natgillin/translations-raw huggingface dataset:
Non-clinical and clinical trials with retrospective bi-directional Sanger sequencing analyses have shown that the test also detects the less common BRAF V600D mutation and V600E/K601E mutation with lower sensitivity.
Neklinička i klinička ispitivanja s retrospektivnom dvosmjernom Sanger sekvencionirajućom analizom pokazala su da test s manjom osjetljivosti također otkriva manje česte BRAF V600D mutacije i V600E/K601E mutacije.
• Hypnotics (e.g. diazepam, midazolam, zolpidem)
• Hipnotike (npr. diazepam, midazolam, zolpidem)
Prior to initiation of treatment patients should undergo a head and neck examination with minimally visual inspection of oral mucosa and lymph node palpation, as well as chest/abdomen computerised tomography (CT) scan.
Prije početka liječenja bolesnici moraju biti podvrgnuti pregledu glave i vrata minimalno s inspekcijom sluznice usne šupljine i palpacijom limfnih čvorova, kao i snimanju prsnog koša/abdomena kompjuteriziranom tomografijom (CT).
d a - Progression-free survival (investigator assessed) b - Overall Response Rate = Complete Response + Partial Response c - Duration of response d - At the time of the reporting the majority (59% of dabrafenib+trametinib and 42% of vemurafenib) of investigator-assessed responses were still ongoing NR = Not reached
d a - Preživljenje bez progresije (procjena ispitivača) b - Ukupna stopa odgovora = kompletan odgovor + djelomični odgovor c - Trajanje odgovora d - U vrijeme izvješćivanja većina (59% za dabrafenib+trametinib i 42% za vemurafenib) odgovora koje je procijenio ispitivač bila je još u tijeku
Patients should be made aware of the potential for fatigue and eye problems to affect these activities.
Bolesnike treba obavijestiti o mogućem umoru i poteškoćama s očima koji mogu utjecati na navedene aktivnosti.
Date of first authorisation: 26 August 2013 Date of latest renewal: 08 May 2018
Datum posljednje obnove odobrenja: 08. svibnja 2018.
How to take it Swallow the capsules whole with water, one after the other.
Kapsule progutajte cijele s vodom, jednu po jednu.
Although dabrafenib and its metabolites, hydroxy-dabrafenib, carboxy-dabrafenib and desmethyl-dabrafenib, were inhibitors of human organic anion transporter (OAT) 1 and OAT3 in vitro, and dabrafenib and its desmethyl metabolite were found to be inhibitors of organic cation transporter 2 (OCT2) in vitro, the risk of a drug-drug interaction at these transporters is minimal based on clinical exposure of dabrafenib and its metabolites.
Iako su dabrafenib i njegovi metaboliti, hidroksidabrafenib, karboksidabrafenib i desmetildabrafenib, bili inhibitori humanih transportera organskih aniona (OAT) 1 i OAT3 in vitro, i dabrafenib i njegov desmetil metabolit su inhibitori transportera organskih kationa 2 (OCT2) in vitro, temeljem kliničke izloženosti dabrafenibu i njegovim metabolitima rizik od interakcije lijeka s drugim lijekom na tim transporterima je minimalan.
Some medicines may affect how Tafinlar works, or make it more likely that you will have side effects.
Neki lijekovi mogu utjecati na djelovanje lijeka Tafinlar, ili mogu povećati vjerojatnost pojave nuspojava.
separation of the light-sensitive membrane in the back of the eye (the retina) from its supporting layers (retinal detachment) and swelling around the eyes
(korioretinopatija), odvajanje membrane osjetljive na svjetlost u pozadini oka (mrežnice) od potpornih slojeva (odignuće mrežnice) i oticanje oko očiju
The onset of these serious non-infectious febrile events was typically within the first month of therapy.
Navedeni događaji ozbiljne neinfektivne vrućice obično su se javljali unutar prvog mjeseca liječenja.
• Inflammation of the fatty layer under the skin (panniculitis)
• upala masnog sloja ispod kože (panikulitis)
The potential effect of dabrafenib on QT prolongation was assessed in a dedicated multiple dose QT study.
Potencijalni učinak dabrafeniba na produljenje QT intervala procjenjivan je u ciljanom QT ispitivanju s višestrukim dozama.
Potent inducers of these enzymes should be avoided when possible as these agents may decrease the efficacy of dabrafenib (see section 4.5).
Kada je to moguće, potrebno je izbjegavati snažne induktore tih enzima budući da mogu umanjiti djelotvornost dabrafeniba (vidjeti dio 4.5).
These changes in dabrafenib AUC and Cmax are considered not clinically meaningful.
Te promjene AUC-a i Cmax-a za dabrafenib ne smatraju se klinički značajnima.
Signs that your liver may not be working properly may include: - loss of appetite - feeling sick (nausea) - being sick (vomiting) - pain in your stomach (abdomen) - yellowing of your skin or the whites of your eyes (jaundice) - dark-coloured urine - itching of your skin
Znakovi da Vaša jetra možda ne radi kako treba mogu uključivati: - gubitak apetita - mučninu - povraćanje - bol u trbuhu (abdomenu) - žutilo kože ili bjeloočnica (žutica) - tamnu mokraću - svrbež na koži
There is no specific treatment for an overdose of dabrafenib.
Ne postoji specifična terapija za slučaj predoziranja dabrafenibom.
Medicinal products that are strong inhibitors or inducers of CYP2C8 or CYP3A4 are therefore likely to increase or decrease, respectively, dabrafenib concentrations.
Lijekovi koji su snažni inhibitori ili induktori CYP2C8 ili CYP3A4 vjerojatno će stoga povisiti ili sniziti koncentracije dabrafeniba.
The assay was designed to detect the BRAF V600E and V600K mutations with high sensitivity (down to 5% V600E and V600K sequence in a background of wild-type sequence using DNA extracted from FFPE tissue).
Test je dizajniran za detekciju BRAF V600E i V600K mutacija s visokom osjetljivosti (manje od 5% V600E i V600K sekvenci u pozadini sekvenci divljeg tipa koristeći DNK izoliranu iz FFPE tkiva).
Tafinlar in combination with trametinib is also used to treat a type of lung cancer called non-small cell lung cancer (NSCLC).
Tafinlar u kombinaciji s trametinibom koristi se i za liječenje vrste raka pluća koji se zove rak pluća nemalih stanica (NSCLC).
In clinical trials in unresectable or metastatic melanoma,these cases were identified within the first 5 months of dabrafenib as monotherapy.
U kliničkim ispitivanjima neoperabilnog ili metastatskog melanoma, ti slučajevi identificirani su unutar prvih 5 mjeseci monoterapije dabrafenibom.
A small decrease in trametinib bioavailability, corresponding to a decrease in AUC of 12%, was estimated when trametinib is administered in combination with dabrafenib, a CYP3A4 inducer, using a population pharmacokinetic analysis.
Malo smanjenje u bioraspoloživosti trametiniba, koje odgovara smanjenju AUC-a od 12%, bilo je procijenjeno kada je trametinib bio primijenjen u kombinaciji s dabrafenibom, CYP3A4 induktorom, koristeći analizu populacijske farmakokinetike.
Check with your doctor if you think any of these may apply to you.
Porazgovarajte sa svojim liječnikom ako mislite da se bilo što od ovog odnosi na Vas.
The Kaplan-Meier OS curve appears to stabilise from 3 to 5 years (see Figure 2).
Čini se da se Kaplan-Meierova krivulja OS-a stabilizira od 3. do 5. godine (vidjeti sliku 2).
Therapy should be interrupted if the patient's temperature is ≥38.5ºC.
Terapija se mora prekinuti u slučaju povišenja tjelesne temperature bolesnika na ≥ 38,5ºC.
The majority of subjects had Stage IVM1c disease (67%).
Većina ispitanika imala je bolest stadija IVM1c (67%).
• Joint pain, muscle pain, or pain in the hands or feet
• bolovi u zglobovima, bolovi u mišićima ili bolovi u šakama i stopalima
It should be noted that approximately half of these occurrences with dabrafenib monotherapy (4%) and 1% with dabrafenib in combination with trametinib were Grade 3 in severity.
Treba napomenuti da je oko polovine od tih slučajeva s dabrafenibom kao monoterapijom (4%) i 1% s dabrafenibom u kombinaciji s trametinibom bilo 3. stupnja težine.
No clinically relevant effect of dabrafenib or its metabolites on the QTc interval was observed.
Nije uočen klinički značajan učinak dabrafeniba ili njegovih metabolita na QTc interval.
• Birth control medicines containing hormones (such as pills, injections or patches) may not work as well while you are taking Tafinlar or combination treatment (Tafinlar as well as trametinib).
• Lijekovi za sprječavanje trudnoće koji sadrže hormone (poput pilula, injekcija ili flastera) mogu imati oslabljeno djelovanje tijekom uzimanja lijeka Tafinlar ili kombinirane terapije (i Tafinlar i trametinib).
If possible, show them the Tafinlar pack with this leaflet.
Ako je moguće, pokažite im pakiranje lijeka Tafinlar te ovu uputu o lijeku.
A supratherapeutic dose of 300 mg dabrafenib twice daily was administered in 32 subjects with BRAF V600 mutation-positive tumours.
Supraterapijska doza od 300 mg dabrafeniba dva puta dnevno primjenjivana je u 32 ispitanika s tumorima pozitivnim na BRAF V600 mutaciju.
The ORR results assessed by IRC were consistent with the investigator assessment.
Rezultati za ORR koje je procijenio neovisni odbor za procjenu bili su u skladu s procjenom ispitivača.
Dabrafenib exposure (Cmax and AUC) increased in a dose proportional manner between 12 and 300 mg following single-dose administration, but the increase was less than dose-proportional after repeat twice daily dosing.
Izloženost dabrafenibu (Cmax i AUC) povećavala se proporcionalno dozi između 12 i 300 mg nakon primjene u jednoj dozi, ali je povećanje bilo manje proporcionalno dozi nakon dva puta dnevno ponovljene doze.
For additional information on warnings and precautions associated with trametinib treatment, please refer to the trametinib SmPC.
Za dodatne informacije o upozorenjima i mjerama opreza povezanima s liječenjem trametinibom, pogledajte sažetak opisa svojstava lijeka za trametinib.
Table 4 Adverse reactions reported in the integrated safety population of dabrafenib in combination with trametinib in the studies MEK115306, MEK116513
Tablica 4 Nuspojave zabilježene u objedinjenoj populaciji u kojoj se ispitivala sigurnost za dabrafenib u kombinaciji s trametinibom u ispitivanjima MEK115306, MEK116513
The Kaplan-Meier OS curve appears to stabilise from 3 to 5 years (see Figure 1).
Čini se da se Kaplan-Meierova krivulja OS-a stabilizira od 3. do 5. godine (vidjeti sliku 1).
• Infection of the urinary system
• infekcija mokraćnog sustava
Therapy with dabrafenib should be interrupted if the patient's temperature is ≥38.5ºC (please refer to Table 2 for dose modification guidance).
Terapija dabrafenibom mora se prekinuti u slučaju porasta tjelesne temperature bolesnika na ≥ 38,5ºC (pogledajte tablicu 2 za smjernice o prilagodbi doze).
If the fever is severe, your doctor may recommend that you stop taking Tafinlar while they treat the fever with other medicines.
Ako je vrućica izrazita, liječnik Vam može predložiti prekid terapije lijekom Tafinlar dok traje liječenje vrućice drugim lijekovima.
Skin peeling.
Ljuštenje kože.
As of 25 June 2012 cut-off, thirty five subjects (55.6%) of the 63 randomised to DTIC had crossed over to dabrafenib and 63% of subjects randomised to dabrafenib and 79% of subjects randomised to DTIC had progressed or died.
Prema podacima od 25. lipnja 2012., 35 ispitanika (55,6%) od 63 randomiziranih na DTIC je prešlo na dabrafenib, te je 63% ispitanika randomiziranih na dabrafenib i 79% ispitanika randomiziranih na DTIC imalo progresiju bolesti ili je umrlo.
b This study was designed to support or reject the null hypothesis of OIRR ≤10% (based on historical results) in favour of the alternative hypothesis of OIRR ≥ 30% in BRAF V600E mutation positive subjects.
b Ovo je ispitivanje dizajnirano za potvrdu ili odbacivanje nulte hipoteze OIRR ≤ 10% (temeljeno na ranijim podacima) u prilog alternativne hipoteze OIRR ≥ 30% u ispitanika s BRAF V600E
• reddish patches on the trunk that are circular or target-shaped, with central blisters.
• crvenkaste mrlje na trupu koje su kružnog oblika ili u obliku mete, s mjehurićima u sredini.
Prior BRAF inhibitor therapy
Prethodna terapija BRAF inhibitorom
Patients taking Tafinlar may commonly (may affect up to 1 in 10 people) develop a different type of skin cancer called cutaneous squamous cell carcinoma (cuSCC).
Bolesnici koji uzimaju Tafinlar mogu često (može se javiti u do 1 na 10 osoba) razviti drugačiju vrstu kožnog raka koji se naziva planocelularni karcinom kože.
The median time to onset of the first occurrence of cuSCC in the combination arm of the adjuvant treatment study was approximately 18 weeks and was 33 weeks in the placebo arm.
Medijan vremena do prve pojave cuSCC-a bio je otprilike 18 tjedana u skupini koja je primala kombinaciju u ispitivanju adjuvantnog liječenja i 33 tjedna u skupini koja je primala placebo.
Sixty percent of patients were male and 99.6% were Caucasian; the median age was 52 years with 21% of patients being ≥65 years, 98.4% had ECOG status of 0 or 1, and 97% of patients had metastatic disease.
Šezdeset posto bolesnika su bili muškarci i 99,6% bijele rase; medijan dobi je bio 52 godine s 21% bolesnika ≥ 65 godina, 98,4% je imalo ECOG status 0 ili 1, a 97% bolesnika je imalo metastatsku bolest.
Among the total of 93 patients who were enrolled in the combination therapy cohorts B and C, most patients were Caucasian (>90%), and similar female versus male (54% versus 46%), with a median age of 64 years in second line or higher patients and 68 years in the first line patients.
Od ukupno 93 bolesnika koliko ih je bilo uključeno u kohorte B i C koje su primale kombiniranu terapiju, većina su bili bijelci (>90%), sa sličnim omjerom žena u odnosu na muškarce (54% naspram 46%), uz medijan dobi od 64 godine u bolesnika na drugoj ili višoj liniji terapije te 68 godina u bolesnika na prvoj liniji.
Activation of MAP-kinase signalling in BRAF wild type cells which are exposed to BRAF inhibitors may lead to increased risk of non-cutaneous malignancies, including those with RAS mutations (see section 4.4).
Aktivacija signalnog puta MAP-kinaze u stanicama s divljim tipom BRAF gena koje su izložene BRAF inhibitorima može dovesti do povećanog rizika od zloćudnih bolesti koje neće zahvatiti kožu, uključujući onih s RAS mutacijama (vidjeti dio 4.4).
Effect of food on dabrafenib
Učinak hrane na dabrafenib
OS data from a further post-hoc analysis based on the 18 December 2012 data cut demonstrated a 12-month OS rate of 63% and 70% for DTIC and dabrafenib treatments, respectively.
Podaci o OS-u iz daljnje post-hoc analize temeljene na podacima sa zaključno 18. prosinca 2012. pokazali su da dvanaestomjesečni OS iznosi 63% za DTIC i 70% za dabrafenib.
Tafinlar in combination with trametinib can cause problems with your liver which may develop into serious conditions such as hepatitis and liver failure, which may be fatal.
Tafinlar u kombinaciji s trametinibom može uzrokovati tegobe s jetrom koji se mogu razviti u ozbiljne bolesti kao što su hepatitis i zatajenje jetre, koje mogu biti smrtonosne.
All patients received study medicinal product as first-line treatment for metastatic disease.
Svi su bolesnici primali ispitivani lijek kao prvu liniju terapije za mestastatsku bolest.
MEK proteins are components of the extracellular signal-related kinase (ERK) pathway.
MEK proteini su sastavni dijelovi signalnog puta kinaze regulirane izvanstaničnim signalima (engl. extracellular signal-regulated kinase, ERK).
Pelvic examinations (for women) and anal examinations are also recommended before and at the end of your treatment.
Također se preporučuje pregled zdjelice (za žene) kao i analni pregled prije i na kraju liječenja.
If the missed dose is more than 6 hours late, skip that dose and take your next dose at the usual time.
Ako s propuštenom dozom kasnite više od 6 sati, propustite tu dozu i uzmite sljedeću dozu u uobičajeno vrijeme.
Included in these clinical trials were in total 402 subjects with BRAF V600E and 49 subjects with BRAF V600K mutation.
U ova klinička ispitivanja je ukupno uključeno 402 ispitanika s BRAF V600E i 49 ispitanika s BRAF V600K mutacijom.
You may also get additional side effects due to taking trametinib at the same time as Tafinlar.
Mogli biste dobiti i dodatne nuspojave zbog uzimanja trametiniba istodobno s Tafinlarom.
(actinic keratosis), chapping or cracking of the skin
(aktinička keratoza), isušena ili ispucala koža
If dabrafenib is being used in combination with trametinib then therapy with dabrafenib may be continued at the same dose.
Ako se dabrafenib koristi u kombinaciji s trametinibom, terapija dabrafenibom može se nastaviti u istoj dozi.
When dabrafenib is used alone and in combination with trametinib, therapy with dabrafenib should be interrupted if the patient's temperature is ≥38.5
Kada se dabrafenib primjenjuje sam i u kombinaciji s trametinibom, terapiju dabrafenibom treba privremeno prekinuti ako je tjelesna temperatura bolesnika ≥ 38,5
• Blurred vision, eyesight problems, inflammation of the eye (uveitis)
• zamagljeni vid, problemi s vidom, upala oka (uveitis)
The response was durable with median DoR in the previously treated population reaching 9.8 months (95% CI, 6.9, 16.0) by investigator assessment.
Odgovor je bio dugotrajan uz medijan DoR-a u prethodno liječenoj populaciji od 9,8 mjeseci (95% CI, 6,9; 16,0) prema procjeni ispitivača.
The safety profile from MEK116513 is generally similar to that of MEK115306 with the following exceptions: 1) The following adverse reactions have a higher frequency category as compared to MEK115306: muscle spasm (very common); renal failure and lymphoedema (common); acute renal failure (uncommon); 2) The following adverse reactions have occurred in MEK116513 but not in MEK115306: cardiac failure, left ventricular dysfunction, interstitial lung disease (uncommon).
Sigurnosni profil iz MEK116513 je općenito sličan onome iz MEK115306 sa sljedećim iznimkama: 1) Sljedeće nuspojave imaju veću učestalost u usporedbi s MEK115306: spazam mišića (vrlo često); zatajenje bubrega i limfedem (često); akutno zatajenje bubrega (manje često); 2) Sljedeće nuspojave su se pojavile u MEK116513, ali ne u MEK 115306: zatajenje srca, disfunkcija lijeve klijetke, intersticijska bolest pluća (manje često).
Age greater than 75 years was a significant predictor of carboxy- and desmethyl-dabrafenib plasma concentrations with a 40% greater exposure in subjects ≥75 years of age, relative to subjects <75 years old.
Dob iznad 75 godina bila je značajan prediktor koncentracije karboksi- i desmetildabrafeniba u plazmi s 40% jačom izloženosti u ispitanika
• some medicines that reduce cholesterol levels, such as atorvastatin and simvastatin
• neke lijekove koji smanjuju razinu kolesterola, poput atorvastatina i simvastatina
Patients ≥65 years were more likely to experience SAEs and AEs leading to permanent discontinuation of medicinal product, dose reduction and dose interruption than those <65 years.
≥ 65 godina veća je bila vjerojatnost da će doživjeti ozbiljne štetne događaje i štetne događaje koji će dovesti do trajne obustave uzimanja lijeka, smanjenja doze i prekida doziranja nego u onih u dobi
How to take Tafinlar
Kako uzimati Tafinlar
Administration of dabrafenib with food reduced the bioavailability (Cmax and AUC decreased by 51% and 31% respectively) and delayed absorption of dabrafenib capsules when compared to the fasted state.
Primjena dabrafeniba uz hranu smanjila je bioraspoloživost (Cmax i AUC smanjeni za 51% odnosno 31%) i odgodila je apsorpciju kapsula dabrafeniba u usporedbi s primjenom natašte.
Co-administration resulted in increases in hydroxy- and desmethyl-dabrafenib AUC (increases of 82% and 68%, respectively).
Istovremena primjena rezultirala je porastom AUC-a hidroksi- i desmetildabrafeniba (porast od 82% odnosno 68%).
Medicinal products that alter the pH of the upper gastrointestinal (GI) tract (e.g. proton pump inhibitors, H2-receptor antagonists, antacids) are not expected to reduce the bioavailability of dabrafenib.
Ne očekuje se da lijekovi koji mijenjaju pH u gornjem dijelu probavnog sustava (npr. inhibitori protonske pumpe, antagonisti H2-receptora, antacidi) smanjuju bioraspoloživost dabrafeniba.
Tell your doctor as soon as possible if you have severe abdominal pain.
Obratite se svom liječniku čim prije ako imate jaku bol u trbuhu.
• Anticoagulants (e.g. acenocoumarol, warfarin, see section 4.4)
• Antikoagulanse (npr. acenokumarol, varfarin, vidjeti dio 4.4)
For the primary endpoint of investigator-assessed ORR, the ORR in the first line population was 61.1% (95% CI, 43.5%, 76.9%) and in the previously treated population was 66.7% (95% CI, 52.9%, 78.6%).
Za ORR kao primarnu mjeru ishoda prema procjeni ispitivača, ORR u populaciji na prvoj liniji terapije bio je 61,1% (95% CI, 43,5%, 76,9%), a u prethodno liječenoj populaciji bio je 66,7% (95% CI, 52,9%, 78,6%).
Mean metabolite to parent AUC ratios following repeat-dose administration were 0.9, 11 and 0.7 for hydroxy-, carboxy-, and desmethyl-dabrafenib, respectively.
Srednji AUC omjeri metabolita i roditeljskog spoja nakon primjene ponovljenih doza bile su 0,9, 11 i 0,7 za hidroksi-, karboksi-, i desmetildabrafenib.
When dabrafenib and trametinib are taken in combination, the once-daily dose of trametinib should be taken at the same time each day with either the morning dose or the evening dose of dabrafenib.
Kada se dabrafenib i trametinib uzimaju u kombinaciji potrebno je uzeti dozu trametiniba jedanput na dan u isto vrijeme svakoga dana bilo s jutarnjom ili s večernjom dozom dabrafeniba.
At 1 year
Na 1 godinu
Worst-case QTc prolongation of >60 millisecond (msec) was observed in 3% of dabrafenib-treated subjects (one >500 msec in the integrated safety population).
Najteži slučaj produljenja QTc od > 60 milisekundi (ms) zabilježen je u 3% ispitanika liječenih dabrafenibom (jedan > 500 ms u objedinjenoj populaciji u kojoj se ispitivala sigurnost).
Subjects were stratified by lactate dehydrogenase (LDH) level (> the upper limit of normal (ULN) versus ≤ULN) and BRAF mutation (V600E versus V600K).
Ispitanici su bili stratificirani prema razini laktat dehidrogenaze (LDH) (> gornje granice normale (GGN) naspram  GGN) i BRAF mutaciji (V600E naspram V600K).
Please also read the trametinib package leaflet for details of the side effects you may get with trametinib.
Pročitajte i uputu o lijeku za trametinib za pojedinosti o nuspojavama koje biste mogli dobiti uz trametinib.
Dabrafenib terminal half-life after a single oral dose is 8 hours due to absorption-limited elimination after oral administration (flip-flop pharmacokinetics).
Poluvrijeme dabrafeniba nakon jedne oralne doze je 8 sati zahvaljujući eliminaciji koja je nakon peroralne primjene, limitirana apsorpcijom (flip-flop farmakokinetika).
• If you are a woman who could become pregnant you must use a reliable birth control method while you are taking Tafinlar and for at least 2 weeks after you stop taking it and for at least 16 weeks following the last dose of trametinib when given in combination with Tafinlar.
• Ako ste žena koja može ostati trudna, tada tijekom uzimanja lijeka Tafinlar i još najmanje 2 tjedna nakon prestanka njegovog uzimanja, te još najmanje 16 tjedana nakon posljednje doze trametiniba kada se daje u kombinaciji s Tafinlarom, morate koristiti pouzdana sredstva za sprječavanje trudnoće.
Dabrafenib is absorbed orally with median time to achieve peak plasma concentration of 2 hours post-dose.
Dabrafenib se apsorbira oralno pri čemu je medijan vremena postizanja vršne koncentracije u plazmi 2 sata nakon primjene doze.
Dabrafenib has not been studied in patients with renal insufficiency (defined as creatinine >1.5 x ULN) therefore caution should be used in this setting (see section 5.2).
Dabrafenib nije ispitivan u bolesnika s bubrežnom insuficijencijom (definirana kao kreatinin > 1,5 x GGN), te je stoga potreban oprez u ovakvim slučajevima (vidjeti dio 5.2).
Adjuvant treatment of Stage III melanoma
Adjuvantno liječenje melanoma stadija III
Tafinlar can affect how well your heart pumps blood when taken in combination with trametinib.
Tafinlar može utjecati na to koliko će dobro srce izbacivati krv kada se uzima u kombinaciji s trametinibom.
• Decrease in number of red blood cells (anaemia), blood platelets (cells that help blood to clot),
• smanjenje broja crvenih krvnih stanica (anemija), trombocita u krvi (stanice koje pomažu u zgrušavanju krvi), i vrste bijelih krvnih stanica (leukopenija)