qanastek/EMEA-V3 huggingface dataset:
Thyroid disorder.
Disturbi tat- tirojde.
Elevation of liver enzymes, impaired kidney function, low protein in blood, weight gain.
Żieda fl- enzimi tal- fwied, indeboliment tal- funzjoni tal- kliewi, livell baxx ta ’ proteina fid- demm, żieda fil- piż.
Insomnia, dizziness, reduced skin sensation.
Nuqqas ta ’ rqad, sturdament, tnaqqis fis- sensazzjoni tal- ġilda.
Dry eyes, deafness, abnormal sensations of the eye including irritation and heaviness.
Għajnejn xotti, tittarrax, sensazzjonijiet anormali ta ’ l- għajnejn li jinkludu irritazzjoni u tħoss l - għajnejn tqal.
Swelling of legs and arms.
Nefħa fir- riġlejn u fid- dirgħajn.
Nausea, diarrhoea, dry mouth, dry lips, loss of appetite, constipation, excess gas, abnormal liver function tests, vomiting.
Nawseja, dijarea, ħalq xott, xufftejn xotti, telf ta ’ aptit, stitikezza, gass eċċessiv, testijiet tal- funzjoni tal- fwied b’ riżultat anormali, rimettar.
Dry skin, skin disorder, loss of hair, skin ulcer, acne, skin thickening, skin nodule, increased sweating.
Ġilda xotta, disturbi fil- ġilda, telf ta ’ xagħar, ulċera fil- ġilda, akne, ġilda li teħxien, għoqod fil- ġilda, żieda fl- għaraq.
Joint aches, bone pain, muscle aches.
Uġigħ fil- ġogi, uġigħ fl- għadam, uġigħ fil- muskoli.
Chills, abdominal pain, allergic reaction, infection.
Tertir ta ’ bard, uġigħ ta ’ żaqq, reazzjoni allerġika, infezzjoni.
Uncommon (can occur in less than 1 in 100 but in more than 1 in 1000 patients treated):
Mhux komuni (jistgħu jseħħu f’ anqas minn 1 minn kull 100 pazjenti, iżda f’ aktar minn 1 minn kull 1000 pazjent ikkurat):
Blood disorders, eosinophilia, leukocytosis, lymphocytosis, purpura, elevated and decreased numbers of blood platelets.
Disturbi fid- demm, eosinofilja, lewkoċitosi, limfoċitosi, purpura, numru għoli jew baxx ta ’ plejtlits fid- demm.
Overactive thyroid.
21 Tirojde attiva żżejjed.
Elevated bilirubin in the blood, impaired kidney function, gout, decreased HDL cholesterol.
Bilirubina għolja fid- demm, indeboliment tal- funzjoni tal- kliewi, gotta, tnaqqis fil- kolesterol HDL.
Agitation, difficulties with balance, depression, increased skin sensation on touching, abnormal nerve sensations, vertigo.
Aġitazzjoni, diffikultajiet fil- bilanċ, dipressjoni, żieda fis- sensazzjoni fil- ġilda meta tmiss xi ħaġa, sensazzjonijiet anormali tan- nervaturi, sturdament.
Abnormal vision, blurred vision, inflammation of the eye lids, cataract, inflammation of the white part of the eye, lesion of the cornea of the eye, ear disorder, defect in field of vision.
Vista anormali, vista mċajpra, infjammazzjoni ta ’ tebqet il- għajnejn, katarretti, infjammazzjoni tal - parti l- bajda ta ’ l- għajnejn, leżjoni tal- kornea ta ’ l- għajnejn, disturbi fil- widnejn, difett fil- kamp tal - vista.
Swelling, bleeding, high blood pressure, fast heart rate, visible vein enlargement, dilation of blood vessels.
Nefħa, ħruġ ta ’ demm, pressjoni tad- demm għolja, rata mgħaġġla ta ’ taħbit tal- qalb, tkabbir viżibbli tal- vini, twessigħ tal- vini/ arterji.
Gastrointestinal disorder, liver failure, inflammation of the pancreas.
Disturbi gastrointestinali, insuffiċjenza tal- fwied, infjammazzjoni tal- pankreas.
Changes in hair, herpes simplex, nail disorder, pustular rash, serous drainage, skin discoloration.
Tibdil fix- xagħar, herpes simplex, disturbi fid- dwiefer, raxx bil- ponot, ħruġ ta ’ likwidu qisu serum, tibdil fil- kulur tal- ġilda.
20 Muscle weakness.
Dgħjufija fil- muskoli.
Proteins in urine, abnormal kidney function.
Proteini fl- awrina, funzjoni anormali tal- kliewi.
Back pain, skin infection, fever, parasitic infection, abnormal laboratory test, disorder of mucous membrane, tumour.
Uġigħ fid- dahar, infezzjoni tal- ġilda, deni, infezzjoni parassitika, test tal- laboratorju b’ riżultat anormali, disturb tal- membrana mukuża, tumur.
Rare fatal side effects are acute inflammation of the pancreas, bleeding in the head, and liver failure.
Effetti sekondarji rari fatali huma infjammazzjoni akuta tal- pankreas, ħruġ ta ’ demm fir- ras, u insuffiċjenza tal- fwied.
If any of the side effects gets serious, or if you notice any side effects not mentioned in this leaflet, tell your doctor or pharmacist.
Jekk xi wieħed mill- effetti sekondarji jiggrava, jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, għid lit- tabib jew lill- ispiżjar tiegħek.
HOW TO STORE TARGRETIN
KIF TAĦŻEN TARGRETIN
What Targretin contains
X’ fih Targretin
Each Targretin capsule contains 75 mg of the active substance bexarotene.
Kull kapsula Targretin fiha 75 mg tas- sustanza attiva bexarotene.
The capsules also contain the other ingredients macrogol, polysorbate, povidone and butylated hydroxyanisole.
Il- kapsuli fihom ukoll is- sustanzi l - oħra macrogol, polysorbate, povidone u butylated hydroxyanisole.
The capsule shell consists of gelatin, sorbitol special-glycerine blend (glycerin, sorbitol, sorbitol anhydrides (1,4-sorbitan), mannitol and water), titanium dioxide (E171) and printing ink (SDA 35A alcohol (ethanol & ethyl acetate), propylene glycol (E1520), iron oxide black (E172), polyvinyl acetate phthalate, purified water, isopropyl alcohol, macrogol 400, ammonium hydroxide 28%)
Il- qoxra tal- kapsula tikkonsisti minn gelatin, sorbitol special- glycerine blend (glycerin, sorbitol, sorbitol anhydrides (1, 4- sorbitan), mannitol u ilma), titanium dioxide (E171) u linka ta ’ l- istampar (SDA 35A alcohol (ethanol u ethyl acetate), propylene glycol (E1520), iron oxide black (E172), polyvinyl acetate phthalate, purified water, isopropyl alcohol, macrogol 400, ammonium hydroxide 28%)
What Targretin looks like and contents of the pack
Id- dehra ta ’ Targretin u l- kontenuti tal- pakkett
Targretin is available as soft capsules for oral use in a white plastic bottle containing 100 capsules.
Targretin hu disponibbli bħala kapsuli rotob biex jittieħdu mill- ħalq, fi flixkun tal- plastik abjad li fih 100 kapsula.
Marketing Authorisation Holder Eisai Ltd.
22 Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq Eisai Ltd.
Manufacturer Eisai Manufacturing Limited Mosquito Way Hatfield Hertfordshire AL10 9SN United Kingdom
Manifattur Eisai Manufacturing Limited Mosquito Way Hatfield Hertfordshire AL10 9SN Ir- Renju Unit
21 For any information about this medicine please contact the local representative of the Marketing Authorisation Holder:
Għal kull tagħrif dwar din il- mediċina, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq:
Nowogrodzka PL – 02- 014 Warszawa LENGYELORSZÁG Tel: +48(0)22 50 40 890
Nowogrodzka PL – 02 - 014 Warszawa LENGYELORSZÁG Tel: +48( 0) 22 50 40 890
Nowogrodzka PL – 02- 014 Warszawa POLSKA Tel: +48(0)22 50 40 890
Nowogrodzka PL – 02 - 014 Warszawa POLSKA Tel: +48( 0) 22 50 40 890
Mosquito Way Hatfield Hertfordshire AL10 9SN RENJU UNIT Tel: +44 (0)20 8600 1400
Mosquito Way Hatfield Hertfordshire AL10 9SN UNITED KINGDOM Tel: +44 (0) 20 8600 1400
Nowogrodzka PL – 02- 014 Warszawa POOLA Tel: +48(0)22 50 40 890
Nowogrodzka DEUTSCHLAND PL – 02 - 014 Warszawa Tel: +49 (0) 89 89 55 70 0 POOLA Tel: +48( 0) 22 50 40 890
Nowogrodzka PL – 02- 014 Warszawa Tel: +48(0)22 50 40 890
Nowogrodzka PL – 02 - 014 Warszawa Tel: +48( 0) 22 50 40 890
Detailed information on this medicine is available on the European Medicines Agency web site: http: / /www. emea. europa. eu/.
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropea dwar il - Mediċini (EMEA): http: // www. emea. europa. eu /.
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FIR- RIGWARD TA ’ L- UŻU MINGĦAJR PERIKLU U EFFETTIV TAL- PRODOTT MEDIĊINALI LI GĦANDHOM JITWETTQU MILL- ISTATI MEMBRI
1 CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE ADDRESSED TO THE MEMBER STATES
1 KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FIR- RIGWARD TA ’ L- UŻU MINGĦAJR PERIKLU U EFFETTIV TAL- PRODOTT MEDIĊINALI LI GĦANDHOM JIĠU INDIRIZZATI LILL- ISTATI MEMBRI
The MAH shall ensure that prior to launch, all doctors who intend to prescribe Tasigna, and all pharmacists who may dispense Tasigna, are provided with a healthcare professional information pack containing the following: • Educational brochure • Summary of Product Characteristics (SPC) and Package Leaflet and Labelling
L- MAH għandu jiżgura li qabel ma joħroġ fis- suq, it- tobba kollha li jkollhom l- intenzjoni li jordnaw Tasigna, u li l- ispiżjara kollha li jistgħu jagħtu Tasigna, jingħataw pakkett ta ’ informazzjoni għall- professjonisti fil- qasam tas- saħħa li jkun fih dan li ġej: • Ktejjeb edukattiv • Sommarju tal- Karatteristiċi tal- Prodott (SPC) u Fuljett ta ’ Tagħrif u Tikketta
Key elements to be included in the educational brochure
Punti ewlenin li għandhom jiġu inklużi fil- ktejjeb edukattiv
• Brief background on Tasigna, its authorised indication and posology • Information on the cardiac risks associated with the use of Tasigna o That Tasigna can cause prolongation of the QT interval and that patients at risk of arrythmia, especially torsade de pointes, should not be prescribed Tasigna. o The need to avoid co-prescription with any other medicines that might prolong the QT interval o Caution in prescribing to patients with a history of or risk factors for coronary heart disease o That Tasigna may cause fluid retention, cardiac failure and pulmonary oedema
• Tagħrif fil- qosor fuq Tasigna, u l- indikazzjoni u l- pożoloġija awtorizzati għaliha. • Informazzjoni dwar ir- riskji kardijaċi assoċjati ma ’ Tasigna o Li Tasigna tista ’ jtawwal l- intervall QT u li pazjenti li għandhom riskju ta ’ arritmija, l- aktar torsade de pointes, m’ għandhomx jingħataw riċetti għal Tasigna. o Il- bżonn li jiġi evitat li jiġu ordnati flimkien kwalunkwe mediċini oħrajn li jistgħu jtawwlu l- intervall QT o Attenzjoni meta tiġi ordnata lill- pazjenti li fil- passat kellhom jew għandhom fatturi ta’ riskju għall- mard koronarju tal- qalb o Li Tasigna tista ’ tikkawża ritenzjoni ta ’ fluwidi, insuffiċjenza tal- qalb u edema pulmonari
• That Tasigna is metabolised by CYP3A4 and that strong inhibitors or inducers of this enzyme may significantly affect exposure to Tasigna. o That inhibitors may increase the potential for adverse drug reactions in particular QT interval prolongation. o To warn patients about OTC medicines in particular St John’ s Wort
John’ s Wort
• The need to inform patients about the effects of food on Tasigna o Not to eat within two hours before and one hour after taking Tasigna o The need to avoid foods such as grapefruit juice which inhibit CYP3A4 enzymes
• Il- bżonn li jinforma l- pazjent dwar l- effetti ta ’ l- ikel fuq Tasigna o Sabiex ma jieklux fi żmien sagħtejn qabel u siegħa wara li jieħdu Tasigna o Il- bżonn li jevitaw ikel bħall- meraq tal- grejpfrut li jinibixxu l- enzimi CYP3A4
What is Tasigna?
X’ inhi TASIGNA?
Tasigna is a medicine containing the active substance nilotinib.
TASIGNA hija mediċina li fiha s- sustanza attiva nilotinib.
It is available as pale yellow capsules (200 mg).
Hija disponibbli f’ pilloli sofor ċari (200 mg).
What is Tasigna used for?
Għalxiex jintuża TASIGNA?
Tasigna is used to treat adults with chronic myelogenous leukaemia (CML), a type of cancer of the white blood cells where granulocytes (a type of white blood cell) start growing out of control.
Tasigna hija wżata sabiex jiġu trattati adulti b’ lewkimja miloġenja kronika (CML), tip ta ’ kanċer taċ - ċelloli bojod tad- demm fejn il- granulocytes (tip ta ’ ċelloli bojod tad- demm) jibdew jikbru bla kontroll.
It is used when the patient is ‘ Philadelphia chromosome positive’ (Ph+), which means that some of the patient ’ s genes have re-arranged themselves to form a special chromosome called the Philadelphia chromosome.
Huwa wżat meta l- pazjent isofri minn ‘ Kromożoma pożittiva Philadelphia ‘ (Ph+), li jfisser li xi ġene tal- pazjenti inbidlu f’ format sabiex jifformaw kromożoma speċjali msejjħa l- kromożoma ta ’ Philadelphia.
This chromosome produces an enzyme that leads to the development of leukaemia.
Din il- kromożoma tipproduċi enżima li twassal għall- iżvilupp tal- lewkemja.
Tasigna is used in the ‘ chronic’ and ‘ accelerated ’ phases of CML.
Tasigna hija wżata f’ fażijiet ‘ kroniċi ’ u ‘ aċċellerati ’ tas- CML.
There is no information available on its effectiveness in patients whose disease is in ‘ blast crisis’ (another phase of CML).
M’ hemmx informazzjoni disponibbli dwar l - effettività f’ pazjenti li l- marda tagħhom hija fi stadju ta ’ ‘ blast crisis ’ (fażi oħra tas- CML).
Tasigna is used when patients cannot tolerate other treatments including imatinib (another anticancer medicine), or when their disease is not responding to them.
Tasigna hija wżata meta pazjenti ma jistgħux jittolleraw trattamenti oħrajn inklużi imatinib (mediċina antikanċeroġena oħra), jew meta l- marda tagħhom ma tkunx qed tirrispondi għalihom.
Because the number of patients with CML is low, the disease is considered ‘ rare’, and Tasigna was designated an ‘ orphan medicine ’ (a medicine used in rare diseases) on 26 May 2006.
Billi l- għadd ta 'pazjenti li għandhom CML huwa wieħed baxx, il- marda hi meqjusa' rari 'u Tasigna ġie propost bħala' mediċina orfni '(mediċina użata fil- mardiet rari) fis- 26 ta' Mejju 2006.
How is Tasigna used?
Kif tintuża Tasigna?
Treatment with Tasigna should be initiated by a doctor who has experience in the diagnosis and treatment of CML.
It- trattament b' Tasigna għandu jinbeda minn tabib li jkollu esperjenza fit- trattament fid- dijanjożi u t - trattament tas- CML.
The recommended dose is two capsules twice a day, for as long as the patient continues to benefit.
Id- doża rakkommandata hija żewġ kapsuli darbtejn kuljum, għal żmien sakemm il- pazjent ikun qed jibbenefika.
The dose should be reduced or treatment interrupted if the patient has certain side effects affecting the blood.
Id- doża għandha titnaqqas jew it- trattament jiġi mwaqqaf jekk il - pazjent għandu ċerti effetti sekondarji li jaffettwaw id- demm.
The two doses should be taken around 12 hours apart.
Iż- żewġ dożi għandhom jiġu meħuda madwar 12 – il siegħa bogħod minn xulxin.
The capsules are swallowed whole with a glass of water, without eating anything for two hours before and one hour after each dose.
Il- kapsuli għandhom jiġu miblugħin sħaħ ma ’ tazza ilma, mingħajr ma jiġi mikul xejn għal sagħtejn qabel u siegħa wara kull doża.
Tasigna can be given with certain other medicines if appropriate.
Tasigna tista ’ tingħata ma ’ ċerti mediċini oħrajn jekk ikun xieraq.
It should be used with caution in patients who have severe problems with their liver or certain heart problems.
Għandu jintuża b’ kawtela f’ pazjenti li jkollhom problemi severi fil- fwied jew ċerti problemi tal- qalb.
See the Summary of Product Characteristics (also part of the EPAR) for more information.
Ara s- Sommarju tal - Karatteristiċi tal- Prodott (ukoll parti mill- EPAR) għad- detallji kollha.
How does Tasigna work?
Kif jaħdem Tasigna?
The active substance in Tasigna, nilotinib, belongs to a group of medicines called protein kinase inhibitors.
Is- sustanza attiva f’ Tasigna, nilotinib, tappartjeni għal grupp ta ’ mediċini msejjħa inibituri protein kinase.
These compounds act by blocking types of enzymes known as protein kinases.
Dawn il- kompawnda jaġixxu billi jibblokaw tipi ta ’ enżimi magħrufa bħala protein kinases.
Nilotinib acts by blocking the protein kinase called ‘ Bcr-Abl’ kinase.
Nilotinib jaġixxi billi jibblokka l- proteina kinase msejjħa ‘ Bcr- Abl ’ kinase.
This enzyme is produced by leukaemia 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Din l- enżima hija prodotta 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged cells, and causes them to multiply uncontrollably.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged miċ- ċelloli lewkemja u kkawżata minnhom sabiex timmultiplika bla kontroll.
By blocking Bcr-Abl kinase, Tasigna helps to control the spread of leukaemia cells.
Billi tiġi blokkata l- Bcr - abl kinase, Tasigna tgħin sabiex tikkontrolla l- firxa taċ- ċelloli lewkemja.
How has Tasigna been studied?
Kif ġiet studjata Tasigna?
The effects of Tasigna were first tested in experimental models before being studied in humans.
L- effetti ta ’ Tasigna għall- ewwel ġew ittestjati f’ mudelli esperimentali qabel ma ’ ġew studjati fil - bniedem.
The effectiveness of Tasigna was studied in two main studies involving a total of 439 patients with CML, who could not tolerate imatinib or whose disease had stopped responding to it.
L- effettività ta ’ Tasigna kienet studjata f’ żewġ studji prinċipali li jinvolvu total ta ’ 439 pazjenti bis - CML, li ma jistgħux jittolleraw l- imatinib jew li l- marda tagħhom ma baqgħetx tirrispondi għaliha.
Tasigna was not compared to any other treatment.
Tasigna ma ġietx paragunata ma ’ ebda trattament ieħor.
The first study included a total of 320 patients whose disease was in the ‘ chronic phase’, three quarters of whom had stopped responding to imatinib.
L- ewwel studju inkluda total ta ’ 320 pazjent li l- marda tagħhom kienet f ’ ‘ fażi kronika ’, tliet kwarti minnhom ma baqgħux jirrispondu għal imatinib.
Its main measure of effectiveness was the proportion of patients who had had a ‘ major cytogenetic response’ (the proportion of the patient’ s white blood cells that contained the Philadelphia chromosome had fallen to below 35%).
Il- miżura prinċipali ta ’ effettivit kienet il- proporzjon ta ’ pazjenti li kellhom ‘ rispons maġġuri ċitoġenetiku ’ (il- proporzjoni taċ- ċelloli bojod tal- pazjent li fihom il- kromożoma Philadelphia waqgħu taħt il- 35%).
The second study included a total of 119 patients whose disease was in the ‘ accelerated phase’, four fifths of whom had stopped responding to imatinib.
It- tieni studju inkluda total ta ’ 119 pazjent li l - marda tagħhom kienet f ’ ‘ fażi aċċelerata ’, erba ’ kwinti minnhom ma baqgħux jirrispondu għal imatinib.
Its main measure of effectiveness was the proportion of patients who had had a ‘ haematological response’ (a return to normal of the number of white cells in the blood).
Il- miżura ta ’ effettività tagħha kienet il- proporzjoni ta ’ pazjenti li kellhom ‘ rispons ħematoloġiku ’ (in- numru ta ’ ċelloli bojod fid- demm reġgħa lura għan- normal).
What benefit has Tasigna shown during the studies?
Liema benefiċċju wriet Tasigna waqt l- istudji li ġew mwettqa?
In the study of chronic phase CML, 156 (49%) of the 320 patients had a major cytogenetic response, after having received Tasigna for an average of 341 days (around eleven months).
Fl- istudju ta ’ fażi kronika CML, 156( 49%) tat- 320 pazjenti kellhom rispons maġġuri ċytoġenetiku, wara li rċevew Tasigna għal medja ta ’ 341 jum (madwar ħdax – il xahar).
In the study of accelerated phase CML, 50 (42%) of the 119 patients had a haematological response, after having received Tasigna for an average of 202 days (around seven months).
Fl- istudju ta ’ fażi aċċellerata CML, 50( 42%) tal- 119 pazjenti kellhom rispons maġġuri ċitoġenetiku, wara li rċevew Tasigna għal medja ta ’ 202 jum (madwar seba ’ xhur).
In both studies, Tasigna had a similar effect in patients who could not tolerate imatinib and those whose disease had stopped responding to it.
Fiż- żewġ studji, Tasinga kellha effett simili f’ pazjenti li ma jistgħu jittolleraw imatinib u dawk li l- marda tagħhom waqfet tirrispondi għaliha.
What is the risk associated with Tasigna?
X’ inhu r- riskju assoċjat ma ’ Tasigna?
The most common side effects with Tasigna (seen in more than 1 patient in 10) are thrombocytopenia (low blood platelet counts), neutropenia (low white blood cell counts), anaemia (low red blood cell counts), headache, nausea (feeling sick), constipation, diarrhoea, rash, pruritus (itching), fatigue (tiredness) and increased blood levels of lipase (an enzyme produced by the pancreas).
L- effetti sekondarji ta ’ Tasigna (dehru f’ madwar pazjent 1 u 10 pazjenti f’ 100) huma thrombocytopenja (tnaqqis fil- għadd ta ’ platelets fid- demm), neutropenja (tnaqqis fil- għadd ta ’ ċelloli bojod fid- demm), anemija (tnaqqis fil- għadd ta ’ ċelloli ħomor fid- demm), uġieħ ta ’ ras, nawżja (dardir), xedda, dijarrea, raxx, pruritus (ħakk), għejja kbira (għejja) u livelli għola ta ’ lipaż fid- demm (enżima prodotta mil- frixa).
For the full list of all side effects reported with Tasigna, see the Package Leaflet.
Għal- lista sħiħa ta 'l- effetti sekondarji rrapportati b' Tasigna, ara l- Fuljett ta' Tagħrif.
Tasigna should not be used in people who may be hypersensitive (allergic) to nilotinib or any of the other ingredients.
Tasigna m’ għandux jintuża f’ nies li huma sensittivi żżejjed (allerġiċi) għal nilotinib jew għal xi sustanza oħra tiegħu.
Why has Tasigna been approved?
Għaliex ġie approvata Tasigna?
The Committee for Medicinal Products for Human Use (CHMP) concluded that, even though it was not directly compared to any other treatment, the effectiveness of Tasigna had been demonstrated sufficiently and was the same as that of another medicine in the same class.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda, li għalkemm ma ġietx imqabbla direttament ma ’ xi trattament ieħor, l- effettività ta ’ Tasigna ġiet murija b’ mod suffiċjenti u kienet l- istess bħal dik ta ’ mediċina oħra fl- istess klassi.
The Committee decided that Tasigna’ s benefits are greater than its risks for the treatment of adults with chronic phase and accelerated phase Philadelphia chromosome positive CML with resistance or intolerance to prior therapy including imatinib.
Il- Kumitat iddeċieda li l - benefiċċji ta ’ Tasigna huma akbar mir- riskji tagħha għat- trattament ta ’ adulti b’ fażi kronika u b’ fażi aċċellerata b’ CML b’ kromożoma pożittiva Philadelphia b’ reżistenza jew intolleranza għal terapija ta ’ qabel inkluża imatinib.
The Committee recommended that Tasigna be given marketing authorisation.
Il- Kumitat irrakkomanda li Tasigna tingħata l- awtorizzazzjoni għat- tqegħid fis- suq.
Which measures are being taken to ensure the safe use of Tasigna?
X’ miżuri qed jittieħdu biex ikun żgurat l- użu sigur ta ’ Tasigna?
The company that makes Tasigna will provide an information pack in each Member State for doctors and pharmacists who will prescribe or dispense the medicine.
Il- kumpanija li tagħma Tasigna ser tipprovdi pakkett ta ’ informazzjoni f’ kull Stat Membru għal tobba u spiżjara li jippreskrivu jew jagħtu din il- mediċina.
The pack will remind them of how Tasigna should be used safely in patients.
Il- pakkett ser ifakkarhom kif Tasigna għandha tiġi wżata b’ mod sigur f’ pazjenti.
Other information about Tasigna:
Informazzjoni oħra dwar Tasigna:
The European Commission granted a marketing authorisation valid throughout the European Union for Tasigna to Novartis Europharm Limited on 19 November 2007.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq għal Tasigna valida fl- Unjoni Ewropea kollha lil Novartis Europharm Limited on 19 ta ’ Novembru 2007.
The summary of opinion of the Committee for Orphan Medicinal Products for Tasigna is available here.
Is- sommarju ta ’ l- opinjoni tal- Kumitat għal Prodotti Mediċinali Orfni għal Tasigna huwa disponibbli minn hawnhekk.
The full EPAR for Tasigna can be found here.
L- EPAR sħiħ għal Tasigna jista ’ jinstab hawnhekk.
Blister (PVC/ PVDC/ Al)
Folja (PVC/ PVDC/ Al)
Blister (PA/ Al/ PVC/ Al)
Folja (PA/ Al/ PVC/ Al)
112 capsules
112- il kapsula
Tasigna 200 mg hard capsules
Tasigna 200 mg kapsuli iebsin
One hard capsule contains 200 mg nilotinib (as hydrochloride monohydrate).
Kapsula iebsa waħda fiha 200 mg nilotinib (bħala hydrochloride monohydrate).
156.11 mg per capsule.
156. 11 mg għal kull kapsula.
White to slightly yellowish powder in light yellow opaque hard gelatin capsules, size 0 with red axial imprint “ NVR/ TKI”.
Trab abjad jagħti ftit fl- isfar f’ kapsuli sofor ċari opaki iebsin tal- ġelatina, daqs 0 b’ timbru aħmar ma ’ l - assi “ NVR/ TKI ”.
Tasigna is indicated for the treatment of adults with chronic phase and accelerated phase Philadelphia chromosome positive chronic myelogenous leukaemia (CML) with resistance or intolerance to prior therapy including imatinib.
Tasigna jintuża għall- kura ta ’ adulti fil- fażi kronika u l- fażi aċċellerata tal- lewkemija majeloġena kronika pożittiva għall- kromosoma ta ’ Filadelfja (CML) b’ reżistenza għal jew b’ intolleranza għal terapija li jkunu ngħataw qabel inkluż imatinib.
Efficacy data in patients with CML in blast crisis are not available.
Dejta dwar l- effikaċja f’ pazjenti b’ CML fi blast crisis mhijiex disponibbli.
Therapy should be initiated by a physician experienced in the diagnosis and the treatment of patients with CML.
It- terapija għandha tinbeda minn tabib b’ esperjenza fid- dijanjosi u l- kura ta ’ pazjenti b’ CML.
The recommended dose of Tasigna is 400 mg twice daily.
Id- doża rakkomandata ta ’ Tasigna hija 400 mg darbtejn kuljum.
Treatment should be continued as long as the patient continues to benefit.
Il- kura għandha tkompli sakemm il - pazjent jibqa ’ jikseb benefiċċju.
Tasigna should be taken twice daily approximately 12 hours apart and must not be taken with food.
Tasigna għandu jittieħed darbtejn kuljum madwar 12- il siegħa waħda mill- oħra u m’ għandux jittieħed ma ’ l- ikel.
No food should be consumed for 2 hours before the dose is taken and no food should be consumed for at least one hour after the dose is taken.
M’ għandux jittieħed ikel għal sagħtejn qabel ma tittieħed id- doża u m’ għandux jittieħed ikel sa siegħa wara li tittieħed id- doża.
Tasigna may be given in combination with haematopoietic growth factors such as erythropoietin or granulocyte colony-stimulating factor (G-CSF) if clinically indicated.
Tasigna jista ’ jingħata f’ kombinazzjoni ma ’ fatturi ta ’ tkabbir emopojetiċi bħal erythropoeitin jew fattur li jistimula l- kolonji tal- granuloċiti (G- CSF) jekk ikun indikat b’ mod kliniku.
Tasigna may be given with hydroxyurea or anagrelide if clinically indicated.
Tasigna jista ’ jingħata ma ’ hydroxyurea jew anagrelide jekk ikun indikat b’ mod kliniku.
Dose adjustments or modifications Tasigna may need to be temporarily withheld and/ or dose reduced for haematological toxicities (neutropenia, thrombocytopenia) that are not related to underlying leukaemia (see Table 1).
2 Tabella 1
2 Table 1
Aġġustamenti tad- doża għal newtropenja u tromboċitopenja
Dose adjustments for neutropenia and thrombocytopenia
ANC * < 1. 0 x 109/ l u/ jew għadd
Chronic phase CML at 400 mg twice daily
Fażi kronika CML
ANC* < 1.0 x 109/ l and/ or platelet counts < 50 x 109/ l
tal- plejtlits < 50 x 109/ l
If blood counts remain low, a dose reduction to 400 mg once daily may be required.
Jekk l- għadd tad- demm jibqa baxx, tnaqqis għal 400 mg darba kuljum jista ’ jkun meħtieġ.
Accelerated phase CML at 400 mg twice daily
Fażi aċċelerata CML
ANC* < 0.5 x 109/ l and/ or platelet counts < 10 x 109/ l
tal- plejtlits < 10 x 109/ l
If blood counts remain low, a dose reduction to 400 mg once daily may be required.
Jekk l- għadd tad- demm jibqa baxx, tnaqqis tad- doża għal 400 mg darba kuljum jista ’ jkun meħtieġ.
*ANC = absolute neutrophil count
* ANC = għadd assolut tan- newtrofili
If clinically significant moderate or severe non-haematological toxicity develops, dosing should be interrupted, and may be resumed at 400 mg once daily once the toxicity has resolved.
Jekk tiżviluppa tossiċità mhux ematoloġika klinikament sinifikanti moderata jew severa, id- dożi għandhom jitwaqqfu, u jistgħu jerġgħu jitkomplew b’ 400 mg darba kuljum ladarba t- tossiċità tgħaddi.
If clinically appropriate, re-escalation of the dose to 400 mg twice daily should be considered.
Jekk ikun klinikament xieraq, jista ’ jiġi kkonsidrat li d- doża terġa tiżdied għal 400 mg darbtejn kuljum.
Elevated serum lipase:
Lipase tas- serum għoli:
For Grade 3-4 serum lipase elevations, doses should be reduced to 400 mg once daily or interrupted.
Għal żiediet fis- serum lipase ta ’ Grad 3- 4, id- dożi għandhom jitnaqqsu għal 400 mg darba kuljum jew imwaqqfa.
Serum lipase levels should be tested monthly or as clinically indicated.
Il- livelli ta ’ lipase fis- serum għandhom jiġu eżaminati kull xahar jew kif ikun indikat b’ mod kliniku.
Elevated bilirubin and hepatic transaminases:
Il- bilirubin u l- livelli ta ’ transaminases tal- fwied:
For Grade 3-4 bilirubin elevations, doses should be reduced to 400 mg once daily or interrupted.
Għal żiediet tal- bilirubin ta ’ Grad 3- 4, id- dożi għandhom jitnaqqsu għal 400 mg darba kuljum jew imwaqqfa.
Bilirubin and hepatic transaminases levels should be tested monthly or as clinically indicated.
Il- livelli ta ’ bilirubin u transaminases tal- fwied għandhom jiġu eżaminati kull xahar jew kif ikun indikat b’ mod kliniku.
If a dose is missed the patient should not take an additional dose, but take the usual prescribed next dose.
Jekk tinqabeż doża, il- pazjent m’ għandux jieħu doża oħra, iżda jieħu d- doża tas- soltu li jmiss kif ordnat.
Children and adolescents Tasigna is not recommended for use in children and adolescents below 18 years of age due to a lack of data on safety and efficacy (see section 5.1).
Tfal u adolexxenti Tasigna mhux irrakkomandat għall- użu fit- tfal u adolexxenti ta ’ taħt it- 18- il sena peress li m’ hemmx dejta dwar is- sigurtà u l- effikaċja (ara sezzjoni 5. 1).
Elderly patients Approximately 30% of subjects in clinical studies were 65 years of age or over.
Pazjenti anzjani Madwar 30% ta ’ l- individwi fi studji kliniċi kellhom 65 sena jew aktar.
No major differences were observed for safety and efficacy in patients ≥ 65 years of age as compared to adults aged 18 to 65 years.
Ma deherx li kien hemm differenzi kbar fis- sigurtà u l- effikaċja f’ pazjenti ≥65 sena kif imqabbla ma ’ adulti ta ’ bejn 18 u 65 sena.
Patients with renal impairment Clinical studies have not been performed in patients with impaired renal function.
Pazjenti b’ indeboliment renali Ma sarux studji kliniċi f’ pazjenti b’ indeboliment tal- funzjoni renali.
Since nilotinib and its metabolites are not renally excreted, a decrease in total body clearance is not anticipated in patients with renal impairment.
Peress li nilotinib u l- metaboli tiegħu ma jitkeċċewx b’ mod renali, mhux mistenni li jkun hemm tnaqqis fit- tneħħija totali mill- ġisem f’ pazjenti b’ indeboliment renali.
Patients with hepatic impairment Tasigna has not been investigated in patients with hepatic impairment.
Pazjenti b’ indeboliment epatiku Tasigna ma kienx investigat f’ pazjenti b’ indeboliment epatiku.
Patients with hepatic impairment should be treated with caution (see section 4.4).
Pazjenti b’ indeboliment epatiku għandhom jingħataw il- kura b’ attenzjoni (ara sezzjoni 4. 4).
Cardiac disorders In clinical studies, patients with uncontrolled or significant cardiac disease (e. g. recent myocardial infarction, congestive heart failure, unstable angina or clinically significant bradycardia) were excluded.
3 Disturbi tal- qalb Fi studji kliniċi, pazjenti b ’ mard kardijaku mhux kontrollat jew sinifikanti (eż infart mijokardijaku reċenti, insuffiċjenza tal- qalb konġestiva, anġina mhux stabbli jew bradikardija klinikament sinifikanti) kienu esklużi.
Caution should be exercised in patients with relevant cardiac disorders (see section 4.4).
Għandha ssir attenzjoni f’ pazjenti b’ disturbi tal- qalb rilevanti (ara sezzjoni 4. 4).
Myelosuppression Treatment with Tasigna is associated with (National Cancer Institute Common Toxicity Criteria grade 3-4) thrombocytopenia, neutropenia and anaemia.
Majelosuppressjoni Il- kura b’ Tasigna hija assoċjata ma ’ (Kriterji dwar it- Tossiċità Komuni ta ’ L- Istitut Nazzjonali tal - Kanċer grad 3- 4) tromboċitopenja, newtropenja u anemija.
Occurrence is more frequent in patients with accelerated-phase CML.
Dawn iseħħu aktar ta ’ spiss f’ pazjenti li jkunu fil- fażi- aċċellerata CML.
Complete blood counts should be performed every two weeks for the first 2 months and then monthly thereafter, or as clinically indicated.
L- għadd komplet tad- demm għandu jsir kull ġimgħatejn għall- ewwel xahrejn u imbagħad kull xahar minn hemm ‘ l quddiem, jew hekk kif ikun indikat b’ mod kliniku.
Myelosuppression was generally reversible and usually managed by withholding Tasigna temporarily or dose reduction (see section 4.2).
Il - majelosuppressjoni kienet ġeneralment riversibbli u normalment setgħet tiġi kkontrollata billi titwaqqaf Tasigna b’ mod temporanju jew bill titnaqqas id- doża (ara sezzjoni 4. 2).
QT prolongation Tasigna has been shown to prolong cardiac ventricular repolarisation as measured by the QT interval on the surface ECG in a concentration-dependent manner.
Titwil tal- QT Intwera li Tasigna jtawwal ir- ripolarizzazzjoni ventrikulari kardijaka hekk kif imkejjel mill- intervall QT fuq l- ECG tas- superfiċi b’ mod dipendenti mill- konċentrazzjoni.
In the Phase II study in imatinib-resistant and intolerant CML patients in chronic and accelerated phase, the change from baseline in mean time-averaged QTcF interval at steady state was 6 and 8 msec, respectively.
Fl- istudju tal- Fażi II f’ pazjenti reżistenti għal imatinib u CML intolleranti fil- fażi kronika u aċċelerata, il- bidla mill- linja bażi għall- medja tal- ħin medju ta ’ l- intervall QTcF fi stat fiss kien 6 u 8 msek, rispettivament.
QTcF of > 500 msec was observed in < 1% of these patients.
QTcF ta ’ > 500 msek dehret f ’ < 1% ta ’ dawn il- pazjenti.
No episodes of torsade de pointes were observed in clinical studies.
Ma dehrux episodji ta ’ torsade de pointes fl- istudji kliniċi.
In a healthy volunteer study with exposures that were comparable to the exposures observed in patients, the time-averaged mean placebo-subtracted QTcF change from baseline was 7 msec (CI ± 4 msec).
Fi studju fuq voluntiera b’ saħħithom li kellhom esponimenti li setgħu jitqabblu ma ’ l- esponimenti li dehru f’ pazjenti, il- bidla mill- linja bażi tal- QTcF imnaqqas mill- ħin medju tal- medja tal- plaċebo kien 7 msek (CI ±4 msek).
No subject had a QTcF > 450 msec.
L- ebda individwu ma kellu QTcF > 450 msek.
Additionally, no clinically relevant arrhythmias were observed during the conduct of the trial.
Minbarra hekk, ma dehru l- ebda arritmiji ta ’ rilevanza klinika waqt li kienet għaddejja l- prova.
In particular, no episodes of torsade de pointes (transient or sustained) were observed.
B’ mod partikolari, l- ebda episodju ta ’ torsade de pointes (mumentanju jew fit- tul) ma deher.
Significant prolongation of the QT interval may occur when nilotinib is inappropriately taken with strong CYP3A4 inhibitors and/ or medicinal products with a known potential to prolong QT, and/ or food (see section 4.5).
Jista ’ jkun hemm titwil sinifikanti fl- intervall QT meta nilotinib jittieħed b’ mod mhux xieraq ma ’ impedituri CYP3A4 qawwija u/ jew prodotti mediċinali li huma magħrufa li jistgħu jtawwlu l- QT, u/ jew l- ikel (ara sezzjoni 4. 5).
The presence of hypokalaemia and hypomagnesaemia may further enhance this effect.
Jekk ikun hemm ipokalimja jew ipomagneżimja, dan l- effett jista ’ jkun aktar qawwi.
Prolongation of the QT interval may expose patients to the risk of fatal outcome.
Titwil ta ’ l- intervall QT jista ’ jesponi l- pazjenti għal riskju li jwassal għal mewt.
Tasigna should be used with caution in patients who have or who are at significant risk of developing prolongation of QTc, such as those:
Tasigna għandha tintuża b’ attenzjoni f’ pazjenti li għandhom jew qegħdin f’ riskju sinifikanti li jiżviluppaw titwil tal- QTc, bħal dawk: − bi QT imtawwal b’ mod konġenitu. − b’ mard kardijaku mhux kontrollat jew sinifikanti inkluż infart mijokardijaku reċenti, insuffiċjenza tal- qalb konġestiva, anġina instabbli jew bradikardija klinikament sinifikanti. − li jkunu qed jiehħdu prodotti mediċinali kontra l- arritmiji tal- qalb jew sustanzi oħra jwasslu għal QT mtawwal.
Close monitoring for an effect on the QTc interval is advisable and a baseline ECG is recommended prior to initiating therapy with Tasigna and as clinically indicated.
Monitoraġġ mill- qrib għal effett fuq l- intervall QTc huwa konsiljat u ECG tal- linja bażi huwa rakkomandat qabel ma tinbeda terapija b’ Tasigna hekk kif ikun indikat b’ mod kliniku.
Hypokalaemia or hypomagnesaemia must be corrected prior to Tasigna administration and should be monitored periodically during therapy.
Ipokalimja jew ipomagneżimja għandhom jiġu kontrollati qabel tingħata Tasigna u għandhom jiġu monitorati perjodikament waqt it- terapija.
Interactions with other medicinal products The administration of Tasigna with agents that are strong CYP3A4 inhibitors (including, but not limited to, ketoconazole, itraconazole, voriconazole, moxifloxacin, clarithromycin, telithromycin, ritonavir) should be avoided.
4 Interazzjonijiet ma ’ prodotti mediċinali oħrajn L- għotja ta ’ Tasigna ma ’ sustanzi li huma inibituri qawwija ta ’ CYP3A4 (inkluż, iżda mhux biss, ketoconazole, itraconazole, voriconazole, moxifloxacin, clarithromycin, telithromycin, ritonavir) għandha tiġi evitata.
Should treatment with any of these agents be required, it is recommended that therapy with Tasigna be interrupted if possible (see section 4.5).
Jekk ikun meħtieġ li tingħata kura b’ xi wieħed minn dawn is- sustanzi, huwa rakkomandat li jekk ikun possibli l- kura b’ Tasigna titwaqqaf (ara sezzjoni 4. 5).
If transient interruption of treatment with Tasigna is not possible, close monitoring of the individual for prolongation of the QT interval is indicated (see sections 4.2, 4.5 and 5.2).
Jekk ma jkunx possibli li l- kura b’ Tasigna titwaqqaf għal xi żmien, huwa indikat li jkun hemm monitoraġġ mill- qrib għal titwil ta ’ l- intervall QT (ara sezzjonijiet 4. 2, 4. 5 u 5. 2).
Concomitant use of Tasigna with medicinal products that are potent inducers of CYP3A4 (e. g. phenytoin, rifampicin, carbamazepine, phenobarbital and St.
L- użu fl- istess ħin ta ’ Tasigna ma ’ prodotti mediċinali li jinduċu b’ mod potenti s- CYP3A4 (eż phenytoin, rifampicin, carbamazepine, phenobarbital and St.
John’ s Wort) is likely to reduce exposure to nilotinib to a clinically relevant extent.
John’ s Wort) x’ aktarx inaqqas l - esponiment għal nilotinib għal punt klinikament rilevanti.
Therefore, in patients receiving Tasigna, coadministration of alternative therapeutic agents with less potential for CYP3A4 induction should be selected (see section 4.5).
Għalhekk, f’ pazjenti li qed jirċievu Tasigna, għandhom jintgħażlu biex jingħataw fl- istess ħin sustanzi alternattivi b’ potenzjal inqas li jinduċu s - CYP3A4 (ara sezzjoni 4. 5).
Suppression of gastric acid secretion might result in lower exposure to nilotinib.
Soppressjoni tas- sekrezzjoni ta ’ l- aċidu gastriku jista ’ jwassal għal esponiment aktar baxx għal nilotinib.
Therefore, concomitant use of antacids, H2 blockers, or proton pump inhibitors with Tasigna is not recommended
Għalhekk, l- użu fl- istess ħin ta ’ antaċidi, imblukkaturi H2, jew inibituri tal- pompi tal- protoni ma ’ Tasigna mhux rakkomandat (ara sezzjoni 4. 5).
Food effect The bioavailability of nilotinib is increased by food.
Effett ta ’ l- ikel Il- biodisponibilità ta ’ nilotinib tiżdied bl- ikel.
Tasigna should not be taken in conjunction with food (see sections 4.2 and 4.5) and should be taken 2 hours after a meal.
Tasigna m’ għandux jingħata ma ikel (ara sezzjonijiet 4. 2 u 4. 5) u għandu jittieħed sagħtejn wara ikla.
No food should be consumed for at least one hour after the dose is taken.
M’ għandux jittieħed ikel għal mill- anqas siegħa wara li tittieħed doża.
Grapefruit juice and other foods that are known to inhibit CYP3A4 should be avoided.
Il- meraq tal- grejpfrut u ikel ieħor magħruf li jinibixxi CYP3A4 għandu jiġi evitat.
Hepatic impairment Tasigna has not been investigated in patients with hepatic impairment.
Indeboliment epatiku Tasigna ma ġiex investigat f’ pazjenti b’ indeboliment epatiku.
Clinical studies have excluded patients with alanine transaminase (ALT) and/ or aspartate transaminase (AST) > 2.5 (or > 5, if related to disease) times the upper limit of the normal range and/ or total bilirubin > 1.5 times the upper limit of the normal range.
Studji kliniċi eskludew pazjenti b’ alanine transaminase (ALT) u/ jew aspartate transaminase (AST) > 2. 5 (jew > 5, jekk relatat mal - marda) darbiet aktar fuq il- limitu ta ’ fuq tal- medda normali u/ jew bilirubin totali ta ’ > 1. 5 darbiet aktar fuq il- limitu ta ’ fuq tal- medda normali.
Metabolism of nilotinib is mainly hepatic.
Il- metaboliżmu ta ’ nilotinib huwa fil- parti l- kbira epatiku.
Patients with hepatic impairment might therefore have increased exposure to nilotinib and should be treated with caution (see section 4.2).
Pazjenti b’ indeboliment epatiku għalhekk jista ’ jkollhom esponiment akbar għal nilotinib u għandhom jiġu kkurati b’ attenzjoni (ara sezzjoni 4. 2).
Serum lipase Elevation in serum lipase has been observed.
Lipase fis- serum Żiediet tal- lipase fis- serum dehru.
Caution is recommended in patients with previous history of pancreatitis.
L- attenzjoni hija rakkomandata f’ pazjenti li fil- passat kellhom pankrejatite.
Lactose Tasigna capsules contain lactose.
Lactose Il- kapsuli Tasigna fihom lactose.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Pazjenti li għandhom problemi ereditarji rari ta ’ intolleranza għall - galactose, nuqqas ta ’ Lapp lactase jew malassorbiment tal- glucose- galactose m’ għandhomx jieħdu dan il- prodott mediċinali.
Substances that may increase nilotinib serum concentrations Nilotinib is mainly metabolised in the liver and is also a substrate for the multi-drug efflux pump, P- glycoprotein (Pgp).
Sustanzi li jistgħu jgħollu l- konċentrazzjoni ta ’ nilotinib fis- serum Nilotinib jiġi metabolizzat fil- parti l- kbira fil- fwied u huwa sottostrat ukoll għall- pompa ta ’ effluss ta ’ ħafna mediċini glikoproteina- P (Pgp).
Therefore, absorption and subsequent elimination of systemically absorbed nilotinib may be influenced by substances that affect CYP3A4 and/ or Pgp.
Għalhekk, l- assorbiment u l- eliminazzjoni sussegwenti ta ’ nilotinib li jkun ġie assorbit b’ mod sistemiku jista ’ jiġi influwenzat minn sustanzi li jaffettwaw is - CYP3A4 u/ jew Pgp.
The exposure to nilotinib in healthy subjects was increased 3-fold when co-administered with the strong CYP3A4 inhibitor ketoconazole.
L- esponiment għal nilotinib f’ individwi b’ saħħithom żdied bi 3 darbiet meta ngħata flimkien ma ’ inibitur qawwi tas- CYP3A4, ketoconazole.
Concomitant treatment with strong CYP3A4 inhibitors, including ketoconazole, itraconazole, voriconazole, ritonavir, moxifloxacin, clarithromycin, and telithromycin, should therefore be avoided (see sections 4.2 and 4.4).
Il- kura fl- istess ħin ma ’ inibituri qawwija ta ’ CYP3A4, inklużi ketoconazole, itraconazole, voriconazole, ritonavir, moxifloxacin, clarithromycin, u telithromycin għalhekk għandha tiġi evitata (ara sezzjonijiet 4. 2 u 4. 4).
Increased exposure to nilotinib might also be expected with moderate CYP3A4 inhibitors.
Żieda fl - esponiment għal nilotinib jista ’ jkun mistenni wkoll b’ inibituri moderati tas- CYP3A4.
Alternative concomitant medications with no or minimal CYP3A4 inhibition should be considered.
Medikazzjonijiet oħra li ma jikkawżawx l- inibizzjoni ta ’ CYP3A4 jew jikkawżawh b’ mod minimu għandhom jitqiesu.
Substances that may decrease nilotinib serum concentrations Rifampicin, a potent CYP3A4 inducer, decreases nilotinib Cmax by 64% and reduces nilotinib AUC by 80%.
5 Sustanzi li jistgħu jnaqqsu l- konċentrazzjonijiet ta ’ nilotinib fis- serum Rifampicin, induttur CYP3A4 potenti, inaqqas nilotinib Cmax b’ 64% u inaqqas nilotinib AUC b’ 80%.
Rifampicin and nilotinib should not be used concomitantly.
Rifampicin u nilotinib m’ ghandhoms jintuzaw flimkien.
The concomitant administration of other medicinal products that induce CYP3A4 (e. g. phenytoin, carbamazepine, phenobarbital and St.
L- għotja fl- istess ħin ta ’ prodotti oħra mediċinali li jinduċu CYP3A4 (eż. phenytoin, carbamazepine, phenobarbital u St.
John’ s Wort) is likewise likely to reduce exposure to nilotinib to a clinically relevant extent.
John’ s Wort) x’ aktarx jnaqqsu l- esponiment għal nilotinib għal punt klinikament rilevanti.
In patients for whom CYP3A4 inducers are indicated, alternative agents with less enzyme induction potential should be selected.
F’ pazjenti li jkollhom bżonn indutturi ta ’ CYP3A4, sustanzi oħra li jikkawżaw anqas induzzjoni ta ’ l- enzimi għandhom jintgħażlu.
Nilotinib has pH dependent solubility, therefore, absorption of nilotinib might be reduced by substances that suppress gastric acid secretion.
Is- solubilità ta ’ nilotinib tiddependi mill- pH, għalhekk, l - assorbiment ta ’ nilotinib jista ’ jitnaqqas minn sustanzi li jissoprimu s- sekrezzjoni ta ’ l- aċidu gastriku.
The concomitant use of antacids, H2 blockers, or proton pump inhibitors with Tasigna is not recommended.
L- użu fl- istess ħin ta ’ antaċidi, imblukkaturi H2, jew inibituri tal- pompi tal- protoni ma ’ Tasigna mhux rakkomandat.
Substances that may have their systemic concentration altered by nilotinib Nilotinib is a relatively strong inhibitor of CYP3A4, CYP2C8, CYP2C9, CYP2D6 and UGT1A1 in vitro, potentially increasing the concentrations of substances eliminated by these enzymes.
Sustanzi li jista ’ jkollhom il- konċentrazzjoni sistemika tagħhom mibdula minn nilotinib Nilotinib huwa inibitur relattivament qawwi ta ’ CYP3A4, CYP2C8, CYP2C9, CYP2D6 and UGT1A1 in vitro, b’ hekk jista ’ potenzjalment iżid il- konċentrazzjonijiet ta ’ sustanzi li jitneħħew minn dawn l - enzimi.
The clinical relevance of these potential interactions has not been studied but caution is advised especially with concomitant use of nilotinib and medicinal products with a narrow therapeutic index.
Ir- rilevanza klinika ta ’ dawn l- interazzjonijiet potenzjali ma ġietx studjata iżda hija konsiljata l- attenzjoni bl- użu fl- istess ħin ta ’ nilotinib u prodotti mediċinali b’ indiċi terapewtiku dejjaq.
In addition, single-dose administration of Tasigna with orally administered midazolam to healthy subjects increased midazolam exposure by 30%.
Minbarra hekk, l- għotja ta ’ doża waħda ta ’ Tasigna ma ’ midazolam mogħti mill- ħalq lill- individwi b’ saħħithom żiedet l- esponiment għal midazolam b’ 30%.
It cannot be excluded that the effect of nilotinib is greater at steady state.
Ma jistax jiġi eskluż li l- effett ta ’ nilotinib ikun akbar fl - istat fiss.
5 quinidine, bepridil or ergot alkaloids (ergotamine, dihydroergotamine)].
Għandha ssir attenzjoni meta Tasigna jingħata flimkien ma ’ sottostrati ta ’ dawn l- enzimi li jkollhom indiċi terapewtiku dejjaq [eż astemizole, terfenadine, cisapride, pimozide, quinidine, bepridil jew ergot alkaloids (ergotamine, dihydroergotamine)].
Since warfarin is metabolised by CYP2C9 and CYP3A4 it should be given with caution.
Peress li warfarin huwa metabolizzat minn CYP2C9 u CYP3A4 għandu jingħata b’ attenzjoni.
Other medicinal products for anticoagulation should be considered.
Prodotti mediċinali oħrajn kontra l- koagulazzjoni għandhom jitqiesu.
Anti-arrhythmic medicinal products and other substances that may prolong QT Nilotinib should be used with caution in patients who have or may develop prolongation of QT, including those patients taking anti-arrhythmic medicinal products such as amiodarone, disopyramide, procainamide, quinidine and sotalol or other medicinal products that may lead to QT prolongation such as chloroquine, halofantrine, clarithromycin, haloperidol and methadone (see section 4.4).
Prodotti mediċinali kontra l- arritmiji u sustanzi oħrajn li jistgħu jtawwlu l- QT Nilotinib għandu jintuża b’ attenzjoni f’ pazjenti li jkollhom jew ikunu jistgħu jiżviluppaw titwil tal- QT inklużi dawk il- pazjenti li jkunu qed jieħdu prodotti mediċinali kontra l- arritmiji bħal amiodarone, disopyramide, procainamide, quinidine u sotalol jew prodotti mediċinali oħra li jistgħu jtawwlu l- QT bħal chloroquine, halofantrine, clarithromycin, haloperidol u methadone (ara sezzjoni 4. 4).