FrancophonIA/ELRC3.0 huggingface dataset:
English: 36 to less than 75 Three 320 mg/40 mg tablets a day
Danish: 36 til under 75 Tre 320 mg/40 mg tabletter dagligt
English: Consequently, if Eurartesim is more suitable for a pregnant woman than other artemisinin-based combination therapies with a higher range of experience (or sulfadoxine-pyrimethamine), Eurartesim may be used in the 2nd and 3 trimester.
Danish: Som følge heraf kan Eurartesim anvendes i det 2. og 3. trimester, hvis Eurartesim er mere egnet til en gravid kvinde end andre artemisinin-baserede kombinationsbehandlinger med et højere erfaringsgrundlag (eller sulfadoxin-pyrimethamin).
English: nitrendipine, verapamil, felodipine, amlodipine); - some medicines used to treat HIV (antiretroviral medicines): protease inhibitors (such as amprenavir, atazanavir, indinavir, nelfinavir, ritonavir), non-nucleoside reverse transcriptase inhibitors (such as efavirenz, nevirapine); - some medicines used to treat microbial infections (such as telithromycin, rifampicin, dapsone); - medicines used to help you fall asleep: benzodiazepines (such as midazolam, triazolam,
Danish: - nogle former for medicin, der anvendes til at behandle høje kolesterolniveauer i blodet (såsom atorvastatin, lovastatin, simvastatin), - medicin, der anvendes til at behandle hypertension og hjerteproblemer (såsom diltiazem, nifedipin, nitrendipin, verapamil, felodipin, amlodipin), - nogle former for medicin, der anvendes til at behandle HIV (antiretroviral medicin): proteasehæmmere (såsom amprenavir, atazanavir, indinavir, nelfinavir, ritonavir), nonnukleosid revers transcriptase-hæmmere (såsom efavirenz, nevirapin), - nogle former for medicin, som anvendes til at behandle mikrobielle infektioner (såsom telithromycin, rifampicin, dapson), - medicin, der anvendes til at hjælpe dig med at falde i søvn: benzodiazepiner (såsom midazolam, triazolam, diazepam, alprazolam), zaleplon, zolpidem, - medicin, der anvendes til at forebygge/behandle epileptiske anfald: barbiturater (såsom phenobarbital), carbamazepin eller phenytoin,
English: 3 tablets Film-coated tablets.
Danish: 3 tabletter Filmovertrukne tabletter.
English: 24 to less than 36 Two 320 mg/40 mg tablets a day
Danish: 24 til under 36 To 320 mg/40 mg tabletter dagligt
English: Film-coated tablet 3 tablets
Danish: Filmovertrukket tablet 3 tabletter.
English: Pruritis
Danish: Hoste
English: Absorption of piperaquine is increased in the presence of fatty food (see sections 4.4 and 5.2) which may increase its effect on QTc interval.
Danish: 4.4 og 5.2), hvilket kan forøge dets virkning på QTc-intervallet.
English: Thrombocytopenia Leukopenia/neutrope nia
Danish: Trombocytopeni Leukopeni/neutropeni Leukocytose ikke andetsteds klassificeret Anæmi
English: Dermatitis Rash
Danish: Dermatitis Udslæt
English: Италия, Olaszország, Itàlie, Italja, Italien, Italia, Itaalia, Włochy, Italija, Ítalía, taliansko, Itālija Teл/Tel/Tlf/Sími/Puh: +39 051 6489602
Danish: Италия, Olaszország, Itàlie, Italja, Italien, Italia, Itaalia, Włochy, Italija, Ítalía, taliansko, Itālija
English: Rhinorrhoea Epistaxis
Danish: Rhinorré Epistakse
English: Then take the third (last) dose approximately 24 hours after the second dose.
Danish: Hvis du eller dit barn har glemt at tage den anden Eurartesim-dosis til det rigtige tidspunkt, skal du tage den så snart, du husker det.Tag derefter den tredje (sidste) dosis ca. 24 timer efter den anden dosis.
English: Breast-feeding
Danish: Bradykardi
English: Each film-coated tablet contains 320 mg piperaquine tetraphosphate (as the tetrahydrate) and 40 mg artenimol.
Danish: Hver filmovertrukne tablet indeholder 320 mg piperaquintetrafosfat (som tetrahydrat) og 40 mg artenimol.
English: Each film-coated tablet contains 160 mg piperaquine tetraphosphate (as the tetrahydrate; PQP) and 20 mg artenimol.
Danish: Hver filmovertrukne tablet indeholder 160 mg piperaquintetrafosfat (som tetrahydrat, PQP) og 20 mg artenimol.
English: Each film-coated tablet contains 160 mg of piperaquine tetraphosphate (as the tetrahydrate) and 20 mg of artenimol.
Danish: Hver filmovertrukne tablet indeholder 160 mg piperaquintetrafosfat (som tetrahydrat) og 20 mg artenimol.
English: • The Patient Information Leaflet
Danish: • Indlægsseddel
English: Convulsion Dizziness
Danish: Krampeanfald Svimmelhed
English: Jaundice
Danish: Pruritus
English: • is taking other medicines that can have an effect on heart rhythm, such as: quinidine, disopyramide, procainamide, amiodarone, dofetilide, ibutilide, hydroquinidine or sotalol; medicines used to treat depression such as amitriptyline, fluoxetine or sertraline; medicines used to treat mental health problems such as phenothiazines, sertindole, sultopride, chlorpromazine, haloperidol, mesoridazine, pimozide, or thioridazine;
Danish: - er allergiske over for de aktive stoffer, piperaquintetrafosfat eller artenimol eller et af de øvrige indholdsstoffer i Eurartesim (angivet i punkt 6), - har en alvorlig form for malariainfektion, som har påvirket legemsdele såsom hjernen, lungerne eller nyrerne, - har en hjertesygdom, såsom ændringer af hjerterytmen eller hvor hurtigt hjertet slår, eller en hjertesygdom, - ved at et familiemedlem (forældre, bedsteforældre, brødre eller søstre) døde pludseligt på grund af et hjerteproblem, eller havde medfødte hjerteproblemer, - lider af ændringer i saltniveauet i kroppen (elektrolytforstyrrelser), - tager anden medicin, der kan have en virkning på hjerterytmen, såsom: quinidin, disopyramid, procainamid, amiodaron, dofetilid, ibutilid, hydroquinidineor sotalol, - medicin, der anvendes til at behandle depression, såsom amitriptylin, fluoxetin eller sertralin, medicin, der anvendes til at behandle psykiatriske problemer, såsom phenothiazimer, sertindol, sultoprid, chlorpromazin, haloperidol, mesoridazin, pimozid eller tioridazin,
English: Pregnancy
Danish: Mavesmerter
English: Each film-coated tablet contains 320 mg piperaquine tetraphosphate (as the tetrahydrate; PQP) and 40 mg artenimol (artenimol).
Danish: Hver filmovertrukne tablet indeholder 320 mg piperaquintetrafosfat (som tetrahydrat, PQP) og 40 mg artenimol.
English: What Eurartesim is and what it is used for What you need to know before you or your child takes Eurartesim How to take Eurartesim
Danish: Det skal du vide, før du eller dit barn begynder at tage Eurartesim Sådan skal du tage Eurartesim
English: Abnormal liver function tests
Danish: Nedsat lever- og nyrefunktion
English: 1 vial + 1 adapter + 15 syringes + 15 applicator tips
Danish: 1 hætteglas + 1 adapter + 15 sprøjter + 15 applikatorspidser
English: N/A
Danish: 10 ml
English: Invented Name administration
Danish: Særnavn Styrke Lægemiddel
English: Dogs Transdermal use Vial (glass) 10 ml
Danish: Hætteglas (glas)
English: He/she may decide if your dose should be adjusted.
Danish: Han/hun kan beslutte, om din dosis skal justeres.
English: Date of first authorisation: 26 August 2011 Date of latest renewal: 15 July 2016
Danish: Dato for første markedsføringstilladelse: 26. august 2011 Dato for seneste fornyelse: 15. juli 2016
English: България Актавис ЕАД
Danish: България TeАктавис ЕАД
English: Levetiracetam Teva must be taken twice a day, once in the morning and once in the evening, at about the same time each day.
Danish: Levetiracetam Teva skal tages to gange dagligt, én gang om morgenen og én gang om aftenen, på omtrent samme tidspunkt hver dag.
English: The elimination half-life was approximately 5 hours.
Danish: Eliminationshalveringstiden var tilnærmelsesvis 5 timer.
English: You may take Levetiracetam Teva with or without food.
Danish: Du kan tage Levetiracetam Teva med eller uden mad.
English: Read all of this leaflet carefully before you or your child start taking this medicine because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt, inden du eller dit barn begynder at tage dette lægemiddel, da den indeholder vigtige oplysninger.
English: There was no effect on embryomortality and no increased incidence of malformations.
Danish: Der var ingen virkning på embryo mortaliteten og ingen øget forekomst af malformationer.
English: An oral solution is the preferred formulation for use in this population.
Danish: En oral opløsning er den foretrukne formulering til anvendelse hos denne population.
English: • encephalopathy (see sub-section “Tell your doctor immediately” for a detailed description of symptoms);
Danish: • encefalopati (se underafsnittet ”Kontakt omgående lægen” for en detaljeret beskrivelse af symptomer)
English: This effect was pronounced for the younger infants, and subsided as age increased, to become negligible around 4 years of age.
Danish: Denne virkning var udtalt for de yngste spædbørn og aftog med stigende alder for til sidst at forsvinde omkring 4 års alderen.
English: • If you notice any slow down in the growth or unexpected puberty development of your child, please contact your doctor.
Danish: • Hvis du bemærker en stagnation i væksten eller uventet pubertetsudvikling hos dit barn, så kontakt din læge.
English: Therefore a 50 % reduction of the daily maintenance dose is recommended when the creatinine clearance is < 60 ml/min/1.73 m2.
Danish: Derfor anbefales en 50 % reduktion af daglig vedligeholdelsesdosis, når kreatininclearance er <60 ml/min/1,73 m2.
English: The dialyser extraction efficiency is 60 % for levetiracetam and 74 % for the primary metabolite.
Danish: Effektiviteten ved dialyse-ekstraktion er 60 % for levetiracetam og 74 % for den primære metabolit.
English: Therefore, patients should be monitored for signs of depression and/or suicidal ideation and behaviours and appropriate treatment should be considered.
Danish: Derfor bør patienterne overvåges for, om de får tegn på depression og/eller selvmordstanker og -adfærd, og passende behandling bør overvejes.
English: The efficacy analysis consisted of 109 patients who had at least 24 hours of video EEG in both baseline and evaluation periods.
Danish: Virkningsanalyserne omfattede 109 patienter, som havde mindst 24 timers video EEG i både baseline samt i evalueringsperioderne.
English: Neither levetiracetam nor its primary metabolite are significantly bound to plasma proteins (< 10 %).
Danish: Hverken levetiracetam eller den primære metabolit bindes signifikant til plasmaproteiner (<10 %).
English: 74770 Opava-Komarov Czech Republic
Danish: 74770 Opava-Komarov Tjekkiet
English: In addition it partially reverses the reductions in GABA- and glycine-gated currents induced by zinc and β-carbolines.
Danish: Desuden ophæver det delvist reduktionen i GABA- og glycin -medierede strømme, induceret af zink og βcarboliner.
English: Transparent PVC/PVdC - aluminium blisters.
Danish: Transparent pvc/PVdC-aluminiumblister.
English: ks = 0.45 in Term infants to 1 year old; ks = 0.55 in Children to less than 13 years and in adolescent female; ks = 0.7 in adolescent male
Danish: ks= 0,45 hos spædbørn op til 1 år; ks= 0,55 hos børn under 13 år og hos unge kvinder; ks= 0,7 hos unge drenge.
English: If stopping treatment, Levetiracetam Teva should be discontinued gradually to avoid an increase of seizures.
Danish: Ved ophør af behandling skal Levetiracetam Teva nedtrappes gradvist for at undgå en forøgelse af anfald.
English: Patients are advised not to drive or use machines until it is established that their ability to perform such activities is not affected.
Danish: Patienter skal rådes til ikke at føre motorkøretøj og betjene maskiner, før det er fastslået, at deres evne til at udføre sådanne aktiviteter ikke er påvirket.
English: Six-month seizure freedom was achieved in 73.0 % of levetiracetam-treated patients and 72.8 % of carbamazepine-CR treated patients; the adjusted absolute difference between treatments was 0.2 % (95 % CI: -7.8 8.2).
Danish: 6 måneders anfaldsfrihed blev opnået hos 73,0 % af de patienter, som blev behandlet med levetiracetam og hos 72,8 % af de patienter, som blev behandlet med carbamazepin CR; den tilpassede absolutte forskel mellem behandlingerne var 0,2 % (95 % CI: -7,8 8,2).
English: Do not take macrogol (a drug used as laxative) for one hour before and one hour after taking levetiracetam as this may results in a loss of its effect.
Danish: Tag ikke macrogol (et lægemiddel, som anvendes som afføringsmiddel) en time før og en time efter levetiracetam, da dette kan medføre tab af levetiracetams virkning.
English: • A small number of people being treated with anti-epileptics such as Levetiracetam Teva have had thoughts of harming or killing themselves.
Danish: • En lille andel af de personer, der bliver behandlet med epilepsimedicin som for eksempel Levetiracetam Teva, har haft selvmordstanker eller tanker om at gøre skade på sig selv.
English: Example: if your daily dose is 1,000 mg, you might take 2 tablets of 250 mg in the morning and 2 tablets of 250 mg in the evening.
Danish: Eksempel: Hvis din daglige dosis er 1.000 mg, kan du tage 2 tabletter på 250 mg om morgenen og 2 tabletter på 250 mg om aftenen.
English: Your doctor will prescribe the most appropriate pharmaceutical form of levetiracetam according to the age, weight and dose.
Danish: Din læge vil ordinere den mest hensigtsmæssige lægemiddelform af levetiracetam i henhold til alder, vægt og dosis.
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.
Danish: • tegn på alvorlige mentale forandringer, eller hvis nogen omkring dig bemærker tegn på forvirring, somnolens (døsighed), amnesi (hukommelsestab), hukommelsessvækkelse (glemsomhed), unormal adfærd, eller andre neurologiske tegn, herunder ufrivillige eller ukontrollerede bevægelser.
English: Toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme
Danish: Toksisk epidermal nekrolyse, StevensJohnson syndrom, erythema multiforme
English: Due to possible different individual sensitivity, some patients might experience somnolence or other central nervous system related symptoms, especially at the beginning of treatment or following a dose increase.
Danish: Da den individuelle følsomhed er forskellig, kan nogle patienter opleve døsighed eller andre CNSrelaterede symptomer især i begyndelsen af behandlingen eller ved øgning af dosis.
English: In vitro studies show that levetiracetam affects intraneuronal Ca2+ levels by partial inhibition of N-type Ca2+ currents and by reducing the release of Ca2+ from intraneuronal stores.
Danish: In vitro-studier viser, at levetiracetam påvirker de intraneuronale Ca2+ -niveauer ved delvis hæmning af N-type Ca2+ -strømme og ved reduktion af frigivelsen af Ca2+ fra intraneuronale lagre.
English: This medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet that is to say essentially `sodium-free ´.
Danish: Dette lægemiddel indeholder mindre end 1 mmol (23 mg) natrium pr. filmovertrukket tablet, dvs. den er i det væsentlige natrium-fri.
English: Adverse reactions reported in clinical studies (adults, adolescents, children and infants > 1 month) and from post-marketing experience are listed in the following table per System Organ Class and per frequency.
Danish: Bivirkninger rapporteret i kliniske studier (voksne, unge, børn og spædbørn >1 måned) og efter markedsføring er angivet i nedenstående tabel i henhold til systemorganklasse og frekvens.
English: Therefore, the interaction of levetiracetam with other substances, or vice versa, is unlikely.
Danish: Derfor er interaktion mellem Levetiracetam Teva og andre lægemidler eller vice versa ikke sandsynlig.
English: The fractional removal of levetiracetam was 51 % during a typical 4-hour dialysis session.
Danish: Den fraktionelle elimination af levetiracetam var 51 % under et typisk 4-timers dialyseforløb.
English: When you will first start taking Levetiracetam Teva, your doctor will prescribe you a lower dose (500 mg each day) during 2 weeks before giving you the lowest general dose of 1,000 mg.
Danish: Når du først begynder at tage Levetiracetam Teva, vil din læge ordinere en lavere dosis (500 mg dagligt) i 2 uger, før du får den laveste sædvanlige dosis på 1.000 mg.
English: The apparent body weight adjusted clearance was approximately 30 % higher than in epileptic adults.
Danish: Den tilsyneladende vægtjusterede clearance var ca. 30 % højere end hos voksne med epilepsi.
English: • If you are allergic to levetiracetam, pyrrolidone derivatives or any of the other ingredients of this medicine (listed in Section 6).
Danish: • Hvis du er allergisk over for levetiracetam, pyrrolidon-derivater eller et af de øvrige indholdsstoffer i Levetiracetam Teva (angivet i punkt 6).
English: However, data suggested a 20 % higher levetiracetam clearance in children taking enzyme-inducing antiepileptic medicinal products.
Danish: Data tydede imidlertid på en 20 % højere levetiracetamclearance hos børn, som tog enzyminducerende antiepileptiske lægemidler.
English: In a study reflecting clinical practice, the concomitant antiepileptic medication could be withdrawn in a limited number of patients who responded to levetiracetam adjunctive therapy (36 adult patients out of 69).
Danish: I et studie, som afspejlede klinisk praksis, kunne samtidig antiepileptisk medicin seponeres hos et afgrænset antal patienter, som responderede på levetiracetam som tillægsbehandling (36 voksne patienter ud af 69).
English: Should your doctor decide to stop your Levetiracetam Teva treatment, he/she will instruct you about the gradual withdrawal of Levetiracetam Teva.
Danish: Hvis lægen beslutter at stoppe din behandling med Levetiracetam Teva, vil han/hun instruere dig i, hvordan du gradvist skal ophøre med at tage Levetiracetam Teva.
English: Levetiracetam Teva is used:
Danish: Levetiracetam Teva anvendes:
English: 305, 74770 Opava-Komarov
Danish: 305, 74770 Opava-Komarov Tjekkiet
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.
Danish: Det blev konkluderet, at Levetiracetam Teva ikke adskilte sig (non-inferiort) fra placebo, hvad angår ændrindring i forhold til baseline i score opnået i ”Leiter-R Attention and Memory, Memory Screen Composite"-testen i per protokol-populationen.
English: Results related to behavioural and emotional functioning indicated a worsening in levetiracetam treated patients on aggressive behaviour as measured in a standardised and systematic way using a validated instrument (CBCL - Achenbach Child Behaviour Checklist).
Danish: Resultater relateret til adfærds- og følelsesmæssig funktion indikerede en forværring i aggressiv adfærd hos patienter behandlet med Levetiracetam Teva, vurderet på en standardiseret og systematisk måde ved brug af et valideret værktøj (CBLC - Achenbach Child Behavior Checklist).
English: At the beginning of the treatment or at dose increase side effects like sleepiness, tiredness and dizziness may be more common.
Danish: I begyndelsen af behandlingen eller i forbindelse med dosisøgning kan nogle af bivirkningerne såsom søvnighed, træthed og svimmelhed være mere almindelige.
English: Package Leaflet: Information for the patient
Danish: Indlægsseddel: Information til brugeren
English: Drug reaction with eosinophilia and systemic symptoms (DRESS), Hypersensitivity (including angioedema and anaphylaxis)
Danish: Medikamentelt udslæt med eosinofili og systemiske symptomer (DRESS) hypersensitivitet (inklusive angioødem og anafylaksi)
English: • a more severe form of rash causing skin peeling in more than 30 % of the body surface (toxic epidermal necrolysis)
Danish: • et mere alvorligt udslæt, der forårsager afskalning af huden på mere end 30 % af kropsoverfladen (toksisk epidermal nekrolyse)
English: Levetiracetam is an antiepileptic medicine (a medicine used to treat seizures in epilepsy).
Danish: Levetiracetam er et lægemiddel mod epilepsi (et lægemiddel, som anvendes til behandling af epileptiske anfald).
English: The primary measure of effectiveness was the responder rate (percent of patients with ≥ 50 % reduction from baseline in average daily partial onset seizure frequency) assessed by a blinded central reader using a 48-hour video EEG.
Danish: Det primære mål for effektivitet var responsraten (procent af patienter med ≥ 50 % reduktion i frekvensen af daglige partielle anfald i forhold til baseline) vurderet af en centralt blindet læser ved brug af 48 timers video EEG.
English: A retrospective assessment of pharmacokinetic interactions in children and adolescents with epilepsy (4 to 17 years) confirmed that adjunctive therapy with orally administered levetiracetam did not influence the steady-state serum concentrations of concomitantly administered carbamazepine and valproate.
Danish: Retrospektiv vurdering af farmakokinetiske interaktioner hos børn og unge (4 til 17 år) med epilepsi bekræftede at tillægsbehandling med oralt administreret levetiracetam ikke havde indflydelse på steady state serumkoncentrationer af samtidigt administreret carbamazepin og valproat.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Danish: Du kan finde yderligere oplysninger om dette lægemiddel på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: Dose and frequency(1) Infants 1 to less than 6 months
Danish: Dosis og hyppighed(1) Spædbørn fra 1 måned til under 6 måneder
English: Levetiracetam has minor or moderate influence on the ability to drive and use machines.
Danish: Levetiram påvirker i mindre grad eller i moderat grad evnen til at føre motorkøretøj og betjene maskiner.
English: However subjects, who took levetiracetam in the long-term open label follow-up study, did not experience a worsening, on average, in their behavioural and emotional functioning; in particular measures of aggressive behaviour were not worse than baseline.
Danish: Deltagerere, som fik Levetiracetam Teva i det langvarige, open-label opfølgningsstudie, oplevede imidlertid generelt ikke nogen forværring af deres adfærds- og følelsesmæssige funktion; særligt blev graden af aggressiv adfærd ikke forværret i forhold til baseline.
English: However, if levetiracetam treatment is needed during breast-feeding, the benefit/risk of the treatment should be weighed considering the importance of breast-feeding.
Danish: Hvis behandling med levetiracetam imidlertid er nødvendig under amning, skal fordele/risici ved behandlingen afvejes i forhold til fordele ved amning.
English: The dose level of 1800 mg/kg/day induced a marked maternal toxicity and a decrease in foetal weight associated with increased incidence of foetuses with cardiovascular/skeletal anomalies.
Danish: Dosisniveauet på 1.800 mg/kg/dag inducerede markant maternel toksicitet samt et fald i fostervægt associeret med en øget forekomst af fostre med kardiovaskulære/skeletale anomalier.
English: Levetiracetam Teva may impair your ability to drive or operate any tools or machinery, as it may make you feel sleepy.
Danish: Levetiracetam Teva kan påvirke din evne til at føre motorkøretøj eller betjene værktøj og maskiner, da det kan give døsighed.
English: In a pooled analysis, the percentage of patients who achieved 50 % or greater reduction from baseline in the partial onset seizure frequency per week at stable dose (12/14 weeks) was of 27.7 %, 31.6 % and 41.3 % for patients on 1000, 2000 or 3000 mg levetiracetam respectively and of 12.6 % for patients on placebo.
Danish: I en sammenfattende analyse var den procentdel af patienterne, som opnåede 50 % eller større reduktion fra baseline i frekvensen af partielle anfald pr. uge ved stabil dosis (12/14 uger) på 27,7 %, 31,6 % og 41,3 % for patienter, som fik hhv. 1.000, 2.000 eller 3.000 mg levetiracetam og på 12,6 % hos patienter, som fik placebo.