FrancophonIA/ELRC3.0 huggingface dataset:
English: Swallow the tablet whole, with a full glass of water.
Slovenian: Tablete in kapsule zaužijte cele s polnim kozarcem vode.
English: Dermatitis acneiform Dry skin
Slovenian: Zelo pogosti izpuščaj akneiformni dermatitis suha koža srbenje alopecija
English: Deep vein thrombosis (DVT)/Pulmonary embolism (PE)
Slovenian: Globoka venska tromboza/pljučna embolija
English: The secondary endpoints were PFS in the ITT population and OS, ORR, and DoR in the primary efficacy population and ITT population.
Slovenian: Sekundarni opazovani dogodki so bili preživetje brez napredovanja bolezni v populaciji ZNZ, celokupno preživetje (OS), celokupni delež odziva (ORR) in trajanje odziva (DoR) v primarni populaciji učinkovitosti in v populaciji ZNZ.
English: 1-year rate (95% CI)
Slovenian: 1-letna stopnja (95-odstotni IZ)
English: Renal impairment is unlikely to have a clinically relevant effect on trametinib pharmacokinetics given the low renal excretion of trametinib.
Slovenian: Glede na majhno izločanje trametiniba skozi ledvice ni verjetno, da bi okvara ledvic klinično pomembno vplivala na farmakokinetiko trametiniba.
English: Mekinist 0.5 mg tablets trametinib
Slovenian: Mekinist 0,5 mg tablete trametinib
English: Tablet film coating Hypromellose (E464) Titanium dioxide (E171) Polyethylene glycol Iron oxide yellow(E172)
Slovenian: Filmska obloga tablete hipromeloza (E464) titanov dioksid (E171) polietilenglikol rumeni železov oksid (E172)
English: In rats decreased foetal weights and increased post-implantation loss were seen at exposures below or slightly above the clinical exposures based on AUC.
Slovenian: Pri podganah so ob izpostavljenostih, ki so bile na podlagi AUC nižje ali rahlo višje od kliničnih izpostavljenosti, opažali zmanjšano telesno maso plodov in več poimplantacijskih izgub.
English: No dosage adjustment is required in patients with mild hepatic impairment (see section 5.2).
Slovenian: Bolnikom z blago okvaro jeter odmerka ni treba prilagoditi (glejte poglavje 5.2).
English: 3) The following adverse reaction has occurred in MEK116513 and BRF115532 but not in MEK115306 and BRF113928: rhabdomyolysis (uncommon) b Cutaneous squamous cell carcinoma (cu SCC): SCC, SCC of the skin, SCC in situ (Bowen's disease) and keratoacanthoma c Papilloma, skin papilloma d
Slovenian: 3. naslednji neželeni učinek se je pojavljal v študijah MEK116513 in BRF115532, ni pa se pojavljal v študijah MEK115306 in BRF113928: rabdomioliza (občasni).
English: Folliculitis Paronychia Cellulitis Rash pustular
Slovenian: Pogosti folikulitis paronihija celulitis pustulozen izpuščaj
English: Not Known
Slovenian: Neznana pogostnost
English: Symptoms such as blurred vision, decreased acuity, and other visual disturbances have been reported in the clinical trials with trametinib (see sections 4.2 and 4.4).
Slovenian: V kliničnih preskušanjih s trametinibom so bili opisani simptomi, npr. zamegljen vid, zmanjšanje ostrine vida in druge motnje vida (glejte poglavji 4.2 in 4.4).
English: Take Mekinist tablets and dabrafenib capsules with you when possible.
Slovenian: Če je mogoče, vzemite tablete zdravila Mekinist in kapsule dabrafeniba s seboj in, če je možno, pokažite pakiranji zdravila Mekinist in dabrafeniba ter priloženi navodili za uporabo.
English: Trametinib has been reported to decrease LVEF, when used as monotherapy or in combination with dabrafenib (see section 4.8).
Slovenian: Poročali so, da trametinib zmanjša LVEF pri uporabi v monoterapiji ali v kombinaciji z dabrafenibom (glejte poglavje 4.8).
English: There are no data in humans for trametinib as monotherapy or in combination with dabrafenib.
Slovenian: Podatkov pri ljudeh za zdravljenje s trametinibom, bodisi v monoterapiji ali v kombinaciji z dabrafenibom, ni.
English: Hazard ratio is obtained from the stratified Pike model.
Slovenian: Razmerje ogroženosti je izračunano na osnovi stratificiranega Pikeovega modela.
English: Each film-coated tablet contains trametinib dimethyl sulfoxide equivalent to 0.5 mg or 2 mg of trametinib.
Slovenian: Ena filmsko obložena tableta vsebuje trametinibijev dimetilsulfoksid v količini, ki ustreza 0,5 mg ali 2 mg trametiniba.
English: If RPED is diagnosed, follow the dose modification schedule in Table 3 below for trametinib (see section 4.4).
Slovenian: Če je diagnosticiran odstop mrežničnega pigmentnega epitelija (RPED - Retinal pigment epithelial detachment), za trametinib upoštevajte shemo prilagoditve odmerka v preglednici 3 (glejte poglavje 4.4).
English: Progression-free survival, median, months (95% CI)
Slovenian: preživetje brez napredovanja bolezni, mediana, meseci (95 % IZ)
English: In clinical trials uveitis and iridocyclitis have also been reported in patients treated with trametinib in combination with dabrafenib.
Slovenian: V kliničnih preskušanjih so pri bolnikih, ki so prejemali trametinib v kombinaciji z dabrafenibom, poročali tudi o uveitisu in iridociklitisu.
English: Fatal intracranial haemorrhages occurred in the integrated safety population of trametinib in combination with dabrafenib in <1% (8/1076) of patients.
Slovenian: V skupini za vrednotenje varnosti zdravila, zdravljeni s trametinibom v kombinaciji z dabrafenibom je do intrakranialne krvavitve, ki je povzročila smrt, prišlo pri manj kot 1 % (8/1076) bolnikov.
English: Tablet film coating Hypromellose (E464) Titanium dioxide (E171) Polyethylene glycol Polysorbate 80 (E433) Iron oxide red (E172)
Slovenian: Filmska obloga tablete hipromeloza (E464) titanov dioksid (E171) polietilenglikol polisorbat 80 (E433) rdeči železov oksid (E172)
English: • Skin rash, acne-like rash, redness of the face, dry or itching skin (see also “Changes in your skin” earlier in section 4)
Slovenian: • izpuščaj na koži, aknam podoben izpuščaj, pordelost obraza, suha ali srbeča koža (glejte tudi
English: Vision blurred Periorbital oedema Visual impairment
Slovenian: Pogosti zamegljen vid periorbitalni edem okvara vida
English: Your doctor may take blood samples to monitor your liver function while you are taking this medicine.
Slovenian: Zdravnik vam bo med zdravljenjem s tem zdravilom morda jemal kri, da vam bo kontroliral delovanje jeter.
English: DoRc (months) Median (95% CI)
Slovenian: mediana vrednost DoRc (meseci) (95-odstotni IZ)
English: When you take Mekinist and dabrafenib together you may get any of the side effects given in the lists above, although the frequency may change (increase or decrease).
Slovenian: V času jemanja zdravila Mekinist skupaj z dabrafenibom se lahko pojavi katerikoli od zgoraj naštetih neželenih učinkov, vendar je pogostnost pojavljanja lahko drugačna (večja ali manjša).
English: Cardiac failure
Slovenian: Srčna bolezen
English: 3rd dose reduction (combination only)
Slovenian: 75 mg dvakrat na dan tretje znižanje odmerka (velja samo za uporabo v kombinaciji)
English: If you are breast-feeding, or planning to breast-feed, you must tell your doctor.
Slovenian: Če dojite ali nameravate dojiti, o tem obvestite zdravnika.
English: The following convention has been utilised for the classification of frequency: Very common ≥1/10
Slovenian: Neželeni učinki so navedeni spodaj po organskih sistemih MedDRA. Za razvrstitev pogostnosti je uporabljen naslednji dogovor: Zelo pogosti
English: Description of selected adverse reactions
Slovenian: Opis izbranih neželenih učinkov Novi malignomi
English: • Changes in how the heart pumps blood (left ventricular dysfunction) (see also “Heart conditions” earlier in section 4)
Slovenian: • spremenjeno črpalno delovanje srca (disfunkcija levega prekata) (glejte tudi "Srčne motnje"
English: Do not take Mekinist after the expiry date (EXP) which is stated on the bottle label and carton.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki plastenke in na škatli poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
English: Tell your doctor immediately if it feels like your heart is pounding, racing, or beating irregularly, or if you experience dizziness, tiredness, light-headedness, shortness of breath or swelling in the legs.
Slovenian: Zdravniku morate takoj povedati, če čutite: razbijanje srca, hitro ali neredno bitje srca,
English: If you have any further questions on how to take Mekinist, ask your doctor, nurse or pharmacist.
Slovenian: Če imate dodatna vprašanja o jemanju zdravila Mekinist, se posvetujte z zdravnikom, medicinsko sestro ali farmacevtom.
English: How to store Mekinist
Slovenian: Shranjevanje zdravila Mekinist
English: Palmar-plantar erythrodysaesthesia syndrome
Slovenian: Pogosti eritem sindrom palmarno-plantarne eritrodisestezije fisure na koži razpokana koža
English: Mekinist 2 mg film-coated tablets
Slovenian: Mekinist 2 mg filmsko obložene tablete
English: The safety and efficacy of the combination of trametinib and dabrafenib have been evaluated in a multi-cohort, open-label, Phase II study in patients with BRAF V600 mutant melanoma with brain metastases.
Slovenian: Trametinib v kombinaciji z dabrafenibom pri bolnikih z metastazami v možganih Varnost in učinkovitost kombinacije trametiniba in dabrafeniba so ocenili v odprti študiji faze II z več kohortami pri bolnikih z melanomom z mutacijo BRAF V600, ki je metastaziral v možgane.
English: Mekinist 0.5 mg film-coated tablets Mekinist 2 mg film-coated tablets
Slovenian: Mekinist 0,5 mg filmsko obložene tablete Mekinist 2 mg filmsko obložene tablete
English: Please refer to the dabrafenib SmPC (section 4.4).
Slovenian: Glejte povzetek glavnih značilnosti zdravila za dabrafenib (poglavje 4.4).
English: Elevations in blood pressure have been reported in association with trametinib as monotherapy and in combination with dabrafenib, in patients with or without pre-existing hypertension.
Slovenian: V povezavi s trametinibom pri uporabi v monoterapiji ali v kombinaciji z dabrafenibom so bila opisana zvišanja krvnega tlaka tako pri bolnikih, ki so že prej imeli hipertenzijo, kot pri tistih, ki je prej niso imeli.
English: Call your doctor or nurse right away if you develop high blood pressure, your blood pressure worsens, or you have severe headache, light-headedness, or dizziness.
Slovenian: Če se vam visok krvni tlak pojavi ali poslabša, ali če imate hud glavobol, vrtoglavico ali omotico, takoj pokličite zdravnika ali medicinsko sestro.
English: Updated analysis (data cutoff: 12-Jan-2015)
Slovenian: Posodobljena analiza (konec zbiranja podatkov: 12-jan-2015)
English: Common side effects (may affect up to 1 in 10 people):
Slovenian: Pogosti neželeni učinki (pojavijo se lahko pri do 1 od 10 oseb):
English: Mekinist 0.5 mg film-coated tablets
Slovenian: Mekinist 0,5 mg filmsko obložene tablete
English: Vomiting Constipation Abdominal pain Dry mouth
Slovenian: Zelo pogosti driska navzea bruhanje zaprtost bolečine v trebuhu suha usta
English: Each film-coated tablet contains trametinib dimethyl sulfoxide equivalent to 2 mg trametinib.
Slovenian: Ena filmsko obložena tableta vsebuje trametinibijev dimetilsulfoksid v količini, ki ustreza 2 mg trametiniba.
English: Grade (CTC-AE)* Recommended trametinib dose modifications Used as monotherapy or in combination with dabrafenib
Slovenian: Stopnja (CTC-AE)* Priporočene prilagoditve odmerka trametiniba pri uporabi v monoterapiji ali v kombinaciji z dabrafenibom 1. in 2. stopnja (znosni) Nadaljujte zdravljenje in nadzorujte, kot je klinično indicirano.
English: Elevations in blood pressure have been reported in association with trametinib as monotherapy and in combination with dabrafenib, in patients with or without pre-existing hypertension (see section 4.8).
Slovenian: V povezavi s trametinibom, bodisi v monoterapiji ali v kombinaciji z dabrafenibom, 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: The incidence and severity of pyrexia are increased with the combination therapy (see dabrafenib SmPC section 4.4).
Slovenian: Pri kombiniranem zdravljenju sta pogostnost in izraženost zvišane telesne temperature večji (glejte poglavje 4.4 v povzetku glavnih značilnosti zdravila za dabrafenib).
English: Trametinib should be used with caution in patients with moderate or severe hepatic impairment (see sections 4.2 and 4.4).
Slovenian: Pri bolnikih z zmerno ali hudo okvaro jeter je treba trametinib uporabljati previdno (glejte poglavje 4.2 in 4.4).
English: Trametinib should be permanently discontinued for patients diagnosed with treatment-related ILD or pneumonitis (see section 4.2).
Slovenian: Pri bolnikih, ki imajo diagnosticirano z zdravljenjem povezano IBP ali pnevmonitis, je treba zdravljenje s trametinibom trajno končati (glejte poglavje 4.2).
English: Microcrystalline cellulose (E460) Hypromellose (E464) Croscarmellose sodium (E468) Magnesium stearate (E470b) Sodium laurilsulfate Colloidal silicon dioxide(E551)
Slovenian: Mekinist 2 mg filmsko obložene tablete Jedro tablete manitol (E421) mikrokristalna celuloza (E460) hipromeloza (E464) premreženi natrijev karmelozat (E468) magnezijev stearat (E470b) natrijev lavrilsulfat koloidni silicijev dioksid (E551)
English: • Swelling in the eye caused by fluid leakage (chorioretinopathy) (see also “Eye (vision)
Slovenian: • oteklost v očesu, ki jo povzroči pronicanje tekočine (horioretinopatija) (glejte tudi "Težave z očmi (težave z vidom)" zgoraj v poglavju 4)
English: (7.9, NR)
Slovenian: (8,3; NO)
English: Mekinist 0.5 mg film-coated tablets Mekinist 2 mg film-coated tablets trametinib
Slovenian: Mekinist 0,5 mg filmsko obložene tablete Mekinist 2 mg filmsko obložene tablete trametinib
English: Side effects when Mekinist and dabrafenib are taken together
Slovenian: Neželeni učinki pri uporabi zdravila Mekinist skupaj z dabrafenibom
English: Each film-coated tablet contains trametinib dimethyl sulfoxide equivalent to 0.5 mg trametinib.
Slovenian: Ena filmsko obložena tableta vsebuje trametinibijev dimetilsulfoksid v količini, ki ustreza 0,5 mg trametiniba.
English: The recommended dose of trametinib, either used as monotherapy or in combination with dabrafenib, is 2 mg once daily.
Slovenian: Priporočeni odmerek trametiniba, bodisi v monoterapiji ali v kombinaciji z dabrafenibom, je 2 mg enkrat na dan. Priporočeni odmerek dabrafeniba, kadar se uporablja v kombinaciji s trametinibom, je 150 mg dvakrat na dan.
English: In mice, lower heart rate, heart weight and left ventricular function were observed without cardiac histopathology after 3 weeks at ≥0.25 mg/kg/day trametinib (approximately 3 times human clinical exposure based on AUC) for up to 3 weeks.
Slovenian: Pri miših so po 3-tedenski uporabi trametiniba ≥ 0,25 mg/kg/dan (to je na podlagi AUC približno 3-kratnik klinične izpostavljenosti pri človeku) po 3 tednih opažali nižjo srčno frekvenco, manjšo maso srca in zmanjšanje delovanja levega prekata, brez histopatoloških sprememb.
English: th
Slovenian: oC
English: • Blockage of the vein draining the eye (retinal vein occlusion) (see also “Eye (vision) problems”
Slovenian: • zapora vene, po kateri odteka kri iz očesa (zapora mrežnične vene) (glejte tudi "Težave z očmi
English: The usual dose of Mekinist either used alone or in combination with dabrafenib is one 2 mg tablet once a day.
Slovenian: Običajni odmerek zdravila Mekinist, bodisi pri samostojni uporabi ali pri uporabi v kombinaciji z dabrafenibom, je ena 20-mg tableta enkrat na dan. Priporočeni odmerek dabrafeniba pri uporabi v kombinaciji z zdravilom Mekinist je 150 mg dvakrat na dan.
English: P value f
Slovenian: < 0,001f
English: e - ORR difference calculated based on the ORR result not rounded f - Updated analysis was not pre-planned and the p-value was not adjusted for multiple testing NR = Not reached
Slovenian: a - PFS: preživetje brez napredovanja bolezni (angl. Progression Free Survival) (po oceni raziskovalca) b - ORR: stopnja celokupnega odziva (angl. Overall Response Rate) = popolni odziv + delni odziv c - DoR : trajanje odziva (angl. duration of response) d - v času poročanja je večina (≥ 59 %) odzivov po oceni raziskovalca še trajala e - razlika v stopnji celokupnega odziva (ORR) je izračunana iz nezaokroženih vrednosti posameznih ORR f - posodobljena analiza ni bila vnaprej načrtovana, vrednost p pa se ni prilagodila za večkratno testiranje.
English: In patients who are diagnosed with RVO, treatment with trametinib, whether given as monotherapy or in combination with dabrafenib, should be permanently discontinued.
Slovenian: Pri bolnikih s hudo okvaro ledvic je treba trametinib, bodisi v monoterapiji ali v kombinaciji z dabrafenibom, uporabljati previdno.
English: Dabrafenib + trametinib Placebo
Slovenian: dabrafenib + placebo
English: • feeling sick (nausea)
Slovenian: • vnetje črevesja (kolitis)
English: Mekinist 2 mg film-coated tablets trametinib
Slovenian: Mekinist 2 mg filmsko obložene tablete trametinib
English: Check with your doctor if you think any of these may apply to you.
Slovenian: Če menite, da karkoli od navedenega velja za vas, se posvetujte z zdravnikom.
English: Hazard ratio (95% CI) p-value
Slovenian: Razmerje ogroženosti (95-% IZ) p-vrednost
English: • pain in your stomach (abdomen)
Slovenian: • bolečine v trebuhu,
English: Trametinib should not be administered to breast-feeding mothers.
Slovenian: Doječe matere ne smejo dobivati trametiniba.
English: You will be checked for any heart problems while you are taking Mekinist.
Slovenian: Med jemanjem zdravila Mekinist vas bo zdravnik pregledoval glede morebitnih težav s srcem.
English: If you take too many tablets of Mekinist, contact your doctor, nurse or pharmacist for advice.
Slovenian: Če ste vzeli večji odmerek zdravila Mekinist, kot bi smeli Če ste vzeli preveč tablet zdravila Mekinist, se posvetujte z zdravnikom, medicinsko sestro ali farmacevtom.
English: • Inflammation of pancreas
Slovenian: • okužba sečil
English: Trametinib monotherapy has not been compared with a BRAF inhibitor in a clinical study in patients with BRAF V600 mutation positive unresectable or metastatic melanoma.
Slovenian: Pri bolnikih z inoperabilnim ali metastatskim melanomom s pozitivno mutacijo BRAF V600 monoterapije s trametinibom niso primerjali z zaviralcem BRAF v nobeni klinični študiji.
English: No dose modification of dabrafenib is required when trametinib is taken in combination with dabrafenib.
Slovenian: Odmerka dabrafeniba ni treba prilagajati, če bolnik v kombinaciji z dabrafenibom jemlje trametinib.
English: Symptoms such as blurred vision, decreased acuity, and other visual phenomena have been reported in the clinical trials with trametinib (see section 4.8).
Slovenian: V kliničnih preskušanjih s trametinibom so bili opisani simptomi, npr. zamegljen vid, zmanjšanje ostrine vida in druge spremembe vida (glejte poglavje 4.8).
English: • Dry mouth
Slovenian: • oteklost obraza
English: Trametinib should be used with caution in patients with impaired left ventricular function.
Slovenian: Pri bolnikih z okrnjenim delovanjem levega prekata je treba trametinib uporabljati previdno.
English: Pancreatitis has been reported in patients treated with trametinib in combination with dabrafenib in clinical trials.
Slovenian: Pri bolnikih, ki so v kliničnih preskušanjih prejemali trametinib v kombinaciji z dabrafenibom, so poročali o primerih pankreatitisa.
English: Trametinib must be permanently discontinued in patients diagnosed with treatment-related ILD or pneumonitis.
Slovenian: Pri bolnikih, ki imajo diagnosticirano z zdravljenjem povezano IBP ali pnevmonitis, je treba zdravljenje s trametinibom trajno končati.
English: NE2 (8.3, NE) NE (6.9, NE)
Slovenian: NO (6,9; NO)
English: Cases of cuSCC (including keratoacanthoma) have been reported in patients treated with trametinib in combination with dabrafenib.
Slovenian: Pri bolnikih, zdravljenih s trametinibom v kombinaciji z dabrafenibom, so poročali o primerih ploščatoceličnega karcinoma kože (vključno s primeri keratoakantoma).
English: Mekinist 0.5 mg film-coated tablets trametinib
Slovenian: Mekinist 0,5 mg filmsko obložene tablete trametinib
English: Trametinib should be used with caution in patients with moderate or severe hepatic impairment when administered as monotherapy or in combination with dabrafenib.
Slovenian: Pri bolnikih z zmerno ali hudo okvaro jeter je treba trametinib, bodisi v monoterapiji ali v kombinaciji z dabrafenibom, uporabljati previdno.
English: • Inflammation of the mucosa
Slovenian: • bolečinami v mišicah
English: Rhabdomyolysis has been reported in patients taking trametinib as monotherapy or in combination with dabrafenib (see section 4.8).
Slovenian: Pri bolnikih, ki so prejemali trametinib bodisi v monoterapiji ali v kombinaciji z dabrafenibom, so poročali o rabdomiolizi (glejte poglavje 4.8).
English: • fatigue
Slovenian: • zadihanost
English: Gastrointestinal perforation Colitis
Slovenian: Občasni perforacija prebavil kolitis
English: Serious skin reactions have been reported in people taking Mekinist in combination with dabrafenib.
Slovenian: Pri bolnikih, ki so jemali zdravilo Mekinist v kombinaciji z dabrafenibom, so poročali o resnih kožnih reakcijah.
English: May present with symptoms such as fever, rash, increased liver transaminases, and visual disturbances b Events include but are not limited to: epistaxis, haematochezia, gingival bleeding, haematuria, and rectal, haemorrhoidal, gastric, vaginal, conjunctival, intracranial and post-procedural haemorrhage.
Slovenian: Učinki med drugim vključujejo: epistakso, hematohezijo, krvavitev iz dlesni, hematurijo ter krvavitve iz danke, hemoroidov, krvavitve v želodcu, iz nožnice, v veznici, intrakranialne krvavitve in krvavitve po posegih.
English: oC please refer to the dabrafenib SmPC (section 4.2) for dose modifications for dabrafenib.
Slovenian: oC ali več, za prilagoditev odmerka dabrafeniba glejte povzetek glavnih značilnosti zdravila za dabrafenib (poglavje 4.2).
English: 150 mg twice daily
Slovenian: 150 mg dvakrat na dan prvo znižanje odmerka
English: Trametinib should be used with caution in patients with severe renal impairment (see sections 4.2 and
Slovenian: Pri bolnikih s hudo okvaro ledvic je treba trametinib uporabljati previdno (glejte poglavje 4.2 in 4.4).
English: There are limited data in patients taking the combination of trametinib with dabrafenib who have progressed on a prior BRAF inhibitor.
Slovenian: O uporabi trametiniba v kombinaciji z dabrafenibom pri bolnikih, pri katerih je bolezen napredovala med predhodnim zdravljenjem z zaviralcem BRAF, je na voljo malo podatkov.
English: Renal failure has been identified in patients treated with trametinib in combination with dabrafenib in clinical trials.
Slovenian: V kliničnih preskušanjih so pri bolnikih, ki so prejemali trametinib v kombinaciji z dabrafenibom, ugotavljali primere odpovedi ledvic.
English: Colitis and gastrointestinal perforation, including fatal outcome, have been reported in patients taking trametinib as monotherapy and in combination with dabrafenib (see section 4.8).
Slovenian: Pri bolnikih, ki so prejemali trametinib v monoterapiji ali v kombinaciji z dabrafenibom, so poročali o kolitisu in perforaciji prebavil, vključno s primeri, ki so se končali s smrtjo (glejte poglavje 4.8).
English: • Inflammation of the fatty layer under the skin (panniculitis)
Slovenian: • vnetje podkožnega maščevja (panikulitis)
English: Pancreatitis Colitis
Slovenian: Občasni pankreatitis kolitis
English: Tell your doctor or nurse as soon as possible if you get any of these symptoms 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 ali medicinsko sestro.
English: Dose level
Slovenian: 3. stopnja
English: No dose modification of trametinib is required for RAS mutation positive malignancies when taken in combination with dabrafenib.
Slovenian: V primerih malignomov s prisotno mutacijo RAS ni treba prilagajati odmerjanja trametiniba, če ga bolnik jemlje v kombinaciji z dabrafenibom.
English: • dizziness
Slovenian: • kašljem
English: Disorders associated with visual disturbances, including RPED and RVO, have been observed with trametinib.
Slovenian: Med zdravljenjem s trametinibom so opažali motnje, povezane z motnjami vida, vključno z odstopom mrežničnega pigmentnega epitelija (RPED) in zaporo mrežnične vene (RVO).