natgillin/translations-raw huggingface dataset:
The occurrence of Grade ≥ 3 haemorrhagic events should be managed with dose interruption, reduction or treatment discontinuation (see Table 2 in section 4.2) and as clinically indicated.
Pojava krvarenja stupnja ≥ 3 mora se zbrinuti prekidom doze, smanjenjem doze ili trajnom obustavom liječenja (vidjeti Tablicu 2, dio 4.2) i postupiti kao što je klinički indicirano.
Renal impairment No dose adjustment is recommended for patients with renal impairment (see section 5.2).
U bolesnika s oštećenjem funkcije bubrega nije potrebna prilagodba doze (vidjeti dio 5.2).
Effect of transporters on binimetinib
Učinak transportnih proteina na binimetinib
Effects of other medicinal products on binimetinib Binimetinib is primarily metabolised through UGT1A1 mediated glucuronidation.
Binimetinib se pretežno metabolizira glukuronidacijom putem UGT1A1.
• dark urine
• tamno obojena mokraća
If during treatment patient develops uveitis, see section 4.2 of encorafenib SmPC for guidance.
Ako tijekom liječenja bolesnik razvije uveitis, za smjernice vidjeti dio 4.2 sažetka opisa svojstava lijeka za enkorafenib.
In the pooled Combo 450 population, diarrhoea was observed in 38 % (104/274) of patients and was Grade 3 or 4 in 3.3 % (9/274) of patients.
U ukupnoj populaciji kombinirane terapije 450 proljev je primijećen u 38% (104/274) bolesnika i bio je stupnja 3 ili 4 u 3,3% (9/274) bolesnika.
HRa (95% CI) (vs Enco 300)
HRa (95% CI) (naspram enkorafeniba 300)
Package leaflet: Information for the patient Mektovi 15 mg film-coated tablets binimetinib This medicine is subject to additional monitoring.
Uputa o lijeku: Informacije za bolesnika Mektovi 15 mg filmom obložene tablete binimetinib
In cell free system, binimetinib inhibits MEK1 and MEK2 with the half maximal inhibitory concentration (IC50)'s in the 12-46 nM. MEK proteins are upstream regulators of the extracellular signal-related kinase (ERK) pathway, which promotes cellular proliferation.
U bezstaničnom sustavu binimetinib inhibira MEK1 i MEK2 uz IC50 (koncentracija pri kojoj dolazi do 50% inhibicije) u rasponu12-46 nM.
Combination with encorafenib
Kombinirana primjena s enkorafenibom
Mektovi 15 mg film-coated tablets binimetinib
Mektovi 15 mg filmom obložene tablete binimetinib
Inducers of CYP1A2 enzymes (such as carbamazepine and rifampicin) and inducers of Pgp transport (such as Saint John's wort or phenytoin) may decrease binimetinib exposure, which could result in a decrease of efficacy.
Pgp prijenosa (kao što je gospina trava i fenitoin) mogu smanjiti izloženost binimetinibu, što može rezultirati smanjenom djelotvornošću lijeka.
• halo (seeing blurred outline around objects)
• halo (viđenje nejasnih aura oko objekata) • bol u oku, oticanje ili crvenilo
Common
National
Mektovi contains lactose.
Lijek Mektovi sadrži laktozu.
If no improvement within 2 weeks, binimetinib should be withheld until improved to Grade 0 or 1 or to baseline levels, and then resumed at the same dose.
• Ako nema poboljšanja unutar 2 tjedna, treba prekinuti binimetinib dok se ne postigne poboljšanje na stupanj 0 ili 1
The management of adverse reactions may require dose reduction, temporary interruption or treatment discontinuation (see below, Table 1 and Table 2).
Zbog zbrinjavanja nuspojava će možda biti potrebno smanjiti dozu, privremeno prekinuti liječenje ili trajno obustaviti liječenje (vidjeti u nastavku Tablicu 1 i Tablicu 2).
Or, binimetinib should be permanently discontinued.
Ili, treba trajno obustaviti binimetinib.
Bleeding problems: Mektovi can cause serious bleeding problems.
Krvarenja: lijek Mektovi može prouzročiti ozbiljna krvarenja.
Vemurafenib
Nuspojave
VTE can occur when binimetinib is administered (see section 4.8).
Prilikom primjene binimetiniba može se pojaviti VTE (vidjeti dio 4.8).
Abdominal pain*
Poremećaji probavnog sustava bol u abdomenu*
In Study CMEK162B2301-Part 2, in the Combo 300 arm, anaemia was observed in 9.7% (25/257) of patients with Grade 3-4 reported in 2.7% (7/257) patients.
U ispitivanju CMEK162B2301, dio 2, u skupini kombinirane terapije 300, anemija je zapažena u 9,7% (25/257) bolesnika sa stupnjem 3-4 prijavljenim u 2,7% (7/257) bolesnika.
The occurrence of symptomatic RPED can be managed with treatment interruption, dose reduction or with treatment discontinuation (see Table 1 in section 4.2).
Pojava simptomatskog RPED-a može se zbrinuti privremenim prekidom liječenja, smanjenjem doze ili trajnom obustavom liječenja (vidjeti Tablicu 1 u dijelu 4.2).
Musculoskeletal and connective tissue disorders
Poremećaji mišićno koštanog sustava i vezivnog tkiva artralgija*
Mektovi contains lactose
Lijek Mektovi sadrži laktozu
In urine, 6.5 % of the radioactivity was excreted as binimetinib.
Na količinu nepromijenjenog binimetiniba izlučenog putem mokraće otpadalo je 6,5% radioaktivnosti.
• If improved to Grade 2, binimetinib should be resumed at a lower dose.
• Ako je došlo do poboljšanja na stupanj 2, treba nastaviti sa smanjenom dozom binimetiniba.
Haemorrhages, including major haemorrhagic events, can occur when binimetinib is administered (see section 4.8).
Do krvarenja, uključujući događaje obilnog krvarenja, može doći kod primjene binimetiniba (vidjeti dio 4.8).
Mektovi is for oral use.
Lijek Mektovi je namijenjen za peroralnu primjenu.
HRa (95 % CI) (vs. Vem) Nominal p-value
HRa (95% CI) (naspram vemurafeniba) Nominalna p-vrijednost HRa (95% CI) (naspram vemurafeniba) Nominalna p-vrijednost
HRa (95 % CI) (vs Vem)
HRa (95% CI) (naspram vemurafeniba)
A similar proportion of patients in each treatment arm received subsequent treatment with checkpoint inhibitors, mainly pembrolizumab, nivolumab and ipilimumab (34.4 % Combo 450 arm, 36.1 % encorafenib arm, 39.8 % vemurafenib arm).
uglavnom pembrolizumabom, nivolumabom i ipilimumabom (34,4% skupina liječena kombiniranom terapijom 450, 36,1% skupina liječena enkorafenibom, 39,8% skupina liječena vemurafenibom).
Blood creatine phosphokinase increased
Pretrage povišenje kreatin fosfokinaze u krvi vrlo često porast transaminaza*
The PFS for encorafenib 300 mg orally daily used in combination with binimetinib 45 mg orally twice daily (Combo 300, n = 258) was compared to the PFS for Enco 300 (n = 280, including 194 patients from Part 1 and 86 patients from Part 2).
PFS za enkorafenib 300 mg peroralno jednom dnevno u kombinaciji s binimetinibom 45 mg peroralno dvaput dnevno (komb. 300, n = 258) bio je uspoređen s PFS-om za enkorafenib 300 (n = 280,
• If improved to Grade 0 or 1, binimetinib should be resumed at same dose.
• Ako je došlo do poboljšanja na stupanj 0 ili 1, treba nastaviti s istom dozom binimetiniba.
Blood creatinine elevation and renal failure occurred when binimetinib was used in combination with encorafenib (see section 4.8 of encorafenib SmPC).
Povišenje kreatinina u krvi i zatajenje bubrega zabilježeni su pri primjeni binimetiniba u kombinaciji s enkorafenibom (vidjeti dio 4.8 sažetka opisa svojstava lijeka za enkorafenib).
It is recommended that LVEF is assessed by echocardiogram or multi-gated acquisition (MUGA) scan before initiation of binimetinib, 1 month after initiation, and then at approximately 3-month intervals or more frequently as clinically indicated, while on treatment.
prije početka primjene binimetiniba, 1 mjesec nakon početka primjene te približno svaka 3 mjeseca ili češće ako je klinički indicirano tijekom trajanja liječenja.
Vomiting occurred in 28.1 % (77/274) of patients with Grade 3 or 4 reported in 2.2 % (6/274) of patients.
Povraćanje se javilo u 28,1% (77/274) bolesnika, a stupanj 3 ili 4 prijavljen je u 2,2%
• Binimetinib should be permanently discontinued.
• Treba trajno obustaviti binimetinib.
• headaches, dizziness or weakness
• glavobolje, omaglicu ili slabost • iskašljavanje krvi ili krvnih ugrušaka
The safety of binimetinib (45 mg orally twice daily) in combination with encorafenib (450 mg orally once daily) (hereafter referred to as Combo 450) was evaluated in 274 patients with BRAF V600 mutant unresectable or metastatic melanoma, based on two Phase II studies (CMEK162X2110 and CLGX818X2109) and one Phase III study (CMEK162B2301, Part 1) (hereafter referred to as the pooled Combo 450 population).
274 bolesnika s neoperabilnim ili metastatskim melanomom s pozitivnom mutacijom BRAF V600, na temelju dva ispitivanja faze II (CMEK162X2110 i CLGX818X2109) te jednog ispitivanja faze III (CMEK162B2301, dio 1) (u daljnjem tekstu: ukupna populacija kombinirane terapije 450).
Haemorrhagic events led to discontinuation of treatment in 1.1 % (3/274) of patients.
Događaji krvarenja koji su doveli do trajne obustave liječenja javili su se u 1,1% (3/274) bolesnika.
The primary efficacy outcome measure was progression-free survival (PFS) of Combo 450 compared with vemurafenib as assessed by a blinded independent review committee (BIRC).
Progression-Free Survival) u skupini bolesnika liječenih kombiniranom terapijom 450 u usporedbi sa skupinom bolesnika liječenih vemurafenibom, kako je procijenjeno od strane zaslijepljenog,
Mektovi is not recommended while breast-feeding.
Lijek Mektovi ne preporučuje se tijekom dojenja.
The extent of drug interactions mediated by UGT1A1 is unlikely to be clinically relevant (see section 5.2); however, as this has not been evaluated in a formal clinical study, UGT1A1 inducers (such as rifampicin and phenobarbital) and inhibitors (such as indinavir, atazanavir, sorafenib) should be co-administered with caution.
Nije vjerojatno da bi razmjer interakcija lijekova posredovanih s UGT1A1 bio klinički relevantan (vidjeti dio 5.2); međutim, budući da to nije procijenjeno u službenom kliničkom ispitivanju, potreban je oprez kod istodobne primjene s
Heart problems: Mektovi can affect how well your heart works (left ventricular ejection fraction decrease); signs and symptoms can include:
Vaše srce radi (smanjenje ejekcijske frakcije lijeve klijetke); znakovi i simptomi mogu uključivati:
Binimetinib should be resumed at a reduced dose if all of the following are present within 4 weeks: o LVEF is at or above the LLN o Absolute decrease from baseline is 10 % or less.
Treba nastaviti sa smanjenom dozom binimetiniba ako je sve u nastavku prisutno unutar 4 tjedna:
Binimetinib should be permanently discontinued.
Treba trajno obustaviti binimetinib.
In Study CMEK162B2301-Part 2, in the Combo 300 arm, nausea was observed in 27.2% (70/257) of patients and was Grade 3 in 1.6% (4/257) of patients.
U ispitivanju CMEK162B2301, dio 2, u skupini kombinirane terapije 300, mučnina je zapažena u 27,2% (70/257) bolesnika i bila je stupnja 3 u 1,6% (4/257) bolesnika.
In Study CMEK162B2301-Part 2, in the Combo 300 arm, haemorrhagic events were observed in 6.6% (17/257) of patients and were Grade 3-4 in 1.6% (4/257) of patients.
U ispitivanju CMEK162B2301-dio 2, u skupini kombinirane terapije 300, događaji krvarenja zapaženi su u 6,6% (17/257) bolesnika i bili su stupnja 3-4 u 1,6% (4/257) bolesnika.
In Study CMEK162B2301-Part 2, in the Combo 300 arm, RPED was observed in 12.5% (32/257) of patients with 0.4% (1/257) Grade 4 event.
U ispitivanju CMEK162B2301, dio 2, u skupini kombinirane terapije 300, RPED je zapažen u 12,5% (32/257) bolesnika s 0,4% (1/257) za nuspojave stupnja 4.
Pruritus*
vrlo često pruritus*
Other secondary efficacy comparisons between Combo 450 and either vemurafenib or Enco 300 included overall survival (OS), objective response rate (ORR), duration of response (DoR) and disease control rate (DCR) as assessed by BIRC and by investigator assessment.
Druga sekundarna usporedba djelotvornosti između skupine liječene kombiniranom terapijom 450 i skupine liječene vemurafenibom ili enkorafenibom 300 uključivala je ukupno preživljenje (engl.
Uveitis was also reported when binimetinib was used in combination with encorafenib (see section 4.8 of encorafenib SmPC).
Uveitis je također prijavljen kod primjene binimetiniba u kombinaciji s enkorafenibom (vidjeti dio 4.8 sažetka opisa svojstava lijeka za enkorafenib).
(see section 4.2 of encorafenib SmPC).
(vidjeti dijelove 4.2 i 5.2).
HRa (95 % CI) (vs Enco 300) p value (stratified log-rank)b
HRa (95% CI) (naspram vemurafeniba) p-vrijednost (stratificirani lograng)b
Pneumonitis/ILD can occur with binimetinib.
Prilikom primjene binimetiniba može se pojaviti pneumonitis/ILD (engl.
Liver laboratory abnormalities should be managed with dose interruption, reduction or treatment discontinuation (see Table 1 in section 4.2).
Odstupanja od normalnih vrijednosti pretraga jetrene funkcije potrebno je zbrinuti prekidom doze, smanjenjem doze ili trajnom obustavom liječenja (vidjeti Tablicu 1 u dijelu 4.2).
Study CMEK162B2301, Part 1: Overall survival interim results (cut-off date: 7 November 2017)
Tablica 5: Ispitivanje CMEK162B2301, dio 1: Interim rezultati ukupnog preživljenja (datum prestanka prikupljanja podataka: 7. studenoga 2017.) Encorafenib + binimetinib n = 192 (kombinirana terapija
• If improved to Grade 0 or 1 or baseline level, binimetinib should be resumed at reduced dose, or
• Ako je došlo do poboljšanja na stupanj 0 ili 1 ili na početne razine, treba nastaviti sa smanjenom dozom binimetiniba, ili
Binimetinib should be withheld.
Treba prekinuti binimetinib.
The safety of binimetinib in combination with encorafenib has not been established in patients with a baseline LVEF that is either below 50 % or below the institutional LLN.
LVEF-om koji je ispod 50% ili ispod DGN ustanove.
• First occurrence of Grade 3 adverse reactions
• Prva pojava nuspojava stupnja 3
Effect of UGT1A1 inducers or inhibitors on binimetinib Binimetinib is primarily metabolised through UGT1A1 mediated glucuronidation.
Učinak UGT1A1 induktora ili inhibitora na binimetinib
• Retinal vein occlusion (RVO) Binimetinib should be permanently discontinued.
• Ponovljene nuspojave stupnja 4 • Treba trajno obustaviti binimetinib.
In Study CMEK162B2301-Part 2, in the Combo 300 arm, fatigue was observed in 33.5% (86/257) of patients with 1.6% (4/257) Grade 3-4 events.
U ispitivanju CMEK162B2301, dio 2, u skupini kombinirane terapije 300, umor je zapažen u 33,5% (86/257) bolesnika i bio je stupnja 3-4 u 1,6% (4/257) bolesnika.
In patients treated with Combo 450, VTE occurred in 4.7 % (13/274) of patients, including 2.2 % (6/274) of patients who developed pulmonary embolism.
uključujući 2,2% (6/274) bolesnika koji su razvili plućnu emboliju.
Facial paresis was reported when binimetinib was used in combination with encorafenib (see section 4.8 of encorafenib SmPC).
Facijalna pareza bila je zabilježena kod primjene binimetiniba u kombinaciji s enkorafenibom (vidjeti dio 4.8 sažetka opisa svojstava lijeka za enkorafenib).
Non-cutaneous malignancies
Zloćudne bolesti koje nisu na koži
• If improved to Grade 0 or 1, binimetinib should be resumed at reduced dose, or
• Ako je došlo do poboljšanja na stupanj 0 ili 1, treba nastaviti sa smanjenom dozom binimetiniba, ili
LVD defined as symptomatic or asymptomatic decreases in ejection fraction can occur when binimetinib is administered.
Kod primjene binimetiniba može doći do disfunkcije lijevog ventrikula definirane kao simptomatsko ili asimptomatsko smanjenje ejekcijske frakcije.
PPES can occur when binimetinib is used in combination with encorafenib (see section 4.8 of encorafenib SmPC).
Sindrom palmarno-plantarne eritrodizestezije (PPES) može se pojaviti kad se binimetinib primjenjuje u kombinaciji s enkorafenibom (vidjeti dio 4.8 sažetka opisa svojstava lijeka za enkorafenib).
- itching - dry skin - hair loss or thinning (alopecia) - skin rash of various types - thickening of the outer layers of the skin - joint pain (arthralgia) - muscle pain, weakness or spasm - back pain - pain in the extremities - fever - swelling of the hands or feet (peripheral oedema), localised swelling - fatigue - abnormal blood test results for liver function - abnormal blood test result related to blood creatine kinase, indicating damage to heart and muscle
- crvenilo, ispucala ili oštećena koža - upala masnog potkožnog sloja, simptomi uključuju osjetljive kožne kvržice - osip na koži koji može biti u obliku područja promijenjene boje, u razini kože ili u obliku uzdignutih čvorića poput akni (dermatitis s aknama)
Pancreatitis was reported when binimetinib was used in combination with encorafenib (see section 4.8 of encorafenib SmPC).
Pankreatitis je također prijavljen kod primjene binimetiniba u kombinaciji s enkorafenibom (vidjeti dio 4.8 sažetka opisa svojstava lijeka za enkorafenib).
Panniculitis*
često panikulitis*
• If asymptomatic: Binimetinib should be withheld for up to 4 weeks.
• Prva pojava nuspojava stupnja 4 Treba prekinuti binimetinib u razdoblju do 4 tjedna.
Probability of Overall Survival (%)
Broj događaja (%)
• feeling dizzy, tired or lightheaded
• osjećaj omaglice, umora ili ošamućenosti • nedostatak zraka
Renal dysfunction
Oštećenje jetrene funkcije
Table 4:
Tablica 4 i slika 1
The first dose is taken in the morning and the second dose in the evening around 12 hours later.
Prva doza uzima se ujutro, a druga doza navečer, otprilike 12 sati kasnije.
Further information on Zelboraf can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Više informacija o lijeku Zelboraf možete naći na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
This overview was last updated in 02-2018.
Ovaj pregled informacija posljednji je put ažuriran u 02. 2018.
The recommended dose is 960 mg (four tablets) twice daily.
Preporučena je doza 960 mg (četiri tablete) dvaput dnevno.
Each dose can be taken with or without food, but Zelboraf should be taken in the same way day-to-day.
Svaka se doza može uzimati s hranom ili bez nje, ali način svakodnevnog uzimanja lijeka Zelboraf mora biti isti.
What is Zelboraf and what is it used for?
Što je Zelboraf i za što se koristi?
What measures are being taken to ensure the safe and effective use of Zelboraf?
Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Zelboraf?
The main measures of effectiveness were how long the patients lived (overall survival) and how long they lived without their disease getting worse (progression-free survival).
Glavne mjere djelotvornosti bile su duljina života bolesnika (ukupno preživljenje) i vrijeme koje su bolesnici preživjeli bez pogoršanja bolesti (preživljenje bez progresije bolesti).
Zelboraf is available as tablets (240 mg).
Lijek Zelboraf dostupan je u obliku tableta (240 mg).
Zelboraf received a marketing authorisation valid throughout the EU on 17 February 2012.
Lijek Zelboraf dobio je odobrenje za stavljanje lijeka u promet koje je na snazi u Europskoj uniji od 17. veljače 2012.
Other information about Zelboraf
Ostale informacije o lijeku Zelboraf
The most common side effects with Zelboraf (which may affect more than 3 in 10 patients) include arthralgia (joint pain), tiredness, rash, photosensitivity reaction (sunburn-like reactions following exposure to light), nausea and vomiting (feeling sick and being sick), alopecia (hair loss), diarrhoea, headache, pruritus (itching), skin papilloma (warts) and hyperkeratosis (thickening and toughening of the skin).
Najčešće nuspojave lijeka Zelboraf (koje se mogu javiti u više od 3 na 10 osoba) uključuju artralgiju (bol u zglobovima), umor, osip, fotosenzitivne reakcije (reakcije slične opeklinama od sunca nakon izlaganja svjetlu), mučninu i povraćanje (osjećaj slabosti i povraćanje), alopeciju (gubitak kose), proljev, glavobolju, pruritus (svrbež), papilome kože (bradavice) i hiperkeratozu (zadebljanje i očvršćivanje kože).
What are the risks associated with Zelboraf?
Koji su rizici povezani s lijekom Zelboraf?
As for all medicines, data on the use of Zelboraf are continuously monitored.
Kao za sve lijekove, podatci o primjeni lijeka Zelboraf kontinuirano se prate.
Zelboraf can only be obtained with a prescription and treatment should be started and supervised by a specialist doctor experienced in treating cancer.
Zelboraf se izdaje samo na liječnički recept, a liječenje mora započeti i nadzirati liječnik specijalist s iskustvom u liječenju raka.
By blocking the action of the abnormal BRAF, Zelboraf helps to slow down the growth and spread of the cancer.
Blokiranjem djelovanja abnormalnog BRAF-a Zelboraf pomaže usporiti rast i širenje raka.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Zelboraf have been included in the summary of product characteristics and the package leaflet.
Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Zelboraf nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
The study showed that patients taking Zelboraf lived on average for 13.2 months compared with 9.9 months for patients on dacarbazine, and it took on average 5.3 months for the disease to worsen in the Zelboraf group compared with 1.6 months in the dacarbazine group.
U ispitivanju se pokazalo da su bolesnici koji su uzimali lijek Zelboraf živjeli u prosjeku 13,2 mjeseca, u usporedbi s 9,9 mjeseci u slučaju bolesnika koji su liječeni dakarbazinom, a pogoršanje bolesti nastupilo je u prosjeku nakon 5,3 mjeseca u skupini koja je uzimala lijek Zelboraf, u usporedbi s 1,6 mjeseci u skupini koja je uzimala dakarbazin.
Side effects reported with Zelboraf are carefully evaluated and any necessary action taken to protect patients.
Nuspojave prijavljene za lijek Zelboraf pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
Treatment should be continued until the disease worsens or the side effects become too severe.
Liječenje treba nastaviti sve dok se bolest ne pogorša ili dok nuspojave ne postanu preozbiljne.
Why is Zelboraf authorised in the EU?
Zašto je lijek Zelboraf odobren u EU-u?
Zelboraf was shown to be effective at prolonging patients' lives and delaying the worsening of the disease.
Lijek Zelboraf pokazao se učinkovitim u produljenju života bolesnika i u usporavanju pogoršanja bolesti.
The Agency considered the side effects to be manageable and included recommendations for doctors to help reduce the risks in the product information.
Agencija smatra da je moguće kontrolirati nuspojave te je u informacije o lijeku uvrstila preporuke za liječnike, što će pomoći u smanjenju rizika.
Before starting treatment a test must be carried out to make sure that the patient's tumours have the BRAF V600 mutation.
Prije početka liječenja potrebno je provesti ispitivanje kako bi se utvrdilo da tumori bolesnika imaju mutaciju BRAF V600.
Zelboraf is a cancer medicine used to treat adults with melanoma (a type of skin cancer) that has spread to other parts of the body or cannot be surgically removed.
Zelboraf je lijek protiv raka koji se koristi za liječenje odraslih osoba s melanomom (vrsta raka kože) koji se proširio na druge dijelove tijela ili se ne može kirurški odstraniti.
An overview of Zelboraf and why it is authorised in the EU
Pregled informacija o lijeku Zelboraf i zašto je odobren u EU-u
The European Medicines Agency decided that Zelboraf's benefits are greater than its risks and it can be authorised for use in the EU.
Europska agencija za lijekove zaključila je da koristi lijeka Zelboraf nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u Europskoj uniji.
Zelboraf is only for patients whose melanoma tumour cells have a specific mutation (genetic change) called ‘BRAF V600'.
Zelboraf je namijenjen samo bolesnicima čije tumorske stanice melanoma imaju specifičnu mutaciju (genetsku promjenu) koja se naziva BRAF V600.
The most common serious side effects include another type of skin cancer called ‘cutaneous squamous cell carcinoma', which is commonly treated by local surgery, keratoacanthoma (benign skin tumour), rash, arthralgia and change in liver test results (increased gamma-glutamyltransferase [GGT]).
Najčešće ozbiljne nuspojave uključuju drugi oblik raka kože naziva planocelularni karcinom kože, koji se uglavnom liječi lokalnim kirurškim zahvatom, keratoakantom (benigni tumor kože), osip, artralgiju i promjene rezultata testova jetrene funkcije (povišena razina gamaglutamiltransferaze (GGT)).
How is Zelboraf used?
Kako se Zelboraf koristi?
Zelboraf contains the active substance vemurafenib.
Zelboraf sadrži djelatnu tvar vemurafenib.