FrancophonIA/ELRC3.0 huggingface dataset:
English: If you have any further questions on the effect of this medicine on fertility, ask your doctor, nurse or pharmacist.
Slovenian: Če imate kakšna dodatna vprašanja o vplivu tega zdravila na plodnost, vprašajte zdravnika, medicinsko sestro ali farmacevta.
English: • If you miss a dose of Mekinist or dabrafenib, take it as soon as you remember: Do not make up for missed doses and just take your next dose at your regular time: o If it is less than 12 hours to your next scheduled dose of Mekinist, which is taken once daily.
Slovenian: Izpuščenega odmerka pa ne nadomeščajte in vzemite samo naslednji odmerek po razporedu, če: o je manj kot 12 ur do naslednjega rednega odmerka zdravila Mekinist, ki ga jemljete enkrat na dan, o je manj kot 6 ur do naslednjega rednega odmerka dabrafeniba, ki ga jemljete dvakrat na dan.
English: High-density polyethylene (HDPE) bottle with child-resistant polypropylene closure.
Slovenian: Plastenka iz polietilena velike gostote (HDPE) z zaporko iz polipropilena, varno za otroke.
English: Mekinist in combination with dabrafenib is also used to treat a type of lung cancer called non-small cell lung cancer (NSCLC).
Slovenian: Zdravilo Mekinist v kombinaciji z dabrafenibom uporabljamo tudi pri zdravljenju vrste pljučnega raka, ki ga imenujemo nedrobnocelični pljučni rak.
English: Improvements were also observed for overall response rate (ORR) and a longer duration of response (DoR) was observed in the combination arm compared to dabrafenib monotherapy (Table 7).
Slovenian: V skupini s kombinacijo so v primerjavi z monoterapijo z dabrafenibom opazili tudi izboljšanje stopnje celokupnega odziva (ORR - overall response rate) in daljše trajanje odziva (DoR - duration of response) (preglednica 7).
English: • Birth control using hormones (such as pills, injections or patches) may not work as well if you are taking Mekinist or combination treatment (Mekinist as well as dabrafenib).
Slovenian: • Med uporabo zdravila Mekinist ali kombiniranega zdravljenja (jemanja zdravila Mekinist in dabrafeniba) se lahko zgodi, da hormonska kontracepcija (na primer kontracepcijske tablete, injekcije ali obliži) ne deluje enako dobro.
English: In adult rats, mineralisation of multiple organs was associated with increased serum phosphorus and was closely associated with necrosis in heart, liver and kidney and haemorrhage in the lung at exposures comparable to the human clinical exposure.
Slovenian: Pri odraslih podganah je bilo ob izpostavljenostih, podobnih klinični izpostavljenosti pri človeku, zvišanje fosforja v serumu povezano z mineralizacijo več organov in je bilo tesno povezano z nekrozo srca, jeter in ledvic ter s krvavitvami v pljučih.
English: Very common side effects (may affect more than 1 in 10 people):
Slovenian: Zelo pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 10 oseb):
English: As metabolism and biliary excretion are the primary routes of elimination of trametinib, administration of trametinib should be undertaken with caution in patients with moderate to severe hepatic impairment (see sections 4.2 and 5.2).
Slovenian: Ker sta presnova v jetrih in izločanje v žolču glavni poti odstranjevanja trametiniba, je treba trametinib previdno uporabljati pri bolnikih z zmerno do hudo okvaro jeter (glejte poglavji 4.2 in 5.2).
English: Mekinist as monotherapy or in combination with dabrafenib can cause rash or acne-like rash.
Slovenian: Zdravilo Mekinist pri samostojni uporabi ali v kombinaciji z dabrafenibom lahko povzroči izpuščaj ali aknam podoben izpuščaj.
English: No dosage adjustment is required in patients with mild or moderate renal impairment (see section 5.2).
Slovenian: Bolnikom z blago ali zmerno okvaro ledvic odmerka ni treba prilagoditi (glejte poglavje 5.2).
English: Trametinib in combination with dabrafenib is indicated for the treatment of adult patients with advanced non-small cell lung cancer with a BRAF V600 mutation.
Slovenian: Trametinib je v kombinaciji z dabrafenibom indiciran za zdravljenje odraslih bolnikov z napredovalim nedrobnoceličnim pljučnim rakom z mutacijo BRAF V600.
English: When trametinib is used in combination with dabrafenib see sections 4.4 and 4.5 of the dabrafenib SmPC for interactions.
Slovenian: Za interakcije pri uporabi trametiniba v kombinaciji z dabrafenibom glejte poglavji 4.4 in 4.5 v povzetku glavnih značilnosti zdravila za dabrafenib.
English: Film coating: hypromellose (E464), titanium dioxide (E171), polyethylene glycol, iron oxide yellow (E172) (for 0.5 mg tablets), polysorbate 80 (E433) and iron oxide red (E172) (for 2 mg tablets).
Slovenian: Filmska obloga: hipromeloza (E464), titanov dioksid (E171), polietilenglikol, rumeni železov oksid (E172) (za 0,5-mg tablete), polisorbat 80 (E433) in rdeči železov oksid (E172) (za 2-mg tablete).
English: Interrupt therapy until toxicity is Grade 0 to 1 and reduce by one dose level when resuming therapy.
Slovenian: Prekinite zdravljenje, dokler niso toksični učinki 0 ali 1. stopnje; ko znova uvedete zdravljenje, odmerek znižajte za eno odmerno raven.
English: If haemorrhage occurs, treat as clinically indicated (see section 4.4).
Slovenian: Če pride do krvavitve, je treba bolnika zdraviti v skladu s kliničnimi indikacijami (glejte poglavje 4.4).
English: Opened bottle
Slovenian: Odprta plastenka
English: Dabrafenib + Trametinib Dabrafenib + Placebo
Slovenian: dabrafenib + trametinib dabrafenib + placebo dabrafenib + trametinib
English: The combination of trametinib with dabrafenib has shown anti-tumour activity in BRAF V600 mutation positive melanoma cell lines in vitro and delays the emergence of resistance in vivo in BRAF V600 mutation positive melanoma xenografts.
Slovenian: Kombinacija trametiniba in dabrafeniba je pokazala protitumorsko aktivnost pri melanomskih celičnih linijah z mutacijo BRAF V600 in vitro, in vivo pa zakasni nastanek rezistence pri heterolognih melanomskih presadkih z mutacijo BRAF V600.
English: Most subjects were Caucasian (>99%) and male (53%), with a median age of 56 years (28% were ≥65 years).
Slovenian: Preiskovanci so bili večinoma belci (> 99 %) in moškega spola (53 %), mediana starost pa je bila 56 let (28 % jih je bilo starih najmanj 65 let).
English: If trametinib is being used in combination with dabrafenib then therapy with dabrafenib may be continued at the same dose.
Slovenian: Če bolnik uporablja trametinib v kombinaciji z dabrafenibom, je mogoče zdravljenje z dabrafenibom nadaljevati z nespremenjenim odmerkom.
English: In rats, hepatocellular necrosis and transaminase elevations were seen after 8 weeks at ≥0.062 mg/kg/day (approximately 0.8 times human clinical exposure based on AUC).
Slovenian: Pri podganah so po 8-tedenski uporabi ≥ 0,062 mg/kg/dan (to je na podlagi AUC približno 0,8-kratnik klinične izpostavljenosti pri človeku) ugotovili nekrozo jetrnih celic in zvišanje transaminaz.
English: Your doctor will run tests to check that your heart is working properly before and during your treatment with this medicine.
Slovenian: Zdravnik bo pred zdravljenjem s tem zdravilom in med zdravljenjem z njim opravil preiskave, s katerimi bo preveril, da vam srce deluje pravilno.
English: In studies MEK115306 and MEK116513 <1% (2/209) and 1 % (4/350), respectively, of patients treated with trametinib in combination with dabrafenib developed pneumonitis or ILD (see section 4.8).
Slovenian: V študiji MEK115306 je med bolniki, ki so prejemali trametinib v kombinaciji z dabrafenibom, do pnevmonitisa ali IBP prišlo pri < 1 % (2/209) bolnikov, v študiji MEK116513 pa pri 1 % (4/350) takih bolnikov (glejte poglavje 4.8).
English: Uncommon side effects (may affect up to 1 in 100 people):
Slovenian: Občasni neželeni učinki (pojavijo se lahko pri do 1 od 100 oseb):
English: If patients report new visual disturbances, such as diminished central vision, blurred vision or loss of vision at any time while on trametinib therapy, a prompt ophthalmological assessment is recommended.
Slovenian: Če se bolniku kadar koli med zdravljenjem s trametinibom pojavijo novonastale motnje vida, na primer poslabšanje centralnega vida, zamegljen vid ali izguba vida, je priporočljiva takojšnja oftalmološka ocena.
English: For patients diagnosed with treatment-related ILD or pneumonitis trametinib should be permanently discontinued (see sections 4.2 and 4.4).
Slovenian: Pri bolnikih, ki imajo diagnosticirano z zdravljenjem povezano IBP ali pnevmonitis, je treba zdravljenje s trametinibom trajno končati (glejte poglavji 4.2 in 4.4).
English: NR=not reached
Slovenian: ND = ni doseženo
English: Trametinib must be withheld in patients with suspected ILD or pneumonitis, including patients presenting with new or progressive pulmonary symptoms and findings including cough, dyspnoea, hypoxia, pleural effusion, or infiltrates, pending clinical investigations.
Slovenian: Pri bolnikih, pri katerih obstaja sum na IBP ali pnevmonitis, je treba zdravljenje s trametinibom prekiniti; to velja tudi za bolnike z novonastalimi ali napredujočimi pljučnimi simptomi ali izvidi, vključno s kašljem, dispnejo, hipoksijo, plevralnim izlivom ali infiltrati, dokler niso opravljene klinične preiskave.
English: • have eye problems including blockage of the vein draining the eye (retinal vein occlusion) or swelling in the eye which may be caused by fluid blockage (chorioretinopathy).
Slovenian: • če imate težave z očmi, med katere sodi zapora vene, ki odvaja kri iz očesa (zapora mrežnične vene) ali otekanje očesa zaradi zastajanja tekočine (horioretinopatija).
English: Trametinib has been reported to decrease LVEF when used as monotherapy or in combination with dabrafenib.
Slovenian: Poročali so, da trametinib zmanjša LVEF pri uporabi v monoterapiji ali v kombinaciji z dabrafenibom.
English: Take the doses of Mekinist and dabrafenib exactly as your doctor, nurse or pharmacist tells you.
Slovenian: Zdravilo Mekinist in dabrafenib jemljite v natanko takšnih odmerkih, kot vam naroči zdravnik, medicinska sestra ali farmacevt.
English: Therefore other treatment options should be considered before treatment with the combination in this prior BRAF inhibitor treated population.
Slovenian: Pri tej skupini bolnikov, ki so bili predhodno zdravljeni z zaviralcem BRAF, je zato pred zdravljenjem z navedeno kombinacijo treba razmisliti tudi o drugih možnostih zdravljenja.
English: In the integrated safety population of trametinib in combination with dabrafenib, decreased LVEF has been reported in 6% (65/1076) of patients, with most cases being asymptomatic and reversible.
Slovenian: V skupini za vrednotenje varnosti zdravila, zdravljeni s trametinibom v kombinaciji z dabrafenibom so o zmanjšanju iztisnega deleža levega prekata poročali pri 6 % (65/1076) bolnikov, pri čemer je bila večina teh bolnikov brez simptomov, navedene motnje pa so bile reverzibilne.
English: 2 mg once daily
Slovenian: 2 mg enkrat na dan
English: Trametinib in combination with dabrafenib is indicated for the adjuvant treatment of adult patients with Stage III melanoma with a BRAF V600 mutation, following complete resection.
Slovenian: Trametinib je v kombinaciji z dabrafenibom indiciran za adjuvantno zdravljenje odraslih bolnikov po totalni resekciji melanoma stadija III z mutacijo BRAF V600.
English: Cases of cuSCC can be managed with excision and do not require treatment modification.
Slovenian: V primeru ploščatoceličnega karcinoma kože je bolnika mogoče zdraviti z ekscizijo, spremembe v zdravljenju niso potrebne.
English: *Please refer to the dabrafenib SmPC, Posology and method of administration, for dosing instructions for treatment with dabrafenib monotherapy.
Slovenian: * Za navodila za odmerjanje dabrafeniba v monoterapiji glejte poglavje Odmerjanje in način uporabe v povzetku glavnih značilnosti zdravila za dabrafenib.
English: Trametinib should be used with caution in patients with conditions that could impair left ventricular function (see sections 4.2 and 4.4).
Slovenian: Trametinib je treba uporabljati previdno pri bolnikih z motnjami, ki bi lahko poslabšale delovanje levega prekata (glejte poglavji 4.2 in 4.4).
English: How should you take Mekinist in combination with dabrafenib
Slovenian: Kako je treba jemati zdravilo Mekinist v kombinaciji z dabrafenibom
English: As metabolism and biliary excretion are the primary routes of elimination of trametinib, administration of trametinib should be undertaken with caution in patients with moderate to severe hepatic impairment (see section 4.2).
Slovenian: Ker sta presnova v jetrih in izločanje z žolčem glavni poti odstranjevanja trametiniba, je treba trametinib le previdno uporabljati pri bolnikih z zmerno do hudo okvaro jeter (glejte poglavje 4.2).
English: In clinical trials with trametinib monotherapy one case of accidental overdose was reported; a single dose of 4 mg. No AEs were reported following this event of trametinib overdose.
Slovenian: V kliničnih preskušanjih s trametinibom v monoterapiji je bil opisan en primer naključnega prevelikega odmerjanja z enkratnim odmerkom 4 mg.
English: • Separation of the light-sensitive membrane in the back of the eye (the retina) from its supporting layers (retinal detachment) (see also “Eye (vision) problems” earlier in section 4).
Slovenian: • odstop za svetlobo občutljive opne na zadnji strani očesa (mrežnice) od plasti, na katero je pritrjena (odstop mrežnice) (glejte tudi "Težave z očmi (težave z vidom)" zgoraj v poglavju 4)
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: Dose adjustment for trametinib below 1 mg once daily is not recommended, whether used as monotherapy or in combination with dabrafenib.
Slovenian: Znižanje odmerka trametiniba pod 1 mg enkrat na dan, bodisi pri uporabi v monoterapiji ali v kombinaciji z dabrafenibom, ni priporočeno.
English: The efficacy and safety of trametinib in combination with dabrafenib were studied in a Phase III, multicentre, randomised, double-blind, placebo-controlled study in patients with Stage III (Stage IIIA [lymph node metastasis >1 mm], IIIB, or IIIC) cutaneous melanoma with a BRAF V600 E/K mutation, following complete resection.
Slovenian: Učinkovitost in varnost trametiniba v kombinaciji z dabrafenibom so proučevali v multicentrični randomizirani, dvojno slepi, s placebom kontrolirani študiji faze III pri bolnikih po totalni resekciji kožnega melanoma z mutacijo BRAF V600 E/K v stadiju III (stadij IIIA [metastaze bezgavk > 1 mm], IIIB ali IIIC).
English: RAS-mutation-positive non-cutaneous malignancies The benefits and risks must be considered before continuing treatment with dabrafenib in patients with a non-cutaneous malignancy that has a RAS mutation.
Slovenian: Pri bolnikih z nekožnim malignomom z mutacijo RAS je treba pred odločitvijo za nadaljevanje zdravljenja z dabrafenibom pretehtati koristi in tveganja takega zdravljenja.
English: Interstitial lung disease
Slovenian: Občasni intersticijska bolezen pljuč
English: Full recovery was observed when stopping treatment.
Slovenian: Po prekinitvi zdravljenja so bolniki povsem okrevali.
English: • Take Mekinist in combination with dabrafenib exactly as your doctor, nurse or pharmacist tells you.
Slovenian: • Zdravilo Mekinist v kombinaciji z dabrafenibom jemljite natančno po navodilih zdravnika, medicinske sestre ali farmacevta.
English: The clinical status of the patient and the adverse reaction profile should be borne in mind when considering the patient's ability to perform tasks that require judgement, motor and 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 zdravila.
English: Before taking trametinib or the combination with dabrafenib, patients must have BRAF V600 mutation-positive tumour status confirmed by a validated test.
Slovenian: Pred uporabo trametiniba ali kombinacije z dabrafenibom je treba z validirano preiskavo potrditi, da ima bolnik tumor s pozitivno mutacijo BRAF V600.
English: The Mekinist 2 mg film-coated tablets are pink, round, biconvex, with “GS” debossed on one face and “HMJ” on the opposing face.
Slovenian: 2-mg filmsko obložene tablete zdravila Mekinist so rožnate, okrogle, bikonveksne in imajo na eni strani vtisnjeno oznako "GS" in na drugi "HMJ".
English: Trametinib dose Used as monotherapy or in combination with dabrafenib
Slovenian: Odmerek trametiniba pri uporabi v monoterapiji ali v kombinaciji z dabrafenibom
English: • Sore mouth or mouth ulcers, inflammation of mucous membranes
Slovenian: • pekoča usta ali razjede v ustih, vnetje sluznic
English: Progressive disease or death, n (%) Median PFS (months) (95% CI)
Slovenian: a napredovanje bolezni ali smrt, n (%) mediani čas PFS (meseci) (95-odstotni IZ) razmerje ogroženosti (95-odstotni IZ)
English: Men taking trametinib in combination with dabrafenib
Slovenian: Moški, ki jemljejo trametinib v kombinaciji z dabrafenibom
English: Tablet: mannitol (E421), microcrystalline cellulose (E460), hypromellose (E464), croscarmellose sodium (E468), magnesium stearate (E470b), sodium laurilsulfate and colloidal silicon dioxide (E551).
Slovenian: Tableta: manitol (E421), mikrokristalna celuloza (E460), hipromeloza (E464), premreženi natrijev karmelozat (E468), magnezijev stearat (E470b), natrijev lavrilsulfat in koloidni silicijev dioksid (E551).
English: • yellowing of your skin or the whites of your eyes (jaundice)
Slovenian: • porumenelost kože ali beločnic (zlatenica),
English: The 5-year overall survival rate was 46% (95% CI: 38.8, 52.0) in the combination arm versus 28% (95% CI: 22.5, 34.6) in the vemurafenib monotherapy arm for patients who had a normal lactate dehydrogenase level at baseline, and 16% (95% CI: 9.3, 23.3) in the combination arm versus 10% (95% CI: 5.1, 17.4) in the vemurafenib monotherapy arm for patients with an elevated lactate dehydrogenase level at baseline.
Slovenian: Pri bolnikih, ki so imeli normalno raven laktat dehidrogenaze ob izhodišču, je bil delež 5-letnega celokupnega preživetja 46-odstoten (95-% IZ: 38,8; 52,0) v skupini s kombinacijo in 28-odstoten (95-% IZ: 22,5; 34,6) pri monoterapiji z vemurafenibom, pri bolnikih s povišano ravnjo laktat dehidrogenaze ob izhodišču pa 16-odstoten (95-% IZ: 9,3; 23,3) pri kombinaciji in 10-odstoten (95-% IZ: 5,1; 17,4) pri monoterapiji z vemurafenibom.
English: Table 13 Investigator-assessed RFS results for Study BRF115532 (COMBI-AD)
Slovenian: Preglednica 13 Rezultati preživetja brez ponovitve bolezni po oceni raziskovalcev v študiji BRF115532 (COMBI-AD)
English: In addition, men who are taking dabrafenib may have a reduced sperm count, and their sperm count may not return to normal levels after they stop taking this medicine.
Slovenian: Lahko se zgodi, da se število semenčic po koncu jemanja tega zdravila ne vrne na normalno raven.
English: Effect of food on trametinib
Slovenian: Vpliv hrane na trametinib
English: Mekinist 2 mg tablets trametinib
Slovenian: Mekinist 2 mg tablete trametinib
English: Permanently discontinue trametinib.
Slovenian: Trajno končajte zdravljenje s trametinibom.
English: Trametinib in combination with dabrafenib in patients with melanoma who have progressed on a BRAF inhibitor
Slovenian: Trametinib v kombinaciji z dabrafenibom pri bolnikih z melanomom, pri katerih je bolezen napredovala med zdravljenjem z zaviralcem BRAF
English: Of these patients, 559 were treated with the combination for BRAF V600 mutant melanoma in two randomised Phase III studies, 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 trametiniba v kombinaciji z dabrafenibom so ocenjevali v skupini za vrednotenje varnosti zdravila pri 1.076 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 trametinib 2 mg enkrat na dan in dabrafenib 150 mg dvakrat na dan. Od teh bolnikov jih je bilo 559 zdravljenih s kombinacijo zaradi melanoma z mutacijo BRAF V600 v dveh randomiziranih 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: The efficacy and safety of trametinib in combination with dabrafenib 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 trametiniba v kombinaciji z dabrafenibom 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: Pink, round, biconvex, film-coated tablets, approximately 7.5 mm, with “GS” debossed on one face and “HMJ” on the opposing face.
Slovenian: Rožnate, bikonveksne filmsko obložene tablete okrogle oblike, velikosti približno 7,5 mm, z vtisnjeno oznako "GS" na eni strani in "HMJ" na drugi strani.
English: When trametinib is used in combination with dabrafenib please refer to the dabrafenib SmPC (section 4.4).
Slovenian: Pri uporabi trametiniba v kombinaciji z dabrafenibom glejte povzetek glavnih značilnosti zdravila za dabrafenib (poglavje 4.4).
English: • have had a different type of cancer other than melanoma or NSCLC, as you may be at greater risk of developing non-skin cancers when taking Mekinist.
Slovenian: • ali ste kdaj imeli drugo vrsto raka razen melanoma in nedrobnoceličnega pljučnega raka,
English: 2-year rate (95% CI)
Slovenian: 2-letna stopnja (95-odstotni IZ)
English: 3-year rate (95% CI)
Slovenian: 3-letna stopnja (95-odstotni IZ)
English: Mekinist 0.5 mg film-coated tablets Each film-coated tablet contains trametinib dimethyl sulfoxide equivalent to 0.5 mg of trametinib.
Slovenian: Mekinist 0,5 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 0,5 mg trametiniba v obliki trametinibijevega dimetilsulfoksida.
English: Before taking trametinib, patients must have confirmation of BRAF V600 mutation using a validated test.
Slovenian: Pred uporabo trametiniba mora biti z validirano preiskavo potrjeno, da ima bolnik mutacijo BRAF V600.
English: Mekinist 2 mg film-coated tablets Each film-coated tablet contains trametinib dimethyl sulfoxide equivalent to 2 mg of trametinib.
Slovenian: Mekinist 2 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 2 mg trametiniba v obliki trametinibijevega dimetilsulfoksida.
English: • A hole (perforation) in the stomach or intestines
Slovenian: • predrtje (perforacija) stene želodca ali črevesa
English: problems” earlier in section 4)
Slovenian: (težave z vidom)" zgoraj v poglavju 4)
English: You may also get additional side effects due to taking dabrafenib at the same time as Mekinist in the list below.
Slovenian: Poleg teh se zaradi jemanja dabrafeniba sočasno z zdravilom Mekinist lahko pojavijo še drugi neželeni učinki, ki so navedeni spodaj.
English: The Mekinist 0.5 mg film-coated tablets are yellow, modified oval, biconvex, with “GS” debossed on one face and “TFC” on the opposing face.
Slovenian: 0,5-mg filmsko obložene tablete zdravila Mekinist so rumene, bikonveksne, prilagojene ovalne oblike in imajo na eni strani vtisnjeno oznako "GS" in na drugi "TFC".