FrancophonIA/ELRC3.0 huggingface dataset:
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/667/018 84 tablets (4x21)
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/11/667/018 84 tablete (4 x 21)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/667/019 252 tablets (3x84)
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/11/667/019 252 tablete (3x84)
English: 2 bottles each containing 21 film-coated tablets (42 film-coated tablets in total) 1 bottle containing 42 film-coated tablets 1 bottle containing 90 film-coated tablets 2 bottles each containing 90 film-coated tablets (180 film-coated tablets in total) 1 bottle containing 180 film-coated tablets
Croatian: 2 boce od kojih svaka sadrži 90 filmom obloženih tableta (ukupno 180 filmom obloženih tableta) 1 boca koja sadrži 180 filmom obloženih tableta
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/667/020
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/11/667/020
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/667/017 252 tablets (3x84)
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/11/667/017 252 tablete (3x84)
English: ; 100 (26.3) mg•h/L and 168 (67.4)
Croatian: 100b (26,3)
English: Pruritus; erythema; dry skin; rash erythematous; rash macular; rash pruritic Musculoskeletal and connective tissue disorders Common
Croatian: Često svrbež, eritem, suha koža, eritematozni osip, makularni osip, pruritični osip
English: Table 1 Adverse reactions by SOC and MedDRA frequency Infections and infestations
Croatian: Tablica 1 Nuspojave prema klasifikaciji organskih sustava i učestalosti prema MedDRA
English: ANCOVA); 26% of patients receiving Esbriet showed a decline of ≥50 m in 6MWT distance compared to 36% of patients receiving placebo.
Croatian: Esbriet utvrđeno je smanjenje udaljenosti prijeđene tijekom 6MWT testa za ≥50 m, dok je isto primijećeno u 36% bolesnika koji su primali placebo.
English: Hepatic function
Croatian: Oštećenje funkcije bubrega
English: No dose adjustment is required in patients with mild renal impairment who are receiving pirfenidone.
Croatian: U bolesnika s blagim oštećenjem funkcije bubrega koji se liječe pirfenidonom nije potrebno prilagođavati dozu.
English: Phototoxicity and irritation were noted in guinea pigs after oral administration of pirfenidone and with exposure to UVA/UVB light.
Croatian: Nakon peroralne primjene pirfenidona i uz izlaganje UVA/UVB svjetlosti, u zamoraca su primijećeni fototoksičnost i iritacija.
English: ● Day 15 onward: three capsules, three times a day (2403 mg/day)
Croatian: Od 15. dana nadalje: doza od 801 mg, primijenjena triput na dan (2403 mg/dan)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/667/021
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/11/667/021
English: Median (25th-75th) AUC0-∞ = area under the concentration-time curve from time zero to infinity.
Croatian: Medijan (25.-75.) AUC0-∞ = površina ispod krivulje koncentracija-vrijeme od nulte točke do beskonačnosti a p-vrijednost naspram normalne funkcije = 1,00 (usporedba parova uz Bonferronijevu korekciju) b p-vrijednost naspram normalne funkcije = 0,009 (usporedba parova uz Bonferronijevu korekciju)
English: If the rash persists after 7 days, Esbriet should be discontinued for 15 days, with re-escalation to the recommended daily dose in the same manner as the dose escalation period.
Croatian: Ako osip potraje duže od 7 dana, primjenu lijeka Esbriet treba prekinuti na
English: Dyspnoea; cough; productive cough Gastrointestinal disorders Very Common Dyspepsia; nausea; diarrhoea Common
Croatian: Poremećaji probavnog sustava Vrlo često dispepsija, mučnina, proljev
English: 267 mg film-coated tablets 1 bottle containing 21 film-coated tablets
Croatian: Filmom obložene tablete od 534 mg 1 boca koja sadrži 21 filmom obloženu tabletu 1 boca koja sadrži 90 filmom obloženih tableta
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/667/011
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/11/667/011
English: ● If you get any side effects, talk to your doctor or pharmacist.
Croatian: • Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika ili ljekarnika.
English: 5 How to store Esbriet Contents of the pack and other information
Croatian: Sadržaj pakiranja i druge informacije Što Esbriet sadrži
English: Hepatic impairment
Croatian: Psihijatrijski poremećaji Često nesanica
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/667/001
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/11/667/001
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/667/009
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/11/667/009
English: The mean (SD) AUC0-∞ of 5carboxy-pirfenidone was significantly higher in the moderate (p = 0.009) and severe (p < 0.0001) renal impairment groups than in the group with normal renal function.
Croatian: Srednje vrijednosti (standardno odstupanje, SD) AUC0-∞ za 5-karboksi-pirfenidon bile su značajno više u skupinama s umjerenim
English: The recommended maintenance daily dose of Esbriet is three 267 mg capsules three times a day with food for a total of 2403 mg/day.
Croatian: Preporučena dnevna doza održavanja lijeka Esbriet je 801 mg triput na dan s hranom, što čini ukupnu dozu od 2403 mg/dan.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/667/005
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/11/667/005
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/667/002
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/11/667/002
English: Microcrystalline cellulose Croscarmellose sodium Povidone
Croatian: Sadržaj kapsule celuloza, mikrokristalična karmelozanatrij, umrežena povidon magnezijev stearat
English: At Week 52, a decline from Baseline in percent predicted FVC of ≥10% or death was seen in 17% of patients receiving Esbriet compared to 32% receiving placebo (Table 4).
Croatian: ≥10% u odnosu na početne vrijednosti ili smrt primijećeni su u 17% bolesnika koji su primali Esbriet,
English: Propylene glycol
Croatian: • proljev
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/667/007
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/11/667/007
English: ● Patient information (PIL)
Croatian: • Informacije o lijeku (Sažetak opisa svojstava lijeka)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/667/003
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/11/667/003
English: Patients should drink plenty of water throughout the day.
Croatian: Bolesnici trebaju piti mnogo vode tijekom dana.
English: The recommended dose is one tablet once daily, in the morning.
Croatian: Preporučena je doza jedna tableta jedanput dnevno, ujutro.
English: Further information on Duzallo can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Više informacija o lijeku Duzallo nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Duzallo (allopurinol / lesinurad)
Croatian: Duzallo (alopurinol / lesinurad)
English: What measures are being taken to ensure the safe and effective use of Duzallo?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Duzallo?
English: Combining the active substances in a single tablet has the advantage of simplifying treatment.
Croatian: Kombinacijom djelatnih tvari u jednoj tableti pojednostavljeno je liječenje.
English: Other information about Duzallo
Croatian: Ostale informacije o lijeku Duzallo
English: Duzallo is available as tablets containing either 200 or 300 mg of allopurinol in combination with 200 mg of lesinurad.
Croatian: Duzallo je dostupan u obliku tableta koje sadržavaju 200 mg ili 300 mg alopurinola u kombinaciji s 200 mg lesinurada.
English: Allopurinol has been marketed in the EU since the 1960s.
Croatian: Alopurinol je dostupan u Europskoj uniji (EU) od 1960.-ih.
English: It must also not be taken in patients with tumour lysis syndrome (a complication due to the rapid breakdown of cancer cells during cancer treatment) or Lesch-Nyhan syndrome (a rare genetic disease).
Croatian: Ne smiju ga uzimati ni bolesnici sa sindromom tumorske lize (komplikacija koja nastaje uslijed brzog razlaganja stanica karcinoma tijekom liječenja karcinoma) ili Lesch-Nyhanovim sindromom (rijetka genetska bolest).
English: Adding lesinurad 200 mg once daily to the treatment led to 55% patients having levels below 60 mg/litre after 6 months.
Croatian: Dodavanje 200 mg lesinurada jednom dnevno dovelo je do razina nižih od 60 mg/litra u 55 % bolesnika nakon šest mjeseci.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Duzallo have been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Duzallo nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: The most common side effects with Duzallo (which may affect up to 1 in 10 people) are flu, gastrooesophageal reflux disease (stomach acid coming back to the mouth), headache and blood tests showing increased blood creatinine levels (a marker of kidney function).
Croatian: Najčešće nuspojave lijeka Duzallo (koje se mogu pojaviti u 1 na 10 osoba) su gripa, gastroezofagealni refluks (povratni tijek želučanog sadržaja u jednjak), glavobolja i krvne pretrage koje pokazuju povišene razine kreatinina u krvi (pokazatelj funkcije bubrega).
English: What is Duzallo and what is it used for?
Croatian: Što je Duzallo i za što se koristi?
English: Lesinurad has been authorized in the EU as Zurampic since 2016.
Croatian: Lesinurad je od 2016. odobren u Europskoj uniji (EU) pod nazivom Zurampic.
English: The active substances in Duzallo have already been shown to be effective when used as separate tablets.
Croatian: Djelatne tvari u lijeku Duzallo već su se pokazale učinkovitima kad su se upotrebljavale kao zasebne tablete.
English: The safety profile of Duzallo is similar to the individual components.
Croatian: Sigurnosni profil lijeka Duzallo sličan je sigurnosnom profilu zasebnih komponenti.
English: The two active substances in Duzallo work in different ways to prevent the build-up of uric acid:
Croatian: Dvije djelatne tvari u lijeku Duzallo djeluju na različite načine kako bi spriječile nakupljanje mokraćne kiseline:
English: For more information about using Duzallo, see the package leaflet or contact your doctor or pharmacist.
Croatian: Više informacija o primjeni lijeka Duzallo pročitajte u uputi o lijeku ili se obratite liječniku ili ljekarniku.
English: Side effects reported with Duzallo are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Duzallo pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: Why is Duzallo authorised in the EU?
Croatian: Zašto je lijek Duzallo odobren u EU-u?
English: The European Medicines Agency decided that Duzallo's benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove odlučila je da koristi lijeka Duzallo nadmašuju s njim povezane rizike te da se može izdati odobrenje za njegovu primjenu u EU-u.
English: Gout results from a build-up of uric acid crystals in and around the joints, especially in the toes, which causes pain and swelling.
Croatian: Giht nastaje nakupljanjem kristala mokraćne kiseline u zglobovima i oko njih, posebice u nožnim prstima, što uzrokuje bol i oticanje.
English: This compared with 26% of patients who received placebo (a dummy treatment) in addition to allopurinol.
Croatian: Za usporedbu, to je zabilježeno u 26 % bolesnika koji su primali placebo (prividno liječenje) uz alopurinol.
English: What are the risks associated with Duzallo?
Croatian: Koji su rizici povezani s lijekom Duzallo?
English: Duzallo must not be taken by patients with severely reduced kidney function, including those who have severely impaired kidney function, who are on dialysis or have received a kidney transplant.
Croatian: Duzallo ne smiju uzimati bolesnici s ozbiljno smanjenom funkcijom bubrega, uključujući bolesnike s ozbiljno oštećenom funkcijom bubrega, bolesnike na dijalizi ili bolesnike s transplantiranim bubregom.
English: As for all medicines, data on the use of Duzallo are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Duzallo kontinuirano se prate.
English: In addition two studies were carried out to show that Duzallo produced similar levels of active substances in the blood to the active substances given separately.
Croatian: Uz to su provedena dva ispitivanja kako bi se dokazalo da je lijek Duzallo proizveo slične razine djelatnih tvari u krvi kao i djelatne tvari primijenjene zasebno.
English: • Lesinurad helps to remove uric acid from the body by blocking a protein called ‘uric acid transporter-1' (URAT1) in the kidneys.
Croatian: • Lesinurad pomaže uklanjanju mokraćne kiseline iz organizma blokiranjem proteina koji se naziva „transporter mokraćne kiseline-1” (URAT1) u bubrezima.
English: The two studies involved over 800 adults with gout whose blood level of uric acid was high (above 65 mg/litre) despite allopurinol treatment.
Croatian: U dvama ispitivanjima sudjelovalo je više od 800 odraslih osoba s gihtom u kojih su razine mokraćne kiseline u krvi bile visoke (iznad 65 mg/litra) unatoč liječenju alopurinolom.
English: An overview of Duzallo and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Duzallo i zašto je odobren u EU-u
English: Duzallo is a medicine used in adults with gout to reduce high levels of uric acid in the blood.
Croatian: Duzallo je lijek koji se primjenjuje u odraslih osoba s gihtom za smanjenje visokih razina mokraćne kiseline u krvi.
English: The most serious adverse reactions were kidney failure, reduced kidney function, and kidney stones, which affected less than 1 patient in 100.
Croatian: Najozbiljnije nuspojave bile su zatajenje bubrega, smanjena funkcija bubrega te bubrežni kamenci, koje su se pojavile u manje od jednog na 100 bolesnika.
English: By reducing the production of uric acid, allopurinol can reduce levels of uric acid in the blood and keep them low, stopping crystals from building up.
Croatian: Smanjivanjem proizvodnje mokraćne kiseline alopurinol može sniziti razine mokraćne kiseline u krvi i održavati ih na niskoj razini, zaustavljajući nakupljanje kristala.
English: By blocking URAT1, more uric acid is passed out in the urine and less remains in the blood.
Croatian: Blokiranjem proteina URAT1 u mokraću se propušta više mokraćne kiseline, a manje ostaje u krvi.
English: • Allopurinol reduces the production of uric acid in the body by blocking an enzyme called xanthine oxidase, which is needed to make uric acid in the body.
Croatian: • Alopurinol smanjuje proizvodnju mokraćne kiseline u organizmu blokiranjem enzima koji se naziva ksantin oksidaza, koji je potreban za stvaranje mokraćne kiseline u organizmu.
English: Duzallo contains the active substances allopurinol and lesinurad.
Croatian: Duzallo sadržava djelatne tvari alopurinol i lesinurad.
English: URAT1 allows uric acid to return to the blood after the kidneys have filtered it out.
Croatian: URAT1 omogućuje vraćanje mokraćne kiseline u krv nakon filtriranja u bubrezima.
English: The strength of Duzallo tablet is chosen to match the dose of allopurinol the patient has been taking.
Croatian: Potrebno je odabrati jačinu tablete lijeka Duzallo koja odgovara dozi alopurinola koju bolesnik uzima.
English: What benefits of Duzallo have been shown in studies?
Croatian: Koje su koristi od lijeka Duzallo utvrđene u ispitivanjima?
English: Two main studies showed that the combination of allopurinol and lesinurad can help lower uric acid levels when allopurinol on its own is not working well enough.
Croatian: U dvama glavnim ispitivanjima utvrđeno je da kombinacija alopurinola i lesinurada može pomoći u snižavanju razina mokraćne kiseline kada sam alopurinol ne djeluje dovoljno dobro.
English: How does Duzallo work?
Croatian: Kako djeluje Duzallo?
English: How is Duzallo used?
Croatian: Kako se Duzallo koristi?
English: Two main studies showed that lesinurad in combination with allopurinol reduced the blood levels of uric acid in gout patients in whom allopurinol alone was not sufficient.
Croatian: U dvama glavnim ispitivanjima utvrđeno je da je lesinurad u kombinaciji s alopurinolom smanjio razine mokraćne kiseline u krvi u bolesnika s gihtom u kojih sam alopurinol nije bio dovoljan.
English: It is used when allopurinol on its own is not able to control uric acid levels sufficiently.
Croatian: Primjenjuje se ako se razine mokraćne kiseline ne mogu dovoljno dobro kontrolirati samo alopurinolom.
English: For the full list of side effects reported with Duzallo, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Duzallo potražite u uputi o lijeku.
English: On 25 January 2016 the Netherlands therefore triggered a referral under Article 31 of Directive 2001/83/EC, and requested the CHMP to assess the impact of the above concerns on the benefit-risk balance of metformin containing products and to issue an opinion on whether the relevant marketing authorisations should be maintained, varied, suspended or revoked.
Croatian: Stoga je Nizozemska 25. siječnja 2016. pokrenula postupak upućivanja u skladu s člankom 31. Direktive 2001/83/EZ te je zatražila od CHMP a da ocijeni utjecaj navedenih razmatranja na omjer koristi i rizika od lijekova koji sadrže metformin te da izda mišljenje o tome treba li odgovarajuća odobrenja za stavljanje u promet zadržati, izmijeniti, obustaviti ili opozvati.
English: In addition, routine risk minimisation will be extended to include cumulative review of lactic acidosis in the PSURs and a targeted questionnaire.
Croatian: Osim toga, rutinsko smanjivanje rizika na najmanju moguću mjeru proširit će se tako da se kumulativno ocjenjivanje laktacidoze uključi u PSUR ove i ciljani upitnik.
English: In conclusion, the possible elevated risk of lactic acidosis could be sufficiently minimised in patients with moderate renal impairment (GFR greater than 30 ml/min) with a clear dosing recommendation, additional monitoring of GFR levels before and during treatment, and updated warnings and precautions in the SmPC and package leaflet.
Croatian: Konačno, mogućnost povećanog rizika od laktacidoze može se dostatno smanjiti na najmanju moguću mjeru u bolesnika s umjerenim oštećenjem bubrega (GFR veći od 30 ml/min) jasnim preporukama o doziranju, dodatnim praćenjem razine GFR a prije i tijekom liječenja te ažuriranjem upozorenja i mjera opreza u sažetku opisa svojstava lijeka i uputi o lijeku.
English: Metformin, alone or in combination with other medicines, is considered the first choice in the treatment for Type 2 diabetes mellitus (T2DM) and it is widely used in the EU.
Croatian: Metformin, u monoterapiji ili kombinaciji s drugim lijekovima, smatra se prvim odabirom u liječenju dijabetesa tipa 2 (T2DM) i u širokoj je primjeni u EU u Primjena metformina u bolesnika sa zatajenjem bubrega trenutačno nije usklađena u EU u s obzirom na to da je lijek kontraindiciran u bolesnika s različitim fazama umjerenog zatajenja bubrega, ovisno o državi članici i proizvodu.
English: Further information on Mektovi can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Više informacija o lijeku Mektovi možete naći na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: These side effects occurred in more than 1 in 4 patients.
Croatian: Ove su se nuspojave pojavile u više od 1 od 4 bolesnika.
English: What measures are being taken to ensure the safe and effective use of Mektovi?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Mektovi?
English: Patients who took this combination lived on average for nearly 15 months without the disease getting worse.
Croatian: Bolesnici koji su uzimali ovu kombinaciju u prosjeku su živjeli gotovo 15 mjeseci bez pogoršanja bolesti.
English: The dose of the other medicine, encorafenib, may also have to be reduced.
Croatian: Doza drugog lijeka, enkorafeniba, također će se možda morati smanjiti.
English: What is Mektovi and what is it used for?
Croatian: Što je Mektovi i za što se primjenjuje?
English: Mektovi is available as 15 mg tablets.
Croatian: Lijek Mektovi dostupan je u obliku tableta od 15 mg.
English: Other information about Mektovi
Croatian: Ostale informacije o lijeku Mektovi
English: What are the risks associated with Mektovi?
Croatian: Koji su rizici povezani s lijekom Mektovi?
English: For more information about using Mektovi, see the package leaflet or contact your doctor or pharmacist.
Croatian: Za više informacija o primjeni lijeka Mektovi, pogledajte uputu o lijeku ili se obratite liječniku ili ljekarniku.
English: Patients normally take 45 mg (3 tablets) by mouth twice a day but can have the dose reduced or treatment stopped temporarily if they experience troublesome side effects.
Croatian: Bolesnici najčešće uzimaju 45 mg (3 tablete) peroralno dvaput dnevno, ali ta se doza može smanjiti ili se liječenje može privremeno zaustaviti u slučaju nastanka nuspojava.
English: It contains the active substance binimetinib.
Croatian: Sadrži djelatnu tvar binimetinib.
English: The European Medicines Agency therefore decided that Mektovi's benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove zaključila je da koristi od lijeka Mektovi nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u Europskoj uniji.
English: Why is Mektovi authorised in the EU?
Croatian: Zašto je lijek Mektovi odobren u EU-u?
English: Side effects reported with Mektovi are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Mektovi pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: The side effects seen with Mektovi are similar to those seen with other medicines in the same class and are considered manageable.
Croatian: Nuspojave uočene kod uzimanja lijeka Mektovi slične su nuspojavama uočenim s drugim lijekovima istog razreda i smatra se da se njima može upravljati.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Mektovi have been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Mektovi nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: Mektovi can only be obtained with a prescription and treatment should be started and supervised by a doctor experienced in prescribing cancer medicines.
Croatian: Mektovi se izdaje samo na liječnički recept, a liječenje treba započeti i nadzirati liječnik s iskustvom u propisivanju lijekova protiv raka.
English: The most common side effects with Mektovi and encorafenib taken together at the highest recommended doses are tiredness, nausea (feeling sick), diarrhoea, vomiting, retinal detachment (an eye problem that leads to poor vision), abdominal pain, joint pain, muscle pain and high levels of an enzyme called creatine kinase, which may indicate muscle problems.
Croatian: Najčešće nuspojave koje su se javljale tijekom liječenja kombinacijom lijekova Mektovi i enkorafenib u najvećim preporučenim dozama bile su umor, mučnina (slabost), proljev, povraćanje, odvajanje mrežnice (problem s očima koji uzrokuje loš vid), bol u trbuhu, bol u zglobovima, bol u mišićima i visoke razine enzima pod nazivom kreatin kinaza, koje mogu ukazivati na probleme s mišićima.