natgillin/translations-raw huggingface dataset:
cobicistat, telaprevir, lopinavir, itraconazole, voriconazole, clarithromycin, telithromycin, posaconazole, nefazodone and grapefruit juice.
kobicistat, telaprevir, lopinavir, itrakonazol, vorikonazol, klaritromicin, telitromicin, posakonazol,
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).
Pred začetkom zdravljenja je treba z validirano preiskavo potrditi, da ima bolnik melanom z mutacijo BRAF V600 (glejte poglavji 4.4 in 5.1).
When cobimetinib is co-administered with a moderate CYP3A inhibitor, patients should be carefully monitored for safety.
Če se kobimetinib uporablja sočasno z zmernim zaviralcem CYP3A, je treba bolnike skrbno nadzirati glede varnosti.
No evidence of phototoxicity was observed with Cotellic as a single agent.
Med uporabo zdravila Cotellic kot edinega zdravila niso zabeležili fototoksičnosti.
No formal pharmacokinetic study has been conducted in patients with renal impairment.
Formalnih farmakokinetičnih študij pri bolnikih z okvaro ledvic niso izvedli.
What Cotellic looks like and contents of the pack Cotellic film-coated tablets are white, round with “COB” debossed on one side.
Zdravilo Cotellic filmsko obložene tablete so bele, okrogle tablete, ki imajo na eni strani vtisnjeno oznako "COB".
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.
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.
Mild CYP3A inhibitors: Cobimetinib can be co-administered with mild inhibitors of CYP3A without dose adjustment.
Blagi zaviralci CYP3A: Z blagimi zaviralci CYP3A je mogoče kobimetinib uporabiti brez prilagoditve odmerka.
Depending on the severity of symptoms or CPK elevation; treatment interruption, dose reduction or treatment discontinuation may be required (see section 4.2).
Odvisno od izrazitosti simptomov ali zvišanja CPK je lahko potrebna prekinitev zdravljenja, zmanjšanje odmerka ali prenehanje zdravljenja (glejte poglavje 4.2).
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.
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.
Special populations Elderly patients
Posebne populacije bolnikov
Assessed and confirmed by the investigator (INV) using RECIST v1.1 b Stratified analysis by geographic region and metastasis classification (disease stage)
a Ocenil in potrdil raziskovalec (INV) z uporabo RECIST v 1.1.
Dose modification advice for Cotellic when used with vemurafenib Liver laboratory abnormalities
Nasvet za prilagoditev odmerka zdravila Cotellic med uporabo z vemurafenibom Jetrna laboratorijska odstopanja
QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains cobimetinib hemifumarate equivalent to 20 mg cobimetinib.
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena filmsko obložena tableta vsebuje kobimetinibijev hemifumarat, kolikor ga ustreza 20 mg kobimetiniba.
If CPK elevations do not improve to Grade ≤3 within 4 weeks following dose interruption, Cotellic treatment should be permanently discontinued.
Če se zvišanje CPK v 4 tednih po prekinitvi odmerjanja ne izboljša do stopnje ≤ 3, je potrebno trajno prenehanje zdravljenja z zdravilom
The majority of events were Grades 1 or 2, with Grade ≥3 events occurring in 4% of patients in the Cotellic plus vemurafenib arm vs 0% in the placebo plus vemurafenib arm.
Dogodki stopnje ≥ 3 so se pojavili pri 4 % bolnikov v skupini z zdravilom Cotellic in vemurafenibom ter pri 0 % v skupini s placebom in vemurafenibom.
Signs include yellowing of the skin or eyes · inflammation of the lungs that may cause difficulty breathing, and can be life-threatening (called “pneumonitis”).
• vnetje pljuč, ki lahko povzroči težko dihanje in je lahko smrtno nevarno (to imenujemo
NAME OF THE MEDICINAL PRODUCT Cotellic 20 mg film-coated tablets cobimetinib
IME ZDRAVILA Cotellic 20 mg filmsko obložene tablete kobimetinib
Cobimetinib was extensively metabolised and eliminated in faeces.
Kobimetinib se je izdatno presnovil in izločil v blatu.
No clinical DDI studies have been conducted to assess the clinical relevance of this finding.
Kliničnih študij medsebojnega delovanja zdravil za oceno pomembnosti tega izsledka niso izvedli.
No dose adjustment is required in patients aged ≥65 years old.
Bolnikom, starim ≥ 65 let, odmerka ni treba prilagoditi.
Cotellic in combination with vemurafenib in patients who have progressed on a BRAF inhibitor There are limited data in patients taking the combination of Cotellic with vemurafenib who have progressed on a prior BRAF inhibitor.
Zdravilo Cotellic v kombinaciji z vemurafenibom pri bolnikih, katerih bolezen je napredovala med zdravljenjem z zaviralcem BRAF Podatkov pri bolnikih, zdravljenih z zdravilom Cotellic v kombinaciji z vemurafenibom, katerih bolezen je med predhodnim zdravljenjem z zaviralcem BRAF napredovala, je malo.
There is no evidence of any clinically significant drug-drug interaction between cobimetinib and vemurafenib in unresectable or metastatic melanoma patients and therefore no dose adjustments is recommended.
Pri bolnikih z neoperabilnim ali metastatskim melanomom ni dokazov o klinično pomembnem medsebojnem delovanju med kobimetinibom in vemurafenibom, zato prilagoditve odmerkov niso potrebne.
Malta (see Ireland)
(See United Kingdom)
The mean apparent CL following oral dosing of 60 mg in cancer patients was 13.8 L/hr.
Povprečni navidezni očistek po peroralnem odmerku 60 mg je bil pri onkoloških bolnikih 13,8 l/uro.
Key baseline characteristics included: 58% of patients were male, median age was 55 years (range 23 to 88 years), 60% had metastatic melanoma stage M1c and the proportion of patients with elevated LDH was 46.3% in the cobimetinib plus vemurafenib arm and 43.0% in the placebo plus vemurafenib arm.
23 do 88 let), 60 % je imelo metastatski melanom v stadiju M1c, delež bolnikov z zvišanjem LDH pa je bil v skupini s kobimetinibom in vemurafenibom 46,3 % ter v skupini s placebom in vemurafenibom 43,0 %.
Rare ≥ 1/10,000 to < 1/1,000
Redki ≥ 1/10.000 do < 1/1000
Depending on the area of the bleeding, symptoms may include: · headaches, dizziness, or weakness · vomiting blood · abdominal pain · red or black coloured stools.
Odvisno od območja krvavitve so med simptomi lahko: • glavoboli, omotica ali šibkost,
Visual disturbances have been reported in some patients treated with cobimetinib during clinical trials (see sections 4.4 and 4.8).
Pri nekaterih bolnikih, zdravljenih s kobimetinibom, so v kliničnih preskušanjih poročali o motnjah vida (glejte poglavji 4.4 in 4.8).
No studies have been conducted to investigate the pharmacokinetics of cobimetinib in paediatric patients.
Študij farmakokinetike kobimetiniba pri pediatričnih bolnikih niso izvedli.
If you are not sure, talk to your doctor, pharmacist or nurse before taking Cotellic.
Če ste negotovi, se pred začetkom jemanja zdravila Cotellic posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
Depending on the severity of rhabdomyolysis, dose reduction or treatment discontinuation may be required (see section 4.2).
Odvisno od izrazitosti rabdomiolize je lahko potrebno zmanjšanje odmerka ali prenehanje zdravljenja (glejte poglavje 4.2).
Liver value abnormalities should be monitored by liver laboratory tests before initiation of combination treatment and monthly during treatment, or more frequently as clinically indicated (see section 4.2).
Jetrna laboratorijska odstopanja je treba kontrolirati z laboratorijskimi preiskavami jeter pred začetkom kombiniranega zdravljenja in vsak mesec med zdravljenjem, lahko pa tudi pogosteje, če je klinično indicirano (glejte poglavje 4.2).
In juvenile rats, cobimetinib administration resulted in similar changes as seen in the pivotal toxicity studies in adults, including reversible degenerative changes in the thymus and liver, decreased spleen and thyroid/parathyroid weights, increased phosphorus, bilirubin and red blood cell mass and decreased triglycerides.
Pri mladih podganah je uporaba kobimetiniba povzročila podobne spremembe, kot so jih opazili v ključnih študijah toksičnosti pri odraslih, vključno z reverzibilnimi degenerativnimi spremembami v timusu in jetrih, zmanjšanjem mase vranice in ščitnice/obščitnic, zvišanjem fosforja,
· Liver problems
• težave z jetri,
Vemurafenib dosing can be continued when Cotellic treatment is interrupted, if clinically indicated.
Odmerjanje vemurafeniba lahko po prekinitvi zdravljenja z zdravilom Cotellic nadaljujete, če je klinično indicirano.
Asymptomatic CPK elevations
Nesimptomatska zvišanja CPK:
P-glycoprotein inhibitors
Zaviralci P-glikoproteina
No dedicated fertility studies in animals have been performed with cobimetinib.
Namenskih študij plodnosti na živalih s kobimetinibom niso izvedli.
Therefore, it may take up to 2 weeks following treatment cessation for cobimetinib to be completely removed from systemic circulation.
Zato se lahko kobimetinib popolnoma odstrani iz sistemskega obtoka šele do 2 tedna po prenehanju uporabe.
For strong CYP3A inhibitors used short-term (7 days or less), consider interrupting cobimetinib therapy during the duration of inhibitor use.
V primeru kratkotrajne (≤ 7-dnevne) uporabe močnih zaviralcev CYP3A pride v poštev prekinitev zdravljenja s kobimetinibom med obdobjem uporabe zaviralca.
· If you have any further questions, ask your doctor, pharmacist or nurse.
• Če imate dodatna vprašanja, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
Grade 2 (intolerable) or Grade ≥3 acneiform rash: General dose modification recommendations in Table 1 for Cotellic should be followed.
Akneiformen izpuščaj stopnje 2 (neznosen) ali stopnje ≥ 3: Za prilagoditev odmerka zdravila Cotellic upoštevajte splošna priporočila v preglednici 1.
Secondary efficacy endpoints included overall survival (OS), objective response rate, duration of response (DoR) as assessed by INV and PFS as assessed by an independent review facility (IRF).
trajanje odziva (DoR, duration of response) po oceni raziskovalca in PFS po oceni neodvisnega revizijskega telesa (IRF, independent review facility).
Gender does not have an effect on the exposure of cobimetinib, based on a population pharmacokinetic analysis including 210 women and 277 men.
Na podlagi populacijske farmakokinetične analize, ki je vključila 210 žensk in 277 moških, spol ne vpliva na izpostavljenost kobimetinibu.
Before taking Cotellic in combination with vemurafenib, patients must have BRAF V600 mutationpositive tumour status confirmed by a validated test.
Pred uporabo zdravila Cotellic v kombinaciji z vemurafenibom je treba z validirano preiskavo potrditi, da ima bolnik tumor z mutacijo BRAF V600.
Unchanged medicinal product in faeces and urine accounted for 6.6% and 1.6% of the administered dose, respectively, indicating that cobimetinib is primarily metabolised with minimal renal elimination.
Nespremenjeno zdravilo je v blatu predstavljalo 6,6 % uporabljenega odmerka in v urinu 1,6 % uporabljenega odmerka.
Cotellic treatment should be permanently discontinued for haemorrhage events attributed to Cotellic.
Trajno prenehanje zdravljenja z zdravilom Cotellic je potrebno v primeru krvavitev, ki jih pripisujete zdravilu Cotellic.
Uncommon ≥ 1/1,000 to < 1/100
Občasni ≥ 1/1000 do < 1/100
How Cotellic works
Kako deluje zdravilo Cotellic
Bleeding events have been reported more frequently in the Cotellic plus vemurafenib arm than in the placebo plus vemurafenib arm (all types and Grades: 13% vs 7%).
Pogostnost krvavitev je bila v skupini z zdravilom Cotellic in vemurafenibom večja kot v skupini s placebom in vemurafenibom (vse vrste in stopnje: 13 % v primerjavi s 7 %).
Blood CPK increased, ALT increased, AST increased, GammaGlutamyltransferase (GGT) increased, Blood ALP increased
Preiskave zvišanja CPK, ALT, AST, gamaglutamiltransferaze (GGT) in AF v krvi zmanjšan iztisni delež, zvišanje bilirubina v krvi
Recommended Cotellic daily dose
Priporočeni dnevni odmerek zdravila Cotellic
Rhabdomyolysis has been reported in the post-marketing setting.
O rabdomiolizi so poročali v obdobju po prihodu zdravila na trg.
Alternative agents with no or minimal CYP3A induction should be considered.
Razmisliti je treba o uporabi drugih zdravil, ki CYP3A inducirajo le malo ali sploh ne.
1st occurrence: 40 mg nd occurrence: 20 mg rd occurrence: permanent discontinuation
2. pojav: 20 mg
495 previously untreated patients with unresectable locally advanced or metastatic melanoma were randomised to receive either: · Placebo once daily on Days 1-21 of each 28-day treatment cycle and 960 mg vemurafenib twice daily on Days 1-28, or · Cotellic 60 mg once daily on Days 1-21 of each 28-day treatment cycle and 960 mg vemurafenib twice daily on Days 1-28
• placebo enkrat na dan od 1. do 21. dne vsakega 28-dnevnega cikla zdravljenja in 960 mg vemurafeniba dvakrat na dan od 1. do 28. dne, ali na
Each film-coated tablet contains cobimetinib hemifumarate equivalent to 20 mg cobimetinib.
Ena filmsko obložena tableta vsebuje kobimetinibijev hemifumarat, kolikor ga ustreza 20 mg kobimetiniba.
If liver laboratory abnormalities improve to Grade ≤1 within 4 weeks, Cotellic should be restarted at a dose reduced by 20 mg and vemurafenib at a clinically appropriate dose, per its SmPC.
Če se jetrna laboratorijska odstopanja v 4 tednih izboljšajo na stopnjo ≤ 1, je treba zdravilo Cotellic znova uvesti v odmerku, zmanjšanem za 20 mg, vemurafenib pa v klinično ustreznem odmerku v skladu z njegovim povzetkom glavnih značilnosti zdravila.
Hypertension, Haemorrhage*
Žilne bolezni hipertenzija, krvavitev*
Cases of serous retinopathy have been reported in patients treated with Cotellic (see section 4.4.)
Pri bolnikih, zdravljenih z zdravilom Cotellic, so poročali o primerih serozne retinopatije (glejte poglavje 4.4).
The 1-year (75 %) and 2-year (48 %) OS estimates for the Cotellic plus vemurafenib arm were greater than those for placebo plus vemurafenib arm (64 % and 38 % respectively).
(48 %) je bilo za za skupino, ki je prejemala zdravilo Cotellic in vemurafenib, večje kot za skupino, ki je prejemala placebo in vemurafenib (64 % po 1 letu in 38 % po 2 letih).
Vemurafenib dosing can be continued when Cotellic treatment is modified.
Odmerjanje vemurafeniba lahko po prilagoditvi zdravljenja z zdravilom Cotellic nadaljujete.
Liver laboratory abnormalities can occur when Cotellic is used in combination with vemurafenib and with vemurafenib as a single agent (please refer to its SmPC).
Jetrna laboratorijska odstopanja se lahko pojavijo tako med uporabo zdravila Cotellic v kombinaciji z vemurafenibom kot med samostojnim zdravljenjem z vemurafenibom (glejte povzetek glavnih značilnosti vemurafeniba).
Moderate CYP3A inhibitors include, but are not limited to, amiodarone, erythromycin, fluconazole, miconazole, diltiazem, verapamil, delavirdine, amprenavir, fosamprenavir, imatinib.
Med zmerne zaviralce CYP3A spadajo amiodaron, eritromicin, flukonazol, mikonazol, diltiazem, verapamil, delavirdin, amprenavir, fosamprenavir in imatinib, vendar ta seznam ni izčrpen.
Best Overall Response (BOR) Complete Response Partial Response
Najboljši celokupni odziv
Liver laboratory abnormalities
Jetrna laboratorijska odstopanja
· Bleeding
• Krvavitev
Drug-drug interactions: CYP3A inhibitors
Medsebojno delovanje zdravil: zaviralci CYP3A4
Asymptomatic increases in blood CPK levels were observed with a higher frequency in the Cotellic plus vemurafenib arm vs placebo plus vemurafenib arm in Study GO28141 (see section 4.2 and 4.4).
V študiji GO28141 je bilo nesimptomatsko zvišanje CPK v krvi v skupini z zdravilom Cotellic in vemurafenibom pogostejše kot v skupini s placebom in vemurafenibom (glejte poglavji 4.2 in 4.4).
Cases of Grade ≥3 and serious diarrhoea have been reported in patients treated with Cotellic.
Pri bolnikih, zdravljenih z zdravilom Cotellic, so poročali o primerih driske stopnje ≥ 3 in resni driski.
Pneumonitis
"pnevmonitis").
Respiratory, thoracic and mediastinal disorders
Bolezni dihal, prsnega koša in mediastinalnega prostora pnevmonitis
No clinical DDI studies have been conducted to assess this finding, and clinically relevant inhibition of intestinal BCRP cannot be ruled out.
Kliničnih študij medsebojnega delovanja zdravil za oceno tega izsledka niso izvedli in klinično pomembnega zavrtja
Age does not have an effect on the exposure of cobimetinib, based on a population pharmacokinetic analysis including 133 patients ≥ 65 years of age.
Na podlagi populacijske farmakokinetične analize, ki je vključila 133 bolnikov, starih ≥ 65 let, starost ne vpliva na izpostavljenost kobimetinibu.
Tell your doctor straight away if you notice any of the side effects listed below or if these get worse during treatment.
Če opazite katerega od spodaj opisanih neželenih učinkov, ali če se vam takšni učinki med zdravljenjem poslabšajo, takoj obvestite zdravnika.
Tell your doctor straight away if it feels like your heart is pounding, racing or beating unevenly, or if you experience dizziness, lightheadedness, shortness of breath, tiredness, or swelling in the legs.
Zdravnika takoj obvestite, če se vam pojavi občutek razbijanja srca, hitrega ali nerednega bitja srca ali če se vam pojavijo omotica,
· The other ingredients are: · lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, and magnesium stearate in the tablet core; and · polyvinyl alcohol, titanium dioxide, macrogol and talc in the film-coating.
• laktoza monohidrat, mikrokristalna celuloza, premreženi natrijev karmelozat in magnezijev stearat v jedru tablete ter
What you need to know before you take Cotellic Do not take Cotellic: · if you are allergic to cobimetinib or any of the other ingredients of this medicine (listed in section 6).
• če ste alergični na kobimetinib ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Photosensitivity has been observed with a higher frequency in the Cotellic plus vemurafenib arm vs placebo plus vemurafenib arm (47% vs 35%).
Pogostnost fotosenzibilnosti je bila v skupini z zdravilom Cotellic in vemurafenibom večja kot v skupini s placebom in vemurafenibom (47 % v primerjavi s 35 %).
There are no data in humans for cobimetinib.
Podatkov za kobimetinib pri človeku ni.
(or 40-49% and < 10% absolute decrease from baseline)
(ali in ≥ 10 % absolutno zmanjšanje od izhodišča)
The apparent volume of distribution was 806 L in cancer patients based on population pharmacokinetic analysis.
Pri zdravih osebah, ki so dobile intravenski odmerek 2 mg, je bil volumen porazdelitve 1050 l. Na podlagi populacijske farmakokinetične analize je bil navidezni volumen porazdelitve pri onkoloških bolnikih 806 l.
Dose modification advice for haemorrhage
Nasvet za prilagoditev odmerka pri krvavitvah
In case of suspected overdose, cobimetinib should be withheld and supportive care instituted.
Pri sumu na preveliko odmerjanje je treba uporabo kobimetiniba prekiniti in uvesti podporno zdravljenje.
No pharmacokinetic trial in subjects with renal impairment has been conducted.
Farmakokinetičnih preskušanj pri osebah z okvaro ledvic niso izvedli.
Cotellic in combination with vemurafenib in patients with brain metastases The safety and efficacy of the combination of Cotellic and vemurafenib have not been evaluated in patients with a BRAF V600 mutation-positive melanoma which has metastasised to the brain.
Varnost in učinkovitost kombinacije zdravila Cotellic in vemurafeniba pri bolnikih z melanomom z mutacijo BRAF V600, ki je zaseval v možgane, ni bila ocenjena.
0.70 (95% CI: 0.55, 0.90) (p-value = 0.0050
(p-vrednost = 0,0050
The safety and efficacy of Cotellic in non-Caucasian patients have not been established.
Pri bolnikih, ki niso belci, varnost in učinkovitost zdravila Cotellic nista ugotovljeni.
What Cotellic is used for
Za kaj uporabljamo zdravilo Cotellic
Asymptomatic and
Nesimptomatski in
Cotellic should be used with caution in patients with severe renal impairment.
Pri bolnikih s hudo okvaro ledvic je treba zdravilo Cotellic uporabljati previdno.
and ≥ 10%
(ali in < 10 %
The efficacy of Cotellic was evaluated in Phase Ib Study, NO25395, which was designed to assess the safety, tolerability, pharmacokinetics and efficacy of Cotellic when added to vemurafenib for the treatment of patients with BRAFV600 mutation-positive (as detected by the cobas® 4800 BRAF V600
Študija je bila izvedena za oceno varnosti, prenašanja, farmakokinetike in učinkovitosti zdravila Cotellic, dodanega vemurafenibu, za zdravljenje bolnikov z neoperabilnim ali metastatskim melanomom z mutacijo BRAF V600 (ugotovljeno s testom mutacije cobas® 4800 BRAF V600).
Caution should be exercised if a moderate CYP3A inhibitor is co-administered with Cotellic.
Previdnost je potrebna, če je sočasno z zdravilom Cotellic uporabljen kakšen zmeren zaviralec CYP3A4.
Serous retinopathya, Blurred vision
Očesne bolezni serozna retinopatijaa, zamegljen vid okvara vida
Vemurafenib dosing can be continued when Cotellic treatment is modified (if clinically indicated).
Med prilagajanjem odmerka zdravila Cotellic je mogoče zdravljenje z vemurafenibom nadaljevati (če je klinično primerno).
Purpose of the medicine itraconazole, clarithromycin, erythromycin, telithromycin, voriconazole, rifampicin, posaconazole, fluconazole, miconazole for some fungal and bacterial infections ritonavir, cobicistat, lopinavir, delavirdine, amprenavir, fosamprenavir for HIV infection telaprevir for hepatitis C
posakonazol, flukonazol, mikonazol proti nekaterim glivičnim in bakterijskim okužbam ritonavir, kobicistat, lopinavir, delavirdin, amprenavir, fosamprenavir proti okužbi s HIV
Hazard ratio (95% CI)
Razmerje ogroženosti (95-% interval zaupanja)
Serous retinopathy (fluid accumulation within the layers of the retina) has been observed in patients treated with MEK-inhibitors, including Cotellic (see section 4.8).
Pri bolnikih, zdravljenih z zaviralci MEK, vključno z zdravilom Cotellic, so opažali serozno retinopatijo (kopičenje tekočine v plasteh mrežnice) (glejte poglavje 4.8).
Always take Cotellic exactly as your doctor or pharmacist has told you.
Pri jemanju zdravila Cotellic natančno upoštevajte navodila zdravnika ali farmacevta.
Decrease in LVEF from baseline can be managed using treatment interruption, dose reduction or with treatment discontinuation (see section 4.2).
Zmanjšanje LVEF od izhodišča je mogoče obvladati s prekinitvijo zdravljenja, zmanjšanjem odmerka ali prenehanjem zdravljenja (glejte poglavje 4.2).
· If you get any side effects, talk to your doctor, pharmacist or nurse.
• Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
Serous retinopathy can be managed with treatment interruption, dose reduction or with treatment discontinuation (see Table 1 in section 4.2).
Serozno retinopatijo je mogoče obvladovati s prekinitvijo zdravljenja, zmanjšanjem odmerka ali prenehanjem zdravljenja (glejte preglednico 1 v poglavju 4.2).
No dose adjustment is recommended in patients with hepatic impairment.
Bolnikom z okvaro jeter odmerka ni treba prilagoditi.
Avoid taking Cotellic with grapefruit juice.
Zdravilo Cotellic s hrano in pijačo Izogibajte se jemanju zdravila Cotellic z grenivkinim sokom, ker bi lahko ta povečal količino zdravila
Hyperkeratosis has been reported with a lower frequency in the Cotellic plus vemurafenib vs placebo plus vemurafenib arm (all Grade: 11% vs 30%).
Pogostnost hiperkeratoze je bila v skupini z zdravilom Cotellic in vemurafenibom manjša kot v skupini s placebom in vemurafenibom (vse stopnje: 11 % v primerjavi s 30 %).
Laboratory abnormalities
Laboratorijska odstopanja
3rd Appearance
3. pojav
Rhabdomyolysis has been reported in patients receiving Cotellic (see section 4.8).
Pri bolnikih, ki prejemajo zdravilo Cotellic, so poročali o rabdomiolizi (glejte poglavje 4.8).
Recommended Cotellic dose modification
Priporočene prilagoditve odmerka zdravila Cotellic