FrancophonIA/ELRC3.0 huggingface dataset:
English: In adult rats, mineralisation of multiple organs was associated with increased serum phosphorus and was closely associated with necrosis in heart, liver and kidney and haemorrhage in the lung at exposures comparable to the human clinical exposure.
Maltese: Fil-firien adulti, mineralizzazzjoni ta' organi multipli kienet assoċjata ma' żieda tal-fosfru fis-serum u kienet assoċjata mill-qrib ma' nekrożi fil-qalb, fil-fwied u fil-kliewi u fl-emorraġija fil-pulmun f'espożizzjonijiet komparabbli għall-esponiment kliniku uman.
English: The trametinib 2 mg once daily and dabrafenib 150 mg twice daily combination demonstrated limited clinical activity in patients who had progressed on a BRAF inhibitor (see section 4.4).
Maltese: Il-kombinazzjoni ta' trametinib 2 mg darba kuljum u dabrafenib 150 mg darbtejn kuljum uriet attività klinika limitata f'pazjenti li wrew progress fuq inibitur BRAF (ara sezzjoni 4.4).
English: Results for the primary analysis of RFS are presented in Table 13.
Maltese: Ir-riżultati tal-analiżi primarja ta' RFS huma ppreżentati f'Tabella 13.
English: The most common adverse reactions (incidence 20%) for trametinib in combination with dabrafenib were: pyrexia, fatigue, nausea, chills, headache, diarrhoea, vomiting, arthralgia and rash.
Maltese: L-aktar reazzjonijiet avversi komuni (inċidenza ta' ≥ 20%) għal trametinib flimkien ma' dabrafenib kienu: deni, għejja, dardir, tertir ta' bard, uġigħ ta' ras, dijarrea, rimettar, artralġja u raxx.
English: Tablet film coating Hypromellose (E464) Titanium dioxide (E171) Polyethylene glycol Polysorbate 80 (E433) Iron oxide red (E172)
Maltese: Kisja tal-pillola b'rita Hypromellose (E464) Titanium dioxide (E171) Polyethylene glycol Polysorbate 80 (E433) Iron oxide red (E172)
English: Subjects were stratified by lactate dehydrogenase (LDH) level (> the upper limit of normal (ULN) versus ULN) and BRAF mutation (V600E versus V600K).
Maltese: L-endpoint primarju tal-istudju kien OS b'endpoint sekondarju ewlieni ta' PFS. Lindividwi kienu stratifikati b'livell ta' lactate dehydrogenase (LDH) (> il-limitu massimu tan-normal (ULN) versus  ULN) u mutazzjoni BRAF (V600E versus V600K).
English: The majority of subjects had Stage IVM1c disease (67%).
Maltese: Il-maġġoranza tal-individwi kellhom marda flIstadju IVM1c (67%).
English: The assay was designed to detect the BRAF V600E and V600K mutations with high sensitivity (down to 5% V600E and V600K sequence in a background of wild-type sequence using DNA extracted from FFPE tissue).
Maltese: Il-prova kienet maħsuba biex tikxef il-mutazzjonijiet BRAF V600E u V600K b'sensittività għolja (bi tnaqqis sa 5% fis-sekwenza ta' V600E u V600K fi sfond ta' sekwenza tat-tip selvaġġ bl-użu ta' DNA estratt minn tessut tal-FFPE).
English: In these patients a 13% (95% CI: 5.0, 27.0) confirmed response rate was observed with a median PFS of 3.6 months (95% CI: 2, 4).
Maltese: F'dawn il-pazjenti ġiet osservata rata ta' rispons ikkonfermata ta' 13% (95% CI: 5.0, 27.0) b'PFS medja ta' 3.6 xhur (95% CI: 2, 4).
English: Discontinue permanently, or interrupt therapy until Grade 0 to 1 and reduce by one dose level when resuming therapy.
Maltese: Waqqaf għal kollox, jew interrompi t-terapija sa Grad 0-1 u naqqas b'livell ta' doża waħda meta terġa' tibda t-terapija.
English: • Decreased red blood cells (anaemia), abnormal test related to creatine phosphokinase, an enzyme found mainly in heart, brain, and skeletal muscle
Maltese: • Tnaqqis taċ-ċelluli ħomor tad-demm (anemija), test mhux normali relatat mal creatine phosphokinase, enzima li tinsab prinċipalment fil-qalb, fil-moħħ, u fil-muskoli skeletali
English: In patients with BRAF and NRAS mutation positive melanoma, administration of trametinib resulted in dose-dependent changes in tumour biomarkers including inhibition of phosphorylated ERK, inhibition of Ki67 (a marker of cell proliferation), and increases in p27 (a marker of apoptosis).
Maltese: F'pazjenti b'melanoma pożittiva għal mutazzjonijiet BRAF u NRAS, l-għoti ta' trametinib irriżultat f'bidliet dipendenti fuq id-doża fil-bijomarkaturi tat-tumur inkluż inibizzjoni ta' ERK fosforilat, inibizzjoni ta' Ki67 (markatur ta' proliferazzjoni taċ-ċelluli), u żidiet fil-P27 (markatur ta' apoptożi).
English: In a Phase III trial, 2.4% (5/211) of patients treated with trametinib monotherapy developed ILD or pneumonitis; all five patients required hospitalisation.
Maltese: Fi prova tal-Fażi III, 2.4% (5/211) tal-pazjenti kkurati b'monoterapija bi trametinib żviluppaw ILD jew pulmonite; il-ħames pazjenti kollha kellhom bżonn ta' rikoveru l-isptar.
English: When trametinib is used in combination with dabrafenib and the patient's temperature is ≥38.5
Maltese: Meta trametinib jintuża flimkien ma' dabrafenib u t-temperatura tal-pazjent tkun ≥ 38.5
English: Interrupt therapy until toxicity is Grade 0 to 1 and reduce by one dose level when resuming therapy.
Maltese: Interrompi t-terapija sakemm tossiċità hija ta' Grad 0 sa 1u naqqas b'livell ta' doża waħda meta terġa' tibda t-terapija.
English: Trametinib accumulates with repeat daily dosing with a mean accumulation ratio of 6.0 at 2 mg once daily dose.
Maltese: Trametinib jakkumula b'dożaġġ ripetut ta' kuljum bi proporzjon medju ta' akkumulazzjoni ta' 6.0 sa doża ta' 2 mg darba kuljum.
English: Rash has been observed in about 60% of patients in trametinib monotherapy studies and in about 24% of patients when trametinib is used in combination with dabrafenib (see section 4.8).
Maltese: Ir-raxx kien osservat f'madwar 60% tal-pazjenti fi studji ta' monoterapija bi trametinib u f'madwar 24% tal-pazjenti meta trametinib jintuża flimkien ma' dabrafenib (ara sezzjoni 4.8).
English: In the previously-treated population, 38 patients (67%) had one line of systemic anti-cancer therapy for metastatic disease.
Maltese: Fil-popolazzjoni kkurata qabel, 38 pazjent (67%) kellhom tip wieħed ta' terapija sistemika kontra l-kanċer għal mard metastatiku.
English: Of these patients, 559 were treated with the combination for BRAF V600 mutant melanoma in two randomised Phase III studies, MEK115306 (COMBI-d) and MEK116513 (COMBI-v), 435 were treated with the combination in the adjuvant treatment of Stage III BRAF V600 mutant melanoma after complete resection in a randomised Phase III study BRF115532 (COMBI-AD) and 82 were treated with the combination for BRAF V600 mutant NSCLC in a multi-cohort, non-randomised Phase II study BRF113928 (see section 5.1).
Maltese: III, MEK115306 (COMBI-d) u MEK116513 (COMBI-v), 435 kienu ttrattati b'taħlita ta' trattament adjuvanti ta' melanoma fi Stadju III b'mutazzjoni BRAF V600 wara tneħħija sħiħa b'intervent kirurġiku waqt studju randomizzat BRF115532 (COMBI-AD) f'Fażi III u 82 kienu kkurati bilkombinazzjoni għal NSCLC bil-mutazzjoni BRAF V600 fi studju mhux randomizzat, b'diversi gruppi ta' Fażi
English: In embryo-foetal developmental toxicity studies in rats and rabbits, trametinib induced maternal and developmental toxicity.
Maltese: Fi studji ta' tossiċità tal-iżvilupp embrijofetali, trametinib ta' bidu għal tossiċità materna u tal-iżvilupp.
English: Left ventricular ejection fraction (LVEF) reduction/Left ventricular dysfunction Trametinib should be interrupted in patients who have an asymptomatic, absolute decrease of >10% in LVEF compared to baseline and the ejection fraction is below the institution's lower limit of normal (LLN) (see section 4.4).
Maltese: Tnaqqis tal-frazzjoni tal-ħruġ ventrikolari tax-xellug (LVEF)/ disfunzjoni ventrikulari tax-xellug Trametinib għandu jitwaqqaf f'pazjenti li jkollhom tnaqqis asintomatiku assolut ta' > 10% fl-LVEF meta mqabbla mal-linja bażi u l-frazzjoni tal-ħruġ huwa taħt il-limitu minimu tal-istituzzjoni tannormal (LLN) (ara sezzjoni 4.4).
English: In clinical trials with the combination of trametinib and dabrafenib 11 patients reported trametinib overdose (4 mg); no SAEs were reported.
Maltese: Fi provi kliniċi bil-kombinazzjoni ta' trametinib u dabrafenib kien hemm 11il pazjent li rrapportaw li ħadu doża eċċessiva ta' trametinib (4 mg); ma ġewx irrapportati SAEs.
English: Non-clinical and clinical trials with retrospective bi-directional Sanger sequencing analyses have shown that the test also detects the less common BRAF V600D mutation and V600E/K601E mutation with lower sensitivity.
Maltese: Studji mhux kliniċi u provi kliniċi b'analiżi b'sekwenzar Sanger retrospettivi bidirezzjonali urew li ttest jikxef ukoll il-mutazzjonijiet inqas komuni BRAF V600D u V600E/K601E b'sensittività mnaqqsa.
English: In rats, hepatocellular necrosis and transaminase elevations were seen after 8 weeks at ≥0.062 mg/kg/day (approximately 0.8 times human clinical exposure based on AUC).
Maltese: Fil-firien, ġew osservati nekrożi epatoċellulari u żidiet fit-transaminase wara 8 ġimgħat bi ≥ 0.062 mg/kg/jum (madwar 0.8 drabi l-esponiment kliniku uman ibbażat fuq l-AUC).
English: Drug-related material was excreted predominantly in the faeces (>80% of recovered radioactivity) and to a minor extent in urine (≤19%).
Maltese: B'mod predominanti, il-materjal relatat mal-mediċina tneħħa fl-ippurgar (80% tar-radjuattività rkuprata) u sa ċertu punt minuri fl-awrina (≤19%).
English: Treatment with trametinib monotherapy or in combination with dabrafenib should be used with caution in patients with risk factors for gastrointestinal perforation, including history of diverticulitis, metastases to the gastrointestinal tract and concomitant use of medicinal products with a recognised risk of gastrointestinal perforation.
Maltese: It-trattament b'trametinib bħala monoterapija jew flimkien ma' dabrafenib għandu jingħata b'għaqal f'pazjenti li jinsabu f'riskju ta' perforazzjoni gastrointestinali, inkluż bi storja ta' divertikulite, metastażi filpassaġġ gastrointestinali u meta jingħata flimkien ma' prodotti mediċinali li għandhom riskju magħruf ta' perforazzjoni gastrointestinali.
English: Among the total of 93 patients who were enrolled in the combination therapy cohorts B and C, most patients were Caucasian (>90%), and similar female versus male (54% versus 46%), with a median age of 64 years in second-line or higher patients and 68 years in the first-line patients.
Maltese: Fost it-total ta' 93 pazjent li kienu rreġistrati fil-gruppi B u C ta' terapija ta' kombinazzjoni, il-biċċa lkbira tal-pazjenti kienu Kawkażjatiċi (>90%), kien hemm ammont simili ta' nisa u rġiel (54% f'paragun ma' 46%), b'età medjana ta' 64 sena f'pazjenti fuq terapija tat-tieni linja u ogħla u 68 sena fil-pazjenti fuq terapija tal-ewwel linja.
English: Cough Dyspnoea
Maltese: Sogħla Dispnea
English: DoRc (months) Median (95% CI)
Maltese: DoRċ (xhur) Medju (95% CI)
English: Most subjects were Caucasian (>99%) and male (53%), with a median age of 56 years (28% were ≥65 years).
Maltese: Il-biċċa l-kbira tal-individwi kienu Kawkażjatiċi (> 99%) u rġiel (53%), b'età medja ta' 56 sena (28% kellhom l-età ta' ≥ 65 sena).
English: Trametinib monotherapy has not demonstrated clinical activity in patients who have progressed on a prior BRAF inhibitor therapy (see section 5.1).
Maltese: Monoterapija bi trametinib ma wriet ebda attività klinika f'pazjenti li wrew progress fuq terapija ta' inibituri BRAF qabel (ara sezzjoni 5.1).
English: Mucosal inflammation Face oedema
Maltese: Vista mċajpra Edema periorbitali
English: Similar results were seen in the 45 patients who crossed over from dabrafenib monotherapy to the trametinib 2 mg once daily and dabrafenib 150 mg twice daily combination in Part C of this study.
Maltese: Ġew osservati riżultati simili fil-45 pazjent li qasmu millmonoterapija b'dabrafenib għat-terapija b'kombinazzjoni ta' trametinib 2 mg darba kuljum u dabrafenib 150 mg darbtejn kuljum fil-Parti Ċ ta' dan l-istudju.
English: In the Phase III study with trametinib in patients with unresectable or metastatic melanoma (n=211), 49 patients (23%) were ≥65 years of age, and 9 patients (4%) were ≥75 years of age.
Maltese: III bi trametinib, f'pazjenti b'melanoma li ma setgħetx titneħħa jew metastatika (n = 211), 49 pazjent (23%) kellhom ≥ 65 sena, u 9 pazjenti (4%) kellhom ≥ 75 sena.
English: Not known (cannot be estimated from the available data) Categories have been assigned based on absolute frequencies in the clinical trial data.
Maltese: Il-kategoriji ġew assenjati abbażi tal-frekwenzi assoluti fid-dejta tal-provi kliniċi.
English: The secondary endpoints were PFS in the ITT population and OS, ORR, and DoR in the primary efficacy population and ITT population.
Maltese: L-endpoints sekondarji kienu l-PFS fil-popolazzjoni ITT u l-OS, l-ORR, u d-DoR fil-popolazzjoni tal-effikaċja primarja u l-popolazzjoni ITT.
English: Patients (N=322) who were treatment naïve or may have received one prior chemotherapy treatment in the metastatic setting [Intent to Treat (ITT) population] were randomised 2:1 to receive trametinib 2 mg once daily or chemotherapy (dacarbazine 1000 mg/m every 3 weeks or paclitaxel 175 mg/m every 3 weeks).
Maltese: Pazjenti (N = 322) li qatt ma kienu ħadu l-kura qabel jew li setgħu rċevew kura kimoterapika waħda preċedenti fl-ambjent metastatiku [Popolazzjoni b'Intenzjoni li Tiġi Kkurata (ITT)] ġew randomizzati 2:1 biex jirċievu trametinib 2 mg darba kuljum jew kimoterapija (dacarbazine 1000 mg/m kull
English: Blood alkaline phosphatase increased Gamma-glutamyltransferase increased Blood creatine phosphokinase increased a The safety profile from MEK116513 is generally similar to that of MEK115306 with the following exceptions:
Maltese: Il-profil ta' sigurtà minn MEK116513 ġeneralment jixbah lil dak ta' MEK115306 bl-eċċezzjonijiet li ġejjin:
English: Trametinib may result in transient inhibition of BCRP substrates (e.g. pitavastatin) in the gut, which may be minimised with staggered dosing (2 hours apart) of these agents and trametinib.
Maltese: Trametinib jista' jirriżulta fl-inibizzjoni temporanja ta' substrati BCRP (eż. pitavastatin) fl-imsaren, li jista' jiġi minimizzat b'dożaġġ mqassam (sagħtejn apparti) ta' dawn issustanzi u trametinib.
English: The median age was 54 years (22% were 65 years); all patients had an ECOG performance score of 0 or 1; and 3 % had history of brain metastases.
Maltese: L-età medjana kienet 54 sena (22% kienu  65 sena); il-pazjenti kollha kellhom punteġġ ta' prestazzjoni ECOG ta' 0 jew 1; u 3% kellhom storja ta' metastasi fil-moħħ.
English: • Cohort B: Combination therapy (dabrafenib 150 mg twice daily and trametinib 2 mg once daily), 59 patients enrolled.
Maltese: • Grupp B: Terapija ta' kombinazzjoni (dabrafenib 150 mg darbtejn kuljum u trametinib 2 mg darba kuljum), 59 pazjent irreġistrati. 57 pazjent kellhom minn waħda sa tliet ta' kuri sistemiċi preċedenti għall-mard metastatiku tagħhom.
English: Dabrafenib + Placebo (n=212)
Maltese: Dabrafenib+ Plaċebo (n=212)
English: Patients with left ventricular dysfunction, New York Heart Association Class II, III, or IV heart failure, acute coronary syndrome within the past 6 months, clinically significant uncontrolled arrhythmias, and uncontrolled hypertension were excluded from clinical trials; safety of use in this population is therefore unknown.
Maltese: II, III jew IV ta' New York Heart Association, sindromu koronarju akut fl-aħħar 6 xhur, arritmiji klinikament sinifikanti mhux ikkontrollati, u pressjoni għolja mhux ikkontrollata kienu esklużi mill-provi kliniċi; is-sigurtà tal-użu f'din il-popolazzjoni għalhekk mhijiex magħrufa.
English: The median DoR and PFS were not yet estimable (Table 14).
Maltese: Id-DoR u l-PFS medjani kienu għadhom ma setgħux jiġu stmati (Tabella 14).
English: Adverse reactions are listed below by MedDRA body system organ class.
Maltese: Ir-reazzjonijiet avversi huma elenkati hawn taħt skont is-sistema tal-klassifika tal-organi tal-ġisem MedDRA.
English: The efficacy and safety of trametinib in combination with dabrafenib were studied in a Phase III, multicentre, randomised, double-blind, placebo-controlled study in patients with Stage III (Stage IIIA [lymph node metastasis >1 mm], IIIB, or IIIC) cutaneous melanoma with a BRAF V600 E/K mutation, following complete resection.
Maltese: III, multiċentriku, mhux randomizzat, double--blind, ikkontrollat bi plaċebo f'pazjenti b'melanoma fi Stadju III (Stadju IIIA, [metastasi tan-nodi limfatiċi >1 mm], IIIB jew IIIC) b'mutazzjoni BRAF V600 E/K fil-ġilda, wara tneħħija sħiħa b'intervent kirurġiku.
English: Effects of other drugs on trametinib: In vivo and in vitro data suggest that the pharmacokinetics of trametinib are unlikely to be affected by other medicinal products.
Maltese: Effetti ta' Mediċini Oħra fuq Trametinib: Dejta in vivo u in vitro tindika li l-PK ta trametinib mhuwiex probabbli li jiġi affettwat minn prodotti mediċinali oħrajn.
English: Vision blurred Visual impairment Uveitis
Maltese: Vista mċajpra Vista batuta Uveite
English: Combination with dabrafenib
Maltese: Kombinazzjoni ma' dabrafenib
English: Of the specimens from the non-clinical and clinical trials (n=876) that were mutation positive by the THxID BRAF assay and subsequently were sequenced using the reference method, the specificity of the assay was 94%.
Maltese: Mill-kampjuni mill-provi mhux kliniċi u kliniċi (n = 876) li kienu pożittivi għall-mutazzjoni mill-prova THxID BRAF u sussegwentement ġew sekwenzati permezz tal-metodu ta' referenza, lispeċifiċità tal-prova kienet 94%.
English: Table 11 Investigator-assessed efficacy results (ITT population)
Maltese: Tabella 11 L-investigatur evalwa r-riżultati tal-effikaċja (popolazzjoni ITT)
English: 1) The following adverse reactions have a higher frequency category as compared to MEK115306: muscle spasm (very common); renal failure and lymphoedema (common); acute renal failure (uncommon); 2) The following adverse reactions have occurred in MEK116513 but not in MEK115306: cardiac failure, left ventricular dysfunction, interstitial lung disease (uncommon).
Maltese: 1) Ir-reazzjonijiet mhux mixtieqa li ġejjin għandhom kategorija ta' frekwenza ogħla meta mqabbel ma' MEK115306: spażmi fil-muskoli (komuni ħafna); insuffiċjenza renali u limfoedema (komuni); insuffiċjenza renali akuta (mhux komuni); 2) Ir-reazzjonijiet mhux mixtieqa li ġejjin seħħew f'MEK116513 imma mhux f'MEK115306: insuffiċjenza kardijaka, disfunzjoni ventrikulari tax-xellug, mard interstizjali tal-pulmun (mhux komuni); 3) Ir-reazzjonijiet mhux mixtieqa li ġejjin seħħew f'MEK116513 u BRF115532 imma mhux f'MEK115306 u BRF113928: rabdomijolożi(mhux komuni) b Karċinoma taċ-ċelluli skwamużi tal-ġilda (cu SCC):
English: Most subjects were Caucasian (>96%) and male (55%), with a median age of 55 years (24% were ≥65 years).
Maltese: Ilbiċċa l-kbira tal-individwi kienu Kawkażjatiċi (> 96%) u rġiel (55%), b'età medja ta' 55 sena (24% kellhom l-età ta' ≥ 65 sena).
English: Effects of trametinib on drug-metabolising enzymes and transporters: In vitro and in vivo data suggest that trametinib is unlikely to affect the pharmacokinetics of other medicinal products.
Maltese: Effetti ta' trametinib fuq enzimi u trasportaturi metabolizzanti tal-mediċina: Dejta in vitro u in vivo tissuġġerixxi li trametinib x'aktarx ma jaffettwax il-farmakokinetiċi ta' prodotti mediċinali oħra.
English: In rats and dogs given trametinib at or below clinical exposures, bone marrow necrosis, lymphoid atrophy in thymus and GALT and lymphoid necrosis in lymph nodes, spleen and thymus were observed, which have the potential to impair immune function.
Maltese: Fil-firien u l-klieb li ngħataw trametinib fi jew taħt espożizzjonijiet kliniċi, ġew osservati nekrożi tal-mudullun, atrofija tal-limfojde fit-timu u GALT u nekrożi limfojde fin-nodi tal-limfa, fil-milsa u fit-timu, li għandhom il-potenzjal li jfixklu l-funzjoni immuni.
English: In clinical trials uveitis and iridocyclitis have also been reported in patients treated with trametinib in combination with dabrafenib.
Maltese: Fil-provi kliniċi, uveite u iridocyclitis kienu rrapportati wkoll f'pazjenti kkurati bi trametinib flimkien ma' dabrafenib.
English: Survival estimates at 1 and 2 years from randomisation were 97% and 91% in the combination arm and 94% and 83% in the placebo arm, respectively.
Maltese: Is-sopravivenza stmata f'sena u f'sentejn mir-randomizzazzjoni kienet 97% u 91% fil-grupp mogħti t-taħlita u 94% u 83% fil-grupp mogħti lplaċebo, rispettivament.
English: • Swelling of nerves at the back of the eye (papilloedema) (see also “Eye (vision) problems”
Maltese: • Nefħa tan-nervituri fuq wara tal-għajn (papilloedema) (ara wkoll "Problemi fl-għajnejn (vista)",
English: Mekinist can cause eye problems including blindness.
Maltese: Mekinist jista' jikkawża problemi fl-għajnejn inkluż għama.
English: Cases of cuSCC (including keratoacanthoma) have been reported in patients treated with trametinib in combination with dabrafenib.
Maltese: Ġew irrapportati każijiet ta' cuSCC (inkluża keratoakantoma) f'pazjenti kkurati bi trametinib flimkien ma' dabrafenib.
English: BATCH NUMBER
Maltese: Numru ta' mwiet
English: • Eyesight problems (see also “Eye (vision) problems” earlier in section 4)
Maltese: • Problemi fil-vista (ara wkoll "Problemi fl-għajnejn (vista)", aktar kmieni f'sezzjoni 4)
English: If RPED is diagnosed, follow the dose modification schedule in Table 3 below for trametinib (see section 4.4).
Maltese: Jekk jiġi dijanjostikat RPED, segwi l-iskeda ta' modifikazzjoni fid-doża fit-Tabella 3 hawn taħt għal trametinib (ara sezzjoni 4.4).
English: Pink, round, biconvex, film-coated tablets, approximately 7.5 mm, with “GS” debossed on one face and “HMJ” on the opposing face.
Maltese: Pilloli miksijin b'rita, bikonvessi, tondi, sofor ta' madwar 7.5 mm, b'‘GS' imnaqqxa fuq wiċċ wieħed u ‘HMJ' fuq in-naħa l-oħra.
English: Trametinib may impair female fertility in humans, as in repeat-dose studies, increases in cystic follicles and decreases in corpora lutea were observed in female rats at exposures below the human clinical exposure based on AUC.
Maltese: Trametinib jista' jfixkel il-fertilità femminili fil-bnedmin, hekk kif fi studji b'dożi ripetuti, żidiet filfollikuli ċistiċi u tnaqqis fil-corpora lutea ġew osservati fil-firien nisa f'espożizzjonijiet taħt lesponiment kliniku uman ibbażat fuq l-AUC.
English: The incidence and severity of pyrexia are increased with the combination therapy (see dabrafenib SmPC section 4.4).
Maltese: L-inċidenza u s-severità tad-deni jiżdiedu bit-terapija ta' kombinazzjoni (ara sezzjoni 4.4 tal-SmPC ta' dabrafenib).
English: • feeling light-headed
Maltese: • Tnaqqis fl-aptit
English: Trametinib was found to be an in vitro inhibitor of CYP2C8, CYP2C9 and CYP2C19, an inducer of CYP3A4 and an inhibitor of the transporters OAT1, OAT3, OCT2, MATE1, OATP1B1, OATP1B3, P-gp and BCRP.
Maltese: Trametinib instab li huwa inibitur in vitro ta' CYP2C8, CYP2C9 u CYP2C19, induttur ta' CYP3A4 u inibitur tat-trasportaturi
English: Fever has been reported in clinical trials with trametinib as monotherapy and in combination with dabrafenib (see section 4.8).
Maltese: Id-deni kien irrapportat fi provi kliniċi bi trametinib bħala monoterapija u flimkien ma' dabrafenib (ara sezzjoni 4.8).
English: Please refer to the dabrafenib SmPC (section 4.4).
Maltese: Jekk jogħġbok irreferi għall-SmPC ta' dabrafenib (sezzjoni 4.4).
English: Subsequently, all patient samples were re-tested using the CE-marked bioMerieux (bMx) THxID BRAF validated assay.
Maltese: Sussegwentement, il-kampjuni kollha ta' pazjenti ġew ittestjati mill-ġdid bl-użu ta' prova vvalidata ta' bioMerieux (bMx) THxID BRAF immarkat b'CE.
English: Mekinist can cause inflammation of the lung (pneumonitis or interstitial lung disease).
Maltese: Mekinist jista' jikkawża infjammazzjoni tal-pulmun (pulmonite jew mard interstizjali tal-pulmun).
English: In animals, no fertility studies have been performed, but adverse effects were seen on female reproductive organs (see section 5.3).
Maltese: Flannimali, ma sar l-ebda studju dwar il-fertilità, imma ġew osservati effetti avversi fuq l-organi riproduttivi tal-mara (ara sezzjoni 5.3).
English: Each film-coated tablet contains trametinib dimethyl sulfoxide equivalent to 0.5 mg trametinib.
Maltese: Kull pillola miksija b'rita fiha trametinib dimethyl sulfoxide ekwivalenti għal 0.5 mg trametinib.