FrancophonIA/ELRC3.0 huggingface dataset:
English: Gynaecomastia, breast induration, menorrhagia, nipple swelling General disorders and administration site conditions Common:
Maltese: Ginekomastja, ebusija tas-sider, mestrwazzjoni esaġerata, beżżula minfuħa Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata Komuni:
English: Accelerated phase n=137
Maltese: Fażi aċċellerata n=137
English: Metabolism and nutrition disorders Decreased appetite **
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni Tnaqqis fl-aptit
English: Posology for Philadelphia chromosome positive CML adult patients The recommended dose is 300 mg twice daily.
Maltese: Pożoloġija għal pazjenti adulti bi kromosoma pożittiva ta' Filadelfja CML Id-doża rakkomandata hija 300 mg darbtejn kuljum.
English: The following other side effects have been reported with frequency not known (cannot be estimated from the available data): - allergy (hypersensitivity to Tasigna) - memory loss, disturbed mood - skin cyst, thinning or thickening of the skin, thickening of the outermost layer of the skin, skin discolouration, fungal infection of the feet - thickened patches of red/silver skin (signs of psoriasis) - bleeding, tender or enlarged gums - oral warts - reddening and/or swelling and possibly peeling on the palms and soles (so called hand-foot syndrome) - increased sensitivity of the skin to light - difficulty hearing, ear pain, noises (ringing) in the ears - joint inflammation - urinary incontinence - enterocolitis (inflammation of the bowel) - haemorrhoids, anal abscess - feeling of hardening in the breasts, heavy periods, nipple swelling - symptoms of restless legs syndrome (an irresistable urge to move a part of the body, usually the leg, accompanied by uncomfortable sensations)
Maltese: L-effetti sekondarji oħrajn li kienu rrappurtati bi frekwenza mhijiex magħrufa u (ma tistax tkun stmata mid-dejta disponibbli): - allerġija (sensittività eċċessiva għal Tasigna) - telf ta' memorja, tibdil tal-burdata - ċesta tal-ġilda, traqqiq jew tħaxxin tal-ġilda, tħaxxin tal-aktar saff estern tal-ġilda, il-ġilda titlef il-kulur, infezzjoni fungali tas-saqajn - irqajja' ħoxnin fuq il-ġilda lewn ħamrani/il-fidda (sinjali ta' psorjasi) - fsada, ħniek sensittivi jew minfuħin - felul fil-ħalq - ħmura u/jew nefħa u jista' jkun hemmm ukoll tqaxxir fil-keff tal-id u l-qiegħ tas-sieq (hekk imsejjaħ sindrome tal-id u tas-sieq) - żieda tas-sensittività tal-ġilda għad-dawl - tbatija biex tisma', uġigħ fil-widnejn, ħsejjes (żarżir) fil-widnejn - infjamazzjoni tal-ġogi - inkontinenza tal-awrina - enterokolite (infjammazzjoni tal-musrana) - murliti, axxess anali - tħoss sidrek jibbies, mestrwazzjonijiet esaġerata, beżżula minfuħa - sintomi tas-sindrome tas-saqajn mingħajr serħan (bżonn bla kontroll li ċċaqlaq parti minn ġismek, normalment is-saqajn, flimkien ma' sensazzjonijiet ta' skumdità)
English: PVC/PVDC/Alu [in wallet] 112 hard capsules
Maltese: PVC/PVDC/Alu [f'wolit] 112-il kapsula iebsa
English: Post authorisation efficacy study (PAES): In order to investigate the efficacy of nilotinib in paediatric patients with Ph+ CML-CP resistant or intolerant to either imatinib or dasatinib and in newly diagnosed patients, the MAH should submit the final results of the phase II CAMN107A2203 study.
Maltese: Sabiex tiġi investigata l-effikaċja ta' nilotinib f'pazjenti pedjatriċi b'Ph+ CML-CP reżistenti jew intolleranti jew għal imatinib jew dasatinib u f'pazjenti li għadhom kif ġew dijanjostikati, l-MAH għandu jissottometti r-riżultati finali tal-istudju tal-fażi II CAMN107A2203.
English: Cochran-Mantel-Haenszel (CMH) test p-value for response rate (vs. imatinib 400 mg) <0.0001 Only patients who were in MMR at a specific time point are included as responders for that time point.
Maltese: It-test tal-valur-p ta' Cochran-Mantel-Haenszel (CMH) għar-rata ta' rispons (vs. imatinib 400 mg)
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 in Tasigna clinical studies that serve as the basis for the approved indications 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 fi studji kliniċi b'Tasigna li jservu ta' bażi għall-indikazzjonijiet approvati qed jidhru f'Tabella 3.
English: Hypertensive crisis, peripheral arterial occlusive disease, intermittent claudication, arterial stenosis limb, haematoma, arteriosclerosis
Maltese: Kriżi ta' pressjoni għolja, mard okklussiv tal-arterji periferali, klawdazzjoni intermittenti, stenożi arterjali tar-riġlejn u d-dirgħajn, ematoma, arterijosklerożi
English: CCyR rate by 24 months (includes patients who achieved CCyR at or before the 24 month time point as responders) was statistically higher for both the nilotinib 300 mg twice daily and 400 mg twice daily groups compared to the imatinib 400 mg once daily group.
Maltese: Ir-rata tas-CcyR sal-24 xahar (inkluż pazjenti li bħala dawk li wrew rispons, kisbu CCyR fit-time point tal-24 xahar jew qabel) kienet statistikament ogħla sew fiż-żewġ gruppi mogħtija 300 mg u 400 mg nilotinib darbtejn kuljum meta mqabbla mal-grupp mogħti 400 mg imatinib darba kuljum.
English: Figure 2 Cumulative incidence of molecular response of ≤0.01% (4-log reduction)
Maltese: Figura 3 Inċidenza kumulattiva ta' rispons molekulari ta' ≤0.
English: Pulmonary hypertension, wheezing, oropharyngeal pain Gastrointestinal disorders
Maltese: Disturbi fis-sistema nervuża Komuni ħafna Uġigħ ta' ras Disturbi gastro-intestinali
English: Uncommon cases (0.1 to 1%) of sudden deaths have been reported in patients with imatinib-resistant or intolerant CML in chronic phase or accelerated phase with a past medical history of cardiac disease or significant cardiac risk factors.
Maltese: Każijiet mhux komuni (0.1 to 1%) ta' mwiet zoptu kienu rrappurtati f'pazjenti b'reżistenza għal imatinib jew CML intolleranti fil-fażi kronika jew fil-fażi aċċellerata li kellhom storja medika ta' mard tal-qalb u fatturi sinifikanti ta' riskji tal-qalb.
English: Musculoskeletal stiffness, joint swelling
Maltese: Ebusija muskoluskeletrika, nefħa fil-ġogi
English: Tasigna is indicated for the treatment of: - adult and paediatric patients with newly diagnosed Philadelphia chromosome positive chronic myelogenous leukaemia (CML) in the chronic phase, - adult patients with chronic phase and accelerated phase Philadelphia chromosome positive CML with resistance or intolerance to prior therapy including imatinib.
Maltese: Tasigna jintuża għall-kura ta': - pazjenti adulti u pedjatriċi li fid-dijanjosi l-ġdida nstab li jinsabu fil-fażi kronika tal-lewkemija majeloġena kronika għall-kromosoma pożittiva ta' Filadelfja (CML), - pazjenti adulti li jinsabu fil-fażi kronika u l-fażi aċċellerata għall-kromosoma pożittiva ta' Filadelfja CML b'reżistenza għal jew b'intolleranza għal terapija li jkunu ngħataw qabel inkluż imatinib.
English: Dyspnoea, cough
Maltese: Qtugħ ta' nifs, sogħla
English: Some side effects are uncommon (may affect up to 1 in 100 people) - increased skin sensitivity - dry mouth, sore throat, mouth sores - breast pain - painful and swollen joints (gout) - increased appetite - attention disorder - inability to achieve or maintain an erection - breast enlargement in men - flu-like symptoms - pneumonia, bronchitis - urinary tract infection - herpes virus infection - oral or vaginal thrush - muscle and joint stiffness, joint swelling - feeling body temperature change (including feeling hot, feeling cold) - sensitive teeth
Maltese: Xi effetti sekondarji mhumiex komuni (jistgħu jaffettwaw sa 1 minn kull 100 persuna) - żieda tas-sensittività tal-ġilda - ħalq xott, grieżem misluħin, selħiet fil-ħalq - uġigħ tas-sider - ġogi juġgħu jew minfuħin (gotta) - żieda tal-aptit - disturb fl-attenzjoni - ma tkunx tista' tikseb jew iżżomm erezzjoni - jikber is-sider fl-irġiel - sintomi bħal tal-influwenza - pulmonite, bronkite - infezzjoni fil-passaġġ tal-awrina - infezzjoni bil-virus tal-erpete - traxx fil-ħalq jew fil-vaġina - ebusija fil-muskoli u fil-ġogi, ġogi minfuħin - tħoss bidla fit-temperatura tal-ġisem (inkluż li tħoss is-sħana, tħoss il-bard) - snien sensittivi
English: Approximately 12% of subjects in the clinical study were 65 years of age or over.
Maltese: Madwar 12% tal-individwi fl-istudju kliniku kellhom 65 sena jew aktar.
English: Discontinuation due to adverse drug reactions was observed in 10% of patients.
Maltese: Twaqqif minħabba reazzjonijiet avversi tal-mediċina kien osservat f'10% tal-pazjenti.
English: 9/l and/or platelets >75 x 10 9/l.
Maltese: 9/l u/jew il-plejtlits >75 x 10
English: Patients with BCR-ABL levels ≤10% at 3 months of treatment show a greater overall survival at 72 months compared to those who did not achieve this molecular response level (94.5% vs. 77.1% respectively [p=0.0005]).
Maltese: Il-pazjenti b'livelli ta' BCR-ABL ta' ≤10% wara 3 xhur ta' trattament urew sopravivenza totali akbar fis-72 xahar imqabbel ma' dawk li ma kisbux livell ta' rispons molekulari (94.5% vs.
English: MCyR rate was 30% with a median time to response of 2.8 months.
Maltese: Ir-rata MCyR kienet 30% bi żmien medjan għar-rispons ta' 2.8 xhur.
English: Very common Rash Very common Pruritus Very common Alopecia Common
Maltese: Komuni ħafna Raxx Komuni ħafna Ħakk Komuni ħafna Alopeċja Komuni
English: Elevation in serum lipase has been observed.
Maltese: Żiediet tal-lipase fis-serum dehru.
English: Eighty-five of these 86 patients (98.8%) regained MMR, (one patient discontinued study permanently due to subject decision) and 76 patients (88.4%) regained MR4.5 by the time of the cut-off date.
Maltese: Ħamsa u tmenin minn dawn is-86 pazjent (98.8%) reġgħu kisbu MMR, (pazjent wieħed waqaf għal kollox mill-istudju qabel iż-żmien minħabba deċiżjoni tas-suġġett) u 76 pazjent (88.4%) reġgħu kisbu MR4.5 sa dakinhar li ntemm l-istudju.
English: ≤0.01% IS), and maintained for one year - the last assessment being MR4.5 (BCR-ABL/ABL ≤0.0032% IS) - no more than two assessments falling between MR4.0 and MR4.5
Maltese: (BCR-ABL/ABL ≤0.01% IS), u baqgħu hekk għal sena waħda - l-anqas evalwazzjoni tkun ta' MR4.5 (BCR-ABL/ABL ≤0.0032% IS) - mhux aktar minn żewġ evalwazzjonijiet li jaqgħu bejn MR4.0 u MR4.5
English: In an interim analysis in a study in the CML paediatric population, with a median exposure of 33 months in each cohort (newly diagnosed and resistant or intolerant Ph+ CML-CP), growth retardation (crossing two main percentile lines from baseline) has been documented in 12.1%.
Maltese: F'analiżi interim waqt studju fost il-popolazzjoni pedjatrika b'CML, b'espożizzjoni medjana ta' 33 xhur f'kull wieħed mill-koorti (għadha kemm saritilhom dijanjosi ta' Ph+ CML-CP reżistenti jew intolleranti), kien iddokumentat dewmien fir-rata tat-tkabbir (żewġ linji perċentwali ewlenin imsallbin mil-linja bażi) fi 12.1%.
English: Very common Myalgia Common
Maltese: Komuni ħafna Mijalġja Komuni
English: Nilotinib was shown to absorb light in the UV-B and UV-A range, is distributed into the skin and showed a phototoxic potential in vitro, but no effects have been observed in vivo.
Maltese: Intwera li nilotinib jassorbi d-dawl fil-medda tal-UV-B u UV-A, jinfirex ġol-ġilda u wera li jista' jkun fototossiku in vitro, iżda ma dehrux effetti in vivo.
English: The doctor will monitor growth at regular visits.
Maltese: Ittabib se josserva r-rata t-tkabbir waqt visti regolari.
English: Eye pruritus, conjunctivitis, dry eye (including xerophthalmia)
Maltese: Ħakk fl-għajnejn, kunġunktivite, għajnejn xotti (inkluż kseroftalmija)
English: Eyelid oedema, photopsia, conjunctival haemorrhage, hyperaemia (scleral, conjunctival, ocular)
Maltese: Edema mad-dawra tal-għajnejn, fotopsja, emorraġija konġunktivali, iperimija (sklerali, konġunktivali, tal-għajn)
English: Interaction studies have only been performed in adults.
Maltese: Studji dwar interazzjoni saru biss fost l-adulti.
English: Increases in blood glucose levels have been reported with nilotinib therapy (see section 4.4).
Maltese: Kienu rrappurtati żidiet fil-livelli tal-glukosju fid-demm b'terapija b'nilotinib (ara sezzjoni 4.4).
English: Monitoring of patients who have discontinued therapy Frequent monitoring of BCR-ABL transcript levels in patients eligible for treatment discontinuation must be performed with a quantitative diagnostic test validated to measure molecular response levels with a sensitivity of at least MR4.5 (BCR-ABL/ABL ≤0.0032% IS).
Maltese: Monitoraġġ ta' pazjenti li waqqfu għal kollox it-terapija Monitoraġġ frekwenti tal-livelli tat-traskritti ta' BCR-ABL f'pazjenti eliġibbli għat-twaqqif għal kollox tat-trattament għandu jsir permezz ta' test dijanjostiku kwantitattiv li jkejjel il-livelli tar-rispons molekulari b'sensittività ta' mill-inqas MR4.5 (BCR-ABL/ABL≤0.0032%IS).
English: Inter-patient variability in nilotinib pharmacokinetics was moderate to high.
Maltese: Varjabilità bejn il-pazjenti fil-farmakokinetika ta' nilotinib kienet moderata għal għolja.
English: Tasigna contains lactose
Maltese: Jekk tinsa tieħu Tasigna
English: For a dose of 300 mg twice daily, 150 mg hard capsules are available.
Maltese: Għal doża ta' 300 mg darbtejn kuljum, jeżistu kapsuli ibsin ta' 150 mg.
English: For patients who lose MR4 (MR4=BCR-ABL/ABL ≤0.01%IS) but not MMR (MMR=BCR-ABL/ABL ≤0.1%IS) during the treatment-free phase, BCR-ABL transcript levels should be monitored every 2 weeks until BCR-ABL levels return to a range between MR4 and MR4.5.
Maltese: Għal pazjenti li jitilfu MR4 (MR4=BCR-ABL/ABL≤0.01%IS) iżda mhux MMR (MMR=BCR-ABL/ABL≤0.1%IS) matul il-fażi mingħajr trattament, il-livelli tat-traskritti BCR-ABL għandhom jiġu mmonitorjati kull ġimagħtejn sakemm il-livelli ta' BCR-ABL jerġgħu lura għal firxa ta' bejn MR4 u MR4.5.
English: BCR-ABL transcript levels must be assessed prior to and during treatment discontinuation (see sections 4.2 and 5.1).
Maltese: Il-livelli tat-traskritti ta' BCR--ABL għandhom jiġu assessjati qabel u waqt it-twaqqif għal kollox tat-trattament (ara sezzjonijiet 4.2 u 5.1).
English: One hard capsule contains 150 mg nilotinib (as hydrochloride monohydrate).
Maltese: Kapsula iebsa waħda fiha 150 mg nilotinib (bħala hydrochloride monohydrate).
English: By 3 years
Maltese: Sa 3 snin
English: What Tasigna is Tasigna is a medicine containing an active substance called nilotinib.
Maltese: X'inhu Tasigna Tasigna hija mediċina li fih sustanza attiva msejjħa nilotinib.
English: Hypericum perforatum); - midazolam - used to relieve anxiety before surgery; - alfentanil and fentanyl - used to treat pain and as a sedative before or during surgery or medical procedures; - cyclosporine, sirolimus and tacrolimus - medicines that suppress the “self-defence” ability of the body and fight infections and are commonly used to prevent the rejection of transplanted organs such as the liver, heart and kidney; - dihydroergotamine and ergotamine - used to treat dementia; - lovastatin, simvastatin - used to treat high level of fats in blood; - warfarin - used to treat blood coagulation disorders (such as blood clots or thromboses); - astemizole, terfenadine, cisapride, pimozide, quinidine, bepridil or ergot alkaloids (ergotamine,
Maltese: John's Wort - prodott magħmul mill-ħxejjex li jintuża għall-kura ta' depressjoni u kundizzjonijiet oħra (magħruf ukoll bħala Hypericum perforatum); - midazolam - jintuża biex iserraħ mill-ansjetà qabel operazzjoni; - alfentanil u fentanyl - jintużaw biex jikkuraw l-uġigħ u bħala sedattivi qabel jew waqt kirurġija jew proċeduri mediċi; - cyclosporine, sirolimus u tacrolimus - mediċini li jrażżnu l-kapaċità ta “difiża” tal-ġisem u biex jiġġieldu infezzjonijiet u huma użati b'mod komuni biex jipprevjenu r-rifjut ta' organi trapjantati bħal fwied, qalb u kliewi; - dihydroergotamine u ergotamine - jintużaw biex jikkuraw d-dimenzja; - lovastatin, simvastatin - jintużaw biex jikkuraw livell għoli ta' xaħmijiet fid-demm; - warfarin - tintuża għall-kura ta' disturbi tal-koagulazzjoni tad-demm (bħal demm magħqud jew trombożi); - astemizole, terfenadine, cisapride, pimozide, quinidine, bepridil jew ergot alkaloids
English: PVC/PVDC/Alu [in carton] 40 hard capsules
Maltese: PVC/PVDC/Alu [f'kaxxa tal-kartun] 40 kapsula iebsa
English: • Multipacks containing 112 (4 packs of 28) hard capsules, 120 (3 packs of 40) hard capsules or
Maltese: • Il-pakketti b'ħafna li fihom 112-il kapsula iebsa (4 pakketti ta' 28), 120 kapsula iebsa (3 pakketti ta' 40) jew 392 kapsula iebsa (14-il pakkett ta' 28).
English: Isolated reports of intentional overdose with nilotinib were reported, where an unspecified number of Tasigna hard capsules were ingested in combination with alcohol and other medicinal products.
Maltese: Rapporti iżolati ta' doża eċċessiva b'intenzjoni b'nilotinib kienu rrappurtati fejn numru mhux speċifikat ta' kapsuli ibsin Tasigna inbelgħu flimkien mal-alkoħol u prodotti mediċinali oħra.
English: 0 Common
Maltese: Sa 0.
English: For laboratory abnormalities, very common events (1/10) not included in Table 3 are also reported.
Maltese: Għal anormalitajiet tal-laboratorju, reazzjonijiet avversi komuni ħafna (1/10) mhux inklużi f'Tabella 3 huma rrappurtati wkoll.
English: In newly diagnosed CML patients, the cumulative MMR rate was 64.0% by cycle 12.
Maltese: F'pazjenti b'CML li għadhom kif ġew iddijanjonizzati, ir-rata kumulattiva tal-MMR kienet ta' 64.0% mat-12-il ċiklu.
English: If a HMG-CoA reductase inhibitor (a lipid-lowering agent) is required, please refer to section 4.5 before initiating treatment since certain HMG-CoA reductase inhibitors are also metabolised by the CYP3A4 pathway.
Maltese: Jekk ikun meħtieġ inibitur ta' HMG-CoA reductase (aġent li jbaxxi l-lipidi), jekk jogħġbok irreferi għas-sezzjoni 4.5 qabel ma tibda t-terapija minħabba li ċertu inibituri ta' HMG-CoA reductase huma wkoll immetabolizzati bil-mogħdija ta' CYP3A4.
English: Component of a multipack comprising 14 cartons.
Maltese: Komponent tal-pakkett b'ħafna li fih 14-il kartuna.
English: Newly diagnosed CML-CP 300 mg twice daily
Maltese: Pazjenti b' dijanjosi ġdida ta' CML-CP 300 mg darbtejn kuljum
English: One hard capsule contains 200 mg nilotinib (as hydrochloride monohydrate).
Maltese: Kull kapsula iebsa fiha 200 mg nilotinib (bħala hydrochloride monohydrate).
English: Adult Philadelphia chromosome positive CML patients in chronic phase who have been treated with nilotinib as first-line therapy and who achieved a sustained deep molecular response (MR4.5) Discontinuation of treatment may be considered in eligible adult Philadelphia chromosome positive (Ph+) CML patients in chronic phase who have been treated with nilotinib at 300 mg twice daily for a minimum of 3 years if a deep molecular response is sustained for a minimum of one year immediately prior to discontinuation of therapy.
Maltese: Pazjenti adulti ta' CML fil-fażi kronika pożittivi għall-kromosoma ta' Filadelfja li ġew ittrattati b'nilotinib bħala terapija preferuta u li kisbu rispons molekulari profond sostenibbli (MR4.5) It-twaqqif għal kollox tat-trattament jista' jitqies f'pazjenti adulti b'CML fil-fażi kronika eliġibbli u li huma pożittivi għall-kromosoma ta' Filadelfja (PH+) li ġew ittrattati bi 300 mg nilotinib darbtejn kuljum għal mill-inqas 3 snin kemm-il darba jinżamm rispons molekulari profond għal mill-inqas sena immedjatament qabel it-twaqqif għal kollox tat-terapija.
English: One hard capsule contains 50 mg nilotinib (as hydrochloride monohydrate).
Maltese: Kapsula iebsa waħda fiha 50 mg nilotinib (bħala hydrochloride monohydrate).
English: Tumour lysis syndrome
Maltese: Sindrome tad-diżentigrazzjoni tat-tumur
English: The major target organs for non-neoplastic lesions were the skin (epidermal hyperplasia), the growing teeth (degeneration/atrophy of the enamel organ of upper incisors and inflammation of the gingiva/odontogenic epithelium of incisors) and the thymus (increased incidence and/or severity of decreased lymphocytes).
Maltese: L-organi ewlenin milquta għall-feriti mhux-neoplastiċi kienu l-ġilda (iperplasija epidermika), is-snien li qed jikbru (deġenerazzjoni/atrofija tal-organu tal-enemel tas-snien inċiżuri u infjammazzjoni tal-ħanek/epitelju odontoġeniku tas-snien inċiżuri) u t-thymus (żieda fl-inċidenza u/jew gravità tal-limfoċiti mnaqqsa).
English: The estimated 24-month overall survival rate in CML-CP patients was 87%.
Maltese: L-istima tar-rata globali ta' sopravivenza għal 24 xahar f'pazjenti b'CML-CP kienet ta' 87%.
English: In healthy subjects receiving esomeprazole at 40 mg once daily for 5 days, gastric pH was markedly increased, but nilotinib absorption was only decreased modestly (27% decrease in Cmax and 34% decrease in AUC0-∞).
Maltese: tal-istonku żdiedet b'mod qawwi, iżda l-assorbiment ta' nilotinib ma naqasx b'ħafna (tnaqqis ta' 27% fis-Cmax u tnaqqis ta' 34% fl-AUC0-∞).
English: In adult patients with imatinib-resistant or intolerant CML in chronic phase and accelerated phase The data described below reflect exposure to nilotinib in 458 adult patients in an open-label multicentre Phase II study in 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: F'pazjenti adulti b'reżistenza għal imatinib jew CML intolleranti fil-fażi kronika u fil-fażi aċċellerata Id-dejta deskritta hawn taħt tirrifletti l-esponiment għal nilotinib f'458 pazjent adulti fi studju open-label multriċentriku tal-Fażi II f'pazjenti b'CML reżistenti jew intolleranti għal imatinib fil-fażi kronika (n=321) jew fil-fażi aċċellerata (n=137) kkurati bid-doża rrakkomandata ta' 400 mg darbtejn kuljum.
English: Of the 126 patients who entered the TFR phase, 73 patients (57.9%, [95% CI: 48.8, 66.7]) had no loss of MMR, no confirmed loss of MR4.0, and no re-initiation of nilotinib within 48 weeks.
Maltese: TFR, 73 pazjent (57.9%, [95% CI: 48.8, 66.7]) ma kellhom l-ebda telf ta' MMR, l-ebda telf ikkonfermat ta' MR4.0, u l-ebda teħid mill-ġdid ta' nilotinib fi żmien 48 ġimgħa.
English: The pharmacokinetic exposure of nilotinib following a single or multiple doses appeared to be comparable between paediatric patients from 2 years to <10 years and from ≥10 years to <18 years.
Maltese: L-espożizzjoni farmakokintetika ta' nilotinib wara doża waħda jew dożi multipli deher li kienet komparabbli bejn il-pazjenti pedjatriċi minn sentejn sa <10 snin u minn ≥10 snin sa <18-il sena.
English: PVC/PVDC/Alu [in carton] 28 hard capsules
Maltese: PVC/PVDC/Alu [f'kaxxa tal-kartun] 28 kapsula iebsa
English: Upper abdominal pain
Maltese: Uġigħ addominali
English: Some side effects are common (may affect up to 1 in 10 people) - upper respiratory tract infections - stomach discomfort after meals, flatulence, swelling or bloating of the abdomen - bone pain, pain in joints, muscle spasms, muscle weakness - pain including back pain, neck pain and pain in extremity, pain or discomfort in the side of the body - dry skin, acne, wart, decreased skin sensitivity, hives - loss of appetite, disturbed sense of taste, weight decrease or increase - insomnia, depression, anxiety - night sweats, excessive sweating - generally feeling unwell - voice disorder - nose bleed - frequent urine output
Maltese: Xi effetti sekondarji huma komuni (jistgħu jaffettwaw sa 1 minn kull 10 persuni) - infezzjonijiet fil-parti ta' fuq tal-passaġġ respiratorju - fastidju fl-istonku wara l-ikel, gass, nefħa fl-addome - uġigħ fl-għadam, uġigħ fil-ġogi, spażmi tal-muskoli, dgħufija fil-muskoli - uġigħ li jinkludi uġigħ fid-dahar, uġigħ fl-għonq u uġigħ fl-idejn u fis-saqajn, uġigħ jew skumdità mal-ġenb ta' ġismek - ġilda xotta, akne, felul, tnaqqis fis-sensittività tal-ġilda, ħorriqija - titlef l-aptit, disturb fit-tegħim, tnaqqas jew iżżid fil-piż - tbati biex torqod, depressjoni, ansjetà - tgħereq matul il-lejl, tgħereq b'mod eċċessiv - tħossok ma tiflaħx b'mod ġenerali - disturbi tal-vuċi - fġir l-imnieħer - tgħaddi l-awrina b'mod frekwenti