natgillin/translations-raw huggingface dataset:
Nilotinib may be used concurrently with esomeprazole or other proton pump inhibitors as needed.
Nilotinib se može istodobno koristiti s esomeprazolom ili drugim inhibitorima protonske pumpe ako je potrebno.
For all Sokal risk groups, the MMR rates at all time points remained consistently higher in the two nilotinib groups than in the imatinib group.
Za sve rizične skupine prema Sokalu, stope MMR-a u svim su vremenskim točkama ostale dosljedno više u dvjema skupinama koje su primale nilotinib nego u skupini koja je primala imatinib.
Prolongation of the QT interval may expose patients to the risk of fatal outcome.
Produženje QT intervala može povećati rizik od smrtnog ishoda.
Therefore, absorption and subsequent elimination of systemically absorbed nilotinib may be influenced by substances that affect CYP3A4 and/or P-gp.
Radi toga, na apsorpciju i posljedičnu eliminaciju sistemski apsorbiranog nilotiniba mogu utjecati tvari koje djeluju na CYP3A4 i/ili P-gp.
The safety and efficacy of nilotinib in paediatric patients with Ph+ CML in chronic phase have been investigated in two studies.
Sigurnost i djelotvornost nilotiniba u pedijatrijskih bolesnika s Ph+ KML-om u kroničnoj fazi istraživane su u dva ispitivanja.
The safety and efficacy of Tasigna in paediatric patients with Philadelphia chromosome positive CML in chronic phase from 2 to less than 18 years of age have been established (see sections 4.8, 5.1 and 5.2).
Ustanovljene su sigurnost i djelotvornost Tasigne u pedijatrijskih bolesnika s KML-om s pozitivnim Philadelphia kromosomom u kroničnoj fazi u dobi od 2 do manje od 18 godina (vidjeti dijelove 4.8, 5.1 i 5.2).
Biochemical adverse drug reactions include alanine aminotransferase increased (24%), hyperbilirubinaemia (16%), aspartate aminotransferase increased (12%), lipase increased (11%), blood bilirubin increased (10%), hyperglycaemia (4%), hypercholesterolaemia (3%) and hypertriglyceridaemia (<1%).
Biokemijske nuspojave na lijek uključuju povišenje alanin aminotransferaze (24%), hiperbilirubinemiju (16%), povišenje aspartat aminotransferaze (12%), povišenje lipaze (11%), povišenje bilirubina u krvi (10%), hiperglikemiju (4%), hiperkolesterolemiju (3%) i hipertigliceridemiju (<1%).
Serum lipase levels should be tested monthly or as clinically indicated (see section 4.4).
Razine serumske lipaze treba mjeriti jednom mjesečno ili kad je klinički indicirano (vidjeti dio 4.4).
Laboratory abnormalities of mild to moderate transient elevations of aminotransferases and total bilirubin have been observed in children at a higher frequency than in adults, indicating a higher risk of hepatotoxicity in the paediatric population (see section 4.8).
Laboratorijske abnormalnosti blagih do umjerenih prolaznih povećanja vrijednosti aminotransferaza i ukupnog bilirubina opažene su u djece s većom učestalošću nego u odraslih, ukazujući na povišeni rizik hepatotoksičnosti u pedijatrijskoj populaciji (vidjeti dio 4.8).
In vitro cardiac safety studies demonstrated a preclinical signal for QT prolongation, based upon block of hERG currents and prolongation of the action potential duration in isolated rabbit hearts by nilotinib.
In vitro ispitivanja sigurnosti srčanih parametara pokazala su pretklinički signal za produženje QT intervala, temeljeno na blokiranju hERG protoka i produženju trajanja akcijskog potencijala u izoliranim zečjim srcima pod djelovanjem nilotiniba.
Pleural and pericardial effusions as well as complications of fluid retention occurred in <1% of patients receiving Tasigna.
Pleuralni i perikardijalni izljevi, kao i komplikacije vezane uz retenciju tekućine pojavile su se u <1% bolesnika liječenih Tasignom.
Among the 53 patients who discontinued the TFR phase due to confirmed loss of MR4.0 or loss of MMR, 51 patients restarted nilotinib and 2 patients discontinued the study.
Od 53 bolesnika koji su prekinuli TFR fazu zbog potvrđenog gubitka MR4,0 ili gubitka MMR-a, 51 bolesnik ponovo je započeo terapiju nilotinibom, a 2 bolesnika prekinula su ispitivanje.
Concomitant administration of nilotinib with imatinib (a substrate and moderator of P-gp and CYP3A4), had a slight inhibitory effect on CYP3A4 and/or P-gp.
Istodobna primjena nilotiniba s imatinibom (supstrat i moderator P-gp i CYP3A4) imala je blagi inhibitorni učinak na CYP3A4 i/ili P-gp.
- taking anti-arrhythmic medicinal products or other substances that lead to QT prolongation.
- koji uzimaju antiaritmike ili druge tvari koje dovode do produženja QT intervala.
Accelerated phase (n=137)*
Ubrzana faza (n=137)*
What Tasigna is Tasigna is a medicine containing an active substance called nilotinib.
Što je Tasigna Tasigna je lijek koji sadrži djelatnu tvar zvanu nilotinib.
If so, you may sprinkle the content of each hard capsule in one teaspoon of apple sauce and take it immediately.
U tom slučaju, možete istresti sadržaj svake tvrde kapsule u jednu čajnu žličicu kaše od jabuke i odmah ju uzeti.
Eighty-eight patients (46.3%) discontinued the TFR phase due to loss of MMR, and 1 (0.5%), 1 (0.5%), and 3 patients (1.6%) due to death from unknown cause, physician decision and subject decision, respectively.
Osamdeset osam bolesnika (46,3%) prekinulo je TFR fazu zbog gubitka MMR-a, 1 (0,5%) zbog smrti od nepoznatog uzroka, 1 (0,5%) zbog liječničke odluke i 3 bolesnika (1,6%) zbog ispitanikove odluke.
Haematological Response (%) Overall (95%CI) Complete NEL
Hematološki odgovor (%) Ukupno (95%CI) Kompletan NEL
The dose was 400 mg twice daily and dose escalation to 600 mg twice daily was allowed.
Doza je iznosila 400 mg dva puta na dan i povećanje doze do 600 mg dva puta na dan je bilo dozvoljeno.
BCR-ABL transcript levels must be assessed prior to and during treatment discontinuation (see sections 4.2 and 5.1).
Razine BCR-ABL transkripcija moraju se ocijeniti prije i za vrijeme prekida liječenja (vidjeti dijelove 4.2 i 5.1).
Patients with a CHR at baseline achieved a MCyR faster (1.9 versus 2.8 months).
Bolesnici s CHR-om na početku su brže postigli MCyR (1,9 u odnosu na 2,8 mjeseci).
However, percentages with one decimal precision are used to identify terms with a frequency of at least 5% and to classify terms according to frequency categories.
Međutim, postotci s točnošću od jedne decimale koriste se za navođenje nuspojava s učestalošću od najmanje 5% te za klasifikaciju nuspojava prema kategorijama učestalosti.
There is no experience with the use of Tasigna in newly diagnosed children below 10 years of age and limited experience in patients below 6 years of age who are no longer benefiting from previous treatment for CML.
Nema iskustva s primjenom Tasigne u novodijagnosticirane djece mlađe od 10 godina, a iskustvo je ograničeno u bolesnika mlađih od 6 godina kojima više ne pomaže prethodna terapija za KML.
If you are told to discontinue this medicine, your doctor will continue to monitor your CML and may tell you to re-start Tasigna if your condition indicates that this is necessary.
Ako Vam kaže da prestanete uzimati ovaj lijek, liječnik će nastaviti pratiti Vaš KML i može Vam reći da ponovo počnete uzimati Tasignu ako Vaše stanje bude ukazivalo da je to potrebno.
Complete haematological response (CHR) in CP patients was evaluated as a secondary endpoint.
Kompletni hematološki odgovor (CHR - engl. complete hematological response) u bolesnika u kroničnoj fazi procjenjivao se kao sekundarni ishod.
Figure 1 Cumulative incidence of MMR
Slika 1 Kumulativna incidencija MMR-a
The predicted steady-state Cmax of nilotinib showed an increase of 29%, 18% and 22%, respectively.
Predviđeni Cmax nilotiniba u stanju dinamičke ravnoteže pokazao je povećanje od 29%, 18%, odnosno 22%.
The primary endpoint in the CP patients was major cytogenetic response (MCyR), defined as elimination (CCyR, complete cytogenetic response) or significant reduction to <35% Ph+ metaphases (partial cytogenetic response) of Ph+ haematopoietic cells.
Primarni ishod u bolesnika u kroničnoj fazi bio je veliki citogenetski odgovor (MCyR), definiran kao eliminacija (CCyR, kompletni citogenetski odgovor) ili značajno smanjenje na <35% Ph+ metafaza (djelomični citogenetski odgovor) Ph+ hematopoetskih stanica.
Nilotinib should be used with caution in patients who have or may develop prolongation of the QT interval, 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, methadone and moxifloxacin (see section 4.4).
Nilotinib se treba oprezno primjenjivati u bolesnika koji imaju ili mogu razviti produženi QT interval, uključujući one bolesnike koji uzimaju antiaritmike, kao što su amiodaron, dizopiramid, prokainamid, kinidin i sotalol ili ostale lijekove koji mogu dovesti do produženja QT intervala, kao što su klorokin, halofantrin, klaritromicin, haloperidol, metadon i moksifloksacin (vidjeti dio 4.4).
The primary endpoint in the AP patients was overall confirmed haematological response (HR), defined as either a complete haematological response, no evidence of leukaemia or return to chronic phase.
Primarni ishod u bolesnika u ubrzanoj fazi bio je cjelokupni potvrđeni hematološki odgovor (HR - engl. hematological response), definiran bilo kao kompletan hematološki odgovor, nemogućnost dokazivanja leukemije ili kao povratak u kroničnu fazu.
There are no or limited amount of data from the use of nilotinib in pregnant women.
Nema podataka ili su podaci o primjeni nilotiniba u trudnica ograničeni.
Among newly diagnosed patients, the percentage of patients who achieved MR4.0 was 32%, while 28.0% achieved MR4.5.
Među novodijagnosticiranim bolesnicima, postotak bolesnika koji su postigli MR4,0 bio je 32%, dok ih je 28,0% postiglo MR4,5.
What Tasigna contains - The active substance is nilotinib.
Što Tasigna sadrži - Djelatna tvar je nilotinib.
Appropriate therapy should be prescribed to manage cardiovascular risk factors (see section 4.2 for instructions on managing non-haematological toxicities).
Za zbrinjavanje čimbenika kardiovaskularnog rizika treba propisati odgovarajuću terapiju (vidjeti dio 4.2 za upute o zbrinjavanju nehematoloških toksičnosti).
There is no experience in paediatric patients below 2 years of age or in paediatric patients with Philadelphia chromosome positive CML in accelerated phase or blast crisis.
Nema iskustva u pedijatrijskih bolesnika mlađih od 2 godine ili u pedijatrijskih bolesnika s KML-om s pozitivnim Philadelphia kromosomom u ubrzanoj fazi ili blastičnoj krizi.
In healthy subjects receiving esomeprazole at 40 mg once daily for 5 days, gastric pH was markedly increased, but nilotinib absorption was only decreased modestly (27% decrease in Cmax and 34% decrease in AUC0-∞).
U zdravih ispitanika koji su primali esomeprazol u dozi od 40 mg jedanput na dan tijekom 5 dana, želučani pH je bio značajno povećan, ali je apsorpcija nilotiniba bila umjereno snižena (27% sniženje u Cmax i 34% sniženje AUC0-∞).
Nilotinib has pH dependent solubility, with lower solubility at higher pH.
Topljivost nilotiniba ovisna je o pH, uz nižu topljivost pri višem pH.
Figure 5 Kaplan-Meier estimate of treatment-free survival after start of TFR (full analysis set)
Slika 5 Kaplan-Meierova procjena preživljenja bez liječenja nakon početka TFR-a (potpuni skup podataka za analizu)
The hard capsules should be swallowed whole with water.
Tvrde kapsule se trebaju uzimati s vodom i progutati cijele.
Warnings and precautions Talk to your doctor or pharmacist before taking Tasigna: - if you have suffered prior cardiovascular events such as a heart attack, chest pain (angina), problems with the blood supply to your brain (stroke) or problems with the blood flow to your leg (claudication) or if you have risk factors for cardiovascular disease such as high blood pressure (hypertension), diabetes or problems with the level of fats in your blood (lipid disorders).
Upozorenja i mjere opreza Obratite se svom liječniku ili ljekarniku prije nego uzmete Tasignu: - ako ste ranije imali srčanožilne događaje, kao što su srčani udar, bol u prsnom košu (angina), problemi s dotokom krvi u mozak (moždani udar) ili problemi s dotokom krvi u nogu (klaudikacija), ili ako imate rizične čimbenike za srčanožilne bolesti kao što su visoki krvni tlak (hipertenzija), šećerna bolest ili problemi s razinom masnoća u krvi (poremećaji lipida).
In a healthy subjects study, no significant change in nilotinib pharmacokinetics was observed when a single 400 mg dose of nilotinib was administered 10 hours after and 2 hours before famotidine.
U ispitivanju provedenom na zdravim ispitanicima nije opažena značajna promjena u farmakokinetici nilotiniba prilikom primjene jednokratne doze od 400 mg nilotiniba 10 sati nakon i 2 sata prije primjene famotidina.
Tasigna is used to treat a type of leukaemia called Philadelphia chromosome positive chronic myeloid leukaemia (Ph-positive CML).
Tasigna se koristi za liječenje jedne vrste leukemije koja se zove kronična mijeloična leukemija s pozitivnim Philadelphia kromosomom (Ph-pozitivni KML).
The overall confirmed HR rate in 137 AP patients was 50%.
Ukupna potvrđena stopa HR-a u 137 bolesnika u ubrzanoj fazi bila je 50%.
Face oedema, localised oedema
Edem lica, lokalizirani edem
It is also used in adult and paediatric patients who experienced serious side effects with previous treatment and are not able to continue taking it.
Također se primjenjuje u odraslih i pedijatrijskih bolesnika s ozbiljnim nuspojavama na prethodno liječenje koje nisu mogli nastaviti primati.
Table 3 Non-haematological adverse reactions (≥5% of all patients)*
Tablica 3 Nehematološke nuspojave (≥5% svih bolesnika)*
Available toxicological data in animals have shown excretion of nilotinib in milk (see section 5.3).
Dostupni toksikološki podaci u životinja pokazali su da se nilotinib izlučuje u mlijeko (vidjeti dio 5.3).
If pregnancy is planned during the TFR phase, the patient must be informed of a potential need to re-initiate nilotinib treatment during pregnancy (see sections 4.2 and
Ako je planirana trudnoća tijekom TFR faze, bolesnica se mora obavijestiti o mogućoj potrebi za ponovnim započinjanjem liječenja nilotinibom tijekom trudnoće (vidjeti dijelove 4.2 i 4.4).
Eighty-five of these 86 patients (98.8%) regained MMR, (one patient discontinued study permanently due to subject decision) and 76 patients (88.4%) regained MR4.5 by the time of the cut-off date.
Osamdeset pet od tih 86 bolesnika (98,8%) ponovo je postiglo MMR, (jedan bolesnik trajno je prekinuo ispitivanje vlastitom odlukom), a 76 bolesnika (88,4%) ponovo je postiglo MR4,5 do isključnog datuma.
NEL = no evidence of leukaemia/marrow response 114 CP patients had a CHR at baseline and were therefore not assessable for complete haematological response * Missing information on imatinib-resistant/intolerant status for one patient.
NEL = nema dokaza za leukemiju/odgovor koštane srži 114 bolesnika u kroničnoj fazi je imalo CHR na početku, pa nisu mogli ući u procjenu kompletnog hematološkog odgovora * Nedostaje podatak o statusu jednog bolesnika s rezistencijom/intolerancijom na imatinib.
Loss of major molecular response (MMR=BCR-ABL/ABL ≤0.1%IS) will trigger treatment re-initiation within 4 weeks of when loss of remission is known to have occurred.
Gubitak velikog molekularnog odgovora (MMR=BCR-ABL/ABL ≤0,1% IS) potaknut će ponovno započinjanje liječenja u roku od 4 tjedna od trenutka saznanja o gubitku remisije.
For laboratory abnormalities, very common events (1/10) not included in Table 3 are also reported.
4. Za abnormalne vrijednosti laboratorijskih nalaza, prijavljeni su vrlo česti događaji (1/10) koji nisu uključeni u Tablicu
Figure 4 Kaplan-Meier estimate of treatment-free survival after start of TFR (full analysis set)
Slika 4 Kaplan-Meierova procjena preživljenja bez liječenja nakon početka TFR-a (potpuni skup podataka za analizu)
Phototoxicity studies
Ispitivanja fototoksičnosti
Discontinuation due to adverse drug reactions was observed in 16% of chronic phase and 10% of accelerated phase patients.
Prekid primjene lijeka zbog nuspojava vezanih uz primjenu lijeka je uočen u 16% bolesnika u kroničnoj fazi i u 10% bolesnika u ubrzanoj fazi.
Regular tests, including blood tests, will be performed during treatment.
Tijekom liječenja redovito će se obavljati kontrole, koje uključuju krvne pretrage.
Tasigna is available in packs containing 28 or 40 hard capsules and in multipacks of 112 hard capsules (comprising 4 cartons, each containing 28 hard capsules), 120 hard capsules (comprising 3 cartons, each containing 40 hard capsules) or 392 hard capsules (comprising 14 cartons, each containing 28 hard capsules).
Tasigna je dostupna u pakiranjima koja sadrže 28 ili 40 tvrdih kapsula ili u višestrukim pakiranjima koja sadrže 112 tvrdih kapsula (sastoje se od 4 kutije, svaka sadrži 28 tvrdih kapsula), 120 tvrdih kapsula (sastoje se od 3 kutije, svaka sadrži 40 tvrdih kapsula) ili 392 tvrde kapsule (sastoje se od 14 kutija, svaka sadrži 28 tvrdih kapsula).
The safety of nilotinib in paediatric patients (from 2 to <18 years of age) with Philadelphia chromosome positive CML in chronic phase (n=69) has been investigated in two studies (see section 5.1).
Sigurnost nilotiniba u pedijatrijskih bolesnika (u dobi od 2 do <18 godina) s KML-om s pozitivnim Philadelphia kromosomom u kroničnoj fazi (n=69) istraživana je u dva ispitivanja (vidjeti dio 5.1).
None of the 21 resistant or intolerant CML patients who were in MMR on treatment had confirmed loss of MMR.
Nijedan od 21 rezistentnog ili intolerantnog bolesnika s KML-om koji su bili u MMR-u tijekom terapije nije imao potvrđen gubitak MMR-a.
In case lipase elevations are accompanied by abdominal symptoms, nilotinib therapy should be interrupted and appropriate diagnostic measures considered to exclude pancreatitis.
U slučaju kada su povišenja serumske lipaze praćena abdominalnim simptomima, terapiju nilotiniba treba prekinuti i napraviti odgovarajuće pretrage kako bi se isključio pankreatitis.
In the 2-year rat carcinogenicity study, the major target organ for non-neoplastic lesions was the uterus (dilatation, vascular ectasia, endothelial cell hyperplasia, inflammation and/or epithelial hyperplasia).
U dvogodišnjem ispitivanju karcinogenosti kod štakora glavni ciljni organ za ne-neoplasične lezije bila je maternica (dilatacija, vaskularna ektazija, hiperplazija endotelnih stanica, upala i/ili epitelna hiperplazija).
Discontinuation of nilotinib therapy should be initiated by a physician experienced in the treatment of patients with CML (see sections 4.4 and 5.1).
Prekid terapije nilotinibom mora započeti liječnik s iskustvom u liječenju bolesnika s KML-om (vidjeti dijelove 4.4 i 5.1).
Monitoring during Tasigna treatment
Praćenje tijekom liječenja Tasignom
These antacids should be taken approximately 2 hours before or approximately 2 hours after you take Tasigna.
Takve je antacide potrebno uzimati približno 2 sata prije ili približno 2 sata nakon uzimanja Tasigne.
Final CSR: April 2021
Završno izvješće o kliničkom ispitivanju: travanj, 2021.
A single-dose drug-drug interaction study in healthy volunteers with 25 mg warfarin, a sensitive CYP2C9 substrate, and 800 mg nilotinib did not result in any changes in warfarin pharmacokinetic parameters or warfarin pharmacodynamics measured as prothrombin time (PT) and international normalised ratio (INR).
Ispitivanje jednokratne doze interakcije lijekova u zdravih dobrovoljaca s 25 mg varfarina, osjetljivog CYP2C9 supstrata, i 800 mg nilotiniba nije dovelo do promjena farmakokinetičkih parametara varfarina ili farmakodinamike varfarina mjerene kao protrombinsko vrijeme (PV) i međunarodni normalizirani omjer (INR - engl. international normalised ratio).
No food should be consumed for at least one hour after the dose is taken.
Hranu ne treba uzimati najmanje jedan sat nakon uzimanja doze.
By 1 year
Do 1. godine
The median duration of exposure was 60.5 months (range 0.1-70.8 months).
Medijan trajanja izloženosti lijeku bio je 60,5 mjeseci (raspon od 0,1-70,8 mjeseci).
Elevations of bilirubin and hepatic transaminases should be managed by withholding nilotinib temporarily, dose reduction and/or discontinuation of nilotinib (see section 4.2).
Povećanja vrijednosti bilirubina i jetrenih transaminaza treba zbrinjavati privremenim ukidanjem nilotiniba, smanjenjem doze i/ili obustavom primjene nilotiniba (vidjeti dio 4.2).
Complete cytogenetic response (CCyR) was defined as 0% Ph+ metaphases in the bone marrow based on a minimum of 20 metaphases evaluated.
Potpuni citogenetski odgovor (CCyR - engl. complete cytogenetic response) je određen kao 0% Ph+ metafaza u koštanoj srži na temelju najmanje 20 procijenjenih metafaza.
In the same study as above, administration of an antacid (aluminium hydroxide/magnesium hydroxide/simethicone) 2 hours before or after a single 400 mg dose of nilotinib also did not alter nilotinib pharmacokinetics.
U istome, prethodno spomenutome ispitivanju primjena antacida (aluminij hidroksid/magnezij hidroksid/simetikon) 2 sata prije ili poslije jednokratne doze od 400 mg nilotiniba također nije promijenila farmakokinetiku nilotiniba.
Myelosuppression was generally reversible and usually managed by withholding Tasigna temporarily or dose reduction (see section 4.2).
Mijelosupresija je u pravilu reverzibilna i najčešće se može riješiti privremenim prestankom primjene ili smanjenjem doze Tasigne (vidjeti dio 4.2).
Insomnia, depression, anxiety
Nesanica, depresija, anksioznost
Nilotinib has been evaluated in safety pharmacology, repeated-dose toxicity, genotoxicity, reproductive toxicity, phototoxicity and carcinogenicity (rats and mice) studies.
Kod nilotiniba su provedena ispitivanja farmakološke sigurnosti primjene, toksičnosti ponovljenih doza, genotoksičnosti, reproduktivne toksičnosti, fototoksičnosti i karcinogenosti (na štakorima i miševima).
After imatinib failure, 24 different BCR-ABL mutations were noted in 42% of chronic phase and 54% of accelerated phase CML patients who were evaluated for mutations.
Nakon neuspjeha liječenja imatinibom, zabilježene su 24 različite Bcr-Abl mutacije u 42% bolesnika s KML-om u kroničnoj i u 54% bolesnika s KML-om u ubrzanoj fazi u kojih se ispitivala mutacija.
Exposures at the lowest dose levels at which the liver effects were seen were lower than the exposure in humans at a dose of 800 mg/day.
Izloženosti uz najniže razine doza pri kojima su zamijećeni učinci na jetru bile su niže nego izloženost u ljudi u dozi od 800 mg/dan.
Cardiac failure, cyanosis
Zatajenje srca, cijanoza
For a dose of 300 mg twice daily, 150 mg hard capsules are available.
Za dozu od 300 mg dva puta na dan, dostupne su tvrde kapsule od 150 mg.
Tasigna is available in a wallet containing 28 hard capsules and in a carton containing 28 or 40 hard capsules.
Tasigna je dostupna u džepnom pakiranju koje sadrži 28 tvrdih kapsula te u kutiji koja sadrži 28 ili 40 tvrdih kapsula.
The median time on treatment with nilotinib was 13.80 months (range: 0.7-30.9 months).
Medijan vremena na terapiji nilotinibom bio je 13,80 mjeseci (raspon: 0,7-30,9 mjeseci).
- pancreas and liver function in the body to see how Tasigna is tolerated.
- funkcija gušterače i jetre u tijelu da se vidi kako se Tasigna podnosi. - elektroliti u tijelu (kalij, magnezij).
Close monitoring for an effect on the QTc interval is advisable and a baseline ECG is recommended prior to initiating nilotinib therapy and as clinically indicated.
Savjetuje se pažljivo praćenje utjecaja na QT interval te se preporučuje učiniti bazični EKG prije početka liječenja nilotinibom, kao i kada je klinički indicirano.
Pat Evt Cen
Bol Dog Cen
Safety information from two Tasigna treatment discontinuation studies is also provided.
Navedene su i sigurnosne informacije iz dvaju ispitivanja prekida liječenja Tasignom.
Cardiovascular events were reported in a randomised Phase III study in newly diagnosed CML patients and observed in post-marketing reports.
Kardiovaskularni događaji bili su zabilježeni u randomiziranom ispitivanju faze III na bolesnicima s novodijagnosticiranim KML-om i uočeni u izvješćima nakon stavljanja lijeka u promet.
If you forget to take Tasigna
Ako ste zaboravili uzeti Tasignu