FrancophonIA/ELRC3.0 huggingface dataset:
English: Reference to the vial collar as visual reminder of this difference and the instruction that it must
Maltese: Referenza għall-anell imwaħħal mal-kunjett biex wieħed jiftakar b'din id-differenza u l-istruzzjoni li dan m'għandu qatt jitneħħa minn postu.
English: Annex
Maltese: MEMBRI
English: • Key signs and symptoms of serious adverse reactions
Maltese: • Sinjali u sintomi importanti ta' reazzjonijiet avversi serji
English: The Marketing Authorisation Holder (MAH) shall ensure that, prior to launch, all physicians who are expected to prescribe Siklos are provided with a physician information pack containing the following:
Maltese: Id-Detentur ta' L-Awtorizzazzjoni għat-tqegħid fis-Suq ser jiżgura li qabel it-tqegħid fis-suq, it-tobba kollha li huma mistennija jippreskrivu Siklos huma pprovduti b'pakkett ta' informazzjoni għat-tabib li fih dan li ġej:
English: • Management of adverse drug reactions
Maltese: • Immanniġjar ta' reazzjonijiet avversi tal-mediċina
English: • Patient information pack
Maltese: • Pakkett ta' informazzjoni għall-pazjent
English: The treatment guide for physicians should contain the following key elements:
Maltese: Il-pakkett ta' informazzjoni għall-pazjent għandu jkollu dawn l-elementi essenzjali:
English: • Information on crisis or infections
Maltese: • Informazzjoni dwar kriżijiet jew infezzjonijiet
English: • Information on growth follow-up of treated children for their parents
Maltese: • Informazzjoni għall-ġenituri dwar osservazzjoni tat-tkabbir fi tfal ikkurati
English: • Risk of medication error due to the availability of two different strengths The patient information pack should contain the following key elements:
Maltese: Il-gwida dwar il-kura għat-tobba għandu jkollha dawn l-elementi essenzjali:
English: • Package leaflet
Maltese: • Is-Sommarju tal-Karatteristiċi tal-Prodott
English: The MAH must implement this educational plan nationally, prior to marketing, and as agreed with the competent authorities in the Member States
Maltese: Qabel ma joħroġ fis-suq il-prodott mediċinali f'kull Stat Membru, id-Detentur tal-Awtorizzazzjoni ser jiftiehem dwar il-kontenut u l-format tal-materjal edukattiv mal-awtorità nazzjonali kompetenti.
English: The full EPAR for Clopidogrel Teva Pharma can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: EMA website/Find medicine/Human medicines/European Public Assessment Reports.
English: • atrial fibrillation (irregular rapid contractions of the upper chambers of the heart), when it should be given with aspirin.
Maltese: • pazjenti b'fibrillazzjoni atrijali (kontrazzjonijiet irregolari u mgħaġġla tal-kavitajiet ta' fuq tal-qalb), meta għandha tingħata mal-aspirina.
English: • peripheral arterial disease (problems with blood flow in the arteries);
Maltese: • pazjenti b'mard fl-arterji periferali (problemi bil-fluss tad-demm fl-arterji);
English: 1 Previously known as Clopidogrel HCS.
Maltese: Clopidogrel HCS
English: Clopidogrel Teva Pharma is a ‘generic medicine'.
Maltese: Clopidogrel HCS huwa ‘mediċina ġenerika'.
English: The active substance in Clopidogrel Teva Pharma, clopidogrel, is an inhibitor of platelet aggregation.
Maltese: Is-sustanza attiva ta' Clopidogrel HCS, il-klopidogrel, hija inibitur tal-aggregazzjoni tal-pjastrini.
English: What are the benefit and risk of Clopidogrel Teva Pharma?
Maltese: X'inhuma l-benefiċċju u r-riskju ta' Clopidogrel HCS?
English: In acute coronary syndrome and atrial fibrillation, Clopidogrel Teva Pharma is used together with aspirin, the dose of which should not be higher than 100 mg.
Maltese: Fil-każi ta' sindromu koronarju akut u ta' fibrillazzjoni atrijali, Clopidogrel HCS jittieħed flimkien mal-aspirina u f'dal-każi d-doża m'għandhiex taqbeż il-100 mg.
English: This means that Clopidogrel Teva Pharma is similar to a ‘reference medicine' already authorised in the European Union (EU) called Plavix.
Maltese: Dan ifisser li Clopidogrel HCS huwa simili għall-‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) bl-isem Plavix.
English: This is then followed by the standard 75-mg dose once a day for at least four weeks (in ‘ST-segment-elevation' myocardial infarction) or for up to 12 months (in unstable angina or ‘non-Q-wave' myocardial infarction).
Maltese: Imbagħad il-kura titkompla b'doża standard ta' 75-mg darba kuljum tul tal-inqas erba' ġimgħat (fil-każi ta' infart mijokardiku b'elevazzjoni tas-segment ST) jew sa 12-il xahar (fil-każi ta' anġina instabbli jew infart mijokardiku ‘mingħajr ilmewġa Q').
English: This document is a summary of the European Public Assessment Report (EPAR) for Clopidogrel Teva Pharma.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Clopidogrel HCS.
English: Because Clopidogrel Teva Pharma is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Plavix.
Maltese: Billi Clopidogrel HCS huwa mediċina ġenerika, l-istudji fuq in-nies ġew limitati għal testijiet biex jiddeterminaw il-bijoekwivalenza tiegħu mal-mediċina ta' referenza, Plavix.
English: Clopidogrel Teva Pharma clopidogrel
Maltese: klopidogrel
English: The standard dose of Clopidogrel Teva Pharma is one 75-mg tablet once a day.
Maltese: Id-doża rakkomandata ta' Clopidogrel HCS hija pillola waħda ta' 75-mg kuljum.
English: The CHMP concluded that, in accordance with EU requirements, Clopidogrel Teva Pharma has been shown to have comparable quality and to be bioequivalent to Plavix.
Maltese: Is-CHMP kkonkluda li, b'mod konformi mar-rekwiżiti tal-UE, Clopidogrel HCS wera li għandu kwalità komparabbli ma' u huwa bijoekwivalenti għal Plavix.
English: This summary was last updated in 02-2016.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'06-2015.
English: Because Clopidogrel Teva Pharma is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as the reference medicine's.
Maltese: Billi Clopidogrel HCS huwa mediċina ġenerika u bijoekwivalenti għall-mediċina ta' referenza, ilbenefiċċji u r-riskji tiegħu huma meqjusa l-istess bħal dawk tal-mediċina ta' referenza.
English: Clopidogrel Teva Pharma is used to prevent problems caused by blood clots in adults who have:
Maltese: Clopidogrel HCS jintuża fl-adulti biex jipprevjeni problemi kkawżati mill-formazzjoni tal-emboli taddemm.
English: The European Commission granted a marketing authorisation valid throughout the EU for Clopidogrel HCS on 21 September 2009.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Clopidogrel HCS valida fl-Unjoni Ewropea kollha fit-28 ta' Ottubru 2010.
English: Clopidogrel Teva Pharma is a medicine that contains the active substance clopidogrel.
Maltese: Clopidogrel HCS huwa mediċina li traqqaq id-demm li fiha s-sustanza attiva klopidogrel.
English: Other information about Clopidogrel Teva Pharma:
Maltese: Clopidogrel HCS jista' jingħata lill-gruppi ta' pazjenti li ġejjin:
English: Brentuximab vedotin - Cytomegalovirus (CMV) reactivation (EPITT no 18789)
Maltese: Brentuximab vedotin - riattivazzjoni tas-Ċitomegalovirus (CMV) (EPITT nru 18789)
English: Serious infections such as pneumonia, staphylococcal bacteraemia, sepsis/septic shock (including fatal outcomes) and herpes zoster, Cytomegalovirus (CMV) (reactivation) and opportunistic infections such as Pneumocystis jiroveci pneumonia and oral candidiasis have been reported in patients treated with brentuximab vedotin.
Maltese: Infezzjonijiet serji bħall-pulmonite, il-bacteraemia stafilokokkali, sepsis/xokk settiku (inkluż riżultati fatali) u herpes zoster, Ċitomegalovirus (CMV) (riattivazzjoni) u infezzjonijiet opportunistiċi bħal Pneumocystis jiroveci pneumonia u kandidiażi orali ġew irrappurtati f'pazjenti kkurati bil-brentuximab vedotin.
English: Adopted at the 2-5 May 2017 PRAC
Maltese: Adottati fil-PRAC ta' bejn il-2-5 ta' Mejju 2017
English: Frequency ‘uncommon': Cytomegalovirus infection or reactivation
Maltese: Frekwenza ‘mhux komuni': Infezzjoni Ċitomegalovirus jew riattivazzjoni
English: Uncommon side effects (affects less than 1 in 100 people) - new or recurring cytomegalovirus (CMV) infection
Maltese: Effetti sekondarji mhux komuni (jaffetwaw anqas minn persuna 1 minn kull 100) - infezzjoni ġdida jew rikorrenti taċ-ċitomegalovirus (CMV)
English: Patients should be carefully monitored during treatment for the emergence of possible serious and opportunistic infections.
Maltese: Il-pazjenti għandhom ikunu sorveljati mill-qrib waqt il-kura għall-ħruġ ta' infezzjonijiet serji u opportunistiċi possibbli.
English: Manufacturer Ebewe Pharma Ges.m.b.H Nfg.KG
Maltese: Ebewe Pharma Ges.m.b.H Nfg.KG
English: Latvia filiāle K.Valdemāra iela 33-30 Rīga, LV1010
Maltese: Sandoz d.d. Latvia filiāle K.Valdemāra iela 33-30 Rīga, LV1010
English: 1526 Ljubljana Slovenia
Maltese: 1526 Ljubljana Is-Slovenja
English: Бизнес Парк София, Младост 4, Сгр.7Б, ет.3
Maltese: Бизнес Парк София, Младост 4,
English: 28023 (Aravaca) Madrid España
Maltese: Osa Mayor, nº 4 28023 (Aravaca) Madrid España
English: The overall response rate was 14.1%.
Maltese: Il-rata ta' respons globali kienet ta' 14.1%.
English: SI-1526 Ljubljana Slovenia
Maltese: 1526 LjubljanaIs-Slovenja
English: Eesti filiaal Pärnu mnt105
Maltese: Sandoz d.d. Eesti filiaal Pärnu mnt105
English: Adenocarcinoma (N = 847)
Maltese: Adenokarċinoma (N=847)
English: 10 A-6250 Kundl Tel: +43 5338 2000
Maltese: Kundl Tel: +43 5338 2000
English: Non-small cell lung cancer
Maltese: Large Cell Carcinoma
English: United Kingdom Sandoz Limited Frimley Business Park Camberley, GU16 7SR, UK Tel: + 44 1276 698020 uk.regaffairs@sandoz.com
Maltese: United Kingdom Sandoz Limited Frimley Business Park Camberley, GU16 7SR, UK Tel: + 44 1276 698020
English: • 95% CI for HR
Maltese: 95 % CI għal HR
English: filialas Šeimyniškių 3A,
Maltese: Sandoz Pharmaceuticals d.d. filialas Šeimyniškių 3A,
English: • Loss of sensation
Maltese: •Telf ta' sensazzjoni
English: Dose for Cisplatin (mg/m2)
Maltese: Doża ta' Cisplatin (mg/m2)
English: Pack of 1 vial with protective plastic overwrap.
Maltese: Pakkett b'kunjett wieħed bi tgeżwira protettiva tal-plastik.
English: Contains mannitol (E421), hydrochloric acid and sodium hydroxide (for pH adjustment).
Maltese: Fih mannitol (E421), hydrochloric acid, sodium hydroxide (għal aġġustament tal-pH).
English: A-4866 Unterach Austria
Maltese: 4866 L-Awstrija
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: Dose of Pemetrexed (mg/m2)
Maltese: Doża ta' Pemetrexed (mg/m2)
English: Abbreviations: ALT = alanine aminotransferase; AST = aspartate aminotransferase; CTCAE = Common Terminology Criteria for Adverse Event; NCI = National Cancer Institute; SGOT = serum glutamic oxaloacetic aminotransferase; SGPT = serum glutamic pyruvic aminotransferase.
Maltese: SGOT = serum glutamic oxaloacectic aminotransferase; SGPT = serum glutamic pyruvic aminotransferase.
English: Stomatitis ALT (SGPT) elevation
Maltese: Żieda fl-SGPT (ALT)
English: Renal impairment (standard Cockcroft and Gault formula or glomerular filtration rate measured Tc99m DPTA serum clearance method): Pemetrexed is primarily eliminated unchanged by renal excretion.
Maltese: Indeboliment tal-kliewi (Formula standard Cockcroft & Gault jew Metodu tat-tneħħija mis-serum Tc99m-DPTA biex tiġi kkalkulata r-rata ta' filtrazzjoni glomerulari): Pemetrexed primarjament jiġi eliminat bla ebda modifikazzjoni permezz ta' tneħħija mill-kliewi.
English: Abbreviation: CI = confidence interval.
Maltese: CI = intervall ta' kunfidenza;
English: Between-patient variability in clearance is moderate at 19.3 %.
Maltese: Il-varjabilità fit-tneħħija bejn il-pazjenti hija moderata f'perċentwali ta' 19.3 %.
English: NSCLC, maintenance treatment
Maltese: NSCLC, kura ta' manteniment:
English: Efficacy of Pemetrexed vs. Docetaxel in NSCLC - ITT population
Maltese: Effikaċja ta' Pemetrexed vs docetaxel f'popolazzjoni ITT - NSCLC Pemetrexed
English: Frequency estimate: Very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000) and not known (cannot be estimated from available data).
Maltese: Komuni ħafna ( > 1/10 ), Komuni ( > 1/100 sa < 1/10), Mhux komuni ( > 1/1000 sa < 1/100), Rari ( > 1/10,000 sa < 1/1000), Rari ħafna (≤ 1/10,000) u mhijiex magħrufa (ma tistax tiġi stimata mit-tagħrif li hemm disponibbli).
English: The corticosteroid should be equivalent to 4 mg of dexamethasone administered orally twice a day (see section 4.4).
Maltese: Il-kortikosterojd għandu jkun ekwivalenti għal 4mg ta' dexamethasone meħud b'mod orali darbtejn kuljum (ara sezzjoni 4.4).
English: Sandoz GmbH Biochemiestrasse 10 6250 Kundl Austria
Maltese: Sandoz GmbH Biochemiestrasse 10 6250
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: 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: Pharmacotherapeutic group: Antineoplastic agents, folic acid analogues, ATC code: L01BA04
Maltese: Sustanzi antineoplastiċi, analogi ta' folic acid, Kodiċi ATC:
English: Table 2.
Maltese: B12.
English: Pemetrexed Sandoz 500 mg contains 54 mg sodium per vial.
Maltese: Pemetrexed Sandoz 500 mg fih 54 mg sodium għal kull kunjett.
English: 75% of previous dose
Maltese: 75 % tad-doża ta' qabel
English: Vitamin supplementation: your doctor will prescribe you oral folic acid (vitamin) or a multivitamin containing folic acid (350 to 1000 micrograms) that you must take once a day while you are taking Pemetrexed Sandoz.
Maltese: Supplimentazzjoni b'vitamini: it-tabib tiegħek jordnalek folic acid (vitamina) orali jew xi prodott multivitaminiku li fih folic acid (350 sa 1000 microgramma) li trid tieħu darba kuljum waqt ittrattament b'Pemetrexed Sandoz.
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: organizačná zložka Galvaniho 15/C SK-821 04 Bratislava Tel: + 421 2 48 200 600 info@sandoz.sk
Maltese: SK-821 04 Bratislava Tel: + 421 2 48 200 600 info@sandoz.sk
English: Hydrochloric acid (for pH adjustment) Sodium hydroxide (for pH adjustment)
Maltese: Hydrochloric acid (għal aġġustament tal-pH) Sodium hydroxide (għal aġġustament tal-pH)
English: Pemetrexed can suppress bone marrow function as manifested by neutropenia, thrombocytopenia, and anaemia (or pancytopenia) (see section 4.8).
Maltese: Pemetrexed jista' jissopprimi l-funzjoni tal-mudullun kif manifestat min-newtropenja, mittromboċitopenja u mill-anemija (jew panċitopenja) (ara sezzjoni 4.8).
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 (adjusted hazard ratio (HR) 0.94; 95% CI= 0.84-1.05).
Maltese: Studju ta' Fażi 3, open-label, randomised, 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 avanzat jew metastatiku (Stadju IIIb jew IV) u li qatt ma ħadu ebda kimoterapija, wera li pemetrexed flimkien ma' cisplatin (popolazzjoni bl-Intenzjoni Li Tikkura (ITT) n = 862) laħaq l-endpoint 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 = 0.841.05).
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' 4.8xhur għal pemetrexedflimkien ma' cisplatin kontra 5.1xhur 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) għalpemetrexedflimkien ma' cisplatinkontra 28.2% (95% CI =25.
English: Tel: +386 1 580 21 11
Maltese: Lek farmacevtska družba d.d. Tel: +386 1 580 21 11
English: Rash/ desquamation Pruritus
Maltese: Raxx/ deskwamazzjoni
English: Each pack of Pemetrexed Sandoz consists of one vial with protective plastic overwrap, containing 100 mg, 500 mg or 1000 mg of pemetrexed.
Maltese: Kull pakkett ta' Pemetrexed Sandoz huwa magħmul minn kunjett wieħed bi tgeżwira protettiva tal-plastik, li fih 100 mg, 500 mg jew 1000 mg ta' pemetrexed.
English: Squamous cell (N = 473)
Maltese: Ċellula tat-tip squamous (N=473)
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 90ml/min).
Maltese: It-tneħħija sistemika totali ta' Pemetrexed hija ta' 91.8 ml/min u lhalf-life tal-eliminazzjoni mill-plażma hija ta' 3.5 sigħat f'pazjenti b'funzjoni tal-kliewi normali
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' 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: Mondseestrasse 11, Unterach 4866 Austria
Maltese: Mondseestrasse 11, Unterach
English: Sandoz S.p.A Largo Umberto Boccioni 1 I - 21040 Origgio/VA Tel: + 39 02 96541
Maltese: Sandoz S.p.A Largo Umberto Boccioni 1 I - 21040
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.Alkaline Phosphatase, AST u ALT ≤ 5 darbiet il-limitu massimu tan-normal hu aċċettabbli jekk il-fwied ikun sit ta' metastasi f'każ ta' tumur.
English: The other ingredients are mannitol (E421), hydrochloric acid (for pH adjustment) and sodium hydroxide (for pH adjustment) (see section 2 “Pemetrexed Sandoz contains sodium”).
Maltese: Is-sustanzi l-oħra huma mannitol (E421), hydrochloric acid (għal aġġustament tal-pH) u sodium hydroxide (għal aġġustament tal-pH) (ara sezzjoni 2 “Pemetrexed Sandoz fih sodium”).
English: **In the pemetrexed/cisplatin arm, randomised and treated (N=225) and fully supplemented (N=167).
Maltese: ** Fil-fergħa ta' pemetrexed/cisplatin, ntgħażlu b'mod arbitrarju u kkurati (N = 225) u mogħtija suppliment tul it-terapija kollha (N = 167)
English: Additional medicines:
Maltese: Kategorija farmakoterapewtika:
English: Marketing Authorisation Holder Sandoz GmbH
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq Sandoz GmbH
English: Pemetrexed is incompatible with diluents containing calcium, including lactated Ringer's Injection and Ringer's Injection.
Maltese: Pemetrexed huwa fiżikament inkompatibbli ma' dilwenti li fihom calcium, inklużi l-injezzjoni ta' lactated Ringer u l-injezzjoni ta' Ringer.
English: You must continue taking the folic acid for 21 days after the last dose of Pemetrexed Sandoz.
Maltese: Trid tkompli tieħu folic acid għal 21 ġurnata wara l-aħħar doża ta' Pemetrexed Sandoz.
English: • Hypernatraemia - increased sodium in blood
Maltese: • Hypernatraemia - żieda ta' sodju fid-demm
English: Of the randomised patients, 44.9% had a complete/partial response and 51.9% had a response of stable disease to pemetrexed plus cisplatin induction.
Maltese: Mill-pazjenti li ġew magħżula b'mod arbitrarju, 44.9 % kellhom rispons komplet/parzjali u 51.9 % kellhom rispons ta' marda stabbli għallkura inizjali ta' pemetrexed flimkien ma' cisplatin.
English: Pemetrexed Sandoz contains sodium
Maltese: Pemetrexed Sandoz fih sodium
English: • Fatigue (tiredness)
Maltese: • Epatite (infjammazzjoni tal-fwied)
English: • Kidney: abnormal blood tests
Maltese: • Kliewi : testijiet tad-demm anormali
English: • Diarrhoea
Maltese: • Deidrazzjoni.
English: Rare (may affect up to 1 in 1,000 people)
Maltese: Rari (jistgħu jaffettwaw sa persuna 1 minn kull 1,000)
English: Chemical and physical in-use stability of infusion solutions of Pemetrexed Sandoz has been demonstrated for 4 days at 2°C to 8°C and for 2 days below 25°C.
Maltese: L-istabbilità kimika u fiżika ta' waqt l-użu, tas-soluzzjonijiet rikostitwiti ta' Pemetrexed Sandoz intweriet għal 4 ijiem f'temperatura ta' 2°C sa 8°C u għal 4 ijiem f'temperatura inqas minn 25°C.
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 b'mod arbitrarju ġew magħżula biex jirċievu pemetrexed jinkludu: reazzjoni allerġika/sensittività eċċessiva, eritema multiforme, arritmja supraventrikulari u emboliżmu pulmunarju.
English: Common Dyspepsia Rash
Maltese: Rash Alopeċja
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines webportal.
Maltese: Ir-rekwiżiti tar- rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunke aġġornament sussegwenti ppubblikati fuq il-portal elettroniku Ewropew tal-mediċini.
English: Pemetrexed Sandoz 1000 mg contains 108 mg sodium per vial.
Maltese: Pemetrexed Sandoz 1000 mg fih 108 mg sodium għal kull kunjett.
English: In vitro studies have shown that pemetrexed behaves as a multi-targeted 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 jinibbixxi 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.Pemetrexed jittieħed ġewwa ċ-ċelluli permezz taż-zewġ sistemi tat-trasport, it-trasportatur ta' folat ridott u proteina fil-membrana li jeħel magħha l-folat.
English: Other medicines and Pemetrexed Sandoz
Maltese: Mediċini oħra u Pemetrexed Sandoz