FrancophonIA/ELRC3.0 huggingface dataset:
English: 300 ml oral solution with a 1 ml oral syringe and an adaptor.
Danish: 300 ml oral opløsning med en 1 ml sprøjte og en adapter.
English: Three presentations are available: - A 300 ml bottle with a 10 ml oral syringe (delivering up to 1,000 mg levetiracetam) graduated every 0.25 ml (corresponding to 25 mg).
Danish: Der er tre tilgængelige pakningsstørrelser: - En 300 ml flaske med en 10 ml oral sprøjte (som afgiver op til 1.000 mg levetiracetam) med en målestreg for hver 0,25 ml (svarende til 25 mg).
English: • decreased blood sodium concentration;
Danish: • nedsat natriumindhold i blodet;
English: It is therefore recommended to adjust the maintenance daily dose of Levetiracetam Actavis Group, based on creatinine clearance in patients with moderate and severe renal impairment (see section 4.2).
Danish: Hos patienter med moderat og udtalt nyrefunktionsnedsættelse anbefales det derfor at justere daglig vedligeholdelsesdosis af Levetiracetam Actavis Group i forhold til kreatininclearance (se pkt.
English: The most frequently reported adverse reactions were nasopharyngitis, somnolence, headache, fatigue and dizziness.
Danish: De hyppigst rapporterede bivirkninger var nasofaryngitis, døsighed, hovedpine, træthed og svimmelhed.
English: 300 ml oral solution with a 3 ml oral syringe and an adaptor.
Danish: 300 ml oral opløsning med en 3 ml sprøjte og en adapter.
English: The initial therapeutic dose is 500 mg twice daily.
Danish: Den initiale terapeutiske dosis er 500 mg to gange daglig.
English: In addition, the oral solution should be used for initial treatment in children weighing less than 25 kg,
Danish: Desuden bør den orale opløsning anvendes til initialbehandling af børn, som vejer mindre end 25 kg, til patienter, som ikke er i stand til at synke tabletter, eller til administration af doser under 250 mg.
English: With continued long-term treatment, 8.6% of the patients were seizure-free for at least 6 months and 7.8 % were seizure-free for at least 1 year.
Danish: Ved fortsat langtidsbehandling var 8,6 % af patienterne anfaldsfrie i mere end 6 måneder, og 7,8 % var anfaldsfrie i mindst 1 år.
English: • skin rash, which may form blisters and looks like small targets (central dark spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme), a widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens
Danish: • hududslæt, der kan danne blærer, og som ligner små skydeskiver (mørk plet i midten omgivet af et blegere område, med en mørk ring om kanten) (erythema multiforme), et bredt udslæt med blærer og skællende hud, især omkring munden, næsen, øjnene og kønsdelene (Stevens-Johnson syndrom) og en mere alvorlig form, der forårsaget afskalning af hud på mere end 30 % af kropsoverfladen (toksisk epidermal nekrolyse).
English: With continued long-term treatment, 11.4% of the patients were seizure-free for at least 6 months and 7.2% were seizure-free for at least 1 year.
Danish: Ved fortsat langtidsbehandling var 11,4 % af patienterne anfaldsfrie i mindst 6 måneder, og 7,2 % var anfaldsfrie i mindst 1 år.
English: A double-blind, placebo-controlled paediatric safety study with a non-inferiority design has assessed the cognitive and neuropsychological effects of levetiracetam in children 4 to 16 years of age with partial onset seizures.
Danish: Levetiracetams kognitive og neuropsykologiske virkning hos 4-16 årige børn med anfald af partiel type blev undersøgt i en dobbeltblind, placebokontrolleret pædiatrisk sikkerhedsundersøgelse med non-inferiort design.
English: A dose of 20 mg/kg/day titrating to 40 mg/kg/day for infants one month to less than six months and a dose of 25 mg/kg/day titrating to 50 mg/kg/day for infants and children 6 months to less than 4 years old, was use in this study.
Danish: I dette forsøg fik patienterne en daglig dosis oral opløsning på 20 mg/kg, 25 mg/kg, 40 mg/kg eller 50 mg/kg baseret på en titreringsplan i forhold til deres alder. Der blev anvendt en dosis på 20 mg/kg/dag titreret til 40 mg/kg/dag for spædbørn fra 1 måned op til 6 måneder og en dosis på 25 mg/kg/dag titreret til 50 mg/kg/dag for spædbørn og børn fra 6 måneder op til 4 år i denne undersøgelse.
English: Package Leaflet: Information for the patient Levetiracetam Actavis Group 100 mg/ml oral solution
Danish: INDLÆGSSEDDEL: INFORMATION TIL BRUGEREN Levetiracetam Actavis Group 100 mg/ml oral opløsning
English: General dose: Levetiracetam Actavis Group is taken twice daily, in two equally divided doses, each individual dose being measured between 0.07 ml (7 mg) and 0.21 ml (21 mg), per kg bodyweight of the infant.
Danish: Sædvanlig dosis: Levetiracetam Actavis Group gives to gange dagligt i to lige store doser, idet der til hver dosis afmåles mellem 0,07 ml (7 mg) og 0,21 ml (21 mg) pr. kg af spædbarnets legemsvægt (se tabellen nedenfor, der indeholder eksempler på dosis).
English: Diplopia, vision blurred
Danish: Diplopi, sløret syn
English: For children above 4 years, measure the appropriate dosage using the 10 ml syringe included in the package.
Danish: Til børn over 4 år afmåles den korrekte dosis ved hjælp af 10 ml-sprøjten, som er vedlagt pakningen.
English: If you forget to take Levetiracetam Actavis Group
Danish: Hvis du har glemt at tage Levetiracetam Actavis Group
English: Levetiracetam Actavis Group is indicated as monotherapy in the treatment of partial onset seizures with or without secondary generalisation in adults and adolescents from 16 years of age with newly diagnosed epilepsy.
Danish: Indikationen for Levetiracetam Actavis Group er monoterapibehandling af voksne og unge over 16 år, som for nyligt har fået stillet diagnosen partiel epilepsi med eller uden sekundær generalisering.
English: Levetiracetam Actavis Group 100 mg/ml oral solution Levetiracetam
Danish: Levetiracetam Actavis Group 100 mg/ml oral opløsning Levetiracetam
English: - A 300 ml bottle with a 3 ml oral syringe (delivering up to 300 mg levetiracetam) graduated every 0.1 ml (corresponding to 10 mg).
Danish: - En 300 ml flaske med en 3 ml oral sprøjte (som afgiver op til 300 mg levetiracetam) med en målestreg for hver 0,1 ml (svarende til 10 mg).
English: Dose recommendations for infants aged from 1 month to less than 6 months:
Danish: Dosisanbefalinger til spædbørn i alderen fra 1 måned til under 6 måneder:
English: 450 mg (4.5 ml) twice daily
Danish: 450 mg (4,5 ml) to gange daglig
English: The 300 ml glass bottle of Levetiracetam Actavis Group (for infants aged 1 month to less than 6 months) is packed in a cardboard box containing a 1 ml oral syringe (graduated every 0.05 ml) and an adaptor for the syringe.
Danish: Glasflasken med 300 ml Levetiracetam Actavis Group (til spædbørn fra 1 måned til under 6 måneder) er pakket i en æske, der indeholder en 1 ml oral doseringssprøjte (med en målestreg for hver 0,05 ml) samt en adapter til sprøjten.
English: The initial therapeutic dose is 10 mg/kg twice daily.
Danish: Den initiale terapeutiske dosis er 10 mg/kg to gange dagligt.
English: If you stop taking Levetiracetam Actavis Group
Danish: Hvis du holder op med at tage Levetiracetam Actavis Group
English: Method of administration:
Danish: Indtagelsesmåde:
English: The initial therapeutic dose is 7 mg/kg twice daily.
Danish: Den initiale terapeutiske dosis er 7 mg/kg to gange dagligt.
English: The 300 ml glass bottle of Levetiracetam Actavis Group (for infants and young children aged from 6 months to less than 4 years) is packed in a cardboard box containing a 3 ml oral syringe (graduated every 0.1 ml) and an adaptor for the syringe.
Danish: Glasflasken med 300 ml Levetiracetam Actavis Group (til spædbørn og små børn fra 6 måneder til under 4 år) er pakket i en æske, der indeholder en 3 ml oral doseringssprøjte (med en målestreg for hver 0,1 ml) samt en adapter til sprøjten.
English: Monotherapy in the treatment of partial onset seizures with or without secondary generalisation in patients from 16 years of age with newly diagnosed epilepsy.
Danish: Monoterapi behandling af patienter over 16 år med nyligt diagnosticeret partiel epilepsi med eller uden sekundær generalisering
English: - A 300 ml bottle with a 1 ml oral syringe (delivering up to 100 mg levetiracetam) graduated every 0.05 ml (corresponding to 5 mg).
Danish: - En 300 ml flaske med en 1 ml oral sprøjte (som afgiver op til 100 mg levetiracetam) med en målestreg for hver 0,05 ml (svarende til 5 mg).
English: Citric acid monohydrate Methyl parahydroxybenzoate (E218) Propyl parahydroxybenzoate (E216) Ammonium glycyrrhizate
Danish: Citronsyremonohydrat Methylparahydroxybenzoat (E 218) Propylparahydroxybenzoat (E 216) Ammoniumglycyrrhizat Glycerin
English: Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Danish: Yderligere oplysninger om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside .
English: • cough;
Danish: • hoste;
English: • convulsion, balance disorder (equilibrium disorder), dizziness (sensation of unsteadiness),
Danish: • kramper, problemer med at holde balancen, svimmelhed (følelse af usikker gang), letargi
English: Levetiracetam Actavis Group is used: on its own in adults and adolescents from 16 years of age with newly diagnosed epilepsy, to treat a certain form of epilepsy.
Danish: • som monoterapi (eneste lægemiddel) hos voksne og unge over 16 år med nydiagnosticeret epilepsi til behandling af en bestemt type epilepsi.
English: Use the 1 ml syringe and adaptor included in the package.
Danish: Anvend 1 ml sprøjten og adapteren inkluderet i pakningen
English: • If you suffer from kidney problems, follow your doctor's instructions.
Danish: • Hvis du lider af nyreproblemer.
English: 300 ml amber glass bottle (type III) with a white child resistant closure (polypropylene) in a cardboard box also containing a 10 ml graduated oral syringe (polypropylene, polyethylene).
Danish: 300 ml gyldenbrun glasflaske (type III) med et hvidt børnesikret låg (polypropylen) i en papkarton, som også indeholder en 10 ml måleinddelt oral doseringssprøjte (polypropylen, polyetylen).
English: Name and address of the manufacturer responsible for batch release
Danish: Navn og adresse på fremstilleren, der er ansvarlig for batchfrigivelse Balkanpharma - Troyan AD
English: Clear, faint yellowish-brown solution.
Danish: Oral opløsning Klar, svag gullig-brun opløsning.
English: For infants 1 month to less than 6 months, measure the appropriate dosage using the 1 ml syringe included in the package.
Danish: Dosis til spædbørn (1 måned til under 6 måneder): Til spædbørn fra 1 måned til under 6 måneder afmåles den korrekte dosis ved hjælp af 1 ml sprøjten, som er vedlagt pakningen.
English: Levetiracetam Actavis Group 100 mg/ml oral solution
Danish: Levetiracetam Actavis Group 100 mg/ml oral opløsning
English: 150 mg (1.5 ml) twice daily
Danish: 150 mg (1,5 ml) to gange daglig
English: 10 to 20 mg/kg (0.10 to 0.20 ml/kg) once daily (3) (5)
Danish: 10 til 20 mg/kg (0,10 til 0,20 ml/kg) to gange dagligt (3) (5)
English: Levetiracetam Actavis Group is indicated as adjunctive therapy
Danish: Indikationen for Levetiracetam Actavis Group er tillægsbehandling
English: 300 ml amber glass bottle (type III) with a white child resistant closure (polypropylene) in a cardboard box also containing a 3 ml graduated oral syringe (polypropylene, polyethylene) and an adaptor for the syringe (polyethylene).
Danish: 300 ml gyldenbrun glasflaske (type III) med et hvidt børnesikret låg (polypropylen) i en papkarton, som også indeholder en 3 ml måleinddelt oral doseringssprøjte (polypropylen, polyethylen) og en adapter til sprøjten (polyethylen).
English: България Актавис ЕАД
Danish: Актавис ЕАД Teл.
English: 250 to 750 mg twice daily
Danish: 250 til 750 mg 2 gange dagligt
English: 300 ml amber glass bottle (type III) with a white child resistant closure (polypropylene) in a cardboard box also containing a 1 ml graduated oral syringe (polypropylene, polyethylene) and an adaptor for the syringe (polyethylene).
Danish: 300 ml gyldenbrun glasflaske (type III) med et hvidt børnesikret låg (polypropylen) i en papkarton, som også indeholder en 1 ml måleinddelt oral doseringssprøjte (polypropylen, polyetylen) og en adapter til sprøjten (polyethylen).
English: Maximum dose: 30 mg/kg twice daily
Danish: Maksimal dosis: 30 mg/kg to gange daglig
English: Group with or without food.
Danish: Du kan tage Levetiracetam Actavis Group med eller uden mad.
English: Maximum dose: 21 mg/kg twice daily
Danish: Maksimal dosis: 21 mg/kg to gange dagligt
English: Adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with Juvenile Myoclonic Epilepsy.
Danish: Tillægsbehandling af voksne og unge over 12 år med juvenil myoklon epilepsi med myoklone anfald
English: • pancreatitis;
Danish: • udslæt;
English: 7 to 21 mg/kg (0.07 to 0.21 ml/kg) twice daily
Danish: 7 til 21 mg/kg (0,07 til 0,2 1 ml/kg)to gange daglig
English: 0.85 ml twice daily
Danish: 0,85 ml to gange dagligt
English: 7.5 ml twice daily
Danish: 7,5 ml to gange dagligt
English: Add-on therapy for infants from 1 month to less than 6 months
Danish: Tillægsbehandling til spædbørn i alderen fra 1 måned til mindre end 6 måneder
English: 500 mg twice daily
Danish: 500 mg to gange daglig
English: 5 to 15 mg/kg (0.05 to 0.15 ml/kg) twice daily
Danish: 5 til 15 mg/kg (0,05 til 0,15 ml/kg) to gange dagligt
English: 500 to 1,500 mg twice daily
Danish: 500 til 1,500 mg 2 gange dagligt
English: Adjunctive therapy in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with idiopathic generalised epilepsy.
Danish: Tillægsbehandling af voksne og unge fra 12 år med idiopatisk generaliseret epilepsi med primært generaliserede tonisk-kloniske anfald:
English: 500 to 1,000 mg twice daily
Danish: 500 til 1,000 mg 2 gange dagligt
English: Levetiracetam Actavis Group 100 mg/ml oral solution contains maltitol liquid.
Danish: Levetiracetam Actavis Group 100 mg/ml oral opløsning indeholder også flydende maltitol.
English: 750 mg twice daily
Danish: 750 mg to gange daglig
English: Other medicines and Levetiracetam Actavis Group
Danish: Brug af anden medicin sammen med Levetiracetam Actavis
English: 15 ml twice daily
Danish: 15 ml to gange dagligt
English: 1.25 ml twice daily
Danish: 1,25 ml to gange dagligt
English: Liver function test abnormal
Danish: Unormale leverfunktionsprøver
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Danish: Kontakt lægen, før du tager denne medicin, hvis lægen har fortalt dig, at du ikke tåler visse sukkerarter.
English: • in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with Idiopathic Generalised Epilepsy.
Danish: • primært generaliserede tonisk-kloniske anfald (større anfald inklusiv bevidstløshed) hos voksne og unge over 12 år med idiopatisk generaliseret epilepsi (den type epilepsi, som menes at være genetisk forårsaget)
English: For children aged 1 month to less than 6 months.
Danish: Til spædbørn fra 1 måned til under 6 måneder.
English: Starting dose: 7 mg/kg twice daily
Danish: Initialdosis: 7 mg/kg to gange dagligt
English: 10 to 30 mg/kg (0.10 to 0.30 ml/kg) twice daily
Danish: 10 til 30 mg/kg (0.10 til 0,30 ml/kg) to gange dagligt
English: • in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with Juvenile Myoclonic Epilepsy.
Danish: • af voksne og unge over 12 år med juvenil myoklon epilepsi med myoklone anfald.
English: Use the 3 ml oral syringe and adaptor included in the package
Danish: Anvend den orale 1 ml sprøjte og adapter inkluderet i pakningen
English: 10 to 20 mg/kg (0.10 to 0.20 ml/kg) twice daily
Danish: 10 til 20 mg/kg (0,10 til 0,20 ml/kg) to gange dagligt
English: • asthenia/fatigue (tiredness).
Danish: • kraftesløshed og svaghed/træthed.
English: 250 mg twice daily
Danish: 250 mg to gange daglig
English: Adjunctive therapy in the treatment of partial onset seizures with or without secondary generalisation in adults, adolescents, children and infants from 1 month of age with epilepsy:
Danish: Tillægsbehandling af voksne, unge, børn og spædbørn over 1 måned med partiel epilepsi med eller uden sekundær generalisering
English: 0.6 ml twice daily
Danish: 0,6 ml to gange dagligt
English: Starting dose: 10 mg/kg twice daily
Danish: Initialdosis: 10 mg/kg to gange daglig
English: 250 to 500 mg twice daily
Danish: 250 til 500 mg 2 gange dagligt
English: Levetiracetam is excreted in human breast milk.
Danish: Levetiracetam udskilles i human mælk og bør ikke anvendes under amning.
English: 600 mg (6 ml) twice daily
Danish: 200 mg (2 ml) to gange daglig 600 mg (6 ml) to gange daglig
English: Balkanpharma - Troyan AD 1 Krayrechna Str.
Danish: 1 Krayrechna Str.
English: (impaired coordinated movements), paraesthesia (tingling), disturbance in attention (loss of concentration);
Danish: opmærksomhedsforstyrrelser (koncentrationsbesvær);
English: 1.05 ml twice daily
Danish: 1,05 ml to gange dagligt
English: 0.8 ml twice daily
Danish: 0,8 ml to gange dagligt
English: 1.8 ml twice daily
Danish: 1,8 ml to gange dagligt
English: • in the treatment of partial onset seizures with or without secondary generalisation in adults, adolescents, children and infants from 1 month of age with epilepsy.
Danish: • af voksne, unge, børn og spædbørn over 1 måned med partiel epilepsi med eller uden sekundær generalisering.
English: 5 to 10 mg/kg (0.05 to 0.10 ml/kg) twice daily
Danish: 5 til 10 mg/kg (0,05 til 0,10 ml/kg) to gange dagligt
English: Levetiracetam efficacy was established in a double-blind, placebo-controlled study of 16 weeks duration, in patients 12 years of age and older suffering from idiopathic generalized epilepsy with myoclonic seizures in different syndromes.
Danish: Effekten af levetiracetam, hos patienter over 12 år med idiopatisk generaliseret epilepsi med myoklone anfald i forskellige syndromer, blev påvist i et dobbeltblindt placebokontrolleret forsøg med en behandlingsvarighed på 16 uger.
English: 0.45 ml twice daily
Danish: 0,45 ml to gange dagligt
English: 0.35 ml twice daily
Danish: 0,35 ml to gange dagligt
English: • muscle weakness, myalgia (muscle pain);
Danish: • muskelsvaghed, muskelsmerter;
English: Mild
Danish: Moderat
English: 0.5 ml twice daily
Danish: 0,5 ml to gange dagligt
English: 28 mg (0.3 ml) twice daily 84 mg (0.85 ml) twice daily
Danish: 84 mg (0,85 ml) to gange dagligt
English: How to take Levetiracetam Actavis Group
Danish: Sådan skal du tage Levetiracetam Actavis Group
English: 60 mg (0.6 ml) twice daily
Danish: 28 mg (0,3 ml) to gange dagligt
English: Rare disorders headache disorder, dizziness, lethargy, tremor impairment, coordination abnormal/ataxia, paraesthesia, disturbance in attention dyskinesia, hyperkinesia, gait disturbance, encephalopathy
Danish: Koreoatetose, dyskinesi, hyperkinesi, gangforstyrrelse, encefalopati opmærksomhedsforstyrrelser
English: 6 ml twice daily
Danish: 6 ml to gange dagligt
English: please contact your doctor.
Danish: Følg lægens instruktioner.
English: 1 ml twice daily
Danish: 1 ml to gange dagligt
English: • diplopia (double vision), vision blurred;
Danish: • dobbeltsyn, sløret syn;
English: Nervous system Somnolence,
Danish: Nervesystemet
English: 180 mg (1.8 ml) twice daily
Danish: 60 mg (0,6 ml) to gange daglig 180 mg (1,8 ml) to gange daglig
English: 100 mg (1 ml) twice daily
Danish: 100 mg (1 ml) to gange daglig 300 mg (3 ml) to gange daglig
English: How to store Levetiracetam Actavis Group
Danish: Levetiracetam Actavis Group anvendes
English: 2.4 ml twice daily
Danish: 2,4 ml to gange dagligt
English: 0.3 ml twice daily
Danish: 0,3 ml to gange dagligt
English: 49 mg (0.5 ml) twice daily 147 mg (1.5 ml) twice daily
Danish: 147 mg (1,5 ml) to gange dagligt
English: 2 ml twice daily
Danish: 2 ml to gange dagligt
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton for Bottle of 300 ml with 1 ml syringe
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Æske til 300 ml flaske med 1 ml sprøjte
English: 3 ml twice daily
Danish: 3 ml to gange dagligt
English: Starting dose: 0.1 ml/kg twice daily Maximum dose: 0.3 ml/kg twice daily
Danish: Maksimal dosis: 0,3 ml/kg to gange dagligt
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton for Bottle of 300 ml with 3 ml syringe
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Æske til 300 ml flaske med 3 ml sprøjte
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING Label for Bottle of 300 ml with 1 ml syringe
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Label til 300 ml flaske med 1 ml sprøjte
English: Posology
Danish: Udtalt
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton for Bottle of 300 ml with 10 ml syringe
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Æske til 300 ml flaske med 10 ml sprøjte
English: 35 mg (0.35 ml) twice daily 105 mg (1.05 ml) twice daily
Danish: 105 mg (1,05 ml) to gange dagligt
English: 7 to 14 mg/kg (0.07 to 0.14 ml/kg) once daily (2)
Danish: 7 til 14 mg/kg en gang daglig (2) (4)
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING Label for Bottle of 300 ml with 3 ml syringe
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Label til 300 ml flaske med 3 ml sprøjte
English: Injury
Danish: Skader ved uheld
English: 2.5 ml twice daily
Danish: 2,5 ml to gange dagligt
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING Label for Bottle of 300 ml with 10 ml syringe
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Label til 300 ml flaske med 10 ml sprøjte
English: Choreoathetosis,
Danish: Brugsanvisning:
English: 1.5 ml twice daily
Danish: 1,5 ml to gange dagligt
English: Renal and Urinary disorders
Danish: Nyrer og urinveje
English: patients have been treated with levetiracetam in placebo-controlled and open label extension studies.
Danish: I alt 645 patienter i alderen 4-16 år er blevet behandlet med levetiracetam i placebokontrollerede og åbne, forlængede studier.
English: A joint study is encouraged.
Danish: En fælles undersøgelse anbefales.
English: The wording of the condition to the marketing authorisation has been amended accordingly.
Danish: Ordlyden af betingelsen for markedsføringstilladelsen er blevet ændret i overensstemmelse hermed.
English: Other published data from larger cohorts did not support the findings (Pol et al, 2016).
Danish: Andre offentliggjorte data fra store kohorter understøttede ikke disse resultater (Pol et al, 2016).
English: Hepatocellular carcinoma
Danish: Hepatocellulært carcinom
English: The product information should reflect these recommendations and inform healthcare professionals about this risk.
Danish: Produktinformationen skal afspejle disse anbefalinger og informere sundhedspersonalet om risikoen.
English: However, the difficulty of fully controlling confounding in this non-randomised comparison was recognised.
Danish: Det anerkendes dog, at det vil være vanskeligt fuldt ud at kontrollere uafklarede sammenhænge i denne ikke-randomiserede sammenligning.
English: In addition, patients should be advised to contact their doctor if they have ever been infected with HBV as close monitoring is required.
Danish: Derudover skal patienter rådgives om at kontakte sin læge, hvis vedkommende nogensinde har været inficeret med HBV, da tæt monitorering er påkrævet.
English: Should the use of existing data sources not show feasible, a proposal for a prospective collection of data should be provided.
Danish: Skulle brugen af eksisterende datakilder vise sig uhensigtsmæssig, skal der i forundersøgelsen indarbejdes et forslag til en prospektiv indsamling af data.
English: The RMP of the relevant medicinal products will be updated accordingly.
Danish: Risikostyringsplanen (RMP) for de relevante lægemidler skal opdateres i overensstemmelse hermed.
English: ANNEX IV SCIENTIFIC CONCLUSIONS
Danish: BILAG IV VIDENSKABELIGE KONKLUSIONER