qanastek/EMEA-V3 huggingface dataset:
In obese hypertensive patients who did not adequately respond to HCTZ 25 mg, add-on treatment with Sprimeo 300 mg provided additional blood pressure reduction that was comparable to add-on treatment with irbesartan 300 mg or amlodipine 10 mg.
F’ pazjenti obeżi li għandhom il- pressjoni għolja li ma wrewx rispons xieraq għal HCTZ 25 mg, kura bl- inklużjoni ta ’ Sprimeo 300 mg ipprovdiet tnaqqis addizzjonali fil- pressjoni tad- demm li seta ’ jitqabbel ma ’ kura bl- inklużjoni ta ’ irbesartan 300 mg jew amlodipine 10 mg.
In diabetic hypertensive patients, Sprimeo provided additive blood pressure reductions when added to ramipril, while the combination of Sprimeo and ramipril had a lower incidence of cough (1.8%) than ramipril (4.7%).
F’ pazjenti dijabetiċi li għandhom il- pressjoni għolja, Sprimeo ipprovda tnaqqis addittiv tal- pressjoni tad- demm meta ngħata ma ’ ramipril, filwaqt li l- kombinazzjoni ta ’ Sprimeo u ramipril kellha anqas każijiet ta ’ sogħla (1. 8%) minn ramipril (4. 7%).
Excessive hypotension was uncommonly (0.1%) seen in patients with uncomplicated hypertension treated with Sprimeo alone.
Pressjoni baxxa żżejjed kienet mhux komuni (0. 1%) f’ pazjenti bi pressjoni għolja mingħajr komplikazzjoni li kienu kkurati b’ Sprimeo waħdu.
In a 3-month study of 302 patients with mild stable heart failure, all of whom were receiving standard therapy for stable heart failure, addition of Sprimeo 150 mg was well tolerated.
Fi studju ta ’ 3 xhur fuq 302 pazjenti b’ insuffiċjenza tal- qalb stabbli u mhux severa (Klassi funzjonali NYHA II u III), li kollha kemm huma kienu qed jirċievu terapija standard għall- insuffiċjenza tal- qalb iż- żieda ta ’ Rasliez 150 mg kienet tollerata sew.
However the clinical significance of this reduction is unknown.
Il- livelli ta ’ peptajd natrijuretiku tat- tip- B (BNP) kienu mnaqqsa b’ 25% fil- fergħa ta ’ Sprimeo meta mqabbla mal- plaċebo għalkemm is- sinifikat kliniku għadu mhux magħruf.
In a 6-month study of 599 patients with hypertension, type 2 diabetes mellitus, and nephropathy, all of whom were receiving losartan 100 mg and optimised antihypertensive background therapy, addition of Sprimeo 300 mg achieved a 20% reduction versus placebo in urinary albumin: creatinine ratio (UACR), i. e. from 58 mg/ mmol to 46 mg/ mmol.
Fi studju ta ’ 6 xhur ta ’ 599 pazjent bi pressjoni għolja, dijabete mellitus tat- tip 2, u nefropatija, li kollha kemm huma kienu qed jingħataw losartan 100 mg u terapija ta ’ sfond adattata għal kontra l - pressjoni għolja, iż- żieda ta ’ Sprimeo 300 mg kisbet tnaqqis ta ’ 20% kontra plaċebo, i. e. minn 58 mg/ mmol għal 46 mg/ mmol, fil- proporzjon ta ’ l- albumina mal- krejatina fl- awrina (UACR).
The proportion of patients who had UACR reduced at least 50% from baseline to endpoint was 24.7% and 12.5% for Sprimeo and placebo, respectively.
Il - proporzjon tal- pazjenti li kellhom tnaqqis fil- UACR b’ mill- anqas 50% mill- linja bażi sat- tragward finali kien ta ’ 24. 7% u 12. 5% għal Sprimeo u l- plaċebo, rispettivament.
1.9% for placebo) of serum potassium concentration (≥ 6.0 mmol/ l), although this was not statistically significant.
Sprimeo ma effettwax il - konċentrazzjoni fis- serum tal- krejatinina iżda kien assoċjat ma ’ żieda fil- frekwenza (4. 2% vs 1. 9% għal plaċebo) tal- konċentrazzjoni tal- potassium fis- serum (≥ 6. 0 mmol/ l), għalkemm dan ma kienx statistikament sinifikanti.
7 Beneficial effects of Sprimeo on mortality and cardiovascular morbidity and target organ damage are currently unknown.
7 L- effetti benefiċi ta ’ Sprimeo fuq il- mortalità jew morbidità kardjovaskulari u l- ħsara fl- organu milqut bħalissa mhumhiex magħrufa.
No adjustment of the initial dosage of Sprimeo is required in patients with mild to severe renal impairment, however caution should be exercised in patients with severe renal impairment.
Mhux meħtieġ bdil tad - doża tal- bidu ta ’ Sprimeo f’ pazjenti b’ indeboliment renali ħafif għal sever, iżda għandha tingħata attenzjoni f’ pazjenti b’ indeboliment renali sever.
Sprimeo 300 mg film-coated tablets
Sprimeo 300 mg pilloli miksijin b’ rita
When administered with atorvastatin, steady-state Sprimeo AUC and Cmax increased by 50%.
Meta ngħata ma ’ atorvastatin, l- AUC
Digoxin bioavailability may be slightly decreased by Sprimeo.
Il- biodisponibilità ta ’ digoxin tista ’ titnaqqas xi ftit b’ Sprimeo.
12 Preliminary data suggest that irbesartan may decrease Sprimeo AUC and Cmax.
Tagħrif preliminari jindika li irbesartan jista ’ jnaqqas xi ftit l- AUC u s- Cmax ta ’ Sprimeo.
It is therefore recommended that the effects be monitored when initiating and adjusting furosemide therapy to avoid possible underutilisation in clinical situations of volume overload.
Għalhekk huwa irrakkomandat li l- effetti jkunu monitorati meta tinbeda u tkun qed tiġi
Potassium and potassium-sparing diuretics Based on experience with the use of other substances that affect the renin-angiotensin system, concomitant use of potassium-sparing diuretics, potassium supplements, salt substitutes containing
13 aġġustata t- terapija ta ’ furosemide biex dan ma jkunx sotto- utilizzat f’ sitwazzjonijiet kliniċi ta ’ volum żejjed.
13 potassium or other substances that may increase serum potassium levels (e. g. heparin) may lead to increases in serum potassium.
Potassium u dijuretiċi li ma jħallux il- potassium jintilef Minn esperjenza b’ sustanzi oħrajn li jeffettwaw is- sistema renin- angiotensin, l- użu ta ’ dijuretiċi li ma jħallux il- potassium jintilef, supplimenti tal- potassium, sostituti tal- melħ li fihom il- potassium jew sustanzi oħra li jistgħu jżidu l- livelli ta ’ potassium fis- serum (eż heparin) jistgħu jwasslu għal żidied tal- potassium fis- serum.
15 Hypertension In hypertensive patients, once-daily administration of Sprimeo at doses of 150 mg and 300 mg provided dose-dependent reductions in both systolic and diastolic blood pressure that were maintained over the entire 24-hour dose interval (maintaining benefit in the early morning) with a mean peak to trough ratio for diastolic response of up to 98% for the 300 mg dose.
Pressjoni għolja F’ pazjenti bil- pressjoni għolja, l- għotja darba kuljum ta ’ Sprimeo b’ dożi ta ’ 150 mg u 300 mg ikkawżaw tnaqqis dipendenti mid- doża fil- pressjoni tad- demm sistolika u dijastolika li nżammu fuq perijodu sħiħ ta ’ 24 siegħa ta ’ l- intervall bejn id- dożi (b’ hekk żammew il- benefiċċju ta ’ kmieni filgħodu) b’ medja fil- proporzjon bejn l- oghla u l- anqas għar- rispons dijastoliku sa ’ 98% għad- doża ta ’ 300 mg.
Sprimeo did not affect the serum concentration of creatinine but was associated with an increased frequency (4.2% vs.
Sprimeo ma effettwax il -
16 Beneficial effects of Sprimeo on mortality and cardiovascular morbidity and target organ damage are currently unknown.
L- effetti benefiċi ta ’ Sprimeo fuq il- mortalità jew morbidità kardjovaskulari u l- ħsara fl- organu milqut bħalissa mhumhiex magħrufa.
Consequently, no adjustment of the initial dose of aliskiren is required in patients with mild to severe hepatic impairment.
Mhux meħtieġ bdil tad - doża tal- bidu ta ’ Sprimeo f’ pazjenti b’ indeboliment renali ħafif għal sever, iżda għandha tingħata attenzjoni f’ pazjenti b’ indeboliment renali sever.
Sprimeo 150 mg film-coated tablets Aliskiren
Sprimeo 150 mg pilloli miksijin b’ rita Aliskiren
Sprimeo 300 mg film-coated tablets Aliskiren
Sprimeo 300 mg pilloli miksijin b’ rita Aliskiren
What Sprimeo is and what it is used for 2.
X’ inhu Sprimeo u għalxiex jintuża 2.
Before you take Sprimeo 3.
Qabel ma tieħu Sprimeo 3.
How to take Sprimeo 4.
Kif għandek tieħu Sprimeo 4.
How to store Sprimeo 6.
Kif taħżen Sprimeo 6.
WHAT SPRIMEO IS AND WHAT IT IS USED FOR
X’ INHU SPRIMEO U GĦALXIEX JINTUŻA
Sprimeo belongs to a new class of medicines called renin inhibitors.
Rasliez jagħmel parti minn klassi ġdida ta ’ mediċini li jissejjħu inibituri ta ’ renin.
Sprimeo helps to lower high blood pressure.
Sprimeo jgħin biex ibaxxi l- pressjoni tad- demm għolja.
BEFORE YOU TAKE SPRIMEO
QABEL MA TIEĦU SPRIMEO
Do not take Sprimeo
Tieħux Sprimeo
Take special care with Sprimeo
Oqgħod attent ħafna b’ Sprimeo
If any of these apply to you, tell your doctor before you take Sprimeo.
Jekk xi wieħed minn dawn jgħodd għalik, għid lit- tabib tiegħek qabel tieħu Sprimeo.
The use of Sprimeo in children and adolescents is not recommended.
L- użu ta ’ Sprimeo fi tfal u adolexxenti mhux rakkomandat.
Taking Sprimeo with food and drink You should take Sprimeo with a light meal once a day, preferably at the same time each day.
Meta tieħu Sprimeo ma ’ l- ikel u max- xorb Għandek tieħu Sprimeo ma ’ ikla ħafifa darba kuljum, l- aħjar fl- istess ħin kuljum.
You should not take Sprimeo together with grapefruit juice.
M’ għandekx tieħu Sprimeo mal- meraq tal- grejpfrut.
Pregnancy and breast-feeding Do not take Sprimeo if you are pregnant.
Tqala u treddigħ Tieħux Sprimeo jekk ħriġt tqila.
Do not breast-feed if you are taking Sprimeo.
Treddax jekk qed tieħu Sprimeo.
Before you drive a vehicle, use machinery, or carry out other activities that require concentration, you should make sure you know how you react to the effects of Sprimeo.
Qabel issuq karozza, tħaddem makkinarju, jew tagħmel attivitajiet oħra li jeħtieġu konċentrazzjoni, għandhekk taċċerta ruħek li tkun taf x’ tip ta ’ reazjoni jkollok għall- effetti ta ’ Sprimeo.
HOW TO TAKE SPRIMEO
KIF GĦANDEK TIEĦU SPRIMEO
Always take Sprimeo exactly as your doctor has told you.
Dejjem għandek tieħu Sprimeo skond il- parir eżatt tat- tabib.
Your doctor may prescribe Sprimeo together with other medicines used to treat high blood pressure.
It- tabib tiegħek jista ’ jordnalek Sprimeo ma ’ mediċini oħra li jintużaw biex jikkuraw il- pressjoni tad- demm għolja.
You should take Sprimeo with a light meal once a day, preferably at the same time each day.
Għandek tieħu Sprimeo ma ’ ikla ħafifa darba kuljum, l- aħjar fl- istess ħin kuljum.
You should not take Sprimeo together with grapefruit juice.
M’ ghandekx tieħu Sprimeo mal- meraq tal- grejpfrut.
If you take more Sprimeo than you should If you have accidentally taken too many Sprimeo tablets, consult a doctor immediately.
Jekk tieħu Sprimeo aktar milli suppost Jekk bi żball ħadt wisq pilloli Sprimeo, ikkonsulta mat- tabib tiegħek minnufih.
If you forget to take Sprimeo If you forget to take a dose of Sprimeo, take it as soon as you remember and then take the next dose at
Jekk tinsa tieħu Sprimeo Jekk tinsa tieħu doża ta ’ Sprimeo, ħudha hekk kif tiftakar u imbagħad ħu d- doża li jmissek fil- ħin tas - soltu.
Like all medicines, Sprimeo can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Sprimeo jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
HOW TO STORE SPRIMEO
KIF TAĦŻEN SPRIMEO
Do not use Sprimeo after the expiry date which is stated on the carton and blister.
Tużax Sprimeo wara d- data ta ’ skadenza li tidher fuq il- kartuna u l- folja.
What Sprimeo contains
X’ fih Sprimeo
What Sprimeo looks like and contents of the pack Sprimeo 150 mg film coated tablets are light-pink, biconvex round tablets, imprinted “ IL” on one side and “ NVR” on the other side.
Id- Dehra ta ’ Sprimeo u l- kontenuti tal- pakkett Sprimeo 150 mg pilloli miksijin b’ rita huma pilloli roża ċar, konvessi miż- żewġ naħat, tondi, ittimbrati ‘ IL ’ fuq naħa u ‘ NVR ’ fuq in- naħa l- oħra.
Sprimeo is available in packs containing 7, 14, 28, 30, 50, 56, 84, 90, 98 or 280 tablets.
Sprimeo jiġi f’ pakketti li jkun fihom 7, 14, 28, 30, 50, 56, 84, 90, 98 jew 280 pillola.
45 its usual time.
45 Jekk tinsa tieħu Sprimeo Jekk tinsa tieħu doża ta ’ Sprimeo, ħudha hekk kif tiftakar u imbagħad ħu d- doża li jmissek fil- ħin tas - soltu.
What Sprimeo looks like and contents of the pack Sprimeo 300 mg film coated tablets are light-red, biconvex, ovaloid tablets, imprinted “ IU” on one side and “ NVR” on the other side.
Id- Dehra ta ’ Sprimeo u l- kontenuti tal- pakkett Sprimeo 300 mg pilloli miksijin b’ rita huma pilloli aħmar ċar, konvessi miż- żewġ naħat, f’ għamla ovali, ittimbrati ‘ IU ’ fuq naħa u ‘ NVR ’ fuq in- naħa l- oħra.
What is Sprycel?
X’ inhu Sprycel?
Sprycel is a medicine that contains the active substance dasatinib.
Sprycel huwa mediċina li fiha s- sustanza attiva dasatinib.
It is available as white tablets (round:
Huwa disponibbli f' forma ta ’ pilloli bojod (tondi:
20 and 70 mg; oval:
20 u 70 mg; ovali:
50 and 100 mg).
50 u 100 mg).
What is Sprycel used for?
Għal xiex jintuża Sprycel?
It is used to treat adult patients who have leukaemia (cancer of the white blood cells): • it is used in chronic myeloid leukaemia (CML), a type of leukaemia where granulocytes (a type of white blood cell) start growing out of control, in all phases of the disease (chronic, accelerated and blast).
Sprycel huwa mediċina kontra l- kanċer li jintuża għat- trattament ta ’ pazjenti adulti bil- lewċemija (kanċer taċ- ċelloli bojod tad- demm): • jintuża fil- lewċemija mjelojde kronika (CML) fil- fażijiet kollha tal- marda (kronika, aċċelerata u blastika), tip ta ’ lewċemija li fiha l- granuloċiti (tip ta ’ ċelloli bojod tad- demm) jibdew jikbru mingħajr kontroll.
Sprycel is used when patients cannot tolerate, or when their disease is not responding to other treatments including imatinib (another anticancer medicine); • it is also used in acute lymphoblastic leukaemia (ALL), a type of leukaemia where lymphocytes (another type of white blood cell) multiply too quickly, or blast phase CML, when the patients are ‘ Philadelphia chromosome positive ’ (Ph+).
Sprycel jintuża f’ pazjenti b’ intolleranza jew reżistenza għal trattamenti oħra, inkluż dawk b’ imatinib (mediċina oħra kontra l- kanċer); • jintuża wkoll għal- lewċemija linfoblastika akuta (ALL), tip ta ’ lewċemija li fiha l- linfoċiti (tip ieħor ċelloli bojod tad- demm) jirriproduċu ruħhom malajr wisq, jew fl- LMC f’ fażi blastika, meta l- pazjenti huma Ph+, jiġifieri bi kromożoma Philadelphia pożittiva.
This means that some of their genes have rearranged themselves to form a special chromosome called the Philadelphia chromosome.
Dan ifisser li xi ġeni organizzaw ruħhom mill- ġdid biex jiffurmaw kromożoma speċjali, bl- isem kromożoma Philadelphia.
This chromosome produces an enzyme that leads to the development of leukaemia.
Din il- kromożoma tipproduċi enzima li twassal għall- iżvilupp tal- lewċemija.
Sprycel is used when patients cannot tolerate, or when their disease is not responding to other treatments.
Minħabba li n- numru ta ’ pazjenti li jbatu minn dawn il- forom ta ’ lewċemija huwa baxx, il- mardiet jitqiesu bħala ‘ rari ’.
Because the number of patients with these two forms of leukaemia is low, the diseases are considered ‘ rare’, and Sprycel was designated an ‘ orphan medicine ’ (a medicine used in rare diseases) on 23 December 2005.
Fit- 23 ta ’ Diċembru 2005 Sprycel ġie kkwalifikat bħala ‘ mediċina orfni ’ (mediċina użata fil- mard rari).
How is Sprycel used?
Kif jintuża Sprycel?
Treatment with Sprycel should be started by a doctor who has experience in the diagnosis and treatment of leukaemia.
It- terapija bi Sprycel għandha tinbeda minn tabib b’ esperjenza fid- dijanjożi u fit- trattament tal - lewċemija.
For chronic phase CML, the starting dose of Sprycel is 100 mg once a day, taken at the same time every day.
Għas- CML f’ fażi kronika, id- doża inizjali ta ’ Sprycel hija 100 mg darba kuljum, meħuda dejjem fl- istess ħin kuljum.
For advanced (accelerated or blast) phase CML and for Ph+ ALL, the starting dose is 70 mg twice a day, with one tablet in the morning and one in the evening.
Għall- LMC f’ fażi avvanzata (aċċelerata jew blastika) u għall- ALL Ph+, id- doża inizjali hija 70 mg darbtejn kuljum, b’ pillola filgħodu u oħra filgħaxija.
The dose can be increased or decreased based on the patient’ s response to the medicine.
Id- doża tista ’ tiżdied jew titnaqqas skont ir- rispons tal- pazjent għall- mediċina.
Treatment with Sprycel is continued until either the disease gets worse or until the patient cannot tolerate the medicine.
It- trattament bi Sprycel ikompli sa meta l- marda taggrava jew sal- intolleranza tal- pazjent għall - mediċina.
Patients must be monitored during treatment to check their blood levels of platelets (the components that help clotting) and neutrophils (the white blood cells that fight infection).
Il- pazjenti għandhom ikunu sorveljati matul it- trattament biex il- livelli ta ’ platelets fid - demm (komponenti li jgħinu d- demm jgħaqqad) u n- newtrofili (iċ- ċelloli bojod tad- demm li jiġġieldu l- infezzjoni) jiġu kkontrollati.
Doctors may recommend a lower dose or a break from treatment if these values change or if patients 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Jekk dawn il- valuri jinbidlu jew jekk jiġu osservati ċerti effetti 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel.
Reproduction is authorised provided the source is acknowledged. have certain side effects.
Reproduction is authorised provided the source is acknowledged. sekondarji, it- tobba jistgħu jirrakkomandaw dożaġġ anqas qawwi jew waqfa tat- trattament.
The treatment should also be used with caution in patients who have moderate to severe liver disease.
It - trattament għandu wkoll jintuża b’ kawtela fil- pazjenti li jbatu minn marda epatika minn moderata għal gravi.
Sprycel can be taken with or without a meal, but the tablets must be swallowed whole.
Sprycel jista ’ jittieħed fuq stonku vojt jew le, imma l- pilloli għandhom jinbelgħu sħaħ.
See the Summary of Product Characteristics (also part of the EPAR) for full details.
Ara s - Sommarju tal- Karatteristiċi tal- Prodott (parti wkoll mill- EPAR) għad- dettalji kollha.
How does Sprycel work?
Kif jaħdem Sprycel?
The active substance in Sprycel, dasatinib, belongs to a group of medicines called ‘ protein kinase inhibitors’.
Is- sustanza attiva fi Spryvel, dasatinib, tappartjeni għal grupp ta ’ mediċini msejħa ‘ inibituri tal - proteina kinażi ’.
These compounds act by blocking types of enzymes known as protein kinases.
Dawn il- komposti jaġixxu billi jimblukkaw tipi ta ’ enzimi magħrufa bħala proteini kinażi.
Dasatinib acts mainly by blocking the protein kinase called ‘ BCR-ABL’ kinase.
Dasatinib jaġixxi prinċipalment billi jimblokka l- proteina kinażi msejħa kinażi ‘ BCR- ABL ’.
This enzyme is produced by leukaemia cells, and causes them to multiply uncontrollably.
Din l- enzima hija prodotta miċ- ċelloli lewċemiċi u ġġegħelhom jimmultiplikaw mingħajr kontroll.
By blocking BCR-ABL kinase, as well as other kinases, Sprycel helps to control the spread of leukaemia cells.
Sprycel jgħin biex jikkontrolla l- multiplikazzjoni taċ- ċelloli lewċemiċi billi jimblokka, flimkien ma ’ kinażi oħrajn, il- kinażi BCR- ABL.
How has Sprycel been studied?
Kif ġie studjat Sprycel?
The five main studies of Sprycel, taken twice a day, involved 515 patients, all of whom had received prior treatment with imatinib, and either failed or had become resistant to the medicine.
Il- ħames studji ewlenin ta ’ Sprycel, meħud darbtejn kuljum, involvew 515- il pazjent, kull wieħed minnhom kien ġie sottopost qabel għal trattament b’ imatinib, li kien falla jew il- pazjenti kienu żviluppaw reżistenza għalih.
None of these studies included a head-to-head comparison of Sprycel with any other medicine.
L- ebda wieħed minn dawn l- istudji inkluda tqabbil ras imb ras bejn Sprycel u mediċina oħra.
Two studies were carried out in chronic CML (198 and 36 patients), one was in accelerated CML (120 patients), one was in myeloid blast CML (80 patients), and one was in Ph+ ALL and lymphoid blast CML (81 patients).
Twettqu żewġ studji fuq CML f’ fażi kronika (198 u 36 pazjent), wieħed fuq CML f’ fażi aċċelerata (120 pazjent), wieħed fuq CML f’ fażi mjelojde blastika (80 pazjent) u wieħed fuq CML f’ fażi linfojde blastika u LLA Ph+ (81 pazjent).
Two further studies compared the effects of Sprycel taken once or twice a day, one in 670 patients with chronic phase CML and the other in 611 patients with advanced phase CML or Ph+ ALL.
Żewġ studji ulterjuri qabblu l- effetti ta ’ Sprycel meħud darba jew darbtejn kuljum, wieħed f’ 670 pazjent bi CML f’ fażi kronika u l- ieħor f’ 611- il pazjent bi CML f’ fażi avvanzata jew LLA Ph+.
These studies were still ongoing at the time of assessment.
Dawn l- istudji kienu għadhom għaddejjin fiż- żmien tal- valutazzjoni.
All of the studies assessed the patients’ responses by measuring the amount of white cells and platelets in the blood, to see if they were returning to normal levels, and the proportion of the patients’ white blood cells that contained the Philadelphia chromosome, to see if it was decreasing.
L- istudji kollha vvalutaw ir- risponsi tal- pazjenti billi kejlu l- kwantità ta ’ ċelloli bojod u platelets fid - demm, biex isir magħruf jekk kienu qegħdin jerġgħu lura għal- livelli normali, u l- proporzjon ta ’ globuli bojod li fihom il- kromożoma Philadelphia, biex isir magħruf jekk kienx qiegħed jonqos.
What benefit has Sprycel shown during the studies?
Liema benefiċċju wera Sprycel fl- istudji mwettqa?
In the larger main study of patients with chronic phase CML, 90% of the patients responded to treatment, with blood levels of platelets and white blood cells returning to within predefined, normal values.
Fl- studju ewlieni fuq skala akbar fuq pazjenti bi CML f’ fażi kronika, 90% tal- pazjenti kellu rispons għat- trattament, b’ livelli ta ’ platelets u globuli bojod fid- demm li reġgħu lura fil- valuri normali predefiniti.
In patients with CML in other phases (accelerated, myeloid blast and lymphoid blast) and in ALL, between a quarter and a third of patients showed a complete response.
Fil- pazjenti bi CML f’ fażijiet oħra (aċċelerata, mjelojde blastika u linfojde blastika) u f’ ALL ġie osservat rispons komplut f’ perċentwal ta ’ pazjenti bejn kwart u terz.
In addition, between one and two thirds of the patients in the five main trials showed a reduction in the number of white blood cells containing the Philadelphia chromosome.
Barra minn hekk, fil - ħames studji ewlenin, perċentwal ta ’ pazjenti bejn terz u żewġ terzi wera tnaqqis tan- numru ta ’ globuli bojod li fihom il- kromożoma Philadelphia.
In the additional study of patients with chronic phase CML, although once- and twice-daily Sprycel had similar rates of effectiveness, the once-daily dose caused fewer side effects.
Fl- istudju addizzjonali tal- pazjenti bi CML f’ fażi kronika, minkejja li Sprycel meħud darba jew darbtejn kuljum kellu rati simili ta ’ effikaċja, it- teħid ta ’ darba kuljum ikkawża inqas effetti sekondarji.
In the study of patients with advanced phase CML or Ph+ ALL, the response in terms of blood counts was also similar with once- and twice-daily Sprycel.
Fl- istudju tal- pazjenti bi CML f’ fażi avvanzata jew LLA Ph+, ir- rispons f’ termini ta ’ għadd tad- demm kien simili għal Sprycel meħud darba jew darbtejn kuljum.
However, patients taking Sprycel twice a day continued to respond to the medicine for longer than those taking it once a day.
Il- pazjenti ttrattati bi Sprycel darbtejn kuljum madankollu komplew jirrispondu għall- mediċina għal aktar żmien meta mqabbla mal- pazjenti ttrattati darba kuljum.
What is the risk associated with Sprycel?
X’ inhu r- riskju assoċjat ma ’ Sprycel?
In studies, the most common side effects with Sprycel (seen in more than 1 patient in 10) were headache, pleural effusion (fluid around the lungs), dyspnoea (shortness of breath), cough, diarrhoea, nausea (feeling sick), vomiting, abdominal (tummy) pain, skin rash, musculoskeletal pain (pain in the joints and muscles), infection, haemorrhage (bleeding), superficial oedema (swelling), fatigue (tiredness), pyrexia (fever), neutropenia (low white blood cell counts), thrombocytopenia (low blood platelet counts) and anaemia (low red blood cell counts).
Waqt l- istudji l- effetti sekondarji l- aktar komuni bi Sprycel (li dehru f’ aktar minn pazjent 1 minn 10) kienu wġigħ ta ’ ras, effużjoni plewrika (fluwidu madwar il- pulmuni), dispnea (diffikultà biex tieħu n - nifs), sogħla, dijarrea, nawżea (dardir), remettar, uġigħ addominali (ta ’ żaqq), raxx fil- ġilda, uġigħ muskoloskeletriku (uġigħ fil- ġogi u fil- muskoli), infezzjoni, emorraġija (fsada), edema superfiċjali (nefħa), għeja, piressija (deni), newtropenija (numru baxx ta ’ globuli bojod), tromboċitopenija (numru baxx ta ’ platelets) u anemija (numru baxx ta ’ globuli ħomor).
For the full list of all side effects reported with Sprycel, see the Package Leaflet.
Għal- lista sħiħa tal- effetti sekondarji rrapportati bi Sprycel, ara l- Fuljett ta ’ Tagħrif.
Sprycel should not be used in people who may be hypersensitive (allergic) to dasatinib or any of the other ingredients.
Sprycel ma għandux jintuża f’ persuni li jistgħu jkunu ipersensittivi (allerġiċi) għal dasatinib jew għal xi sustanza oħra tiegħu.
Why has Sprycel been approved?
Għaliex ġie approvat Sprycel?
The Committee for Medicinal Products for Human Use (CHMP) decided that Sprycel’ s benefits are greater than its risks for the treatment of adults with chronic, accelerated or blast phase CML, and for the treatment of adults with Ph+ ALL and lymphoid blast CML, with resistance or intolerance to prior therapy.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċida li l- benefiċċji ta ’ Sprycel huma ogħla mir- riskji tiegħu fit- trattament ta ’ adulti bi CML f’ fażi kronika, aċċelerata jew blastika u fit- trattament ta ’ adulti b’ ALL Ph+ u CML linfojde blastika, reżistenti jew intolleranti għal terapiji preċedenti.
The Committee recommended that Sprycel be given marketing authorisation.
Il- Kumitat irrakkomanda li Sprycel jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Sprycel:
2/ 3 Aktar tagħrif dwar Sprycel:
The European Commission granted a marketing authorisation valid throughout the European Union for Sprycel to Bristol-Myers Squibb Pharma EEIG on 20 November 2006.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida fl- UE kollha għal Sprycel lil Bristol- Myers Squibb Pharma EEIG fl- 20 ta ’ Novembru 2006.
2/ 3 The summaries of opinion of the Committee for Orphan Medicinal Products for Sprycel are available here (CML) and here (ALL).
Is- sommarji tal- opinjoni tal- Kumitat għall- Prodotti Mediċinali Orfni għal Sprycel huma disponibbli hawn (CML) u hawn (ALL).
The full EPAR for Sprycel can be found here.
L- EPAR sħiħ għal Sprycel jista ’ jiġi kkonsultat hawn.
Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet
Pillola miksija b' rita Pillola miksija b' rita Pillola miksija b' rita Pillola miksija b' rita Pillola miksija b' rita Pillola miksija b' rita Pillola miksija b' rita Pillola miksija b' rita Pillola miksija b' rita Pillola miksija b' rita Pillola miksija b' rita
bottle (HDPE) bottle (HDPE) bottle (HDPE) blister (alu/ alu) blister (alu/ alu) blister (alu/ alu) blister (alu/ alu) blister (alu/ alu) blister (alu/ alu) bottle (HDPE) blister (alu/ alu)
Flixkun (HDPE) Flixkun (HDPE) Flixkun (HDPE) Folji (Alu/ Alu) Folji (Alu/ Alu) Folji (Alu/ Alu) Folji (Alu/ Alu) Folji (Alu/ Alu) Folji (Alu/ Alu) Flixkun (HDPE) Folji (Alu/ Alu)
60 tablets 60 tablets 60 tablets 56 tablets 56 tablets 56 tablets 60 x 1 tablets (unit dose) 60 x 1 tablets (unit dose) 60 x 1 tablets (unit dose) 30 tablets 30 x 1 tablets (unit dose)
56 pillola miksijin b’ rita 56 pillola miksijin b’ rita 56 pillola miksijin b’ rita 60 pillola miksijin b’ rita 50 pillola miksijin b’ rita 60 pillola miksijin b’ rita 60 x 1 pillola miksijin b’ rita 60 x 1 pillola miksijin b’ rita 60 x 1 pillola miksijin b’ rita 30 pillola miksijin b’ rita 30 x 1 pillola miksijin b’ rita
SPRYCEL 20 mg film-coated tablets
SPRYCEL 20 mg pilloli miksijin b’ rita
Each film-coated tablet contains 20 mg dasatinib (as monohydrate).
Kull pillola miksija b’ rita fiha 20 mg dasatinib (bħala monoidrat).
Excipients: each tablet contains 27 mg of lactose monohydrate.
Sustanzi mhux attivi: kull pillola fiha 27 mg ta ’ lactose monohydrate.
Film-coated tablet (tablet)
Pillola miksija b' rita (pillola)
White to off-white, biconvex, round tablet with "BMS" debossed on one side and "527" on the other side.
Pillola tonda, tvarja minn bajda għal offwajt, ibbuzzata fuq iż- żewġ naħat, b '"BMS" imnaqqxa fuq naħa waħda u "527" fuq in- naħa l- oħra.
SPRYCEL is indicated for the treatment of adults with chronic, accelerated or blast phase chronic myeloid leukaemia (CML) with resistance or intolerance to prior therapy including imatinib mesilate.
SPRYCEL huwa indikat għat- trattament ta 'adulti b' kondizzjoni kronika ta ’ lewkimja majelojd kronika (CML), aċċellerata jew splussiva b' reżistenza jew intolleranza għal terapija li tkun saret qabel inkluż b’ imatinib mesilate.
SPRYCEL is also indicated for the treatment of adults with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukaemia (ALL) and lymphoid blast CML with resistance or intolerance to prior therapy.
SPRYCEL huwa indikat ukoll għat- trattament ta 'adulti li għandhom lewkimja limfoblastika akuta (ALL) b' Philadelphia chromosome positive (Ph+) u lymphoid blast CML b' reżistenza jew intolleranza għal terapija li tkun saret qabel.
Therapy should be initiated by a physician experienced in the diagnosis and treatment of patients with leukaemia.
It- terapija għandha tinbeda minn tabib b' esperjenza fid- dijanjożi u trattamenti ta ’ pazjenti b’ lewkimja.
The recommended starting dose for chronic phase CML is 100 mg dasatinib once daily, administered orally, consistently either in the morning or in the evening (see section 4.4).
Id- doża tal- bidu rakkomandata għal CML ta ’ fażi kronika hija ta '100 mg ta ’ dasatinib darba kuljum, tittieħed mill- ħalq, b’ mod konsistenti jew filgħodu jew filgħaxija (ara sezzjoni 4. 4).
The recommended starting dose for accelerated, myeloid or lymphoid blast phase (advanced phase) CML or Ph+ALL is 70 mg twice daily administered orally, one tablet in the morning and one in the evening.
Id- doża tal- bidu rakkomandata għal CML aċċellerata, majelojd jew tal- fażi lymphoid blast (fażi avanzata) jew Ph+ALL hija ta ’ 70 mg darbtejn kuljum mogħtija b’ mod orali, pillola filgħodu u oħra filgħaxija.
Tablets must not be crushed or cut, they must be swallowed whole.
Il- pilloli m' għandhomx jitfarrku jew jinqasmu, imma għandhom jinbelgħu sħaħ.
SPRYCEL can be taken with or without a meal.
SPRYCEL jista ’ jittieħed ma ’ l- ikel jew fuq stonku vojt.
Treatment duration: in clinical trials, treatment with SPRYCEL was continued until disease progression or until no longer tolerated by the patient.
It- tul tat- trattament: fil- provi kliniċi, it- trattament bi SPRYCEL baqa 'sejjer sal- progressjoni tal- marda jew sakemm ma baqax jiġi ittollerat mill- pazjent.
The effect of stopping treatment after the achievement of a complete cytogenetic response (CCyR) has not been investigated.
L- effett tal- waqfien tat- trattament wara li ntlaħaq respons ċitoġenetiku komplet (CCyR) ma ġiex investigat.
To achieve the recommended dose, SPRYCEL is available as 20 mg, 50 mg, 70 mg and 100 mg film- coated tablets.
Biex tikseb id- doża rakkomandata, SPRYCEL hu disponibbli bħala pilloli miksija b’ rita ta ’ 20 mg, 50 mg, 70 mg u 100 mg.
Dose increase or reduction is recommended based on patient response and tolerability.
Iż- żieda jew it- tnaqqis fid- doża hi rakkomandata bbażata fuq ir- rispons u t - tollerabilità tal- pazjent.
2 Dose escalation:
2 Żieda fid- doża:
In clinical trials of adult CML and Ph+ ALL patients, dose escalation to 140 mg once daily (chronic phase CML) or 100 mg twice daily (advanced phase CML or Ph+ ALL) was allowed in patients who did not achieve a haematologic or cytogenetic response at the recommended starting dose.
Fil- provi kliniċi b’ pazjenti adulti b' CML u Ph+ ALL, kienet permessa żieda fid- doża sa 140 mg darba kuljum (CML ta 'fażi kronika) jew 100 mg darbtejn kuljum (CML ta ’ fażi avanzata jew Ph+ ALL) f' pazjenti li ma kellhomx respons ematoloġiku jew ċitoġenetiku fid- doża tal- bidu rakkomandata.
Dose adjustment for undesirable effects:
Aġġustamenti tad- doża għal effetti mhux mixtieqa:
Myelosuppression:
Majelosuppressjoni:
In clinical trials, myelosuppression was managed by dose interruption, dose reduction, or discontinuation of study therapy.
Fil- provi kliniċi, majelosuppressjoni kienet ikkontrollata billi twaqqfet jew tnaqqset id- doża, jew twaqqfet it- terapija studjata.
Platelet transfusion and red cell transfusion were used as appropriate.
Intużaw trasfużjonijiet ta 'platelets u ta ’ ċelloli ħomor skond il- bżonn.
Haematopoetic growth factor has been used in patients with resistant myelosuppression.
Il - fattur ta 'tkabbir ematopoetiku ntuża f' pazjenti b' majelosuppressjoni reżistenti.
Guidelines for dose modifications are summarized in Table 1.
F' tabella 1 hemm linji gwida mqassra, għall- modifikazzjonijiet tad- doża.
Dose adjustments for neutropenia and thrombocytopenia
Aġġustamenti fid- doża għal newtropenja u tromboċitopenja
1 Stop treatment until ANC ≥ 1.0 x 109/ l and platelets ≥ 50 x 109/ l.
1 Waqqaf it- trattament sakemm ANC ≥ 1. 0 x 109/ l u platelets ≥ 50 x 109/ l.
Chronic Phase CML
2 Erġa 'ibda t- trattament bid- doża oriġinali tal- bidu.
ANC < 0.5 x 109/ l
ANC < 0. 5 x 109/ l CML ta 'Fażi Kronika 3 Jekk platelets < 25 x 109/ l u/ jew (doża tal- bidu 100 mg darba kuljum)
and/ or Platelets < 50 x 109/ l
u/ jew Platelets < 50 x 109/ l
If platelets < 25 x 109/ l and/ or recurrence of ANC < 0.5 x 109/l for > 7 days, repeat step 1 and resume treatment at a reduced dose of 80 mg once daily (second episode) or discontinue (third episode).
ikun hemm rikorrenza ta 'ANC ta ’ < 0. 5 x 109/ l għal > 7 ġranet, irrepeti numru 1 u erġa' ibda t- trattament b' doża mnaqqsa ta ’ 80 mg darba kuljum (it - tieni episodju) jew waqqaf it- trattament (it- tielet episodju).
Check if cytopenia is related to leukaemia (marrow aspirate or biopsy).
1 Iċċekkja jekk iċ- ċitopenja hiex relatata mal- lewkimja (aspirate tal- mudullun jew bijopsija).
2 If cytopenia is unrelated to leukaemia, stop treatment until ANC ≥ 1.0 x 109/ l and platelets ≥ 20 x 109/ l and resume at the original starting dose.
2 Jekk iċ- ċitopenja ma tkunx relatata mal- lewkimja, waqqaf it- trattament sakemm ANC ≥ 1. 0 x 109/ l u platelets ≥ 20 x 109/ l u erġa 'ibda bid- doża oriġinali tal- bidu.
Accelerated and Blast Phase ANC < 0.5 x 109/ l CML and Ph+ ALL (starting dose 70 mg twice
CML u Ph+ ALL b' Fażi ANC < 0. 5 x 109/ l Aċċellerata u Splussiva (doża tal- bidu 70 mg
and/ or
u/ jew
If recurrence of cytopenia, repeat step 1
F' każ ta 'rikorrenza ta' ċitopenja,
daily)
darbtejn kuljum)
Platelets < 10 x 109/ l
Platelets < 10 x 109/ l
and resume treatment at a reduced dose of 50 mg twice daily (second episode) or 40 mg twice daily (third episode).
irrepeti numru 1 u erġa 'ibda t - trattament b' doża mnaqqsa ta' 50 mg darbtejn kuljum (it- tieni episodju) jew 40 mg darbtejn kuljum (it- tielet episodju).
If cytopenia is related to leukaemia, consider dose escalation to 100 mg twice daily.
Jekk iċ- ċitopenja tkun relatata ma 'lewkimja, ikkunsidra żieda fid- doża sa 100 mg darbtejn kuljum.
ANC: absolute neutrophil count
ANC: għadd assolut ta 'newtrofili
Non-haematological adverse reactions:
Reazzjonijiet avversi mhux ematoloġiċi:
If a severe non-haematological adverse reaction develops with dasatinib, treatment must be withheld until the event has resolved.
Jekk tiżviluppa reazzjoni serja mhux ematoloġika b’ dasatinib, irid jitwaqqaf it- trattament sakemm il - każ ikun ġie solvut.
Thereafter, treatment can be resumed as appropriate at a reduced dose depending on the initial severity of the event.
Minn hemm- il quddiem, it- trattament jista 'jerġa' jinbeda skond il- ħtieġa b' doża mnaqqsa, jiddependi fuq kemm kien sever il- każ fil- bidu.
Paediatric patients:
3 Pazjenti pedjatriċi:
SPRYCEL is not recommended for use in children and adolescents below 18 years of age due to a lack of data on safety and efficacy (see section 5.1).
SPRYCEL mhux irrakkomandat għal użu fit- tfal u fl- addoloxxenti taħt it- tmintax- il sena peress li m’ hemmx biżżejjed informazzjoni dwar is- sigurtà u l- effikaċja (ara sezzjoni 5. 1).
Elderly patients: no clinically relevant age-related pharmacokinetic differences have been observed in these patients.
Pazjenti anzjani: ma ġew osservati ebda differenzi farmakokinetiċi klinikament rilevanti relatati ma 'l - età f' dawn il- pazjenti.
No specific dose recommendation is necessary in the elderly.
M' hemmx bżonn ta 'rakkomandazzjoni ta' doża speċifika għall- anzjani.
3 Hepatic impairment: no clinical trials were conducted with SPRYCEL in patients with moderate to severe hepatic impairment (trials excluded patients with ALT and/ or AST > 2.5 times the upper limit of the normal range and/ or total bilirubin > 2 times the upper limit of the normal range).
Indeboliment epatiku: ma sarux provi kliniċi bi SPRYCEL f' pazjenti b' indeboliment epatiku minn moderat sa sever (il- provi eskludew pazjenti b' ALT u/ jew AST > 2. 5 darbiet l- ogħla limitu tal- medda normali u/ jew bilirubin totali > darbtejn l- ogħla limitu tal- medda normali).
Since dasatinib is mainly metabolised through the liver, exposure to dasatinib is expected to increase if liver function is impaired.
Minħabba li dasatinib jiġi metabolizzat l- aktar fil- fwied, l- espożizzjoni għal dasatinib tkun mistennija li tiżdied jekk ikun hemm indeboliment fil- funzjoni tal- fwied.
SPRYCEL should be used with caution in patients with moderate to severe hepatic impairment (see section 4.4).
SPRYCEL għandu jintuża b' kawtela f' pazjenti b' indeboliment epatiku moderat sa sever (ara sezzjoni 4. 4).
Renal impairment: no clinical trials were conducted with SPRYCEL in patients with decreased renal function (trials excluded patients with serum creatinine concentration > 1.5 times the upper limit of the normal range).
Indeboliment renali: ma sarux provi kliniċi bi SPRYCEL f' pazjenti b' funzjoni renali imnaqqsa (il- provi eskludew pazjenti b' konċentrazzjoni tal- krejatinina fis- serum > 1. 5 darbiet l- ogħla limitu tal- medda normali).
Since the renal clearance of dasatinib and its metabolites is < 4%, a decrease in total body clearance is not expected in patients with renal insufficiency.
Minħabba li t- tneħħija mill- kliewi ta 'dasatinib u tal- metaboliti tiegħu hija < 4%, mhux mistenni li jkun hemm tnaqqis fit- tneħħija totali mill- ġisem f' pazjenti b' insuffiċjenza renali.
Clinically relevant interactions Dasatinib is a substrate and an inhibitor of cytochrome P450 (CYP) 3A4.
Interazzjonijiet klinikalment rilevanti Dasatinib huwa sottostrat u inibitur ta ’ cytochrome P450 (CYP) 3A4.
Therefore, there is a potential for interaction with other concomitantly administered medicinal products that are metabolized primarily by or modulate the activity of CYP3A4 (see section 4.5).
Għalhekk hemm il- possibilità li jkollu effett fuq prodotti mediċinali oħra mogħtija flimkien miegħu li jiġu metabolizzati primarjament b’ CYP3A4 jew jimmodulaw l- attività ta 'CYP3A4 (ara sezzjoni 4. 5).
Concomitant use of dasatinib and medicinal products that potently inhibit CYP3A4 (e. g. ketoconazole, itraconazole, erythromycin, clarithromycin, ritonavir, telithromycin) may increase exposure to dasatinib.
L- għoti fl- istess ħin ta 'dasatinib ma ’ prodotti mediċinali li jinibixxu CYP3A4 b’ mod qawwi (eż. ketoconazole, itraconazole, erythromycin, clarithromycin, ritonavir, telithromycin) jista' jżid l - espożizzjoni għal dasatinib.
Therefore, in patients receiving dasatinib, coadministration of a potent CYP3A4 inhibitor is not recommended (see section 4.5).
Għalhekk, f' pazjenti li qed jieħdu dasatinib, l- għoti fl- istess ħin ta 'inibitur qawwi ta ’ CYP3A4 qawwi m' huwiex rakkomandat (ara sezzjoni 4. 5).
Concomitant use of dasatinib and medicinal products that induce CYP3A4 (e. g. dexamethasone, phenytoin, carbamazepine, rifampicin, phenobarbital or herbal preparations containing Hypericum perforatum, also known as St.
L- għoti fl- istess ħin ta 'dasatinib ma ’ prodotti mediċinali li jinduċu CYP3A4 (eż. dexamethasone, phenytoin, carbamazepine, rifampicin, phenobarbital jew preparazzjonijiet li ġejjin mill- ħxejjex li fihom Hypericum perforatum, magħruf ukoll bħala St.
John's Wort) may substantially reduce exposure to dasatinib, potentially increasing the risk of therapeutic failure.
John' s Wort) jista 'jnaqqas b' mod sostanzjali l - espożizzjoni ta' dasatinib, bil- possibilità li jiżdied ir- riskju li intervent terapewtiku ma jirnexxiex.
Therefore, in patients receiving dasatinib, coadministration of alternative medicinal products with less potential for CYP3A4 induction should be selected (see section 4.5).
Għalhekk, f' pazjenti li qed jieħdu dasatinib, għandhom jingħażlu prodotti mediċinali alternattivi li għandhom anqas possibbilta ’ li jinduċu CYP3A4 (ara sezzjoni 4. 5).
Concomitant use of dasatinib and a CYP3A4 substrate may increase exposure to the CYP3A4 substrate.
L- għoti fl- istess ħin ta 'dasatinib ma ’ sottostrat ta' CYP3A4 jista 'jżid l- espożizzjoni għas- sottostrat ta' CYP3A4.
Therefore, caution is warranted when dasatinib is coadministered with CYP3A4 substrates of narrow therapeutic index, such as astemizole, terfenadine, cisapride, pimozide, quinidine, bepridil or ergot alkaloids (ergotamine, dihydroergotamine) (see section 4.5).
Għalhekk, wieħed għandu joqgħod attent meta dasatinib jingħata flimkien ma 'sottostrat ta' CYP3A4 b' indiċi terawpetiku dejjaq, bħalma huma astemizole, terfenadine, cisapride, pimozide, quinidine, bepridil jew alkolojdi ta ’ l- ergot (ergotamine, dihydroergotamine) (ara sezzjoni 4. 5).
The concomitant use of dasatinib and a histamine-2 (H2) antagonist (e. g. famotidine), proton pump inhibitor (e. g. omeprazole), or aluminium hydroxide/ magnesium hydroxide may reduce the exposure to dasatinib.
L- għoti fl- istess ħin ta 'dasatinib ma ’ antagonist ta ’ histamine- 2 (H2) (eż. famotidine), inibituri tal - proton pump (eż. omeprazole), jew aluminium hydroxide/ magnesium hydroxide jista' jnaqqas l - espożizzjoni ta 'dasatinib.
Thus, H2 antagonists and proton pump inhibitors are not recommended and aluminium hydroxide/ magnesium hydroxide products should be administered up to 2 hours prior to, or 2 hours following the administration of dasatinib (see section 4.5).
Għalhekk, antagonist ta ’ H2 u inibituri tal- proton pump m’ humiex rakkomandati u prodotti ta 'aluminium hydroxide/ magnesium hydroxide għandhom jittieħdu sa sagħtejn qabel, jew sagħtejn wara li jittieħed dasatinib (ara sezzjoni 4. 5).
Special populations There are currently no data available from clinical trials with SPRYCEL in patients with moderate to severe liver impairment.
Popolazzjonijiet speċjali Bħalissa m' hemmx tagħrif disponibbli minn provi klinici bi SPRYCEL f' pazjenti indeboliment tal - fwied minn moderat sa sever.
Caution is recommended when administering SPRYCEL to patients with moderate to severe hepatic impairment (see section 4.2).
Hu rrakkomandat li wieħed juża kawtela meta jagħti SPRYCEL lil pazjenti b' indeboliment tal- fwied minn moderat sa sever (ara sezzjoni 4. 2).
Important adverse reactions Myelosuppression: treatment with dasatinib is associated with anaemia, neutropenia and thrombocytopenia.
4 Reazzjonijiet avversi importanti Majelosuppressjoni: trattament b’ dasatinib hu assoċjat ma 'anemija, newtropenja u tromboċitopenja.
Their occurrence is more frequent in patients with advanced phase CML or Ph+ ALL than in chronic phase CML.
L- okkorrenza tagħhom hija aktar frekwenti f' pazjenti b' CML jew Ph+ ALL f' fażi avvanzata milli b' CML b' fażi kronika.
Myelosuppression was generally
Għall- ewwel xahrejn għandhom jittieħdu testijiet ta ’ l- għadd tad- demm komplut ta 'kull ġimgħa, u mbagħad dawn għandhom isiru darba fix- xahar, jew skond kif ikun indikat klinikament.
4 reversible and usually managed by withholding dasatinib temporarily or by dose reduction (see sections 4.2 and 4.8).
Il- majelosuppressjoni kienet ġeneralment riversibbli u normalment ikkontrollata bil- waqfien temporanju ta 'dasatinib jew bi tnaqqis tad- doża (ara sezzjonijiet 4. 2 u 4. 8).
In a Phase III dose-optimisation study in patients with chronic phase CML, grade 3 or 4 myelosuppression was reported more frequently in patients treated with 70 mg twice daily than in patients treated with 100 mg once daily; fluid retention was also reported more frequently in patients treated with twice daily schedule compared to once daily (see section 4.8).
Fi studju ta ’ l- ottimizzazzjoni tad- doża ta ’ Fażi III f’ pazjenti b’ CML ta ’ fażi kronika, majelosuppressjoni ta ’ grad 3 jew 4 ġiet irrappurtata b’ mod aktar frekwenti f’ pazjenti ttrattati b’ 70 mg darbtejn kuljum milli f’ pazjenti ttrattati b’ 100 mg darba kuljum; l- akkumulazzjoni tal- fluwidi ġiet irrapportata wkoll b’ mod aktar frekwenti f’ pazjenti ttrattati bi skeda ta ’ darbtejn kuljum meta mqabbla ma ’ skeda ta ’ darba kuljum (ara sezzjoni 4. 8).
Therefore, the starting dose of 100 mg once daily is the recommended initial dose for patients with chronic phase CML.
Għalhekk, id- doża tal- bidu ta ’ 100 mg darba kuljum hija d- doża tal- bidu rakkomandata għal pazjenti b’ CML ta ’ fażi kronika.
Bleeding: in all clinical studies, severe central nervous system (CNS) haemorrhage occurred in < 1% of patients.
Fsada: fl- istudji kliniċi kollha, emorraġija severa tas- sistema nervuża ċentrali (CNS) ġrat f '< 1% tal - pazjenti.
Eight cases were fatal and 5 of them were associated with Common Toxicity Criteria (CTC) grade 4 thrombocytopenia.
Tmien każijiet kienu fatali u 5 minnhom kienu assoċjati ma 'Kriterji ta ’ Tossiċità Komuni (CTC) tromboċitopenja tar- 4 grad.
Severe gastrointestinal haemorrhage occurred in 4% of patients and generally required treatment interruptions and transfusions.
F' 4% tal- pazjenti kien hemm emorraġija gastrointestinali severa u ġeneralment kellhom bżonn iwaqqfu l- kura u ssirilhom trasfużjoni.
Other severe haemorrhage occurred in 2% of patients.
Emorraġiji severi oħrajn seħħew fi 2% tal- pazjenti.
Most bleeding related events were typically associated with severe thrombocytopenia (see section 4.8).
Il- biċċa l- kbira tal- każijiet ta 'fsada kienu tipikament assoċjati ma' tromboċitopenja severa (ara sezzjoni 4. 8).
Patients were excluded from participation in SPRYCEL clinical trials if they took medicinal products that inhibit platelet function or anticoagulants.
Pazjenti li jieħdu prodotti mediċinali li jinibixxu l- funzjoni tal- platelets jew antikoagulanti ġew esklużi milli jipparteċipaw fil- provi kliniċi ta 'SPRYCEL.
In some trials, the use of anticoagulants, acetylsalicylic acid, and non-steroidal anti-inflammatory drugs (NSAIDs) was allowed concurrently with SPRYCEL 3 if the platelet count was > 50,000/ mm.
F’ xi provi, l- użu ta ’ antikoagulanti, acetylsalicylic acid, u mediċini kontra l- infjammazzjoni li mhumiex sterojdi (NSAIDs) kien permess fl- istess ħin ma ’ SPRYCEL jekk l- għadd tal- plejtlits kien > 50, 000/ mm3.
Caution should be exercised if patients are required to take medicinal products that inhibit platelet function or anticoagulants.
Għandha tintuża kawtela jekk il- pazjenti jkollhom il- ħtieġa li jieħdu prodotti mediċinali li jinibixxu l- funzjoni tal- platelets jew antikoagulanti.
Fluid retention: dasatinib is associated with fluid retention.
Akkumulazzjoni ta 'fluwidi: dasatinib hu assoċjat ma ’ akkumulazzjoni ta' fluwidi.
In all clinical studies, severe fluid retention was reported in 9% of patients, including severe pleural and pericardial effusion reported in 6% and 1% of patients, respectively.
Fl- istudji kliniċi kollha, akkumulazzjoni severa ta ’ fluwidi ġiet irrappurtata f' 9% tal- pazjenti, inkluż effużjoni severa tal- plewra u tal- perikardju rrapportati f' 6% u 1% tal- pazjenti, rispettivament.
Severe ascites and generalised oedema were each reported in < 1% of patients.
Axxite severa u edema ġeneralizzata ġew irrapportati f '< 1% tal- pazjenti.
Severe non-cardiogenic pulmonary oedema was reported in 1% of patients.
Edema severa pulmonari mhux kardjoġenika ġiet irrapportata f' 1% tal- pazjenti.
Patients who develop symptoms suggestive of pleural effusion such as dyspnoea or dry cough should be evaluated by chest X-ray.
Pazjenti li jiżviluppaw sintomi li jagħtu ndikazzjoni ta 'effużjoni tal - plewra bħalma huma dispneja jew sogħla vojta għandhom jiġu evalwati b' X- ray tas- sider.
Severe pleural effusion may require thoracocentesis and oxygen therapy.
Effużjoni tal- plewra severa jista 'jkollha bżonn toraċoċenteżi u terapija bl- ossiġnu.
Fluid retention events were typically managed by supportive care measures that include diuretics and short courses of steroids.
Każijiet ta 'akkumulazzjoni ta' fluwidi kienu tipikament ikkontrollati b' miżuri ta 'kura t' appoġġ li jinkludu pilloli dijuretiċi u korsijiet qosra ta' sterojdi.