FrancophonIA/ELRC3.0 huggingface dataset:
English: It was concluded that levetiracetam was not different (non inferior) from placebo with regard to the change from baseline of the Leiter-R Attention and Memory, Memory Screen Composite score in the per-protocol population.
Icelandic: Niðurstöður sýndu að levetiracetam væri ekki frábrugðið (heldur jafngilt) lyfleysu með tilliti til breytinga frá upphafi rannsóknarinnar samkvæmt mælikvarða á athygli og minni og sjónrænu minnisprófi (Leiter-R Attention and Memory, Memory
English: Results related to behavioural and emotional functioning indicated a worsening in levetiracetam treated patients on aggressive behaviuor as measured in a standardised and systematic way using a validated instrument (CBCL - Achenbach Child Behavior Checklist).
Icelandic: Niðurstöður mælinga samkvæmt staðlaðri og kerfisbundinni leið með viðurkenndri aðferð við að meta hegðun og tilfinningaþroska ( spurningalisti varðandi atferli og tilfinningar barna og unglinga (CBCL - Achenbach Child Behavior Checklist)) gáfu til kynna versnun árásargirni hjá sjúklingum sem meðhöndlaðir voru með levetiracetam.
English: [140-age (years)] x weight (kg) CLcr (ml/min) = ----------------------------------------- (x 0.85 for women) 72 x serum creatinine (mg/dl)
Icelandic: = ----------------------------------------- (x 0,85 fyrir konur) 72 x kreatínín í sermi (mg/dl)
English: Important information about some of the ingredients of Levetiracetam Accord Levetiracetam Accord 750 mg film-coated tablet contains sunset yellow FCF (E110) colouring agent which may cause allergic reactions.
Icelandic: Levetiracetam Accord 750 mg töflur innihalda sunset yellow FCF (E110) Litarefnið sunset yellow FCF (E110) getur valdið ofnæmisviðbrögðum.
English: In all of the above cases levetiracetam oral solution should be used.
Icelandic: Í öllum ofangreindum tilfellum á að nota levetiracetam mixtúru, lausn.
English: The NOAEL was ≥ 1800 mg/kg/day for the F0 females, and for the survival, growth and development of the F1 offspring up to weaning (x 6 the MRHD on a mg/m2 basis).
Icelandic: 1.800 mg/kg/sólarhring fyrir F0 móðurdýrið og fyrir lifun, vöxt og þroska F1 afkvæmanna þangað til þau hættu á spena (sexfaldur ráðlagður hámarksskammtur fyrir menn þegar miðað er við mg/m2).
English: Add-on therapy for infants aged from 6 to 23 months, children (2 to 11 years) and adolescents (12 to 17 years) weighing less than 50 kg
Icelandic: Viðbótarmeðferð hjá ungbörnum á aldrinum 6 til 23 mánaða, börnum (2 til 11 ára) og unglingum (12 til 17 ára), sem vega minna en 50 kg
English: Single pack containing 10, 20, 30, 50, 60, 100, 200 tablets.
Icelandic: Stök pakkning sem inniheldur 10, 20, 30, 50, 60, 100, 200 töflur.
English: Somnolence, agitation, aggression, depressed level of consciousness, respiratory depression and coma were observed with Levetiracetam overdoses.
Icelandic: Svefnhöfgi, æsingur, árásargirni, minnkuð meðvitund, öndunarslæving og dá hafa sést við ofskammtanir levetiracetams.
English: (4) Following dialysis, a 3.5 to 7 mg /kg (0.035 to 0.07 ml/kg) supplemental dose is recommended.
Icelandic: (4) Eftir skilun er mælt með 3,5 til 7 mg/kg (0,035 til 0,07 ml/kg) aukaskammti.
English: Following single oral dose administration (20 mg /kg) to epileptic children (6 to 12 years), the half-life of levetiracetam was 6.0 hours.
Icelandic: Hjá flogaveikum börnum (6 til 12 ára) var helmingunartími levetiracetams 6,0 klst.
English: If you take more Levetiracetam Accord than you should The possible side effects of an overdose of Levetiracetam are sleepiness, agitation, aggression, decrease of alertness, inhibition of breathing and coma.
Icelandic: Hugsanlegar aukaverkanir vegna ofskömmtunar levetiracetams eru syfja, æsingur, árásargirni, minnkuð árvekni, öndunarbæling og dá.
English: • suicide attempt and suicidal ideation, mental disorder, abnormal behaviour, hallucination,
Icelandic: Tilraunir til sjálfsvígs og sjálfsvígshugsanir geðsjúkdómar, óeðlileg hegðun, ofskynjanir, reiði,
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.
Icelandic: Í rannsókninni voru notaðir skammtar fyrir ungbörn frá 1 mánaðar til 6 mánaða sem voru frá 20 mg/kg/sólarhring títraðir upp í 40 mg/kg/sólarhring, en fyrir ungbörn frá 6 mánaða til 4 ára voru skammtarnir frá 25 mg/kg/sólarhring títraðir upp í 50 mg/kg/sólarhring.
English: Depression, hostility/ aggression, anxiety, insomnia, nervousness/irritabi lity
Icelandic: Þunglyndi, óvild/ árásargirni, kvíði, svefnleysi, taugaóstyrkur/skapstyggð
English: Iron oxide red (E172) Sunset yellow FCF (E110) 6.2 Incompatibilities Not applicable.
Icelandic: Rautt járnoxíð (E172) Sunset yellow FCF (E110)
English: The patients were randomized to carbamazepine CR 400 - 1200 mg /day or levetiracetam 1000 - 3000 mg /day, the duration of the treatment was up to 121 weeks depending on the response.
Icelandic: Sjúklingum var með slembivali skipt þannig að þeir fengu annaðhvort carbamazepin forðatöflur 400-1.200 mg/sólarhring eða levetiracetam 1.000-3.000 mg/sólarhring, meðferðarlengd var allt að 121 vika, háð svörun.
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.
Icelandic: Meðferð með öðrum lyfjum, við hlutaflogum með eða án síðkominna alfloga hjá fullorðnum, unglingum, börnum og ungbörnum frá 1 mánaðar aldri með flogaveiki.
English: In this study, levetiracetam dose was 3000 mg /day for adults and adolescents or 60 mg /kg/day for children, given in 2 divided doses.
Icelandic: Í þessari rannsókn fengu fullorðnir og unglingar levetiracetam 3.000 mg/sólarhring, skipt í 2 skammta og börn fengu levetiracetam 60 mg/kg/sólarhring, skipt í 2 skammta.
English: 0.20 ml/kg) once daily (3) (5) (1) Levetiracetam oral solution should be used for doses under 250 mg, for doses not multiple of 250 mg when dosing recommendation is not achievable by taking multiple tablets and for patients unable to swallow tablets.
Icelandic: (1) Levetiracetam mixtúru, lausn skal nota fyrir skammta sem eru undir 250 mg, fyrir skammta sem eru ekki margfeldi af 250 mg þegar ávísaður skammtur næst ekki með því að taka margar töflur og fyrir sjúklinga sem geta ekki gleypt töflur.
English: (5) Following dialysis, a 5 to 10 mg /kg (0.05 to 0.10 ml/kg) supplemental dose is recommended.
Icelandic: (5) Eftir skilun er mælt með 5 til 10 mg/kg (0,05 til 0,10 ml/kg) aukaskammti.
English: Levetiracetam oral solution is the preferred formulation for use in this population.
Icelandic: Levetiracetam mixtúra, lausn, er ákjósanlegra lyfjaform til notkunar hjá þessum hópi.
English: United Kingdom
Icelandic: Bretland.
English: The blisters are further packed in to carton with leaflet in pack size of 10, 20, 30, 50, 60, 100 and 200 tablets per pack.
Icelandic: Þynnupakkningunum er pakkað ásamt fylgiseðli í öskjur sem innihalda hver fyrir sig 10, 20, 30, 50, 60, 100 eða 200 töflur.
English: INFORMATION IN BRAILLE Levetiracetam Accord 250 mg
Icelandic: MEÐ BLINDRALETRI Levetiracetam Accord 250 mg
English: INFORMATION IN BRAILLE Levetiracetam Accord 750 mg
Icelandic: MEÐ BLINDRALETRI Levetiracetam Accord 750 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.
Icelandic: Við áframhaldandi langtímameðferð voru 8,6% sjúklinganna lausir við flog í að minnsta kosti 6 mánuði og 7,8% voru lausir við flog í að minnsta kosti 1 ár.
English: • uncontrollable muscle spasms affecting the head, torso and limbs, difficulty in controlling movements, hyperkinesia (hyperactivity);
Icelandic: Ósjálfráðir vöðvakrampar á höfði, búk og útlimum, erfiðleikar með að stjórna hreyfingum,
English: How to store Levetiracetam Accord
Icelandic: Hvernig geyma á Levetiracetam Accord
English: In paediatric patients (1 month to less than 4 years of age), levetiracetam efficacy was established in a double-blind, placebo-controlled study, which included 116 patients and had a treatment duration of 5days.
Icelandic: Sýnt var fram á verkun levetiracetams hjá börnum (1 mánaðar og yngri en 4 ára), í tvíblindri samanburðarrannsókn með lyfleysu sem var gerð hjá 116 sjúklingum sem fengu meðferð í 5 sólarhringa.
English: • suicide, personality disorders (behavioural problems), thinking abnormal (slow thinking,
Icelandic: Sjálfsvíg, persónuleikabreytingar (hegðunarvandamál),
English: For 1000mg:
Icelandic: Fyrir 1000 mg:
English: • signs of serious mental changes or if someone around you notices signs of confusion, somnolence (sleepiness), amnesia (loss of memory), memory impairment (forgetfulness), abnormal behaviour or other neurological signs including involuntary or uncontrolled movements.
Icelandic: ef einhver í kringum þig tekur eftir einkennum ringlunar, svefnhöfga (syfju), minnisleysis, minnisskerðingar (gleymni), afbrigðilegrar hegðunar eða önnur merki frá taugakerfi þar með taldar ósjálfráð hreyfingar eða hreyfingar sem ekki næst stjórn á. Þetta gætu verið einkenni heilakvilla.
English: Levetiracetam Accord 500 mg film-coated tablets Yellow coloured, oval, biconvex, debossed ‘L 65' and break line on one side and plain on the other side.
Icelandic: Levetiracetam Accord 500 mg filmuhúðaðar töflur Gul, sporöskjulaga, tvíkúpt tafla greypt með „L 65“ og deiliskoru á annarri hliðinni og slétt á hinni hliðinni.
English: 7 to 14 mg /kg (0.07 to 0.14 ml/kg)once daily (2)
Icelandic: 7 til 14 mg/kg (0,07 til 0,14 ml/kg) einu sinni á sólarhring (2) (4)
English: 7 to 21 mg /kg (0.07 to 0.21 ml/kg) twice daily
Icelandic: 7 til 21 mg/kg (0,07 til 0,21 ml/kg) tvisvar sinnum á sólarhring
English: • in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with Idiopathic Generalised Epilepsy.
Icelandic: til meðferðar við frumkomnum þankippaalflogum (primary generalised tonic-clonic seizures) hjá fullorðnum og unglingum frá 12 ára aldri með sjálfvakta flogaveiki.
English: If you stop taking Levetiracetam Accord
Icelandic: Ef gleymist að taka Levetiracetam Accord:
English: Levetiracetam Accord 750 mg film-coated tablets Pink coloured, oval, biconvex, debossed ‘L 66' and break line on one side and plain on the other side.
Icelandic: Levetiracetam Accord 750 mg filmuhúðaðar töflur Bleik, sporöskjulaga, tvíkúpt tafla greypt með „L 66“ og deiliskoru á annarri hliðinni og slétt á hinni hliðinni.
English: • in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with Juvenile Myoclonic Epilepsy.
Icelandic: til meðferðar við vöðvakippaflogum (myoclonic seizures) hjá fullorðnum og unglingum, 12 ára eða eldri, með vöðvakippaflog sem koma fram á unglingsárum (juvenile myoclonic epilepsy).
English: Levetiracetam Accord 250 mg film-coated tablets
Icelandic: Levetiracetam Accord 250 mg filmuhúðaðar töflur
English: How to take Levetiracetam Accord
Icelandic: Hvernig nota á Levetiracetam Accord
English: The NOAEL (No Observed Adverse Effect Level) was 3600 mg /kg/day for pregnant female rats (x 12 the MRHD on a mg/m2basis) and 1200 mg /kg/day for fetuses.
Icelandic: 3.600 mg/kg/sólarhring fyrir ungafullar rottur (12-faldur ráðlagður hámarksskammtur fyrir menn þegar miðað er við mg/m2) og 1.200 mg/kg/sólarhring fyrir fóstur.
English: Levetiracetam 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.
Icelandic: Levetiracetam er ætlað til einlyfjameðferðar við hlutaflogum með eða án síðkominna alfloga, hjá fullorðnum og unglingum frá 16 ára aldri, með nýgreinda flogaveiki.
English: For 250mg:
Icelandic: Fyrir 250 mg:
English: Levetiracetam Accord 750 mg film-coated tablets Levetiracetam
Icelandic: Levetiracetam Accord 750 mg filmuhúðaðar töflur Levetiracetam
English: The leaflet was last revised in (month/YYYY).
Icelandic: Þessi fylgiseðill var síðast uppfærður í {mánuður ÁÁÁÁ}.
English: Contains sunset yellow (E110).
Icelandic: Inniheldur sólsetursgult FCF (E110).
English: INFORMATION IN BRAILLE Levetiracetam Accord 1000 mg
Icelandic: MEÐ BLINDRALETRI Levetiracetam Accord 1000 mg
English: INFORMATION IN BRAILLE Levetiracetam Accord 500 mg
Icelandic: MEÐ BLINDRALETRI Levetiracetam Accord 500 mg
English: 3.5 to 7 mg /kg (0.035 to 0.07 ml/kg) twice daily
Icelandic: 3,5 til 7 mg/kg (0,035 til 0,07 ml/kg) tvisvar sinnum á sólarhring
English: For 750mg:
Icelandic: Fyrir 750 mg:
English: 10 to 20 mg /kg (0.10 to 0.20 ml/kg) twice daily
Icelandic: 10 til 20 mg/kg (0,10 til 0,20 ml/kg) tvisvar sinnum á sólarhring
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
Icelandic: SÉRSTAKAR VARÚÐARRÁÐSTAFANIR VIÐ FÖRGUN LYFJALEIFA EÐA
English: 500 mg: polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, iron oxide yellow (E172)
Icelandic: Pólývinýlalkóhól, títantvíoxíð (E171), macrogol, talkúm, járnoxíðrautt (E172).
English: For 500mg:
Icelandic: Fyrir 500 mg:
English: 10 to 30 mg /kg (0.10 to 0.30 ml/kg) twice daily
Icelandic: 10 til 30 mg/kg (0,10 til 0,30 ml/kg) tvisvar sinnum á sólarhring
English: 7 to 14 mg /kg (0.07 to 0.14 ml/kg) twice daily
Icelandic: 7 til 14 mg/kg (0,07 til 0,14 ml/kg) tvisvar sinnum á sólarhring
English: 3.5 to 10.5 mg /kg (0.035 to 0.105 ml/kg) twice daily
Icelandic: 3,5 til 10,5 mg/kg (0,035 til 0,105 ml/kg) tvisvar sinnum á sólarhring
English: 5 to 15 mg /kg (0.05 to 0.15 ml/kg) twice daily
Icelandic: 5 til 15 mg/kg (0,05 til 0,15 ml/kg) tvisvar sinnum á sólarhring
English: MINIMUMPARTICULARS TO APPEAR ON BLISTERS OR STRIPS
Icelandic: LÁGMARKS UPPLÝSINGAR SEM SKULU KOMA FRAM Á ÞYNNUM EÐA STRIMLUM PVC-ál þynnupakkning
English: This includes any possible side effects not listed in this leaflet.You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Icelandic: Einnig er hægt að tilkynna aukaverkanir beint samkvæmt fyrirkomulagi sem gildir í hverju landi fyrir sig, sjá Appendix V*.
English: Accord Healthcare Limited Sage House
Icelandic: Accord Healthcare Ltd.
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
Icelandic: sem viðbótarmeðferð með öðrum flogaveikilyfjum til að meðhöndla: - hlutaflog með eða án alfloga hjá fullorðnum, unglingum, börnum og ungbörnum frá 1 mánaðar aldri.
English: Thrombocytopenia, leukopenia Pancytopenia, neutropenia, agranulocytosis
Icelandic: Fettu- og brettuhreyfingar (choreoathetosis), hreyfingatregða, ofhreyfingar, röskun á göngulagi, heilakvilli
English: In this study, levetiracetam, dose was 3000 mg /day given in 2 divided doses.
Icelandic: Í þessari rannsókn var gefinn levetiracetam skammturinn 3.000 mg/sólarhring, sem skipt var í 2 skammta.
English: The administration of levetiracetam to patients with renal impairment may require dose adjustment.
Icelandic: Vera má að breyta þurfi skömmtum hjá sjúklingum með nýrnabilun sem fá meðferð með levetiracetam.
English: 5 to 10 mg /kg (0.05 to 0.10 ml/kg) twice daily
Icelandic: 5 til 10 mg/kg (0,05 til 0,10 ml/kg) tvisvar sinnum á sólarhring
English: Duration of treatment - Levetiracetam Accord is used as a chronic treatment.
Icelandic: Levetiracetam Accord er notað til langtíma meðhöndlunar.
English: NAME OF THE MARKETING AUTHORISATION HOLDER
Icelandic: NAFN MARKAÐSLEYFISHAFA Accord
English: Musculoskeletal and connective
Icelandic: LYFJAFORM OG INNIHALD
English: 500 to 1, 500 mg twice daily 500 to 1,000 mg twice daily 250 to 750 mg twice daily 250 to 500 mg twice daily 500 to 1,000 mg once daily (2)
Icelandic: 500-1.500 mg tvisvar sinnum á sólarhring
English: Muscular weakness, myalgia Rhabdomyolysis and blood creatine tissue disorders phosphokinase increased*
Icelandic: Rákvöðalýsa og hækkun á kreatínkínasa í blóði*
English: anger, confusion, panic attack,emotional instability/mood swings, agitation;
Icelandic: ringlun, kvíðakast, tilfinningalegt ójafnvægi/skapsveiflur, æsingur;
English: Levetiracetam Accord 1000 mg film-coated tablet Levetiracetam
Icelandic: Levetiracetam Accord 1000 mg filmuhúðaðar töflur Levetiracetam
English: • decreased blood sodium concentrations
Icelandic: Minnkað magn natríums í blóði;•
English: Pink coloured, oval, biconvex, film coated tablet, debossed ‘L 66' and break line on one side and plain on the other side.
Icelandic: Bleik, sporöskjulaga, tvíkúpt, filmuhúðuð tafla greypt með „L 66“ og deiliskoru á annarri hliðinni og slétt á hinni hliðinni.
English: White to off white, oval, biconvex, film coated tablet, debossed ‘L 67' and break line on one side and plain on the other side.
Icelandic: Hvít til beinhvít, sporöskjulaga, tvíkúpt, filmuhúðuð tafla greypt með „L 67“ og deiliskoru á annarri hliðinni og slétt á hinni hliðinni.
English: NAME OF THE MEDICINAL PRODUCT Levetiracetam Accord 500 mg film-coated tablets Levetiracetam
Icelandic: Levetiracetam Accord 500 mg filmuhúðaðar töflur Levetiracetam
English: EU/1/11/712/015-021 (10/20/30/50/60/100/200 tablets in PVC/alu Blister) EU/1/11/712/035-037 (30/60/100tablets in Unit dose Blister)
Icelandic: EU/1/11/712/015-021 (10/20/30/50/60/100/200 töflur í PVC/álþynnupakkningu) EU/1/11/712/035-037 (30/60/100 töflur í þynnupakkningu með stökum skömmtum)
English: 1000 mg: polyvinyl alcohol, titanium dioxide (E171), macrogol, talc
Icelandic: Pólývinýlalkóhól, títantvíoxíð (E171), macrogol, talkúm.
English: White to off white, oval, biconvex, film coated tablet, debossed ‘L 64' and break line on one side and plain on the other side.
Icelandic: Hvít til beinhvít, sporöskjulaga, tvíkúpt, filmuhúðuð tafla greypt með „L 64“ og deiliskoru á annarri hliðinni og slétt á hinni hliðinni.
English: EU/1/11/712/001-007 (10/20/30/50/60/100/200 tablets in PVC/alu Blister) EU/1/11/712/029-031(30/60/100 tablets in Unit dose Blister)
Icelandic: EU/1/11/712/001-007 (10/20/30/50/60/100/200 töflur í PVC/álþynnupakkningu) EU/1/11/712/029-031(30/60/100 töflur í þynnupakkningu með stökum skömmtum)
English: Completed suicide,personality disorder, thinking abnormal, delirium
Icelandic: Sjálfsvíg, persónuleikabreytingar, óeðlilegur þankagangur, óráð
English: CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to medical prescription.
Icelandic: D. FORSENDUR EÐA TAKMARKANIR ER VARÐA ÖRYGGI OG VERKUN VIÐ NOTKUN LYFSINS
English: EU/1/11/712/008-014 (10/20/30/50/60/100/200 tablets in PVC/alu Blister) EU/1/11/712/032-034 (30/60/100tablets in Unit dose Blister)
Icelandic: EU/1/11/712/008-014 (10/20/30/50/60/100/200 töflur í PVC/álþynnupakkningu) EU/1/11/712/032-034 (30/60/100 töflur í þynnupakkningu með stökum skömmtum)
English: Swallow Levetiracetam Accord with a sufficient quantity of liquid (e.g. a glass of water).
Icelandic: Gleypið Levetiracetam Accord töflurnar með nægilega miklum vökva (t.d. glasi af vatni).
English: Yellow coloured, oval, biconvex, film coated tablet, debossed ‘L 65' and break line on one side and plain on the other side.
Icelandic: Gul, sporöskjulaga, tvíkúpt filmuhúðuð tafla greypt með „L 65“ og deiliskoru á annarri hliðinni og slétt á hinni hliðinni.
English: - If you notice any slow down in the growth or unexpected puberty development of your child, please contact your doctor - A small number of people being treated with anti-epileptics such as Levetiracetam Accord have had thoughts of harming or killing themselves.
Icelandic: Ef þú tekur eftir að hægja fer á vexti barnsins eða óvæntum kynþroska vinsamlegast hafið samband við lækninn.
English: Pharmacotherapeutic group: antiepileptics, other antiepileptics ATC code: N03AX14.
Icelandic: Flogaveikilyf, önnur flogaveikilyf, ATC flokkur:
English: • as an add-on to other antiepileptic medicines to treat: - partial onset seizures with or without generalisation in adults, adolescents, children and infants from one month of age; - myoclonic seizures (short, shock-like jerks of a muscle or group of muscles) in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy - primary generalised tonic-clonic seizures (major fits, including loss of consciousness) in adults and adolescents from 12 years of age with idiopathic generalised epilepsy (the type of epilepsy that is thought to have a genetic cause).
Icelandic: - frumkomin þankippaalflog (stór flogaköst, þ.m.t. meðvitundarleysi) hjá fullorðnum og unglingum frá 12 ára aldri með sjálfvakta flogaveiki (sú tegund flogaveiki sem talið er að hafi erfðafræðilega orsök).
English: What you need to know before you take Levetiracetam Accord
Icelandic: Áður en byrjað er að nota Levetiracetam Accord
English: EU/1/11/712/022-028 (10/20/30/50/60/100/200 tablets in PVC/alu Blister) EU/1/11/712/038-040(30/60/100tablets in Unit dose Blister)
Icelandic: EU/1/11/712/022-028 (10/20/30/50/60/100/200 töflur í PVC/álþynnupakkningu) EU/1/11/712/038-040(30/60/100 töflur í þynnupakkningu með stökum skömmtum)
English: MedDRA SOC
Icelandic: VIRK(T) EFNI
English: Abdominal pain, diarrhoea, dyspepsia, vomiting, nausea
Icelandic: Kviðverkir, niðurgangur, meltingartruflun, uppköst, ógleði
English: White to off white, oval, biconvex, debossed ‘L 64' and break line on one side and plain on the other side
Icelandic: Hvít til beinhvít, sporöskjulaga, tvíkúpt tafla greypt með „L 64“ og deiliskoru á annarri hliðinni og slétt á hinni hliðinni.
English: Dose in adults and adolescents (12 to 17 years) weighing 50 kg or more General dose: between 1,000 mg and 3,000 mg each day.
Icelandic: Skammtar handa fullorðnum og unglingum (12 til 17 ára) sem vega 50 kg eða meira:
English: In several cases of alopecia, recovery was observed when levetiracetam was discontinued.Bone marrow suppression was identified in some of the cases of pancytopenia.
Icelandic: Í nokkrum tilvikum kom í ljós að hárlos gekk til baka þegar notkun levetiracetam var hætt.
English: Diplopia, vision blurred
Icelandic: Lifur og gall
English: Hepatic failure, hepatitis
Icelandic: Vöðva slappleiki, vöðvaverkir
English: encephalopathy
Icelandic: Líffærakerfi
English: --1 Live attenuated avian infectious bronchitis virus (IBV), variant strain 4-91: ≥3.6 log10 EID50* per dose * EID50: 50% embryo infective dose - the virus titre required to produce infection in 50% of the embryos inoculated.
Icelandic: Lifandi veikluð fuglaberkjubólguveira (infectious bronchitis virus, IBV) stofn 4-91:
English: 1 Bottle
Icelandic: 1 Glas
English: 3 Bottles
Icelandic: 3 Glös
English: 1st injection: from 2.5 months of age.
Icelandic: Fyrri inndæling: frá 2,5 mánaða aldri.
English: Adjuvants: Aluminium hydroxide (Al3+)
Icelandic: Álhýdroxíð (Al3+)
English: According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council as amended, a Member State may, in accordance with its national legislation, prohibit the manufacture, import, possession, sale, supply and/or use of the immunological veterinary medicinal products on the whole or part of their territory if it is established that:
Icelandic: Samkvæmt ákvæðum 71. greinar í tilskipun Evrópuráðsins og þingsins 2001/82/EB með viðaukum getur aðildarríki, í samræmi við löggjöf sína, bannað framleiðslu, innflutning, vörslu, sölu, dreifingu og/eða notkun ónæmislyfja á öllu yfirráðasvæði sínu eða hluta þess ef sýnt er að:
English: Potassium dihydrogen phosphate Disodium hydrogen phosphate dodecahydrate Sodium chloride
Icelandic: Tvínatríum-hýdrógenfosfat-dódekahýdrat
English: A slight to moderate increase of local reactions may commonly be observed after a 2-fold overdose lasting for a maximum of 56 days.
Icelandic: Almennt má greina væga til meðal aukningu á staðbundnum viðbrögðum eftir tvöfalda ofskömmtun sem stendur í allt að 56 daga.
English: No information is available on the use of the vaccine in animals with maternally derived antibodies.
Icelandic: Engar upplýsingar liggja fyrir um notkun bóluefnisins hjá dýrum sem eru með mótefni frá móður.
English: Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Icelandic: DAGSETNING ENDURSKOÐUNAR TEXTANS Ítarlegar upplýsingar um dýralyfið eru birtar á vef Lyfjastofnunar Evrópu http://www.ema.europa.eu/