FrancophonIA/ELRC3.0 huggingface dataset:
English: In two multicentre, randomised, double-blind, parallel group, controlled clinical studies (Study 1 and Study 2), the rolapitant regimen (180 mg rolapitant, 10 mcg/kg intravenous granisetron and 20 mg oral dexamethasone) was compared with control therapy (placebo, 10 mcg/kg intravenous granisetron and 20 mg oral dexamethasone) on Day 1 in patients receiving a chemotherapy regimen that included cisplatin ≥60 mg/m2.
Maltese: F'żewġ studji kliniċi multiċentriċi, każwali, double-blind, ikkontrollati, fuq gruppi paralleli (Studju 1 u Studju 2), il-programm ta' kura b' rolapitant (180 mg rolapitant, 10 µg/kg granisetron fil-vini u 20 mg dexamethasone orali) ġie mqabbel ma' terapija ta' kontroll (plaċebo, 10 µg/kg granisetron fil-vini u 20 mg dexamethasone orali) f'Jum 1 f'pazjenti li kienu qegħdin jirċievu l-programm ta kura għall kimoterapija li kien jinkludi cisplatin ≥ 60 mg/m2.
English: Do not use this medicine after the expiry date which is stated on the carton and blister after ‘EXP'.
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq il-kartuna u l-folja wara “EXP”.
English: Increased plasma concentration of CYP2D6 substrates may result in potential adverse reactions.
Maltese: Iż-żieda fil-konċentrazzjoni ta' substrati ta' CYP2D6 fil-plażma tista' twassal għal reazzjonijiet avversi potenzjali.
English: The tablets are blue, debossed with T0101 on one side and 100 on the other side.
Maltese: Il-pilloli huma ta' lewn blu, imnaqqxa b'T0101 fuq naħa u 100 fuq in-naħa l-oħra.
English: Complete Response
Maltese: RESPONSABBLI
English: The percentage of patients who received carboplatin in Cycle 1 was 30%.
Maltese: Il-perċentwal ta' pazjenti li rċevew carboplatin fiċ-Ċiklu 1 kien ta' 30 %.
English: Due to its strong inducing effect, St John's wort is contraindicated with rolapitant (see section 4.3).
Maltese: Minħabba l-effett induttiv qawwi tiegħu, St John's wort huwa kontraindikat ma' rolapitant (ara sezzjoni 4.3).
English: A total of 1369 patients were randomised to either the rolapitant regimen (N=684) or control therapy (N=685).
Maltese: Total ta' 1,369 pazjent ġew magħżula b'mod aleatorju jew għall-programm ta' kura ta' rolapitant (N = 684) jew għat-terapija ta' kontroll (N = 685).
English: Varuby is not recommended in patients who require chronic administration of strong (e.g. rifampicin, carbamazepine, phenobarbital, enzalutamide, phenytoin) or moderate enzyme inducers (e.g. efavirenz, rifabutin) (see section 4.5)
Maltese: Varuby mhuwiex rakkomandat f'pazjenti li jeħtieġu l-amministrazzjoni kronika ta' indutturi qawwija (eż. rifampicin, carbamazepine, phenobarbital, enzalutamide, phenytoin) jew moderati (eż. efavirenz,
English: A 70% increase in Cmax and 30% increase in AUC of digoxin, a P-gp substrate, were observed when administered with a single dose of 180 mg rolapitant.
Maltese: Kienu osservati żieda ta' 70 % fis-Cmax u żieda ta' 30 % fl-AUC ta' digoxin, li huwa substrat tal-P-gp, meta dan ingħata ma' doża waħda ta' 180 mg rolapitant.
English: The exposure ratio of M19 to rolapitant was approximately 50% in plasma.
Maltese: Il proporzjon tal-esponiment ta' M19 għal rolapitant kien ta' madwar 50 % fil-plażma.
English: International Normalised Ratio increased Leukopenia
Maltese: Żieda fil-Proporzjon Normalizzat Internazzjonali Lewkopenija
English: At the 180 mg dose of rolapitant, the mean NK1 receptor occupancy in the cortical regions was greater than 90% for at least 120 hours.
Maltese: Bid-doża ta' 180 mg ta' rolapitant, l-okkupanza medja tar-riċetturi NK1 fir-reġjuni kortikali kienet akbar minn 90 % għal mill-anqas 120 siegħa.
English: Rolapitant did not affect the fertility or general reproductive performance of male rats.
Maltese: Rolapitant ma affettwax il-fertilità jew il-prestazzjoni riproduttiva ġenerali tal-firien irġiel.
English: The safety profile in the multiple-cycle extensions of highly and moderately emetogenic chemotherapy studies for up to 6 cycles of chemotherapy is similar to the profile observed in Cycle 1.
Maltese: Il-profil tas-sigurtà fl-istudji ta' estensjonijiet ta' ċikli multipli ta' kimoterapija emetoġenika qawwija u moderata sa 6 ċikli ta' kimoterapija huwa simili għall-profil osservat f'Ċiklu 1.
English: Following single oral doses (4.5 to 180 mg) of rolapitant, the mean terminal half-life (t1/2) of rolapitant ranged from 169 to 183 hours (approximately 7 days) and was independent of dose.
Maltese: Wara dożi orali waħdiena (4.5 sa 180 mg) ta' rolapitant, il-half-life terminali medja (t½) ta' rolapitant kienet tvarja minn 169 sa 183 siegħa (madwar 7 ijiem) u kienet indipendenti mid-doża.
English: Rolapitant displays linear PK with exposures increased in a dose-proportional manner.
Maltese: Rolapitant juri farmakokinetika lineari bl-esponimenti jiżdiedu b'mod proporzjonali għad-doża.
English: Complete Response Rolapitant
Maltese: Rispons Komplet
English: The pharmacokinetics of Varuby was not studied in patients with severe hepatic impairment (Child-Pugh Class C).
Maltese: Ilfarmakokinetika ta' Varuby ma ġietx studjata f'pazjenti b'indeboliment epatiku sever (Child-Pugh
English: A single dose of 180 mg rolapitant had no significant effects on the pharmacokinetics of midazolam compared to oral midazolam 3 mg alone on Day 1, Day 8 and Day 11.
Maltese: 180 mg rolapitant ma kellha l-ebda effett sinifikanti fuq il-farmakokinetika ta' midazolam meta mqabbel ma' midazolam 3 mg orali waħdu f'Jum 1, Jum 8 u Jum 11.
English: Angioedema Dermatitis acneiform Dry skin
Maltese: Dermatite tixbah lill-akne
English: Dizziness and fatigue may occur following administration of rolapitant (see section 4.8).
Maltese: Jista' jkun hemm sturdament u għeja wara l-għoti ta' rolapitant (ara sezzjoni 4.8).
English: This medicinal product contains 230 mg of lactose (as monohydrate) per dose (two tablets).
Maltese: Dan il-prodott mediċinali fih 230 mg ta' lactose (bħala monohydrate) f'kull doża (żewġ pilloli).
English: Delayed
Maltese: Ittardjat
English: In a mass balance study, the metabolite M19 was the major circulating metabolite.
Maltese: Fi studju ta' bilanċ tal-massa, il-metabolit M19 kien il metabolit prinċipali fiċ-ċirkolazzjoni.
English: A 3-fold increase in the exposure of dextromethorphan, a CYP2D6 substrate, was observed 7 days after a single oral dose of rolapitant and may last longer.
Maltese: dextromethorphan, li huwa substrat ta' CYP2D6, kienet osservata 7 ijiem wara doża orali waħda ta' rolapitant u tista' ddum aktar.
English: A total of 1087 patients were randomised to either the rolapitant regimen (N=544) or control therapy (N=543) across Study 1 and Study 2; 1070 patients were included in the evaluation of efficacy; 37% were women and 63% were men.
Maltese: Total ta' 1,087 pazjent intgħażlu b'mod aleatorju jew għall-programm ta' kura ta' rolapitant (N = 544) jew għat-terapija ta' kontroll (N = 543) fl-Istudju 1 u fl-Istudju 2; 1,070 pazjent kienu inklużi flevalwazzjoni tal-effikaċja; 37 % kienu nisa u 63 % kienu rġiel.
English: Dexamethasone
Maltese: Mhux-AC
English: ANNEX II
Maltese: Appelhof 13
English: The absolute bioavailability of rolapitant is approximately 100%, indicating minimal first pass effect.
Maltese: Il-bijodisponibbiltà assoluta ta' rolapitant hija ta' madwar 100 %, li tindika effett minimu tal-ewwel passaġġ.
English: A dose-dependent increase in mean NK1 receptor occupancy was observed in the dose range from 4.5 mg to 180 mg of rolapitant.
Maltese: Kienet osservata żieda dipendenti fuq id-doża fl-okkupanza medja tar-riċetturi NK1 fil-medda ta' dożi minn 4.5 mg sa 180 mg ta' rolapitant.
English: - you have severe liver or kidney problems - you need to take certain medicines which may reduce the effectiveness of Varuby, such as: - rifampicin, to treat tuberculosis and other infections - carbamazepine, to treat epilepsy and nerve pain - phenobarbital, to treat epilepsy - enzalutamide, to treat prostate cancer - phenytoin, to treat epilepsy - efavirenz, to treat human immunodeficiency virus (HIV) - rifabutin, to treat tuberculosis and other infections - other medicines that contain an NK1 antagonist, such as aprepitant and a combination of netupitant and palonosetron hydrochloride (for the prevention of nausea and vomiting associated with cancer chemotherapy) (see section 2 under ‘Other medicines and Varuby')
Maltese: • trid tieħu ċerti mediċini li jistgħu jnaqqsu l-effettività ta' Varuby, bħal: rifampicin, għall-kura tat-tuberkulożi u infezzjonijiet oħra carbamazepine, għall-kura ta' epilessija u l-uġigħ fin-nervi phenobarbital, għall-kura ta' epilessija enzalutamide, għall-kura tal-kanċer tal-prostata phenytoin, għal trattament ta' epilessija - efavirenz, għall-kura tal-virus tal-immunodefiċjenza umana (HIV) - rifabutin għall-kura tat-tuberkulożi u infezzjonijiet oħra - mediċini oħra li fihom antagonist ta' NK1, bħal aprepitant u netupitant u palonosetron hydrochloride (għall-prevenzjoni ta' dardir u rimettar assoċjati ma' kimoterapija għallkanċer) (ara sezzjoni 2 taħt ‘Mediċini oħra u Varuby')
English: Each tablet contains 90 mg of rolapitant.
Maltese: Kull pillola fiha 90 mg ta' rolapitant.
English: 5-HT3 receptor antagonist
Maltese: Antagonist tar riċettur 5-HT3
English: Tablet content
Maltese: Kontenut tal-pillola
English: In population pharmacokinetic analyses, creatinine clearance (CLcr) at baseline did not show a significant effect on rolapitant pharmacokinetics in cancer patients with mild (CLcr: 60 to 90 mL/min) or moderate (CLcr: 30 to 60 mL/min) renal impairment compared to cancer patients with normal kidney function.
Maltese: F'analiżi farmakokinetika tal-popolazzjoni, it-tneħħija tal-kreatinina (CLcr) fil-linja bażi ma wrietx effett sinifikanti fuq il-farmakokinetika ta' rolapitant f'pazjenti morda bil-kanċer li kellhom indeboliment renali ħafif (CLcr: 60 sa 90 mL/min) jew moderat (CLcr: 30 sa 60 mL/min) meta mqabbel ma' pazjenti morda bil-kanċer li kellhom funzjoni tal-kliewi normali.
English: No clinically significant interaction is expected with the following medicinal products when administered with a single dose of 180 mg rolapitant on Day 1 and without rolapitant on Day 8: repaglinide 0.25 mg (a CYP2C8 substrate), efavirenz 600 mg (a CYP2B6 substrate), tolbutamide 500 mg (a CYP2C9 substrate) or omeprazole 40 mg (a CYP2C19 substrate).
Maltese: 0.25 mg (substrat ta' CYP2C8), efavirenz 600 mg (substrat ta' CYP2B6), tolbutamide 500 mg (substrat ta' CYP2C9) jew omeprazole 40 mg (substrat ta' CYP2C19).
English: A. LABELLING
Maltese: • deidrazzjoni
English: P-Valuea
Maltese: Valur-Pa
English: There are limited data in patients with severe renal impairment (see section 5.2).
Maltese: Pazjenti b'indeboliment renali sever Hemm dejta limitata dwar pazjenti b'indeboliment renali sever (ara sezzjoni 5.2).
English: In a population pharmacokinetic analysis the apparent total clearance (CL/F) of rolapitant was 0.96 L/hour in cancer patients.
Maltese: F'analiżi farmakokinetika tal-popolazzjoni, it-tneħħija apparenti totali (CL/F) ta' rolapitant kienet ta' 0.96
English: Single dose = 2 tablets
Maltese: OĦRA, JEKK MEĦTIEĠA Doża waħda = 2 pilloli
English: Contents of the pack and other information What Varuby contains
Maltese: Kontenut tal-pakkett u informazzjoni oħra X'fih Varuby
English: - if you take an herbal medicine called St John's wort (Hypericum performatum), used to treat depression and difficulty sleeping (see section 2 under ‘Other medicines and Varuby').
Maltese: • jekk tieħu mediċina erboristika msejħa St John's wort (Hypericum perforatum), użata għall-kura tad-dipressjoni u d-diffikultà biex torqod (ara sezzjoni 2 taħt ‘Mediċini oħra u Varuby').
English: Varuby in patients who require chronic administration of strong inducers (e.g. rifampicin, carbamazepine, enzalutamide, phenytoin) is not recommended (see section 4.4).
Maltese: carbamazepine, enzalutamide, phenytoin) (ara sezzjoni 4.4).
English: Varuby is given as part of a regimen that includes dexamethasone and a 5-HT3 receptor antagonist.
Maltese: Varuby jingħata bħala parti minn programm ta' kura li jinkludi dexamethasone u antagonist tarriċettur 5-HT3.
English: Arthralgia Back pain Muscular weakness Rhabdomyolysis
Maltese: Uġigħ fid-dahar Dgħufija fil-muskoli Rabdomjoliżi
English: The systemic exposures (Cmax and AUC) to rolapitant increased in a dose-proportional manner when the dose of rolapitant increased from 4.5 mg to 180 mg. With an increase in dose by 4 times from the recommended clinical dose of 180 mg, the Cmax and AUC of rolapitant increased by 3.1 fold and 3.7 fold, respectively.
Maltese: B'żieda ta' 4 darbiet fid-doża mid-doża klinika rakkomandata ta' 180 mg, is-Cmax u l-AUC ta' rolapitant żdiedu b'3.1 darbiet u 3.7 darbiet, rispettivament.
English: Cisplatin-Based Highly Emetogenic Chemotherapy (HEC)
Maltese: Effikaċja klinika u sigurtà Kimoterapija Emetoġenika Qawwija (HEC) Ibbażata fuq Cisplatin
English: Rolapitant had no effects on the pharmacokinetics of caffeine (a CYP1A2 substrate) when an oral dose of 200 mg caffeine was administered with a single dose of 180 mg rolapitant on Day 1, and without rolapitant on Day 8 and Day 15.
Maltese: Rolapitant ma kellu l-ebda effett fuq il-farmakokinetika tal-kaffeina (substrat ta' CYP1A2) meta doża orali ta' 200 mg kaffeina ġiet mogħtija flimkien ma' doża waħda ta' 180 mg rolapitant f'Jum 1, u mingħajr rolapitant f'Jum 8 u Jum 15.
English: At a dose equivalent to 4.5 mg/kg per day free base (approximately 0.2 times the recommended human dose on a body surface area basis), there were decreases in the number of corpora lutea and implantation sites.
Maltese: B'doża ekwivalenti għal 4.5 mg/kg kuljum bażi libera (madwar 0.2 darbiet id-doża rakkomandata fil-bniedem abbażi tal-erja tas superfiċje tal-ġisem), kien hemm tnaqqis fin-numru ta' corpora lutea u fis-siti tal-impjantazzjoni.
English: Adverse reactions per system organ class
Maltese: Reazzjonijiet avversi skont is-sistema tal-klassifika tal-organi
English: If use cannot be avoided, patients should be monitored for adverse reactions to Varuby (see section 4.8).
Maltese: Jekk l-użu ma jkunx jista' jiġi evitat, il-pazjenti għandhom jiġu mmonitorjati għar-reazzjonijiet avversi għal Varuby (ara sezzjoni 4.8).
English: Based on the environmental risk assessment, rolapitant is considered as very persistent, bioaccumulative and not readily biodegradable.
Maltese: Abbażi ta' stima ta' riskju ambjentali, rolapitant jitqies bħala persistenti ħafna, bijoakkumulattiv u mhux faċilment bijodegradabbli.
English: Study medicinal products were administered prior to chemotherapy on Day 1 at the following intervals: rolapitant (1 to 2 hours prior); granisetron and dexamethasone (30 minutes prior).
Maltese: 1 bl-intervalli li ġejjin: rolapitant (siegħa sa sagħtejn qabel); granisetron u dexamethasone (30 minuta qabel).
English: Hypoacusis Tinnitus
Maltese: • ġilda xotta
English: Table 1: Proportion of patients receiving cisplatin chemotherapy responding by treatment group and phase (Studies 1 and 2 - HEC Individual Results)
Maltese: Tabella 1: Proporzjon ta' pazjenti li kienu qegħdin jirċievu kimoterapija b'cisplatin li kellhom rispons skont il-grupp tal-kura u l-fażi (Studju 1 u 2 - Riżultati Individwali dwar HEC)
English: Vision blurred
Maltese: • vista mċajpra
English: Rolapitant This medicine is subject to additional monitoring.
Maltese: Dan il-prodott mediċinali huwa suġġett għal monitoraġġ addizzjonali.
English: Hepatic Impairment
Maltese: Indeboliment Epatiku
English: The proportion of patients with no impact on daily life was higher in the Varuby group than in the control group (MEC: 73.2% vs. 67.4%; p=0.027).
Maltese: 73.2 % vs. 67.4 %; p = 0.027).
English: When 600 mg rifampicin was administered once daily for 7 days before and 7 days after administration of a single dose of 180 mg rolapitant, the mean AUC was reduced by 87% and its active metabolite by 89% compared to administration of rolapitant alone.
Maltese: Meta 600 mg rifampicin ingħata darba kuljum għal 7 jiem qabel u 7 ijiem wara l-għoti ta' doża waħda ta' 180 mg rolapitant, l-AUC medju tnaqqas b'87% u l-metabolit attiv tiegħu b'89% meta mqabbel mal-għoti ta' rolapitant waħdu.
English: A total of 2,798 subjects received oral rolapitant at any dose, including 1,567 subjects in the CINV (chemotherapy-induced nausea and vomiting) studies.
Maltese: Aktar minn 4,375 pazjent ingħataw kura b'Varuby jew mediċina ta' tqabbil fl-istudji kliniċi ta' Fażi 1, 2, u 3. Total ta' 2,798 pazjent ingħataw rolapitant orali fi kwalunkwe doża, inkluż 1,567 pazjent flistudji dwar is-CINV (chemotherapy-induced nausea and vomiting) (dardir u rimettar ikkawżati mill kimoterapija).
English: On Day 2 to 3, patients received 2 mg once daily of oral granisetron.
Maltese: 2 mg darba kuljum ta' granisetron orali.
English: Study 3 - MEC Rolapitant (N=666) Rate (%)
Maltese: Rolapitant (N = 666) Rata (%)
English: Gastrooesophageal reflux disease
Maltese: Mard ta' rifluss gastroesofagali
English: Varuby contains lactose.
Maltese: Varuby fih il-lactose.
English: Figure 2: Kaplan-Meier Plot of Proportions of Patients without Emesis or Use of Rescue Medication (Study 3--MEC)
Maltese: Figura 2: Plott ta' Kaplan-Meier tal-Proporzjonijiet ta' Pazjenti mingħajr Rimettar jew Użu ta' Medikazzjoni ta' Salvataġġ (Studju 3-MEC)
English: A total of 1332 patients were included in the evaluation of efficacy, 80% were women and 20% were men.
Maltese: Fl-evalwazzjoni tal-effikaċja kienu inklużi total ta' 1,332 pazjent, 80 % kienu nisa u 20 % kienu rġiel.
English: In vitro studies suggest that rolapitant is not expected to inhibit OATP1B1 at clinically relevant concentrations and rolapitant is not an inhibitor of OATP1B3 at the tested concentrations up to 20 µM.
Maltese: f'konċentrazzjonijiet klinikament rilevanti, u rolapitant mhuwiex inibitur ta' OATP1B3 fil konċentrazzjonijiet ittestjati sa 20 µM.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with rolapitant in all subsets of the paediatric population in prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cisplatin-based cancer therapy and moderately emetogenic cancer therapy (see section 4.2 for information on paediatric use).
Maltese: L-Aġenzija Ewropea għall-Mediċini ddiferiet l-obbligu li jiġu ppreżentati r-riżultati tal-istudji b'rolapitant f'kull sett tal-popolazzjoni pedjatrika fil-prevenzjoni ta' dardir u rimettar akut u ttardjat assoċjati ma' korsijiet inizjali u ripetuti ta' terapija emetoġenika ħafna kontra l-kanċer ibbażata fuq cisplatin u terapija moderatament emetoġenika kontra l-kanċer (ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku).
English: Concurrent administration of 400 mg ketoconazole once daily for 21 days following a single 90 mg dose of rolapitant, did not significantly affect the Cmax of rolapitant while the AUC increased by 21%.
Maltese: L-għoti fl-istess ħin ta' 400 mg ketoconazole darba kuljum għal 21 jum wara doża waħda ta' 90 mg ta' rolapitant, ma affettwax b'mod sinifikanti s-Cmax ta' rolapitant filwaqt li l-AUC żdiedet b'21%.
English: 180 mg orally; Within 2 hours prior to chemotherapy
Maltese: 180 mg b'mod orali;
English: A human Positron Emission Tomography (PET) study with rolapitant demonstrated that rolapitant crosses the blood brain barrier and occupies brain NK1 receptors.
Maltese: Studju ta' Tomografija b'Emissjoni ta' Pożitroni (PET - Positron Emission Tomography) fil-bniedem b'rolapitant wera li rolapitant jaqsam il-barriera ematoenċefalika u jokkupa r-riċetturi NK1 tal-moħħ.
English: A summary of the results from the non-AC and AC subsets are provided in Table 3.
Maltese: Sommarju tar-riżultati mis-subsettijiet mhux AC u AC huwa mogħti f'Tabella 3.
English: Control (N=262)
Maltese: Kontroll (N=262) Rata (%)
English: Abdominal distension Abdominal pain Stomatitis
Maltese: Distensjoni addominali
English: Effects of Varuby on the pharmacokinetics of other active substances
Maltese: Interazzjoni ma' prodotti mediċinali oħra u forom oħra ta' interazzjoni Effetti ta' Varuby fuq il-farmakokinetika ta' sustanzi attivi oħra
English: How to take Varuby
Maltese: X'inhu Varuby
English: The median Tmax for M19 was delayed to 204 hours in patients with mild or moderate hepatic impairment compared to 168 hours in healthy subjects.
Maltese: It-Tmax medjan għal M19 kien ittardjat għal 204 sigħat f'pazjenti b'indeboliment epatiku ħafif jew moderat meta mqabbel ma' 168 siegħa f'individwi b'saħħithom.
English: Decreases in the number of corpora lutea and implantation sites were observed in the female rat fertility and early embryonic development study (see section 5.3).
Maltese: Kien osservat biss tnaqqis żgħir fin-numru ta' corpora lutea u tas-siti ta' impjantazzjoni fl-istudju dwar ilfertilità tal-firien nisa u l-iżvilupp bikri tal-embrijun (ara sezzjoni 5.3).
English: Moderately Emetogenic Chemotherapy and Combinations of Anthracycline and Cyclophosphamide Chemotherapy
Maltese: Kimoterapija Moderatament Emetoġenika u Kombinazzjonijiet ta' Kimoterapija b'Anthracycline u
English: Rate
Maltese: Astenja
English: There are no data in patients with severe hepatic impairment (see section 5.2).
Maltese: Pazjenti b'indeboliment epatiku sever M'hemm l-ebda dejta dwar pazjenti b'indeboliment epatiku sever (ara sezzjoni 5.2).
English: Moderately emetogenic chemotherapy regimen Day 1
Maltese: Programm ta' kura għal kimoterapija moderatament emetoġenika
English: Other medicines and Varuby
Maltese: Mediċini oħra u Varuby
English: Varuby contains lactose
Maltese: Varuby fih il-lactose
English: Lactose
Maltese: Deidrazzjoni
English: Information is insufficient for the effect of severe renal impairment.
Maltese: L-informazzjoni mhijiex suffiċjenti għall-effett ta' indeboliment renali sever.
English: No clinically significant effect was seen on the pharmacokinetics of rolapitant when ketoconazole, a strong CYP3A4 inhibitor was administered with rolapitant.
Maltese: Ma deher l-ebda effett klinikament sinifikanti fuq il-farmakokinetika ta' rolapitant meta ngħata ketoconazole, inibitur qawwi ta' CYP3A4, ma' rolapitant.
English: Following a single dose administration of 180 mg rolapitant under fasting conditions to healthy subjects, rolapitant was measurable in plasma between 30 minutes and the peak plasma concentration (Cmax) for rolapitant which was reached in about 4 hours and mean Cmax was 968 ng/mL (%CV:28%).
Maltese: Wara l-għoti ta' doża waħda ta' 180 mg rolapitant f'kundizzjonijiet ta' sawm lil individwi b'saħħithom, rolapitant seta' jitkejjel fil-plażma bejn 30 minuta u l-konċentrazzjoni massima filplażma (Cmax) għal rolapitant li ntlaħqet f'madwar 4 sigħat u s-Cmax medja kienet 968 ng/mL
English: Figure 1.
Maltese: Jum 1
English: Delayed phase: >24 to 120 hours postcisplatin treatment; Acute phase: 0 to 24 hours post-cisplatin treatment; Overall phase: 0 to 120 hours postcisplatin treatment b Unadjusted P-values are obtained from Cochran-Mantel Haenszel test, stratified for sex. c Unadjusted P-values are obtained from Cochran-Mantel-Haenszel test, stratified by study and sex. N.S.=Not significant (p>0.05) *Not significant after applying pre-specified multiplicity adjustment.
Maltese: Kienu evalwati wkoll il-punti aħħarin addizzjonali speċifikati minn qabel li ġejjin: rispons komplet fil-fażi akuta (0 sa 24 siegħa) u fil-fażi globali (0 sa 120 siegħa); l-ebda rimettar f'kull fażi tas-CINV, l-ebda dardir sinifikanti f'kull fażi tas-CINV, u ż-żmien sal-ewwel rimettar jew l-użu ta' prodott mediċinali ta' salvataġġ.
English: Drug metabolising enzymes (and drug transporters) other than CYP3A4 involved in rolapitant hepatobiliary elimination remain to be elucidated.
Maltese: Enzimi li jimmetabolizzaw il-mediċina (u trasportaturi tal-mediċina) għajr CYP3A4 involuti fl-eliminazzjoni ta' rolapitant mill-fwied u l-marrara għad iridu jiġu ċċarati.