FrancophonIA/ELRC3.0 huggingface dataset:
English: Metabolism of imatinib is mainly hepatic, and only 13% of excretion is through the kidneys.
Maltese: Il-metaboliżmu ta' imatinib issir l-aktar permezz tal-fwied, u 13% biss ta'l-eskrezzjoni hija minn ġol-kliewi.
English: Active substances that may have their plasma concentration altered by imatinib Imatinib increases the mean Cmax and AUC of simvastatin (CYP3A4 substrate) 2- and 3.5-fold, respectively, indicating an inhibition of the CYP3A4 by imatinib.
Maltese: Sustanzi attivi li jista' jkollhom il-konċentrazzjoni fil-plażma tagħhom mibdula minħabba f'imatinib Imatinib iżid is-Cmax intermedju u l-AUC ta' simvastatin (sustanza li fuqha jaħdem is-CYP3A4)
English: Imatinib Teva 100 mg film-coated tablets imatinib
Maltese: Imatinib Teva 100 mg kapuli ibsin imatinib
English: Seven years after the last patient had been recruited, the median duration of first-line treatment was 82 and 8 months in the imatinib and IFN arms, respectively.
Maltese: Seba' snin wara li kien reklutat l-aħħar pazjent, iż żmien medjan ta' kemm damet il-kura preferita kien 82 u 8 xhur fil-friegħi bi imatinib u IFN, rispettivament.
English: Meloxidolor is a medicine that contains the active substance meloxicam.
Maltese: Meloxidolor huwa mediċina li fiha s-sustanza attiva meloxicam.
English: It is available as a solution for injection (5 mg/ml, 20 mg/ml and 40 mg/ml).
Maltese: Huwa disponibbli bħala soluzzjoni għal injezzjoni (5 mg/ml, 20 mg/ml u 40 mg/ml).
English: It must not be used in cats weighing less than 2 kg.
Maltese: Ma jistax jintuża fi qtates li jiżnu inqas minn 2 kg.
English: While the reference medicine, Metacam, is available as 5 mg/ml and 20 mg/ml solutions for injection, Meloxidolor is also available as a 40 mg/ml solution for injection.
Maltese: Filwaqt li lmediċina ta' referenza, Metacam, hija disponibbli bħala soluzzjonijiet għal tilqima 5 mg/ml u 20 mg/ml, Meloxidolor huwa disponibbli wkoll bħala soluzzjoni għal injezzjoni 40 mg/ml.
English: What is the withdrawal period?
Maltese: Liema benefiċċju wera Meloxidolor waqt l-istudji li twettqu?
English: Meloxidolor solution for injection (5 mg/ml, 20 mg/ml and 40 mg/ml) is used in cattle, together with appropriate antibiotic therapy, to reduce signs of disease in acute respiratory infections (infection of the lungs and airways).
Maltese: Meloxidolor soluzzjoni għal injezzjoni (5 mg/ml, 20 mg/ml u 40 mg/ml) jintuża fl-ifrat, flimkien ma' terapija antibijotika xierqa, biex inaqqas is-sinjali ta' mard f'infezzjonijiet respiratorji akuti (infezzjoni tal-pulmuni u l-passaġġi tal-arja).
English: This means that Meloxidolor is similar to a ‘reference veterinary medicine' containing the same active substance, but it is also available at a higher strength.
Maltese: Dan ifisser li Meloxidolor huwa simili għal ‘mediċina veterinarja ta' referenza' li fiha l-istess sustanza attiva, iżda huwa disponibbli wkoll b'qawwiet ogħla.
English: The 5 mg/ml solution for injection can also be used for the relief of post-operative pain associated with minor soft tissue surgery such as castration (surgical removal of the testicles) and the 20 mg/ml solution for injection can be used together with appropriate antibiotic therapy for the treatment of diseases that occur after farrowing (giving birth) such as puerperal septicaemia (bacteria present in blood) and toxaemia (a toxic state) (mastitis-metritis-agalactia syndrome).
Maltese: Is-soluzzjoni għal injezzjoni 5 mg/ml tista' tintuża wkoll biex ittaffi l-uġigħ wara operazzjoni assoċjat ma' kirurġija minuri fit-tessut artab bħal kastrazzjoni (it-tneħħija kirurġika tat-testikoli) u s-soluzzjoni għal injezzjoni 20 mg/ml tista' tintuża flimkien ma' terapija antibijotika xierqa għall-kura ta' mard li jseħħ wara t-tifrigħ (it-twelid) bħal settikemija pwerperali (batterji preżenti fid-demm) u tossemija (stat tossiku) (sindromu ta' mastitis-metritis-agalactia).
English: Side effects sometimes seen with other NSAIDs, such as loss of appetite, vomiting, diarrhoea, blood appearing in the stools, renal (kidney) failure and apathy (lack of vitality) are occasionally seen with Meloxidolor in dogs and cats.
Maltese: L-effetti sekondarji li xi drabi feġġew b'NSAIDs oħrajn, bħal nuqqas ta' aptit, rimettar, dijarea, demm li jidher fl-ippurgar, insuffiċjenza renali (tal-kliewi) u apatija (nuqqas ta' vitalità) jidhru xi kultant b'Meloxidolor fil-klieb u l-qtates.
English: This summary was last updated on 22/04/2013.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f' 22/04/2013.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Meloxidolor on 22/04/2013.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fi ħdan l-Unjoni Ewropea għal Meloxidolor fi 22/04/2013.
English: Meloxidolor is a 'generic'.
Maltese: Meloxidolor huwa 'ġeneriku'.
English: Meloxidolor solution for injection (20 mg/ml and 40 mg/ml) is used in horses to relieve colic (abdominal pain) and the inflammation and pain in musculo-skeletal disorders.
Maltese: Meloxidolor soluzzjoni għal injezzjoni (20 mg/ml u 40 mg/ml) jintuża fi żwiemel biex itaffi l-kolika (uġigħ fl-addome) u l-infjammazzjoni u l-uġigħ f'disturbi muskulo-skelettriċi.
English: What is the risk associated with Meloxidolor?
Maltese: X'riskji huma assoċjati ma' Meloxidolor?
English: In very rare cases they may be serious or fatal.
Maltese: F'każijiet ferm rari jistgħu jkunu serji jew fatali.
English: Meloxidolor solution for injection (5 mg/ml) can be used to relieve inflammation and pain in dogs following surgery involving the bones or soft tissue (tissue just below the skin), and in cats following ovariohysterectomy (spaying) and minor soft tissue surgery.
Maltese: Meloxidolor soluzzjoni għal injezzjoni (5 mg/ml) jista' jintuża biex itaffi l-infjammazzjoni u l-uġigħ filklieb wara kirurġija li tinvolvi l-għadam jew it-tessut artab (it-tessut eżatt taħt il-ġilda), u fi qtates wara ovarjoisterektomija (tiswija) u kirurġija minuri fit-tessut artab.
English: What is Meloxidolor?
Maltese: X'inhu Meloxidolor?
English: The 20 mg/ml and 40/mg/ml solutions for injection are also used in combination with antibiotic therapy to treat acute mastitis (inflammation of the udder).
Maltese: Is-soluzzjonijiet għal injezzjoni 20 mg/ml u 40 mg/ml jintużaw ukoll flimkien ma' terapija antibijotika biex jikkuraw mastite akuta (infjammazzjoni tal-bżieżel).
English: As Meloxidolor is considered to be bioequivalent to the reference medicine, its benefit is taken as being the same as that of the reference medicine.
Maltese: Peress li Meloxidolor huwa kkunsidrat bħala bijoekwivalenti għall-mediċina ta' referenza, il-benefiċċju tiegħu jitqies li huwa l-istess bħal dak tal-mediċina ta' referenza.
English: People who are hypersensitive (allergic) to NSAIDs should avoid contact with Meloxidolor.
Maltese: Nies li għandhom sensittività eċċessiva (allerġiċi) għal NSAIDs għandhom jevitaw kuntatt ma' Meloxidolor.
English: Meloxidolor solution for injection (5 mg/ml and 20 mg/ml) is used in pigs to reduce the symptoms of lameness (inability to walk normally) and inflammation in non-infectious locomotor disorders (diseases that affect the ability to move).
Maltese: Meloxidolor soluzzjoni għal injezzjoni (5 mg/ml u 20 mg/ml) jintuża fi ħnieżer biex inaqqas is-sintomi taz-zappip (nuqqas ta' ħila ta' mixi normali) u infjammazzjoni f'disturbi lokomotorji mhux infettużi (mard li jaffettwa l-ħila ta' ċaqliq).
English: Meloxidolor contains meloxicam, which belongs to a class of medicines called non-steroidal antiinflammatory drugs (NSAIDs).
Maltese: Meloxidolor fih meloxicam, li jappartjeni għal klassi ta' mediċini msejħa mediċini antiinflammatorji mhux sterojdali (NSAIDs). Meloxicam jaġixxi billi jimblokka enzima msejħa ċiklossiġenasi li hija involuta fil-produzzjoni tal-prostaglandini.
English: Information on the prescription status of this product may be found on the label/outer package.
Maltese: L-informazzjoni fuq l-istatus tal-preskrizzjoni ta' dan il-prodott tista' tinstab fuq it-tikketta/il-pakkett ta' barra.
English: For subcutaneous and intramuscular use no studies were need for the 5 mg/ml and 20 mg/ml strengths as they contain the same concentration of active substance and have a similar composition to the reference product Metacam.
Maltese: Għal użu taħt il-ġilda u intramuskolari ma kien hemm bżonn ta' ebda studju għall-qawwiet ta' 5 mg/ml u 20 mg/ml peress li fihom l-istess konċentrazzjoni ta' sustanza attiva u għandhom kompożizzjoni simili għall-prodott ta' referenza Metacam.
English: ITT population (N = 1,725)
Maltese: Popolazzjoni ITT (N = 1,725)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1038/001 Pemetrexed medac 100 mg EU/1/15/1038/002 Pemetrexed medac 500 mg EU/1/15/1038/003 Pemetrexed medac 1,000 mg
Maltese: EU/1/15/1038/001 Pemetrexed medac 100 mg EU/1/15/1038/002 Pemetrexed medac 500 mg EU/1/15/1038/003 Pemetrexed medac 1,000 mg
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 27 November 2015
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 27 Novembru 2015
English: − loss of sensation
Maltese: − telf ta' sensazzjoni
English: Efficacy of pemetrexed vs. docetaxel in NSCLC - ITT population Pemetrexed
Maltese: Effikaċja ta' pemetrexed vs docetaxel f'popolazzjoni ITT - NSCLC Pemetrexed
English: Frequency Event**
Maltese: Frekwenza Avveniment**
English: Dose for cisplatin (mg/m²)
Maltese: Doża ta' cisplatin (mg/m²)
English: Adenocarcinoma (N = 847)
Maltese: Adenokarċinoma (N = 847)
English: • 95 % CI for HR
Maltese: • 95 % CI għal HR
English: Alkaline phosphatase (AP), aspartate aminotransferase (AST or SGOT) and alanine aminotransferase (ALT or SGPT) should be ≤ 3 times upper limit of normal.
Maltese: L-alkaline phosphatase (AP), l-aspartate aminotransferase (AST jew SGOT) u l-alanine aminotransferase (ALT jew SGPT) għandhom ikunu ≤ 3 darbiet il-limitu massimu tan-normal.
English: Dose of pemetrexed (mg/m²)
Maltese: Doża ta' pemetrexed (mg/m²)
English: Female fertility was not investigated.
Maltese: Il-fertilità fin-nisa ma ġietx investigata.
English: PFS data were partially confirmed by an independent review (400/1,725 patients were randomly selected for review).
Maltese: Id-dejta tal-PFS ġiet parzjalment ikkonfermata minn stħarriġ indipendenti (400/1,725 pazjent intgħażlu b'mod każwali għall-istħarriġ).
English: Pemetrexed total systemic clearance is 91.8 ml/min and the elimination half-life from plasma is 3.5 hours in patients with normal renal function (creatinine clearance of 90 ml/min).
Maltese: L-eliminazzjoni sistemika totali ta' Pemetrexed hija ta' 91.8 ml/min u l-half-life tal-eliminazzjoni mill-plażma hija ta' 3.5 sigħat f'pazjenti b'funzjoni talkliewi normali (eliminazzjoni tal-krejatinina ta' 90 ml/min).
English: In vitro studies indicate that pemetrexed is approximately 81 % bound to plasma proteins.
Maltese: Studji in vitro jindikaw li madwar 81 % ta' pemetrexed jintrabat mal-proteini talplażma.
English: Myelosuppression is usually the dose-limiting toxicity.
Maltese: Il-majelosoppressjoni normalment hija t-tossiċità li tillimita d-doża.
English: Brněnská 32/čp.
Maltese: Brněnská 32/čp. 597 Blansko
English: In vitro studies indicate that pemetrexed is actively secreted by OAT3 (organic anion transporter).
Maltese: Studji in vitro juru li b'mod attiv OAT3 (organic anion transporter) inixxi pemetrexed.
English: Results from in vitro studies with human liver microsomes indicated that pemetrexed would not be predicted to cause clinically significant inhibition of the metabolic clearance of drugs metabolised by CYP3A, CYP2D6, CYP2C9, and CYP1A2.
Maltese: Studji in vitro b'mikrożomi tal-fwied umani juru li mhux previst li pemetrexed jikkawża l-inibizzjoni klinikament sinifikanti tal-eliminazzjoni metabolika ta' mediċini li jkunu metabolizzati b'CYP3A, CYP2D6, CYP2C9, u CYP1A2.
English: Sensitivity analyses of main efficacy endpoints were also assessed on the Protocol Qualified (PQ) population.
Maltese: Ġew evalwati wkoll l-analiżi ta' sensittività ta' punti ta' tmiem ta' effikaċja primarja fil-popolazzjoni Kwalifikata b'Protokoll (PQ).
English: Pemetrexed N = 265
Maltese: N = 265
English: The percentage of patients that received post study treatment was 64.3 % for pemetrexed and 71.7 % for placebo.
Maltese: Il-persentaġġ ta' pazjenti li rċevew kura wara l-istudju kien ta' 64.3 % għal pemetrexed u 71.7 % għal plaċebo.
English: Patients also required lower administration of erythropoietin/darbopoietin (10.4 % versus 18.1 %, p < 0.001), G-CSF/GM-CSF (3.1 % versus 6.1 %, p = 0.004), and iron preparations (4.3 % versus 7.0 %, p = 0.021).
Maltese: Il-pazjenti kellhom bżonn ukoll ta' inqas għotjiet ta' erythropoietin/darbopoietin (10.4 % kontra 18.1 %, p < 0.001), G-CSF/GM-CSF (3.1 % kontra 6.1 %, p = 0.004), u preparazzjonijiet ta' ħadid (4.3 % kontra 7.0 %, p = 0.021).
English: − infection including sepsis
Maltese: − infezzjoni li tinkludi s-sepsis
English: 50 % of previous dose a National Cancer Institute Common Toxicity Criteria (CTC v2.0; NCI 1998)
Maltese: 50 % tad-doża ta' qabel a Kriterji ta' Tossiċità Komuni tal-Istitut Nazzjonali tal-Kanċer (CTC; v2.0; NCI 1998)
English: The corticosteroid should be equivalent to 4 mg of dexamethasone administered orally twice a day (see section 4.4).
Maltese: Il-kortikosterojde għandu jkun ekwivalenti għal 4 mg ta' dexamethasone meħud b'mod orali darbtejn kuljum (ara sezzjoni 4.4).
English: A total of 213 patients (48.3 %) completed ≥ 6 cycles and a total of 103 patients (23.4 %) completed ≥ 10 cycles of treatment with pemetrexed.
Maltese: Kien hemm total ta' 213-il pazjent (48.3 %) li temmew ≥ 6 ċikli u total ta' 103 pazjenti (23.4 %) li temmew ≥ 10 ċikli ta' kura b'pemetrexed.
English: In vitro studies have shown that pemetrexed behaves as a multitargeted antifolate by inhibiting thymidylate synthase (TS), dihydrofolate reductase (DHFR), and glycinamide ribonucleotide formyltransferase (GARFT), which are key folate-dependent enzymes for the de novo biosynthesis of thymidine and purine nucleotides.
Maltese: Studji in vitro wrew li pemetrexed jaġġixxi bħala antifolat b'iżjed minn objettiv wieħed billi jinibixxi thymidylate synthase (TS), dihydrofolate reductase (DHFR), u glycinamide ribonucleotide formyltransferase (GARFT), li huma enzimi dipendenti fuq il-folat u huma kruċjali għall-bijosintesi de novo tan-nukleotidi thymidine u purine.
English: − low haemoglobin level (anaemia)
Maltese: − livell baxx ta' emoglobina (anemija)
English: Pemetrexed medac.
Maltese: tieħu Pemetrexed medac.
English: Pemetrexed can suppress bone marrow function as manifested by neutropenia, thrombocytopenia and anaemia (or pancytopenia) (see section 4.8).
Maltese: Pemetrexed jista' jrażżan il-funzjoni tal-mudullun kif manifestat min-newtropenja, mittromboċitopenja u mill-anemija (jew panċitopenja) (ara sezzjoni 4.8).
English: 67801 Blansko Czech Republic Tel.: +420 516 427 311 Fax: +420 516 417 350
Maltese: +420 516 427 311 Fax:
English: Progression free survival (PFS) and overall response rate were similar between treatment arms: median PFS was 4.8 months for pemetrexed plus cisplatin versus 5.1 months for gemcitabine plus cisplatin (adjusted hazard ratio 1.04; 95 % CI = 0.94 - 1.15), and overall response rate was 30.6 % (95 % CI = 27.3 - 33.9) for pemetrexed plus cisplatin versus 28.2 % (95 % CI = 25.0 - 31.4) for gemcitabine plus cisplatin.
Maltese: Is-sopravivenza mingħajr progressjoni (PFS) u r-rata ta' rispons totali kienu simili fiż-żewġ fergħat ta' kura: il-medjan ta' PFS kien ta' 4.8 xhur għal pemetrexed flimkien ma' cisplatin kontra 5.1 xhur għal gemcitabine flimkien ma' cisplatin (proporzjon aġġustat ta' riskju 1.04; 95 % CI = 0.94 - 1.15), u rrata ta' rispons totali kienet 30.6 % (95 % CI = 27.3 - 33.9) għal pemetrexed flimkien ma' cisplatin kontra 28.2 % (95 % CI = 25.0
English: A multicentre, 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 (adjusted hazard ratio 0.94; 95 % CI = 0.84 - 1.05).
Maltese: Studju ta' Fażi 3, open-label, randomizzat, magħmul f'ħafna ċentri b'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 Tiġi Kkurata (ITT) n = 862) laħaq il-punt ta' tmiem primarju u wera effikaċja klinika simili għal gemcitabine flimkien ma' cisplatin (ITT n = 863) fis-sopravivenza totali (proporzjon aġġustat ta' riskju 0.94; 95 % CI = 0.84 - 1.05).
English: − if you have recently received or are about to receive a vaccine against yellow fever.
Maltese: − jekk ħadt dan l-aħħar jew dalwaqt ser tieħu tilqima kontra l-yellow fever.
English: Frequency estimate: Very common (≥ 1/10), Common (≥ 1/100 to < 1/10), Uncommon (≥ 1/1,000 to
Maltese: Stima tal-frekwenza: komuni ħafna (≥ 1/10), komuni (> 1/100 sa < 1/10), mhux komuni (≥ 1/1,000 sa < 1/100), rari (≥ 1/10,000 sa < 1/1,000), rari ħafna (< 1/10,000) u mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Pemetrexed has a steady-state volume of distribution of 9 l/m².
Maltese: Pemetrexed għandu volum tad-distribuzzjoni fiss ta' 9 l/ m².
English: No relationships between AST (SGOT), ALT (SGPT), or total bilirubin and pemetrexed pharmacokinetics were identified.
Maltese: Ma ġiet identifikata l-ebda relazzjoni bejn l-AST (SGOT), l-ALT (SGPT), jew it-total ta' bilirubina u l-farmakokinetika ta' pemetrexed.
English: Log Rank p-value* Overall response rate** (95 % CI)
Maltese: Log Rank valur-p* Ir-rata ta' rispons globali**
English: − diarrhoea
Maltese: − deidrazzjoni.
English: Patients treated with pemetrexed and cisplatin required fewer transfusions (16.4 % versus 28.9 %, p < 0.001), red blood cell transfusions (16.1 % versus 27.3 %, p < 0.001) and platelet transfusions (1.8 % versus 4.5 %, p = 0.002).
Maltese: Pazjenti kkurati b'pemetrexed u cisplatin kellhom bżonn ta' inqas trasfużjonijiet (16.4 % kontra 28.9 %, p < 0.001), trasfużjonijiet ta' ċelluli ħomor tad-demm (16.1 % kontra 27.3 %, p < 0.001) u trasfużjonijiet ta' plejtlits (1.8 % kontra 4.5 %, p = 0.002).
English: − anaphylactic shock (severe allergic reaction)
Maltese: − xokk anafilattiku (reazzjoni allerġika severa)
English: Squamous cell (N = 473)
Maltese: Ċellula tat-tip skwamuż (N = 473)
English: For instructions on reconstitution and dilution of Pemetrexed medac before administration, see section 6.6.
Maltese: Għal istruzzjonijiet fuq rikostituzzjoni u dilwizzjoni ta' Pemetrexed medac qabel l-amministrazzjoni, ara sezzjoni 6.6.
English: Median overall survival (months) (95 % CI)
Maltese: • Perċentwal ta' rispons (%) (95 % CI)
English: 75 % of previous dose (both pemetrexed and cisplatin)
Maltese: 75 % tad-doża ta' qabel (kemm pemetrexed kif ukoll cisplatin).
English: Rarely seen events include Stevens-Johnson syndrome and Toxic epidermal necrolysis.
Maltese: Avvenimenti li dehru b'mod rari jinkludu s-sindromu ta' Stevens-Johnson u nekroliżi epidermali tossika.
English: Each 500 mg vial contains approximately 54 mg sodium.
Maltese: Kull kunjett ta' 500 mg fih madwar 54 mg ta' sodium.
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 *** According to National Cancer Institute CTC (v2.0; NCI 1998), taste disturbance and alopecia should only be reported as Grade 1 or 2
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: Clinically relevant CTC toxicity that was reported in < 1 % of the patients that were randomly assigned to pemetrexed include: allergic reaction/hypersensitivity, erythema multiforme, supraventricular arrhythmia and pulmonary embolism.
Maltese: Tossiċità CTC klinikament rilevanti li ġiet irrapportata f'< 1 % tal-pazjenti li ntgħażlu b'mod każwali biex jirċievu pemetrexed tinkludi: reazzjoni allerġika/sensittività eċċessiva, eritema multiforme, arritmja supraventrikulari u emboliżmu pulmunarju.
English: Czech Republic medac Gesellschaft für klinische Spezialpräparate mbH Theaterstr.
Maltese: Ir-Repubblika Ċeka medac Gesellschaft für klinische Spezialpräparate mbH Theaterstr.
English: The other ingredients are mannitol, hydrochloric acid and sodium hydroxide, please see section 2 “Pemetrexed medac contains sodium”.
Maltese: Is-sustanzi l-oħrajn huma mannitol, hydrochloric acid u sodium hydroxide; jekk jogħġbok ara sezzjoni 2 “Pemetrexed medac fih sodium”.
English: A statistically significant improvement of the clinically relevant symptoms (pain and dyspnoea) associated with malignant pleural mesothelioma in the pemetrexed/cisplatin arm (212 patients) versus the cisplatin arm alone (218 patients) was demonstrated using the Lung Cancer Symptom Scale.
Maltese: Titjib statistikament sinifikanti fis-sintomi klinikament rilevanti (uġigħ u qtugħ ta' nifs) assoċjati ma' mesoteljoma plewrali malinna ntwera fil-fergħa ta' pemetrexed/cisplatin (212-il pazjent) meta kkomparat mal-fergħa ta' cisplatin waħdu (218-il pazjent) meta ntużat l-Iskala tas-Sintomi tal-Kanċer tal-Pulmun.
English: Grade 34 toxicity
Maltese: Grad ta' tossiċità 3
English: Pemetrexed*** (N = 800)
Maltese: Frekwenza* Avveniment** Pemetrexed*** (N = 800)
English: No statistically significant differences in any other individual Grade 3/4/5 adverse reactions were seen with longer exposure.
Maltese: Ma dehret ebda differenza statistikament sinifikanti fir-reazzjonijiet individwali avversi oħra ta' Grad 3/4/5 b'espożizzjonijiet itwal.
English: You will also receive an injection of Vitamin B12 (1,000 µg) in the week before administration of Pemetrexed medac and then approximately every 9 weeks (corresponding to 3 courses of Pemetrexed medac treatment).
Maltese: B12 (1,000 µg) fil-ġimgħa ta' qabel li tingħata Pemetrexed medac u mbagħad madwar kull 9 ġimgħat (li jikkorrispondu għal 3 korsijiet ta' kura b'pemetrexed medac).
English: 100 % of previous dose a National Cancer Institute Common Toxicity Criteria (CTC v2.0; NCI 1998) b Excluding neurotoxicity
Maltese: 100 % tad-doża ta' qabel a Kriterji ta' Tossiċità Komuni tal-Istitut Nazzjonali tal-Kanċer (CTC; v2.0; NCI 1998) b Minbarra n-newrotossiċità
English: Pemetrexed medac 500 mg powder for concentrate for solution for infusion This medicinal product contains 54 mg sodium per 500 mg vial, equivalent to 2.70% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Maltese: Pemetrexed medac 500 mg trab għal konċentrat għal soluzzjoni għall-infużjoni Dan il-prodott mediċinali fih 54 mg sodium f'kull kunjett ta' 500 mg, ekwivalenti għal 2.70% talammont massimu rakkomandat mill-WHO ta' 2 g sodium li għandu jittieħed kuljum minn adult.
English: Clinically relevant toxicities with respect to gender were similar to the overall population in patients receiving pemetrexed plus cisplatin.
Maltese: Tossiċitajiet klinikament rilevanti skont is-sess kienu simili għall-popolazzjoni totali f'pazjenti li rċevew pemetrexed flimkien ma' cisplatin.
English: Log Rank p-value* Median time to tumour progression (months) (95 % CI)
Maltese: Log Rank valur-p* Żmien medjan fil-progress tat-tumur (xhur)
English: Hydrochloric acid (for pH adjustment) Sodium hydroxide (for pH adjustment)
Maltese: Hydrochloric acid (għall-aġġustament tal-pH)