FrancophonIA/ELRC3.0 huggingface dataset:
English: Dispose
Maltese: Tqala
English: 30 pre-filled syringes of solvent 30 injection needles
Maltese: 30 siringa mimlija għal-lest ta' solvent 30 labra għall-injezzjoni
English: - SOMAVERT 30 mg: One vial of powder contains 30 mg pegvisomant.
Maltese: - SOMAVERT 30 mg: Kunjett wieħed bit-trab fih 30 mg ta' pegvisomant.
English: In clinical studies, for patients treated with pegvisomant (n=550), the majority of adverse reactions to pegvisomant were of mild to moderate intensity, of limited duration and did not require discontinuation of treatment.
Maltese: Fi studji kliniċi, għal dawk il-pazjenti ttrattati b'pegvisomant (n=550), il-maġġoranza tar-reazzjonijiet avversi għal pegvisomant kienu ħfief għal moderati, ta' żmien limitat u li ma ħtiġux li jitwaqqaf ittrattament.
English: A cohort of 38 acromegalic subjects has been followed in a long-term, open-label, dose-titration study for at least 12 consecutive months of daily dosing with pegvisomant (mean = 55 weeks).
Maltese: Ġemgħa ta' 38 pazjent akromegaliku ġew segwiti fi studju open label, fuq perjodu fit-tul, b'titrazzjoni tad-doża, għal mill-anqas 12-il xahar konsekuttiv ta' dożaġġ kuljum b'pegvisomant (medja = 55 ġimgħa).
English: 10 vials of powder
Maltese: 10 kunjetti ta' trab
English: Statistically significant differences from placebo (p<0.05) were observed for improvements in the total signs and symptoms score for all dose groups compared to placebo.
Maltese: Differenzi statistikament sinifikanti mill-plaċebo (p<0.05) ġew innutati għat-titjib fil-punteġġ totali tas-sinjali u s-sintomi għall-gruppi kollha li ħadu d-doża, kif imqabbla mal-plaċebo.
English: The active substance in SOMAVERT, pegvisomant is known as a growth hormone receptor antagonist.
Maltese: Is-sustanza attiva f'SOMAVERT, pegvisomant huwa magħruf bħala riċettur antagonista ta' l-ormon tat-tkabbir.
English: Remove syringe cap
Maltese: STRUZZJONIJIET GĦALL-UŻU
English: • All questions should be handled by a doctor, nurse or pharmacist familiar with SOMAVERT.
Maltese: • Il-mistoqsijiet kollha għandhom jiġu indirizzati minn tabib, infermer jew spiżjar li jkun familjari ma' SOMAVERT.
English: 1 pre-filled syringe of solvent 1 injection needle
Maltese: 1 siringa mimlija għal-lest ta' solvent 1 labra għall-injezzjoni
English: Nervous system disorders headache somnolence, tremor, dizziness, hypoaesthesia narcolepsy, migraine, dysgeusia
Maltese: Disturbi fis-sistema nervuża uġigħ ta' ras ngħas, rogħda, sturdament, ipoestesija narkolepsija, emigranja, togħma ħażina
English: - SOMAVERT 25 mg: One vial of powder contains 25 mg pegvisomant.
Maltese: - SOMAVERT 25 mg: Kunjett wieħed bit-trab fih 25 mg ta' pegvisomant.
English: SOLVENT PRE-FILLED SYRINGE
Maltese: dispnea spażmi tallarinġi
English: Psychiatric disorders abnormal dreams panic attack, short term memory loss, apathy, confusion, sleep disorder, libido increased anger
Maltese: attakk ta' paniku, telf tal-memorja għal perjodu qasir, apatija, konfużjoni, disturb flirqad, żieda fil-libido rabja
English: Inhibition of growth hormone action with pegvisomant leads to decreased serum concentrations of insulin-like growth factor-I (IGF-I), as well as other growth hormone-responsive serum proteins such as free IGF-I, the acid-labile subunit of IGF-I (ALS), and insulin-like growth factor binding protein-3 (IGFBP-3).
Maltese: L-inibizzjoni ta' l-azzjoni ta' l-ormoni tat-tkabbir permezz ta' pegvisomant tirriżulta fi tnaqqis talkonċentrazzjonijiet fis-serum tal-fattur tat-tkabbir li jixbah lill-insulina - I (IGF-I), kif ukoll proteini oħra tas-serum risponsivi għall-ormoni tat-tkabbir bħall-IGF-I ħieles, is-subunit ta' l-acid-labile IGF-I (ALS) u l-proteina 3 li tgħin lill-fattur tat-tkabbir jaqbad mar-riċetturi (tixbah l-insulina) (IGFBP-3).
English: Store the pre-filled syringe(s) below 30C or store in a refrigerator (2ºC - 8°C).
Maltese: Aħżen is-siringa mimlija għal-lest taħt 30C jew aħżen fi friġġ (2ºC - 8ºC).
English: Most injection site reactions characterised as localised erythemas and soreness, spontaneously resolved with local symptomatic treatment, while pegvisomant therapy continued.
Maltese: Ir-reazzjonijiet tas-siti ta' l-injezzjoni kienu l-aktar karatterizzati b'eritema lokali u uġiegħ, u tfejqu bi trattament sintomatiku lokali, filwaqt li terapija b'pegvisomant tkompliet.
English: • Determine if cholelithiasis or choledocholithiasis is present, particularly in patients with a history of prior therapy with somatostatin analogs.
Maltese: • Iddetermina jekk hemmx preżenti kolelitjażi jew koledokolitjażi, partikolarment f'pazjenti bi storja ta' terapija preċedenti b'analogi ta' somatostatin.
English: Common:
Maltese: Nota:
English: The 15 mg strength of the medicinal product contains 0.4 mg of sodium per vial of powder.
Maltese: Il-qawwa ta' 15 mg tal-prodott mediċinali fih 0.4 mg ta' sodium għal kull kunjett ta' trab.
English: - SOMAVERT 10 mg: One vial of powder contains 10 mg pegvisomant.
Maltese: - SOMAVERT 10 mg: Kunjett wieħed bit-trab fih 10 mg ta' pegvisomant.
English: Pharmacokinetic properties
Maltese: .1 Proprjetajiet farmakodinamiċi
English: - SOMAVERT 15 mg: One vial of powder contains 15 mg pegvisomant.
Maltese: - SOMAVERT 15 mg: Kunjett wieħed bit-trab fih 15 mg ta' pegvisomant.
English: Table B. Clinical recommendations based on abnormal liver test results while on SOMAVERT
Maltese: Tabella B. Rakkomandazzjonijiet kliniċi abbażi ta' riżultati tat-test tal-fwied anormali waqt fuq SOMAVERT
English: 1 ml of solvent, 1 ml of the solution contains 20 mg pegvisomant.
Maltese: Wara rikostituzzjoni, 1 mL ta' soluzzjoni jkollu 20 mg pegvisomant.*
English: Inject medicine
Maltese: TAL-PRODOTT MEDIĊINALI
English: Respiratory, thoracic and mediastinal disorders dyspnoea laryngospasmb
Maltese: Disturbi respiratorji, toraċiċi u medjastinali:
English: • If LTs normalize (regardless of whether an alternative cause of the liver dysfunction is discovered), consider cautious reinitiation of therapy with SOMAVERT, with frequent LT monitoring.
Maltese: • Jekk l-LTs jinnormalizzaw (irrispettivament jekk tiġix skoperta kawża alternattiva tad-disfunzjoni tal-fwied), ikkunsidra bidu mill-ġdid kawtel ta' terapija b'SOMAVERT, b'monitoraġġ frekwenti tal-LT.
English: Patients receiving insulin or oral hypoglycaemic medicinal products may require dose reduction of these active substances due to the effect of pegvisomant on insulin sensitivity (see section 4.4).
Maltese: Il-pazjenti li jkunu qed jieħdu l-insulina jew prodotti mediċinali ipoglikemiċi orali jista' jkollhom bżonn ta' tnaqqis fid-doża ta' dawn is-sustanzi attivi minħabba l-effett ta' pegvisomant fuq issensittività ta' l-insulina (ara sezzjoni 4.4).
English: The 25 mg strength of the medicinal product contains 0.5 mg of sodium per vial of powder.
Maltese: Il-qawwa ta' 25 mg tal-prodott mediċinali fih 0.4 mg ta' sodium għal kull kunjett ta' trab.
English: 1 ml of solvent, 1 ml of the solution contains 25 mg pegvisomant.
Maltese: Wara rikostituzzjoni, 1 mL ta' soluzzjoni jkollu 25 mg pegvisomant.*
English: The therapeutic benefits of a reduction in IGF-I concentration which results in improvement of the patient's clinical condition could potentially increase fertility in female patients.
Maltese: Il-benefiċċji terapewtiċi ta' tnaqqis fil-konċentrazzjoni ta' IGF-I, li jirriżulta f'titjib fil-kundizzjoni klinika tal-pazjent, jistgħu potenzjalment iżidu l-fertilità f'pazjenti femminili.
English: Cardiac disorders oedema peripheral
Maltese: Disturbi fil-qalb edema periferali
English: SOMAVERT is injected under the skin.
Maltese: SOMAVERT huwa injettat taħt il-ġilda.
English: 1 ml of solvent, 1 ml of the solution contains 30 mg pegvisomant.
Maltese: Wara rikostituzzjoni, 1 mL ta' soluzzjoni jkollu 30 mg pegvisomant.*
English: The mean extent of absorption of a subcutaneous dose was 57% relative to an intravenous dose.
Maltese: L-ammont medju ta' assorbiment ta' doża taħt il-ġilda kien ta' 57% relattiv għal doża fil-vini.
English: Signs or symptoms suggestive of hepatitis or other liver injury (e.g., jaundice, bilirubinuria, fatigue, nausea, vomiting, right upper quadrant pain, ascites, unexplained edema, easy bruisability)
Maltese: Sinjali jew sintomi li jindikaw epatite jew ħsara oħra fil-fwied (eż., suffejra, bilirubinurja, għeja, dardir, rimettar, uġigħ fil-kwadrant tan-naħa ta' fuq tal-lemin, axxite, edema bla spjegazzjoni, tbenġil malajr)
English: Note: You will hear a click when the needle guard has been locked.
Maltese: Nota: Se tisma' ħoss ta' klikk meta l-għatu ta' protezzjoni tal-labra jitwaħħal.
English: • Headache
Maltese: • Rabja
English: 1 ml of solvent, 1 ml of the solution contains 10 mg pegvisomant.
Maltese: Wara rikostituzzjoni, 1 mL ta' soluzzjoni jkollu 10 mg pegvisomant.*
English: • Abnormal sense of taste, migraine.
Maltese: • Sens tal-mess, sens abnormali tat-togħma, emigranja.
English: SOMAVERT 25 mg powder for injection pegvisomant SC
Maltese: SOMAVERT 25 mg trab għal injezzjoni pegvisomant SC
English: SOMAVERT 20 mg powder for injection pegvisomant SC
Maltese: SOMAVERT 20 mg trab għal injezzjoni pegvisomant SC
English: Excipient with known effect The 10 mg strength of the medicinal product contains 0.4 mg of sodium per vial of powder.
Maltese: Il-qawwa ta' 10 mg tal-prodott mediċinali fih 0.4 mg ta' sodium għal kull kunjett ta' trab.
English: One vial contains 10 mg pegvisomant After reconstitution, 1 ml of solution contains 10 mg pegvisomant
Maltese: Kull kunjett fih 10 mg ta' pegvisomant.Wara rikostituzzjoni, 1 mL ta' soluzzjoni jkollu 10 mg pegvisomant.*
English: SOMAVERT 30 mg powder for injection pegvisomant SC
Maltese: SOMAVERT 30 mg trab għal injezzjoni pegvisomant SC
English: Add liquid
Maltese: Żid il-likwidu
English: SOMAVERT 25 mg powder and solvent for solution for injection pegvisomant
Maltese: SOMAVERT 25 mg trab u solvent għal soluzzjoni għal injezzjoni pegvisomant
English: Symptoms of a serious allergic reaction may include one or more of the following: swelling of the face, tongue, lips, or throat; wheezing or trouble breathing (spasm of the larynx); generalized skin rash, nettle rash (urticaria) or itching; or dizziness.
Maltese: Sintomi ta' reazzjoni allerġika serja jistgħu jinkludu wieħed jew aktar minn dawn li ġejjin: nefħa tal-wiċċ, ilsien, xufftejn, jew gerżuma; tħarħir jew problemi biex tieħu n-nifs (spażmu tallarinġi); raxx ġeneralizzat tal-ġilda, ħorriqija (urtikarja) jew ħakk; jew sturdament.
English: Two weeks after stopping treatment, leukocytosis and moderate bleeding from injection and vein puncture sites was observed which were considered possibly related to pegvisomant.
Maltese: Ġimagħtejn wara li twaqqaf ittrattament, ġew innutati lewkoċitożi u telf moderat ta' demm fejn kien ġie injettat il-pazjent, inkluż mill-vini, liema effetti kienu konsiderati bħala possibbilment relatati ma' pegvisomant.
English: List of excipients
Maltese: 6.1 Lista ta' eċċipjenti
English: • Only mix Somavert and the solvent when you are ready to inject your dose.
Maltese: • Ħallat Somavert u s-solvent biss meta tkun lest biex tinjetta d-doża.
English: SOMAVERT 30 mg powder and solvent for solution for injection pegvisomant
Maltese: SOMAVERT 30 mg trab u solvent għal soluzzjoni għal injezzjoni pegvisomant
English: Serum IGF-I concentrations should be monitored and maintained within the age-adjusted normal range by adjustment of the pegvisomant dose.
Maltese: Il-konċentrazzjonijiet ta' IGF-I fis-serum għandhom jiġu sorveljati u miżmuma fil-medda normali determinata bl-età, b'aġġustament fid-doża ta' pegvisomant.
English: SOMAVERT 10 mg powder for injection pegvisomant SC
Maltese: SOMAVERT 10 mg trab għal injezzjoni pegvisomant SC
English: SOMAVERT 10 mg powder and solvent for solution for injection pegvisomant
Maltese: SOMAVERT 10 mg trab u solvent għal soluzzjoni għal injezzjoni pegvisomant
English: SOMAVERT 15 mg powder for injection pegvisomant SC
Maltese: SOMAVERT 15 mg trab għal injezzjoni pegvisomant SC
English: Vascular disorders hypertension
Maltese: virga tal-planġer
English: • Perform a comprehensive hepatic workup, including serial LTs, to determine if and when serum levels return to normal.
Maltese: • Wettaq studju dijanjostiku tal-fwied komprensiv, inkluż LTs serjali, biex tiddetermina jekk u meta l-livelli fis-serum jirritornaw għan-normal.
English: • Constipation, feeling sick, being sick, feeling bloated, indigestion, gas.
Maltese: • Stitikezza, sensazzjoni ta' dardir, dardir, sensazzjoni ta' nefħa, indiġestjoni, gass.
English: One vial contains 25 mg pegvisomant After reconstitution, 1 ml of solution contains 25 mg pegvisomant
Maltese: Kunjett fih 25 mg pegvisomant Wara r-rikostituzzjoni, 1 ml ta' soluzzjoni jkun fih 25 mg ta' pegvisomant
English: • Dry mouth, increased saliva, tooth problems, haemorrhoids.
Maltese: • Ħalq xott, żieda fis-saliva, problemi fis-snien, murliti.
English: SOMAVERT 20 mg powder and solvent for solution for injection pegvisomant
Maltese: SOMAVERT 20 mg trab u solvent għal soluzzjoni għal injezzjoni pegvisomant
English: In the week following discontinuation of treatment the adverse reactions noted were: insomnia, increased fatigue, oedema peripheral, tremor, and weight gain.
Maltese: Fil-ġimgħa ta' wara li twaqqaf it-trattament, ir-reazzjonijiet avversi nnutati ki enu: insomnja, għeja akbar, edema periferali, rogħda, u żieda fil-piż.
English: Excipient with known effect: The 20 mg strength of the medicinal product contains 0.4 mg of sodium per vial of powder.
Maltese: Il-qawwa ta' 20 mg tal-prodott mediċinali fih 0.4 mg ta' sodium għal kull kunjett ta' trab.
English: The list below contains adverse reactions seen in clinical trials or that were spontaneously reported, classified by system organ class and frequency.
Maltese: Reazzjonijiet avversi li rriżultaw waqt provi kliniċi jew li kienu rrapurtati b'mod spontanju huma mniżżla fil-lista t'hawn taħt bis-sistema tal-klassifika tal-organi u l-frekwenza.
English: The pre-filled solvent syringe may be stored at room temperature.
Maltese: Is-siringa(i) tas-solvent mimlija minn qabel tista' tinħażen f'temperatura tal-kamra.
English: Insert needle
Maltese: Ż-ŻGHAR EWLENIN
English: Blood and lymphatic system disorders thrombocytopenia, leukopenia, leukocytosis, haemorrhagic diathesis
Maltese: Disturbi fil-kliewi u fissistema urinarja ħematurja proteinurja, poliurja, indeboliment tal-kliewi
English: Malignant fibrous histiocytomas associated with fibrosis and histiocytic inflammation were observed at injection sites in males in the rat carcinogenicity study at exposure levels equivalent to three times the human exposure based on mean plasma concentrations in two long-term studies at a daily dose of 30 mg.
Maltese: Histiocytomas fibrotiċi malinni assoċjati ma' fibrożi u infammazzjoni tat-tip histiocytic kienu osservati fis-siti ta' l-injezzjoni fis-sess maskili, fl-istudju ta' karċinoġeniċità tal-far, b'livelli ta' esponiment tal-mediċina ekwivalenti għal tlett darbiet ogħla minn dik fil-bnedmin, hekk kif inhi bbażata fuq konċentrazzjonijiet medji fil-plażma minn żewġ studji fuq żmien twil b'doża ta' 30mg kuljum.
English: Excipient with known effect The 30 mg strength of the medicinal product contains 0.6 mg of sodium per vial of powder.
Maltese: Il-qawwa ta' 30 mg tal-prodott mediċinali fih 0.4 mg ta' sodium għal kull kunjett ta' trab.
English: SOMAVERT 15 mg powder and solvent for solution for injection pegvisomant
Maltese: SOMAVERT 15 mg trab u solvent għal soluzzjoni għal injezzjoni pegvisomant
English: Therapeutic indications
Maltese: 4.3 Kontraindikazzjonijiet
English: Baseline LT Levels
Maltese: Akbar minn 3 darbiet l-ULN
English: • A vial of Somavert powder.
Maltese: • Jistgħu jiġu kkurati b'SOMAVERT.
English: These can be seen in the results of blood tests.
Maltese: DATA TA' REVIŻJONI TAT-TEST
English: Pegvisomant is slowly eliminated from serum, with mean estimates of half-life generally ranging from 74 to 172 hours following either single or multiple-doses.
Maltese: Pegvisomant jiġi mneħħi bil-mod mis-serum, bl-istimi medji tal-half-life ġeneralment ivarjaw minn 74 sa 172 siegħa kemm wara doża waħdanija jew wara dożi multipli.
English: The liquid comes in a pre-filled syringe labeled ‘Solvent for SOMAVERT'.
Maltese: Tużax kwalunkwe likwidu ieħor sabiex tħallat ma' Somavert.
English: • Facial swelling, dry skin, night sweats, redness of the skin (erythema), raised itchy bumps on the skin (urticaria).
Maltese: • Nefħa fil-wiċċ, ġilda xotta, għaraq bil-lejl, ħmura fil-ġilda (eritrema), ponot li jqabbdu l-ħakk fuq il-ġilda (urtikarja).
English: Pegvisomant is a potent antagonist of growth hormone action.
Maltese: Pegvisomant hu antagonist qawwi kontra l-azzjoni ta' l-ormoni tat-tkabbir.
English: One vial contains 20 mg pegvisomant After reconstitution, 1 ml of solution contains 20 mg pegvisomant
Maltese: Kunjett fih 20 mg pegvisomant Wara r-rikostituzzjoni, 1 ml ta' soluzzjoni jkun fih 20 mg ta' pegvisomant
English: SOMAVERT contains sodium
Maltese: SOMAVERT fih is-sodium
English: • A pre-filled syringe with solvent.
Maltese: • Siringa mimlija għal-lest bis-solvent.
English: Since serum concentrations of therapeutically-effective doses of this medicine are generally 100 to 1000 times higher than the actual serum growth hormone concentrations seen in acromegalics, measurements of serum growth hormone concentrations will be spuriously reported in commercially available growth hormone assays.
Maltese: Peress li l-konċentrazzjonijiet fis-serum ta' dożi ta' din il-mediċina li huma terapewtikament effettivi, huma ġeneralment minn 100 sa 1000 darba ogħla mill-konċentrazzjonijiet attwali ta' l-ormoni tat-tkabbir fis-serum kif jirriżultaw f'akromegaliċi, f'assays ta' ormoni tat-tkabbir li jinsabu fis-suq, il-kejl tal-konċentrazzjoni ta' l-ormoni tat-tkabbir jiġi rrappurtat b'mod falz.
English: Treatment of adult patients with acromegaly who have had an inadequate response to surgery and/or radiation therapy and in whom an appropriate medical treatment with somatostatin analogues did not normalize IGF-I concentrations or was not tolerated.
Maltese: Trattament ta' pazjenti adulti b'akromegalija li kellhom reazzjoni mhux tajba biżżejjed (inadegwata) għall-kirurġija u/jew għat-terapija ta' radjazzjoni,fejn trattament mediku xieraq bi prodotti analogi ta' somatostatin ma nnormalizzawx il-konċentrazzjonijiet ta' IGF-I jew ma ġiex ittollerat.
English: The pharmacokinetics of pegvisomant are similar in normal healthy volunteers and acromegaly patients, although heavier individuals tend to have a higher total body clearance of pegvisomant than lighter individuals, and may thus require greater doses of pegvisomant.
Maltese: Il-farmakokinetika ta' pegvisomant hija simili fil-każ ta' voluntiera normali b'saħħithom u pazjenti akromegaliċi, għalkemm individwi ta' piż akbar ikollhom it-tendenza ta' tneħħija totali akbar ta' pegvisomant mill-ġisem, minn individwi ta' piż inqas u għalhekk jista' jkollhom bżonn ta' dożi akbar ta' pegvisomant.
English: Pegvisomant is highly selective for the GH receptor, and does not cross-react with other cytokine receptors, including prolactin.
Maltese: Pegvisomant huwa selettiv ħafna għar-riċettur GH u ma jagħmilx reazzjoni ma' riċetturi cytokine oħra, inkluż prolaktin.
English: Renal and urinary disorders haematuria proteinuria, polyuria, renal impairment
Maltese: IL-KONTENUT SKONT IL-PIŻ, IL-VOLUM, JEW PARTI
English: General disorders and administration site conditions injection site reaction (including injection site hypersensitivity), injection site bruising or bleeding, injection site hypertrophy (e.g. lipohypertro phy)
Maltese: Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata reazzjoni fis-sit ta' l-injezzjoni (inkluża reazzjoni ta' ipersensittivita fis-sit ta' linjezzjoni), tbenġil jew telf ta' demm fis-sit ta' linjezzjoni, ipertrofija fis-sit ta' l-injezzjoni (eż. lipoipertrofija)
English: The mean total body systemic clearance of pegvisomant following multiple doses is estimated to be 28 ml/h for subcutaneous doses ranging from 10 to 20 mg/day.
Maltese: Il-medja totali tat-tneħħija sistemika mill-ġisem ta' pegvisomant wara dożi multipli, hi stmata li hija ta' 28 ml fis-siegħa għal dożi ta' taħt il-ġilda ta' bejn 10 u 20 mg kuljum.
English: At least 5 times ULN, or transaminase elevations at least 3 times ULN associated with any increase in serum TBIL (with or without signs/symptoms of hepatitis or other liver injury)
Maltese: Tal-inqas 5 darbiet l-ULN, jew livelli għoljin ta' transaminase tal-inqas 3 darbiet l-ULN assoċjati ma' xi żieda fit-TBIL fis-serum (bi jew mingħajr sinjali/sintomi ta' epatite jew ħsara oħra fil-fwied)
English: If you inject more SOMAVERT than you should If you accidentally inject more SOMAVERT than told to by your doctor it is unlikely to be serious, but you should contact your doctor, pharmacist or nurse immediately.
Maltese: Jekk aċċidentalment tinjetta Somavert aktar milli qallek it-tabib, mhux probabbli li tkun xi ħaġa serja, iżda għandek tkellem lit-tabib, lill-ispiżjar jew lill-infermier tiegħek immedjatament.
English: • Serum concentrations of ALT and AST should be monitored at 4- to 6-week intervals for the first 6 months of treatment with SOMAVERT, or at any time in patients exhibiting symptoms suggestive of hepatitis.
Maltese: • Jekk ikollok disturbi fil-vista jew uġigħ ta' ras meta tuża SOMAVERT inti trid tikkuntattja littabib tiegħek immedjatament.
English: 2132NP Hoofddorp Netherlands
Maltese: 2132 NP Hoofddorp In-Netherlands
English: Risk Diff (M vs. V)
Maltese: Diff fir-Riskju (M vs. V)
English: 100-1 Hagiwara-machi, Takasaki-shi, Gunma, 370-0013, Japan
Maltese: 100-1 Hagiwara-machi, Takasaki-shi Gunma, 370-0013, Il-Ġappun
English: CI=confidence interval; CR=complete response; PR=partial response
Maltese: CI=intervall ta' kunfidenza; CR=rispons komplet; PR=rispons parzjali
English: Kyowa Kirin Co., Ltd.
Maltese: Kyowa Kirin Co.
English: Response Rate (n, %)
Maltese: Rata ta' Rispons (n, %)
English: Overall response rate (ORR), n (%) Compartment:
Maltese: Rata ta' rispons globali (ORR), n Kompartiment:
English: Nodal (n) Response Rate (n, %) 95% CIa M=mogamulizumab.
Maltese: Nodali (n) Rata ta' Rispons (n, %) 95% CIa M=mogamulizumab. V= vorinostat
English: Response Rate (n, %) 95% CIa
Maltese: Ġilda (n) Rata ta' Rispons (n, %) 95% CIa
English: The most common prior systemic therapies used by subjects in Europe were bexarotene (70%), interferon (59%), methotrexate (49%), extracorporeal photopheresis (ECP) (31%) and gemcitabine/gemcitabine regimens (28%).
Maltese: L-aktar terapiji sistemiċi komuni preċedenti użati mill-individwi fl-Ewropa kienu bexarotene (70%), interferon (59%), methotrexate (49%), fotopheresi extrakorporali (ECP) (31%) u reġimi ta' gemcitabine/gemcitabine (28%).
English: Northumberland Morpeth
Maltese: Whalton Road Morpeth
English: Figure 1: Plot of Kaplan-Meier curve of progression-free survival by investigator's assessment (ITT) population
Maltese: Figura 1: Plot tal-kurva Kaplan-Meier ta' sopravivenza mingħajr progressjoni skont il valutazzjoni tal-investigatur tal-popolazzjoni (ITT)
English: Store in a refrigerator (2ºC to 8ºC).
Maltese: Aħżen fi friġġ (2ºC - 8ºC).
English: Blood (n)
Maltese: Demm (n)
English: At study baseline, 38% had stage IB-II disease, 10% stage III, 52% stage IV.
Maltese: Fil-linja bażi tal-istudju, 38% kellhom mard fi stadju IB-II, 10% fl-istadju III, 52% fl-istadju IV.
English: See section 2 “POTELIGEO contains sodium”.
Maltese: Ara sezzjoni 2 “POTELIGEO fih is-sodju”.
English: Table 2: Response during randomised treatment period in study 0761-010 (intent-to-treat)
Maltese: Tabella 2: Rispons waqt perjodu ta' kura randomizzat fi studju 0761-010 (intenzjoni li tingħata kura)
English: Median PFS for the mogamulizumab group was 7.70 months (95% CI: 5.67, 10.33) and 3.10 months (95% CI: 2.87, 4.07) for the vorinostat group with resultant hazard ration of 0.53 (95% CI: 0.41, 0.69), p<0.0001 (2sided, stratified log rank test).
Maltese: 33) u ta' 3.10 xhur (95% CI: 2.87, 4.07) għall-grupp ta' vorinostat bi proporzjon ta' periklu riżultanti ta' 0.53 (95% CI: 0.41, 0.69), p<0.0001 (test log rank stratifikat b'żewġ naħat).