qanastek/EMEA-V3 huggingface dataset:
Except in newly diagnosed chronic phase CML, there are no controlled trials demonstrating a clinical benefit, such as improvement in disease-related symptoms or increased survival.
89 dijanjostikata, ma hemmx provi b’ kontroll li juru xi benefiċċju mill- aspett kliniku, bħal xi titjib fis - sintomi li għandhom x’ jaqsmu mal- marda jew xi żieda fis- sopravivenza.
The percentage of some adverse reactions was higher in the 40 patients in whom the dose was increased to 800 mg daily compared to the population of patients before dose increase (n=551).
91 reazzjonijiet avversi kien ogħla fl- 40 pazjent li kellhom id- doża miżjuda għall- 800 mg kuljum imqabbla mal- popolazzjoni tal- pazjenti qabel żdiedet id- doża (n=551).
88 response was also higher in the patients treated at 600 mg (33%) as compared to the patients treated at 400 mg (16%, p=0.0220).
Ir- rata tar- rispons kienet ukoll ogħla fil- pazjenti li ħadu doża ta ’ 600 mg (33%) meta mqabbla mal- pazjenti li kienu ħadu doża ta ’ 400 mg (16%, p=0. 0220).
% of patients (CI95%) 1 Haematological response Complete haematological response (CHR)
% tal- pazjenti (CI95%) 92 Rispons ematoloġiku1 Rispons ematoloġiku komplet (CHR)
89 majority of patients who achieved a CCyR developed the CCyR between months 3 and 10 with a median time to response based on the Kaplan-Meier estimate of 5.6 months.
Il- maġġoranza tal- pazjenti li kisbu CCyR żviluppaw is- CCyR bejn it- 3 u l- 10 xahar b’ ħin medjan għar- rispons bażat fuq l- istima Kaplan- Meier ta ’ 5. 6 xhur.
All patients received imatinib and consolidation chemotherapy (see Table 5) after induction and the levels of bcr-abl transcripts were identical in the two arms at 8 weeks.
93 pazjenti kollha rċevew imatinib u terapija konsolidata (ara Tabella 5) wara induzzjoni u l- livelli ta ’ bcr- abl transcripts kienu identiċi fiż- żewġ friegħi mat- 8 ġimgħa.
Induction- consolidation therapy
94
92 In two clinical studies (study B2222 and an intergroup study S0033) the daily dose of Glivec was escalated to 800 mg in patients progressing at the lower daily doses of 400 mg or 600 mg.
F’ żewġ studji kliniċi (studju B2222 u studju b’ grupp intern S0033), id- doża ta ’ Glivec kienet miżjuda għall 800 mg kuljum fil- pazjenti li kienu għaddejin tajjeb bid- dożi aktar baxxi ta ’ 400 mg u 600 mg kuljum.
Clinical studies in DFSP One phase II, open label, multicentre clinical trial (study B2225) was conducted including 12 patients with DFSP treated with Glivec 800 mg daily.
96 Studji kliniċi f’ DFSP Prova klinika waħda ta ’ Fażi II, open label, f’ ħafna ċentri (studju B2225) kien imwettaq b’ 12- il pazjent b’ DFSP kurata b’ Glivec 800 mg kuljum.
There was high between- patient variability in plasma imatinib AUC levels after an oral dose.
Il- varjabilità minn pazjent għall- ieħor tal- livelli ta ’ l- AUC ta ’ imatinib fil- plażma wara li tkun ingħatat doża mill- ħalq, kienet kbira.
93 Imatinib was shown in vitro to be a competitive inhibitor of marker substrates for CYP2C9, CYP2D6 and CYP3A4/ 5.
Ir- riżultati in vitro wrew li imatinib jinibixxi b’ mod kompetittiv lis- sustanzi markaturi li fuqhom jaħdmu l- enzimi CYP2C9, CYP2D6 u CYP3A4/ 5.
94 5.3 Preclinical safety data
98 5. 3 Tagħrif ta ’ qabel l- użu kliniku dwar is- sigurtà tal- mediċina
Imatinib was teratogenic in rats when administered during organogenesis at doses ≥ 100 mg/ kg, approximately equal to the maximum clinical dose of 800 mg/ day, based on body surface area.
99 Imatinib kellu effett teratoġeniku fil- far, meta ngħata fiż- żmien l- organoġenesi f’ dożi ta ’ ≥ 100 mg/ kg, li jiġu bejn wieħed u ieħor ekwivalenti għall- ogħla doża klinika ta ’ 800 mg/ jum, jekk wieħed jikkunsidra l- erja tas- superfiċje tal- ġisem.
95 In the 2-year rat carcinogenicity study administration of imatinib at 15, 30 and 60 mg/ kg/ day resulted in a statistically significant reduction in the longevity of males at 60 mg/ kg/ day and females at ≥ 30 mg/ kg/ day.
Fi studju dwar l- effett kanċeroġenu fil- far li dam sentejn, meta imatinib ingħata b’ 15, 30 u 60 mg/ kg/ jum wassal għal tnaqqis statistikament sinifikanti fit- tul tal- ħajja tal- firien maskili b’ 60 mg/ kg/ jum u fil- firien femminili b ’ ≥30 mg/ kg/ jum.
6.3 Shelf life
100 6. 3 Żmien kemm idum tajjeb il- prodott mediċinali
96 6.4 Special precautions for storage
6. 4 Prekwazjonijiet speċjali għall- ħażna
PVDC/ alu blisters
Folji ta ’ l- alu/ PVDC
Packs containing 10, 30 or 90 film-coated tablets
Pakketti li fihom 10, 30 jew 90 pilloli miksija b’ rita.
97 ANNEX II
101 ANNESS II
The MAH will continue to submit yearly PSURs unless otherwise requested by the CHMP.
L- MAH se jkompli jissottometti l- PSURs kull sena sakemm ma jkunx mitlub mod ieħor mis- CHMP.
99 ANNEX III
104 ANNESS III
101 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
106 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Glivec 50 mg hard capsules Imatinib
Glivec 50 mg kapsuli iebsin Imatinib
Each capsule contains 50 mg of imatinib (as mesilate).
Kull kapsula fiha 50 mg ta ’ imatinib (bħala mesilate).
30 hard capsules
30 kapsula iebsa
Use only as directed by a doctor.
Uża biss kif jgħidlek it- tabib.
103 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
108 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
Glivec 50 mg capsules Imatinib
Glivec 50 mg kapsuli Imatinib
104 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
109 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Glivec 100 mg hard capsules Imatinib
Glivec 100 mg kapsuli iebsin Imatinib
Each capsule contains 100 mg of imatinib (as mesilate).
Kull kapsula fiha 100 mg ta ’ imatinib (bħala mesilate).
24 hard capsules 48 hard capsules 96 hard capsules 120 hard capsules 180 hard capsules
24 kapsula iebsa 48 kapsula iebsa 96 kapsula iebsa 120 kapsula iebsa 180 kapsula iebsa
105 10.
110 10.
24 capsules 48 capsules 96 capsules 120 capsules 180 capsules
24 kapsuli 48 kapsuli 96 kapsuli 120 kapsuli 180 kapsuli
106 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
111 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
Glivec 100 mg capsules Imatinib
Glivec 100 mg kapsuli Imatinib
107 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
112 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Glivec 100 mg film-coated tablets Imatinib
Glivec 100 mg pilloli miksija b’ rita Imatinib
20 film-coated tablets 60 film-coated tablets 120 film-coated tablets 180 film-coated tablets
20 pilloli miksija b’ rita 60 pilloli miksija b’ rita 120 pilloli miksija b’ rita 180 pilloli miksija b’ rita
108 10.
113 10.
20 tablets 60 tablets 120 tablets 180 tablets
20 pilloli 60 pilloli 120 pilloli 180 pilloli
109 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
114 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
Glivec 100 mg tablets Imatinib
Glivec 100 mg pilloli Imatinib
110 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
115 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Glivec 400 mg film-coated tablets Imatinib
Glivec 400 mg pilloli miksija b’ rita Imatinib
Each film-coated tablet contains 400 mg of imatinib (as mesilate).
Kull pillola miksija b’ rita fiha 400 mg ta ’ imatinib (bħala mesilate).
10 film-coated tablets 30 film-coated tablets 90 film-coated tablets
10 pilloli miksija b’ rita 30 pilloli miksija b’ rita 90 pilloli miksija b’ rita
111 10.
116 10.
10 tablets 30 tablets 90 tablets
10 pilloli 30 pilloli 90 pilloli
112 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
117 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
Glivec 400 mg tablets Imatinib
Glivec 400 mg pilloli Imatinib
113 B.
118 B.
114 PACKAGE LEAFLET:
119 FULJETT TA ’ TAGĦRIF:
- This medicine has been prescribed only for you.
- Din il- mediċina ġiet mogħtija lilek.
What Glivec is and what it is used for 2.
X’ inhu Glivec u għalxiex jintuża 2.
Before you take Glivec 3.
Qabel ma tieħu Glivec 3.
How to take Glivec 4.
Kif għandek tieħu Glivec 4.
How to store Glivec 6.
Kif taħżen Glivec 6.
WHAT GLIVEC IS AND WHAT IT IS USED FOR
X’ INHU GLIVEC U GĦALXIEX JINTUŻA
Glivec is a treatment for adults and children for:
Glivec huwa kura għall- adulti u tfal għall -:
Chronic myeloid leukaemia (CML).
Lewkimja majelojd kronika (CML).
Leukaemia is a cancer of white blood cells.
Il- lewkemja hija kanċer taċ- ċelloli bojod tad- demm.
These white cells usually help the body to fight infection.
Dawn iċ - ċelloli bojod issoltu jgħinu lill- ġisem biex jiġġieled l- infezzjonijiet.
Chronic myeloid leukaemia is a form of leukaemia in which certain abnormal white cells (named “ myeloid” cells) start growing out of control.
Lewkimja majelojd kronika hija forma ta ’ lewkimja fejn iċ- ċelloli bojod (li jissejħu “ majelojd ”), jibdew jitkattru mingħajr kontroll.
Glivec is also a treatment for adults for:
Glivec huwa wkoll kura f’ adulti għall -:
Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph-positive ALL).
Lewkimja limfoblastika akuta posittiva għall- kromosoma ta ’ Filadelfja (Ph- posittiva ALL).
Leukaemia is a cancer of white blood cells.
Il - lewkimja hija kanċer taċ- ċelluli bojod tad- demm.
These white cells usually help the body to fight infection.
Dawn iċ- ċelloli bojod issoltu jgħinu lill- ġisem biex jiġġieled l- infezzjonijiet.
Acute lymphoblastic leukaemia is a form of leukaemia in which certain abnormal white cells (named “ lymphoblasts”) start growing out of control.
Lewkimja limfoblastika akuta hija forma ta ’ lewkimja li fiha ċerti ċelluli bojod anormali (li jissejjħu “ limfoblasts ”) jibdew jitkattru mingħajr kontroll.
Glivec inhibits the growth of these cells.
Glivec jinibixxi t- tkattir ta ’ dawn iċ- ċelluli.
Myelodysplastic/ myeloproliferative diseases (MDS/ MPD).
Mard majelodisplastiku/ majeloproliferattiv (MDS/ MPD).
These are a group of blood diseases in which some blood cells start growing out of control.
Dawn huma grupp ta ’ mard tad- demm li bihom iċ- ċelluli tad- demm jibdew jitkattru mingħajr kontroll.
Glivec inhibits the growth of these cells in a certain subtype of these diseases.
Glivec jinibixxi t- tkattir ta ’ dawn iċ - ċelluli f’ xi sittotipi ta ’ dawn il- mard.
Hypereosinophilic syndrome (HES) and/ or chronic eosinophilic leukaemia (CEL).
Sindrome ipereżinofilika (HES) u/ jew Lewkimja eżinofilika kronika (CEL).
These are blood diseases in which some blood cells (named “ eosinophils”) start growing out of control.
Dawn huma mard tad - demm li bihom ftit miċ- ċelluli bojod tad- demm (li jissejħu “ eżinofils ”) jibdew jitkattru mingħajr kontroll.
Glivec inhibits the growth of these cells in a certain subtype of these diseases.
Glivec jinibixxi t- tkattir ta ’ dawn iċ- ċelluli f’ xi sottotipi ta ’ dawn il- mard.
Gastrointestinal stromal tumours (GIST).
Tumur fl- istroma gastro- intestinali (GIST).
GIST is a cancer of the stomach and bowels.
GIST huwa kanċer ta ’ l- istonku u ta ’ l- imsaren.
It arises from uncontrolled cell growth of the supporting tissues of these organs.
Dan jiġi minn żtkattir bla kontroll taċ- ċelluliji tat- tessuti li jagħtu support lil dawn l- organi.
DFSP is a cancer of the tissue beneath the skin in which some cells start growing out of control.
DFSP huwa kanċer tat- tessut ta ’ taħt il- ġilda li fih xi ċelluli jibdew jitkattru mingħajr kontroll.
Glivec works by inhibiting the growth of abnormal cells in the diseases listed above.
Glivec jaħdem billi jinibixxi t- tkattir ta ’ dawn iċ- ċelluli anormali fil- mard elenkat hawn fuq.
If you have any questions about how Glivec works or why this medicine has been prescribed for you, ask your doctor.
Jekk għadek xi mistoqsijiet dwar kif jaħdem Glivec jew għala din il- mediċina ġiet ordnata lilek, staqsi lit - tabib tiegħek.
115 2.
120 2.
BEFORE YOU TAKE GLIVEC
QABEL MA TIEĦU GLIVEC
Glivec will only be prescribed to you by a doctor with experience in medicines to treat blood cancers or solid tumours.
Glivec jista ’ jiġi ordnat lilek biss minn tabib li għandu esperjenza fil- mediċini għall- kura ta ’ tipi ta ’ kanċer tad- demm jew tumuri solidi.
Follow all your doctor’ s instructions carefully, even if they differ from the general information contained in this leaflet.
Segwi sewwa l- istruzzjonijiet tat- tabib tiegħek anke jekk il- pariri tiegħu jkunu differenti mit- tagħrif ġenerali li hawn f’ dan il- fuljett.
Do not take Glivec:
Tieħux Glivec:
- if you are allergic (hypersensitive) to imatinib or any of the other ingredients of Glivec listed at
- Jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal imatinib jew sustanzi oħra ta ’ Glivec
the end of this leaflet (see section 6).
li huma mniżżlin fl- aħħar ta ’ dan il- fuljett (ara sezzjoni 6).
If you think you may be allergic, ask your doctor for advice.
Jekk taħseb li int tista ’ tkun allerġiku/ a, staqsi lit- tabib tiegħek għal parir.
Take special care with Glivec:
Oqgħod attent ħafna b’ Glivec:
- if you have a liver, kidney or heart problem, or used to have one.
- jekk kont jew għadek tbati minn problemi fil- fwied, fil- kliewi jew fil- qalb.
- if you are receiving treatment with levothyroxine because your thyroid has been removed.
- jekk qed tirċievi kura b’ levothyroxine minħabba li tneħħietlek it- tajrojd.
If any of these apply to you, tell your doctor before you take Glivec.
Jekk xi punti minn dawn jgħoddu għalik, għid lit- tabib qabel tieħu Glivec.
While you are taking Glivec, you may get severe fluid retention.
Waqt li qed tieħu Glivec, jista ’ jkollok żamma ta ’ fluwidi qawwija.
If you put on weight rapidly tell your doctor straight away.
Għarraf lit- tabib tiegħek mill - ewwel jekk iżżid fil- piż f’ daqqa.
Your doctor will regularly monitor your condition to check whether Glivec is having the desired effect.
It- tabib se jeżaminak b’ mod regolari biex jara li Glivec qed jaħdem kif mixtieq.
You will also have blood tests and be weighed regularly while you are taking Glivec.
Waqt li tkun qed tieħu Glivec, ser jittieħdulek ukoll testijiet tad- demm u jiżnuk b’ mod regolari.
Glivec is a treatment for children with CML.
Glivec huwa kura għal tfal b’ CML.
There is no experience in children with CML below 2 years of age.
M’ hemmx esperjenza bl- użu ta ’ Glivec fi tfal taħt is- sentejn li jsofru b’ CML.
There is limited experience in children with Ph-positive ALL.
Hemm esperjenza limitata dwar l- użu ta ’ Glivec fi tfal li jsofru minn Ph- posittiva ALL.
There is no experience in children or adolescents with GIST.
M’ hemmx esperjenza fi tfal jew adolexxenti b’ GIST.
St.
Meta tieħu mediċini oħra Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta (paracetamol) u inklużi mediċini derivati minn ħxejjex (eż.
John’ s Wort).
St John’ s Wort).
Certain medicines may interfere with the effect of Glivec when taken together.
Ċerti mediċini jistgħu jtellfu l- effett ta ’ Glivec meta jittieħdu flimkien.
They may increase or decrease the effect of Glivec either leading to increased side effects or making Glivec ineffective.
Jistgħu iżidu jew inaqqsu l- effett ta ’ Glivec u jwasslu jew għal żieda fl- effetti sekondarji jew ixejnu l- effett ta ’ Glivec.
Glivec may do the same to some other medicines.
Glivec jista ’ jagħmel l- istess lill- mediċini oħra.
Pregnancy and breast-feeding If you are pregnant or think you may be, tell your doctor.
Tqala u Treddigħ Jekk ħriġt tqila jew taħseb li tista ’ tkun, għid lit- tabib tiegħek.
Glivec is not to be used during pregnancy unless clearly necessary.
Glivec m’ għandux jintuża waqt it - tqala sakemm ma ’ jkunx hemm bżonn ċar.
Your doctor will discuss with you the potential risk of taking Glivec during pregnancy.
It- tabib tiegħek ser jiddiskuti r- riskji li jista ’ jkun hemm bl - użu ta ’ Glivec waqt it- tqala.
Women who might become pregnant are advised to use effective contraception during treatment.
Nisa li jistgħu joħorġu tqal għandhom jingħataw parir sabiex jużaw miżuri ta ’ kontraċezzjoni effettivi meta jkunu qed jirċievu l- kura.
If you are breast-feeding, tell your doctor.
Jekk qed tredda ’, għid lit- tabib tiegħek.
Do not breast-feed during treatment with Glivec.
M’ għandekx tredda ’ meta tkun qed tieħu Glivec.
Driving and using machines If you feel dizzy or if you have blurred vision while taking Glivec, do not drive a vehicle or operate any tools or machines until you are feeling well again.
Sewqan u tħaddim ta ’ magni Jekk tħossok sturdut jew ikollok vista mċajpra waqt l- użu b’ Glivec, issuqx jew tuża xi għodod jew magni sakemm tħossok aħjar mill- ġdid.
HOW TO TAKE GLIVEC
KIF GĦANDEK TIEĦU GLIVEC
Always take Glivec exactly as your doctor has told you.
Dejjem għandek tieħu Glivec eżattament skond il- parir tat- tabib.
116 How much to take Adults:
121 Kemm għandek tieħu Adulti:
Your doctor will tell you how many capsules of Glivec to take.
It- tabib għandu jgħidlek in- numru ta ’ kapsuli ta ’ Glivec li għandek tieħu.
If you are being treated for CML, the usual starting dose given is:
Jekk qed tieħu kura għal CML id- doża li normalment tibda ’ biha hija ta ’:
- either 400 mg to be taken as 4 capsules of 100 mg (or as 8 capsules of 50 mg) once a day,
- jew 400 mg li tittieħed bħala 4 kapsuli ta ’ 100 mg (jew 8 kapsuli ta ’ 50 mg) darba kuljum,
- or 600 mg to be taken as 6 capsules of 100 mg (or as 12 capsules of 50 mg) once a day.
- jew 600 mg li tittieħed bħala 6 kapsuli ta ’ 100 mg (jew 12- il kapsula ta ’ 50 mg) darba kuljum.
If you are being treated for GIST, the starting dose is 400 mg, to be taken as 4 capsules of 100 mg (or as 8 capsules of 50 mg) once a day.
Jekk qed tirċievi kura għal GIST, id- doża tal- bidu hija 400 mg, li tittieħed bħala 4 kapsuli ta ’ 100 mg (jew 8 kapsuli ta ’ 50 mg) darba kuljum.
Depending on how you respond to the treatment, your doctor may prescribe a higher or lower dose.
Skond il- mod kif ikun ir- rispons tiegħek għall- kura, it- tabib jista ’ jżidlek jew inaqqaslek id- doża.
If your daily dose is 800 mg, you should take 4 capsules of 100 mg in the morning and 4 capsules of 100 mg in the evening (or 8 capsules of 50 mg in the morning and 8 capsules of 50 mg in the evening).
Jekk id- doża ta ’ kuljum tkun 800 mg, għandek tieħu 4 kapsuli ta ’ 100 mg filgħodu u 4 kapsuli ta ’ 100 mg filgħaxija (jew 8 kapsuli ta ’ 50 mg filgħodu u 8 kapsuli ta ’ 50 mg filgħaxija).
If you are being treated for Ph-positive ALL, the starting dose is 600 mg to be taken as 6 capsules of 100 mg (or 12 capsules of 50 mg) once a day.
Jekk qed tirċievi kura għal Ph- posittiva ALL, id- doża tal- bidu hija 600 mg li għandhom jittieħdu bħala 6 kapsuli ta ’ 100 mg (jew 12- il kapsula ta ’ 50 mg) darba kuljum.
If you are being treated for MDS/ MPD, the starting dose is 400 mg, to be taken as 4 capsules of 100 mg (or as 8 capsules of 50 mg) once a day.
Jekk qed tirċievi kura għal MDS/ MPD, id- doża tal- bidu hija ta ’ 400 mg li għandhom jittieħdu bħala 4 kapsuli ta ’ 100 mg (jew 8 kapsuli ta ’ 50 mg) darba kuljum.
If you are being treated for HES/ CEL, the starting dose is 100 mg, to be taken as one capsule of 100 mg (or as 2 capsules of 50 mg) once a day.
Jekk qed tirċievi kura għal HES/ CEL, id- doża tal- bidu hija 100 mg li għandhom jittieħdu bħala kapsula 1 ta ’ 100 mg (jew 2 kapsuli ta ’ 50 mg) darba kuljum.
Your doctor may decide to increase the dose to 400 mg, to be taken as 4 capsules of 100 mg (or as 8 capsules of 50 mg) once a day, depending on how you respond to treatment.
It- tabib tiegħek jista ’ jiddeċidi li jżid id - doża għal 400 mg, li għandhom jittieħdu bħala 4 kapsuli ta ’ 100 mg (jew 8 kapsuli ta ’ 50 mg) darba kuljum, skond kif ikun ir- rispons tiegħek għall- kura.
If you are being treated for DFSP, the dose is 800 mg per day, to be taken as 4 capsules of 100 mg in the morning and 4 capsules of 100 mg in the evening (or as 8 capsules of 50 mg in the morning and 8 capsules of 50 mg in the evening).
Jekk qed tirċievi kura għal DFSP, id- doża hija 800 mg, li għandha tittieħed bħala 4 kapsuli ta ’ 100 mg filgħodu u 4 kapsuli ta ’ 100 mg filgħaxija (jew 8 kapsuli ta ’ 50 mg filgħodu u 8 kapsuli ta ’ 50 mg filgħaxija).
The doctor will tell you how many capsules of Glivec should be given to your child.
It- tabib għandu jgħidlek in- numru ta ’ kapsuli ta ’ Glivec li ghandek tagħti lit- tifel jew tifla tiegħek.
The amount of Glivec given will depend on your child’ s condition and also his or her body weight and height.
L - ammont ta ’ Glivec jiddependi mill- kundizzjoni tat- tifel jew tifla kif ukoll mill- piż u t- tul ta ’ ġismu/ ġisimha.
The total daily dose in children must not exceed 800 mg, to be taken as 8 capsules of 100 mg (or 16 capsules of 50 mg).
Id- doża totali fit- tfal ma tistgħax taqbeż it- 800 mg, li għandhom jittiedu bħala 8 kapsuli ta ’ 100 mg (jew 16- il kapsula ta ’ 50 mg).
The treatment can either be given to your child as a once-daily dose or alternatively the daily dose can be split into two administrations (one in the morning and one in the evening).
Il- kura tista ’ tingħata lit- tifel jew tifla tiegħek f’ darba kuljum jew inkella tinqasam f’ darbtejn (waħda filgħodu u waħda filgħaxija).
When and how to take Glivec Take Glivec with a meal as this will help protect your stomach.
Meta u kif għandek tieħu Glivec Ħu Glivec ma ’ l- ikel għax dan jgħinek tipproteġi l- istonku.
Swallow the capsules whole with a large glass of water.
Ibla ’ l- kapsula sħiħa b’ tazza ilma kbira.
Do not open or crush the capsules unless you have difficulty in swallowing (e. g. in children).
Sakemm m’ għandekx problemi biex tibla ’ (eż. fit- tfal), tiftaħx jew tfarrakx il- kapsuli.
The contents of the capsules can then be diluted in a glass of either still water or apple juice.
Il - kontenuti tal- kapsula jistgħu jiġi mħallta f’ tazza bl- ilma bla gass, jew mal- meraq tat- tuffieħ.
If you are a woman who is pregnant or might get pregnant and are trying to open the capsules, you should handle the contents with caution in order to avoid skin-eye contact or inhalation.
Jekk inti mara tqila jew tista ’ toħroġ tqila u qed tipprova tiftaħ il- kapsuli, għandek toqgħod attenta biex tevita kuntatt mal- ġilda jew ma ’ l- għajnejn u li tiġbdu ġol- pulmun man- nifs.
You should wash your hands immediately after opening the capsules.
Għandek taħsel idejk mill - ewwel wara li tiftaħ il- kapsuli.
How long to take Glivec Take Glivec daily until your doctor tells you to stop.
Kemm iddum tieħu Glivec Ħu Glivec kuljum sakemm jgħidlek it- tabib biex tieqaf.
Make sure you take Glivec for as long as it is prescribed.
Kun ċert li tieħu Glivec għat- tul taż- żmien kollu li jordnalek it- tabib.
If you take more Glivec than you should If you have accidentally taken too many capsules, talk to your doctor straight away.
Jekk tieħu Glivec aktar milli suppost Jekk bi żball tieħu aktar kapsuli, għid lit- tabib tiegħek mill- ewwel.
You may require medical attention.
Jista ’ jkun li jkollok bżonn attenzjoni medika.
If you forget to take Glivec Take the missed dose as soon as you remember on the day you missed, then continue with your normal schedule.
Jekk tinsa tieħu Glivec Ħu d- doża li qbiżt hekk kif tiftakar fil- jum li tkun qbiżtha, imbagħad kompli bl- iskeda normali tiegħek.
Do not take a double dose the next day to make up a forgotten dose.
M’ għandekx tieħu doża doppja il- ġurnata ta ’ wara biex tpatti għal doża li tkun insejt tieħu.
117 If you have any further questions on the use of this product, ask your doctor or pharmacist.
122 Jekk għandek aktar mistoqsijiet dwar l- użu ta ’ dan il- prodott, staqsi lit- tabib jew lill- ispiżjar tiegħek.
Like all medicines, Glivec can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Glivec jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
They are usually mild to moderate.
Normalment dawn ikunu ħfief għal moderati.
If you experience any of these, tell your doctor straight away.
Jekk ikollok xi wieħed minn dawn, għid lit- tabib tiegħek mill- ewwel.
Some effects could be serious:
Xi effetti jistgħu jkunu serji:
These side effects are common or very common, that is they may affect from 1 to more than 10 in every 100 patients: • Rapid weight gain.
Dawn l- effetti huma komuni jew komuni ħafna li jfisser li jistgħu jaffettwaw minn 1 sa mhux aktar minn 10 f’ kull 100 pazjent: • Żieda tal- piż f’ daqqa.
Treatment with Glivec may cause your body to retain water (fluid retention). • Signs of infection such as fever, severe chills, sore throat or mouth ulcers.
Il- kura b’ Glivec tista ’ tikkawża lill- ġismek iżomm l- ilma (żamma ta ’ fluwidi). • Sinjali ta ’ infezzjoni bħal deni, tkexkix ta ’ bard qawwi, uġigħ fil- griżmejn jew ulċeri fil- ħalq.
Glivec can reduce the number of white cells in the blood, resulting in greater sensitivity to infection. • Unexpected bleeding or bruising in the absence of any injury.
Glivec jista ’ jnaqqaslek in- numru ta ’ ċelluli bojod fid- demm u b’ hekk iżidlek is- sensitività tiegħek għall- infezzjonijiet. • Jekk ikollok fsada mhux mistennija jew titbenġel mingħajr ma tintlaqat.
These effects are very rare or uncommon, that is they may affect between 1 to 100 in every 10,000 patients: • chest pain, irregular heart rhythm. • cough, difficulty breathing or painful breathing. • light-headedness, dizziness or fainting. • nausea, loss of appetite, light-coloured urine, yellowing of skin or eyes. • rash, red skin, blistering of the lips, eyes, skin or mouth, skin peeling, fever, raised red or purple skin patches, itching, burning sensation. • severe abdominal pain, blood in your vomit, stools or urine, black stools. • severely decreased urine output, thirst • nausea, diarrhoea, vomiting, abdominal pain or fever (signs of inflammatory bowel disease). • severe headache, weakness or paralysis of limbs or face, difficulty speaking, sudden loss of consciousness (signs of nervous system disorder). • pale skin, tiredness, breathlessness, dark urine (signs of low levels of red blood cells). • pain in your eyes or deterioration in vision. • pain in your hips or difficulty walking. • numb or cold toes and fingers (signs of Raynaud’ s syndrome). • acute inflammation of the skin caused by infection (signs of cellulites). • difficulty hearing. • muscle weakness, muscle spasms, abnormal heart rhythm (signs of changes in level of potassium in the blood). • bruising. • stomach pain, nausea.
Dawn l- effetti huma rari ħafna jew mhux komuni li jfisser li jistgħu jeffettwaw bejn 1 u 100 f’ kull 10, 000 pazjent: • uġigħ f’ sidrek, qalb tħabbat b’ mod mhux regolari. • sogħla jew tweġġa biex tieħu n- nifs. • tħoss rasek ħafifa, sturdut jew tintilef minn sensik. • dardir, nuqqas ta ’ aptit, l- awrina tkun ċara, il- ġilda jew għajnejk jisfaru. • raxx, ġilda ħamra, jitilgħu nuffati fuq ix- xofftejn, għajnejn, il- ġilda titqaxxar, deni, dbabar ħomor jew vjola mgħollija fil- ġilda, ħakk, jew sensazzjoni ta ’ ħruq. • uġigħ qawwi fl- addome, demm fir- rimettar, fl- ippurgar jew fl- awrina, l- ippurgar ikun iswed. • tnaqqis sever f’ kemm tagħmel awrina, għatx. • dardir, dijarea, rimettar, uġigħ fl- addome jew deni (sinjali tal- marda ta ’ infjammazzjoni ta ’ l - imsaren). • uġigħ ta ’ ras qawwi, dgħjufija jew paraliżi tar- riġlejn u d- dirgħajn jew il- wiċċ, tbati biex titkellem, telf mis- sensi f’ salt wieħed (sinjali ta ’ disturbi tas- sistema nervuża). • ġilda ċara, għeja, qtugħ ta ’ nifs, awrina skura (sinjali ta ’ livelli baxxi ta ’ ċelluli ħomor tad - demm). • uġigħ f’ għajnejk, jew il- vista tiegħek tmur lura. • uġigħ f’ ġenbek jew tbati biex timxi. • swaba ta ’ saqajk u ta ’ jdejk imnemnim jew kesħin (sinjali tas- sindrome ta ’ Raynaud). • infjammazzjoni akuta tal- ġilda ikkawżata minn infezzjoni (sinjali ta ’ ċellulite). • tbatija biex tisma. • dgħjufija fil- muskoli, spażmi fil- muskoli, ritmu tal- qalb anormali (sinjali ta ’ bidla fil- livell ta ’ potassium fid- demm). • dbengil. • uġigħ fl- istonku, dardir.
Other very common effects:
Effetti oħra komuni ħafna:
These are likely to affect more than 10 in every 100 people Headache, nausea, vomiting, diarrhoea, indigestion, rash, muscle cramps, pain in the muscles and bones, and swelling (including puffy eyes and ankle swelling), joint pain, tiredness, increased weight.
Dawn jaffettwaw aktar minn 10 f’ kull 100 persuna Uġigħ ta ’ ras, tqallih, rimettar, dijarrea, indiġistjoni, raxx, bugħawwieġ, uġigħ fil- muskoli u fl - għadam, u nefħa (jinkludi nefħa fl- għajnejn u fl- għekiesi), uġigħ fil- ġogi, għeja, żieda fil- piż.
If any of these affects you severely, tell your doctor.
Jekk xi wieħed minn dawn l- effetti jkunu severi, għid lit- tabib tiegħek.
Other possible side effects:
Effetti oħra possibli:
These are likely to affect between 1 and 10 in every 100 people Anorexia, dizziness, insomnia, conjunctivitis, increased tear production, taste disturbance, nose bleeds, pain or swelling in the abdomen, flatulence, constipation, itching, unusual hair loss or thinning, night sweats, weakness, numbness of the hands or feet, heartburn, blurred vision, mouth ulceration, joint swelling and joint pain, decreased weight, dry mouth, dry skin, dry eye, decreased skin sensitivity, increased skin sensitivity, hot flushes, chills.
Dawn jaffettwaw bejn 1 sa 10 f’ kull 100 persuna Anoressija, sturdament, nuqqas ta ’ rqad, konġunktivite, żieda fid- dmugħ, tibdil fit- togħma, tinfaraġ, uġigħ jew nefħa fl- addome, nefħa b’ gass fl- istonku jew l- imsaren, stitikezza, ħakk, jiħfieflek jew 123 jaqalek xagħrek b’ mod mhux tas- soltu, tgħereq ħafna matul il- lejl, tħossok bla saħħa, tnemnim ta ’ l - idejn jew tas- saqajn, żieda fil- piż, ħruq ta ’ stonku, vista mċajpra, ulċeri fil- ħalq, nefħa fil- ġogi u uġigħ fil- ġogi, tnaqqis fil- piż, ħalq xott, għajnejn xotti, tnaqqis tas- sensittività tal- ġilda, żieda tas- sensittività tal- ġilda, fwawar ta ’ sħana, dehxiet.
118 If any of these affects you severely, tell your doctor.
Jekk xi wieħed minn dawn l- effetti ikunu severi, għid lit- tabib tiegħek.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please inform your doctor or pharmacist.
Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
HOW TO STORE GLIVEC
KIF TAĦŻEN GLIVEC
• Keep out of the reach and sight of children. • Do not use after the expiry date shown on the box. • Do not use any pack that is damaged or shows signs of tampering. • Do not store above 30°C. • Store in the original package in order to protect from moisture.
• Żomm fejn ma jintlaħaqx u ma jidhirx mit- tfal. • Tużax wara d- data ta ’ skadenza li tidher fuq il- kartuna. • M’ għandekx tuża pakkett li jkun bil- ħsara jew juri sinjali ta ’ tbabis. • Taħżinx f’ temperatura ‘ l fuq minn 30°C. • Aħżen fil- pakkett oriġinali sabiex tilqa ’ mill- umdità.
What Glivec contains
X’ fih Glivec
- The active substance is imatinib mesilate.
- Is- sustanza attiva imatinib mesilate.
- The other ingredients are microcrystalline cellulose, crospovidone, magnesium stearate and
- Is- sustanzi l- oħra huma microcrystalline cellulose, crospovidone, magnesium stearate u
anhydrous colloidal silica.
anhydrous colloidal silica.
The capsule shell is composed of gelatin, yellow iron oxide (E172) and titanium dioxide (E171).
Il- qoxra tal- kapsula hija magħmula minn gelatin, yellow iron oxide (E172) u titanium dioxide (E171).
The printing ink is composed of red iron oxide (E172), shellac, soya lecithin.
L- inka ta ’ l- istampar hija magħmula minn red iron oxide (E172), shellac, soya lecithin.
What Glivec looks like and contents of the pack Glivec 50 mg capsules are light yellow to orange-yellow and marked “ NVR SH”.
Id- Dehra ta ’ Glivec u l- kontentuti tal- pakkett Kapsuli Glivec tal- 50 mg huma sofor ċari jagħtu fl- isfar- oranġjo u mmarkati “ NVR SH ”.
They contain a white to yellow powder.
Fihom trab abjad jagħti fl- isfar.
They are supplied in packs containing 30 capsules.
Jiġu f’ pakketti li jkun fihom 30 kapsula.
Marketing Authorisation Holder Novartis Europharm Limited Wimblehurst Road Horsham West Sussex, RH12 5AB United Kingdom
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq Novartis Europharm Limited Triq Wimblehurst Horsham West Sussex, RH12 5AB Ir- Renju Unit
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq.
България Novartis Pharma Services Inc.
124 България Novartis Pharma Services Inc.
Tel: +356 2298 3217
Tel: +00 356 2298 3217
Polska Novartis Poland Sp. z o. o.
Polska Novartis Poland Sp. z. o. o.
Tel: +386 1 300 75 77
Tel: +386 1 300 75 50
Tel: +370 5 269 16 50
Tel. +370 5 269 16 50
This leaflet was last approved in {MM/ YYYY}
125 Dan il- fuljett kien approvat l- aħħar f ’ {XX/ SSSS}
120 PACKAGE LEAFLET:
126 FULJETT TA ’ TAGĦRIF:
121 2.
127 2.
Do not breast-feed during the treatment with Glivec.
M’ għandekx tredda ’ meta tkun qed tieħu Glivec.
122 How much to take Adults:
128 Kemm għandek tieħu Adulti:
When and how to take Glivec Take Glivec with a meal as this will help to protect your stomach.
Meta u kif għandek tieħu Glivec Ħu Glivec ma ’ l- ikel għax dan jgħinek tipproteġi l- istonku.
123 If you have any further questions on the use of this product, ask your doctor or pharmacist.
129 Jekk għandek aktar mistoqsijiet dwar l- użu ta ’ dan il- prodott, staqsi lit- tabib jew lill- ispiżjar tiegħek.
These are likely to affect between 1 and 10 in every 100 people Anorexia, dizziness, insomnia, conjunctivitis, increased tear production, taste disturbance, nose bleeds, pain or swelling in the abdomen, flatulence, constipation, itching, unusual hair loss or thinning, night sweats, weakness, numbness of the hands or feet, heartburn, blurred vision, mouth ulceration, joint swelling and joint pain, decreased weight, dry mouth, dry skin, dry eye, decreased skin sensitivity, increased skin sensitivity, hot flushes, chills.
Dawn jaffettwaw bejn 1 sa 10 f’ kull 100 persuna Anoressija, sturdament, nuqqas ta ’ rqad, konġunktivite, żieda fid- dmugħ, tibdil fit- togħma, tinfaraġ, uġigħ jew nefħa fl- addome, nefħa b’ gass fl- istonku jew l- imsaren, stitikezza, ħakk, jiħfieflek jew 130 jaqalek xagħrek b’ mod mhux tas- soltu, tgħereq ħafna matul il- lejl, tħossok bla saħħa, tnemnim ta ’ l - idejn jew tas- saqajn, żieda fil- piż, ħruq ta ’ stonku, vista mċajpra, ulċeri fil- ħalq, nefħa fil- ġogi u uġigħ fil- ġogi, tnaqqis fil- piż, ħalq xott, għajnejn xotti, tnaqqis tas- sensittività tal- ġilda, żieda tas- sensittività tal- ġilda, fwawar ta ’ sħana, dehxiet.
124 If any of these affects you severely, tell your doctor.
Jekk xi wieħed minn dawn l- effetti ikunu severi, għid lit- tabib tiegħek.
If any of the side effects gets serious, or if you notice any other side effects not listed in this leaflet, please inform your doctor or pharmacist.
Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
The capsule shell is composed of gelatin, red iron oxide (E172), yellow iron oxide (E172) and titanium dioxide (E171).
Il- qoxra tal- kapsula hija magħmula gelatin, red iron oxide (E172), yellow iron oxide (E172) u titanium dioxide (E171).
What Glivec looks like and contents of the pack Glivec 100 mg capsules are orange to greyish-orange and marked “ NVR SI”.
Id- Dehra ta ’ Glivec u l- kontentuti tal- pakkett Kapsuli Glivec tal- 100 mg huma oranġjo jagħtu fl- oranġjo- griż u mmarkati “ NVR SI ”.
They are supplied in packs containing 24, 48, 96, 120 or 180 capsules, but these may not all be available in your country.
Jiġu f’ pakketti ta ’ 24, 48, 96, 120 jew 180 kapsula, iżda jista ’ jkun li mhux il- pakketti kollha jkunu disponibbli f’ pajjiżek.
This leaflet was last approved in {MM/ YYYY}
132 Dan il- fuljett kien approvat l- aħħar f ’ {XX/ SSSS}
126 PACKAGE LEAFLET:
133 FULJETT TA ’ TAGĦRIF:
Glivec 100 mg film-coated tablets Imatinib
Glivec 100 mg pilloli miksija b' rita Imatinib
127 2.
134 2.
128 How much to take Adults:
135 Kemm għandek tieħu Adulti:
Your doctor will tell you how many tablets of Glivec to take.
It- tabib għandu jgħidlek in- numru ta ’ pilloli ta ’ Glivec li għandek tieħu.
If you are being treated for CML, the usual starting dose is:
Jekk qed tieħu trattament għal CML id- doża li normalment tibda ’ biha hija:
- either 400 mg to be taken as one tablet of 400 mg once a day,
- jew 400 mg li għandha tittieħed bħala pillola waħda ta ’ 400 mg darba kuljum,
- or 600 mg to be taken as one tablet of 400 mg plus 2 tablets of 100 mg once a day.
- jew 600 mg li għandha tittieħed bħala pillola waħda ta ’ 400 mg flimkien ma ’ 2 pilloli ta ’
If you are being treated for GIST, the starting dose is 400 mg, to be taken as one tablet of 400 mg once a day.
Jekk qed tingħata kura għal GIST, id- doża tal- bidu hija ta ’ pillola waħda ta ’ 400 mg, li għandha tittieħed bħala pillola waħda ta ’ 400 mg darba kuljum.
Depending on how you respond to the treatment, your doctor may prescribe a higher or lower dose.
Skond kif tkun qed tirrispondi għall- kura, it- tabib tiegħek jista ’ jordnalek doża ogħla jew doża aktar baxxa.
If your daily dose is 800 mg, you should take one tablet of 400 mg in the morning and a second tablet of 400 mg in the evening.
Jekk id- doża ta ’ kuljum hija 800 mg, għandek tieħu pillola ta ’ 400 mg filgħodu u t- tieni pillola ta ’ 400 mg filgħaxija.
If you are being treated for Ph-positive ALL, the starting dose is 600 mg to be taken as one tablet of 400 mg plus 2 tablets of 100 mg once a day.
Jekk qed tirċievi kura għal Ph- posittiva ALL, id- doża tal- bidu hija 600 mg li għandha tittieħed bħala pillola waħda ta ’ 400 mg flimkien ma ’ 2 pilloli ta ’ 100 mg darba kuljum.
If you are being treated for MDS/ MPD, the starting dose is 400 mg, to be taken as one tablet of 400 mg once a day.
Jekk qed tirċievi kura għal MDS/ MPD, id- doża tal- bidu hija ta ’ 400 mg li għandhom jittieħdu bħala pillola waħda ta ’ 400 mg darba kuljum.
If you are being treated for HES/ CEL, the starting dose is 100 mg, to be taken as one tablet of 100 mg once a day.
Jekk qed tirċievi kura għal HES/ CEL, id- doża tal- bidu hija 100 mg li għandhom jittieħdu bħala pillola 1 ta ’ 100 mg darba kuljum.
Your doctor may decide to increase the dose to 400 mg, to be taken as one tablet of 400 mg once a day, depending on how you respond to treatment.
It- tabib tiegħek jista ’ jiddeċidi li jżid id- doża għal 400 mg, li għandhom jittieħdu bħala pillola waħda ta ’ 400 mg darba kuljum, skond kif ikun ir- rispons tiegħek għall- kura.
If you are being treated for DFSP, the dose is 800 mg per day, to be taken as one tablet of 400 mg in the morning and a second tablet of 400 mg in the evening.
Jekk qed tirċievi kura għal DFSP, id- doża hija 800 mg, li għandha tittieħed bħala pillola ta ’ 400 mg filgħodu u pillola ta ’ 400 mg filgħaxija.
The doctor will tell you how many tablets of Glivec should be given to your child.
It- tabib għandu jgħidlek in- numru ta ’ pilloli ta ’ Glivec li ghandek tagħti lit- tifel jew tifla tiegħek.
The total daily dose in children must not exceed 800 mg, to be taken as 2 tablets of 400 mg.
Id- doża totali fit- tfal ma tistgħax taqbeż 800 mg kuljum, li għandha tittieħed bħala 2 pilloli ta ’ 400 mg.
Swallow the tablet(s) whole with a large glass of water.
Ibla ’ l- pillola sħiħa b’ tazza ilma kbira.
If you are unable to swallow the tablets, you can dissolve them in a glass of mineral water or apple juice: • Put the required number of tablets in a sufficient quantity of liquid (approximately 50 ml for a 100 mg tablet and 200 ml for a 400 mg tablet) • Stir with a spoon until the tablets have dissolved completely • Immediately drink the whole content of the glass.
Jekk għandek problemi biex tibla ’ il- pilloli, tista ’ ddewwibhom f’ tazza ilma minerali jew meraq tat - tuffieħ: • Poġġi n- numru ta ’ pilloli f’ volum xieraq ta ’ likwidu (bejn wieħed u ieħor 50 ml għall- pillola ta ’ 100 mg, u 200 ml għall- pillola ta ’ 400 mg). • Ħawwad b’ kuċċarina sakemm il- pilloli jdubu għall- kollox. • Ixrob il- kontenut tat- tazza mill- ewwel.
Traces of the dissolved tablet(s) may be left behind in the glass.
Traċċi tal- pillola( i) imdewba jistgħu jibqgħu fil- qiegħ tat- tazza.
If you take more Glivec than you should If you have accidentally taken too many tablets, talk to your doctor straight away.
Jekk tieħu Glivec aktar milli suppost Jekk bi żball tieħu aktar pilloli, għid lit- tabib tiegħek mill- ewwel.
129 If you forget to take Glivec Take the missed dose as soon as you remember on the day you missed, then continue with your normal schedule.
136 Jekk tinsa tieħu Glivec Ħu d- doża li qbiżt hekk kif tiftakar fil- jum li tkun qbiżtha, imbagħad kompli bl- iskeda normali tiegħek.
Like all medicines, Glivec can cause side effects, although not everybody gets them..
Bħal kull mediċina oħra, Glivec jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
These effects are very rare or uncommon, that is they may affect between 1 to 100 in every 10,000 patients: • chest pain, irregular heart rhythm. • cough, difficulty breathing or painful breathing. • light-headedness, dizziness or fainting. • nausea, loss of appetite, light-coloured urine, yellowing of the skin or eyes. • rash, red skin, blistering of the lips, eyes, skin or mouth, skin peeling, fever, raised red or purple skin patches, itching, burning sensation. • severe abdominal pain, blood in your vomit, stools or urine, black stools. • severely decreased urine output, thirst. • nausea, diarrhoea, vomiting, abdominal pain or fever (signs of inflammatory bowel disease). • severe headache, weakness or paralysis of limbs or face, difficulty speaking, sudden loss of consciousness (signs of nervous system disorder). • pale skin, tiredness, breathlessness, dark urine (signs of low levels of red blood cells). • pain in your eyes or deterioration in vision. • pain in your hips or difficulty walking. • numb or cold toes and fingers (signs of Raynaud’ s syndrome). • acute inflammation of the skin caused by infection (signs of cellulites). • difficulty hearing. • muscle weakness, muscle spasms, abnormal heart rhythm (signs of changes in level of potassium in the blood). • bruising. • stomach pain, nausea.
Dawn l- effetti huma rari ħafna jew mhux komuni li jfisser li jistgħu jeffettwaw bejn 1 u 100 f’ kull 10, 000 pazjent: • uġigħ f’ sidrek, qalb tħabbat b’ mod mhux regolari. • sogħla jew tweġġa biex tieħu n- nifs. • tħoss rasek ħafifa, sturdut jew tintilef minn sensik. • dardir, nuqqas ta ’ aptit, l- awrina tkun ċara, il- ġilda jew għajnejk jisfaru. • raxx, ġilda ħamra, jitilgħu nuffati fuq ix- xofftejn, għajnejn, il- ġilda titqaxxar, deni, dbabar ħomor jew vjola mgħollija fil- ġilda, ħakk, jew sensazzjoni ta ’ ħruq. • uġigħ qawwi fl- addome, demm fir- rimettar, fl- ippurgar jew fl- awrina, l- ippurgar ikun iswed. • tnaqqis sever f’ kemm tagħmel awrina, għatx. • dardir, dijarea, rimettar, uġigħ fl- addome jew deni (sinjali tal- marda ta ’ infjammazzjoni ta ’ l - imsaren). • uġigħ ta ’ ras qawwi, dgħjufija jew paraliżi tar- riġlejn u d- dirgħajn jew il- wiċċ, tbati biex titkellem, telf mis- sensi f’ salt wieħed (sinjali ta ’ disturbi tas- sistema nervuża). • ġilda ċara, għeja, qtugħ ta ’ nifs, awrina skura (sinjali ta ’ livelli baxxi ta ’ ċelluli ħomor tad - demm). • uġigħ f’ għajnejk, jew il- vista tiegħek tmur lura. • uġigħ f’ ġenbek jew tbati biex timxi. • swaba ta ’ saqajk u ta ’ jdejk imnemnim jew kesħin (sinjali tas- sindrome ta ’ Raynaud). • infjammazzjoni akuta tal- ġilda ikkawżata minn infezzjoni (sinjali ta ’ ċellulite). • tbatija biex tisma. • dgħjufija fil- muskoli, spażmi fil- muskoli, ritmu tal- qalb anormali (sinjali ta ’ bidla fil- livell ta ’ potassium fid- demm). • dbengil. • uġigħ fl- istonku, dardir.
Other possible side effects:
137 Effetti oħra possibli:
130 sweats, weakness, numbness of the hands or feet, heartburn, blurred vision, mouth ulceration, joint swelling and joint pain, decreased weight, dry mouth, dry skin, dry eye, decreased skin sensitivity, increased skin sensitivity, hot flushes, chills.
Dawn jaffettwaw bejn 1 sa 10 f’ kull 100 persuna Anoressija, sturdament, nuqqas ta ’ rqad, konġunktivite, żieda fid- dmugħ, tibdil fit- togħma, tinfaraġ, uġigħ jew nefħa fl- addome, nefħa b’ gass fl- istonku jew l- imsaren, stitikezza, ħakk, jiħfieflek jew jaqalek xagħrek b’ mod mhux tas- soltu, tgħereq ħafna matul il- lejl, tħossok bla saħħa, tnemnim ta ’ l - idejn jew tas- saqajn, żieda fil- piż, ħruq ta ’ stonku, vista mċajpra, ulċeri fil- ħalq, nefħa fil- ġogi u uġigħ fil- ġogi, tnaqqis fil- piż, ħalq xott, għajnejn xotti, tnaqqis tas- sensittività tal- ġilda, żieda tas- sensittività tal- ġilda, fwawar ta ’ sħana, dehxiet.
If any of these affects you severely, tell your doctor.
Jekk xi wieħed minn dawn l- effetti ikunu severi, għid lit- tabib tiegħek.
If any of the side effects gets serious or if you notice any side effects not listed in this leaflet, please inform your doctor or pharmacist.
Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
- The other ingredients are microcrystalline cellulose, crospovidone, hypromellose, magnesium
- Is- sustanzi l- oħra huma microcrystalline cellulose, crospovidone, hypromellose, magnesium
stearate and anhydrous colloidal silica.
stearate u anhydrous colloidal silica.
- The coating is composed of red iron oxide (E172), yellow iron oxide (E172), macrogol, talc and
- Il- kisja hija magħmula minn red iron oxide (E172), yellow iron oxide (E172), macrogol, talc u
What Glivec looks like and contents of the pack Glivec 100 mg film-coated tablets are very dark yellow to brownish-orange round tablets with “ NVR” on one side and “ SA” and a score line on the other side.
Id- Dehra ta ’ Glivec u l- kontentuti tal- pakkett Pilloli miksija b’ rita Glivec tal- 100 mg huma pilloli tondi sofor skuri ħafna jagħtu fil- kannella- oranġjo b ’ “ NVR ” fuq naħa waħda u b ’ “ SA ” u rig mnejn taqsam fuq l- oħra.
They are supplied in packs containing 20, 60, 120 or 180 tablets, but these may not all be available in your country.
Jiġu f’ pakketti ta ’ 20, 60, 120 jew 180 pillola, iżda jista ’ jkun li mhux il- pakketti kollha jkunu disponibbli f’ pajjiżek.
België/ Belgique/ Belgien Novartis Pharma N. V.
138 België/ Belgique/ Belgien Novartis Pharma N. V.
132 Lietuva Novartis Pharma Services Inc.
139 Lietuva Novartis Pharma Services Inc.
133 PACKAGE LEAFLET:
140 FULJETT TA ’ TAGĦRIF:
Glivec 400 mg film-coated tablets Imatinib
Glivec 400 mg pilloli miksija b' rita Imatinib
134 2.
141 2.
Including medicines obtained without a prescription (e. g. paracetamol) and including herbal medicines (e. g.
Meta tieħu mediċini oħra Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta (paracetamol) u inklużi mediċini derivati minn ħxejjex (eż.
St.
St John’ s Wort).
John’ s Wort) Certain medicines may interfere with the effect of Glivec when taken together.
Ċerti mediċini jistgħu jtellfu l- effett ta ’ Glivec meta jittieħdu flimkien.
135 How much to take Adults:
142 Kemm għandek tieħu Adulti:
If you are unable to swallow the tablets, you can dissolve them in a glass of mineral water or apple juice: • Put the required number of tablet(s) in a sufficient quantity of liquid (approximately 50 ml for a 100 mg tablet and 200 ml for a 400 mg tablet) • Stir with a spoon until the tablets have dissolved completely • Immediately drink the whole content of the glass.
Jekk għandek problemi biex tibla ’ il- pilloli, tista ’ ddewwibhom f’ tazza ilma minerali jew meraq tat - tuffieħ: • Poġġi n- numru ta ’ pilloli f’ volum xieraq ta ’ likwidu (bejn wieħed u ieħor 50 ml għall- pillola ta ’ 100 mg, u 200 ml għall- pillola ta ’ 400 mg). • Ħawwad b’ kuċċarina sakemm il- pilloli jdubu għall- kollox. • Ixrob il- kontenut tat- tazza mill- ewwel.
136 If you forget to take Glivec Take the missed dose as soon as you remember on the day you missed, then continue with your normal schedule.
143 Jekk tinsa tieħu Glivec Ħu d- doża li qbiżt hekk kif tiftakar fil- jum li tkun qbiżtha, imbagħad kompli bl- iskeda normali tiegħek.
Other possible side effects:
144 Effetti oħra possibli: