FrancophonIA/ELRC3.0 huggingface dataset:
English: Retinal vein occlusion (RVO) and Retinal pigment epithelial detachment (RPED) If patients report new visual disturbances such as diminished central vision, blurred vision, or loss of vision at any time while on combination therapy with dabrafenib and trametinib, please refer to the trametinib SmPC (see section 4.2) for dose modification instructions for trametinib.
Croatian: Ako bolesnici u bilo kojem trenutku tijekom kombinirane terapije dabrafenibom i trametinibom prijave novonastale vidne smetnje poput slabljenja centralnoga vida, zamagljenja vida ili gubitka vida, pogledajte sažetak opisa svojstava lijeka za trametinib (dio 4.2) za prilagodbe doze trametiniba.
English: Table 9 Efficacy results for Study MEK116513 (COMBI-v)
Croatian: Tablica 9 Rezultati djelotvornosti za ispitivanje MEK116513 (COMBI-v)
English: Complete blood cell counts and blood chemistry should be performed as clinically indicated.
Croatian: U slučaju kliničke indikacije potrebna je kontrola kompletne krvne slike i biokemijska pretraga krvi.
English: If uveitis does not respond to local ocular therapy, dabrafenib should be withheld until resolution of ocular inflammation and then dabrafenib should be restarted reduced by one dose level.
Croatian: Ako uveitis ne reagira na lokalnu okularnu terapiju, treba prekinuti primjenu dabrafeniba do povlačenja upale oka i tada ponovno započeti primjenu dabrafeniba u dozi smanjenoj za jednu razinu.
English: Elevations in blood pressure have been reported in association with dabrafenib in combination with trametinib, in patients with or without pre-existing hypertension (see section 4.8).
Croatian: Tijekom liječenja dabrafenibom u kombinaciji s trametinibom prijavljena su povišenja krvnog tlaka i u bolesnika koji su otprije bolovali od hipertenzije i u onih koji nisu (vidjeti dio 4.8).
English: Tafinlar 75 mg hard capsules
Croatian: Tafinlar 75 mg tvrde kapsule
English: Table 7 Efficacy results for Study MEK115306 (COMBI-d)
Croatian: Tablica 7 Rezultati djelotvornosti za ispitivanje MEK115306 (COMBI-d)
English: Dabrafenib should be used with caution in patients with moderate or severe hepatic impairment when administered as monotherapy or in combination with trametinib.
Croatian: Potreban je oprez pri uporabi dabrafeniba u bolesnika s umjerenim do teškim oštećenjem jetre kada se primjenjuje kao monoterapija ili u kombinaciji s trametinibom.
English: It is recommended that skin examination be performed prior to initiation of therapy with dabrafenib and monthly throughout treatment and for up to six months after treatment for cuSCC.
Croatian: Prije započinjanja terapije dabrafenibom preporučuje se učiniti pregled kože, a tijekom liječenja kao i tijekom razdoblja do šest mjeseci nakon završetka liječenja preporučuju se redoviti mjesečni pregledi radi planocelularnog karcinoma kože.
English: Cohort B N=16
Croatian: Kohorta B N=16
English: Overall response,% (95% CI)
Croatian: Ukupni odgovor, % (95% CI)
English: December 19, 2011 DTIC
Croatian: 19. prosinca 2011.
English: Concomitant use of dabrafenib with medicinal products that are sensitive substrates of certain metabolising enzymes or transporters (see section 4.5) should generally be avoided if monitoring for efficacy and dose adjustment is not possible.
Croatian: Ako praćenje djelotvornosti i prilagodba doze nisu moguće, općenito treba izbjegavati istovremenu primjenu dabrafeniba i lijekova koji su osjetljivi supstrati određenih metabolizirajućih enzima ili transportera (vidjeti dio 4.5).
English: Tafinlar 50 mg hard capsules
Croatian: Tafinlar 50 mg tvrde kapsule
English: Intracranial response rate, % (95 % CI)
Croatian: Stopa intrakranijalnog odgovora, % (95 % CI)
English: Dabrafenib + Trametinib Dabrafenib + Placebo
Croatian: Dabrafenib + placebo
English: Do not stop unless your doctor, pharmacist or nurse advises you to.
Croatian: Nemojte prestati uzimati Tafinlar osim ako to nije zatražio liječnik, ljekarnik ili medicinska sestra.
English: Dabrafenib in combination with trametinib is indicated for the treatment of adult patients with advanced non-small cell lung cancer with a BRAF V600 mutation.
Croatian: Rak pluća nemalih stanica (engl. non-small cell lung cancer, NSCLC) Dabrafenib u kombinaciji s trametinibom indiciran je za liječenje odraslih bolesnika s uznapredovalim rakom pluća nemalih stanica s BRAF V600 mutacijom.
English: The safety and efficacy of the combination of dabrafenib and trametinib have been evaluated in a multi-cohort, open-label, Phase II study in patients with BRAF V600 mutant melanoma with brain metastases.
Croatian: Sigurnost i djelotvornost kombinacije dabrafeniba i trametiniba bile su ocjenjivane u otvorenom ispitivanju faze II s više kohorti u bolesnika s melanomom pozitivnim na BRAF V600 mutaciju koji je metastazirao u mozak.
English: EU/1/13/865/003 28 capsules EU/1/13/865/004 120 capsules
Croatian: EU/1/13/865/003 28 kapsula EU/1/13/865/004 120 kapsula
English: Investigations
Croatian: Ispitivačeva
English: EU/1/13/865/001 28 capsules EU/1/13/865/002 120 capsules
Croatian: EU/1/13/865/001 28 kapsula EU/1/13/865/002 120 kapsula
English: Discuss with your doctor, pharmacist or nurse if you are unsure about anything.
Croatian: Porazgovarajte s liječnikom, ljekarnikom ili medicinskom sestrom ako imate bilo kakvih pitanja ili ako niste sigurni.
English: Opaque dark pink capsules, approximately 19 mm long, with capsule shell imprinted with “GS LHF” and “75 mg”.
Croatian: Neprozirne tamnoroze kapsule, približno 19 mm duge, s otisnutim ‘GS LHF' i '75 mg' na ovojnici kapsule.
English: Tafinlar 50 mg hard capsules Tafinlar 75 mg hard capsules
Croatian: Tafinlar 50 mg tvrde kapsule Tafinlar 75 mg tvrde kapsule
English: You need to use another effective method of birth control so you do not become pregnant while you are taking this medicine.
Croatian: Kako ne biste zatrudnjeli za vrijeme uzimanja ovog lijeka, trebate koristiti drugu učinkovitu kontracepcijsku metodu.
English: Dry mouth Stomatitis
Croatian: • upala gušterače
English: No dose modification of dabrafenib is required when taken in combination with trametinib.
Croatian: Nije potrebna prilagodba doze dabrafeniba kada se uzima u kombinaciji s trametinibom.
English: Median PFS (months) (95% CI) Hazard Ratio (95% CI)
Croatian: Medijan PFS-a (mjeseci) (95% CI) Omjer hazarda (95% CI) P vrijednost f
English: From an OS analysis at 5 years, the median OS for the combination arm was approximately 7 months longer than for dabrafenib monotherapy (25.8 months versus 18.7 months) with 5-year survival rates of 32% for the combination versus 27% for dabrafenib monotherapy (Table 6, Figure 1).
Croatian: Medijan OS-a i procijenjene 1-godišnje, 2-godišnje, 3-godišnje, 4-godišnje i 5-godišnje stope preživljenja prikazane su u tablici 6. Iz analize OS-a na 5 godina, medijan OS-a za skupinu koja je primala kombinaciju bio je približno 7 mjeseci duži od onog za monoterapiju dabrafenibom (25,8 mjeseci naspram 18,7 mjeseci) s 5-godišnjim stopama preživljenja od 32% za skupinu koja je primala kombinaciju naspram 27% za monoterapiju dabrafenibom (tablica 6, slika 1).
English: No dose modification of dabrafenib is required when taken in combination with trametinib following diagnosis of RVO or RPED.
Croatian: Nije potrebna prilagodba doze dabrafeniba kada se uzima u kombinaciji s trametinibom nakon dijagnosticiranja RVO-a ili RPED-a.
English: Tafinlar should only be used to treat melanomas and NSCLC with the BRAF mutation.
Croatian: Što morate znati prije nego počnete uzimati Tafinlar Tafinlar se smije koristiti samo u liječenju melanoma i raka pluća nemalih stanica s mutacijom BRAF.
English: Reversible haematological effects have been observed in dogs and rats given dabrafenib.
Croatian: Kod pasa i štakora su nakon aplikacije dabrafeniba uočeni reverzibilni hematološki učinci.
English: If uveitis does not respond to local ocular therapy, withhold dabrafenib until resolution of ocular inflammation and then restart dabrafenib reduced by one dose level.
Croatian: Ako uveitis ne reagira na lokalnu terapiju za oko, potrebno je uskratiti dabrafenib dok se upala oka ne riješi te zatim ponovno uvesti dabrafenib u dozi smanjenoj za jednu razinu.
English: No dose modification of trametinib is required when taken in combination with dabrafenib.
Croatian: Nije potrebna prilagodba doze trametiniba kada se uzima u kombinaciji s dabrafenibom.
English: You should have your eyes examined by your doctor while you are taking this medicine.
Croatian: Tijekom uzimanja ovog lijeka trebali biste otići liječniku na pregled očiju.
English: Muscle pain
Croatian: Bol u mišićima
English: • Inflammation of the mucosa
Croatian: • grčevi u mišićima
English: Dabrafenib may impair male and female fertility as adverse effects on male and female reproductive organs have been seen in animals (see section 5.3).
Croatian: Budući da su štetni učinci dabrafeniba na muške i ženske reproduktivne organe zamijećeni u životinja (vidjeti dio 5.3), dabrafenib može oštetiti plodnost muškaraca i žena.
English: Blood and lymphatic system disorders
Croatian: Poremećaji krvi i limfnog sustava često neutropenija anemija trombocitopenija leukopenija
English: Updated analysis (data cut-off: 12-Jan-2015)
Croatian: Ažurirana analiza (završni datum za podatke: 12. siječnja 2015.)
English: No dose modification of trametinib is required when taken in combination with dabrafenib following diagnosis of uveitis.
Croatian: Nije potrebna prilagodba doze trametiniba kada se uzima u kombinaciji s dabrafenibom nakon dijagnosticiranja uveitisa.
English: STATEMENT OF ACTIVE SUBSTANCE(S)
Croatian: Medijan trajanja odgovora c
English: Tafinlar 50 mg hard capsules Tafinlar 75 mg hard capsules dabrafenib
Croatian: Tafinlar 50 mg tvrde kapsule Tafinlar 75 mg tvrde kapsule dabrafenib
English: Only subjects with BRAF V600E or V600K mutation positive tumours were eligible for study participation.
Croatian: Za sudjelovanje u ispitivanju bili su podobni samo ispitanici s tumorima pozitivnim na BRAF V600E ili V600K mutacije.
English: 3rd dose reduction
Croatian: 3. smanjenje doze
English: Pregnancy, breast-feeding and fertility Tafinlar is not recommended during pregnancy.
Croatian: Tafinlar se ne preporučuje tijekom trudnoće.
English: Patients were stratified by BRAF mutation status (V600E versus V600K) and stage of disease prior to surgery using the American Joint Committee on Cancer (AJCC) 7th edition Melanoma Staging System (by Stage III sub-stage, indicating different levels of lymph node involvement and primary tumour size and ulceration).
Croatian: Bolesnici su stratificirani prema BRAF mutacijskom statusu (V600E naspram V600K) i stadiju bolesti prije operacije koristeći 7. izdanje AJCC (engl.
English: Effect of dabrafenib on other medicinal products
Croatian: Učinak dabrafeniba na druge lijekove
English: 3.7 (1.6, 5.2) 5.0 (3.5, NR) Abbreviations: CI: confidence interval; NR: not reached; NA: not applicable a Confirmed response.
Croatian: Kratice: CI: interval pouzdanosti; ND: nije dostignuto; NP: nije primjenjivo a Potvrđen odgovor.
English: nail disorders such as nail bed changes, nail pain, infection and swelling of the cuticles, skin rash with pus-filled blisters, cutaneous squamous cell carcinoma (a type of skin cancer),
Croatian: • kožne nuspojave uključujući infekciju kože (celulitis), upalu folikula kose u koži, poremećaji noktiju kao što su promjene na ležištu nokta, bolovi u noktima, infekcija i oticanje kožice oko noktiju, kožni osip s gnojnim mjehurićima, planocelularni karcinom kože (vrsta raka kože), papilom (vrsta tumora kože koji obično nije štetan), bradavičaste izrasline, povećana osjetljivost kože na sunce (pogledajte i odlomak "Kožne promjene" ranije u dijelu 4)
English: (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.
Croatian: Za bolesnike koji su imali normalnu razinu laktat dehidrogenaze na početku, 5-godišnja stopa ukupnog preživljenja bila je 46% (95% CI: 38,8; 52,0) u skupini koja je primala kombinaciju naspram 28% (95% CI: 22,5; 34,6) u skupini koja je primala monoterapiju vemurafenibom, a za bolesnike koji su imali povišenu razinu laktat dehidrogenaze na početku, 5-godišnja stopa ukupnog preživljenja bila je 16% (95% CI: 9,3; 23,3) u skupini koja je primala kombinaciju naspram 10% (95% CI: 5,1; 17,4) u skupini koja je primala monoterapiju vemurafenibom.
English: Estimates of OS (months) Median (95% CI)
Croatian: Procjene OS-a (mjeseci) Medijan (95% CI)
English: Adjusted hazard ratio (95% CI) p-value
Croatian: Prilagođen omjer hazarda (95% CI) p-vrijednost
English: Effects of dabrafenib on other medicinal products
Croatian: Učinci dabrafeniba na druge lijekove
English: Tafinlar 75 mg capsules dabrafenib
Croatian: Tafinlar 75 mg kapsule dabrafenib
English: Overall response rate, % (95% CI)
Croatian: Stopa ukupnog odgovora, % (95% CI)
English: • coloured dots in your vision
Croatian: • obojene mrljice u vidnom polju
English: Progression-free survival, median, months (95% CI)
Croatian: Preživljenje bez progresije bolesti, medijan, mjeseci (95% CI)
English: • Cohort A: Monotherapy (dabrafenib 150 mg twice daily), 84 patients enrolled.
Croatian: • Kohorta A: monoterapija (dabrafenib 150 mg dvaput na dan), uključeno 84 bolesnika. 78 bolesnika prethodno je primalo sistemsku terapiju za svoju metastatsku bolest.
English: Tafinlar 50 mg capsules dabrafenib
Croatian: Tafinlar 50 mg kapsule dabrafenib
English: 7.2 (5.9, NR)
Croatian: 10,2d (7,5; ND)
English: Overall intracranial response rate,% (95% CI)
Croatian: Stopa ukupnog intrakranijalnog odgovora; % (95% CI)
English: • Cohort D: patients with BRAFV600D/E/K/R mutant melanoma with symptomatic brain metastases, with or without prior local brain-directed therapy and ECOG performance status of 0 or 1 or 2.
Croatian: • Kohorta D: bolesnici s melanomom s pozitivnom BRAFV600D/E/K/R mutacijom sa simptomatskim metastazama u mozgu, s ili bez prethodne lokalne terapije usmjerene na mozak i ECOG funkcionalnim statusom od 0 ili 1 ili 2.
English: OS analysis (data cut-off: 12-Jan-2015)
Croatian: Analiza OS-a (završni datum za podatke: 12. siječnja 2015.)
English: This may occur commonly (may affect up to 1 in 10 people) in patients taking Tafinlar in combination with trametinib.
Croatian: U bolesnika koji uzimaju Tafinlar u kombinaciji s trametinibom to se može dogoditi često (može se javiti u do 1 na 10 osoba).
English: Thrombocytopenia Leukopenia
Croatian: valproične kiseline ili karbamazepina
English: NE (44.5, NE)
Croatian: NP (44,5; NP)
English: Serious skin reactions have been reported in people taking Tafinlar in combination with trametinib.
Croatian: U ljudi koji su uzimali Tafinlar u kombinaciji s trametinibom prijavljene su ozbiljne kožne reakcije.
English: Dabrafenib was not mutagenic or clastogenic using in vitro tests in bacteria and cultured mammalian cells, and an in vivo rodent micronucleus assay.
Croatian: U in vitro testovima na bakterijama i kulturama stanica sisavaca, i u in vivo na mikronukleus testu na glodavcima, dabrafenib nije pokazao mutagenu ili klastogenu aktivnost.
English: • tiredness
Croatian: • omaglicu
English: • antidepressant medicines such as nefazodone and the herbal medicine St John's wort
Croatian: • lijekove koji djeluju protiv depresije poput nefazodona i biljnih pripravaka od gospine trave
English: 5-year OS analysis (data cut-off: 08-Oct-2018)
Croatian: Analiza 5-godišnjeg OS-a (završni datum za podatke: 08. listopada 2018.)
English: Your doctor will run tests to check that your heart is working properly before and during your treatment with Tafinlar in combination with trametinib.
Croatian: Liječnik će prije i tijekom liječenja Tafinlarom u kombinaciji s trametinibom obavljati pretrage kako bi provjerio radi li Vam srce pravilno.
English: Each hard capsule contains dabrafenib mesilate equivalent to 50 mg or 75 mg of dabrafenib.
Croatian: Jedna tvrda kapsula sadrži 50 mg ili 75 mg dabrafeniba u obliku dabrafenibmesilata.
English: Erythema, generalised erythema i Muscle spasms, musculoskeletal stiffness
Croatian: Spazam mišića, ukočenost mišićno-koštanog sustava Opis odabranih nuspojava
English: Each hard capsule contains dabrafenib mesilate equivalent to 50 mg of dabrafenib.
Croatian: Jedna tvrda kapsula sadrži 50 mg dabrafeniba u obliku dabrafenibmesilata.
English: Median PFS (months) (95% CI)
Croatian: Medijan PFS-a (mjeseci) (95% CI)
English: Median PFS Months (95% CI)
Croatian: Medijan PFS-a Mjeseci (95% CI)
English: The efficacy and safety of dabrafenib in combination with trametinib in patients with BRAF mutant-positive melanoma that has metastasised to the brain was studied in a non-randomised, open-label, multicentre, Phase II study (COMBI-MB study).
Croatian: Djelotvornost i sigurnost dabrafeniba u kombinaciji s trametinibom bile su proučavane u nerandomiziranom, otvorenom ispitivanju faze II s više centara (ispitivanje COMBI-MB) u bolesnika s melanomom pozitivnim na BRAF mutaciju koji je metastazirao u mozak.
English: Gastrointestinal perforation
Croatian: Prijavljivanje nuspojava
English: • Localised tissue swelling
Croatian: • lokalizirano oticanje tkiva
English: Two dabrafenib capsule strengths, 50 mg and 75 mg, are available to effectively manage dose modification requirements.
Croatian: Kako bi se moglo vršiti učinkovito prilagođavanje doze, na raspolaganju su dvije jačine kapsula dabrafeniba, od 50 mg i 75 mg.
English: Tafinlar 75 mg hard capsules dabrafenib
Croatian: Tafinlar 75 mg tvrde kapsule dabrafenib
English: Each hard capsule contains dabrafenib mesilate equivalent to 75 mg of dabrafenib.
Croatian: Jedna tvrda kapsula sadrži 75 mg dabrafeniba u obliku dabrafenibmesilata.
English: New primary melanomas have been reported in clinical trials with dabrafenib as monotherapy and in combination with trametinib in melanoma studies.
Croatian: U kliničkim ispitivanjima dabrafeniba kao monoterapije i u kombinaciji s trametinibom u ispitivanjima za melanom zabilježeni su slučajevi pojave novih primarnih melanoma.
English: Skin fissures
Croatian: Teške kožne nuspojave
English: Renal failure
Croatian: Mjera ishoda
English: Combination 2
Croatian: PRILOG II.
English: Hypertension Haemorrhage f
Croatian: P vrijednost f
English: Progression-free survival Median, months (95% CI)
Croatian: Preživljenje bez progresije bolesti Medijan, mjeseci (95% CI)
English: Check your skin regularly whilst taking Tafinlar If you notice any of the following:
Croatian: Za vrijeme uzimanja lijeka Tafinlar redovito provjeravajte svoju kožu.
English: Not known
Croatian: NO: ne može se ocijeniti
English: Constipation Diarrhoea Nausea Vomiting
Croatian: • mučnina, povraćanje
English: Tafinlar 50 mg hard capsules dabrafenib
Croatian: Tafinlar 50 mg tvrde kapsule dabrafenib
English: • Cohort C: patients with BRAFV600D/K/R mutant melanoma with asymptomatic brain metastases, with or without prior local brain-directed therapy and ECOG performance status of 0 or 1.
Croatian: • Kohorta C: bolesnici s melanomom s pozitivnom BRAFV600D/K/R mutacijom s asimptomatskim metastazama u mozgu, s ili bez prethodne lokalne terapije usmjerene na mozak i ECOG funkcionalnim statusom od 0 ili 1.
English: • Cohort A: patients with BRAFV600E mutant melanoma with asymptomatic brain metastases without prior local brain-directed therapy and ECOG performance status of 0 or 1.
Croatian: • Kohorta A: bolesnici s melanomom s pozitivnom BRAFV600E mutacijom s asimptomatskim metastazama u mozgu bez prethodne lokalne terapije usmjerene na mozak i ECOG funkcionalnim statusom od 0 ili 1.
English: No dose adjustment is required for patients with mild or moderate renal impairment.
Croatian: U bolesnika s blagim ili umjerenim oštećenjem bubrega nije potrebna prilagodba doze.
English: • medicines to treat seizures (epilepsy), such as phenytoin, phenobarbital, primidone, valproic acid or carbamazepine
Croatian: • lijekove za liječenje epileptičnih napada (epilepsije), poput fenitoina, fenobarbitala, primidona,
English: • Dizziness
Croatian: • ošamućenost
English: Hazard ratio (95% CI) p-value
Croatian: Omjer hazarda (95% CI) p-vrijednost
English: No dose adjustment is required for patients with mild hepatic impairment.
Croatian: U bolesnika s blagim oštećenjem jetre nije potrebna prilagodba doze.
English: • Stomach ache
Croatian: • oticanje lica
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 leakage (chorioretinopathy).
Croatian: Vaš liječnik također mora znati: - ako imate tegobe sa srcem kao što su zatajenje srca ili problemi s otkucajima srca. - ako imate tegobe s očima uključujući blokadu vene koja istječe iz oka (okluzija mrežnične vene)
English: Hepatic impairment
Croatian: Tegobe s jetrom
English: • some calcium channel blockers, used to treat high blood pressure, such as diltiazem,
Croatian: • neke blokatore kalcijevih kanala koji se koriste za liječenje visokog krvnog tlaka, poput diltiazema, felodipina, nikardipina, nifedipina ili verapamila
English: • Cohort B: patients with BRAFV600E mutant melanoma with asymptomatic brain metastases with prior local brain-directed therapy and ECOG performance status of 0 or1.
Croatian: • Kohorta B: bolesnici s melanomom s pozitivnom BRAFV600E mutacijom s asimptomatskim metastazama u mozgu s prethodnom lokalnom terapijom usmjerenom na mozak i ECOG funkcionalnim statusom od 0 ili 1.
English: • stomach pain
Croatian: • suha usta
English: Cutaneous squamous cell carcinoma
Croatian: Planocelularni karcinom kože
English: Heart disorder
Croatian: Oštećenje jetre
English: • Dry mouth
Croatian: • upala bubrega
English: Median OS Months (95% CI)
Croatian: Medijan DoR-a Mjeseci (95% CI)
English: (months) Median (95% CI)
Croatian: (mjeseci) (95% CI)
English: - If you get any side effects, talk to your doctor, pharmacist or nurse.
Croatian: • Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika, ljekarnika ili medicinsku sestru.
English: Cutaneous malignancies
Croatian: Kožne zloćudne bolesti
English: • eye pain
Croatian: • bol u oku
English: Cases of pneumonitis or ILD have been reported in clinical trials with dabrafenib in combination with trametinib.
Croatian: U kliničkim ispitivanjima dabrafeniba u kombinaciji s trametinibom prijavljeni su slučajevi pneumonitisa ili IBP.
English: • Nasal and throat inflammation
Croatian: • upala nosa i grla
English: palpitations and chest pain
Croatian: • problemi s bubrezima, zatajenje bubrega
English: Hepatic adverse events have been reported in clinical trials with dabrafenib in combination with trametinib (see section 4.8).
Croatian: U kliničkim ispitivanjima dabrafeniba u kombinaciji s trametinibom prijavljeni su štetni događaji u jetri (vidjeti dio 4.8).
English: • Inflammation of kidneys
Croatian: • zatajenje bubrega
English: This may lead to increased risk of non-cutaneous malignancies with dabrafenib exposure (see section 4.8) when RAS mutations are present.
Croatian: Izlaganje dabrafenibu kada su prisutne RAS mutacije može dovesti do povećanog rizika od razvoja zloćudnih bolesti koje ne zahvaćaju kožu (vidjeti dio 4.8).
English: ORRb % (95% CI) ORR difference (95% CI)
Croatian: Razlika u ORR-u (95% CI)
English: Respiratory, thoracic and mediastinal disorders
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja vrlo često kašalj
English: Haemorrhagic events, including major haemorrhagic events and fatal haemorrhages, have occurred in patients taking dabrafenib in combination with trametinib.
Croatian: U bolesnika koji su uzimali dabrafenib u kombinaciji s trametinibom zabilježeni su hemoragijski događaji, uključujući velike hemoragijske događaje i smrtonosna krvarenja.
English: Trametinib (n=211)
Croatian: Dabrafenib trametinib (n=211)
English: Hepatic adverse events have been reported in clinical trials with dabrafenib in combination with trametinib.
Croatian: U kliničkim ispitivanjima dabrafeniba u kombinaciji s trametinibom prijavljeni su štetni događaji u jetri.
English: Acrochordon (skin tags)
Croatian: • upala crijeva (kolitis)