FrancophonIA/ELRC3.0 huggingface dataset:
English: EU/1/11/706/023 10 film-coated tablets EU/1/11/706/024 30 film-coated tablets EU/1/11/706/025 100 film-coated tablets EU/1/11/706/026 130 film-coated tablets EU/1/11/706/027 175 film-coated tablets EU/1/11/706/028 250 film-coated tablets
Maltese: EU/1/11/706/023 10 pilloli miksija b'rita EU/1/11/706/024 30 pillola miksija b'rita EU/1/11/706/025 100 pillola miksija b'rita EU/1/11/706/026 130 pillola miksija b'rita EU/1/11/706/027 175 pillola miksija b'rita EU/1/11/706/028 250 pillola miksija b'rita
English: EU/1/11/706/007 10 film-coated tablets EU/1/11/706/008 30 film-coated tablets EU/1/11/706/009 100 film-coated tablets EU/1/11/706/010 130 film-coated tablets EU/1/11/706/011 175 film-coated tablets
Maltese: EU/1/11/706/007 10 pilloli miksija b'rita EU/1/11/706/008 30 pillola miksija b'rita EU/1/11/706/009 100 pillola miksija b'rita EU/1/11/706/010 130 pillola miksija b'rita EU/1/11/706/011 175 pillola miksija b'rita
English: Levodopa/Carbidopa/Entacapone Orion 200 mg/50 mg/200 mg: dark brownish red, oval, unscored film-coated tablets marked with ‘LCE 200' on one side.
Maltese: Levodopa/Carbidopa/Entacapone Orion 200 mg/50 mg/200 mg: pilloli miskija b'rita, bla sinjal imnaqqax, ovali, ta' lewn aħmar skur fil-kannella immarkati b'‘LCE 200' fuq naħa waħda.
English: Paediatric population: The safety and efficacy of Levodopa/Carbidopa/Entacapone Orion in children aged below 18 years have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Levodopa/Carbidopa/Entacapone Orion fit-tfal b'età inqas minn 18-il sena ma ġewx determinati s'issa.
English: Each film-coated tablet contains 125 mg of levodopa, 31.25 mg of carbidopa and 200 mg of entacapone.
Maltese: Kull pillola miksija b'rita fiha 125 mg ta' levodopa, 31.25 mg ta' carbidopa u 200 mg ta' entacapone.
English: EU/1/11/706/029 10 film-coated tablets EU/1/11/706/030 30 film-coated tablets EU/1/11/706/031 100 film-coated tablets EU/1/11/706/032 130 film-coated tablets EU/1/11/706/033 175 film-coated tablets
Maltese: EU/1/11/706/029 10 pilloli miksija b'rita EU/1/11/706/030 30 pillola miksija b'rita EU/1/11/706/031 100 pillola miksija b'rita EU/1/11/706/032 130 pillola miksija b'rita EU/1/11/706/033 175 pillola miksija b'rita
English: Levodopa/Carbidopa/Entacapone Orion contains sucrose (1.9 mg/tablet).
Maltese: Levodopa/Carbidopa/Entacapone Orion fih sucrose (1.9 mg/pillola).
English: Excipient with known effect: Each tablet contains 1.89 mg of sucrose.
Maltese: Kull pillola fiha 1.89 mg ta' sucrose.
English: Excipient with known effect: Each tablet contains 1.6 mg of sucrose.
Maltese: Kull pillola fiha 1.6 mg ta' sucrose.
English: Common (may affect up to 1 in 10 people) - light-headedness or fainting due to low blood pressure, high blood pressure - worsening of Parkinson's symptoms, dizziness, drowsiness - vomiting, abdominal pain and discomfort, heartburn, dry mouth, constipation - inability to sleep, hallucinations, confusion abnormal dreams (including nightmares), tiredness - mental changes - including problems with memory, anxiety and depression (possibly with thoughts of suicide) - heart or artery disease events (e.g. chest pain), irregular heart rate or rhythm - more frequent falling - shortness of breath - increased sweating, rashes - muscle cramps, swelling of legs - blurred vision - anaemia - decreased appetite, decreased weight - headache, joint pain - urinary tract infection
Maltese: Mhux komuni (jistgħu jaffettwaw sa persuna waħda minn kull 100) - attakk tal-qalb - fsada fil-musrana - bidliet fl-għadd ta' ċelluli tad-demm li jistgħu jwasslu għal fsada, testijiet tal-funzjoni tal-fwied mhux normali - konvulżjonijiet - tħossok aġitat - sintomi psikotiċi - kolite (infjammazzjoni tal-musrana l-ħoxna) - bidla fil-kulur minbarra bidla fil-kulur tal-awrina (eż. ġilda, dwiefer, xagħar, għaraq) - diffikultà biex tibla - żamma tal-awrina
English: Each film-coated tablet contains 175 mg of levodopa, 43.75 mg of carbidopa and 200 mg of entacapone.
Maltese: Kull pillola miksija b'rita fiha 175 mg ta' levodopa, 43.75 mg ta' carbidopa u 200 mg ta' entacapone.
English: EU/1/11/706/001 10 film-coated tablets EU/1/11/706/002 30 film-coated tablets EU/1/11/706/003 100 film-coated tablets EU/1/11/706/004 130 film-coated tablets EU/1/11/706/005 175 film-coated tablets EU/1/11/706/006 250 film-coated tablets
Maltese: EU/1/11/706/001 10 pilloli miksija b'rita EU/1/11/706/002 30 pillola miksija b'rita EU/1/11/706/003 100 pillola miksija b'rita EU/1/11/706/004 130 pillola miksija b'rita EU/1/11/706/005 175 pillola miksija b'rita EU/1/11/706/006 250 pillola miksija b'rita
English: Adverse reactions that are mainly attributable to entacapone or are more frequent with entacapone than levodopa/DDC inhibitor alone are indicated with an asterisk in Table 1, section 4.8b.
Maltese: Ir-reazzjonijiet avversi li huma fil-biċċa l-kbira attribwiti għal entacapone jew li huma aktar frekwenti b'entacapone milli b'levodopa/inibitur ta' DDC waħdu huma indikati b'asterisk f'Tabella 1, sezzjoni 4.8b.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web portal.
Maltese: Ir-rekwiżiti biex jiġu ppreżentati rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont lArtikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq ilportal elettroniku Ewropew tal-mediċini.
English: Each film-coated tablet contains 50 mg of levodopa, 12.5 mg of carbidopa and 200 mg of entacapone.
Maltese: Kull pillola miksija b'rita fiha 50 mg ta' levodopa, 12.5 mg ta' carbidopa u 200 mg ta' entacapone.
English: EU/1/11/706/012 10 film-coated tablets EU/1/11/706/013 30 film-coated tablets EU/1/11/706/014 100 film-coated tablets EU/1/11/706/015 130 film-coated tablets EU/1/11/706/016 175 film-coated tablets EU/1/11/706/017 250 film-coated tablets
Maltese: EU/1/11/706/012 10 pilloli miksija b'rita EU/1/11/706/013 30 pillola miksija b'rita EU/1/11/706/014 100 pillola miksija b'rita EU/1/11/706/015 130 pillola miksija b'rita EU/1/11/706/016 175 pillola miksija b'rita EU/1/11/706/017 250 pillola miksija b'rita
English: Excipient with known effect: Each tablet contains 1.4 mg of sucrose.
Maltese: Kull pillola fiha 1.4 mg ta' sucrose.
English: Each film-coated tablet contains 100 mg of levodopa, 25 mg of carbidopa and 200 mg of entacapone.
Maltese: Kull pillola miksija b'rita fiha 100 mg ta' levodopa, 25 mg ta' carbidopa u 200 mg ta' entacapone.
English: Each film-coated tablet contains 75 mg of levodopa, 18.75 mg of carbidopa and 200 mg of entacapone.
Maltese: Kull pillola miksija b'rita fiha 75 mg ta' levodopa, 18.75 mg ta' carbidopa u 200 mg ta' entacapone.
English: Each film-coated tablet contains 150 mg of levodopa, 37.5 mg of carbidopa and 200 mg of entacapone.
Maltese: Kull pillola miksija b'rita fiha 150 mg ta' levodopa, 37.5 mg ta' carbidopa u 200 mg ta' entacapone.
English: No particular studies are reported on the pharmacokinetics of levodopa and carbidopa in patients with renal insufficiency, therefore Levodopa/Carbidopa/Entacapone Orion therapy should be administered cautiously to patients in severe renal impairment including those receiving dialysis therapy (see section 5.2).
Maltese: Ma ġew irrappurtati l-ebda studji partikolari dwar il-farmakokinetika ta' levodopa u carbidopa f'pazjenti b'insuffiċjenza renali, għalhekk terapija b'Levodopa/Carbidopa/Entacapone Orion għandha tingħata b'kawtela lill-pazjenti b'insuffiċjenza renali severa inkluż dawk li qed jirċievu terapija b'dijalisi (ara sezzjoni 5.2).
English: EU/1/11/706/018 10 film-coated tablets EU/1/11/706/019 30 film-coated tablets EU/1/11/706/020 100 film-coated tablets EU/1/11/706/021 130 film-coated tablets EU/1/11/706/022 175 film-coated tablets
Maltese: EU/1/11/706/018 10 pilloli miksija b'rita EU/1/11/706/019 30 pillola miksija b'rita EU/1/11/706/020 100 pillola miksija b'rita EU/1/11/706/021 130 pillola miksija b'rita EU/1/11/706/022 175 pillola miksija b'rita
English: Levodopa/Carbidopa/Entacapone Orion 75 mg/18.75 mg/200 mg film-coated tablets levodopa/carbidopa/entacapone
Maltese: Levodopa/Carbidopa/Entacapone Orion 75 mg/18.75 mg/200 mg pilloli miksija b'rita Levodopa/carbidopa/entacapone
English: Levodopa/Carbidopa/Entacapone Orion contains sucrose (1.6 mg/tablet).
Maltese: Levodopa/Carbidopa/Entacapone Orion fih sucrose (1.6 mg/pillola).
English: Levodopa/Carbidopa/Entacapone Orion contains sucrose (1.2 mg/tablet).
Maltese: Levodopa/Carbidopa/Entacapone Orion fih sucrose (1.2 mg/pillola).
English: Psychosis, agitation*
Maltese: Psikosi, aġitazzjoni* Mhux magħruf:
English: Levodopa/Carbidopa/Entacapone Orion contains sucrose (1.4 mg/tablet).
Maltese: Levodopa/Carbidopa/Entacapone Orion fih sucrose (1.4 mg/pillola).
English: Levodopa/Carbidopa/Entacapone Orion 125 mg/31.25 mg/200 mg film-coated tablets levodopa/carbidopa/entacapone
Maltese: Levodopa/Carbidopa/Entacapone Orion 125 mg/31.25 mg/200 mg pilloli miksija b'rita Levodopa/carbidopa/entacapone
English: Levodopa/Carbidopa/Entacapone Orion 175 mg/43.75 mg/200 mg film-coated tablets Levodopa/carbidopa/entacapone
Maltese: Levodopa/Carbidopa/Entacapone Orion 175 mg/43.75 mg/200 mg pilloli miksija b'rita levodopa/carbidopa/entacapone
English: Levodopa/Carbidopa/Entacapone Orion 50 mg/12.5 mg/200 mg film-coated tablets Levodopa/carbidopa/entacapone
Maltese: Levodopa/Carbidopa/Entacapone Orion 50 mg/12.5 mg/200 mg pilloli miksija b'rita Levodopa/carbidopa/entacapone
English: Levodopa/Carbidopa/Entacapone Orion 50 mg/12.5 mg/200 mg film-coated tablets levodopa/carbidopa/entacapone
Maltese: Levodopa/Carbidopa/Entacapone Orion 50 mg/12.5 mg/200 mg pilloli miksija b'rita levodopa/carbidopa/entacapone
English: - are allergic to levodopa, carbidopa or entacapone, or any of the other ingredients of this medicine (listed in section 6) - have narrow-angle glaucoma (an eye disorder) - have a tumour of the adrenal gland - are taking certain medicines for treating depression (combinations of selective MAO-A and
Maltese: (imniżżla fis-sezzjoni 6) - għandek glawkoma ta' angolu dejjaq (disturb fl-għajn) - għandek tumur tal-glandola adrenali - qed tieħu ċertu mediċini biex tikkura d-depressjoni (taħlita ta' inibituri selettivi ta' MAO-A u
English: Levodopa/Carbidopa/Entacapone Orion 50 mg/12.5 mg/200 mg: brownish or greyish red, round, convex unscored film-coated tablets marked with ‘LCE 50' on one side.
Maltese: Levodopa/Carbidopa/Entacapone Orion 50 mg/12.5 mg/200 mg: pilloli miskija b'rita, bla sinjal imnaqqax, ta' lewn aħmar fil-kannella jew fil-griż, tondi, ibbuzzati u mmarkati b'‘LCE 50' fuq naħa waħda.
English: - A previous history of Neuroleptic Malignant Syndrome (NMS) and/or non-traumatic rhabdomyolysis.
Maltese: - Okkorrenza minn qabel tas-Sindrome Newrolettiku Malinn (NMS - Neuroleptic Malignant
English: Levodopa/Carbidopa/Entacapone Orion 150 mg/37.5 mg/200 mg film-coated tablets levodopa/carbidopa/entacapone
Maltese: levodopa/carbidopa/entacapone orion 150 mg/37.5 mg/200 mg pilloli miksija b'rita levodopa/carbidopa/entacapone
English: Weight decreased*, decreased appetite*
Maltese: Tnaqqis fil-piż*, tnaqqis fl-aptit*
English: Levodopa/Carbidopa/Entacapone Orion 100 mg/25 mg/200 mg film-coated tablets Levodopa/carbidopa/entacapone
Maltese: Levodopa/Carbidopa/Entacapone Orion 100 mg/25 mg/200 mg pilloli miksija b'rita Levodopa/carbidopa/entacapone
English: Each film-coated tablet contains 200 mg of levodopa, 50 mg of carbidopa and 200 mg of entacapone.
Maltese: Kull pillola miksija b'rita fiha 200 mg ta' levodopa, 50 mg ta' carbidopa u 200 mg ta' entacapone.
English: Constipation*, vomiting*, dyspepsia, abdominal pain and discomfort*, dry mouth*
Maltese: Stitikezza*, rimettar*, dispepsja, uġigħ u skomdu addominali*, ħalq xott*
English: Levodopa/Carbidopa/Entacapone Orion 200 mg/50 mg/200 mg film-coated tablets Levodopa/carbidopa/entacapone
Maltese: Levodopa/Carbidopa/Entacapone Orion 200 mg/50 mg/200 mg pilloli miksija b'rita Levodopa/carbidopa/entacapone
English: Dopamine dysregulation syndrome is a well-recognised risk for dopaminergic medication used in Parkinson's disease.
Maltese: Is-sindrome ta' indeboliment firregolazzjoni ta' dopamine huwa riskju magħruf sew għall-mediċini dopaminerġiċi użati fil-marda ta' Parkinson.
English: Patients and carers should be made aware that behavioural symptoms of impulse control disorders including pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists and/or other dopaminergic treatments containing levodopa including Levodopa/Carbidopa/Entacapone Orion.
Maltese: Il-pazjenti u minn jieħu ħsiebhom għandhom ikunu konxji li jista' jkun hemm sintomi ta' mġiba li twassal għal disturbi tal-kontroll tal-impulsi li jinkludu logħob tal-ażżard patoloġiku, żieda fil-libido, ipersesswalità, infiq jew xiri kompulsiv, ikel bl-addoċċ u b'mod kompulsiv f'pazjenti mogħtija agonisti ta' dopamine u/jew trattamenti dopaminerġiċi oħrajn li fihom levodopa inkluż Levodopa/Carbidopa/Entacapone Orion.
English: Levodopa/Carbidopa/Entacapone Orion 100 mg/25 mg/200 mg: brownish or greyish red, oval, unscored film-coated tablets marked with ‘LCE 100' on one side.
Maltese: Levodopa/Carbidopa/Entacapone Orion 100 mg/25 mg/200 mg: pilloli miskija b'rita, bla sinjal imnaqqax, ta' lewn aħmar fil-kannella jew fil-griż, ovali u mmarkati b'‘LCE 100' fuq naħa waħda.
English: - Patients with chronic wide-angle glaucoma may be treated with Levodopa/Carbidopa/Entacapone Orion with caution, provided the intra-ocular pressure is well controlled and the patient is monitored carefully for changes in intra-ocular pressure.
Maltese: - Pazjenti bi glawkoma ta' angolu wiesa' kronika jistgħu jiġu kkurati b'Levodopa/Carbidopa/Entacapone Orion b'kawtela, dejjem jekk il-pressjoni intra-okulari tkun ikkontrollata sew u li l-pazjent ikun sorveljat b'kawtela għal bidliet fil-pressjoni intra-okulari.
English: General disorders and administration site conditions Common:
Maltese: Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata Komuni:
English: How to take Levodopa/Carbidopa/Entacapone Orion
Maltese: X'fih Levodopa/Carbidopa/Entacapone Orion
English: Your doctor may take some regular laboratory tests during a long term treatment with Levodopa/Carbidopa/Entacapone Orion.
Maltese: It-tabib tiegħek jista' jagħmel xi testijiet tal-laboratorju regolari waqt kura fit-tul b'Levodopa/Carbidopa/Entacapone Orion.
English: As levodopa is extensively metabolised in the periphery, only a small portion of a given dose reaches the central nervous system when levodopa is administered without metabolic enzyme inhibitors.
Maltese: Minħabba li levodopa jiġi metabolizzat b'mod estensiv fil-periferija, porzjon żgħir biss tad-doża mogħtija tilħaq is-sistema nervuża ċentrali meta levodopa jingħata mingħajr inibituri tal-enzimi metaboliċi.
English: 5 How to store Levodopa/Carbidopa/Entacapone Orion Contents of the pack and other information
Maltese: Kif taħżen Levodopa/Carbidopa/Entacapone Orion Kontenut tal-pakkett u informazzjoni oħra
English: As part of this PSUSA procedure, update of the levodopa/carbidopa/entacapone SmPCs with identical changes regarding dopamine dysregulation syndrome as agreed previously by the CMDh in the PSUSA process for levodopa/carbidopa containing products is considered warranted.
Maltese: - Sindrome ta' Indeboliment fir-Regolazzjoni ta' Dopamine (DDS - Dopamine Dysregulation Syndrome) huwa disturb ta' dipendenza li jwassal għal użu eċċessiv tal-prodott osservat f'xi pazjenti ttrattati b'carbidopa/ levodopa.
English: - If you are taking Levodopa/Carbidopa/Entacapone Orion 200 mg/50 mg/200 mg, do not take more than 7 tablets of this strength per day.
Maltese: - Jekk qed tieħu pilloli ta' Levodopa/Carbidopa/Entacapone Orion 200 mg/50 mg/200 mg, tiħux aktar minn 7 pilloli ta' din il-qawwa kuljum.
English: - a liver problem, because your dose may need to be adjusted - kidney or hormone-related diseases - stomach ulcers or convulsions - if you experience prolonged diarrhoea consult your doctor as it may be a sign of inflammation of the colon - any form of severe mental disorder like psychosis - chronic wide-angle glaucoma, because your dose may need to be adjusted and the pressure in your eyes may need to be monitored.
Maltese: infjammazzjoni tal-musrana - kull forma ta' disturb mentali sever bħal psikosi - glawkoma kronika ta' angolu wiesa', għax id-doża tiegħek jista' jkollha bżonn tiġi aġġustata u l-pressjoni ta' ġo għajnejk jista' jkollha bżonn tiġi sorveljata.
English: How to store Levodopa/Carbidopa/Entacapone Orion
Maltese: Kif taħżen Levodopa/Carbidopa/Entacapone Orion
English: What Levodopa/Carbidopa/Entacapone Orion contains
Maltese: Kif jidher Levodopa/Carbidopa/Entacapone Orion u l-kontenut tal-pakkett
English: Patients being treated with Levodopa/Carbidopa/Entacapone Orion and presenting with somnolence and/or sudden sleep onset episodes must be instructed to refrain from driving or engaging in activities where impaired alertness may put themselves or others at risk of serious injury or death (e.g. operating machines) until such recurrent episodes have resolved (see section 4.4).
Maltese: Pazjenti li qed jiġu kkurati b'Levodopa/Carbidopa/Entacapone Orion u jaqbadhom in-ngħas u/jew episodji ta' attakki ta' rqad f'daqqa għandhom jiġu avżati biex ma jsuqux jew jagħmlu attivitajiet fejn nuqqas fil-viġilanza tista' tpoġġi lilhom jew lill-oħrajn f'riskju ta' korriment serju jew mewt (eż. tħaddim ta' magni) sakemm dawn l-episodji rikorrenti jgħaddu (ara sezzjoni 4.4).
English: UContent (concentration)
Maltese: UKontenut (konċentrazzjoni)
English: 1 ml (125 mg/ml) 12 (4 x 3) pre-filled pens (multipack)
Maltese: 12 (4 x 3) pinen mimlijin għal-lest (pakkett multiplu)
English: UImmediate Packaging
Maltese: UDaqs tal-pakkett
English: UStrength UPharmaceutical Form
Maltese: UQawwa UGħamla farmaċewtika
English: 1 ml (125 mg/ml) 4 pre-filled pens
Maltese: 4 pinen mimlijin għal-lest
English: UPack size
Maltese: UNumru ta' l-EU UIsem (ivvintat)
English: 111 Power Rd, Unit G.07, Chiswick London, W4 5PY, United Kingdom
Maltese: 111 Power Rd, Unit G.07, Chiswick London, W4 5PY, Ir-Renju Unit
English: NTBC study (N=250)
Maltese: Studju NTBC (N=250)
English: - The active substance is nitisinone.
Maltese: - Is-sustanza attiva hi nitisinone.
English: 60 capsules
Maltese: 60 kapsula
English: Elevated tyrosine levels
Maltese: Livelli ta' tyrosine elevati
English: 7 Grimes Gate, Diseworth Leicestershire, DE74 2QD United Kingdom
Maltese: 7 Grimes Gate, Diseworth Leicestershire, DE74 2QD Ir-Renju Unit
English: MedDRA system organ class Frequency
Maltese: Sistema tal-klassifika talorgani MedDRA
English: Probability of no HCC (95% confidence interval) at
Maltese: Probabbiltà ta' ebda HCC (intervall ta' kunfidenza ta' 95%) wara
English: Data from a study used as a historical control (van Spronsen et al., 1994) showed the following survival probability.
Maltese: Data minn studju użata bħala kontroll storiku (van Spronsen et al., 1994) uriet il-probabbiltà ta' sopravivenza li ġejja.
English: Date of first authorisation: 24 August 2017
Maltese: Data tal-ewwel awtorizzazzjoni: 24 ta' Awissu 2017
English: Blepharitis
Maltese: Blefarite
English: It is recommended to also monitor serum alpha-fetoprotein concentrations.
Maltese: alpha-fetoprotein fis-serum.
English: Pharmacotherapeutic group: Other alimentary tract and metabolism products, Various alimentary tract and metabolism products, ATC code: A16A X04.
Maltese: Prodotti oħrajn tal-passaġġ alimentari u tal-metaboliżmu, Prodotti varji tal-passaġġ alimentari u tal-metaboliżmu, Kodiċi ATC: A16A X04.
English: The clinical study was open-labelled and uncontrolled.
Maltese: L-istudju kliniċi kien open-label u mhux ikkontrollat.
English: No mutagenic but a weak clastogenic activity was observed in in vitro studies.
Maltese: L-ebda attività mutaġenika ma ġiet osservata, iżda attività klastoġenika dgħajfa ġiet osservata fi studji in vitro.
English: Capsule shell ˗ Gelatin ˗ Titanium dioxide (E171)
Maltese: Qoxra tal-kapsula - Ġelatina - Diossidu tat-titanju (E 171)
English: Frequency is defined as 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
Maltese: Ilfrekwenza hija definita bħala 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: In vitro studies using human liver microsomes and cDNA-expressed P450 enzymes have shown limited CYP 3A4-mediated metabolism.
Maltese: Studji in vitro bl-użu ta' mikrosomi tal-fwied uman u enzimi cDNA-expressed P450 urew metaboliżmu limitat medjat minn CYP 3A4.
English: 6 years
Maltese: 6 snin
English: Monitoring of plasma tyrosine levels
Maltese: Monitoraġġ tal-livelli ta' tyrosine fil-plasma
English: Conjunctivitis, corneal opacity, keratitis, photophobia, eye pain
Maltese: Konġuntivite, opaċità tal kornea, keratite, fotofobija,
English: Nitisinone is a moderate CYP2C9 inhibitor.
Maltese: Nitisinone huwa inibitur moderat ta' CYP 2C9.
English: ≤ 24 months
Maltese: ≤ 24 xahar
English: Nitisinone is a weak inducer of CYP2E1 (30% decrease in chlorzoxazone AUC) and a weak inhibitor of OAT1 and OAT3 (1.7-fold increase in AUC of furosemide), whereas nitisinone did not inhibit CYP2D6 (see section 5.2).
Maltese: Nitisinone huwa induttur dgħajjef ta' CYP 2E1 (tnaqqis ta' 30% fl-AUC ta' chlorzoxazone) u inibitur dgħajjef ta' OAT1 u OAT3 (żieda ta' 1.7 darbiet fl-AUC ta' furosemide), filwaqt li nitisinone ma inibixxiex CYP 2D6 (ara sezzjoni 5.2).
English: Nitisinone is a competitive inhibitor of 4-hydroxyphenylpyruvate dioxygenase, an enzyme which precedes fumarylacetoacetate hydrolase in the tyrosine catabolic pathway.
Maltese: Nitisinone hu inibitur kompetittiv ta' 4-hydroxyphenylpyruvate dioxygenase, enzima li għandha preċedenza fuq fumarylacetoacetate hydrolase fil-passaġġ kataboliku ta' tyrosine.
English: Available data from a clinical study indicates that in more than 90% of the patients urine succinylacetone was normalized during the first week of treatment.
Maltese: Data disponibbli minn studju kliniku tindika li iktar minn 90% ta' succinylacetone fl awrina tal-pazjenti kien normalizzat matul l-ewwel ġimgħa tal-kura.
English: Each bottle contains 60 capsules.
Maltese: Kull flixkun fih 60 kapsula.
English: Formal absorption, distribution, metabolism and elimination studies have not been performed with nitisinone.
Maltese: Ma sarux studji formali dwar l-assorbiment, id-distribuzzjoni, il-metaboliżmu u l-eliminazzjoni b'nitisinone.
English: The clearance and half-life were determined to be 0.0956 l/kg body weight/day and 52.1 hours respectively.
Maltese: It-tneħħija u l-half-life ġew stabbiliti li huma 0.0956 Litri /kg ta' piż tal-ġisem / kuljum u 52.1 sigħat rispettivament.
English: During regular monitoring, it is appropriate to follow urine succinylacetone, liver function test values and alpha-fetoprotein levels (see section 4.4).
Maltese: Matul il-monitoraġġ regolari, ikun xieraq li tiċċekkja l-livelli ta' succinylacetone fl-awrina, il-valuri tat-test tal-funzjoni tal-fwied u l-livelli ta' alpha-fetoprotein (ara sezzjoni 4.4).
English: 2 years 4 years 6 years
Maltese: Bidu sentejn 4 snin 6 snin sentejn 4 snin
English: The active ingredient of Nitisinone MDK is nitisinone.
Maltese: Is-sustanza attiva ta' Nitisinone MDK hija nitisinone.
English: In clinical studies, granulocytopenia was only uncommonly severe (<0.5x109/L) and not associated with infections.
Maltese: Fi studji kliniċi, granuloċitopenija rarament kienet severa (<0.
English: Fertility There are no data on nitisinone affecting fertility.
Maltese: Fertilità M'hemm ebda data dwar netisinone li taffettwa l-fertilità.