FrancophonIA/ELRC3.0 huggingface dataset:
English: If trametinib is used during pregnancy, or if the patient becomes pregnant while taking trametinib, the patient should be informed of the potential hazard to the foetus.
Slovenian: Če je trametinib uporabljen med nosečnostjo, ali če bolnica med zdravljenjem s trametinibom zanosi, jo je treba seznaniti z možno nevarnostjo za plod.
English: Trametinib was not genotoxic in studies evaluating reverse mutations in bacteria, chromosomal aberrations in mammalian cells and micronuclei in the bone marrow of rats.
Slovenian: Trametinib ni bil genotoksičen v študijah, ki so ocenjevale reverzne mutacije pri bakterijah, kromosomske aberacije v celicah sesalcev in mikrojedra v kostnem mozgu podgan.
English: • after taking Mekinist, you must wait at least 1 hour before eating, or
Slovenian: • morate po zaužitju zdravila Mekinist počakati vsaj 1 uro, preden jeste, ali
English: Results for the primary analysis of RFS are presented in Table 13.
Slovenian: V preglednici 13 so prikazani rezultati primarne analize RFS.
English: 9.2d (7.4, NR)
Slovenian: 9,2d (7,4; ND)
English: Taking Mekinist with dabrafenib: Dabrafenib may permanently reduce male fertility.
Slovenian: Jemanje zdravila Mekinist skupaj z dabrafenibom: Dabrafenib lahko pri moških trajno zmanjša plodnost.
English: Studies in juvenile animals have shown adverse effects of trametinib which were not observed in adult animals (see section 5.3).
Slovenian: V študijah na mladih živalih so se pokazali neželeni učinki trametiniba, ki jih pri odraslih živalih niso opažali (glejte poglavje 5.3).
English: Continue treatment with retinal evaluation monthly until resolution.
Slovenian: Nadaljujte zdravljenje in vsak mesec opravite pregled mrežnice, dokler odstop ne izgine.
English: Kaplan-Meier curves of investigator-assessed OS (post-hoc analysis 20 May 2013) is presented in Figure 3.
Slovenian: Kaplan-Meierjeve krivulje celokupnega preživetja po oceni raziskovalcev (post-hoc analiza 20. maja 2013) so prikazane na sliki 3.
English: Take Mekinist once a day, on an empty stomach (at least 1 hour before a meal or 2 hours after a meal).
Slovenian: Zdravilo Mekinist vzemite enkrat na dan, na prazen želodec (vsaj 1 uro pred jedjo ali 2 uri po jedi).
English: • have or have ever had lung or breathing problems.
Slovenian: • če imate ali ste kdaj imeli težave s pljuči ali dihanjem,
English: It is recommended that patients continue treatment with trametinib until patients no longer derive benefit or the development of unacceptable toxicity (see Table 2).
Slovenian: Zdravljenje s trametinibom je priporočljivo nadaljevati, dokler bolniku koristi, oziroma do pojava nesprejemljivih toksičnih učinkov (glejte preglednico 2).
English: Resume trametinib at a lower dose (reduced by 0.5 mg) or discontinue trametinib in patients taking trametinib 1 mg daily.
Slovenian: Znova začnite uporabljati trametinib v nižjem odmerku (zmanjšan za 0,5 mg), ali ukinite trametinib pri bolnikih, ki ga jemljejo po 1 mg na dan.
English: • Breakdown of muscle which can cause muscle pain and kidney damage (rhabdomyolysis)
Slovenian: • razgradnja mišic, ki lahko povzroči bolečine v mišicah in okvaro ledvic (rabdomioliza)
English: There are no clinical data in patients with moderate or severe hepatic impairment; therefore, the potential need for starting dose adjustment cannot be determined.
Slovenian: Kliničnih podatkov za bolnike z zmerno ali hudo okvaro jeter ni, zato morebitne potrebe po prilagoditvi začetnega odmerka ni mogoče opredeliti.
English: Very common side effects that may show up in your blood tests • Abnormal blood test results related to the liver
Slovenian: Zelo pogosti neželeni učinki, ki se lahko pokažejo v izvidih krvnih preiskav • nenormalni izvidi krvnih preiskav, povezanih z jetri
English: • Take Mekinist and dabrafenib on an empty stomach, at least one hour before or two hours after a meal.
Slovenian: • Zdravilo Mekinist in dabrafenib jemljite na prazen želodec, najmanj eno uro pred obrokom in najmanj dve uri po obroku.
English: The PFS result was consistent in the subgroup of patients with V600K mutation positive melanoma (HR=0.50; [95% CI: 0.18, 1.35], p=0.0788).
Slovenian: Rezultat PFS se je skladal v podskupini bolnikov, ki so imeli melanom s pozitivno mutacijo V600K (razmerje ogroženosti = 0,50, [95-odstotni IZ: 0,18; 1,35], p = 0,0788).
English: Left ventricular ejection fraction (LVEF) reduction/Left ventricular dysfunction Trametinib should be interrupted in patients who have an asymptomatic, absolute decrease of >10% in LVEF compared to baseline and the ejection fraction is below the institution's lower limit of normal (LLN) (see section 4.4).
Slovenian: Znižanje iztisnega deleža levega prekata (LVEF)/disfunkcija levega prekata Zdravljenje s trametinibom je treba prekiniti pri bolnikih, ki imajo asimptomatsko, absolutno zmanjšanje LVEF za > 10 % v primerjavi z izhodiščem, iztisni delež pa je pod spodnjo normalno mejo v ustanovi (glejte poglavje 4.4).
English: Before you take Mekinist in combination with dabrafenib your doctor needs to know if you:
Slovenian: Preden boste začeli jemati zdravilo Mekinist v kombinaciji z dabrafenibom, mora vaš zdravnik vedeti:
English: • Decreased red blood cells (anaemia), abnormal test related to creatine phosphokinase, an enzyme found mainly in heart, brain, and skeletal muscle
Slovenian: • zmanjšano število rdečih krvnih celic (anemija), nenormalni izvidi preiskav, povezanih s kreatin-fosfokinazo (to je encim, ki se večinoma nahaja v srcu, možganih in skeletnih mišicah)
English: Secondary endpoints include overall survival (OS; key secondary endpoint), freedom from relapse (FFR) and distant metastasis-free survival (DMFS).
Slovenian: Med sekundarnimi cilji opazovanja so bili celokupno preživetje (OS; ključni sekundarni cilj opazovanja), stanje brez ponovitve bolezni (FFR - freedom from relapse) in preživetje brez oddaljenih metastaz (DMFS - distant metastasis-free survival).
English: 7.5d a - Progression-free survival (investigator assessed) b - Overall Response Rate = Complete Response + Partial Response c - Duration of response d - At the time of the reporting the majority (59% of dabrafenib+trametinib and 42% of vemurafenib) of investigator-assessed responses were still ongoing
Slovenian: d a - preživetje brez napredovanja (kot ga oceni raziskovalec) b - celokupni odziv = popoln odziv + delen odziv c - trajanje odziva d - v času poročanja je večina odzivov (59 % pri dabrafenibu + trametinibu in 42 % pri vemurafenibu), kot jih je ocenil raziskovalec, še trajala
English: Grade 2-3 RPED that improves to Grade 0-1 within 3 weeks
Slovenian: RPED 2. do 3. stopnje, ki se v 3 tednih izboljša na 1. stopnjo ali stopnjo 0
English: Based on in vitro and in vivo data, trametinib is unlikely to significantly affect the pharmacokinetics of other medicinal products via interaction with CYP enzymes or transporters (see section 5.2).
Slovenian: Glede na podatke in vitro in in vivo ni verjetno, da bi trametinib pomembno vplival na farmakokinetiko drugih zdravil preko interakcij z encimi CYP ali prenašalci (glejte poglavje 5.2).
English: Most of the findings are reversible after drug-free recovery.
Slovenian: Večina ugotovljenih učinkov je bila reverzibilna po obdobju brez zdravila.
English: The safety and efficacy of trametinib in non-Caucasian patients have not been established.
Slovenian: Varnost in učinkovitost trametiniba nista ugotovljeni pri bolnikih, ki niso belci.
English: There are no data with trametinib in patients with severe renal impairment; therefore, the potential need for starting dose adjustment cannot be determined.
Slovenian: Podatkov o trametinibu pri bolnikih s hudo okvaro ledvic ni, zato ni mogoče ugotoviti morebitne potrebe po prilagoditvi začetnega odmerka.
English: and BRF115532 (n=1,076)
Slovenian: a, BRF113928 in BRF115532 (n = 1.076)
English: All of these effects were reversible following an off-treatment period and attributable to pharmacology.
Slovenian: Vsi našteti učinki so po obdobju brez zdravljenja izzveneli in jih je mogoče pripisati farmakološkemu delovanju učinkovine.
English: Signs or symptoms of rhabdomyolysis should warrant an appropriate clinical evaluation and treatment as indicated.
Slovenian: V primeru znakov ali simptomov rabdomiolize je potrebno ustrezno klinično ovrednotenje in zdravljenje, kot je indicirano.
English: • Take Mekinist once daily and take dabrafenib twice daily.
Slovenian: • Zdravilo Mekinist jemljite enkrat na dan, dabrafenib pa dvakrat na dan.
English: • Inflammation of hair follicles in the skin
Slovenian: • vnetje mešičkov las/dlak v koži
English: Trametinib is not a substrate of CYP enzymes or of the transporters BCRP, OATP1B1, OATP1B3, OATP2B1, OCT1, MRP2, and MATE1.
Slovenian: Trametinib ni substrat encimov CYP ali prenašalcev BCRP, OATP1B1, OATP1B3, OATP2B1, OCT1, MRP2 in MATE1.
English: Number of deaths
Slovenian: Zdravljenje Število smrti
English: The film-coated tablets are supplied in opaque white plastic bottles with threaded plastic closures.
Slovenian: Filmsko obložene tablete so na voljo v motno belih plastenkah s plastično navojno zaporko.
English: Keep the bottle tightly closed with the dessicant inside (small cylinder shaped container).
Slovenian: Plastenko shranjujte tesno zaprto, s sušilnim sredstvom (majhen cilindrično oblikovan vsebnik) v plastenki.
English: As it cannot be excluded that strong inhibition of hepatic P-gp may result in increased levels of trametinib, caution is advised when co-administering trametinib with medicinal products that are strong inhibitors of P-gp (e.g. verapamil, cyclosporine, ritonavir, quinidine, itraconazole).
Slovenian: Ni mogoče izključiti možnosti, da bi močno zaviranje prenašalca P-gp v jetrih povzročilo zvišanje koncentracije trametiniba, zato je priporočena previdnost pri sočasnem odmerjanju trametiniba in zdravil, ki so močni zaviralci P-gp (na primer verapamila, ciklosporina, ritonavirja, kinidina, itrakonazola).
English: Mekinist is not recommended if you have ever had blockage of the vein draining the eye (retinal vein occlusion).
Slovenian: Zdravila Mekinist ni priporočljivo uporabljati, če ste kdaj imeli zaporo vene, po kateri kri odteka iz očesa (zaporo mrežnične vene).
English: In patients who are diagnosed with RVO, treatment with trametinib should be permanently discontinued.
Slovenian: Pri bolnikih, pri katerih je diagnosticirana RVO, je treba zdravljenje s trametinibom trajno končati.
English: Following single and repeated doses of trametinib, trametinib as parent is the main circulating component in plasma.
Slovenian: Po enkratnem in večkratnih odmerkih je trametinib glavna snov, ki kroži v plazmi.
English: Patients ≥65 years were more likely to experience ARs leading to permanent discontinuation of medicinal product, dose reduction and dose interruption than those <65 years.
Slovenian: Bolniki, stari ≥ 65 let, so imeli večjo verjetnost NU, ki so povzročili trajno prenehanje uporabe zdravila, znižanje odmerka ali prekinitev odmerjanja, kot bolniki, stari < 65 let.
English: In the ITT population, 54% of patients were male and all were Caucasian.
Slovenian: V populaciji ZNZ je bilo 54 % moških in vsi bolniki in bolnice so bili belci.
English: In clinical trials, the median time to first occurrence of left ventricular dysfunction, cardiac failure and LVEF decrease was between 2 to 5 months.
Slovenian: V kliničnih preskušanjih je bila mediana časa do prvega pojava disfunkcije levega prekata, srčnega popuščanja in zmanjšanja LVEF od 2 do 5 mesecev.
English: Do not change your dose or stop Mekinist or dabrafenib unless your doctor, nurse or pharmacist tells you to.
Slovenian: Ne spreminjajte odmerka in ne prekinjajte zdravljenja z zdravilom Mekinist ali dabrafenibom, razen če vam tako naroči zdravnik, medicinska sestra ali farmacevt.
English: No initial dose adjustment is required in patients >65 years of age.
Slovenian: Bolnikom, starim > 65 let, začetnega odmerka ni treba prilagoditi.
English: Chemotherapy (n=108)
Slovenian: Kemoterapija (n = 108)
English: When trametinib and dabrafenib are taken in combination, the once-daily dose of trametinib should be taken at the same time each day with either the morning dose or the evening dose of dabrafenib.
Slovenian: Pri jemanju trametiniba in dabrafeniba v kombinaciji, je treba dnevni odmerek trametiniba vzeti enkrat na dan vsak dan ob istem času skupaj z bodisi jutranjim ali večernim odmerkom dabrafeniba.
English: • Heart pumping less efficiently, causing shortness of breath, extreme tiredness and swelling in ankles and legs (heart failure)
Slovenian: • manj učinkovito črpalno delovanje srca, ki povzroča kratko sapo, skrajno utrujenost in otekanje gležnjev in nog (srčno popuščanje)
English: Patients should take trametinib as monotherapy or in combination with dabrafenib at least one hour prior to or two hours after a meal due to the effect of food on trametinib absorption (see section 4.2 and 5.2).
Slovenian: Bolniki morajo trametinib, bodisi v monoterapiji ali v kombinaciji z dabrafenibom, vzeti vsaj eno uro pred jedjo ali vsaj dve uri po jedi, ker hrana vpliva na absorpcijo trametiniba (glejte poglavji 4.2 in
English: Your doctor may advise an eye examination before you take Mekinist and while you are taking it.
Slovenian: Zdravnik vam lahko svetuje pregled oči pred začetkom jemanja zdravila Mekinist in med jemanjem tega zdravila.
English: Lung or breathing problems
Slovenian: Težave s pljuči ali dihanjem
English: The deacetylated metabolite was further metabolised by glucuronidation.
Slovenian: Deacetiliran presnovek se nadalje presnavlja z glukuronidacijo.
English: Median OS and estimated 1-year, 2-year, 3-year, 4-year and 5-year survival rates are presented in Table 6.
Slovenian: Mediana celokupnega preživetja (OS) in ocene 1-letnega, 2-letnega, 3-letnega, 4-letnega ter 5-letnega preživetja so predstavljene v preglednici 6.
English: No data are available in patients with moderate or severe hepatic impairment.
Slovenian: Za bolnike z zmerno ali hudo okvaro jeter podatkov ni.
English: Mekinist can cause eye problems including blindness.
Slovenian: Zdravilo Mekinist lahko povzroči težave z očmi, tudi slepoto.
English: Chemotherapy included patients on dacarbazine (DTIC) 1000 mg/m2 every 3 weeks or paclitaxel 175 mg/m every 3 weeks.
Slovenian: Kemoterapija je vključevala bolnike na dakarbazinu (DTIC) 1000 mg/m na 3 tedne ali na paklitakselu 175 mg/m2 na 3 tedne.
English: What Mekinist looks like and contents of the pack
Slovenian: Izgled zdravila Mekinist in vsebina pakiranja
English: As trametinib is metabolised predominantly via deacetylation mediated by hydrolytic enzymes (e.g. carboxyl-esterases), its pharmacokinetics are unlikely to be affected by other agents through metabolic interactions (see section 5.2).
Slovenian: Presnova trametiniba poteka predvsem z deacetilacijo, ki jo katalizirajo hidrolitični encimi (npr. karboksilesteraze), zato ni verjetno, da bi na njegovo farmakokinetiko vplivala druga zdravila preko presnovnih interakcij (glejte poglavje 5.2).
English: In patients with BRAF and NRAS mutation positive melanoma, administration of trametinib resulted in dose-dependent changes in tumour biomarkers including inhibition of phosphorylated ERK, inhibition of Ki67 (a marker of cell proliferation), and increases in p27 (a marker of apoptosis).
Slovenian: Pri bolnikih z melanomom s pozitivno mutacijo BRAF in NRAS je trametinib povzročil od odmerka odvisne spremembe tumorskih bioloških označevalcev, vključno z zavrtjem fosforilirane ERK, zavrtjem Ki67 (označevalec celične proliferacije) in zvišanjem p27 (označevalec apoptoze).
English: Based on in vitro studies, trametinib is not an inhibitor of CYP1A2, CYP2A6, CYP2B6, CYP2D6 and CYP3A4.
Slovenian: Študije in vitro kažejo, da trametinib ne zavira CYP1A2, CYP2A6, CYP2B6, CYP2D6 in CYP3A4.
English: Patients in the chemotherapy arm were allowed to cross over to the trametinib arm after independent confirmation of progression.
Slovenian: Bolnikom v skupini s kemoterapijo je bil dovoljen prehod v skupino s trametinibom, če je bilo neodvisno potrjeno napredovanje.
English: Female patients of reproductive potential must be advised to use effective methods of contraception during treatment with trametinib and for 16 weeks after stopping treatment.
Slovenian: Ženskam v rodni dobi je treba svetovati, da morajo med zdravljenjem in še 16 tednov po prenehanju zdravljenja s trametinibom uporabljati učinkovite kontracepcijske metode.
English: Median OS and estimated 1-year, 2-year, 3-year, 4-year and 5-year survival rates are presented in Table 8.
Slovenian: Mediana celokupnega preživetja (OS) in ocene 1-letnega, 2-letnega, 3-letnega, 4-letnega ter 5-letnega preživetja so predstavljene v preglednici 8.
English: If the LVEF recovers, treatment with trametinib may be restarted, but the dose should be reduced by one dose level with careful monitoring (see section 4.4).
Slovenian: Če se LVEF popravi, je mogoče znova uvesti trametinib, vendar je odmerek treba znižati za eno odmerno raven in potreben je skrben nadzor (glejte poglavje 4.4).
English: The median time to onset of the first occurrence of haemorrhagic events for the combination of trametinib and dabrafenib was 94 days in the melanoma Phase III studies and 75 days in the NSCLC study for the patients who had received prior anti-cancer therapy.
Slovenian: Mediana časa do pojava prve krvavitve pri zdravljenju s kombinacijo trametiniba in dabrafeniba je bila 94 dni v študijah melanoma faze III in 75 dni v študiji nedrobnoceličnega pljučnega raka pri bolnikih, ki so že prej prejemali zdravila za zdravljenje raka.
English: In a study in dogs in which trametinib and dabrafenib were given in combination for 4 weeks, signs of gastro-intestinal toxicity and decreased lymphoid cellularity of the thymus were observed at lower exposures than in dogs given trametinib alone.
Slovenian: V študiji na psih, ki so jim 4 tedne dajali trametinib in dabrafenib v kombinaciji, so opažali znake gastrointestinalne toksičnosti in zmanjšano število limfatičnih celic v timusu pri izpostavljenostih, ki so bile nižje kot pri psih, ki so jim dajali samo trametinib.
English: Up to 3 in 100 people taking Mekinist in combination with dabrafenib may develop a different type of skin cancer called cutaneous squamous cell carcinoma (cuSCC).
Slovenian: Pri največ 3 od 100 ljudi, ki jemljejo zdravilo Mekinist v kombinaciji z dabrafenibom, se lahko razvije druga vrsta kožnega raka, ki ga imenujemo ploščatocelični karcinom kože.
English: Trametinib should be permanently discontinued in patients with Grade 3 or 4 left ventricular cardiac dysfunction or clinically significant LVEF reduction which does not recover within 4 weeks (see section 4.4).
Slovenian: Zdravljenje s trametinibom je treba dokončno ukiniti pri bolnikih z disfunkcijo levega prekata 3. ali 4. stopnje ali s klinično pomembnim zmanjšanjem LVEF, ki se ne popravi v 4 tednih (glejte poglavje 4.4).
English: Some people taking Mekinist in combination with dabrafenib may also notice that new melanomas have appeared.
Slovenian: Nekateri ljudje, ki jemljejo zdravilo Mekinist v kombinaciji z dabrafenibom, lahko opazijo tudi pojav novega melanoma.
English: The mean trametinib concentrations observed following repeat dose administration of 2 mg once daily exceeds the preclinical target concentration over the 24-hr dosing interval, thereby providing sustained inhibition of the MEK pathway.
Slovenian: Povprečna koncentracija trametiniba, opažena po uporabi ponavljajočih se odmerkov 2 mg enkrat na dan, v 24-urnem odmernem intervalu presega predklinično ciljno koncentracijo in tako doseže dolgotrajno zavrtje poti MEK.
English: Patients with LVEF lower than the institutional lower limit of normal were not included in clinical trials with trametinib.
Slovenian: Bolniki, pri katerih je bila vrednost iztisnega deleža levega prekata nižja od spodnje meje normalnih vrednosti v posamezni ustanovi, niso biti vključeni v klinične študije s trametinibom.
English: Mekinist is a medicine that contains the active substance trametinib.
Slovenian: Zdravilo Mekinist vsebuje učinkovino trametinib.
English: Table 5 Adverse reactions reported in the integrated safety population of trametinib in combination with dabrafenib in the studies MEK115306, MEK116513
Slovenian: Preglednica 5 Neželeni učinki, o katerih so poročali pri skupini za vrednotenje varnosti zdravila, zdravljeni s trametinibom v kombinaciji z dabrafenibom v študijah MEK115306, MEK116513
English: Take whole with a full glass of water.
Slovenian: Tableto zaužijte celo s polnim kozarcem vode.
English: Mekinist can cause inflammation of the lung (pneumonitis or interstitial lung disease).
Slovenian: Zdravilo Mekinist lahko povzroči vnetje pljuč (pnevmonitis ali intersticijsko bolezen pljuč).
English: 7 film-coated tablets 30 film-coated tablets
Slovenian: filmsko obložena tableta 7 filmsko obloženih tablet 30 filmsko obloženih tablet
English: Thus, trametinib and dabrafenib inhibit two kinases in this pathway, MEK and RAF, and therefore the combination provides concomitant inhibition of the pathway.
Slovenian: Trametinib in dabrafenib torej zavirata dve kinazi, MEK in RAF, ki sta del te poti, tako da je s kombinacijo mogoče doseči sočasno dvojno zaviranje te poti.
English: Blood pressure should be measured at baseline and monitored during treatment with trametinib, with control of hypertension by standard therapy as appropriate.
Slovenian: Krvni tlak je treba izmeriti izhodiščno in ga kontrolirati med zdravljenjem s trametinibom; hipertenzijo je treba obvladovati s standardnim zdravljenjem, kot je ustrezno.
English: Effect of other medicinal products on trametinib
Slovenian: Vpliv drugih zdravil na trametinib
English: In animals, no fertility studies have been performed, but adverse effects were seen on female reproductive organs (see section 5.3).
Slovenian: Pri živalih niso izvedli študij plodnosti, opažali pa so neželene učinke na reproduktivne organe samic (glejte poglavje 5.3).
English: The side effects that you may see when you take Mekinist in combination with dabrafenib are as follows:
Slovenian: Neželeni učinki, ki jih lahko opazite v času jemanja zdravila Mekinist v kombinaciji z dabrafenibom, so naslednji:
English: In a Phase III trial, 2.4% (5/211) of patients treated with trametinib monotherapy developed ILD or pneumonitis; all five patients required hospitalisation.
Slovenian: V preskušanju faze III se je IBP ali pnevmonitis med zdravljenjem s trametinibom v monoterapiji pojavil pri 2,4 % (5/211) bolnikov; vseh pet bolnikov je potrebovalo sprejem v bolnišnico.
English: Trametinib monotherapy has not demonstrated clinical activity in patients who have progressed on a prior BRAF inhibitor therapy (see section 5.1).
Slovenian: Trametinib v monoterapiji ni izkazal klinične aktivnosti pri bolnikih, ki jim je bolezen napredovala med predhodnim zdravljenjem z zaviralcem BRAF (glejte poglavje 5.1).
English: Based on a population pharmacokinetic analysis, gender and body weight were found to influence trametinib oral clearance.
Slovenian: Populacijska farmakokinetična analiza je pokazala, da spol in telesna masa vplivata na peroralni očistek trametiniba.
English: Your doctor may arrange to check your lung function before you start taking your medicine.
Slovenian: Zdravnik vas lahko napoti na testiranje pljučne funkcije, preden boste začeli jemati zdravilo.
English: Trametinib has minor influence on the ability to drive or use machines.
Slovenian: Trametinib ima blag vpliv na sposobnost vožnje in upravljanja strojev.
English: Contact your doctor immediately if you get a severe skin rash with any of the following symptoms: blisters on your skin, blisters or sores in your mouth, peeling of your skin, fever, redness or swelling of your face, or soles of your feet.
Slovenian: Takoj se posvetujte z zdravnikom, če se vam pojavi hud izpuščaj na koži s katerim od naslednjih simptomov: mehurji na koži, mehurji ali ranami v ustih, lupljenjem kože, zvišano telesno temperaturo, pordelostjo ali oteklostjo obraza, dlani ali podplatov.