FrancophonIA/ELRC3.0 huggingface dataset:
English: Clinically relevant CTC toxicity of any grade that was reported in ≥1% and ≤5% of the patients that were randomly assigned to pemetrexed include: febrile neutropenia, infection, decreased platelets, diarrhoea, constipation, alopecia, pruritus/itching, fever (in the absence of neutropenia), ocular surface disease (including conjunctivitis), increased lacrimation, dizziness and motor neuropathy.
Maltese: Tossiċità CTC klinikament rilevanti ta' kwalunkwe grad li ġiet irrapportata f' ≥ 1% u ≤ 5% tal-pazjenti li b'mod każwali ġew magħżula biex jirċievu pemetrexed jinkludu: newtropenja bid-deni, infezzjoni, tnaqqis fil-plejtlits, dijarea, stitikezza, alopeċja, ħakk, deni (fin-nuqqas ta' newtropenja), mard fis-superfiċji tal-għajn (inkluża l-konġuntivite), żieda fit-tixrid ta' dmugħ, sturdament u newropatija motorja.
English: Breast-feeding must be discontinued during pemetrexed therapy (see section 4.3).
Maltese: It-treddigħ għandu jieqaf waqt it-terapija b'pemetrexed (ara sezzjoni 4.3).
English: Children and adolescents There is no relevant use of pemetrexed in the paediatric population.
Maltese: Tfal u adolexxenti M'hemm ebda użu rilevanti ta' pemetrexed fil-popolazzjoni pedjatrika.
English: Rash/ desquamation Common Pruritus Alopecia
Maltese: Dispepsja/qrusa talistonku
English: Efficacy of pemetrexed + cisplatin vs. gemcitabine + cisplatin in first-line non-small cell lung cancer - ITT population and histology subgroups
Maltese: L-effikaċja ta' pemetrexed + cisplatin vs gencitabine + cisplatin bħala kura tal-ewwel preferenza f'kanċer mhux b'ċelluli żgħar - Popolazzjoni ITT u sottogruppi istoloġiċi Popolazzjoni
English: Clinically relevant CTC toxicities that were reported in ≥ 1% and ≤ 5% of the patients that were randomly assigned to receive cisplatin and pemetrexed include: renal failure, infection, pyrexia, febrile neutropenia, increased AST, ALT, and GGT, urticaria and chest pain.
Maltese: Tossiċitajiet CTC klinikament rilevanti li ġew irrapportati f' ≥ 1% u ≤ 5% tal-pazjenti li ntgħażlu b'mod każwali biex jirċievu cisplatin u pemetrexed jinkludu: insuffiċjenza renali, infezzjoni, deni, newtropenja bid-deni, żieda fl-AST,ALT u GGT, urtikarja, u uġigħ fis-sider.
English: An insufficient number of patients have been studied with creatinine clearance of below 45 ml/min.
Maltese: Ġew studjati numru insuffiċjenti ta' pazjenti bi tneħħija tal- kreatinina ta' inqas minn 45 ml/min.
English: Clinically relevant CTC toxicities that were reported in ≥ 1% and ≤ 5% of the patients that were randomly assigned to pemetrexed include: infection without neutropenia, febrile neutropenia, allergic reaction/hypersensitivity, increased creatinine, motor neuropathy, sensory neuropathy, erythema multiforme, and abdominal pain.
Maltese: Tossiċitajiet CTC klinikament rilevanti li ġew irrapportati f' > 1% u < 5% tal-pazjenti li ntgħażlu b'mod każwali biex jirċievu pemetrexed jinkludu: infezzjoni mingħajr newtropenja, newtropenja bid-deni, reazzjoni allerġika/sensittività eċċessiva, żieda fil-kreatinina, newropatija motorja, newropatija sensittiva, eritema multiforme u wġigħ addominali.
English: Time to treatment failure (TTTF - months)
Maltese: Żmien sal-falliment tal-kura (TTTF - xhur)
English: *p-values < 0.05 comparing pemetrexed/cisplatin to gemcitabine/cisplatin, using Fisher Exact test. **Refer to National Cancer Institute CTC (v2.0; NCI 1998) for each Grade of Toxicity.
Maltese: *Valuri P <0.05 meta tqabbel pemetrexed/cisplatin ma' gemcitabine/cisplatin, permezz tal-Fisher Exact test. ** Irreferi għas-CTC (v 2.0; NCI 1998) tal-Istitut Nazzjonali tal-Kanċer għal kull Grad ta' Tossiċità. *** Skont is-CTC (v 2.0; NCI 1998) tal-Istitut Nazzjonali tal-Kanċer, it-tibdil fit-togħma u l-alopeċja għandhom jiġu rrapportati bħala Grad 1 jew 2 biss..
English: Pemetrexed Pfizer 100mg vial:
Maltese: Pemetrexed Pfizer kunjett ta' 100 mg:
English: An analysis of the impact of NSCLC histology on the treatment effect on overall survival was in favour of pemetrexed versus docetaxel for other than predominantly squamous histologies (N = 399, 9.3 versus 8.0 months, (HR) = 0.78; 95% CI = 0.61-1.00, p = 0.047) and was in favour of docetaxel for squamous cell carcinoma histology (N =172, 6.2 versus 7.4 months, adjusted HR = 1.56; 95% CI = 1.08-2.26, p = 0.018).
Maltese: 047) u istoloġija ta' karċinoma b'tip ta' ċellula skwamuża (NN=172, 6.2 kontra 7.4 xhur, HR aġġustat = 1.56; 95% CI =1.08-2.26, p = 0.018).
English: JMEN: Kaplan-Meier plots of progression-free survival (PFS) and overall survival pemetrexed versus placebo in patients with NSCLC other than predominantly squamous cell histology:
Maltese: Dijagrammi Kaplan-Meier ta' sopravivenza mingħajr progressjoni (PFS) u sopravivenza totali ta' pemetrexed kontra plaċebo f'pazjenti b' NSCLC minbarra dwak fejn l-istoloġija turi li ċ-ċelluli huma l-iżjed tat-tip skwamużi:
English: 100% of previous dose
Maltese: 100% tad-doża ta' qabel
English: 1050 Bruxelles
Maltese: 1,000 mg
English: Stomatitis/Pharyngitis Diarrhoea without colostomy
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT
English: Infectious and non-infectious disorders of the dermis, the hypodermis and/or the subcutaneous tissue have been reported with an unknown frequency (e.g. acute bacterial dermo-hypodermitis, pseudocellulitis, dermatitis).
Maltese: Bi frekwenza mhux magħrufa ġew irrapportati disturbi infettivi u mhux infettivi tal-ġilda, l-ipoderma u/jew tat-tessut ta' taħt il-ġilda (eż. dermo-ipodermite batterjali akuta, psewdoċellulite, dermatite).
English: Tel: +385 1 3908 777
Maltese: Pfizer Croatia d.o.o. Tel: +385 1 3908 777
English: Reconstitute 500 mg vials with 20 ml of sterile water for injections, resulting in a solution containing 25 mg/ml pemetrexed.
Maltese: Irrikostitwixxi kunjetti ta' 500 mg b'20 ml ta' ilma sterili għall-injezzjonijiet, li jirriżulta f'soluzzjoni li jkun fiha 25 mg/ml pemetrexed.
English: • 95% CI for median
Maltese: • 95% CI għal medjan
English: At the time of this final survival analysis, 28.7% of patients were alive or lost to follow up on the pemetrexed arm versus 21.7% on the placebo arm.
Maltese: Fil-ħin ta' din l-analiżi finali ta' sopravivenza, 28.7% tal-pazjenti kienu ħajjin jew ma baqgħux jiġu segwiti fuq il-fergħa ta' pemetrexed kontra 21.7% fuq il-fergħa ta' plaċebo.
English: Interstitial pneumonitis (scarring of the air sacs of the lung) Oedema (excess fluid in body tissue, causing swelling).
Maltese: Pulmonite interstizjali (il-boroż ta' l-arja ġewwa ‘l pulmun irabbu qoxra) Edema (fluwidu żejjed fit-tessuti tal-ġisem li jikkawża nefħa).
English: In patients with normal renal function (creatinine clearance ≥ 80 ml/min), high doses of non-steroidal anti-inflammatory drugs (NSAIDs, such as ibuprofen > 1600 mg/day) and acetylsalicylic acid at higher doses (≥ 1.3 g daily) may decrease pemetrexed elimination and, consequently, increase the occurrence of pemetrexed adverse events.
Maltese: F'pazjenti li jkollhom il-kliewi jaħdmu normali (tneħħija tal-kreatinina ≥ 80 ml/min), dożi għolja ta' mediċini antinfjammatorji li mhumiex sterojdi (NSAIDs, bħal ibuprofen > 1600 mg/kuljum) kif ukoll doża għolja ta' acetylsalicylic acid (≥ 1.3 g kuljum) jistgħu jnaqqsu l-eliminazzjoni ta' pemetrexed u, b'hekk, tiżdied l-inċidenza ta' każijiet avversi ta' pemetrexed.
English: Skin rash
Maltese: OĦRAJN
English: • Fever or infection (common): if you have a temperature of 38ºC or greater, sweating or other signs of infection (since you might have less white blood cells than normal which is very common).
Maltese: • Deni jew infezzjoni (komuni): jekk għandek temperatura ta' 38ºC jew aktar, għarqan jew għandek sinjali oħra ta' infezzjoni (peress li jista' jkollok inqas ċelluli bojod tad-demm min-normal, li huwa komuni ħafna).
English: Sepsis, sometimes fatal, has been commonly reported during clinical trials with pemetrexed.
Maltese: Sepsis, xi kultant fatali, ġie rrapportat b'mod komuni f'studji kliniċi b'pemetrexed.
English: Maidenhead
Maltese: Treddigħ
English: Use an inactivated vaccine where it exists (poliomyelitis) (see section 4.4).
Maltese: Uża vaċċin inattivat jekk ikun jeżisti (poljomajelite) (ara sezzjoni 4.4).
English: Fatigue (tiredness)
Maltese: Konġunktivite (għajn infjammata)
English: A multi-centre, randomised, open-label, Phase-3 study of pemetrexed plus cisplatin versus gemcitabine plus cisplatin in chemonaive patients with locally advanced or metastatic (Stage IIIb or IV) non-small cell lung cancer (NSCLC) showed that pemetrexed plus cisplatin (Intent-To-Treat [ITT] population N = 862) met its primary endpoint and showed similar clinical efficacy as gemcitabine plus cisplatin (ITT N = 863) in overall survival (HR 0.94; 95% CI= 0.84-1.05).
Maltese: Studju każwali u multiċentriku ta' Fażi 3, bit-tikketta tingħaraf, bi pemetrexed flimkien ma' cisplatin kontra gemcitabine flimkien ma' cisplatin f'pazjenti b'kanċer tal-pulmun mhux b'ċelluli żgħar (NSCLC) lokalment avvanzat jew metastatiku (Stadju IIIb jew IV) u li qatt ma ħadu ebda kimoterapija, wera li pemetrexed flimkien ma' cisplatin (popolazzjoni bl-Intenzjoni Li Tittratta (ITT) n = 862) laħaq il-punt aħħari primarju u wera effikaċja klinika simili għal gemcitabine flimkien ma'
English: Patients must take oral folic acid or a multivitamin containing folic acid (350 to 1,000 micrograms) on a daily basis.
Maltese: Il-pazjenti għandhom jieħdu b'mod orali folic acid jew xi prodotti multivitaminiku li jkun fih folic acid (minn 350 sa 1,000 mikrogramma) kuljum.
English: The study met its primary endpoint and showed a statistically significant improvement in PFS in the pemetrexed arm over the placebo arm (N = 472, independently reviewed population; median of 3.9 months and 2.6 months, respectively) (hazard ratio = 0.64, 95% CI = 0.51-0.81, p = 0.0002).
Maltese: L-istudju laħaq il-punt aħħari primarju tiegħu u wera titjib statistikament sinifikanti fil-PFS fil-fergħa ta' pemetrexed meta mqabbel mal-fergħa tal-plaċebo (N=472, popolazzjoni eżaminata b'mod indipendenti; medjan ta' 3.9 ta' xahar u 2.6 ta' xahar rispettivament) (hazard ratio = 0.64, 95% CI = 0.51-0.81, p = 0.0002).
English: Pemetrexed Pfizer 1,000 mg powder for concentrate for solution for infusion Each vial contains 1,000 milligrams of pemetrexed (as pemetrexed ditromethamine).
Maltese: Kull kunjett fih 1,000 milligramma ta' pemetrexed (bħala pemetrexed ditromethamine).
English: In clinical trials, cases of colitis (including intestinal and rectal bleeding, sometimes fatal, intestinal perforation, intestinal necrosis and typhlitis) have been reported uncommonly in patients treated with pemetrexed.
Maltese: Fi studji kliniċi, b'mod mhux komuni, ġew irrapportati każijiet ta' kolite (li jinkludu fsada intestinali u rettali, xi kultant fatali, perforazzjoni intestinali, nekrożi intestinali u tiflite), f'pazjenti kkurati b'pemetrexed.
English: PARAMOUNT: Kaplan-Meier plot of progression-free survival (PFS) and Overall Survival (OS) for continuation pemetrexed maintenance versus placebo in patients with NSCLC other than predominantly squamous cell histology (measured from randomisation)
Maltese: Dijagrammi Kaplan-Meier ta' sopravivenza mingħajr progressjoni (PFS) u Sopravivenza Totali (OS) għat-tkomplija ta' manteniment bi pemetrexed kontra plaċebo f'pazjenti b'NSCLC minbarra dawk fejn l-istoloġija turi li ċ-ċelluli huma l-iżjed tat-tip skwamużi (kwantifikat permezz ta' għażla b'mod arbitrarju)
English: 9 l/m2.
Maltese: 100 mg
English: • Non-inferiority p-value (HR)
Maltese: • Il-valur p (HR) mhux ta' inferjorità
English: Dose modification table for pemetrexed (as a single agent or in combination) and cisplatin - Haematologic toxicities Nadir ANC < 500/mm3 and nadir platelets ≥ 50,000/mm3
Maltese: L-għadd l-iktar baxx t'ANC < 500/mm 3 u l-għadd l iktar baxx ta' plejtlits ≥ 50,000/mm
English: • Allergic reaction: if you develop skin rash (very common) / burning or prickling sensation (common), or fever (common).
Maltese: • Reazzjoni allerġika: jekk tiżviluppa raxx fil-ġilda (komuni ħafna) / sensazzjoni ta' ħruq jew tingiż (komuni), jew deni (komuni).
English: Pemetrexed Pfizer 100 mg powder for concentrate for solution for infusion Each vial contains 100 milligrams of pemetrexed (as pemetrexed ditromethamine).
Maltese: Kull kunjett fih 100 milligramma ta' pemetrexed (bħala pemetrexed ditromethamine).
English: Chemical and physical in-use stability of reconstituted and infusion solutions of Pemetrexed Pfizer were demonstrated for 24 hours at refrigerated temperature and 25°C.
Maltese: L-istabbilità kimika u fiżika ta' waqt l-użu, tas-soluzzjonijiet rikostitwiti u ta' soluzzjoni għallinfużjonijiet ta' Pemetrexed Pfizer ġiet ippruvata għal 24 siegħa f'temperatura ta' friġġ u f'temperatura ta' 25°C.
English: Pemetrexed Pfizer is a medicine used in the treatment of cancer.
Maltese: Pemetrexed Pfizer hija mediċina li tintuża fil-kura tal-kanċer.
English: For patients with NSCLC other than predominantly squamous cell histology (N = 430, independently reviewed population) median PFS was 4.4 months for the pemetrexed arm and 1.8 months for the placebo arm, hazard ratio = 0.47 (95% CI = 0.37-0.60, p = 0.00001).
Maltese: Għal pazjenti b'NSCLC minbarra dwak fejn l-istoloġija turi li ċ-ċelluli huma liżjed tat-tip skwamużi (N= 430, popolazzjoni analizzata indipendentement), il-medjan tal-PFS kien ta' 4.4 xhur għall-fergħa ta'pemetrexed u ta' 1.8 xhur għall-fergħa tal-plaċebo, hazard ratio = 0.47, 95 % CI = 0.37-0.60,p= 00001.
English: *p-value refers to comparison between arms.
Maltese: *p-value jirreferi għat-tqabbil ta' bejn iż-żewġ fergħat.
English: All grades toxicity
Maltese: Grad ta' tossiċità
English: The table below provides the frequency and severity of undesirable effects that have been reported in > 5% of 265 patients randomly assigned to receive single-agent pemetrexed with folic acid and vitamin B12 supplementation, and 276 patients randomly assigned to receive single-agent docetaxel.
Maltese: It-tabella hawn taħt tagħti l-frekwenza u s-severità tal-effetti mhux mixtieqa li ġew irrapportati f'>5% tal-265 pazjent li ntgħażlu b'mod każwali biex jirċievu pemetrexed waħdu b'supplimentazzjoni ta' folic acid u vitamina
English: Pemetrexed Pfizer 500 mg powder for concentrate for solution for infusion Each vial contains 500 milligrams of pemetrexed (as pemetrexed ditromethamine).
Maltese: Kull kunjett fih 500 milligramma ta' pemetrexed (bħala pemetrexed ditromethamine).
English: Reconstitute each 500 mg vial with 20 ml of sterile water for injections, resulting in a solution containing 25 mg/ml pemetrexed.
Maltese: Irrikostitwixxi kull kunjett ta' 500 mg b'20 ml ta' ilma sterili għall-injezzjonijiet, li jirriżulta f'soluzzjoni li jkollha 25 mg/ml pemetrexed.
English: ** Which is derived from the term “renal/genitourinary other”.
Maltese: *Definizzjoni tat-termini ta' frekwenza:
English: Leucocytes decreased 53.0 14.9 16.6 Haemoglobin decreased 26.2 4.2 Platelets decreased
Maltese: Tnaqqis fil-lewkoċiti 5.8 1.9 0.7 Tnaqqis fin-newtrofili 8.4
English: Pemetrexed Pfizer 100 mg powder for concentrate for solution for infusion 18 months
Maltese: Pemetrexed Pfizer 100 mg trab għal konċentrat għal soluzzjoni għall-infużjoni 18-il xahar
English: Time to treatment failure (months) (95% CI)
Maltese: Falliment fil-ħin għattrattament(Time to treatment failure) (xhur) (95% CI)
English: Median overall survival (months) (95% CI)
Maltese: Sopravivenza globali medjana (xhur) (95% CI)
English: Clinically relevant CTC toxicities that were reported in < 1% of the patients that were randomly assigned to pemetrexed include supraventricular arrhythmias.
Maltese: Tossiċitajiet CTC klinikament rilevanti li ġew irrapportati f'< 1% tal-pazjenti li ntgħażlu b'mod każwali biex jirċievu pemetrexed jinkludu arritmiji supraventrikulari.
English: Anticipated complications of overdose include bone marrow suppression as manifested by neutropenia, thrombocytopenia, and anaemia.
Maltese: Komplikazzjonijiet mistennija ta' doża eċċessiva jinkludu: soppressjoni tal-mudullun kif jixhdu n-newtropenja, it-tromboċitopenja u l-anemija.
English: Use in combination with cisplatin
Maltese: Gemcitabine + Cisplatin
English: Neutrophils/Granulocytes decreased
Maltese: Tnaqqis finnewtrofili/granuloċiti
English: All patients included in this study had an ECOG performance status 0 or 1.
Maltese: Il-pazjenti kollha inklużi f'dan listudju kellhom stat ta' prestazzjoni ECOG ta' 0 jew 1.
English: Limited clinical data from a separate randomised, Phase-3, controlled trial, suggest that efficacy data (overall survival, progression-free survival) for pemetrexed are similar between patients previously pre-treated with docetaxel (N = 41) and patients who did not receive previous docetaxel treatment (N =
Maltese: Informazzjoni klinika limitata, minn prova separata b'kontrolli u każwali ta' Fażi-3, tissuġġerixxi li linformazzjoni dwar l-effikaċja (sopravivenza totali, sopravivenza mingħajr progressjoni) għal pemetrexed hija simili bejn il-pazjenti li kienu ġew ikkurati qabel b'docetaxel (N=41) u pazjenti li ma rċevewx kura b'docetaxel qabel (NN=540).
English: The pemetrexed maintenance safety profiles from the two studies JMEN and PARAMOUNT were similar.
Maltese: Il-profili ta' sigurtà dwar il-manteniment bi pemetrexed kienu simili għaż-żewġ studji JMEN u PARAMOUNT.
English: Rare cases of hepatitis, potentially serious, have been reported during clinical studies with pemetrexed.
Maltese: Każijiet rari ta' epatite, potenzjalment serji, ġew irrapportati matul l-istudji kliniċi b'pemetrexed.
English: Rare cases of bullous conditions have been reported including Stevens-Johnson syndrome and Toxic epidermal necrolysis which in some cases were fatal.
Maltese: Ġew irrapportati każijiet rari ta' kundizzjonijiet tat-tip bullożi li jinkludu s-sindromu ta' StevensJohnson u nekroliżi epidermali tossika li f'xi każijiet kienu fatali.
English: After reconstitution as directed, the solution contains 25 mg/ml of pemetrexed.
Maltese: Wara r-rikostituzzjoni, kull kunjett fih 25 mg/ml ta' pemetrexed.
English: PHARMACEUTICAL FORM AND CONTENTS Powder for concentrate for solution for infusion 500 mg
Maltese: Trab għal konċentrat għal soluzzjoni għall-infużjoni. 500 mg
English: Concomitant yellow fever vaccine (see section 4.5).
Maltese: Vaċċin tad-deni isfar fl-istess żmien (ara sezzjoni 4.5)
English: During post-marketing surveillance, the following adverse reactions have been reported in patients treated with pemetrexed:
Maltese: Waqt sorveljanza ta' wara t-tqegħid fis-suq, ġew irrapportati dawn ir-reazzjonijiet avversi f'pazjenti kkurati b'pemetrexed:
English: Pancytopenia has been uncommonly reported during clinical trials with pemetrexed.
Maltese: Panċitopenja ġiet irrapportata mhux frekwentement matul l-istudji kliniċi b'pemetrexed.
English: Pemetrexed Pfizer 100 mg powder for concentrate for solution for infusion Store below 30°C.
Maltese: Pemetrexed Pfizer 100 mg trab għal konċentrat għal soluzzjoni għall-infużjoni Aħżen f'temperatura taħt 30C.
English: Large cell (N = 153)
Maltese: Ċellula kbira (N = 153)
English: The median OS for patients with NSCLC other than predominantly squamous cell histology (N = 481) was 15.5 months for the pemetrexed arm and 10.3 months for the placebo arm, hazard ratio = 0.70 (95% CI = 0.56-0.88, p = 0.002).
Maltese: 3 xhur għall-fergħa tal-plaċebo (hazard ratio = 0.70, 95% CI = 0.56-0.88, p=0.002).
English: The 1 year and 2 year survival rates for patients on pemetrexed were 58% and 32% respectively, compared to 45% and 21% for patients on placebo.
Maltese: Ir-rati ta' sopravivenza għall-ewwel sena u għat-tieni sena għal pazjenti fuq pemetrexed kienu ta' 58% u 32% rispettivament meta mqabbla ma' 45% u 21% għal pazjenti fuq plaċebo.
English: Reconstitute 1000 mg vials with 40 ml of sterile water for injections resulting in a solution containing 25 mg/ml pemetrexed.
Maltese: Irrikostitwixxi kunjetti ta' 1,000 mg b'40 ml ta' ilma sterili għall-injezzjonijiet li jirriżulta f'soluzzjoni li jkun fiha 25 mg/ml pemetrexed.
English: Including the induction phase, the median OS for patients with NSCLC other than predominantly squamous cell histology was 18.6 months for the pemetrexed arm and 13.6 months for the placebo arm, hazard ratio = 0.71 (95% CI = 0.56-0.88, p = 0.002).
Maltese: Meta tinkludi l fażi tal-induzzjoni l-medjan tal-OS għal pazjenti b'NSCLC minbarra dwak fejn l-istoloġija turi li ċċelluli huma l-iżjed tat-tip skwamużi kien ta' 18.6 xhur għall-fergħa ta' pemetrexed u ta' 13.6 xhur għall-fergħa tal-plaċebo (hazard ratio =0.71, 95% CI = 0.56-0.88, p = 0.002).
English: The appropriate volume of reconstituted pemetrexed solution must be further diluted to 100 ml with 5% glucose solution for injection, without preservative, and administered as an intravenous infusion over 10 minutes.
Maltese: Ilvolum xieraq tas-soluzzjoni rikostitwita ta' pemetrexed irid jerġa' jiġi dilwit sa 100 ml b'soluzzjoni għall-injezzjoni ta' 5% glukożju, mingħajr preservattiv, u jingħata bħala infużjoni fil-vini għal 10 minuti.
English: Hepatobiliary disorders
Maltese: Newropatijasensorjali
English: Grade 3 or 4 mucositis
Maltese: Mukożite ta' Grad 3 jew 4
English: In the absence of data regarding potential interaction with NSAIDs having longer half-lives such as piroxicam or rofecoxib, the concomitant administration with pemetrexed in patients with mild to moderate renal insufficiency should be interrupted for at least 5 days prior to, on the day of, and at least 2 days following pemetrexed administration (see section 4.4).
Maltese: Fin-nuqqas ta' tagħrif dwar l-interazzjoni potenzjali ma' NSAIDs li jkollhom half-life itwal bħal piroxicam jew rofecoxib, l-għoti ta' pemetrexed fl-istess żmien f'pazjenti b'insuffiċjenza renali minn ħafifa għal moderata għandu jitwaqqaf mill-anqas minn 5 ijiem qabel, dakinhar u sa mill-inqas jumejn wara l-għoti ta' pemetrexed (ara sezzjoni 4.4).
English: UNIQUE IDENTIFIER- HUMAN READABLE DATA PC:
Maltese: Prekawzjonijiet fil-preparazzjoni u l-amministrazzjoni:
English: *** According to National Cancer Institute CTC (v2.0; NCI 1998), taste disturbance and alopecia should only be reported as Grade 1 or 2.
Maltese: * Irreferi għal verżjoni 2 tas-CTC tal-Istitut Nazzjonali tal-Kanċer għal kull grad ta' tossiċità. ** Skont is-CTC (v 2.0; NCI 1998) tal-Istitut Nazzjonali tal-Kanċer, l-alopeċja għandha tiġi rrapportata biss bħala Grad 1 jew 2.
English: ***Integrated adverse reactions table combines the results of the JMEN pemetrexed maintenance (N=663) and PARAMOUNT continuation pemetrexed maintenance (N=539) studies.
Maltese: N=663) u tat-tkomplija ta' manteniment b'pemetrexed (PARAMOUNT:
English: Pemetrexed Pfizer 500 mg powder for concentrate for solution for infusion Each vial contains 500 mg of pemetrexed (as pemetrexed ditromethamine).
Maltese: Kull kunjett fih 500 mg pemetrexed (bħala pemetrexed ditromethamine ).
English: Common Neuropathysensory
Maltese: SOMMARJU TAL-KARATTERISTIĊI
English: Response (n: qualified for response)
Maltese: Rispons (n: eliġibbli għar-rispons)
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1,000 mg
Maltese: KARTUNA TA' BARRA TA' 1,000 mg
English: Pemetrexed is a multi-targeted anti-cancer antifolate agent that exerts its action by disrupting crucial folate-dependent metabolic processes essential for cell replication.
Maltese: Pemetrexed hija sustanza antifolatika, antikanċeroġenika b'iżjed minn objettiv wieħed.
English: Common Neuropathy-sensory Taste disturbance
Maltese: Disturbi fis-sistema nervuża
English: Concomitant administration of nephrotoxic medicinal products (e.g., aminoglycoside, loop diuretics, platinum compounds, ciclosporin) could potentially result in delayed clearance of pemetrexed.
Maltese: Jekk jingħataw prodotti mediċinali nefrotossiċi (eż. aminoglikosidi, dijuretiċi li jaħdmu fuq il-liwja tubulari, komposti tal-platinu, cyclosporin) fl-istess żmien, dawn jistgħu jwasslu għal dewmien fit-tneħħija ta' pemetrexed.
English: Superio rity pvalue pemetrexed + cisplatin gemcitabine + cisplatin
Maltese: Kif jidher Pemetrexed Pfizer u l-kontenut tal-pakkett