FrancophonIA/ELRC3.0 huggingface dataset:
English: Serious cardiovascular and cerebrovascular events, including myocardial infarction, angina pectoris, cerebrovascular accident and transient ischaemic attack have been uncommonly reported during clinical studies with pemetrexed, usually when given in combination with another cytotoxic agent.
Maltese: Avvenimenti serji ċerebrovaskulari u kardjovaskulari, li jinkludu infart mijokardijaku, angina pectoris, inċident ċerebrovaskulari u attakk iskemiku tranżitorju ġew irrapportati b'mod mhux frekwenti matul l-istudji kliniċi b'pemetrexed, ħafna drabi meta ngħata ma' sustanza ċitotossika oħra.
English: When prepared as directed, chemical and physical in-use stability of reconstituted and infusion solutions of pemetrexed were demonstrated for 24 hours at refrigerated temperature (2 °C - 8 °C).
Maltese: Meta ppreparat kif suppost, l-istabbilità kimika u fiżika ta' waqt l-użu, tas-soluzzjonijiet rikostitwiti u ta' infużjoni ta' pemetrexed, ingħatat prova tagħha għal 24 siegħa f'temperatura ta' friġġ (2 °C - 8 °C).
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: From the start of pemetrexed plus cisplatin first line induction treatment, the median OS of patients was 16.9 months for the pemetrexed arm and 14.0 months for the placebo arm (hazard ratio = 0.78, 95 % CI = 0.64 - 0.96).
Maltese: Mill-bidu tal-kura primarja inizjali ta' pemetrexed flimkien ma' cisplatin, l-OS medjan tal-pazjenti kien ta' 16.9 xhur għall-fergħa ta' pemetrexed u ta' 14.0 xhur għall-fergħa ta' plaċebo (proporzjon tal-periklu = 0.78, 95 % CI = 0.640.96).
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, adjusted 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 (n = 172, 6.2 kontra 7.4 xhur, HR aġġustat = 1.56; 95 % CI = 1.08 - 2.26, p = 0.018).
English: Pemetrexed medac must only be administered under the supervision of a physician qualified in the use of anti-cancer chemotherapy.
Maltese: Pemetrexed medac għandu jingħata biss bis-superviżjoni ta' tabib ikkwalifikat fl-użu tal-kemoterapija kontra l-kanċer.
English: Reported symptoms of overdose include neutropenia, anaemia, thrombocytopenia, mucositis, sensory polyneuropathy and rash.
Maltese: Sintomi ta' doża eċċessiva li ġew irrapportati jinkludu: newtropenija, anemija, tromboċitopenija, mukożite, polinewropatija sensittiva, u raxx.
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 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) (proporzjon tal-periklu = 0.64, 95 % CI = 0.51 - 0.81, p = 0.0002).
English: Cisplatin is also given by infusion into one of your veins, and is given approximately 30 minutes after the infusion of Pemetrexed medac has finished.
Maltese: Cisplatin ukoll jingħata b'infużjoni f'waħda mill-vini tiegħek, u jingħata madwar 30 minuta wara li tkun spiċċat l-infużjoni ta' Pemetrexed medac.
English: Each 100 mg vial contains approximately 11 mg sodium.
Maltese: Kull kunjett ta' 100 mg fih madwar 11 mg ta' sodium.
English: A phase 2 study of pemetrexed in 31 solid tumour patients with stable third space fluid demonstrated no difference in pemetrexed dose normalized plasma concentrations or clearance compared to patients without third space fluid collections.
Maltese: Studju tat-2 fażi ta' pemetrexed f'31 pazjent b'tumur solidu bi fluwidu stabbli fit-tielet spazju ma wera ebda differenza fil-konċentrazzjonijiet fil-plażma normalizzati taddoża ta' pemetrexed jew fl-eliminazzjoni meta mqabbla ma' pazjenti li ma kellhomx akkumulazzjoni ta' fluwidu fit-tielet spazju.
English: In patients with normal renal function (creatinine clearance ≥ 80 ml/min), high doses of non-steroidal anti-inflammatory drugs (NSAIDs, such as ibuprofen > 1,600 mg/day) and acetylsalicylic acid at higher dose (≥ 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 b'mod normali (tneħħija tal-krejatinina ≥ 80 ml/min), dożi għoljin ta' mediċini anti-infjammatorji li mhumiex sterojdi (NSAIDs, bħal ibuprofen > 1,600 mg/kuljum) kif ukoll doża għolja ta' acetylsalicylic acid (≥ 1.3 g kuljum) jistgħu jnaqqsu leliminazzjoni ta' pemetrexed u, b'hekk, tiżdied l-inċidenza ta' reazzjonijiet avversi ta' pemetrexed.
English: In patients treated for non-small cell lung cancer after prior chemotherapy, the recommended dose of Pemetrexed medac is 500 mg/m² BSA administered as an intravenous infusion over 10 minutes on the first day of each 21-day cycle.
Maltese: F'pazjenti kkurati għall-kanċer tal-pulmun mhux b'ċelluli żgħar wara kemoterapija preċedenti, id-doża rrakkomandata ta' Pemetrexed medac hi ta' 500 mg/m² BSA mogħtija b'infużjoni minn ġol-vina fuq perijodu ta' 10 minuti fl-ewwel ġurnata ta' kull ċiklu ta' 21 ġurnata.
English: Other medicines and Pemetrexed medac
Maltese: Mediċini oħra u Pemetrexed medac
English: Neutrophils/
Maltese: Raxx/
English: This is equivalent to 5.40% of the recommended maximum daily dietary intake of sodium for an adult.
Maltese: Dan hu ekwivalenti għal 5.40% tal-ammont massimu rakkomandat ta' sodium li ghandu jittieħed kuljum mad-dieta minn adult.
English: − allergic reaction: skin rash / burning or prickling sensation
Maltese: − reazzjoni allerġika: raxx tal-ġilda/ sensazzjoni ta' tingiż jew ħruq
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 pemetrexed kontra plaċebo f'pazjenti b' NSCLC minbarra dwak fejn listoloġija turi li ċ-ċelluli huma l-iżjed tat-tip skwamuż:
English: − nausea
Maltese: − dijarrea
English: − loss of appetite
Maltese: − nuqqas ta' aptit
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: * Refer to National Cancer Institute CTC version 2 for each grade of toxicity except the term “creatinine clearance decreased” ** Which is derived from the term “renal/genitourinary other” *** 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 ħlief għat-terminu “tnaqqis fleliminazzjoni tal-krejatinina” ** Li ġejja mit-terminu “renali/ġenito-urinarji oħrajn”. *** Skont is-CTC (v2.0; NCI 1998) tal-Istitut Nazzjonali tal-Kanċer, it-tibdil fit-togħma u l-alopeċja għandhom jiġu rrapportati biss bħala Grad 1 jew 2.
English: Pharmacotherapeutic group: antineoplastic agents, folic acid analogues, ATC code: L01BA04 Pemetrexed medac is a multi-targeted anti-cancer antifolate agent that exerts its action by disrupting crucial folate-dependent metabolic processes essential for cell replication.
Maltese: Kategorija farmakoterapewtika: sustanzi antineoplastiċi, analogi ta' folic acid, Kodiċi ATC:
English: The most commonly reported undesirable effects related to pemetrexed, whether used as monotherapy or in combination, are bone marrow suppression manifested as anaemia, neutropenia, leukopenia, thrombocytopenia; and gastrointestinal toxicities, manifested as anorexia, nausea, vomiting, diarrhoea, constipation, pharyngitis, mucositis, and stomatitis.
Maltese: L-aktar effetti mhux mixtieqa li ġew irrapportati b'mod komuni u li għandhom x'jaqsmu ma' pemetrexed kemm jekk jintuża bħala monoterapija kif ukoll jekk jintuża flimkien ma' prodotti mediċinali oħra huma t-tnaqqis fil-funzjoni tal-mudullun li jidher bħala anemija, newtropinja, lewkopinja, tromboċitopinja, u tossiċitajiet gastrointestinali li jidhru bħala anoressija, dardir, rimettar dijarrea, stitikezza, farinġite, mukosite u stomatite.
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 għallewwel 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: The independent review of patient scans confirmed the findings of the investigator assessment of PFS. For randomised patients, as measured from the start of pemetrexed plus cisplatin first line induction treatment, the median investigator-assessed PFS was 6.9 months for the pemetrexed arm and 5.6 months for the placebo arm (hazard ratio = 0.59 95 % CI = 0.47 - 0.74).
Maltese: Għal dawk il-pazjenti magħżula b'mod każwali, kif mkejjel mill-bidu tal-kura primarja inizjali ta' pemetrexed flimkien ma' cisplatin, il-medjan talPFS evalwat mill-investigatur kien ta' 6.9 xhur għall-fergħa ta' pemetrexed u ta' 5.6 ta' xahar għallfergħa tal-plaċebo (proporzjon tal-periklu = 0.59 95 % CI = 0.47 - 0.74).
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 b'pemetrexed kontra plaċebo f'pazjenti b'NSCLC minbarra dawk fejn l-istoloġija turi li ċ-ċelluli huma l-iżjed tat-tip skwamuż (kkwantifikat permezz ta' għażla b'mod każwali)
English: INFORMATION IN BRAILLE <Justification for not including Braille accepted>
Maltese: INFORMAZZJONI BIL-BRAILLE <Il-ġustifikazzjoni biex ma jkunx inkluż il-Braille hija aċċettata>
English: Pemetrexed medac in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma.
Maltese: Ilpazjenti kollha kellhom dijanjożi ta' kanċer tal-pulmun mhux b'ċelluli żgħar lokalment avvanzat jew metastatiku u qabel kienu diġà rċevew il-kemoterapija.
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 skwamuż (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, proporzjon talperiklu = 0.47, (95 % CI = 0.37 - 0.60, p = 0.00001).
English: Table 2 - Dose modification table for pemetrexed (as single agent or in combination) and cisplatin - Non-haematologic toxicitiesa,b
Maltese: Tabella 2 - Tabella għall-modifikazzjoni fid-doża ta' pemetrexed (bħala sustanza waħdenija jew f'terapija kombinata) u cisplatin- Tossiċitajiet li mhumiex ematoloġiċia,b
English: For precautions to be taken before handling or administering Pemetrexed medac, see section 6.6.
Maltese: Għal prekawzjonijiet li għandhom jittieħdu qabel ma tmiss jew tamministra Pemetrexed medac, ara sezzjoni 6.6.
English: Leukocytes decreased
Maltese: Mediċini oħra
English: Pemetrexed medac is given in combination with cisplatin, another anti-cancer medicine, as treatment for malignant pleural mesothelioma, a form of cancer that affects the lining of the lung, to patients who have not received prior chemotherapy.
Maltese: Pemetrexed medac jingħata flimkien ma' cisplatin, mediċina oħra kontra l-kanċer, bħala kura għal mesoteljoma plewrali malinna, tip ta' kanċer li jaffettwa r-rita tal-pulmun, lil pazjenti li jkunu għadhom ma ngħatawx kemoterapija.
English: Reconstitute each 500 mg vial with 20 ml of 9 mg/ml (0.9 %) sodium chloride solution for injection, without preservative, resulting in a solution containing 25 mg/ml pemetrexed.
Maltese: Irrikostitwixxi kunjetti ta' 500 mg b'20 ml ta' soluzzjoni għall-injezzjoni ta' 9 mg/ml (0.9 %) sodium chloride, mingħajr preservattiv, li tirriżulta f'soluzzjoni li jkollha 25 mg/ml pemetrexed.
English: Clinically relevant CTC toxicities that were reported in < 1 % of the patients that were randomly assigned to receive cisplatin and pemetrexed include arrhythmia and motor neuropathy.
Maltese: Tossiċitajiet CTC klinikament rilevanti li ġew irrapportati f'< 1 % (mhux komuni) tal-pazjenti li ntgħażlu b'mod każwali biex jirċievu cisplatin u pemetrexed jinkludu arritmja u newropatija motorja.
English: Reconstitute 500 mg vials with 20 ml of sodium chloride 9 mg/ml (0.9 %) solution for injection, without preservative, resulting in a solution containing 25 mg/ml pemetrexed.
Maltese: Irrikostitwixxi kull kunjett ta' 500 mg b'20 ml ta' soluzzjoni għall-injezzjoni ta' 9 mg/ml (0.9 %) sodium chloride, mingħajr preservattiv, li jirriżulta f'soluzzjoni li jkollha 25 mg/ml pemetrexed.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1038/002
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/15/1038/002
English: A hospital pharmacist, nurse or doctor will have mixed the Pemetrexed medac powder with 9 mg/ml (0.9 %) sodium chloride solution for injection before it is given to you.
Maltese: Qabel ma' jingħatalek, it-trab ta' Pemetrexed medac jiġi mħallat ma' soluzzjoni għall-injezzjoni ta' 9 mg/ml (0.9 %) sodium chloride, mill-ispiżjar tal-isptar, infermier jew tabib.
English: After reconstitution, each vial contains 25 mg/ml of pemetrexed.
Maltese: Wara r-rikostituzzjoni, kull kunjett fih 25 mg/ml ta' pemetrexed.
English: Reconstitute each 1,000 mg vial with 40 ml of 9 mg/ml (0.9 %) sodium chloride solution for injection, without preservative, resulting in a solution containing 25 mg/ml pemetrexed.
Maltese: Irrikostitwixxi kunjetti ta' 1,000 mg b'40 ml ta' soluzzjoni għall-injezzjoni ta' 9 mg/ml (0.9 %) sodium chloride, mingħajr preservattiv, u dan jirriżulta f'soluzzjoni li jkollha 25 mg/ml pemetrexed.
English: This is equivalent to 2.70% of the recommended maximum daily dietary intake of sodium for an adult.
Maltese: Dan hu ekwivalenti għal 2.70% tal-ammont massimu rakkomandat ta' sodium li ghandu jittieħed kuljum mad-dieta minn adult.
English: When prepared as directed, reconstituted and infusion solutions of pemetrexed contain no antimicrobial preservatives.
Maltese: Meta ppreparati kif suppost, is-soluzzjonijiet rikostitwiti u ta' infużjoni ta' pemetrexed ma jkun fihom ebda preservattiv antimikrobiku.
English: Log Rank p-value* Time to treatment failure (months) (95 % CI)
Maltese: Log Rank valur-p* Żmien sal-falliment fil-kura (xhur)
English: Patients must take oral folic acid or a multivitamin containing folic acid (350 - 1,000 µg) on a daily basis.
Maltese: Il-pazjenti għandhom jieħdu b'mod orali folic acid jew xi prodott multivitaminiku li jkun fih folic acid (minn 350 - 1,000 µg) kuljum.
English: Name and address of the manufacturers responsible for batch release Synthon Hispania, S.L.
Maltese: Synthon Hispania, S.L.
English: Common Neuropathy-sensory 7.4
Maltese: Tibdil fit-togħma 7.7
English: Reconstitute each 100 mg vial with 4.2 ml of 9 mg/ml (0.9 %) sodium chloride solution for injection, without preservative, resulting in a solution containing 25 mg/ml pemetrexed.
Maltese: Irrikostitwixxi kunjetti ta' 100 mg b'4.2 ml ta' soluzzjoni għall-injezzjoni ta' 9 mg/ml (0.9 %) sodium chloride, mingħajr preservattiv, li jirriżulta f'soluzzjoni li jkollha 25 mg/ml pemetrexed.
English: Skin and subcutaneous tissue disorders
Maltese: Johnson u nekrożi epidermali tossika
English: − blood clots in the lung blood vessels (pulmonary embolism)
Maltese: − ċapep tad-demm fis-sistema vaskulari tal-pulmun (emboliżmu pulmunarju)
English: Reconstitute 1,000 mg vials with 40 ml of sodium chloride 9 mg/ml (0.9 %) solution for injection, without preservative, resulting in a solution containing 25 mg/ml pemetrexed.
Maltese: Irrikostitwixxi kull kunjett ta' 1,000 mg b'40 ml ta' soluzzjoni għall-injezzjoni ta' 9 mg/ml (0.9 %) sodium chloride, mingħajr preservattiv, li jirriżulta f'soluzzjoni li jkollha 25 mg/ml pemetrexed.
English: Renal and urinary disorders
Maltese: Disturbi fil-kliewi u fis- sistema urinarja
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: Il-medjan tal-OS għal pazjenti b'NSCLC minbarra dwak fejn l-istoloġija turi li ċ-ċelluli huma l-iżjed tat-tip skwamuż (n = 481) kien ta' 15.5 xhur għall-fergħa ta' pemetrexed u ta' 10.3 xhur għall-fergħa tal-plaċebo proporzjon talperiklu = 0.70 (95 % CI = 0.56 - 0.88, p = 0.002).
English: Table 1 - Dose modification table for pemetrexed (as single agent or in combination) and cisplatin - Haematologic toxicities Nadir ANC < 500/mm³ and nadir platelets ≥ 50,000/mm³
Maltese: Qabel ma jibda kull ċiklu ta' kemoterapija, il-pazjenti jeħtieġ ikollhom dan li ġej: l-għadd assolut ta' newtrofili (ANC) għandu jkun ta' ≥ 1,500 celluli/mm³ u l-plejtlits għandhom ikunu ≥ 100,000 ċelluli/mm³.
English: Reconstitute 100 mg vials with 4.2 ml of sodium chloride 9 mg/ml (0.9 %) solution for injection, without preservative, resulting in a solution containing 25 mg/ml pemetrexed.
Maltese: Irrikostitwixxi kull kunjett ta' 100 mg b'4.2 ml ta' soluzzjoni għall-injezzjoni ta' 9 mg/ml (0.9 %) sodium chloride, mingħajr preservattiv, li jirriżulta f'soluzzjoni li jkollha 25 mg/ml pemetrexed.
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-inqas minn 5 ijiem qabel, dakinhar u sa mill-inqas jumejn wara l-għoti ta' pemetrexed (ara sezzjoni 4.4).
English: All patients were diagnosed with Stage IIIB or IV NSCLC and had received prior platinum-based chemotherapy.
Maltese: Ilpazjenti kollha kienu ddijanjostikati li kellhom NSCLC fi Stadju IIIB jew IV u li diġà kienu rċevew kemoterapija bbażata fuq il-platinum.
English: − acute renal failure
Maltese: Komuni ħafna
English: − hair loss
Maltese: U LUŻU
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1038/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/15/1038/001
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1038/003
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/15/1038/003
English: Granulocytes decreased
Maltese: Twissijiet u prekawzjonijiet
English: Efficacy of pemetrexed plus cisplatin vs. cisplatin in malignant pleural mesothelioma Randomized and treated patients
Maltese: Matul l-istudju, sabiex titnaqqas it-tossiċità, ġew introdotti mat-terapija tal-pazjenti, folic acid f'doża baxxa u l-vitamina
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-newtropenija, t-tromboċitopenija u l-anemija.
English: Nadir platelets < 50,000/mm³ regardless of nadir ANC
Maltese: L-għadd l-iktar baxx ta' plejtlits < 50,000/mm³ hu x'inhu lgħadd l-iktar baxx ta' ANC
English: This medicine contains 54 mg sodium (main component of cooking/table salt) in each 500 mg vial.
Maltese: Din il-mediċina fiha 54 mg sodium (il-komponent prinċipali ta' melħ tat-tisjir/li jintuża mal-ikel) f'kull kunjett ta' 500 mg.
English: The table below provides the frequency and severity of undesirable effects that have been reported in > 5 % of 168 patients with mesothelioma who were randomised to receive cisplatin and pemetrexed and 163 patients with mesothelioma randomised to receive single agent cisplatin.
Maltese: It-tabella hawn taħt tagħti l-frekwenza u s-severità tal-effetti mhux mixtieqa li ġew irrapportati f'> 5 % tal-168 pazjent b'mesoteljoma li ntgħażlu b'mod każwali biex jirċievu cisplatin u pemetrexed u 163 pazjent b'mesoteljoma li ntgħażlu b'mod każwali biex jirċievu cisplatin waħdu.
English: NAME OF THE MEDICINAL PRODUCT Pemetrexed medac 100 mg powder for concentrate for solution for infusion pemetrexed
Maltese: U KWANTITATTIVA Pemetrexed medac 100 mg trab għal konċentrat għal soluzzjoni għall-infużjoni
English: Neuropathy-sensory 10.1 Common Taste disturbance
Maltese: .7 Effetti fuq il-ħila biex issuq u tħaddem magni
English: Pemetrexed was not mutagenic in either the in vitro chromosome aberration test in Chinese hamster ovary cells, or the Ames test. Pemetrexed has been shown to be clastogenic in the in vivo micronucleus test in the mouse.
Maltese: Qabel l-għoti ta' kull kemoterapija għandhom jinġabru t-testijiet kimiċi tad-demm biex tkun evalwata lfunzjoni tal-kliewi u tal-fwied.
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 jinkludi l-fażi tal-induzzjoni, il-medjan tal-OS għal pazjenti b'NSCLC minbarra dawk fejn l-istoloġija turi li ċ-ċelluli huma l-iżjed tat-tip skwamuż, kien ta' 18.6 xhur għall-fergħa ta' pemetrexed u ta' 13.6 xhur għall-fergħa tal-proporzjon ta' periklu tal-plaċebo = 0.71 (95 % CI = 0.56 - 0.88, p = 0.002).
English: • age ≥ 75 years
Maltese: • età ≥ 75 sena
English: Ethnic origin and race
Maltese: Oriġini etnika u razza
English: AVERROES STUDY
Maltese: STUDJU AVERROES
English: Fatal, n
Maltese: Fatali, n
English: • diabetes mellitus
Maltese: • dijabete mellitus
English: Alu-PVC/PVdC blisters.
Maltese: Folji tal-Alu-PVC/PVdC.
English: • Active clinically significant bleeding.
Maltese: • Fsada attiva klinikament sinifikanti.
English: Table 2 System Organ Class
Maltese: Tabella 2 Sistema tal-Klassifika tal-Organi
English: It does not require antithrombin III for antithrombotic activity.
Maltese: Ma jeħtieġx antithrombin III għal attività antitrombotika.
English: • symptomatic heart failure (NYHA Class ≥ II)
Maltese: • insuffiċjenza sintomatika tal-qalb (NYHA Klassi ≥ II)
English: EU/1/11/691/001 EU/1/11/691/002 EU/1/11/691/003 EU/1/11/691/004 EU/1/11/691/005 EU/1/11/691/013 EU/1/11/691/015
Maltese: EU/1/11/691/001 EU/1/11/691/002 EU/1/11/691/003 EU/1/11/691/004
English: ARISTOTLE STUDY
Maltese: STUDJU ARISTOTLE
English: Anti-Xa Activity Min (IU/mL)
Maltese: Anti-Xa Attività Minima (IU/mL)