FrancophonIA/ELRC3.0 huggingface dataset:
English: Reported adverse reactions are listed below, by system organ class and by frequency.
Maltese: Reazzjonijiet avversi rapportati huma elenkati hawn isfel, skont is-sistema tal-klassifika ta' l-organi u skond il-frekwenza.
English: Do not take Carbaglu:
Maltese: Oqgħod attent ħafna b'Carbaglu:
English: Carglumic acid is secreted in the milk of lactating rats and although developmental parameters were unaffected, there were some effects on body weight / body weight gain of pups breast-fed by dams treated with 500 mg/kg/day and a higher mortality of pups from dams treated with 2000 mg/kg/day, a dose that caused maternotoxicity.
Maltese: Carglumic acid jitnixxa fil-ħalib ta' firien li jreddhħu u għalkemm il-parametri ta' żvilupp ma kinux affettwati, kien hemm xi effetti fuq il-piż korporali / żieda fil-piż korporali ta' ġriewi mredgħa min-nisa trattati b'2000 mg/kg/kuljum, doża li kkawżat maternotossiċità.
English: In patients with organic acidaemia (neonates and non-neonates), the treatment with carglumic acid induced a quick decrease of ammonia plasma levels, reducing the risk of neurological complications.
Maltese: F'pazjenti b'aċidemija organika (trabi li għadhom jitwieldu u le), it-trattament b'carglumic acid induċa tnaqqis ta' malajr fil-livelli ta' ammonja fil-plażma, u tnaqqis fir-riskju ta' komplikazzjonijiet newroloġiċi.
English: OUTER CARTON BOX AND TABLET CONTAINER LABEL X 15 TABLETS
Maltese: KAXXA TAL-KARTUN TA' BARRA U TIKKETTA TAL-KONTENITUR TAL-PILLOLI X 15-IL PILLOLA
English: What Carbaglu looks like and contents of the pack Carbaglu 200mg tablet is a bar-shaped tablet, with 4 punches on one side with 3 break-mark sides.
Maltese: Il-pillola Carbaglu ta' 200 mg tikkonsisti minn pillola f'għamla ta' żbarra b'4 puntelli fuq naħa waħda bi 3 naħat ta' marki ta' qsim.
English: Despite a lower affinity of carbamoyl phosphate synthetase for carglumic acid than for N-acetylglutamate, carglumic acid has been shown in vivo to stimulate carbamoyl phosphate synthetase and to be much more effective than N-acetylglutamate in protecting against ammonia intoxication in rats.
Maltese: Minkejja l-affinità aktar baxxa ta' carbamoyl phosphate synthetase għal carglumic acid milli għal N-acetylglutamate, in vivo instab li carglumic acid jistimula carbamoyl phosphate synthetase u li hu ħafna aktar effettiv minn N-acetylglutamate biex iħares kontra l-intossikazzjoni bl-ammonja fil-firien.
English: Plasma levels of carglumic acid were measured in patients of all age categories, from newborn infants to adolescents, treated with various daily doses (7 - 122 mg/kg/day).
Maltese: Il-livelli ta' carglumic acid fil-plażma kienu mkejjla f'pazjenti fil-kategoriji ta' kull eta, minn trabi għadhom kif jitwieldu sa adoloxxenti, li ngħataw trattament b'dożi ta' kuljum li jvarjaw (7122 mg/kg/kuljum).
English: 2.2 Qualitative and quantitative composition For a full list of excipients, see section 6.1
Maltese: Għal-lista kompleta ta' sustanzi mhux attivi, ara sezzjoni 6.1.
English: • hyperammonaemia due to N-acetylglutamate synthase primary deficiency.
Maltese: • iperammonemija kkawżata minħabba nuqqas primarju għal N-acetylglutamate synthase.
English: Pregnancy and Breast-feeding
Maltese: Immaniġġjar nutrizzjonali
English: Recordati Rare Diseases Immeuble “Le Wilson” 70, avenue du Général de Gaulle F-92800 Puteaux France
Maltese: Recordati Rare Diseases Immeuble “Le Wilson” 70, Avenue du Général de Gaulle F-92800
English: Recordati Rare Diseases Immeuble ‘Le Wilson' 70, avenue du Général de Gaulle F-92800 Puteaux France or
Maltese: Recordati Rare Diseases Immeuble ‘Le Wilson ' 70, Avenue du Général de Gaulle F-92800
English: One metabolite that has been identified in the faeces is glutamic acid.
Maltese: Metabolit wieħed li ġie identifikat fl-ippurgar hu glutamic acid.
English: The plasma elimination curve of carglumic acid is biphasic with a rapid phase over the first 12 hours after administration followed by a slow phase (terminal half life up to 28 hours).
Maltese: Il-kurva ta' l-eliminazzjoni minn ġol-plażma ta' carglumic acid hi bifażika b'fażi rapida fl-ewwel 12-il siegħa wara l-amministrazzjoni segwita minn fażi kajmana (ħalf-life terminali sa 28 siegħa).
English: The tablets must be dispersed in a minimum of 5 to 10 ml of water and taken immediately.
Maltese: Il-pilloli għandhom jinfirxu f'minimu ta' 5 sa 10 ml ilma u għandhom jittieħdu minnufih.
English: Uncommon: pyrexia
Maltese: 15-il pillola li jinfirxu
English: As very few data on the safety of carglumic acid are available, systematic surveillance of liver, renal, cardiac functions and haematological parameters is recommended.
Maltese: Minħabba li teżisti biss ftit informazzjoni dwar is-sigurtà ta' carglumic acid, hu rakkomandat li ssir sorveljanza sistematika tal-funzjonijiet tal-fwied, tal-kliewi, tal-funzjoni tal-qalb u tal-parametri ematoloġiċi.
English: Carglumic acid was shown to decrease blood ammonia levels and increase urea levels in blood and urine, whereas the liver content of carbamoyl phosphate synthetase activators was significantly increased.
Maltese: Instab li carglumic acid jnaqqas il-livelli ta' ammonja fid-demm u jżid il-livelli ta' l-urea fid-demm u fl-awrina, filwaqt li l-kontenut ta'attivaturi ta' carbamoyl phosphate synthetase fil-kliewi żdied b'mod sinifikanti.
English: It is suggested that depending on its activity, the intestinal bacterial flora may contribute to the initiation of the degradation process, thus leading to a variable extent of metabolism of the molecule.
Maltese: Hu suġġerit li skond l-attività, il-flora batterika fl-imsaren tista' tikkontribwixxi għal bidu tal-proċess ta' degradazzjoni, li b'hekk twassal għal metaboliżmu varjabbli tal-molekula.
English: This could be explained by the following observations: i) The mitochondrial membrane is more readily permeable for carglumic acid than for Nacetylglutamate ii) Carglumic acid is more resistant than N-acetylglutamate to hydrolysis by aminoacylase present in the cytosol.
Maltese: Dan jista' jkun spjegat permezz ta' l-osservazzjonijiet li ġejjin: i) Ir-rita mitokondrijali hi aktar permeabbli għal carglumic acid milli għal N-acetylglutamate. ii) Carglumic acid hu aktar reżistenti minn N-acetylglutamate għall-idroliżi minn aminoacylase preżenti fis-cytosol.
English: Write the date of opening on the tablet container.
Maltese: Ikteb id-data ta' meta ftaħtu fuq il-kontenitur tal-pilloli.
English: In patients with N-acetylglutamate synthase deficiency, carglumic acid was shown to induce a rapid normalisation of plasma ammonia levels, usually within 24 hours.
Maltese: F'pazjenti b'nuqqas ta' N-acetylglutamate synthase, instab li carglumic acid jżid in-normalizzazzjoni ta' malajr tal-livelli ta' ammonja fil-plażma, ġeneralment fi żmien 24 siegħa.
English: Carbaglu can help eliminating excessive ammonia plasma levels (elevated ammonia level in the blood).
Maltese: Carbaglu jista' jgħin jelimina livelli t'ammonja eċċessivi fil-plażma (livell għoli ta' ammonja fid-demm).
English: Opened:
Maltese: Recordati
English: Carbaglu 200 mg dispersible tablets
Maltese: Carbaglu 200 mg pilloli li jinfirxu
English: 5 dispersible tablets
Maltese: 5 pilloli li jinfirxu
English: • hyperammonaemia due to methymalonic acidaemia.
Maltese: • iperammonemija minħabba aċidemija metilmalonika
English: Based on clinical experience, the treatment may be started as early as the first day of life.
Maltese: Skond l-esperjenza klinika, it-trattament jista' jinbeda minn kmieni sa mill-ewwel jum ta' ħajja.
English: Do not take Carbaglu if you are hypersensitive (allergic) to carglumic acid or any of the other ingredients of Carbaglu.
Maltese: Tieħux Carbaglu jekk tbati minn sensittività eċċessiva (allerġija) għal carglumic aċid jew sustanzi oħra ta' Carbaglu.
English: The pharmacokinetics of carglumic acid has been studied in healthy male volunteers using both radiolabelled and unlabelled product.
Maltese: Il-farmakokinetiċi ta' carglumic acid ġew studjati f'voluntieri rġiel b'saħħithom bl-użu ta' prodotti radjutikkettati u mhux radjutikkettati.
English: For carglumic acid no clinical data on exposed pregnancies are available.
Maltese: Għal carglumic acid l-ebda dejta klinika fuq tqalat esposti mhu disponibbli.
English: Ref. EMEA/CHMP/563259/2009 EMEA/H/A-29/1060
Maltese: EMEA/CHMP/559831/2009 EMEA/H/A-29/1060
English: 29 May 2009
Maltese: 29 ta' Mejju 2009
English: Prof. Michal Pirożynski (Poland)
Maltese: Michal Pirożynski (il-Polonja)
English: Dr Pieter Neels (Belgium)
Maltese: Dr Pieter Neels (il-Belġju)
English: Company responses provided on: 23 March 2009 Opinion date:
Maltese: Risposti tal-kumpanija ngħataw nha 23 ta' Marzu 2009 Data tal-opinjoni:
English: London, 17 August 2009 Doc.
Maltese: Londra, 17 ta' Awwissu 2009 Dok. ta' Ref.
English: The review was carried out under an ‘Article 29' referral1.
Maltese: Ir-reċensjoni twettqet skont referenza tal-‘Artikolu 29'1.
English: Loratadine Sandoz 10 is a ‘generic medicine'.
Maltese: Loratadine Sandoz 10 huwa ‘mediċina ġenerika'.
English: Loratadine is an antihistamine.
Maltese: Loratadine huwa antistaminiku.
English: The company wanted the authorisation to be recognised in Bulgaria, the Czech Republic, Estonia, France, Hungary, Italy, Latvia, Lithuania, Poland, Romania, Slovenia and Slovakia (the ‘concerned Member States').
Maltese: Il-kumpanija riedet li lawtorizzazzjoni tkun rikonoxxuta fil-Bulgarija, fir-Repubblika Ċeka, fl-Estonja, fi Franza, fl-Ungerija, fl-Italja, fil-Latvja, fil-Litwanja, fil-Polonja, fir-Rumanija, fis-Slovenja u fis-Slovakkja (l-‘Istati Membri kkonċernati').
English: What is Loratadine Sandoz 10?
Maltese: X'inhu Loratadine Sandoz 10?
English: Loratadine Sandoz 10 is used to relieve the symptoms of allergic rhinitis (inflammation of the nasal passages caused by an allergy such as hay fever or allergy to dust mites) and long-term idiopathic urticaria (itching and patches on the skin).
Maltese: Loratadine Sandoz 10 jintuża għas-solliev tas-sintomi tar-rinite allerġika (infjammazzjoni tal-passaġġi nażali kkawżata minn allerġija bħalma hija l-hay fever (riħ tal-ħuxlief) jew allerġija għall-insetti mikroskopiċi tat-trab (dust mites)) u urtikarja idjopatika li tibqa' għal perijodu ta' żmien twil (ħakk u rqajja' fuq il-ġilda.
English: Questions and answers on the referral for Loratadine Sandoz 10 loratadine 10 mg tablets
Maltese: Mistoqsijiet u tweġibiet dwar ir-referenza għal Loratadine Sandoz 10 loratadine pilloli ta' 10 mg
English: These countries are Austria, Denmark, Finland, Germany, Greece, Norway, Portugal, Spain, Sweden and the United Kingdom.
Maltese: Dawn il-pajjiżi huma l-Awstrija, id-Danimarka, il-Finlandja, il-Ġermanja, il-Greċja, inNorveġja, il-Portugall, Spanja, l-Iżvezja u r-Renju Unit.
English: The grounds for the referral were a disagreement from the Czech Republic and Poland, which were of the opinion that ‘bioequivalence' with the reference medicine had not been shown.
Maltese: Ir-raġunijiet għar-referenza kienu nuqqas ta' qbil bejn ir-Repubblika Ċeka u l-Polonja, li kienu talopinjoni li il-‘bijoekwivalenza' mal-mediċina ta' referenza ma ntwerietx.
English: Sandoz B.V. submitted Loratadine Sandoz 10 for mutual recognition on the basis of the initial authorisation granted in the Netherlands on 22 July 2001.
Maltese: Sandoz B.V. issottomettiet Loratadine Sandoz 10 għal rikonoxximent reċiproku fuq il-bażi talawtorizzazzjoni inizjali mogħtija fl-Olanda fit-22 ta' Lulju 2001.
English: The European Medicines Agency has completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Loratadine Sandoz 10.
Maltese: L-Aġenzija Ewropea dwar il-Mediċini (EMEA) temmet proċedura ta' arbitraġġ wara nuqqas ta' qbil fost l-Istati Membri tal-Unjoni Ewropea (UE) fir-rigward tal-awtorizzazzjoni tal-mediċina Loratadine Sandoz 10.
English: This means that it is similar to a ‘reference medicine' already authorised in the EU called Clarityne.
Maltese: Dan ifisser li huwa simili għal ‘mediċina ta' referenza' li diġà hija awtorizzata fil-UE, imsejħa Clarityne.
English: In addition, the Committee also required that the company carried out additional studies to show bioequivalence of Loratadine Sandoz 10 and Clarityne in accordance with the current guidelines.
Maltese: Barra minn hekk, il-Kumitat talab ukoll li lkumpanija twettaq studji addizzjonali biex turi l-bijoekwivalenza ta' Loratadine Sandoz 10 u Clarityne b'konformità mal-linji gwida attwali.
English: The Czech Republic and Poland argued that the original study presented by the company was not in line with current guidance, and did not show bioequivalence of Loratadine Sandoz 10 and Clarityne.
Maltese: Ir-Repubblika Ċeka u lPolonja argumentaw li l-istudju oriġinali li ġie ppreżentat mill-kumpanija ma kienx konformi malgwida attwali, u ma weriex il-bijoekwivalenza ta' Loratadine Sandoz 10 u Clarityne.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Loratadine Sandoz 10 do not outweigh its risks, and the marketing authorisation granted in the Netherlands cannot be recognised in other Member States of the EU.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għal Użu mill-Bniedem (CHMP) tal-Aġenzija kkonkluda li l-benefiċċji ta' Loratadine Sandoz 10 huma akbar mir-riskji tiegħu, u li l-awtorizzazzjoni għat-tqegħid fis-suq li ngħatat fl-Olanda ma tistax tiġi rikonoxxuta fi Stati Membri oħrajn tal-UE. Lawtorizzazzjoni għat-tqegħid fis-suq fl-Olanda għandha tiġi sospiża wkoll.
English: Why was Loratadine Sandoz 10 reviewed?
Maltese: Għaliex ġie rivedut Loratadine Sandoz 10?
English: However, these Member States were not able to reach an agreement and the Dutch medicines regulatory agency referred the matter to the CHMP for arbitration on 31 July 2008.
Maltese: Iżda, dawn l-Istati Membri ma setgħux jilħqu ftehim u fil-31 ta' Lulju 2008, laġenzija regolatorja tal-mediċini Olandiża rreferiet il-kwistjoni lill-CHMP għall-arbitraġġ.
English: The CHMP therefore concluded that Loratadine Sandoz 10 could not be considered a generic medicine of Clarityne, and therefore that the marketing
Maltese: Għalhekk, is-CHMP ikkonkluda li Loratadine Sandoz 10 ma jistax jiġi kkunsidrat bħala mediċina ġenerika ta' Clarityne, u għalhekk li l-awtorizzazzjoni għat-tqegħid fis
English: 28 capsules 120 capsules
Maltese: 28 kapsula 120 kapsula
English: Endpoints/ assessment
Maltese: Endpoints/ evalwazzjoni
English: Extremadura, 3, Pol. Ind. Allendeduero 09400, Aranda de Duero (Burgos) Spain
Maltese: Extremadura, 3, Pol. Ind. Allendeduero 09400, Aranda de Duero (Burgos) Spanja
English: Cmax of S- and R-warfarin increased 18% and 19%.
Maltese: Is-Cmax ta' S- u R-warfarin żdied bi 18 % u bi 19 %.
English: dabrafenib 55 (29%) December 18, 2012 DTIC
Maltese: dabrafenib 55 (29%) 18 ta' Diċembru 2013 DTIC
English: Dabrafenib is an in vitro inhibitor of human organic anion transporting polypeptide (OATP) 1B1 (OATP1B1), OATP1B3 and BCRP.
Maltese: Dabrafenib huwa inibitur in vitro ta' human organic anion transporting polypeptide (OATP) 1B1 (OATP1B1), OATP1B3 u BCRP.
English: Figure 3 Kaplan-Meier curves of overall survival (BREAK-3) (18 December 2012)
Maltese: Figura 3 Kurvi Kaplan-Meier ta' sopraviveva globali (BREAK-3) (18 ta' Diċembru 2012)
English: Study BRF113928
Maltese: Studju BRF113928
English: • Statins metabolised by CYP3A4 (e.g. atorvastatin, simvastatin)
Maltese: • Statins metabolizzati b'CYP3A4 (eż. atorvastatin, simvastatin)
English: Grade 2 (Intolerable) or Grade 3
Maltese: Grad 2 (Intollerabbli) jew Grad 3
English: Mean absolute bioavailability of oral dabrafenib is 95% (90% CI: 81, 110%).
Maltese: Il-bijodisponibbiltà assoluta medja ta' dabrafenib orali hija ta' 95 % (90 % CI: 81, 110 %).
English: Alanine aminotransferase increased Aspartate aminotransferase increased
Maltese: Żieda fl-alanine aminotransferase Żieda fl-aspartate aminotransferase
English: Do not take Tafinlar:
Maltese: Tiħux Tafinlar:
English: Hypersensitivity e
Maltese: Sensittività eċċessiva e
English: * The intensity of clinical adverse events graded by the Common Terminology Criteria for Adverse Events (CTC-AE) v4.0
Maltese: * L-intensità ta' avvenimenti avversi kliniċi kklassifikati skont il-Kriterji ta' Terminoloġija Komuni għall-Avvenimenti Avversi (CTC-AE) v4.0
English: Papilloma, skin papilloma d
Maltese: Papilloma, papilloma tal-ġilda d
English: Inhibitory concentration 50 (nM)
Maltese: Konċentrazzjoni inibitorja ta' 50 (nM)
English: Acrochordon (skin tags)
Maltese: Acrochordon (felul tal-ġilda)
English: a, BRF113928, and
Maltese: a, BRF113928, u
English: • Hormonal contraceptives (see section 4.6)
Maltese: • Kontraċettivi ormonali (ara sezzjoni 4.6)
English: • Analgesics (e.g. fentanyl, methadone)
Maltese: • Analġesiċi (eż. fentanyl, methadone)
English: • Anticoagulants (e.g. acenocoumarol, warfarin, see section 4.4)
Maltese: • Antikoagulanti (eż. acenocoumarol, warfarin, ara sezzjoni 4.4)
English: • Corticosteroids (e.g. dexamethasone, methylprednisolone)
Maltese: • Kortikosterojdi (eż. dexamethasone, methylprednisolone)
English: No clinical data are available.
Maltese: M'hemm l-ebda data klinika disponibbli.
English: HR for recurrence = 0.49 95% CI (0.40, 0.59)
Maltese: HR għal rikorrenza = 0.49 95% CI (0.40, 0.59)
English: A total of 870 patients were randomised to the combination therapy (n=438) and placebo (n=432) arms.
Maltese: Total ta' 870 pazjent kienu randomizzati fi gruppi ta' terapija mħallta (n=438) u plaċebo (n=432).
English: RFS parameter
Maltese: Parametru tal-RFS
English: BRAF V600E BRAF V600K BRAF V600D BRAF WT CRAF WT
Maltese: BRAF V600E BRAF V600E BRAF V600E
English: P value
Maltese: valur p
English: Palmar-plantar erythrodysaesthesia syndrome
Maltese: Sindrome ta' eritrodisaestesija palmarplantar
English: Cohort A N=15
Maltese: Koorti A N=15
English: - The other ingredients are: microcrystalline cellulose, magnesium stearate, colloidal silicone dioxide, red iron oxide (E172), titanium dioxide (E171), and hypromellose (E464).
Maltese: • Is-sustanzi mhux attivi l-oħra huma: microcrystalline cellulose, magnesium stearate, colloidal silicone dioxide, red iron oxide (E172), titanium dioxide (E171), u hypromellose (E464).
English: • Infection of the urinary system
Maltese: • Infezzjoni fis-sistema urinarja
English: efavirenz, fosamprenavir, lopinavir, nelfinavir, tipranavir, saquinavir and atazanavir
Maltese: efavirenz, fosamprenavir, lopinavir, nelfinavir, tipranavir, saquinavir u atazanavir
English: Table 12 Survival data from the primary analysis and post-hoc analyses
Maltese: Tabella 12 Dejta ta' sopravivenza mill-analiżi primarja u analiżijiet post-hoc
English: • Immunosuppressants (e.g. cyclosporin, tacrolimus, sirolimus)
Maltese: • Immunosuppressanti (eż. cyclosporin, tacrolimus, sirolimus)
English: • Antibiotics (e.g. clarithromycin, doxycycline)
Maltese: • Antibijotiċi (eż. clarithromycin, doxycyline)
English: Hydroxy-dabrafenib terminal half-life parallels that of parent with a half-life of 10 hrs while the carboxy- and desmethyl-metabolites exhibited longer half-lives (21-22 hours).
Maltese: Il-half-life terminali ta' Hydroxy-dabrafenib hija parallela ma dik ta' ġenitur b'half-life ta' 10 sigħat filwaqt li lmetaboliti ta' carboxy u desmethyl esibew half-life itwal (21-22 siegħa).
English: New primary melanoma d
Maltese: Melanoma primarja ġdida d
English: Renal and urinary disorders
Maltese: Disturbi renali u urinarji
English: Onset of induction is likely to occur after 3 days of repeat dosing with dabrafenib.
Maltese: Il-bidu tal-induzzjoni huwa probabbli li jseħħ wara 3 ijiem ta' dożi ripetuti b'dabrafenib.
English: • HIV antivirals (e.g. amprenavir, atazanavir, darunavir, delavirdine, efavirenz, fosamprenavir,
Maltese: • Antivirali tal-HIV (eż. amprenavir, atazanavir, darunavir, delavirdine, efavirenz, fosamprenavir,
English: • Antiepileptic (e.g. carbamazepine, phenytoin, primidone, valproic acid)
Maltese: • Antiepilettiċi (eż. carbamazepine, phenytoin, primidone, valproic acid)
English: By Investigator By IRC
Maltese: Mill-Investigatur Mill-IRC
English: • Calcium channel blockers (e.g. diltiazem, felodipine, nicardipine, nifedipine, verapamil)
Maltese: • Imblokkaturi tal-kanal tal-kalċju (eż. diltiazem, felodipine, nicardipine, nifedipine, verapamil)
English: Mean accumulation AUC Day 18/Day 1 ratios was 0.73.
Maltese: L-akkumulazzjoni medja talproporzjonijiet tal-Jum 18/Jum 1 AUC kienet ta' 0.73.
English: • some medicines for tuberculosis (TB), such as rifampicin
Maltese: • xi mediċini għat-tuberkulożi (TB), bħal rifampicin
English: Mean metabolite to parent AUC ratios following repeat-dose administration were 0.9, 11 and 0.7 for hydroxy-, carboxy-, and desmethyl-dabrafenib, respectively.
Maltese: Il-proporzjonijiet tal-AUC tal-metabolit għal ġenitur wara għoti ripetut ta' dożi kienu 0.9, 11 u 0.7 0 għal dabrafenib hydroxy-, carboxy-, u desmethyl-, rispettivament.
English: BRAF V600K
Maltese: BRAF V600E
English: Grade 1 or Grade 2 (Tolerable)
Maltese: Grad 1 jew Grad 2 (Tollerabbli)
English: A total of 423 subjects were randomised 1:1 to either combination (N=211) or dabrafenib (N=212).
Maltese: Għadd totali ta' 423 individwu ġew randomizzati 1:1 għal kombinazzjoni (N = 211) jew għal dabrafenib (N = 212).
English: Primary analysis (Data cut-off: 17Apr-2014)
Maltese: Analiżi primarja (Data tallimitu: 17-Apr-2014)
English: Adjuvant treatment of melanoma
Maltese: Trattament adjuvanti tal-melanoma
English: Cohort A N=74
Maltese: Koorti A N=74
English: Gemfibrozil had no clinically relevant effect on the systemic exposure to dabrafenib metabolites (≤13%).
Maltese: Gemfibrozil ma kellu ebda effett klinikament relevanti fuq l-espożizzjoni sistemika għall-metaboliti ta' dabrafenib (≤ 13 %).
English: MEK proteins are components of the extracellular signal-related kinase (ERK) pathway.
Maltese: Proteini MEK huma komponenti talmogħdija tal-kinase relatata mas-sinjal ekstraċellulari (Erk).
English: Secondary endpoints included DoR, PFS, OS, safety and population pharmacokinetics.
Maltese: L-endpoints sekondarji inkludew DoR, PFS, OS, u l-farmakokinetika tassigurtà u tal-popolazzjoni.
English: By IRC
Maltese: Mill-IRC
English: • Cardiac glycosides (e.g. digoxin, see section 4.4)
Maltese: • Glikosidi kardijaċi (eż. digoxin, ara sezzjoni 4.4)
English: Co-administration resulted in increases in hydroxy- and desmethyl-dabrafenib AUC (increases of 82% and 68%, respectively).
Maltese: L-għoti flimkien irriżulta f'żidiet flAUC ta' hydroxy- u desmethyl-dabrafenib (żidiet ta' 82 % u 68 %, rispettivament).
English: Pancreatitis Colitis
Maltese: Pankreatite Kolite
English: Induction of OATP1B1/1B3 and BCRP is not likely based on the observations from a clinical study with rosuvastatin.
Maltese: L-induzzjoni ta' OATP1B1/1B3 u BCRP x'aktarx mhux ibbażata fuq l-osservazzjonijiet minn studju kliniku b'rosuvastatin.
English: Dabrafenib is a substrate of human P-glycoprotein (Pgp) and human BCRP in vitro.
Maltese: Dabrafenib huwa sottostratt ta' P-glycoprotein (Pgp) tal-bniedem u BCRP uman tal-firien in vitro.
English: Subjects at Risk:
Maltese: Suġġetti f'Riskju:
English: • Lack of energy
Maltese: • Nuqqas ta' enerġija
English: Malignant melanoma, metastatic malignant melanoma, and superficial spreading melanoma stage III
Maltese: Melanoma malinni, melanoma malinni metastatika, u melanoma superfiċjali fi stadju III li tinfirex e
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-individwi kienu stratifikati b'livell ta' lactate dehydrogenase (LDH) (> il-limitu massimu tan-normal (ULN) versus  ULN) u mutazzjoni BRAF (V600E versus V600K).
English: Placebo (n=212)
Maltese: Plaċebo (n=212)
English: N=12 NR (5.0, NR)
Maltese: N=12 5.6 (5.0, NR)
English: Interstitial lung disease (ILD)/Pneumonitis
Maltese: Mard interstizjali tal-pulmun (ILD)/pulmonite
English: Number of events, n (%) Recurrence Relapsed with distant metastasis
Maltese: Għadd ta' episodji, n (%) Rikorrenza Rikaduta b'metastażi distanti
English: Cohort B N=65
Maltese: Koorti B N=65
English: N Events Median, months (95% CI) NA (46.9, NA)
Maltese: Medju, xhur (95% CI) NA (46.9, NA)