natgillin/translations-raw huggingface dataset:
Mortality occurred in juvenile animals at a dose (3 mg/kg) which did not lead to mortalities in adult animals.
Umrljivost se je pri mladih podganah pojavila ob odmerku (3 mg/kg), ki ni povzročil umrljivosti odraslih živali.
The difference in ORR was 22.9 % (p-value<0.0001).
Razlika v ORR je bila 22,9 % (vrednost p < 0,0001).
Your doctor will discuss with you the benefits and risks of taking Cotellic, if you are breast-feeding.
Zdravnik se bo z vami pogovoril o koristih in tveganjih jemanja zdravila Cotellic, če dojite.
Patients with ECOG performance status 2 or higher were excluded from the study.
Bolniki s stanjem zmogljivosti po ECOG 2 ali več so bili iz študije izključeni.
Follow your doctor's instructions for what to do to help prevent or treat diarrhoea.
Upoštevajte zdravnikova navodila, kako ukrepati, da boste pomagali preprečiti ali zdraviti drisko.
These data show that the efficacy of the combination will be lower in these patients (see section 5.1).
Ti podatki kažejo, da je učinkovitost kombinacije pri teh bolnikih manjša (glejte poglavje 5.1).
The effects of Cotellic in people younger than 18 years old are not known.
Učinki zdravila Cotellic pri osebah, mlajših od 18 let, niso znani.
Transparent PVC/PVDC blisters containing 21 tablets.
Prosojni pretisni omoti iz PVC/PVDC, ki vsebujejo 21 tablet.
The magnitude of interaction could potentially be lower in patients.
Izrazitost medsebojnega delovanja je pri bolnikih morda lahko manjša.
Cotellic is taken on a 28 day cycle.
Zdravilo Cotellic je treba uporabljati v 28-dnevnem ciklu.
Interrupt treatment for 4 weeks
Prekinite zdravljenje za 4 tedne
Continue to take Cotellic as normal, the next day.
Nadaljujte z jemanjem zdravila Cotellic kot običajno, naslednji dan.
Ask your doctor about the best contraception for you.
Z zdravnikom se pogovorite o tem, katera kontracepcija je najprimernejša za vas.
This is available without prescription.
Na voljo je brez recepta.
4.5 Interaction with other medicinal products and other forms of interaction
4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Učinki drugih zdravil na kobimetinib
Take the medicine package and this leaflet with you.
S seboj vzemite pakiranje zdravila in to navodilo.
Talc (E553b)
Smukec (E553b)
· After the 21 days, do not take any Cotellic tablets for 7 days.
• Po 21 dneh naslednjih 7 dni ne vzemite nobene tablete zdravila Cotellic.
LVEF value following treatment break
Vrednost LVEF po prekinitvi zdravljenja
Interrupt treatment for 2 weeks
Prekinite zdravljenje za 2 tedna
· Do not throw away any medicines via wastewater or household waste.
• Zdravila ne smete odvreči v odpadne vode ali med gospodinjske odpadke.
Your doctor will do blood tests to check these amounts and monitor how well your liver is working.
Zdravnik bo opravil preiskave krvi, da bo preveril raven teh encimov in da bo spremljal, kako dobro vam delujejo jetra.
The decision on whether to reduce the dose for either or both treatments should be based on the prescriber's assessment of individual patient safety or tolerability.
Odločitev za zmanjšanje odmerka enega ali obeh zdravil mora temeljiti na zdravnikovi oceni varnosti in prenašanja pri posameznem bolniku.
There were no apparent trends in the time of onset of Grade ≥3 events.
Glede časa do pojava dogodkov stopnje ≥ 3 ni bilo opaznih trendov.
Avoid driving or using machines if you have problems with your vision or other problems that might affect your ability e.g. if you feel dizzy or tired.
Ne upravljajte vozil ali strojev, če imate težave z vidom ali druge težave, ki lahko vplivajo na vaše sposobnosti, npr. če ste omotični ali utrujeni.
· It is used in combination with another anti-cancer medicine called vemurafenib.
• Uporablja se v kombinaciji z drugim zdravilom proti raku, imenovanim vemurafenib.
Study GO28141 (coBRIM)
Študija GO28141 (coBRIM)
Severe diarrhoea can cause loss of body fluid (dehydration).
Huda driska lahko povzroči izgubljanje tekočine iz telesa (dehidracijo).
Cotellic should not be used during pregnancy unless clearly necessary and after a careful consideration of the needs of the mother and the risk to the foetus.
Zdravila Cotellic se med nosečnostjo ne sme uporabljati, razen če je nujno potrebno in po skrbnem pretehtanju potreb matere in tveganja za plod.
Fatigue was observed at similar frequencies in both arms.
Utrujenost je bila v obeh skupinah podobno pogosta.
Global health status / health-related quality of life by patient-report were measured using the EORTC Quality of Life Questionnaire - Core 30 (QLQ-C30).
Splošno zdravstveno stanje/kakovost življenja, povezano z zdravjem, po navedbi bolnika so merili z vprašalnikom EORTC QLQ-C30 (Quality of Life Questionnaire - Core 30).
· It is not known if Cotellic passes into breast milk.
• Ni znano, ali zdravilo Cotellic prehaja v materino mleko.
Patients with a baseline LVEF either below institutional lower limit of normal (LLN) or below 50% have not been studied.
Bolnikov z izhodiščnim LVEF pod spodnjo mejo normalne vrednosti (SMN) za ustanovo ali pod 50 % niso proučevali.
Please refer to the vemurafenib SmPC for complete descriptions of all undesirable effects associated with vemurafenib treatment.
Prosimo, glejte povzetek glavnih značilnosti vemurafeniba za popoln opis vseh neželenih učinkov, povezanih z zdravljenjem z vemurafenibom.
Some of these eye problems may be a result of “serous retinopathy” (a build-up of fluid under the retina in the eye).
Nekatere od teh težav z očmi so lahko posledica "serozne retinopatije" (kopičenja tekočine pod očesno mrežnico).
Each pack contains 63 tablets.
Eno pakiranje vsebuje 63 tablet.
The BRAFi-naïve patients (n=63) attained an 87% objective response rate, including a complete response in 16% of patients.
Bolniki, predhodno še nezdravljeni z BRAFi (n = 63), so dosegli 87-% delež objektivnega odziva, vključno s popolnim odzivom pri 16 % bolnikov.
The median duration of response was 6.8 months.
Mediana trajanja odziva je bila 6,8 meseca.
Increased GGT
Zvišanje GGT
Cotellic is used to treat adult patients with a type of skin cancer called melanoma, that has spread to other parts of the body or cannot be removed by surgery.
Zdravilo Cotellic uporabljamo za zdravljenje odraslih bolnikov s posebno vrsto kožnega raka, imenovanega melanom, ki se je razširil v druge dele telesa ali ga ni mogoče odstraniti z operacijo.
Patients should be advised not to drive or use machines if they experience visual disturbances or any other adverse effects that may affect their ability.
Bolnikom je treba naročiti, naj ne upravljajo vozil ali strojev, če se jim pojavijo motnje vida ali kakršni koli drugi neželeni učinki, ki lahko vplivajo na to sposobnost.
PHARMACEUTICAL FORM AND CONTENTS 63 film-coated tablets
FARMACEVTSKA OBLIKA IN VSEBINA 63 filmsko obloženih tablet
· It can only be used in patients whose cancer has a change (mutation) in a protein called “BRAF”.
• Uporabljati ga je mogoče le pri bolnikih, katerih rak ima spremembo (mutacijo) v beljakovini,
Treatment with Cotellic should continue until the patient no longer derives benefit or until the development of unacceptable toxicity (see Table 1 below).
Zdravljenje z zdravilom Cotellic je treba nadaljevati, dokler bolniku ne koristi več oziroma do pojava nesprejemljive toksičnosti (glejte preglednico 1 spodaj).
The intracranial activity of cobimetinib is currently unknown (see sections 5.1 and 5.2).
Intrakranialna aktivnost kobimetiniba trenutno ni poznana (glejte poglavji 5.1 in 5.2).
The safety and efficacy of Cotellic in children and adolescents below 18 years of age have not been established.
Varnost in učinkovitost zdravila Cotellic pri otrocih in mladostnikih, mlajših od 18 let, nista ugotovljeni.
Caution should be used in patients with additional risk factors for bleeding, such as brain metastases, and/or in patients that use concomitant medications that increase the risk of bleeding (including antiplatelet or anticoagulant therapy).
Previdnost je potrebna pri bolnikih z dodatnimi dejavniki tveganja za krvavitve, kot so zasevki v možganih, in/ali pri bolnikih s sočasnimi zdravili, ki povečajo tveganje za krvavitve (vključno z antitrombotično ali antikoagulantno terapijo).
One pack size is available: 63 tablets (3 blisters of 21 tablets).
Na voljo je ena velikost pakiranja: 63 tablet (3 pretisni omoti po 21 tablet).
A decision should be made whether to discontinue breast-feeding or discontinue Cotellic therapy, taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Odločiti se je treba bodisi za prenehanje dojenja bodisi za prenehanje zdravljenja z zdravilom Cotellic, z upoštevanjem koristi dojenja za otroka in koristi zdravljenja za žensko.
However, sensitivity analysis suggests neither of these covariates had clinically significant impact on steady state exposure.
Vendar analiza občutljivosti ne kaže, da bi katera od teh dveh sospremenljivk klinično pomembno vplivala na izpostavljenost v stanju dinamičnega ravnovesja.
The primary analysis for Study GO28141 was conducted with a data cut-off date of 09 May 2014.
Primarna analiza za študijo GO28141 je bila izvedena s podatki s presečnim datumom 9. maj 2014.
In vitro, cobimetinib is a potential inducer of CYP1A2 and may therefore reduce the exposure of substrates of this enzyme e.g., theophylline.
In vitro je kobimetinib potencialen induktor CYP1A2 in lahko zato zmanjša izpostavljenost substratom tega encima, npr. teofilinu.
Cobimetinib is 94.8% bound to human plasma proteins in vitro.
Kobimetinib je in vitro 94,8-% vezan na beljakovine v človeški plazmi.
Grade 1 or Grade 2 (tolerable)
Stopnja 1 ali 2 (znosni)
When Cotellic is used in combination with vemurafenib (which targets the changed “BRAF” protein), it further slows down or stops the growth of your cancer.
Če je zdravilo Cotellic uporabljeno v kombinaciji z vemurafenibom (ki je usmerjen na spremenjeno beljakovino "BRAF"), dodatno upočasni ali ustavi rast raka.
Diarrhoea (very common: may affect more than 1 in 10 people) Tell your doctor straight away if you get diarrhoea and follow your doctor's instructions for what to do to help prevent or treat diarrhoea.
Driska (zelo pogosti: pojavijo se lahko pri več kot 1 od 10 bolnikov) Zdravnika morate takoj obvestiti, če se vam pojavi driska, in upoštevati morate zdravnikova navodila, kako ukrepati, da boste pomagali preprečiti ali zdraviti drisko.
· Cotellic can be taken with or without food.
• Zdravilo Cotellic lahko vzamete s hrano ali brez nje.
g The data cut-off date for the final OS analysis is 28 August 2015 and median follow-up was 18.5 months.
Presečni datum zbiranja podatkov za končno analizo celokupnega preživetja je bil 28. avgust 2015; mediana spremljanja je bila 18,5 meseca.
Changes in reported laboratory data
Spremembe v zabeleženih rezultatih laboratorijskih preiskav
*** Please refer to the paragraph Rhabdomyolysis in the “Description of selected adverse reactions” section.
*** Glejte odstavek Rabdomioliza v poglavju "Opis izbranih neželenih učinkov".
Since food does not alter the pharmacokinetics of cobimetinib, it can be administered with or without food.
Ker hrana ne vpliva na farmakokinetiko kobimetiniba, ga je mogoče jemati s hrano ali brez nje.
Among the 63 BRAFi naïve patients, 20 patients had received prior systemic therapy for advanced melanoma with the majority (80%) being immunotherapy.
Od 63 bolnikov, ki predhodno še niso dobivali BRAFi, je bilo 20 bolnikov predhodno sistemsko zdravljenih zaradi napredovalega melanoma, večina (80 %) z imunoterapijo.
Table 4 provides the frequency of measured liver laboratory abnormalities and elevated creatine phosphokinase for all Grades and Grades 3-4.
Preglednica 4 prikazuje pogostnost izmerjenih jetrnih laboratorijskih odstopanj in zvišanje kreatin-fosfokinaze za vse stopnje in za stopnjo 3-4.
The median time to first occurrence of Grade 3 or 4 CPK elevations was 16 days (range: 11 days to 10 months); the median time to complete resolution was 16 days (range: 2 days to 15 months).
Mediana časa do prvega pojava zvišanja CPK stopnje 3 ali 4 je bila 16 dni (razpon: od 11 dni do 10 mesecev); mediana časa do dokončnega izboljšanja je bila 16 dni (razpon: od 2 dni do 15 mesecev).
This is because Cotellic can affect the way some other medicines work.
Zdravilo Cotellic namreč lahko vpliva na delovanje nekaterih drugih zdravil.
Therefore, concomitant use of moderate and strong CYP3A inducers (e.g. carbamazepine, rifampicin, phenytoin, and St. John's Wort) should be avoided.
Zato se je treba izogibati sočasni uporabi z zmernimi in močnimi induktorji CYP3A (npr. s karbamazepinom, rifampicinom, fenitoinom ali šentjanževko).
Also, some other medicines can affect the way Cotellic works.
Prav tako lahko nekatera druga zdravila vplivajo na delovanje zdravila Cotellic.
The fraction absorbed was ~88% indicating high absorption and first pass metabolism.
Absorbirani delež je bil ~ 88 %: to kaže veliko absorpcijo in presnovo prvega prehoda.
There are no data from the use of Cotellic in pregnant women.
O uporabi zdravila Cotellic pri nosečnicah ni podatkov.
Additionally, for:
Dodatno:
In Study GO28141, there were 89 patients (18.1%) aged 65-74, 38 patients (7.7%) aged 75-84 and 5 patients (1.0%) aged 85 years and older.
V študiji GO28141 je bilo 89 bolnikov (18,1 %) starih od 65 do 74 let, 38 bolnikov (7,7 %) od 75 do 84 let in 5 bolnikov (1,0 %) starih 85 let ali več.
If serum CPK is elevated, check for signs and symptoms of rhabdomyolysis or other causes.
Če je serumska CPK zvišana, preverite pisotnost znakov in simptomov rabdomiolize ali drugih vzrokov.
There are minimal data for Cotellic in patients with severe renal impairment, therefore an effect cannot be excluded.
Podatkov o zdravilu Cotellic za bolnike s hudo okvaro ledvic je zelo malo, zato vpliva ni mogoče izključiti.
Therefore other treatment options should be considered before treatment with the combination in this prior BRAF inhibitor treated population.
Zato je treba razmisliti o drugih možnostih zdravljenja pred uvedbo kombinacije pri tej populaciji bolnikov, ki so se predhodno zdravili z zaviralcem BRAF.
If you are pregnant or breast-feeding, think you might be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Nosečnost in dojenje Če ste noseči ali dojite, menite, da ste noseči, ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom, preden vzamete to zdravilo.
The tablets should be swallowed whole with water.
Tablete je treba zaužiti cele, z vodo.
· If you become pregnant during treatment with Cotellic or in the 3 months after your last dose, tell your doctor straight away.
• Če med zdravljenjem z zdravilom Cotellic ali v 3 mesecih po zadnjem odmerku tega zdravila zanosite, morate o tem takoj obvestiti zdravnika.
Patients should be assessed at each visit for symptoms of new or worsening visual disturbances.
Bolnike je treba na vsakem pregledu oceniti glede simptomov novih motenj vida ali poslabšanja obstoječih motenj vida.
The clinical relevance of these findings has not been investigated.
Klinični pomen teh izsledkov ni raziskan.
· Cotellic is not recommended during pregnancy - although the effects of Cotellic have not been studied in pregnant women, it may cause permanent harm or birth defects to an unborn baby.
• Zdravilo Cotellic ni priporočljivo med nosečnostjo: učinki zdravila Cotellic pri nosečnicah sicer niso raziskani, vendar je mogoče, da zdravilo povzroči trajno okvaro ali prirojene hibe pri še nerojenem otroku.
Cotellic targets a protein called “MEK” that is important in controlling cancer cell growth.
Zdravilo Cotellic je usmerjeno na beljakovino, imenovano "MEK", ki je pomembna za nadzor rasti rakavih celic.
Each dose consists of three 20 mg tablets (60 mg) and should be taken once daily for 21 consecutive days (Days 1 to 21-treatment period); followed by a 7-day break (Days 22 to 28-treatment break).
Vsak odmerek obsega tri 20-mg tablete (60 mg) in ga je treba vzeti enkrat na dan 21 dni zapored (obdobje zdravljenja od 1. do 21. dne), temu sledi 7-dnevni premor (premor zdravljenja od 22. do 28. dne).
Using Clopper-Pearson method d Using Hauck-Anderson method e
Z uporabo Hauck-Andersonove metode.
The tablets contain lactose (a type of sugar).
Tablete vsebujejo laktozo (vrsto sladkorja).
Treatment with Cotellic in combination with vemurafenib should only be initiated and supervised by a qualified physician experienced in the use of anticancer medicinal products.
Zdravljenje z zdravilom Cotellic v kombinaciji z vemurafenibom sme uvesti in nadzorovati le usposobljen zdravnik, ki ima izkušnje z uporabo zdravil proti raku.
All patients restarting treatment with a dose reduction of Cotellic should have LVEF measurements taken after approximately 2 weeks, 4 weeks, 10 weeks and 16 weeks, and then as clinically indicated.
Vsem bolnikom, ki znova začnejo zdravljenje z zmanjšanim odmerkom zdravila Cotellic, je treba LVEF izmeriti po približno 2, 4, 10 in 16 tednih, potem pa kot je klinično indicirano.
Grade 2 (intolerable) or Grade 3/4 1st Appearance
Stopnja 2 (neznosni) ali stopnja 3/4
Pharmacotherapeutic group: Antineoplastic agents, ATC code: L01XE38
Farmakoterapevtska skupina: zdravila z delovanjem na novotvorbe (citostatiki), oznaka ATC: L01XE38
Among patients who had progressed on vemurafenib (n=66), the objective response rate was 15%.
Med bolniki, ki jim je bolezen med uporabo vemurafeniba napredovala (n = 66), je bil delež objektivnega odziva 15 %.
If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before taking this medicine.
Če vam je zdravnik povedal, da ne prenašate nekaterih sladkorjev, se z njim posvetujte, preden vzamete to zdravilo.
No preferential binding to human red blood cells was observed (blood to plasma ratio 0.93).
Prednostne vezave na človeške eritrocite niso opazili (razmerje med krvjo in plazmo 0,93).
The median follow up was 14.2 months.
Mediana spremljanja je bila 14,2 meseca.
Other medicines and Cotellic
Druga zdravila in zdravilo Cotellic
During this 7 day break in Cotellic treatment, you should keep taking vemurafenib as told by your doctor.
Med tem 7-dnevnim premorom v jemanju zdravila Cotellic morate še naprej jemati vemurafenib, kot vam je naročil zdravnik.
Your doctor should do tests before and during your treatment with Cotellic to check how well your heart can pump blood.
Zdravnik mora pred zdravljenjem z zdravilom Cotellic in med zdravljenjem opraviti preiskave, s katerimi preveri, kako dobro vaše srce črpa kri.
It is important to keep taking Cotellic for as long as your doctor prescribes it.
Pomembno je, da zdravilo Cotellic jemljete toliko časa, kot vam je predpisal zdravnik.
Each subsequent Cotellic treatment cycle should start after the 7-day treatment break has elapsed.
Vsak nadaljnji cikel zdravljenja z zdravilom Cotellic se mora začeti po preteku 7-dnevnega premora.
In animals, no fertility studies have been performed, but adverse effects were seen on reproductive organs (see section 5.3).
Pri živalih niso izvedli študij plodnosti, opažali pa so neželene učinke na reproduktivne organe (glejte poglavje 5.3).
Grade 3: Cotellic should be continued at the prescribed dose.
Stopnja 3: Zdravilo Cotellic je treba nadaljevati v predpisanem odmerku.
· This medicine does not require any special storage conditions.
• Za shranjevanje zdravila niso potrebna posebna navodila.
The risk of haemorrhage may be increased with concomitant use of antiplatelet or anticoagulant therapy.
Tveganje za krvavitve se lahko poveča pri sočasni uporabi antitrombotične ali antikoagulantne terapije.
Cotellic treatment and vemurafenib treatment should be discontinued if liver laboratory abnormalities do not resolve to Grade ≤1 within 4 weeks or if Grade 4 liver laboratory abnormalities recur after initial improvement.
Zdravljenje z zdravilom Cotellic in zdravljenje z vemurafenibom je treba prenehati, če se jetrna laboratorijska odstopanja v 4 tednih ne zmanjšajo na stopnjo ≤ 1, ali če se jetrna laboratorijska odstopanja stopnje 4 po začetnem izboljšanju ponovijo.
A population pharmacokinetic analysis using data from 151 patients with mild renal impairment (creatinine clearance (CRCL) 60 to less than 90 mL/min), 48 patients with moderate renal impairment (CRCL 30 to less than 60 mL/min), and 286 patients with normal renal function (CRCL greater than or equal to 90 mL/min), showed that CRCL had no meaningful influence on exposure of cobimetinib.
Populacijska farmakokinetična analiza s podatki 151 bolnikov z blago okvaro ledvic (očistek kreatinina od 60 do manj kot 90 ml/min), 48 bolnikov z zmerno okvaro ledvic (očistek kreatinina od 30 do manj kot 60 ml/min) in 286 bolnikov z normalnim delovanjem ledvic (očistek kreatinina večji ali enak 90 ml/min) je pokazala, da očistek kreatinina ne vpliva pomembno na izpostavljenost kobimetinibu.
Cobimetinib and its metabolites were characterised in a mass balance study in healthy subjects.
Kobimetinib in njegove presnovke so opredelili v študiji masnega ravnovesja pri zdravih osebah.
If you stop taking Cotellic
Če ste prenehali jemati zdravilo Cotellic
Most events resolved with no change in Cotellic dose.
Večina dogodkov se je izboljšala brez spremembe odmerka zdravila Cotellic.
Patients with rare hereditary problems of galactose intolerance, congenital lactase deficiency or glucose-galactose malabsorption should consult with their physician and discuss whether the benefits outweigh the risks on an individual basis.
Bolniki z redko dedno intoleranco za galaktozo, laponsko obliko pomanjkanja laktaze ali malabsorpcijo glukoze/galaktoze se morajo posvetovati z zdravnikom in se z njim pogovoriti, ali zanje koristi zdravljenja odtehtajo tveganje.
Scores for all functioning domains and most symptoms (appetite loss, constipation, nausea and vomiting, dyspnoea, pain, fatigue) showed that the mean change from baseline was similar between the two treatment arms and did not demonstrate a clinically meaningful change (all scores were ≤ 10 point change from baseline).
Rezultati za vsa funkcijska področja in večino simptomov (izgubo apetita, zaprtost, navzeo in bruhanje, dispnejo, bolečine, utrujenost) so pokazali, da je bila povprečna sprememba od izhodišča med zdravljenima skupinama podobna in se ni klinično pomembno spremenila (vsi rezultati so se od izhodiščne vrednosti razlikovali za ≤ 10 točk).
Film coating Polyvinyl alcohol Titanium dioxide (E171) Macrogol 3350
Titanov dioksid (E171) Makrogol 3350
· Do not take a double dose to make up for a missed dose.
• Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
If concomitant use with a strong or moderate CYP3A inhibitor is unavoidable, patients should be carefully monitored for safety and dose modifications applied if clinically indicated (see Table 1 in section 4.2).
Če se sočasni uporabi močnega ali zmernega zaviralca CYP3A ni mogoče izogniti, je treba bolnike skrbno nadzirati glede varnosti in odmerek prilagoditi, če je to klinično indicirano (glejte preglednico 1 v poglavju 4.2).
The dose of vemurafenib may be reduced as clinically appropriate.
Odmerek vemurafeniba je mogoče zmanjšati, kot je klinično primerno.
Cotellic can cause severe bleeding, especially in your brain or stomach (see also “Severe bleeding” in Section 4).
Zdravilo Cotellic lahko povzroči hudo krvavitev, zlasti v možganih ali trebuhu (glejte tudi "Huda krvavitev" v poglavju 4).
Cotellic can cause increased levels of creatine phosphokinase, an enzyme that is found mainly in the muscle, heart, and brain.
Zdravilo Cotellic lahko povzroči zvečane koncentracije kreatin-fosfokinaze, encima, ki se nahaja predvsem v mišicah, srcu in možganih.
In case of vomiting after administration of Cotellic, the patient should not take an additional dose on that day and treatment should be continued as prescribed the following day.
Če bolnik po uporabi zdravila Cotellic bruha, tisti dan ne sme vzeti dodatnega odmerka, temveč mora zdravljenje nadaljevati naslednji dan, kot je predpisano.
Please also refer to the Package Leaflet for vemurafenib, which is used in combination with Cotellic.
Glejte tudi navodilo za uporabo vemurafeniba, ki se uporablja v kombinaciji z zdravilom Cotellic.
Median time to initial onset of events was 4 months (1-13 months).
Mediana časa do začetnega pojava je bila 4 mesece (od 1 do 13 mesecev).