FrancophonIA/ELRC3.0 huggingface dataset:
English: You may also get additional side effects due to taking trametinib at the same time as Tafinlar.
Slovenian: Poleg teh se zaradi jemanja trametiniba sočasno z zdravilom Tafinlar lahko pojavijo še drugi neželeni učinki.
English: Dabrafenib dose Used as monotherapy or in combination with trametinib
Slovenian: Odmerek dabrafeniba pri uporabi v monoterapiji ali v kombinaciji s trametinibom
English: Cohort C N=16
Slovenian: kohorta C N = 16
English: Co-administration of repeat doses of dabrafenib 150 mg twice daily and the pH-elevating agent rabeprazole 40 mg once daily resulted in a 3% increase in AUC and a 12% decrease in dabrafenib Cmax.
Slovenian: Sočasna uporaba ponavljajočih odmerkov dabrafeniba 150 mg dvakrat dnevno in učinkovine rabeprazol, ki zvišuje pH, v odmerku 40 mg enkrat dnevno, je povzročila 3 % povečanje AUC in 12 % zmanjšanje Cmax dabrafeniba.
English: Tafinlar is not recommended while breast-feeding.
Slovenian: Zdravilo Tafinlar ni priporočljivo med obdobjem dojenja.
English: OS analysis (data cut-off: 12-Jan-2015)
Slovenian: Analiza OS (konec zbiranja podatkov: 12-jan-2015)
English: In a clinical drug interaction study, Cmax and AUC of oral midazolam (a CYP3A4 substrate) decreased by 47% and 65%, respectively with co-administration of repeat-dose dabrafenib.
Slovenian: V klinični študiji medsebojnega delovanja zdravil se je med uporabo ponavljajočih se odmerkov dabrafeniba Cmax peroralnega midazolama (substrata CYP3A4) zmanjšala za 47 % in AUC za 65 %.
English: • Kidney problems, kidney failure
Slovenian: • težave z ledvicami, odpoved ledvic
English: A drug utilisation review (DUR) is therefore essential when initiating dabrafenib treatment.
Slovenian: Ob uvedbi zdravljenja z dabrafenibom je zato nujno opraviti pregled uporabljenih zdravil.
English: N=4 3.8 (NR, NR)
Slovenian: N = 4 3,8 (ND; ND)
English: Co-administration of repeat dosing of trametinib 2 mg once daily and dabrafenib 150 mg twice daily resulted in no clinically meaningful changes in trametinib or dabrafenib Cmax and AUC with increases of 16 and 23%, respectively, in dabrafenib Cmax and AUC.
Slovenian: Sočasno odmerjanje večkratnih odmerkov trametiniba 2 mg enkrat na dan in dabrafeniba 150 mg dvakrat na dan ni povzročilo klinično pomembnih sprememb Cmax ali AUC trametiniba ali dabrafeniba, je pa prišlo do zvišanja Cmax dabrafeniba za 16 % in do povečanja AUC dabrafeniba za 23 %.
English: Estimates of OS (months) Median (95% CI)
Slovenian: Ocene OS (v mesecih) mediana (95-% IZ)
English: • Skin tags
Slovenian: • otekanje nog
English: Following discontinuation of dabrafenib, monitoring for non-cutaneous secondary/recurrent malignancies should continue for up to 6 months or until initiation of another anti-neoplastic therapy.
Slovenian: Nadzor glede nekožnih sekundarnih/ponovnih malignomov se mora nadaljevati še do 6 mesecev po prenehanju zdravljenja z dabrafenibom ali do uvedbe drugega antineoplastičnega zdravljenja.
English: Opaque dark pink capsules, approximately 19 mm long, with capsule shell imprinted with “GS LHF” and “75 mg”.
Slovenian: Neprozorne temnorožnate kapsule, dolge približno 19 mm, ki imajo na ovojnici kapsule natisnjeni oznaki "GS LHF" in "75 mg".
English: Overall, 54% of subjects had <3 disease sites at baseline.
Slovenian: Skupno 54 % bolnikov je imelo ob izhodišču melanom na manj kot 3 mestih.
English: (19.2, NR)
Slovenian: (19,2; ND)
English: Tafinlar can cause eye problems when taken in combination with trametinib.
Slovenian: Zdravilo Tafinlar lahko pri jemanju v kombinaciji s trametinibom povzroči težave z očmi.
English: Patients should be closely monitored when re-starting dabrafenib after an episode of pancreatitis.
Slovenian: Ob ponovnem začetku uporabe dabrafeniba po pankreatitisu je treba bolnike skrbno kontrolirati.
English: Of these patients, 559 were treated with the combination for BRAF V600 mutant melanoma in two randomised Phase III clinical trials, MEK115306 (COMBI-d) and MEK116513 (COMBI-v), 435 were treated with the combination in the adjuvant treatment of Stage III BRAF V600 mutant melanoma after complete resection in a randomised Phase III study BRF115532 (COMBI-AD) and 82 were treated with the combination for BRAF V600 mutant NSCLC in a multi-cohort, non-randomised Phase II study BRF113928 (see section 5.1).
Slovenian: Varnost uporabe dabrafeniba v kombinaciji s trametinibom so ocenjevali v skupini za vrednotenje varnosti zdravila pri 1076 bolnikih z inoperabilnim ali metastatskim melanomom z mutacijo BRAF V600, z melanomom stadija III z mutacijo BRAF V600 po totalni resekciji (adjuvantno zdravljenje) ali z napredovalim nedrobnoceličnim pljučnim rakom z mutacijo BRAF V600, ki so prejemali dabrafenib 150 mg dvakrat na dan in trametinib 2 mg enkrat na dan. Od teh bolnikov jih je bilo 559 zdravljenih s kombinacijo zaradi melanoma z mutacijo BRAF V600 v dveh randomiziranih kliničnih študijah faze III z oznakama MEK115306 (COMBI-d) in MEK116513 (COMBI-v), 435 je bilo zdravljenih s kombinacijo v okviru adjuvantnega zdravljenja zaradi melanoma stadija III z mutacijo BRAF V600 po totalni resekciji v randomizirani študiji faze III z oznako BRF115532 (COMBI-AD), 82 bolnikov pa je bilo zdravljenih s kombinacijo zaradi nedrobnoceličnega pljučnega raka z mutacijo BRAF V600 v nerandomizirani študiji faze II z več kohortami z oznako BRF113928 (glejte poglavje 5.1).
English: Subjects were stratified by lactate dehydrogenase (LDH) level (> the upper limit of normal (ULN) versus ≤ULN) and BRAF mutation (V600E versus V600K).
Slovenian: Preiskovanci so bili stratificirani glede na koncentracijo laktat dehidrogenaze (LDH), in sicer na tiste z vrednostjo nad zgornjo mejo normalnih vrednosti (ZMN) in tiste z vrednostjo  ZMN ter glede na vrsto mutacije BRAF (V600E oziroma V600K).
English: Desmethyl-dabrafenib may also be formed in the gut and reabsorbed.
Slovenian: Dezmetildabrafenib lahko nastaja tudi v črevesju in se reabsorbira.
English: Table 14 Investigator-assessed RFS results for Study BRF115532 (COMBI-AD)
Slovenian: Preglednica 14 Rezultati preživetja brez ponovitve bolezni po oceni raziskovalcev v študiji BRF115532 (COMBI-AD)
English: Tell your doctor as soon as possible if you have severe abdominal pain.
Slovenian: V primeru hudih bolečin v trebuhu čimprej obvestite zdravnika.
English: Developmental toxicity including embryo-lethality and ventricular septal defects and variation in thymic shape were seen at 300 mg/kg/day, and delayed skeletal development and reduced foetal body weight at ≥20 mg/kg/day (≥0.5 times human clinical exposure based on AUC).
Slovenian: Ob odmerku 300 mg/kg/dan so opažali razvojno toksičnost, vključno s smrtjo zarodkov, defekti prekatnega pretina in razvojem timusa različnih oblik, ob odmerkih ≥ 20 mg/kg/dan (to je ≥ 0,5-kratna klinična izpostavljenost pri človeku na podlagi AUC) pa zapoznel skeletni razvoj in manjšo telesno maso plodov.
English: Dabrafenib in combination with trametinib in patients with melanoma who have progressed on a BRAF inhibitor
Slovenian: Dabrafenib v kombinaciji s trametinibom pri bolnikih z melanomom, pri katerih je bolezen napredovala med zdravljenjem z zaviralcem BRAF
English: Decreased LVEF has been reported in 6% (65/1076) of patients in the integrated safety population of dabrafenib in combination with trametinib.
Slovenian: Zmanjšanje iztisnega deleža levega prekata (LVEF)/disfunkcija levega prekata Zmanjšanje LVEF je bilo opisano pri 6 % (65/1076) bolnikov v skupini za vrednotenje varnosti zdravila, ki so prejemali dabrafenib v kombinaciji s trametinibom.
English: If you have any further questions on the effect of this medicine on sperm count, ask your doctor, pharmacist or nurse.
Slovenian: Če imate kakšna dodatna vprašanja o vplivu tega zdravila na število semenčic, vprašajte zdravnika, farmacevta ali medicinsko sestro.
English: Table 6 Overall Survival results for Study MEK115306 (COMBI-d)
Slovenian: Preglednica 6 Rezultati za celokupno preživetje v študiji MEK115306 (COMBI-d)
English: Retinal vein occlusion (RVO) and Retinal pigment epithelial detachment (RPED) If patients report new visual disturbances such as diminished central vision, blurred vision, or loss of vision at any time while on combination therapy with dabrafenib and trametinib, please refer to the trametinib SmPC (see section 4.2) for dose modification instructions for trametinib.
Slovenian: Zapora mrežnične vene (RVO) in odstop mrežničnega pigmentnega epitelija (RPED) Če se bolniku kadarkoli med zdravljenjem s kombinacijo dabrafeniba in trametiniba pojavijo novonastale motnje vida, na primer poslabšanje centralnega vida, zamegljen vid ali izguba vida, za prilagajanje odmerka trametiniba glejte povzetek glavnih značilnosti zdravila za trametinib (poglavje 4.2).
English: Dabrafenib was not mutagenic or clastogenic using in vitro tests in bacteria and cultured mammalian cells, and an in vivo rodent micronucleus assay.
Slovenian: Dabrafenib v testih in vitro na bakterijah in gojenih sesalskih celicah ter v mikrojedrnem testu pri glodalcih in vivo ni bil mutagen ali klastogen.
English: In the Phase III study BRF115532 in the adjuvant treatment of melanoma, the incidence and severity of pyrexia were higher in the dabrafenib in combination with trametinib arm (67%; 6% Grade 3/4) as compared to the placebo arm (15%; <1% Grade 3).
Slovenian: V študiji faze III BRF115532 adjuvantnega zdravljenja melanoma sta bili pogostnost in izraženost zvišane telesne temperature večji pri uporabi dabrafeniba v kombinaciji s trametinibom (67 %, pri 6 % s 3. oz. 4. stopnjo izraženosti) v primerjavi z uporabo placeba (15 %, pri < 1 % s 3. stopnjo izraženosti).
English: Uveitis may develop rapidly and the symptoms include:
Slovenian: Uveitis se lahko razvije hitro.
English: Muscle pain
Slovenian: Bolečine v mišicah
English: Study MEK116513 was a 2-arm, randomised, open-label, Phase III study comparing dabrafenib and trametinib combination therapy with vemurafenib monotherapy in BRAF V600 mutation-positive unresectable or metastatic melanoma.
Slovenian: Študija MEK116513 je bila randomizirana, odprta študija faze III z dvema skupinama, v kateri so primerjali uporabo kombinacije dabrafeniba in trametiniba z uporabo vemurafeniba v monoterapiji pri zdravljenju inoperabilnega ali metastatskega melanoma z mutacijo BRAF V600.
English: In clinical trials ophthalmologic reactions, including uveitis, iridocyclitis and iritis, have been reported in patients treated with dabrafenib as monotherapy and in combination with trametinib.
Slovenian: V kliničnih študijah so pri bolnikih, ki so prejemali dabrafenib v monoterapiji ali v kombinaciji s trametinibom, opisovali oftalmološke reakcije, vključno z uveitisom, iridociklitisom in iritisom.
English: • Cohort B: Combination therapy (dabrafenib 150 mg twice daily and trametinib 2 mg once daily), 59 patients enrolled.
Slovenian: • kohorta B: zdravljenje s kombinacijo (dabrafenib 150 mg dvakrat na dan in trametinib 2 mg enkrat na dan), vključenih je bilo 59 bolnikov.
English: No data is available in patients with melanoma harbouring BRAF V600 mutations others than V600E and V600K.
Slovenian: O bolnikih z melanomom, ki bi imel druge mutacije BRAF V600 razen V600E in V600K, ni podatkov.
English: 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.
Slovenian: Omeniti je treba, da je do 3. stopnje izraženosti prišlo v približno polovici primerov pri uporabi dabrafeniba v monoterapiji (4 %) in pri 1 % bolnikov, ki so uporabljali dabrafenib v kombinaciji s trametinibom.
English: When an individual's adverse reactions are under effective management, dose re-escalation following the same dosing steps as de-escalation may be considered.
Slovenian: Ko so neželeni učinki učinkovito obvladani, pride v poštev ponovno zvišanje odmerka.
English: 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.
Slovenian: Po podatkih populacijske farmakokinetične analize so ocenili, da pri odmerjanju trametiniba v kombinaciji z dabrafenibom, ki je induktor CYP3A4, pride do majhnega zmanjšanja biološke uporabnosti trametiniba, ki se ujema z zmanjšanjem njegove AUC za 12 %.
English: Opaque dark red capsules, approximately 18 mm long, with capsule shell imprinted with “GS TEW” and “50 mg”.
Slovenian: Neprozorne temnordeče kapsule, dolge približno 18 mm, ki imajo na ovojnici kapsule natisnjeni oznaki "GS TEW" in "50 mg".
English: Mucosal inflammation Face oedema
Slovenian: Pogosti vnetje sluznice edem obraza
English: • Thickening of the outer layer of the skin (hyperkeratosis), patches of thick, scaly, or crusty skin
Slovenian: • zadebelitev zunanje plasti kože (hiperkeratoza), predeli kože, ki je zadebeljena, se lušči ali jo pokrivajo kraste (aktinična keratoza), pojavljanje manjših ali večjih razpok na koži
English: Combination with trametinib
Slovenian: Kombinacija s trametinibom
English: How to store Tafinlar
Slovenian: Shranjevanje zdravila Tafinlar
English: Tafinlar can affect how well your heart pumps blood when taken in combination with trametinib.
Slovenian: Zdravilo Tafinlar lahko pri jemanju v kombinaciji s trametinibom vpliva na to, kako dobro srce črpa kri.
English: If uveitis does not respond to local ocular therapy, withhold dabrafenib until resolution of ocular inflammation and then restart dabrafenib reduced by one dose level (see section 4.4).
Slovenian: Če se uveitis ne odziva na lokalna očesna zdravila, je treba zdravljenje z dabrafenibom prekiniti, dokler očesno vnetje ni odpravljeno, nato pa dabrafenib ponovno uvesti v odmerku, ki je za eno odmerno raven nižji (glejte poglavje 4.4).
English: Influenza-like illness
Slovenian: Pogosti gripi podobna bolezen
English: The clinical status of the patient and the adverse reaction profile of dabrafenib should be borne in mind when considering the patient's ability to perform tasks that require judgement, motor or cognitive skills.
Slovenian: Pri ocenjevanju bolnikove zmožnosti za izvajanje opravil, ki zahtevajo presojo in motorične ali kognitivne sposobnosti, je treba upoštevati njegovo klinično stanje in profil neželenih učinkov dabrafeniba.
English: Dry skin Pruritus Rash Erythema h
Slovenian: Zelo pogosti suha koža srbenje izpuščaj eritem h
English: 5-year OS analysis (data cut-off: 10-Dec-2018)
Slovenian: Analiza po 5 letih (konec zbiranja podatkov: 10-dec-2018)
English: The efficacy and safety of dabrafenib in combination with trametinib was studied in a Phase II, three-cohort, multicentre, non-randomised and open-label study in which patients with stage IV BRAF V600E mutant NSCLC were enrolled.
Slovenian: Učinkovitost in varnost dabrafeniba v kombinaciji s trametinibom so proučevali v multicentrični, nerandomizirani odprti študiji faze II s tremi kohortami, v katere so bili vključeni bolniki s IV. stadijem nedrobnoceličnega pljučnega raka z mutacijo BRAF V600E.
English: Dabrafenib may impair male and female fertility as adverse effects on male and female reproductive organs have been seen in animals (see section 5.3).
Slovenian: Podatkov glede zdravljenja z dabrafenibom, bodisi v monoterapiji ali v kombinaciji s trametinibom, pri človeku ni. Dabrafenib lahko prizadene plodnost moških in žensk, pri živalih so namreč ugotovili neželene učinke na reproduktivne organe samcev in samic (glejte poglavje 5.3).
English: Ulcers of mouth, throat, nose, genitals and eyes.
Slovenian: • vnetje v nosu in žrelu oziroma grlu
English: What Tafinlar looks like and contents of the pack Tafinlar 50 mg hard capsules are opaque dark red and imprinted with “GS TEW” and “50 mg”.
Slovenian: Tafinlar 50 mg trde kapsule so neprozorne temnordeče in imajo natisnjeni oznaki "GS TEW" in "50 mg".
English: Table 9 Efficacy results for Study MEK116513 (COMBI-v)
Slovenian: Preglednica 9 Rezultati učinkovitosti v študiji MEK116513 (COMBI-v)
English: • Cohort C: Combination therapy (dabrafenib 150 mg twice daily and trametinib 2 mg once daily), 34 patients.
Slovenian: • kohorta C: zdravljenje s kombinacijo (dabrafenib 150 mg dvakrat na dan in trametinib 2 mg enkrat na dan) je vključevalo 34 bolnikov.
English: Carboxy-dabrafenib can be decarboxylated via a non-enzymatic process to form desmethyl-dabrafenib.
Slovenian: Karboksidabrafenib se lahko neencimsko dekarboksilira v dezmetildabrafenib.
English: The safety of dabrafenib monotherapy is based on the integrated safety population from five clinical trials, BRF113683 (BREAK-3), BRF113929 (BREAK-MB), BRF113710 (BREAK-2), BRF113220, and BRF112680, which included 578 patients with BRAF V600 mutant unresectable or metastatic melanoma treated with dabrafenib 150 mg twice daily.
Slovenian: Varnost uporabe dabrafeniba v monoterapiji temelji na podatkih skupine bolnikov za vrednotenje varnosti zdravila iz petih kliničnih študij, BRF113683 (BREAK-3), BRF113929 (BREAK-MB), BRF113710 (BREAK-2), BRF113220 in BRF112680, ki so zajemale 578 bolnikov z inoperabilnim ali metastatskim melanomom z mutacijo BRAF V600, ki so prejemali dabrafenib 150 mg dvakrat na dan. Najpogostejši neželeni učinki (s pogostnostjo  15 %), opisani z dabrafenibom, so bili hiperkeratoza, glavobol, povišana telesna temperatura, artralgija, utrujenost, navzea, papilom, alopecija, izpuščaj in bruhanje.
English: A decrease of 16% in AUC was noted for carboxy-dabrafenib.
Slovenian: AUC karboksidabrafeniba se je zmanjšala za 16 %.
English: No new primary melanoma was reported from the Phase II NSCLC study (BRF113928).
Slovenian: V študiji faze II pri bolnikih z nedrobnoceličnim pljučnim rakom (BRF113928) niso poročali o nobenem primeru novega primarnega melanoma.
English: At 3 years
Slovenian: Po 3 letih
English: Reversible haematological effects have been observed in dogs and rats given dabrafenib.
Slovenian: Pri psih in podganah, ki so prejemali dabrafenib, so opažali reverzibilne hematološke učinke.
English: Intracranial response rate, % (95 % CI)
Slovenian: delež intrakranialnega odziva, % (95 % IZ)
English: 3.7 (1.6, 5.2) 5.0 (3.5, NR) Abbreviations: CI: confidence interval; NR: not reached; NA: not applicable a Confirmed response.
Slovenian: Okrajšave: IZ: interval zaupanja; ND: ni doseženo; NP: ne pride v poštev a Potrjen odziv.
English: Rash has been observed in about 24% of patients in clinical trials when dabrafenib is used in combination with trametinib (see section 4.8).
Slovenian: V kliničnih študijah so pri uporabi dabrafeniba v kombinaciji s trametinibom izpuščaj opažali pri približno 24 % bolnikov (glejte poglavje 4.8).
English: • antidepressant medicines such as nefazodone and the herbal medicine St John's wort
Slovenian: • antidepresivna zdravila, npr. nefazodon, in zeliščno zdravilo šentjanževka (Hypericum perforatum)
English: • Low levels of phosphate (hypophosphataemia) in the blood
Slovenian: • znižana vrednost fosfatov v krvi (hipofosfatemija)
English: Before taking dabrafenib, patients must have confirmation of tumour BRAF V600 mutation using a validated test.
Slovenian: Pred uporabo dabrafeniba mora biti z validirano preiskavo potrjeno, da ima bolnik tumor z mutacijo BRAF V600.
English: • Feeling sick (nausea), being sick (vomiting)
Slovenian: • siljenje na bruhanje (navzea), bruhanje
English: Cohort B N=16
Slovenian: kohorta B N = 16
English: Tafinlar can cause serious bleeding problems, especially in your brain when taken in combination with trametinib.
Slovenian: Zdravilo Tafinlar lahko pri jemanju v kombinaciji s trametinibom povzroči resne težave s krvavitvami, še posebno v možganih.
English: Co-administration resulted in increases in hydroxy- and desmethyl-dabrafenib AUC (increases of 82% and 68%, respectively).
Slovenian: Pri sočasni uporabi se je povečala AUC hidroksidabrafeniba za 82 % in AUC dezmetildabrafeniba za 68 %.
English: If uveitis does not respond to local ocular therapy, dabrafenib should be withheld until resolution of ocular inflammation and then dabrafenib should be restarted reduced by one dose level.
Slovenian: Če se uveitis ne odziva na lokalna očesna zdravila, je treba zdravljenje z dabrafenibom prekiniti, dokler očesno vnetje ni odpravljeno, nato pa dabrafenib ponovno uvesti v odmerku, ki je nižji za eno odmerno raven.
English: If signs and symptoms suggestive of SCARs appear, dabrafenib and trametinib should be withdrawn.
Slovenian: Če se pojavijo znaki in simptomi, ki lahko pomenijo, da gre za hudo kožno neželeno reakcijo, mora bolnik prekiniti zdravljenje z dabrafenibom in trametinibom.
English: Previously untreated patients (results from the Phase III study [BREAK-3]) The efficacy and safety of dabrafenib were evaluated in a Phase III randomised, open-label study [BREAK 3] comparing dabrafenib to dacarbazine (DTIC) in previously untreated patients with BRAF V600E mutation positive advanced (unresectable Stage III) or metastatic (Stage IV) melanoma.
Slovenian: Predhodno nezdravljeni bolniki (rezultati študije III. faze [BREAK-3]) Učinkovitost in varnost dabrafeniba so ocenili v randomizirani, odprti študiji III. faze [BREAK 3].
English: Each hard capsule contains dabrafenib mesilate equivalent to 50 mg or 75 mg of dabrafenib.
Slovenian: Ena trda kapsula vsebuje dabrafenibijev mesilat, kar ustreza 50 mg ali 75 mg dabrafeniba.
English: Tell your doctor as soon as possible if you get any of these symptoms, either for the first time or if they get worse.
Slovenian: Če se vam pojavi kateri od teh simptomov - bodisi prvič bodisi da se poslabša - o tem čim prej obvestite zdravnika.
English: Elevations in blood pressure have been reported in association with dabrafenib in combination with trametinib, in patients with or without pre-existing hypertension (see section 4.8).
Slovenian: V povezavi z dabrafenibom v kombinaciji s trametinibom so bila opisana zvišanja krvnega tlaka tako pri bolnikih, ki so že prej imeli hipertenzijo, kot pri tistih, ki je prej niso imeli (glejte poglavje 4.8).
English: Overall survival estimate, % (95% CI)
Slovenian: Ocena celokupnega preživetja, % (95-% IZ)
English: Before taking dabrafenib or combination with trametinib, patients must have BRAF V600 mutation-positive tumour status confirmed by a validated test.
Slovenian: Pred uporabo dabrafeniba ali kombinacije s trametinibom je treba z validiranim testom potrditi, da ima bolnik tumor z mutacijo BRAF V600.
English: Only subjects with BRAF V600E or V600K mutation positive tumours were eligible for study participation.
Slovenian: Za sodelovanje v študiji so bili primerni le bolniki, ki so imeli tumorje z mutacijo BRAF V600E ali V600K.
English: Desmethyl-dabrafenib is metabolised by CYP3A4 to oxidative metabolites.
Slovenian: Dezmetildabrafenib se s CYP3A4 presnovi v oksidativne presnovke.
English: Table 7 Efficacy results for Study MEK115306 (COMBI-d)
Slovenian: Preglednica 7 Rezultati učinkovitosti v študiji MEK115306 (COMBI-d)
English: Tafinlar 50 mg hard capsules Tafinlar 75 mg hard capsules
Slovenian: Tafinlar 50 mg trde kapsule Tafinlar 75 mg trde kapsule
English: Tafinlar 75 mg hard capsules
Slovenian: Tafinlar 75 mg trde kapsule
English: Tafinlar 50 mg hard capsules
Slovenian: Tafinlar 50 mg trde kapsule
English: Pancreatitis Colitis
Slovenian: Občasni pankreatitis
English: Cardiovascular effects, including coronary arterial degeneration/necrosis and/or haemorrhage, cardiac atrioventricular valve hypertrophy/haemorrhage and atrial fibrovascular proliferation were seen in dogs (≥2 times clinical exposure based on AUC).
Slovenian: Pri psih so (ob ≥ 2-kratni klinični izpostavljenosti na podlagi AUC) ugotovili kardiovaskularne učinke, vključno z degeneracijo/nekrozo in/ali krvavitvami koronarnih arterij, hipertrofijo/krvavitvijo srčne atrioventrikularne zaklopke in atrijsko fibrovaskularno proliferacijo.
English: Kinase
Slovenian: Kinaza
English: A supratherapeutic dose of 300 mg dabrafenib twice daily was administered in 32 subjects with BRAF V600 mutation-positive tumours.
Slovenian: 32 bolnikov z BRAF V600E pozitivnimi tumorji je prejelo supraterapevtski odmerek 300 mg dabrafeniba dvakrat dnevno.
English: Serious skin reactions have been reported in people taking Tafinlar in combination with trametinib.
Slovenian: Pri bolnikih, ki so jemali zdravilo Tafinlar v kombinaciji s trametinibom, so poročali o resnih kožnih reakcijah.