FrancophonIA/ELRC3.0 huggingface dataset:
English: A starting dose of 75 mg can be used in patients receiving haemodialysis (a blood clearance technique) or in patients over 75 years of age.
Danish: Til patienter i hæmodialyse (en blodrensningsteknik) eller til patienter over 75 år kan der anvendes en startdosis på 75 mg.
English: For the full description of all side effects reported with Irbesartan Zentiva, see the package leaflet.
Danish: Den fuldstændige liste over de indberettede bivirkninger ved Irbesartan Zentiva fremgår af indlægssedlen.
English: In the first kidney disease study, Irbesartan Zentiva was more effective than placebo at reducing the risk of developing kidney damage as measured by protein excretion.
Danish: I den første undersøgelse vedrørende nyresygdom var Irbesartan Zentiva mere effektivt end placebo til at reducere risikoen for at udvikle nyreskader, hvilket blev målt ved proteinudskillelsen.
English: In the blood pressure studies, Irbesartan Zentiva was more effective than placebo at reducing diastolic blood pressure and had similar effects to the other medicines for hypertension.
Danish: I undersøgelserne af virkningen på blodtrykket var Irbesartan Zentiva mere effektivt end placebo til at nedsætte det diastoliske blodtryk, og virkningerne af Irbesartan Zentiva svarede til virkningerne af de andre lægemidler mod forhøjet blodtryk.
English: Why has Irbesartan Zentiva been approved?
Danish: Hvorfor blev Irbesartan Zentiva godkendt?
English: What is Irbesartan Zentiva?
Danish: Hvad er Irbesartan Zentiva?
English: How has Irbesartan Zentiva been studied?
Danish: Hvordan blev Irbesartan Zentiva undersøgt?
English: What benefit has Irbesartan Zentiva shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Irbesartan Zentiva?
English: How is Irbesartan Zentiva used?
Danish: Hvordan anvendes Irbesartan Zentiva?
English: What is Irbesartan Zentiva used for?
Danish: Hvad anvendes Irbesartan Zentiva til?
English: How does Irbesartan Zentiva work?
Danish: Hvordan virker Irbesartan Zentiva?
English: Date of first authorisation: 08 January 2014 Date of latest renewal: 20 November 2018
Danish: Dato for første markedsføringstilladelse: 8. januar 2014 Dato for seneste fornyelse: 20. november 2018
English: He/she may decide if your dose should be adjusted.
Danish: Han/hun kan afgøre, om din dosis skal justeres.
English: A risk of birth defects for your unborn child cannot be completely excluded.
Danish: Risiko for medfødte misdannelser hos dit ufødte barn kan ikke udelukkes helt.
English: If not used immediately, in-use storage time and conditions are the responsibility of the user.
Danish: Hvis det ikke anvendes straks, er opbevaringstid og -forhold, brugerens ansvar.
English: You should not stop your treatment without discussing this with your doctor.
Danish: Du bør ikke standse med behandlingen uden aftale med din læge.
English: There is no modification of the clearance after repeated administration.
Danish: Der ses ikke ændringer i clearance efter gentagen administration.
English: This decrease is more pronounced during the third trimester (up to 60% of baseline concentration before pregnancy).
Danish: Dette fald er mere udtalt i 3. trimester (op til 60 % af baseline-koncentrationen før graviditet).
English: Height (cm) x ks
Danish: Højde (cm) x ks
English: The pharmacokinetic and safety profiles did not identify any safety concerns.
Danish: De farmakokinetiske og sikkerhedsprofiler har ikke identificeret nogen sikkerhedsproblemer.
English: EXP Use immediately after dilution.
Danish: EXP Bruges straks efter fortynding.
English: Read all of this leaflet carefully before you or your child start using 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 effekt på embryomortaliteten og ingen øget forekomst af misdannelser.
English: However, current epidemiological studies (on about 100 children) do not suggest an increased risk of neurodevelopmental disorders or delays.
Danish: De nuværende epidemiologiske undersøgelser (med ca. 100 børn) tyder imidlertid ikke på øget risiko for neuroudviklingsmæssige forstyrrelser eller -forsinkelser.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: Kravene for fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på den europæiske webportal for lægemidler..
English: Levetiracetam Hospira must be administered twice a day, once in the morning and once in the evening, at about the same time each day.
Danish: Levetiracetam Hospira skal gives to gange dagligt, én gang om morgenen og én gang om aftenen, på omtrent samme tidspunkt hver dag.
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 reduction 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: 15 minutes
Danish: 15 minutt er
English: The major metabolic pathway (24% of the dose) is an enzymatic hydrolysis of the acetamide group.
Danish: Den vigtigste metaboliseringsvej (24 % af dosis) er enzymatisk hydrolyse af acetamid-gruppen.
English: Elderly (65 years and older)
Danish: Ældre (65 år og derover)
English: Total Daily Dose
Danish: Samlet daglig dosis
English: The physician should prescribe the most appropriate pharmaceutical form, presentation and strength according to age, weight and dose.
Danish: Lægen bør ordinere den mest hensigtsmæssige lægemiddelform, pakningsstørrelse og styrke afhængigt af alder, vægt og dosis.
English: Dose in adults and adolescents (from 16 years of age):
Danish: Dosis til voksne og unge (fra 16 år):
English: Physiological changes during pregnancy may affect levetiracetam concentration.
Danish: Fysiologiske forandringer under graviditeten kan påvirke koncentrationen af levetiracetam.
English: There is no evidence for any relevant gender, race or circadian variability.
Danish: Der er ikke tegn på nogen relevante variationer med hensyn til køn, race eller cirkadian rytme.
English: Therefore a 50% reduction of the daily maintenance dose is recommended when the creatinine clearance is < 60 ml/min/1.73 m
Danish: Derfor anbefales en reduktion på 50 % af den daglige vedligeholdelsesdosis, når kreatininclearance er < 60 ml/min/1,73 m
English: This should be taken into consideration if you are on a controlled sodium diet.
Danish: Dette skal tages i betragtning hvis du er på en kontrolleret natriumdiæt.
English: Dose recommendations for children and adolescents: Weight
Danish: Dosisanbefalinger til børn og unge: Vægt
English: The pharmacokinetic profile has been characterized following oral administration.
Danish: Den farmakokinetiske profil er blevet karakteriseret efter oral administration.
English: When you first start taking Levetiracetam Hospira, your doctor will prescribe you a lower dose for 2 weeks before giving you the lowest general dose.
Danish: Når du begynder at bruge Levetiracetam Hospira, vil din læge ordinere en lavere dosis i 2 uger, før du får den laveste vedligeholdelsesdosis.
English: Conversion to or from oral to intravenous administration can be done directly without titration.
Danish: Overgang til eller fra oral til intravenøs administration kan foretages direkte uden titrering.
English: Do not use this medicine after the expiry date stated on the vial and carton box after EXP: The expiry date refers to the last day of the month.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Adverse reactions are presented in the order of decreasing seriousness and their frequency is defined as follows: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000) and very rare (<1/10,000).
Danish: Bivirkningerne er præsenteret i rækkefølge efter faldende alvorlighed, og deres hyppighed er defineret på følgende måde: meget almindelig (≥1/10); almindelig (≥1/100 til <1/10); ikke almindelig (≥ 1/1.000 til <1/100); sjælden (≥1/10.000 til <1/1.000) og meget sjælden (< 1/10.000).
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: Elderly people
Danish: Ældre mennesker
English: Appropriate clinical management of pregnant women treated with levetiracetam should be ensured.
Danish: Der skal sikres en passende klinisk kontrol af gravide kvinder, som behandles med levetiracetam.
English: ks= 0.55 in Children to less than 13 years and in adolescent female; ks= 0.7 in adolescent male
Danish: ks= 0,55 hos børn under 13 år og hos unge kvinder; ks= 0,7 hos unge drenge.
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: No impact on fertility was detected in animal studies (see section 5.3).
Danish: Der er ikke fundet nogen indvirkning på fertilitet i dyreforsøg (se pkt.
English: Currently available data are described in sections 4.8, 5.1, and 5.2 but no recommendation on a posology can be made.
Danish: 4.8, 5.1 og 5.2, men der kan ikke gives nogen anbefaling vedrørende dosering.
English: There is no specific antidote for levetiracetam.
Danish: Der er ingen specifik antidot mod levetiracetam.
English: 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.
Danish: Du eller Dine pårørende kan også indberette bivirkninger direkte til Lægemiddelstyrelsen via det nationale rapporteringssystem anført i Appendiks V. Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: A doctor or a nurse will administer you Levetiracetam Hospira as an intravenous infusion.
Danish: En læge eller en sygeplejerske vil give dig Levetiracetam Hospira som en intravenøs infusion.
English: The pharmacokinetics in paediatric patients has not been investigated after intravenous administration.
Danish: Farmakokinetikken hos pædiatriske patienter er ikke undersøgt efter intravenøs administration.
English: Therefore, caution is recommended in those patients when performing skilled tasks, e.g. driving vehicles or operating machinery.
Danish: Derfor tilrådes forsigtighed hos disse patienter ved udførelse af krævende opgaver, f.eks. kørsel eller betjening af maskiner.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, genotoxicity and carcinogenic potential.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, genotoksicitet og karcinogenicitet.
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: For doctors and nurses, more detailed direction for the proper use of Levetiracetam Hospira is provided in section 6.
Danish: For læger og sygeplejersker er der angivet mere detaljerede retningslinjer for korrekt anvendelse af Levetiracetam Hospira i punkt 6.
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 rådes til ikke at føre motorkøretøj eller betjene maskiner, før det er fastslået, at deres evne til at udføre sådanne aktiviteter ikke er påvirket.
English: * Prevalence is significantly higher in Japanese patients when compared to non-Japanese patients.
Danish: * Prævalensen er signifikant højere hos patienter af japansk afstamning end hos patienter af ikkejapansk afstamning.
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: 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: The pharmacokinetic profile is linear with low intra- and inter-subject variability.
Danish: Den farmakokinetiske profil er lineær med lille intra- og inter-individuel variation.
English: Toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme
Danish: Toksisk epidermal nekrolyse, Stevens-Johnsons syndrom, erythema multiforme
English: Neither levetiracetam nor its primary metabolite are significantly bound to plasma proteins (< 10 %).
Danish: Hverken levetiracetam eller dens primære metabolit er signifikant bundne til plasmaproteiner (< 10
English: You can switch from the filmcoated tablets or from the oral solution to the intravenous formulation or reverse directly without dose adaptation.
Danish: Du kan skifte fra filmovertrukne tabletter eller fra oral opløsning til intravenøs formulering eller omvendt uden dosisjustering.
English: As in adults, there is no evidence of clinically significant medicinal product interactions in paediatric patients receiving up to 60 mg/kg/day levetiracetam.
Danish: Som for voksne er der ikke nogen evidens for klinisk signifikante lægemiddelinteraktioner hos pædiatriske patienter, som fik op til 60 mg/kg levetiracetam pr. dag.
English: Levetiracetam Hospira concentrate is an alternative for patients when oral administration is temporarily not feasible.
Danish: Levetiracetam Hospira koncentrat er et alternativ til patienter, når oral administration midlertidigt ikke er mulig.
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 ogadfærd, og passende behandling bør overvejes.
English: Chemical and physical in-use stability of the diluted product stored in PVC bags has been demonstrated for 24 hours at 30 °C and at 2-8 °C.
Danish: Kemisk og fysisk stabilitet under brug af det fortyndede produkt opbevaret i PVC beholdere er blevet påvist i 24 timer ved 30 °C og ved 2-8 °C.
English: Levetiracetam therapy can be initiated with either intravenous or oral administration.
Danish: Levetiracetam-behandling kan indledes med enten intravenøs eller oral administration.
English: The major route of excretion was via urine, accounting for a mean 95% of the dose (approximately 93% of the dose was excreted within 48 hours).
Danish: Hovedparten blev udskilt via urinen, gennemsnitligt 95 % af dosis (ca. 93 % af dosis var udskilt inden for 48 timer).
English: Production of the primary metabolite, ucb L057, is not supported by liver cytochrome P450 isoforms.
Danish: Dannelse af den primære metabolit, ucb L057 er ikke afhængig af lever cytochrom P450 isoformer.
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 fra kliniske studier (voksne, unge, børn og spædbørn >1 måned) og efter markedsføring er angivet i nedenstående tabel i henhold til systemorganklasse og hyppighed.
English: Since there was limited exposure for levetiracetam intravenous use and since oral and intravenous formulations are bioequivalent, the safety information of levetiracetam intravenous will rely on levetiracetam oral use.
Danish: Da der var begrænset eksponering for levetiracetam til intravenøs anvendelse, og da orale og intravenøse formuleringer er bioækvivalente, vil sikkerhedsinformationen for levetiracetam til intravenøs brug baseres på levetiracetam til oral brug.
English: No data on the interaction of levetiracetam with alcohol are available.
Danish: Der foreligger ingen data vedrørende interaktion mellem levetiracetam og alkohol.
English: Suicide, suicide attempt, suicidal ideation and behaviour have been reported in patients treated with antiepileptic agents (including levetiracetam).
Danish: Selvmord, selvmordsforsøg, selvmordstanker og -adfærd er rapporteret hos patienter i behandling med antiepileptika (inklusive levetiracetam).
English: A large amount of post-marketing data on pregnant women exposed to levetiracetam monotherapy (more than 1800, among which in more than 1500 exposure occurred during the 1st trimester) do not suggest an increase in the risk for major congenital malformations.
Danish: En stor mængde data indsamlet efter markedsføring fra gravide kvinder, der har fået levetiracetam monoterapi (flere end 1.800, hvoraf eksponeringen hos flere end 1.500 forekom i løbet af 1. trimester) tyder ikke på en stigning i risikoen for alvorlige medfødte misdannelser.
English: The plasma half-life in adults was 7±1 hours and did not vary either with dose, route of administration or repeated administration.
Danish: Halveringstiden for levetiracetam hos voksne var 7±1 timer og påvirkedes hverken af dosis, administrationsvej eller gentagen dosering.
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, pyrrolidonderivater eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt 6).
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, søvninghed, hukommelsestab (amnesi), glemsomhed (hukommelsessvækkelse), unormal adfærd eller andre neurologiske tegn, herunder ufrivillige eller ukontrollerede bevægelser.
English: To be taken into consideration by patients on a controlled sodium diet.
Danish: Dette skal der tages hensyn til hos patienter, som er på en kontrolleret natriumdiæt.
English: Withdrawal Volume Volume of Diluent
Danish: Udtrækningsvolumen Volumen af fortyndingsvæsken
English: The volume of distribution of levetiracetam is approximately 0.5 to 0.7 l/kg, a value close to the total body water volume.
Danish: Fordelingsvolumen for levetiracetam er ca. 0,5 til 0,7 l/kg, en værdi der ligger tæt på den totale vandfase.
English: Levetiracetam Hospira may impair your ability to drive or operate any tools or machinery, as it may make you feel sleepy.
Danish: Levetiracetam Hospira kan påvirke din evne til at køre eller betjene værktøj eller maskiner, da det kan give døsighed.
English: Serum Creatinine (mg/dl)
Danish: Serum-kreatinin (mg/dl)
English: Prevalence is significantly higher in Japanese patients when compared to non-Japanese patients;
Danish: Forekomsten er betydeligt højere hos patienter af japansk afstamning end hos patienter af ikke-japansk afstamning;
English: Dose changes should not exceed increases or decreases of 10 mg/kg twice daily every two weeks.
Danish: Dosisændringer bør ikke overskride en øgning eller reduktion på 10 mg/kg to gange daglig hver anden uge.
English: • decreased number of blood platelets, decreased number of white blood cells;
Danish: • nedsat antal blodplader, nedsat antal hvide blodlegemer;
English: Linear and dose proportional increases were observed for peak plasma concentrations and area under the curve.
Danish: Lineær og dosisproportional stigning blev observeret for peak -plasmakoncentrationer og arealet under kurven (AUC).
English: The risk of anorexia is higher when levetiracetam is co-administered with topiramate.
Danish: Risikoen for anoreksi er større, når levetiracetam administreres samtidigt med topiramat.
English: A 750 mg loading dose is recommended on the first day of treatment with levetiracetam.
Danish: En 750 mg støddosis anbefales på første behandlingsdag med levetiracetam.
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 CNS-relaterede symptomer især i begyndelsen af behandlingen eller ved dosisøgning.
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 fik enzyminducerende antiepileptika.
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 ikke adskilte sig (non-inferiort) fra placebo hvad angår ændring i forhold til baseline i score opnået i ”Leiter-R Attention and Memory, Memory Screen Composite"- testen i per protokol-populationen.
English: Only limited evidence is available on the neurodevelopment of children exposed to levetiracetam monotherapy in utero.
Danish: Der findes kun begrænset evidens vedrørende neuroudvikling hos børn udsat for levetiracetam monoterapi in utero.
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: Deltagere, som fik levetiracetam i det langvarige, åbne opfølgningsstudie, oplevede imidlertid generelt ikke nogen forværring af deres adfærds- og følelsesmæssige funktion; navnlig var graden af aggressiv adfærd ikke forværret i forhold til baseline.
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 af aggressiv adfærd hos patienter behandlet med levetiracetam, vurderet på en standardiseret og systematisk måde ved brug af et valideret værktøj (CBLCAchenbach Child Behavior Checklist).
English: Patients (and caregivers of patients) should be advised to seek medical advice should signs of depression and/or suicidal ideation or behaviour emerge.
Danish: Patienter (og plejepersonale) bør rådes til straks at kontakte en læge, hvis der opstår tegn på depression og/eller selvmordstanker eller -adfærd.
English: Tell your doctor immediately, or go to your nearest emergency department, if you experience:
Danish: Kontakt omgående lægen eller skadestuen, hvis du oplever: