FrancophonIA/ELRC3.0 huggingface dataset:
English: As for all medicines, data on the use of Shingrix is continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Shingrix hija ssorveljata kontinwament.
English: Shingrix is a vaccine used to protect adults aged 50 years and over against shingles (herpes zoster) and post-herpetic neuralgia (long-lasting nerve pain following shingles).
Maltese: Shingrix huwa vaċċin li jintuża biex jipproteġi adulti li jkollhom 50 sena u aktar kontra l-ħruq ta' Sant'Antnin (herpes zoster) u nevralġija ta' wara l-erpete (uġigħ fin-nervituri li jdum wara l-ħruq ta' Sant'Antnin).
English: What are the risks associated with Shingrix?
Maltese: X'inhuma r-riskji assoċjati ma' Shingrix?
English: For the full list of side effects and restrictions with Shingrix, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u restrizzjonijiet b'Shingrix, ara l-fuljett ta' tagħrif.
English: Shingrix has been designed to prevent shingles in people who have been in contact with the varicella zoster virus (the virus that causes chickenpox) and have already developed antibodies against the virus.
Maltese: Shingrix tfassal biex jipprevjeni l-ħruq ta' Sant'Antnin f'nies li ġew f'kuntatt mal-virus variċella zoster (il-virus li jikkawża l-ġidri r-riħ) u li diġà jkunu żviluppaw antikorpi kontra l-virus.
English: Shingrix contains small amounts of the surface antigens (proteins from the surface) of the virus to stimulate the body to make antibodies against the virus.
Maltese: Shingrix fih ammonti żgħar ta' antiġeni tal-wiċċ (proteini mill-wiċċ) tal-virus biex jistimulaw il-ġisem jagħmel antikorpi kontra l-virus.
English: After 4 years, 4 adults had had post-herpetic neuralgia in the Shingrix group compared with 36 in the placebo group.
Maltese: Wara 4 snin, 4 adulti kellhom nevralġija ta' wara l-erpete filgrupp ta' Shingrix meta mqabbel ma' 36 fil-grupp tal-plaċebo.
English: This indicates that Shingrix prevented 97% of shingles cases and 100% of cases of post-herpetic neuralgia in this study.
Maltese: Dan jindika li Shingrix ipprevjena 97 % tal-każijiet ta' ħruq ta' Sant'Antnin u 100 % tal-każijiet ta' nevralġija ta' wara l-erpete f'dan l-istudju.
English: The second study involved adults aged 70 and over who received either Shingrix or placebo.
Maltese: It-tieni studju involva adulti li kellhom 70 sena u aktar li rċievew jew Shingrix jew il-plaċebo.
English: Shingrix has been shown to be highly effective at preventing shingles and post-herpetic neuralgia across all age groups older than 50 years for at least 4 years after vaccination.
Maltese: Shingrix intwera li huwa effettiv ħafna biex jipprevjeni l-ħruq ta' Sant'Antnin u nevralġija ta' wara lerpete fil-gruppi kollha tal-età ikbar minn 50 sena għal tal-inqas 4 snin wara t-tilqim.
English: How does Shingrix work?
Maltese: X'inhu Shingrix u għal xiex jintuża?
English: The vaccination course consists of 2 injections given 2 months apart.
Maltese: Il-kors tat-tilqim jikkonsisti minn 2 injezzjonijiet li jingħataw xahrejn minn xulxin.
English: Side effects reported with Shingrix are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati b'Shingrix huma evalwati bir-reqqa u tittieħed kull azzjoni meħtieġa biex tipproteġi lill-pazjenti.
English: Overall, the vaccine effectiveness was similar across ages.
Maltese: B'mod globali, l-effikaċja tal-vaċċin kienet simili fost l-etajiet.
English: Shingrix has been shown to be effective at preventing shingles and post-herpetic neuralgia.
Maltese: Għaliex Shingrix ġie awtorizzat fl-UE?
English: After just over 3 years on average, 6 adults had had shingles in the Shingrix group compared with 210 in the placebo group.
Maltese: Bħala medja, wara ftit aktar minn 3 snin, 6 adulti kellhom il-ħruq ta' Sant'Antnin fil-grupp ta' Shingrix meta mqabbel ma' 210 fil-grupp tal-plaċebo.
English: What measures are being taken to ensure the safe and effective use of Shingrix?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Shingrix?
English: This overview was last updated in 03-2018.
Maltese: Facsimile +44 (0)20
English: Further information on Incruse Ellipta can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The most common side effects with Incruse Ellipta (which may affect up to 1 in 10 people) are headache, nasopharyngitis (inflammation of the nose and throat), upper respiratory tract infection (nose and throat infection), sinusitis (inflammation of the sinuses), cough, urinary tract infection (infection of the structures that carry urine), and tachycardia (increased heart rate).
Maltese: L-effetti sekondarji l-aktar komuni b'Incruse Ellipta (li jistgħu jaffettwaw sa persuna 1 minn kull 10) huma uġigħ ta' ras, nażofarinġite (infjammazzjoni tal-imnieħer u tal-griżmejn), infezzjoni fl-apparat respiratorju ta' fuq (infezzjoni tal-imnieħer u tal-griżmejn), sinusite (infjammazzjoni tas-sinusis), sogħla, infezzjoni fl-apparat tal-awrina (infezzjoni tal-istrutturi li jġorru l-awrina) u takkikardija (żieda fir-rata tal-qalb).
English: Incruse Ellipta contains the active substance umeclidinium bromide.
Maltese: Incruse Ellipta fih is-sustanza attiva umeclidinium bromide.
English: The active substance in Incruse Ellipta, umeclidinium bromide, is a muscarinic receptor antagonist.
Maltese: Is-sustanza attiva f'Incruse Ellipta, l-umeclidinium bromide, hija antagonista tar-riċettur muskariniku.
English: Other information about Incruse Ellipta
Maltese: Informazzjoni oħra dwar Incruse Ellipta
English: Incruse Ellipta is a medicine used to relieve the symptoms of chronic obstructive pulmonary disease (COPD) in adults.
Maltese: Incruse Ellipta huwa mediċina użata biex ittaffi s-sintomi tal-mard pulmonari ostruttiv kroniku (COPD) fl-adulti.
English: Incruse Ellipta received a marketing authorisation valid throughout the EU on 28 April 2014.
Maltese: Incruse Ellipta rċieva awtorizzazzjoni għat-tqegħid fis-suq valida fl-EU kollha fit-28 ta' April 2014.
English: Results showed that Incruse Ellipta improved lung function by an average FEV1 of 127 ml more than placebo after 12 weeks of treatment and by 115 ml more than placebo after 24 weeks of treatment.
Maltese: Ir-riżultati wrew li Incruse Ellipta tejjeb il-funzjoni tal-pulmun b'FEV1 medju ta' 127 ml aktar minn plaċebo wara 12-il ġimgħa ta' kura u b'115-il ml aktar minn plaċebo wara 24 ġimgħa ta' kura.
English: Incruse Ellipta was investigated in four main studies involving over 4,000 patients.
Maltese: Incruse Ellipta ġie investigat f'erba' studji ewlenin li involvew aktar minn 4,000 pazjent.
English: 1 Previously known as Incruse.
Maltese: 1 Preċedentement magħruf bħala Incruse.
English: How is Incruse Ellipta used?
Maltese: Kif jaħdem Incruse Ellipta?
English: Incruse Ellipta is used for maintenance (regular) treatment.
Maltese: Incruse Ellipta jintuża għal kura ta' manutenzjoni (regolari).
English: For the full list of side effects and restrictions with Incruse Ellipta, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u restrizzjonijiet b'Incruse Ellipta, ara l-fuljett ta' tagħrif.
English: Three studies compared Incruse Ellipta with placebo (a dummy treatment), while one study compared Incruse Ellipta with tiotropium (another medicine for COPD).
Maltese: Tliet studji qabblu Incruse Ellipta ma' plaċebo (kura finta), filwaqt li studju wieħed qabbel Incruse Ellipta ma' tiotropium (mediċina oħra għas-COPD).
English: What are the risks associated with Incruse Ellipta?
Maltese: X'inhuma r-riskji assoċjati ma' Incruse Ellipta?
English: As for all medicines, data on the use of Incruse Ellipta are continuously monitored.
Maltese: Bħal għall-mediċini kollha, id-data dwar l-użu ta' Incruse Ellipta hija ssorveljata kontinwament.
English: It is available as an inhalation powder in a portable inhaler device.
Maltese: Dan jiġi bħala trab għall-inalazzjoni f'inalatur portabbli.
English: In the study comparing Incruse Ellipta with tiotropium, FEV1 improvements over 24 weeks were similar for both medicines.
Maltese: Fl-istudju li qabbel Incruse Ellipta ma' tiotropium, it-titjib fil-FEV1 fuq 24 ġimgħa kien simili għaż-żewġ mediċini.
English: • Educate patients about the potential food-drug interaction (i.e. chelation with polyvalent cations such as iron, calcium, magnesium, aluminium, selenium and zinc).
Maltese: • Eduka l-pazjenti dwar il-fatt li jista' jkun hemm interazzjonijiet mal-ikel (i.e. kelazzjoni ma' katjoni polivalenti bħal iron, calcium, magnesium, aluminium, selenium u zinc).
English: • A dose reduction is recommended for ITP patients with platelet counts between 150,000250,000/μl.
Maltese: • Tnaqqis fid-doża huwa rrakkomandat għall-pazjenti b'għadd tal-plejtlits bejn 150,000-250,000/μl.
English: Antacids, dairy products and other products containing polyvalent cations, such as mineral supplements, must be administered at least four hours apart from Revolade dosing to avoid significant reduction in Revolade absorption due to chelation.
Maltese: Antaċidi, prodotti tal-ħalib u prodotti oħra li fihom katjoni polivalenti bħal supplimenti ta' minerali, għandhom jingħataw millanqas erba' sigħat bogħod minn ghoti ta' doża ta' Revolade biex jiġi evitat tnaqqis sinifikanti flassorbiment ta' Revolase minħabba kelazzjoni.
English: Haematological malignancies
Maltese: Mard ematoloġiku malinn
English: Reoccurrence of Thrombocytopenia
Maltese: Tossiċità fil-fwied
English: • Educate patients about the potential for thromboembolic events (TEE) in patients with chronic ITP and those known risk factors for thromboembolic events (e.g., Factor V Leiden, ATIII deficiency, antiphospholipid syndrome).
Maltese: • Eduka l-pazjenti dwar il-fatt li jista' jkun hemm każijiet tromboemboliċi f'pazjenti b'ITP kronika u dawk il-fatturi ta' riskju magħrufa li jwasslu għal każijiet tromboemboliċi (eż. Fattur V Leiden, defiċjenza ATIII, sindrome antifosfolipidu).
English: • Educate patients about chronic liver disease and the risk of thromboembolic events.
Maltese: • Eduka l-pazjenti dwar il-mard kroniku tal-fwied u r-riskju ta' każijiet tromboemboliċi.
English: • Discontinue Revolade if ALT levels increase (≥ 3X the upper limit of normal [ULN]) and are: - progressive, or - persistent for > 4 weeks, or - accompanied by increased direct bilirubin, or - accompanied by clinical symptoms of liver injury or evidence for hepatic decompensation.
Maltese: • Waqqaf Revolade jekk il-livelli tal-ALT jiżdiedu (≥ 3X aktar mill-ogħla livell tan-normal [ULN]) u jkunu: - progressivi, jew - persistenti għal > 4 ġimgħat, jew - msieħba ma' żieda fil-bilirubin dirett, jew - msieħba ma' sintomi kliniċi ta' ħsara fil-fwied jew evidenza ta' dikumpensazzjoni fil-fwied.
English: The MAH shall agree the details of an educational programme with the National Competent Authorities and must implement such programme nationally to ensure that, prior to prescribing, all physicians are provided with a healthcare professional information pack containing the following:
Maltese: Id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq għandu jiftiehem id-dettalji ta' programm ta' edukazzjoni mal-Awtoritajiet Nazzjonali Kompetenti u għandu jimplimenta tali programm b'mod nazzjonali biex jaċċerta ruħu li, qabel ma jiġi preskritt, it-tobba kollha jingħatalhom pakkett ta' informazzjoni għall-professjonisti fil-qasam mediku li jkun fih dan li ġej:
English: • Revolade should be interrupted if platelet counts increase to > 250,000/μl.
Maltese: • Revolade għandu jitwaqqaf għal ftit żmien jekk l-għadd tal-plejtlits jiżdied għal > 250,000/μl.
English: Increased Bone Marrow Reticulin Fibres
Maltese: Żieda fil-Fibri tar-Retikulin fil-Mudullun tal-Għadam
English: • Importance of not using Revolade outside the context of its license unless in a clinical trial setting.
Maltese: • L-importanza li ma tużax Revolade barra mill-kuntest tal-liċenzja tiegħu sakemm mhux fi sfond ta' prova klinika.
English: Once the platelet count is < 100,000/μl, reinitiate therapy at a reduced daily dose.
Maltese: Ladarba l-għadd tal-plejtlits jkun ta' < 100,000/μl, erġa' ibda t-terapija b'doża ta' kuljum mnaqqsa.
English: If use of eltrombopag is deemed necessary, the starting dose must be 25mg once daily.
Maltese: Jekk l-użu ta' eltrombopag jkun maħsub li huwa meħtieġ, id-doża tal-bidu għandha tkun ta' 25 mg darba kuljum.
English: • Following identification of a stable dose of Revolade, perform complete blood count (CBC) with white blood cell count (WBC) differential monthly.
Maltese: • Wara li tiġi identifikata doża stabbli ta' Revolade, kull xahar agħmel għadd komplut tad-demm (CBC) flimkien mal-grad ta' differenza fl-għadd ta' ċelluli bojod tad-demm (WBC).
English: • Summary of Product Characteristics (SmPC) and Package Leaflet and Labelling
Maltese: • Sommarju tal-Karatteristiċi tal-Prodott (SPC) u Fuljett ta' Tagħrif u Tikketta
English: • Educate patients about the theoretical risk of haematological malignancies with thrombopoietin receptor agonists.
Maltese: • Eduka l-pazjenti dwar ir-riskju teoretiku ta' mard ematoloġiku malinn b'agonisti tar-riċetturi ta' trombopoetin.
English: • If immature or dysplastic cells are observed, examine peripheral blood smears for new or worsening morphological abnormalities (e.g., teardrop and nucleated red blood cells, immature white blood cells) or cytopenia(s).
Maltese: • Jekk jiġu osservati ċelluli immaturi jew displastiċi, is-smears tad-demm periferali għandhom jiġu eżaminati għal morfoloġiji mhux normali ġodda jew li marru għal agħar (eż., ċelluli ħomor tad-demm li għandhom forma ta' demgħa u nukleju, ċelluli bojod tad-demm immaturi) jew ċitopenija(i).
English: • Eltrombopag should not be used in patients with hepatic impairment (Child Pugh score ≥ 5) unless the expected benefit outweighs the identified risk of portal venous thrombosis.
Maltese: • Eltrombopag m'għandux jintuża f'pazjenti b'indeboliment minn moderat sa qawwi tal-fwied sakemm il-benefiċċju mistenni ma jkunx akbar mir-riskju identifikat ta' trombożi tal-vina portali.
English: • The diagnosis of ITP in adults and elderly patients should have been confirmed by excluding other clinical entities with thrombocytopenia.
Maltese: • Id-dijanjosi ta' ITP f'pazjenti adulti u anzjani għandha tkun ġiet ikkonfermata permezz talesklużjoni ta' entitajiet kliniċi oħra li jidhru bħala tromboċitopenija.
English: • Educate patients about the potential risk of bleeding after treatment has stopped (include incidence in clinical trials and likelihood of reoccurrence of thrombocytopenia after cessation of treatment).
Maltese: • Eduka l-pazjenti dwar il-fatt li jista' jkun hemm riskju ta' fsada wara li titwaqqaf il-kura (inkludi linċidenza fil-provi kliniċi u kemm hija probabbli li tromboċitopenija sseħħ mill-ġdid wara l-waqfien mill-kura).
English: • If the patient develops new or worsening morphological abnormalities or cytopenia(s), discontinue treatment with Revolade and consider a bone marrow biopsy, including staining for fibrosis.
Maltese: • Jekk il-pazjent jiżviluppa morfoloġiji mhux normali ġodda jew li jmorru għal agħar jew ċitopenija(i), waqqaf il-kura b'Revolade u kkunsidra bijopsija tal-mudullun tal-għadam, li tinkludi staining għal fibrożi.
English: Consideration should be given to performing a bone marrow aspirate and biopsy over the course of the disease and treatment, particularly in patients over 60 years of age, those with systemic symptoms or abnormal signs.
Maltese: Għandu jiġi kkunsidrat li ssir aspirazzjoni u bijopsija mill-mudullun tal-għadam matul il-marda u l-kura, b'mod partikolari f'pazjenti li għandhom aktar minn 60 sena, dawk b'sintomi sistemiċi jew b'sinjali mhux normali.
English: • Background information on reticulin in the bone marrow (i.e. background rates of reticulin in bone marrow in ITP patients and the observed incidence and potential mechanism of action of reticulin deposition in response to Revolade).
Maltese: • Informazzjoni ġenerali dwar ir-retikulin fil-mudullun tal-għadam (i.e. rati ġenerali ta' retiklulin filmudullun tal-għadam ta' pazjenti b'ITP u l-frekwenza osservata u l-mekkaniżmu ta' azzjoni li jista' jkun li bih isir id-depożitu ta' retikulin b'rispons għal Revolade).
English: • Prior to initiation of Revolade, examine the peripheral blood smear closely to establish a baseline level of cellular morphologic abnormalities.
Maltese: • Għoti lill-pazjenti b'indeboliment minn moderat sa qawwi tal-fwied għandu jiġi aċċettat li jsir b'kawtela u sorveljanza mill-qrib minħabba żieda fl-esponiment għall-prodott mediċinali.
English: • Educate patients about the potential for bone marrow reticulin fibre formation.
Maltese: • Eduka l-pazjenti dwar il-fatt li jista' jkun hemm formazzjoni ta' fibri tar-retikulin fil-mudullun talgħadam.
English: • Educate patients on the appropriate administration of Revolade (e.g. titration of Revolade, fooddrug interaction, dose recommendations for special populations [e.g. east Asians]).
Maltese: • Eduka l-pazjenti dwar l-għoti ta' Revolade kif xieraq (eż. titrazzjoni ta' Revolade, interazzjoni bejn l-ikel u l-mediċina, rakkomandazzjonijiet tad-doża għal popolazzjonijiet speċjali [eż. Ażjatiċi talLvant]).
English: • Educate patients about the potential for hepatic enzyme elevations, importance of monthly laboratory monitoring of ALT and AST, as well as the signs and symptoms associated with liver injury (e.g. jaundice).
Maltese: • Eduka l-pazjenti dwar il-fatt li jistgħu jogħlew il-livelli tal-enzimi tal-fwied, l-importanza ta' sorveljanza fil-laboratorju tal-ALT u l-AST kull xahar, kif ukoll sinjali u sintomi assoċjati ma' ħsara fil-fwied (eż. suffejra).
English: • Measure serum ALT, AST and bilirubin prior to initiation of Revolade, every 2 weeks during the dose adjustment phase and monthly following establishment of a stable dose.
Maltese: • Kejjel il-livelli tal-ALT, tal-AST u tal-bilirubin fis-serum qabel ma tinbeda kura b'Revolade, kull ġimagħtejn waqt il-fażi ta' aġġustament fid-doża u kull xahar wara li tiġi stabbilita doża stabbli.
English: CZ Pfizer, spol.
Maltese: Pfizer, spol.
English: Hospira UK Limited
Maltese: Manifattur Hospira UK Limited Horizon
English: HU Pfizer Kft.
Maltese: Pfizer Kft.
English: Alkaline phosphatase (ALP), aspartate aminotransferase (AST or SGOT), and alanine aminotransferase (ALT or SGPT) should be ≤ 3-times upper limit of normal.
Maltese: Alkaline phosphatase (ALP), aspartate aminotransferase (AST jew SGOT) u alanine aminotransferase (ALT jew SGPT) għandhom ikunu ≤ 3 darbiet il-massimu tan-normal.
English: Stomatitis/Pharyngitis 23.2 Nausea
Maltese: Stomatite/Farinġite 23.2 Dardir
English: Dose of Pemetrexed Hospira (mg/m2)
Maltese: Doża ta' Pemetrexed Hospira (mg/m
English: Dose for cisplatin (mg/m2)
Maltese: Doża għal cisplatin (mg/m
English: The total bilirubin should be ≤ 1.5-times upper limit of normal.
Maltese: It-total ta' bilirubina għandu jkun ta' ≤ 1.5 il-limitu massimu tan-normal.
English: Patients with renal impairment (Standard Cockcroft and Gault formula or glomerular filtration rate measured Tc99m DPTA serum clearance method)
Maltese: Pazjenti b'indeboliment tal-kliewi: (Formula Standard ta' Cockcroft & Gault jew Metodu tat-tneħħija mis-serum ta' Tc99m-DPTA biex tiġi kkalkulata r-rata ta' filtrazzjoni glomerulari):
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' anqas għotjiet ta' eritropoijetin/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: A significant increase in the incidence of possibly study-drug-related Grade 3/4 neutropenia was observed with longer exposure to pemetrexed (≤6 cycles: 3.3%, >6 cycles: 6.4%: p=0.046).
Maltese: Ġiet osservata, wisq probabbli kkawżata mill-mediċina taħt studju, żieda fl-inċidenza ta' newtropenja ta' Grad 3/4 b'espożizzjoni itwal għal pemetrexed (≤6 ċikli: 3.3%, > 6 ċikli: 6.4%: p=0.046).
English: Excipients: mannitol, hydrochloric acid concentrated, sodium hydroxide (see package leaflet for further information)
Maltese: Eċċipjenti: mannitol, hydrochloric acid concentrated, sodium hydroxide (għal aktar informazzjoni ara l-fuljett ta' tagħrif).
English: Efficacy of pemetrexed vs. docetaxel in NSCLC - ITT population Pemetrexed
Maltese: Effikaċja ta' pemetrexed vs docataxel f'popolazzjoni ta' NSCLC - ITT
English: Pemetrexed Hospira.
Maltese: X'fih Pemetrexed Hospira
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: Riżultati ta' studji in vitro b'mikrożomi tal-fwied umani juru li mhux previst li pemetrexed jikkawża l-inibizzjoni klinikament sinifikanti tat-tneħħija metabolika ta' mediċini li jkunu metabolizzati b'CYP3A, CYP2D6, CYP2C9, u CYP1A2.
English: Refer to section 2 “Pemetrexed Hospira contains sodium”.
Maltese: Irreferi għas-sezzjoni 2, “Pemetrexed Hospira fih is-sodju”.
English: Vitamin supplementation: your doctor will prescribe you oral folic acid (vitamin) or a multivitamin containing folic acid (350 to 1,000 micrograms) that you must take once a day while you are taking Pemetrexed Hospira.
Maltese: Supplimentazzjoni b'vitamini: it-tabib tiegħek ser jordnalek folic acid (vitamina) orali jew xi prodott multivitaminiku li fih folic acid (350 sa 1000 mikrogramma) li trid tieħu darba kuljum waqt it-trattament b'Pemetrexed Hospira.
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 (HR) 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: 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 r-rata ta' rispons totali kien 30.6% (95% CI = 27.3- 33.9) għal pemetrexed flimkien ma' cisplatin kontra 28.2% (95% CI = 25.
English: Pemetrexed Hospira 100 mg contains less than 1 mmol (23 mg) of sodium i.e. essentially ‘sodium free'.
Maltese: Pemetrexed Hospira 100 mg fih inqas minn 1 mmol (23 mg) ta' sodium i.e. huwa essenzjalment ‘ħieles mis-sodju'.
English: The other ingredients are mannitol (E421), hydrochloric acid (for pH adjustment) and sodium hydroxide (for pH adjustment).
Maltese: Is-sustanzi l-oħra huma mannitol (E421), hydrochloric acid (għal aġġustament ta' pH) u sodium hydroxide (għal aġġustament ta' pH).
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 bi pemetrexed u cisplatin kellhom bżonn ta' anqas 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: For precautions to be taken before handling or administering Pemetrexed Hospira, see section 6.6.
Maltese: Għal istruzzjonijiet fuq rikostituzzjoni u dilwazzjoni ta' Pemetrexed Hospira qabel l-amministrazzjoni, ara sezzjoni 6.6.