natgillin/translations-raw huggingface dataset:
Encorafenib N=194 (Enco 300)
Enkorafenib N = 194 (enkorafenib 300)
This could affect the ability to father a child. Talk to your doctor if this is a concern for you.
To bi moglo utjecati na sposobnost da imate dijete.
Encorafenib treatment in combination with binimetinib should be initiated and supervised under the responsibility of a physician experienced in the use of anticancer medicinal products.
4.2 Doziranje i način primjene Liječenje enkorafenibom u kombinaciji s binimetinibom mora započeti i nadzirati liječnik s iskustvom u primjeni antitumorskih lijekova.
• Increased transaminases: 13.2% (34/257) overall - Grade 3-4: 5.4% (14/257)
• Povišenje transaminaza: 13,2% (34/257) ukupno - stupanj 3-4: 5,4% (14/257)
- Bleeding problems: Braftovi may cause serious bleeding problems.
- Krvarenje: Lijek Braftovi može prouzročiti ozbiljne probleme s krvarenjem.
Blood creatinine should be monitored as clinically indicated and creatinine elevation managed with dose modification or discontinuation (see Table 3 in section 4.2).
Potrebno je pratiti kreatinin u krvi kako je klinički indicirano i zbrinuti povećanje kreatinina pomoću prilagodbe doze ili obustave liječenja (vidjeti
Liver laboratory abnormalities including AST and ALT elevations have been observed with encorafenib (see section 4.8).
Odstupanja od normalnih vrijednosti pretraga jetrene funkcije, uključujući porast ALT i AST, prijavljena su pri liječenju enkorafenibom (vidjeti dio 4.8).
Examples of strong CYP3A4 inhibitors include, but are not limited to, ritonavir, itraconazole, clarithromycin, telithromycin, posaconazole and grapefruit juice.
Primjeri snažnih inhibitora CYP3A4 uključuju, ali nisu ograničeni na ritonavir, itrakonazol, klaritromicin,
In the Combo 300 arm in Part 2 of the pivotal study, PPES was observed in 3.9% (10/257) of patients with Grade 3 reported in 0.4% (1/257) of patients.
U skupini kombinirane terapije 300 dijela 2 pivotalnog ispitivanja, PPES je zapažen u 3,9% (10/257) bolesnika sa stupnjem 3 prijavljenim u 0,4% (1/257) bolesnika.
Effect of transporters on encorafenib
Učinak transportera na enkorafenib
In the pooled Combo 450 population, uveitis was reported in 4.4% (12/274) of patients, and was Grade 1 in 0.4% (1/274), Grade 2 in 3.6% (10/274) and Grade 3 in 0.4% (1/274).
U ukupnoj populaciji kombinirane terapije 450, uveitis je prijavljen u 4,4% (12/274) bolesnika, i to kao stupanj 1 u 0,4% (1/274), stupanj 2 u 3,6% (10/274) i stupanj 3 u 0,4% (1/274) bolesnika.
Gamma-glutamyl transferase (GGT) increased* Transaminase increased*
povišenje kreatin fosfokinaze u krvi povišenje gama-glutamil transferaze (GGT)* povišenje transaminaza*
Encorafenib should be used with caution in patients with severe renal impairment.
Enkorafenib se mora s oprezom davati bolesnicima s teškim oštećenjem bubrežne funkcije.
Combination with binimetinib
Kombinirana primjena s binimetinibom
Administration of encorafenib at a dose of 450 mg once daily as a single agent is not recommended.
Ne preporučuje se primjena enkorafeniba u dozi od 450 mg jednom dnevno kao monoterapija.
The encorafenib single agent (300 mg orally once daily) safety profile is based on data from 217 patients with unresectable or metastatic BRAF V600-mutant melanoma (hereafter referred to as the pooled encorafenib 300 population).
Sigurnosni profil enkorafeniba kao monoterapije (300 mg peroralno jednom dnevno) temelji se na podacima 217 bolesnika s neoperabilnim ili metastatskim melanomom s pozitivnom BRAF V600 mutacijom (u daljnjem tekstu ukupna populacija 300 enkorafeniba).
The safety of encorafenib (300 mg orally once daily) in combination with binimetinib (45 mg orally twice daily) was evaluated in 257 patients with BRAF V600 mutant unresectable or metastatic melanoma (hereafter referred to as the Combo 300 population), based on the Phase III study (CMEK162B2301, Part 2).
Sigurnost enkorafeniba (300 mg peroralno, jednom dnevno) u kombinaciji s binimetinibom (45 mg peroralno, dvaput dnevno) procijenjena je na 257 bolesnika s pozitivnom mutacijom BRAF V600 s neoperabilnim ili metastatskim melanomom (u daljnjem tekstu: kombinirana 300 populacija), na temelju ispitivanja faze III (CMEK162B2301, dio 2).
The pharmacokinetics of encorafenib have not been studied in patients with severe renal impairment.
Farmakokinetika enkorafeniba nije ispitivana u bolesnika s teškim oštećenjem bubrežne funkcije.
Bleeding problems: Braftovi can cause serious bleeding problems.
Krvarenja: lijek Braftovi može prouzročiti ozbiljna krvarenja.
Encorafenib was phototoxic in an in vitro 3T3 Neutral Red Uptake Test. Encorafenib was not a sensitiser in the in vivo mouse sensitization assay.
Enkorafenib je pokazao fototoksičnost u in vitro testu 3T3 Neutral Red Uptake.
Nausea occurred in 41.6% (114/274) with Grade 3 or 4 observed in 2.6% (7/274) of patients.
Mučnina se javila u 41,6% (114/274) bolesnika, a stupanj 3 ili 4 prijavljen je u 2,6% (7/274) bolesnika.
If no improvement within 4 weeks, encorafenib should be withheld until improved to Grade 0 or 1 or to pretreatment/baseline levels and then resumed at the same dose.
Ako nema poboljšanja unutar 4 tjedna, treba prekinuti enkorafenib dok se ne postigne poboljšanje na stupanj 0 ili 1 ili na početne vrijednosti, a potom nastaviti s istom dozom.
Dilatation of the aortic arc was observed in some foetuses.
U nekih fetusa zapaženo je proširenje luka aorte.
In the pooled Combo 450 population, diarrhoea was observed in 38% (104/274) of patients and was Grade 3-4 in 3.3% (9/274) patients.
U ukupnoj populaciji kombinirane terapije 450, proljev je primijećen u 38% (104/274) bolesnika i bio je stupnja 3-4 u 3,3% (9/274) bolesnika.
Diarrhoea occurred in 28.4% (73/257) of patients with Grade 3 reported in 1.6% (4/257) of patients.
Proljev je zapažen u 28,4% (73/257) bolesnika i to stupnja 3 prijavljenog u 1,6% (4/257) bolesnika.
In the pooled Combo 450 population, headache occurred in 21.5% (59/274) of patients, including Grade 3 in 1.5% (4/274) of patients.
U ukupnoj populaciji kombinirane terapije 450, glavobolja se javila u 21,5% (59/274) bolesnika uključujući i nuspojave stupnja 3 u 1,5% (4/274) bolesnika.
No dose adjustment is required for patients with mild or moderate renal impairment based on a population pharmacokinetics (PK) analysis.
Oštećenje bubrežne funkcije Nije potrebno posebno prilagođavati dozu bolesnicima s blagim do umjerenim oštećenjem bubrežne funkcije na temelju populacijske farmakokinetičke analize.
For information on the posology and recommended dose modifications of binimetinib, see section 4.2 of binimetinib SmPC.
Za informacije o doziranju i preporučenoj prilagodbi doze binimetiniba, vidjeti dio 4.2 sažetka opisa svojstava lijeka za binimetinib.
• If improved to Grade 0 or 1 or to baseline levels, it should be resumed at a reduced dose.
• Ako je došlo do poboljšanja na stupanj 0 ili 1 ili na početne vrijednosti, treba nastaviti sa smanjenom dozom.
Vomiting* Constipation Abdominal pain* Diarrhoea*
konstipacija bol u abdomenu* proljev*
Each hard capsule contains 50 mg encorafenib.
Jedna tvrda kapsula sadrži 50 mg enkorafeniba.
In the pooled Combo 450 population, cuSCC including keratoacanthomas was observed in 3.3% (9/274) of patients.
U ukupnoj populaciji kombinirane terapije 450, planocelularni karcinom kože, uključujući keratoakantom, zapažen je u 3,3% (9/274) bolesnika.
Each hard capsule contains 75 mg encorafenib.
Jedna tvrda kapsula sadrži 75 mg enkorafeniba.
• Printing ink: shellac (E904), iron oxide black (E172), propylene glycol (E1520)
• Boja za označavanje: šelak (E904), željezov oksid, crni (E172), propilenglikol (E1520)
Study CMEK162B2301, Part 1: Overall survival interim results (cut-off date: 7 November 2017)
Tablica 6: Ispitivanje CMEK162B2301, dio 1: Interim rezultati ukupnog preživljenja (krajnji rok: 7. studenoga 2017.)
Encorafenib in combination with binimetinib in patients with brain metastases There are limited efficacy data with the combination of encorafenib and binimetinib in patients with a BRAF V600 mutant melanoma which have metastasised to the brain (see section 5.1).
Ograničeni su podaci o djelotvornosti kombinacije enkorafeniba i binimetiniba u bolesnika s melanomom s BRAF V600 mutacijom koji je metastazirao u mozak (vidjeti dio 5.1).
If uveitis is Grade 1 and it improves to Grade 0, then treatment should be resumed at the same dose.
Ako nastupi uveitis stupnja 1 i poboljša se do stupnja 0, treba nastaviti s istom dozom.
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% (6/274) bolesnika.
Haemorrhagic events were observed in 17.9% (49/274) of patients in the pooled Combo 450 population.
Krvarenje je zapaženo u 17,9% (49/274) bolesnika iz ukupne populacije kombinirane terapije 450.
HRa (95% CI) (vs Enco 300)
HRa (95 % CI) (naspram enkorafeniba 300)
Uncommon (may affect up to 1 in 100 people) - type of skin cancer such as basal cell carcinoma - inflammation of the eye (uveitis) - inflammation of the pancreas (pancreatitis) causing severe abdominal pain - abnormal blood test result for pancreas function (amylase)
Manje često (može se javiti u do 1 na 100 osoba) - vrsta raka kože, kao što je bazocelularni karcinom - upala oka (uveitis) - upala gušterače (pankreatitis) koja izaziva jaku bol u abdomenu
• If improved to Grade 0 or 1 or to baseline levels, then it should be resumed at a reduced dose level.
• Ako je došlo do poboljšanja na stupanj 0 ili 1 ili na početne vrijednosti, treba nastaviti sa smanjenom razinom doze.
In the pooled Combo 450 population, fatigue occurred in 43.8% (120/274) of patients including Grade 3 in 2.9% (8/274) of patients.
U ukupnoj populaciji kombinirane terapije 450, umor se javio u 43,8% (120/274) bolesnika, uključujući i stupanj 3 u 2,9% (8/274) bolesnika.
Shellac (E904) Iron oxide black (E172) Propylene glycol (E1520)
Željezov oksid, crni (E172) Propilenglikol (E1520)
If during treatment LVD occurs, see section 4.2 of binimetinib SmPC.
Ako se tijekom liječenja pojavi disfunkcija lijeve klijetke (LVD), vidjeti dio 4.2 sažetka opisa svojstava lijeka za binimetinib.
Caution should be exercised if a moderate CYP3A inhibitor is co-administered with encorafenib.
Nužan je oprez pri istodobnoj primjeni umjereno jakih inhibitora CYP3A s enkorafenibom.
In the pooled encorafenib 300 population, facial paresis was observed in 7.4% (16/217) of patients.
U ukupnoj populaciji enkorafeniba 300, facijalna pareza se javila u 7,4% (16/217) bolesnika.
Encorafenib dose when used in combination with binimetinib
Doziranje enkorafeniba kad se primjenjuje u kombinaciji s binimetinibom
Nausea Vomiting* Constipation
konstipacija mučnina povraćanje*
The embryo-foetal development study in rats indicated that encorafenib induced foetal toxicity with lower foetal weights and delays in skeletal development.
Ispitivanje embriofetalnog razvoja kod štakora pokazalo je da enkorafenib izaziva toksičnost u fetusa,
Muscle problems: Braftovi, when taken with binimetinib, can cause breakdown of muscles (rhabdomyolysis) which can lead to kidney damage and can be fatal; signs and symptoms can include: - muscle pain, cramps, stiffness or spasm - dark urine
(rabdomioliza) koje može prouzročiti oštećenje bubrega i može biti opasno po život; znakovi i simptomi mogu uključivati: - bol u mišićima, grčeve, ukočenost ili spazam - tamno obojena mokraća
The hard capsule (capsule) has a flesh coloured opaque cap and white opaque body, with a stylised “A” printed on the cap and “LGX 75mg” printed on the body.
Tvrda kapsula (kapsula) ima neprozirnu kapicu boje mesa i neprozirno tijelo bijele boje, sa stiliziranim „A” tiskanim na kapici i „LGX 75mg” na tijelu kapsule.
Rash led to discontinuation in 0.4% (1/274) patients and to dose interruption or dose modification in 1.1% (3/274) of patients.
Osip je doveo do obustavljanja liječenja u 0,4% (1/274) bolesnika i privremenog prekida ili prilagodbe doze u 1,1%
Uncommon (may affect up to 1 in 100 people) - weakness and paralysis of face muscles - inflammation of the pancreas (pancreatitis) causing severe abdominal pain
Manje često (može se javiti u do 1 na 100 osoba) - slabost ili paraliza mišića lica
Dose interruption or dose modification occurred in 1.1% (3/274) of patients.
Do privremenog prekida ili prilagodbe doze došlo je u 1,1% (3/274) bolesnika.
An additional secondary endpoint included PFS of Combo 450 compared with Enco 300.
Dodatna sekundarna mjera ishoda uključuje preživljenje bez progresije (PFS) u skupini bolesnika liječenih kombiniranom 450 terapijom u usporedbi sa skupinom liječenom enkorafenibom 300.
Concomitant agents that are substrates of UGT1A1 (e.g. raltegravir, atorvastatin, dolutegravir) may have increased exposure and should be therefore administered with caution.
Lijekovi koji su supstrati UGT1A1 (npr. raltegravir, atorvastatin,
HRa (95% CI) (vs Vem)
HRa (95 % CI) (naspram vemurafeniba)
Overall response rate, n (%)
Stopa ukupnog odgovora, n (%) (95 % CI)
Common cuSCC a New Primary Melanoma*
Često planocelularni karcinom kožea novi primarni melanom*
Side effects when Braftovi and binimetinib are taken together
Nuspojave pri istodobnoj primjeni lijeka Braftovi i binimetiniba
Encorafenib should be withheld (see monitoring in section
Treba prekinuti enkorafenib (vidjeti praćenje u dijelu 4.4).
Braftovi 75 mg: Each hard capsule contains 75 mg encorafenib.
Braftovi 75 mg: Jedna tvrda kapsula sadrži 75 mg enkorafeniba.
Rash led to discontinuation in 0.5% (1/217) of patients and to dose interruption or dose modification in 7.4% (16/217) of patients.
Osip je doveo do obustavljanja liječenja u 0,5% (1/217) bolesnika i privremenog prekida ili prilagodbe doze u 7,4%
Decreased appetite
- tamnjenje kože - gubitak apetita
Encorafenib has minor influence on the ability to drive or use machines.
Enkorafenib malo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
The hard capsule (capsule) has an orange opaque cap and flesh opaque body, with a stylised “A” printed on the cap and “LGX 50mg” printed on the body.
Tvrda kapsula (kapsula) ima narančastu neprozirnu kapicu i neprozirno tijelo boje mesa, sa stiliziranim „A” tiskanim na kapici i „LGX 50mg” na tijelu kapsule.
Dose interruption or dose modification was reported in 0.4% (1/274) of patients.
Privremeni prekid ili prilagodba doze zabilježeni su u 0,4% (1/274) bolesnika.
Pancreatitis led to dose interruption or adjustment in (0.4 %) 1/274 of patients.
Upala gušterače dovela je do potrebe za prilagodbom doze ili obustavom liječenja u (0,4%) 1/274 bolesnika.
Braftovi 50 mg hard capsules Braftovi 75 mg hard capsules
Braftovi 50 mg tvrde kapsule Braftovi 75 mg tvrde kapsule
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 do 4 prijavljenim u 2,7% (7/257) bolesnika.
Braftovi 50 mg: Each hard capsule contains 50 mg encorafenib.
Braftovi 50 mg: Jedna tvrda kapsula sadrži 50 mg enkorafeniba.
In the 13-week study, partial reversibility was noted at the highest dose level (60 mg/kg/d).
13-tjednom ispitivanju, djelomična reverzibilnost zabilježena je pri najvišoj razini doze
It is recommended that left ventricular ejection fraction (LVEF) is assessed by echocardiogram or multi-gated acquisition (MUGA) scan before initiation of encorafenib and binimetinib, one month after initiation, and then at approximately 3-month intervals or more frequently as clinically indicated, while on treatment.
Multi-Gated Acquisition) prije uvođenja enkorafeniba i binimetiniba, mjesec dana nakon uvođenja i potom u intervalima na približno svaka tri mjeseca ili češće ukoliko je to klinički indicirano tijekom liječenja.
Simulations of 450 mg encorafenib co-administered with probe substrates for CYP2B6, CYP1A2, CYP2C9, CYP2C19 and CYP2D6 on Day 1 and Day 15 all indicated no clinically relevant interactions are expected.
Simulacije istodobne primjene 450 mg enkorafeniba sa supstratima za CYP2B6, CYP1A2, CYP2C9, CYP2C19 i
Muscular disorders/Myalgial Pain in extremity Back pain
Vrlo često artralgija* mijalgijag bol u ekstremitetu bol u leđima artralgija* poremećaji mišićnog sustava/mijalgijal bol u ekstremitetu bol u leđima
RPED has also been reported in patients treated with encorafenib in combination with binimetinib (see section 4.8).
Odvajanje pigmentnog epitela mrežnice (RPED) također je prijavljeno u bolesnika liječenih enkorafenibom u kombinaciji s binimetinibom (vidjeti dio 4.8).
Encorafenib should be discontinued if more than one recurrence.
Treba trajno obustaviti enkorafenib ako se pojavi više nastupa produljenja.
Transaminase increased* Blood creatinine increased* Lipase increased
Često povišenje transaminaza* povišenje kreatinina u krvi* povišenje lipaze povišenje alkalne fosfataze u krvi povišenje kreatinina u krvi* povišenje amilaze povišenje lipaze
Recommended dose modifications for encorafenib (when used in combination with binimetinib)
Tablica 2: Preporučena prilagodba doze za enkorafenib (kada se primjenjuje u kombinaciji s binimetinibom) za određene nuspojave
In the pooled encorafenib 300 population, cuSCC was reported in 7.4% (16/217) patients.
U ukupnoj populaciji enkorafenib 300, planocelularni karcinom je prijavljen u 7,4% (16/217) bolesnika.
Very common (may affect more than 1 in 10 people): - reduced red blood cell count (anaemia) - problem with the nerves resulting in pain, loss of sensation or tingling in hands and feet - headache - dizziness - bleeding at various sites in the body - high blood pressure - problems with your vision (visual impairment) - stomach pain - diarrhoea - being sick (vomiting) - feeling sick (nausea) - constipation - 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 results related to blood creatine kinase, indicating damage to the heart and muscle
Vrlo često (može se javiti u više od 1 na 10 osoba): - smanjen broj crvenih krvnih stanica (anemija) - problem sa živcima koji može uzrokovati bol, gubitak osjeta ili trnce u šakama i stopalima - glavobolja - omaglica - krvarenja s raznih mjesta u tijelu - visok krvni tlak - problemi s vidom (poremećaj vida) - bol u trbuhu - proljev
New primary melanoma has been observed in patients treated with BRAF inhibitors including encorafenib (see section 4.8).
U bolesnika liječenih BRAF inhibitorima, uključujući i enkorafenib, zabilježeni su slučajevi novih primarnih melanoma (vidjeti dio 4.8).
Encorafenib should be used with caution in patients with severe renal impairment (see sections 4.4 and 5.2).
Bolesnike s teškim oštećenjem bubrežne funkcije treba pomno nadzirati tijekom primjene enkorafeniba (vidjeti dijelove 4.4 i 5.2).
Recommended dose modifications for encorafenib (used in combination with binimetinib) for other adverse reactions Severity of adverse reaction Encorafenib
Tablica 3: Preporučena prilagodba doze za enkorafenib (kad se primjenjuje u kombinaciji s binimetinibom) za druge nuspojave Težina nuspojave
HRa (95% CI) (vs Vem) Nominal p-value
HRa (95 % CI) (naspram vemurafeniba) Nominalna p-vrijednost HRa (95 % CI) (naspram vemurafeniba) Nominalna p-vrijednost
Very common
Često kolitisk
Skin papilloma* Melanocytic nevus
- neke vrste benignih tumora kože, kao što su melanocitni nevus i papilom kože
Flesh coloured opaque cap and white opaque body, printed with a stylised “A” on the cap and “LGX 75mg” on the body.
Neprozirna kapica boje mesa i bijelo neprozirno tijelo, sa stiliziranim „A” tiskanim na kapici i „LGX 75mg” na tijelu kapsule.
Effects of encorafenib on other medicinal products CYP substrates
Učinak enkorafeniba na druge lijekove
Braftovi 50 mg capsules encorafenib
Braftovi 50 mg kapsule enkorafenib
Pruritus*
RPED*
Braftovi 75 mg capsules encorafenib
Braftovi 75 mg kapsule enkorafenib
HRa (95% CI) (vs Vem) p-value (stratified log-rank)b
HRa (95 % CI) (naspram vemurafeniba) p-vrijednost (stratificirani lograng)b
HR (95% CI) (vs Enco 300) p-value (stratified log-rank)
HR (95 % CI) (naspram enkorafenib 300) p-vrijednost (stratificirani lograng)
In vitro experiments indicate encorafenib is a relatively potent reversible inhibitor of UGT1A1, CYP2B6, CYP2C9 and CYP3A4/5, as well as a time-dependent inhibitor of CYP3A4.
UGT1A1, CYP2B6, CYP2C9 i CYP3A4/5, kao i inhibitor CYP3A4 ovisan o vremenu.
Braftovi 50 mg hard capsules
Braftovi 50 mg tvrde kapsule
Braftovi 75 mg hard capsules
Braftovi 75 mg tvrde kapsule
Arthritis *
Često artritis*
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) događaja stupnja 4.
In Study CMEK162B2301-Part 2, in the Combo 300 arm, headache was reported in 12.1% (31/257) of patients and was Grade 3 in 0.4% (1/257) of patients.
U ispitivanju CMEK162B2301, dio 2, u skupini kombinirane terapije 300, glavobolja se javila u 12,1% (31/257) bolesnika i bila je stupnja 3 u 0,4% (1/257) bolesnika.
HR (95% CI) (vs Vem) p-value (stratified log-rank)
HR (95 % CI) (naspram vemurafenib) p-vrijednost (stratificirani lograng)
Therefore, female patients using hormonal contraception are advised to use an additional or alternative method such as a barrier method (e.g. condom) during treatment with encorafenib and for at least 1 month following the last dose.
Stoga se ženama u reproduktivnoj dobi koje koriste hormonsku kontracepciju savjetuje koristiti dodatnu ili alternativnu metodu kao što je metoda barijere
Agents that are CYP3A4 substrates should be co-administered with caution.
Lijekove koji su supstrati CYP3A4 enzima treba veoma oprezno primjenjivati istodobno s enkorafenibom.
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.
(engl. overall survival, OS), stopu objektivnog odgovora (engl. objective response rate, ORR), trajanje odgovora (engl. duration of response, DoR) i stopu kontrole bolesti (engl. disease control rate, DCR)
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 kod 27,2% (70/257) bolesnika i bila je stupnja 3 u 1,6% (4/257) bolesnika.
Neuropathy peripheral* Dysgeusia*
Poremećaji živčanog sustava Vrlo često glavobolja* periferna neuropatija* disgeuzija*
Haemorrhagei Hypertension *
zatajenje bubrega*
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.
Tabulated list of adverse reactions
Tablični sažeti prikaz nuspojava
Metabolism and nutrition disorders
Poremećaji metabolizma i prehrane Vrlo često smanjeni apetit
This observation was similar to that described in humans as central serous-like chorioretinopathy or central serous retinopathy.
kao što je središnja serozna korioretinopatija ili središnja serozna retinopatija.
Braftovi 50 mg hard capsules encorafenib
Braftovi 50 mg tvrde kapsule enkorafenib
The incidences of liver laboratory abnormalities reported in the pooled Combo 450 population are listed below:
Odstupanja od normalnih vrijednosti pretraga jetrene funkcije Incidencija odstupanja od normalnih vrijednosti pretraga jetrene funkcije u ukupnoj populaciji kombinirane terapije 450 je sljedeća:
Braftovi 75 mg hard capsules encorafenib
Braftovi 75 mg tvrde kapsule enkorafenib