FrancophonIA/ELRC3.0 huggingface dataset:
English: - If you or your child have a family history of congenital or hereditary immunodeficiency, unless the immune competence of your or your child is demonstrated.
Maltese: Storja fil-familja ta' immunodefiċjenza konġenitali jew ereditarja, sakemm il-kompetenza ta' limmunità tar-reċipjent ma tkunx intweriet.
English: Eye disorders Conjunctivitis, Retinitis
Maltese: Konġuntivite, Retinite
English: Powder in a vial (glass) with a stopper (butyl rubber) and solvent in a pre-filled syringe (glass) with plunger stopper (chlorobutyl rubber) and tip cap (styrene-butadiene rubber), with one or two unattached needles, in pack size 1, 10 and 20.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Trab f'kunjett (ħġieġ) b'tapp (gomma tal-butyl) u solvent f'kunjett (ħġieġ) b'tapp (gomma talchlorobutyl) f'pakkett ta' 1 u 10.
English: Sorbitol, sodium phosphate, potassium phosphate, sucrose, hydrolysed gelatine, medium 199 with Hanks' salts, MEM, monosodium L-glutamate, neomycin, phenol red, sodium bicarbonate, hydrochloric acid , sodium hydroxide and water for injections.
Maltese: L-glutamate, neomycin, phenol red, sodium bicarbonate, hydrochloric acid, sodium hydroxide u ilma għall-injezzjonijiet.
English: IM or SC use
Maltese: OĦRA, JEKK MEĦTIEĠA
English: M-M-RVAXPRO is given to help protect you or your child against measles, mumps, and rubella.
Maltese: Ġew irrappurtati każijiet ta' meninġite asettika wara tilqim kontra l-ħosba, gattone, u rubella.
English: Psychiatric disorders Crying
Maltese: Disturbi psikjatriċi Biki
English: In 297 reports a clear time to onset could be determined.
Maltese: F'297 rapport seta' jiġi determinat żmien ċar għall-bidu.
English: Although a causal relationship between other strains of mumps vaccine and aseptic meningitis has been shown, there is no evidence to link Jeryl Lynn™ mumps vaccine to aseptic meningitis.
Maltese: Għalkemm intweriet relazzjoni kawżali bejn tipi oħra ta' vaċċin kontra l-gattone u l-meninġite asettika, m'hemmx evidenza li torbot il-vaċċin kontra l-gattone Jeryl Lynn™ mal-meninġite asettika.
English: Before mixing with the solvent, the powder is a light yellow compact crystalline cake.
Maltese: Qabel ma tħallat mas-solvent, it-trab huwa kejk kristallin kumpatt isfar ċar.
English: A comparative study in 752 subjects who received M-M-RVAXPRO either by intramuscular route or subcutaneous route demonstrated a similar immunogenicity profile between both administration routes.
Maltese: Studju komparattiv f'752 suġġett li rċevew M-M-RVAXPRO jew ġol-muskoli jew taħt il-ġilda wera profil ta' immunoġeniċità simili bejn iż-żewġ rotot ta' għoti.
English: INFORMATION IN BRAILLE 17.
Maltese: INFORMAZZJONI BIL-BRAILLE 17.
English: Age ≥ 65 years
Maltese: Età ≥ 65 sena
English: Grade ≥ 3
Maltese: Grad ≥ 3
English: N at risk (Events)
Maltese: N f'riskju (Avvenimenti)
English: Placebo + R
Maltese: Plaċebo + R
English: FL subset (N=72) n (%)
Maltese: Sottosett ta' FL (N=72) n (%)
English: ALPHA-1 ADRENORECEPTOR ANTAGONISTS
Maltese: ANTAGONISTI TA' ALPHA 1-ADRENORECEPTOR Alfuzosin
English: Oral budesonide
Maltese: Budesonide orali
English: • The active substance is idelalisib.
Maltese: • Is-sustanza attiva hi idelalisib.
English: Lymphocytosis**
Maltese: Limfoċitożi**
English: Stevens-Johnson syndrome/ toxic epidermal necrolysis
Maltese: Sindrome ta' Stevens-Johnson/ nekrolisi epidermali tossika
English: Ciclosporin, sirolimus, tacrolimus
Maltese: Ciclosporin, sirolimus,
English: Repeated dose toxicity
Maltese: Tossiċità minn dożi ripetuti
English: BCRP, OATP1B1, OATP1B3 and P-gp substrates
Maltese: Substrati ta' BCRP, OATP1B1, OATP1B3 u P-gp
English: Overall iNHL cohort (N=125) n (%)
Maltese: Koorti ta' iNHL globali (N=125) n (%)
English: Each carton contains 1 bottle.
Maltese: Kull kartuna fiha 1 flixkun.
English: ANTIDEPRESSANTS
Maltese: ANTIDEPRESSANTI
English: CYP2C8 substrates
Maltese: Substrati ta' CYP2C8
English: IMMUNOSUPPRESSANTS
Maltese: IMMUNOSOPPRESSANTI
English: ANC 1,000 to < 1,500/mm3
Maltese: ANC 1,000 sa < 1,500/mm3
English: Amiodarone, quinidine
Maltese: MEDIĊINI ANTIARRITMIĊI Amiodarone, quinidine
English: Diarrhoea/colitis
Maltese: Dijarea/kolite
English: Date of first authorisation: 18 September 2014 Date of latest renewal: 30 April 2019
Maltese: Data tal-aħħar tiġdid: 30 ta' April, 2019
English: 17p deletion/TP53 mutation
Maltese: Tħassir ta' 17p/mutazzjoni ta' TP53
English: Idelalisib + R 110 (0) 101 (3) 93 (7) 73 (9) 59 (14) 31 (19) 20 (21) 9 (24) 7 (24) 4 (24) 1 (25) 0 (25) Placebo + R 110 (0) 84 (21) 48 (38) 29 (46) 20 (53) 9 (63) 4 (67) 1 (69) 0 (70) 0 (70) 0 (70) 0 (70)
Maltese: Idelalisib + R 110 (0) 101 (3) 93 (7) 73 (9) 59 (14) 31 (19) 20 (21) 9 (24) 7 (24) 4 (24) 1 (25) 0 (25) Plaċebo + R 110 (0) 84 (21) 48 (38) 29 (46) 20 (53) 9 (63) 4 (67) 1 (69) 0 (70) 0 (70) 0 (70) 0 (70)
English: The primary endpoint was progression free survival (PFS).
Maltese: Il-punt finali primarju kien sopravivenza mingħajr progressjoni (PFS - progression free survival).
English: Response category*†
Maltese: Kategorija ta' rispons*†
English: ANC 500 to < 1,000/mm3
Maltese: ANC 500 sa < 1,000/mm3
English: Solid line: idelalisib + O (N = 174), dashed line: ofatumumab (N = 87) O: ofatumumab; N: number of subjects per group
Maltese: Sinjal solidu: idelalisib + O (N = 174), sinjal maqtugħ: ofatumumab (N = 87) O: ofatumumab; N: l-għadd ta' individwi f'kull grupp
English: Gilead Sciences Poland Sp. z o.o.
Maltese: Latvija Gilead Sciences Poland Sp. z o.o.
English: Zydelig contains sunset yellow FCF (E110)
Maltese: Zydelig fih sunset yellow FCF (E110)
English: Idelalisib is 93% to 94% bound to human plasma proteins at concentrations observed clinically.
Maltese: Idelalisib huwa 93% sa 94% marbut mal-proteini tal-plasma tal-bniedem f'konċentrazzjonijiet osservati klinikament.
English: Progression free survival (%)
Maltese: Sopravivenza mingħajr progressjoni (%)
English: Infections (see section 4.4)
Maltese: Infezzjonijiet (ara sezzjoni 4.4)
English: Solid line: idelalisib + R (N = 110), dashed line: placebo + R (N = 110) R: rituximab; N: number of subjects per group
Maltese: Sinjal solidu: idelalisib + R (N = 110), sinjal maqtugħ: plaċebo + R (N = 110) R: rituximab; N: l-għadd ta' individwi f'kull grupp
English: Elevations in ALT and AST of Grade 3 and 4 (> 5 x ULN) have been observed in clinical studies of idelalisib.
Maltese: Żidiet fl-ALT u l-AST ta' Grad 3 u 4 (> 5 x ULN) kienu osservati fi studji kliniċi ta' idelalisib.
English: In vitro interaction data
Maltese: Data dwar l-interazzjonijiet in vitro
English: Subjects had a median Cumulative Illness Rating Scale (CIRS) score of 8.
Maltese: Kumulattiva tal-Klassifikazzjoni tal-Marda (CIRS - Cumulative Illness Rating Scale) medjan ta' 8.
English: PHOSPHODIESTERASE INHIBITORS
Maltese: INIBITURI TA' PHOSPHODIESTERASE
English: Investigations Increased triglycerides
Maltese: Żieda ta' triglycerides
English: GS-563117 is not an inhibitor of the metabolising enzymes CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 or UGT1A1, or of the transporters P-gp, BCRP, OATP1B1, OATP1B3, OAT1, OAT3, or OCT2.
Maltese: GS-563117 mhuwiex inibitur tal-enzimi metabolizzanti CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 jew UGT1A1, jew tat-trasportaturi P-gp, BCRP, OATP1B1, OATP1B3, OAT1, OAT3, jew OCT2.
English: ORR * 95% CI
Maltese: ORR* CI ta' 95%
English: Any grade
Maltese: Kwalunkwe Grad
English: Treatment with Zydelig must be withheld in the event of a Grade 3 or 4 aminotransferase elevation (alanine aminotransferase [ALT]/aspartate aminotransferase [AST] > 5 x upper limit of normal [ULN]).
Maltese: It-trattament b'Zydelig għandu jitwaqqaf f'każ ta' żieda fl-aminotransferase ta' Grad 3 jew 4 (alanine aminotransferase [ALT]/aspartate aminotransferase [AST] > 5 x il-limitu ta' fuq tan-normal [ULNupper limit of normal]).
English: • carbamazepine, S-mephenytoin, phenytoin, medicines used to prevent seizures
Maltese: • carbamazepine, S-mephenytoin, phenytoin, mediċini li jintużaw għall-prevenzjoni tal aċċessjonijiet
English: Following a single 150 mg dose, idelalisib AUC (total, i.e., bound plus unbound) was ~60% higher in moderate and severe impairment compared to matched controls.
Maltese: Wara doża unika ta' 150 mg, l-AUC ta' idelalisib (total, i.e., marbuta flimkien ma' mhux marbuta) kienet ~60% ogħla f'indeboliment moderat u sever meta mqabbla ma' kontrolli mqabbla.
English: In studies 312-0116/0117 and 312-0119, rash (reported as dermatitis exfoliative generalised, drug eruption, rash, rash erythematous, rash generalised, rash macular, rash maculo-papular, rash papular, rash pruritic, rash pustular, rash vesicular, papule and skin plaque) occurred in 31.1% of subjects who received idelalisib + an anti-CD20 monoclonal antibody (rituximab or ofatumumab) and 8.2% who received an anti-CD20 monoclonal antibody only (rituximab or ofatumumab).
Maltese: Fi studji 312-0116/0117 u 312-0119, raxx (irrapportat bħala dermatite bil-qxur ġeneralizzata, reazzjoni avversa fil-ġilda kkawżata mill-mediċina, raxx, raxx eritematiku, raxx ġeneralizzat, raxx makulari, raxx makulo-papulari, raxx papulari, raxx pruritiku, raxx bil-ponot, raxx bl-infafet, nuffata u qoxra fuq ġilda infjammata) seħħ f'31.1% tal-individwi li rċivew idelalisib + antikorp monoklonali anti-CD20 (rituximab jew ofatumumab) u 8.2% li rċivew antikorp monoklonali anti-CD20 biss (rituximab jew ofatumumab).
English: Substrates of inducible enzymes (e.g., CYP2C9, CYP2C19, CYP2B6 and UGT) In vitro, idelalisib was an inducer of several enzymes, and a risk for decreased exposure and thereby decreased efficacy of substrates of inducible enzymes such as CYP2C9, CYP2C19, CYP2B6 and UGT cannot be excluded.
Maltese: Substrati ta' enzimi induċibbli (eż., CYP2C9, CYP2C19, CYP2B6 u UGT) In vitro, idelalisib kien induttur ta' diversi enzimi, u riskju għal esponiment imnaqqas u għalhekk effikaċja mnaqqsa ta' substrati ta' enzimi induċibbli bħal CYP2C9, CYP2C19, CYP2B6 u UGT ma jistax jiġi eskluż.
English: Figure 2: Kaplan-Meier curve of PFS from study 312-0119 (intent-to-treat population)
Maltese: Figura 2: Kurva ta' Kaplan Meier ta' PFS minn studju 312-0119 (popolazzjoni intent-to-treat)
English: Subjects received idelalisib 150 mg twice daily and rituximab 375 mg/m2 BSA weekly for 8 doses.
Maltese: L-individwi rċevew idelalisib 150 mg darbtejn kuljum u rituximab 375 mg/m2 BSA fil-ġimgħa għal 8 dożi.
English: CYP3A/P-gp inhibitors
Maltese: Inibituri ta' CYP3A/P-gp
English: Co-administration of multiple doses of idelalisib 150 mg twice daily to healthy subjects resulted in comparable exposures for rosuvastatin (AUC 90% CI: 87, 121) and digoxin (AUC 90% CI: 98, 111), suggesting no clinically relevant inhibition of BCRP, OATP1B1/1B3 or systemic P-gp by idelalisib.
Maltese: L-għoti flimkien ta' dożi multipli ta' idelalisib 150 mg darbtejn kuljum lil individwi b'saħħithom irriżulta f'esponimenti komparabbli għal rosuvastatin (AUC ta' 90% CI: 87, 121) u digoxin (AUC ta' 90% CI: 98, 111), ma jissuġġerixxi l-ebda inibizzjoni klinikament rilevanti ta' BCRP, OATP1B1/1B3 jew P-gp sistematiku minn idelalisib.
English: Table 7: Summary of efficacy in Study 101-09 (IRC assessment) Characteristic
Maltese: Sommarju tal-effikaċja fl-Istudju 101-09 (evalwazzjoni IRC)
English: • amiodarone, bepridil, disopyramide, lidocaine, quinidine, medicines used to treat heart problems
Maltese: • amiodarone, bepridil, disopyramide, lidocaine, quinidine, mediċini li jintużaw għat trattament ta' problemi tal-qalb
English: Stevens-Johnson syndrome and toxic epidermal necrolysis (see section 4.4) Rarely, cases of SJS and TEN have occurred when idelalisib was administered concomitantly with other medicinal products associated with these syndromes (bendamustine, rituximab, allopurinol, and amoxicillin).
Maltese: Sindrome ta' Stevens-Johnson u nekrolisi epidermali tossika (ara sezzjoni 4.4) Rarament, każijiet ta' SJS u TEN seħħew meta idelalisib ingħata fl-istess ħin ma' prodotti mediċinali oħrajn assoċjati ma' dawn is-sindromi (bendamustine, rituximab, allopurinol u amoxicillin).
English: Chronic hepatitis
Maltese: Epatite kronika
English: Idelalisib and GS-563117 are substrates of P-gp and BCRP.
Maltese: Idelalisib u GS-563117 huma substrati ta' P-gp u BCRP.
English: Organising pneumonia
Maltese: Pulmonite organizzattiva
English: Midazolam (oral), triazolam
Maltese: SEDATTIVI/MEDIĊINI IPNOTIĊI Midazolam (orali), triazolam
English: ** LNR defined as the proportion of subjects who achieved a ≥ 50% decrease in the sum of products of the greatest perpendicular diameters of index lesions.
Maltese: ** LNR definit bħala l-proporzjoni ta' individwi li kisbu tnaqqis ta' ≥ 50% fit-total tal-multiplikazzjoni tal-akbar dijametri perpendikulari ta' leżjonijiet indiċi.
English: Through inhibition of chemokine receptors CXCR4 and CXCR5 signalling induced by the chemokines CXCL12 and CXCL13, respectively, idelalisib inhibits homing and retention of malignant B-cells in the tumour microenvironment including lymphoid tissues and the bone marrow.
Maltese: Permezz tal-inibizzjoni ta' sinjalazzjoni tar-riċetturi chemokine CXCR4 u CXCR5 indotta minn chemokines CXCL12 u CXCL13, rispettivament, idelalisib jinibixxi homing u żamma ta' ċelluli B malinni fil-mikro-ambjent tat-tumur inklużi t-tessuti limfatiċi u l-mudullun.
English: Concomitant treatment of idelalisib with CYP3A substrates with serious and/or life-threatening adverse reactions (e.g., alfuzosin, amiodarone, cisapride, pimozide, quinidine, ergotamine, dihydroergotamine, quetiapine, lovastatin, simvastatin, sildenafil, midazolam, triazolam) should be avoided and alternative medicinal products that are less sensitive to CYP3A4 inhibition should be used if possible.
Maltese: Trattament fl-istess ħin b'idelalisib b'substrati ta' CYP3A b'reazzjonijiet avversi serji u/jew ta' periklu għall-ħajja (eż., alfuzosin, amiodarone, cisapride, pimozide, quinidine, ergotamine, dihydroergotamine, quetiapine, lovastatin, simvastatin, sildenafil, midazolam, triazolam) għandu jiġi evitat u prodotti mediċinali alternattivi li huma anqas sensittivi għall-inibizzjoni ta' CYP3A4 għandhom jintużaw jekk possibbli.
English: Figure 1: Kaplan-Meier curve of PFS from study 312-0116 (intent-to-treat population)
Maltese: Figura 1: Kurva ta' Kaplan Meier ta' PFS minn studju 312-0116 (popolazzjoni intent-to-treat)
English: • quetiapine, a medicine used to treat schizophrenia, bipolar disorder and major depressive disorder
Maltese: • quetiapine, mediċina li tintuża għal trattament ta' skiżofrenija, disturb bipolari u disturb depressiv maġġuri
English: Idelalisib is a selective inhibitor of adenosine-5'-triphosphate (ATP) binding to the catalytic domain of PI3Kδ, resulting in inhibition of the phosphorylation of the key lipid second messenger phosphatidylinositol and prevention of Akt (protein kinase B) phosphorylation.
Maltese: Idelalisib huwa inibitur selettiv ta' adenosine-5'-triphosphate (ATP) li jintrabat mad-dominju katalitiku ta' PI3Kδ, li jwassal għall-inibizzjoni tal-fosforilazzjoni ta' phosphatidylinositol, messaġġier sekondarju tal-lipidi importanti, u l-prevenzjoni ta' fosforilazzjoni ta' Akt (proteina kinase B).
English: Frequencies are defined as follows: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), and not known (cannot be estimated from available data).
Maltese: Il-frekwenzi huma definiti kif ġej: 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), u mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Clinical monitoring is recommended for patients with CrCl < 90 mL/min.
Maltese: Monitoraġġ kliniku hu rakkomandat għal pazjenti b'CrCl ta' < 90 mL/min.
English: Polyvinyl alcohol (E1203), macrogol 3350 (E1521), titanium dioxide (E171), talc (E553B), iron oxide red (E172).
Maltese: Polyvinyl alcohol (E1203), macrogol 3550 (E1521), titanium dioxide (E171), talc (E553B), iron oxide aħmar (E172).
English: CI: confidence interval; n: number of responding subjects NR: not reached * Response as determined by an independent review committee (IRC) where ORR = complete response (CR) + partial response (PR) + minor response (MR) in subjects with WM. † In the overall iNHL cohort, 1 subject (0.6%) with WM had the best overall response of MR
Maltese: CI: intervall ta' kunfidenza, n: l-għadd ta' individwi li rrispondew NR: ma ntlaħqitx * Rispons kif stabbilit minn kumitat ta' analiżi indipendenti (IRC - independent review committee) fejn ORR = rispons totali (CR) + rispons parzjali (PR) + rispons minuri (MR - minor response) f'individwi b'WM. †
English: The apparent volume of distribution for idelalisib (mean) was approximately 96 L.
Maltese: Il-volum apparenti ta' distribuzzjoni għal idelalisib (medju) kien madwar 96 L.
English: Amlodipine, diltiazem, felodipine, nifedipine, nicardipine
Maltese: MEDIĊINI KONTRA L-PRESSJONI GĦOLJA Amlodipine, diltiazem, felodipine, nifedipine, nicardipine
English: • buspirone, clorazepate, diazepam, estazolam, flurazepam, zolpidem, medicines used to treat nervous system disorders
Maltese: • buspirone, clorazepate, diazepam, estazolam, flurazepam, zolpidem, mediċini li jintużaw għat-trattament ta' disturbi fis-sistema nervuża
English: • itraconazole, ketoconazole, posaconazole, voriconazole, medicines used to treat fungal infections • boceprevir, telaprevir, medicines used to treat hepatitis C
Maltese: • itraconazole, ketoconazole, posaconazole, voriconazole, mediċini li jintużaw għat-trattament ta' infezzjonijiet fungali
English: Orange, oval-shaped, film-coated tablet of dimensions 9.7 mm by 6.0 mm, debossed on one side with “GSI” and “100” on the other side.
Maltese: Pillola oranġjo, b'forma ovali, miksija b'rita b'dimensjonijiet ta' 9.7 mm b'6.0 mm, imnaqqxa b'“GSI” fuq naħa waħda u “100” fuq in-naħa l-oħra.
English: Respiratory, thoracic and mediastinal disorders Pneumonitis
Maltese: Disturbi respiratorji, toraċiċi u medjastinali Pulmonite
English: Elevated liver transaminases
Maltese: Żieda fit-transaminase
English: Idelalisib in combination with ofatumumab
Maltese: Idelalisib + O Ofatumumab
English: • Zydelig is indicated in combination with rituximab for the treatment of adult patients with chronic lymphocytic leukaemia (CLL):
Maltese: • Zydelig huwa indikat f'kombinazzjoni ma' rituximab għat-trattament ta' pazjenti adulti b'lewkimja limfoċitika kronika (CLL - chronic lymphocytic leukaemia):
English: Inhaled/nasal corticosteroids: Budesonide, fluticasone
Maltese: Kortikosterojdi li jinġibdu man nifs/nażali: Budesonide, fluticasone
English: Nearly all (95.9%) subjects had received prior anti-CD20 monoclonal antibodies.
Maltese: Kważi l-individwi kollha (95.9%) kienu rċevew antikorpi monoklonali anti-CD20 qabel.
English: Zydelig can cause lung inflammation.
Maltese: Zydelig jista' jikkawża infjammazzjoni tal-pulmun.
English: Potential interactions between idelalisib and co-administered medicinal products that are CYP3A substrates are listed in Table 1 (increase is indicated as “↑”).
Maltese: Interazzjonijiet potenzjali bejn idelalisib u prodotti mediċinali mogħtija flimkien li huma substrati ta' CYP3A huma elenkati f'Tabella 1 (żieda hi indikata bħala “↑”).
English: How to take Zydelig
Maltese: Tiħux Zydelig
English: Serious and fatal infections have occurred with idelalisib, including opportunistic infections such as Pneumocystis jirovecii pneumonia (PJP) and cytomegalovirus (CMV).
Maltese: Infezzjonijiet serji u fatali seħħew b'idelalisib, li jinkludu infezzjonijiet opportunistiċi bħal pnewmonja Pneumocystis jirovecii (PJP) u cytomegalovirus (CMV).
English: The following pack size is available: outer carton containing 1 plastic bottle of 60 film-coated tablets.
Maltese: Huwa disponibbli d-daqs tal-pakkett li ġej: kartuna ta' barra li fiha flixkun tal-plastik ta' 60 pillola miksija b'rita.
English: The idelalisib AUC (unbound), after accounting for differences in protein binding, was ~80% (1.8-fold) higher in moderate and ~152% (2.5-fold) higher in severe impairment compared to matched controls.
Maltese: L-AUC ta' idelalisib (mhux marbut), wara li jiġu kkunsidrati d-differenzi fit-twaħħil mal-proteina, kien ta' ~80% (1.8 darbiet) ogħla f'indeboliment moderat u ~152% (2.5 darbiet) ogħla f'indeboliment sever meta pparagunat ma' kontrolli mqabbla.
English: The primary endpoint was the ORR defined as the proportion of subjects who achieved a CR or PR (based on the Revised Response Criteria for Malignant Lymphoma [Cheson]), and, for subjects with Waldenström macroglobulinaemia, a minor response (MR) (based on the Response Assessment for Waldenström macroglobulinaemia [Owen]).
Maltese: Il-punt finali primarju kien l-ORR definit bħala l-proporzjon ta' individwi li kisbu CR jew PR (abbażi tal-Kriterji Riveduti ta' Rispons għal Limfoma Malinna [Cheson]), u, għall-individwi b'makroglobulinemija ta' Waldenström, rispons minuri (MR - minor response) (abbażi talValutazzjoni tar-Rispons għal makroglobulinemija ta' Waldenström [Owen]).
English: Antimycobacterials
Maltese: Antimikobatterjali
English: Tyrosine kinase inhibitors such as dasatinib and nilotinib, also vincristine and vinblastine
Maltese: MEDIĊINI KONTRA L-KANĊER Inibituri ta' kinase tyrosine bħal dasatinib u nilotinib, kif ukoll vincristine u vinblastine
English: Treatment with Zydelig must be permanently discontinued in the event of moderate or severe symptomatic pneumonitis or organising pneumonia (see sections 4.4 and 4.8).
Maltese: It-trattament b'Zydelig għandu jitwaqqaf b'mod permanenti fil-każ ta' pulmonite sintomatika moderata jew severa jew pulmonite organizzattiva (ara sezzjonijiet 4.4 u 4.8).
English: The plasma exposures (Cmax and AUC) of idelalisib are approximately dose proportional between 50 mg and 100 mg and less than dose proportional above 100 mg.
Maltese: L-esponimenti fil-plażma (Cmax u AUC) għal idelalisib huma bejn wieħed u ieħor proporzjonali għal doża bejn 50 mg u 100 mg u inqas milli proporzjonali mad-doża ogħla minn100 mg.
English: • dihydroergotamine, ergotamine, medicines used to treat migraine headache
Maltese: • dihydroergotamine, ergotamine, mediċini li jintużaw għal trattament ta' uġigħ ta' emigranja fir-ras
English: • rifabutin, a medicine used to treat bacterial infections including tuberculosis
Maltese: • rifabutin, mediċina li tintuża għat-trattament ta' infezzjonijiet batterjali li jinkludu t-tuberkulożi
English: Following 150 mg twice daily administration of idelalisib, average (range) Cmax and AUC at steady-state were 1,953 (272; 3,905) ng/mL and 10,439 (2,349; 29,315) ng•h/mL for idelalisib and 4,039 (669; 10,897) ng/mL and 39,744 (6,002; 119,770) ng•h/mL for GS-563117, respectively.
Maltese: Wara għoti ta' 150 mg darbtejn kuljum ta' idelalisib, il-medda tas-Cmax medja u tal-AUC medja fi stat fiss kienu 1,953 (272; 3,905) ng/mL u 10,439 (2,349; 29,315) ng•h/mL għal idelalisib u 4,039 (669; 10,897) ng/mL u 39,744 (6,002; 119,770) ng•h/mL għal GS-563117, rispettivament.
English: Idelalisib is metabolised primarily via aldehyde oxidase, and to a lesser extent via CYP3A and glucuronidation (UGT1A4).
Maltese: Idelalisib huwa metabolizzat primarjament permezz ta' aldehyde oxidase, u fuq livell inqas permezz ta' CYP3A u glucuronidation (UGT1A4).
English: Microcrystalline cellulose Hydroxypropyl cellulose (E463) Croscarmellose sodium Sodium starch glycolate Magnesium stearate
Maltese: Microcrystalline cellulose Hydroxypropyl cellulose (E463) Croscarmellose sodium
English: Zydelig is indicated in combination with rituximab for the treatment of adult patients with chronic lymphocytic leukaemia (CLL):
Maltese: Zydelig huwa indikat f'kombinazzjoni ma' rituximab għat-trattament ta' pazjenti adulti b'lewkimja limfoċitika kronika (CLL - chronic lymphocytic leukaemia):
English: Boceprevir, telaprevir
Maltese: Inibituri tal-protease tal-HCV Boceprevir, telaprevir
English: The effect of idelalisib (150 mg and 400 mg) on the QT/QTc interval was evaluated in a placebo- and positive-controlled (moxifloxacin 400 mg) crossover study in 40 healthy subjects.
Maltese: L-effett ta' idelalisib (150 mg u 400 mg) fuq l-intervall QT/QTc kien evalwat fi studju crossover ikkontrollat bi plaċebo u b'mod pożittiv (moxifloxacin 400 mg) fuq 40 individwu f'saħħithom.