with late-onset Pompe disease.
Maltese: Normalment, din tkun ikkaratterizzata mill-preżenza ta' attività GAA residwa suffiċjenti li tipprekludi l-iżvilupp ta' kardjomijopatija; madankollu xi involviment kardijaku kien irrappurtat f'sa madwar 4% tal-pazjenti li fihom il-marda ta' Pompe bdiet tard fil-ħajja.
English: After 78 weeks, patients treated with Myozyme showed improvement in distance walked as measured by 6MWT and stabilization of pulmonary function as measured by FVC % predicted as compared to placebo-treated patients.
Maltese: Wara 78 ġimgħa, il-pazjenti kkurati b'Myozyme wrew titjib fid-distanza li mxew kif imkejla bis-6MWT u stabilizzazzjoni tal-funzjoni pulmonari kif imkejla bil-% imbassar talFVC meta mqabbel mal-pazjenti kkurati bil-plaċebo.
English: Abdominal pain Retching
Maltese: Edema periorbitali
English: Medical or healthcare professionals are encouraged to register patients who are diagnosed with Pompe disease at www.PompeRegistry.com.
Maltese: Persuni mediċi jew professjonisti fil-qasam tas-saħħa huma inkoraġġiti biex jirreġistraw pazjenti li huma dijanjostikati bil-marda ta' Pompe, fuq www.PompeRegistry.com.
English: Face edema Feeling hot Pyrexia
Maltese: Tertir ta' bard Skonfort fis-sider Irritabilità
English: There was no difference in the pharmacokinetic profile of alglucosidase alfa in these juvenile lateonset patients compared to infantile-onset patients.
Maltese: Ma kien hemm l-ebda differenza fil-profil farmakokinetiku ta' alglucosidase alfa f'pazjenti li fihom il-marda bdiet tard fil-ħajja meta mqabbla ma' pazjenti li fihom il-marda bdiet fl-infanzja.
English: Tremor Headache
Maltese: Fwawar mhux magħruf
English: Erythema
Maltese: Dardir
English: Patients received 20 mg/kg Myozyme once every two weeks for 52 weeks except for 8 patients who received 40 mg/kg after at least 26 weeks of treatment.
Maltese: Il-pazjenti rċivew 20 mg/kg ta' Myozyme darba kull ġimagħtejn għal 52 ġimgħa ħlief għal 8 pazjenti li rċivew 40 mg/kg wara mill-inqas 26 ġimgħa ta'
English: Immune-mediated reactions
Maltese: IL-PRODOTT MEDIĊINALI
English: Symptoms of life-threatening allergic reactions include, but are not limited to, low blood pressure, very fast heart rate, difficulty breathing, vomiting, facial swelling, hives or rash.
Maltese: Sintomi ta' reazzjonijiet allerġiċi ta' periklu għall-ħajja jinkludu, iżda mhumiex limitati għal, pressjoni tad-demm baxxa, rata mgħaġla ħafna ta' taħbit tal-qalb, diffikultà biex tieħu n-nifs, rimettar, nefħa fil-wiċċ, urtikarja jew raxx.
English: There does not appear to be a correlation between the onset of IARs and the time of IgG antibody formation.
Maltese: Ma jidher li hemm l-ebda korrelazzjoni bejn il-bidu ta' IARs u ż-żmien talformazzjoni ta' l-antikorpi għal IgG.
English: Patients who experience hypersensitivity reactions may also be tested for IgE antibodies to alglucosidase alfa and other mediators of anaphylaxis.
Maltese: Pazjenti li jkollhom reazzjonijiet ta' sensittività eċċessiva jistgħu wkoll jiġu ttestjati għal antikorpi għal IgE għal alglucosidase alfa u medjaturi oħrajn tal-anafilassi.
English: In the rabbit embryofoetal development study, following administration of Myozyme (10-40 mg/kg/day) with coadministration of diphenhydramine, a treatment-related increase in the incidence of abortions and early delivery was observed.
Maltese: Fi studju dwar l-iżvilupp embrijufetali fil-fniek, wara l-għoti ta' Myozyme (10-40 mg/kg/kuljum) flimkien mal-għoti ta' diphenhydramine, kienet osservata żieda fl-inċidenza ta' korrimenti u ħlas qabel iż-żmien relatata mal-kura.
English: Survival
Maltese: Sfura
English: The company wanted the authorisation of Nanotop to be recognised in Austria, Finland, France, Italy, Norway, Portugal, Spain, Sweden and the United Kingdom (the ‘concerned Member States').
Maltese: Il-kumpanija riedet li l-awtorizzazzjoni ta' Nanotop tiġi rikonoxxuta fl-Awstrija, fil-Finlandja, fi Franza, fl-Italja, fin-Norveġja, fil-Portugall, fi Spanja, flIsvezja u fir-Renju Unit (‘l-Istati Membri kkonċernati').
English: What is Nanotop?
Maltese: X'inhu Nanotop?
English: Nanotop is a kit for the preparation of a radioactive suspension for injection.
Maltese: Nanotop huwa kitt għall-preparazzjoni ta' suspensjoni radjuattiva għal injezzjoni.
English: It contains particles of the human protein albumin which are attached to radioactive technetium (99mTc) before use.
Maltese: Fih partikuli talalbumina tal-proteina umana li huma mwaħħlin ma' technetium (99mTc) radjuattiv qabel l-użu.
English: Why was Nanotop reviewed?
Maltese: Għaliex ġie rivedut Nanotop?
English: ROTOP Pharmaka AG submitted Nanotop for mutual recognition on the basis of the initial authorisation granted by the German medicines regulatory agency on 8 December 2011.
Maltese: ROTOP Pharmaka AG issottomettiet Nanotop għal rikonoxximent reċiproku fuq il-bażi talawtorizzazzjoni inizjali mogħtija mill-aġenzija regolatorja tal-mediċini Ġermaniża fit-8 ta' Diċembru 2011.
English: Questions and answers on Nanotop and associated names (human albumin colloidal particles, kit for radiopharmaceutical preparation)
Maltese: Mistoqsijiet u tweġibiet dwar Nanotop u ismijiet assoċjati (partikuli kollojdali talalbumina umana, kitt għall-preparazzjoni radjofarmaċewtika)
English: The initial authorisation was based on a well-established-use application, which relied on published data with a similar product named Nanocoll.
Maltese: L-awtorizzazzjoni inizjali kienet ibbażata fuq applikazzjoni ta' użu stabbilit sew, li ddependiet fuq dejta ppubblikata bi prodott simili msejjaħ Nanocoll.
English: The CHMP therefore considered that these medicines can be considered comparable in quality and that the benefits of Nanotop outweigh its risks.
Maltese: Għaldaqstant, is-CHMP qies li dawn il-mediċini jistgħu jitqiesu bħala komparabbli fil-kwalità u li l-benefiċċji ta' Nanotop jisbqu r-riskji tiegħu.
English: The CHMP assessed additional supportive data provided by the company comparing the particle size of Nanotop with that of Nanocoll and the variability in particle size between different batches of each medicine.
Maltese: Is-CHMP ivvaluta dejta ta' appoġġ addizzjonali pprovduta mill-kumpanija li tqabbel id-daqs talpartikula ta' Nanotop ma' dak ta' Nanocoll u l-varjabilità fid-daqs tal-partikula bejn lottijiet differenti ta' kull mediċina.
English: During a scan the radioactive technetium can be detected, which help to obtain a clear image of the lymphatic system and to detect whether tumours have spread to the lymph nodes in patients with breast cancer or malignant melanoma (a type of skin cancer).
Maltese: Matul skennjatura, jista' jiġi rilevat technetium radjuattiv, li jgħin sabiex jikseb immaġni ċara tas-sistema limfatika u sabiex jikxef jekk tumuri jkunux infirxu għan-nodi limfatiċi f'pazjenti b'kanċer tas-sider jew b'melanoma (tip ta' kanċer tal-ġilda) malinna.
English: However, the Member States were not able to reach an agreement and the German medicines regulatory agency referred the matter to the CHMP for arbitration on 26 September 2013.
Maltese: Madankollu, l-Istati Membri ma setgħux jilħqu ftehim u l-aġenzija regolatorja tal-mediċini talĠermanja, irriferiet il-kwistjoni lis-CHMP għal arbitraġġ fis-26 ta' Settembru 2013.
English: When injected, it passes through in the lymphatic system (a network of vessels that transport fluid from tissues through the lymph nodes and into the bloodstream).
Maltese: Meta injettat, jgħaddi mis-sistema limfatika (netwerk ta' vini li jġorru l-fluwidu mit-tessuti permezz ta' nodi limfatiċi u fil-fluss tad-demm).
English: Nanotop is for diagnostic use.
Maltese: Nanotop huwa għal użu dijanjostiku biss.
English: Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that particle size and its batch variability are similar for Nanotop and Nanocoll.
Maltese: Abbażi tal-evalwazzjoni tad-dejta disponibbli u tad-diskussjoni xjentifika fi ħdan ilKumitat, is-CHMP ikkonkluda li d-daqs tal-partikula u l-varjabbiltà tal-lott tagħha huma simili għal Nanotop u Nanocoll.
English: The grounds for the referral were concerns raised by Sweden that Nanotop could not be considered comparable in quality to Nanocoll, particularly because of supposed differences in particle sizes between the two products.
Maltese: Ir-raġunijiet għar-referenza kienu tħassib imqajjem mill-Isvezja li Nanotop ma jistax jitqies komparabbli fil-kwalità ma' Nanocoll, b'mod partikolari minħabba d-differenzi preżunti fid-daqsijiet talpartikuli bejn iż-żewġ prodotti.
English: It recommended that Nanotop be granted marketing authorisation in the concerned Member States.
Maltese: Mistoqsijiet u tweġibiet dwar Nanotop u ismijiet assoċjati
English: On 19 December 2013, the European Medicines Agency completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Nanotop.
Maltese: Fid-19 ta' Diċembru 2013, l-Aġenzija Ewropea tal-Mediċini temmet proċedura ta' arbitraġġ wara nuqqas ta' ftehim bejn Stati Membri tal-Unjoni Ewropea (UE) fir-rigward tal-awtorizzazzjoni talmediċina Nanotop. Il-Kumitat tal-Aġenzija għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) ikkonkluda li l-benefiċċji ta' Nanotop jisbqu r-riskji tiegħu, u li l-awtorizzazzjoni għat-tqegħid fis-suq li ngħatat fil-Ġermanja tista' tiġi rikonoxxuta fl-Istati Membri tal-UE l-oħrajn.
English: 1114 AB Amsterdam-Duivendrecht Netherlands
Maltese: 1114 AB Amsterdam-Duivendrecht L-Olanda
English: Study 3 (MEC)
Maltese: Studju 3 (MEC)
English: Date of first authorisation: 20 April 2017
Maltese: April 2017
English: The active substance is rolapitant.
Maltese: Is-sustanza attiva hi rolapitant.
English: OATP1B1 and 1B3 substrates
Maltese: Substrati ta' OATP1B1 u ta' 1B3
English: - Film-coat: polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, indigo carmine (E132), and polysorbate 80.
Maltese: • Il-kisja tal-pillola: polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, indigo carmine (E 132), u polysorbate 80.
English: Day 2 Day 3 Day 4
Maltese: Jum 2 Jum 3 Jum 4
English: Age, Sex and Race/Ethnicity
Maltese: Farmakokinetika f'popolazzjonijiet speċjali Età, Sess u Razza/Etniċità
English: Dexamethasone 20 mg orally; 30 min prior to chemotherapy
Maltese: Dexamethasone 20 mg b'mod orali; 30 min qabel il-kimoterapija
English: Rolapitant is a selective antagonist of human substance P/neurokinin 1 (NK1) receptors.
Maltese: Rolapitant huwa antagonist selettiv tar-riċetturi tas-sustanza umana P/neurokinin 1 (NK1).
English: HEC Study 1
Maltese: Studju HEC 1
English: - The recommended dose is 180 mg (two 90 mg tablets).
Maltese: • Id-doża rakkomandata hija 180 mg (żewġ pilloli ta' 90 mg).
English: This is not expected to be clinically relevant.
Maltese: Dan mhuwiex mistenni li jkun klinikament rilevanti.
English: Elderly people (≥ 65 years)
Maltese: Anzjani (≥ 65 sena)
English: Rolapitant is a moderate CYP2D6 inhibitor.
Maltese: Rolapitant huwa inibitur moderat ta' CYP2D6.
English: Delayed Acute Overall
Maltese: Ittardjata Akuta Globali
English: No Significant Nausea (maximum VAS <25 on 0-100 scale)
Maltese: L-Ebda Dardir Sinifikanti (VAS massima < 25 fuq skala ta' 0-100 )
English: HEC Study 2
Maltese: Studju HEC 2
English: Each tablet contains 90 mg of rolapitant (as hydrochloride monohydrate).
Maltese: Kull pillola fiha 90 mg ta' rolapitant (bħala hydrochloride monohydrate).
English: Control (N=535) Rate
Maltese: Kontroll (N=535) Rata
English: Delayed Acute
Maltese: Ittardjata Akuta
English: NK1 Receptor Occupancy
Maltese: Okkupanza tar-Riċetturi NK1
English: The most common adverse reactions were fatigue (1.9%) and headache (1.5%).
Maltese: L-aktar reazzjonijiet avversi komuni kienu għeja (1.9 %) u wġigħ ta' ras (1.5 %).
English: Pharmacotherapeutic group: Antiemetics and antinauseants, other antiemetics, ATC code: A04AD14
Maltese: Antiemetiċi u antinawsjanti, antiemetiċi oħra, Kodiċi ATC:
English: Rolapitant was highly protein bound to human plasma (99.8%).
Maltese: Rolapitant weħel ħafna mal-proteini tal-plażma tal-bniedem (99.8 %).
English: Study 1 and Study 2 (HEC)
Maltese: Studju 1 u Studju 2 (HEC)
English: Rolapitant is an inhibitor of P-glycoprotein (P-gp).
Maltese: Rolapitant huwa inibitur tal-glikoproteina P (P-gp - P-glycoprotein).
English: Effects of other medicinal products on the pharmacokinetics of Varuby
Maltese: Effetti ta' prodotti mediċinali oħra fuq il-farmakokinetika ta' Varuby
English: UGT1A1 and UGT2B7 substrates (e.g. irinotecan and morphine, respectively) Rolapitant modestly inhibited UGT1A1 and UGT2B7 in vitro.
Maltese: Substrati ta' UGT1A1 and UGT2B7 (eż. irinotecan u morfina, rispettivament)
English: CYP3A4 substrates
Maltese: Substrati ta' CYP3A4
English: Control (N=666) Rate (%)
Maltese: Kontroll (N = 666) Rata (%)
English: Standard dose of 5-HT3 receptor antagonist.
Maltese: Doża standard tal-antagonist tar riċettur 5-HT3.
English: Varuby 90 mg tablets Rolapitant
Maltese: Varuby 90 mg pilloli Rolapitant
English: Acute
Maltese: Akut
English: Balance disorder Movement disorder Syncope
Maltese: Disturb fil-bilanċ Disturb fil-moviment Sinkope
English: Rolapitant is metabolised by CYP3A4 to form a major active metabolite, M19 (C4-pyrrolidinehydroxylated rolapitant).
Maltese: Rolapitant jiġi metabolizzat minn CYP3A4 biex jifforma metabolit attiv prinċipali, M19 (C4-pyrrolidine-hydroxylated rolapitant).
English: Delayed Overall
Maltese: Ittardjat Globali
English: Pack size of two tablets.
Maltese: Pakkett ta' żewġ pilloli
English: Study 1 and 2 Combined
Maltese: Studju Kombinat 1 u2
English: The following adverse reactions were observed in a pooled analysis of the Highly Emetogenic Chemotherapy (HEC) and Moderately Emetogenic Chemotherapy (MEC) studies.
Maltese: Emetoġenika Qawwija (HEC - Highly Emetogenic Chemotherapy) u Kimoterapija Moderatament Emetoġenika (MEC - Moderately Emetogenic Chemotherapy
English: Lactose monohydrate Pregelatinised starch Microcrystalline cellulose (E460) Povidone (K-30) Croscarmellose sodium Colloidal silicon dioxide Magnesium stearate
Maltese: pregelantinised starch, microcrystalline cellulose (E460), povidone (K-30), croscarmellose sodium, colloidal silicon dioxide u magnesium stearate.
English: Rolapitant is metabolised by CYP3A4 to form a major active metabolite, M19.
Maltese: Rolapitant jiġi metabolizzat minn CYP3A4 biex jifforma metabolit attiv prinċipali, M19.
English: Following administration of a single oral 180-mg dose of [14C]-rolapitant, on average 14.2% (range 9% to 20%) and 73% (range 52% to 89%) of the dose was recovered in the urine and feces, respectively over 6 weeks.
Maltese: 180-mg [14C]-rolapitant, medja ta' 14.2 % (medda ta' 9 % sa 20 %) u 73 % (medda ta' 52 % sa 89 %) tad-doża kienet irkuprata fl-awrina u fl-ippurgar, rispettivament fuq perjodu ta' 6 ġimgħat.
English: In a population pharmacokinetic analysis of rolapitant, the Vd/F was 387 L in cancer patients.
Maltese: F'analiżi farmakokinetika tal-popolazzjoni b'rolapitant, il-Vd/F kien 387 L f'pazjenti morda bil-kanċer.
English: Polyvinyl chloride/polychlorotrifluoroethylene/aluminium foil twinned blister.
Maltese: Folja tal-polyvinyl chloride/polychlorotrifluoroethylene/fojl tal-aluminju għal żewġ pilloli
English: P-gp substrates
Maltese: Substrati tal-P-gp
English: Rolapitant (N=535) Rate (%)
Maltese: Rolapitant (N=535) Rata (%)
English: Gait disturbance
Maltese: Disturbi vaskulari
English: Frequencies are defined as: Very common (≥1/10); common (≥1/100 to < 1/10); uncommon (≥1/1,000
Maltese: Komuni ħafna (≥ 1/10); komuni (≥ 1/100 sa < 1/10); mhux komuni (≥ 1/1,000 sa < 1/100); rari (≥ 1/10,000 sa < 1/1,000); rari ħafna (< 1/10,000); mhux magħruf: frekwenza ma tistax tiġi stmata mid-dejta disponibbli.
English: Rolapitant (N=271) Rate (%)
Maltese: Rolapitant (N=271) Rata (%)
English: TESARO Bio Spain S.L.U
Maltese: TESARO Bio Spain S.
English: At rolapitant plasma concentrations of >15 ng/mL and 348 ng/mL, the NK1 receptor occupancies in the cortical regions were approximately >50% and 90% respectively.
Maltese: B'konċentrazzjonijiet ta' rolapitant fil-plażma ta' > 15 ng/mL u 348 ng/mL, l-okkupanzi tar-riċetturi NK1 fir-reġjuni kortikali kienu madwar > 50 % u 90 %
English: Following multiple oral doses 9 to 45 mg once daily of rolapitant; accumulation of rolapitant was approximately 5-fold.
Maltese: Wara dożi orali multipli ta' 9 sa 45 mg darba kuljum ta' rolapitant; l-akkumulazzjoni ta' rolapitant kienet ta' madwar 5 darbiet.
English: The apparent volume of distribution (Vd/F) was 460 L in healthy subjects, indicating an extensive tissue distribution of rolapitant.
Maltese: Il-volum tad-distribuzzjoni apparenti (Vd/F) kien 460 L f'individwi b'saħħithom, li jindika distribuzzjoni estensiva ta' rolapitant fit-tessuti.
English: Of the 1070 patients, 26% were greater than 65 years of age and 3% were greater than 75 years of age.
Maltese: Mill-1,070 pazjent, 26 % kellhom aktar minn 65 sena u 3 % kellhom aktar minn 75 sena.
English: Each dose (two tablets) contains 230 mg of lactose.
Maltese: Kull doża (żewġ pilloli) fiha 230 mg ta' lattosju.
English: Rolapitant (N=264) Rate (%)
Maltese: Rolapitant (N=264) Rata (%)
English: Varuby is given as part of combination therapy (see section 4.2).
Maltese: Varuby jingħata bħala parti minn terapija kombinata (ara sezzjoni 4.2).
English: There are limited data in patients aged 75 years and older.
Maltese: Hemm data limitata f'pazjenti li għandhom 75 sena jew aktar.
English: Control (N=273) Rate
Maltese: Kontroll (N=273) Rata (%)
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Maltese: Pazjenti li għandhom problemi ereditarji rari ta' intolleranza għall-galactose,
English: Oral fungal infection Candidiasis Oral candidiasis
Maltese: Infezzjoni fungali orali
English: OCT1 substrates In vitro, rolapitant is not an inhibitor of OCT1 at the tested concentrations up to 20 µM.
Maltese: Substrati ta' OCT1 In vitro, rolapitant mhuwiex inibitur ta' OCT1 fil-konċentrazzjonijiet ittestjati sa 20 µM.
English: Increased plasma concentrations of BCRP substrates (e.g. methotrexate, irinotecan, topotecan, mitoxantrone, rosuvastatin, sulfasalazine, doxorubicin, bendamustine) may result in potential adverse reactions.
Maltese: topotecan, mitoxantrone, rosuvastatin, sulfasalazine, doxorubicin, bendamustine) fil-plażma jistgħu jwasslu għal reazzjonijiet avversi potenzjali.
English: In Study 3, a multicentre, randomised, double-blind, parallel group, controlled clinical study in moderately emetogenic chemotherapy, the rolapitant regimen (180 mg rolapitant, 2 mg oral granisetron and 20 mg oral dexamethasone) was compared with control therapy (placebo, 2 mg oral granisetron and 20 mg oral dexamethasone) on Day 1 in patients receiving a moderately emetogenic chemotherapy regimen that included 53% of patients receiving a combination of anthracycline and cyclophosphamide (AC).
Maltese: Fl-Istudju 3, studju kliniku multiċentriku, każwali double-blind, ikkontrollat, fuq grupp parallel dwar kimoterapija moderatament emetoġenika, il-programm ta' kura b'rolapitant (180 mg rolapitant, 2 mg granisetron orali u 20 mg dexamethasone orali) ġie mqabbel ma' terapija ta' kontroll (plaċebo, 2 mg granisetron orali u 20 mg dexamethasone orali) f'Jum 1 f'pazjenti li kienu qegħdin jirċievu programm ta' kura ta' kimoterapija moderatament emetoġenika li kien jinkludi 53 % tal-pazjenti li kienu qegħdin jirċievu kombinazzjoni ta' anthracycline u cyclophosphamide (AC).
English: Pack size of two tablets in a polyvinyl chloride/polychlorotrifluoroethylene/aluminium foil twinned blister.
Maltese: Pakkett ta' żewġ pilloli f'folja tal-polyvinyl chloride/polychlorotrifluoroethylene/fojl tal-aluminju għal żewġ pilloli.
English: Of these 1332 patients, 28% were greater than 65 years of age and 6% were greater than 75 years of age.
Maltese: Minn dawn l-1,332 pazjent, 28 % kellhom aktar minn 65 sena u 6 % kellhom aktar minn 75 sena.
English: Wallet card, each containing 2 film-coated tablets - WITH BLUE BOX
Maltese: KARTUNA TA' BARRA Kard tal-kartiera, kull waħda fiha 2 pilloli miksijin b'rita - BI "BLUE BOX"
English: Rolapitant is slowly eliminated with a mean terminal half-life of approximately 7 days.
Maltese: Rolapitant jiġi eliminat bil-mod b'half-life terminali medja ta' madwar 7 ijiem.
English: In vivo, rolapitant is not expected to exhibit any inhibitory or inducing effect on CYP3A4.
Maltese: In vivo, rolapitant mhuwiex mistenni li juri effetti inibitorji jew induttivi fuq CYP3A4.
English: In pooled samples collected over 2 weeks, 8.3% of the dose was recovered in the urine primarily as metabolites and 37.8% of the dose was recovered in the feces primarily as unchanged rolapitant.
Maltese: F'kampjuni kombinati miġburin fuq perjodu ta' ġimagħtejn, 8.3 % tad-doża kienet irkuprata fl-awrina prinċipalment bħala metaboliti u 37.8 % tad-doża kienet irkuprata fl-ippurgar prinċipalment bħala rolapitant mhux mibdul.
English: 8 mg orally twice daily
Maltese: 8 mg b'mod orali darbtejn kuljum
English: The formation of M19 was significantly delayed with the median Tmax of 120 hours (range: 24-168 hours) and the mean half-life of M19 was 158 hours.
Maltese: Il-formazzjoni ta' M19 kienet ittardjata b'mod sinifikanti bitTmax medjan ta' 120 siegħa (medda: 24-168 siegħa) u l-half-life medja ta' M19 kienet 158 siegħa.