FrancophonIA/ELRC3.0 huggingface dataset:
English: Rare ≥ 1/10,000 to < 1/1,000
Maltese: Mhux komuni ≥ 1/1,000 sa < 1/100 Rari ≥ 1/10,000 sa < 1/1,000
English: (or ≥ 10% absolute decrease from baseline)
Maltese: (jew tnaqqis assolut ta' ≥ 10% mil-linja bażi)
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Maltese: Informazzjoni ddettaljata dwar din il-mediċina tinsab fuq is-sit web tal-Aġenzija Ewropea għallMediċini: http://www.ema.europa.eu.
English: · Risk Management Plan (RMP)
Maltese: Pjan tal-Ġestjoni tar-Riskju (RMP)
English: 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).
Maltese: Punti finali sekondarji tal-effikaċja kienu jinkludu sopravivenza ġlobali (OS - overall survival), rata ta' rispons oġġettiv, tul tar-rispons (DoR - duration of response) kif evalwat mill-INV u PFS kif evalwata minn faċilità ta' analiżi indipendenti (IRF
English: Malta (see Ireland)
Maltese: Malta (ara Renju Unit)
English: ADRs which were reported in melanoma patients are listed below by MedDRA body system organ class, frequency and grade of severity.
Maltese: L-ADRs li kienu rrappurtati f'pazjenti b'melanoma huma elenkati hawn taħt skont il-klassi tas-sistemi u tal-organi tal-ġisem MedDRA, il-frekwenza u l-grad ta' severità.
English: Grade 2 (intolerable) or Grade ≥3 photosensitivity: Cotellic and vemurafenib should be interrupted until resolution to Grade ≤1.
Maltese: Fotosensittività ta' Grad 2 (intollerabbli) jew ta' Grad ≥3: Cotellic u vemurafenib għandhom jiġu interrotti sakemm ikun hemm titjib għal Grad ≤1.
English: Results of the BRAFi naïve population from Study NO25395 were generally consistent with those from Study GO28141.
Maltese: Riżultati tal-popolazzjoni li qatt ma ħadet BRAF minn Studju NO25395 ġeneralment kienu konsistenti ma' dawk minn Studju GO28141.
English: White, round film-coated tablets of approximately 6.6 mm diameter, with “COB” debossed on one side.
Maltese: Pilloli miksija b'rita bojod u tondi b'dijametru ta' madwar 6.6 mm, b'“COB” imnaqqxa fuq naħa waħda.
English: The median estimate for independent review of PFS was 11.3 months for the Cotellic plus vemurafenib arm vs. 6.0 months for the placebo plus vemurafenib arm (HR 0.60 (0.45; 0.79); p-value = 0.0003).
Maltese: vemurafenib kontra 6.0 xhur għall-grupp ta' plaċebo flimkien ma' vemurafenib (HR 0.60 (0.45; 0.79);
English: The safety of Cotellic in combination with vemurafenib has also been evaluated in 129 patients with advanced BRAF V600 mutated melanoma in Study NO25395.
Maltese: Is-sigurtà tal-Cotellic flimkien ma' vemurafenib ġiet evalwata wkoll f'129 pazjenti li għandhom melanoma avanzata b'mutazzjoni BRAF V600 fl-Istudju NO25395.
English: The BRAFi-naïve patients (n=63) attained an 87% objective response rate, including a complete response in 16% of patients.
Maltese: Pazjenti li qatt ma kienu ħadu BRAFi qabel (n=63) laħqu rata ta' rispons oġġettiv ta' 87%, inkluż rispons komplut f'16% tal-pazjenti.
English: If haemorrhage occurs, treat as clinically indicated (see section 4.2 and 4.4).
Maltese: Jekk isseħħ emorraġija, ittratta kif indikat klinikament (ara sezzjoni 4.2 u 4.4)..
English: 1st occurrence: 40 mg nd occurrence: 20 mg rd occurrence: permanent discontinuation
Maltese: L-ewwel dehra: 40 mg It-tieni dehra: 20 mg It-tielet dehra: twaqqif permanenti
English: The intracranial activity of cobimetinib is currently unknown (see sections 5.1 and 5.2).
Maltese: cobimetinib fil-preżent mhux magħrufa (ara sezzjonijiet 5.1 u 5.2).
English: In vitro, cobimetinib produced moderate hERG ion channel inhibition (IC50= 0.5 µM [266 ng/mL]), which is approximately 18 fold higher than peak plasma concentrations (Cmax) at the 60 mg to be marketed dose (unbound Cmax=14 ng/mL [0.03 µM]).
Maltese: [266 ng/mL]), li hija madwar 18-il darba ogħla mill-konċentrazzjonijiet massimi fil-plażma (Cmax) bid doża ta' 60 mg li għandha titqiegħed fis-suq (Cmax mhux marbut =14 ng/mL [0.03 µM]).
English: Median time to initial onset of events was 4 months (1-13 months).
Maltese: Iż-żmien medjan sa bidu inizjali ta' avvenimenti kien ta' 4 xhur (firxa 1-13-il xahar).
English: Rhabdomyolysis
Maltese: Rispons parzjali
English: What Cotellic is Cotellic is an anti-cancer medicine that contains the active substance cobimetinib.
Maltese: Cotellic huwa mediċina kontra l-kanċer li fih is-sustanza attiva cobimetinib.
English: Pharmacotherapeutic group: Antineoplastic agents, ATC code: L01XE38
Maltese: Sustanzi antineoplastiċi, kodiċi ATC:
English: Duration of Response (DoR) Median DoR (months) (95% CI) for median NE = Not evaluable a
Maltese: Tul tar-Rispons (DoR - Duration of Response) DoR medjan (xhur) (CI ta' 95%) għal medjan
English: In toxicology studies, degenerative changes were observed in reproductive tissues including increased apoptosis/necrosis of corpora lutea and seminal vesicle, epididymal and vaginal epithelial cells in rats, and epididymal epithelial cells in dogs.
Maltese: kienu osservati bidliet deġenerattivi f'tessuti riproduttivi inkluż żieda ta' apoptożi/nekrożi tal-corpora lutea u tal-bużżieqa seminali, ċelluli tal-epitelju tal-epididime u tal-vaġina fil-firien, u ċelluli talepitelju tal-epididime fil-klieb.
English: · After the 21 days, do not take any Cotellic tablets for 7 days.
Maltese: Wara 21 ġurtana, tiħux pilloli Cotellic għal 7 ijiem.
English: The recommended dose is 3 tablets (a total of 60 mg) once a day.
Maltese: Id-doża rakkomandata hija 3 pilloli (total ta' 60 mg) darba kuljum.
English: St John's Wort a herbal medicine, used to treat depression.
Maltese: St John's Wort mediċina mill-ħxejjex, tintuża għall-kura tad-depressjoni.
English: The tablets contain lactose (a type of sugar).
Maltese: Il-pilloli fihom lactose (tip ta' zokkor).
English: Effects of cobimetinib on drug transport systems
Maltese: Effetti ta' cobimetinib fuq prodotti mediċinali oħra
English: The clinical relevance of these findings has not been investigated.
Maltese: Irrilevanza klinika ta' dawn is-sejbiet ma ġietx investigata.
English: Cobimetinib is metabolized by CYP3A and cobimetinib AUC increased approximately 7 fold in the presence of a strong CYP3A inhibitor (itraconazole) in healthy subjects.
Maltese: Cobimetinib huwa metabolizzat minn CYP3A u l-AUC ta' cobimetinib żdiedet b'madwar 7 darbiet fil-preżenza ta' inibitur qawwi ta' CYP3A (itraconazole) f'individwi f'saħħithom.
English: NAME OF THE MEDICINAL PRODUCT Cotellic 20 mg film-coated tablets cobimetinib
Maltese: Cotellic 20 mg pilloli miksija b'rita cobimetinib
English: 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).
Maltese: Żidiet mingħajr sintomi fil-livelli ta' CPK fid-demm kienu osservati bi frekwenza ogħla fil-grupp ta' Cotellic flimkien ma' vemurafenib kontra l-grupp ta' plaċebo flimkien ma' vemurafenib fi Studju GO28141 (ara sezzjoni 4.2 u 4.4).
English: N/A = Not Applicable
Maltese: N/A = Mhux applikabbli
English: Cobimetinib was extensively metabolised and eliminated in faeces.
Maltese: Cobimetinib kien metabolizzat u eliminat b'mod estensiv fl-ippurgar.
English: Systemic total cobimetinib exposures after a single dose were similar in subjects with mild or moderate hepatic impairment compared to healthy subjects, while subjects with severe hepatic impairment had lower total cobimetinib exposures (AUC0-∞ geometric mean ratio of 0.69 compared to healthy subjects) which is not considered to be clinically significant.
Maltese: Esponimenti sistemiċi wara doża waħda kienu simili f'individwi b'indeboliment ħafif jew moderat tal-fwied meta mqabbla ma' individwi f'saħħithom, filwaqt li individwi b'indeboliment sever tal-fwied kellhom esponimenti għal cobimetinib aktar baxxi (proporzjon tal-medja ġeometrika tal-AUC0-∞ ta' 0.69 imqabbel ma' individwi f'saħħithom) li mhumiex meqjusa bħala klinikament sinifikanti.
English: Therefore, concomitant use of moderate and strong CYP3A inducers (e.g. carbamazepine, rifampicin, phenytoin, and St. John's Wort) should be avoided.
Maltese: Għalhekk, l-użu fl-istess waqt ta' indutturi moderati u qawwija ta' CYP3A (eż. carbamazepine, rifampicin, phenytoin, u St.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 20 November 2015
Maltese: 20 ta' Novembru 2015
English: Strong CYP3A inhibitors include, but are not limited to ritonavir,
Maltese: Inibituri qawwija ta' CYP3A jinkludu, iżda mhumiex limitati għal,
English: Basal cell carcinoma, Cutaneous squamous cell carcinoma**, Keratoacanthoma**
Maltese: Karċinoma taċ-ċellula bażi, Karċinoma taċċelluli skwamużi talġilda**,
English: Among patients who had progressed on vemurafenib (n=66), the objective response rate was 15%.
Maltese: Fost pazjenti li kellhom progressjoni fuq vemurafenib (n=66), ir-rata ta' rispons oġġettiv kienet ta' 15%.
English: Placebo plus Vemurafenib (n = 246)
Maltese: Placebo flimkien ma' Vemurafenib (n = 246)
English: Blood creatine phosphokinase increase
Maltese: Żieda ta' creatine phosphokinase fid-demm
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.
Maltese: Pazjenti ta' ≥65 sena kienu aktar probabbli li jkollhom avvenimenti avversi serji (SAEs - serious adverse events) u esperjenza ta' AEs li jwasslu għat-twaqqif ta' cobimetinib minn dawk ta' <65 sena.
English: Among the 63 BRAFi naïve patients, 20 patients had received prior systemic therapy for advanced melanoma with the majority (80%) being immunotherapy.
Maltese: Fost it-63 pazjent li qatt ma kienu ħadu BRAFi qabel, 20 pazjent kienu rċevew terapija sistemika għal melanoma avanzata minn qabel bil-maġġoranza (80%) ta' din tkun immunoterapija.
English: Effects of other medicinal products on cobimetinib
Maltese: Interazzjoni ma' prodotti mediċinali oħra u forom oħra ta' interazzjoni Effetti ta' prodotti mediċinali oħra fuq cobimetinib
English: ADR frequencies are based upon the safety analysis of patients treated with cobimetinib plus vemurafenib with a median follow up of 11.2 months (data cut-off date of 19 September 2014).
Maltese: Il-frekwenzi tal-ADR huma bbażati fuq l-analiżi tas-sigurtà ta' pazjenti ttrattati b'cobimetinib flimkien ma' vemurafenib b'segwitu medjan ta' 11.2 xhur (data meta waqqfet tinġabar id-dejta 19 ta'
English: Serous retinopathya, Blurred vision
Maltese: Retinopatija seruża
English: Asymptomatic CPK elevations
Maltese: GĦAMLA KWALITATTIVA
English: Dose modification advice for rhabdomyolysis and Creatine phosphokinase (CPK) elevations Rhabdomyolysis or symptomatic CPK elevations
Maltese: Rakkomandazzjoni dwar modifikazzjoni fid-doża għal rabdomijolisi u żidiet ta' Creatine phosphokinase (CPK)
English: Cotellic is for oral use.
Maltese: Cotellic huwa għal użu orali.
English: No oxidative metabolites greater than 10% of total circulating radioactivity or human specific metabolites were observed in plasma.
Maltese: Ma kienu osservati l-ebda metaboliti ossidattivi akbar minn 10% tar-radjuattività totali fiċ-ċirkolazzjoni jew metaboliti speċifiċi umani fil-plażma.
English: This study treated 129 patients with Cotellic and vemurafenib: 63 were BRAF inhibitor (BRAFi) therapy naïve and 66 patients had previously progressed on prior vemurafenib therapy.
Maltese: F'dan l-istudju kienu ttrattati 129 pazjent b'Cotellic u vemurafenib: 63 qatt ma kienu rċevew terapija b'inibitur ta' BRAF (BRAFi) qabel u 66 pazjent kellhom progressjoni waqt li kienu qed jirċievu terapija preċedenti ta' vemurafenib.
English: The mean elimination half-life following oral dosing of cobimetinib was 43.6 hours (range: 23.1 to 69.6 hours).
Maltese: Il-half-life medja tal-eliminazzjoni wara dożaġġ orali ta' cobimetinib kienet ta' 43.6 sigħat (firxa: 23.1 sa 69.6 sigħat).
English: Vemurafenib dosing can be continued when Cotellic treatment is interrupted, if clinically indicated.
Maltese: Id-doża ta' Cotellic u/jew ta' vemurafenib tista' tiġi interrotta temporanjament u/jew imnaqqsa kif indikat klinikament.
English: The following convention has been used for the classification of frequency:
Maltese: Intużat il-konvenzjoni li ġejja għall-klassifikazzjoni tal-frekwenza:
English: The pharmacokinetics of cobimetinib were evaluated in 6 subjects with mild hepatic impairment (Child Pugh A), 6 subjects with moderate hepatic impairment (Child Pugh B), 6 subjects with severe hepatic impairment (Child Pugh C) and 10 healthy subjects.
Maltese: Pugh A), f'6 individwi b'indeboliment moderat tal-fwied (Child Pugh B), f'6 individwi b'indeboliment sever tal-fwied (Child Pugh Ċ) u f'10 individwi f'saħħithom.
English: Continue at current dose
Maltese: Proporzjon ta' periklu
English: ADRs are based on results from a multi-centre, randomised, double-blind, placebo-controlled, Phase III Study (GO28141) that evaluated the safety and efficacy of Cotellic in combination with vemurafenib as compared to vemurafenib alone in previously untreated BRAF V600 mutation-positive patients with unresectable locally advanced (Stage IIIc) or metastatic melanoma (Stage IV).
Maltese: III, b'aktar minn ċentru wieħed, randomised, double-blind, ikkontrollat bil-plaċebo (GO28141), li evalwa is-sigurtà u l-effikaċja ta' Cotellic flimkien ma' vemurafenib meta mqabbla ma' vemurafenib waħdu f'pazjenti li ma kinux ikkurati qabel, b'melanoma avanzata lokalment li ma tistax titneħħa (Stadju IIIc) jew metastatika (Stadju IV)
English: Assessed and confirmed by the investigator (INV) using RECIST v1.1 b Stratified analysis by geographic region and metastasis classification (disease stage)
Maltese: Evalwat u kkonfermat mill-investigatur (INV) bl-użu ta' RECIST v1.1
English: Visual disturbances have been reported in some patients treated with cobimetinib during clinical trials (see sections 4.4 and 4.8).
Maltese: Disturbi fil-vista kienu rrappurtati f'xi pazjenti kkurati b'cobimetinib waqt provi kliniċi (ara sezzjonijiet 4.4 u 4.8).
English: Patients with a baseline LVEF either below institutional lower limit of normal (LLN) or below 50% have not been studied.
Maltese: Pazjenti b'LVEF fil-linja bażi taħt il-limitu istituzzjonali l-aktar baxx tan-normal (LLN - lower limit of normal) jew taħt 50% ma ġewx studjati.
English: BATCH NUMBER
Maltese: Mhux bojod
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: Rapporti Perjodiċi Aġġornati dwar is-Sigurtà Ir-rekwiżiti biex jiġu ppreżentati rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont lArtikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq ilportal web Ewropew tal-mediċini.
English: Muscle problems (uncommon: may affect up to 1 in 100 people) Cotellic can result in the breakdown of muscle (rhabdomyolysis), symptoms may include: · muscle aches · muscle spasms and weakness · dark- or red-coloured urine.
Maltese: Problemi fil-muskoli (mhux komuni: jistgħu jaffettwaw sa persuna waħda minn kull 100) Cotellic jista' jwassal fil-kollass Suggest jinħallu l-muskoli (rabdomajolisi), Sintomi jistgħu jinkludu: · uġigħ fil-muskoli
English: Standard genotoxicity studies with cobimetinib were negative.
Maltese: Studji standard dwar l-effett tossiku fuq il-ġeni b'cobimetinib kienu negattivi.
English: Significant improvement in the primary endpoint, investigator-assessed PFS, was observed in patients assigned to the Cotellic plus vemurafenib arm compared to the placebo plus vemurafenib arm (HR 0.51 (0.39; 0.68); p-value < 0.0001).
Maltese: plaċebo flimkien ma' vemurafenib (HR 0.51 (0.39; 0.68); valur p < 0.0001).
English: 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
Maltese: Ib, NO25395, li kien maħsub biex jiġu evalwati is-sigurtà, it-tollerabilità, il-farmakokinetika u l-effikaċja ta' Cotellic meta jiġi miżjud ma'
English: In a repeat dose toxicity study in juvenile rats, cobimetinib systemic exposures were 2 to11 fold higher on post natal day 10 than on post natal day 38 when exposures were similar to those in adult rats.
Maltese: Fi studju dwar l-effett tossiku minn dożi ripetuti f'firien frieħ, espożizzjonijiet sistemiċi għal cobimetinib kienu 2 sa 11-il darba ogħla f'jum 10 wara t-twelid milli f'jum 38 wara t-twelid meta l espożizzjonijiet kienu simili għal dawk f'firien adulti.
English: The safety of Cotellic in combination with vemurafenib has been evaluated in 247 patients with advanced BRAF V600 mutated melanoma in Study GO28141.The median time to onset for the first Grade ≥3 adverse events was 0.6 months in the Cotellic plus vemurafenib arm vs 0.8 months in the placebo plus vemurafenib arm.
Maltese: Is-sigurtà ta' Cotellic flimkien ma' vemurafenib kienet evalwata f'247 pazjent b'melanoma avanzata b'mutazzjoni BRAF V600 fi Studju GO28141.
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
Maltese: Fil-mudelli ta' qabel l-użu kliniku, il-kombinazzjoni ta' cobimetinib u vemurafenib uriet li jekk jiġu mmirati fl-istess waqt proteini b'mutazzjoni BRAF V600 u proteini MEK f'ċelluli tal-melanoma, ilkombinazzjoni taż-żewġ prodotti tinibixxi l-attivazzjoni mill-ġdid tar-rotta MAPK permezz ta' MEK1/2, li twassal għall-inibizzjoni aktar qawwija ta' sinjalar intraċellulari u proliferazzjoni taċ ċelluli tat-tumur imnaqqsa
English: Progression-Free Survival (PFS) Median (months) (95 % CI)
Maltese: Sopravivenza Mingħajr Progressjoni (PFS - Progression-free survival)
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.
Maltese: Wara dożaġġ orali ta' 60 mg f'pazjenti bil-kanċer, cobimetinib wera rata moderata ta' assorbiment b'Tmax medjana ta' 2.4 sigħat.
English: What Cotellic contains · The active substance is cobimetinib.
Maltese: Is-sustanza attiva hija cobimetinib.
English: Liver laboratory abnormalities, specifically ALT, AST, and ALP have been observed in patients treated with Cotellic in combination with vemurafenib (see section 4.4).
Maltese: Anormalitajiet tal-laboratorju tal-fwied, speċifikament ALT, AST, u ALP kienu osservati f'pazjenti kkurati b'Cotellic flimkien ma' vemurafenib (ara sezzjoni 4.4).
English: Interrupt treatment until Grade ≤ 1, restart treatment at 40 mg once daily (2 tablets)
Maltese: Waqqaf il-kura sa Grad ≤ 1, ibda l-kura mill-ġdid b'40 mg darba kuljum (2 pilloli)
English: Cotellic can cause increased levels of creatine phosphokinase, an enzyme that is found mainly in the muscle, heart, and brain.
Maltese: Cotellic jista' jikkawża żieda fil-livelli ta' creatine phosphokinase, enzima li tinsab prinċipalment fil muskoli, fil-qalb, u fil-moħħ.
English: Grade 3 events: Cotellic treatment should be interrupted during evaluation to avoid any potential contribution to the event.
Maltese: Każijiet ta' Grad 3: It-trattament b'Cotellic għandu jiġi interrott waqt l-evalwazzjoni biex tiġi evitata kull kontribuzzjoni potenzjali għall-każ.
English: Liver function test Increased ALP
Maltese: Test tal-funzjoni tal-fwied
English: Alternative agents with no or minimal CYP3A induction should be considered.
Maltese: Għandhom jiġu kkunsidrati sustanzi alternattivi bl-ebda induzzjoni jew b'induzzjoni minima ta' CYP3A.
English: In Study GO28141, the most common adverse reactions (>20%) observed with a higher frequency in the Cotellic plus vemurafenib arm were diarrhoea, rash, nausea, pyrexia, photosensitivity reaction, increased alanine aminotransferase, increased aspartate aminotransferase, increased blood creatine phosphokinase, and vomiting.
Maltese: Fi Studju GO28141, l-aktar reazzjonijiet avversi komuni (>20%) osservati bi frekwenza ogħla fil grupp ta' Cotellic flimkien ma' vemurafenib kienu, dijarea, raxx, dardir, deni, reazzjoni ta'
English: Within each frequency grouping, ADRs are presented in order of decreasing severity and were reported according to NCICTCAE v 4.0 (common toxicity criteria) for assessment of toxicity in Study GO28141.
Maltese: F'kull sezzjoni ta' frekwenza, l-ADRs huma mniżżla skont is-severità tagħhom, bl-aktar severi l-ewwel u kienu rrappurtati skont NCI-CTCAE v 4.0 (kriterji ta' tossiċità komuni) għall-valutazzjoni tat-tossiċità fi Studju GO28141.
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.
Maltese: Studji dwar l-effett tossiku fil-firien u l-klieb identifikaw bidliet deġenerattiv ġeneralment riversibbli fil-mudullun, fl-apparat gastrointestinali, fil-ġilda, fit-timu, fil-glandola adrenali, fil-fwied, fil-milsa, fil-glandola limfatika, fil-kliewi, fil-qalb, fl-ovarji, u fil-vaġina b'espożizzjonijiet fil-plażma taħt il livelli ta' effikaċja klinika.
English: No dose adjustment is required in patients aged ≥65 years old.
Maltese: Mhux meħtieġ aġġustament fid-doża f'pazjenti b'età ta' ≥65 sena.
English: In vitro studies show that cobimetinib is not a substrate of the liver uptake transporters OATP1B1, OATP1B3 and OCT1, however, it weakly inhibits these transporters.
Maltese: OATP1B1, OATP1B3 u OCT1, madankollu, dan jinibixxi b'mod dgħajjef lil dawn it-trasportaturi.
English: P-glycoprotein inhibitors
Maltese: X'inhu Cotellic
English: Other medicines and Cotellic
Maltese: Mediċini oħra u Cotellic
English: Gastrointestinal disorders
Maltese: GammaGlutamyltransferase
English: Hyperkeratosis has been reported with a lower frequency in the Cotellic plus vemurafenib vs placebo plus vemurafenib arm (all Grade: 11% vs 30%).
Maltese: vemurafenib kontra l-grupp tal-plaċebo flimkien ma' vemurafenib (kull Grad: 11% kontra 30%).
English: Keratoacanthoma has been reported with a lower frequency in the Cotellic plus vemurafenib arm vs placebo plus vemurafenib arm (all Grade: 2% vs 9%).
Maltese: Keratoakantoma kienet irrappurtata bi frekwenza aktar baxxa fil-grupp ta' Cotellic flimkien ma' vemurafenib kontra l-grupp tal-plaċebo flimkien ma' vemurafenib (kull Grad: 2% kontra 9%).
English: Moderate CYP3A inhibitors (see section 4.4.
Maltese: Inibituri qawwija ta' CYP3A (see sezzjoni 4.4.): Evita użu fl-istess waqt ta' inibituri qawwija ta'
English: Median time to initial onset of serous retinopathy events was 1 month (range 0-9 months).
Maltese: Iż-żmien medjan sa bidu inizjali ta' avvenimenti ta' retinopatija seruża kien ta' xahar (firxa 0-9 xhur).
English: There were no apparent trends in the time of onset of Grade ≥3 events.
Maltese: Ma kienx hemm tendenzi evidenti fil-ħin ta' bidu ta' avvenimenti ta' Grad ≥3.
English: Cotellic can cause eye problems (see also “Eye (vision) problems” in Section 4).
Maltese: Cotellic jista' jnaqqas l-ammont ta' demm ippumpjat mill-qalb tiegħek (ara wkoll “Problemi fil-qalb” fis-Sezzjoni 4).
English: Only patients with ECOG performance status 0 and 1 were enrolled in Study GO28141.
Maltese: Pazjenti bi stat ta' ħila ta' ECOG ta' 0 u 1 biss iddaħħlu fi Studju GO28141.