FrancophonIA/ELRC3.0 huggingface dataset:
English: Carcinogenicity studies have not been conducted with cobimetinib.
Slovenian: Študij kancerogenosti s kobimetinibom niso izvedli.
English: Cobimetinib is the predominant moiety in plasma.
Slovenian: Kobimetinib je prevladujoča snov v plazmi.
English: The proportion of patients experiencing adverse events (AE) was similar in the patients aged <65 years and those aged ³65 years.
Slovenian: Delež bolnikov, ki so se jim pojavili neželeni učinki, je bil med mlajšimi od 65 let podoben kot med starimi 65 let ali več.
English: Baseline age and baseline body weight were identified as statistically significant covariates on cobimetinib clearance and volume of distribution respectively.
Slovenian: Izhodiščna starost in izhodiščna telesna masa sta se izkazali za statistično značilni sospremenljivki, kar zadeva očistek kobimetiniba in njegov volumen porazdelitve.
English: If you take more Cotellic than you should, talk to a doctor straight away.
Slovenian: Če ste vzeli večji odmerek zdravila Cotellic, kot bi smeli Če ste vzeli večji odmerek zdravila Cotellic, kot bi smeli, se takoj posvetujte z zdravnikom.
English: When administered to pregnant rats, cobimetinib caused embryolethality and foetal malformations of the great vessels and skull at systemic exposures similar to human exposure at recommended dose.
Slovenian: Pri brejih podganah uporabljeni kobimetinib je povzročil smrtnost zarodkov in malformacije velikih žil in lobanje pri sistemskih izpostavljenostih, ki so bile podobne kot pri človeku ob priporočenem odmerku.
English: For Grade 1 and 2 liver laboratory abnormalities, Cotellic and vemurafenib should be continued at the prescribed dose.
Slovenian: V primeru jetrnih laboratorijskih odstopanj stopenj 1 in 2 je treba zdravljenje z zdravilom Cotellic in vemurafenibom nadaljevati v predpisanem odmerku.
English: Table 3 Adverse drug reactions in patients treated with Cotellic in combination with vemurafenib in Study GO28141^
Slovenian: Neželeni učinki pri bolnikih, zdravljenih z zdravilom Cotellic v kombinaciji z vemurafenibom, v študiji GO28141^
English: * Please refer to the paragraph Haemorrhage in the “Description of selected adverse reactions” section ** Please refer to the paragraph Cutaneous squamous cell carcinoma, keratoacanthoma and hyperkeratosis in the “Description of selected adverse reactions” section.
Slovenian: ** Glejte odstavek Ploščatocelični karcinom kože, keratoakantom in hiperkeratoza v poglavju "Opis izbranih neželenih učinkov".
English: In the preclinical models, the combination of cobimetinib and vemurafenib showed that by simultaneously targeting mutated BRAF V600 proteins and MEK proteins in melanoma cells, the combination of the two products inhibits MAPK pathway reactivation through MEK1/2, resulting in a stronger inhibition of intracellular signalling and decreased tumour cell proliferation
Slovenian: Predklinični modeli so pokazali, da kombinacija kobimetiniba in vemurafeniba s sočasnim delovanjem na mutirane beljakovine BRAF V600 in beljakovine MEK v melanomskih celicah zavre reaktivacijo poti MAPK z MEK1/2 in tako močneje zavre znotrajcelično signalizacijo in zmanjša proliferacijo tumorskih celic.
English: Grade 4: Cotellic treatment should be interrupted.
Slovenian: Stopnja 4: zdravljenje z zdravilom Cotellic je treba prekiniti.
English: Strong CYP3A inhibitors include, but are not limited to ritonavir,
Slovenian: Med močne zaviralce CYP3A spadajo na primer ritonavir,
English: If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before taking Cotellic.
Slovenian: Če kaj od naštetega velja za vas (ali če ste negotovi), se pred začetkom jemanja zdravila Cotellic posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: If you forget to take Cotellic · If it is more than 12 hours before your next dose, take the missed dose as soon as you remember.
Slovenian: • Če je do naslednjega odmerka več kot 12 ur, vzemite pozabljeni odmerek takoj, ko se spomnite.
English: Women of childbearing potential should use two effective methods of contraception, such as a condom or other barrier method (with spermicide, if available) during treatment and for at least 3 months after treatment has finished.
Slovenian: Ženske v rodni dobi morajo med zdravljenjem in vsaj še 3 mesece po koncu zdravljenja uporabljati dva učinkovita načina kontracepcije, na primer kondom ali kakšno drugo pregradno metodo (s spermicidom, če je na voljo).
English: Toxicity studies in rats and dogs identified generally reversible degenerative changes in the bone marrow, gastrointestinal tract, skin, thymus, adrenal gland, liver, spleen, lymph node, kidney, heart, ovary, and vagina at plasma exposures below clinical efficacious levels.
Slovenian: Študije toksičnosti pri podganah in psih so pokazale na splošno reverzibilne degenerativne spremembe v kostnem mozgu, prebavilih, koži, timusu, nadledvičnih žlezah, jetrih, vranici, bezgavkah, ledvicah, srcu, jajčnikih in nožnici pri plazemski izpostavljenosti, nižji od klinično učinkovite.
English: A human mass balance study was conducted in healthy subjects, and showed that cobimetinib was extensively metabolised and eliminated in faeces.
Slovenian: Pri zdravih osebah so opravili študijo masnega ravnovesja, ki je pokazala, da se pri človeku kobimetinib izdatno presnavlja in izloča z blatom.
English: Grade ≤3: After rhabdomyolysis has been ruled out, Cotellic dosing does not need to be modified.
Slovenian: Stopnja ≤ 3: po izključitvi rabdomiolize odmerjanja zdravila Cotellic ni treba prilagoditi.
English: Grade 3 liver laboratory abnormalities should be managed with vemurafenib treatment interruption or dose reduction.
Slovenian: Laboratorijska odstopanja stopnje 3 je treba obvladati s prekinitvijo uporabe vemurafeniba ali zmanjšanjem odmerka.
English: Cotellic is indicated for use in combination with vemurafenib for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation (see sections 4.4 and 5.1).
Slovenian: Zdravilo Cotellic je v kombinaciji z vemurafenibom indicirano za zdravljenje odraslih bolnikov z neoperabilnim ali metastatskim melanomom, ki ima mutacijo BRAF V600 (glejte poglavji 4.4 in 5.1).
English: What you need to know before you take Cotellic 3.
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Cotellic Kako jemati zdravilo Cotellic
English: · Do not take this medicine after the expiry date which is stated on the blister and the carton after EXP.
Slovenian: • Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na pretisnem omotu in škatli poleg oznake EXP/Uporabno do. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
English: If Grade ≥3 diarrhoea recurs, the dose of Cotellic and vemurafenib should be reduced (see section 4.2).
Slovenian: Če se driska stopnje ≥ 3 ponovi, je treba odmerek zdravila Cotellic in vemurafeniba zmanjšati (glejte poglavje 4.2).
English: Women of childbearing potential should be advised to use two effective contraceptive methods, such as a condom or other barrier method (with spermicide, if available) during treatment with Cotellic and for at least three months following treatment discontinuation.
Slovenian: Ženskam v rodni dobi je treba naročiti, da morajo med zdravljenjem z zdravilom Cotellic in vsaj še 3 mesece po prenehanju zdravljenja uporabljati dva učinkovita načina kontracepcije, npr. kondom ali drugo pregradno metodo (s spermicidom, če je na voljo).
English: Interrupt treatment until Grade ≤ 1, restart treatment at 40 mg once daily (2 tablets)
Slovenian: Prekinite zdravljenje, dokler ni neželeni učinek stopnje ≤ 1, in znova začnite zdravljenje s 40 mg enkrat na dan (2 tableti).
English: NAME OF THE MEDICINAL PRODUCT Cotellic 20 mg film-coated tablets
Slovenian: IME ZDRAVILA Cotellic 20 mg filmsko obložene tablete
English: Cotellic dosing can be continued without modification.
Slovenian: Zdravilo Cotellic je mogoče še naprej uporabljati brez prilagoditve.
English: The median time to first onset was 6.1 months in the Cotellic plus vemurafenib arm.
Slovenian: Mediana časa do prvega pojava je bila v skupini z zdravilom Cotellic in vemurafenibom 6,1 meseca.
English: Patients with severe hepatic impairment may have increased plasma concentrations of unbound cobimetinib compared to patients with normal hepatic function (see section 5.2).
Slovenian: Bolniki s hudo okvaro jeter imajo lahko v primerjavi z bolniki z normalnim delovanjem jeter zvečane koncentracije prostega kobimetiniba v plazmi (glejte poglavje 5.2).
English: Liver laboratory tests should be monitored before initiation of combination treatment and monthly during treatment, or more frequently if clinically indicated (see section 4.2).
Slovenian: Laboratorijske preiskave jeter je treba kontrolirati pred uvedbo kombiniranega zdravljenja in vsak mesec med zdravljenjem oziroma pogosteje, če je klinično primerno (glejte poglavje 4.2).
English: Vemurafenib dosing should be reduced as clinically appropriate, please refer to its SmPC for further information.
Slovenian: Odmerjanje vemurafeniba je treba zmanjšati, kot je klinično primerno; za dodatne informacije glejte povzetek glavnih značilnosti vemurafeniba.
English: Significant improvement in OS was observed in patients assigned to the Cotellic plus vemurafenib arm compared to the placebo plus vemurafenib arm (Figure 1).
Slovenian: Pomembno izboljšanje v celokupnem preživetju so opazili pri bolnikih, dodeljenih v skupino, ki je prejemala zdravilo Cotellic in vemurafenib, v primerjavi s skupino, ki je prejemala placebo in vemurabenib (slika 1).
English: Interrupt treatment until Grade ≤ 1, restart treatment at 20 mg once daily (1 tablet)
Slovenian: Prekinite zdravljenje, dokler ni neželeni učinek stopnje ≤ 1, in znova začnite zdravljenje z 20 mg enkrat na dan (1 tableta).
English: Film-coated tablet.
Slovenian: FARMACEVTSKA OBLIKA Filmsko obložena tableta.
English: Only patients with ECOG performance status 0 and 1 were enrolled in Study GO28141.
Slovenian: V študijo GO28141 so bili vključeni samo bolniki s stanjem zmogljivosti po ECOG 0 in 1.
English: Following oral dosing of 60 mg in cancer patients, cobimetinib showed a moderate rate of absorption with a median Tmax of 2.4 hours.
Slovenian: Po peroralnem odmerku 60 mg pri onkoloških bolnikih je bila hitrost absorpcije kobimetiniba zmerna in mediana tmax je bila 2,4 ure.
English: If rhabdomyolysis is diagnosed, Cotellic treatment should be interrupted and CPK levels and other symptoms monitored until resolution.
Slovenian: V primeru diagnoze rabdomiolize je treba zdravljenje z zdravilom Cotellic prekiniti ter koncentracijo CPK in druge simptome spremljati do izboljšanja.
English: Diarrhoea, Nausea, Vomiting
Slovenian: Bolezni prebavil driska, navzea, bruhanje
English: · Muscle problems
Slovenian: • Težave z mišicami
English: Given that cobimetinib concentrations are likely to be significantly reduced when co-administered with moderate to strong CYP3A inducers, patient's efficacy may be compromised.
Slovenian: Ker se med sočasno uporabo zmernih do močnih induktorjev CYP3A koncentracija kobimetiniba verjetno bistveno zmanjša, se lahko njegova učinkovitost pri bolniku poslabša.
English: Tell your doctor straight away if you get the following symptoms: blurred vision, distorted vision, partly missing vision, or any other changes to your sight during treatment.
Slovenian: Takoj obvestite zdravnika, če se vam med zdravljenjem pojavi kateri od naslednjih simptomov: zamegljen vid, popačen vid, delni izpad vida ali kakršne koli druge spremembe vida.
English: If during treatment the QTc exceeds 500 msec, please refer to the vemurafenib SmPC (section 4.2) for dose modifications for vemurafenib.
Slovenian: Če interval QTc med zdravljenjem preseže 500 ms, prosimo, glejte povzetek glavnih značilnosti vemurafeniba (poglavje 4.2) za prilagoditev odmerkov vemurafeniba.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use
Slovenian: POSTOPEK IN POT(I) UPORABE ZDRAVILA Pred uporabo preberite priloženo navodilo Peroralna uporaba
English: If a dose is missed, it can be taken up to 12 hours prior to the next dose to maintain the once-daily regimen.
Slovenian: Izpuščeni odmerki Če bolnik izpusti odmerek, ga lahko vzame do 12 ur pred naslednjim odmerkom, da ohrani shemo enkrat na dan. Bruhanje
English: Patients ≥65 years were more likely to experience serious adverse events (SAEs) and experience AEs leading to discontinuation of cobimetinib than those <65 years.
Slovenian: Bolniki, stari 65 let ali več, so imeli večjo verjetnost za resne neželene učinke in za neželene učinke, ki so povzročili prenehanje zdravljenja s kobimetinibom, kot bolniki, mlajši od 65 let.
English: absolute decrease from baseline)
Slovenian: absolutno zmanjšanje od izhodišča)
English: ^ Data cut-off date of 19 September 2014
Slovenian: 20. november 2015
English: Tell your doctor straight away if you get any of these symptoms: muscle aches, muscle spasms, weakness, or dark- or redcoloured urine.
Slovenian: Takoj obvestite zdravnika, če opazite katerega koli od navedenih simptomov: bolečine v mišicah, mišični krči, šibkost in temno ali rdeče obarvan urin.
English: Grade 2 (intolerable) or Grade ≥3 non-acneiform or maculopapular rash: Cotellic dosing can be continued without modification if clinically indicated.
Slovenian: Neakneiformen ali makulopapulozen izpuščaj stopnje 2 (neznosen) ali stopnje ≥ 3: Uporabo zdravila Cotellic je mogoče nadaljevati brez prilagoditve, če je klinično primerno.
English: Vemurafenib dosing may be either temporarily interrupted and/or reduced, please refer to its SmPC for further information.
Slovenian: Odmerjanje vemurafeniba je mogoče ali začasno prekiniti ali zmanjšati; za dodatne informacije glejte povzetek glavnih značilnosti vemurafeniba.
English: Signs or symptoms of rhabdomyolysis warrant an appropriate clinical evaluation and treatment as indicated, along with Cotellic dose modification or discontinuation according to the severity of the adverse reaction (see section 4.2 and 4.4).
Slovenian: Znaki ali simptomi rabdomiolize zahtevajo ustrezno klinično oceno in zdravljenje, kot je indicirano, skupaj s prilagoditvijo odmerka ali prekinitvijo zdravljenja z zdravilom Cotellic, odvisno od izrazitosti neželenega učinka (glejte poglavji
English: Liver laboratory abnormalities can occur with Cotellic and caution should be used in patients with any degree of hepatic impairment (see section 4.4).
Slovenian: Pri zdravljenju z zdravilom Cotellic se lahko pojavijo z jetri povezane laboratorijske nepravilnosti, zato je treba pri bolnikih z okvaro jeter katere koli stopnje zdravilo uporabljati previdno (glejte poglavje 4.4).
English: No dose adjustment is recommended in patients with hepatic impairment (see section 5.2).
Slovenian: Bolnikom z okvaro jeter odmerka ni treba prilagoditi (glejte poglavje 5.2).
English: · Start your next Cotellic 21 day treatment period after the 7 day break.
Slovenian: • Po 7 dneh premora začnite naslednje 21-dnevno obdobje zdravljenja z zdravilom Cotellic.
English: Grade 2 (intolerable) or Grade ≥3 photosensitivity: Cotellic and vemurafenib should be interrupted until resolution to Grade ≤1.
Slovenian: Fotosenzibilnost stopnje 2 (neznosna) ali stopnje ≥ 3: zdravili Cotellic in vemurafenib je treba prekiniti, dokler se ne zmanjša na stopnjo ≤ 1.
English: There are minimal data for Cotellic in patients with severe renal impairment.
Slovenian: Podatkov o zdravilu Cotellic za bolnike s hudo okvaro ledvic je zelo malo.
English: Study GO28141 is a multi-centre, randomised, double-blind, placebo-controlled, Phase III study to evaluate the safety and efficacy of Cotellic in combination with vemurafenib as compared to vemurafenib plus placebo, in previously untreated patients with BRAF V600 mutation-positive unresectable locally advanced (Stage IIIc) or metastatic melanoma (Stage IV).
Slovenian: Študija GO28141 je bila multicentrična, randomizirana, dvojno slepa, s placebom kontrolirana študija faze III za oceno varnosti in učinkovitosti zdravila Cotellic v kombinaciji z vemurafenibom v primerjavi s kombinacijo vemurafeniba in placeba pri predhodno nezdravljenih bolnikih z neoperabilnim, lokalno napredovalim (stadij IIIc) ali metastatskim (stadij IV) melanomom z mutacijo BRAF V600.
English: Grade 3 and 4 CPK elevations, including asymptomatic elevations over baseline, also occurred in patients receiving Cotellic with vemurafenib in clinical trials (see section 4.8).
Slovenian: Zvišanja CPK stopnje 3 ali 4, vključno z nesimptomatskimi zvišanji nad izhodiščno vrednost, so se pojavila tudi pri bolnikih, ki so v kliničnih preskušanjih prejemali zdravilo Cotellic v kombinaciji z vemurabenibom (glejte poglavje 4.8).
English: Dose limiting toxicities included skin ulcerations, surface exudates, and acanthosis in the rat and chronic active inflammation and degeneration of the oesophagus associated with varying degrees of gastroenteropathy in dogs.
Slovenian: Med toksičnimi učinki, ki so omejili odmerek, so bile kožne razjede, eksudati na površini in akantoza pri podganah, pri psih pa kronično aktivno vnetje in degeneracija požiralnika, povezana z različnimi stopnjami gastroenteropatije.
English: There is no experience with overdose in human clinical trials.
Slovenian: V kliničnih preskušanjih pri človeku ni bilo izkušenj s prevelikim odmerjanjem.
English: Oxidation by CYP3A and glucuronidation by UGT2B7 appear to be the major pathways of cobimetinib metabolism.
Slovenian: Kot kaže, sta glavni poti presnove kobimetiniba oksidacija s CYP3A in glukuronidacija z UGT2B7.
English: Table 4 Liver function and other laboratory tests observed in the Phase III Study GO28141
Slovenian: Preiskave delovanja jeter in druge laboratorijske preiskave v študiji faze III
English: If during treatment the QTc exceeds 500 msec, please refer to the vemurafenib SmPC sections 4.2 and
Slovenian: Če interval QTc med zdravljenjem preseže 500 ms, prosimo, glejte poglavji 4.2 in 4.4 povzetka glavnih značilnosti vemurafeniba.
English: How to take Cotellic
Slovenian: Kako jemati zdravilo Cotellic
English: In vitro, cobimetinib is a moderate inhibitor of BCRP (Breast Cancer Resistance Protein).
Slovenian: Substrati BCRP In vitro kobimetinib zmerno zavira BCRP (Breast Cancer Resistance Protein).
English: Dehydration, Hypophosphataemia, Hyponatremia, Hyperglycaemia
Slovenian: Presnovne in prehranske motnje dehidracija, hipofosfatemija, hiponatriemija, hiperglikemija
English: Results of the BRAFi naïve population from Study NO25395 were generally consistent with those from Study GO28141.
Slovenian: V študiji NO25395 so se rezultati populacije, še nezdravljene z BRAFi, na splošno ujemali s tistimi v študiji GO28141.
English: Liver function test Increased ALP
Slovenian: Preiskave delovanja jeter Zvišanje AF
English: Progression-free survival (PFS) as assessed by the investigator (INV) was the primary endpoint.
Slovenian: Primarni opazovani dogodek je bilo preživetje brez napredovanja bolezni (PFS, progresion-free survival) po oceni raziskovalca (INV, investigator).
English: For Grade ≥3 diarrhoea that occurs despite supportive care, Cotellic and vemurafenib should be withheld until diarrhoea has improved to Grade ≤1.
Slovenian: V primeru driske stopnje ≥ 3, ki se pojavi kljub podpornemu zdravljenju, je treba obe zdravili, Cotellic in vemurafenib, prekiniti, dokler se driska ne izboljša na stopnjo ≤ 1.
English: Cotellic can lower the amount of blood pumped by your heart (see also “Heart problems” in Section 4).
Slovenian: • Težave s srcem Zdravilo Cotellic lahko zmanjša količino krvi, ki jo prečrpa srce (glejte tudi "Težave s srcem" v poglavju 4).
English: One event of rhabdomyolysis was observed in each treatment arm of the study with concurrent increases in blood CPK.
Slovenian: V obeh skupinah v študiji so zabeležili po en primer rabdomiolize s sočasnim zvišanjem CPK v krvi.
English: Table 2 Recommended dose modifications for Cotellic in patients with left ventricular ejection fraction (LVEF) decrease from baseline
Slovenian: Priporočene prilagoditve odmerka zdravila Cotellic pri bolnikih z zmanjšanjem iztisnega deleža levega prekata (LVEF) v primerjavi z izhodiščem
English: Neoplasms benign, malignant and unspecified (incl.
Slovenian: Benigne, maligne in neopredeljene neoplazme (vključno s cistami in polipi)
English: There is no data on the effectiveness of Cotellic dose modification for haemorrhage events.
Slovenian: O učinkovitosti prilagoditve odmerka zdravila Cotellic pri krvavitvah ni podatkov.
English: Name and address of the manufacturer responsible for batch release
Slovenian: Ime in naslov izdelovalca (izdelovalcev), odgovornega (odgovornih) za sproščanje serij Roche Pharma AG
English: cobicistat, telaprevir, lopinavir, itraconazole, voriconazole, clarithromycin, telithromycin, posaconazole, nefazodone and grapefruit juice.
Slovenian: kobicistat, telaprevir, lopinavir, itrakonazol, vorikonazol, klaritromicin, telitromicin, posakonazol,
English: Before starting this treatment, patients must have BRAF V600 mutation-positive melanoma tumour status confirmed by a validated test (see sections 4.4 and 5.1).
Slovenian: Pred začetkom zdravljenja je treba z validirano preiskavo potrditi, da ima bolnik melanom z mutacijo BRAF V600 (glejte poglavji 4.4 in 5.1).
English: When cobimetinib is co-administered with a moderate CYP3A inhibitor, patients should be carefully monitored for safety.
Slovenian: Če se kobimetinib uporablja sočasno z zmernim zaviralcem CYP3A, je treba bolnike skrbno nadzirati glede varnosti.
English: No evidence of phototoxicity was observed with Cotellic as a single agent.
Slovenian: Med uporabo zdravila Cotellic kot edinega zdravila niso zabeležili fototoksičnosti.
English: No formal pharmacokinetic study has been conducted in patients with renal impairment.
Slovenian: Formalnih farmakokinetičnih študij pri bolnikih z okvaro ledvic niso izvedli.
English: What Cotellic looks like and contents of the pack Cotellic film-coated tablets are white, round with “COB” debossed on one side.
Slovenian: Zdravilo Cotellic filmsko obložene tablete so bele, okrogle tablete, ki imajo na eni strani vtisnjeno oznako "COB".
English: If severity is improved by at least one grade within 4 weeks, Cotellic could be restarted at a dose reduced by 20 mg, if clinically indicated.
Slovenian: Če se izrazitost zmanjša vsaj za eno stopnjo v 4 tednih, lahko zdravljenje z zdravilom Cotellic ponovno uvedete v odmerku, zmanjšanem za 20 mg, če je klinično indicirano.
English: Mild CYP3A inhibitors: Cobimetinib can be co-administered with mild inhibitors of CYP3A without dose adjustment.
Slovenian: Blagi zaviralci CYP3A: Z blagimi zaviralci CYP3A je mogoče kobimetinib uporabiti brez prilagoditve odmerka.
English: Depending on the severity of symptoms or CPK elevation; treatment interruption, dose reduction or treatment discontinuation may be required (see section 4.2).
Slovenian: Odvisno od izrazitosti simptomov ali zvišanja CPK je lahko potrebna prekinitev zdravljenja, zmanjšanje odmerka ali prenehanje zdravljenja (glejte poglavje 4.2).
English: Dose modification advice for left ventricular dysfunction Permanent discontinuation of Cotellic treatment should be considered if cardiac symptoms are attributed to Cotellic and do not improve after temporary interruption.
Slovenian: Nasvet za prilagoditev odmerka v primeru disfunkcije levega prekata Če so srčni simptomi posledica zdravila Cotellic in se po prehodni prekinitvi njegove uporabe ne izboljšajo, je treba razmisliti o trajnem prenehanju zdravljenja z zdravilom Cotellic.
English: Special populations Elderly patients
Slovenian: Posebne populacije bolnikov
English: Assessed and confirmed by the investigator (INV) using RECIST v1.1 b Stratified analysis by geographic region and metastasis classification (disease stage)
Slovenian: a Ocenil in potrdil raziskovalec (INV) z uporabo RECIST v 1.1.
English: Dose modification advice for Cotellic when used with vemurafenib Liver laboratory abnormalities
Slovenian: Nasvet za prilagoditev odmerka zdravila Cotellic med uporabo z vemurafenibom Jetrna laboratorijska odstopanja