FrancophonIA/ELRC3.0 huggingface dataset:
English: p-value from the Cochran Mantel-Haenszel chi-square test adjusted for the stratification factors; analysis by line of therapy excludes stratification for therapeutic history
Maltese: valur-p mit-test chi-square Cochran Mantel-Haenszel aġġustat għal fatturi stratifikati; analiżi skont il-linja tat-terapija teskludi stratifikazzjoni għall-istorja terapewtika * CR+PR+MR**CR=CR, (IF-); nCR=CR (IF+)
English: Oedema (inc peripheral), Chills, Pain*, Malaise* Uncommon General physical health deterioration*, Face oedema*, Injection site reaction*, Mucosal disorder*, Chest pain, Gait disturbance, Feeling cold, Extravasation*, Catheter related complication*, Change in thirst*, Chest discomfort, Feeling of body temperature change*, Injection site pain*
Maltese: Mhux Komuni Deterjorament ġenerali tas-saħħa fiżika*, Edema tal-wiċċ*, Reazzjoni fis-sit tal-injezzjoni*, Disturb mukosali*, Uġigħ fis-sider, Disturb fil-pass, Tħoss il-ksieħ, Ekstravażazzjoni*, Komplikazzjoni marbuta mal-katiter*, Bidla fl-għatx*, Dwejjaq fis-sider, Tħoss bidla fit-temperatura tal-ġisem*, Uġigħ fis-sit tal-injezzjoni*
English: Patients who had received 2 to 3 prior therapeutic regimens had a response rate of 32% (10/32) and patients who received greater than 7 prior therapeutic regimens had a response rate of 31% (21/67).
Maltese: Pazjenti li kienu ħadu minn 2 sa 3 terapiji qabel kellhom rata ta' rispons ta' 32 % (10/32) u pazjenti li kellhom iktar minn 7 terapiji minn qabel kellhom rata ta' rispons ta' 31 %
English: A - 1210 Wien, Austria
Maltese: A - 1210 Wien, Austrija
English: SE: standard error.
Maltese: SE: żball standard.
English: 1324 Lysaker Norway
Maltese: 1324 Lysaker Norveġja
English: Rivium Westlaan 142 2909 LD Capelle a/d IJssel
Maltese: Westlaan 142 2909 LD Capelle a/d IJssel Olanda
English: Vetenskapsvagen 10, SE 191 90 Sollentuna Sweden
Maltese: Vetenskapsvagen 10, SE 191 90 Sollentuna Svezja
English: Pfizer Oy, Tietokuja 4, 00330 Helsinki, Finland
Maltese: Pfizer Oy, Tietokuja 4, 00330 Helsinki, Finlandja
English: Laboratorios Pfizer, Lda., Lagoas Park, Edifício 10, 2740-271 Porto Salvo, Portugal
Maltese: Laboratorios Pfizer, Lda., Lagoas Park, Edifício 10, 2740-271 Porto Salvo, Portugall
English: p-value vs. timolol
Maltese: Valur- p vs. timolol
English: B-1050 Brussels, Belgium
Maltese: B-1050 Brussels, Belġjum
English: Pharmacia Ireland Limited
Maltese: Pharmacia Ireland Limited 9 Riverwalk
English: Pfizer ApS, Lautrupvang 8, 2750 Ballerup, Denmark
Maltese: Pfizer ApS, Lautrupvang 8, 2750 Ballerup, Danimarka
English: s r.o., Stroupežnického 17, 150 00 Prague 5, Czech Republic
Maltese: s r.o., Stroupežnického 17, 150 00
English: 23-25 Avenue du Docteur Lannelongue 75014 Paris France
Maltese: Pfizer Holding France 23-25 Avenue du Docteur Lannelongue 75014
English: Pfizer SA Boulevard de la Plaine
Maltese: Belgium Pfizer SA Boulevard de la Plaine 17
English: 154 51 Νeo Psychiko, Athens, Greece
Maltese: 243, Messoghion Ave., 154 51 Νeo Psychiko, Athens, Greċja
English: †Adjusted estimate based on an analysis of covariance (ANCOVA) model.
Maltese: †Stima rranġata skond l-analiżi tal-mudell ta' covariance (ANCOVA).
English: Pharmacia GmbH Linkstraße 10 10785 Berlin, Germany
Maltese: Pharmacia GmbH Linkstraße 10 10785
English: Pharmacia GmbH, Linkstraße 10 10785 Berlin, Germany
Maltese: Pharmacia GmbH, Linkstraße 10 10785
English: Pfizer Europe MA EEIG, Ramsgate Road,
Maltese: Pfizer Europe MA EEIG, Ramsgate Road, Sandwich,
English: Data in the age group < 1 year (4 patients) are very limited (see Section 5.1).
Maltese: L-informazzjoni f'età ta' < 1 sena (4 pazjenti) hija limitata hafna (ara Sezzjoni 5.1).
English: 04100 Latina - Italy
Maltese: Latina - Italja
English: Baseline Mean (SE)
Maltese: Linja bażi medja (SE)
English: Slovak Republic Pfizer Europe MA EEIG, Ramsgate
Maltese: Slovak Republic Pfizer Europe MA EEIG, Ramsgate Road,
English: Kennedy, L-1855 Luxembourg, G. D. of Luxembourg
Maltese: Kennedy, L-1855 Lussemburgu, Lussemburgu
English: - make clear/provide reassurance that Adverse Drug Reactions are transmitted to NCAs within the legal timelines; - include information with regard to the absolute frequency or maximum time interval between audits for the Pharmacovigilance system for Drug Safety and Surveillance.
Maltese: - jiċċara/jipprovdi riassigurazzjoni li r-Reazzjonijiet Avversi għall-Mediċina jiġu trasmessi lill-NCAs fi żmien il-limiti ta' żmien legali; - jinkludu informazzjoni fir-rigward tal-frekwenza assoluta jew l-intervall ta' żmien massimu bejn verifiki għas-sistema ta' Farmakoviġilanza għas-Sigurtà u Sorveljanza tal-Mediċina.
English: Rond-Point du Kirchberg
Maltese: Kennedy Rond-Point du Kirchberg L-1855 Lussemburgu
English: In all age groups studied (0 to <3 years, 3 to <12 years and 12 to 18 years of age) the mean IOP reduction at Week 12 in the latanoprost group was similar to that in the timolol group.
Maltese: Fil-gruppi kollha li ġew studjati (0 sa <3 snin, 3 sa <12 -il sena u 12 sa 18 -il sena) it-tnaqqis medju fl-IOP f' ġimgħa 12 fil-grupp ta' latanoprost kien simili għal dak tal grupp ta' timolol.
English: Patients received either latanoprost 0.005% once daily or timolol 0.5% (or optionally 0.25% for subjects younger than 3 years old) twice daily.
Maltese: Il-pazjenti rċevew jew latanoprost 0.005% darba kuljum jew timolol 0.5% (jew skond l-għażla 0.25%, f' pazjenti iżgħar minn 3 snin) darbtejn kuljum.
English: Pfizer KFT, 1123 Budapest, Alkotás u. 53.
Maltese: 1123 Budapest, Alkotás u. 53. MOM Park "F" Ép.,
English: In two short term clinical trials ( 12 weeks) involving 93 (25 and 68) paediatric patients the safety profile was similar to that in adults and no new adverse events were identified.
Maltese: F'żewġt studji klinici qosra (< 12 -il ġimgħa), b' involviment ta' 93 (25 u 68) pazjent pedjatriku, ilprofil ta' sigurtà kien simili ta' dak fl-adulti u ma ġewx identifikati l-ebda avvenimenti avversi ġodda.
English: Content
Maltese: Uża
English: Table: IOP reduction (mmHg) at week 12 by active treatment group and baseline diagnosis Latanoprost N=53
Maltese: Tabella: Tnaqqis fl-IOP (mmHg) f' ġimgħa 12 skond il-grupp ta' trattament attiv u d-dijanjosi fuq linja bażi
English: The final version of the CRF will be annexed to the study A6111143 protocol; - The MAH discussion whether the OCT (optical coherence tomography) technique can be recommended in the protocol's Appendix 1 “recommended assessment methods”; - The PASS (Post-Authorisation Safety) studies will include a comparison between macular oedema reported in aphakin and non-aphakin patients;
Maltese: Il-verżjoni finali tas-CRF sejra tiġi annessa għall-protokoll tal-istudju A6111143; - Id-diskussjoni tal-MAH dwar jekk it-teknika tal-OCT (tomografija ta' koerenza ottika) tistax tkun irrakkomandata fl-Appendiċi 1 tal-protokoll “metodi ta' valutazzjoni rrakkomandati”; - L-istudji tal-PASS (Sigurtà Wara l-Awtorizzazzjoni) sejrin jinkludu tqabbil bejn edema makulari rrapportata f'afakin u pazjenti mhux afakin;
English: Pfizer Luxembourg SARL, 51, Avenue J. F. Kennedy, L-1855 Luxembourg, Luxembourg
Maltese: Pfizer Enterprises SARL, Rond-point du Kirchberg, 51, Avenue J.F. Kennedy, L-1855 Lussemburgu, G. D. of Lussemburgu
English: IOP reductions among subjects in the primary congenital/infantile glaucoma (PCG) subgroup were similar between the latanoprost group and the timolol group.
Maltese: It-tnaqqis medju fl-IOP fil-grupp ta pazjenti li kellhom glawkoma primarja konġenitali/infantili (PCG), kien simili fil-gruppi ta' latanoprost u timolol.
English: Pfizer Enterprises SARL, Rond-point du Kirchberg, 51, Avenue J.F.
Maltese: Pfizer Enterprises SARL 51, Avenue J.F.
English: The non-PCG (e.g. juvenile open angle glaucoma, aphakic glaucoma) subgroup showed similar results as the PCG subgroup.
Maltese: Il-gruppi ż-żgħar, dawk li m'humiex PCG (e.ż. glawkoma juvenile tat-tip open angle, glawkoma aphakic) urew riżultati simili tal-grupp PCG.
English: In children from 0 to < 3 years old) that mainly suffers from PCG (Primary Congenital Glaucoma), surgery (e.g. trabeculotomy/goniotomy) remains the first line treatment.
Maltese: Fi tfal li ghandom bejn 0 sa < 3 snin u li primarjament isofru minn PCG (Glawkoma Primarja Kongenitali), l-ewwel trattament tibqa operazzjoni (e.ż. trabeculotomy/goniotomy).
English: The median plasma elimination half-life was short (<20 minutes), similar for paediatric and adult patients, and resulted in no accumulation of latanoprost acid in the systemic circulation under steady-state conditions.
Maltese: Il- half-life medja ta' eliminazzjoni mill-plażma kienet qasira (<20 minuta), kienet simili għal pazjenti pedjatriċi u pazjenti adulti, u ma wasslet għal ebda akkomulazzjoni ta' aċtu ta' latanoprost fic-cirkolazzjoni sistemika f'kundizzjonijiet ta' steady-state.
English: 0,005% Eye drops, solution Ocular use
Maltese: Xalatan 0,005% Augentropfen
English: Mean IOP reductions in the latanoprost and timolol groups were similar.
Maltese: It-tnaqqis medju fl-IOP fil-gruppi ta' latanoprost u timolol kienu simili.
English: All age groups were treated with latanoprost 0.005%, one drop daily in each eye for a minimum of 2 weeks.
Maltese: Il-gruppi ta kull età ġew trattati b' latanoprost 0.005%, qatra kuljum f'kull għajn għal ta l-anqas ġimgħatejn.
English: Latanoprost acid systemic exposure was approximately 2-fold higher in 3 to <12 year olds and 6fold higher in children <3 years old compared with adults, but a wide safety margin for systemic adverse effects was maintained (see section 4.9).
Maltese: L-espożizzjoni sistemika tal-aċtu ta' Latanoprost kienet bejn wiehed u ieħor darbtejn aktar għolja f'pazjenti li għandhom 3 sa <12 -il sena u 6 darbiet aktar għolja fi tfal li għandhom <3 snin meta mqabbla ma' adulti, iżda nżamm marġini ta' sigurtà wiesgħa għal avvenimenti avversi sistemiċi (ara sezzjoni 4.9).
English: Baseline Mean (SE) Week 12 Change from Baseline Mean†(SE)
Maltese: Linja bażi medja (SE) Ġimgħa 12 Bidla mil-linja bażi medja †(SE)
English: The efficacy of latanoprost in paediatric patients ≤18 years of age was demonstrated in a 12-week, doublemasked clinical study of latanoprost compared with timolol in 107 patients diagnosed with ocular hypertension and paediatric glaucoma.
Maltese: L-effikaċja ta' latanoprost f'pazjenti pedjatriċi < 18 -il sena, ħarġet minn studju kliniku double masked ta' 12 -il ġimgħa, fejn latanoprost ġie mqabbel ma' timolol f'107 pazjenti li kellhom pressjoni għolja fl-għajnejn u glawkoma pedjatrika.
English: Efficacy and safety data in the age group < 1 year (4 patients) are very limited (see Section 5.1).
Maltese: L-informazzjoni dwar l-effikaċja u s-sigurtà f'età < 1 sena (4 pazjenti) hija limitata hafna (ara sezzjoni 5.1).
English: Within the next updated version of the Detailed Description of the Pharmacovigilance System (DDPS) the MAH will:
Maltese: Fi żmien il-verżjoni aġġornata li jmiss tas-Sistema ta' Deskrizzjoni Dettaljata talFarmakoviġilanza (DDPS), il-MAH ser:
English: An open-label pharmacokinetic study of plasma latanoprost acid concentrations was undertaken in 22 adults and 25 paediatric patients (from birth to < 18 years of age) with ocular hypertension and glaucoma.
Maltese: L-istudju sar f' 22 pazjent adult u 25 patient pedjatriku (mit-twelid sa < 18 -il sena) li kellhom pressjoni għolja fl-għajnejn u glawkoma.
English: Week 12 Change from Baseline Mean†(SE)
Maltese: Ġimgħa 12 Bidla mil-linja bażi medja †(SE)
English: Nevertheless, efficacy data in the age group 0 - < 3 year old were based on only 13 patients for latanoprost and no relevant efficacy was shown from the 4 patients representing the age group 0 -< 1 year old in the clinical paediatric study.
Maltese: Madankollu l-informazzjoni ta' effikaċja fil-grupp ta' 0 - < 3 snin kienet ibbażata fuq 13 -il pazjent fuq latanoprost biss u ma dehret l-ebda effikaċja relevanti fl- 4 pazjenti li rrapreżentaw il-grupp ta' età bejn 0 -< 1 sena fl-istudju kliniku pedjatriku.
English: Sandwich, Kent, CT13 9NJ, United Kingdom
Maltese: Kent, CT13 9NJ, Renju Unit
English: Kennedy
Maltese: Qawwa
English: - Risk of drug interactions in paediatric patients as important missing information; - Cystoid macular oedema assessment using the study Adverse Event (AE) report page in the case report form (CRF).
Maltese: Il-verżjoni aġġornata li jmiss tal-Pjan ta' Ġestjoni tar-Riskji (RMP) jeħtieġ li jinkludi ddokumenti annessi rilevanti kollha u l-emendi li jirriflettu li ġej:- Riskju ta' interazzjonijiet talmediċina f'pazjenti pedjatriċi minħabba informazzjoni importanti nieqsa; - Valutazzjoni ta' edema makulari ċistojde billi tintuża l-paġna tar-rapport tal-Avveniment Avvers (AE) tal-istudju fil-formola tar-rapport tal-każ (CRF).
English: 50 micrograms / ml
Maltese: 50 microg/ ml
English: 50 micrograms/ ml
Maltese: 50 microg/ml
English: National Competent Authorities (NCAs), coordinated by the Reference Member State where applicable, shall ensure that the following conditions are fulfilled by the Marketing Authorisation Holders (MAHs):
Maltese: L-Awtoritajiet Kompetenti Nazzjonali (NCAs), ikkoordinati mill-Istat Membru ta' Referenza fejn applikabbli, għandhom jiżguraw li l-kundizzjonijiet li ġejjin jiġu ssodisfati mid-Detenturi talAwtorizzazzjoni għat-Tqegħid fis-Suq (MAHs):
English: The PSURs will include a separate review on drug interaction in the paediatric population and on the current and lost to follow up numbers in PASSs;
Maltese: Il-PSURs sejrin jinkludu reviżjoni separata dwar l-interazzjoni tal-mediċina fil-popolazzjoni pedjatrika u dwar in-numri attwali u n-numri mitlufin f'follow-up f'PASSs;
English: Median time to reach peak plasma concentration was 5 minutes post-dose across all age groups.
Maltese: Il-ħin medju biex tintleħaq ilkonċentrazzjoni massima fil-plażma kien ta' 5 minuti wara li ttieħdet id-doża fil-gruppi kollha ta' etajiet differenti.
English: Talk to your doctor, or the doctor treating your child or your pharmacist before you take {Invented name} or before you give this to you child if you think any of the following apply to you or your child: If you or your child are about to have or have had eye surgery (including cataract surgery) If you or your child suffer from eye problems (such eye pain, irritation or inflammation, blurred vision) If you or your child suffers from dry eyes
Maltese: - Jekk int jew it-tifel/tifla tiegħek ser tagħmel jew għadek kif għamilt operazzjoni f' għajnejk (li tinkludi operazzjoni tal-katarretti) - Jekk int jew it-tifel/tifla tiegħek issofru minn problemi fl-għajnejn (bħal ugiegħ fl-għajnejn, irritazzjoni jew infjammazzjoni, viżjoni mċajpra) - Jekk int jew it-tifel/tifla tiegħek issofru minn għajnejn xotti - Jekk int jew it-tifel/tifla tiegħek għandkom ażżma qawwija jew l-ażżma mhux ikkontrollata sew.
English: Pfizer.
Maltese: Czech Republic Pfizer.
English: Marketing Authorisation Holder
Maltese: Berlin, Ġermanja
English: Pfizer Hellas A. E. 243, Messoghion Ave.,
Maltese: Pfizer Hellas A. E.
English: ANNEX II AMENDMENTS TO THE SUMMARY OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLET
Maltese: ANNESS II EMENDI FIS-SOMMARJI TAL-KARATTERISTIĊI
English: Avda.
Maltese: TAL-PRODOTT
English: After using {Invented name} you should wait 15 minutes before putting the contact lenses back in. See the instructions for contact lens wearers in Section 3.
Maltese: Wara li tużaw {Isem ivvintat} għandkom tistennew 15-il minuta qabel ma terġgħu tilbsu l-lentijiet ta' kuntatt.
English: Date of first authorisation: 2 December 2015
Maltese: 2 Diċembru 2015
English: Placebo*** (N =402)
Maltese: Plaċebo*** (N =402)
English: Oncotec Pharma Produktion GmbH Am Pharmapark
Maltese: Oncotec Pharma Produktion GmbH Am
English: The overall response rate was 14.1 %.
Maltese: Il-rata ta' rispons globali kienet ta' 14.1 %.
English: Dose of CIAMBRA (mg/m
Maltese: Doża ta' CIAMBRA (mg/m
English: IE A. Menarini Pharmaceuticals Ltd Tel: +353 1 284 6744
Maltese: Menarini Pharmaceuticals Ltd Tel: +353 1 284 6744
English: 95 % CI for median HR
Maltese: 95 % CI għal medjan HR
English: * Definition of frequency terms: Very common - ≥ 10%; Common - > 5% and < 10%.
Maltese: Komuni - > 5% and < 10%.
English: ≥ 50,000 /mm
Maltese: ≥ 100,000 ċellula/mm
English: Neutrophils/ Granulocytes decreased
Maltese: Tnaqqis finnewtrofili/ granuloċiti Neutrophils/ Granulocytes decreased
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: 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: National Cancer Institute Common Toxicity Criteria (CTC v2.0; NCI 1998)
Maltese: Kriterji ta' Tossiċità Komuni tal-Istitut Nazzjonali tal-Kanċer (CTC; v2.0; NCI 1998)
English: Log Rank p-value* Overall response rate** (95 % CI)
Maltese: Log Rank p-value* Ir-rata ta' rispons globali** (95 % CI)
English: NSCLC, maintenance treatment:
Maltese: NSCLC, kura ta' manteniment:
English: IT A. Menarini Industrie Farmaceutiche Riunite s.r.l.
Maltese: Menarini Industrie Farmaceutiche Riunite s.r.l.
English: LV SIA Berlin-Chemie/Menarini Baltic Tel: +371 67103210
Maltese: LT SIA Berlin-Chemie/Menarini Baltic Tel: +371 67103210
English: CIAMBRA contains sodium
Maltese: CIAMBRA fih sodium
English: The percentage of patients that received post study treatment was 64.3% for pemetrexed and 71.7% for placebo.
Maltese: Ilpersentagg ta' pazjenti li rċevew kura wara l-istudju kien ta' 64.3% għal pemetrexed u 71.7% għal plaċebo.
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 bi Protokoll (PQProtocol Qualified).
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) tal-Istitut Nazzjonali tal-Kanċer għal kull Grad ta' Tossiċità.
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: NN: {number}
Maltese: Twaqqigħ ta' xagħar
English: Hydrochloric acid (pH adjustment) Sodium hydroxide (pH adjustment)
Maltese: Hydrochloric acid (għal aġġustament tal-pH) Sodium hydroxide (għal aġġustament tal-pH)
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 mogħti b'mod orali darbtejn kuljum (ara sezzjoni 4.4).
English: Efficacy parameter pemetrexed / cisplatin (N = 226)
Maltese: Parametru ta' effikaċja pemetrexed / cisplatin (N = 226)
English: Other undesirable effects include renal toxicities, increased aminotransferases, alopecia, fatigue, dehydration, rash, infection/sepsis and neuropathy.
Maltese: Effetti mhux mixtieqa oħra jinkludu tossiċitajiet renali, żieda fl-aminotransferases, alopeċja, għeja, diżidratazzjoni, raxx, infezzjoni/sepsis u newropatija.
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 sinifikanti fl-inċidenza ta' newtropenja ta' Grad 3/4 b'espożizzjoni itwal għal pemetrexed (≤6 ċikli: 3.3%, > 6ċikli: 6.4%: p=0.046).
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 minn 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: 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 mhux magħrufa (ma tistax tiġi stmata mid-dejta disponibbli).
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, 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 = 0.84-1.05).
English: PC: {number} SN: {number} NN: {number}
Maltese: Kanċer tal-pulmun mhux b'ċelluli żgħar
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 l-half-life taleliminazzjoni mill-plażma hija ta' 3.5 sigħat f'pazjenti b'funzjoni tal-kliewi normali (tneħħija talkreatinina ta' 90 ml/min).
English: 100 % of previous dose a
Maltese: 100 % tad-doża ta' qabel a
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: 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: 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 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.
English: CIAMBRA.
Maltese: GmbH.
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.