FrancophonIA/ELRC3.0 huggingface dataset:
English: The dose of 0.2 mg/kg achieved the mean percent inhibition of 49.3% (5 µM ADP-induced platelet aggregation) which was comparable to that of adults taking Plavix 75 mg/day.
Maltese: 3% (5 µM ta' aggregazzjoni tal-plejtlits ikkaġunat millADP) li huwa simili għal dak ta' adulti li jieħdu 75 mg/ġurnata ta' Plavix.
English: Jaundice; severe abdominal pain with or without back pain; fever, breathing difficulties sometimes associated with cough; generalised allergic reactions; swelling in the mouth; blisters of the skin; skin allergy; inflammation of the mouth (stomatitis); decrease in blood pressure; confusion; hallucinations; joint pain; muscular pain; changes in the way things taste.
Maltese: -Effetti sekondarji rari ħafna: suffejra; uġigħ addominali qawwi flimkien ma' jew mingħajr uġigħ fid-dahar; deni, diffikultajiet fin-nifs kultant assoċjati mas-sogħla; reazzjonijiet allerġiċi ġeneralizzati; nefħa fil-ħalq; infafet fil-ġilda; reazzjoni allerġika fil-ġilda; infjammazzjoni tal-ħalq (stomatite); tnaqqis fil-pressjoni tad-demm; konfużjoni; alluċinazzjonijiet; uġigħ fil-ġogi; uġigħ muskolari; tibdiliet fil-mod ta' kif jintegħmu l-affarijiet.
English: Haematuria
Maltese: Pożoloġija
English: Clopidogrel Acino Pharma is taken to prevent blood clots (thrombi) forming in hardened blood vessels (arteries), a process known as atherothrombosis, which can lead to atherothrombotic events (such as stroke, heart attack, or death).
Maltese: Clopidogrel Acino Pharma jittieħed biex inaqqas ir-riskju li emboli tad-demm (trombi) jifformaw flarterji mwebbsin (arterji), proċess imsejjaħ aterotrombosi, li jista' jwassal għal konsegwenzi aterotrombotiċi (bħal puplesija, attakk tal-qalb, jew mewt).
English: If any of the situations mentioned below apply to you, you should tell your doctor before taking Clopidogrel Acino Pharma: if you have a risk of bleeding such as a medical condition that puts you at risk of internal bleeding (such as a stomach ulcer) a blood disorder that makes you prone to internal bleeding (bleeding inside any tissues, organs or joints of your body) a recent serious injury a recent surgery (including dental) a planned surgery (including dental) in the next seven days if you have had a clot in an artery of your brain (ischaemic stroke) which occurred within the last seven days if you have kidney or liver disease
Maltese: • jekk tinsab f'riskju ta' fsada bħal: kundizzjoni medika li tpoġġik f'riskju ta' fsada interna (bħal ulċera fl-istonku) mard fid-demm li jwassal għal fsada interna (dmija f'xi tessuti, organi jew ġogi ta' ġismek); ferita serja riċenti; operazzjoni riċenti (anki tas-snien); operazzjoni li ser issirlek (anki tas-snien) fis-sebat ijiem li ġejjin.
English: HOW TO TAKE CLOPIDOGREL ACINO PHARMA
Maltese: X'fih Clopidogrel Acino Pharma
English: Thrombotic Thrombocytopenic Purpura (TTP)
Maltese: Rapporti Perjodiċi dwar l-Aġġornament tas-Sigurtà (PSURs):
English: Musculoskeletal , connective tissue and bone disorders
Maltese: Disturbi muskoluskeltrali, tat-tessut konnettiv u fl-għadam
English: As a precaution concomitant use of strong or moderate CYP2C19 inhibitors should be discouraged (see section 4.5 for a list of CYP2C19 inhibitors, see also section 5.2).
Maltese: Bħala prekawzjoni, l-użu konkomitanti ta' inibituri qawwijin jew moderati ta' CYP2C19għandu jiġu skoraġġut (ara sezzjoni 4. 5 għal lista ta' inibituri ta' CYP2C19, ara wkoll sezzjoni 5.2).
English: • You should also tell your doctor immediately if you develop a medical condition (also known as Thrombotic Thrombocytopenic Purpura or TTP) that includes fever and bruising under the skin that may appear as red pinpoint dots, with or without unexplained extreme tiredness, confusion, yellowing of the skin or eyes (jaundice) (see section 4 ‘POSSIBLE SIDE EFFECTS').
Maltese: • Għandek ukoll tgħid lit-tabib tiegħek minnufih jekk tiżviluppa kundizzjoni medika (magħrufa wkoll bħala Purpura Trombotika Tromboċitopenika jew TTP) li tinkludi deni u tbenġil taħt il-ġilda li jidher bħal tikek ħomor irqaq, flimkien ma' jew mingħajr għeja kbira mhux spjegata, konfużjoni, sfurija tal-ġilda jew ta' l-għajnejn (suffejra) (ara sezzjoni 4 'EFFETTI SEKONDARJI LI JISTA' JKOLLU').
English: Thrombotic Thrombocytopenic Purpura (TTP) has been reported very rarely following the use of clopidogrel, sometimes after a short exposure.
Maltese: Purpura Trombotika Tromboċitopenika (TTP) Ġiet irrapurtata Purpura Trombotika Tromboċitopenika (TTP) b'mod rari ħafna wara l-użu ta' clopidrogel, xi kultant wara espożizzjoni qasira.
English: There was no evidence of carcinogenic effect when clopidogrel was administered for 78 weeks to mice and 104 weeks to rats when given at doses up to 77 mg/kg per day (representing at least 25 times the exposure seen in humans receiving the clinical dose of 75 mg/day).
Maltese: Ma kienx hemm evidenza ta' riskju ta' kanċer meta clopidogrel ingħata għal 78 ġimgħa lill-ġrieden u 104 ġimgħa lill-firien meta dawn ingħataw dożi sa 77 mg/kg kuljum (li jirrappreżenta espożizzjoni mill-inqas 25 darba dik osservata fil-bnedmin li kienu qed jingħataw doża klinika ta' 75 mg/jum).
English: PHARMACEUTICAL FORM AND CONTENTS 14 film-coated tablets
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT
English: As with other antiplatelet agents, clopidogrel should be used with caution in patients who may be at risk of increased bleeding from trauma, surgery or other pathological conditions and in patients receiving treatment with ASA, heparin, glycoprotein IIb/IIIa inhibitors or nonsteroidal anti-inflammatory drugs (NSAIDs) including Cox-2 inhibitors.
Maltese: Bħal fil-każ ta' sustanzi oħra kontra l-plejtlets, clopidogrel għandu jintuża b'kawtela f'pazjenti li jista' jkollhom riskju ta' iktar dmija minn trawma, operazzjoni jew kundizzjonijiet patoloġiċi oħra u pazjenti li jkunu qed jirċievu l-kura b'ASA, heparin, inibituri ta' glycoprotein IIb/IIIa jew mediċini kontra l-infjammazzjoni li m'humiex sterojdi (NSAIDs) li jinkludu l-inibituri ta' Cox-2.
English: Recent myocardial infarction (MI), recent stroke or established peripheral arterial disease
Maltese: Infart mijokardijaku reċenti (MI), puplesija reċenti jew mard periferali stabbilit ta' l-arterji
English: NAME OF THE MEDICINAL PRODUCT Clopidogrel Acino Pharma 75 mg film-coated tablets
Maltese: TAL-PRODOTT MEDIĊINALI Clopidogrel Acino Pharma 75 mg pilloli miksija b'rita
English: What Clopidogrel Acino Pharma contains The active substance is clopidogrel.
Maltese: Is-sustanza attiva hi clopidogrel.
English: Mean peak plasma levels of unchanged clopidogrel (approximately 2.2 - 2.5 ng/ml after a single 75 mg oral dose) occurred approximately 45 minutes after dosing.
Maltese: Il-livell medju fil-plażma ta' clopidogrel mhux mibdul (bejn wieħed u ieħor 2.2-2.5ng/ml wara doża orali waħda ta' 75 mg) seħħew bejn wieħed u ieħor 45 minuta wara d-dożaġġ.
English: Take special care with Clopidogrel Acino Pharma:
Maltese: Effetti oħra li ġew irrappurtati bi Clopidogrel Acino Pharma huma:
English: Clopidogrel should be given as a single daily dose of 75 mg.
Maltese: Clopidogrel għandu jingħata darba kuljum bħala doża ta' 75 mg.
English: What Clopidogrel Acino Pharma looks like and contents of the pack
Maltese: Id-Dehra ta' Clopidogrel Acino Pharma u l-kontenuti tal-pakkett
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 75 mg of clopidogrel (as besilate).
Maltese: Kull pillola miksija b'rita fiha 75 mg ta' clopidogrel (bħala besilate).
English: In addition to clinical studies experience, adverse reactions have been spontaneously reported.
Maltese: Minbarra lesperjenza ta' l-istudji kliniċi, reazzjonijiet avversi ġew ukoll irrapportati b'mod spontanju.
English: Fever
Maltese: Lott
English: As a precaution concomitant use strong or moderate CYP2C19 inhibitors should be discouraged (see sections 4.4 and 5.2).
Maltese: Bħala prekawzjoni, l-użu konkomitanti ta' inibituri qawwija jew moderati ta' CYP2C19 għandu jiġi skoraġġut (ara sezzjonijiet 4.4 u 5.2).
English: Less pronounced reductions of metabolite exposure has been observed with pantoprazole or lansoprazole.
Maltese: Ġie osservat li b'pantoprazole jew lansoprazole t-tnaqqis fl-espożizzjoni tal-metabolit mhuwiex daqshekk spikkat.
English: Acetylsalicylic acid (ASA): ASA did not modify the clopidogrel-mediated inhibition of ADP-induced platelet aggregation, but clopidogrel potentiated the effect of ASA on collagen-induced platelet aggregation.
Maltese: It-teħid flimkien ma' heparin ma kellu l-ebda effett fuq l-inibizzjoni ta' l-aggregazzjoni tal-plejtlets indott minn clopidogrel.
English: Headache, stomach ulcer, vomiting, nausea, constipation, excessive gas in stomach or intestines, rashes, itching, dizziness, sensation of tingling and numbness.
Maltese: Uġigħ ta' ras, ulċera fl-istonku, rimettar, tqalligħ, stitikezza, gass żejjed fl-istonku jew flimsaren, raxxijiet, ħakk, sturdament, sensazzjoni ta' tnemnim u tirżiħ.
English: Clopidogrel significantly reduced the incidence of new ischaemic events (combined end point of myocardial infarction, ischaemic stroke and vascular death) when compared to ASA.
Maltese: L-inċidenza ta' każi severi kienet simili għal clopidogrel u simili għal ASA.
English: NAME OF THE MEDICINAL PRODUCT Clopidogrel Acino Pharma 75 mg film-coated tablets Clopidogrel NAME OF THE MARKETING AUTHORISATION HOLDER Acino Pharma GmbH EXPIRY DATE
Maltese: Id-doża normali hija ta' pillola waħda ta' 75 mg Clopidogrel Acino Pharma kuljum li għandha tittieħed mill-ħalq ma' l-ikel jew fuq stonku vojt u fl-istess ħin kull ġurnata.
English: The valid summary of product characteristics, labelling and package leaflet are the final versions achieved during the Coordination group procedure.
Maltese: Sommarju validu tal-karatteristiċi tal-prodott, tikkettar u fuljett ta' tagħrif jinsab fil-verżjoni finali tal-proċedura tal-Grupp koordinatur
English: Ελλάδα ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε.
Maltese: ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε.
English: The active substance is pemetrexed.
Maltese: Is-sustanza attiva hi pemetrexed.
English: Event**
Maltese: Avveniment**
English: * Definition of frequency terms: Very common - ≥ 10%; Common - > 5% and < 10%.
Maltese: Komuni ħafna- ≥ 10%; Komuni - > 5% and < 10%.
English: Date of latest renewal: 20 September 2009
Maltese: Data tal-aħħar tiġdid: 20 ta' Settembru 2009
English: 95 % CI for HR
Maltese: 95 % CI għal HR
English: Adenocarcinoma (N=847)
Maltese: Adenokarċinoma (N=847)
English: rue du Colonel Lilly F-67640 Fegersheim France
Maltese: Rue du Colonel Lilly F-67640
English: Hrvatska Eli Lilly Hrvatska d.o.o.
Maltese: Eli Lilly Hrvatska d.o.o.
English: ITT population and histology subgroups
Maltese: Popolazzjoni ITT u sottogruppi istoloġiċi
English: Dose of ALIMTA (mg/m2)
Maltese: Doża ta' ALIMTA (mg/m2)
English: Efficacy of ALIMTA vs docetaxel in NSCLC - ITT population ALIMTA
Maltese: Effikaċja ta' ALIMTA vs docetaxel f'popolazzjoni ITT - NSCLC
English: Dose for cisplatin (mg/m2)
Maltese: Doża ta' cisplatin (mg/m2)
English: 2 rue du Colonel Lilly 67640 Fegersheim France
Maltese: 2 rue du Colonel Lilly 67640
English: The pH of the reconstituted solution is between 6.6 and 7.8.
Maltese: Il-pH tas-soluzzjoni rikostitwita hi bejn 6.6 u 7.8.
English: ** Refer to NCI CTCAE Criteria (Version 3.0; NCI 2003) for each grade of toxicity.
Maltese: ** Irriferi għall-Kriterji NCI CTCAE (Verżjoni 3.0; NCI 2003) għal kull grad ta' tossiċità.
English: 6.1 List of excipients
Maltese: 6.1 Lista ta' eċċipjenti Mannitol
English: 100 mg
Maltese: INDIVIDWALI 100 mg
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' endpoints ta' effikaċja primarja fil-popolazzjoni Kwalifikata b'Protokoll (PQ).
English: Pharmacotherapeutic group: Folic acid analogues, ATC code: L01BA04
Maltese: Kategorija farmakoterapewtika: analogi ta' folic acid, Kodiċi ATC:
English: Manufacturer Lilly France S.A.S.
Maltese: Manifattur Lilly France S.A.S.
English: 500 mg
Maltese: INDIVIDWALI 500mg
English: N=863 0.94
Maltese: N=863 0.94a
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 tal-plażma.
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 Cockcroft & Gault jew Metodu tat-tneħħija misserum Tc99m-DPTA biex tiġi kkalkulata r-Rata ta' Filtrazzjoni Glomerulari)
English: The total bilirubin should be ≤ 1.5 times upper limit of normal.
Maltese: It-total ta' bilirubina għandu jkun ≤ 1.5 darbiet il-limitu massimu tan-normal.
English: Frequency* Event**
Maltese: Frekwenza Avveniment**
English: ALIMTA contains sodium
Maltese: ALIMTA fih sodium
English: Rarely seen events include Stevens-Johnson syndrome and Toxic epidermal necrolysis.
Maltese: Avvenimenti li dehru b'mod rari jinkludu s-sindromu ta' StevensJohnson u Toxic epidermal necrolysis.
English: The percentage of patients that received post study treatment was 64.3% for ALIMTA and 71.7% for placebo.
Maltese: Il-persentaġġ ta' pazjenti li rċevew kura wara l istudju kien ta' 64.3% għal ALIMTA u 71.7% għal plaċebo.
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 4 mg ta' dexamethasone meħud b'mod orali darbtejn kuljum (ara sezzjoni 4.4).
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)
English: PC: SN:
Maltese: SN:
English: *P-values <0.05 comparing pemetrexed/cisplatin to gemcitabine/cisplatin, using Fisher Exact test. **Refer to National Cancer Institute CTC (v2.0; NCI 1998) for each Grade of Toxicity.
Maltese: * Valuri P <0.05 meta tqabbel pemetrexed/cisplatin ma' gemcitabine/cisplatin, permezz tal-Fisher Exact test. ** Irreferi għas-CTC (v 2.0; NCI 1998) ta' l-Istitut Nazzjonali tal-Kanċer għal kull Grad ta'
English: What is in this leaflet:
Maltese: Soluzzjonijiet Rikostitwiti u ta' Infużjoni :
English: Overall response rate** (95 % CI)
Maltese: Ir-rata ta' rispons globali** (95 % CI)
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 ta' l-Istitut Nazzjonali tal-Kanċer (CTC; v2.0; NCI 1998)
English: Frequency Event*
Maltese: Frekwenza Avveniment*
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%, > 6cycles: 6.4%: p=0.046).
Maltese: Ġiet osservata, wisq probabbli kkawżata mill-mediċina taħt studju, żieda fl-inċidenza ta' newtropinja ta' Grad 3/4 b'espożizzjoni itwal għal pemetrexed (≤6 ċikli: 3.3%, > 6 ċikli: 6.4%: p=0.046).
English: 75 % of previous dose
Maltese: 75 % tad-doża ta' qabel
English: Frequency estimate: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1000 to <1/100), Rare (≥1/10,000 to <1/1000), 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: 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, mit tromboċitopenja u mill-anemija (jew panċitopenja) (ara sezzjoni 4.8).
English: Concomitant yellow fever vaccine (see section 4.5).
Maltese: Vaċċin tal-yellow fever fl-istess żmien (ara sezzjoni 4.5).
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: mediċini li jkunu metabolizzati b'CYP3A, CYP2D6, CYP2C9, u CYP1A2.
English: Gemcitabine + cisplatin
Maltese: ALIMTA + cisplatin Gemcitabine + cisplatin
English: For the full list of excipients see section 6.1.
Maltese: Għal-lista kompluta ta' eċċipjenti, ara sezzjoni 6.1.
English: Squamous cell (N=473)
Maltese: Ċellula tat-tip squamous (N=473)
English: Pemetrexed total systemic exposure (AUC) and maximum plasma concentration increase proportionally with dose.
Maltese: L-espożizzjoni sistemika totali (AUC) u l-ogħla konċentrazzjoni fil-plażma ta' Pemetrexed jiżdiedu proporzjonament mad-doża.
English: Mannitol Hydrochloric acid Sodium hydroxide
Maltese: Hydrochloric acid Sodium hydroxide 6.2 Inkompatibbilitajiet
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: It-tneħħija sistemika totali ta' Pemetrexed hija ta' 91.8 ml/min u lhalf-life ta' l-eliminazzjoni mill-plażma hija ta' 3.5 sigħat f'pazjenti b'funzjoni tal-kliewi normali (tneħħija tal-krejatinina ta' 90 ml/min).
English: Progression free survival (PFS) and overall response rate were similar between treatment arms: median PFS was 4.8 months for ALIMTA 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 ALIMTA 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 ALIMTA 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 ALIMTA flimkien ma' cisplatin kontra 28.2% (95% CI = 25.
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 lil pemetrexed.
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 ALIMTA.
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'ALIMTA.
English: PFS data were partially confirmed by an independent review (400/1725 patients were randomly selected for review).
Maltese: Id-data tal-PFS ġew parzjalment ikkonfermati minn stħarriġ indipendenti (400/1725 pazjent ġew magħżula b'mod arbitrarju għallistħarriġ).
English: Breast-feeding (see section 4.6).
Maltese: It-treddigħ (ara sezzjoni 4.6).
English: Side effects with ALIMTA may include:
Maltese: Effetti sekondarji ta' ALIMTA jistgħu jinkludu:
English: How to store ALIMTA
Maltese: Tużax ALIMTA
English: 8.3 months for patients treated with ALIMTA (Intent To Treat population n = 283) and 7.9 months for patients treated with docetaxel (ITT n = 288).
Maltese: Jiġu Kkurati(ITT) , n = 283) u 7.9 xhur f'pazjenti kkurati b'docetaxel (ITT n = 288).
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). NSCLC, kura ta' manteniment
English: No statistically significant differences in any other individual Grade 3/4/5 adverse reactions were seen with longer exposure.
Maltese: Ma dehru ebda differenzi statistikament sinifikanti fir-reazzjonijiet individwali avversi oħra ta' Grad 3/4/5
English: Kaplan Meier plots of overall survival by histology
Maltese: Dijagrammi Kaplan Meier tas-sopravivenza totali skont l-istoloġija
English: Creatinine clearance should be ≥ 45 ml/min.
Maltese: It-tneħħija tal-krejatinina għandha tkun ta' ≥ 45 ml/min.
English: There were no clinically relevant differences observed for the safety profile of ALIMTA within the histology subgroups.
Maltese: Ma ġewx osservati differenzi klinikament relevanti fil-profil ta' sigurtà ta' ALIMTA fis-sottogruppi istoloġiċi.
English: There were no clinically relevant differences observed for the safety profile of ALIMTA plus cisplatin within the histology subgroups.
Maltese: Ma dehrux differenzi klinikament rilevanti fil-profil ta' sigurtà ta' Alimta flimkien ma' cisplatin fis sottogruppi ta' istoloġija.
English: Common Pain Edema Renal Disorders Common Renal disorders**** Abbreviations: ALT = alanine aminotransferase; AST = aspartate aminotransferase; CTCAE = Common Terminology Criteria for Adverse Event; NCI = National Cancer Institute; SGOT = serum glutamic oxaloacectic aminotransferase; SGPT = serum glutamic pyruvic aminotransferase.
Maltese: SGOT = serum glutamic oxaloacectic aminotransferase; SGPT = serum glutamic pyruvic aminotransferase.
English: ** In the ALIMTA/cisplatin arm, randomized and treated (N = 225) and fully supplemented (N = 167)
Maltese: ** Fil-fergħa ta' ALIMTA/cisplatin, ntgħażlu bl-addoċċ u kkurati (N = 225) u mogħtija suppliment tul it-terapija kollha (N = 167)
English: The other ingredients are mannitol, hydrochloric acid and sodium hydroxide
Maltese: Is-sustanzi l-oħra huma mannitol, hydrochloric acid u sodium hydroxide.
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: After reconstitution (see section 6.6), each vial contains 25 mg/ml of pemetrexed.
Maltese: Wara r-rikostituzzjoni (ara sezzjoni 6.6), kull kunjett fih 25 mg/ml ta' pemetrexed.
English: Pemetrexed/cisplatin
Maltese: Frekwenza Avveniment* Pemetrexed/cisplatin
English: ALIMTA 500 mg: Each vial contains 500 milligrams of pemetrexed (as pemetrexed disodium).
Maltese: ALIMTA 500 mg: Kull kunjett fih 500 milligramm ta' pemetrexed (bħala pemetrexed disodium)
English: Other (N=252)
Maltese: (N=252)
English: A multicentre, randomised, open-label, Phase 3 study of ALIMTA 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 ALIMTA 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: (NSCLC) lokalment avanzat jew metastatiku (Stadju IIIb jew IV) u li qatt ma ħadu ebda kimoterapija, wera li ALIMTA flimkien ma' cisplatin (popolazzjoni bl-Intenzjoni Li Tikkura (ITT) n = 862) laħaq lendpoint 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: Clinically relevant toxicities with respect to gender were similar to the overall population in patients receiving pemetrexed plus cisplatin.
Maltese: Tossiċitajiet klinikament rilevanti skond is-sess,kienu simili għall-popolazzjoni totali f'pazjenti li rċevew pemetrexed flimkien ma' cisplatin.
English: ALIMTA 100 mg: Each vial contains 100 milligrams of pemetrexed (as pemetrexed disodium).
Maltese: ALIMTA 100 mg: Kull kunjett fih 100 milligramm ta' pemetrexed (bħala pemetrexed disodium)