FrancophonIA/ELRC3.0 huggingface dataset:
English: The third study showed a fall in blood pressure of 8.5 mmHg with Rasilamlo 150/5 mg compared with 8.0 mmHg and 4.8 mmHg with amlodipine 10 mg and 5 mg, respectively.
Maltese: It-tielet studju wera tnaqqis fil-pressjoni tad-demm ta' 8.5 mmHg b'Rasilamlo 150/5 mg meta mqabbel ma' 8.0 mmHg u 4.8 mmHg bl-amlodipina 10 mg u 5 mg, rispettivament.
English: Rasilamlo contains two active substances, aliskiren and amlodipine.
Maltese: Rasilamlo fih żewġ sustanzi attivi, l-aliskiren u l-amlodipina.
English: Rasilamlo can be used with other antihypertensive medicines, with the exception of ‘angiotensin converting enzyme (ACE) inhibitors' or ‘angiotensin receptor blockers' (ARBs) in patients with diabetes, or moderate or severe kidney impairment.
Maltese: Rasilamlo jista' jintuża ma' mediċini oħra antiipertensivi, bl-eċċezzjoni ta' ‘inibituri ta' enzimi li jikkonvertu l-anġjotensini' (ACE) jew ‘imblokkaturi tar-riċetturi tal-anġjotensini' (ARBs) f'pazjenti biddijabete, jew b'indeboliment renali moderat jew sever.
English: Why has Rasilamlo been approved?
Maltese: Għaliex ġie approvat Rasilamlo?
English: The most common side effects with Rasilamlo are hypotension (low blood pressure) and peripheral oedema (swelling, especially of the ankles and feet).
Maltese: L-effetti sekondarji l-aktar komuni rrappurtati b'Rasilamlo huma ipotensjoni (pressjoni tad-demm baxxa) u edema periferika (nefħa, speċjalment tal-għekiesi u tas-saqajn).
English: Rasilamlo is a medicine that contains the active substances aliskiren and amlodipine.
Maltese: Rasilamlo huwa mediċina li fiha s-sustanzi attivi aliskiren u amlodipina.
English: Other information about Rasilamlo
Maltese: Informazzjoni oħra dwar Rasilamlo
English: It blocks special channels on the surface of cells called calcium channels, through which calcium ions normally enter.
Maltese: Jimblokka kanali speċjali fuq is-superfiċje taċ-ċelloli magħrufa bħala kanali tal-kalċju, li minnhom normalment jidħlu l-joni tal-kalċju.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Rasilamlo on 14 April 2011.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Rasilamlo valida fl-Unjoni Ewropea kollha fl-14 ta' April 2011.
English: What is the risk associated with Rasilamlo?
Maltese: X'inhu r-riskju assoċjat ma' Rasilamlo?
English: Rasilamlo must not be used in people who are hypersensitive (allergic) to aliskiren, amlodipine, to any of the other ingredients of the medicine or other substances derived from dihydropyridine (a group that includes amlodipine).
Maltese: Rasilamlo ma għandux jintuża f'persuni li huma ipersensittivi (allerġiċi) għall-aliskiren, l-amlodipina, għal xi sustanza oħra tal-mediċina jew għal sustanzi oħra li huma derivati minn diidropiridiniċi (grupp li jinkludi l-amlodipina).
English: What is Rasilamlo?
Maltese: X'inhu Rasilamlo?
English: In the first study, patients taking Rasilamlo 300/10 mg and 300/5 mg had a fall in their sitting diastolic blood pressure of 13.1 mmHg and 10.5 mmHg, respectively, compared with a fall of 5.8 mmHg in patients taking aliskiren 300 mg.
Maltese: Fl-ewwel studju, il-pazjenti li kienu qegħdin jieħdu Rasilamlo 300/10 mg u 300/5 mg kellhom tnaqqis fil-pressjoni dijastolika tad-demm waqt li kienu bilqiegħda ta' 13.1 mmHg u 10.
English: Angiotensin I is converted into the hormone angiotensin II, which is a powerful vasoconstrictor (a substance that narrows blood vessels).
Maltese: L-anġjotensina I tiġi konvertita fl-ormon anġjotensina II, li huwa vażokostrittur qawwi (sustanza li ddejjaq il-vini).
English: It must not be used in patients with a history of angioedema (swelling beneath the skin) with aliskiren, hereditary angioedema or angioedema of no obvious cause, severe hypotension, shock, narrowing of the aortic heart valve or in patients with heart failure after a heart attack.
Maltese: Ma għandux jintuża f'pazjenti li għandhom storja ta' anġjodema (nefħa taħt ilġilda) bl-aliskiren, anġjodema ereditarja jew anġjodema mingħajr kawża evidenti, ipotensjoni severa, xokk, tidjiq tal-valv aortiku tal-qalb jew f'pazjenti b'insuffiċjenza tal-qalb wara attakk tal-qalb.
English: Rasilamlo was more effective at controlling essential hypertension than placebo, aliskiren or amlodipine used alone.
Maltese: Rasilamlo kien aktar effettiv fil-kontroll tal-ipertensjoni essenzjali mill-plaċebo, l-aliskiren jew lamlodipina meta użati weħidhom.
English: The CHMP decided that Rasilamlo's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' Rasilamlo huma akbar mir-riskji tiegħu u rrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: For the full list of all side effects reported with Rasilamlo, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrappurtati b'Rasilamlo, ara l-fuljett ta' tagħrif.
English: Imatinib n=553
Maltese: n=553
English: % of patients (CI95%)
Maltese: % tal-pazjenti (CI95 %)
English: - The active substance is imatinib mesilate.
Maltese: - Is-sustanza attiva hi imatinib mesilate.
English: Study 0102 38-month data Myeloid blast crisis (n=260)
Maltese: Studu 0102 Dejta ta' 38 xhur Blast crisis talmajelojd (n=260)
English: Cytogenetic response criteria: complete (0% Ph+ metaphases), partial (1-35%), minor (36-65%) or minimal (66-95%).
Maltese: Kriterji ta' rispons ċitoġenetiku: komplet (0 % Ph+ metafażijiet), parzjali (1-35 %), minuri (36-65 %) jew minimu (66-95 %).
English: 6 doses)iii: days 2, 3, 16, and 17
Maltese: 6 dożi)iii: jiem 2, 3, 16, u 17
English: At 84 months the estimated overall survival is 86.4% (83, 90) vs. 83.3% (80, 87) in the randomised Imatinib and the IFN+Ara-C groups, respectively (p=0.073, log-rank test).
Maltese: Wara 84 xahar, is-sopravivenza ġenerali stmata hi ta' 86.4 % (83, 90) kontra 83.3 % (80, 87) fil-gruppi randomizzati Imatinib u IFN+Ara-C, rispettivament (p=0.073, test log-rank).
English: There were 59% males and 41% females; 89.9% caucasian and 4.7% black patients.
Maltese: Kien hemm 59 % irġiel u 41 % nisa; 89.9% pazjenti bojod u 4.7 % suwed.
English: doses)iii: days 2 and 3
Maltese: dożi)iii: jiem 2 and 3
English: Date of first authorization: 01 July 2013 Date of latest renewal: 19th April 2018
Maltese: Id-19 ta 'April 2018
English: Chronic phase, Interferon failure
Maltese: Fażi kronika, Falliment ta' interferon
English: Polyethylene glycol Iron oxide yellow (E172) Iron oxide red (E172)
Maltese: Iron oxide, yellow (E172)
English: Ara-C 60 mg/ m2 i.v., days 22-25, 29-32
Maltese: Ara-C 60 mg/m2 i.v., jiem 22-25, 29-32
English: A total of 71 (12.8%) and 85 (15.4%) patients died in the Imatinib and IFN+Ara-C groups, respectively.
Maltese: Total ta' 71(12.8 %) u 85 (15.4 %) pazjent mietu fil-gruppi Imatinab u IFN+Ara-C, rispettivament.
English: Silica colloidal, anhydrous Magnesium stearate
Maltese: Silica colloidal, anhydrous
English: Mean absolute bioavailability for imatinib is 98%.
Maltese: Il-biodisponibiltà assoluta medja għal imatinib hija ta' 98%.
English: G-CSF = granulocyte colony stimulating factor, VP-16 = etoposide, MTX = methotrexate, IV = intravenous, SC = subcutaneous, IT = intrathecal, PO = oral, IM = intramuscular, ARA-C = cytarabine, CPM = cyclophosphamide, VCR = vincristine, DEX = dexamethasone, DAUN = daunorubicin, 6-MP = 6-mercaptopurine, E.Coli L-ASP = L-asparaginase, PEG-ASP = PEG asparaginase, MESNA= 2-mercaptoethane sulfonate sodium, iii= or until MTX level is < 0.1 μM, q6h = every 6 hours, Gy= Gray
Maltese: G-CSF = fattur stimulanti tal-kolonja granuloċite, VP-16 = etoposide, MTX = methotrexate, IV = minn ġol-vina, SC = minn taħt il-ġilda, IT = intrathecal, PO = orali, IM = intramuskulari, ARA-C = cytarabine, CPM = cyclophosphamide, VCR = vincristine, DEX = dexamethasone, DAUN = daunorubicin, 6-MP = 6-mercaptopurine, E.Coli L-ASP = L-asparaginase, PEG-ASP = PEG asparaginase, MESNA= 2-mercaptoethane sulfonate sodium, iii= jew sa meta l-livell MTX ikun < 0.1 µM, q6h = kull 6 sigħat, Gy= Gray
English: Posology for HES/CEL
Maltese: Pożoloġija għal HES/CEL
English: Middlesex, HA1 4HF United Kingdom
Maltese: Middlesex, HA1 4HF Ir-Renju Unit
English: Patients were treated at doses of imatinib of 260 mg/m2/day (n=5), 340 mg/m2/day (n=9), 440 mg/m2/day (n=7) and 570 mg/m2/day (n=5).
Maltese: Il-pazjenti ġew ikkurati b'dożi ta' imatinib ta' 260 mg/m2/jum (n=5), 340 mg/m2/jum (n=9), 440 mg/m2/jum (n=7), u 570 mg/m2/jum (n=5).
English: BCR-ABL tyrosine kinase inhibitors (TKIs) have been associated with thrombotic microangiopathy (TMA), including individual case reports for Imatinib Accord (see section 4.8).
Maltese: Inibituri ta' tyrosine kinase (TKIs - tyrosine kinase inhibitors) BCR-ABL ġew assoċjati ma' mikroanġjopatija trombotika (TMA - thrombotic microangiopathy), inklużi rapporti ta' każijiet individwali għal Imatinib Accord (ara sezzjoni 4.8).
English: Hypromellose 6 cps (E464) Talc (E553b)
Maltese: Hypromellose 6 cps (E464)
English: Chronic myeloid leukaemia (CML).
Maltese: Lewkimja majelojd kronika (CML).
English: Acute respiratory failure11*, interstitial lung disease* Gastrointestinal disorders
Maltese: Insuffiċjenza respiratorja akuta11*, marda tal-interstizju tal-pulmun* Disturbi gastro-intestinali
English: Complete CyR n (%) Partial CyR n (%)
Maltese: CyR komplet n (%)
English: Daunorubicin 45 mg/ m2 i.v., days 6-7, 13-14
Maltese: Daunorubicin 45 mg/m2 i.v., jiem 6-7, 13-14
English: VCR 1 mg i.v., days 7, 14;
Maltese: VCR 1 mg i.v., jiem 7, 14;
English: Posology for DFSP
Maltese: Pożoloġija għal DFSP
English: VCR 2 mg i.v., days 6, 13, 20;
Maltese: VCR 2 mg i.v., jiem 6, 13, 20;
English: VCR 1.3 g/ m2 i.v., day 1; Prednisolone 60 mg/m2 oral, days 1-5
Maltese: VCR 1.3 g/m2 i.v., jum 1; Prednisolone 60 mg/m2 orali, jiem 1-5
English: Study AJP01 Induction therapy
Maltese: Studju AJP01 Terapija ta' induzzjoni
English: Methylprednisolone 40 mg intrathecal, day1
Maltese: Methylprednisolone 40 mg intrathecal, jum 1
English: Cytogenetic abnormalities were evaluated in 117 of the total population of 176 patients.
Maltese: Abnormalitajiet ċitoġenetiċi kienu evalwati f'117 mill-popolazzjoni kollha ta' 176 pazjent.
English: Thrombosis/embolism*
Maltese: Trombożi/emboliżmu*
English: PVC/PVdC/Alu or Alu/Alu blisters.
Maltese: Folji tal-PVC/PVdC/Alu jew Alu/Alu.
English: - The other ingredients are microcrystalline cellulose, crospovidone, hypromellose 6 cps (E464), magnesium stearate and anhydrous colloidal silica.The tablet coating is made of hypromellose 6 cps (E464), talc (E553b), polyethylene glycol, iron oxide yellow (E172) and iron oxide red (E172).
Maltese: - Is-sustanzi l-oħra huma microcrystalline cellulose, crospovidone, hypromellose 6 cps (E464), magnesium stearate u anhydrous colloidal silica.Il-kisja tal-pillola hija magħmula minn hypromellose 6 cps (E464), talc (E553b), polyethylene glycol, iron oxide yellow (E172) u iron oxide red (E172).
English: Confusional state Nervous system disorders Very common Headache2
Maltese: Stat konfużjonali Disturbi fis-sistema nervuża Komuni ħafna
English: Posology for MDS/MPD
Maltese: Pożoloġija għal MDS/MPD
English: Chronic phase CML, MDS/MPD (starting dose 400 mg) HES/CEL (at dose 400 mg)
Maltese: CML fil-fażi kronika, MDS/MPD (doża talbidu 400 mg) HES/CEL (b'doża ta' 400 mg)
English: Daunorubicin 30 mg/ m2 i.v., days 1-3, 15-16;
Maltese: Daunorubicin 30 mg/m2 i.v., jiem 1-3, 15-16;
English: VCR 2 mg total dose i.v., days 1, 8, 15, 22; CP 750 mg/m2 i.v., days 1, 8;
Maltese: VCR 2 mg doża totali i.v., jiem 1, 8, 15, 22; CP 750 mg/m2 i.v., jiem 1, 8;
English: Imatinib did not interfere with the biotransformation of 5-fluorouracil, but it inhibited paclitaxel metabolism as a result of competitive inhibition of CYP2C8 (Ki = 34.7 μM).
Maltese: Imatinib ma fixkilx ilbiotrasformazzjoni ta' 5-fluoruracil, iżda inibixxa l-metaboliżmu ta' paclitaxel billi inibixxa b'mod kompetittiv lill-CYP2C8 (Ki=34.7 μM).
English: Frequency categories are defined using the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).
Maltese: Il-kategoriji tal-frekwenzi huma definiti bl-użu ta' din il-konvenzjoni li jmiss: komuni ħafna ( 1/10), komuni ( 1/100 sa < 1/10), mhux komuni ( 1/1,000 sa < 1/100), rari ( 1/10,000 sa < 1/1,000), rari ħafna (< 1/10,000), mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Median age was 51 years (range 18-70 years), with 21.9% of patients ≥ 60 years of age.
Maltese: L-età medjana kienet ta' 51 sena (firxa 18-70 sena), b'21.9 % tal-pazjenti ta' età ta' ≥ 60 sena.
English: Myelodysplastic/myeloproliferative diseases (MDS/MPD).
Maltese: Mard majelodisplastiku/majeloproliferattiv (MDS/MPD).
English: Ara-C: cytosine arabinoside; CP: cyclophosphamide; DEX: dexamethasone; MTX: methotrexate; 6-MP: 6-mercaptopurine VM26: Teniposide; VCR: vincristine; IDA: idarubicine; i.v.
Maltese: MTX: methotrexate; 6-MP: 6-mercaptopurine VM26: Teniposide; VCR: vincristine;
English: Imatinib is a small molecule protein-tyrosine kinase inhibitor that potently inhibits the activity of the Bcr-Abl tyrosine kinase (TK), as well as several receptor TKs: Kit, the receptor for stem cell factor (SCF) coded for by the c-Kit proto-oncogene, the discoidin domain receptors (DDR1 and DDR2), the colony stimulating factor receptor (CSF-1R) and the platelet-derived growth factor receptors alpha and beta (PDGFR-alpha and PDGFR-beta).
Maltese: Imatinib hu inibitur molekulari żgħir ta' protein-tyrosine kinase b'potenzjal li jinibixxi l-attività ta' Bcr-Abl tyrosine kinase (TK), kif ukoll ta' riċetturi oħrajn ta' TKs: Kit, ir-riċettur tal-istem cell factor (SCF) kkodifikat bis-c-Kit proto-oncogene, id-discoidin domain receptors (DDR1 u DDR2), il-colony stimulating factor receptor (CSF-1R) u l-platelet-derived growth factor receptors alpha u beta (PDGFR-alpha u PDGFR-beta).
English: Ileus/intestinal obstruction*, gastrointestinal perforation*, diverticulitis*, gastric antral vascular ectasia (GAVE)* Hepatobiliary disorders Common
Maltese: Ileus/imblukkar tal-imsaren*, titqib gastro-intestinali*, divertikulite*, ektażja vaskulari tal-antrum tal-istonku (GAVE)* Disturbi fil-fwied u fil-marrara Komuni
English: G-CSF (5 μg/kg, SC): days 27-36 or until ANC > 1500 post nadir ARA-C (3 g/m2, q12h, IV): days 43, 44
Maltese: G-CSF (5 μg/kg, SC): jiem 27-36 jew sa ANC > 1500 postnadir ARA-C (3 g/m2, q12h, IV): jiem 43, 44
English: The active substance imatinib demonstrates an environmental risk for sediment organisms.
Maltese: Is-sustanza attiva imatinib turi riskju ambjentali għall-organiżmi tas-sediment.
English: • adult patients with advanced hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL) with FIP1L1-PDGFRα rearrangement.
Maltese: • pazjenti li jkollhom sindrome ipereżinofilika avvanzata (HES) u/jew lewkimja kronika eżinofolika (CEL) b'tibdil FIP1L1- PDGFRα.
English: The translocation t(17:22)[(q22:q13)], or its gene product, was present in nearly all responders to imatinib treatment.
Maltese: It-translokazzjoni t17:22)[(q22:q13)], jew il-prodott tal-ġene tiegħu, instab fil-pazjenti kollha li wrew rispons għall-kura b'imatinib.
English: The patients were distributed in three main categories: haematological failure (29%), cytogenetic failure (35%), or intolerance to interferon (36%).
Maltese: Il-pazjenti tqassmu fi tliet kategoriji ewlenin: falliment ematoloġiku (29 %), falliment ċitoġenetiku (35 %), jew intolleranza għal interferon
English: Ki values in human liver microsomes were 27, 7.5 and 7.9 mol/l, respectively.
Maltese: Il-valuri Ki fil-mikrosomi tal-fwied tal-bniedem kienu 27, 7.5 u 7.9 µmol/l, rispettivament.
English: Total bilirubin: > 3-10 ULN AST: any ULN = upper limit of normal for the institution AST = aspartate aminotransferase
Maltese: AST: li jkun ULN = il-limitu ta' fuq in-normal tal-instituzzjoni AST = aspartate aminotransferase
English: MESNA (360 mg/m2/dose q3h, x 8 doses/day, IV): days 1-5 G-CSF (5 μg/kg, SC): days 6-15 or until ANC > 1500 post nadir IT Methotrexate (age-adjusted): day 1 ONLY Triple IT therapy (age-adjusted): day 8, 15
Maltese: MESNA (360 mg/m2/doża q3h, x 8 dożi/kuljum, IV): jiem 1-5 G-CSF (5 μg/kg, SC): jiem 6-15 jew sa ANC > 1500 postnadir IT Methotrexate (aġġustata skont l-età): jum 1 BISS Terapija IT tripla (aġġustata skont l-età): jum 8, 15
English: INFORMATION IN BRAILLE Imatinib Accord 100 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Imatinib Accord 100 mg
English: INFORMATION IN BRAILLE Imatinib Accord 400 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Imatinib Accord 400 mg
English: A further 162 patients with HES/CEL, reported in 35 published case reports and case series received imatinib at doses from 75 mg to 800 mg daily.
Maltese: 162 pazjent ieħor b'HES/CEL, rappurtati f'35 rapporti ta' każijiet u serje ta' każijiet li ġew pubblikati irċevew imatinib b'dożi bejn 75 mg sa 800 mg kuljum.
English: Hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL).
Maltese: Sindrome ipereżinofilika (HES) u/jew Lewkimja eżinofilika kronika (CEL).
English: A complete haematological response was achieved in 95% of patients.
Maltese: Inkiseb rispons ematoloġiku komplet f'95 % talpazjenti.
English: Haematological and cytogenetic responses have been sustained for a median of 49 months (range 19-60) and 47 months (range 16-59), respectively.
Maltese: Risponsi ematoloġiċi u ċitoġenetiċi inżammu għall-medja ta' 49 xahar (medda bejn 19 u 60) u 47 xahar (medda 16-59), rispettivament.
English: Hypromellose 6 cps (E464) Microcrystalline cellulose pH 102 Crospovidone
Maltese: Microcrystalline cellulose pH 102
English: DEX 10 mg/ m2 oral, days 1-5;
Maltese: DEX 10 mg/m2 orali, jiem 1-5;
English: Of a panel of potential comedications (acetaminophen, aciclovir, allopurinol, amphotericin, cytarabine, erythromycin, fluconazole, hydroxyurea, norfloxacin, penicillin V) only erythromycin (IC50 50 μM) and fluconazole (IC50 118 μM) showed inhibition of imatinib metabolism which could have clinical relevance.
Maltese: Minn fost għadd ta' medikazzjonijiet li jistgħu jingħataw fl-istess ħin (acetaminophen, aciclovir, allopurinol, amphoteracin, cytarabine, erythromycin, fluconazole, hydroxyurea, norfloxacin, penicillin V), kienu biss erythromycin (IC50 50 μM) u fluconazole (IC50 118 μM) li inibixxew il-metaboliżmu ta' imatinib b'mod li seta' kellu xi relevanza klinika.
English: Table 3 Response in adult CML studies Study 0110 37-month data Chronic phase, IFN failure (n=532)
Maltese: Studju 0110 Dejta ta' 37 xahar Fażi kronika, Falliment ta' IFN (n=532)
English: A confirmed haematological response was achieved in 71.5% of patients (Table 3).
Maltese: Inkiseb rispons ematoloġiku kkonfermat f'71.5 % tal-pazjenti (Tabella 3).
English: Accelerated phase CML and blast crisis and Ph+ ALL (starting dose 600 mg)
Maltese: CML fil-fażi aċċellerata u blast crisis u Ph+ ALL (doża tal-bidu 600 mg)
English: Pharmacotherapeutic group: antineoplastic agents, protein kinase inhibitor, ATC code: L01XE01
Maltese: Kategorija farmakoterapewtika: sustanza li tinpedixxi l-enzima protein-tyrosine kinase, Kodiċi ATC:
English: An additional four HES patients were found to be FIP1L1-PDGFRα-positive in other 3 published reports.
Maltese: Erba' pazjenti oħra instabu posittivi għal FIP1L1-PDGFRα f'3 rapporti oħra li ġew pubblikati.
English: (1 h), days 28-31, 35-38, 42-45; 6-MP 60 mg/ m2 oral, days 26-46
Maltese: Ara-C 75 mg/m2 i.v. (1 h), jiem 28-31, 35-38, 42-45; 6-MP 60 mg/m2 orali, jiem 26-46
English: Study 0109 40.5-month data Accelerated phase (n=235)
Maltese: Studju 0109 Dejta ta' 40.5 xhur Fażi aċċellerata (n=235)
English: The free drug clearance of imatinib is probably similar between renal impairment and those with normal renal function, since renal excretion represents only a minor elimination pathway for imatinib (see sections 4.2 and 4.4).
Maltese: Il-clearance tal-mediċina ħielsa ta' imatinib hija probabbli simili bejn indeboliment tal-kliewi u dawk b'funzjoni tal-kliewi normali, peress li l-eliminazzjoni renali tirrappreżenta mezz ta' eliminazzjoni minuri għal imatinib (ara sezzjonijiet 4.2 u 4.4).
English: Imatinib at 400 mg twice daily had an inhibitory effect on CYP2D6-mediated metoprolol metabolism, with metoprolol Cmax and AUC being increased by approximately 23% (90%CI [1.16-1.30]).
Maltese: Imatinib 400 mg darbtejn kuljum kellu effett li inibixxa il-metaboliżmu ta' metoprolol medjat b'CYP2D6, b'żieda tas-Cmax u lAUC ta' metoprolol b'madwar 23% (90%CI [1.16-1.30]).
English: Importantly, 27.7% of patients also achieved a major cytogenetic response, which was complete in 20.4% (confirmed 16%) of patients.
Maltese: B'mod importanti, 27.7 % tal-pazjenti kisbu wkoll rispons ċitoġenetiku maġġuri, li kien komplet f'20.4 % (ikkonfermat f'16 %) tal-pazjenti.
English: With 7 years follow-up, there were 93 (16.8%) progression events in the Imatinib arm: 37 (6.7%) involving progression to accelerated phase/blast crisis, 31 (5.6%) loss of MCyR, 15 (2.7%) loss of CHR or increase in WBC, and 10 (1.8%) CML unrelated deaths.
Maltese: B'7 snin ta' segwitu, kien hemm 93 (16.8 %) avveniment ta' avvanz fil-fergħa b'Imatinib: 37 (6.7 %) li kienu jinvolvu avvanz lejn fażi aċċellerata/blast crisis, 31 (5.6 %) telf ta' MCyR, 15 (2.7 %) telf ta' CHR jew żieda f'WBC, u 10 (1.8 %) imwiet mhux relatati ma' CML.
English: Out of 9 patients with chronic phase CML and cytogenetic data available, 4 (44%) and 3 (33%) achieved a complete and partial cytogenetic response, respectively, for a rate of MCyR of 77%.
Maltese: Minn 9 pazjenti b'CML fil-fażi kronika u mittagħrif ċitoġenetiku disponibbli, jirriżulta li 4 (44%) u 3 (33%) kellhom rispons ċitoġenetiku komplet u parzjali, rispettivament, għal rata ta' MCyR ta' 77%.
English: DEX 10 mg/m2 oral, days 1-5; CP 200 mg/ m2 i.v., days 3, 4, 5;
Maltese: DEX 10 mg/m2 oralii, jiem 1-5; CP 200 mg/m2 i.v., jiem 3, 4, 5;
English: 1200 to 1600 mg (duration varying between 1 to 10 days): Nausea, vomiting, diarrhoea, rash, erythema, oedema, swelling, fatigue, muscle spasms, thrombocytopenia, pancytopenia, abdominal pain, headache, decreased appetite.
Maltese: 1200 sa 1600 mg (tul ta' żmien ivarja minn jum 1 sa 10 ijiem): Nawseja, rimettar, dijarea, raxx, eritema, edima, nefħa, għejja, spażmi fil-muskoli, tromboċitopenija, panċitopenija, uġigħ fl-addome, uġigħ ta' ras, nuqqas t'aptit.
English: Palmoplantar erythrodysesthesia syndrome*, lichenoid keratosis*, lichen planus*, toxic epidermal necrolysis*, drug rash with eosinophilia and systemic symptoms
Maltese: Sindrome ta' eritrodisasteżija palmoplantari*, keratożi lichenoid*, lichen planus*, nekrolisi tossika tal-epidermide*, raxx ikkawżat mill-mediċina b'eosinofilja u sintomi sistemiċi (DRESS - drug rash with eosinophilia and systemic symptoms)* , psewdoporfirja* Disturbi muskolu-skelettriċi u tat-tessuti konnettivi Komuni ħafna
English: Packs containing 20, 60, 120 or 180 film-coated tablets.
Maltese: Pakketti fihom 20, 60, 120 jew 180 pillola miksija b'rita.
English: Imatinib in combination with chemotherapy induction (see Table 3) resulted in a complete haematological response rate of 93% (147 out of 158 evaluable patients) and in a major cytogenetic response rate of 90% (19 out of 21 evaluable patients).
Maltese: Imatinib kombinat ma' induzzjoni b'kemoterapija (ara Tabella 3) wassal għal rata ta' rispons ematoloġiku komplet ta' 93% (147 minn 158 pazjenti li setgħu jkunu evalwati) u f'rata ta' rispons citoġenetika maġġuri ta' 90% (19 minn 21 pazjenti li setgħu jkunu evalwati).
English: EU/1/13/845/009-011 EU/1/13/845/012-014 EU/1/13/845/020-022
Maltese: EU/1/13/845/009-011 EU/1/13/845/012-014