natgillin/translations-raw huggingface dataset:
Loss of major molecular response (MMR=BCR-ABL/ABL ≤0.1%IS) in CML patients who received nilotinib as first- or second-line therapy, or confirmed loss of MR4 (two consecutive measures separated by at least 4 weeks showing loss of MR4 (MR4=BCR-ABL/ABL ≤0.01%IS)) in CML
Gubitak velikog molekularnog odgovora (MMR=BCR-ABL/ABL ≤0,1% IS) u bolesnika s KML-om koji su primali nilotinib kao prvu ili drugu liniju terapije ili potvrđeni gubitak MR4 (dva uzastopna mjerenja u razmaku od najmanje 4 tjedna koja pokazuju gubitak MR4 (MR4=BCR-ABL/ABL ≤0,01% IS)) u bolesnika s KML-om koji su primali nilotinib kao drugu liniju terapije potaknut će ponovno započinjanje liječenja u roku od 4 tjedna od trenutka saznanja o gubitku remisije.
Imatinib 400 mg once daily (n = 283)
Imatinib 400 mg 1xdan (n = 283)
Nilotinib 300 mg twice daily (n = 282) Nilotinib 400 mg twice daily (n = 281)
Nilotinib 300 mg 2xdan (n = 282) Nilotinib 400 mg 2xdan (n = 281)
Tasigna 50 mg hard capsules nilotinib
Tasigna 50 mg tvrde kapsule nilotinib
10 <1 Very common
<1 Vrlo često 10
- 120 (3 packs of 40) hard capsules.
- 120 (3 pakiranja po 40) tvrdih kapsula.
Tasigna 150 mg hard capsules nilotinib
Tasigna 150 mg tvrde kapsule nilotinib
- 392 (14 packs of 28) hard capsules.
- 392 (14 pakiranja po 28) tvrde kapsule.
Very common Headache
Bol u udovima Često
Treatment discontinuation in adult CML patients in chronic phase who have achieved a sustained deep molecular response on nilotinib treatment following prior imatinib therapy In an open-label, single-arm study, 163 adult patients with Ph+ CML in chronic phase taking tyrosine kinase inhibitors (TKIs) for ≥3 years (imatinib as initial TKI therapy for more than 4 weeks without documented MR4.5 on imatinib at the time of switch to nilotinib, then switched to nilotinib for at least two years), and who achieved MR4.5 on nilotinib treatment as measured with the MolecularMD MRDx BCR-ABL test were enrolled to continue nilotinib treatment for additional 52 weeks (nilotinib consolidation phase).
U otvorenom ispitivanju s jednom skupinom, 163 odraslih bolesnika s Ph+ KML-om u kroničnoj fazi koji su uzimali inhibitore tirozin kinaze (TKI) ≥3 godine (imatinib kao početna terapija TKI-jem tijekom više od 4 tjedna bez dokumetniranog MR4,5 na imatinibu u vrijeme prijelaza na nilotinib, zatim prijelaz na nilotinib na najmanje dvije godine), i koji su postigli MR4,5 na terapiji nilotinibom izmjeren pomoću MolecularMD MRDx BCR-ABL testa bilo je uključeno da nastavi liječenje nilotinibom tijekom dodatnih 52 tjedna (faza konsolidacije nilotiniba).
The estimated rates of patients alive at 72 months were 91.6%, 95.8% and 91.4%, respectively (HR=0.8934 and stratified log-rank p=0.7085 between nilotinib 300 mg twice daily and imatinib, HR=0.4632 and stratified log-rank p=0.0314 between nilotinib 400 mg twice daily and imatinib).
Procijenjene stope bolesnika koji su bili živi u 72. mjesecu bile su 91,6%, 95,8% odnosno 91,4% (HR=0,8934 i stratificirani log-rang p=0,7085 između 300 mg nilotiniba dva put na dan i imatiniba, HR=0,4632 i stratificirani log-rang p=0,0314 između 400 mg nilotiniba dva put na dan i imatiniba).
Some side effects are uncommon (may affect up to 1 in 100 people) - increased skin sensitivity - dry mouth, sore throat, mouth sores - breast pain - painful and swollen joints (gout) - increased appetite - attention disorder - inability to achieve or maintain an erection - breast enlargement in men - flu-like symptoms - pneumonia, bronchitis - urinary tract infection - herpes virus infection - oral or vaginal thrush - muscle and joint stiffness, joint swelling - feeling body temperature change (including feeling hot, feeling cold) - sensitive teeth
Neke nuspojave su manje česte (mogu se javiti u manje od 1 na 100 ljudi) - povećana osjetljivost kože - suha usta, grlobolja, ranice u ustima - bol u dojkama - bolni i otečeni zglobovi (giht) - pojačan apetit - poremećaj pažnje - nemogućnost postizanja ili održavanja erekcije - povećanje dojki u muškaraca - simptomi nalik na gripu - pneumonija, bronhitis - infekcije mokraćnog trakta - infekcija s virusom herpesa - gljivična infekcija u ustima ili rodnici - ukočenost mišića i zglobova, naticanje zglobova - osjećaj promjene tjelesne temperature (uključujući osjećaj vrućine i osjećaj hladnoće) - osjetljivi zubi
Constipation, dry skin, asthenia, muscle spasms, diarrhoea, arthralgia, abdominal pain, vomiting and peripheral oedema were observed less commonly (<10% and ≥5%) were of mild to moderate severity, manageable and generally did not require dose reduction.
Konstipacija, suha koža, astenija, grčevi u mišićima, proljev, artralgija, bol u abdomenu, povraćanje i periferni edem rjeđe (<10% i ≥5%) su zapaženi i bili su blagi do umjereni s obzirom na težinu.
A total of 199 (35.2%) of all patients were not evaluable for MMR at 36 months (87 in the nilotinib 300 mg twice daily group and 112 in the imatinib group) due to missing/unevaluable PCR assessments (n=17), atypical transcripts at baseline (n=7), or discontinuation prior to the 36-month time point (n=175).
Kod ukupno 199 (35,2%) bolesnika nije bilo moguće ocijeniti MMR u 36. mjesecu (87 u skupini koja je primala nilotinib 300 mg dva puta na dan i 112 u skupini koja je primala imatinib) zbog nedostajućih/neocjenjivih PCR nalaza (n=17), atipičnih transkripcija na početku (n=7) ili prekida sudjelovanja prije isteka 36-mjesečne vremenske točke (n=175).
Black iron oxide (E172) Propylene glycol Ammonium hydroxide
Tinta za označavanje šelak željezov oksid, crni (E172) propilenglikol amonijev hidroksid
CMLCP n=321 Grade
KMLkronična faza n=321 stupanj
Imatinib-resistant or intolerant CML-CP and CML-AP 400 mg twice daily n=279
KML u kroničnoj i ubrzanoj fazi s rezistencijom ili intolerancijom na imatinib 400 mg dva puta na dan n=279
The hard capsule shell is composed of gelatin, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172) and, shellac, black iron oxide (E172), propylene glycol and ammonium hydroxide for stamping of the imprint.
Ovojnica tvrde kapsule se sastoji od želatine, titanijevog dioksida (E171), crvenog željezovog oksida (E172), žutog željezovog oksida (E172), dok šelak, crni željezov oksid (E172), propilenglikol i amonijev hidroksid čine tintu za označavanje.
The estimated rates of patients free from progression to accelerated phase or blast crisis including clonal evolution at 72 months were 98.7%, 97.9% and 93.2%, respectively (HR=0.1626 and stratified log-rank p=0.0009 between nilotinib 300 mg twice daily and imatinib once daily, HR=0.2848 and stratified log-rank p=0.0085 between nilotinib 400 mg twice daily and imatinib once daily).
Procijenjene stope bolesnika bez progresije do ubrzane faze ili blastične krize uključujući klonalnu evoluciju u 72. mjesecu bile su 98,7%, 97,9% odnosno 93,2% (HR=0,1626 i stratificirani log-rang p=0,0009 između 300 mg nilotiniba dva puta na dan i imatiniba jedanput na dan, HR=0,2848 i stratificirani log-rang p=0,0085 između 400 mg nilotiniba dva put na dan i imatiniba jedanput na dan).
120 (3 packs of 40) hard capsules.
120 (3 pakiranja po 40) tvrdih kapsula.
Tasigna 50 mg hard capsules
Tasigna 50 mg tvrde kapsule
1 Common
1 Često
Return to CP
Povratak u kroničnu fazu
In the Phase III study in patients with newly diagnosed CML in chronic phase receiving 300 mg nilotinib twice daily, the change from baseline in mean time-averaged QTcF interval at steady state was 6 msec. No patient had a QTcF >480 msec. No episodes of torsade de pointes were observed.
U ispitivanju faze III u bolesnika s novodijagnosticiranim KML-om u kroničnoj fazi koji su primali 300 mg nilotiniba dva puta na dan, promjena srednjeg prosječnog vremena QTcF intervala u stanju dinamičke ravnoteže bila je 6 msek u odnosu na početnu vrijednost.
PA/Alu/PVC/Alu [in wallet] 112 hard capsules
PA/Al/PVC/Al [u džepnom pakiranju] 112 tvrdih kapsula
One hard capsule contains 200 mg nilotinib (as hydrochloride monohydrate).
Jedna tvrda kapsula sadrži 200 mg nilotiniba (u obliku nilotinibklorid hidrata).
The estimated rates of patients free from progression to accelerated phase or blast crisis at 72 months were 99.3%, 98.7% and 95.2%, respectively (HR=0.1599 and stratified log-rank p=0.0059 between nilotinib 300 mg twice daily and imatinib once daily, HR=0.2457 and stratified log-rank p=0.0185 between nilotinib 400 mg twice daily and imatinib once daily).
Procijenjene stope bolesnika bez progresije do ubrzane faze ili blastične krize u 72. mjesecu bile su 99,3%, 98,7% odnosno 95,2% (HR=0,1599 i stratificirani log-rang p=0,0059 između 300 mg nilotiniba dva puta na dan i imatiniba jedanput na dan, HR=0,2457 i stratificirani log-rang p=0,0185 između 400 mg nilotiniba dva put na dan i imatiniba jedanput na dan).
Erythema multiforme, erythema nodosum, skin ulcer, palmar-plantar erythrodysaesthesia syndrome, petechiae, photosensitivity, blister, dermal cysts, sebaceous hyperplasia, skin atrophy, skin discolouration, skin exfoliation, skin hyperpigmentation, skin hypertrophy, hyperkeratosis, psoriasis
Eritem multiforme, nodozni eritem, ulkus kože, palmarnoplantarni eritrodisestezijski sindrom, petehije, fotoosjetljivost, mjehurići, kožne ciste, hiperplazija žlijezda lojnica, atrofija kože, promjena boje kože, eksfolijacija kože, hiperpigmentacija kože, hipertrofija kože, hiperkeratoza, psorijaza Poremećaji mišićno koštanog sustava i vezivnog tkiva Često:
Oesophageal ulcer, gastric ulcer, oesophageal pain, stomatitis, dry mouth, enterocolitis, haemorrhoids, hiatus hernia, rectal haemorrhage, gingivitis Hepatobiliary disorders Very common:
Ulkus jednjaka, želučani ulkus, bol u jednjaku, stomatitis, suha usta, enterokolitis, hemoroidi, hijatalna hernija, rektalno krvarenje, gingivitis Poremećaji jetre i žuči Vrlo često:
• Multipacks containing 112 (4 packs of 28) hard capsules.
• višestruka pakiranja koja sadrže 112 (4 pakiranja po 28) tvrdih kapsula.
In adult patients with imatinib-resistant or intolerant CML in chronic phase and accelerated phase The data described below reflect exposure to nilotinib in 458 adult patients in an open-label multicentre Phase II study in patients with imatinib-resistant or intolerant CML in chronic phase (n=321) and accelerated phase (n=137) treated at the recommended dose of 400 mg twice daily.
Podaci prikazani u nastavku odražavaju izloženost nilotinibu u 458 odraslih bolesnika u otvorenom multicentričnom ispitivanju faze II u bolesnika s KML-om u kroničnoj (n=321) i ubrzanoj fazi (n=137) s rezistencijom ili intolerancijom na imatinib, a koji su liječeni preporučenom dozom od 400 mg dva puta na dan.
One hard capsule contains 150 mg nilotinib (as hydrochloride monohydrate).
Jedna tvrda kapsula sadrži 150 mg nilotiniba (u obliku nilotinibklorid hidrata).
Adult patients with imatinib-resistant or intolerant CML in accelerated phase at 400 mg twice daily
Odrasli bolesnici u ubrzanoj fazi KML-a s rezistencijom ili intolerancijom na imatinib uz primjenu 400 mg dva puta na dan
Gelatin
Žutica
During Tasigna treatment, you may also have some abnormal blood test results such as: low level of blood cells (white cells, red cells, platelets) or haemoglobin increase in the number of platelets or white cells, or specific types of white cells (eosinophils) in the blood high blood level of lipase or amylase (pancreas function) high blood level of bilirubin or liver enzymes (liver function) high blood level of creatinine or urea (kidney function) low or high blood level of insulin (a hormone regulating blood sugar level) low or high level of sugar, or high level of fats (including cholesterol) in the blood high blood level of parathyroid hormone (a hormone regulating calcium and phosphorus level) change in blood proteins (low level of globulins or presence of paraprotein) high blood levels of enzymes (alkaline phosphatase, lactate dehydrogenase or creatine phosphokinase) high blood level of potassium, calcium, phosphorus or uric acid low blood level of magnesium, potassium, sodium, calcium, or phosphorus
(eozinofila) u krvi - povišena razina lipaze ili amilaze u krvi (funkcija gušterače) - povišena razina bilirubina ili jetrenih enzima u krvi (funkcija jetre) - povišena razina kreatinina ili ureje u krvi (funkcija bubrega) - snižena ili povišena razina inzulina u krvi (hormona koji regulira razinu šećera u krvi) - snižena ili povišena razina šećera ili povišena razina masnoća (uključujući kolesterol) u krvi - povišena razina paratireoidnog hormona u krvi (hormona koji regulira razine kalcija i fosfora u krvi) - promjena proteina u krvi (snižena razina globulina ili prisutnost paraproteina) - povišena razina enzima u krvi (alkalne fosfataze, laktat dehidrogenaze ili kreatin fosfokinaze) - povišena razina kalija, kalcija, fosfora ili mokraćne kiseline u krvi - snižena razina magnezija, kalija, natrija, kalcija ili fosfora u krvi
PVC/PVDC/Alu [in carton] 120 hard capsules
PVC/PVDC/Al [u kutiji] 120 tvrdih kapsula
A total of 322 (38.1%) of all patients were not evaluable for MMR at 60 months (99 in the nilotinib 300 mg twice daily group, 93 in the nilotinib 400 mg twice daily group and 130 in the imatinib group) due to missing/unevaluable PCR assessments (n=9), atypical transcripts at baseline (n=8) or discontinuation prior to the 60-month time point (n=305).
Kod ukupno 322 (38,1%) bolesnika nije bilo moguće ocijeniti MMR u 60. mjesecu (99 u skupini koja je primala nilotinib 300 mg dva puta na dan, 93 u skupini koja je primala nilotinib 400 mg dva puta na dan i 130 u skupini koja je primala imatinib) zbog nedostajućih/neocjenjivih PCR nalaza (n=9), atipičnih transkripcija na početku (n=8) ili prekida sudjelovanja prije vremenske točke u 60. mjesecu (n=305).
CML-AP n=137
KML - ubrzana faza n=137
By 6 years 79%; P < .0001
Do 6. godine 79%; P < 0,0001
Some side effects are common (may affect up to 1 in 10 people) - diarrhoea, vomiting, abdominal pain, stomach discomfort after meals, flatulence, swelling or bloating of the abdomen, constipation - bone pain, pain in joints, muscle spasms, muscle weakness, pain in extremity, back pain, pain or discomfort in the side of the body - upper respiratory tract infections - dry skin, acne, wart, decreased skin sensitivity - loss of appetite, disturbed sense of taste, weight increase - insomnia, anxiety, depression - night sweats, excessive sweating
Neke nuspojave su česte (mogu se javiti u manje od 1 na 10 ljudi) - proljev, povraćanje, bol u trbuhu, nelagoda u želucu nakon obroka, vjetrovi, nadutost ili nadimanje u trbuhu, zatvor - bol u kostima, bol u zglobovima, grčevi u mišićima, slabost mišića, bol u udovima, bol u leđima, bol ili nelagoda u jednom dijelu tijela - infekcije gornjeg dišnog sustava - suha koža, akne, bradavice, smanjena osjetljivost kože - gubitak apetita, poremećen osjet okusa, porast tjelesne težine - nesanica, tjeskoba, depresija - noćno znojenje, pojačano znojenje
Adult Philadelphia chromosome positive CML patients in chronic phase who have been treated with nilotinib as first-line therapy and who achieved a sustained deep molecular response (MR4.5) Discontinuation of treatment may be considered in eligible adult Philadelphia chromosome positive (Ph+) CML patients in chronic phase who have been treated with nilotinib at 300 mg twice daily for a minimum of 3 years if a deep molecular response is sustained for a minimum of one year immediately prior to discontinuation of therapy.
Prekid liječenja može se razmotriti kod podobnih odraslih bolesnika s KML-om s pozitivnim Philadelphia kromosomom (Ph+) u kroničnoj fazi koji su bili liječeni nilotinibom od 300 mg dvaput na dan tijekom najmanje 3 godine ako se duboki molekularni odgovor održao najmanje godinu dana neposredno prije prekida terapije.
Some side effects are very common (may affect more than 1 in 10 people) - headache - tiredness - muscle pain - itching, rash - nausea - hair loss - musculoskeletal pain, muscle pain, pain in extremity, pain in joints, bone pain and spinal pain upon discontinuing treatment with Tasigna - slowing of growth in children and adolescents
Neke nuspojave su vrlo česte (mogu se javiti u više od 1 na 10 ljudi) - glavobolja - umor - bol u mišićima - svrbež, osip - mučnina - gubitak kose - mišićno-koštana bol, bol u mišićima, bol u udovima, bol u zglobovima, bol u kostima i bol u kralježnici nakon prekida liječenja Tasignom - usporen rast kod djece i adolescenata
CMH test p-value for response rate (versus imatinib 400 mg once daily)
Do 24. mjeseca Odgovor (95% CI) Bez odgovora p-vrijednost CMH* testa za stopu odgovora (u odnosu na 400 mg imatiniba jedanput na dan)
A total of 395 (46.7%) of all patients were not evaluable for MMR at 72 months (130 in the nilotinib 300 mg twice daily group, 110 in the nilotinib 400 mg twice daily group and 155 in the imatinib group) due to missing/unevaluable PCR assessments (n=25), atypical transcripts at baseline (n=8) or discontinuation prior to the 72-month time point (n=362).
Kod ukupno 395 (46,7%) bolesnika nije bilo moguće ocijeniti MMR u 72. mjesecu (130 u skupini koja je primala nilotinib 300 mg dva puta na dan, 110 u skupini koja je primala nilotinib 400 mg dva puta na dan i 155 u skupini koja je primala imatinib) zbog nedostajućih/neocjenjivih PCR nalaza (n=25), atipičnih transkripcija na početku (n=8) ili prekida sudjelovanja prije vremenske točke u 72. mjesecu (n=362).
9/l and/or platelets >75 x 10 9/l.
9/l i/ili trombociti >75 x 10
0 Very common
0 Često
By 3 years
Do 3. godine
Some side effects are very common (may affect more than 1 in 10 people) - diarrhoea - headache - tiredness, lack of energy - muscle pain - itching, rash - nausea - abdominal pain - constipation - vomiting - hair loss - musculoskeletal pain, muscle pain, pain in extremity, pain in joints, bone pain and spinal pain upon discontinuing treatment with Tasigna - slowing of growth in children and adolescents
Neke nuspojave su vrlo česte (mogu se javiti u više od 1 na 10 ljudi) - proljev - glavobolja - umor, nedostatak energije - bol u mišićima - svrbež, osip - mučnina - bol u trbuhu - zatvor - povraćanje - gubitak kose - mišićno-koštana bol, bol u mišićima, bol u udovima, bol u zglobovima, bol u kostima i bol u kralježnici nakon prekida liječenja Tasignom - usporen rast kod djece i adolescenata
During Tasigna treatment, you may also have some abnormal blood test results such as: - low level of blood cells (white cells, red cells, platelets) or haemoglobin - increase in the number of platelets or white cells, or specific types of white cells (eosinophils) in the blood - high blood level of lipase or amylase (pancreas function) - high blood level of bilirubin or liver enzymes (liver function) - low or high blood level of insulin (a hormone regulating blood sugar level) - low or high level of sugar, or high level of fats (including cholesterol) in the blood - high blood level of parathyroid hormone (a hormone regulating calcium and phosphorus level) - change in blood proteins (low level of globulins or presence of paraprotein) - high blood level of alkaline phosphatase - high blood level of potassium, calcium, phosphorus or uric acid - low blood level of potassium or calcium
(eozinofila) u krvi - povišena razina lipaze ili amilaze u krvi (funkcija gušterače) - povišena razina bilirubina ili jetrenih enzima u krvi (funkcija jetre) - snižena ili povišena razina inzulina u krvi (hormona koji regulira razinu šećera u krvi) - snižena ili povišena razina šećera ili povišena razina masnoća (uključujući kolesterol) u krvi - povišena razina paratireoidnog hormona u krvi (hormona koji regulira razine kalcija i fosfora u krvi) - promjena proteina u krvi (snižena razina globulina ili prisutnost paraproteina) - povišena razina alkalne fosfataze u krvi - povišena razina kalija, kalcija, fosfora ili mokraćne kiseline u krvi - snižena razina kalija ili kalcija u krvi
One hard capsule contains 50 mg nilotinib (as hydrochloride monohydrate).
Jedna tvrda kapsula sadrži 50 mg nilotiniba (u obliku nilotinibklorid hidrata).
PA/Alu/PVC/Alu [in wallet] 28 hard capsules
PA/Al/PVC/Al [u džepnom pakiranju] 28 tvrdih kapsula
Newly diagnosed CML-CP 300 mg twice daily
Novodijagnosticirani KML u kroničnoj fazi 300 mg dva puta na dan
Some side effects are common (may affect up to 1 in 10 people) - upper respiratory tract infections - stomach discomfort after meals, flatulence, swelling or bloating of the abdomen - bone pain, pain in joints, muscle spasms, muscle weakness - pain including back pain, neck pain and pain in extremity, pain or discomfort in the side of the body - dry skin, acne, wart, decreased skin sensitivity, hives - loss of appetite, disturbed sense of taste, weight decrease or increase - insomnia, depression, anxiety - night sweats, excessive sweating - generally feeling unwell - voice disorder - nose bleed - frequent urine output
Neke nuspojave su česte (mogu se javiti u manje od 1 na 10 ljudi) - infekcije gornjeg dišnog sustava - nelagoda u želucu nakon obroka, vjetrovi, nadutost ili nadimanje u trbuhu - bol u kostima, bol u zglobovima, grčevi u mišićima, slabost mišića - bol, uključujući bol u leđima, bol u vratu i bol u udovima, bol ili nelagoda u jednom dijelu tijela - suha koža, akne, bradavice, smanjena osjetljivost kože, koprivnjača - gubitak apetita, poremećen osjet okusa, pad ili porast tjelesne težine - nesanica, depresija, tjeskoba - noćno znojenje, pojačano znojenje - opće loše stanje - poremećaj glasa - krvarenje iz nosa - često mokrenje
Eyelid oedema, photopsia, conjunctival haemorrhage, hyperaemia (scleral, conjunctival, ocular)
Edem kapka, fotopsija, krvarenje konjunktive, hiperemija (bjeloočnice, konjunktive, oka)
Exfoliative rash, drug eruption, skin pain, ecchymosis, swelling face
Eksfolijativni osip, izbijanje kožnih promjena uzrokovano lijekom, kožna bol, ekhimoza, oticanje lica
PVC/PVDC/Alu [in carton] 40 hard capsules
PVC/PVDC/Al [u kutiji] 40 tvrdih kapsula
Adult Philadelphia chromosome positive CML patients in chronic phase who have achieved a sustained deep molecular response (MR 4.5) on nilotinib following prior imatinib therapy Discontinuation of treatment may be considered in eligible adult Philadelphia chromosome positive (Ph+) CML patients in chronic phase who have been treated with nilotinib for a minimum of 3 years if a deep molecular response is sustained for a minimum of one year immediately prior to discontinuation of therapy.
Prekid liječenja može se razmotriti kod podobnih odraslih bolesnika s KML-om s pozitivnim Philadelphia kromosomom (Ph+) u kroničnoj fazi koji su bili liječeni nilotinibom tijekom najmanje 3 godine ako se duboki molekularni odgovor održao najmanje godinu dana neposredno prije prekida terapije.
The recommended dose of nilotinib is 230 mg/m twice daily, rounded to the nearest 50 mg dose (to a maximum single dose of 400 mg) (see Table 1).
Doziranje za pedijatrijske bolesnike s KML-om s pozitivnim Philadelphia kromosomom Doziranje u pedijatrijskih bolesnika je individualizirano i temelji se na tjelesnoj površini (mg/m Preporučena doza nilotiniba je 230 mg/m dva puta na dan, zaokruženo na najbližu dozu od 50 mg (do maksimalne pojedinačne doze od 400 mg) (vidjeti Tablicu 1).
Metabolism and nutrition disorders Very common:
Sekundarni hiperparatireoidizam Poremećaji metabolizma i prehrane Vrlo često:
The data described below reflect exposure to nilotinib in 279 adult patients from a randomised Phase III study in patients with newly diagnosed Ph+ CML in chronic phase treated with 300 mg of nilotinib twice daily.
Podaci navedeni u nastavku prikazuju izloženost nilotinibu u 279 odraslih bolesnika iz randomiziranog ispitivanja faze III u novodijagnosticiranih bolesnika s KML-om u kroničnoj fazi liječenih dozom od 300 mg nilotiniba dva puta na dan.Navedene su i sigurnosne informacije iz ispitivanja prekida liječenja nilotinibu u KML bolesnika koji su liječeni Tasignom u prvoj liniji.
Cerebrovascular accident, brain oedema, optic neuritis, lethargy, dysaesthesia, restless legs syndrome
Cerebrovaskularni inzult, edem mozga, upala očnog živca, letargija, disestezija, sindrom nemirnih nogu
CML-CP n=321
KML - kronična faza n=321