FrancophonIA/ELRC3.0 huggingface dataset:
English: musculoskeletal pain (musculoskeletal discomfort, back pain, musculoskeletal stiffness, musculoskeletal chest pain and torticollis) w. myositis (myalgia, myopathy, polymyalgia rheumatica and rhabdomyolysis) x. arthritis (joint swelling, polyarthritis and joint effusion) y. tenosynovitis (tendonitis, synovitis and tendon pain) z. nephritis (nephritis autoimmune, tubulointerstitial nephritis and renal failure, renal failure acute, or acute kidney injury with evidence of nephritis, nephrotic syndrome) aa. oedema (oedema peripheral, generalised oedema, fluid overload, fluid retention, eyelid oedema and lip oedema, face oedema, localised oedema and periorbital oedema)
Maltese: pemfigojd, ħakk, ħakk mifrux, raxx, raxx eritematuż, raxx mifrux, raxx makulopapulari, raxx bil-ħakk, raxx bl-infafet u ferita fil-ġilda) t. vitiligo (telf tal-kulur tal-ġilda, ipopigmentazzjoni tal-ġilda u ipopigmentazzjoni ta' tebqet l-għajn) u. keratożi likenuża (lichen planus u lichen sclerosus) v. uġigħ muskoluskeletriku (skonfort muskoluskeletriku, uġigħ fid-dahar, ebusija muskoluskeletrika, uġigħ muskoluskeletriku fis-sider u tortikollis) w. mijosite (mijalġja, mijopatija, polimijalġja rewmatika u rabdomijolisi) x. artrite (nefħa fil-ġogi, poliartrite u effużjoni mill-ġogi) y. sinovite tal-għerq (infjammazzjoni tal-għerq, sinovite u uġigħ fl-għerq) z. nefrite (nefrite awtoimmuni, nefrite tubulointerstizjali u insuffiċjenza tal-kliewi, insuffiċjenza akuta tal-kliewi, jew ħsara akuta fil-kliewi b'evidenza ta' nefrite, sindrome nefrotiku) aa. edima (edima periferali, edima mifruxa, ammont eċċessiv ta' fluwidu, żamma ta' fluwidu, edima f'tebqet l-għajn u edima fix-xoffa, edima fil-wiċċ, edima lokalizzata u edima madwar l-għajnejn)
English: There are limited data on the safety and efficacy of KEYTRUDA in patients with ocular melanoma (see section 5.1).
Maltese: Hemm data limitata dwar is-sigurtà u l-effikaċja ta' KEYTRUDA f'pazjenti b'melanoma tal-għajnejn (ara sezzjoni 5.1).
English: Among the 616 patients in KEYNOTE-189, baseline characteristics were: median age of 64 years (49% age 65 or older); 59% male; 94% White and 3% Asian; 43% and 56% ECOG performance status of 0 or 1 respectively; 31% PD-L1 negative (TPS < 1%); and 18% with treated or untreated brain metastases at baseline.
Maltese: Fost is-616-il pazjent f'KEYNOTE-189, il-karatteristiċi fil-linja bażi kienu: età medjan ta' 64 sena (49% kellhom 65 sena jew aktar); 59% irġiel; 94% Bojod u 3% Asjatiċi; 43% u 56% kellhom stat ta' eżekuzzjoni ta' ECOG ta' 0 jew 1 rispettivament;
English: Pembrolizumab + Chemo Standard
Maltese: Pembrolizumab Standard
English: % (95% CI)
Maltese: ORR % (95% CI)
English: Table 27: Efficacy of pembrolizumab 200 mg every 3 weeks in HNSCC patients with TPS ≥ 50% who were previously treated with platinum chemotherapy in KEYNOTE-040
Maltese: Tabella 27: Effikaċja ta' pembrolizumab 200 mg kull 3 ġimgħat f'pazjenti b'HNSCC b'TPS ≥ 50% li qabel kienu ġew ittrattati b'kimoterapija bil-platinum f'KEYNOTE-040
English: Administer the infusion solution intravenously over 30 minutes using a sterile, non-pyrogenic, low-protein binding 0.2 to 5 µm in-line or add-on filter.
Maltese: Agħti s-soluzzjoni tal-infużjoni fil-vini fuq perjodu ta' 30 minuta permezz ta' filtru fil-pajp jew filtru li jiżdied apparti, sterili, mhux piroġeniku, ta' 0.2 sa 5 µm bi rbit baxx mal-proteini.
English: The median OS was 8.4 months for pembrolizumab compared to 7.1 months for standard treatment.
Maltese: L-OS medjana kienet 8.4 xhur għal pembrolizumab meta mqabbel ma' 7.1 xhur għal trattament standard.
English: Sixty-seven percent (67%) of patients had M1 disease and the majority had Stage IV disease (Stage IV 32%, Stage IVa 14%, Stage IVb 4%, and Stage IVc 44%).
Maltese: Sebgħa u sittin fil-mija (67%) tal-pazjent kellhom mard M1 u l-maġġoranza kellhom marda fl-Istadju IV (Stadju IV 32%, Stadju IVa 14%, Stadju IVb 4%, u Stadju IVc 44%).
English: KEYTRUDA 50 mg powder for concentrate for solution for infusion pembrolizumab
Maltese: KEYTRUDA 50 mg trab għall-konċentrat għal soluzzjoni għall-infużjoni pembrolizumab
English: j.
Maltese: C.
English: The median trough concentrations (Cmin) at steady-state were approximately 22 mcg/mL at a dose of 2 mg/kg every 3 weeks and 29 mcg/mL at a dose of 200 mg every 3 weeks.
Maltese: Il-medjan tal-inqas konċentrazzjonijiet (Cmin) fl-istat fiss kienu madwar 22 mcg/mL bid-doża ta' 2 mg/kg kull 3 ġimgħat u 29 mcg/mL bid-doża ta' 200 mg kull 3 ġimgħat.
English: An analysis was performed in KEYNOTE-407 in patients who had PD-L1 TPS < 1% [pembrolizumab plus chemotherapy arm: n=95 (34%) vs. placebo plus chemotherapy arm: n=99 (35%)], TPS 1% to 49% [pembrolizumab plus chemotherapy arm: n=103 (37%) vs. placebo plus chemotherapy arm: n=104 (37%)] or TPS ≥ 50% [pembrolizumab plus chemotherapy arm: n=73 (26%) vs. placebo plus chemotherapy arm: n=73 (26%)] (see Table 16).
Maltese: Saret analiżi f'KEYNOTE-407 f'pazjenti li kellhom PD-L1 b'TPS ta' < 1% [fergħa ta' pembrolizumab flimkien ma' kimoterapija: n=95 (34%) vs. fergħa ta' plaċebo flimkien ma' kimoterapija: n=99 (35%)], TPS 1% sa 49% [fergħa ta' pembrolizumab flimkien ma' kimoterapija: n=103 (37%) vs. fergħa ta' plaċebo flimkien ma' kimoterapija: n=104 (37%)] jew TPS ta' ≥ 50% [fergħa ta' pembrolizumab flimkien ma' kimoterapija: n=73 (26%) vs. fergħa ta' plaċebo flimkien ma' kimoterapija: n=73 (26%)] (ara Tabella 16).
English: Hyperthyroidism occurred in 244 (4.1%) patients, including Grade 2 or 3 cases in 64 (1.1%) and 7 (0.1%) patients, respectively, receiving pembrolizumab.
Maltese: Ipertirojdiżmu seħħ f'244 (4.1%) pazjent, inkluż każijiet ta' Grad 2 jew 3 f'64 (1.1%) pazjent u 7 (0.1%) pazjenti, rispettivament , li kienu qed jirċievu pembrolizumab.
English: The Kaplan-Meier curves for OS and PFS are shown in Figures 7 and 8.
Maltese: Il-kurvi Kaplan-Meier għal OS u PFS qed jintwerew f'Figuri 7 u 8.
English: Among patients with BRAF mutant tumours, 10 (50%) were previously treated with a BRAF inhibitor.
Maltese: Fost il-pazjenti b'tumuri b'mutazzjoni BRAF, 10 (50%) kienu ġew ttrattati b'inibitur ta' BRAF qabel.
English: Table 4: Efficacy results in KEYNOTE-002
Maltese: Tabella 4: Riżultati ta' effikaċja f'KEYNOTE-002 Skop finali
English: A total of 1,019 adult patients were randomised (1:1) to receive pembrolizumab 200 mg every three weeks (n=514) or placebo (n=505), for up to one year until disease recurrence or unacceptable toxicity.
Maltese: Total ta' 1,019-il pazjent adult intagħżlu b'mod arbitrarju (1:1) biex jirċievu pembrolizumab 200 mg kull tliet ġimgħat (n=514) jew plaċebo (n=505), sa sena sakemm il-marda feġġet mill-ġdid jew kien hemm tossiċità mhux aċċettabbli.
English: Of the 51 patients receiving 2 mg/kg of pembrolizumab who were naïve to treatment with ipilimumab, 63% were male, 35% were ≥ 65 years of age and the median age was 60 years (range 35-80).
Maltese: Mill-51 pazjent li kienu qed jirċievu 2 mg/kg ta' pembrolizumab li qatt ma kienu ħadu trattament b'ipilimumab qabel, 63% kienu rġiel, 35% kellhom età ta' ≥65 sena u l-medjan tal-età kien 60 sena (firxa minn 35-80).
English: Hyperthyroidism led to discontinuation of pembrolizumab in 3 (0.1%) patients.
Maltese: L-ipertirojdiżmu wassal għat-twaqqif ta' pembrolizumab fi 3 (0.1%) pazjenti.
English: Adrenal insufficiency occurred in 46 (0.8%) patients, including Grade 2, 3 or 4 cases in 19 (0.3%), 20 (0.3%) and 3 (0.1%) patients, respectively, receiving pembrolizumab.
Maltese: Insuffiċjenza tal-glandoli adrenali seħħet f'46 (0.8%) pazjent, inklużi każijiet ta' Grad 2, 3 jew 4 f'19 (0.3%), 20 (0.3%) u 3 (0.1%) pazjenti, rispettivament, li kienu qed jirċievu pembrolizumab.
English: For use in combination, see the SmPC for the concomitant therapies.
Maltese: Għall-użu f'kombinazzjoni, ara l-SmPC tat-terapiji konkomitanti.
English: • a kind of cancer called classical Hodgkin lymphoma
Maltese: • tip ta' kanċer imsejjaħ limfoma klassika ta' Hodgkin
English: Two patients (< 0.1%) discontinued pembrolizumab due to hypothyroidism.
Maltese: Żewġ pazjenti (< 0.1%) waqqfu pembrolizumab minħabba l-ipotirojdiżmu.
English: Patients should be monitored for signs and symptoms of pneumonitis.
Maltese: Ilpazjenti għandhom jiġu mmonitorjati għal sinjali u sintomi ta' pulmonite.
English: Each vial contains an excess fill of 10 mg (0.4 mL) to ensure the recovery of 50 mg of KEYTRUDA per vial.
Maltese: Kull kunjett ikollu mili żejjed ta' 10 mg (0.4 mL) biex jiġi aċċertat l-irkupru ta' 50 mg ta' KEYTRUDA minn kull kunjett.
English: An analysis was performed in KEYNOTE-045 in patients who had PD-L1 CPS < 10 [pembrolizumab: n=186 (69%) vs. chemotherapy: n= 176 (65%)] or ≥ 10 [pembrolizumab: n=74 (27%) vs. chemotherapy: n= 90 (33%)] in both pembrolizumab- and chemotherapy-treated arms (see Table 20).
Maltese: Twettqet analiżi f'KEYNOTE-045 f'pazjenti li kellhom CPS ta' PD-L1 ta' <10 [pembrolizumab: n=186 (69%) vs. kimoterapija: n= 176 (65%)] jew ≥10 [pembrolizumab: n=74 (27%) vs. kimoterapija: n= 90 (33%)] fil-fergħat kemm ta' dawk ittrattati b'pembrolizumab kif ukoll ta' dawk ittrattati bilkimoterapija (ara Tabella 20).
English: Of the 89 patients receiving 2 mg/kg of pembrolizumab who were previously treated with ipilimumab, 53% were male, 33% were ≥ 65 years of age and the median age was 59 years (range 18-88).
Maltese: Mid-89 pazjent li kienu qed jirċievu 2 mg/kg ta' pembrolizumab li kienu ttrattati b'ipilimumab qabel, 53% kienu rġiel, 33% kellhom età ta' ≥65 sena u l-medjan tal-età kien 59 sena (firxa minn 18-88).
English: ORR % * Hazard ratio (pembrolizumab combination therapy compared to chemotherapy) based on the stratified Cox proportional hazard model
Maltese: ORR % * Proporzjon ta' periklu (terapija ta' kombinazzjoni b'pembrolizumab mqabbla mal-kimoterapija) abbażi tal-mudell ta'
English: Hazard ratio* (98% CI) p-Value (stratified log-rank) RFS at 6 months RFS rate RFS at 12 months RFS rate RFS at 18 months RFS rate
Maltese: Proporzjon ta' periklu* (95% CI) RFS Rata ta' RFS wara 6 xhur pożittiv għall-mutazzjoni BRAF
English: An analysis was performed in KEYNOTE-048 in patients whose tumours expressed PD-L1 CPS ≥ 20 [pembrolizumab plus chemotherapy: n=126 (49%) vs. standard treatment: n=110 (43%) and pembrolizumab monotherapy: n=133 (52%) vs. standard treatment: n=122 (48%)] (see Table 25).
Maltese: Saret analiżi f'KEYNOTE-048 f'pazjenti li t-tumuri tagħhom kienu jesprimu PD-L1 b'CPS ≥ 20 [pembrolizumab flimkien ma' kimoterapija: n=126 (49%) vs. trattament standard: n=110 (43%) u monoterapija b'pembrolizumab: n=133 (52%) vs. trattament standard: n=122 (48%)] (ara Tabella 25).
English: Number (%) of patients with event Hazard ratio* (95% CI) p-Value
Maltese: Numru (%) ta' pazjenti b'avveniment Proporzjon ta' periklu* (95% CI) Valur p†
English: The median time to onset of adrenal insufficiency was 5.4 months (range 1 day to 17.7 months).
Maltese: Iżżmien medjan għall-bidu ta' insuffiċjenza tal-glandoli adrenali kien 5.4 xhur (firxa jum 1 sa 17.7 xhur).
English: Uncommon tenosynovitis tenosynovitis
Maltese: 4.1 Indikazzjonijiet terapewtiċi
English: The efficacy of pembrolizumab in combination with pemetrexed and platinum chemotherapy was investigated in a multicentre, randomised, active-controlled, double-blind trial, KEYNOTE-189.
Maltese: L-effikaċja ta' pembrolizumab mogħti flimkien ma' kimoterapija b'pemetrexed u platinum ġiet investigata fi prova b'ħafna ċentri, arbitrarja, ikkontrollata b'mod attiv, fejn la l-investigaturi u lanqas l-individwi ma kienu jafu liema sustanza qed tintuża, KEYNOTE-189.
English: Disease characteristics were squamous (21%) and non-squamous (70%); M1 (91%); stable brain metastases (15%) and the incidence of mutations was EGFR (8%) or ALK (1%).
Maltese: M1 (91%); metastasi stabbli fil-moħħ (15%) u l-inċidenza ta' mutazzjonijiet kienet EGFR (8%) jew ALK (1%).
English: Among KEYNOTE-013 patients, the baseline characteristics were median age 32 years (7% age 65 or older), 58% male, 94% White; and 45% and 55% had an ECOG performance status 0 and 1, respectively.
Maltese: Fost il-pazjenti ta' KEYNOTE-013, il-karatteristiċi tal-linja bażi kienu età medjana ta' 32 sena (7% ta' 65 sena jew aktar), 58% irġiel, 94% Bojod; u 45% u 55% kellhom stat ta' esekuzzjoni ta' ECOG ta' 0 u 1, rispettivament.
English: One vial contains 50 mg of pembrolizumab.
Maltese: Kunjett wieħed fih 50 mg ta' pembrolizumab.
English: EU/1/15/1024/002
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/15/1024/002
English: Of the 834 patients, 60% were male, 44% were ≥ 65 years (median age was 62 years [range 18-89]) and 98% were white.
Maltese: Mit-834 pazjent, 60% kienu rġiel, 44% kellhom ≥ 65 sena (medjan tal-età kien 62 sena [firxa minn 18-89]) u 98% kienu bojod.
English: Each vial contains an excess fill of 0.25 ml (total content per vial 4.25 ml) to ensure the recovery of 4 ml of concentrate.
Maltese: Kull kunjett ikollu mili żejjed ta' 0.25 ml (kontenut totali 4.25 ml f'kull kunjett) biex jiġi aċċertat l-irkupru ta' 4 ml ta' konċentrat.
English: Severe infusion-related reactions, including hypersensitivity and anaphylaxis, have been reported in patients receiving pembrolizumab (see section 4.8).
Maltese: Ġew irrappurtati reazzjonijiet severi marbuta mal-infużjoni, inklużi sensittività eċċessiva u anafilassi, f'pazjenti li kienu qed jirċievu pembrolizumab (ara sezzjoni 4.8).
English: Pembrolizumab 2 mg/kg every 3 weeks:
Maltese: Pembrolizumab 2 mg/kg kull 3 ġimgħat:
English: Table 11: Efficacy results by PD-L1 expression and BRAF mutation status in KEYNOTE-054
Maltese: Tabella 11: Riżultati ta' effikaċja skont l-espressjoni ta' PD-L1 u l-istat tal-mutazzjoni BRAF
English: - Keep this leaflet.
Maltese: Proporzjon ta' periklu* (CI ta' Valur p†
English: • KEYTRUDA 200 mg every 3 weeks
Maltese: • KEYTRUDA 200 mg kull 3 ġimgħat
English: Combination with chemotherapy
Maltese: Komuni pulmonitel,
English: Pembrolizumab 200 mg every 3 weeks n=210
Maltese: Pembrolizumab 200 mg kull 3 ġimgħat n=210
English: KEYTRUDA is used in adults to treat:
Maltese: KEYTRUDA jintuża fl-adulti għat-trattament ta':
English: Pembrolizumab 10 mg/kg every 2 weeks n=279
Maltese: Pembrolizumab 10 mg/kg kull ġimagħtejn n=279
English: Uncommon type 1 diabetes mellitus type 1 diabetes mellitus type 1 diabetes mellitus
Maltese: Mhux komuni dijabete mellitus tat-tip 1f dijabete mellitus tat-tip 1 dijabete mellitus tat tip 1f
English: Colitis occurred in 107 (1.8%) patients, including Grade 2, 3 or 4 cases in 31 (0.5%), 62 (1.1%) and 3 (< 0.1%) patients, respectively, receiving pembrolizumab.
Maltese: Kolite seħħet f'107 (1.8%) pazjent, inkluż każijiet ta' Grad 2, 3 jew 4 f'31 (0.5%) pazjent, 62 (1.1%) pazjent u 3 (<0.
English: Hepatitis occurred in 50 (0.8%) patients, including Grade 2, 3 or 4 cases in 8 (0.1%), 31 (0.5%) and 8 (0.1%) patients, respectively, receiving pembrolizumab.
Maltese: Epatite seħħet f'50 (0.8%) pazjent, inkluż każijiet ta' Grad 2, 3 jew 4 fi 8 (0.1%) pazjenti, 31 (0.5%) pazjent u fi 8 (<0.
English: Human immunoglobulins G4 (IgG4) are known to cross the placental barrier; therefore, being an IgG4, pembrolizumab has the potential to be transmitted from the mother to the developing foetus.
Maltese: Immunoglobulini G4 tal-bniedem (IgG4 - immunoglobulins G4) huma magħrufa li jgħaddu minn ġol-plaċenta; għalhekk, minħabba li huwa IgG4, pembrolizumab għandu l-possibbiltà li jgħaddi mill-omm għall-fetu li qed jiżviluppa.
English: The effects of various covariates on the pharmacokinetics of pembrolizumab were assessed in population pharmacokinetic analyses.
Maltese: L-effetti ta' diversi kovarjati fuq il-farmakokinetika ta' pembrolizumab ġew ivvalutati f'analiżi ta' farmakokinetika ta' popolazzjoni.
English: Patients were stratified by PD-L1 expression (TPS ≥ 50%), HPV status and ECOG performance status and then randomised (1:1) to receive either pembrolizumab 200 mg every 3 weeks (n=247) or one of three standard treatments (n=248): methotrexate 40 mg/m2 once weekly (n=64), docetaxel 75 mg/m2 once every 3 weeks
Maltese: Il-pazjenti ġew stratifikati skont l-espressjoni ta' PD-L1 (TPS ≥ 50%), l-istat tal-HPV u l-istat ta' eżekuzzjoni ta' ECOG imbagħad intgħażlu b'mod arbitrarju (1:1) biex jirċievu pembrolizumab 200 mg kull 3 ġimgħat (n=247) jew wieħed mit-tliet trattamenti standard (n=248): methotrexate 40 mg/m2 darba fil-ġimgħa (n=64), docetaxel 75 mg/m2 darba kull 3 ġimgħat (n=99), jew cetuximab b'doża għolja ta' 400 mg/m2 fil-bidu imbagħad 250 mg/m2 darba fil-ġimgħa (n=71).
English: * Hazard ratio (pembrolizumab compared to docetaxel) based on the stratified Cox proportional hazard model Based on stratified Log rank test
Maltese: * Proporzjon ta' periklu (pembrolizumab mqabbel ma' docetaxel) abbażi tal-mudell ta' periklu proporzjonali stratifikat Cox †
English: KEYTRUDA must be administered by intravenous infusion over 30 minutes.
Maltese: KEYTRUDA għandu jingħata permezz ta' infużjoni fil-vini fuq perjodu ta' 30 minuta.
English: Figure 11: Kaplan-Meier curve for overall survival by treatment arm in KEYNOTE-010 (patients with PD-L1 expression tumour proportion score  1%, intent to treat population)
Maltese: Kaplan-Meier għal sopravivenza globali skont il-fergħa ta' trattament f'KEYNOTE-010 (pazjenti b'punteġġ ta' proporzjon tat-tumur għal espressjoni PD-L1 ta' ≥ 1%, popolazzjoni bl-intenzjoni li tiġi ttrattata)
English: Of 23 patients with cHL who proceeded to allogeneic HSCT after treatment with pembrolizumab, 6 patients (26%) developed GVHD, one of which was fatal, and 2 patients (9%) developed severe hepatic VOD after reduced-intensity conditioning, one of which was fatal.
Maltese: Minn 23 pazjent b'cHL li pproċedew għal HSCT alloġenejku wara trattament b'pembrolizumab, 6 pazjenti (26%) żviluppaw GVHD, li waħda minnhom kienet fatali, u 2 pazjenti (9%) żviluppaw VOD epatika severa wara kondizzjonar b'intensità baxxa, li każ minnhom kien fatali.
English: Pembrolizumab 10 mg/kg every 3 weeks:
Maltese: Pembrolizumab 10 mg/kg kull 3 ġimgħat:
English: Among 370 patients with urothelial carcinoma who were not eligible for cisplatin-containing chemotherapy baseline characteristics were: median age 74 years (82% age 65 or older); 77% male; and 89% White and 7% Asian.
Maltese: Fost it-370 pazjent b'karċinoma uroteljali li ma kinux eliġibbli għal kimoterapija li kien fiha cisplatin il-karatteristiċi fil-linja bażi kienu: età medjana ta' 74 sena (82% li kellhom 65 sena jew aktar); 77% kienu rġiel; u 89% kienu Bojod u 7% kienu Asjatiċi.
English: After reconstitution, 1 mL of concentrate contains 25 mg of pembrolizumab.
Maltese: Wara r-rikostituzzjoni, 1 mL ta' konċentrat ikun fih 25 mg ta' pembrolizumab.
English: Pembrolizumab CL is approximately 23% lower (geometric mean, 195 mL/day [CV%: 40%]) after achieving maximal change at steady-state compared with the first dose (252 mL/day [CV%: 37%]); this decrease in CL with time is not considered clinically meaningful.
Maltese: Is-CL ta' pembrolizumab hija madwar 23% aktar baxxa (medja ġeometrika, 195 mL/jum [CV%: 40%]) wara li tinkiseb l-ogħla bidla fl-istat fiss meta mqabbla mal-ewwel doża (252 mL/jum [CV%: 37%]); dan it-tnaqqis fis-CL mal-ħin mhuwiex meqjus li għandu sinifikat kliniku.
English: Figure 15: Kaplan-Meier curve for overall survival by treatment arm in KEYNOTE-040 patients with PD-L1 expression (TPS ≥ 50%)
Maltese: Kaplan-Meier għal sopravivenza globali skont il-fergħa ta' trattament ta' pazjenti f'KEYNOTE-040 b'espressjoni ta' PD-L1 (TPS ≥ 50%)
English: The following side effects have been reported in clinical trials with pembrolizumab in combination with chemotherapy:
Maltese: L-effetti sekondarji li ġejjin kienu rrappurtati fi provi kliniċi b'pembrolizumab flimkien malkimoterapija:
English: KEYTRUDA as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who are not eligible for cisplatin-containing chemotherapy and whose tumours express PD-L1 with a combined positive score (CPS) ≥ 10 (see section 5.1).
Maltese: KEYTRUDA bħala monoterapija huwa indikat għat-trattament ta' karċinoma uroteljali avvanzata lokalment jew metastatika f'adulti li mhumiex eliġibbli għal kimoterapija li fiha cisplatin u li t-tumuri tagħhom jesprimu PD-L1 b'punteġġ pożittiv ikkombinat (CPS - combined positive score) ≥ 10 (ara sezzjoni 5.1).
English: Figure 16: Kaplan-Meier curve for overall survival by treatment arm in KEYNOTE-426 (intent to treat population)*
Maltese: Kaplan-Meier għal sopravivenza globali skont il-grupp ta' trattament F'KEYNOTE-426 (popolazzjoni bl-intenzjoni li tiġi ttrattata*)
English: Hazard ratio* (95% CI) ORR %
Maltese: Proporzjon ta' periklu għal OS* (95% CI) ORR %
English: Table 5: Efficacy results in KEYNOTE-001
Maltese: Riżultati ta' effikaċja f'KEYNOTE-001
English: The safety and efficacy of pembrolizumab were investigated in KEYNOTE-040, a multicentre, openlabel, randomised, controlled study for the treatment of histologically confirmed recurrent or metastatic HNSCC of the oral cavity, pharynx or larynx in patients who had disease progression on or after platinum-containing chemotherapy administered for recurrent or metastatic HNSCC or following platinum-containing chemotherapy administered as part of induction, concurrent, or adjuvant therapy, and were not amenable to local therapy with curative intent.
Maltese: Is-sigurtà u l-effikaċja ta' pembrolizumab ġew investigati f'KEYNOTE-040, studju b'ħafna ċentri, arbitrarju, ikkontrollat, fejn kemm l-investigaturi kif ukoll l-individwi kienu jafu liena sustanza qed tintuża, għat-trattament ta' HNSCC rikurrenti jew metastatika kkonfermata istoloġikament tal-kavità orali, tal-farinġi jew tal-larinġi f'pazjenti li kellhom progressjoni tal-marda waqt jew wara kimoterapija li kien fiha l-platinum mogħtija bħala parti minn terapija ta' induzzjoni, konkorrenti jew miżjuda, u ma kinitx taqbel magħhom terapija lokali b'intenzjoni ta' kura.
English: Table 23: Efficacy results for pembrolizumab plus chemotherapy in KEYNOTE-048 with PDL1 expression (CPS ≥ 1)
Maltese: Tabella 23: Riżultati tal-effikaċja għal pembrolizumab flimkien ma' kimoterapija f'KEYNOTE-048 b'espressjoni ta' PD-L1 (CPS ≥ 1)
English: How to store KEYTRUDA
Maltese: Mediċini oħra u KEYTRUDA
English: KEYTRUDA 50 mg powder for concentrate for solution for infusion.
Maltese: KEYTRUDA 50 mg trab għall-konċentrat għal soluzzjoni għall-infużjoni.
English: The median follow-up time was 7.8 months (range: 0.1 to 19.1 months).
Maltese: Iż-żmien medjan ta' segwitu kien ta' 7.8 xhur (medda: 0.1 sa 19.1 xhur).
English: Sixty-one percent of patients had received Auto-SCT, 38% were transplant ineligible; 17% had no prior brentuximab vedotin use; and 36% of patients had prior radiation therapy.
Maltese: Wieħed u sittin filmija tal-pazjenti kienu rċivew Awto-SCT, 38% ma kinux eliġibbli għat-trapjant; 17% ma kellhomx użu preċedenti ta' brentuximab vedotin; u 36% tal-pazjenti kellhom terapija preċedenti bir-radjazzjoni.
English: Pembrolizumab 200 mg every 3 weeks n=270
Maltese: Pembrolizumab 200 mg kull 3 ġimgħat n=270
English: Pembrolizumab 10 mg/kg every 2 weeks n=31
Maltese: Pembrolizumab 10 mg/kg kull ġimagħtejn n=31
English: OS results are reported from the final analysis at a median follow-up of 25 months.
Maltese: Pazjenti mingħajr progressjoni tal-marda setgħu jiġu ttrattati sa 24 xahar.
English: Randomisation was stratified by tumour PD-L1 expression (TPS < 1% [negative] vs. TPS ≥ 1%), investigator's choice of paclitaxel or nabpaclitaxel, and geographic region (East Asia vs. non-East Asia).
Maltese: TPS ≥ 1%), l-għażla tal-investigatur ta' paclitaxel jew nab-paclitaxel, u r-reġjun ġeografiku (mill-Asja talLvant vs. mhux mill-Asja tal-Lvant).
English: KEYTRUDA, as monotherapy or as combination therapy, should be permanently discontinued for Grade 4 or recurrent Grade 3 immune-related adverse reactions, unless otherwise specified in Table 1.
Maltese: KEYTRUDA, bħala monoterapija jew bħala terapija kombinata, għandu jitwaqqaf għalkollox għal reazzjonijiet avversi marbuta mal-immunità ta' Grad 4 jew ta' Grad 3 rikurrenti, sakemm ma jkunx speċifikat mod ieħor f'Tabella 1.
English: One vial of 4 mL of concentrate contains 100 mg of pembrolizumab.
Maltese: U KWANTITATTIVA Kunjett wieħed ta' 4 mL ta' konċentrat fih 100 mg ta' pembrolizumab.
English: t.
Maltese: D.