FrancophonIA/ELRC3.0 huggingface dataset:
English: ↔ boosted PIs cobicistat-boosted PIs (darunavir, atazanavir)
Maltese: †Valur pożittiv jiffavorixxi doravirine fuq efavirenz. ††
English: Effects of doravirine on other medicinal products
Maltese: Effetti ta'doravirine fuq prodotti mediċinali oħra
English: If co-administration with other moderate CYP3A inducers (e.g., dabrafenib, lesinurad, bosentan, thioridazine, nafcillin, modafinil, telotristat ethyl) cannot be avoided, the doravirine dose should be increased to 100 mg twice daily (the doses should be taken approximately 12 hours apart) (see section 4.2).
Maltese: Jekk l-għoti flimkien ma' indutturi moderati oħra ta' CYP3A (eż., dabrafenib, lesinurad, bosentan, thioridazine, nafcillin, modafinil, telotristat ethyl) ma jistax jiġi evitat, id-doża ta' doravirine għandha tiżidied għal 100 mg darbtejn kuljum (iddożi għandhom jittieħdu madwar 12-il siegħa bogħod minn xulxin) (ara sezzjoni 4.2).
English: Treatment emergent doravirine resistance associated substitutions may confer cross resistance to efavirenz, rilpivirine, nevirapine, and etravirine.
Maltese: Sostituzzjonijiet assoċjati ma' reżistenza għal doravirine li jfiġġu minħabba t-trattament jistgħu jagħtu reżistenza inkroċjata għal efavirenz, rilpivirine, nevirapine, u etravirine.
English: Pifeltro 100 mg film-coated tablets.
Maltese: Pifeltro 100 mg pilloli miksija b'rita.
English: See also “Other Medicines and Pifeltro” section.
Maltese: Ara wkoll is-sezzjoni “Mediċini oħra u Pifeltro”.
English: If co-administration with other moderate CYP3A inducers (e.g., dabrafenib, lesinurad, bosentan, thioridazine, nafcillin, modafinil, telotristat ethyl) cannot be avoided, one 100 mg tablet of Pifeltro should be taken twice daily (approximately 12 hours apart).
Maltese: Jekk l-għoti flimkien ma' indutturi moderati oħra ta' CYP3A (eż., dabrafenib, lesinurad, bosentan, thioridazine, nafcillin, modafinil, telotristat ethyl) ma jistax jiġi evitat, għandha tittieħed pillola waħda ta' 100 mg ta' Pifeltro darbtejn kuljum (madwar 12-il siegħa bogħod minn xulxin).
English: Pharmacokinetic Enhancers ritonavir (100 mg BID, doravirine 50 mg SD)
Maltese: Mediċini li Jsaħħu b'mod Farmakokinetiku ritonavir (100 mg BID, doravirine 50 mg SD)
English: • 90 film-coated tablets (3 bottles of 30 film-coated tablets).
Maltese: • 90 pillola miksija b'rita (3 fliexken ta' 30 pillola miksija b'rita).
English: Pifeltro 100 mg film-coated tablets doravirine
Maltese: Pifeltro 100 mg pilloli miksija b'rita doravirine
English: ↔ elvitegravir cobicistat-boosted elvitegravir
Maltese: Elvitegravir imsaħħaħ b'Cobicistat
English: No clinically relevant pharmacokinetic differences have been identified between men and women for doravirine.
Maltese: Ma ġew identifikati l-ebda differenzi farmakokinetiċi rilevanti b'mod kliniku bejn irġiel u nisa għal doravirine.
English: Subjects were randomized to either switch to DOR/3TC/TDF at baseline [N = 447, Immediate Switch Group (ISG)], or stay on their baseline regimen until Week 24, at which point they switched to DOR/3TC/TDF [N = 223, Delayed Switch Group (DSG)].
Maltese: L-individwi ntagħżlu b'mod arbitrarju biex jew jaqilbu għal DOR/3TC/TDF fil-linja bażi [N= 447, Grupp b'Bidla Immedjata (ISG, Immediate Switch Group)], jew jibqgħu fuq liskeda ta' trattament tagħhom tal-linja bażi sa Ġimgħa 24, meta qalbu għal DOR/3TC/TDF [N = 223, Grupp b'Bidla Ttardjata (DSG, Delayed Switch Group)].
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu .
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini: http://www.ema.europa.eu.
English: The administration of a single doravirine tablet with a high-fat meal to healthy subjects resulted in a 16 % and 36 % increase in doravirine AUC and C24, respectively, while Cmax was not significantly affected.
Maltese: L-għoti ta' pillola waħda ta' doravirine ma' ikla b'ammont kbir ta' xaħam lill-individwi f'saħħithom wassal għal żieda ta' 16 % u 36 % fl-AUC u s-C24 ta' doravirine, rispettivament, filwaqt li s-Cmax ma ġiex affettwat b'mod sinifikanti.
English: Caution should be given to prescribing doravirine with medicinal products that may reduce the exposure of doravirine (see sections 4.3 and 4.5).
Maltese: Għandha tingħata attenzjoni meta wieħed jordna doravirine flimkien ma' prodotti mediċinali li jistgħu jnaqqsu l-esponiment għal doravirine (ara sezzjonijiet 4.3 u 4.5).
English: Pifeltro is used to treat HIV infection in people 18 years of age and older.
Maltese: Pifeltro jintuża għat-trattament ta' infezzjoni tal-HIV f'persuni li għandhom 18-il sena u aktar.
English: Doravirine at a dose of 100 mg once daily is not likely to have a clinically relevant effect on the plasma concentrations of medicinal products that are dependent on transport proteins for absorption and/or elimination or that are metabolized by CYP enzymes.
Maltese: Doravirine bid-doża ta' 100 mg darba kuljum mhux probabbli li jkollu effett rilevanti b'mod kliniku fuq il-konċentrazzjonijiet fil-plażma ta' prodotti mediċinali li huma dipendenti fuq il-proteini tattrasport għall-assorbiment u/jew l-eliminazzjoni jew li huma metabolizzati mill-enzimi CYP.
English: Patients should be informed that fatigue, dizziness, and somnolence have been reported during treatment with doravirine (see section 4.8).
Maltese: Il-pazjenti għandhom jiġu infurmati li għeja, sturdament, u ħedla ta' ngħas ġew irrappurtati waqt it-trattament b'doravirine (ara sezzjoni 4.8).
English: •bosentan (a medicine to treat lung disease) •dabrafenib (a medicine to treat skin cancer)
Maltese: • dabrafenib (mediċina biex tittratta kanċer tal-ġilda)
English: • increased levels of liver enzymes (AST)
Maltese: • żieda fil-livelli tal-enzimi tal-fwied (AST)
English: Proportion (%) of Subjects With HIV-1 RNA < 40 copies/mL by Baseline CD4
Maltese: Proporzjon (%) ta' Individwi b'RNA ta' HIV-1 < 40 kopja/mL skont l-Iskeda ta' Trattament Mogħti fil-Linja Bażi
English: 3, 84 % were male, 27 % were non-white, 4 % had hepatitis B and/or C virus co-infection, 10 % had a history of AIDS, 20 % had HIV-1 RNA greater than 100,000 copies per mL, 13 % received ABC/3TC and 87 % received FTC/TDF; these characteristics were similar between treatment groups.
Maltese: Fil-linja bażi, l-età medjana tal-individwi kienet ta' 33 sena (firxa minn 18 sa 69 sena), 86 % kellhom għadd ta' ċelluli T CD4+ ta' aktar minn 200 ċellula f'kull mm3, 84 % kienu rġiel, 27 % ma kinux bojod, 4 % kellhom infezzjoni tal-epatite B u/jew Ċ fl-istess waqt, 10 % kellhom storja ta' AIDS, 20 % kellhom RNA ta' HIV-1 aktar minn 100,000 kopja f'kull mL, 13 % irċivew ABC/3TC u 87 % irċivew FTC/TDF; dawn il-karatteristiċi kienu jixxiebhu bejn il-gruppi ta'
English: The efficacy of switching from a baseline regimen consisting of two nucleoside reverse transcriptase inhibitors in combination with a ritonavir- or cobicistat-boosted PI, or cobicistat-boosted elvitegravir, or an NNRTI to DOR/3TC/TDF was evaluated in a randomized, open-label trial (DRIVE-SHIFT), in virologically suppressed HIV-1 infected adults.
Maltese: L-effikaċja ta' bidla minn skeda ta' trattament tal-linja bażi li jikkonsisti f'żewġ inibituri ta' nucleoside reverse transcriptase flimkien ma' PI imsaħħaħ b'ritonavir jew cobicistat, jew elvitegravir imsaħħaħ b'cobicistat, jew NNRTI għal DOR/3TC/TDF ġiet evalwata fi prova arbitrarja, fejn kemm linvestigaturi kif ukoll l-individwi kienu jafu liema sustanza qed tintuża (DRIVE-SHIFT), f'individwi adulti infettati b'HIV-1 soppressi b'mod viroloġiku.
English: What Pifeltro looks like and contents of the pack Pifeltro is available as a white, oval-shaped, film-coated tablet, and is debossed with the corporate logo and 700 on one side and plain on the other side.
Maltese: Pifeltro huwa disponibbli bħala pillola bajda, ta' għamla ovali, miksija b'rita, u hija mnaqqxa billowgow tal-kumpanija u 700 fuq naħa waħda u bla marki fuq in-naħa l-oħra.
English: See list under “Do not take Pifeltro” section.
Maltese: Ara l-lista taħt is-sezzjoni “Tiħux Pifeltro”.
English: The recommended dose is 1 tablet once a day.
Maltese: Id-doża rakkomandata hija ta' pillola 1 darba kuljum.
English: In the DRIVE-SHIFT trial, an immediate switch to DOR/3TC/TDF was demonstrated to be noninferior at Week 48 compared to continuation of the baseline regimen at Week 24 as assessed by the proportion of subjects with HIV-1 RNA < 40 copies/mL.
Maltese: Fil-prova DRIVE-SHIFT, bidla immedjata għal DOR/3TC/TDF ntweriet li ma kinitx inferjuri f'Ġimgħa 48 meta mqabbla mat-tkomplija tal-iskeda ta' trattament tal-linja bażi f'Ġimgħa 24 kif stmat mill-proporzjon ta' individwi b'RNA ta' HIV-1 ta' < 40 kopja/mL.
English: Pifeltro tablets contain lactose
Maltese: Il-pilloli Pifeltro fihom il-lactose
English: Integrase Strand Transfer Inhibitors dolutegravir (50 mg QD, doravirine 200 mg QD)
Maltese: Rakkomandazzjoni Dwar l-Għoti Flimkien ma' doravirine dolutegravir (50 mg QD, doravirine 200 mg QD)
English: The use of Pifeltro in people aged less than 18 years has not yet been studied.
Maltese: L-użu ta' Pifeltro f'persuni li għandhom inqas minn 18-il sena għadu ma ġiex studjat.
English: No clinically relevant racial differences in the pharmacokinetics of doravirine have been identified based on a population pharmacokinetic analysis of doravirine in healthy and HIV-1 infected subjects.
Maltese: Ma ġew identifikati l-ebda differenzi rilevanti b'mod kliniku minħabba r-razza fil-farmakokinetika ta' doravirine abbażi ta' analiżi farmakokinetika ta' popolazzjoni ta' doravirine f'individwi f'saħħithom u infettati bl-HIV-1.
English: Ritonavir- or Cobicistat-boosted PI
Maltese: BIJOLOĠIKA(ĊI ATTIVA/I
English: Multiple dose rifampicin (600 mg QD, doravirine 100 mg SD)
Maltese: Ħafna dożi ta'rifampicin (600 mg QD, doravirine 100 mg SD)
English: Doravirine 200 mg
Maltese: 200 mg
English: Doravirine should not be coadministered with medicinal products that are strong CYP3A enzyme inducers as significant decreases in doravirine plasma concentrations are expected to occur, which may decrease the effectiveness of doravirine (see sections 4.3 and 5.2).
Maltese: Doravirine m'għandux jingħata flimkien ma' prodotti mediċinali li huma indutturi qawwija tal-enzima CYP3A minħabba li jkun mistenni li jseħħ tnaqqis sinifikanti fil-konċentrazzjonijiet ta' doravirine fil-plażma, li jista' jnaqqas l-effikaċja ta' doravirine (ara sezzjonijiet 4.3 u 5.2).
English: Protease Inhibitors ritonavir
Maltese: Inibituri tal-Protease
English: Animal studies do not indicate harmful effects of doravirine on fertility at exposure levels higher than the exposure in humans at the recommended clinical dose (see section 5.3).
Maltese: Studji flannimali ma jindikawx effetti ħżiena ta' doravirine fuq il-fertilità b'livelli ta' esponiment ogħla millesponiment fil-bniedem bid-doża klinika rakkomandata (ara sezzjoni 5.3).
English: There is no information on potential acute symptoms and signs of overdose with doravirine.
Maltese: M'hemm l-ebda informazzjoni dwar is-sintomi u s-sinjali akuti possibbli ta' doża eċċessiva b'doravirine.
English: Doravirine 100 mg
Maltese: 100 mg
English: Subsequently F227(L/C/V) or L234I emerged in addition to V106 substitution (double mutants yielding a fold change of > 100).
Maltese: Sussegwentement barra mis-sostituzzjoni V106 dehru s-sostituzzjonijiet F227(L/C/V) jew L234I (mutazzjonijiet doppji li jagħtu drabi ta' bidla ta' > 100).
English: Treatment-naïve adult subjects
Maltese: Individwi adulti li qatt ma ħadu trattament
English: Renal and urinary disorders Rare acute kidney injury, renal disorder, calculus urinary, nephrolithiasis General disorders and administration site conditions Common fatigue
Maltese: Disturbi fil-kliewi u fis-sistema urinarja Rari ħsara akuta fil-kliewi, disturb fil-kliewi, kalkulus fl-awrina, nefrolitjasi Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata Komuni għeja
English: Film-coated tablets 30 film-coated tablets 90 (3 bottles of 30) film-coated tablets
Maltese: 90 (3 fliexken ta' 30) pillola miksija b'rita
English: Package leaflet: Information for the user Pifeltro 100 mg film-coated tablets doravirine
Maltese: Informazzjoni għall-utent Pifeltro 100 mg pilloli miksija b'rita doravirine
English: Musculoskeletal and connective tissue disorders Uncommon myalgia, arthralgia
Maltese: Mhux komuni mijalġja, artralġja
English: • trouble concentrating, memory problems, tingling of hands and feet, stiff muscles, poor quality sleep
Maltese: • problema biex tikkonċentra, problemi bil-memorja, tnemnim fl-idejn u s-saqajn, muskoli ibsin,
English: Autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also occur after you start taking medicines for the treatment of your HIV infection.
Maltese: Disturbi awtoimmuni (kundizzjoni li sseħħ meta s-sistema immuni tattakka tessut f'saħħtu tal-ġisem) jistgħu jseħħu wkoll wara li tibda tieħu mediċini għat-trattament tal-infezzjoni tiegħek tal-HIV.
English: Animal studies with doravirine do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
Maltese: Studji fl-annimali b'doravirine ma jurux effetti ħżiena diretti jew indiretti rigward l-effett tossiku fuq is-sistema riproduttiva (ara sezzjoni 5.3).
English: • 1 bottle with 30 film-coated tablets.
Maltese: • Flixkun 1 bi 30 pillola miksija b'rita.
English: Efavirenz 600 mg
Maltese: 600 mg
English: Blood tests may also show: • increased levels of liver enzymes (ALT)
Maltese: • żidiet fil-livelli tal-enzimi tal-fwied (ALT)
English: Expected: ↔ buprenorphine ↔ naloxone
Maltese: ↔ buprenorphine
English: Resistance
Maltese: Kontraċettivi
English: Gastrointestinal disorders Common nausea, diarrhoea, flatulence, abdominal pain vomiting
Maltese: Disturbi gastrointestinali Komuni nawsja, dijarea, gass, uġigħ fl-addome4, rimettar
English: • abnormal dreams, difficulty in sleeping (insomnia)
Maltese: • ħolm mhux normali, diffikultà biex torqod (insomnja)
English: 50 to < 65
Maltese: 50 sa < 65
English: Triple-negative
Maltese: Triplu negattiv
English: Haemoglobin < 8 g/dL
Maltese: Emoglobina < 8 g/dL
English: g. For talazoparib Grade 1 is 21% and Grade 2 is 2%.
Maltese: Għal talazoparib Grad 1 huwa 21% u Grad 2 huwa 2%.
English: Overall survival (interim analysis)c
Maltese: Sopravivenza globali (analiżi interim)
English: Median age (y [range]) Age category (y), n (%)
Maltese: Età medjana ([medda] y) Kategorija tal-età (y), n (%)
English: f. Stratified CMH test.
Maltese: Test CMH stratifikat.
English:  Grade 1
Maltese:  Grad 1
English: 90537 Feucht Germany
Maltese: 90537 Feucht Il-Ġermanja
English: Talazoparib is an inhibitor of PARP enzymes, PARP1, and PARP2.
Maltese: Talazoparib huwa inibitur ta' enzimi ta' PARP, PARP1, u PARP2.
English: 30 capsules
Maltese: Kapsula iebsa 30 kapsula
English: Talazoparib is a substrate of P-gp and BCRP transporters.
Maltese: Talazoparib huwa substrat ta' P-gp u trasportaturi ta' BCRP.
English: Black or African American White
Maltese: Suwed jew Afrikani Amerikani Bojod
English: Platinum
Maltese: Platinu
English: Frequency categories are defined as: very common (≥ 1/10) and common (≥ 1/100 to < 1/10).
Maltese: Il-kategoriji ta' frekwenza huma definiti bħala: komuni ħafna (≥ 1/10), u komuni (≥ 1/100 sa < 1/10).
English: Manufacturer Excella GmbH & Co. KG Nürnberger Strasse 12 90537 Feucht Germany
Maltese: KG Nürnberger Strasse 12 90537 Feucht Il-Ġermanja
English: Adverse reactions based on pooled dataset from 5 studies (N=494) System organ class Frequency Preferred term
Maltese: Tabella 3. Reazzjonijiet avversi abbażi ta' sett ta' data miġbur minn 5 studji (N=494) Sistema tal-klassifika tal-organi Frekwenza Terminu ppreferut
English: Concomitant use of strong P-gp inhibitors (including but not limited to amiodarone, carvedilol, clarithromycin, cobicistat, darunavir, dronedarone, erythromycin, indinavir, itraconazole, ketoconazole, lapatinib, lopinavir, propafenone, quinidine, ranolazine, ritonavir, saquinavir, telaprevir, tipranavir, and verapamil) should be avoided.
Maltese: L-użu konkomitanti ta' inibituri qawwija ta' P-gp (inkluż iżda mhux limitat għal amiodarone, carvedilol, clarithromycin, cobicistat, darunavir, dronedarone, erythromycin, indinavir, itraconazole, ketoconazole, lapatinib, lopinavir, propafenone, quinidine, ranolazine, ritonavir, saquinavir, telaprevir, tipranavir, u verapamil) għandu jiġi evitat.
English: Kaplan-Meier curves of PFS - EMBRACA study
Maltese: Kaplan-Meier tal-PFS - l-istudju EMBRACA
English: Talzenna 1 mg hard capsules EU/1/19/1377/005
Maltese: Talzenna 1 mg kapsuli ibsin EU/1/19/1377/005
English: Cobicistat, darunavir, indinavir, lopinavir, ritonavir, saquinavir, telaprevir and tipranavir - used to treat HIV infections/AIDS.
Maltese: - Cobicistat, darunavir, indinavir, lopinavir, ritonavir, saquinavir, telaprevir u tipranavir - li jintużaw biex jikkuraw infezzjonijiet tal-HIV/AIDS.
English: Median (IQR), months
Maltese: Medjana (IQR), xhur
English: The OS interim analysis was performed at 51% for the total number of planned events.
Maltese: L-analiżi interim tal-OS saret f'51% għan-numru totali ta' avvenimenti ppjanati.
English: Capsule content: silicified microcrystalline cellulose (sMCC) (microcrystalline cellulose and silicone dioxide).
Maltese: - Kontenut tal-kapsula: silicified microcrystalline cellulose (sMCC) (microcrystalline cellulose u silicone dioxide).
English: Myelodysplastic syndrome/Acute Myeloid Leukaemia (MDS/AML) have been reported in patients who received poly (adenosine diphosphate-ribose) polymerase (PARP) inhibitors, including talazoparib.
Maltese: Sindrome majelodisplastiku/Lewkimja Majelojde Akuta (MDS/AML, Myelodysplastic syndrome/Acute Myeloid Leukaemia) ġew irrappurtati f'pazjenti li riċvew inibituri ta' poly (adenosine diphosphate-ribose) polymerase (PARP), inkluż talazoparib.
English: The secondary objectives were objective response rate (ORR), overall survival (OS), safety, and PK.
Maltese: L-objettivi sekondarji kienu rata ta' rispons oġġettiv (ORR), sopravivenza globali (OS), sigurtà, u PK.
English: Talzenna 0.25 mg hard capsules EU/1/19/1377/001
Maltese: Talzenna 0.25 mg kapsuli ibsin EU/1/19/1377/001
English: Printing ink: shellac (E904), propylene glycol (E1520), ammonium hydroxide (E527), black iron oxide (E172), and potassium hydroxide (E525).
Maltese: Inka tal-istampar: shellac (E904), propylene glycol (E1520), ammonium hydroxide (E527), black iron oxide (E172), u potassium hydroxide (E525).
English: Figure 1 shows the Kaplan-Meier curve for the EMBRACA study.
Maltese: Figura 1 turi l-kurva Kaplan-Meier għall-istudju EMBRACA.
English: It is a type of anticancer medicine known as a ‘PARP (poly-ADP ribose polymerase) inhibitor'.
Maltese: Dan huwa tip ta' mediċina kontra l-kanċermagħrufa bħala “inibitur ta' PARP (poly-ADP ribose polymerase)”.
English: b. Stratified Log-rank test. c. 51% of the projected final number of OS events occurred (163 of 321 deaths).
Maltese: Seħħew 51% tan-numru finali mbassar tal-avvenimenti ta' OS (163 minn 321 mewta).
English: EU/1/19/1377/002 (30 hard capsules) EU/1/19/1377/003 (60 hard capsules) EU/1/19/1377/004 (90 hard capsules)
Maltese: EU/1/19/1377/002 (30 kapsula iebsa) EU/1/19/1377/003 (60 kapsula iebsa) EU/1/19/1377/004 (90 kapsula iebsa)
English: Clarithromycin and erythromycin antibiotics - used to treat bacterial infections.
Maltese: - L-antibijotiċi clarithromycin u erythromycin - jintużaw biex jikkuraw infezzjonijiet batteriċi.
English: Recommended dose reductions are indicated in Table 1.
Maltese: Ittnaqqis fid-doża rakkomandat huwa indikat f'Tabella 1.
English: ORR (%, 95% CI) Odds ratio (95% CI) 2-sided p-valuef p<0.0001
Maltese: ORR (%, 95% CI) Proporzjon ta' probabilità (95% CI) valur p b'żewġ naħat p<0.0001
English: Myelodysplastic syndrome/Acute myeloid leukaemia
Maltese: Sindrome majelodisplastiku/Lewkimja majelojde akuta
English: Overall, MDS/AML has been reported in 2 out of 584 (0.3%) solid tumour patients treated with talazoparib in clinical studies.
Maltese: B'mod globali, MDS/AML ġiet irrappurtata fi 2 minn 584 (0.3%) pazjent b'tumur solidu kkurati b'talazoparib fl-istudji kliniċi.
English: Pack sizes: cartons of 30 × 1 capsules, or 60 × 1 capsules, or 90 × 1 capsules in unit dose blisters.
Maltese: Daqsijiet tal-pakkett: kartun ta' 30 × 1 kapsuli, jew 60 × 1 kapsuli, jew 90 × 1 kapsuli f'folji ta' unità tad-doża.
English: Resume Talzenna
Maltese: Kompli Talzenna
English: In vitro, talazoparib did not inhibit any of the major uridine-diphosphate glucuronosyltransferase (UGT) isoforms (1A1, 1A4, 1A6, 1A9, 2B7, and 2B15) at clinically relevant concentrations.
Maltese: In vitro, talazoparib ma inibixxiex xi wieħed mill-iżoformi ewlenin ta' uridine-diphosphate glucuronosyltransferase (UGT) (1A1, 1A4, 1A6, 1A9, 2B7, u 2B15) f'konċentrazzjonijiet klinikament rilevanti.
English: In vitro, talazoparib was not an inhibitor of cytochrome (CYP)1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, or CYP3A4/5 or inducer of CYP1A2, CYP2B6, or CYP3A4 at clinically relevant concentrations.
Maltese: In vitro, talazoparib ma kienx inibitur taċ-ċitokromu (CYP)1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, jew CYP3A4/5 jew induttur ta' CYP1A2, CYP2B6, jew CYP3A4 f'konċentrazzjonijiet klinikament rilevanti.
English: Pharmacotherapeutic group: other antineoplastic agents, ATC code: L01XX60
Maltese: Kategorija farmakoterapewtika: sustanzi antineoplastiċi oħra, Kodiċi ATC:
English: Fertility Talazoparib may reduce fertility in men.
Maltese: Fertilità Talazoparib jista' jnaqqas il-fertilità fl-irġiel.
English: Following repeated daily dosing of 1 mg talazoparib to patients, the geometric mean (% coefficient of variation [CV%]) area under the plasma concentration-time curve (AUC) and maximum observed plasma concentration (Cmax) of talazoparib at steady-state was in the range of 126 (107) ng•hr/mL to 208 (37) ng•hr/mL and 11 (90) ng/mL to 19 (27) ng/mL, respectively.
Maltese: Wara dożaġġ ta' kuljum ripetut ta' 1 mg talazoparib lillpazjenti, l-erja medja ġeometrika (% ta' koeffiċjent ta' varjazzjoni [CV%]) taħt il-kurva (AUC) u lkonċentrazzjoni osservata massima fil-plażma (Cmax) ta' talazoparib fi stat fiss kienet fil-medda ta' 126 (107) ng•hr/mL sa 208 (37) ng•hr/mL u 11 (90) ng/mL sa 19 (27) ng/mL, rispettivament.
English: Neutrophil count < 1,000/μL ≥ 1,500/µL Non-haematologic adverse reaction Grade 3 or Grade 4
Maltese: Għadd tal-pjastrini < 50,000/μL ≥ 75,000/μL Għadd tan-newtrofili < 1,000/μL ≥ 1,500/µL Reazzjoni avversa mhux ematoloġika ta' Grad 3 jew Grad 4
English: Silicified microcrystalline cellulose (sMCC) (microcrystalline cellulose and silicone dioxide) 0.25 mg capsule shell
Maltese: Silicified microcrystalline cellulose (sMCC) (microcrystalline cellulose u silicone dioxide)
English: How to store Talzenna 6.
Maltese: Kif taħżen Talzenna 6.
English: Objective response by investigatord,e
Maltese: Rispons oġġettiv skont l-investigatur d,e
English: There is limited experience of overdose with talazoparib.
Maltese: Hemm esperjenza limitata ta' doża eċċessiva b'talazoparib.
English: Pack size: cartons of 30 × 1 capsules in unit dose blisters.
Maltese: Daqsijiet tal-pakkett: kartuni ta' 30 × 1 kapsuli f'folji ta' unità taddoża.
English: In vitro, talazoparib did not inhibit any of the major intestinal, hepatic or renal membrane transporters (P-gp, BCRP, organic anion transporting polypeptide [OATP]1B1, OATP1B3, organic cationic transporter [OCT]1, OCT2, organic anion transporter [OAT]1, OAT3, bile salt export pump [BSEP], multidrug and toxin extrusion [MATE]1 and MATE2-K) at clinically relevant concentrations.
Maltese: In vitro, talazoparib ma inibixxiex xi wieħed mit-trasportaturi ewlenin tal-membrana intestinali, talfwied jew tal-kliewi P-gp, BCRP, polypeptide organiku li jittrasporta l-anjoni [OATP]1B1, OATP1B3, trasportatur katjoniku organiku [OCT]1, OCT2, trasportatur anjoniku organiku [OAT]1, OAT3, pompa ta' esportazzjoni ta' melħ tal-bili
English: Randomised Phase 3 study EMBRACA
Maltese: Studju randomizzat ta' Fażi 3 EMBRACA
English: Duration of response by investigatord
Maltese: Durata ta' rispons skont l-investigatur
English: 30 × 1 capsules
Maltese: Kapsula iebsa 30 × 1 kapsula
English: Pack size: cartons of 30 capsules in a HDPE bottle.
Maltese: Daqs tal-pakkett: kartuni ta' 30 kapsula fi flixkun HDPE.