FrancophonIA/ELRC3.0 huggingface dataset:
English: Heart and lungs: palpitations, irregular heartbeat, congestive heart failure, weak heart muscle, high blood pressure, increased blood pressure in the lungs, cough Digestive problems: appetite disturbances, taste disturbance, bloated or distended tummy (abdomen), inflammation of the colon, constipation, heartburn, mouth ulceration, weight increase, weight decrease, gastritis
Slovenian: Srce in pljuča: razbijanje srca, motnje srčnega ritma, kongestivno srčno popuščanje, oslabelost srčne mišice, visok krvni tlak, zvišan krvni tlak v pljučih in kašelj.
English: CHR (advanced CML/Ph+ ALL): WBC ≤ institutional ULN, ANC ≥ 1,000/mm3, platelets ≥ 100,000/mm3, no blasts or promyelocytes in peripheral blood, bone marrow blasts ≤ 5%, < 5% myelocytes plus metamyelocytes in peripheral blood, basophils in peripheral blood < 20%, and no extramedullary involvement.
Slovenian: Popoln hematološki odziv (KML v napredovalem obdobju/Ph+ ALL): število belih krvnih celic ≤ zgornje meje referenčnih vrednosti, absolutno število nevtrofilcev ≥ 1.000/mm3, trombociti ≥ 100.000/mm3, brez blastov ali promielocitov v periferni krvi, blasti v kostnem mozgu ≤ 5%, < 5% mielocitov in metamielocitov v periferni krvi, < 20% bazofilcev v periferni krvi in brez ekstramedularne vpletenosti.
English: EU/1/06/363/015 - 30 x 1 film-coated tablets (unit dose blisters) EU/1/06/363/014 - 30 film-coated tablets (bottle)
Slovenian: EU/1/06/363/015 - 30 x 1 filmsko obložena tableta (enoodmerni pretisni omoti) EU/1/06/363/014 - 30 filmsko obloženih tablet (plastenka)
English: SPRYCEL 20 mg film-coated tablets dasatinib
Slovenian: SPRYCEL 20 mg filmsko obložene tablete dasatinib
English: White to off-white, biconvex, round film-coated tablet with "BMS" debossed on one side and "527" on the other side.
Slovenian: Bele do sivobele, bikonveksne in okrogle filmsko obložene tablete z oznako "BMS" na eni in "527" na drugi strani.
English: EU/1/06/363/011 - 30 x 1 film-coated tablets (unit dose blisters) EU/1/06/363/010 - 30 film-coated tablets (bottle)
Slovenian: EU/1/06/363/011 - 30 x 1 filmsko obložena tableta (enoodmerni pretisni omoti) EU/1/06/363/010 - 30 filmsko obloženih tablet (plastenka)
English: Each film-coated tablet contains 20 mg dasatinib (as monohydrate).
Slovenian: Ena filmsko obložena tableta vsebuje 20 mg dasatiniba (v obliki monohidrata).
English: SPRYCEL contains sucrose
Slovenian: Zdravilo SPRYCEL vsebuje saharozo
English: Dasatinib is extensively metabolised in humans with multiple enzymes involved in the generation of the metabolites.
Slovenian: Pri nastanku presnovkov so vključeni številni encimi.
English: By 4 years 73%, p<.0021
Slovenian: V 4 letih p<0,0021
English: Imatinib-intolerant patients 100% (100, 100) 95% (88, 100)
Slovenian: SMRTI / Št. zajetih bolnikov MEDIANA (95% IZ) RAZMERJE OGROŽENOSTI (95% IZ)
English: j Conjunctival oedema, eye oedema, eye swelling, eyelid oedema, face oedema, lip oedema, macular oedema, oedema mouth, orbital oedema, periorbital oedema, swelling face.
Slovenian: ij Edem veznic, očesni edem, oteklina oči, edem očesnih vek, edem obraza, edem ustnic, makularni edem, edem ust,
English: Guidelines for dose modifications in paediatric patients with CML-CP are summarised in Table 3.Guidelines for paediatric patients with Ph+ ALL treated in combination with chemotherapy are in a separate paragraph following the table.
Slovenian: Smernice za pediatrične bolnike s Ph+ ALL, ki se zdravijo v kombinaciji s kemoterapijo, so navedene v ločenem odstavku, ki sledi preglednicam.
English: Common weight decreased, weight increased
Slovenian: Pogosti zmanjšanje telesne mase, povečanje telesne mase
English: Forty-two percent of the imatinib-resistant patients with no prior MCyR to imatinib (n= 188) achieved a MCyR with dasatinib.
Slovenian: Pri uporabi dasatiniba je bil dober citogenetski odziv dosežen pri 42% bolnikov, odpornih na imatinib, pri katerih dober citogenetski odziv na zdravljenje z imatinibom (n = 188) ni bil dosežen.
English: White to off-white, biconvex, round film-coated tablet with "BMS" debossed on one side and "524" on the other side.
Slovenian: Bele do sivobele, bikonveksne in okrogle filmsko obložene tablete z oznako "BMS" na eni in "524" na drugi strani.
English: CHR: WBC ≤ institutional ULN, ANC ≥ 1,000/mm3, platelets ≥ 100,000/mm3, no blasts or promyelocytes in peripheral blood, bone marrow blasts ≤ 5%, < 5% myelocytes plus metamyelocytes in peripheral blood, basophils in peripheral blood < 20%, and no extramedullary involvement.
Slovenian: Popoln hematološki odziv (CHR): število belih krvnih celic ≤ zgornje meje referenčnih vrednosti, absolutno število nevtrofilcev ≥ 1.000/mm3, trombociti ≥ 100.000/mm3, brez blastov ali promielocitov v periferni krvi, blasti v kostnem mozgu ≤ 5%, < 5% mielocitov in metamielocitov v periferni krvi, < 20% bazofilcev v periferni krvi in brez ekstramedularne vpletenosti.
English: EU/1/06/363/013 - 30 x 1 film-coated tablets (unit dose blisters) EU/1/06/363/012 - 30 film-coated tablets (bottle)
Slovenian: EU/1/06/363/013 - 30 x 1 filmsko obložena tableta (enoodmerni pretisni omoti) EU/1/06/363/012 - 30 filmsko obloženih tablet (plastenka)
English: Pain: pain in the muscles (during or after discontinuing treatment), tummy (abdominal) pain Tests may show: low blood platelet count, low white blood cells count (neutropaenia), anaemia, fluid around the lungs
Slovenian: Preiskave lahko pokažejo: zmanjšano število trombocitov, zmanjšano število belih krvnih celic (nevtropenija), anemijo in tekočino okrog pljuč.
English: Escalation
Slovenian: Povečanje
English: CHR (chronic CML): WBC ≤ institutional ULN, platelets < 450,000/mm3, no blasts or promyelocytes in peripheral blood, < 5% myelocytes plus metamyelocytes in peripheral blood, basophils in peripheral blood < 20%, and no extramedullary involvement.
Slovenian: Popoln hematološki odziv (KML v kroničnem obdobju): število belih krvnih celic ≤ zgornje meje referenčnih vrednosti, trombociti < 450.000/mm3, brez blastov ali promielocitov v periferni krvi, < 5% mielocitov in metamielocitov v periferni krvi, < 20% bazofilcev v periferni krvi in brez ekstramedularne vpletenosti.
English: One-level dose reduction
Slovenian: Odmerek, zmanjšan za eno stopnjo
English: Four single-arm, uncontrolled, open-label Phase II clinical studies were conducted to determine the safety and efficacy of dasatinib in patients with CML in chronic, accelerated, or myeloid blast phase, who were either resistant or intolerant to imatinib.
Slovenian: Za določitev varnosti in učinkovitosti dasatiniba pri bolnikih s KML v kroničnem obdobju, obdobju pospešenega poteka ali obdobju mieloblastne preobrazbe, ki se na zdravljenje z imatinibom niso odzvali ali ga niso prenašali, so bile izvedene štiri enoskupinske (“single-arm”), nenadzorovane, odprte klinične študije II.
English: Each film-coated tablet contains 50 mg dasatinib (as monohydrate).
Slovenian: Ena filmsko obložena tableta vsebuje 50 mg dasatiniba (v obliki monohidrata).
English: SPRYCEL must be administered orally.
Slovenian: Zdravilo SPRYCEL je namenjeno za peroralno uporabo.
English: White to off-white, biconvex, oval film-coated tablet with "BMS" debossed on one side and "528" on the other side.
Slovenian: Bele do sivobele, bikonveksne in ovalne filmsko obložene tablete z oznako "BMS" na eni in "528" na drugi strani.
English: Prior imatinib (N = 46)b a Patients from Phase II paediatric study of newly diagnosed CML-CP receiving oral tablet formulation b Patients from Phase I and Phase II paediatric studies of imatinib-resistant or intolerant CML-CP receiving oral tablet formulation
Slovenian: Predhodno imatinib (N = 46)b a Bolniki iz pediatričnih študij II.
English: Not known thrombotic microangiopathy Respiratory, thoracic and mediastinal disorders Very common pleural effusion*, dyspnoea
Slovenian: Neznana pogostnost trombotična mikroangiopatija Bolezni dihal, prsnega koša in mediastinalnega prostora
English: NAME OF THE MEDICINAL PRODUCT SPRYCEL 140 mg tablets dasatinib
Slovenian: SPRYCEL 140 mg tablete dasatinib
English: An open-label, single-arm, multicentre study was conducted in patients intolerant or resistant to imatinib.
Slovenian: Pri bolnikih, ki imatiniba niso prenašali ali so bili nanj odporni, je bila izvedena odprta, enoskupinska (“single-arm”), multicentrična študija.
English: The majority of SPRYCEL-treated patients experienced adverse reactions at some time.
Slovenian: V določenem času so se neželeni učinki pojavili pri večini z zdravilom SPRYCEL zdravljenih bolnikov.
English: Progression-free survivalb
Slovenian: Preživetje brez napredovanja boleznib
English: achieved in 93% of the overall patient population.
Slovenian: Predhodni popolni hematološki odziv na imatinib je bil dosežen pri 93% vseh bolnikov.
English: You cannot be sure you will receive the correct dose if you crush, cut, chew or disperse the tablets.
Slovenian: Če zdrobite, razpolovite, žvečite ali raztopite tablete, ne morete vedeti zagotovo, če boste prejeli pravi odmerek.
English: CHR (95% CI) NEL (95% CI)
Slovenian: MaHRb (95% IZ) CHRb (95% IZ) NELb (95% IZ) MCyRc (95% IZ) CCyR (95% IZ)
English: By 1 year 46%, p<.0001
Slovenian: V 1 letu p<0,0001
English: Very common haemorrhage*d Common hypertension, flushing Uncommon hypotension, thrombophlebitis, thrombosis
Slovenian: Občasni hipotenzija, tromboflebitis, tromboza
English: By 2 years 64%, p<.0001
Slovenian: V 2 letih p<0,0001
English: At all post-dose time points on day 8, the mean changes from baseline in QTcF interval were 4 - 6 msec, with associated upper 95% confidence intervals < 7 msec. Of the 2,182 patients with resistance or intolerance to prior imatinib therapy who received SPRYCEL in clinical studies, 15 (1%) had QTc prolongation reported as an adverse reaction.
Slovenian: V vseh časovnih točkah po odmerku na 8. dan so bile srednje spremembe od izhodišča v intervalu QTcF 4 -6 milisekund, s pridruženimi zgornjimi 95-odstotnimi intervali zaupanja < 7 milisekund.
English: Pyrexia
Slovenian: CCyRb
English: Dasatinib should be administered with caution to patients who have or may develop prolongation of QTc.
Slovenian: Pri bolnikih s podaljšanim intervalom QTc oziroma bolnikih, pri katerih bi se podaljšanje intervala QTc lahko pojavilo, je potrebna previdnost pri predpisovanju dasatiniba.
English: Median duration of treatment on dasatinib was 3 months with 2% treated for > 24 months to date.
Slovenian: Zdravljenje z dasatinibom je v povprečju trajalo 3 mesece, pri 2% bolnikov je zdravljenje do danes trajalo dlje kot 24 mesecev.
English: Common asthenia, pain, chest pain, generalised oedema*k, chills Uncommon malaise, other superficial oedemal
Slovenian: Pogosti astenija, bolečina, bolečina v prsih, generalizirani edem*k, mrzlica
English: b Includes central nervous system haemorrhage, cerebral haematoma, cerebral haemorrhage, extradural haematoma, haemorrhage intracranial, haemorrhagic stroke, subarachnoid haemorrhage, subdural haematoma, and subdural haemorrhage.
Slovenian: b Vključuje krvavitve v osrednjem živčevju, cerebralni hematom, cerebralno krvavitev, ekstraduralni hematom,
English: NAME OF THE MEDICINAL PRODUCT SPRYCEL 140 mg film-coated tablets dasatinib
Slovenian: SPRYCEL 140 mg filmsko obložene tablete dasatinib
English: Other secondary endpoints included duration of MCyR, PFS, and overall survival.
Slovenian: Drugi sekundarni opazovani dogodki so vključevali trajanje dobrega citogenetskega odziva, preživetje brez progresije bolezni (PFS - “progression-free survival”) in skupno preživetje.
English: An open-label, single-arm, multicentre study was conducted in patients with lymphoid blast phase CML or Ph+ ALL who were resistant or intolerant to prior imatinib therapy.
Slovenian: Pri bolnikih s KML v obdobju limfoblastne preobrazbe ali s Ph+ ALL, ki imatiniba niso prenašali ali pa so bili na predhodno zdravljenje z imatinibom odporni, je bila izvedena odprta, enoskupinska (“single-arm”), multicentrična študija.
English: Prior complete haematologic response (CHR) to imatinib was
Slovenian: Popoln hematološki odziv (CHR)
English: Ninety-three percent of patients in the dasatinib arm and 82% of patients in the imatinib arm achieved a CHR prior to crossover.
Slovenian: V skupini, ki je prejemala dasatinib, je bil pred prehodom v skupino z alternativnim zdravljenjem popolni hematološki odziv dosežen pri 93% bolnikov, v skupini, ki je prejemala imatinib, pa pri 82% bolnikov.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 140 mg dasatinib (as monohydrate).
Slovenian: Ena filmsko obložena tableta vsebuje 140 mg dasatiniba (v obliki monohidrata).
English: However, SPRYCEL should be used with caution in patients with hepatic impairment (see section 5.2).
Slovenian: Pri bolnikih z blago, zmerno ali s hudo okvaro jeter se zdravljenje lahko uvede s priporočenim začetnim odmerkom, vendar pa je pri bolnikih z okvaro jeter kljub temu potrebna previdnost pri uporabi zdravila SPRYCEL (glejte poglavje 5.2).
English: • spread to other parts of the body or cannot be removed by surgery.
Slovenian: • se je razširila na druge dele telesa ali je ni mogoče kirurško odstraniti.
English: PFS (primary analysis)
Slovenian: PFS (primarna analiza)
English: They may be taken with or without food.
Slovenian: Lahko se jemljejo skupaj s hrano ali brez.
English: Specific inducers of these enzymes have not been studied and may result in a loss of efficacy.
Slovenian: Specifični induktorji teh encimov se niso preučevali in lahko povzročijo izgubo učinkovitosti.
English: These data show that the efficacy of the combination would be lower in these patients.
Slovenian: Ti podatki kažejo, da je učinkovitost uporabe te kombinacije pri teh bolnikih nižja.
English: Then continue taking your tablets at regular times as usual.
Slovenian: Nato tablete jemljite redno kot običajno.
English: EU/1/18/1315/001 84 film-coated tablets EU/1/18/1315/002 168 film-coated tablets
Slovenian: EU/1/18/1315/001 84 filmsko obloženih tablet EU/1/18/1315/002 168 filmsko obloženih tablet
English: PFS as assessed by investigators (investigator assessment) was a supportive analysis.
Slovenian: PFS, kot so ga ocenili raziskovalci (ocenjevanje raziskovalcev), je predstavljal podporno analizo.
English: All events occurred in the setting of new or progressive brain metastases.
Slovenian: Vsi dogodki so se zgodili v primeru novih ali napredujočih metastaz v možganih.
English: If necessary, your doctor may interrupt your treatment or stop it altogether.
Slovenian: Po potrebi zdravnik lahko prekine zdravljenje ali ga v celoti preneha izvajati.
English: Confirmed overall responses
Slovenian: Potrjeni skupni odzivi
English: Patients should be assessed at each visit for symptoms of new or worsening visual disturbances.
Slovenian: Bolnike je treba ob vsakem obisku pregledati za simptome novih ali poslabšanih motenj vida.
English: LVEF should be evaluated every 2 weeks.
Slovenian: LVEF je treba oceniti vsaka 2 tedna.
English: Mektovi is not recommended for children and adolescents under 18 years of age.
Slovenian: Zdravilo Mektovi se ne priporoča za uporabo pri otrocih in mladostnikih, mlajših od 18 let.
English: Visual impairment was generally reversible.
Slovenian: Okvara vida je bila večinoma reverzibilna.
English: These differences were within the variability observed for these parameters in both cohorts of this study (25 % - 49 %) and the variability previously observed in patient clinical studies, hence these differences are unlikely to be clinically relevant.
Slovenian: Te razlike so v obsegu variabilnosti, ki so jo opazili za te parametre pri obeh kohortah te študije (od 25 % do 49 %), in variabilnosti, ki so jo predhodno opazili pri bolnikih v kliničnih študijah, zato ni verjetno, da so te razlike klinično pomembne.
English: • a particular change (mutation) in a gene responsible for producing a protein called BRAF, and
Slovenian: • pri kateri je prišlo do posebne spremembe (mutacije) gena, ki proizvaja protein z imenom BRAF, ter
English: • red or black stools that look like tar
Slovenian: • rdeče ali črno blato, ki je videti kot katran,
English: Dose modifications recommendations in case of adverse reactions are presented below and in Tables 1 and 2.
Slovenian: Priporočene spremembe odmerka v primeru neželenih učinkov so navedene spodaj in v preglednicah 1 in 2.
English: The safety and efficacy of binimetinib in children and adolescents have not yet been established.
Slovenian: Varnost in učinkovitost zdravila binimetinib pri otrocih in mladostnikih še nista bili dokazani.
English: Mektovi can be taken with food or between meals.
Slovenian: Zdravilo Mektovi se lahko jemlje skupaj s hrano ali med obroki.
English: You will also receive treatment with another medicine, encorafenib.
Slovenian: Zdravili se boste še z enim zdravilom, enkorafenibom.
English: As a precaution, drink plenty of fluids during treatment.
Slovenian: Kot previdnostni ukrep med zdravljenjem pijte veliko tekočin.
English: Genital examinations (for women) and anal examinations are also recommended before the initiation and at the end of your treatment.
Slovenian: Pregledi spolovil (za ženske) in analni pregledi se prav tako priporočajo pred začetkom zdravljenja in na koncu zdravljenja.
English: Similar results were observed per Investigator assessment.
Slovenian: Podobni rezultati so se pokazali tudi pri posameznih ocenah raziskovalca.
English: The efficacy results based on investigator assessment were consistent with the independent central assessment.
Slovenian: Rezultati učinkovitosti po oceni raziskovalcev so se ujemali z rezultati neodvisnega centralnega ocenjevanja.
English: Each pack contains either 84 or 168 tablets.
Slovenian: Eno pakiranje vsebuje 84 ali 168 tablet.
English: Binimetinib is more distributed in plasma than blood.
Slovenian: Binimetinib je bolj porazdeljen v plazmi kot v krvi.
English: Table 4 and Figure 1 summarise the PFS and other efficacy results based on central review of the data by a blinded independent radiology committee.
Slovenian: preglednici 4 in na sliki 1 je povzetek vrednosti PFS in drugih rezultatov učinkovitosti glede na centralni pregled podatkov, ki ga je izvedel neodvisni slepi radiološki odbor.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Slovenian: V vsaki skupini pogostnosti so neželeni učinki razvrščeni padajoče po resnosti.
English: • unusual vaginal bleeding
Slovenian: • nenavadno vaginalno krvavenje.
English: What you need to know before you take Mektovi 3.
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Mektovi 3.
English: Updated analysis, cut-off date: 07 November 2017
Slovenian: Posodobljena analiza, končni datum: 7. november 2017
English: If you miss a dose of Mektovi, take it as soon as you remember.
Slovenian: Če pozabite vzeti odmerek zdravila Mektovi, ga vzemite takoj, ko se spomnite.
English: There is no specific treatment of overdose.
Slovenian: Za preveliko odmerjanje ni specifičnega zdravljenja.
English: Your doctor will check your skin before initiation of treatment, every 2 months during treatment, and for up to 6 months after you stop taking these medicines to look for any new skin cancer.
Slovenian: Zdravnik vam bo kožo pregledal pred začetkom zdravljenja in na vsaka 2 meseca med zdravljenjem, preglede pa bo izvajal tudi do 6 mesecev po tem, ko prenehate jemati ta zdravila, da bi preveril nastanek morebitnega novega kožnega raka.
English: If overdose occurs, the patient should be treated supportively with appropriate monitoring as necessary.
Slovenian: V primeru prevelikega odmerjanja moramo bolnika zdraviti s potrebnimi podpornimi ukrepi in ga ustrezno spremljati.
English: In urine, 6.5 % of the radioactivity was excreted as binimetinib.
Slovenian: V urinu je bilo 6,5 % radioaktivnosti izločene kot binimetinib.
English: 84 film-coated tablets 168 film-coated tablets
Slovenian: 84 filmsko obloženih tablet 168 filmsko obloženih tablet
English: New primary malignancies
Slovenian: Nove primarne malignosti
English: Do not take a double dose to make up for a forgotten dose.
Slovenian: Ne vzemite dvojnega odmerka, da bi nadomestili odmerek.
English: Based on its mechanism of action, encorafenib may promote malignancies associated with activation of RAS through mutation or other mechanisms.
Slovenian: Na podlagi svojega mehanizma delovanja lahko enkorafenib povzroči malignosti, povezane z aktivacijo gena RAS preko mutacije ali drugih mehanizmov.
English: a National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03
Slovenian: 4.03 (National Cancer Institute Common Terminology Criteria for Adverse Events; NCI CTCAE)
English: Therapy should be discontinued if the patient is not able to tolerate 30 mg orally twice daily.
Slovenian: Zdravljenje je treba prekiniti, če bolnik ne prenaša 30 mg peroralno dvakrat dnevno.
English: Swallow the tablets whole with water.
Slovenian: Cele tablete pogoltnite z vodo.
English: CI = confidence interval; CR = complete response; DCR = disease control rate (CR+PR+SD+NonCR/Non-PD; Non-CR/Non-PD applies only to patients without a target lesion who did not achieve CR or have PD); HR = hazard ratio; NE = not estimable; PFS = progression-free survival; PR = partial response; SD = stable disease.
Slovenian: IZ = interval zaupanja; CR = skupni odziv; DCR = stopnja nadzora bolezni (CR + PR + SD + brez CR/brez PD; brez CR/brez PD velja samo za bolnike brez ciljne lezije, ki niso dosegli CR ali ki nimajo progresivne bolezni (PD)); HR = razmerje tveganja; NE = neovrednoteno; PFS = preživetje brez napredovanja; PR = delni odziv; SD = stabilna bolezen; Vem = vemurafenib.
English: Dose reduction below 30 mg twice daily is not recommended.
Slovenian: Odmerek, manjši od 30 mg dvakrat dnevno, ni priporočen.
English: The patient should be advised to maintain an adequate fluid intake during treatment.
Slovenian: Bolnikom je treba svetovati, da med zdravljenjem vzdržujejo vnos zadostne količine tekočin.
English: Mutations in the BRAF gene can produce proteins that cause the melanoma to grow.
Slovenian: Mutacije gena BRAF lahko proizvedejo proteine, zaradi katerih melanom raste.
English: LVEF should be evaluated every 2 weeks until recovery.
Slovenian: LVEF je treba oceniti vsaka 2 tedna do okrevanja.
English: Carcinogenic potential of binimetinib was not evaluated.
Slovenian: Kancerogeni potencial binimetiniba ni bil ocenjen.
English: PVC/PVDC/Alu blister containing 12 tablets.
Slovenian: Pretisni omot iz PVC/PVDC/aluminija z 12 tabletami.
English: Prior treatment with BRAF/MEK inhibitors was not allowed.
Slovenian: Predhodno zdravljenje z zaviralci BRAF/MEK ni bilo dovoljeno.
English: What Mektovi is and what it is used for 2.
Slovenian: Kaj je zdravilo Mektovi in za kaj ga uporabljamo 2.
English: Cardiac electrophysiology
Slovenian: Kardiološka elektrofiziologija
English: In melanoma and other cancers, this pathway is often activated by mutated forms of BRAF which activates MEK.
Slovenian: Pri melanomu in drugih vrstah raka to pot pogosto aktivirajo mutirane oblike gena BRAF, ki aktivirajo MEK.
English: Enrolment in Part 2 started after all Part 1 patients were randomised.
Slovenian: Sodelovanje v 2. delu se je začelo, ko so bili vsi bolniki iz 1. dela randomizirani.
English: The tablets are to be swallowed whole with water.
Slovenian: Tablete je treba pogoltniti cele z vodo.
English: Patients should be advised not to drive or use machines if they experience visual disturbances or any other adverse reaction that may affect their ability to drive and use machines (see sections 4.4 and 4.8).
Slovenian: Bolnikom je treba svetovati, naj ne vozijo ali upravljajo strojev, če zaznajo motnje vida ali kateri koli drug neželeni učinek, ki bi lahko vplival na njihovo sposobnost vožnje in upravljanja strojev (glejte poglavji 4.4. in 4.8).
English: • some medicines to treat HIV such as indinavir, atazanavir
Slovenian: • nekatera zdravila za zdravljenje virusa HIV, kot sta indinavir, atazanavir,
English: Each film-coated tablet contains 133.5 mg of lactose monohydrate.
Slovenian: Ena filmsko obložena tableta vsebuje 133,5 mg laktoze monohidrata.
English: The tablets also contain lactose.
Slovenian: Tablete vsebujejo tudi laktozo.