natgillin/translations-raw huggingface dataset:
l Genital swelling, incision site oedema, oedema genital, penile oedema, penile swelling, scrotal oedema, skin swelling, testicular swelling, vulvovaginal swelling. 
l Oticanje genitalija, edem na mjestu incizije, genitalni edem, edem penisa, oticanje penisa, edem skrotuma, oticanje kože,
SPRYCEL 50 mg film-coated tablets EU/1/06/363/005 
SPRYCEL 50 mg filmom obložene tablete EU/1/06/363/005
SPRYCEL 20 mg film-coated tablets Each film-coated tablet contains 20 mg dasatinib (as monohydrate). 
SPRYCEL 20 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 20 mg dasatiniba (u obliku hidrata).
White to off-white, biconvex, round film-coated tablet with "BMS 140" debossed on one side and "857" on the other side. 
Bijela do gotovo bijela, bikonveksna okrugla filmom obložena tableta s oznakom "BMS 140" utisnutom s jedne i oznakom"857" s druge strane.
85% of the radioactivity recovered in the urine and faeces, respectively. 
dana, s time da je 4% radioaktivnosti bilo otkriveno u mokraći, a 85% u stolici.
Each film-coated tablet contains 70 mg dasatinib (as monohydrate). 
Jedna filmom obložena tableta sadrži 70 mg dasatiniba (u obliku hidrata).
SPRYCEL 80 mg film-coated tablets Each film-coated tablet contains 80 mg dasatinib (as monohydrate). 
SPRYCEL 80 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 80 mg dasatiniba (u obliku hidrata).
SPRYCEL 100 mg film-coated tablets EU/1/06/363/011 
SPRYCEL 100 mg filmom obložene tablete EU/1/06/363/011
Cardiac adverse reactions 
Srčane nuspojave
SPRYCEL 50 mg film-coated tablets Each film-coated tablet contains 50 mg dasatinib (as monohydrate). 
SPRYCEL 50 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 50 mg dasatiniba (u obliku hidrata).
Median duration of treatment on dasatinib was 24 months with 51% of patients treated for > 24 months to date. 
Medijan trajanja liječenja dasatinibom iznosio je 24 mjeseca s time da je 51% bolesnika do tada bilo liječeno >24 mjeseca.
SPRYCEL is indicated for the treatment of paediatric patients with: newly diagnosed Ph+ CML in chronic phase (Ph+ CML-CP) or Ph+ CML-CP resistant or intolerant to prior therapy including imatinib. 
SPRYCEL je indiciran u liječenju pedijatrijskih bolesnika kod: novodijagnosticiranog Ph+ KML u kroničnoj fazi ili Ph+ KML u kroničnoj fazi u bolesnika koji ne podnose ili su otporni na prethodnu terapiju, uključujući imatinib. novodijagnosticiranog Ph+ ALL u kombinaciji s kemoterapijom.
Notably, 22% of patients reported a complete cytogenetic response (CCyR) in the dasatinib arm while only 8% achieved a CCyR in the imatinib arm. With longer treatment and follow-up (median of 24 months), MCyR was achieved in 53% of the dasatinib-treated patients (CCyR in 44%) and 33% of the imatinib-treated patients (CCyR in 18%) prior to crossover. 
Nakon dugotrajnijeg liječenja i praćenja (medijan trajanja, 24 mjeseca), značajni citogenetski odgovor postiglo je 53% bolesnika liječenih dasatinibom (potpuni citogenetski odgovor u 44%) te 33% bolesnika liječenih imatinibom (potpuni citogenetski odgovor u 18%) prije prelaska u suprotnu skupinu.
SPRYCEL 100 mg film-coated tablets Each film-coated tablet contains 100 mg dasatinib (as monohydrate). 
SPRYCEL 100 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 100 mg dasatiniba (u obliku hidrata).
Each film-coated tablet contains 20 mg dasatinib (as monohydrate). 
Jedna filmom obložena tableta sadrži 20 mg dasatiniba (u obliku hidrata).
SPRYCEL 50 mg film-coated tablets 
SPRYCEL 50 mg filmom obložene tablete
In patients with myeloid blast phase CML treated with the 140 mg once daily regimen, the median duration of MaHR was 8 months, the median PFS was 4 months, and the median overall survival was 8 months. 
MaHR iznosio je 8 mjeseci, medijan PFS 4 mjeseca, a medijan ukupnog preživljenja 8 mjeseci.
Cytogenetic responsec (%) 
Major Cytogenetic Response - MCyR).
SPRYCEL 100 mg: the film-coated tablet is white to off-white, biconvex, oval with “BMS 100” debossed on one side and “852” on the other side. 
SPRYCEL 100 mg: filmom obložena tableta bijele do gotovo bijele boje, bikonveksna, ovalna, s oznakom “BMS 100” utisnutom s jedne i oznakom “852” s druge strane.
CHR (advanced CML/Ph+ ALL): WBC ≤ institutional ULN, ANC ≥ 1,000/mm3, platelets ≥ 100,000/mm3, no blasts or promyelocytes in peripheral blood, bone marrow blasts ≤ 5%, < 5% myelocytes plus metamyelocytes in peripheral blood, basophils in peripheral blood < 20%, and no extramedullary involvement. 
CHR (uznapredovala KML/Ph+ ALL): broj leukocita ≤ GGN za laboratorij, ABN ≥ 1000/mm3, trombociti ≥ 100 000/mm3, bez blasta ili promijelocita u perifernoj krvi, blasti u koštanoj srži ≤ 5%, < 5% mijelociti plus metamijelociti u perifernoj krvi, bazofili u perifernoj krvi < 20%, i bez ekstramedularne bolesti.
In patients with Ph+ ALL treated with the 140 mg once daily regimen, the median duration of MaHR was 5 months the median PFS was 4 months, and the median overall survival was 7 months. 
MaHR iznosio je 5 mjeseci, medijan PFS 4 mjeseca, a medijan ukupnog preživljenja 7 mjeseci.
CHR: WBC ≤ institutional ULN, ANC ≥ 1,000/mm3, platelets ≥ 100,000/mm3, no blasts or promyelocytes in peripheral blood, bone marrow blasts ≤ 5%, < 5% myelocytes plus metamyelocytes in peripheral blood, basophils in peripheral blood < 20%, and no extramedullary involvement. 
CHR: broj leukocita ≤ GGN za laboratorij, ABN ≥ 1000/mm3, trombociti ≥ 100 000/mm3, bez blasta ili promijelocita u perifernoj krvi, blasti u koštanoj srži ≤ 5%, < 5% mijelocita plus metamijelocita u perifernoj krvi, bazofili u perifernoj krvi < 20%, i bez ekstramedularne infiltracije.
SPRYCEL 50 mg: the film-coated tablet is white to off-white, biconvex, oval with “BMS” debossed on one side and “528” on the other side. 
SPRYCEL 50 mg: filmom obložena tableta bijele do gotovo bijele boje, bikonveksna, ovalna, s oznakom “BMS” utisnutom s jedne i oznakom“528” s druge strane.
Each film-coated tablet contains 50 mg dasatinib (as monohydrate). 
Jedna filmom obložena tableta sadrži 50 mg dasatiniba (u obliku hidrata).
A reaction with fever, blisters on the skin, and ulceration of the mucous membranes Disease of the kidneys with symptoms including oedema and abnormal laboratory test results such as protein in the urine and low protein level in the blood Damage to blood vessels known as thrombotic microangiopathy (TMA), including decreased red blood cell count, decreased platelets, and formation of blood clots 
Ostale prijavljene nuspojave čija učestalost nije poznata (ne može se procijeniti iz dostupnih podataka) uključuju: upalu pluća krvarenje u želucu ili crijevima koje može dovesti do smrti ponovnu pojavu (ponovnu aktivaciju) infekcije virusom hepatitisa B ako ste u prošlosti imali hepatitis B (infekciju jetre) reakciju s vrućicom, mjehurićima na koži i ulceracijom sluznica bolesti bubrega sa simptomima koji uključuju edeme i odstupanja u rezultateima laboratorijskih testova kao što su proteini u urinu i niska razina proteina u krvi oštećenje krvnih žila koje se zove trombotična mikroangiopatija (TMA), uključujući smanjen broj crvenih krvnih stanica, smanjen broj krvnih pločica i stvaranje krvnih ugrušaka
An open-label, single-arm, multicentre study was conducted in patients with lymphoid blast phase CML or Ph+ ALL who were resistant or intolerant to prior imatinib therapy. 
Multicentrično ispitivanje otvorenog tipa u jednoj skupini provelo se u bolesnika u limfoidnoj blastnoj krizi KML ili Ph+ ALL koji su otporni na imatinib ili ga ne podnose.
Ninety-three percent of patients in the dasatinib arm and 82% of patients in the imatinib arm achieved a CHR prior to crossover. 
Prije prelaska u suprotnu skupinu, 93% bolesnika koji su primali dasatinib i 82% bolesnika koji su primali imatinib postiglo je potpuni hematološki odgovor.
SPRYCEL 80 mg film-coated tablets 
SPRYCEL 80 mg filmom obložene tablete
SPRYCEL 100 mg film-coated tablets 
SPRYCEL 100 mg filmom obložene tablete
Common gastrointestinal bleeding*, colitis (including neutropaenic colitis), gastritis, mucosal inflammation (including mucositis/stomatitis), dyspepsia, abdominal distension, constipation, oral soft tissue disorder 
Često gastrointestinalno krvarenje*, kolitis (uključujući neutropenijski kolitis), gastritis, upala sluznica (uključujući mukozitis/stomatitis), dispepsija, distenzija abdomena, konstipacija, poremećaji mekih tkiva usne šupljine Manje često pankreatitis (uključujući akutni pankreatitis), ulkus u gornjem dijelu gastrointestinalnog trakta, ezofagitis, ascites*, analna fisura, disfagija, gastroezofagealna refluksna bolest
Biochemistry 
Biokemijske pretrage
Improvements in haemodynamic and clinical parameters have been observed in patients with PAH following discontinuation of dasatinib. 
Nakon prekida primjene dasatiniba u bolesnika s PAH-om opažena su poboljšanja hemodinamskih i kliničkih parametara.
SPRYCEL 70 mg film-coated tablets dasatinib 
SPRYCEL 70 mg filmom obložene tablete dasatinib
SPRYCEL 20 mg film-coated tablets 
SPRYCEL 20 mg filmom obložene tablete
Table 8: CTC grades 3/4 haematological laboratory abnormalities in clinical studies in patients with resistance or intolerance to prior imatinib therapya 
CTC stupnja u kliničkim ispitivanjima u bolesnika koji nisu podnosili prethodnu terapiju imatinibom ili su otporni na imatiniba
Tell your doctor if you are taking medicines to thin the blood or prevent clots. 
Ako uzimate lijekove za razrjeđivanje krvi ili sprječavanje stvaranja krvnih ugrušaka, obavijestite o tome liječnika.
SPRYCEL 50 mg film-coated tablets dasatinib 
SPRYCEL 50 mg filmom obložene tablete dasatinib
Adverse reaction 
S ODGOVOROM
EU/1/06/363/004 - 56 film-coated tablets (blisters) EU/1/06/363/007 - 60 x 1 film-coated tablets (unit dose blisters) EU/1/06/363/001 - 60 film-coated tablets (bottle) 
EU/1/06/363/004 - 56 filmom obloženih tableta (blisteri) EU/1/06/363/007 - 60 x 1 filmom obložena tableta (blisteri djeljivi na jedinične doze) EU/1/06/363/001 - 60 filmom obloženih tableta (boca)
Imatinib-intolerant patients 
bolesnici otporni na imatinib
Improvements in haemodynamic and clinical parameters have been observed in dasatinib-treated patients with PAH following cessation of dasatinib therapy. 
Nakon prestanka terapije dasatinibom u bolesnika s PAH-om koji su primali dasatinib opažena su poboljšanja hemodinamskih i kliničkih parametara.
White to off-white, biconvex, oval film-coated tablet with "BMS 100" debossed on one side and "852" on the other side. 
Bijela do gotovo bijela, bikonveksna ovalna filmom obložena tableta s oznakom "BMS 100" utisnutom s jedne i oznakom"852" s druge strane.
EU/1/06/363/005 - 56 film-coated tablets (blisters) EU/1/06/363/008 - 60 x 1 film-coated tablets (unit dose blisters) EU/1/06/363/002 - 60 film-coated tablets (bottle) 
EU/1/06/363/005 - 56 filmom obloženih tableta (blisteri) EU/1/06/363/008 - 60 x 1 filmom obložena tableta (blisteri djeljivi na jedinične doze) EU/1/06/363/002 - 60 filmom obloženih tableta (boca)
k Fluid overload, fluid retention, gastrointestinal oedema, generalised oedema, peripheral swelling, oedema, oedema due to cardiac disease, perinephric effusion, post procedural oedema, visceral oedema. 
k Preopterećenje tekućinom, zadržavanje tekućine, gastrointestinalni edem, generalizirani edem, periferno oticanje, edem,
EU/1/06/363/006 - 56 film-coated tablets (blisters) EU/1/06/363/009 - 60 x 1 film-coated tablets (unit dose blisters) EU/1/06/363/003 - 60 film-coated tablets (bottle) 
EU/1/06/363/006 - 56 filmom obloženih tableta (blisteri) EU/1/06/363/009 - 60 x 1 filmom obložena tableta (blisteri djeljivi na jedinične doze) EU/1/06/363/003 - 60 filmom obloženih tableta (boca)
At all post-dose time points on day 8, the mean changes from baseline in QTcF interval were 4 - 6 msec, with associated upper 95% confidence intervals < 7 msec. Of the 2,182 patients with resistance or intolerance to prior imatinib therapy who received SPRYCEL in clinical studies, 15 (1%) had QTc prolongation reported as an adverse reaction. 
Produženja QTc intervala bila su prijavljena kao nuspojava u 15 (1%) od 2182 bolesnika koji ne podnose ili su otporni na prethodnu terapiju imatinibom, a koji su primali dasatinib u kliničkim ispitivanjima.
White to off-white, biconvex, triangular film-coated tablet with "BMS 80" debossed on one side and "855" on the other side. 
Bijela do gotovo bijela, bikonveksna trokutasta filmom obložena tableta s oznakom "BMS 80" utisnutom s jedne i oznakom"855" s druge strane.
Median duration of treatment on dasatinib was 3 months with 7% of patients treated for > 24 months to date. 
Medijan trajanja liječenja dasatinibom iznosio je 3 mjeseca s time da je 7% bolesnika do tada bilo liječeno >24 mjeseca.
White to off-white, biconvex, round film-coated tablet with "BMS" debossed on one side and "527" on the other side. 
Bijela do gotovo bijela, bikonveksna okrugla filmom obložena tableta s oznakom "BMS" utisnutom s jedne i oznakom"527" s druge strane.
EU/1/06/363/015 - 30 x 1 film-coated tablets (unit dose blisters) EU/1/06/363/014 - 30 film-coated tablets (bottle) 
EU/1/06/363/015 - 30 x 1 filmom obložena tableta (blisteri djeljivi na jedinične doze) EU/1/06/363/014 - 30 filmom obloženeihtableta (boca)
White to off-white, biconvex, round film-coated tablet with "BMS" debossed on one side and "524" on the other side. 
Bijela do gotovo bijela, bikonveksna okrugla filmom obložena tableta s oznakom "BMS" utisnutom s jedne i oznakom"524" s druge strane.
SPRYCEL 20 mg film-coated tablets dasatinib 
SPRYCEL 20 mg filmom obložene tablete dasatinib
CHR Cytogenetic responsec (%) (95% CI) 
Citogenetski odgovorc (%) (95% CI)
If you are breast-feeding, tell your doctor. 
Ako dojite, obavijestite o tome liječnika.
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 140 mg dasatinib (as monohydrate). 
2. NAVOĐENJE DJELATNE(IH) TVARI Jedna filmom obložena tableta sadrži 140 mg dasatiniba (u obliku hidrata).
EU/1/06/363/011 - 30 x 1 film-coated tablets (unit dose blisters) EU/1/06/363/010 - 30 film-coated tablets (bottle) 
EU/1/06/363/011 - 30 x 1 filmom obložena tableta (blisteri djeljivi na jedinične doze) EU/1/06/363/010 - 30 filmom obloženih tableta (boca)
EU/1/06/363/013 - 30 x 1 film-coated tablets (unit dose blisters) EU/1/06/363/012 - 30 film-coated tablets (bottle) 
EU/1/06/363/013 - 30 x 1 filmom obložena tableta (blisteri djeljivi na jedinične doze) EU/1/06/363/012 - 30 filmom obloženihtableta (boca)
What SPRYCEL looks like and contents of the pack SPRYCEL 20 mg: the film-coated tablet is white to off-white, biconvex, round with “BMS” debossed on one side and “527” on the other side. 
SPRYCEL 20 mg: filmom obložena tableta bijele do gotovo bijele boje, bikonveksna, okrugla, s oznakom “BMS” utisnutom s jedne i oznakom “527” s druge strane.
All patients 
UDIO BOLESNIKA
With the bottle in an upright position, insert the tip of the syringe firmly into the bottle adapter. 
Postavite bocu uspravno i gurnite vrh štrcaljke čvrsto u nastavak za bocu.
Inflammation of the lungs 
Oštećenje funkcije bubrega
NAME OF THE MEDICINAL PRODUCT SPRYCEL 140 mg tablets dasatinib 
SPRYCEL 140 mg tablete dasatinib
e Includes drug eruption, erythema, erythema multiforme, erythrosis, exfoliative rash, generalised erythema, genital rash, heat rash, milia, miliaria, pustular psoriaisis, rash, rash erythematous, rash follicular, rash generalised, rash macular, rash maculo-papular, rash papular, rash pruritic, rash pustular, rash vesicular, skin exfoliation, skin irritation, toxic skin eruption, urticaria vesiculosa, and vasculitic rash. 
genitalni osip, toplinski osip, milia, milijariju, pustuloznu psorijazu, osip, eritematozni osip, folikularni osip, generalizirani osip, makularni osip, makulopapulozni osip, papulozni osip, pruritički osip, pustulozni osip, vezikularni osip, ljuštenje kože, nadraženost kože, toksičnu kožnu erupciju, vezikularnu urtikariju i vaskulitični osip. f Nakon stavljanja lijeka u promet prijavljeni su pojedinačni slučajevi Stevens-Johnson sindroma.
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 100 mg dasatinib (as monohydrate). 
2. NAVOĐENJE DJELATNE(IH) TVARI Jedna filmom obložena tableta sadrži 100 mg dasatiniba (u obliku hidrata).
n/a = not applicable; CI = confidence interval; ULN = upper limit of normal range. 
MCyR (0%-35%) obuhvaća i potpuni i djelomični odgovor. n/p = nije primjenjivo CI = raspon pouzdanosti; GGN = gornja granica normalnog raspona.
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 80 mg dasatinib (as monohydrate). 
2. NAVOĐENJE DJELATNE(IH) TVARI Jedna filmom obložena tableta sadrži 80 mg dasatiniba (u obliku hidrata).
Reproductive system and breast disorders Uncommon gynecomastia, menstrual disorder General disorders and administration site conditions Very common peripheral oedemai, fatigue, pyrexia, face oedemaj 
Poremećaji reproduktivnog sustava i dojki Manje često ginekomastija, menstrualni poremećaj Opći poremećaji i reakcije na mjestu primjene
b Includes central nervous system haemorrhage, cerebral haematoma, cerebral haemorrhage, extradural haematoma, haemorrhage intracranial, haemorrhagic stroke, subarachnoid haemorrhage, subdural haematoma, and subdural haemorrhage. 
intrakranijalno krvarenje, hemoragijski moždani udar, subarahnoidalno krvarenje, subduralni hematom i subduralno krvarenje.
See the package leaflet for further information. 
Za dodatne informacije pročitajte uputu o lijeku.
Active substances that may increase dasatinib plasma concentrations In vitro studies indicate that dasatinib is a CYP3A4 substrate. 
In vitro ispitivanja pokazuju da je dasatinib supstrat enzima CYP3A4.
White to off-white, biconvex, oval film-coated tablet with "BMS" debossed on one side and "528" on the other side. 
Bijela do gotovo bijela, bikonveksna ovalna filmom obložena tableta s oznakom "BMS" utisnutom s jedne i oznakom"528" s druge strane.
Patients should be evaluated for signs and symptoms of underlying cardiopulmonary disease prior to initiating dasatinib therapy. 
Nakon povlačenja tih znakova i simptoma, a prije nastavka liječenja dasatinibom, mora se izvršiti procjena srčane funkcije.
Progression-free survivalb 
Preživljenje bez progresije bolestib
These reactions are presented by system organ class and by frequency. 
Nuspojave su prikazane prema klasifikaciji organskih sustava i učestalosti.
In patients with lymphoid blast phase CML treated with the 140 mg once daily regimen, the median duration of MaHR was 5 months, the median PFS was 5 months, and the median overall survival was 11 months. 
U bolesnika s KML u mijeloidnoj blastnoj krizi liječenih dozom od 140 mg jedanput dnevno, medijan trajanja
Pyrexia 
CCyRb
Median duration of treatment on dasatinib was 3 months with 2% treated for > 24 months to date. 
Medijan trajanja liječenja dasatinibom iznosio je 3 mjeseca, s time da je do tada 2% bolesnika bilo liječeno >24 mjeseca.
b Haematologic response criteria (all responses confirmed after 4 weeks): Complete haematologic response (CHR) (chronic CML): WBC ≤ institutional ULN, platelets <450,000/mm3, no blasts or promyelocytes in peripheral blood, <5% myelocytes plus metamyelocytes in peripheral blood, basophils in peripheral blood <20%, and no extramedullary involvement. 
CHR (kronična KML): Potpuni hematološki odgovor (CHR) (kronična KML): broj leukocita ≤ GGN za laboratorij, trombociti < 450 000/mm3, bez blasta ili promijelocita u perifernoj krvi, < 5% mijelocita plus metamijelociti u perifernoj krvi, bazofili u perifernoj krvi < 20%, i bez ekstramedularne bolesti.
Hepatic and renal impairment 
Infekcije i infestacije
NAME OF THE MEDICINAL PRODUCT SPRYCEL 140 mg film-coated tablets dasatinib 
SPRYCEL 140 mg filmom obložene tablete dasatinib
Make sure you take SPRYCEL for as long as it is prescribed. 
Uzimajte SPRYCEL onoliko dugo koliko je propisano.
Prior complete haematologic response (CHR) to imatinib was 
Potpuni hematološki odgovor (CHR - engl. complete haematologic response) na prethodno liječenje imatinibom postiglo je 93% svih bolesnika.
CHR (chronic CML): WBC ≤ institutional ULN, platelets < 450,000/mm3, no blasts or promyelocytes in peripheral blood, < 5% myelocytes plus metamyelocytes in peripheral blood, basophils in peripheral blood < 20%, and no extramedullary involvement. 
broj leukocita ≤ GGN za laboratorij, trombociti < 450 000/mm3, bez blasta ili promijelocita u perifernoj krvi, < 5% mijelocita plus metamijelociti u perifernoj krvi, bazofili u perifernoj krvi < 20%, i bez ekstramedularne bolesti.
The mutations detected among the dasatinib-treated patients were T315I, F317I/L and V299L. 
Mutacije T315I, F317I/L i V299L otkrivene su među bolesnicima liječenim dasatinibom dok je u skupini bolesnika liječenih imatinibom otkriven drugačiji spektar mutacija.
CHR (95% CI) NEL (95% CI) 
NEL (95% CI)
SPRYCEL is indicated for the treatment of adult patients with: newly diagnosed Philadelphia chromosome positive (Ph+) chronic myelogenous leukaemia (CML) in the chronic phase. 
SPRYCEL je indiciran u liječenju odraslih bolesnika kod: novodijagnosticirane kronične mijeloične leukemije (KML) s pozitivnim Philadelphia kromosomom (Ph+) u kroničnoj fazi. kronične faze, faze ubrzanja ili faze blastne krize KML uz nepodnošenje ili otpornost na prethodnu terapiju, uključujući imatinib.
Table 4: Dose adjustments for neutropaenia and thrombocytopaenia in paediatric patients with Ph+ CML-CP 
Tablica 4: Prilagodbe doze zbog neutropenije i trombocitopenije u pedijatrijskih bolesnika s
Blood and lymphatic system disorders 
Oštećenje funkcije jetre i bubrega
Table 3: Dose adjustments for neutropaenia and thrombocytopaenia in paediatric patients with Ph+ CML-CP 
Tablica 3: Prilagodbe doze zbog neutropenije i trombocitopenije u pedijatrijskih bolesnika s
If you are sick 
Ako ste bolesni
Talk to your doctor if you are not sure you can drive. 
Obratite se liječniku ako niste sigurni možete li voziti.
Specific inducers of these enzymes have not been studied and may result in a loss of efficacy. 
Specifični induktori ovih enzima nisu proučavani i mogu dovesti do smanjenja djelotvornosti.
These data show that the efficacy of the combination would be lower in these patients. 
Ovi podaci ukazuju da će djelotvornost te kombinacije biti smanjena u ovih bolesnika.
Gilbert's syndrome 
Gilbertov sindrom
EU/1/18/1315/001 84 film-coated tablets EU/1/18/1315/002 168 film-coated tablets 
EU/1/18/1315/001 84 filmom obložene tablete EU/1/18/1315/002 168 filmom obložene tablete
Mektovi can be taken with food or between meals. 
Lijek Mektovi može se uzeti s hranom ili između obroka.
It may cause permanent harm or birth defects to an unborn baby. 
Može uzrokovati trajno oštećenje ili prirođene mane u nerođenog djeteta.
• red or black stools that look like tar 
• crvenu ili crnu stolicu koja izgleda poput katrana
As a precaution, drink plenty of fluids during treatment. 
Kao mjeru opreza, pijte puno tekućine tijekom liječenja.
Mektovi is not recommended for children and adolescents under 18 years of age. 
Lijek Mektovi ne preporučuje se djeci i adolescentima mlađim od 18 godina.
PVC/PVDC/Alu blister containing 12 tablets. 
PVC/PVDC/Al blister sadrži 12 tablete.
• vomit containing blood or that looks like “coffee grounds” 
• povraćanje koje sadrži krv ili izgleda kao „talog kave”
a National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03 
Cancer Institute Common Terminology Criteria for Adverse Events, NCI CTCAE) verzija 4.03
The tablets are to be swallowed whole with water. 
Tablete treba progutati cijele s vodom.
If you miss a dose of Mektovi, take it as soon as you remember. 
Ako propustite dozu lijeka Mektovi, uzmite je čim se sjetite.
Women of childbearing potential/Contraception in females 
Žene u reproduktivnoj dobi / Kontracepcija u žena
Each pack contains either 84 or 168 tablets. 
Svako pakiranje sadrži 84 ili 168 tablete.
Then continue taking your tablets at regular times as usual. 
Zatim nastavite s uzimanjem tableta po uobičajenom rasporedu.
(11.1, NE) 
(11,1; NP)
If you vomit at any time after taking Mektovi, do not take an additional dose. 
Ako budete povraćali u bilo kojem trenutku nakon uzimanja lijeka Mektovi, nemojte uzimati dodatnu dozu.