natgillin/translations-raw huggingface dataset:
Table 9: Overall response rate and progression-free survival in previously untreated patients with BRAF V600 mutation-positive melanoma vemurafenib dacarbazine p-value (x)
Preglednica 9: Celokupni odziv in preživetje brez napredovanja bolezni pri predhodno nezdravljenih bolnikih z melanomom s pozitivno BRAF V600 mutacijo vemurafenib dakarbazin p-vrednost
The most common adverse drug reactions (ADR) of any grade (> 30%) reported with vemurafenib include arthralgia, fatigue, rash, photosensitivity reaction, alopecia, nausea diarrhea, headache,
Med najpogostejšimi neželenimi učinki vseh stopenj (> 30 %), o katerih so poročali v zvezi z vemurafenibom, so artralgija, utrujenost, kožni izpuščaj, fotosenzibilnostna reakcija, alopecija, navzea, diareja, glavobol, srbenje, bruhanje, kožni papilomi in hiperkeratoza.
● Weight loss
• izguba teka,
A total of 675 patients were randomised to vemurafenib (n=337) or dacarbazine (n=338).
Skupaj je bilo randomiziranih 675 bolnikov, 337 zdravljenih z vemurafenibom in 338 z dakarbazinom.
Mild to severe photosensitivity was reported in patients who received vemurafenib in clinical studies (see section 4.8).
Pri bolnikih, ki so v kliničnih študijah prejemali vemurafenib, je bila opisana blaga do huda fotosenzibilnost (glejte poglavje 4.8).
● A type of cancer (non-cutaneous squamous cell carcinoma)
• vrsta raka (ploščatocelični karcinom, ki se ne nahaja na koži),
Potentiation of radiation treatment toxicity has been reported in patients receiving vemurafenib (see sections 4.4 and 4.8).
Pri bolnikih, zdravljenih z vemurafenibom, so poročali o povečanju toksičnosti obsevanja (glejte poglavji 4.4 in 4.8).
Resume dosing at 480 mg twice daily (or discontinue permanently if the dose has already been lowered to 480 mg twice daily).
Ponovno začnite z odmerkom 480 mg dvakrat na dan (ali dokončno prenehajte, če je odmerek že bil znižan na 480 mg dvakrat na dan).
Dose reduction of the concomitant CYP1A2 substrate drug may be considered, if clinically indicated.
Razmisli se lahko o zmanjšanju odmerka sočasno uporabljenega zdravila, če je to klinično indicirano.
Caution should be exercised when dosing vemurafenib concurrently with P-gp substrates (e.g. aliskiren, ambrisentan, colchicine, dabigatran etexilate, digoxin, everolimus, fexofenadine, lapatinib, maraviroc, nilotinib, posaconazole, ranolazine, sirolimus, sitagliptin, talinolol, topotecan) and dose reduction of the concomitant medicinal product may be considered, if clinically indicated.
Ob sočasni uporabi vemurafeniba in substrata P-gp (npr. aliskirena, ambrisentana, kolhicina, dabigatran eteksilata, digoksina, everolimusa, feksofenadina, lapatiniba, maraviroka, nilotiniba, posakonazola, ranolazina, sirolimusa, sitagliptina, talinolola, topotekana) je potrebna previdnost.
Surveillance for non-cuSCC should occur as outlined in section 4.4.
Njegov morebiten pojav je treba nadzorovati, kot je opisano v poglavju 4.4.
● You may develop new melanoma lesions while taking Zelboraf.
• Med jemanjem zdravila Zelboraf lahko pride do nastanka novega melanoma.
Arthritis,
• driska,
Croscarmellose sodium Colloidal anhydrous silica Magnesium stearate Hydroxypropylcellulose
Jedro tablete natrijev karmelozat, premreženi silicijev dioksid, koloidni, brezvodni magnezijev stearat hidroksipropilceluloza
● Medicines that stimulate the metabolising proteins called CYP3A4 or a metabolising process called glucuronidation (e.g. rifampicin, rifabutin, carbamazepine, phenytoin or St John's Wort)
• zdravila, ki spodbujajo beljakovine, ki sodelujejo v presnovi, imenovane CYP3A4 ali pa spodbujajo metabolične procese, imenovane glukuronidacija (npr. rifampicin, rifabutin, karbamazepin, fenitoin ali šentjanževka);
● You should have your eyes examined by your doctor while you are taking Zelboraf.
• Med jemanjem zdravila Zelboraf vam mora zdravnik pregledati oči.
Genital examinations (for women) and anal examinations are also recommended before and at the end of your treatment.
Prav tako je priporočeno pred zdravljenjem in po končanem zdravljenju opraviti ginekološki pregled (pri ženskah) in pregled zadnjika.
There are only limited data available in patients with severe renal impairment (see section 5.2).
Podatkov o bolnikih s hudo ledvično okvaro je malo (glejte poglavje 5.2).
● Thickening of deep tissues underneath the sole of the feet that may be disabling if severe
• zadebelitev globokih tkiv pod stopalom; če je huda, lahko bolnika onesposobi.
Vemurafenib should be used with caution when given concomitantly or sequentially with radiation treatment.
Pri sočasni ali zaporedni uporabi vemurafeniba in obsevanja je potrebna previdnost.
Data are insufficient to determine the effect of metabolic or excretory hepatic impairment on vemurafenib pharmacokinetics (see sections 4.2 and
Na voljo ni dovolj podatkov, da bi določili vpliv okvare jeter, v smislu presnove ali izločanja, na farmakokinetiko vemurafeniba (glejte poglavji 4.2 in 4.4).
Renal elimination does not appear to be of importance for vemurafenib elimiation, whereas biliary excretion of unchanged compound may be an important route of elimination.. Vemurafenib is a substrate and inhibitor of P-gp in vitro.
Izločanje skozi ledvice se ne zdi pomembno za izločanje vemurafeniba, izločanje nespremenjene spojine z žolčem pa je lahko pomembna pot izločanja.
Your doctor will run tests to check that your heart is working properly before and during your treatment with Zelboraf.
Zdravnik bo pred začetkom zdravljenja in med zdravljenjem z zdravilom Zelboraf opravil preiskave, s katerimi bo preveril, ali vaše srce deluje pravilno.
Resume dosing at 720 mg twice daily (or 480 mg twice daily if the dose has already been lowered).
Ponovno začnite z odmerkom 720 mg dvakrat na dan (ali 480 mg dvakrat na dan, če je odmerek že bil zmanjšan).
NAME OF THE MEDICINAL PRODUCT Zelboraf 240 mg film-coated tablets.
IME ZDRAVILA Zelboraf 240 mg filmsko obložene tablete
Co-administration of vemurafenib resulted in an 18% increase in AUC of S-warfarin (CYP2C9 substrate).
Sočasno dajanje vemurafeniba z varfarinom (substratom CYP2C9) je povečalo AUC varfarina v serumu za 18 %.
Each film-coated tablet contains 240 milligrams (mg) of vemurafenib (as a co-precipitate of vemurafenib and hypromellose acetate succinate).
Ena filmsko obložena tableta vsebuje 240 miligramov (mg) vemurafeniba (v obliki precipitata vemurafeniba in hipromeloze acetat sukcinata).
Vemurafenib should be used with caution in combination with strong inhibitors of CYP3A4, glucuronidation and/or transport proteins (e.g. ritonavir, saquinavir, telithromycin, ketoconazole, itraconazole, voriconazole, posaconazole, nefazodone, atazanavir).
Vemurafenib je treba uporabljati previdno v kombinaciji z močnimi zaviralci CYP3A4, glukuronidacije in/ali prenašalnih beljakovin (npr. ritonavirjem, sakvinavirjem, telitromicinom, ketokonazolom, itrakonazolom, vorikonazolom, posakonazolom, nefazodonom, atazanavirjem).
Drug reaction with eosinophilia and systemic symptoms(1)(2)
reakcija na zdravilo z eozinofilijo in sistemskimi simptomi
Responders n (%) (95% CI)b
BORRa v možganih Odzivni bolniki n (%) (95-% IZ)b
Table 5: Acute kidney injury cases in the phase III study Vemurafenib (%) Dacarbazine (%)
Preglednica 5: Primeri akutne poškodbe ledvic v študiji faze III
In patients who experience severe hypersensitivity reactions, vemurafenib treatment should be permanently discontinued.
Pri bolnikih, pri katerih se pojavijo resne preobčutljivostne reakcije, je treba zdravljenje z vemurafenibom dokončno opustiti.
Cases of cuSCC (which include those classified as keratoacanthoma or mixed keratoacanthoma subtype) have been reported in patients treated with vemurafenib (see section 4.8).
Pri bolnikih, zdravljenih z vemurafenibom, so bili opisani primeri ploščatoceličnega karcinoma kože, vključno s ploščatoceličnim karcinomom, opredeljenim kot keratoakantom ali mešani keratoakantom (glejte poglavje 4.8).
Serious hypersensitivity reactions, including anaphylaxis have been reported in association with vemurafenib (see sections 4.3 and 4.8).
V povezavi z vemurafenibom so bile opisane resne preobčutljivostne reakcije, vključno z anafilaksijo (glejte poglavji 4.3 in 4.8).
Patients with moderate to severe hepatic impairment may have increased exposure (see section 5.2).
Izpostavljenost je lahko večja pri bolnikih z zmerno do hudo jetrno okvaro (glejte poglavje 5.2).
Concomitant use of vemurafenib with agents metabolized by CYP3A4 with narrow therapeutic windows is not recommended.
Sočasna uporaba vemurafeniba z učinkovinami, ki se presnavljajo prek CYP3A4 in imajo ozko terapevtsko okno, ni priporočljiva.
In patients who experience a severe dermatologic reaction, vemurafenib treatment should be permanently discontinued.
Pri bolnikih, pri katerih se pojavi huda kožna reakcija, je treba zdravljenje z vemurafenibom dokončno opustiti.
Caution should be used when administering Vemurafenib with strong CYP3A4/PgP inhibitors.
Pri dajanju vemurafeniba z močnimi zaviralci CYP3A4/P-gp je potrebna previdnost.
Cases of radiation recall and radiation sensitization have been reported in patients treated with radiation either prior, during, or subsequent to vemurafenib treatment.
Pri bolnikih, ki so se pred, med ali po zdravljenju z vemurafenibom zdravili z obsevanjem, so poročali o primerih vnetnih reakcij na mestu obsevanja (t.i. radiation recall) in povečane občutljivosti na obsevanje.
No cases of overdose have been observed with vemurafenib in clinical trials.
V kliničnih preskušanjih niso zabeležili primerov prevelikega odmerjanja vemurafeniba.
All patients treated were at least 15 years of age and weighed at least 45 kg. Three patients were treated with vemurafenib 720 mg twice daily, and three patients were treated with vemurafenib 960 mg twice daily.
Tri bolnike so zdravili s 720 mg vemurafeniba dvakrat na dan in tri z 960 mg vemurafeniba dvakrat na dan.
Reversible toxic effects (hepatocellular necrosis and degeneration) in the liver at exposures below the anticipated clinical exposure (based on AUC comparisons) were noted in the 13-week dog study.
V 13-tedenski študiji na psih so v jetrih opazili reverzibilne toksične učinke (nekrozo in degeneracijo jetrnih celic) pri izpostavljenostih, manjših od predvidene klinične izpostavljenosti (na podlagi primerjave AUC).
● Palmar plantar syndrome (i.e. redness, skin peeling or blisters on hands and feet)
rdečica, luščenje kože ali mehurji na rokah in stopalih),
Photosensitivity reaction, actinic keratosis, rash, rash maculo-papular, pruritus, hyperkeratosis, erythema, palmarplantar erythrodysaesthesia syndrome, alopecia, dry skin, sunburn
Bolezni kože in podkožja fotosenzibilna reakcija, aktinična keratoza, kožni izpuščaj, makulopapulozen izpuščaj, srbenje, hiperkeratoza, eritem, sindrom palmarno-plantarne eritrodisestezije, alopecija, suha koža, sončne opekline papulozen izpuščaj, panikulitis (vključno z nodoznim eritemom), pilarna keratoza toksična epidermalna nekroliza
7th nerve paralysis, neuropathy peripheral
Presnovne in prehranske motnje zmanjšanje teka Bolezni živčevja glavobol, disgevzija, omotica ohromelost sedmega živca, periferna nevropatija
The bioavailability at steady state ranged between 32 and 115% (mean 64%) relative to an intravenous microdose, in a phase I study with uncontrolled food conditions in 4 patients with BRAF V600 positive malignancies.
Biološka uporabnost v stanju dinamičnega ravnovesja je bila v študiji faze I brez nadzorovanih pogojev vnosa hrane pri 4 bolnikih z BRAF V600-pozitivnimi malignostmi glede na intravenski mikroodmerek v območju med 32 in 115 % (povprečno 64 %).
Very common (may affect more than 1 in 10 people):
Zelo pogosti neželeni učinki (pojavijo se pri več kot 1 od 10 bolnikov):
In the non-compartmental analysis, after dosing with 960 mg vemurafenib twice daily the Day 15 / Day 1 ratio ranged from 15- to 17-fold for AUC, and 13to 14-fold for Cmax, yielding AUC0-8h and Cmax of 380.2 ± 143.6 µg⋅h/mL and 56.7 ± 21.8 µg/mL, respectively, under steady-state conditions.
V nerazdelčni analizi, po odmerkih 960 mg vemurafeniba dvakrat na dan, je bilo razmerje dan 15/dan 1 med 15 do 17 za AUC in 13 do 14 za Cmax.
Hypersensitivity reaction
Preobčutljivostne reakcije
Dose reduction and/or additional drug level monitoring for P-gp substrate medicinal products with narrow therapeutic index (NTI) (e.g. digoxin, dabigatran etexilate, aliskiren) may be considered if these medicinal products are used concomitantly with vemurafenib (see section 4.5).
Če zdravila, ki so substrati P-gp in imajo ozko terapevtsko okno (npr. digoksin, dabigatran eteksilat, aliskiren), uporabljamo skupaj z vemurafenibom, se lahko razmisli o zmanjšanju odmerka in/ali dodatnem spremljanju koncentracije zdravila (glejte poglavje 4.5).
Electrocardiogram (ECG) and electrolytes (including magnesium) must be monitored in all patients before treatment with vemurafenib, after one month of treatment and after dose modification.
Pred zdravljenjem z vemurafenibom, en mesec po zdravljenju in po spremembi odmerka je treba pri vseh bolnikih posneti elektrokardiogram (EKG) in kontrolirati elektrolite (vključno z magnezijem).
The prescriber should examine the patient monthly during and up to six months after treatment for cuSCC.
Med zdravljenjem in do šest mesecev po zdravljenju ploščatoceličnega karcinoma mora zdravnik enkrat mesečno pregledati bolnika.
Liver injury, including cases of severe liver injury, has been reported with vemurafenib (see section 4.8).
Med uporabo vemurafeniba so poročali o poškodbah jeter, vključno s primeri hudih poškodb (glejte poglavje 4.8).
Anal examinations and pelvic examinations (for women) are recommended before and at the end of treatment or when considered clinically indicated.
Pred in po končanem zdravljenju ali kadar je klinično indicirano, je priporočljivo opraviti pregled zadnjika in ginekološki pregled (pri ženskah).
Renal toxicity, ranging from serum creatinine elevations to acute interstitial nephritis and acute tubular necrosis, has been reported with vemurafenib.
Med uporabo vemurafeniba so poročali o ledvični toksičnosti v razponu od zvišanega serumskega kreatinina do akutnega intersticijskega nefritisa in akutne tubulne nekroze.
Concurrent administration with ipilimumab
Sočasno dajanje ipilimumaba
Patients should undergo a head and neck examination, consisting of at least a visual inspection of oral mucosa and lymph node palpation prior to initiation of treatment and every 3 months during treatment.
Bolnikom je treba pred uvedbo zdravljenja in na 3 mesece med zdravljenjem pregledati glavo in vrat (pregled mora obsegati vsaj ogled ustne sluznice in palpacijo bezgavk).
Fatigue, pyrexia, oedema peripheral, asthenia
Splošne težave in spremembe na mestu aplikacije utrujenost, pireksija, periferni edem, astenija
Uncommon (may affect up to 1 in 100 people):
Občasni neželeni učinki (pojavijo se lahko pri največ 1 od 100 bolnikov):
Zelboraf has side effects that can affect your ability to drive or to operate machines.
Vpliv na sposobnost upravljanja vozil in strojev Zdravilo Zelboraf ima neželene učinke, ki lahko vplivajo na sposobnost upravljanja vozil in strojev.
Cases reported include recall phenomenon, radiation skin injury, radiation pneumonitis, radiation esophagitis, radiation proctitis, radiation hepatitis, cystitis radiation, and radiation necrosis.
Primeri, o katerih so poročali, vključujejo vnetne reakcije na mestu obsevanja (t.i. recall phenomenon), poškodbe kože zaradi obsevanja, pnevmonitis zaradi obsevanja, ezofagitis zaradi obsevanja, proktitis zaradi obsevanja, hepatitis zaradi obsevanja, cistitis zaradi obsevanja in nekrozo zaradi obsevanja.
Following oral dosing, the absorption rate constant for the population of metastatic melanoma patients is estimated to be 0.19 hr-1 (with 101% between patient variability).
Po peroralni uporabi je ocenjena konstanta hitrosti absorpcije za populacijo bolnikov z metastatskim melanomom 0,19 h-1
Concomitant use of vemurafenib with agents metabolized by CYP1A2 and CYP3A4 with narrow therapeutic windows is not recommended.
Sočasna uporaba vemurafeniba z učinkovinami z ozkim terapevtskim oknom, ki se presnavljajo prek CYP1A2 ali CYP3A4, ni priporočljiva.
Before taking vemurafenib, patients must have BRAF V600 mutation-positive tumour status confirmed by a validated test.
Pred uporabo vemurafeniba je treba z validirano preiskavo potrditi, da ima bolnik tumor s pozitivno mutacijo BRAF V600.
Limited data are available in patients with hepatic impairment.
O bolnikih z okvaro ledvic je na voljo malo podatkov.
MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
PROIZVAJALEC, ODGOVOREN ZA SPROŠČANJE SERIJ
Exposure-dependent QT prolongation was observed in an uncontrolled, open-label phase II study in previously treated patients with metastatic melanoma (see section 4.8).
V nekontrolirani, odprti študiji faze II pri predhodno zdravljenih bolnikih z metastatskim melanomom, so opazili podaljšanje intervala QT, odvisnega od izpostavljenosti vemurafenibu (glejte poglavje 4.8).
Carefully consider benefits and risks before administering vemurafenib to patients with a prior or concurrent cancer associated with RAS mutation.
Pred dajanjem vemurafeniba bolnikom, ki so imeli ali imajo raka, povezanega z mutacijo RAS, skrbno razmislite o koristih in tveganjih.
Stage MIC
Stadij M1c
Dose modified for acute kidney injury
Bolezni sečil akutni intersticijski nefritis
Discontinue permanently.
Dokončno prenehajte z zdravljenjem.
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS UNIT DOSE PERFORATED BLISTER
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
Mechanism of action and pharmacodynamic effects Vemurafenib is an inhibitor of BRAF serine-threonine kinase.
Vemurafenib je zaviralec BRAF serin-treonin kinaze.
Most patients were male (56%) and Caucasian (99%), the median age was 54 years (24% were ≥ 65 years), all patients had ECOG performance status of 0 or 1, and the majority of patients had stage M1c disease (65%).
Vsi bolniki so imeli stanje zmogljivosti po ECOG 0 ali 1 in večina bolnikov je imela stadij bolezni M1c (65 %).
In vitro studies suggest that CYP3A4 metabolism and glucuronidation are responsible for the metabolism of vemurafenib.
Vplivi sočasno uporabljenih zdravil na vemurafenib Študije in vitro kažejo, da sta presnova s CYP3A4 in glukuronidacija odgovorni za presnovo vemurafeniba.
● Inflammation of joints
Zvišanje jetrnih encimov
Number of deaths
ŠTEVILKA SERIJE
N
d
Exercise caution and consider additional INR (international normalized ratio) monitoring when vemurafenib is used concomitantly with warfarin (see section 4.4).
Pri sočasnem dajanju varfarina in vemurafeniba sta potrebna previdnost in razmislek o opravljanju dodatnih meritev INR (mednarodno umerjeno razmerje) (glejte poglavje 4.4).
● Inflammation of the fatty tissue under the skin
• vnetje podkožnega maščobnega tkiva,
Vemurafenib is a Class IV substance (low solubility and permeability), using the criteria described in the Biopharmaceutics Classification System.
Glede na biofarmacevtski klasifikacijski sistem (Biopharmaceutics Classification System) spada vemurafenib v razred IV (nizka topnost in permeabilnost).
pancreatic adenocarcinoma
zvišana alkalna fosfataza
Non-Cutaneous Squamous Cell Carcinoma (non-cuSCC) Cases of non-cuSCC have been reported in clinical trials where patients received vemurafenib.
Pri bolnikih, ki so prejemali vemurafenib v kliničnih preskušanjih, so poročali o primerih ploščatoceličnega karcinoma, ki se ne nahaja na koži.
Vemurafenib is absorbed with a median Tmax of approximately 4 hours following a single 960 mg dose (four 240 mg tablets).
Po uporabi enkratnega 960-mg odmerka (štirih 240-mg tablet) se vemurafenib absorbira z mediano tmax približno 4 ure.
Number of events (%) Median PFS (months) (95% CI)
DORc v možganih (n) mediana (meseci) (95-% IZ)
Serious hypersensitivity reactions, including anaphylaxis have been reported in association with vemurafenib.
V povezavi z vemurafenibom so poročali o resnih preobčutljivostnih reakcijah, vključno z anafilaksijo.
Cases of cuSCC have been reported in patients treated with vemurafenib.
Pri bolnikih, zdravljenih z vemurafenibom, so poročali o primerih ploščatoceličnega karcinoma kože.
QTc increase meets values of both >500 ms and >60 ms change from pre-treatment values
Zvišanje intervala QTc na > 500 ms in sprememba intervala za > 60 ms od vrednosti pred zdravljenjem
● Inflammation of blood vessels
• vnetje krvnih žil,
Cough
GGT
alkaline phosphatase increased (c), AST increased (c),bilirubin increased (c) GGT increased (c, weight decreased, electrocardiogram QT prolonged, blood creatinine increased(1)(2) (h)
, izguba telesne mase, podaljšan QT na elektrokardiogramu, zvišan kreatinin v krvi
Arthralgia, myalgia, pain in extremity, musculoskeletal pain, back pain
Bolezni mišičnoskeletnega sistema in vezivnega tkiva artralgija, mialgija, bolečina v okončini, mišičnoskeletne bolečine, bolečine v hrbtu artritis fibromatoza plantarne fascije
● Dizziness
, zvišana
Consider additional drug level monitoring for P-gp substrate medicinal products with a narrow therapeutic index (NTI) (e.g. digoxin, dabigatran etexilate, aliskiren) (see section 4.4).
Pri uporabi zdravil, ki so substrati P-gp in imajo ozko terapevtsko okno (npr. digoksina, dabigatran eteksilata, aliskirena), je treba razmisliti o dodatnem spremljanju koncentracije zdravila (glejte poglavje 4.4).
Non-Caucasian patients
Bolniki, ki niso bele rase
Infections and infestations
Infekcijske in parazitske bolezni folikulitis
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 240 mg of vemurafenib (as a co-precipitate of vemurafenib and hypromellose acetate succinate).
Ena filmsko obložena tableta vsebuje 240 mg vemurafeniba (v obliki precipitata vemurafeniba in hipromeloze acetat sukcinata).
● Changes in the way things taste
• spremenjeno zaznavanje okusov,
Patients who develop adverse reactions should receive appropriate symptomatic treatment.
Specifičnega antidota za preveliko odmerjanje vemurafeniba ni. Bolniki, pri katerih se pojavijo neželeni učinki, morajo biti deležni ustreznega simptomatskega zdravljenja.
QTc>500 ms at baseline
Interval QTc > 500 ms pred pričetkom zdravljenja
Exposure-dependent QT prolongation was observed in an uncontrolled, open-label phase II study in previously treated patients with metastatic melanoma.
V nekontrolirani, odprti študiji faze II pri predhodno zdravljenih bolnikih z metastatskim melanomom so opazili podaljšanje intervala QT, odvisnega od izpostavljenosti vemurafenibu.
Focal bone marrow necrosis was noted in one dog in a prematurely terminated 39-week BID dog study at exposures similar to the anticipated clinical exposure (based on AUC comparisons).
V predčasno končani 39-tedenski študiji uporabe dvakrat na dan pri psih so ob izpostavljenostih, ki so bile podobne predvideni klinični izpostavljenosti (na podlagi primerjave AUC), pri enem psu opazili fokalno nekrozo kostnega mozga.
Exercise caution and consider additional INR (International Normalised Ratio) monitoring when vemurafenib is used concomitantly with warfarin.
Ob sočasnem dajanju varfarina in vemurafeniba sta potrebna previdnost in razmislek o opravljanju dodatnih meritev INR (mednarodno umerjeno razmerje).
Vascular disorders
Žilne bolezni vaskulitis
OTHER
zelboraf
● Inflammation of the eye (uveitis)
• očesno vnetje (uveitis),
Caution should be exercised when dosing vemurafenib concurrently with P-gp substrates.
Pri sočasnem odmerjanju vemurafeniba s substrati P-gp je potrebna previdnost.
● Feeling tired (fatigue)
• utrujenost,
2nd occurrence of QTc>500 ms during treatment and change from pre-treatment value remains <60 ms
2. pojav intervala QTc > 500 ms med zdravljenjem, sprememba intervala pa ostane < 60 ms od vrednosti pred zdravljenjem
Acute kidney injury cases*
Akutne poškodbe ledvic
● Joint or muscle pain, musculoskeletal pain
• bolečine v sklepih ali mišicah, bolečine v kosteh in mišicah,
3rd occurrence of QTc>500 ms during treatment and change from pre-treatment value remains <60 ms
3. pojav intervala QTc > 500 ms med zdravljenjem, sprememba intervala pa ostane < 60 ms od vrednosti pred zdravljenjem