natgillin/translations-raw huggingface dataset:
Tafinlar are also available as 50 mg capsules if a dose reduction is recommended. 
Zdravilo Tafinlar je na voljo tudi v 50-mg kapsulah, če je priporočljivo znižati odmerek.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: 
Za vse morebitne nadaljne informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom:
Observed cases were generally associated with pyrexia and dehydration and responded well to dose interruption and general supportive measures. 
Opaženi primeri so bili na splošno povezani z zvišano telesno temperaturo in dehidracijo ter so se dobro odzvali na prekinitev odmerjanja in splošne podporne ukrepe.
All patients received study medicinal product as first-line treatment for metastatic disease. 
Vsi bolniki so študijsko zdravilo prejemali kot prvo linijo zdravljenja metastatske bolezni.
• If you get side effects your doctor may decide that you should take lower doses of Tafinlar and / or trametinib. 
• Če pride do neželenih učinkov, se zdravnik lahko odloči za znižanje odmerka zdravila Tafinlar in/ali trametiniba.
Median PFS after cross-over was 4.4 months. 
Mediano preživetje brez napredovanja po prehodu je bilo 4,4 meseca.
Time from randomisation (months) 
čas od randomizacije (meseci)
They may arrange for you to see a specialist eye doctor for a complete eye examination. 
Morda vas bodo napotili k specialistu za očesne bolezni, ki bo opravil celoten očesni pregled.
Patients with LVEF lower than the institutional lower limit of normal were not included in clinical trials with dabrafenib. 
Bolniki, ki so imeli LVEF manjši od institucionalne spodnje meje normalne vrednosti, niso bili vključeni v klinična preskušanja dabrafeniba.
It is used either on its own or in combination with another medicine containing trametinib in adults to treat a type of skin cancer called melanoma that has spread to other parts of the body, or cannot be removed by surgery. 
Uporablja se bodisi samostojno ali v kombinaciji z drugim zdravilom, ki vsebuje trametinib, pri odraslih za zdravljenje vrste kožnega raka, imenovanega melanom, ki se je razširil v druge dele telesa ali ga ni mogoče odstraniti z operacijo.
CI = Confidence Interval NR = Not reached 
IZ = interval zaupanja ND = vrednost ni dosežena
Therefore before starting treatment your doctor will test for this mutation. 
Zdravnik vas bo pred zdravljenjem testiral za to mutacijo.
Adverse drug reactions are listed below by MedDRA system organ class ranked by frequency using the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (1/1,000 to <1/100), rare (1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data). 
Neželeni učinki zdravila so navedeni glede na organski sistem po MedDRA klasifikaciji in so razvrščeni po pogostnosti po naslednjem dogovoru: zelo pogosti (≥1/10); pogosti (≥1/100 do <1/10); občasni (≥1/1.000 do <1/100); redki (≥1/10.000 do <1/1.000); zelo redki (<1/10.000) in pogostnost neznana (ni mogoče oceniti iz razpoložljivih podatkov).
Patients who were previously untreated or failed at least one prior systemic therapy (results from the Phase II [BREAK-2]) 
Bolniki, ki predhodno niso bili zdravljeni ali pri katerih je bilo vsaj eno predhodno sistemsko zdravljenje neuspešno (rezultati II.
Patients should be evaluated for signs and symptoms of infection and if necessary treated in line with local practice (see section 4.4). 
Bolnike je treba pregledati glede morebitnih znakov in simptomov okužbe in, če je treba, zdraviti v skladu z lokalno prakso (glejte poglavje 4.4).
Blood pressure should be measured at baseline and monitored during treatment, with control of hypertension by standard therapy as appropriate. 
Krvni tlak je treba izmeriti izhodiščno in ga kontrolirati med zdravljenjem; hipertenzijo je treba obvladovati s standardnim zdravljenjem, kot je ustrezno.
Patients should be routinely monitored for serum creatinine while on therapy. 
Bolnikom je treba med zdravljenjem rutinsko določati vrednost kreatinina v serumu.
The confirmed OIRR and other efficacy results per investigator assessment are presented in Table 13. 
Potrjeni OIRR in druge rezultate učinkovitosti po raziskovalčevi oceni prikazuje preglednica 13.
Terminal half-life of dabrafenib following an intravenous single microdose is 2.6 hours. 
Terminalni razpolovni čas dabrafeniba po intravenski uporabi enega samega mikroodmerka je 2,6 ure.
Table 15 Summary of efficacy in the combination treatment cohorts based on investigator and independent radiology review 
Preglednica 15 Pregled učinkovitosti v kohortah s kombiniranim zdravljenjem po ocenah raziskovalcev in neodvisnih radiologov
Contains desiccant, do not remove or eat. 
Vsebuje sušilo, ki ga ne odstranite in ne zaužijte.
Before initiating treatment, patients should be advised of the signs and symptoms and monitored closely for skin reactions. 
Pred uvedbo zdravljenja je treba bolnike opozoriti na znake in simptome kožnih reakcij in jih skrbno spremljati.
Determination of BRAF mutation status 
Določanje mutacijskega stanja BRAF
Your doctor may ask you to stop taking trametinib or refer you to a specialist, if you develop signs and symptoms in your vision that include: 
Naroči vam lahko, da prenehajte jemati trametinib, ali vas napoti k specialistu, če se vam pojavijo znaki in simptomi, ki prizadenejo vid, na primer:
Treatment with dabrafenib should be initiated and supervised by a qualified physician experienced in the use of anticancer medicinal products. 
Zdravljenje z dabrafenibom mora uvesti in nadzorovati usposobljen zdravnik, ki ima izkušnje z uporabo zdravil proti raku.
• Take Tafinlar and trametinib on an empty stomach, at least one hour before or two hours after a meal. 
• Zdravilo Tafinlar in trametinib jemljite na prazen želodec, najmanj eno uro pred obrokom in najmanj dve uri po obroku.
Tafinlar can cause heart problems, or make existing heart problems worse (see also “Heart conditions” in section 4), in people taking Tafinlar in combination with trametinib. 
Zdravilo Tafinlar lahko povzroči težave s srcem, ali poslabša že obstoječe težave s srcem (glejte tudi »Srčne motnje« v poglavju 4) pri ljudeh, ki jemljejo zdravilo Tafinlar v kombinaciji s trametinibom.
• have any lung or breathing problems, including difficulty in breathing often accompanied by a dry cough, shortness of breath and fatigue. 
• če imate težave s pljuči ali dihanjem, kar vključuje oteženo dihanje, ki ga pogosto spremlja suh kašelj, zadihanost in utrujenost.
Others may develop a type of skin cancer called basal cell carcinoma (BCC). 
Drugi lahko razvijejo vrsto kožnega raka imenovano bazalnocelični karcinom (BCC - basal cell carcinoma).
It may be good for you to get into the habit of taking both medicines at the same times each day. 
Najbolje je, da se navadite jemati vsako od zdravil vsak dan ob istem času.
Treatment with anti-pyretics such as ibuprofen or acetaminophen/paracetamol should be initiated. 
Uvesti je treba zdravljenje z antipiretiki, kot sta ibuprofen ali acetaminofen/paracetamol.
* The intensity of clinical adverse events graded by the Common Terminology Criteria for Adverse Events (CTC-AE) v4.0 
* Izrazitost kliničnih neželenih dogodkov po CTC-AE (Common Terminology Criteria for Adverse Events) verzija 4.0.
A total of 870 patients were randomised to the combination therapy (n=438) and placebo (n=432) arms. 
Skupno 870 bolnikov so randomizirali v skupino s kombiniranim zdravljenjem (n = 438) in v skupino s placebom (n = 432).
• If you miss a dose of Tafinlar or trametinib, take it as soon as you remember. 
• Če pozabite vzeti odmerek zdravila Tafinlar ali trametiniba, ga vzemite takoj, ko se spomnite.
During treatment patients should be monitored as clinically appropriate which may include a head and neck examination every 3 months and a chest/abdomen CT scan every 6 months. 
Med zdravljenjem je treba bolnike nadzirati, kot je klinično primerno; to lahko vključuje pregled glave in vratu na 3 mesece in CT-slikanje prsnega koša/trebuha vsakih 6 mesecev.
• some medicines for tuberculosis (TB), such as rifampicin 
• nekatera zdravila proti tuberkulozi (TB), npr. rifampicin
The primary endpoint of the study was intracranial response in Cohort A, defined as the percentage of patients with a confirmed intracranial response assessed by the investigator using modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. 
Primarni cilj opazovanja v študiji je bil intrakranialni odziv v kohorti A, ki je bil definiran kot odstotek bolnikov s potrjenim intrakranialnim odzivom po oceni raziskovalcev glede na verzijo 1.1 modificiranih kriterijev za vrednotenje odziva pri solidnih tumorjih (RECIST-Response Evaluation Criteria In Solid Tumors).
A decision should be made whether to discontinue breast-feeding or discontinue dabrafenib, taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman. 
Odločiti se je treba bodisi za prenehanje dojenja bodisi za prenehanje zdravljenja z dabrafenibom, upoštevaje koristi dojenja za otroka in koristi zdravljenja za žensko.
Mean absolute bioavailability of oral dabrafenib is 95% (90% CI: 81, 110%). 
Povprečna absolutna biološka uporabnost peroralnega dabrafeniba je 95 % (90-odstotni IZ: od 81 do 110 %).
What you need to know before you take Tafinlar 
Kaj morate vedeti, preden boste vzeli zdravilo Tafinlar
Otherwise, similar toxicities were observed as in comparable monotherapy studies. 
Sicer so pri teh psih opažali podobne toksične učinke kot v primerljivih študijah z monoterapijo.
• warfarin and acenocoumarol, medicines used to thin the blood 
• varfarin in acenokumarol, zdravili proti strjevanju krvi
There are no data from the use of dabrafenib in pregnant women. 
Podatkov o uporabi dabrafeniba pri nosečnicah ni.
Dabrafenib should be taken at least one hour before, or at least 2 hours after a meal. 
Dabrafenib je treba vzeti najmanj eno uro pred jedjo oziroma najmanj 2 uri po jedi.
Alanine aminotransferase increased Aspartate aminotransferase increased 
Zelo pogosti zvišana vrednost alanin aminotransferaze zvišana vrednost aspartat aminotransferaze
Abbreviations: CI: confidence interval; DTIC: dacarbazine; HR: hazard ratio; NR: not reached a 
Okrajšave: IZ: interval zaupanja, DTIC: dakarbazin, ROg: razmerje ogroženosti, ND: ni doseženo a
• Lack of energy, feeling weak 
• pomanjkanje energije, občutek šibkosti
Data as of December 19, 2011 
Podatki z dne 19. decembra 2011
It is very important to tell your doctor, pharmacist or nurse immediately if you develop these symptoms, especially if you have a painful, red eye that does not clear up quickly. 
Zelo pomembno je, da zdravnika, farmacevta ali medicinsko sestro nemudoma obvestite, če se vam pojavijo ti simptomi, zlasti če vas oko boli ali je pordelo in to ne mine hitro.
Patients presenting with malignancies with confirmed activating RAS mutations were not eligible. 
Bolniki z maligno boleznijo s potrjeno aktivacijo mutacije RAS niso bili primerni za vključitev.
If necessary, your doctor may decide to interrupt your treatment or to stop it altogether. 
Če je treba, lahko zdravnik vaše zdravljenje prekine ali ga povsem konča.
Before starting treatment, tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines. 
Pred začetkom zdravljenja obvestite zdravnika, farmacevta ali medicinsko sestro, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
Cmax of S- and R-warfarin increased 18% and 19%. 
Cmax S-varfarina se je povečala za 18 % in R-varfarina za 19 %.
If the missed dose is less than 6 hours late, take it as soon as you remember. 
Če je zamuda z izpuščenim odmerkom krajša od 6 ur, ga vzemite, čim se spomnite.
OS data from a further post-hoc analysis based on a 18 December 2012 data cut are shown in Figure 3. 
Podatki o celokupnem preživetju iz nadaljnje post hoc analize na podlagi podatkov do presečnega datuma 18. decembra 2012 so prikazani na sliki 3.
Number of patients Died (event), n 
Število bolnikov umrli (dogodek), n (%)
A total of 704 subjects were randomised 1:1 to either combination or vemurafenib. 
Skupno so randomizirali 704 preiskovance v razmerju 1:1 tako, da so prejemali bodisi kombinacijo ali pa vemurafenib.
Dabrafenib should not be administered to pregnant women unless the potential benefit to the mother outweighs the possible risk to the foetus. 
Nosečnice naj ne bi prejemale dabrafeniba, razen če možna korist za mater odtehta možno tveganje za plod.
It is not known whether dabrafenib is excreted in human milk. 
Ni znano, ali se dabrafenib pri človeku izloča v materinem mleku.
You and your doctor will decide if you will take this medicine or breast-feed. 
Skupaj z zdravnikom se boste odločili, ali boste jemali to zdravilo ali pa boste dojili.
• New melanoma 
• nov melanom
In the first line population, 68% of patients had not progressed after 9 months. 
V skupini predhodno nezdravljenih bolnikov pri 68 % bolnikov v 9 mesecih ni prišlo do napredovanja bolezni.
Dabrafenib is an in vitro inhibitor of human organic anion transporting polypeptide (OATP) 1B1 (OATP1B1), OATP1B3 and BCRP. 
Dabrafenib in vitro zavira humani polipeptidni prenašalec organskih anionov (OATP - organic anion transporting polypeptide) 1B1 (OATP1B1), OATP1B3 in BCRP.
The dabrafenib dose should not exceed 150 mg twice daily. 
Odmerek dabrafeniba ne sme preseči 150 mg dvakrat na dan.
This results in reduced plasma levels of medicinal products metabolised by these enzymes, and may affect some transported medicinal products. 
Posledica je manjša plazemska koncentracija zdravil, ki se presnavljajo s temi encimi; prizadeta so lahko tudi nekatera zdravila, ki se vežejo na prenašalce.
This may lead to increased risk of non-cutaneous malignancies with dabrafenib exposure (see section 4.8) when RAS mutations are present. 
To lahko poveča tveganje za nekožne malignome med izpostavljenostjo dabrafenibu (glejte poglavje 4.8), kadar so prisotne mutacije RAS.
Some people taking Tafinlar develop other conditions, which can be serious. 
Nekaterim bolnikom, ki jemljejo zdravilo Tafinlar, se pojavijo druge težave, ki so lahko resne.
NE (44.5, NE) 
NO (44,5; NO)
• red or black stools that look like tar 
• rdeče blato ali črno blato, ki je videti kot katran.
The European Medicines Agency has deferred the obligation to submit the results of studies with dabrafenib in one or more subsets of the paediatric population in melanoma and solid malignant tumours (see section 4.2 for information on paediatric use). 
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z dabrafenibom za eno ali več podskupin pediatrične populacije pri melanomu in solidnih malignih tumorjih (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
What Tafinlar is and what it is used for What you need to know before you take Tafinlar How to take Tafinlar 
Kaj je zdravilo Tafinlar in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Tafinlar Kako jemati zdravilo Tafinlar Možni neželeni učinki
QT prolongation 
Podaljšanje QT intervala
Your doctor will also check your head, your neck, your mouth, your lymph glands and you will have scans of your chest and stomach area (called CT scans) regularly. 
Zdravnik vam bo tudi pregledal glavo, vrat, usta in bezgavke, poleg tega boste redno opravili slikanje (tako imenovano CT-slikanje) prsnega koša in trebuha.
Patients with serious non-infectious febrile events responded well to dose interruption and/or dose reduction and supportive care (see sections 4.2 and 4.4). 
Bolniki z resnimi neinfekcijskimi febrilnimi pojavi so se dobro odzvali na prekinitev uporabe in/ali znižanje odmerka ter podporno oskrbo (glejte poglavji 4.2 in 4.4).
Animal studies have shown that the active substance dabrafenib may permanently reduce male fertility. 
Študije na živalih so pokazale, da lahko učinkovina dabrafenib pri moških trajno zmanjša plodnost.
Of the specimens from the non-clinical and clinical trials (n=876) that were mutation positive by the THxID BRAF assay and subsequently were sequenced using the reference method, the specificity of the assay was 94%. 
Na vzorcih predkliničnih in kliničnih študij (n = 876), ki so imeli s testom ThxID določeno mutacijo BRAF in so bili nato sekvencirani z referenčno metodo, je bila specifičnost testa 94 %.
Table 13 Efficacy data in patients with brain metastases (BREAK-MB Study) 
Preglednica 13 Podatki o učinkovitosti pri bolnikih z metastazami na možganih (študija BREAK-MB)
Take Tafinlar in the morning and evening, about 12 hours apart. 
Zdravilo Tafinlar vzemite zjutraj in zvečer, v presledku približno 12 ur.
• passing blood in the urine 
• kri v urinu,
Table 2 Dose modification schedule based on the grade of any adverse events (AE) 
Preglednica 2 Shema prilagoditve odmerka glede na stopnjo katerih koli neželenih dogodkov
Trametinib should be continued at the same dose. 
Zdravljenje s trametinibom je treba nadaljevati z enakim odmerkom.
Each bottle contains either 28 or 120 hard capsules. 
Ena plastenka vsebuje 28 ali 120 trdih kapsul.
Studies in juvenile animals have shown adverse effects of dabrafenib which had not been observed in adult animals (see section 5.3). 
Študije pri mladih živalih so pokazale neželene učinke dabrafeniba, ki jih pri odraslih živalih niso opažali (glejte poglavje 5.3).
• Joint pain, muscle pain, or pain in the hands or feet 
• bolečine v sklepih, bolečine v mišicah ali bolečine v rokah ali stopalih
Potent inducers of these enzymes should be avoided when possible as these agents may decrease the efficacy of dabrafenib (see section 4.5). 
Če je mogoče, se je treba izogniti uporabi močnih induktorjev teh encimov, ker lahko zmanjšajo učinkovitost dabrafeniba (glejte poglavje 4.5).
Concomitant use of dabrafenib with medicinal products that are sensitive substrates of certain metabolising enzymes or transporters (see section 4.5) should generally be avoided if monitoring for efficacy and dose adjustment is not possible. 
Sočasni uporabi dabrafeniba in zdravil, ki so občutljivi substrati določenih presnovnih encimov ali prenašalcev (glejte poglavje 4.5), se je treba na splošno izogniti, če ni možnosti za kontrolo učinkovitosti in prilagoditev odmerka.
Unexplained abdominal pain should be promptly investigated to include measurement of serum amylase and lipase. 
Nepojasnjene bolečine v trebuhu je treba nemudoma raziskati, vključno z meritvijo amilaze in lipaze v serumu.
Caution should be used in this setting (see section 4.4). 
V takšnih okoliščinah je potrebna previdnost (glejte poglavje 4.4).
Read the information about fever, changes in your skin and eye problems in section 4 of this leaflet. 
Informacije o zvišani telesni temperaturi, spremembah na koži in težavah z očmi preberite v 4. poglavju tega navodila.
A total of 423 subjects were randomised 1:1 to either combination (N=211) or dabrafenib (N=212). 
Skupno so randomizirali 423 preiskovancev v razmerju 1:1 tako, da so prejemali bodisi kombinacijo (N = 211) ali samo dabrafenib (N = 212).
Call your doctor or nurse and get medical help right away if you have any unusual signs of bleeding, including: 
Obvestite svojega zdravnika ali medicinsko sestro in takoj poiščite zdravniško pomoč, če imate katerekoli izredne znake krvavitve:
Common side effects that may show up in your blood tests 
Pogosti neželeni učinki, ki se lahko pokažejo v izvidih krvnih preiskav
• Take Tafinlar twice daily and take trametinib once daily. 
• Zdravilo Tafinlar jemljite dvakrat na dan, trametinib pa enkrat na dan.
Possible side effects in patients taking Tafinlar alone 
Možni neželeni učinki pri bolnikih, ki jemljejo samo zdravilo Tafinlar
The assay was specifically designed to differentiate between the V600E and V600K mutations. 
Test je bil zasnovan specifično za razlikovanje med mutacijama V600E in V600K.
Bleeding problems 
Težave s krvavitvami
Very common side effects that may show up in your blood tests • Abnormal blood test results related to the liver 
Zelo pogosti neželeni učinki, ki se lahko pokažejo v izvidih krvnih preiskav • nenormalni izvidi krvnih preiskav delovanja jeter
Dabrafenib may decrease the efficacy of oral or any systemic hormonal contraceptives and an effective alternative method of contraception should be used (see section 4.5). 
Dabrafenib lahko zmanjša učinkovitost peroralnih oziroma katerihkoli sistemskih hormonskih kontraceptivov zato je treba uporabiti drug učinkovit način kontracepcije (glejte poglavje 4.5).
• Swelling of the hands or feet (oedema peripheral) 
• otekanje dlani ali stopal (periferni edemi)
- The other ingredients are: microcrystalline cellulose, magnesium stearate, colloidal silicone dioxide, red iron oxide (E172), titanium dioxide (E171), and hypromellose (E464). 
- Druge sestavine zdravila so: mikrokristalna celuloza, magnezijev stearat, koloidni silicijev dioksid, rdeči železov oksid (E172), titanov dioksid (E171) in hipromeloza (E464).
• have any liver problems. 
• če imate kakšne težave z jetri.
In the previously treated population, 38 patients (67%) had one line of systemic anti-cancer therapy for metastatic disease. 
Med predhodno zdravljenimi bolniki je 38 bolnikov (67 %) prej prejelo eno linijo sistemskega zdravljenja proti raku za zdravljenje metastatske bolezni.
Keep a list of the medicines you take, so you can show it to your doctor, pharmacist or nurse. 
Vodite seznam zdravil, ki jih jemljete, da ga boste lahko pokazali zdravniku, farmacevtu ali medicinski sestri.
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). 
Aktiviranje MAP-kinaznega signaliziranja v celicah z divjim tipom BRAF, izpostavljenih zaviralcem BRAF, lahko poveča tveganje za nekožne malignome, vključno s tistimi, ki imajo mutacije RAS (glejte poglavje 4.4).
• Bleeding, at various sites in the body, which may be mild or serious (haemorrhage) 
• krvavitve na različnih mestih v telesu; krvavitve so lahko blage ali resne
Don't take the morning and evening doses of Tafinlar at the same time. 
Ne vzemite jutranjega in večernega odmerka zdravila Tafinlar ob istem času.
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). 
Pri bolnikih, ki jemljejo zdravilo Tafinlar, se pogosto (pri največ 1 od 10 ljudi) lahko pojavi drugačna vrsta kožnega raka, ki ga imenujemo ploščatocelični karcinom kože (cuSCC - Cutaneous Squamous Cell Carcinoma).
These melanomas are usually removed by surgery and treatment with Tafinlar can be continued without interruption. 
Te melanome po navadi odstranijo z operacijo in zdravljenje z zdravilom Tafinlar je mogoče nadaljevati brez prekinitve.
Patients should be routinely monitored for visual signs and symptoms (such as change in vision, photophobia and eye pain) while on therapy. 
Bolnike je treba med zdravljenjem redno kontrolirati glede znakov in simptomov s strani vida (npr. sprememb vida, fotofobije in bolečin v očesu).
The study included patients with all sub-stages of Stage III disease prior to resection; 18% of these patients had lymph node involvement only identifiable by microscope and no primary tumour ulceration. 
V študijo so bili vključeni bolniki, ki so imeli pred resekcijo melanom vseh podstadijev stadija III; pri 18 % teh bolnikov so bile zajete bezgavke odkrite samo pri mikroskopskem pregledu, niso pa imeli ulceracije primarnega tumorja.
earlier in section 4) 
4. poglavju)
• some medicines used to treat certain psychiatric conditions, such as haloperidol 
• nekatera zdravila za zdravljenje določenih psihiatričnih motenj, npr. haloperidol
Data as of June 25, 2012 
Podatki z dne 25. junija 2012
Enrollment required complete resection of melanoma with complete lymphadenectomy within 12 weeks prior to randomisation. 
Pogoj za vključitev v študijo je bila totalna resekcija melanoma s popolno limfadenektomijo v zadnjih 12 tednih pred randomizacijo.
These changes in dabrafenib AUC and Cmax are considered not clinically meaningful. 
Te spremembe AUC in Cmax dabrafeniba ne veljajo za klinično pomembne.