FrancophonIA/ELRC3.0 huggingface dataset:
English: Corticosteroids should be administered for Grade ≥ 2 events (initial dose of 1-2 mg/kg/day prednisone or equivalent followed by a taper); pembrolizumab should be withheld for Grade 2 pneumonitis, and permanently discontinued for Grade 3, Grade 4 or recurrent Grade 2 pneumonitis (see section 4.2).
Maltese: Il-kortikosterojdi għandhom jingħataw għall-każijiet ta' Grad ≥ 2 (doża tal-bidu ta' 1-2 mg/kg/jum prednisone jew ekwivalenti segwita bi tnaqqis bil-ftit il-ftit għal xejn); pembrolizumab m'għandux jingħata f'pulmonite ta' Grad 2, u għandu jitwaqqaf għalkollox f'pulmonite ta' Grad 3, Grad 4 jew pulmonite ta' Grad 2 rikurrenti (ara sezzjoni 4.2).
English: Pembrolizumab must be permanently discontinued for any Grade 3 immune-related adverse reaction that recurs and for any Grade 4 immune-related adverse reaction (see sections 4.2 and 4.8).
Maltese: Pembrolizumab għandu jitwaqqaf għalkollox għal kwalunkwe reazzjoni avversa marbuta malimmunità ta' Grad 3 li tfiġġ mill-ġdid u għal kwalunkwe reazzjoni avversa marbuta mal-immunità ta' Grad 4 (ara sezzjonijiet 4.2 u 4.8).
English: Forty-five percent had an ECOG Performance Status of 1, 40% had elevated LDH and 23% had a BRAF mutated tumour.
Maltese: Stat ta' Eżekuzzjoni ta' ECOG ta' 1, 40% kellhom LDH għoli u 23% kellhom tumur b'mutazzjoni BRAF.
English: Figure 6: Kaplan-Meier curve for overall survival by treatment arm in KEYNOTE-024 (intent to treat population)
Maltese: Kaplan-Meier għal sopravivenza globali skont il-fergħa tat-trattament f' KEYNOTE-024 (popolazzjoni bl-intenzjoni li tiġi trattata)
English: Ocular melanoma
Maltese: Melanoma tal-għajnejn
English: Treatment with pembrolizumab and axitinib continued until RECIST v1.1-defined progression of disease as verified by BICR or confirmed by the investigator, unacceptable toxicity, or for pembrolizumab, a maximum of 24 months.
Maltese: It-trattament b'pembrolizumab kompla sakemm kien hemm progressjoni tal-marda definita permezz ta' RECIST 1.1 kif determinat mill-investigatur, tossiċità mhux aċċettabbli, jew massimu ta' 24 xahar.
English: Figure 5: Kaplan-Meier curve for progression-free survival by treatment arm in KEYNOTE-024 (intent to treat population)
Maltese: Kaplan-Meier għal sopravivenza mingħajr progressjoni skont il-fergħa tattrattament f'KEYNOTE-024 (popolazzjoni bl-intenzjoni li tiġi trattata
English: thyroiditis e, adrenal insufficiency
Maltese: Pulmonite marbuta mal-immunità
English: In this patient population, the median observation time was 7.3 months (range: 1 day to 31 months) and the most frequent adverse reactions with pembrolizumab were fatigue (32%), nausea (20%), and diarrhoea (20%).
Maltese: F'din il-popolazzjoni ta' pazjenti, iż-żmien medjan ta' osservazzjoni kien ta' 7.3 xhur (firxa: jum 1 sa 31 xahar) u l-aktar reazzjonijiet avversi frekwenti b'pembrolizumab kienu għeja (32%), nawsja (20%), u dijarea (20%).
English: Figure 3: Kaplan-Meier curve for progression-free survival by treatment arm in KEYNOTE-002 (intent to treat population)
Maltese: Kaplan-Meier għal sopravivenza mingħajr progressjoni skont il-fergħa ta' trattament f'KEYNOTE-002 (popolazzjoni bl-intenzjoni li tiġi ttrattata)
English: meningitis (aseptic)
Maltese: TWISSIJA(IET) SPEĊJALI
English: Table 15: Efficacy Results in KEYNOTE-407
Maltese: Riżultati tal-Effikaċja f'KEYNOTE-407
English: The key eligibility criteria for this study were metastatic squamous NSCLC, regardless of tumour PD-L1 expression status, and no prior systemic treatment for metastatic disease.
Maltese: Il-kriterji l-aktar importanti għall-eliġibilità għal dan l-istudju kienu NSCLC skwamuża metastatika, irrispettivament mill-istat ta' espressjoni ta' PD-L1 tat-tumur, u l-ebda trattament sistemiku preċedenti għal mard metastatiku.
English: One vial of powder contains 50 mg of pembrolizumab.
Maltese: U KWANTITATTIVA Kunjett wieħed ta' trab fih 50 mg ta' pembrolizumab.
English: Assessed by BICR using RECIST 1.1
Maltese: Ivvalutat permezz ta' BICR bl-użu ta' RECIST 1.1 ¶
English: Common (may affect up to 1 in 10 people) - lung infection - decrease in the number of platelets (bruising or bleeding more easily); decrease in the number of white blood cell (lymphocytes) - reactions related to the infusion of the medicine - overactive thyroid gland activity; hot flush - decreased sodium, potassium, or calcium in the blood - trouble sleeping - dizziness; inflammation of the nerves causing numbness, weakness, tingling or burning pain of the arms and legs; lack of energy; change in your sense of taste - dry eye - abnormal heart rhythm - high blood pressure - inflammation of the lungs - inflammation of the intestines; dry mouth - red raised rash sometimes with blisters; patches of skin which have lost colour; dry, itchy skin;
Maltese: Komuni (jistgħu jaffettwaw sa persuna waħda minn kull 10) - infezzjoni fil-pulmun - tnaqqis fin-numru ta' plejtlits (titbenġel jew joħroġ id-demm aktar faċilment); tnaqqis fin-numru ta' ċelluli bojod tad-demm (limfoċiti) - reazzjonijiet marbuta mal-infużjoni tal-mediċina - glandola tat-tirojde attiva żżejjed; fawra - tnaqqis fis-sodium, fil-potassium, jew fil-calcium fid-demm - diffikultà biex torqod - sturdament; infjammazzjoni tan-nervituri li tikkawża titrix, dgħufija, tnemnim jew uġigħ bħal ħruq fid-dirgħajn u fir-riġlejn; nuqqas ta' enerġija; bidla fis-sens tat-togħma - għajnejn xotti - ritmu ta' taħbit tal-qalb mhux normali - pressjoni tad-demm għolja - infjammazzjoni tal-pulmuni - infjammazzjoni tal-intestini; ħalq xott - nawsja; uġigħ fl-istonku; stitikezza; rimettar - raxx aħmar u mqabbeż fil-ġilda xi drabi bl-infafet; irqajja' fil-ġilda li tilfu l-kulur; ġilda xotta,
English: When assessing the PD-L1 status of the tumour, it is important that a well-validated and robust methodology is chosen to minimise false negative or false positive determinations.
Maltese: Meta wieħed jistma l-istat ta' PD-L1 tat-tumur, huwa importanti li tingħażel metodoloġija validata tajjeb u robusta biex jitnaqqsu d-determinazzjonijiet negattivi foloz jew pożittivi foloz.
English: The efficacy of pembrolizumab in combination with carboplatin and either paclitaxel or nabpaclitaxel was investigated in Study KEYNOTE-407, a randomised, double-blind, multicentre, placebo-controlled study.
Maltese: Is-sigurtà u l-effikaċja ta' pembrolizumab ġew investigati f'KEYNOTE-006, studju b'ħafna ċentri, ikkontrollat, ta' Fażi
English: Pembrolizumab 200 mg every 3 weeks
Maltese: Pembrolizumab 200 mg kull 3 ġimgħat
English: Median in months (95% CI) Hazard ratio† (95% CI) p-Value‡
Maltese: ORR %, (95% CI) Rispons sħiħ Rispons parzjali
English: Pembrolizumab 10 mg/kg every 3 weeks
Maltese: Pembrolizumab 10 mg/kg kull 3 ġimgħat
English: • KEYTRUDA 200 mg every 3 weeks, carboplatin AUC 5 mg/mL/min every 3 weeks or cisplatin 100 mg/m2 every 3 weeks, and 5-FU 1,000 mg/m2/d 4 days continuous every
Maltese: 5 mg/mL/min kull 3 ġimgħat jew cisplatin 100 mg/m2 kull 3 ġimgħat, u 5-FU
English: Pembrolizumab 2 mg/kg every 3 weeks in patients previously treated with ipilimumab n=89
Maltese: Pembrolizumab 2 mg/kg kull 3 ġimgħat f'pazjenti li kienu ġew trattati b'ipilimumab qabel n=89
English: Administration of pembrolizumab was permitted beyond RECIST-defined disease progression by BICR or beyond discontinuation of pemetrexed if the patient was clinically stable and deriving clinical benefit as determined by the investigator.
Maltese: L-għoti ta' pembrolizumab kien permess wara progressjoni tal-marda ddefinita permezz ta' RECIST jekk ilpazjent kien stabbli b'mod kliniku u kien qed jieħu benefiċċju kliniku kif determinat mill-investigatur.
English: • Prior to reconstitution, the vial of lyophilised powder can be out of refrigeration (temperatures at or below 25°C) for up to 24 hours.
Maltese: • Qabel id-dilwizzjoni, il-kunjett tal-likwidu jista' jkun ilu barra mill-friġġ (f'temperatura ta' 25°C jew anqas) sa 24 siegħa.
English: pneumonitis (interstitial lung disease) m. abdominal pain (abdominal discomfort, abdominal pain upper and abdominal pain lower) n. colitis (colitis microscopic, enterocolitis, enterocolitis haemorrhagic, and autoimmune colitis) o. pancreatitis (autoimmune pancreatitis and pancreatitis acute) p. hepatitis (autoimmune hepatitis, immune-mediated hepatitis and drug induced liver injury) q. rash (rash erythematous, rash follicular, rash generalised, rash macular, rash maculo-papular, rash papular, rash pruritic, rash vesicular and genital rash)
Maltese: sensittività eċċessiva u sindrome ta' rilaxx ta' ċitokin) b. ipotirojdiżmu (miksoedima) c. insuffiċjenza tal-glandoli adrenali (marda ta' Addison, insuffiċjenza adrenokortikali akuta, insuffiċjenza adrenokortikali sekondarja) d. ipofisite (ipopitwitariżmu) e. tirojdite (tirojdite awtoimmuni u disturb tat-tirojde) f. dijabete mellitus tat-tip 1 (ketoaċidożi tad-dijabete) g. Sindrome ta' Guillain-Barré (newropatija aksonali u polinewropatija li tiddemajelinizza) h. sindrome mijasteniku (myasthenia gravis, inkluż taħrix) i. meninġite asettika (meninġite, meninġite mhux infettiva) j. uveite (irite u iridoċiklite) k. mijokardite (mijokardite awtoimmuni) l. pulmonite (marda tal-interstizju tal-pulmun) m. uġigħ fl-addome (skumdità fl-addome, uġigħ fin-naħa ta' fuq tal-addome u uġigħ fin-naħa t'isfel tal-addome) n. kolite (kolite mikroskopika, enterokolite, enterokolite emorraġika, u kolite awtoimmuni) o. pankreatite (pankreatite awtoimmuni u pankreatite akuta) p. epatite (epatite awtoimmuni, epatite medjata mis-sistema immuni u ħsara fil-fwied ikkawżata mill-mediċina) q. raxx (raxx b'eritema, raxx follikulari, raxx mifrux, raxx makulari, raxx makulopapulari, raxx papulari, raxx bil-ħakk,
English: Figure 7: Kaplan-Meier curve for overall survival by treatment arm in KEYNOTE-189 (intent to treat population)
Maltese: Kaplan-Meier għas-sopravivenza totali skont il-fergħa ta' trattament f'KEYNOTE-189 (popolazzjoni bl-intenzjoni li tiġi ttrattata)
English: 75 mg/m or carboplatin AUC 5 mg/mL/min intravenously every 3 weeks for 4 cycles followed by pembrolizumab 200 mg and pemetrexed 500 mg/m intravenously every 3 weeks
Maltese: 5 mg/mL/min fil-vini, skont l-għażla tal-investigatur, kull 3 ġimgħat għal 4 ċikli segwiti minn pembrolizumab 200 mg u pemetrexed 500 mg/m2 fil-vini kull 3 ġimgħat (n=410)
English: Hypophysitis occurred in 36 (0.6%) patients, including Grade 2, 3 or 4 cases in 13 (0.2%), 19 (0.3%) and 1 (< 0.1%) patients, respectively, receiving pembrolizumab.
Maltese: Ipofisite seħħet f'36 (0.6%) pazjent, inkluż każijiet ta' Grad 2, 3, jew 4 fi 13-il (0.2%) pazjent, f'19-il (0.3%) pazjent u f'pazjent wieħed (<0.
English: The efficacy of pembrolizumab was investigated in KEYNOTE-087 and KEYNOTE-013, two multicentre, open-label studies for the treatment of 241 patients with cHL.
Maltese: L-effikaċja ta' pembrolizumab ġiet investigata f'KEYNOTE-087 u KEYNOTE-013, żewġ studji b'ħafna ċentri, fejn kemm l-investigaturi kif ukoll il-pazjenti kienu jafu liema sustanza qed tintuża
English: Excipients: L-histidine, L-histidine hydrochloride monohydrate, sucrose, polysorbate 80, water for injections.
Maltese: L-histidine, L-histidine hydrochloride monohydrate, sucrose, polysorbate 80, ilma għallinjezzjonijiet.
English: Median (95% CI), months
Maltese: Medjan (CI ta' 95%), xhur
English: Powder for concentrate for solution for infusion.
Maltese: Konċentrat għal soluzzjoni għall-infużjoni.
English: Pneumonitis resolved in 138 patients, 2 with sequelae.
Maltese: Il-pulmonite għaddiet f'138 pazjent, 2 minnhom b'konsegwenzi.
English: 4 mL of concentrate in a 10 mL Type I clear glass vial, with a coated grey chlorobutyl stopper and an aluminium seal with a dark blue coloured flip-off cap, containing 100 mg pembrolizumab.
Maltese: 4 mL ta' konċentrat f'kunjett tal-ħġieġ trasparenti tat-Tip 1 ta' 10 mL, b'tapp griż tal-chlorobutyl miksi u siġill tal-aluminju b'għatu li jinqala' b'daqqa ta' saba' ta' lewn blu skur, li fih 100 mg pembrolizumab.
English: Chemistry and haematology laboratory tests were performed at each cycle.
Maltese: Testijiet kimiċi u ematoloġiċi tal-laboratorju saru f'kull ċiklu.
English: Chemotherapy:
Maltese: Plaċebo:
English: Guillain-Barré syndrome g,
Maltese: Wara r-rikostituzzjoni
English: 754 patients included: median age of 61 years (range: 20 to 94); 36% age 65 or older; 82% male; 74% White and 19% Asian; 61% ECOG performance status of 1; and 77% former/current smokers.
Maltese: 36% b'età ta' 65 sena jew aktar; 82% irġiel; 74% Bojod u 19% Asjatiċi; 61% bi stat ta' eżekuzzjoni ta' ECOG ta' 1; u 77% persuni li kienu/għadhom ipejpu.
English: OS Number (%) of patients with event Hazard ratio † (95% CI)
Maltese: Numru (%) ta' avvenimenti Medjan f'xhur (CI ta' 95%)
English: * Hazard ratio (pembrolizumab compared to chemotherapy) based on the stratified Cox proportional hazard model Based on stratified Log rank test
Maltese: * Proporzjon ta' periklu (pembrolizumab imqabbel mal-kimoterapija) abbażi tal-mudell ta' periklu proporzjonali stratifikat Cox
English: Adrenal insufficiency (primary and secondary) has been reported in patients receiving pembrolizumab.
Maltese: Insuffiċjenza tal-glandoli adrenali (primarja u sekondarja) ġiet irrappurtata f'pazjenti li kienu qed jirċievu pembrolizumab.
English: Pembrolizumab 2 mg/kg every 3 weeks in patients naïve to treatment with ipilimumab n=51
Maltese: Pembrolizumab 2 mg/kg kull 3 ġimgħat f'pazjenti li qatt ma kienu ħadu trattament b'ipilimumab qabel n=51
English: An HR=0.96 [95% CI 0.37,2.52] in OS, an HR=0.60 [95% CI 0.29,1.21] in PFS, and an ORR of 47% and 42% for pembrolizumab combination vs chemotherapy was reported within this study subgroup.
Maltese: [CI ta' 95% 0.29,1.21] f'PFS, u ORR ta' 47% u 42% għal
English: 12-month OS rate, % (95% CI)
Maltese: Rata ta' OS wara 12-il xahar, % (CI ta' 95%)
English: Table 16: Efficacy results by PD-L1 Expression in KEYNOTE-407
Maltese: Riżultati tal-effikaċja skont l-Espressjoni ta' PD-L1 f'KEYNOTE-407
English: No formal pharmacokinetic drug interaction studies have been conducted with pembrolizumab.
Maltese: Ma saru l-ebda studji farmakokinetiċi formali dwar interazzjonijiet tal-mediċina b'pembrolizumab.
English: The safety and efficacy of pembrolizumab were investigated in KEYNOTE-052, a multicentre, openlabel study for the treatment of locally advanced or metastatic urothelial carcinoma in patients who were not eligible for cisplatin-containing chemotherapy.
Maltese: Is-sigurtà u l-effikaċja ta' pembrolizumab kienu investigati f'KEYNOTE-052, studju b'ħafna ċentri, fejn kemm l-investigaturi kif ukoll il-pazjenti kienu jafu liema mediċina qed tintuża għat-trattament ta' karċinoma uroteljali avvanzata lokalment jew metastatika f'pazjenti li ma kinux eliġibbli għal kimoterapija li fiha cisplatin.
English: Pembrolizumab + Platinum Chemotherapy + 5-FU n=126
Maltese: Pembrolizumab + Kimoterapija bi Platinum + 5-FU
English: The primary efficacy outcome measures were OS and PFS (assessed by BICR according to RECIST 1.1).
Maltese: Il-miżuri tar-riżultati tal-effikaċja primarja kienu OS u PFS (stmati permezz ta' BICR skont RECIST 1.1).
English: In clinical studies in patients treated with pembrolizumab 2 mg/kg every three weeks, 200 mg every three weeks, or 10 mg/kg every two or three weeks as monotherapy, 36 (1.8%) of 2,034 evaluable patients tested positive for treatment-emergent antibodies to pembrolizumab, of which 9 (0.4%) patients had neutralising antibodies against pembrolizumab.
Maltese: Fi studji kliniċi f'pazjenti ttrattati b'pembrolizumab bid-doża ta' 2 mg/kg kull tliet ġimgħat, 200 mg kull tliet ġimgħat, jew 10 mg/kg kull ġimagħtejn jew tliet ġimgħat bħala monoterapija, 36 (1.8%) pazjent minn 2,034 pazjent li setgħu jiġu evalwati kellhom riżultat pożittiv għat-test ta' antikorpi għal pembrolizumab li jfiġġu minħabba t-trattament, li minnhom 9 (0.4%) pazjenti kellhom antikorpi li jinnewtralizzaw kontra pembrolizumab.
English: The PD-1/PD-L1 pathway is thought to be involved in maintaining tolerance to the foetus throughout pregnancy.
Maltese: Is-sensiela ta' reazzjonijiet PD-1/PD-L1 hija maħsuba li hija involuta biex tinżamm it-tolleranza għall-fetu matul it-tqala kollha.
English: Assessment of tumour status was performed at 9 weeks, then every 6 weeks through week 52, followed by every 9 weeks through 24 months.
Maltese: Stima tal-istat tat-tumur saret fid-9 ġimgħa, imbagħad kull 6 ġimgħat sa ġimgħa 52, segwit minn kull 9 ġimgħat sa 24 xahar.
English: Consistent with a limited extravascular distribution, the volume of distribution of pembrolizumab at steady state is small (~6.0 L; CV: 20%).
Maltese: B'mod konsistenti ma' distribuzzjoni ekstravaskulari limitata, il-volum ta' distribuzzjoni ta' pembrolizumab fl-istat fiss huwa żgħir (~6.0
English: Table 9: Efficacy results by PD-L1 expression in KEYNOTE-006
Maltese: Ir-riżultati ta' effikaċja skont l-espressjoni ta' PD-L1 f'KEYNOTE-006
English: Metabolism and nutrition disorders Very common decreased appetite hypokalaemia, decreased appetite decreased appetite
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni Komuni ħafna tnaqqis fl-aptit ipokalimja, tnaqqis fl aptit tnaqqis fl-aptit
English: 129 patients included: median age 62 years (40% age 65 or older); 81% male; 78% White, 11% Asian, and 2% Black; 23% and 77% with an ECOG performance status 0 or 1, respectively; and 19% with HPV positive tumours.
Maltese: 78% Bojod, 11% Asjatiċi, u 2% Suwed; 23% u 77% bi stat ta' eżekuzzjoni ta' ECOG ta' 0 jew 1, rispettivament; u 19% b'tumuri pożittivi għal HPV.
English: erythema, dry skin, vitiligo t, eczema, alopecia, dermatitis acneiform severe skin reactions s,
Maltese: psorijażi, dermatitis tixbaħ lill-akne,
English: KEYTRUDA may be given in combination with other anti-cancer medicines.
Maltese: KEYTRUDA jista' jingħata flimkien ma' mediċini oħra kontra l-kanċer.
English: Additional biomarkers other than PD-L1 expression status by Immunohistochemistry (IHC) (e.g. PD-L2, RNA signature, etc.) predictive of pembrolizumab efficacy should be investigated together with more information regarding the pattern of expression of PD-L1 obtained in the ongoing NSCLC studies (P001, P010, P024 and P042) and urothelial carcinoma studies (KN045, KN052), HNSCC study (KN040) and resected Stage II melanoma adjuvant study (KN716):
Maltese: Bijomarkaturi addizzjonali apparti l-istat ta' espressjoni PD-L1 permezz ta' Immunoistokimika (IHC - Immunohistochemistry) (eż. PD-L2, RNA signature, eċċ.) li jbassru l-effikaċja ta' pembrolizumab għandhom jiġu investigati flimkien ma' aktar informazzjoni dwar il-modi ta' espressjoni ta' PD-L1 miksuba millistudji ta' NSCLC li għadhom għaddejjin (P001, P010, P024 u P042)
English: Ninety percent of patients were treatment naïve, and 10% received prior adjuvant or neoadjuvant platinum-based chemotherapy.
Maltese: Disgħin fil-mija tal-pazjenti qatt ma kienu ħadu trattament qabel, u 10% kienu rċivew kimoterapija inizjali jew wara dik inizjali bbażata fuq platinum qabel.
English: Treatment with pembrolizumab or placebo continued until RECIST 1.1-defined progression of disease as determined by blinded independent central review (BICR), unacceptable toxicity, or a maximum of 24 months.
Maltese: Trattament b'pembrolizumab jew plaċebo kompla sal-progressjoni tal-marda ddefinita permezz ta' RECIST 1.1 skont kif determinat permezz ta' analiżi ċentrali indipendenti blinded (BICR - blinded independent central review), tossiċità mhux aċċettabbli, jew massimu ta' 24 xahar.
English: Tables 23 and 24 summarise key efficacy results for pembrolizumab in patients whose tumours expressed PD-L1 with a CPS ≥ 1 in KEYNOTE-048 at the final analysis performed at a median follow-up of 13 months for pembrolizumab in combination with chemotherapy and at a median follow-up of 11.5 months for pembrolizumab monotherapy.
Maltese: It-tabelli 23 u 24 jiġbru fil-qosor ir-riżultati ewlenin tal-effikaċja għal pembrolizumab f'pazjenti li t-tumuri tagħhom kienu jesprimu PD-L1 b'CPS ≥ 1 f'KEYNOTE-048 flanaliżi finali li saret b'segwitu medjan ta' 13-il xahar għal pembrolizumab flimkien ma' kimoterapija u b'segwitu medjan ta' 11.5 xhur għal monoterapija b'pembrolizumab.
English: Patients with EGFR activation mutation or ALK translocation also had disease progression on approved therapy for these mutations prior to receiving pembrolizumab.
Maltese: Pazjenti b'mutazzjoni ta' attivazzjoni ta' EGFR jew translokazzjoni ta' ALK kellhom ukoll progressjoni tal-marda fuq terapija approvata għal dawn il-mutazzjonijiet qabel ma' rċivew pembrolizumab.
English: KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the firstline treatment of metastatic non-squamous NSCLC in adults whose tumours have no EGFR or ALK positive mutations.
Maltese: KEYTRUDA, flimkien ma' kimoterapija b'pemetrexed u platinum, huwa indikat bħala t-trattament preferut ta' NSCLC mhux skwamuża metastatika f'adulti li t-tumuri tagħhom ma jkunux pożittivi għall-mutazzjonijiet EGFR jew ALK.
English: uveitis (iritis and iridocyclitis) k. myocarditis (autoimmune myocarditis) l.
Maltese: Is-soluzzjoni rikostitwita jew dilwita m'għandhiex tiġi ffriżata.
English: The recommended dose of KEYTRUDA as monotherapy is either 200 mg every 3 weeks or 400 mg every 6 weeks administered as an intravenous infusion over 30 minutes.
Maltese: Id-doża rakkomandata ta' KEYTRUDA bħala monoterapija hija 200 mg kull 3 ġimgħat jew 400 mg kull 6 ġimgħat mogħtija bħala infużjoni fil-vini fuq perjodu ta' 30 minuta.
English: • a kind of skin cancer called melanoma
Maltese: • tip ta' kanċer tal-ġilda msejjaħ melanoma
English: Corticosteroids should be administered for Grade ≥ 2 events (initial dose of 1-2 mg/kg/day prednisone or equivalent followed by a taper); pembrolizumab should be withheld for Grade 2 or Grade 3 colitis, and permanently discontinued for Grade 4 colitis (see section 4.2).
Maltese: Ilkortikosterojdi għandhom jingħataw għall-każijiet ta' Grad ≥ 2 (doża tal-bidu ta' 1-2 mg/kg/jum prednisone jew ekwivalenti segwita bi tnaqqis bil-ftit il-ftit għal xejn); pembrolizumab m'għandux jingħata f'kolite ta' Grad 2 jew Grad 3, u għandu jitwaqqaf għalkollox f'kolite ta' Grad 4 (ara sezzjoni 4.2).
English: 12-month OS rate
Maltese: It-tieni kwart tal
English: Uncommon amylase increased blood bilirubin increased, amylase increased amylase increased
Maltese: Mhux komuni żieda fl-amylase żieda fil-bilirubina fiddemm, żieda fl-amylase żieda fl-amylase
English: Uncommon (may affect up to 1 in 100 people) - inflammation of the pituitary gland situated at the base of the brain; inflammation of the thyroid; decreased secretion of hormones produced by the adrenal glands - type 1 diabetes - seizure - accumulation of fluid around the heart - inflammation of the pancreas - inflammation of the liver - thickened, sometimes scaly, skin growth; acne-like skin problem; inflammation of the skin;
Maltese: tnaqqis ta' sekrezzjoni ta' ormoni magħmula mill-glandoli adrenali - dijabete tat-tip 1 - aċċessjoni - akkumulazzjoni ta' fluwidu madwar il-qalb - infjammazzjoni tal-frixa - infjammazzjoni tal-fwied - tkabbir ta' ġilda aktar ħoxna, xi drabi bil-qxur; problema fil-ġilda tixbaħ lill-akne;
English: Corticosteroids to treat adrenal insufficiency and other hormone replacement should be administered as clinically indicated, and pembrolizumab should be withheld for adrenal insufficiency or symptomatic hypophysitis until the event is controlled with hormone replacement.
Maltese: Il-kortikosterojdi għandhom jingħataw biex tiġi ttrattata l-insuffiċjenza tal-glandoli adrenali u sostituzzjoni tal-ormoni oħra għandha tingħata kif indikat b'mod kliniku, u pembrolizumab m'għandux jingħata għal insuffiċjenza tal-glandoli adrenali jew ipofisite bis-sintomi sakemm lavveniment jiġi kkontrollat b'sostituzzjoni tal-ormoni.
English: Fatigue has been reported following administration of pembrolizumab (see section 4.8).
Maltese: Ġiet irrappurtata nefrite f'pazjenti li kienu qed jirċievu pembrolizumab (ara sezzjoni 4.8).
English: Chemotherapy Pembrolizumab combination therapy
Maltese: Kimoterapija Terapija ta' kombinazzjoni b'Pembrolizumab
English: Seventy-six percent of patients received prior cisplatin, 23% had prior carboplatin, and 1% was treated with other platinum-based regimens.
Maltese: Sitta u sebgħin fil-mija tal-pazjenti rċivew cisplatin qabel, 23% irċivew carboplatin qabel, u 1% kienu ġew ittrattati bi skedi oħra ibbażati fuq il-platinum.