FrancophonIA/ELRC3.0 huggingface dataset:
English: 150 mg/37.5 mg/200 mg Each tablet contains 150 mg of levodopa, 37.5 mg of carbidopa and 200 mg of entacapone.
Swedish: 150 mg/37,5 mg/200 mg Varje tablett innehåller 150 mg levodopa, 37,5 mg karbidopa och 200 mg entakapon.
English: Uncommon:
Swedish: Hjärtat Vanliga:
English: Women should not breast-feed during treatment with Levodopa/Carbidopa/Entacapone Orion.
Swedish: Amning bör undvikas vid behandling med Levodopa/Carbidopa/Entacapone Orion.
English: 50 mg/12.5 mg/200 mg Each tablet contains 50 mg of levodopa, 12.5 mg of carbidopa and 200 mg of entacapone.
Swedish: 50 mg/12,5 mg/200 mg Varje tablett innehåller 50 mg levodopa, 12,5 mg karbidopa och 200 mg entakapon.
English: levodopa/carbidopa/entacapone orion 175/43.75/200 mg [carton only]
Swedish: levodopa/carbidopa/entacapone orion 175/43,75/200 mg [endast kartong]
English: Levodopa/Carbidopa/Entacapone Orion 150 mg/37.5 mg/200 mg: brownish or greyish red, elongatedellipse shaped, unscored film-coated tablets marked with ‘LCE 150' on one side.
Swedish: Levodopa/Carbidopa/Entacapone Orion 150 mg/37,5 mg/200 mg: brun- eller gråröda förlängt ellipsformade filmdragerade tabletter utan skåra märkta med ”LCE 150” på ena sidan.
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
Swedish: trötthet - mentala förändringar - inklusive minnesstörningar, oro och depression (eventuellt med självmordstankar) hjärt- eller artärsjukdom (t.ex. bröstsmärtor), oregelbunden hjärtfrekvens eller rytm - ökad tendens att falla - andfåddhet - ökad svettning, utslag - muskelkramper, svullnad av benen - dimsyn - blodbrist - minskad aptit, viktminskning - huvudvärk, ledsmärta - urinvägsinfektion
English: levodopa/carbidopa/entacapone orion 125/31.25/200 mg [carton only]
Swedish: levodopa/carbidopa/entacapone orion 125/31,25/200 mg [endast kartong]
English: 100 mg/25 mg/200 mg Each tablet contains 100 mg of levodopa, 25 mg of carbidopa and 200 mg of entacapone.
Swedish: 100 mg/25 mg/200 mg Varje tablett innehåller 100 mg levodopa, 25 mg karbidopa och 200 mg entakapon.
English: Each film-coated tablet contains 125 mg of levodopa, 31.25 mg of carbidopa and 200 mg of entacapone.
Swedish: Varje filmdragerad tablett innehåller 125 mg levodopa, 31,25 mg karbidopa och 200 mg entakapon.
English: No adverse reactions on fertility were observed in preclinical studies with entacapone, carbidopa or levodopa alone.
Swedish: I prekliniska studier med enbart entakapon, karbidopa eller levodopa sågs inga biverkningar med avseende på fertilitet.
English: Levodopa/Carbidopa/Entacapone Orion 75 mg/18.75 mg/200 mg tablet comes in five different pack sizes (10, 30, 100, 130 or 175 tablets).
Swedish: Levodopa/Carbidopa/Entacapone Orion 75 mg/18,75 mg/200 mg tabletter finns i fem olika förpackningsstorlekar (10, 30, 100, 130 eller 175 tabletter).
English: 200 mg/50 mg/200 mg Each tablet contains 200 mg of levodopa, 50 mg of carbidopa and 200 mg of entacapone.
Swedish: 200 mg/50 mg/200 mg Varje tablett innehåller 200 mg levodopa, 50 mg karbidopa och 200 mg entakapon.
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.
Swedish: Levodopa/Carbidopa/Entacapone Orion 175 mg/43,75 mg/200 mg: ljust rödbruna ovala filmdragerade tabletter märkta med ”LCE 175” på ena sidan.
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.
Swedish: Levodopa/Carbidopa/Entacapone Orion 200 mg/50 mg/200 mg: mörkt rödbruna, ovala filmdragerade tabletter utan skåra märkta med ”LCE 200” på ena sidan.
English: Each film-coated tablet contains 50 mg of levodopa, 12.5 mg of carbidopa and 200 mg of entacapone.
Swedish: Varje filmdragerad tablett innehåller 50 mg levodopa, 12,5 mg karbidopa och 200 mg entakapon.
English: Excipient with known effect: Each tablet contains 1.9 mg of sucrose.
Swedish: Hjälpämne med känd effekt: Varje tablett innehåller 1,9 mg sackaros.
English: Levodopa/Carbidopa/Entacapone Orion 125 mg/31.25 mg/200 mg tablet comes in five different pack sizes (10, 30, 100, 130 or 175 tablets).
Swedish: Levodopa/Carbidopa/Entacapone Orion 125 mg/31,25 mg/200 mg tabletter finns i fem olika förpackningsstorlekar (10, 30, 100, 130 eller 175 tabletter).
English: Tabulated list of adverse reactions
Swedish: b. Lista med biverkningar i tabellform
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.
Swedish: Levodopa/Carbidopa/Entacapone Orion 50 mg/12,5 mg/200 mg: brun- eller gråröda runda konvexa (d.v.s. översida och undersida är rundade) filmdragerade tabletter utan skåra märkta med ”LCE 50” på ena sidan.
English: levodopa/carbidopa/entacapone orion 50/12.5/200 mg [carton only]
Swedish: levodopa/carbidopa/entacapone orion 50/12,5/200 mg [endast kartong]
English: How to take Levodopa/Carbidopa/Entacapone Orion
Swedish: Hur du tar Levodopa/Carbidopa/Entacapone Orion
English: Diarrhoea*, nausea*
Swedish: Mycket vanliga: Diarré *, illamående * Vanliga:
English: Levodopa/Carbidopa/Entacapone Orion 200 mg/50 mg/200 mg tablet comes in five different pack sizes (10, 30, 100, 130 or 175 tablets).
Swedish: Levodopa/Carbidopa/Entacapone Orion 200 mg/50 mg/200 mg tabletter finns i fem olika förpackningsstorlekar (10, 30, 100, 130 och 175 tabletter).
English: Levodopa/Carbidopa/Entacapone Orion contains sucrose (1.89 mg/tablet).
Swedish: Levodopa/Carbidopa/Entacapone Orion innehåller sackaros (1,89 mg/tablett).
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).
Swedish: Behandling med Levodopa/Carbidopa/Entacapone Orion bör därför ske med försiktighet till patienter med svår njurfunktionsnedsättning inklusive de patienter som får dialysbehandling (se avsnitt 5.2).
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).
Swedish: Levodopa/Carbidopa/Entacapone Orion 175 mg/43,75 mg/200 mg tabletter finns i fem olika förpackningsstorlekar (10, 30, 100, 130 eller 175 tabletter).
English: Each film-coated tablet contains 150 mg of levodopa, 37.5 mg of carbidopa and 200 mg of entacapone.
Swedish: Varje filmdragerad tablett innehåller 150 mg levodopa, 37,5 mg karbidopa och 200 mg entakapon.
English: mg/200 mg is 8 tablets per day and Levodopa/Carbidopa/Entacapone Orion 200 mg/50 mg/200 mg dose is 7 tablets per day.
Swedish: Orion 175 mg/43,75 mg/200 mg 8 tabletter om dagen och Levodopa/Carbidopa/Entacapone Orion 200 mg/50 mg/200 mg 7 tabletter om dagen.
English: levodopa/carbidopa/entacapone orion 150/37.5/200 mg [carton only]
Swedish: levodopa/carbidopa/entacapone orion 150/37,5/200 mg [endast kartong]
English: Each film-coated tablet contains 100 mg of levodopa, 25 mg of carbidopa and 200 mg of entacapone.
Swedish: Varje filmdragerad tablett innehåller 100 mg levodopa, 25 mg karbidopa och 200 mg entakapon.
English: Excipient with known effect: Each tablet contains 1.2 mg of sucrose.
Swedish: Hjälpämne med känd effekt: Varje tablett innehåller 1,2 mg sackaros.
English: Each film-coated tablet contains 200 mg of levodopa, 50 mg of carbidopa and 200 mg of entacapone.
Swedish: Varje filmdragerad tablett innehåller 200 mg levodopa, 50 mg karbidopa och 200 mg entakapon.
English: Chromaturia*
Swedish: Hrvatska
English: levodopa/carbidopa/entacapone orion 100/25/200 mg [carton only]
Swedish: levodopa/carbidopa/entacapone orion 100/25/200 mg [endast kartong]
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.
Swedish: Levodopa/Carbidopa/Entacapone Orion 100 mg/25 mg/200 mg: brun- eller gråröda ovala filmdragerade tabletter utan skåra märkta med ”LCE 100” på ena sidan.
English: levodopa/carbidopa/entacapone orion 200/50/200 mg [carton only]
Swedish: levodopa/carbidopa/entacapone orion 200/50/200 mg [endast kartong]
English: Excipient with known effect: Each tablet contains 1.4 mg of sucrose.
Swedish: Hjälpämne med känd effekt: Varje tablett innehåller 1,4 mg sackaros.
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
Swedish: EU/1/11/706/023 10 filmdragerade tabletter EU/1/11/706/024 30 filmdragerade tabletter EU/1/11/706/025 100 filmdragerade tabletter EU/1/11/706/026 130 filmdragerade tabletter EU/1/11/706/027 175 filmdragerade tabletter EU/1/11/706/028 250 filmdragerade tabletter
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
Swedish: EU/1/11/706/034 10 filmdragerade tabletter EU/1/11/706/035 30 filmdragerade tabletter EU/1/11/706/036 100 filmdragerade tabletter EU/1/11/706/037 130 filmdragerade tabletter EU/1/11/706/038 175 filmdragerade tabletter
English: Excipient with known effect: Each tablet contains 1.6 mg of sucrose.
Swedish: Hjälpämne med känd effekt: Varje tablett innehåller 1,6 mg sackaros.
English: Thrombocytopenia
Swedish: B. BIPACKSEDEL
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
Swedish: EU/1/11/706/007 10 filmdragerade tabletter EU/1/11/706/008 30 filmdragerade tabletter EU/1/11/706/009 100 filmdragerade tabletter EU/1/11/706/010 130 filmdragerade tabletter EU/1/11/706/011 175 filmdragerade tabletter
English: How to store Levodopa/Carbidopa/Entacapone Orion
Swedish: Hur Levodopa/Carbidopa/Entacapone Orion ska förvaras
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
Swedish: EU/1/11/706/029 10 filmdragerade tabletter EU/1/11/706/030 30 filmdragerade tabletter EU/1/11/706/031 100 filmdragerade tabletter EU/1/11/706/032 130 filmdragerade tabletter EU/1/11/706/033 175 filmdragerade tabletter
English: Levodopa/Carbidopa/Entacapone Orion 75 mg/18.75 mg/200 mg film-coated tablets Levodopa/carbidopa/entacapone
Swedish: Levodopa/Carbidopa/Entacapone Orion 75 mg/18,75 mg/200 mg filmdragerade tabletter levodopa/karbidopa/entakapon
English: The effects of Levodopa/Carbidopa/Entacapone Orion may be weakened by certain medicines.
Swedish: Vissa läkemedel kan försvaga effekten av Levodopa/Carbidopa/Entacapone Orion.
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
Swedish: EU/1/11/706/001 10 filmdragerade tabletter EU/1/11/706/002 30 filmdragerade tabletter EU/1/11/706/003 100 filmdragerade tabletter EU/1/11/706/004 130 filmdragerade tabletter EU/1/11/706/005 175 filmdragerade tabletter EU/1/11/706/006 250 filmdragerade tabletter
English: Levodopa/Carbidopa/Entacapone Orion 175 mg/43.75 mg/200 mg film-coated tablets Levodopa/carbidopa/entacapone
Swedish: Levodopa/Carbidopa/Entacapone Orion 175 mg/43,75 mg/200 mg filmdragerade tabletter levodopa/karbidopa/entakapon
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
Swedish: EU/1/11/706/018 10 filmdragerade tabletter EU/1/11/706/019 30 filmdragerade tabletter EU/1/11/706/020 100 filmdragerade tabletter EU/1/11/706/021 130 filmdragerade tabletter EU/1/11/706/022 175 filmdragerade tabletter
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
Swedish: EU/1/11/706/012 10 filmdragerade tabletter EU/1/11/706/013 30 filmdragerade tabletter EU/1/11/706/014 100 filmdragerade tabletter EU/1/11/706/015 130 filmdragerade tabletter EU/1/11/706/016 175 filmdragerade tabletter EU/1/11/706/017 250 filmdragerade tabletter
English: Levodopa/Carbidopa/Entacapone Orion 125 mg/31.25 mg/200 mg film-coated tablets Levodopa/carbidopa/entacapone
Swedish: Levodopa/Carbidopa/Entacapone Orion 125 mg/31,25 mg/200 mg filmdragerade tabletter levodopa/karbidopa/entakapon
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
Swedish: Vanliga (kan förekomma hos upp till 1 av 10 personer): - tomhets- eller svimningskänsla p.g.a. lågt blodtryck, högt blodtryck - förvärrade symtom på Parkinsons sjukdom, yrsel, dåsighet, - kräkningar, buksmärta och obehagskänslor, halsbränna, muntorrhet, förstoppning - sömnsvårigheter, hallucinationer, förvirring, onormala drömmar (inklusive mardrömmar),
English: Levodopa/Carbidopa/Entacapone Orion 150 mg/37.5 mg/200 mg film-coated tablets levodopa/carbidopa/entacapone
Swedish: Levodopa/Carbidopa/Entacapone Orion 150 mg/37,5 mg/200 mg filmdragerade tabletter levodopa/karbidopa/entakapon
English: Levodopa/Carbidopa/Entacapone Orion contains sucrose (2.3 mg/tablet).
Swedish: Levodopa/Carbidopa/Entacapone Orion innehåller sackaros (2,3 mg/tablett).
English: Levodopa/Carbidopa/Entacapone Orion 100 mg/25 mg/200 mg film-coated tablets Levodopa/carbidopa/entacapone
Swedish: Levodopa/Carbidopa/Entacapone Orion 100 mg/25 mg/200 mg filmdragerade tabletter levodopa/karbidopa/entakapon
English: Levodopa/Carbidopa/Entacapone Orion contains sucrose (1.9 mg/tablet).
Swedish: Levodopa/Carbidopa/Entacapone Orion innehåller sackaros (1,9 mg/tablett).
English: Levodopa/Carbidopa/Entacapone Orion 50 mg/12.5 mg/200 mg film-coated tablets levodopa/carbidopa/entacapone
Swedish: Levodopa/Carbidopa/Entacapone Orion 50 mg/12,5 mg/200 mg filmdragerade tabletter levodopa/karbidopa/entakapon
English: Levodopa/Carbidopa/Entacapone Orion 200 mg/50 mg/200 mg film-coated tablets levodopa/carbidopa/entacapone
Swedish: Levodopa/Carbidopa/Entacapone Orion 200 mg/50 mg/200 mg filmdragerade tabletter levodopa/karbidopa/entakapon
English: Levodopa/Carbidopa/Entacapone Orion contains sucrose (1.4 mg/tablet).
Swedish: Levodopa/Carbidopa/Entacapone Orion innehåller sackaros (1,4 mg/tablett).
English: Levodopa/Carbidopa/Entacapone Orion contains sucrose (1.2 mg/tablet).
Swedish: Levodopa/Carbidopa/Entacapone Orion innehåller sackaros (1,2 mg/tablett).
English: Levodopa/Carbidopa/Entacapone Orion contains sucrose (1.6 mg/tablet).
Swedish: Levodopa/Carbidopa/Entacapone Orion innehåller sackaros (1,6 mg/tablett).
English: - Periodic evaluation of hepatic, haematopoietic, cardiovascular and renal function is recommended during extended therapy with Levodopa/Carbidopa/Entacapone Orion.
Swedish: Om behandlingen måste stoppas tillfälligt, kan Levodopa/Carbidopa/Entacapone Orion-behandlingen återupptas med samma dagliga dos som tidigare så snart perorala läkemedel kan tas. - Periodisk utvärdering av leverfunktion, blodbildning, kardiovaskulära funktioner och njurfunktion rekommenderas vid längre tids behandling med Levodopa/Carbidopa/Entacapone Orion.
English: Hepatic function test abnormal*
Swedish: Angioödem Frekvens okänd: Urtikaria *
English: 1 ml (125 mg/ml) 12 (4 x 3) pre-filled pens (multipack)
Swedish: 1 ml (125 mg/ml) 12 (3 x 4) förfyllda pennor (multipack)
English: 1 ml (125 mg/ml) 4 pre-filled pens
Swedish: 1 ml (125 mg/ml) 4 förfyllda pennor
English: Date of first authorisation: 24 August 2017
Swedish: Datum för det första godkännandet: 24 augusti 2017
English: This dose should be considered as a maximal dose for all patients.
Swedish: Den dosen ska betraktas som den maximala dosen för alla patienter.
English: These substances are accumulated in your body.
Swedish: Dessa ämnen ansamlas i din kropp.
English: Probability of no HCC (95% confidence interval) at
Swedish: Sannolikhet för ingen HCC (95 % konfidensintervall) vid
English: Data from a study used as a historical control (van Spronsen et al., 1994) showed the following survival probability.
Swedish: Data från en studie som använts som en historisk kontroll (van Spronsen et al., 1994) visade följande överlevnadssannolikhet.
English: Please contact your doctor if you plan to become pregnant.
Swedish: Kontakta din läkare om du planerar att bli gravid.
English: Your doctor will adjust the dose individually.
Swedish: Din läkare kommer att anpassa dosen individuellt.
English: Do not change the dose or stop the treatment without talking to your doctor.
Swedish: Ändra inte dosen eller avsluta behandlingen utan att tala med din läkare.
English: The clinical study was open-labelled and uncontrolled.
Swedish: Den kliniska studien var öppen och okontrollerad.
English: Number of patients at
Swedish: Antal patienter vid
English: - The other ingredients are:
Swedish: - Övriga innehållsämnen:
English: Do not forget to mark the date on the bottle, when removed from the refrigerator.
Swedish: Glöm inte att skriva upp datumet på burken då du tar ut den ur kylskåpet.
English: No information about specific treatment of overdose is available.
Swedish: Information om specifik behandling vid överdosering saknas.
English: The dosing frequency in the study was twice daily.
Swedish: Doseringsfrekvensen i studien var två gånger dagligen.
English: A dose of 2 mg/kg body weight/day may be needed based on the evaluation of all biochemical parameters.
Swedish: En dos på 2 mg/kg kroppsvikt/dag kan behövas baserat på bedömning av alla biokemiska parametrar.
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”).
Swedish: Om du upplever biverkningar som påverkar synen ska du dock inte framföra fordon eller använda maskiner förrän synen är normal igen (se avsnitt 4 ”Eventuella biverkningar”).
English: Other pharmaceutical forms are available for paediatric patients who have difficulties swallowing capsules.
Swedish: Andra läkemedelsformer finns för pediatriska patienter som har svårt att svälja kapslar.
English: The study indicates that once daily administration is safe and efficacious across all ages of patients.
Swedish: Studien indikerar att administrering en gång dagligen är säkert och har effekt hos patienter i alla åldrar.
English: Data is, however, limited in patients with body weight <20 kg.
Swedish: Data är dock begränsade hos patienter med kroppsvikt <20 kg.
English: 111 Power Rd, Unit G.07, Chiswick London, W4 5PY, United Kingdom
Swedish: 111 Power Rd, Unit G.07, Chiswick London, W4 5PY, Storbritannien
English: You must follow a special diet while you are taking this medicine, because tyrosine will remain in your body.
Swedish: Du måste hålla en speciell diet när du tar detta läkemedel eftersom tyrosin kommer att finnas kvar i din kropp.
English: The safety of this medicine has not been studied in pregnant and breast-feeding women.
Swedish: Säkerheten för detta läkemedel har inte studerats hos gravida och ammande kvinnor.
English: If the biochemical response is satisfactory, the dose should be adjusted only according to body weight gain.
Swedish: Om det biokemiska svaret är tillfredsställande, ska dosen endast justeras efter ökning av kroppsvikt.
English: There are no adequate data from the use of nitisinone in pregnant women.
Swedish: Det finns inte tillräckliga data från användningen av nitisinon i gravida kvinnor.
English: The capsules are packaged in plastic bottles.
Swedish: Kapslarna är förpackade i plastburkar.
English: 7 Grimes Gate, Diseworth Leicestershire, DE74 2QD United Kingdom
Swedish: 7 Grimes Gate, Diseworth Leicestershire, DE74 2QD Storbritannien
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.
Swedish: Under behandlingen kommer blodprov att tas för att din läkare ska kunna kontrollera att behandlingen är tillräcklig och för att säkerställa att den inte har biverkningar som orsakar blodrubbningar.
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.
Swedish: Behandling av alla genotyper av sjukdomen ska inledas så tidigt som möjligt för att överlevnaden ska öka och komplikationer såsom leversvikt, levercancer och njursjukdom undvikas.
English: Concomitant use with other medicinal products
Swedish: Samtidig användning med andra läkemedel
English: Date when removed from refrigerator:
Swedish: Datum för uttagande ur kylskåp:
English: If you become pregnant you should contact your doctor immediately.
Swedish: Om du blir gravid bör du omedelbart kontakta din läkare.
English: Formal absorption, distribution, metabolism and elimination studies have not been performed with nitisinone.
Swedish: Formella studier av absorption, distribution, metabolism och eliminering har inte utförts med nitisinon.
English: - if you are allergic to nitisinone or any of the other ingredients of this medicine (listed in section 6).
Swedish: - om du är allergisk mot nitisinon eller något annat innehållsämne i detta läkemedel (anges i avsnitt 6).
English: Animal studies have shown adverse postnatal effects via exposure of nitisinone in milk.
Swedish: Djurstudier har uppvisat ogynnsamma postnatala effekter via exponering för nitisinon i mjölk.
English: The dose recommendation in mg/kg body weight is the same in children and adults.
Swedish: Dosrekommendationen i mg/kg kroppsvikt är samma för barn och vuxna.
English: Eye problems could be a sign of inadequate dietary control (see section 4).
Swedish: Ögonproblem kan vara ett tecken på otillräcklig dietkontroll, se avsnitt 4.
English: The clearance and half-life were determined to be 0.0956 l/kg body weight/day and 52.1 hours respectively.
Swedish: Clearance och halveringstid fastställdes till 0,0956 l/kg kroppsvikt/dag respektive 52,1 timmar.
English: Adverse reactions involving the eyes (see section 4.8) can affect the vision.
Swedish: Biverkningar i ögat (se avsnitt 4.8) kan påverka synen.
English: Each carton pack contains one bottle.
Swedish: Varje kartongförpackning innehåller en burk.