FrancophonIA/ELRC3.0 huggingface dataset:
English: • increased appetite; fluid retention (oedema)
Maltese: • żieda fl-aptit, żamma ta' fluwidu (edema)
English: • hot flush
Maltese: • fwawar
English: When to take special care with Zoely
Maltese: Meta m'għandekx tuża Zoely
English: Deep vein thrombosis
Maltese: Kontroll taċ-ċiklu
English: Non-interventional post-authorisation safety study (PASS): A prospective observational study to assess in particular the risk of Venous thromboembolic events (VTE) and ATE in nomegestrol/estradiol users compared with the VTE risk in users of combined oral contraceptives containing levonorgestrel.
Maltese: Studju prospettiv ta' osservazzjoni biex jistma b'mod partikolari r-riskju ta' Każijiet tromboemboliċi fil-vini (VTE - Venous thromboembolic events) u ATE f'dawk li jużaw nomegestrol/estradiol imqabbel ma' riskju ta' VTE f'dawk li jużaw kontraċettivi kkombinati mill-ħalq li fihom levonorgestrel.
English: • Presence or risk of venous thromboembolism (VTE) o Venous thromboembolism - current VTE (on anticoagulants) or history of (e.g. deep venous thrombosis [DVT] or pulmonary embolism [PE]).
Maltese: o Tromboemboliżmu fil-vini - VTE attwali (fuq mediċini kontra l-koagulazzjoni taddemm) jew storja ta' VTE (eż. trombożi fil-vini tal-fond [DVT - deep venous thrombosis] jew emboliżmu fil-pulmun [PE - pulmonary embolism]).
English: Zoely is contraindicated if a woman has one serious or multiple risk factors for ATE that puts her at high risk of arterial thrombosis (see section 4.3).
Maltese: Zoely huwa kontraindikat jekk mara jkollha fattur ta' riskju wieħed serju jew fatturi ta' riskju multipli għal ATE li jqegħduha f'riskju għoli ta' trombożi fl-arterji (ara sezzjoni 4.3).
English: • The Hepatitis C virus (HCV) combination drug regimen ombitasvir/paritaprevir/ritonavir with or without dasabuvir may cause increases in liver function blood test results (increase in ALT liver enzyme) in women using CHCs containing ethinylestradiol.
Maltese: • L-iskeda ta' għoti ta' kombinazzjoni tal-mediċini għall-virus tal-Epatite C (HCV) ombitasvir/paritaprevir/ritonavir flimkien ma' dasabuvir jew mingħajru għall-HCV tista' tikkawża żidiet fir-riżultati tat-testijiet tad-demm għall-funzjoni tal-fwied (żieda fl-enzima ALT tal-fwied) f'nisa li jkunu qed jużaw CHCs li fihom ethinylestradiol.
English: Influence of other medicinal products on Zoely
Maltese: Jekk tieqaf tieħu Zoely
English: The situation is similar to if you forget a white active tablet.
Maltese: Is-sitwazzjoni tkun simili jekk tinsa tieħu pillola bajda attiva.
English: Further information on the possible side effect changes to menstrual periods (e.g. absence or irregular) during the use of Zoely is described in section 3 ‘When and how to take the tablets', ‘If you have unexpected bleeding' and ‘If you have missed one or more periods').
Maltese: Informazzjoni addizzjonali dwar it-tibdil possibbli tal-effetti sekondarji fuq il-mestrwazzjoni (eż. nuqqas ta' mestrwazzjoni jew mestrwazzjoni irregolari) waqt l-użu ta' Zoely hi deskritta f'sezzjoni 3 ‘Kif u meta għandek tieħu l-pilloli', ‘Jekk ikollok ħruġ tad-demm mhux mistenni' u ‘Jekk ma jkollokx mestrwazzjoni waħda jew iżjed').
English: The risk of reduced reliability is imminent because of the forthcoming yellow placebo tablet phase.
Maltese: Ir-riskju ta' tnaqqis fl-affidabilità hu imminenti minħabba l-fażi li tkun ġejja tal-pilloli sofor talplaċebo.
English: Skin and subcutaneous tissue disorders acne hyperhydrosis, alopecia, pruritus, dry skin, seborrhea chloasma, hypertrichosis
Maltese: Disturbi fil-ġilda u fittessuti ta' taħt il-ġilda akne għaraq eċċessiv, alopeċja, ħakk, ġilda xotta, seborrea kloażma, ipertrikosi
English: Risk factors for VTE
Maltese: Fatturi ta' riskju għal VTE
English: Zoely will work immediately.
Maltese: Zoely ser jaħdem immedjatament.
English: Risk increases substantially as BMI rises.
Maltese: Ir-riskju jiżdied sostanzjalment ma' żieda filBMI.
English: If you start later than day 28, you should also use a barrier method of contraception during the first 7 days of Zoely use.
Maltese: Jekk tibda iktar tard minn jum 28, għandek tuża wkoll metodu ta' kontraċezzjoni mekkaniku matul l-ewwel 7 ijiem li fihom tuża Zoely.
English: During clinical trials with the HCV combination drug regimen ombitasvir/paritaprevir/ritonavir with and without dasabuvir, ALT elevations greater than 5 times the upper limit of normal (ULN) were significantly more frequent in women using ethinylestradiol-containing medications such as CHCs.
Maltese: Waqt provi kliniċi bl-iskeda ta' kombinazzjoni tal-mediċini ombitasvir/paritaprevir/ritonavir b'dasabuvir jew mingħajru għall-HCV, żidiet fl-ALT ta' aktar minn 5 darbiet l-ogħla limitu tan-normal (ULN) kienu b'mod sinifikanti aktar frekwenti f'nisa li kienu qed jużaw mediċini li fihom ethinylestradiol bħal ma huma s-CHCs.
English: • feeling sick (nausea)
Maltese: • tħossok imdardra (nawseja)
English: • if you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease);
Maltese: • jekk għandek il-marda ta' Crohn jew kolite ulċerattiva (mard infjammatorju kroniku talimsaren);
English: General notes
Maltese: Noti ġenerali
English: However, if you have missed more than 1 tablet, use a barrier method such as a condom as an extra precaution until you have taken your tablets correctly for 7 days in a row.
Maltese: Madankollu, jekk tkun insejt iktar minn pillola 1, uża metodu ta' kontraċezzjoni mekkanika bħal kondom bħala prekawzjonijiet addizzjonali sakemm inti tkun ħadt ilpilloli tiegħek kif suppost għal 7 ijiem wara xulxin.
English: Estradiol is rapidly transformed in the gut and the liver in several metabolites, mainly estrone, which are subsequently conjugated and undergo entero-hepatic circulation.
Maltese: Estradiol jinbidel malajr fl-imsaren u fil-fwied u jifforma diversi metaboliti, primarjament estrone, li sussegwentement jiġu kkonjugati u jgħaddu minn ċirkolazzjoni enteroepatika.
English: • if you have an inflammation in the veins under the skin (superficial thrombophlebitis);
Maltese: • jekk għandek infjammazzjoni fil-vini ta' taħt il-ġilda (tromboflebite superfiċjali);
English: • Acute or chronic disturbances of liver function may necessitate the discontinuation of COC use until markers of liver function return to normal.
Maltese: • Disturbi akuti jew kroniċi tal-funzjoni tal-fwied jistgħu jeħtieġu t-twaqqif tal-użu ta' COC sakemm il-markaturi tal-funzjoni tal-fwied jerġgħu lura għan-normal.
English: BLISTER
Maltese: Kanċer
English: Nomegestrol acetate is excreted via urine and faeces.
Maltese: Nomegestrol acetate/estradiol
English: Gastrointestinal disorders nausea abdominal distension dry mouth
Maltese: Disturbi gastrointestinali nawseja nefħa taż-żaqq ħalq xott
English: Comment
Maltese: ISEM
English: • if you are going to use other medicines (see also in section 2 ‘Other medicines and Zoely');
Maltese: • jekk tkun se tuża mediċini oħrajn (ara wkoll f'sezzjoni 2 ‘Mediċini oħra u Zoely');
English: o A high risk of arterial thromboembolism due to multiple risk factors (see section 4.4) or to the presence of one serious risk factor such as:
Maltese: o Riskju għoli ta' tromboemboliżmu fl-arterji minħabba fatturi ta' riskju multipli (ara sezzjoni 4.4) jew minħabba l-preżenza ta' fattur ta' riskju wieħed serju bħal:
English: The risk of arterial thromboembolic complications or of a cerebrovascular accident in CHC users increases in women with risk factors (see table).
Maltese: Ir-riskju ta' komplikazzjonijiet ta' tromboemboliżmu fl-arterji jew ta' inċident ċerebrovaskulari f'utenti ta' CHC jiżdied f'nisa b'fatturi ta' riskju (ara t-tabella).
English: • if you have haemolytic uraemic syndrome (HUS - a disorder of blood clotting causing failure of the kidneys);
Maltese: • jekk għandek sindrome uremiku emolitiku (HUS - haemolytic uraemic syndrome, disturb tattagħqid tad-demm li jikkawża insuffiċjenza tal-kliewi);
English: Contraceptives containing ethinylestradiol may decrease the concentrations of lamotrigine by approximately 50%.
Maltese: L-influwenza ta' Zoely fuq prodotti mediċinali oħrajn Kontraċettivi li fihom ethinylestradiol jistgħu jnaqqsu l-konċentrazzjonijiet ta' lamotrigine b'madwar 50%.
English: Psychiatric disorders decreased libido, depression/ depressed mood, mood altered increased libido
Maltese: Disturbi psikjatriċi tnaqqis fil-libido, dipressjoni/burda ta dipressa, tibdil fil-burdata żieda fil-libido
English: If the balance of benefits and risks is considered to be negative a CHC should not be prescribed (see section 4.3).
Maltese: Jekk il-bilanċ bejn il-benefiċċji u r-riskji jitqies li huwa negattiv CHC m'għandux jiġi preskritt (ara sezzjoni 4.3).
English: If possible take it within 24 hours of when you normally take your pill.
Maltese: Jekk ikun possibbli ħudha fi żmien 24 siegħa mill-ħin li fih normalment tieħu l-pillola tiegħek.
English: Hypertension
Maltese: MEDIĊINALI
English: Changing from a progestogen-only-method (minipill, implant, injectable) or from a hormone-medicated intra uterine system (IUS)
Maltese: Meta tibdel minn kontraċettiv li fih progestogen biss li jista' jiġi injettat, impjant jew sistema intrauterina medikata bl-ormoni (IUS)
English: Important things to know about combined hormonal contraceptives (CHCs):
Maltese: Affarijiet importanti li għandek tkun taf dwar il-kontraċettivi kkombinati tal-ormoni (CHCs combined hormonal contraceptives):
English: Women should be advised that hormonal contraceptives do not protect against HIV infections (AIDS) and other sexually transmitted diseases.
Maltese: In-nisa għandhom jiġu mgħarrfa li l-kontraċettivi tal-ormoni ma jipproteġux kontra infezzjonijiet talHIV (AIDS) u mard ieħor li jinfirex permezz tas-sess.
English: The woman should start with Zoely preferably on the day after the last active tablet (the last tablet containing the active substances) of her previous COC, but at the latest on the day following the usual tablet-free or placebo tablet interval of her previous COC.
Maltese: Il-mara għandha tibda b'Zoely preferibbilment fil-jum wara l-aħħar pillola attiva (l-aħħar pillola li jkun fiha s-sustanzi attivi) tas-COC li kienet tieħu qabel, iżda mhux aktar tard mill-jum wara lintervall normali mingħajr pillola jew pillola tal-plaċebo tas-COC li kienet tieħu qabel.
English: Symptoms most commonly occur in one eye:
Maltese: Sintomi ta' inċident ċerebrovaskulari jistgħu jinkludu:
English: Six multi-centre clinical trials of up to one year duration were used to evaluate safety of Zoely.
Maltese: Sitt provi kliniċi multiċentriċi li damu sejrin sa sena ntużaw biex jevalwaw is-sigurtà ta' Zoely.
English: If this is not possible or 24 or more hours have passed, you should follow the advice given under "If you forget to take Zoely".
Maltese: Jekk dan ma jkunx possibbli jew ikunu għaddew 24 siegħa jew aktar, għandek issegwi l-pariri mogħtija fis-sezzjoni "Jekk tinsa tieħu Zoely".
English: Each time you start a new blister of Zoely, take the number 1 white active tablet in the left-hand top corner (see ‘Start').
Maltese: Kull meta tibda folja ġdida ta' Zoely, ħu l-pillola bajda attiva numru 1 fil-kantuniera ta' fuq tan-naħa tax-xellug (ara ‘Ibda').
English: • If a blood clot forms in a vein in the leg or foot it can cause a deep vein thrombosis (DVT).
Maltese: • Jekk jifforma tagħqid tad-demm ġo vina fir-riġel jew fis-sieq dan jista' jikkawża trombożi fil vini tal-fond (DVT - deep vein thrombosis).
English: In animal studies, reproductive toxicity has been observed with the nomegestrol acetate / estradiol combination (see preclinical safety data in section 5.3).
Maltese: Fi studji f'annimali, intwera effett tossiku fis-sistema riproduttiva b'taħlita ta' nomegestrol acetate/estradiol (ara Tagħrif ta' qabel l-użu kliniku dwar is-sigurtà tal-mediċina f'sezzjoni 5.3)
English: Estradiol is subject to a substantial first-pass effect after oral administration.
Maltese: Estradiol hu suġġett għal effett first-pass sostanzjali wara l-għoti orali.
English: • An increased risk of cervical cancer in long-term users of COCs (> 5 years) has been reported in some epidemiological studies, but there continues to be controversy about the extent to which this finding is attributable to the confounding effects of sexual behaviour and other factors such as human papilloma virus (HPV).
Maltese: • Żieda fir-riskju ta' kanċer ċervikali f'utenti li ilhom jużaw COCs (> 5 snin) ġew irrappurtati f'xi studji epidemjoloġiċi, iżda għad hemm kontroversja dwar il-firxa ta' kif riżultat bħal dan huwa attribwibbli għall-effetti konfliġġenti ta' mġiba sesswali u fatturi oħrajn bħal virus talpapilloma uman (HPV).
English: See also ‘General Notes' in section 2 above.
Maltese: Ara wkoll ‘Noti Ġenerali' f'sezzjoni 2 hawn fuq.
English: You can also start later, but never later than the day following the tablet-free break of your present pill (or the day after the last inactive tablet of your present pill).
Maltese: Tista' wkoll tibda aktar tard, iżda qatt aktar tard mill-jum ta' wara l-intervall mingħajr pilloli tal-pillola kurrenti tiegħek (jew il-jum wara l-aħħar pillola inattiva tal-pillola kurrenti tiegħek).
English: Sometimes the symptoms of stroke can be brief with an almost immediate and full recovery, but you should still seek urgent medical attention as you may be at risk of another stroke.
Maltese: Xi drabi s-sintomi ta' puplesija jistgħu ma jdumux b'irkupru kważi immedjat u għalkollox, iżda inti xorta għandek tfittex attenzjoni medika urġenti minħabba li tista' tkun qegħda f'riskju ta' puplesija oħra.
English: 28 % of the women experienced absence of withdrawal bleeding in at least one of the cycles 2, 3 and 4, associated with higher occurrences of absence of withdrawal bleeding in the later cycles of use, ranging from 51 % to 62 %.
Maltese: 4.6 % tan-nisa ma kellhomx ħruġ ta' demm meta waqfu jieħdu l-mediċina fl-ewwel tliet ċikli ta' użu u l-okkorrenzi ta' assenza ta' ħruġ ta' demm meta waqfu jieħdu l-mediċina fiċ-ċikli tal-użu li ġew wara kienu għolja f'dan is-sottogrupp, u varjaw minn 76 % sa 87 % tan-nisa. 28 % tan-nisa kellhom assenza ta' ħruġ ta' demm meta waqfu jieħdu l-mediċina f'mill-inqas wieħed miċ-ċikli 2, 3 u 4, assoċjat ma' okkorrenzi ogħla ta' assenza ta' ħruġ ta' demm mal-waqfien tal-mediċina fiċ-ċikli tal-użu li ġew wara, li jvarjaw minn 51 % sa 62 %.
English: Multiple doses up to five times the daily dose of Zoely and single doses up to 40 times the daily dose of nomegestrol acetate alone have been used in women without safety concern.
Maltese: Dożi multipli sa ħames darbiet tad-doża ta' kuljum ta' Zoely u dożi waħidhom sa 40 darba tad-doża ta' kuljum ta' nomegestrol acetate waħdu, intużaw f'nisa mingħajr l-ebda problema ta' sigurtà.
English: It is unknown whether the amount of estradiol in Zoely is sufficient to maintain adequate levels of estradiol in adolescents, especially for bone mass accrual (see section 5.2).
Maltese: Mhux magħruf jekk l-ammont ta' estradiol f'Zoely hux biżżejjed biex iżomm livelli adegwati ta' estradiol fl-adolexxenti, speċjalment għall-akkumulazzjoni tal-piż tal-għadam (ara sezzjoni 5.2).
English: • if you have (or have ever had) angina pectoris (a condition that causes severe chest pain and may be a first sign of a heart attack ) or transient ischaemic attack (TIA - temporary stroke symptoms);
Maltese: • jekk għandek (jew qatt kellek) anġina pectoris (kondizzjoni li tikkawża wġigħ qawwi fis-sider u tista' tkun l-ewwel sinjal ta' attakk tal-qalb) jew attakk iskemiku temporanju (TIA [transient ischaemic attack] - sintomi ta' puplesija temporanja);
English: No clinically relevant effect of food was observed on the bioavailability of nomegestrol acetate.
Maltese: Ma kien osservat l-ebda effett klinikament rilevanti tal-ikel fuq il-bijodisponibilità ta' nomegestrol acetate.
English: Effect of renal impairment No studies were performed to evaluate the effect of renal disease on the pharmacokinetics of Zoely.
Maltese: Xi mediċini jistgħu jikkawżaw problemi partikulari meta tkun tuża kontraċettivi ormonali, bħal Zoely.
English: • Out of 10,000 women who are using a combined hormonal contraceptive that contains levonorgestrel, norethisterone, or norgestimate, about 5-7 will develop a blood clot in a year.
Maltese: • Minn 10,000 mara li jkunu qed jużaw kontraċettiv ikkombinat tal-ormoni li fih levonorgestrel, norethisterone, jew norgestimate, madwar 5-7 jiżviluppaw tagħqid tad-demm f'sena.
English: • Although COCs may have an effect on peripheral insulin resistance and glucose tolerance, there is no evidence for a need to alter the therapeutic regimen in diabetics using low-dose COCs (containing  0.05 mg ethinylestradiol).
Maltese: • Minkejja li COCs jista' jkollhom effett fuq ir-reżistenza periferika għall-insulina u tolleranza tal-glucose, m'hemm l-ebda evidenza għal ħtieġa li tibdel il-kors terapewtiku f'nisa dijabetiċi li jużaw COCs b'doża baxxa (li fihom (< 0.05 mg ta' ethinylestradiol).
English: This results in a highly variable baseline-corrected elimination half-life of estradiol, which is calculated to be 3.6 ± 1.5 h, after intravenous administration.
Maltese: Dan jirriżulta f'half-life tal-eliminazzjoni ta' estradiol li tvarja ħafna kkoreġuta skont il-linja bażi, li hi kkalkulata li hi 3.6 ± 1.5 sigħat, wara l-għoti ġol-vini.
English: • swollen abdomen
Maltese: • marda tal-bużżieqa tal-marrara
English: No clinically relevant effect of food was observed on the bioavailability of estradiol.
Maltese: Ma kien osservat l-ebda effett klinikament rilevanti tal-ikel fuq il-bijodisponibilità ta' estradiol.
English: PFS (primary analysis)
Maltese: PFS (analiżi primarja)
English: Store below 30°C.
Maltese: Aħżen f'temperatura taħt 30° C.
English: - The active substance is encorafenib.
Maltese: - Is-sustanza attiva hi encorafenib.
English: Duration of treatment
Maltese: Durata tat-trattament
English: Visual impairment* RPED *
Maltese: Indeboliment tal-vista* RPED *
English: Nominal p-value
Maltese: Valur p nominali
English: Pierre Fabre Médicament 45, place Abel Gance 92100 Boulogne-Billancourt France
Maltese: Pierre Fabre Médicament 45, place Abel Gance 92100 Boulogne-Billancourt Franza
English: Dermatitis acneiform* PPES
Maltese: Dermatite akneiforme* PPES
English: Updated analysis, cut-off date: 07 November 2017 PFS
Maltese: Analiżi aġġornata, data ta' limitu: 7 ta' Novembru 2017 PFS
English: Number of events (progressive disease (PD)) (%)
Maltese: Numru ta' avvenimenti (marda progressiva (PD)) (%)
English: Alopecia*
Maltese: Alopeċja*
English: Gastrointestinal disorders were typically managed with standard therapy.
Maltese: Id-disturbi gastrointestinali normalment ġew ġestiti b'terapija standard.
English: a National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03
Maltese: Encorafenib għandu jitwaqqaf b'mod pemanenti. a Common Terminology Criteria for Adverse Events tan-National Cancer Institute (NCI CTCAE)
English: Encorafenib is an inhibitor of UGT1A1.
Maltese: Encorafenib hu inibitur ta' UGT1A1.
English: 42 hard capsules 168 hard capsules
Maltese: 42 kapsula iebsa 168 kapsula iebsa
English: • Grade 1-3
Maltese: • Grad 1- 3
English: • Grade 4
Maltese: • Grad 4
English: In vitro, encorafenib inhibited the hepatic transporter OCT1, but is unlikely to be an effective inhibitor clinically.
Maltese: In vitro, encorafenib inibixxa t-trasportatur epatiku OCT1, iżda hu improbabbli li dan ikun inibitur effettiv klinikament.
English: Dose modification
Maltese: Modifika sussegwenti
English: Cutaneous reactions • Grade 2
Maltese: Reazzjonijiet kutanji • Grad 2
English: Encorafenib should be maintained.
Maltese: inkluż encorafenib.
English: Cut-off date: 19 May 2016
Maltese: Data ta' limitu: 19 ta' Mejju 2016
English: 28 hard capsules 112 hard capsules
Maltese: 28 kapsula iebsa 112-il kapsula iebsa
English: Cellulose microcrystalline (E460i) Succinic acid (E363) Crospovidone (E1202) Silica colloidal anhydrous (E551) Magnesium stearate (E470b)
Maltese: Cellulose microcrystalline (E460i) Succinic acid (E363) Crospovidone (E1202) Silica colloidal (E551) Magnesium stearate (E470b)
English: Encorafenib is moderately (86.1%) bound to human plasma proteins in vitro.
Maltese: Encorafenib teħel b'mod moderat (86.1%) mal-proteini tal-plażma tal-bniedem in vitro.
English: Ocular events
Maltese: Avvenimenti okulari
English: • Capsule contents: copovidone (E1208), poloxamer 188, cellulose microcrystalline (E460i), succinic acid (E363), crospovidone (E1202), silica colloidal anhydrous (E551), magnesium stearate (E470b)
Maltese: • Kontenut tal-kapsuli: copovidone (E1208), poloxamer 188, cellulose microcrystalline (E460i), succinic acid (E363), crospovidone (E1202), silica colloidal anhydrous (E551), magnesium stearate (E470b)
English: Transporter substrates
Maltese: Substrati tat-trasportatur
English: Polyamide/aluminum/PVC/aluminum blister containing 6 capsules.
Maltese: Polyamide/aluminum/PVC - folja tal-aluminju li fiha 6 kapsuli.
English: Gelatin (E441) Titanium dioxide (E171) Iron oxide red (E172) Iron oxide yellow (E172) Iron oxide black (E172)
Maltese: Gelatin (E441) Titanium dioxide (E171) Iron oxide red (E172) Iron oxide yellow (E172)
English: This medicine has not been studied in this age group.
Maltese: Din il-mediċina ma ġietx studjata f'dan il-grupp ta' età.
English: Collectively, these data indicate that encorafenib has a risk of phototoxic potential and minimal risk for sensitization at therapeutic doses in patients.
Maltese: Kollettivament, din id-data tindika li encorafenib għandu riskju ta' potenzjal fototossiku u riskju minimu ta' sensitizzazzjoni f'dożi terapewtiċi fil-pazjenti.
English: Vem=vemurafenib.
Maltese: SD = marda stabbli; Vem = vemurafenib.
English: The inter-subject variability (CV%) of AUC is ranged from 12.3% to 68.9%.
Maltese: Il-varjabbiltà bejn l-individwi (CV %) tal-AUC tvarja minn 12.3% sa 68.9%.
English: Combination with binimetinib
Maltese: binimetinib)
English: • Grade 3
Maltese: • Grad 3
English: Encorafenib is metabolised by CYP3A4, CYP2C19 and CYP2D6.
Maltese: Encorafenib hu metabolizzat minn CYP3A4, minn CYP2C19 u minn CYP2D6.
English: Gamma-glutamyl transferase (GGT) increased*
Maltese: Żiedal fil-gamma-glutamyl transferase (GGT)*
English: Figure 1 Study CMEK162B2301, Part 1: Kaplan-Meier plot of progression-free survival by independent central review (cut-off date: 19 May 2016)
Maltese: Figura 1 Studju CMEK162B2301, Parti 1: Plot Kaplan-Meier ta' sopravivenza ħielsa minn progressjoni skont ir-reviżjoni ċentrali indipendenti (data ta' limitu: 19 ta' Mejju 2016)
English: - The other ingredients are:
Maltese: - Problemi ta' fsada:
English: Polyamide/aluminum/PVC/aluminum blister containing 4 capsules.
Maltese: Polyamide/aluminum/PVC - folja tal-aluminju li fiha 4 kapsuli.
English: Left ventricular dysfunction (LVD)
Maltese: Disfunzjoni ventrikolari tax-xellug (LVD)
English: Effects of other medicinal products on encorafenib.
Maltese: Effetti ta' prodotti mediċinali oħra fuq encorafenib.
English: The half maximal inhibitory concentration (IC50) of encorafenib against BRAFV600E, BRAF and CRAF enzymes was determined to be 0.35, 0.47 and 0.30 nM, respectively.
Maltese: Il-konċentrazzjoni inibitorja massima tan-nofs (IC50) ta' encorafenib kontra l-enzimi talBRAFV600E, tal-BRAF u tas-CRAF ġiet iddeterminata li hi ta' 0.35, ta' 0.47 u ta' 0.30 nM, rispettivament.
English: Table 6:
Maltese: Tabella 5:
English: The confirmed ORR per BIRC was 65.9% (95% CI: 59.8, 71.7) for Combo 300 and 50.4% (95% CI: 44.3, 56.4) for Enco 300 (Parts 1 and 2).
Maltese: LORR ikkonfermat għal kull BIRC kien 65.9 % (95 % CI: 59.8, 71.7 għall Combo 300, u 50.4 % (95 % CI: 44.3, 56.4) għal Enco 300.