FrancophonIA/ELRC3.0 huggingface dataset:
English: The MMR rate at 12, 24, 36, 48, 60 and 72 months is presented in Table 7.
Maltese: Ir-rata tal-MMR fit-12, l-24, is-36, t-48, s-60 u t-72 xahar qed tidher f'Tabella 7.
English: The median time on treatment with nilotinib was 13.80 months (range: 0.7-30.9 months).
Maltese: Iż-żmien medjan tat-trattament b'nilotinib kien ta' 13.80 xhur (medda: 0.7-30.9 xhur).
English: Clinical studies have excluded patients with alanine transaminase (ALT) and/or aspartate transaminase (AST) >2.5 (or >5, if related to disease) times the upper limit of the normal range and/or total bilirubin >1.5 times the upper limit of the normal range.
Maltese: Studji kliniċi eskludew pazjenti b'alanine transaminase (ALT) u/jew aspartate transaminase (AST) >2.5 (jew >5, jekk relatat mal-marda) darbiet aktar fuq il-limitu ta' fuq tal-medda normali u/jew bilirubin totali ta' >1.5 darbiet aktar fuq il-limitu ta' fuq tal-medda normali.
English: Based on the Kaplan-Meier analysis of time to first MMR the probability of achieving MMR at different time points was higher for both nilotinib at 300 mg and 400 mg twice daily compared to imatinib 400 mg once daily (HR=2.17 and stratified log-rank p<0.0001 between nilotinib 300 mg twice daily and imatinib 400 mg once daily, HR=1.88 and stratified log-rank p<0.0001 between nilotinib 400 mg twice daily and imatinib 400 mg once daily).
Maltese: Skont l-analiżi tal-ħin Kaplan-Meier għall-ewwel MMR il-probabbiltà li jinkiseb MMR f'time-points differenti kienet aktar fil-każ ta' 300 mg u 400 mg nilotinib darbtejn kuljum meta mqabbel ma' 400 mg imatinib darba kuljum (HR=2.17 u log-rank stratifikat ta' p<0.0001 bejn 300 mg nilotinib darbtejn kuljum u 400 mg imatinib darba kuljum, HR=1.88 u log-rank stratifikat ta' p<0.0001 bejn 400 mg nilotinib darbtejn kuljum u 400 mg imatinib darba kuljum).
English: Among resistant or intolerant CML patients, the percentage of patients who achieved BCR-ABL/ABL ≤0.01% IS (MR4.0) by the cut-off date was 11.4%, while 4.5% of the patients achieved BCR-ABL/ABL ≤0.0032% IS (MR4.5).
Maltese: Fost il-pazjenti b'CML reżistenti jew intolleranti, il-perċentwali ta' pazjenti li kisbu BCR-ABL/ABL ≤0.01% IS (MR4.0) sal-aħħar data kienet ta' 11.4%, filwaqt li 4.5% tal-pazjenti kisbu BCR-ABL/ABL ≤0.0032% IS (MR4.5).
English: Treatment-free Survival (%)
Maltese: Sopravivenza ħielsa minn Trattament (%)
English: The safety of nilotinib in paediatric patients (from 2 to <18 years of age) with Philadelphia chromosome positive CML in chronic phase (n=69) has been investigated in two studies (see section 5.1).
Maltese: Is-sigurtà ta' nilotinib f'pazjenti pedjatriċi (minn sentejn sa <18-il sena) pożittivi għall-kromosoma ta' Filadelfja b'CML fil-fażi kronika (n=69) ġew investigati f'żewġ studji (ara sezzjoni 5.1).
English: The overall confirmed HR rate in 137 AP patients was 50%.
Maltese: Ir-rata globali ta' HR konfermata f'137 tal-pazjenti AP kienet 50%.
English: Ischaemic stroke, cerebral infarction, migraine, paraestheisa
Maltese: Puplesija iskemika, infart ċerebrali, emikranja, parasteżija
English: 40 hard capsules
Maltese: 40 kapsula iebsa
English: Fluid retention and oedema
Maltese: Retenzjoni fluwida u edima
English: MMR was defined as ≤0.1% BCR-ABL/ABL% by international scale (IS) measured by RQ-PCR, which corresponds to a ≥3 log reduction of BCR-ABL transcript from standardised baseline.
Maltese: L-MMR kien definit bħala ≤0.1% BCR-ABL/ABL% skont skala internazzjonali (IS) mkejla b'RQ-PCR, li jikkorrispondi għal riduzzjoni ≥ log 3 tat-traskrizzjoni BCR-ABL mil-linja bażi standardizzata.
English: Up to 0.32 m
Maltese: 32 m
English: Component of a multipack comprising 3 cartons.
Maltese: Komponent tal-pakkett b'ħafna li fih 3 kartuniet.
English: In 22 CP patients evaluated for efficacy nilotinib induced a 32% MCyR rate and a 50% CHR rate.
Maltese: F'22 pazjent CP evalwati għall-effikaċja Nilotinib inudċit rata ta MCyR ta' 32% u rata ta' CHR ta' 50%.
English: A black imprint is stamped on each hard capsule (“NVR/ABL”).
Maltese: Timbru iswed huwa stampat fuq kull kapsula iebsa (“NVR/ABL”).
English: 28 hard capsules.
Maltese: 28 kapsula iebsa.
English: Complete cytogenetic response (CCyR) was defined as 0% Ph+ metaphases in the bone marrow based on a minimum of 20 metaphases evaluated.
Maltese: Ir-rispons ċitoġenetiku sħiħ (CCyR) kien definit bħala 0% Ph+ metafażijiet fil-mudullun imsejjes fuq minimu ta' 20 metafażi evalwata.
English: Reproductive toxicity and fertility studies
Maltese: Studji dwar it-tossiċità riproduttiva u l-fertilità
English: This study suggests that a clinically meaningful drug-drug interaction between nilotinib and warfarin is less likely up to a dose of 25 mg of warfarin.
Maltese: Dan l-istudju jissuġġerixxi li mhuwiex probabbli li jkun interazzjoni klinikament sinifikanti bejn nilotinib u warfarin sa doża ta' 25 mg warfarin.
English: ANNEX III
Maltese: III)
English: A single-dose drug-drug interaction study in healthy volunteers with 25 mg warfarin, a sensitive CYP2C9 substrate, and 800 mg nilotinib did not result in any changes in warfarin pharmacokinetic parameters or warfarin pharmacodynamics measured as prothrombin time (PT) and international normalised ratio (INR).
Maltese: Waqt studju fost voluntiera b'saħħithom li ngħataw doża waħda b'interazzjoni bejn il-mediċini jiġifieri 25 mg warfarin, substrat sensittiv ta' CYP2C9, u 800 mg nilotinib ma ġabx xi tibdil fil-parametri farmakokinetiċi ta' warfarin jew fil-farmakodinamiċità ta' warfarin kif imkejla skont il-ħin ta' protrombin (PT) u l-proporzjon normalizzat internazzjonali (INR).
English: 28 hard capsules
Maltese: 28 kapsula iebsa
English: Imatinib-resistant or intolerant CML-CP and CML-AP 400 mg twice daily n=279
Maltese: Pazjenti reżistenti għal imatinib jew CML-CP u CML-AP intolleranti 400 mg darbtejn kuljum n=279
English: QTcF of >500 msec was observed in <1% of these patients.
Maltese: QTcF ta' >500 msek dehret f'<1% ta' dawn il-pazjenti.
English: Cardiac failure, cyanosis
Maltese: Insuffiċjenza kardijaka, ċjanożi
English: Tasigna hard capsules contain lactose.
Maltese: Il-kapsuli ibsin Tasigna fihom lattosju.
English: Hepatotoxicity, toxic hepatitis, jaundice
Maltese: Epatotossiċità, epatite tossika, suffejra
English: Treatment with nilotinib is associated with (National Cancer Institute Common Toxicity Criteria grade 3-4) thrombocytopenia, neutropenia and anaemia.
Maltese: Il-kura b'nilotinib hija assoċjata ma' (Kriterji dwar it-Tossiċità Komuni tal-Istitut Nazzjonali tal-Kanċer grad 3-4) tromboċitopenja, newtropenja u anemija.
English: Musculoskeletal and connective tissue disorders Myalgia
Maltese: Disturbi muskoluskeletriċi u tat-tessuti konnettivi Mijalġja
English: Amnesia, dysphoria Nervous system disorders Common:
Maltese: Amneżija, disforja Disturbi fis-sistema nervuża Komuni:
English: The juvenile animals did not exert increased sensitivity to nilotinib relative to adults.
Maltese: L-annimali mhux adulti ma wrewx żieda fis-sensittività għal nilotinib relattiv għall-adulti.
English: Nilotinib 300 mg twice daily n=282
Maltese: Nilotinib 300 mg darbtejn kuljum n=282
English: Chronic phase n=321
Maltese: Fażi kronika n=321
English: The KM estimate of median treatment-free survival (TFS) has not yet been reached (Figure 4); 99 of 190 patients (52.1%) did not have a TFS event.
Maltese: Iż-żmien medju stmat skont il-KM ta' sopravivenza ħielsa minn trattament (TFS) għandu ma ntlaħaqx (Figura 4); 99 mill-190 pazjent (52.1%) ma kellhomx episodju ta' TFS.
English: Patients with a CHR at baseline achieved a MCyR faster (1.9 versus 2.8 months).
Maltese: Pazjenti b'CHR fil-linja bażi kisbu MCyR aktar malajr (1.9 kontra 2.8 xhur).
English: Manufacturer
Maltese: Reżistenti
English: - 392 (14 packs of 28) hard capsules.
Maltese: - 392 kapsula iebsa (14-il pakkett ta' 28).
English: Nilotinib has been evaluated in safety pharmacology, repeated dose toxicity, genotoxicity, reproductive toxicity, phototoxicity and carcinogenicity (rats and mice) studies.
Maltese: Nilotinib ġie evalwat fi studji ta' sigurtà farmakoloġika, kif ukoll dwar tossiċità minn dożi ripetuti, ġenotossiċità, tossiċità fis-sistema riproduttiva, studji fototossiċi u dwar il-karċinoġenità (firien u annimali).
English: Concomitant treatment with strong CYP3A4 inhibitors, including ketoconazole, itraconazole, voriconazole, ritonavir, clarithromycin, and telithromycin, should therefore be avoided (see section 4.4).
Maltese: Il-kura fl-istess ħin ma' inibituri qawwija ta' CYP3A4, inklużi ketoconazole, itraconazole, voriconazole, ritonavir, clarithromycin, u telithromycin għalhekk għandha tiġi evitata (ara sezzjoni 4.4).
English: Dizziness, peripheral neuropathy, hypoaesthesia, paraesthesia
Maltese: Sturdament, newropatija periferali, ipoesteżija, parasteżija
English: Nilotinib did not have effects on CNS or respiratory functions.
Maltese: Nilotinib ma kellux effetti fuq is-CNS jew funzjonijiet respiratorji.
English: Unchanged nilotinib accounted for 69% of the dose.
Maltese: Nilotinib mhux mibdul kien jammonta għal 69% tad-doża.
English: PVC/PVDC/Alu blisters
Maltese: Folji tal-PVC/PVDC/Alu
English: Of these patients 30/36 (83%) were treatment resistant not intolerant.
Maltese: Minn dawn il-pazjenti 30/36 (83%) kienu reżistenti għall-kura u mhux intolleranti.
English: The hard capsule shell is composed of gelatin, titanium dioxide (E171), yellow iron oxide (E172) and, shellac (E904), dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, potassium hydroxide and red iron oxide (E172) for stamping of the imprint.
Maltese: Il-qoxra tal-kapsula iebsa hija magħmula minn gelatin, titanium dioxide (E171), yellow iron oxide (E172) u, shellac (E904), dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, potassium hydroxide u red iron oxide (E172) għat-timbrar tat-timbru.
English: This includes in particular: - anti-arrhythmics - used to treat irregular heart beat; - chloroquine, halofantrine, clarithromycin, haloperidol, methadone, moxifloxacin - medicines that may have an unwanted effect on the electrical activity of the heart; - ketoconazole, itraconazole, voriconazole, clarithromycin, telithromycin - used to treat infections; - ritonavir - a medicine from the class “ antiproteases” used to treat HIV; - carbamazepine, phenobarbital, phenytoin - used to treat epilepsy; - rifampicin - used to treat tuberculosis; - St. John's Wort - a herbal product used to treat depression and other conditions (also known as
Maltese: Dan jinkludi b'mod partikolari: - antiarritmiċi - li jintużaw għall-kura ta' meta l-qalb ma tħabbatx regolari; - chloroquine, halofantrine, clarithromycin, haloperidol, methadone, moxifloxacin - mediċini li jista' jkollhom effett mhux mixtieq fuq l-attività elettrika tal-qalb; - ketoconazole, itraconazole, voriconazole, clarithromycin, telithromycin - jintużaw għall-kura ta' infezzjonijiet; - ritonavir - mediċina mill-klassi “antiproteażi” li tintuża għall-kura tal-HIV; - carbamazepine, phenobarbital, phenytoin - jintużaw għall-kura tal-epilessija; - rifampicin - jintuża għall-kura tat-tuberikulożi;
English: Oral papilloma, paraproteinaemia Blood and lymphatic system disorders Common:
Maltese: Papilloma orali, paraproteinemija Disturbi tad-demm u tas-sistema limfatika Komuni:
English: Nervous system disorders
Maltese: Disturbi fis-sistema endokrinarja
English: Imatinib 400 mg once daily (n = 283)
Maltese: Imatinib 400 mg darba kuljum (n = 283)
English: Increases in total serum cholesterol levels have been reported with nilotinib therapy (see section 4.4).
Maltese: Kienu rrappurtati żidiet fil-livelli totali tal-kolesterol fis-serum b'terapija b'nilotinib (ara sezzjoni 4.4).
English: Musculoskeletal and connective tissue disorders Common:
Maltese: Disturbi muskoluskeletriċi u tat-tessuti konnettivi Komuni:
English: Renal failure, haematuria, urinary incontinence, chromaturia Reproductive system and breast disorders Uncommon:
Maltese: Insuffiċjenza renali, ematurja, inkontinenza tal-awrina, kromaturja Disturbi fis-sistema riproduttiva u fis-sider Mhux komuni:
English: The Kaplan-Meier (KM) estimated median time on nilotinib to regain MR4.0 and MR4.5 was 12.0 weeks (95% CI: 8.3, 12.7) and 13.1 weeks (95% CI: 12.4, 16.1), respectively.
Maltese: Iż-żmien medju stmat skont il-Kaplan-Meier (KM) għal pazjenti ttrattati b'nilotinib sabiex jiksbu mill-ġdid MR4.0 u MR4.5 kien ta' 12.0 ġimgħat (95% CI: 8.3, 12.7) u 13.1 ġimgħat (95% CI: 12.4, 16.1), rispettivament.
English: Dose in mg (twice daily)
Maltese: Doża f'mg (darbtejn kuljum)
English: Face oedema, localised oedema
Maltese: Edema tal-wiċċ, edema lokalizzata
English: Alanine aminotransferase increased, aspartate aminotransferase increased, lipase increased, lipoprotein cholesterol (including low density and high density) increased, total cholesterol increased, blood triglycerides increased
Maltese: Żieda fl-aminotransferasi tal-analina, żieda fl-aminotransferasi tal-aspartat, żieda tal-lipase, żieda fil-kolesterol tal-lipoproteini (inkluż dak ta' densità baxxa u ta' densità għolja), żieda fil-kolesterol totali, żieda fit-trigliċeridi fid-demm
English: Excipient with known effect One hard capsule contains 39.03 mg lactose monohydrate.
Maltese: Kapsula iebsa waħda fiha 39.03 mg lattosju monoidrat.
English: Insomnia, depression, anxiety
Maltese: Nuqqas ta' rqad, depressjoni, ansjetà
English: There were slightly more male than female patients (56.0%, 62.3% and 55.8%, in the nilotinib 300 mg twice daily, 400 mg twice daily and imatinib 400 mg once daily arm, respectively).
Maltese: Kien hemm ftit aktar pazjenti rġiel milli nisa (56.0%, 62.3% u 55.8%, fil-gruppi mogħtija 300 mg nilotinib darbtejn kuljum, 400 mg nilotinib darbtejn kuljum u fil-grupp mogħti 400 mg imatinib darba kuljum, rispettivament).
English: EU/1/07/422/001-004 EU/1/07/422/007-008 EU/1/07/422/011-012 EU/1/07/422/014
Maltese: EU/1/07/422/011-012 EU/1/07/422/014
English: Tasigna 200 mg hard capsules
Maltese: Tasigna 200 mg kapsuli iebsa
English: Median duration of therapy in days (25th-75th percentiles)
Maltese: Medjan tat-tul tat-terapija f'jiem (il-25 u l-75 perċentwali)
English: Nilotinib 300 mg twice daily (n = 282) Nilotinib 400 mg twice daily (n = 281) Imatinib 400 mg once daily (n = 283)
Maltese: Nilotinib 300 mg darbtejn kuljum (n = 282) Nilotinib 400 mg darbtejn kuljum (n = 281) Imatinib 400 mg darba kuljum (n = 283)
English: Hearing impaired, ear pain, tinnitus
Maltese: Jonqos is-smigħ, uġigħ fil-widnejn, tinnitus
English: Nilotinib 300 mg twice daily (n = 282) Nilotinib 400 mg twice daily (n = 281)
Maltese: Nilotinib 300 mg darbtejn kuljum (n = 282) Nilotinib 400 mg darbtejn kuljum (n = 281)
English: In CML patients, nilotinib administered at 400 mg twice daily for 12 days increased the systemic exposure (AUC and Cmax) of oral midazolam (a substrate of CYP3A4) 2.6-fold and 2.0-fold, respectively.
Maltese: F'pazjenti b'CML, nilotinib mogħi bħala 400 mg darbtejn kuljum għal 12-il ġurnata żied l-esponiment sistemiku (AUC u Cmax) għal midazolam orali (sottostrat ta' CYP3A4) b'2.6 darbiet u 2.0 darbiet rispettivament.
English: Nilotinib 400 mg twice daily n=281
Maltese: Nilotinib 400 mg darbtejn kuljum n=281
English: Figure 3 Cumulative incidence of molecular response of ≤0.0032% (4.5 log reduction)
Maltese: 0032% (riduzzjoni log 4.5 log)
English: The data described below reflect exposure to nilotinib in a total of 737 adult patients from a randomised Phase III study in patients with newly diagnosed Ph+ CML in chronic phase treated at the recommended dose of 300 mg twice daily (n=279) and from an open-label multicentre Phase II study in adult patients with imatinib-resistant or intolerant CML in chronic phase (n=321) and accelerated phase (n=137) treated at the recommended dose of 400 mg twice daily.
Maltese: Id-dejta deskritta hawn taħt tirrifletti l-esponiment għal nilotinib f'total ta' 737-il pazjent adulti minn studju randomizzat tal-Fażi III fost pazjenti b'dijanjosi ġdida ta' Ph+ CML fil-fażi kronika kkurati bid-doża rrakkomandata ta' 300 mg darbtejn kuljum (n=279) u minn studju tal-Fażi II open-label multriċentriku fost pazjenti adulti b'reżistenza għal imatinib jew CML intolleranti fil-fażi kronika (n=321) u fil-fażi aċċellerata (n=137) ikkurati bid-doża rrakkomandata ta' 400 mg darbtejn kuljum.
English: PA/Alu/PVC/Alu [in wallet] 28 hard capsules
Maltese: PA/Alu/PVC/Alu [f'wolit] 28 kapsula iebsa
English: Hepatic impairment has a modest effect on the pharmacokinetics of nilotinib.
Maltese: Indeboliment epatiku għandu effett żgħir fuq il-farmakokinetika ta' nilotinib.
English: Cumulative incidence of MR4 (BCR-ABL ≤0.01% on the international scale), %
Maltese: Inċidenza kumulattiva ta' MR4 (BCR-ABL ≤0.01% fuq l-iskala internazzjonali), %
English: There was no evidence of carcinogenicity upon administration of nilotinib at 5, 15 and 40 mg/kg/day.
Maltese: Ma kien hemm l-ebda evidenza dwar il-karċinoġeniċità bl-għoti ta' dożi ta' 5, 15 u 40 mg/kg nilotinib kuljum.
English: Hyperbilirubinaemia (including blood bilirubin increased)
Maltese: Iperbilirubinemija (inkluż żieda tal-bilirubina fid-demm)
English: Cardiac failure, myocardial infarction, coronary artery disease, cardiac murmur, pericardial effusion, cyanosis
Maltese: Insuffiċjenza kardijaka, infart mijokardijaku, mard tal-arterja koronarja, ħsejjes fil-qalb, effużjoni fil-perikardju, ċjanożi
English: If transient interruption of treatment is not possible, close monitoring of the individual for prolongation of the QT interval is indicated (see sections 4.2, 4.5 and 5.2).
Maltese: Jekk ma jkunx possibli li l-kura titwaqqaf għal xi żmien, huwa indikat li jkun hemm monitoraġġ mill-qrib għal titwil tal-intervall QT (ara sezzjonijiet 4.2, 4.5 u 5.2).
English: CMH test p-value for response rate (versus imatinib 400 mg once daily)
Maltese: Test CMH valur-p għar-rata ta' rispons (kontra imatinib 400 mg darba kuljum)
English: The hard capsule shell is composed of gelatin, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172) and, shellac, black iron oxide (E172), propylene glycol and ammonium hydroxide for stamping of the imprint.
Maltese: Il-qoxra tal-kapsula iebsa hija magħmula minn gelatin, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172) u shellac, black iron oxide (E172), propylene glycol u ammonium hydroxide għat-timbrar tat-timbru.
English: Component of a multipack comprising 4 cartons.
Maltese: Komponent tal-pakkett b'ħafna li fih 4 kartuniet.
English: Prior hydroxyurea
Maltese: Ingħataw hydroxyurea qabel
English: Chronic phase
Maltese: Fażi kronika
English: The recommended dose of nilotinib is 230 mg/m twice daily, rounded to the nearest 50 mg dose (to a maximum single dose of 400 mg) (see Table 1).
Maltese: Id-doża rrakkomandata ta' nilotinib hi ta' 230 mg/m darbtejn kuljum, imdawra għall-eqreb doża ta' 50 mg (għal doża singola massima ta' 400 mg) (ara Tabella 1).
English: PVC/PVDC/Alu [in carton] 392 hard capsules
Maltese: PVC/PVDC/Alu [f'kaxxa tal-kartun] 392 kapsula iebsa
English: Electrolyte imbalance (including hypomagnesaemia, hyperkalaemia, hypokalaemia, hyponatraemia, hypocalcaemia, hypercalcaemia, hyperphosphataemia), diabetes mellitus, hyperglycaemia, hypercholesterolaemia, hyperlipidaemia, hypertriglyceridaemia
Maltese: Żbilanċ fl-elettroliti (li jinkludi ipomagneżimja, iperkalimja, ipokalimja, iponatremja, ipokalċemija, iperkalċimija, iperfosfatimja), dijabete mellitus, ipergliċemija, iperkolesterolemija, iperlipidemija, ipertrigliċeridemija
English: Intracranial haemorrhage, ischaemic stroke, transient ischaemic attack, cerebral infarction, migraine, loss of consciousness (including syncope), tremor, disturbance in attention, hyperaesthesia
Maltese: Emorraġija ġol-kranju, puplesija iskemika, attakk iskemiku tranżitorju, infart ċerebrali, emikranja, telf mis-sensi (inkluż sinkope), tregħid, disturb fl-attenzjoni, iperesteżija
English: Twenty-six (26) of these 55 deaths were related to CML (6 in the nilotinib 300 mg twice daily group, 4 in the nilotinib 400 mg twice daily group and 16 in the imatinib 400 mg once daily group).
Maltese: Sitta u għoxrin (26) minn dawn il-55 mewt kienu relatati ma' CML (6 fil-grupp mogħti 300 mg nilotinib darbtejn kuljum, 4 fil-grupp mogħti 400 mg nilotinib darbtejn kuljum u 16 fil-grupp mogħti 400 mg imatinib darba kuljum).
English: Tasigna 50 mg hard capsules Tasigna 200 mg hard capsules
Maltese: Tasigna 50 mg kapsuli ibsin Tasigna 200 mg kapsuli ibsin
English: Concomitant use of nilotinib with medicinal products that are potent inducers of CYP3A4 (e.g., phenytoin, rifampicin, carbamazepine, phenobarbital and St. John's Wort) is likely to reduce exposure to nilotinib to a clinically relevant extent.
Maltese: L-użu fl-istess ħin ta' nilotinib ma' prodotti mediċinali li jinduċu b'mod potenti s-CYP3A4 (eż., phenytoin, rifampicin, carbamazepine, phenobarbital and St.
English: Abdominal distension, abdomnial discomfort, dysgeusia, flatulence
Maltese: Distensjoni tal-addome, fastidju fl-addome, disgweżja, tifwiq
English: In 11 AP patients, evaluated for efficacy, treatment induced a 36% overall HR rate.
Maltese: Fi 11-il pazjent AP, evlawati għall-effikaċja, il-kura induċit rata ta' HR globali ta' 36%.
English: Imatinib 400 mg once daily n=283
Maltese: Imatinib 400 mg darba kuljum n=283
English: The change from baseline in mean time-averaged QTcF interval at steady state was 6 msec. No patient had an absolute QTcF >500 msec while on the study medicinal product.
Maltese: L-ebda pazjent ma kellu QTcF assolut ta' >500 msek waqt li kellhom sehem fl-istudju tal-prodott mediċinali.
English: Most frequently reported adverse reactions in Tasigna clinical studies Non-haematological adverse reactions (excluding laboratory abnormalities) that are reported in at least 5% of the adult patients treated with 300 mg of nilotinib twice daily in the randomised Phase III study are shown in Table 3.
Maltese: Ir-reazzjonijiet avversi rrappurtati l-aktar ta' spiss fl-istudji kliniċi b'Tasigna Reazzjonijiet avversi mhux ematoloġiċi (esklużi anormalitajiet tal-laboratorju) li huma rrappurtati f'mill-anqas 5% tal-pazjenti adulti kkurati bi 300 mg ta' nilotinib darbtejn kuljum waqt studju randomizzat fil-Fażi III qed jidhru f'Tabella 3.
English: Forty-eight of these 51 patients (94.1%) regained MR4.0 and 47 patients (92.2%) regained MR4.5 by the time of the cut-off date.
Maltese: Tmienja u erbgħin minn dawn il-51 pazjent (94.1%) reġgħu kisbu MR4.0 u 47 pazjent (92.2%) reġgħu kisbu MR4.5 sa dakinhar li ntemm l-istudju.
English: Complete haematological response (CHR) in CP patients was evaluated as a secondary endpoint.
Maltese: Rispons ematoloġiku komplet (CHR) f'pazjenti CP kien evalwat bħala r-riżultat sekondarju.
English: Daily systemic exposure to nilotinib with 400 mg twice-daily dosing at steady state was 35% higher than with 800 mg once-daily dosing.
Maltese: Esponiment sistemiku għal nilotinib ta' kuljum b'400 mg darbtejn kuljum fi stat fiss kien 35% ogħla milli b'doża ta' 800 mg darba kuljum.
English: The median actual dose intensity was 593 mg/day for nilotinib 300 mg twice daily, 772 mg/day for nilotinib 400 mg twice daily and 400 mg/day for imatinib 400 mg once daily.
Maltese: Il-qawwa tad-doża medja attwali kienet ta' 593 mg/kuljum fil-każ ta' 300 mg nilotinib darbtejn kuljum, 772 mg/kuljum fil-każ ta' 400 mg nilotinib darbtejn kuljum u ta' 400 mg/kuljum fil-każ ta' 400 mg imatinib darba kuljum.
English: PA/Alu/PVC/Alu [in wallet] 112 hard capsules
Maltese: PA/Alu/PVC/Alu [f'wolit] 112-il kapsula iebsa
English: Use in adults - The recommended dose is 600 mg per day.
Maltese: Użu fl-adulti - Id-doża rakkomandata hija 600 mg kuljum.
English: Tasigna is available in a wallet containing 28 hard capsules and in a carton containing 28 or 40 hard capsules.
Maltese: Tasigna jiġi f'wolit li fih 28 kapsula iebsa u f'pakkett li fih 28 jew 40 kapsula iebsa.
English: Clinically relevant or severe abnormalities of routine haematological or biochemistry laboratory values in adult patients are presented in Table 5.
Maltese: Anormalitajiet klinikament rilevanti jew severi tal-valuri ematoloġiċi jew bijokimiċi f'rutina tal-laboratorju f'pazjenti adulti qed jintwerew f'Tabella 5.
English: PA/Alu/PVC/Alu blisters
Maltese: Folji tal-PA/Alu/PVC/Alu