qanastek/EMEA-V3 huggingface dataset:
41 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).
Important adverse reactions Myelosuppression: treatment with dasatinib is associated with anaemia, neutropenia and thrombocytopenia.
44 Reazzjonijiet avversi importanti Majelosuppressjoni: trattament b’ dasatinib hu assoċjat ma 'anemija, newtropenja u tromboċitopenja.
42 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).
Lactose This medicinal product contains 135 mg of lactose monohydrate in a 100 mg daily dose and 189 mg of lactose monohydrate in a 140 mg daily dose.
45 Lactose Dan il- prodott mediċinali fih 135 mg ta ’ lactose monohydrate f’ doża ta ’ kuljum ta ’ 100 mg u 189 mg ta 'lactose monohydrate f' doża ta' kuljum ta '140 mg.
43 4.5 Interaction with other medicinal products and other forms of interaction
4. 5 Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott u affarijiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott
4.6 Pregnancy and lactation
46 4. 6 Tqala u treddigħ
44 Lactation There is insufficient/ limited information on the excretion of dasatinib in human or animal breast milk.
Treddigħ L- informazzjoni dwar il- ħruġ ta 'dasatinib fil- ħalib tas- sider uman jew ta' annimali oħra mhix suffiċjenti jew hi limitata.
Fluid retention events were typically managed by supportive care measures that include diuretics or short courses of steroids.
47 akkumulazzjoni ta 'fluwidi kienu tipikament ikkontrollati b' miżuri ta' kura t' appoġġ li jinkludu dijuretiċi u korsijiet qosra ta 'sterojdi.
46 Table 2b:
48 Tabella 2b:
Cardiac disorders Common: congestive heart failure/ cardiac dysfunction, pericardial effusion, arrhythmia (including tachycardia), palpitations Uncommon: myocardial infarction, pericarditis, ventricular arrhythmia (including ventricular tachycardia), angina pectoris, cardiomegaly Rare: cor pulmonale, myocarditis, acute coronary syndrome
50 Disturbi fil- qalb Komuni: insuffiċjenza tal- qalb konġestiva/ disfunzjoni tal- qalb, effużjoni tal- perikardju, arritmja (inkluż takikardija), palpitazzjonijiet Mhux komuni: infart mijokardijaku, perikardite, arritmja ventrikulari (fosthom takikardija ventrikulari), anġina pettorali, kardjomegalija Rari: cor pulmonali, mijokardite, sindrome koronarju akut
Injury, poisoning, and procedural complications Common: contusion
51 Korriment, avvelenament u komplikazzjonijiet ta ’ xi proċedura Komuni: tbenġil
49 General disorders and administration site conditions Common: generalised oedema, chills Uncommon: malaise Rare: temperature intolerance
Disturbi ġenerali u kondizzjonijiet ta ’ mnejn jingħata Komuni: edema ġeneralizzata, irjiħat Mhux komuni: telqa Rari: intolleranza tat- temperatura
In the Phase III dose-optimisation study in patients with chronic phase CML, the frequency of neutropenia, thrombocytopenia and anaemia was lower in the SPRYCEL 100 mg once daily than in the SPRYCEL 70 mg twice daily group.
52 Fl- istudju ta ’ l- ottimizzazzjoni tad- doża ta ’ Fażi III f’ pazjenti b’ CML ta ’ fażi kronika, il- frekwenza ta ’ newtropenja, tromboċitopenija u anemija kienet aktar baxxa fil- grupp ta ’ SPRYCEL 100 mg darba kuljum milli fil- grupp ta ’ SPRYCEL 70 mg darbtejn kuljum.
These non-clinical studies show that dasatinib can overcome imatinib resistance resulting from BCR-ABL overexpression, BCR-ABL kinase domain mutations, activation of alternate signaling pathways involving the SRC family kinases (LYN, HCK), and multidrug resistance gene overexpression.
53 imatinib li jirriżulta minn espressjoni żejda ta ’ BCR- ABL, mutazzjonijiet fid- domain tal- kinase BCR - ABL, attivazzjoni ta 'passaġġi tas- sinjalazzjoni alternattivi li jinvolvu l- kinasi tal- familja SRC (LYN, HCK), u espressjoni żejda tal- ġene tar- reżistenza għal ħafna mediċini.
51 Phase II clinical trials in CML:
Provi kliniċi ta ’ Fażi II f’ CML:
Based on the Kaplan-Meier estimates, the proportion of patients who maintained MCyR for 1 year was 92% (95% CI:
54 Abbażi ta ’ l- istimi Kaplan- Meier, il- proporzjon ta ’ pazjenti li żammew MCyR għal sena kien 92% (95% CI:
52 2- An open-label, single-arm, multicenter study was conducted in patients resistant or intolerant to imatinib (i. e. patients who experienced significant toxicity during treatment with imatinib that precluded further treatment).
2 - Sar studju open- label, b' fergħa waħda, f' ċentri varji fuq pazjenti reżistenti jew intolleranti għal imatinib (jiġifieri pazjenti li sofrew tossiċità sinifikanti waqt it- trattament b’ imatinib tant li twaqqfilhom t- trattament).
Median duration of treatment on dasatinib was 14 months with 31% of patients treated for > 24 months to date.
55 It- tul medju tat- trattament b’ dasatinib kien ta ’ 14- il xahar b’ 31% tal- pazjenti ttrattati għal > 24 xahar sa llum.
53 treatment on dasatinib was 3 months with 7% of patients treated for > 24 months to date.
It- tul medju tat- trattament b’ dasatinib kien ta ’ 3 xhur b’ 7% tal- pazjenti ttrattati għal > 24 xahar sa llum.
Efficacy in Phase II SPRYCEL Single-Arm
56 Effikaċja fi provi kliniċi single arm ta ’ Fażi II ta ’ SPRYCELa Tabella 5:
54 Response rates are presented in Table 6.
57 Ir- rati ta ’ respons huma ppreżentati f’ Tabella 6.
55 approximately proportional to the dose increment across doses ranging from 25 mg to 120 mg twice daily.
58 wieħed u ieħor proporzjonali għaż- żieda fid- doża f’ dożi minn 25 mg sa 120 mg darbtejn kuljum.
56 Dasatinib was not mutagenic in in vitro bacterial cell assays (Ames test) and was not genotoxic in an in vivo rat micronucleus study.
59 Dasatinib ma kienx mutaġeniku f’ analiżi ta ’ ċelloli batterjali in vitro (Ames test) u ma kienx ġenotossiku fi studju mikronukleju fuq il- firien in vivo.
Cartons containing 60 film-coated tablets in perforated unit dose blisters.
60 Kaxex tal- kartun li fihom 60 pillola miksija b’ rita f’ folji ta ’ doża waħda perforati.
57 Cartons containing one bottle with 60 film-coated tablets.
Kaxex tal- kartun li fihom flixkun wieħed b’ 60 pillola miksijin b’ rita.
EU/ 1/ 06/ 363/ 006 - 56 film-coated tablets (blisters) EU/ 1/ 06/ 363/ 009 - 60 x 1 film-coated tablets (unit-dose blisters) EU/ 1/ 06/ 363/ 003 - 60 film-coated tablets (bottle)
EU/ 1/ 06/ 363/ 006 - 56 pillola miksijin b’ rita (folji) EU/ 1/ 06/ 363/ 009 - 60 x 1 pillola miksijin b’ rita (folji b’ doża waħda) EU/ 1/ 06/ 363/ 003 - 60 pillola miksijin b’ rita (flixkun)
SPRYCEL 100 mg film-coated tablets
SPRYCEL 100 mg pilloli miksijin b’ rita
Each film-coated tablet contains 100 mg dasatinib (as monohydrate).
Kull pillola miksija b’ rita fiha 100 mg dasatinib (bħala monoidrat).
Excipients: each tablet contains 135.0 mg of lactose monohydrate.
Sustanzi mhux attivi: kull pillola fiha 135. 0 mg ta ’ lactose monohydrate.
White to off-white, biconvex, oval tablet with "BMS 100" debossed on one side and "852" on the other side.
Pillola ovali, tvarja minn bajda għal offwajt, ibbuzzata fuq iż- żewġ naħat, b '"BMS 100" imnaqqxa fuq naħa waħda u "852" fuq in- naħa l- oħra.
59 Dose escalation:
62 Żieda fid- doża:
Paediatric patients:
63 Pazjenti pedjatriċi:
60 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).
Important adverse reactions Myelosuppression: treatment with dasatinib is associated with anaemia, neutropenia and thrombocytopenia.
64 Reazzjonijiet avversi importanti Majelosuppressjoni: trattament b’ dasatinib hu assoċjat ma 'anemija, newtropenja u tromboċitopenja.
61 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).
Lactose This medicinal product contains 135 mg of lactose monohydrate in a 100 mg daily dose and 189 mg of lactose monohydrate in a 140 mg daily dose.
65 Lactose Dan il- prodott mediċinali fih 135 mg ta ’ lactose monohydrate f’ doża ta ’ kuljum ta ’ 100 mg u 189 mg ta 'lactose monohydrate f' doża ta' kuljum ta '140 mg.
4.6 Pregnancy and lactation
66 4. 6 Tqala u treddigħ
63 Lactation There is insufficient/ limited information on the excretion of dasatinib in human or animal breast milk.
Treddigħ L- informazzjoni dwar il- ħruġ ta 'dasatinib fil- ħalib tas- sider uman jew ta' annimali oħra mhix suffiċjenti jew hi limitata.
Fluid retention events were typically managed by supportive care measures that include diuretics or short courses of steroids.
67 akkumulazzjoni ta 'fluwidi kienu tipikament ikkontrollati b' miżuri ta' kura t' appoġġ li jinkludu dijuretiċi u korsijiet qosra ta 'sterojdi.
65 Table 2b:
68 Tabella 2b:
Cardiac disorders Common: congestive heart failure/ cardiac dysfunction, pericardial effusion, arrhythmia (including tachycardia), palpitations Uncommon: myocardial infarction, pericarditis, ventricular arrhythmia (including ventricular tachycardia), angina pectoris, cardiomegaly Rare: cor pulmonale, myocarditis, acute coronary syndrome
70 Disturbi fil- qalb Komuni: insuffiċjenza tal- qalb konġestiva/ disfunzjoni tal- qalb, effużjoni tal- perikardju, arritmja (inkluż takikardija), palpitazzjonijiet Mhux komuni: infart mijokardijaku, perikardite, arritmja ventrikulari (fosthom takikardija ventrikulari), anġina pettorali, kardjomegalija Rari: cor pulmonali, mijokardite, sindrome koronarju akut
Injury, poisoning, and procedural complications Common: contusion
71 Korriment, avvelenament u komplikazzjonijiet ta ’ xi proċedura Komuni: tbenġil
68 General disorders and administration site conditions Common: generalised oedema, chills Uncommon: malaise Rare: temperature intolerance
Disturbi ġenerali u kondizzjonijiet ta ’ mnejn jingħata Komuni: edema ġeneralizzata, irjiħat Mhux komuni: telqa Rari: intolleranza tat- temperatura
In the Phase III dose-optimisation study in patients with chronic phase CML, the frequency of neutropenia, thrombocytopenia and anaemia was lower in the SPRYCEL 100 mg once daily than in the SPRYCEL 70 mg twice daily group.
72 Fl- istudju ta ’ l- ottimizzazzjoni tad- doża ta ’ Fażi III f’ pazjenti b’ CML ta ’ fażi kronika, il- frekwenza ta ’ newtropenja, tromboċitopenija u anemija kienet aktar baxxa fil- grupp ta ’ SPRYCEL 100 mg darba kuljum milli fil- grupp ta ’ SPRYCEL 70 mg darbtejn kuljum.
These non-clinical studies show that dasatinib can overcome imatinib resistance resulting from BCR-ABL overexpression, BCR-ABL kinase domain mutations, activation of alternate signaling pathways involving the SRC family kinases (LYN, HCK), and multidrug resistance gene overexpression.
73 imatinib li jirriżulta minn espressjoni żejda ta ’ BCR- ABL, mutazzjonijiet fid- domain tal- kinase BCR - ABL, attivazzjoni ta 'passaġġi tas- sinjalazzjoni alternattivi li jinvolvu l- kinasi tal- familja SRC (LYN, HCK), u espressjoni żejda tal- ġene tar- reżistenza għal ħafna mediċini.
70 Phase II clinical trials in CML:
Provi kliniċi ta ’ Fażi II f’ CML:
Based on the Kaplan-Meier estimates, the proportion of patients who maintained MCyR for 1 year was 92% (95% CI:
74 Abbażi ta ’ l- istimi Kaplan- Meier, il- proporzjon ta ’ pazjenti li żammew MCyR għal sena kien 92% (95% CI:
71 2- An open-label, single-arm, multicenter study was conducted in patients resistant or intolerant to imatinib (i. e. patients who experienced significant toxicity during treatment with imatinib that precluded further treatment).
2 - Sar studju open- label, b' fergħa waħda, f' ċentri varji fuq pazjenti reżistenti jew intolleranti għal imatinib (jiġifieri pazjenti li sofrew tossiċità sinifikanti waqt it- trattament b’ imatinib tant li twaqqfilhom t- trattament).
Median duration of treatment on dasatinib was 14 months with 31% of patients treated for > 24 months to date.
75 It- tul medju tat- trattament b’ dasatinib kien ta ’ 14- il xahar b’ 31% tal- pazjenti ttrattati għal > 24 xahar sa llum.
72 treatment on dasatinib was 3 months with 7% of patients treated for > 24 months to date.
It- tul medju tat- trattament b’ dasatinib kien ta ’ 3 xhur b’ 7% tal- pazjenti ttrattati għal > 24 xahar sa llum.
Efficacy in Phase II SPRYCEL Single-Arm
76 Effikaċja fi provi kliniċi single arm ta ’ Fażi II ta ’ SPRYCELa Tabella 5:
73 Response rates are presented in Table 6.
77 Ir- rati ta ’ respons huma ppreżentati f’ Tabella 6.
74 approximately proportional to the dose increment across doses ranging from 25 mg to 120 mg twice daily.
78 wieħed u ieħor proporzjonali għaż- żieda fid- doża f’ dożi minn 25 mg sa 120 mg darbtejn kuljum.
75 Dasatinib was not mutagenic in in vitro bacterial cell assays (Ames test) and was not genotoxic in an in vivo rat micronucleus study.
79 Dasatinib ma kienx mutaġeniku f’ analiżi ta ’ ċelloli batterjali in vitro (Ames test) u ma kienx ġenotossiku fi studju mikronukleju fuq il- firien in vivo.
2 years
2 sentejn
Alu/ Alu blisters (unit dose blisters) and high-density polyethylene (HDPE) bottle with child resistant closure of polypropylene.
Folji tal- Alu/ Alu (folji b’ doża waħda) u flixkun tal- polyethylene ta ’ densità għolja( HDPE) b’ tapp tal - polypropylene li t- tfal isibu diffiċli biex jiftħuh.
Cartons containing 30 film-coated tablets in perforated unit dose blisters.
Kaxex tal- kartun li fihom 30 pillola miksija b’ rita f’ folji ta ’ doża waħda perforati.
Cartons containing one bottle with 30 film-coated tablets.
80 Kaxex tal- kartun li fihom flixkun wieħed b’ 30 pillola miksijin b’ rita.
76 Not all pack sizes may be marketed.
Jista ’ jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għall- skop kummerċjali.
EU/ 1/ 06/ 363/ 011 - 30 x 1 film-coated tablets (unit-dose blisters) EU/ 1/ 06/ 363/ 010 - 30 film-coated tablets (bottle)
EU/ 1/ 06/ 363/ 011 - 30 x 1 pillola miksijin b’ rita (folji b’ doża waħda) EU/ 1/ 06/ 363/ 010 - 30 pillola miksijin b’ rita (flixkun)
77 ANNEX II
81 ANNESS II
Bristol-Myers Squibb Rue du Docteur André Gilles 28230 Epernon France
Bristol- Myers Squibb Rue du Docteur André Gilles 28230 Epernon Franza
Summary of Product Characteristics, 4.2).
Sommarju tal- Karatteristiċi tal - Prodott, 4. 2).
The MAH must ensure that the system of pharmacovigilance, as described in version 2.5 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq għandu jiżgura li s- sistema ta ’ farmakoviġilanza, kif deskritta fil- verżjoni 2. 5 ippreżentata fil- Modulu 1. 8. 1. ta ’ l- Applikazzjoni għall- Awtorizzazzjoni għat- Tqegħid fis- Suq, tkun fis- seħħ u li din tkun qegħda taħdem qabel u waqt li l- prodott ikun fis- suq.
Risk Management Plan
Pjan ta ’ l- Immaniġġar tar- Riskju
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 4.0 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq jikkommetti ruħu li jwettaq l- istudji u l - attivitajiet ta ’ farmakoviġilanza addizzjonali mogħtija fid- dettall fil- Pjan ta ’ Farmakoviġilanza, kif sar qbil fuqu fil- verżjoni 4. 0 tal- Pjan ta ’ l- Immaniġġar tar- Riskju (RMP) ippreżentat fil- Modulu 1. 8. 2. ta ’ l- Applikazzjoni ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq u kwalunkwe aġġornament sussegwenti tal- RMP miftiehem mill- CHMP.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Skond il- Linja Gwida tal- CHMP dwar is- Sistemi ta ’ l- Immaniġġar tar- Riskji għal prodotti mediċinali għal użu mill- bniedem, l- RMP aġġornat għandu jiġi ppreżentat fl- istess ħin tar- Rapport ta ’ Aġġornament dwar is- Sigurtà Perjodika (PSUR) li jmiss.
When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached At the request of the EMEA.
Meta tasal informazzjoni ġdida li jista ’ jkollha impatt fuq l- attivitajiet ta ’ Speċifikazzjoni tas - Sigurtà, Pjan ta ’ Farmakoviġilanza jew attivitajiet ta ’ minimizzazzjoni tar- riskji
79 ANNEX III
84 ANNESS III
81 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND IMMEDIATE PACKAGING
86 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
OUTER CARTON AND LABEL TEXT FOR BOTTLE PACK OUTER CARTON TEXT FOR BLISTER PACK
IL- KITBA TA ’ FUQ IL- KARTUNA TA ’ BARRA U FUQ IT- TIKKETTA GĦALL- PAKKETT TAL- FLIXKUN IL- KITBA TA ’ FUQ IL- KARTUNA TA ’ BARRA GĦALL- PAKKETT TAL- FOLJI
SPRYCEL 20 mg film-coated tablets Dasatinib
SPRYCEL 20 mg pilloli miksijin b’ rita Dasatinib
Each film-coated tablet contains 20 mg dasatinib (as monohydrate).
Kull pillola miksija b’ rita fiha 20 mg ta ’ dasatinib (bħala monohydrate).
Excipients: contains lactose monohydrate.
Sustanzi mhux attivi: fiha lactose monohydrate.
56 film-coated tablets 60 x 1 film-coated tablets 60 film-coated tablets
56 pillola miksijin b’ rita 60 x 1 pillola miksijin b’ rita 60 pillola miksijin b’ rita
Outer Carton:
Kartuna ta ’ Barra:
83 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
88 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
BLISTER TEXT
IL- KITBA TA ’ FUQ IL- FOLJI
SPRYCEL 20 mg tablets Dasatinib
SPRYCEL 20 mg pilloli Dasatinib
calendar pack:
pakkett indikat bil- ġranet:
84 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND IMMEDIATE PACKAGING
89 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
SPRYCEL 50 mg film-coated tablets Dasatinib
SPRYCEL 50 mg pilloli miksijin b’ rita Dasatinib
Each film-coated tablet contains 50 mg dasatinib (as monohydrate).
Kull pillola miksija b’ rita fiha 50 mg ta ’ dasatinib (bħala monohydrate).
86 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
91 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
SPRYCEL 50 mg tablets Dasatinib
SPRYCEL 50 mg pilloli Dasatinib
87 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND IMMEDIATE PACKAGING
92 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
SPRYCEL 70 mg film-coated tablets Dasatinib
SPRYCEL 70 mg pilloli miksijin b’ rita Dasatinib
Each film-coated tablet contains 70 mg dasatinib (as monohydrate).
Kull pillola miksija b’ rita fiha 70 mg ta ’ dasatinib (bħala monohydrate).
89 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
94 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
SPRYCEL 70 mg tablets Dasatinib
SPRYCEL 70 mg pilloli Dasatinib
90 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND IMMEDIATE PACKAGING
95 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
SPRYCEL 100 mg film-coated tablets Dasatinib
SPRYCEL 100 mg pilloli miksijin b’ rita Dasatinib
Each film-coated tablet contains 100 mg dasatinib (as monohydrate).
Kull pillola miksija b’ rita fiha 100 mg ta ’ dasatinib (bħala monohydrate).
30 x 1 film-coated tablets 30 film-coated tablets
30 x 1 pillola miksijin b’ rita 30 pillola miksijin b’ rita
92 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
97 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
SPRYCEL 100 mg tablets Dasatinib
SPRYCEL 100 mg pilloli Dasatinib
94 PACKAGE LEAFLET:
99 FULJETT TA 'TAGĦRIF:
SPRYCEL 20 mg film-coated tablets SPRYCEL 50 mg film-coated tablets SPRYCEL 70 mg film-coated tablets SPRYCEL 100 mg film-coated tablets
SPRYCEL 20 mg pilloli miksijin b’ rita SPRYCEL 50 mg pilloli miksijin b’ rita SPRYCEL 70 mg pilloli miksijin b’ rita SPRYCEL 100 mg pilloli miksija b’ rita
What SPRYCEL is and what it is used for 2.
X’ inhu SPRYCEL u għalxiex jintuża 2.
Before you take SPRYCEL 3.
Qabel ma tieħu SPRYCEL 3.
How to take SPRYCEL 4.
Kif għandek tieħu SPRYCEL 4.
How to store SPRYCEL 6.
Kif taħżen SPRYCEL 6.
WHAT SPRYCEL IS AND WHAT IT IS USED FOR
X’ INHU SPRYCEL U GĦALXIEX JINTUŻA
SPRYCEL is a leukaemia treatment for adults with chronic myeloid leukaemia (CML) who are not benefiting from imatinib therapy.
SPRYCEL huwa trattament għal- lewkimja għall- adulti b’ lewkimja kronika tal- majelojd (CML) li ma jkunux qegħdin jibbenefikaw minn terapija b’ imatinib.
Leukaemia is a cancer of white blood cells.
Lewkimja hija kanċer taċ- ċelloli l- bojod tad- demm.
These white cells usually help the body to fight infection.
Dawn iċ- ċelloli l- bojod normalment jgħinu lill- ġisem jiġġieled kontra infezzjoni.
In people with CML, white cells called granulocytes start growing out of control.
F’ nies b’ CML, ċelloli bojod li jissejħu granuloċiti jibdew jikbru mingħajr kontroll.
SPRYCEL inhibits the growth of these leukaemic cells.
SPRYCEL jinibixxi t - tkabbir ta ’ dawn iċ- ċelloli tal- lewkimja.
SPRYCEL is also a treatment for adults with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukaemia (ALL), and lymphoid blast CML who are not benefiting from prior therapies.
SPRYCEL huwa wkoll trattament għal adulti li għandhom lewkimja limfoblastika akuta (ALL) b’ Philadelphia chromosome positive (Ph+) u b’ lymphoid blast CML li ma jkunux qegħdin jibbenefikaw minn terapiji precedenti.
In people with ALL, white cells called lymphocytes multiply too quickly and live too long.
F’ nies b’ ALL, ċelloli bojod imsejjħin limfoċiti jimmultiplikaw malajr wisq u jgħixu għal żmien twil wisq.
SPRYCEL inhibits the growth of these leukaemic cells.
SPRYCEL jinibixxi t- tkabbir ta ’ dawn iċ- ċelloli tal - lewkimja.
If you have any questions about how SPRYCEL works or why this medicine has been prescribed for you, ask your doctor.
Jekk għandek xi mistoqsijiet dwar kif jaħdem SPRYCEL jew għaliex din il- mediċina ġiet preskritta lilek, staqsi lit- tabib tiegħek.
BEFORE YOU TAKE SPRYCEL
QABEL MA TIEĦU SPRYCEL
SPRYCEL will only be prescribed to you by a doctor with experience in medicines to treat leukaemia.
SPRYCEL jiġi preskritt lilek biss minn tabib b’ esperjenza fil- mediċini biex jittratta l- lewkimja.
Do not take SPRYCEL if you are allergic (hypersensitive) to dasatinib or any of the other ingredients of SPRYCEL.
Tiħux SPRYCEL jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal dasatinib jew sustanzi oħra ta ’ SPRYCEL.
If you could be allergic, ask your doctor for advice.
Oqgħod attent ħafna bi SPRYCEL jekk qed tieħu mediċini biex traqqaq id- demm jew biex timpedixxi emboli (ara Meta tuża mediċini oħra) jekk tbati minn problema tal- fwied jew tal- qalb, jew jekk kellek waħda
Take special care with SPRYCEL if you are taking medicines to thin the blood or prevent clots (see Using other medicines) if you have a liver or heart problem, or used to have one if you start having difficulty breathing, chest pain, or a cough when taking SPRYCEL: this may be a sign of fluid retention in the lungs or chest (which can be more common in patients aged 65 years and older).
100 jekk tibda tħoss diffikultà biex tieħu nifs, uġigħ fis- sider, jew sogħla meta tieħu SPRYCEL: dan jista ’ jkun sinjal ta ’ akkumulazzjoni ta ’ fluwidu fil- pulmun jew fis- sider (li jista ’ jkun aktar komuni f’ pazjenti ta ’ 65 sena u aktar).
95 If any of these affects you, tell your doctor.
Jekk inti tħoss xi effett minn dawn, għid lit- tabib tiegħek.
Your doctor will regularly monitor your condition to check whether SPRYCEL is having the desired effect.
It- tabib tiegħek jimmonitorja regolarment il- kundizzjoni tiegħek sabiex jara jekk SPRYCEL hux qed ikollu l- effett mixtieq.
You will also have blood tests regularly while you are taking SPRYCEL.
Waqt li tkun qed tieħu SPRYCEL, isirulek testijiet tad- demm b’ mod regolari.
Children, adolescents and SPRYCEL SPRYCEL is not recommended in patients below 18 years of age.
Tfal, adoloxxenti u SPRYCEL SPRYCEL m’ huwiex rakkomandat f’ pazjenti taħt it- 18- il sena.
There is limited experience with the use of SPRYCEL in this age group.
Hemm esperjenza limitata fuq l- użu ta ’ SPRYCEL f’ dan il- grupp t’ età.
Older people and SPRYCEL SPRYCEL can be used by people over 65 at the same doses as other adults.
Anzjani u SPRYCEL SPRYCEL jista ’ jintuża minn nies li għandhom aktar minn 65 sena bl- istess dożi ta ’ adulti oħrajn.
Using other medicines SPRYCEL is mainly handled by the liver.
Meta tuża mediċini oħra Prinċipalment, SPRYCEL jiġi mmaniġġat mill- fwied.
Certain medicines may interfere with the effect of SPRYCEL when taken together.
Ċerti mediċini jistgħu jinterferixxu mal- effett ta ’ SPRYCEL meta jittieħdu flimkien.
These medicines are not to be used with SPRYCEL: ketoconazole, itraconazole - these are antifungal medicines erythromycin, clarithromycin, telithromycin - these are antibiotics ritonavir - this is an antiviral medicine dexamethasone - this is a corticosteroid phenytoin, carbamazepine, phenobarbital - these are treaments for epilepsy rifampicin - this is a treatment for tuberculosis famotidine, omeprazole - these are medicines that block stomach acids St.
Dawn il- mediċini m’ għandhomx jintużaw ma ’ SPRYCEL: ketoconazole, itraconazole – dawn huma mediċini antifungali erythromycin, clarithromycin, telithromycin – dawn huma antibijotiċi ritonavir – din hija mediċina antivirali dexamethasone – dan huwa kortikosterojde phenytoin, carbamazepine, phenobarbital – dawn huma trattamenti kontra l- epilessija rifampicin – dan huwa trattament għat- tuberkolożi famotidine, omeprazole – dawn huma mediċini li jimblukkaw l- aċidi ta ’ l- istonku St.
John’ s wort - a herbal preparation obtained without a prescription used to treat depression and other conditions (also known as Hypericum perforatum)
John’ s wort - preparazzjoni li ġejja mill- ħxejjex li tinkiseb mingħajr riċetta, li tintuża għall - kura tad- dipressjoni u kundizzjonijiet oħrajn (magħrufa wkoll bħala Hypericum perforatum)
Medicines that neutralise stomach acids (antacids such as aluminium hydroxide/ magnesium hydroxide) may be taken up to 2 hours before or 2 hours after taking SPRYCEL.
Mediċini li jinnewtralizzaw l- aċidi fl- istonku (antaċidi bħal aluminium hydroxide/ magnesium hydroxide) jistgħu jittieħdu sa sagħtejn qabel jew sagħtejn wara t- teħid ta ’ SPRYCEL.
You should tell your doctor if you are taking medicines to thin the blood or prevent clots.
Għandek tgħid lit- tabib tiegħek jekk qiegħed tieħu mediċini li jraqqu d- demm jew li jimpedixxu emboli.
Pregnancy and breast-feeding If you are pregnant or think you may be, tell your doctor immediately.
Tqala u treddigħ Jekk inti tqila jew taħseb li tista ’ tkun tqila, għid lit- tabib tiegħek minnufih.
SPRYCEL is not to be used during pregnancy unless clearly necessary.
SPRYCEL m’ għandux jintuża waqt tqala sakemm dan ma jkunx assolutament meħtieġ.
Your doctor will discuss with you the potential risk of taking SPRYCEL during pregnancy.
It- tabib tiegħek se jiddiskuti miegħek ir- riskju potenzjali li tieħu SPRYCEL matul it- tqala.
Both men and women taking SPRYCEL will be advised to use effective contraception during treatment.
Kemm l- irġiel kif ukoll in- nisa li jkunu qegħdin jieħdu SPRYCEL jingħataw il- parir li jużaw kontraċezzjoni effettiva matul it- trattament.
If you are breast-feeding, tell your doctor.
Jekk qegħda tredda ’, għid lit- tabib tiegħek.
Breast-feeding should be stopped if you are taking SPRYCEL.
It- treddigħ għandu jitwaqqaf jekk qed tieħu SPRYCEL.
Driving and using machines Take special care when driving or using machines in case you experience side effects such as dizziness and blurred vision.
Sewqan u tħaddim ta 'magni Oqgħod attent/ a meta tkun qed issuq jew tħaddem magni fil- każ li tesperjenza effetti sekondarji bħalma huma sturdament u vista mċajpra.
It is not known if SPRYCEL will affect your ability to drive or use machines.
M’ huwiex magħruf jekk SPRYCEL jaffetwax l- abbiltà tiegħek li ssuq jew tħaddem magni.
Important information about some of the ingredients of SPRYCEL SPRYCEL contains lactose.
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ SPRYCEL SPRYCEL fih lactose.
If you have been diagnosed with an intolerance to some sugars, talk to your doctor before taking this medicine.
Jekk inti ġejt iddijanjostikat/ a b’ intolleranza għal xi zokkor, kellem lit- tabib tiegħek qabel tieħu din il- mediċina.
HOW TO TAKE SPRYCEL
KIF GĦANDEK TIEĦU SPRYCEL
Always take SPRYCEL exactly as your doctor has told you.
Dejjem għandek tieħu SPRYCEL skond il- parir eżatt tat- tabib.
SPRYCEL is prescribed for adults.
SPRYCEL huwa preskritt għall- adulti.
96 The starting dose recommended for patients with chronic phase CML is 100 mg once a day, taken at the same time every day.
Id- doża tal- bidu rrakkomandata għal pazjenti b’ CML ta ’ fażi kronika hija 100 mg darba kuljum, meħuda fl- istess ħin kuljum.
The starting dose recommended for patients with accelerated or blast crisis CML or Ph+ALL is 70 mg twice daily: one tablet in the morning one tablet in the evening
Id- doża tal- bidu rrakkomandata għal pazjenti b’ CML aċċellerata jew ta ’ blast crisis jew PH+ALL hija ta ’ 70 mg darbtejn kuljum: pillola filgħodu pillola filgħaxija
Depending on how you respond to the treatment, your doctor may suggest a higher or lower dose, or even stopping treatment briefly.
Skond fuq kif int tirrispondi għat- trattament, it- tabib jista ’ jissuġġerixxi doża ikbar jew iżgħar, jew jista ’ jwaqqaf it- trattament għal ftit taż- żmien.
For higher or lower doses use of combinations of the different tablet strengths may be necessary.
Għal dożi ikbar jew iżgħar jista ’ jkun hemm bżonn l - użu ta ’ kombinazzjonijiet ta ’ pilloli ta ’ qawwiet differenti.
The tablets may come in calendar packs.
Il- pilloli jistgħu jiġu f’ pakketti indikati bil- ġranet.
These are blister packs showing the days of the week.
Dawn huma pakketti ta ’ folji li juru l- jiem tal - ġimgħa.
There are arrows to show the next tablet to be taken according to your treatment schedule.
Hemm vleġeġ biex juru liema pillola jmiss li tittieħed skont l- iskeda tal- kura tiegħek.
If you have been recommended to take the tablet once daily, take it at the same time every day.
Jekk ġie rrakkomandat lilek li tieħu l- pilloli darba kuljum, ħudha fl- istess ħin kuljum.
If you have been recommended to take the tablets twice daily, this will help you remember to take a tablet every day in the morning and in the evening.
Jekk ġie rrakkomandat lilek li tieħu l- pilloli darbtejn kuljum, dan jgħinek tiftakar tieħu pillola kuljum filgħodu u filgħaxija.
This is important for an effective treatment.
Dan huwa importanti għal trattament effettiv.
How to take SPRYCEL The tablets must be swallowed whole, not crushed.
Kif għandek tieħu SPRYCEL Il- pilloli għandhom jinbelgħu sħaħ, u mhux jitfarrku.
They can be taken with or without a meal.
Jistgħu jittieħdu mal- ikel jew mingħajr l- ikel.
Special handling instructions for SPRYCEL In the unlikely event of the tablets being broken, persons other than the patient are recommended to use gloves when handling SPRYCEL.
Struzzjonijiet speċjali dwar l- immaniġġar ta ’ SPRYCEL Fil- każ mhux probabbli li l- pilloli jinkisru, persuni li m’ humiex il- pazjent, huma rrakkomandati li jużaw ingwanti meta jmissu SPRYCEL.
How long to take SPRYCEL You should take SPRYCEL daily until your doctor tells you to stop.
Kemm iddum tieħu SPRYCEL Għandek tieħu SPRYCEL kuljum sakemm it- tabib jgħidlek biex tieqaf.
Make sure you take SPRYCEL for as long as it is prescribed.
Kun żgur li tieħu SPRYCEL għat- tul taż- żmien li hemm miktub fir- riċetta.
If you take more SPRYCEL than you should If you have accidentally taken too many tablets, talk to your doctor immediately.
Jekk tieħu SPRYCEL aktar milli suppost Jekk aċċidentalment ħadt wisq pilloli, kellem lit- tabib tiegħek minnufih.
If you forget to take SPRYCEL Do not take a double dose to make up for a forgotten tablet.
Jekk tinsa tieħu SPRYCEL M’ għandekx tieħu doża doppja biex tpatti għal kull pillola li tkun insejt tieħu.
Take the next scheduled dose at the regular time.
Ħu d- doża skedata li jmiss fil- ħin li jkun imissek toħodha.
Like all medicines, SPRYCEL can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, SPRYCEL jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Tell your doctor immediately if you notice any of the following: if you have chest pain, difficulty breathing, coughing and fainting if you experience unexpected bleeding or bruising without having an injury if you find blood in your vomit, stools or urine, or have black stools if you get signs of infections such as fever, severe chills These can all be signs of serious side effects.
Avża minnufih lit- tabib tiegħek jekk tinnota xi effett minn dawn li ġejjin: jekk għandek uġigħ f’ sidrek, diffikultà biex tieħu nifs, sogħla u ħass ħażin jekk joħroġlok xi demm jew tesperjenza xi tbenġil mingħajr ma tkun korrejt jekk issib demm fir- rimettar, fl- ippurgar jew fl- awrina tiegħek, jew jekk ikollok ippurgar iswed jekk ikollok sinjal t’ infezzjoni bħal deni, kesħa qawwija
97 Frequencies are defined as follows:
Il- frekwenzi huma definiti kif ġej:
very common: common: uncommon: rare: very rare: not known:
komuni ħafna: komuni: mhux komuni: rari: rari ħafna: mhux magħrufa:
affects more than 1 user in 10 affects 1 to 10 users in 100 affects 1 to 10 users in 1,000 affects 1 to 10 users in 10,000 affects less than 1 user in 10,000 frequency cannot be estimated from the available data
jaffettwaw iktar minn utent 1 minn kull 10 jaffettwaw minn 1 sa 10 utenti minn kull 100 jaffettwaw minn 1 sa 10 utenti minn kull 1, 000 jaffettwaw minn 1 sa 10 utenti minn kull 10, 000 jaffettwaw inqas minn utent 1 minn kull 10, 000 il- frekwenza ma tistax tittieħed stima mid- data disponibbli
Very common side effects Infections (including bacterial, viral and fungal) Heart and lungs: shortness of breath, cough Digestive problems: diarrhoea, feeling or being sick (nausea, vomiting) Skin, hair, eye, general: skin rash, fever, swelling around hands and feet, headache, feeling tired or weak, bleeding Pain: pain in the muscles, abdominal (tummy) pain Tests may show: low blood platelet count, low white blood cells count (neutropenia), anaemia, fluid around the lungs
Effetti sekondarji komuni ħafna Infezzjonijiet (inkluż batterjali, virali u fungali) Qalb u pulmun: qtugħ ta ’ nifs, sogħla Problemi fid- diġestjoni: dijarrea, tħossok jew tkun ma tiflaħx (dardir, rimettar) Ġilda, xagħar, għajn, ġenerali: raxx tal- ġilda, deni, nefħa madwar l- idejn u s- saqajn, uġigħ ta ’ ras, tħossok għajjien jew debboli, fsada Uġigħ: uġigħ fil- muskoli, uġigħ addominali (ta ’ żaqq) It- testijiet jistgħu juru: għadd baxx ta ’ platelets tad- demm, għadd baxx ta ’ ċelloli bojod tad - demm (newtropenja), anemija, fluwidu madwar il- pulmun
Common side effects Infections: pneumonia, herpes viral infection, upper respiratory infection, serious infection of the blood or tissues (including fatal outcome) Heart and lungs: palpitations, flushing, dizziness, congestive heart failure, cardiac dysfunction, high blood pressure Digestive problems: appetite disturbances, taste disturbance, bloated or distended tummy (abdomen), inflammation of the colon, constipation, heartburn, mouth ulceration, weight increase, weight decrease, gastritis Skin, hair, eye, general: skin tingling, itching, dry skin, acne, inflamation of the skin, persistant noise in ears, hair loss, excessive perspiration, visual disorder (including blurred vision and disturbed vision), dry eye, haematoma, depression, insomnia, contusion, anorexia, somnolence, generalised oedema Pain: pain in joints, muscle inflammation, muscular weakness, chest pain, pain around hands and feet, chills Tests may show: fluid around the heart, fluid in the lungs, arrhythmia, febrile neutropenia, deficiency in all blood cells, gastrointestinal bleeding
Effetti sekondarji komuni Infezzjonijiet: pnewmonja, infezzjoni virali b’ herpes, infezzjoni tal- parti ta ’ fuq tas- sistema respiratorja, infezzjoni serja tad- demm jew tat- tessuti (inkluż riżultat fatali) Qalb u pulmun: palpitazzjonijiet, fwawar, sturdament, insuffiċjenza tal- qalb konġestiva, disfunzjoni tal- qalb, pressjoni tad- demm għolja Problemi fid- diġestjoni: disturbi fl- aptit, disturbi fit- togħma, żaqq (addome) minfuħa jew bil - gass, infjammazzjoni tal- kolon, stitikezza, ħruq ta ’ stonku, ulċeri fil- ħalq, żieda fil- piż, tnaqqis fil- piż, gastrite Ġilda, xagħar, għajn, ġenerali: tingiż tal- ġilda, ħakk, ġilda xotta, akne, infjammazzjoni tal - ġilda, ħsejjes persistenti fil- widnejn, telf ta ’ xagħar, għaraq eċċessiv, disturb fil- vista (inkluż vista mċajpra u vista ddisturbata), għajnejn xotti, ematoma, dipressjoni, nuqqas ta ’ rqad, tbenġil, anoreksja, ngħas, edema ġeneralizzata Uġigħ: uġigħ fil- ġogi, infjammazzjoni tal- muskoli, dgħjufija muskolari, uġigħ fis- sider, uġigħ madwar is- saqajn u l- idejn, kesħa It- testijiet jistgħu juru: fluwidu madwar il- qalb, fluwidu fil- pulmun, arritmja, newtropenja bid- deni, defiċjenza fiċ- ċelloli tad- demm kollha, fsada gastro- intestinali
Your doctor will check for some of these effects during your treatment.
It- tabib tiegħek jeżaminak għal xi wħud minn dawn l- effetti matul it- trattament tiegħek.
HOW TO STORE SPRYCEL
KIF TAĦŻEN SPRYCEL
Do not use SPRYCEL after the expiry date which is stated on the label, blister or carton after EXP.
Tużax SPRYCEL wara d- data ta ’ skadenza li tidher fuq it- tikketta, il- folja jew il- kartuna wara EXP.
Medicines should not be disposed of via wastewater or household waste.
103 Il- mediċini m’ għandhomx jintremew ma ’ l- ilma tad- dranaġġ jew ma ’ l- iskart domestiku.
What SPRYCEL contains The active substance is dasatinib.
X’ fih SPRYCEL Is- sustanza attiva hi dasatinib.
Each film-coated tablet contains 20 mg, 50 mg, 70 mg or 100 mg dasatinib (as monohydrate).
Kull pillola miksija b’ rita fiha 20 mg, 50 mg, 70 mg jew 100 mg ta ’ dasatinib (bħala monohydrate).
Tablet core: lactose monohydrate; cellulose, microcrystalline; croscarmellose sodium; hydroxypropyl cellulose; magnesium stearate Film-coating: hypromellose; titanium dioxide; macrogol 400
Qalba tal- pillola: lactose monohydrate; cellulose, microcrystalline; croscarmellose sodium; hydroxypropyl cellulose; magnesium stearate Kisja b’ rita: hypromellose; titanium dioxide; macrogol 400
What SPRYCEL looks like and contents of the pack SPRYCEL 20 mg: the film-coated tablet is white to off-white, biconvex, round with “ BMS ” debossed on one side and “ 527” on the other side.
Id- dehra ta 'SPRYCEL u l- kontenut tal- pakkett SPRYCEL 20 mg: il- pillola miksija b’ rita tvarja minn bajda għal offwajt, ibbuzzata fuq iż- żewġ naħat, tonda b ’ “ BMS ” imnaqqxa fuq naħa u “ 527 ” fuq in- naħa l- oħra.
SPRYCEL 50 mg: the film-coated tablet is white to off-white, biconvex, oval with “ BMS ” debossed on one side and “ 528” on the other side.
SPRYCEL 50 mg: il- pillola miksija b’ rita tvarja minn bajda għal offwajt, ibbuzzata fuq iż- żewġ naħat, ovali b ’ “ BMS ” imnaqqxa fuq naħa u “ 528 ” fuq in- naħa l- oħra.
SPRYCEL 70 mg: the film-coated tablet is white to off-white, biconvex, round with “ BMS ” debossed on one side and “ 524” on the other side.
SPRYCEL 70 mg: il- pillola miksija b’ rita tvarja minn bajda għal offwajt, ibbuzzata fuq iż- żewġ naħat, tonda b ’ “ BMS ” imnaqqxa fuq naħa u “ 524 ” fuq in- naħa l- oħra.
SPRYCEL 100 mg: the film-coated tablet is white to off-white, biconvex, oval with “ BMS 100 ” debossed on one side and “ 852” on the other side.
SPRYCEL 100 mg: il- pillola miksija b’ rita hi bajda jew bajda tagħti fl- offwajt, bikonvessa, ovali u b ’ “ BMS 100 ” imnaqqxa fuq naħa waħda u “ 852 ” fuq in- naħa l- oħra.
SPRYCEL 20 mg, 50 mg or 70 mg film-coated tablets are available in cartons containing 56 film-coated tablets in 4 blisters of 14 film-coated tablets each, and in cartons containing 60 film-coated tablets in perforated unit dose blisters. They are also available in bottles with child resistant closure containing 60 film-coated tablets.
Huma wkoll disponibbli fi fliexken b’ tapp li t- tfal isibu diffiċli biex jiftħuh, li fihom 60 pillola miksijin b’ rita.
Each carton contains one bottle.
Kull kaxxa tal- kartun fiha flixkun wieħed.
SPRYCEL 100 mg film-coated tablets are available in cartons containing 30 film-coated tablets in perforated unit dose blisters.
SPRYCEL 100 mg pilloli miksija b’ rita huma disponibbli f’ kaxxi tal- kartun li fihom 30 pillola miksija b’ rita f’ folji perforati b’ doża waħda.
They are also available in bottles with child resistant closure containing 30 film-coated tablets.
Huma disponibbli wkoll fi fliexken b’ għatu li ma jinfetaħx faċilment mit- tfal, li jkun fihom 30 pillola miksija b’ rita.
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder BRISTOL-MYERS SQUIBB PHARMA EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH United Kingdom
Id- Detentur ta 'l- Awtorizzazzjoni għat- Tqegħid fis- Suq u l- Manifattur Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq BRISTOL- MYERS SQUIBB PHARMA EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH Ir- Renju Unit
Manufacturer Bristol-Myers Squibb Rue du Docteur André Gilles 28230 Epernon France
Manifattur Bristol- Myers Squibb Rue du Docteur André Gilles 28230 Epernon Franza
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu There are also links to other websites about rare diseases and treatments.
Hemm ukoll links għal websites oħra dwar mard rari u kura.
This document is a summary of the European Public Assessment Report (EPAR).
Sommarju ta 'l- EPAR għall- pubbliku Dan id- dokument huwa sommarju tar- Rapport ta' Valutazzjoni Pubblika Ewropew (EPAR).
What is Stalevo?
X' inhu Stalevo?
Stalevo is a medicine that contains three active substances: levodopa, carbidopa and entacapone.
Stalevo huwa mediċina li fiha tliet sustanzi attivi: levodopa, carbidopa u entacapone.
It is available as a range of brown oval tablets containing levodopa and carbidopa in four doses (50 mg levodopa and 12.5 mg carbidopa, 100 mg levodopa and 25 mg carbidopa, 150 mg levodopa and 37.5 mg carbidopa, or 200 mg levodopa and 50 mg carbidopa).
Huwa disponibbli f' firxa ta 'pilloli ovali ta' lewn kannella li fihom levodopa u carbidopa f' erba 'dożi (50 mg levodopa u 12. 5 mg carbidopa, 100 mg levodopa u 25 mg carbidopa, 150 mg levodopa u 37. 5 mg carbidopa, jew 200 mg levodopa u 50 mg carbidopa).
All of the tablets contain the same dose of entacapone (200 mg).
Il- pilloli kollha fihom l- istess doża ta 'entacapone (200 mg).
What is Stalevo used for?
Għal xiex jintuża Stalevo?
Stalevo is used to treat patients with Parkinson’ s disease, a progressive brain disorder that causes shaking, slow movement and muscle stiffness.
Stalevo jintuża għat- trattament ta 'pazjenti li jbatu mill- marda ta' Parkinson li hija disturb mentali progressiv li jikkawża rogħda, dewmien fil- movimenti u ebusija muskolari.
Stalevo is used in patients who are being treated with a combination of levodopa and an inhibitor of dopa decarboxylase (two standard treatments for Parkinson’ s disease) but are having ‘ fluctuations’ towards the end of the period between two doses of their medication that cannot be treated with the standard combination alone.
Stalevo jintuża f' pazjenti li qegħdin f' kura bit- trattament abbażi ta 'kombinazzjoni ta' levodopa u inibitur tad- dopa dekarbossilażi (dopa decarboxylase) (żewġ trattamenti standard għall- kura tal- marda ta 'Parkinson) iżda li għandhom' fluttwazzjonijiet 'lejn it- tmiem tal- perjodu bejn żewġ dożi tal- kura tagħhom li ma jistgħux jiġu ttrattati b' kombinazzjoni standard waħedha.
Fluctuations are when the effects of the medicines wear off and symptoms re-emerge.
Il- fluttwazzjonijiet iseħħu meta l- effetti tal- mediċina jonqsu u s - sintomi jfeġġu mill- ġdid.
They are linked with a reduction in the effect of levodopa, when the patient experiences sudden switches between being ‘ on’ and able to move, and being ‘ off ’ and having difficulties moving about.
Dawn huwa marbuta ma 'tnaqqis ta' l- effett ta 'levodopa, meta l- pazjent jesperjenza bidliet għal għarrieda bejn stat ta' 'on' li fih huwa kapaċi jimxi, u stat ta '' off 'li fih għandu diffikultà biex jimxi.
How is Stalevo used?
Kif jintuża Stalevo?
Each Stalevo tablet contains one complete dose of levodopa, in four strengths, with corresponding amounts of carbidopa and entacapone to improve its effectiveness.
Kull pillola ta 'Stalevo fiha doża kompluta ta' levodopa, f' erba 'livelli ta' qawwa li jikkorrispondu mal - kwantitajiet ta 'carbidopa u entacapone li jtejbu l- effikaċja tagħha.
The strength of Stalevo that the patient should use is based on the amount of levodopa they need to control their symptoms.
Id- dożaġġ ta 'Stalevo li l- pazjent għandu jieħu jiddependi mill- kwantità ta' levodopa neċessarja biex tikkontrolla s- sintomi tagħhom.
See the Summary of Product Characteristics (also part of the EPAR) for full instructions on how patients should be switched to Stalevo, and on how the dose is adjusted during treatment.
Għal aktar struzzjonijiet dwar kif tgħaddi għat- terapija bi Stalevo u dwar l- aġġustament korrett tad - doża waqt it- trattament ara s- Sommarju tal- Karatteristiċi tal- Prodott (parti wkoll mill- EPAR).
The maximum daily dose of Stalevo is 10 tablets, except for the tablets containing 200 mg levodopa and 50 mg carbidopa, for which the maximum daily dose is seven tablets.
Id- doża massima ta 'Stalevo hija 10 pilloli kuljum, għajr għall- pilloli li fihom 200 mg levodopa u 50 mg carbidopa, li għalihom id- doża massima hija ta' seba 'pilloli kuljum.
Stalevo tablets should be taken whole, with or without food.
Il- pilloli ta 'Stalevo għandhom jittieħdu sħaħ, fuq stonku vojt jew le.
They should be used with caution in patients with mild to moderate problems with their liver or severe problems with their kidneys.
Stalevo għandu jintuża b' kawtela fil- pazjenti bi problemi minn ħfief għal moderati fil- fwied jew bi problemi gravi fil- kliewi.
They should not be used in patients with severe liver problems.
Il- mediċina ma għandhiex tintuża f' pazjenti bi problemi gravi fil- fwied.
7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Is- sustanzi attivi kollha fi Stalevo jaħdmu 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
In patients with Parkinson’ s disease, the cells in the brain that produce the neurotransmitter dopamine begin to die and the amount of dopamine in the brain decreases.
Reproduction is authorised provided the source is acknowledged. biex iġibu lura l- livelli ta 'dopamina fil- partijiet tal- moħħ li jikkontrollaw il- moviment u l - koordinazzjoni.
Levodopa is converted into dopamine in the brain.
Levodopa tiġi konvertita f' dopamina fil- moħħ.
Both carbidopa and entacapone block some of the enzymes that are involved in the breakdown of levodopa in the body: carbidopa blocks the enzyme dopa decarboxylase, and entacapone blocks the enzyme catechol-O-methyl transferase (COMT).
Kemm carbidopa kif ukoll entacapone jimblukkaw l - enzimi li huma involuti fid- dekompożizzjoni ta 'levodopa fil- ġisem: carbidopa timblokka l- enzima dopa dekarbossilażi filwaqt li entacapone timblokka l- enzima katekol- O- metil transferażi (catechol- O - methyl transferase, COMT).
As a result, levodopa remains active for longer.
B' konsegwenza ta 'dan, levodopa tibqa' attiva għal iktar żmien.
This helps to improve the signs and symptoms of Parkinson’ s disease, such as stiffness and slowness of movement.
Din tgħin biex ittejjeb is- sinjali u s- sintomi tal- marda ta 'Parkinson, bħall- ebusija u d- dewmien fil- movimenti.