FrancophonIA/ELRC3.0 huggingface dataset:
English: Eylea received a marketing authorisation valid throughout the EU on 22 November 2012.
Maltese: Eylea rċieva awtorizzazzjoni għat-tqegħid fis-suq valida fl-EU kollha fit-22 ta' Novembru 2012.
English: Eylea was shown to be as effective as ranibizumab in maintaining vision in patients with wet AMD: looking at the results of the two studies together, the proportions of patients who maintained vision were 96.1% (517 out of 538), 95.4% (533 out of 559) and 95.3% (510 out of 535) for 0.5 mg Eylea every four weeks, 2 mg Eylea every four weeks and 2 mg Eylea every eight weeks, respectively, compared with 94.4% (508 out of 538) of patients treated with ranibizumab every four weeks.
Maltese: Eylea ntwera li kien effettiv daqs ranibizumab fiż-żamma tal-vista f'pazjenti b'AMD imxarrba: ħarsa lejn ir-riżultati taż-żewġ studji flimkien turi li, il-proporzjonijiet ta' pazjenti li żammew il-vista kienu ta' 96.1 % (517 minn 538), 95.4 % (533 minn 559) u 95.3 % (510 minn 535) għal 0.5 mg ta' Eylea kull erba' ġimgħat, 2 mg ta' Eylea kull erba' ġimgħat u 2 mg ta' Eylea kull tmien ġimgħat, rispettivament, meta mqabbel ma' 94.4 % (508 minn 538) tal-pazjenti kkurati b'ranibizumab kull erba' ġimgħat.
English: Eylea contains the active substance aflibercept.
Maltese: Eylea fih is-sustanza attiva aflibercept.
English: Myopic choroidal neovascularisation
Maltese: Neovaskularizzazzjoni korojdali mijopika
English: In myopic choroidal neovascularisation, Eylea was investigated in a main study involving 122 patients, which compared Eylea with a sham injection.
Maltese: Fin-neovaskularizzazzjoni korojdali mijopika, Eylea ġie investigat fi studju ewlieni li involva 122 pazjent, li qabbel Eylea ma' injezzjoni finta.
English: Eylea was also investigated in two other main studies involving 366 patients with macular oedema following CRVO.
Maltese: Eylea ġie investigat ukoll f'żewġ studji ewlenin oħra li involvew 366 pazjent b'edema makulari wara CRVO.
English: • impaired vision due to macular oedema caused by diabetes;
Maltese: • vista indebolita minħabba edema makulari kkawżata mid-dijabete;
English: • the ‘wet' form of age-related macular degeneration (AMD), a disease which affects the central part of the retina (called the macula) at the back of the eye.
Maltese: • il-forma ‘mxarrba' ta' deġenerazzjoni makulari relatata mal-età (AMD), marda li taffettwa l-parti ċentrali tar-retina (imsejħa l-makula) fil-parti ta' wara tal-għajn.
English: Diabetic macular oedema
Maltese: Edema makulari dijabetika
English: Other information about Eylea
Maltese: Informazzjoni oħra dwar Eylea
English: Eylea was investigated in two main studies involving a total of around 2,400 patients with the wet form of AMD.
Maltese: Eylea ġie investigat f'żewġ studji ewlenin li involvew total ta' madwar 2,400 pazjent bil-forma mxarrba tal-AMD.
English: Macular oedema following retinal vein occlusion
Maltese: Edema makulari wara okklużjoni tal-vina tar-retina
English: For CRVO, overall about 60% of patients given Eylea had an improvement of 15 letters or more in the eye test at week 24, compared with 17% of those given sham injections.
Maltese: Għal CRVO, b'mod ġenerali madwar 60 % tal-pazjenti li ngħataw Eylea kellhom titjib ta' 15-il ittra jew iktar fit-test tal-għajnejn fil-ġimgħa 24, meta mqabbla ma' 17 % ta' dawk li ngħataw injezzjonijiet finta.
English: Serious injection-related side effects (which have occurred in less than 1 in around 2,000 injections) include blindness, endophthalmitis (serious infection or inflammation inside the eye), cataracts, increased intraocular pressure, vitreous haemorrhage (bleeding into the jelly-like fluid in the eye, causing temporary loss of vision) and vitreous or retinal detachment.
Maltese: Effetti sekondarji serji relatati mal-injezzjoni (li seħħew f'inqas minn injezzjoni 1 minn kull 2,000) jinkludu għama, endoftalmite (infezzjoni serja jew infjammazzjoni ġewwa l-għajn), katarretti, żieda fil-pressjoni intraokulari, emorraġija fil-vitriju (fsada fil-fluwidu bħallġèli fl-għajn, li tikkawża telf temporanju tal-vista) u stakkar tal-vitriju jew tar-retina.
English: • impaired vision due to macular oedema (swelling) that follows blockage of either the main vein carrying blood from the retina (known as central retinal vein occlusion, CRVO) or of smaller branch veins (known as branch retinal vein occlusion, BRVO);
Maltese: • vista indebolita minħabba edema makulari (nefħa) li sseħħ wara li jkun hemm imblukkar ta' jew ilvina prinċipali li twassal id-demm mir-retina (magħrufa bħala okklużjoni tal-vina tar-retina ċentrali, CRVO) jew ta' vini ta' fergħa iżgħar (magħrufa bħala okklużjoni tal-vina tar-retina tal-fergħa, BRVO);
English: For BRVO, around 53% of patients given Eylea had an improvement of 15 letters or more in the eye test at week 24, compared with 27% of patients who received laser treatment.
Maltese: Għal BRVO, madwar 53 % ta' dawk li ngħataw Eylea kellhom titjib ta' 15-il ittra jew iktar fit-test tal-għajnejn filġimgħa 24, meta mqabbla ma' 27 % ta' dawk li rċivew kura bil-laser.
English: Eylea is a medicine used to treat adults with:
Maltese: Eylea huwa mediċina li tintuża biex tikkura adulti bi:
English: Aflibercept is an engineered protein that has been designed to attach to and block the effects of a substance called vascular endothelial growth factor A (VEGF-A).
Maltese: Aflibercept hija proteina maħduma li tfasslet biex teħel ma' u timblokka l-effetti ta' sustanza msejħa fattur tat-tkabbir tal-endotilju vaskulari A (VEGF-A).
English: The most common side effects (affecting at least 1 in 20 patients) reported with Eylea are conjunctival haemorrhage (bleeding from the small blood vessels on the surface of the eye at the site of injection), reduced vision, eye pain, vitreous detachment (detachment of the jelly-like substance inside the eye), cataract (clouding of the lens), vitreous floaters (small particles or spots in the vision) and increased intraocular pressure (increased pressure inside the eye).
Maltese: L-effetti sekondarji l-aktar komuni (li jaffettwaw mill-inqas pazjent 1 minn kull 20) irrappurtati b'Eylea huma emorraġija konġuntivali (fsada mill-vażi żgħar fuq il-wiċċ tal-għajn fis-sit tal-injezzjoni), vista mnaqqsa, uġigħ fl-għajnejn, stakkar tal-vitriju (stakkar tas-sustanza bħall-ġèli fl-għajn), katarretti (tiċpir tal-lenti), tikek fil-vitriju (partikoli żgħar jew tikek fil-vista) u żieda fil-pressjoni intraokulari (żieda fil-pressjoni ġewwa l-għajn).
English: This effect was maintained at 52 weeks, despite less frequent administration of Eylea between week 24 and 52.
Maltese: Dan l-effett inżamm għal 52 ġimgħa, minkejja għoti inqas frekwenti ta' Eylea bejn il-ġimgħa 24 u 52.
English: In the study in myopic choroidal neovascularisation, the average number of letters patients could read in an eye test before treatment was about 56; patients given Eylea could read on average 12 more letters after 24 weeks of treatment whereas in patients given sham injections the total number of letters they could read decreased on average by 2.
Maltese: Fl-istudju tan-neovaskularizzazzjoni korojdali mijopika, in-numru medju ta' ittri li l-pazjenti setgħu jaqraw f'test tal-għajnejn qabel il-kura kien ta' madwar 56; il-pazjenti li ngħataw Eylea setgħu jaqraw medja ta' 12-il ittra iktar wara 24 ġimgħa ta' kura filwaqt li n-numru totali ta' ittri li setgħu jaqraw ilpazjenti li ngħataw injezzjonijiet finta naqas b'medja ta' 2.
English: Another main study involving 181 patients with macular oedema due to BRVO compared monthly injections of Eylea 2 mg with laser treatment.
Maltese: Studju ewlieni ieħor li kien jinvolvi 181 pazjent b'edema makulari minħabba BRVO qabbel injezzjonijiet fix-xahar ta' 2 mg ta' Eylea ma' kura bil-laser.
English: VEGF-A and PlGF are involved in stimulating the abnormal growth of blood vessels in patients with AMD, certain types of macular oedema and myopic choroidal neovascularisation.
Maltese: Il-VEGF-A u l-PlGF huma involuti fl-istimulazzjoni tat-tkabbir anormali ta' vażi f'pazjenti bl-AMD, ċerti tipi ta' edema makulari u n-neovaskularizzazzjoni korojdali mijopika.
English: Two further main studies involving 872 patients with diabetic macular oedema looked at the effect of Eylea compared with laser treatment.
Maltese: Żewġ studji ewlenin oħra li kienu jinvolvu 872 pazjent b'edema makulari dijabetika ħarsu lejn l-effett ta' Eylea meta mqabbel ma' kura bil-laser.
English: Eylea is given as an injection of 2 mg into the affected eye, repeated as appropriate at intervals of a month or more.
Maltese: Eylea jingħata bħala injezzjoni ta' 2 mg fl-għajn affettwata, ripetut kif meħtieġ f'intervalli ta' xahar jew aktar.
English: Eylea also produced a significant improvement in vision in patients with macular oedema following CRVO and BRVO.
Maltese: Eylea pproduċa wkoll titjib sinifikanti fil-vista ta' pazjenti b'edema makulari wara CRVO u BRVO.
English: Eylea is available as prefilled syringes or vials containing a solution for intravitreal injection (injection into the vitreous humour, the jelly-like fluid inside the eye).
Maltese: Eylea jiġi bħala siringi mimlijin għal-lest jew kunjetti li fihom soluzzjoni għall-injezzjoni intravitreali (injezzjoni fl-umur vitreu, il-fluwidu qisu ġèli ġol-għajn).
English: As for all medicines, data on the use of Eylea are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Eylea hija ssorveljata kontinwament.
English: • impaired vision due to myopic choroidal neovascularisation (a severe type of short-sightedness where the eyeball continues to grow, becoming longer than it should be).
Maltese: • vista indebolita minħabba neovaskularizzazzjoni korojdali mijopika (tip sever ta' nuqqas tal-vista tal-bogħod li fiha l-boċċa tal-għajn tkompli tikber, billi ssir itwal milli suppost).
English: In patients with diabetic macular oedema, the average number of letters they could read in an eye test before treatment was about 59 to 60; in patients given Eylea monthly this improved by around 12 letters, and in those given Eylea every other month by around 11 letters.
Maltese: F'pazjenti b'edema makulari dijabetika, l-għadd medju ta' ittri li setgħu jaqraw f'test tal-għajnejn qabel il-kura kien madwar 59 sa 60; f'pazjenti li ngħataw Eylea kull xagħar dan tjieb b'madwar 12-il ittra, u f'dawk li ngħataw Eylea kull xagħrejn b'madwar 11-il ittra.
English: The wet form of AMD is caused by choroidal neovascularisation (the abnormal growth of blood vessels under the macula), which may leak fluid and blood and cause swelling;
Maltese: Il-forma mxarrba ta' AMD tiġi kkawżata minn neovaskularizzazzjoni korojdali (it-tkabbir anormali ta' vażi taħt il-makula), li jistgħu jnixxu fluwidu u demm u jikkawżaw nefħa;
English: What are the risks associated with Eylea?
Maltese: X'inhu Eylea u għal xiex jintuża?
English: Subsequent results from a supportive study indicated the effectiveness of extended treatment intervals in patients with wet AMD.
Maltese: Riżultati sussegwenti minn studju ta' sostenn indikaw l-effikaċja ta' intervalli ta' kura estiżi f'pazjenti b'AMD imxarrba.
English: The studies compared Eylea (given either as 0.5 mg every four weeks, 2 mg every four weeks or 2 mg every eight weeks, all after three initial monthly doses) with ranibizumab, another treatment for AMD which was given by injection into the eye every four weeks.
Maltese: L-istudji qabblu Eylea (mogħti bħala jew 0.5 mg kull erba' ġimgħat, 2 mg kull erba' ġimgħat jew 2 mg kull tmien ġimgħat, kollha wara tliet dożi inizjali ta' kull xahar) ma' ranibizumab, kura oħra għall-AMD, li tingħata permezz ta' injezzjoni ġol-għajn kull erba' ġimgħat.
English: 1/1 M
Maltese: 1/1 P
English: For all bisphosphonates
Maltese: Għall-bisfosfonati kollha
English: The communication should be based on the “key communication messages document” agreed by CHMP and annexed to the assessment report.
Maltese: Ilkomunikazzjoni għandha tkun ibbażata fuq id-“dokument ta' messaġġi ta' komunikazzjoni ewlenin” miftiehem mis-CHMP u anness mar-rapport ta' valutazzjoni.
English: The MAHs should submit/update the Risk Management Plans to reflect "atypical femoral fractures" as potential risk.
Maltese: Il-MAHs għandhom jissottomettu/jaġġornaw il-Pjanijiet għall-Ġestjoni tar-Riskji biex jirriflettu l-“fratturi femorali atipiċi” bħala riskju potenzjali.
English: Annex IV Conditions of the marketing authorisation
Maltese: Anness IV Kundizzjonijiet tal-awtorizzazzjoni għat-tqegħid fis-suq
English: National Competent Authorities should ensure that Health Care Professionals will be informed of the measures agreed by CHMP to minimise the risk of atypical femoral fractures.
Maltese: L-Awtoritajiet Nazzjonali Kompetenti għandhom jiżguraw li l-Professjonisti tal-Kura tas-Saħħa jiġu infurmati bil-miżuri miftiehma mis-CHMP biex jitnaqqas ir-riskju ta' fratturi femorali atipiċi.
English: Eye drops, solution Ocular use vial (glass)
Maltese: Qtar tal-għajnejn, soluzzjoni
English: 7 multi-dose vials
Maltese: 7 kunjetti ta' ħafna dożi
English: 160 µg/g Gel
Maltese: 160 µg/g Ġell
English: Cutaneous use tube (alu)
Maltese: Użu kutanju stoċċ (alu)
English: 60 g
Maltese: 60 g stoċċ wieħed
English: EU (MA) Number
Maltese: Numru tal-EU (MA) Isem (ivvintat)
English: 4.8 Adverse events
Maltese: 4.8 Avvenimenti avversi
English: Rare: may affect up to 1 in 1,000 people:
Maltese: Rari: jista' jaffettwa sa 1 minn kull 1,000 persuna:
English: Rash, urticaria
Maltese: Raxx, urtikarja
English: Rare: rash, urticaria
Maltese: Rari: raxx, urtikarja
English: Rare: hypersensitivity reactions
Maltese: Rari: reazzjonijiet ta' sensittività eċċessiva
English: Not known: frequency cannot be estimated from the available data Anaphylactic reactions including anaphylactic shock, angioedema (rapidly developing swelling of the skin, subcutaneous, mucosa or submucosal tissues) and pruritus Severe cutaneous adverse reactions (including erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis and acute generalised exanthematous pustulosis).
Maltese: Mhux magħrufa: il-frekwenza ma tistax tiġi stmata mid-data disponibbli Reazzjonijiet anafilattiċi inkluż kollass anafilattiku, anġjoedema (żvilupp mgħaġġel ta' nefħa fil-ġilda, ittessuti ta' taħt il-ġilda, tal-mukuża u ta' taħt il-mukuża) u prurite Reazzjonijiet avversi severi fil-ġilda (inkluż eritema multiformi, sindromu ta' Stevens-Johnson/nekrolisi epidermali tossika u pustulożi esantematika ġeneralizzata akuta)
English: [The following sub-heading should appear at the end of this section] Reporting of side effects
Maltese: [Is-subintestatura li ġejja għandha tidher fl-aħħar ta' din is-sezzjoni] Rappurtar tal-effetti sekondarji
English: There have been reports of severe skin reactions such as erythema multiforme, Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN) and acute generalised exanthematous pustulosis (AGEP) associated with the administration of <active substance>.
Maltese: Kien hemm rapporti ta' reazzjonijiet severi tal-ġilda bħal eritema multiformi, sindromu ta' StevensJohnson (SJS)/nekrolisi epidermali tossika (TEN) u pustulożi esantematika ġeneralizzata akuta (AGEP) assoċjati mal-għoti ta' <sustanza attiva>.
English: Not known: Severe cutaneous adverse reactions (including erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis and acute generalized exanthematous pustulosis).
Maltese: Reazzjonijiet avversi severi fil-ġilda (inkluż eritema multiformi, sindromu ta' StevensJohnson (SJS)/nekrolisi epidermali tossika (TEN) u pustulożi esantematika ġeneralizzata akuta (AGEP))
English: [The following sub-heading should appear at the end of this section] Reporting of suspected adverse reactions
Maltese: [Is-subintestatura li ġejja għandha tidher fl-aħħar ta' din is-sezzjoni] Rappurtar ta' reazzjonijiet avversi suspettati
English: [The below paragraph should be reflected in this section for all ambroxol- and bromhexine-containing medicinal products]
Maltese: [Il-paragrafu hawn taħt għandu jkun rifless f'din is-sezzjoni għall-prodotti mediċinali kollha li fihom ambroxol u bromhexine]
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Maltese: L-informazzjoni tal-prodott tista' sussegwentement tiġi aġġornata mill-awtoritajiet kompetenti tal-Istati Membri, bi ftehim mal-Istat Membru ta' Referenza, kif xieraq, skont il-proċeduri stabbiliti fil-Kapitolu 4 tat-Titolu III tad-Direttiva 2001/83/KE.
English: Not known: anaphylactic reactions including anaphylactic shock, angioedema and pruritus Skin and subcutaneous tissue disorders
Maltese: Mhux magħrufa: reazzjonijiet anafilattiċi inkluż kollass anafilattiku, anġjoedema u prurite Disturbi fil-ġilda u fit-tessuti ta' taħt il-ġilda
English: There have been reports of severe skin reactions associated with the administration of <active substance>.
Maltese: Kien hemm rapporti ta' reazzjonijiet severi tal-ġilda assoċjati mal-għoti ta' <sustanza attiva>.
English: Events/N (%) IMFINZI
Maltese: Episodji/N (%) IMFINZI
English: Placebo 91 59
Maltese: Plaċebo 91 59
English: Hepatitis c,m
Maltese: Epatite c,m
English: Probability of PFS
Maltese: Probabbiltà ta' PFS
English: Placebo (n = 237)
Maltese: Plaċebo (n = 237)
English: Pneumonia b,c
Maltese: Pulmonite b,c
English: Grade 3-4 (%)
Maltese: Grad 3-4 (%)
English: EU/1/18/1322/002 120 mg vial EU/1/18/1322/001 500 mg vial
Maltese: EU/1/18/1322/002 120 mg kunjett EU/1/18/1322/001 500 mg kunjett
English: ALT: alanine aminotransferase; AST: aspartate aminotransferase; ULN: upper limit of normal.
Maltese: ALT: alanina aminotransferażi; AST: aspartataminotransferażi; ULN: limitu ogħla tan-normal.
English: 6545CG Nijmegen, Netherlands
Maltese: 6545CG Nijmegen, In-Netherlands
English: 6545 CG Nijmegen The Netherlands
Maltese: 6545 CG Nijmegen In-Netherlands
English: ATC code: L01XC28
Maltese: L01XC28
English: Common Terminology Criteria for Adverse Events, version 4.03.
Maltese: Kriterji tat-Terminoloġija Komuni għall-Avvenimenti Avversi, verżjoni 4.03.
English: Symptomatic treatment, see section 4.8
Maltese: Kura sintomatika, ara sezzjoni 4.8
English: PFS was assessed by Blinded Independent Central Review (BICR) according to RECIST v1.1.
Maltese: Ċentrali Indipendenti Blinded (BICR, Blinded Independent Central Review) skont RECIST 1.1.
English: Any Grade (%)
Maltese: Kwalunkwe Grad (%)
English: Adrenal insufficiency
Maltese: Insuffiċjenza adrenali
English: Month 0 3 6 9 12 15 18 21 24 27 30 33 36 39 42 45 IMFINZI 212 208 193 187 178 171 165 156 134 105 62 34 12 1 0 0 Placebo 91 81 75 67 64 58 52 46 41 29 17 7 5 2 0 0
Maltese: IMFINZI 212 208 193 187 178 171 165 156 134 105 62 34 12 1 0 0 Plaċebo 91 81 75 67 64 58 52 46 41 29 17 7 5 2 0 0
English: Grade 2-4
Maltese: Grad 2-4
English: Histidine hydrochloride monohydrate Trehalose dihydrate Polysorbate 80
Maltese: Histidine hydrochloride monohydrate Trehalose dihydrate Polisorbat 80
English: Oral candidiasis
Maltese: Kandidjażi orali
English: Of 451 patients with PD L1 expression available, 67% were TC ≥ 1% [PD-L1 TC 1-24% (32%), PD L1 TC ≥ 25% (35%)] and 33% were TC < 1%.
Maltese: Minn 451 pazjent b'espressjoni PD L1 disponibbli, 67% kienu TC ≥ 1% [PD-L1 TC 1-24% (32%), PD L1 TC ≥ 25% (35%)] u 33% kienu TC < 1%.
English: (95% CI) HR (95% CI) p-value p < 0.0001
Maltese: (95% CI) HR (95% CI) valur p p < 0.0001
English: Neutralising antibodies (nAbs) against durvalumab were detected in 0.5% (8/1570) of patients.
Maltese: Ġew identifikati antikorpi newtralizzanti (nAbs) kontra durvalumab f'0.5 % (8/1570) tal-pazjenti.
English: Month 0 3 6 9 12 15 18 21 24 27 30 33 36 39 42 45 IMFINZI 476 464 431 415 385 364 343 319 274 210 115 57 23 2 0 0 Placebo 237 220 198 178 170 155 141 130 117 78 42 21 9 3 1 0
Maltese: IMFINZI 476 464 431 415 385 364 343 319 274 210 115 57 23 2 0 0 Plaċebo 237 220 198 178 170 155 141 130 117 78 42 21 9 3 1 0
English: The most frequent Grade 3-4 adverse reaction was pneumonia (6.5% vs 5.6% in placebo).
Maltese: L-aktar reazzjoni ta' Grad 3-4 frekwenti kienet pulmonite (6.5% vs 5.6% fi plaċebo).
English: Age (19-96 years), body weight (34-149 kg), gender, positive anti-drug antibody (ADA) status, albumin levels, LDH levels, creatinine levels, soluble PD-L1, tumour type, race or ECOG status had no clinically significant effect on the PK of durvalumab.
Maltese: Età (19-96 sena), piż tal-ġisem (34-149 kg), sess, status tal-antikorp kontra l-mediċina (ADA, antidrug antibody) pożittiv, livelli tal-albumina, livelli ta' LDH, livelli tal-kreatinina, PDL1 solubbli, tip tattumur, razza jew status ECOG ma kellhom l-ebda effett klinikament sinifikanti fuq il-PK ta' durvalumab.
English: Events of pancreatitis have been reported in patients in the clinical study programme.
Maltese: Avvenimenti ta' pankreatite ġew irrapportati f'pazjenti fil-programm ta' studju kliniku.
English: Nervous System Disorders Myasthenia gravis
Maltese: Disturbi fis-sistema nervuża Mijastenija gravis
English: Date of first authorisation: 21 September 2018
Maltese: Data tal-ewwel awtorizzazzjoni: 21 ta' Settembru 2018
English: The final concentration of the diluted solution should be between 1 mg/mL and 15 mg/mL.
Maltese: Il-konċentrazzjoni finali tas-soluzzjoni dilwita għandha tkun bejn 1 mg/ml u 15 mg/ml.
English: Durvalumab does not induce antibody dependent cell-mediated cytotoxicity (ADCC).
Maltese: Durvalumab ma jinduċix ċitossiċità medjata miċ-ċelluli dipendenti fuq l-antikorp (ADCC, antibody dependent cellmediated cytotoxicity).
English: Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies.
Maltese: Aġenti antineoplastiċi, antikorpi monoklonali.
English: It is to be administered as an intravenous infusion solution over 60 minutes (see section 6.6).
Maltese: Dan għandu jingħata bħala soluzzjoni ta' infużjoni ġol-vini fuq 60 minuta (ara sezzjoni 6.6).
English: 120 mg/2.4 ml 500 mg/10 ml 1 vial
Maltese: 120 mg/2.4 ml 500 mg/10 ml kunjett 1
English: Rare Respiratory, thoracic and mediastinal disorders Cough/Productive Cough
Maltese: Rari Disturbi respiratorji, toraċiċi u medjastinali Sogħla/Sogħla Produttiva
English: Disease characteristics were as follows: Stage IIIA (53%), Stage IIIB (45%), histological sub-groups of squamous (46%), non-squamous (54%).
Maltese: Il-karatteristiċi tal-marda kienu kif ġej: Stadju IIIA (53%), Stadju IIIB (45%), sottogruppi istoloġiċi ta' skwamuż (46%), mhux skwamuż (54%).
English: PD-L1 Unknown
Maltese: PD-L1 mhux magħruf
English: PK exposure increased more than dose-proportionally (non-linear PK) at doses < 3 mg/kg, and dose proportionally (linear PK) at doses ≥ 3 mg/kg.
Maltese: L-esponiment tal-PK żdied aktar minn b'mod proporzjonali għad-doża (PK mhux lineari) b'dożi <3 mg/kg, u b'mod proporzjonali għad-doża (PK lineari) b'dożi ≤3 mg/kg.
English: g frequency is based on events not observed in the PACIFIC Study but observed in other clinical trials (n=1889).
Maltese: g il-frekwenza hija bbażata fuq episodji mhux osservati fl-Istudju PACIFIC iżda osservati fi provi kliniċi oħrajn (n=1889).
English: • It is very important that you do not miss a dose of this medicine.
Maltese: • Huwa importanti ħafna li ma taqbiżx doża ta' din il-mediċina.
English: Kaplan-Meier curve of OS
Maltese: Il-kurva Kaplan-Meier ta' OS
English: Post-hoc subgroup analysis by PD-L1 expression
Maltese: Analiżi tas-subgrupp post-hoc skont l-espressjoni PD-L1
English: • swelling of the legs (oedema peripheral)
Maltese: • nefħa tas-saqajn (edema periferali)
English: IMFINZI was discontinued in 8 patients.
Maltese: IMFINZI twaqqaf fi 8 pazjenti.
English: PD-L1 blocks T-cell function and activation through interaction with PD-1 and CD80 (B7.1).
Maltese: PDL1 timblokka l-funzjoni taċċellula T u l-attivazzjoni permezz ta' interazzjoni ma' PD1 u CD80 (B7.1).
English: Events of StevensJohnson Syndrome or toxic epidermal necrolysis have been reported in patients treated with PD-1 inhibitors.
Maltese: Episodji tas-Sindrome ta' Stevens-Johnson jew ta' nekroliżi epidermali tossika ġew irrapportati f'pazjenti kkurati b'inibituri PD-1.
English: No formal pharmacokinetic (PK) drug-drug interaction studies have been conducted with durvalumab.
Maltese: Ma sar l-ebda studju tal-interazzjoni mediċinali tal-farmakokinetika (PK) formali b'durvalumab.