FrancophonIA/ELRC3.0 huggingface dataset:
English: Human Coagulation Factor VIII (Rdna) 250 I.U.
Maltese: Fattur tal-Koagulazzjoni Uman VIII (rDNA) 250
English: Csl Behring Gmbh Human Coagulation Factor VIII
Maltese: Csl Behring Gmbh Fattur tal-Koagulazzjoni Uman VIII
English: Human Coagulation Factor VIII, Human Von Willebrand FactorVIII
Maltese: IU Kunjett, Fattur Von Willebrand Uman 500
English: Immunate 250 SV/190 SV pulveris un šķīdinātājs injekciju šķīduma pagatavošanai
Maltese: SV/190 SV pulveris un šķīdinātājs injekciju šķīduma pagatavošanai
English: Octanate 500 SV/5 ml pulveris un šķīdinātājs injekciju šķīduma pagatavošanai
Maltese: SV/5 ml pulveris un šķīdinātājs injekciju šķīduma pagatavošanai
English: Human Coagulation Factor VIII 1000 I.E. Human Von Willebrand Factor 2400 I.E.
Maltese: IU Fattur Von Willebrand Uman 2400
English: Immunate 1000 SV/750 SV pulveris un šķīdinātājs injekciju šķīduma pagatavošanai
Maltese: SV/750 SV pulveris un šķīdinātājs injekciju šķīduma pagatavošanai
English: Haemate P Csl Behring Gmbh Human Coagulation Factor VIII, Human Von
Maltese: Haemate P CSL Behring Gmbh Fattur tal-Koagulazzjoni Uman VIII, Fattur Von
English: Haemate P CSL Behring Gmbh Human Coagulation Factor VIII, Human Von
Maltese: Haemate P Csl Behring Gmbh Fattur tal-Koagulazzjoni Uman VIII, Fattur Von
English: United Kingdom Octanate Lv Octapharma-Ltd Human Coagulation Factor VIII
Maltese: Octanate Lv Octapharma-Ltd Fattur tal-Koagulazzjoni Uman VIII
English: Cardboard box 1 vial of freezedried antigen and 1 vial of aqueous adjuvant
Maltese: 1 fjala ta' freeze-dried fjala aqueous adjuvant
English: Packaging Content
Maltese: Ipakkjar Kontenut Daqs tal-pakett
English: Lactose monohydrate Sodium starch glycolate, Type A Maize starch, pregelatinized Magnesium stearate
Maltese: Lactose monohydrate Sodium starch glycolate, Tip A Maize starch, pregelatinized Magnesium stearate
English: Titanium dioxide (E171)
Maltese: Erythrosine (E127) Titanium dioxide (E171)
English: Fax: +351 22 986 61 90 e-mail: info@bial.com
Maltese: +351 22 986 61 90 e-mail: info@bial.com
English: Medicinal products metabolised by COMT
Maltese: Prodotti mediċinali metabolizzati minn COMT
English: BIAL - Portela & Cª, S.A. Tél/Tel/Teл./Tlf/Τηλ/Sími/Puh: + 351 22 986 61 00
Maltese: Tél/Tel/Teл./Tlf/Τηλ/Sími/Puh: + 351 22 986 61 00
English: CYP2C8 and OATP1B1 substrates
Maltese: Sottostratti ta' CYP2C8 u OATP1B1
English: België/Belgique/Belgien/България/Česká republika/ Danmark/Deutschland/Eesti/Ελλάδα/France/
Maltese: België/Belgique/Belgien/България/Česká republika/ Danmark/Deutschland/Eesti/Ελλάδα/France/ Hrvatska/Ireland/Ísland/Italia/Κύπρος/Latvija/ Lietuva/Luxembourg/Luxemburg/Magyarország/ Malta/Nederland/Norge/Österreich/Polska/Portugal/ România/Slovenija/Slovenská republika/ Suomi/Finland/Sverige/United Kingdom BIAL - Portela & Cª, S.A.
English: Decreased appetite, Hypertriglyceridaemia
Maltese: Tnaqqis fl-aptit, Hypertriglyceridaemia
English: Monoamino oxidase (MAO) inhibitors
Maltese: Inibituri ta' monoamino oxidase (MAO)
English: Indigo carmine aluminium lake (E132) Erythrosine (E127)
Maltese: Indigo carmine aluminium lake (E132)
English: Ongentys is a medicine that contains the active substance opicapone.
Maltese: Ongentys hi mediċina li fiha s-sustanza attiva opicapone.
English: Dysgeusia, Hyperkinesia, Syncope
Maltese: Disgewżja, Iperkineżija, Sinkope
English: Tricyclic antidepressants and noradrenaline re-uptake inhibitors
Maltese: Antidepressanti triċikliċi u inibituri tal-assorbiment mill-ġdid (reuptake inhibitors) ta' noradrenaline
English: Shellac, titanium dioxide (E171), propylene glycol, ammonia, simethicone
Maltese: Shellac, titanium dioxide (E171), propylene glycol, ammonia, simethicone 6.2 Inkompatibbiltajiet
English: Chromaturia, Nocturia
Maltese: Kromaturja, Nokturja
English: Each hard capsule contains 148.2 mg of lactose (as monohydrate).
Maltese: Kull kapsula iebsa fiha 148.2 mg ta' lactose (bħala monohydrate).
English: Opicapone presents a low absorption (~20%).
Maltese: Opicapone għandu assorbiment baxx (~ 20%).
English: Opicapone enhances the effects of levodopa.
Maltese: Opicapone iżid l-effetti ta' levodopa.
English: CI = confidence interval; N = total number of patients; n = number of patients with available information; NA = not applicable; OPC = opicapone
Maltese: CI = intervall ta' kunfidenza; N = numru totali ta' pazjenti; n = numru ta' pazjenti b'informazzjoni disponibbli; NA = mhux applikabbli; OPC = opicapone
English: There is limited clinical experience in patients with moderate hepatic impairment (Child-Pugh Class B).
Maltese: Hemm esperjenza klinika limitata f'pazjenti b'indeboliment moderat tal-fwied (Child-Pugh Klassi B).
English: Other metabolic pathways include glucuronidation, methylation and reduction.
Maltese: Passaġġi metaboliċi oħrajn jinkludu glucuronidation, methylation u reduzzjoni.
English: In Study 1, 122 patients were treated with opicapone 5 mg and 122 patients were treated with entacapone 200 mg (active comparator).
Maltese: Fi Studju 1, 122 pazjent kienu trattati b'opicapone 5 mg u 122 pazjent ġew ikkurati b'entacapone 200 mg (komparatur attiv).
English: An in vitro study showed opicapone inhibited CYP2C8 activity.
Maltese: Studju in vitro wera li opicapone inibixxa l-attività ta' CYP2C8.
English: At clinically relevant concentrations, opicapone is not expected to inhibit OAT1, OAT3, OATP1B1, OATP1B3, OCT1, OCT2, BCRP, P-gp/MDR1, BSEP, MATE1 and MATE2-K transporters as suggested by in vitro and in vivo studies.
Maltese: F'konċentrazzjonijiet klinikament rilevanti, opicapone mhux mistenni li jinibixxi OAT1, OAT3, OATP1B1, OATP1B3, OCT1, OCT2, BCRP, P-gp/MDR1, BSEP, MATE1 u trasportaturi ta' MATE2-K kif indikat minn studji in vitro u in vivo.
English: All reductions in activity essentially occurred at the highest concentration of opicapone (10 mcg/mL).
Maltese: It-tnaqqis kollu fl-attività seħħ essenzjalment fl-ogħla konċentrazzjoni ta' opicapone (10 mcg/mL).
English: CI = confidence interval; LS mean = least square mean; N = number of non-missing values; OPC = opicapone.
Maltese: CI = intervall ta' kunfidenza; medja LS = least square mean; N = numru ta' valuri mhux neqsin; OPC = opicapone.
English: Phaeochromocytoma, paraganglioma, or other catecholamine secreting neoplasms.
Maltese: Phaeochromocytoma, paraganglioma, jew neoplażmi oħrajn li jnixxu ' catecholamines.
English: Date of first authorisation: 24 June 2016
Maltese: Data tal-ewwel awtorizzazzjoni: 24 ta' Ġunju 2016
English: Opicapone may interfere with the metabolism of medicinal products containing a catechol group that are metabolised by COMT, e.g. rimiterole, isoprenaline, adrenaline, noradrenaline, dopamine, dopexamine or dobutamine, leading to potentiated effects of these medicinal products.
Maltese: Opicapone jista' jinterferixxi mal-metaboliżmu ta' prodotti mediċinali li jkun fihom grupp ta' catechol li jiġu metabolizzati minn COMT, eż. rimiterole, isoprenaline, adrenaline, noradrenaline, dopamine, dopexamine jew dobutamine, li jwassal għal effetti potenzjali ta' dawn il-prodotti mediċinali.
English: Shellac, propylene glycol, ammonia, indigo carmine aluminium (E132)
Maltese: Shellac, propylene glycol, ammonia, indigo carmine aluminium (E132) 6.2 Inkompatibbiltajiet
English: Frequency categories are defined as follows: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).
Maltese: Il-kategoriji ta' frekwenza huma definiti kif ġej: komuni ħafna (≥ 1/10); komuni (≥ 1/100 sa < 1/10); mhux komuni (≥ 1/1,000 sa < 1/100); rari (≥ 1/10,000 sa < 1/1,000); rari ħafna (< 1/10,000), mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: History of neuroleptic malignant syndrome and/or non-traumatic rhabdomyolysis.
Maltese: Storja medika ta' sindrome newrolettika malinna (Neuroleptic Malignant Syndrome) u/jew rhabdomyolysis mhux trawmatika.
English: OPA/Al/PVC//Al blisters containing 10 or 30 capsules.
Maltese: Folji tal-OPA/Al/PVC//Al li jkun fihom 10 jew 30 kapsula.
English: Opicapone is a weak in vitro inhibitor of CYP2C8 and OATP1B1, whereas repaglinide is a sensitive CYP2C8 and OATP1B1 substrate.
Maltese: Opicapone hu inibitur in vitro dgħajjef ta' CYP2C8 u OATP1B1, filwaqt li repaglinide hu sottostrat sensittiv ta' CYP2C8 u OATP1B1.
English: - The other ingredients are: o capsule content: lactose monohydrate, sodium starch glycolate (Type A), pregelatinized maize starch and magnesium stearate o capsule shell: gelatine, indigo carmine aluminium lake (E132), erythrosine (E127) and titanium dioxide (E171) o printing ink: shellac, propylene glycol, ammonia, indigo carmine aluminium (E132)
Maltese: - Is-sustanzi mhux attivi l-oħra huma: o kontenut tal-kapsula: lactose monohydrate, sodium starch glycolate (Tip A), pregelatinized maize starch, u magnesium stearate o qoxra tal-kapsula: gelatine, indigo carmine aluminium lake (E132), erythrosine (E127) u titanium dioxide (E171) o linka tal-istampar: shellac, propylene glycol, ammonia, indigo carmine aluminium (E132)
English: - The other ingredients are: o capsule content: lactose monohydrate, sodium starch glycolate (Type A), pregelatinized maize starch and magnesium stearate o capsule shell: gelatine, indigo carmine aluminium lake (E132), erythrosine (E127) and titanium dioxide (E171) o printing ink: shellac, titanium dioxide (E171), propylene glycol, ammonia, simethicone
Maltese: - Is-sustanzi mhux attivi l-oħra huma: o kontenut tal-kapsula: lactose monohydrate, sodium starch glycolate (Tip A), pregelatinized maize starch, u magnesium stearate o qoxra tal-kapsula: gelatine, indigo carmine aluminium lake (E132), erythrosine (E127) u titanium dioxide (E171) o linka tal-istampar: shellac, titanium dioxide (E171), propylene glycol, ammonia, simethicone
English: Opicapone reduced CYP2C9 activity through competitive / mixed type mode of inhibition.
Maltese: Opicapone naqqas l-attività ta' CYP2C9 permezz ta' mod ta' inibizzjoni kompetittiva/ta' tip imħallat.
English: The difference in LS mean change in OFF-time of opicapone 50 mg to entacapone was -24.8 minutes and non-inferiority of opicapone 50 mg to entacapone was demonstrated (95% confidence interval: -61.4, 11.8).
Maltese: 8 minuti u n-noninferjorità ta' opicapone 50 mg meta nqabbel ma' entacapone intweriet (95% intervall ta' kunfidenza: -61.4, 11.8).
English: The most common adverse reactions reported were nervous system disorders.
Maltese: L-iktar reazzjonijiet avversi komuni rrappurtati kienu disturbi fis-sistema nervuża.
English: In in vitro studies in human hepatic microsomes, minor inhibition of CYP1A2 and CYP2B6 was observed.
Maltese: Fi studji in vitro dwar mikrosomi tal-fwied fil-bniedem, ġiet osservata inibizzjoni minuri ta' CYP1A2 u CYP2B6.
English: Dyskinesia was the most frequently reported treatment-emergent adverse reaction (17.7%).
Maltese: Id-dyskinesia kienet ir-reazzjoni avversa l-aktar frekwenti li żviluppat mit-trattament (17.7%).
English: Difference to placebo p-value
Maltese: Differenza millplaċebo valur p
English: In the presence of a DOPA decarboxylase inhibitor (DDCI), COMT becomes the major metabolising enzyme for levodopa, catalysing its conversion to 3-O-methyldopa (3-OMD) in the brain and periphery.
Maltese: Fil-preżenza ta' inibitur ta' DOPA decarboxylase (DDCI), COMT isir l-enzima metabolizzanti ewlenija għal levodopa, u jikkatalizza l-konverżjoni tiegħu għal 3-O-methyldopa (3-OMD) fil-moħħ u l-periferija.
English: Following once-daily multiple oral doses of opicapone in the dose range of 5 to 50 mg, opicapone sulphate presented a long terminal phase with elimination half-life values ranging from 94 h to 122 h and, as a consequence of this long terminal elimination half-life, opicapone sulphate presented a high accumulation ratio in plasma, with values close of up to 6.6.
Maltese: Wara dożi orali multipli ta' opicapone darba kuljum fil-medda ta' doża ta' 5 sa 50 mg, opicapone sulphate kellu fażi terminali twila b'valuri tal-half-life tal-eliminazzjoni li kienu jvarjaw minn 94 siegħa sa 122 siegħa u, b'konsegwenza ta' din il-half-life terminali twila, opicapone sulphate kellu proporzjon ta' akkumulazzjoni għoli fil-plażma, b'valuri qrib ta' sa 6.6.
English: N LS mean
Maltese: N Medja LS
English: The binding of 14C-opicapone to plasma proteins was unaffected by the presence of warfarin, diazepam, digoxin and tolbutamide, and the binding of 14C-warfarin, 2-14C-diazepam, 3H-digoxin and 14C-tolbutamide was unaffected by the presence of opicapone and opicapone sulphate, the major human metabolite.
Maltese: It-twaħħil ta' 14C-opicapone mal-proteini tal-plażma ma kienx affettwat millpreżenza ta' warfarin, diazepam, digoxin u tolbutamide, u t-twaħħil ta' 14C-warfarin, 2-14C-diazepam, 3H-digoxin u 14C-tolbutamide ma kienx affettwat mill-preżenza ta' opicapone u opicapone sulphate, ilmetabolit uman maġġuri.
English: BIA 9-1103, its major metabolite, was transported by OATP1B1 and OATP1B3, and efflux transported by BCRP, but is not a substrate for the P-gp/MDR1 efflux transporter.
Maltese: BIA 9-1103, il-metabolit maġġuri tiegħu, kien ittrasportat minn OATP1B1 u OATP1B3, ttrasportat ‘il barra (efflux transported) minn BCRP, iżda mhuwiex sottostratt għat-trasportatur tal-effluss (efflux transporters)
English: Increases in liver enzymes were reported in studies with nitrocatechol inhibitors of catechol-Omethyltransferase (COMT).
Maltese: Żidiet fl-enzimi tal-fwied ġew irrappurtati fi studji b'inibituri nitrocatechol ta' catecholO-methyltransferase (COMT).
English: Blood creatine phosphokinase increased
Maltese: Żieda fil-creatine phosphokinase fid demm
English: In vitro studies over the opicapone concentration range 0.3 to 30 mcg/mL showed that binding of 14C-opicapone to human plasma proteins is high (99.9%) and concentration-independent.
Maltese: Studji in vitro fuq il-medda ta' konċentrazzjoni ta' opicapone ta' 0.3 sa 30 mcg/mL urew li t-twaħħil ta' 14C-opicapone mal-proteini tal-plażma tal-bniedem hu għoli (99.9%) u indipendenti millkonċentrazzjoni.
English: Change in total ON-time without troublesome dyskinesiasa
Maltese: Bidla fil-ħin totali ON mingħajr dyskinesias li jikkawżaw problemia
English: Concomitant use with monoamine oxidase (MAO-A and MAO-B) inhibitors (e.g. phenelzine, tranylcypromine and moclobemide) other than those for the treatment of Parkinson's disease (see section 4.5).
Maltese: L-użu flimkien ma' inibituri ta' monoamine oxidase (MAO-A u MAO-B) (eż. phenelzine, tranylcypromine u moclobemide) apparti dawk għat-trattament tal-marda ta' Parkinson (ara sezzjoni 4.5).
English: However, an evaluation with 50 mg opicapone was performed in subjects included in both phase 3 studies with GFR/1.73 m2 <60 mL/min (i.e. moderately decreased renal elimination capacity), and using pooled BIA 9-1103 data (major metabolite of opicapone).
Maltese: Madankollu, twettqet evalwazzjoni b'50 mg ta' opicapone f'individwi li kienu inklużi fiżżewġ studji ta' fażi 3 b'GFR/1.73 m2 <60 mL/min (i.e. kapaċità tat-tneħħija mill-kliewi moderatament imnaqqsa), u bl-użu ta' data miġbura ta' BIA 9-1103 (metabolit maġġuri ta' opicapone).
English: The difference in LS mean change in OFF-time of entacapone to placebo in Study 1 was -30.5 minutes.
Maltese: Id-differenza fil-bidla medja f'LS fil-ħin OFF ta' entacapone mal-plaċebo fi Studju 1 kienet ta' -30.5 minuti.
English: Table 1 - Frequency of adverse reactions (MedDRA) in placebo-controlled Phase 3 studies System Organ Class
Maltese: Tabella 1 - Frekwenza ta' reazzjonijiet avversi (MedDRA) fi studji ta' Fażi 3 ikkontrollati bi plaċebo
English: Pharmacotherapeutic group: Anti-parkinson drugs, other dopaminergic agents, ATC code: [not yet assigned]
Maltese: Mediċini kontra l-marda ta' Parkinson, aġenti dopaminerġiċi oħra, Kodiċi ATC:
English: À Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado Portugal (only for outer packaging)
Maltese: 4745-457 S. Mamede do Coronado Il-Portugall
English: Following administration of a single oral dose of 14C-opicapone, the main excretion route of opicapone and its metabolites was faeces, accounting for 58.5% to 76.8% of the administered radioactivity (mean 67.2%).
Maltese: Wara l-għoti ta' doża waħda orali ta' 14C-opicapone, ir-rotta ewlenija tal-eliminazzjoni ta' opicapone u l-metaboliti tiegħu kien l-ippurgar, li tammonta għal 58.5% sa 76.8% tar-radjuattività mogħtija (medja ta' 67.2%).
English: Blisters: 10, 30 or 90 capsules.
Maltese: Folji: 10, 30 jew 90 kapsula.
English: There is limited experience with opicapone when used concomitantly with tricyclic antidepressants and noradrenaline re-uptake inhibitors (e.g. venlafaxine, maprotiline and desipramine).
Maltese: Hemm esperjenza limitata b'opicapone meta jintuża fl-istess ħin ma' antidepressanti triċikliċi u inibituri tal-assorbiment mill-ġdid ta' noradrenaline (eż. venlafaxine, maprotiline u desipramine).
English: Caution must be exercised in patients ≥ 85 years of age as there is limited experience in this age group.
Maltese: Irid ikun hemm kawtela f'pazjenti li jkollhom ≥ 85 sena għax hemm esperjenza limitata f'dan il-grupp ta' età.
English: Each hard capsule contains 171.9 mg of lactose (as monohydrate).
Maltese: 9 mg ta' lactose (bħala monohydrate).
English: Concomitant use of opicapone and MAO inhibitors for the treatment of Parkinson's disease, e.g. rasagiline (up to 1 mg/day) and selegiline (up to 10 mg/day in oral formulation or 1.25 mg/day in buccal absorption formulation), is permissible (see section 4.3).
Maltese: L-użu flimkien ta' opicapone u inibituri ta' MAO għat-trattament tal-marda ta' Parkinson, eż. rasagiline (sa 1 mg/jum) u selegiline (sa 10 mg/jum f' formulazzjoni orali jew 1.25 mg/jum filformulazzjoni tal-assorbiment mil-ħalq), hu permissibbli (ara sezzjoni 4.3).
English: Effect of transporters on opicapone
Maltese: Effett ta' trasportaturi fuq opicapone
English: Table 2 - Change in absolute OFF-time and ON-time (minutes) from baseline to endpoint Treatment
Maltese: Tabella 2 - Bidla fil-ħin OFF u ON assolut (minuti) mil-linja bażi sal-punt aħħari Trattament
English: Ongentys contains lactose.
Maltese: Ongentys fih il-lactose.
English: After oral administration, the apparent volume of distribution of opicapone at a dose of 50 mg was 29 L with an inter-subject variability of 36%.
Maltese: Wara għoti orali, il-volum tad-distribuzzjoni apparenti ta' opicapone f'doża ta' 50 mg kien ta' 29 L, b'varjabilità bejn l-individwi ta' 36%.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER OPA/Al/PVC//Al
Maltese: FOLJA OPA/Al/PVC//Al
English: The reduced metabolite of opicapone (found to be active in non-clinical studies) is a minor metabolite in human plasma, and represented less than 10% of total systemic exposure to opicapone.
Maltese: Il-metabolit ridott ta' opicapone (li nstab li kien attiv fl-istudji mhux kliniċi) hu metabolit minuri filplażma umana, u kien jirrappreżenta inqas minn 10% tal-esponiment sistemiku totali għal opicapone.
English: Other medicines and Ongentys
Maltese: Mediċini oħra u Ongentys
English: The most abundant peaks in plasma after a single-dose of 100 mg 14C-opicapone are metabolites BIA 9-1103 (sulphate) and BIA 9-1104 (methylated), 67.1 and 20.5% of radioactive AUC respectively.
Maltese: BIA 9-1103 (sulphate) u BIA 9-1104 (methylated), 67.1 u 20.
English: Muscle twitching, Musculoskeletal stiffness, Myalgia, Pain in extremity
Maltese: Spażmi fil-muskoli, Ebusija muskoluskeletali, Mijalġja, Uġigħ flestremitajiet
English: At steady state, opicapone 50 mg significantly increased the extent of levodopa systemic exposure approximately 2 fold compared to placebo following a single oral administration of either 100/25 mg levodopa/carbidopa or 100/25 mg levodopa/benserazide administered 12 h after the opicapone dose.
Maltese: Fl-istat fiss, opicapone 50 mg żied b'mod sinifikanti il-grad ta' esponiment sistemiku ta' levodopa b'madwar id-doppju meta mqabbel mal-plaċebo wara għoti ta' doża waħda orali ta' jew 100/25 mg ta' levodopa/carbidopa jew 100/25 mg levodopa/benserazide mogħtija 12-il siegħa wara d-doża ta' opicapone.
English: In both studies, 783 patients were treated with 25 mg or 50 mg of opicapone or placebo.
Maltese: Fiż-żewġ studji, 783 pazjent ġew trattati b'25 mg jew 50 mg ta' opicapone jew plaċebo.
English: Combination of opicapone and MAO inhibitors could result in inhibition of the majority of the pathways responsible for the metabolism of catecholamines.
Maltese: Kombinazzjoni ta' opicapone u inibituri ta' MAO tista' twassal għal inibizzjoni tal-maġġoranza talpassaġġi li huma responsabbli għall-metaboliżmu ta' catecholamines.
English: Opicapone showed a marked (>90%) and long-lasting (>24 hours) COMT inhibition in healthy subjects after administration of 50 mg opicapone.
Maltese: Opicapone wera inibizzjoni notevoli (> 90%) u fit-tul (> 24 siegħa) għal COMT f'individwi b'saħħithom wara l-għoti ta' 50 mg ta' opicapone.
English: Placebo (N=121)
Maltese: (N=121)
English: Sulphation of opicapone appears to be the major metabolic pathway in humans, yielding the inactive opicapone sulphate metabolite.
Maltese: Jidher li s-sulfazzjoni (sulphation) ta' opicapone hi l-passaġġ metaboliku maġġuri fil-bnedmin, u tipproduċi l-metabolit inattiv opicapone sulphate.
English: Study 2 Change in OFF-time
Maltese: Bidla fil-ħin OFF
English: In healthy subjects, the opicapone elimination half-life (t1/2) was 0.7 h to 3.2 h following once-daily multiple-dose administration up to 50 mg opicapone.
Maltese: F'individwi b'saħħithom, il-half-life (t1/2) tal-eliminazzjoni ta' opicapone kienet ta' 0.7 sigħat sa 3.2 sigħat wara l-għoti ta' dożi multipli darba kuljum sa 50 mg ta' opicapone.
English: Dizziness, Headache, Somnolence
Maltese: Mediċini oħrajn li fihom levodopa
English: Table 3 - OFF-time responder rates at endpoint Response type
Maltese: Tabella 3 - Rati ta' ħin OFF ta' persuni li rrispondew fil-punt aħħari
English: Orthostatic Hypotension
Maltese: Pressjoni Baxxa Ortostatika
English: The pharmacokinetics of opicapone was evaluated in elderly subjects (aged 65-78 years old) after 7day multiple-dose administration of 30 mg. An increase in both the rate and extent of systemic exposure was observed for the elderly population when compared to the young population.
Maltese: Il-farmakokinetika ta' opicapone ġiet evalwata f'individwi anzjani (li kellhom 65-78 sena) wara 7 ijiem ta' għoti ta' doża multipli ta' 30 mg.
English: Effect of opicapone on transporters
Maltese: Effett ta' opicapone fuq trasportaturi
English: Ongentys contains lactose
Maltese: Ongentys fih il-lactose
English: Patients had disease severity stages 1 to 3 (modified Hoehn and Yahr) at ON, were treated with 3 to 8 daily doses of levodopa/DDCI and had a daily average OFF-time of at least 1.5 hours.
Maltese: Il-pazjenti kellhom severità tal-mard ta' stadji 1 sa 3 (Hoehn u Yahr modifikati) f'ON), ġew ikkurati bi 3 sa 8 dożi ta' kuljum ta' levodopa/DDCI u kellhom ħin medju OFF ta' kuljum ta' mill-inqas 1.5 sigħat.
English: OPA/Al/PVC//Al blisters containing 10, 30 or 90 capsules Not all pack sizes may be marketed.
Maltese: Folji tal-OPA/Al/PVC//Al li jkun fihom 10, 30 jew 90 kapsula.
English: HDPE BOTTLE
Maltese: TAL-HDPE
English: After oral administration, the apparent total body clearance of opicapone at a dose of 50 mg was 22 L/h, with an inter-subject variability of 45%.
Maltese: Wara għoti orali, it-tneħħija total apparenti mill-ġisem ta' opicapone f'doża ta' 50 mg kienet ta' 22 L/siegħa, b'varjabilità bejn l-individwi ta' 45%.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take Ongentys.
Maltese: Pazjenti li għandhom problemi ereditarji rari ta' intolleranza għall-galactose, nuqqas ta' Lapp lactase jew malassorbiment tal-glucose-galactose m'għandhomx jieħdu Ongentys.