natgillin/translations-raw huggingface dataset:
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
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bodo pred prihodom zdravila na tržišče vsi zdravniki, za katere se pričakuje, da bodo predpisovali zdravilo Tasigna, in vsi lekarnarji, ki bodo lahko izdajali zdravilo Tasigna, prejeli komplet podatkov za strokovno zdravstveno osebje, ki bo vseboval sledeče: • izobraževalno knjižico, • Povzetek glavnih značilnosti zdravila (SPC), Navodilo za uporabo in Označevanje.
• 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
• kratek opis zdravila Tasigna, njegovih odobrenih indikacij in odmerjanja, • informacije o tveganju za srce v povezavi z uporabo zdravila Tasigna in sicer: o da zdravilo Tasigna lahko povzroča podaljšanje intervala QT in da se ga ne sme predpisovati bolnikom s tveganjem za aritmije, še posebno ne tistim s tveganjem za torsade de pointes, o da se je treba izogibati predpisovanju sočasne uporabe drugih zdravil, ki bi lahko podaljševala interval QT, o da je potrebna previdnost pri predpisovanju zdravila bolnikom z anamnezo koronarne bolezni ali s tveganjem za zanjo, o da zdravilo Tasigna lahko povzroča zastajanje tekočine, popuščanje srca in pljučni edem,
• 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
• da se zdravilo Tasigna presnavlja s CYP3A4 in da močni zaviralci ali induktorji tega encima lahko pomembno vplivajo na izpostavljenost zdravilu Tasigna: o da zaviralci lahko povečajo možnost neželenih učinkov, še posebno podaljšanja intervala QT, o da je treba bolnike opozoriti glede uporabe zdravil brez recepta, še posebno šentjanževke,
It is available as pale yellow capsules (200 mg).
Zdravilo je na voljo v kapsulah bledo rumene barve (200 mg).
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.
Zdravilo Tasigna se uporablja za zdravljenje odraslih, ki imajo kronično mieloično levkemijo (CML), vrsto raka belih krvnih celic, pri kateri začnejo granulociti (vrsta belih krvnih celic) nenadzorovano rasti.
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.
Uporablja se pri bolnikih s prisotnim kromosomom Philadelphia (Ph+), kar pomeni, da so se nekateri njegovi geni preuredili in sedaj tvorijo poseben kromosom, imenovan kromosom Philadelphia.
Tasigna is used in the ‘ chronic’ and ‘ accelerated ’ phases of CML.
Zdravilo Tasigna se uporablja pri kronični in pospešeni fazi CML.
There is no information available on its effectiveness in patients whose disease is in ‘ blast crisis’ (another phase of CML).
Podatki o učinkovitosti tega zdravila pri bolnikih, pri katerih je bolezen v blastni krizi (še ena faza CML), niso na voljo.
Tasigna is used when patients cannot tolerate other treatments including imatinib (another anticancer medicine), or when their disease is not responding to them.
Zdravilo Tasigna se uporablja pri bolnikih, ki ne prenašajo drugih zdravil, vključno z imatinibom (drugim zdravilom proti raku), ali pa se njihova bolezen nanje ne odziva.
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.
Ker je število bolnikov s CML majhno, velja ta bolezen za redko, zato je bilo zdravilo Tasigna dne 26. maja 2006 določeno kot „ zdravilo sirota “ (zdravilo, ki se uporablja pri redkih boleznih).
Treatment with Tasigna should be initiated by a doctor who has experience in the diagnosis and treatment of CML.
Zdravljenje z zdravilom Tasigna sme uvesti le zdravnik, ki ima izkušnje z diagnozo in zdravljenjem CML.
The recommended dose is two capsules twice a day, for as long as the patient continues to benefit.
Priporočeni odmerek je dve kapsuli dvakrat na dan, in sicer tako dolgo, dokler zdravilo bolniku koristi.
The dose should be reduced or treatment interrupted if the patient has certain side effects affecting the blood.
Če se pri bolniku pojavilo določeni neželeni učinki, ki vplivajo na kri, je treba odmerek zmanjšati ali zdravljenje začasno prekiniti.
The two doses should be taken around 12 hours apart.
Odmerka je treba vzeti v približno 12- urnem presledku.
The capsules are swallowed whole with a glass of water, without eating anything for two hours before and one hour after each dose.
Kapsule je treba pogoltniti cele s kozarcem vode, dve uri prej in eno uro po vsakem odmerku pa bolnik ne sme ničesar pojesti.
It should be used with caution in patients who have severe problems with their liver or certain heart problems.
Zdravilo je treba pri bolnikih, ki imajo resne težave z jetri ali določena obolenja srca, uporabljati previdno.
See the Summary of Product Characteristics (also part of the EPAR) for more information.
Za podrobne informacije glejte Povzetek glavnih značilnosti zdravila (ki je prav tako del EPAR).
The active substance in Tasigna, nilotinib, belongs to a group of medicines called protein kinase inhibitors.
Zdravilna učinkovina zdravila Tasigna je nilotinib, ki spada v skupino zdravil, imenovanih zaviralci protein- kinaze.
These compounds act by blocking types of enzymes known as protein kinases.
Te spojine delujejo tako, da zavirajo vrste encimov, ki so znani kot protein- kinaze.
Nilotinib acts by blocking the protein kinase called ‘ Bcr-Abl’ kinase.
Nilotinib deluje v glavnem tako, da zavira protein- kinazo, imenovano "Bcr- abl" kinaza.
This enzyme is produced by leukaemia 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Ta encim 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 proizvajajo levkemične celice, povzroča pa njihovo nenadzorovano razmnoževanje.
By blocking Bcr-Abl kinase, Tasigna helps to control the spread of leukaemia cells.
Z zaviranjem Bcr - Abl kinaze zdravilo Tasigna pomaga nadzorovati širjenje levkemičnih celic.
The effects of Tasigna were first tested in experimental models before being studied in humans.
Učinki zdravila Tasigna so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
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.
Učinkovitost zdravila Tasigna je bila preučevana v dveh glavnih študijah, v katerih je sodelovalo skupaj 439 bolnikov s CML, ki ne prenašajo imatiniba ali katerih bolezen se nanj več ne odziva.
Tasigna was not compared to any other treatment.
Zdravila Tasigna niso primerjali z nobenim drugim zdravilom.
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.
V prvo študijo je bilo vključenih 320 bolnikov, katerih bolezen je bila v kronični fazi in katerih tri četrtine se ni več odzivalo na 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%).
Glavno merilo učinkovitosti je bil delež bolnikov, pri katerih je prišlo do pomembnega citogenetičnega odziva (delež bolnikovih belih krvnih celic, ki so vsebovale kromosom Philadelphia, je padel pod 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.
V drugo študijo je bilo vključenih 119 bolnikov, katerih bolezen je bila v pospešeni fazi in katerih štiri petine se niso več odzivale na 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).
Glavno merilo učinkovitosti je bil delež bolnikov, pri katerih je prišlo do hematološkega odziva (ponovna vzpostavitev normalnega števila belih krvničk v krvi).
What benefit has Tasigna shown during the studies?
Kakšne koristi je zdravilo Tasigna izkazalo med raziskavami?
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).
V študiji kronične faze CML je pri 156 (49%) bolnikih prišlo do pomembnega citogenetskega odziva, potem ko so prejemali zdravilo Tasigna v poprečju 341 dni (približno enajst mesecev).
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).
V študiji pospešene faze CML je pri 50 (42%) od 119 bolnikov prišlo do hematološkega odziva, potem ko so prejemali zdravilo Tasigna v poprečju 202 dni (približno sedem mesecev).
In both studies, Tasigna had a similar effect in patients who could not tolerate imatinib and those whose disease had stopped responding to it.
V obeh študijah je imelo zdravilo Tasigna podoben učinek pri bolnikih, ki ne prenašajo imatiniba, ali pri tistih, pri katerih se bolezen nanj več ne odziva.
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).
Najpogostejši neželeni učinki zdravila Tasigna (opaženi pri več kot 1 bolniku od 10) so trombocitopenija (nizko število trombocitov), nevtropenija (nizko število belih krvničk), anemija (nizko število rdečih krvničk), glavobol, navzeja (občutek slabosti), zaprtje, diareja, izpuščaji, pruritus (srbečica), utrujenost in povečane ravni lipaz (encim, ki ga proizvaja trebušna slinavka) v krvi.
For the full list of all side effects reported with Tasigna, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Tasigna, glejte Navodilo za uporabo.
Tasigna should not be used in people who may be hypersensitive (allergic) to nilotinib or any of the other ingredients.
Zdravila Tasigna ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) nilotinib ali katero koli drugo sestavino zdravila.
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.
Odbor za zdravila za uporabo v humani medicini (CHMP) je sklenil, da je bila učinkovitost zdravila Tasigna, čeprav ni bilo neposredno primerjano s kakšnim drugim zdravilom, zadostno dokazana in je bila enaka kot učinkovitost drugega zdravila v istem razredu.
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.
Odbor je sklenil, da so koristi zdravila Tasigna pri zdravljenju odraslih s kronično ali pospešeno fazo kronične mieloične levkemije (CML) s prisotnim kromosomom Philadelphia, ki so odporni na predhodno zdravilo ali ga ne prenašajo, vključno z imatinibom, večje od z njim povezanih tveganj.
The Committee recommended that Tasigna be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Tasigna odobri dovoljenje za promet.
Which measures are being taken to ensure the safe use of Tasigna?
Kateri ukrepi se izvajajo za zagotovitev varne uporabe zdravila 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.
Podjetje, ki izdeluje zdravilo Tasigna, bo v vsaki državi članici pripravilo informacijski paket za zdravnike in farmacevte, ki bodo predpisovali ali izdajali zdravilo.
The pack will remind them of how Tasigna should be used safely in patients.
Informacijski paket jim bo v pomoč pri tem, kako zdravilo Tasigna varno uporabljati pri bolnikih.
Other information about Tasigna:
Druge informacije o zdravilu Tasigna:
The European Commission granted a marketing authorisation valid throughout the European Union for Tasigna to Novartis Europharm Limited on 19 November 2007.
Evropska komisija je dovoljenje za promet z zdravilom Tasigna, veljavno po vsej Evropski uniji, odobrila družbi Novartis Europharm Limited dne 19. novembra 2007.
The summary of opinion of the Committee for Orphan Medicinal Products for Tasigna is available here.
Povzetek mnenja Odbora za zdravila sirote o zdravilu Tasigna je na voljo tukaj.
The full EPAR for Tasigna can be found here.
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Tasigna je na voljo tukaj.
Package size
pot uporabe
Tasigna
ovojnina
Blister (PVC/ PVDC/ Al)
vsebina (koncentracija)
EU/ 1/ 07/ 422/ 002
velikost pakiranja
Capsule, hard
kapsula, trda kapsula, trda kapsula, trda kapsula, trda
Blister (PVC/ PVDC/ Al)
peroralna uporaba peroralna uporaba peroralna uporaba peroralna uporaba
Blister (PA/ Al/ PVC/ Al)
pretisni omot (PVC/ PVDC/ Al) pretisni omot (PA/ Al/ PVC/ Al) pretisni omot (PVC/ PVDC/ Al) pretisni omot (PA/ Al/ PVC/ Al)
112 capsules
28 kapsul 28 kapsul 112 kapsul 112 kapsul
Lactose monohydrate:
Pomožna snov: laktoza monohidrat:
156.11 mg per capsule.
156, 11 mg na kapsulo
White to slightly yellowish powder in light yellow opaque hard gelatin capsules, size 0 with red axial imprint “ NVR/ TKI”.
Bel do rahlo rumenkast prašek v svetlo rumeni neprozorni trdi želatinski kapsuli, velikosti 0 z vtisnjeno rdečo oznako “ NVR/ TKI ” v smeri osi.
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.
Zdravilo Tasigna je indicirano za zdravljenje odraslih s kronično ali pospešeno fazo kronične mieloične levkemije (CML) s prisotnim kromosomom Philadelphia in z rezistenco na predhodno zdravilo ali z neprenašanjem predhodnega zdravila, vključno z imatinibom.
Efficacy data in patients with CML in blast crisis are not available.
Podatki o učinkovitosti pri bolnikih s CML v blastni krizi niso dostopni.
Therapy should be initiated by a physician experienced in the diagnosis and the treatment of patients with CML.
Zdravljenje mora začeti zdravnik, izkušen v diagnostiki in zdravljenju bolnikov s CML.
The recommended dose of Tasigna is 400 mg twice daily.
Priporočeni odmerek zdravila Tasigna je 400 mg dvakrat dnevno.
Tasigna should be taken twice daily approximately 12 hours apart and must not be taken with food.
Zdravila se ne sme jemati s hrano.
Tasigna may be given in combination with haematopoietic growth factors such as erythropoietin or granulocyte colony-stimulating factor (G-CSF) if clinically indicated.
Zdravilo Tasigna se lahko daje v kombinaciji s hematopoetskimi rastnimi dejavniki kot sta eritropoetin ali granulocitne kolonije stimulirajoči faktor (G- CSF), če je to klinično indicirano.
Tasigna may be given with hydroxyurea or anagrelide if clinically indicated.
Zdravilo Tasigna se lahko daje s hidroksiureo ali z anagrelidom, če je to klinično indicirano.
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).
Prilagoditve in modifikacije odmerkov Lahko se zgodi, da je treba zdravljenje z zdravilom Tasigna začasno prekiniti in/ ali zmanjšati odmerek zaradi hematološke toksičnosti (nevtropenije, trombocitopenije), ki ni povezana z osnovno levkemično boleznijo (glejte preglednico 1).
2 Table 1
2 Preglednica 1
Dose adjustments for neutropenia and thrombocytopenia
Prilagoditve odmerkov pri nevtropeniji in trombocitopeniji
Chronic phase CML at 400 mg twice daily
ANC * < 1, 0 x 109/ l in/ ali število
ANC* < 1.0 x 109/ l and/ or platelet counts < 50 x 109/ l
Kronična faza CML,
Accelerated phase CML at 400 mg twice daily
Če se krvna slika ne popravi, je morda potrebno znižanje odmerka na 400 mg enkrat dnevno.
ANC* < 0.5 x 109/ l and/ or platelet counts < 10 x 109/ l
Pospešena faza
*ANC = absolute neutrophil count
* ANC = absolutno število nevtrofilcev
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.
Ko toksičnost izzveni, se sme ponovno začeti zdravljenje z odmerki 400 mg enkrat dnevno.
If clinically appropriate, re-escalation of the dose to 400 mg twice daily should be considered.
Ponovno stopnjevanje odmerka na 400 mg dvakrat dnevno je treba pretehtati, če kaže, da je to klinično primerno.
Elevated serum lipase:
Zvišana koncentracija lipaze v serumu:
For Grade 3-4 serum lipase elevations, doses should be reduced to 400 mg once daily or interrupted.
Pri zvišanju koncentracije lipaze stopnje 3- 4 je treba znižati odmerek na 400 mg enkrat dnevno ali prekiniti zdravljenje.
Serum lipase levels should be tested monthly or as clinically indicated.
Koncentracijo lipaze v serumu je treba določati enkrat mesečno oziroma v skladu s kliničnimi indikacijami.
Elevated bilirubin and hepatic transaminases:
Zvišane koncentracije bilirubina in jetrnih aminotransferaz:
For Grade 3-4 bilirubin elevations, doses should be reduced to 400 mg once daily or interrupted.
Pri zvišanju koncentracije bilirubina stopnje 3- 4 je treba znižati odmerek na 400 mg enkrat dnevno ali prekiniti zdravljenje.
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).
Otroci in mladostniki Zaradi pomanjkanja podatkov o varnosti in učinkovitosti uporaba zdravila Tasigna pri otrocih in mladostnikih pod 18 let ni priporočljiva (glejte poglavje 5. 1).
Elderly patients Approximately 30% of subjects in clinical studies were 65 years of age or over.
Starejši bolniki Približno 30% oseb v kliničnih študijah je bilo starih 65 let ali več.
No major differences were observed for safety and efficacy in patients ≥ 65 years of age as compared to adults aged 18 to 65 years.
Pri bolnikih, starih 65 let ali več, niso opažali večjih razlik glede varnosti in učinkovitosti v primerjavi z odraslimi, starimi 18 do 65 let.
Patients with renal impairment Clinical studies have not been performed in patients with impaired renal function.
Bolniki z okvaro ledvic Kliničnih študij pri bolnikih z okvarjenim delovanjem ledvic niso izvajali.
Patients with hepatic impairment Tasigna has not been investigated in patients with hepatic impairment.
3 Bolniki z okvaro jeter Pri bolnikih z okvaro jeter zdravila Tasigna niso raziskovali.
Patients with hepatic impairment should be treated with caution (see section 4.4).
Pri zdravljenju bolnikov z okvaro jeter je potrebna previdnost (glejte poglavje 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.
Bolezni srca V kliničnih študijah so bile neurejene ali klinično pomembne bolezni srca (kot so nedavni miokardni infarkt, kongestivno srčno popuščanje, nestabilna angina pektoris ali klinično pomembna bradikardija) izključitveni kriterij.
Caution should be exercised in patients with relevant cardiac disorders (see section 4.4).
Pri bolnikih s pomembnimi boleznimi srca je potrebna previdnost (glejte poglavje 4. 4).
Myelosuppression Treatment with Tasigna is associated with (National Cancer Institute Common Toxicity Criteria grade 3-4) thrombocytopenia, neutropenia and anaemia.
Zaviranje delovanja kostnega mozga Zdravljenje z zdravilom Tasigna je povezano s trombocitopenijo, nevtropenijo in anemijo (stopnje 3- 4 po enotnih kriterijih za vrednotenje neželenih učinkov Zveznega inštituta za raka - National Cancer Institute - Common Toxicity Criteria).
Occurrence is more frequent in patients with accelerated-phase CML.
Do tega pride pogosteje pri bolnikih s pospešeno fazo CML.
Myelosuppression was generally reversible and usually managed by withholding Tasigna temporarily or dose reduction (see section 4.2).
Zaviranje delovanja kostnega mozga je bilo večinoma reverzibilno in so ga običajno uravnavali s prekinitvijo ali z zmanjšanjem odmerjanja zdravila Tasigna (glejte poglavje 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.
Podaljšanje intervala QT Ugotovili so, da zdravilo Tasigna podaljšuje repolarizacijo srčnih prekatov v odvisnosti od koncentracije, kar se kaže kot podaljšanje intervala QT pri merjenju površinskih odvodov EKG.
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.
V študiji faze II je pri bolnikih v kronični in v pospešeni fazi CML, ki so bili rezistentni na zdravljenje z imatinibom oziroma ga niso prenašali, v ravnovesnem stanju prišlo do srednjega časovno povprečnega podaljšanja intervala QTcF za 6 oziroma 8 milisekund glede na izhodišče.
QTcF of > 500 msec was observed in < 1% of these patients.
Pri manj kot 1% teh bolnikov so opažali interval QTcF, ki je bil daljši od 500 milisekund.
No episodes of torsade de pointes were observed in clinical studies.
V kliničnih študijah niso opažali epizod “ torsade de pointes ”.
No subject had a QTcF > 450 msec.
Pri nobenem od prostovoljcev trajanje QTcF ni preseglo 450 milisekund.
In particular, no episodes of torsade de pointes (transient or sustained) were observed.
Poleg tega v obdobju preskušanja niso opažali nobenih klinično pomembnih aritmij, še posebno niso opažali epizod “ torsade de pointes ” (niti prehodnih niti trajnih).
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).
Pri neustreznem sočasnem jemanju nilotiniba z močnimi zaviralci CYP3A4 in/ ali z zdravili, za katera je znano, da lahko podaljšujejo interval QT, in/ ali s hrano, lahko pride do pomembnega podaljšanja intervala QT (glejte poglavje 4. 5).