FrancophonIA/ELRC3.0 huggingface dataset:
English: levodopa/carbidopa/entacapone orion 100/25/200 mg [carton only]
Estonian: levodopa/carbidopa/entacapone orion 100/25/200 mg [ainult karp]
English: Brownish or greyish red, round, convex, unscored film-coated tablets marked with ‘LCE 50' on one side.
Estonian: Pruunikas-või hallikaspunase värvusega, ümar, kumer poolitusjooneta õhukese polümeerikattega tablett, mille ühele küljele on pressitud märge “LCE 50”.
English: Levodopa/Carbidopa/Entacapone Orion contains sucrose (1.89 mg/tablet).
Estonian: Levodopa/Carbidopa/Entacapone Orion sisaldab sahharoosi (1,89 mg/tabletis).
English: However, a direct switch from levodopa/DDC inhibitor to Levodopa/Carbidopa/Entacapone Orion is not recommended for patients who have dyskinesias or whose daily levodopa dose is above 800 mg.
Estonian: Seevastu ei ole kohene üleminek levodopa/DDC inhibiitoritelt Levodopa/Carbidopa/Entacapone Orion'ile soovitatav patsientide puhul, kellel esineb düskineesia või kelle päevane levodopa annus ületab 800 mg. Neil juhtudel on soovitatav enne üleminekut ravile Levodopa/Carbidopa/Entacapone Orion'iga alustada ravi entakapooniga eraldi ravina (entakapooni sisaldavad tabletid) ja kohandada vajadusel levodopa annust.
English: Levodopa/Carbidopa/Entacapone Orion 175 mg/43.75 mg/200 mg: light brownish red, oval, unscored film-coated tablets marked with ‘LCE 175' on one side.
Estonian: Levodopa/Carbidopa/Entacapone Orion 175 mg/43,75 mg/200 mg: hele pruunikaspunane, ovaalne poolitusjooneta õhukese polümeerikattega tablett, mille ühele küljele on pressitud märge “LCE 175”.
English: Excipient with known effect: Each tablet contains 1.2 mg of sucrose.
Estonian: Teadaolevat toimet omavad abiained: Iga tablett sisaldab 1,2 mg sahharoosi.
English: levodopa/carbidopa/entacapone orion 200/50/200 mg [carton only]
Estonian: levodopa/carbidopa/entacapone orion 200/50/200 mg [ainult karp]
English: Levodopa/Carbidopa/Entacapone Orion is indicated for the treatment of adult patients with Parkinson's disease and end-of-dose motor fluctuations not stabilised on levodopa/dopa decarboxylase (DDC) inhibitor treatment.
Estonian: Ravim on näidustatud Parkinsoni tõve diagnoosiga täiskasvanud patsientide raviks, samuti toimelõpu fenomeniga levodopa/dopadekarboksülaasi (DDC) inhibiitori ravile mittealluvate motoorika kõikumiste raviks.
English: Levodopa/Carbidopa/Entacapone Orion 175 mg/43.75 mg/200 mg tablet comes in five different pack sizes (10, 30, 100, 130 or 175 tablets).
Estonian: Levodopa/Carbidopa/Entacapone Orion 175 mg/43,75 mg/200 mg tabletid on saadaval viies erinevas pakendi suuruses (10, 30, 100, 130 või 175 tabletti).
English: - Each Levodopa/Carbidopa/Entacapone Orion 200 mg/50 mg/200 mg tablet contains 200 mg of levodopa, 50 mg of carbidopa and 200 mg of entacapone.
Estonian: - Iga Levodopa/Carbidopa/Entacapone Orion'i 200 mg/50 mg/200 mg tablett sisaldab 200 mg levodopat, 50 mg karbidopat ja 200 mg entakapooni.
English: How to take Levodopa/Carbidopa/Entacapone Orion
Estonian: Kuidas Levodopa/Carbidopa/Entacapone Orion'i võtta
English: Gastrointestinal disorders Very common:
Estonian: Seedetrakti häired Väga sage:
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.
Estonian: Levodopa/Carbidopa/Entacapone Orion 100 mg/25 mg/200 mg: pruunikas-või hallikaspunane, ovaalne poolitusjooneta õhukese polümeerikattega tablett, mille ühele küljele on pressitud märge “LCE 100”.
English: Each film-coated tablet contains 150 mg of levodopa, 37.5 mg of carbidopa and 200 mg of entacapone.
Estonian: Iga õhukese polümeerikattega tablett sisaldab 150 mg levodopat, 37,5 mg karbidopat ja 200 mg entakapooni.
English: Each film-coated tablet contains 100 mg of levodopa, 25 mg of carbidopa and 200 mg of entacapone.
Estonian: Iga õhukese polümeerikattega tablett sisaldab 100 mg levodopat, 25 mg karbidopat ja 200 mg entakapooni.
English: - In patients with a history of myocardial infarction who have residual atrial nodal or ventricular arrhythmias; cardiac function should be monitored with particular care during the period of initial dose adjustments.
Estonian: - Patsientidel, kellel anamneesis on müokardi infarkti järgselt esinenud residuaalset kodade, atrioventrikulaarsõlme või vatsakeste arütmiat, tuleb kontrollida kardiaalfunktsioone sobiva Levodopa/Carbidopa/Entacapone Orion'i algannuse reguleerimise ajal.
English: However, a longer dosing interval of Levodopa/Carbidopa/Entacapone Orion may be considered for patients who are receiving dialysis therapy (see section 4.2).
Estonian: Siiski peaks kaalutlema ravimiannuste vahelise perioodi pikendamist dialüüsravi saavate patsientide puhul (vt lõik 4.2).
English: Excipient with known effect: Each tablet contains 1.6 mg of sucrose.
Estonian: Teadaolevat toimet omavad abiained: Iga tablett sisaldab 1,6 mg sahharoosi.
English: Excipient with known effect: Each tablet contains 1.4 mg of sucrose.
Estonian: Teadaolevat toimet omavad abiained: Iga tablett sisaldab 1,4 mg sahharoosi.
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
Estonian: EU/1/11/706/023 10 õhukese polümeerikattega tabletti EU/1/11/706/024 30 õhukese polümeerikattega tabletti EU/1/11/706/025 100 õhukese polümeerikattega tabletti EU/1/11/706/026 130 õhukese polümeerikattega tabletti EU/1/11/706/027 175 õhukese polümeerikattega tabletti EU/1/11/706/028 250 õhukese polümeerikattega tabletti
English: Each film-coated tablet contains 200 mg of levodopa, 50 mg of carbidopa and 200 mg of entacapone.
Estonian: Iga õhukese polümeerikattega tablett sisaldab 200 mg levodopat, 50 mg karbidopat ja 200 mg entakapooni.
English: EU/1/11/706/034 10 film-coated tablets EU/1/11/706/035 30 film-coated tablets EU/1/11/706/036 100 film-coated tablets EU/1/11/706/037 130 film-coated tablets EU/1/11/706/038 175 film-coated tablets
Estonian: EU/1/11/706/034 10 õhukese polümeerikattega tabletti EU/1/11/706/035 30 õhukese polümeerikattega tabletti EU/1/11/706/036 100 õhukese polümeerikattega tabletti EU/1/11/706/037 130 õhukese polümeerikattega tabletti EU/1/11/706/038 175 õhukese polümeerikattega tabletti
English: You should not breast-feed during treatment with Levodopa/Carbidopa/Entacapone Orion.
Estonian: Selegiliini annus ei tohiks ületada 10 mg kasutamisel koos Levodopa/Carbidopa/Entacapone Orion'iga.
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
Estonian: EU/1/11/706/007 10 õhukese polümeerikattega tabletti EU/1/11/706/008 30 õhukese polümeerikattega tabletti EU/1/11/706/009 100 õhukese polümeerikattega tabletti EU/1/11/706/010 130 õhukese polümeerikattega tabletti EU/1/11/706/011 175 õhukese polümeerikattega tabletti
English: Talk to your doctor or pharmacist if you think the effect of Levodopa/Carbidopa/Entacapone Orion is too strong or too weak, or if you experience possible side effects.
Estonian: Kui teil on tunne, et Levodopa/Carbidopa/Entacapone Orion'i toime on liiga tugev või liiga nõrk või olete märganud kõrvaltoimeid, rääkige sellest oma arstile või apteekrile.
English: 10 film-coated tablets 30 film-coated tablets 100 film-coated tablets 130 film-coated tablets 175 film-coated tablets 250 film-coated tablets
Estonian: 10 õhukese polümeerikattega tabletti 30 õhukese polümeerikattega tabletti 100 õhukese polümeerikattega tabletti 130 õhukese polümeerikattega tabletti 175 õhukese polümeerikattega tabletti 250 õhukese polümeerikattega tabletti
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
Estonian: EU/1/11/706/029 10 õhukese polümeerikattega tabletti EU/1/11/706/030 30 õhukese polümeerikattega tabletti EU/1/11/706/031 100 õhukese polümeerikattega tabletti EU/1/11/706/032 130 õhukese polümeerikattega tabletti EU/1/11/706/033 175 õhukese polümeerikattega tabletti
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.
Estonian: Levodopa/Carbidopa/Entacapone Orion, 200 mg/50 mg/200 mg: tume pruunikaspunane, ovaalne poolitusjooneta õhukese polümeerikattega tablett, mille ühele küljele on pressitud märge “LCE 200”.
English: Serious events of gastrointestinal haemorrhage (uncommon) and angioedema (rare) have been identified from the clinical trials with Levodopa/Carbidopa/Entacapone Orion or entacapone combined with levodopa/DDC inhibitor.
Estonian: Levodopa/Carbidopa/Entacapone Orion'i või entakapooni ja levodopa/DDC inhibiitori kombinatsioonravi kliinilistel uuringutel on tuvastatud ka raskeid seedetrakti verejookse (aeg-ajalt) ja angioödeemi (harv).
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
Estonian: EU/1/11/706/012 10 õhukese polümeerikattega tabletti EU/1/11/706/013 30 õhukese polümeerikattega tabletti EU/1/11/706/014 100 õhukese polümeerikattega tabletti EU/1/11/706/015 130 õhukese polümeerikattega tabletti EU/1/11/706/016 175 õhukese polümeerikattega tabletti EU/1/11/706/017 250 õhukese polümeerikattega tabletti
English: - Periodic evaluation of hepatic, haematopoietic, cardiovascular and renal function is recommended during extended therapy with Levodopa/Carbidopa/Entacapone Orion.
Estonian: - Pikaajalise ravi korral Levodopa/Carbidopa/Entacapone Orion'iga on soovitatav perioodiliselt kontrollida maksa-, vereloome-, kardiovaskulaar- ja neerufunktsiooni.
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
Estonian: EU/1/11/706/001 10 õhukese polümeerikattega tabletti EU/1/11/706/002 30 õhukese polümeerikattega tabletti EU/1/11/706/003 100 õhukese polümeerikattega tabletti EU/1/11/706/004 175 õhukese polümeerikattega tabletti EU/1/11/706/005 130 õhukese polümeerikattega tabletti EU/1/11/706/006 250 õhukese polümeerikattega tabletti
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
Estonian: EU/1/11/706/018 10 õhukese polümeerikattega tabletti EU/1/11/706/019 30 õhukese polümeerikattega tabletti EU/1/11/706/020 100 õhukese polümeerikattega tabletti EU/1/11/706/021 130 õhukese polümeerikattega tabletti EU/1/11/706/022 175 õhukese polümeerikattega tabletti
English: Levodopa/Carbidopa/Entacapone Orion contains sucrose (2.3 mg/tablet).
Estonian: Levodopa/Carbidopa/Entacapone Orion sisaldab sahharoosi (2,3 mg/tabletis).
English: How to store Levodopa/Carbidopa/Entacapone Orion
Estonian: Kuidas Levodopa/Carbidopa/Entacapone Orion'i säilitada
English: Cardiac disorders Common:
Estonian: Südame häired Sage:
English: Affected patients show a compulsive pattern of dopaminergic drug misuse above doses adequate to control motor symptoms, which may in some cases result in severe dyskinesias (see also section 4.4).
Estonian: Sündroomiga patsientidel esineb kompulsiivse mustriga dopaminergiliste ravimite väärkasutamine annustes, mis on motoorsete sümptomite kontrollimiseks vajalikest suuremad.
English: Levodopa/Carbidopa/Entacapone Orion contains sucrose (1.9 mg/tablet).
Estonian: Levodopa/Carbidopa/Entacapone Orion sisaldab sahharoosi (1,9 mg/tabletis).
English: Preclinical data of levodopa, carbidopa and entacapone, tested alone or in combination, revealed no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, and carcinogenic potential.
Estonian: Prekliinilised andmed levodopa, karbidopa ja entakapooni kohta eraldi või kombinatsioonis uurituna ei näidanud inimestele erilist ohtu.
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.
Estonian: Levodopa/Carbidopa/Entacapone Orion 50 mg/12,5 mg/200 mg: pruunikas-või hallikaspunane, ümar, kumer poolitusjooneta õhukese polümeerikattega tablett, mille ühele küljele on pressitud märge “LCE
English: Ten tablets of Levodopa/Carbidopa/Entacapone Orion 150 mg/37.5 mg/200 mg equals 375 mg of carbidopa a day.
Estonian: 150 mg/37,5 mg/200 mg Levodopa/Carbidopa/Entacapone Orion'i kümme tabletti vastab 375 mg karbidopa päevadoosile.
English: Levodopa/Carbidopa/Entacapone Orion 125 mg/31.25 mg/200 mg film-coated tablets Levodopa/carbidopa/entacapone
Estonian: Levodopa/Carbidopa/Entacapone Orion 125 mg/31,25 mg/200 mg õhukese polümeerikattega tabletid Levodopa/karbidopa/entakapoon
English: Levodopa/Carbidopa/Entacapone Orion 125 mg/31.25 mg/200 mg film-coated tablets levodopa/carbidopa/entacapone
Estonian: Levodopa/Carbidopa/Entacapone Orion 125 mg/31,25 mg/200 mg õhukese polümeerikattega tabletid levodopa/karbidopa/entakapoon
English: Levodopa/Carbidopa/Entacapone Orion 150 mg/37.5 mg/200 mg film-coated tablets Levodopa/carbidopa/entacapone
Estonian: Levodopa/Carbidopa/Entacapone Orion 150 mg/37,5 mg/200 mg õhukese polümeerikattega tabletid Levodopa/karbidopa/entakapoon
English: Levodopa/Carbidopa/Entacapone Orion 175 mg/43.75 mg/200 mg film-coated tablets levodopa/carbidopa/entacapone
Estonian: Levodopa/Carbidopa/Entacapone Orion 175 mg/43,75 mg/200 mg õhukese polümeerikattega tabletid levodopa/karbidopa/entakapoon
English: Levodopa/Carbidopa/Entacapone Orion 175 mg/43.75 mg/200 mg film-coated tablets Levodopa/carbidopa/entacapone
Estonian: Levodopa/Carbidopa/Entacapone Orion 175 mg/43,75 mg/200 mg õhukese polümeerikattega tabletid Levodopa/karbidopa/entakapoon
English: Levodopa/Carbidopa/Entacapone Orion 75 mg/18.75 mg/200 mg film-coated tablets Levodopa/carbidopa/entacapone
Estonian: Levodopa/Carbidopa/Entacapone Orion 75 mg/18,75 mg/200 mg õhukese polümeerikattega tabletid levodopa/karbidopa/entakapoon
English: Batch
Estonian: Silt
English: Levodopa/Carbidopa/Entacapone Orion contains sucrose (1.4 mg/tablet).
Estonian: Levodopa/Carbidopa/Entacapone Orion sisaldab sahharoosi (1,4 mg/tabletis).
English: Levodopa/Carbidopa/Entacapone Orion contains sucrose (1.2 mg/tablet).
Estonian: Levodopa/Carbidopa/Entacapone Orion sisaldab sahharoosi (1,2 mg/tabletis).
English: If this happens, you should not drive or use any tools or machines (see also section 'Driving and using machines') - notice that uncontrolled movements begin or get worse after you started to take Levodopa/Carbidopa/Entacapone Orion.
Estonian: Sel juhul ei tohi te juhtida autot ega teisi masinaid (vt ka lõik „Autojuhtimine ja masinatega töötamine“) - te tunnete, et kontrollimatud liigutused algavad taas või muutuvad hullemaks peale ravi alustamist Levodopa/Carbidopa/Entacapone Orion'iga: võtke ühendust oma arstiga, sest vajalikuks võib osutuda parkinsonismivastaste ravimite annuse muutmine - tekib kõhulahtisus: jälgige oma kehakaalu, vältimaks võimalikku ulatuslikku kehakaalu langust - ilmneb suhteliselt lühikese aja jooksul progresseeruv isutus, asteenia (nõrkus, kurnatus) ja kaalulangus.
English: Levodopa/Carbidopa/Entacapone Orion contains sucrose (1.6 mg/tablet).
Estonian: Levodopa/Carbidopa/Entacapone Orion sisaldab sahharoosi (1,6 mg/tabletis).
English: Levodopa/Carbidopa/Entacapone Orion 50 mg/12.5 mg/200 mg film-coated tablets Levodopa/carbidopa/entacapone
Estonian: Levodopa/Carbidopa/Entacapone Orion 50 mg/12,5 mg/200 mg õhukese polümeerikattega tabletid levodopa/karbidopa/entakapoon
English: 10 film-coated tablets 30 film-coated tablets 100 film-coated tablets 130 film-coated tablets 175 film-coated tablets
Estonian: 10 õhukese polümeerikattega tabletti 30 õhukese polümeerikattega tabletti 100 õhukese polümeerikattega tabletti 130 õhukese polümeerikattega tabletti 175 õhukese polümeerikattega tabletti
English: Levodopa/Carbidopa/Entacapone Orion 100 mg/25 mg/200 mg film-coated tablets levodopa/carbidopa/entacapone
Estonian: Levodopa/Carbidopa/Entacapone Orion 100 mg/25 mg/200 mg õhukese polümeerikattega tabletid levodopa/karbidopa/entakapoon
English: Hypromellose Magnesium stearate Polysorbate 80
Estonian: Teist tüüpi P450 isoensüümide
English: Levodopa/Carbidopa/Entacapone Orion 200 mg/50 mg/200 mg film-coated tablets Levodopa/carbidopa/entacapone
Estonian: Levodopa/Carbidopa/Entacapone Orion 200 mg/50 mg/200 mg õhukese polümeerikattega tabletid levodopa/karbidopa/entakapoon
English: No adverse reactions on fertility were observed in preclinical studies with entacapone, carbidopa or levodopa alone.
Estonian: Eraldi entakapooni, karbidopa või levodopa prekliinilistes uuringutes ei täheldatud kõrvaltoimeid fertiilsusele.
English: - Levodopa/Carbidopa/Entacapone Orion may induce orthostatic hypotension.
Estonian: - Levodopa/Carbidopa/Entacapone Orion sisaldab sahharoosi.
English: Tabulated list of adverse reactions
Estonian: b. Kõrvaltoimete tabel-nimistu
English: Rhabdomyolysis*
Estonian: Düskineesia*
English: Renal and urinary disorders Very common:
Estonian: Neerude ja kuseteede häired Väga sage:
English: - Severe hepatic impairment.
Estonian: - Raske maksakahjustus.
English: 1 ml (125 mg/ml) 12 (4 x 3) pre-filled pens (multipack)
Estonian: 1 ml (125 mg/ml) 12 (3 x 4) eeltäidetud pen-süstlit (mitmikpakend)
English: 1 ml (125 mg/ml) 4 pre-filled pens
Estonian: 1 ml (125 mg/ml) 4 eeltäidetud pen-süstlit
English: Date of first authorisation: 24 August 2017
Estonian: Müügiloa esmase väljastamise kuupäev: 24 august 2017
English: These substances are accumulated in your body.
Estonian: Need ained ladestuvad teie kehasse.
English: Data from a study used as a historical control (van Spronsen et al., 1994) showed the following survival probability.
Estonian: Andmed varasemast uuringust, mida kasutati ajalooliste võrdlusandmetena (van Spronsen et al., 1994), viitasid järgmisele elumuse tõenäosusele.
English: Date when removed from refrigerator:
Estonian: Külmikust väljavõtmise kuupäev:
English: Do not forget to mark the date on the bottle, when removed from the refrigerator.
Estonian: Ärge unustage märkida pudelile kuupäeva, millal ravim on külmikust välja võetud.
English: Do not change the dose or stop the treatment without talking to your doctor.
Estonian: Ärge muutke annust ega katkestage ravi ilma arstiga rääkimata.
English: 111 Power Rd, Unit G.07, Chiswick London, W4 5PY, United Kingdom
Estonian: 111 Power Rd, Unit G.07, Chiswick London, W4 5PY, Ühendkuningriik
English: 7 Grimes Gate, Diseworth Leicestershire, DE74 2QD United Kingdom
Estonian: 7 Grimes Gate, Diseworth Leicestershire, DE74 2QD Ühendkuningriik
English: Store in the original bottle in order to protect from light.
Estonian: Hoida originaalpudelis valguse eest kaitstult.
English: The clinical study was open-labelled and uncontrolled.
Estonian: Kliiniline uuring oli avatud ja kontrollrühmata.
English: Treatment of all genotypes of the disease should be initiated as early as possible to increase overall survival and avoid complications such as liver failure, liver cancer and renal disease.
Estonian: Kõigi haiguse genotüüpide ravi tuleb alustada nii varakult kui võimalik, et suurendada üldist elumust ning vältida tüsistusi nagu maksapuudulikkus, maksavähk või neeruhaigused.
English: MedDRA system organ class Frequency
Estonian: MedDRA organsüsteemi klass Esinemissagedus
English: This dose should be considered as a maximal dose for all patients.
Estonian: Seda annust tuleb lugeda kõigi patsientide puhul maksimaalseks annuseks.
English: During the treatment, blood samples will be drawn in order for your doctor to check whether the treatment is adequate and to make sure that there are no possible side effects causing blood disorders.
Estonian: Raviperioodi ajal võetakse vereproove, et arst saaks kontrollida, kas ravi on sobiv, ning veenduda, et ei esine mingeid võimalikke kõrvaltoimeid, mis põhjustaks verehaigusi.
English: Do not use this medicine after the expiry date which is stated on the carton and the bottle after “EXP”.
Estonian: Ärge kasutage seda ravimit pärast kõlblikkusaega, mis on märgitud karbil ja pudelil pärast „EXP”.
English: Adverse reactions involving the eyes (see section 4.8) can affect the vision.
Estonian: Silmi hõlmavad kõrvaltoimed (vt lõik 4.8) võivad mõjutada nägemist.
English: Concomitant use with other medicinal products
Estonian: Samaaegne kasutamine teiste ravimitega
English: The capsules are packaged in plastic bottles.
Estonian: Kapslid on pakendatud plastpudelisse.
English: No information about specific treatment of overdose is available.
Estonian: Üleannustamise spetsiifilise ravi kohta informatsioon puudub.
English: Follow-up by your doctor should be performed every 6 months.
Estonian: Peate arsti juures kontrollis käima iga 6 kuu järel.
English: The study indicates that once daily administration is safe and efficacious across all ages of patients.
Estonian: Uuring viitab võimalusele, et manustamine üks kord ööpäevas on ohutu ja efektiivne patsientide kõigis vanuserühmades.
English: Each bottle contains 60 capsules.
Estonian: Igas pudelis on 60 kapslit.
English: - if you are allergic to nitisinone or any of the other ingredients of this medicine (listed in section 6).
Estonian: - kui olete nitisinooni või selle ravimi mis tahes koostisosade (loetletud lõigus 6) suhtes allergiline.
English: Your doctor will adjust the dose individually.
Estonian: Teie arst kohandab annuse teile individuaalselt.
English: Monitoring visits should be performed every 6 months; shorter intervals between visits are recommended in case of adverse events.
Estonian: Kontrollvisiitidel tuleb käia iga 6 kuu tagant; kõrvaltoimete korral on soovitatav lühem visiitidevaheline intervall.
English: 60 capsules
Estonian: 60 kapslit
English: However, if you experience side effects affecting your vision you should not drive or use machines until your vision is back to normal (see section 4 “Possible side effects”).
Estonian: Kui teil siiski esinevad nägemist mõjutavad kõrvaltoimed, peate vältima auto juhtimist või masinatega töötamist, kuni teie nägemine on taastunud (vt lõik 4, „Võimalikud kõrvaltoimed“).
English: Population pharmacokinetic analysis has been conducted on a group of 207 HT-1 patients.
Estonian: Populatsiooni farmakokineetiline analüüs on teostatud 207 HT-1 patsiendi põhjal.
English: Probability of no HCC (95% confidence interval) at
Estonian: HCC puudumise tõenäosus (95% usaldusvahemik) (ajapunktis)
English: If the biochemical response is satisfactory, the dose should be adjusted only according to body weight gain.
Estonian: Kui biokeemiline reaktsioon ravimile on rahuldav, tuleb annust reguleerida üksnes vastavalt kehakaalu suurenemisele.
English: It is recommended to also monitor serum alpha-fetoprotein concentrations.
Estonian: Samuti soovitatakse jälgida seerumi alfafetoproteiini kontsentratsiooni.
English: In clinical studies, granulocytopenia was only uncommonly severe (<0.5x109/L) and not associated with infections.
Estonian: Kliinilistes uuringutes oli granulotsütopeenia harva raske (< 0,5 × 109/l) ning ei olnud seotud infektsioonidega.
English: There are no specific dose recommendations for elderly or patients that have renal or hepatic impairment.
Estonian: Puuduvad spetsiifilised annustamissoovitused eakatele patsientidele või neeru- või maksapuudulikkusega patsientidele.
English: In an international survey of patients with HT-1 on treatment with dietary restriction alone, it was found that HCC had been diagnosed in 18% of all patients aged 2 years and above.
Estonian: HT-1 patsientidel läbi viidud rahvusvahelises uuringus, kus uuriti ainult dieedipiirangutega ravimist, tuvastati, et HCC diagnoositi 18% kõigist patsientidest vanuses 2 aastat ja vanemad.
English: The dose of nitisinone should be adjusted individually.
Estonian: Nitisinooni annust tuleb kohandada individuaalselt.