FrancophonIA/ELRC3.0 huggingface dataset:
English: Questions and answers on Methylphenidate Sandoz (methylphenidate hydrochloride, prolonged-release tablet 18, 36 and 54 mg)
Maltese: Mistoqsijiet u tweġibiet dwar Methylphenidate Sandoz (methylphenidate hydrochloride, pillola li terħi l-mediċina bil-mod, 18, 36 u 54 mg)
English: What is Methylphenidate Sandoz?
Maltese: X'inhu Methylphenidate Sandoz?
English: Methylphenidate is a medicine that is used to treat children aged between 6 and 18 years of age who have ADHD (attention deficit/hyperactivity disorder), a condition in which children show a persistent inability to concentrate, hyperactivity and impulsive behaviour.
Maltese: Methylphenidate huwa mediċina li tintuża fil-kura ta' tfal bejn is-6 u t-18-il sena li għandhom ADHD (disturb ta' nuqqas ta' attenzjoni/iperattività), kundizzjoni li fiha t-tfal juru inabilità persistenti li jikkonċentraw, iperattività u mġiba impulsiva.
English: Methylphenidate Sandoz is a generic medicine based on a ‘reference medicine', Concerta, which is authorised in all the EU Member States.
Maltese: Methylphenidate Sandoz hija mediċina ġenerika bbażata fuq il-‘mediċina ta' referenza', Concerta, li hija awtorizzata fl-Istati Membri kollha tal-UE.
English: Sandoz A/S submitted Methylphenidate Sandoz for mutual recognition on the basis of the initial authorisation granted by Denmark on 29 March 2012 and also valid through a decentralised procedure in Cyprus, Finland, Poland, Portugal and Spain, as well as Iceland and Norway.
Maltese: Sandoz A/S ippreżenta Methylphenidate Sandoz għal rikonoxximent reċiproku abbażi talawtorizzazzjoni inizjali li ngħatat mid-Danimarka fid-29 ta' Marzu 2012 u wkoll valida permezz ta' proċedura deċentralizzata f'Ċipru, il-Finlandja, il-Polonja, il-Portugall u Spanja, kif ukoll fl-Islanda u nNorveġja.
English: Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the failure to show bioequivalence between Methylphenidate Sandoz and its reference medicine in the immediate-release phase under fed conditions were due to differences between patients in the effects of a high-fat meal on the way medicines are handled by the body, and not to differences between the formulations of the two medicinal products, and that bioequivalence to the reference medicinal product has been shown.
Maltese: Abbażi tal-valutazzjoni tad-dejta attwalment disponibbli u d-diskussjoni xjentifika fi ħdan il-Kumitat, isCHMP ikkonkluda li n-nuqqas ta' turija ta' bijoekwivalenza bejn Methylphenidate Sandoz u l-mediċina ta' referenza tiegħu fil-fażi ta' rilaxx immedjat taħt kondizzjonijiet ta' wara l-ikel kienu dovuti għal differenzi bejn il-pazjenti fl-effetti ta' ikla b'kontenut għoli ta' xaħam dwar il-mod kif il-mediċini jiġu ttrattati mill-ġisem, u mhux għal differenzi bejn il-formulazzjonijiet taż-żewġ prodotti mediċinali, u li lbijoekwivalenza għall-prodott mediċinali ta' referenza kienet intweriet.
English: Why was Methylphenidate Sandoz reviewed?
Maltese: Għaliex ġie rivedut Methylphenidate Sandoz?
English: On 25 July 2013, the European Medicines Agency completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Methylphenidate Sandoz.
Maltese: Fit-25 ta' Lulju 2013, l-Aġenzija Ewropea għall-Mediċini (EMEA) temmet proċedura ta' arbitraġġ wara nuqqas ta' qbil fost l-Istati Membri tal-Unjoni Ewropea (UE) dwar l-awtorizzazzjoni tal-mediċina Methylphenidata Sandoz.
English: Methylphenidate belongs to a group of medicines called ‘psychostimulants' and is thought to work by enhancing the activity of areas of the brain that control attention and concentration.
Maltese: Methylphenidate jagħmel parti minn grupp ta' mediċini msejħa "psikostimulanti" u huwa maħsub li jaħdem billi jtejjeb l-attività ta' żoni tal-moħħ li jikkontrollaw l-attenzjoni u l-konċentrazzjoni.
English: Two medicines are bioequivalent if they produce the same levels of the active substance in the body.
Maltese: Żewġ mediċini jkunu bijoekwivalenti meta jipproduċu listess livelli tas-sustanza attiva fil-ġisem.
English: The company wanted the authorisation to be recognised in Belgium, France, Germany, Luxembourg, Malta, Netherlands, Sweden and United Kingdom (the ‘concerned Member States').
Maltese: Il-kumpanija riedet li l-awtorizzazzjoni tkun rikonoxxuta fil-Belġju, Franza, il-Ġermanja,ilLussemburgu, Malta, il-Pajjiżi l-Baxxi, l-Isvizja u r-Renju Unit (l-‘Istati Membri kkonċernati').
English: However, the Member States were not able to reach an agreement and the Danish medicines regulatory agency referred the matter to the CHMP for arbitration on 21 December 2012.
Maltese: Madankollu, l-Istati Membri ma setgħux jilħqu qbil u l-aġenzija regolatorja tal-mediċini Daniża rreferiet il-kwistjoni lis-CHMP għal arbitraġġ fil-21 ta' Diċembru 2012.
English: Further information on Ferriprox can be found on the Agency's website: ema.europa.eu/en/medicines/human/EPAR/ferriprox.
Maltese: Aktar informazzjoni dwar Ferriprox tinstab fis-sit web talAġenzija: ema.europa.eu/en/medicines/human/EPAR/ferriprox.
English: It is available as tablets (500 and 1,000 mg) and as an oral solution (100 mg/ml).
Maltese: Jiġi bħala pilloli (500 u 1,000 mg) u bħala soluzzjoni orali (100 mg/ml).
English: Ferriprox (deferiprone)
Maltese: Ferriprox (deferipron)
English: Ferriprox is used:
Maltese: Ferriprox jintuża:
English: Other information about Ferriprox
Maltese: Aktar informazzjoni dwar Ferriprox
English: Ferriprox contains the active substance deferiprone.
Maltese: Ferriprox fih is-sustanza attiva deferipron.
English: The active substance in Ferriprox, deferiprone, is an iron chelator.
Maltese: Is-sustanza attiva f'Ferriprox, id-deferipron, hija kelatur talħadid.
English: The total dose for the whole day should be less than 100 mg per kilogram body weight.
Maltese: Id-doża totali għall-jum kollu għandha tkun inqas minn 100 mg għal kull kilogramma tal-piż tal-ġisem.
English: The usual dose of Ferriprox is 25 mg per kilogram body weight three times a day.
Maltese: Id-doża rakkomandata ta' Ferriprox hija 25 mg għal kull kilogramm tal-piż tal-ġisem tliet darbiet kuljum.
English: Ferriprox received a marketing authorisation valid throughout the EU on 25 August 1999.
Maltese: Ferriprox ingħata awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fil-25 ta' Awwissu 1999.
English: Ferriprox was studied in 247 patients with thalassaemia major, aged over 6 years.
Maltese: Ferriprox ġie studjat f'247 pazjent li jbatu minn talassemija maġġuri, li għandhom aktar minn sitt snin.
English: Ferriprox must not be used in people who have had neutropenia repeatedly or agranulocytosis.
Maltese: Ferriprox ma għandux jintuża f'nies li kellhom newtropenija ripetutament jew agranuloċitożi.
English: In another study involving 60 patients treated over 12 months, a combination of Ferriprox and deferoxamine (Ferriprox for 5 days plus deferoxamine for 2 days each week) was compared with deferoxamine on its own.
Maltese: Fi studju ieħor li kien jinvolvi 60 pazjent ikkurati fuq medda ta' 12-il xahar, kombinazzjoni ta' Ferriprox u deferossamina (Ferriprox għal ħamest ijiem flimkien mad-deferossamina għal jumejn kull ġimgħa) tqabbel ma' deferossamina waħdu.
English: As for all medicines, data on the use of Ferriprox are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Ferriprox hija ssorveljata kontinwament.
English: What are the risks associated with Ferriprox?
Maltese: X'inhuma r-riskji assoċjati ma' Ferriprox?
English: Ferriprox is an ‘iron chelator' (a substance that attaches to iron) that is used to treat iron overload (an excess of iron in the body) in patients with thalassaemia major.
Maltese: Ferriprox huwa ‘kelatur tal-ħadid' (sustanza li teħel mal-ħadid) li jintuża fil-kura ta' eċċess ta' ħadid (eċċess ta' ħadid fil-ġisem) f'pazjenti b'talassemija maġġuri.
English: For the full list of restrictions and side effects of Ferriprox, see the package leaflet.
Maltese: Għal-lista sħiħa ta' restrizzjonijiet u effetti sekondarji ta' Ferriprox, ara l-fuljett ta' tagħrif.
English: The most common side effects with Ferriprox (which may affect more than 1 in 10 people) are redbrown urine (showing that iron is being removed through the urine), nausea (feeling sick), abdominal pain (stomach ache) and vomiting.
Maltese: L-effetti sekondarji l-aktar komuni b'Ferriprox (li dehru f'aktar minn pazjent 1 minn 10) kienu awrina ħamranija/kannella (sinjal li l-ħadid ikun qiegħed jitneħħa mill-awrina), nawżja (tħossok ma tiflaħx), uġigħ addominali (uġigħ ta' stonku) u remettar.
English: Less common but more serious side effects are agranulocytosis (very low levels of granulocytes, a type of white blood cell) and neutropenia (low levels of neutrophils, a type of white blood cell that fights infections).
Maltese: Effetti sekondarji inqas komuni iżda iktar serji huma agranuloċitożi (livelli baxxi ħafna ta' granuloċiti, tip ta' ċelloli bojod tad-demm) u newtropenija (livelli baxxi ta' newtrofili, tip ta' ċelloli bojod tad-demm li jiġġieldu l-infezzjonijiet).
English: The company that markets Ferriprox must supply a reminder card for patients or their carers about the importance of regular tests for neutrophil counts, the need to watch out for symptoms of infection and for women to avoid becoming pregnant during treatment with Ferriprox.
Maltese: Il-kumpanija li tqiegħed Ferriprox fis-suq għandha tipprovdi kard ta' tfakkira għall-pazjenti jew għal dawk li jindukrawhom dwar l-importanza ta' testijiet regolari għall-għadd ta' newtrofili, il-ħtieġa li wieħed joqgħod attent għal sintomi ta' infezzjoni u għan-nisa biex jevitaw li joħorġu tqal waqt il-kura b'Ferriprox.
English: Patients with thalassaemia major need frequent blood transfusions.
Maltese: Pazjenti li jbatu mit-talassemija maġġuri jeħtieġu trasfużjonijiet tad-demm frekwenti.
English: Blood ferritin levels were reduced to the same extent in patients treated with the combination as with deferoxamine on its own.
Maltese: Il-livelli medji ta' ferritina fid-demm kienu simili fiż-żewġ gruppi ta' kura.
English: Side effects reported with Ferriprox are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati b'Ferriprox huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: How does Ferriprox work?
Maltese: X'inhu Ferriprox u għal xiex jintuża?
English: The main study involving 71 patients compared Ferriprox with deferoxamine, another iron chelator, over 2 years.
Maltese: L-istudju ewlieni li kien jinvolvi 71 pazjent qabbel Ferriprox ma' deferossamina, kelatur tal-ħadid ieħor, fuq medda ta' sentejn.
English: When taking Ferriprox, the patient's neutrophil count should be checked regularly (every week in the first year then less frequently).
Maltese: Meta jieħu Ferriprox, l-għadd ta' newtrofili tal-pazjent għandu jiġi ċċekkjat regolarment (kull ġimgħa fl-ewwel sena mbagħad anqas spiss).
English: How is Ferriprox used?
Maltese: Kif jaħdem Ferriprox?
English: In a published study, Ferriprox together with deferoxamine also led to greater decreases in iron in the heart compared with patients taking deferoxamine alone.
Maltese: Fi studju ppubblikat, Ferripox flimkien maddeferossamina wassal ukoll għal tnaqqis akbar fil-ħadid fil-qalb meta mqabbel ma' pazjenti li ħadu ddeferossamina waħdu.
English: AUC (0-24) (µg x hr/ml)
Maltese: AUC (0-24) (µgx hr/ml)
English: Investigated dose
Maltese: Doża investigata
English: 09400 Aranda De Duero, Burgos Spain
Maltese: Aranda De Duero, Burgos Spanja
English: Pazopanib Placebo HR (95% CI)
Maltese: Pazopanib Plaċebo HR (95% CI)
English: Extremadura, 3, 09400 Aranda De Duero, Burgos, Spain Novartis Pharmaceuticals UK Limited, Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR, United Kingdom
Maltese: Extremadura, 3, 09400 Aranda De Duero, Burgos, Spanja Novartis Pharmaceuticals UK Limited, Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR, Ir-Renju Unit
English: Fatal events have been observed.
Maltese: Kienu osservati avvenimenti fatali.
English: Median PFS was 11.9 months.
Maltese: PFS medjan kien 11.9 xhur.
English: Reproductive, fertility and teratogenic effects
Maltese: Effetti riproduttivi, ta' fertilità u teratoġeniċi
English: OS Overall ITT
Maltese: OS ITT globali
English: Investigations h
Maltese: Investigazzjonijiet h
English: In vitro, pazopanib inhibited human organic anion transporting polypeptide (OATP1B1).
Maltese: In vitro, pazopanib inibita l-organic anion transporting polypeptide (OATP1B1) uman.
English: Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations), Priory Street, Ware, Hertfordshire, SG12 0DJ, United Kingdom.
Maltese: Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations), Priory Street, Ware, Hertfordshire, SG12 0DJ, Ir-Renju Unit.
English: Tablet coating Hypromellose Iron oxide red (E172) Macrogol 400
Maltese: Il-kisi tal-pillola Hypromellose Iron oxide red (E172) Macrogol 400
English: Magnesium stearate Microcrystalline cellulose Povidone (K30) Sodium starch glycolate
Maltese: Il-qalba tal-pillola Magnesium stearate Microcrystalline cellulose Povidone (K30) Sodium starch glycolate
English: Date of first authorisation: 14 June 2010 Date of latest renewal: 08 January 2018
Maltese: Data tal-aħħar tiġdid: 08 Jannar 2018
English: QT prolongation and torsade de pointes
Maltese: Titwil tal-intervall QT u torsade de pointes
English: Frequency (all grades)
Maltese: Frekwenza (gradi kollha)
English: Oedema b
Maltese: Edima b
English: Moderate HI
Maltese: HI Moderat
English: Tablet coating Hypromellose Macrogol 400
Maltese: Il-kisi tal-pillola Hypromellose Macrogol 400
English: Soft-tissue sarcoma (STS)
Maltese: Sarkoma tat-tessut l-artab (STS)
English: Pazopanib is an inhibitor of the uridine diphosphoglucuronosyl-transferase 1A1 (UGT1A1) enzyme in vitro.
Maltese: Pazopanib huwa inibitur tal-enzima uridine diphosphoglucuronosyl-transferase 1A1 (UGT1A1) in vitro.
English: Aspartate aminotransferase increased
Maltese: Aspartate aminotransferase
English: Peritonitis
Maltese: Peritonite
English: PFS Overall* ITT
Maltese: PFS ITT Generali*
English: Thrombotic microangiopathy (TMA)
Maltese: Mikroangjopatija trombotika (TMA)
English: Pharmacotherapeutic group: Antineoplastic agents, other antineoplastic agents, protein kinase inhibitors, ATC code: L01XE11
Maltese: Sustanzi anti-neoplastiċi, sustanzi anti-neoplastiċi oħra, inpedituri ta' protein- kinase, Kodiċi ATC: L01XE11
English: PFS Overall ITT
Maltese: PFS ITT globali
English: Abdominal pain a
Maltese: Uġigħ addominali a
English: The performance status (ECOG) was similar between the pazopanib and placebo groups (ECOG 0: 42% vs. 41%, ECOG 1: 58% vs. 59%).
Maltese: effiċċjenza (ECOG) bejn il-pazopanib u l-gruppi plaċebo kien jixxiebah (ECOG 0: 42% vs. 41%, ECOG 1: 58% vs. 59%).
English: Transaminase elevation of >8 x ULN
Maltese: Żieda fit-transaminases ta' >8 x ULN
English: No statistical differences were observed between treatment groups for Global Quality of Life using EORTC QLQ-C30 and EuroQoL EQ-5D.
Maltese: Ma kienu osservati ebda differenzi bejn il-gruppi tat-trattament għal Global Quality of Life bl-użu ta' EORTC QLQ-C30 u EuroQoL EQ-5D.
English: System Organ Class
Maltese: Klassi tas-sistemi u talOrgani
English: P value = 0.245 (2-sided)
Maltese: aValur P = 0.245
English: Hepatic effects
Maltese: Effetti epatiċi
English: Votrient is a type of medicine called a protein kinase inhibitor.
Maltese: Votrient huwa tip ta' mediċina msejħa inibitur ta' protein kinase.
English: Severe HI
Maltese: HI Sever
English: Possible side effects (including possible serious side effects under the relevant frequency category).
Maltese: Effetti sekondarji possibbli (inklużi effetti sekondarji serji possibbli taħt il-kategorija ta' frekwenza rilevanti).
English: Alanine aminotransferase increased
Maltese: Alanine aminotransferase
English: CYP3A4, P-gp, BCRP inducers
Maltese: Indutturi ta' CYP3A4, P-gp, u BCRP
English: Subgroup analyses of PFS were performed for 20 demographic and prognostic factors.
Maltese: Twettqet analiżi tas-sottogrupp ta' PFS għal 20 fattur demografiku u ta' pronjożi.
English: The active metabolite of irinotecan, SN-38, is a substrate for OATP1B1 and UGT1A1.
Maltese: Il-metabolit attiv ta' irinotecan, SN-38, huwa sustrat għal OATP1B1 u UGT1A1.
English: Table 5 Overall efficacy results (VEG108844)
Maltese: Riżultati globali tal-effikaċja (VEG108844)
English: Grade 4 n (%)
Maltese: Grad 4 n (%)
English: Fatal events that were considered possibly related to pazopanib included gastrointestinal haemorrhage, pulmonary haemorrhage/haemoptysis, abnormal hepatic function, intestinal perforation and ischaemic stroke.
Maltese: Avvenimenti fatali li possibilment setgħu jkunu relatati ma'pazopanib inkludew emorraġija gastrointestinali, emorraġija respiratorji/emopteżi, funzjoni epatika abnormali, perforazzjoni intestinali u puplesija iskemika.
English: Posterior reversible encephalopathy syndrome (PRES)/Reversible posterior leukoencephalopathy syndrome (RPLS)
Maltese: Sindrome ta' Enċefalopatija posterjuri riversibbli (PRES - Posterior reversible encephalopathy syndrome)/Sindrome ta' Lewkoenċefalopatija posterjuri riversibbli (RPLS - Reversible posterior leukoencephalopathy syndrome)
English: Effects of other medicinal products on pazopanib
Maltese: Effetti ta' prodotti mediċinali oħra fuq pazopanib
English: Renal cell carcinoma (RCC)
Maltese: Karċinoma taċ-ċelluli renali (RCC)
English: Patients over 60 years of age may be at greater risk for mild (>3 x ULN) to severe (>8 x ULN) elevation of ALT.
Maltese: Pazjenti li għandhom aktar minn 60 sena jistgħu jkunu f'riskju akbar għal riskju ħafif (>3 x ULN) sa riskju sever (>8 x ULN) elevazzjoni ta' ALT.
English: Uncommon Bradycardia Myocardial infarction 5 (<1%) Cardiac dysfunctionf Myocardial ischaemia 3 (<1%)
Maltese: Mhux komuni Bradikardija Infart mijokardijaku 5 (<1%) Disfunzjoni tal-qalb f 4 (<1%) Iskemija mijokardijaka 3 (<1%)
English: Table 3 Treatment-related adverse reactions reported in STS studies (n=382)
Maltese: Tabella 3 Reazzjonijiet avversi relatati mal-kura rrappurtati fi studji dwar STS (n = 382)
English: Grade 3 n (%)
Maltese: Grad 3 n (%)
English: In vitro studies with human liver microsomes showed that pazopanib inhibited CYP enzymes 1A2, 3A4, 2B6, 2C8, 2C9, 2C19, and 2E1.
Maltese: Studji in vitro b'mikrożomi tal-fwied tal-bniedem urew li pazopanib inibita enżimi CYP 1A2, 3A4, 2B6, 2C8, 2C9, 2C19, u 2E1.
English: Permanently discontinue pazopanib.
Maltese: Waqqaf pazopanib b'mod permanenti.
English: Response rate (CR+PR) % (95% CI) Duration of response Median (weeks) (95% CI) 38.9 (16.7, 40.0)
Maltese: Medjan (ġimgħat) (95% CI) 38.9 (16.7, 40.0)
English: Pneumothorax
Maltese: Pnewmotorax
English: Uncommon Skin ulcer Rash
Maltese: Mhux komuni Ulċera fil-ġilda Raxx
English: Venous thromboembolic events
Maltese: Avvenimenti tromboemboliċi venużi
English: In clinical studies with pazopanib, increase in serum transaminases (ALT, aspartate aminotransferase [AST]) and bilirubin were observed (see section 4.8).
Maltese: Fi studji kliniċi b'pazopanib, ġew osservati żidiet fis-serum transaminases (ALT, aspartate aminotransferase [AST]) u bilirubin (ara sezzjoni 4.8).
English: Pazopanib is an orally administered, potent multi-target tyrosine kinase inhibitor (TKI) of vascular endothelial growth factor receptors (VEGFR) -1, -2, and -3, platelet-derived growth factor (PDGFR) -α and -β, and stem cell factor receptor (c-KIT), with IC50 values of 10, 30, 47, 71, 84 and 74 nM, respectively.
Maltese: Pazopanib huwa impeditur potenti ta' riċċetturi multipli ta' tyrosine kinase (TKI) tal-fattur tal-iżvilupp tal-endotilju vaskulari (VEGFR)-1,-2, u -3, fattur ta żvilupp li ġej mill-plejtlits (PDGFR) -α u -β, u riċċettur tal-fattur taċ-ċelloli tal-għerq (c-KIT), meħud b'mod orali, b'valuri ta' IC50 ta' 10, 30, 47, 71, 84 u 74 nM, rispettivament.
English: In the three smallest of these 20 subgroups, the point estimate of the hazard ratio exceeded 1.25; i.e. in subjects with no prior nephrectomy (n=186, HR=1.403, 95% CI (0.955, 2.061)), baseline LDH >1.5 x ULN (n=68, HR=1.72, 95% CI (0.943, 3.139)), and MSKCC: poor risk (n=119, HR=1.472, 95% CI (0.937, 2.313)).
Maltese: Fl-iżgħar tlieta ta' dawn l-20 sottogrupp, l-istima tal-punt tal- proporzjon ta' periklu qabżet 1.25; jiġifieri, f'individwi li ma kellhomx nefrektomija minn qabel ( n = 186, HR=1.403, 95% CI (0.955, 2.061)), LDH fillinja bażi >1.5 x ULN (n = 68, HR=1.72, 95% CI (0.943, 3.139)), u MSKCC: riskju fqir (n = 119, HR=1.472, 95% CI (0.937, 2.313)).
English: What Votrient contains - The active substance is pazopanib (as hydrochloride).
Maltese: X'fih Votrient - Is-sustanza attiva hija pazopanib (bħala hydrochloride).
English: Thyroid problems
Maltese: Problemi tat-tirojde
English: CYP3A4, P-gp, BCRP inhibitors Pazopanib is a substrate for CYP3A4, P-gp and BCRP.
Maltese: Inibituri ta' CYP3A4, P-gp, BCRP Pazopanib hija sustanza li fuqha jaġixxu l-CYP3A4, P-gp u l-BCRP.
English: Patients who carry the HLA-B*57:01 allele have an increased risk of pazopanib-associated ALT elevations.
Maltese: Pazjenti li jġorru l-allele HLA-B*57:01 għandhom ukoll riskju akbar ta' elevazzjonijiet tal-ALT assoċjati ma' pazopanib.
English: Based on in vitro IC50 and in vivo plasma Cmax values, pazopanib metabolites GSK1268992 and GSK1268997 may contribute to the net inhibitory effect of pazopanib towards BCRP.
Maltese: Fuq il-bażi ta' valuri in vitro tal-IC50 u dawk in vivo tal-Cmax fil-plażma, il-metaboliti ta' pazopanib GSK1268992 u GSK1268997 jistgħu jikkontribwixxu għall-effett nett inibitorju ta' pazopanib fuq lBCRP.
English: In this dataset, 133/2235 (6%) of the patients carried the HLA-B*57:01 allele (see section 4.4).
Maltese: F'dan is-sett ta' dejta, 133/2235 (6%) tal-pazjenti ġarrew l-allel HLA-B* 7:01 (ara sezzjoni 4.4).
English: “Other STS” subgroups*
Maltese: Sottogruppi ta' “STS oħra”*
English: HR = hazard ratio; ITT = intent to treat; PFS = progression-free survival; CR = complete response; PR = partial response.
Maltese: PFS = sopravivenza mingħajr progressjoni; CR = rispons komplut; PR = rispons parzjali.
English: Pharmacokinetic parameter comparisons of pazopanib Cmax (range of means 27.5 to 58.1 µg/ml) and AUC(0-24) (range of means 48.7 to 1040 µg*h/ml) after administration of pazopanib 800 mg alone and after administration of pazopanib 400 mg plus ketoconazole 400 mg (mean Cmax 59.2 µg/ml, mean AUC(0-24)1300 µg*h/ml) indicated that, in the presence of a strong CYP3A4 and P-gp inhibitor a dose reduction to pazopanib 400 mg once daily will, in the majority of patients, result in systemic exposure similar to that observed after administration of 800 mg pazopanib once daily alone.
Maltese: Paragun tal-parametri farmakokinetiċi ta' Cmax (firxa ta' medji minn 27.5 sa 58.1 µg/ml) u AUC(0-24) (firxa ta' medji minn 48.7 sa 1040 µg*h/ml) ta' pazopanib wara għoti ta' pazopanib 800 mg waħdu u wara għoti ta' pazopanib 400 mg flimkien ma' ketoconazole 400 mg (Cmax medja 59.2 µg/ml, AUC(0-24) medja 1300 µg*h/ml) indikaw li, fil-preżenza ta' inibitur qawwi ta' CYP3A4 u P-gp tnaqqis fid-doża ta' pazopanib 400 mg darba kuljum, fil-maġġoranza talpazjenti, twassal għal esponiment sistemiku simili għal dak osservat wara għoti ta' 800 mg pazopanib darba kuljum waħdu.
English: Rash papular
Maltese: Raxx papulari
English: The 200 mg tablets also contain iron oxide red (E172).
Maltese: Il-pilloli tal-200 mg għandhom ukoll iron oxide red (E172)
English: It cannot be excluded that pazopanib will affect the pharmacokinetics of other statins (e.g. atorvastatin, fluvastatin, pravastatin, rosuvastatin).
Maltese: Ma jistax jiġi eskluż li pazopanib jaffettwa l-farmakokinetika ta' statins oħra (eż. atorvastatin, fluvastatin, pravastatin, rosuvastatin).
English: Table 4 Overall efficacy results in RCC by independent assessment (VEG105192)
Maltese: Tabella 4 Riżultati ta'effikaċja ġenerali f'RCC minn evalwazjoni independenti (VEG105192)