FrancophonIA/ELRC3.0 huggingface dataset:
English: Levetiracetam Sun is a medicine that contains the active substance levetiracetam.
Danish: Levetiracetam Sun er et lægemiddel, der indeholder det aktive stof levetiracetam.
English: The daily dose can be increased up to 1,500 mg twice a day.
Danish: Derefter kan dosis øges indtil 1500 mg to gange dagligt.
English: When Levetiracetam Sun is used on its own, the starting dose is 250 mg twice a day, increasing two weeks later to 500 mg twice a day.
Danish: Når Levetiracetam Sun anvendes alene, er startdosis 250 mg to gange dagligt, som efter to uger øges til 500 mg to gange dagligt.
English: When Levetiracetam Sun is added to another anti-epileptic treatment, the starting dose in patients over 12 years weighing more than 50 kg is 500 mg twice a day.
Danish: Når Levetiracetam Sun anvendes som tillægsbehandling til en anden behandling med antiepileptika, er startdosis til patienter over 12 år, som vejer over 50 kg, 500 mg to gange dagligt.
English: Why has Levetiracetam Sun been approved?
Danish: Hvorfor blev Levetiracetam Sun godkendt?
English: The dose can be further increased at two-week intervals according to the patient's response, to a maximum dose of 1,500 mg twice a day.
Danish: Afhængigt af patientens reaktion på behandlingen kan dosis med to ugers mellemrum yderligere øges til en maksimal dosis på 1500 mg to gange dagligt.
English: The company provided data from the published literature on levetiracetam.
Danish: Virksomheden har fremlagt data fra faglitteraturen om levetiracetam.
English: What is Levetiracetam Sun?
Danish: Hvad er Levetiracetam Sun?
English: How has Levetiracetam Sun been studied?
Danish: Hvordan blev Levetiracetam Sun undersøgt?
English: What is Levetiracetam Sun used for?
Danish: Hvad anvendes Levetiracetam Sun til?
English: How is Levetiracetam Sun used?
Danish: Hvordan anvendes Levetiracetam Sun?
English: How does Levetiracetam Sun work?
Danish: Hvordan virker Levetiracetam Sun?
English: 1 bottle + 1 oral syringe + 1 bottle adapter
Danish: 1 flaske + 1 oral sprøjte + 1 flaskeadapter
English: Oral suspension Oral use bottle (glass)
Danish: Oral anvendelse flaske (glas)
English: Route of Administration
Danish: Oral suspension
English: (see also section 5.3)
Danish: (se også afsnit 5.3)
English: This is very rare.
Danish: Dette er meget sjældent.
English: Therefore, this Product Information may not necessarily represent the current text.
Danish: Disse produktoplysninger repræsenterer derfor ikke nødvendigvis den aktuelle tekst.
English: An interaction could occur with:
Danish: En interaktion kan ske med:
English: Formulation 2:
Danish: Formulering 2:
English: It is important that you keep taking your medicine.
Danish: Det er vigtigt, at du fortsætter med at tage din medicin.
English: Dyspnoea may be the only preceding symptom.
Danish: Dyspnø kan være det eneste forudgående symptom.
English: No specific antidote is known.
Danish: Der kendes ingen specifik antidot.
English: Kölblgasse 8-10 A-1030 Wien Austria
Danish: Kölblgasse 8-10 A-1030 Wien ØSTRIG
English: You may need to read it again.
Danish: Du får muligvis behov før at læse den igen.
English: This medicine is used to treat the following conditions:
Danish: Denne medicin er beregnet til behandling af følgende tilstande:
English: PACKAGE LEAFLET: INFORMATION FOR THE USER
Danish: INDLÆGSSEDDEL:INFORMATION TIL BRUGEREN
English: SAFETY ISSUES
Danish: SIKKERHEDSSPØRGSMÅL
English: The need for treatment should be reassessed periodically.
Danish: Behovet for behandling bør periodisk revurderes.
English: A lower or less frequent dose should be considered.
Danish: Her bør en lavere eller mindre hyppig dosering overvejes.
English: • Medicines should not be disposed of via wastewater or household waste.
Danish: • Medicinen må ikke tilføres spildevand eller husholdningsaffald.
English: In some cases manifestations of toxicity have occurred.
Danish: I nogle tilfælde er toksiske manifestationer observeret.
English: It is important that the prescribers discusses carefully the risks and benefits of treatment with the child/young person and/or their parents.
Danish: Det er vigtigt, at de ordinerende læger omhyggeligt drøfter risici og fordele ved behandlingen med barnet/den unge og/eller dennes forældre.
English: For oral administration.
Danish: Til oral administration
English: It has not been established whether there is an effect on achieving normal adult height.
Danish: Det er ikke blevet fastslået, om der er nogen effekt på opnåelse af normal voksenhøjde.
English: You may not feel better immediately when you first start taking your medicine for depression.
Danish: Det kan være, at du ikke straks får det bedre efter, at du er begyndt med at tage din medicin for depression.
English: Information collected to date does not indicate a increased risk when used during pregnancy.
Danish: Den indsamlede information indtil dato indikere ikke at der skulle være en forøget risiko ved brug under graviditet.
English: • You should avoid alcohol while you are taking this medicine.
Danish: • Du bør undgå at indtage alkohol, når du tager denne medicin.
English: In addition, there is a possibility of an increased risk of suicidal behaviour in young adults.
Danish: Derudover er der muligvis øget risiko for selvmordsadfærd hos unge voksne.
English: Greece: Ladose
Danish: Grækenland: Ladose
English: This difference was largely accounted for by weight.
Danish: Forskellen skyldes hovedsagelig vægten.
English: S-16927 Solna, SWEDEN
Danish: S-16927 Solna, SVERIGE
English: This risk persists until improvements of your illness occurs.
Danish: Risikoen vedbliver indtil der ses forbedring i din sygdom.
English: Toxicological Studies:
Danish: Toksikologiske undersøgelser:
English: Read the leaflet for more information.
Danish: Læs indlægssedlen for yderligere information.
English: Athens-Lamia, 145 64 Kifissia, GREECE
Danish: Athens-Lamia, 145 64 Kifissia, GRÆKENLAND
English: • have suicidal thoughts or want to harm your self.
Danish: • Hvis du har selvmordstanker eller ønsker om at gøre skade på dig selv.
English: When dosing is stopped, active drug substances will persist in the body for weeks.
Danish: Ved seponering af behandlingen vil aktive stoffer forblive i kroppen i nogle uger.
English: D-61350 Bad Homburg Germany
Danish: D-61350 Bad Homburg TYSKLAND
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF PROZAC AND ASSOCIATED NAMES (SEE ANNEX I)
Danish: SAMLET RESUME AF DEN FAGLIGE VURDERING AF PROZAC OG TILKNYTTEDE NAVNE (se bilag I)
English: Excretion is mainly (about 60%) via the kidney.
Danish: Udskillelsen foregår hovedsageligt (ca. 60%) gennem nyrerne.
English: • Do not stop taking your medicine without asking your doctor first, even when you start to feel better.
Danish: • Hold ikke op med at tage din medicin uden at konsultere din læge først, også selvom du føler, at du har fået det bedre.
English: Two years.
Danish: 2 år.
English: This is most likely to occur within the first few weeks of treatment.
Danish: Der er størst sandsynlighed for, at dette opstår inden for de første uger af behandlingen.
English: Three years.
Danish: 3 år.
English: • Do not take (Invented name)® after the expiry date which is stated on the pack.
Danish: • Anvend ikke SÆRNAVN® efter udløbsdatoen, som er angivet på pakningen.
English: You should only breast-feed if it is clearly necessary.
Danish: Du bør kun amme, hvis dette er strengt nødvendigt.
English: This is usual because an improvement in depressive symptoms may not occur until after the first few weeks.
Danish: Dette er sædvanligvis fordi en forbedring i en depression ikke sker før efter de første par uger.
English: Lower weight children:
Danish: Børn med lav vægt:
English: This finding would appear to be supported by clinical findings.
Danish: Denne opdagelse understøttes tilsyneladende af de kliniske resultater.
English: This should be borne in mind when starting or stopping treatment.
Danish: Dette bør tages i betragtning, ved påbegyndelse eller seponering af behandling.
English: Lower weight children may need lower doses.
Danish: Børn med lav vægt kan have behov for lavere dosis.
English: Maximum plasma concentration is generally achieved 6 to 8 hours after administration.
Danish: Maksimal plasmakoncentration nås generelt ca. 6-8 timer efter oral administration.
English: In patients who develop these symptoms, increasing the dose may be detrimental.
Danish: Hos patienter, som udvikler disse symptomer, kan det være skadeligt at øge dosen.
English: • prolonged and painful erection;
Danish: • Forlænget og smertefuld erektion.
English: Patients should be advised to avoid driving a car or operating hazardous machinery until they are reasonably certain that their performance is not affected.
Danish: Patienter bør frarådes at køre bil eller betjene farlige maskiner, før de er sikre på, at deres evner ikke er påvirket.
English: The bioavailability is not affected by food intake.
Danish: Fødeindtagelse har ingen indflydelse på biotilgængeligheden.
English: This medicine may affect the way some other medicines work (interaction).
Danish: Disse lægemidler kan påvirke måden som andre lægemidler virker på (interaktion).
English: • the CHMP considered the referral made under Article 6(12) of Commission Regulation EC No 1084/2003, for Prozac and associated names (see Annex I),
Danish: • CHMP behandlede den sag, der var blevet indbragt i henhold til artikel 6, stk. 12, i Kommissionens forordning (EF) nr. 1084/2003 for Prozac og tilknyttede navne (jf. bilag I).
English: • irritability and extreme agitation.
Danish: • Irritabilitet og ekstrem opstemthed.
English: The significance of these findings in humans is unknown.
Danish: Signifikansen af disse resultater i forhold til mennesker kendes ikke.
English: Very rare cases of idiosyncratic hepatitis.
Danish: Meget sjældne tilfælde af idiosynkratisk hepatitis.
English: Cyproheptadine or dantrolene may benefit patients experiencing such reactions.
Danish: Cyproheptadin eller dantrolen vil eventuelt kunne afhjælpe patienter med sådanne reaktioner.
English: • Children and adolescents aged 8 to 18 years with depression: Treatment should be started and be supervised by a specialist.
Danish: • Børn og unge fra 8 år til 18 år med depression: behandlingen bør påbegyndes og overvåges af en specialist.
English: However, for long-term efficacy no conclusion can be drawn.
Danish: For langtids-effekten kunne der ikke drages konklusioner.
English: Patients were included if they had symptoms of sufficient severity to impair social and occupational function and relationships with others.
Danish: Patienterne blev inkluderet i forsøgene, hvis de havde symptomer af en tilstrækkelig sværhedsgrad, der hæmmede den sociale og arbejdsmæssige funktion og forholdet til andre.
English: Treatment should be initiated and monitored under specialist supervision.
Danish: Behandling bør indsættes og monitoreres under overvågning af en specialist.
English: Patients (and caregivers of patients) should be alerted about the need to monitor for the emergence of such events and to seek medical advice immediately if these symptoms present.
Danish: Patienterne (og disses plejepersonale) skal advares om behovet for monitorering for opståen af sådanne hændelser og opfordres til omgående at søge medicinsk rådgivning, hvis disse symptomer viser sig.
English: Additionally in Children and Adolescents (8-18 years) - fluoxetine may slow growth or possibly delay sexual maturity.
Danish: Yderligere hos børn og unge (8-18 år) - fluoxetin kan forsinke vækst eller muligvis forsinke den seksuelle udvikling.
English: Since it can take 3 to 4 weeks before your illness improves following treatment with fluoxetine, your doctor will monitor you closely at the start of the treatment.
Danish: Eftersom det kan tage op 3 til 4 uger inden der sker forbedringer i din tilstand efter start på behandling med fluoxetin, vil din læge føre nøje tilsyn med din tilstand i starten af din behandling.
English: Patients with depression should be treated for a period of at least 6 months.
Danish: Patienter med depression bør behandles i mindst 6 måneder.
English: These patients had no prior episodes of hypomania/mania.
Danish: Disse patienter havde ikke tidligere haft episoder med hypomani/mani.
English: Growth and pubertal development (height, weight and TANNER staging) should therefore be monitored during and after treatment with fluoxetine.
Danish: Vækst og pubertetsudvikling (højde, vægt og TANNER-stadie) bør derfor monitoreres under og efter behandling med fluoxetin.
English: 3991 RA Houten The Netherlands
Danish: 3991 RA Houten HOLLAND
English: If you take more (Invented name)® than you should
Danish: Hvis du tager mere SÆRNAVN® end du bør
English: Some patients have had:
Danish: Nogle patienter har oplevet
English: Stratified analysis by age on children and adolescents indicated no difference in effect sizes between these two groups.
Danish: Stratificeret analyse efter alder hos børn og unge viser ingen forskel i virkning mellem disse to grupper.
English: Like all medicines, (Invented name)® can cause side effects, although not everybody gets them.
Danish: Som alle andre lægemidler kan SÆRNAVN® have bivirkninger, selvom ikke alle får bivirkninger.
English: • Make sure you do not run out of capsules.
Danish: • Vær sikker på ikke at løbe tør for kapsler.
English: Respiratory system: Pharyngitis, dyspnoea.
Danish: Respirationssystemet: Pharyngitis, dyspnø.
English: Interaction with other medicinal products and other forms of interaction
Danish: 4.5 Interaktion med andre lægemidler og andre former for interaktion
English: 203, Bureaux de la Colline 92213 Saint Cloud, FRANCE
Danish: 203, Bureaux de la Colline 92213 Saint Cloud, FRANKRIG
English: The safety of fluoxetine has not been systematically assessed for chronic treatment longer than 19 weeks.
Danish: Sikkerheden i forbindelse med fluoxetin er ikke blevet systematisk undersøgt ved kronisk behandling på mere end 19 uger.
English: The capsule and liquid dosage forms are bioequivalent.
Danish: Kapslen og flydende doseringsformer er bioækvivalent.
English: Note: This Product Information is the one that was Annexed to the Commission Decision on this Article 6(12) referral for fluoxetine containing medicinal products.
Danish: Bemærkning: Disse produktoplysninger er de samme som dem, der var vedlagt Kommissionens afgørelse af denne artikel 6-indbringelse vedrørende lægemidler indeholdende fluoxetin.
English: If you are elderly, your doctor will increase the dose with more caution and the daily dose should generally not exceed 40 mg.
Danish: Hvis du er ældre, vil din læge øge dosis med større forsigtighed og den daglige dosis bør generelt ikke overstige 40 mg.
English: Fluoxetine should be avoided in patients with unstable seizure disorders/epilepsy and patients with controlled epilepsy should be carefully monitored.
Danish: Fluoxetin bør undgås til patienter med dårligt kontrollerede anfaldslidelser/epilepsi og patienter med kontrolleret epilepsi bør nøje monitoreres.
English: There is no information on whether the effect was reversible.
Danish: Der foreligger ingen oplysninger om, hvorvidt denne effekt var reversibel.
English: The third was a trial sponsored by the National Institute of Mental Health (NIMH) - the Treatment of Adolescents with Depression trial (TADS).
Danish: Den tredje undersøgelse er sponsoreret af National Institute of Mental Health (NIMH) - TADS-undersøgelsen (Treatment of Adolescents with Depression).
English: WHAT (Invented name)® IS AND WHAT IT IS USED FOR
Danish: HVAD SÆRNAVN® ER, OG HVAD DET ANVENDES TIL
English: Of these adverse events, 17% in the fluoxetine group and 12% in the placebo group were severe in nature.
Danish: Af disse utilsigtede hændelser var 17% i fluoxetin-gruppen og 12% i placebogruppen af alvorlig karakter.
English: Prozac is currently approved for the treatment of major depressive episodes, obsessive-compulsive disorder and bulimia nervosa, in adults.
Danish: Prozac er aktuelt godkendt til behandling af svære depressive episoder, obsessiv-kompulsiv tilstand og bulimia nervosa hos voksne.
English: In managing overdosage, consider the possibility of multiple drug involvement.
Danish: Ved behandling af overdosering bør muligheden for involvering af flere lægemidler overvejes.
English: Generally these symptoms are selflimiting and usually resolve within 2 weeks, though in some individuals they may be prolonged (2-3 months or more).
Danish: Generelt er disse symptomer selvbegrænsende og forsvinder som regel inden for 2 uger, selvom de hos nogle personer kan være langvarige (2-3 måneder eller mere).
English: When fluoxetine is used in combination with lithium, closer and more frequent clinical monitoring is required.
Danish: Når fluoxetin tages i kombination med lithium er tættere og mere hyppig klinisk monitorering påkrævet.
English: Generally these symptoms are mild to moderate however, in some patients they may be severe in intensity.
Danish: Generelt er disse symptomer milde til moderate, men hos nogle patienter kan de være alvorlige i intensitet.
English: Therefore, fluoxetine is contra-indicated in combination with a non-selective MAOI.
Danish: Fluoxetin er derfor kontraindiceret i kombination med en non-selektiv MAO-hæmmer.
English: National Competent Authorities, coordinated by the Reference Member State (RMS), shall ensure that the following conditions are fulfilled by the Marketing Authorisation Holders:
Danish: De nationale kompetente myndigheder sikrer med referencemedlemsstaten som koordinerende instans, at indehaverne af markedsføringstilladelserne opfylder følgende betingelser:
English: In both studies, patients met criteria for moderate to severe MDD (DSM-III or DSM-IV) at three different evaluations by practising child psychiatrists.
Danish: I begge forsøg opfyldte patienterne kriterierne for vedvarende moderat til svær MDD (DSM-III eller DSM-IV) ved tre forskellige evalueringer af praktiserende børnepsykiatere.
English: MANUFACTURER'S BATCH NUMBER Lot:
Danish: FREMSTILLERENS BATCHNUMMER Lot nr.
English: • Elderly: Kinetic parameters are not altered in healthy elderly when compared to younger subjects
Danish: • Ældre: Farmakokinetiske parametre er ikke ændret hos raske ældre i forhold til yngre personer.
English: If either is slowed, referral to a paediatrician should be considered.
Danish: Hvis en af disse er forsinket, bør henvisning til en pædiater overvejes.
English: Eli Lilly Italia S.p.A., Via Gramsci 731/733, 50019 Sesto Fiorentino (Fi), ITALY
Danish: Eli Lilly Italia S.p.A., Via Gramsci 731/733, 50019 Sesto Fiorentino (Fi), ITALIEN
English: • Measure the right amount of medicine using the measuring cup, syringe or a measuring spoon, then drink it.
Danish: • Afmål den korrekte mængde medicin ved hjælp af målebægeret, sprøjte eller måleske, drik det derefter.
English: For paediatric patients who respond to treatment, the need for continued treatment after 6 months should be reviewed.
Danish: I forbindelse med pædiatriske patienter, som responderer på behandlingen, skal behovet for fortsat behandling efter 6 måneder vurderes.
English: However, data on maintenance of effect is limited.
Danish: Der foreligger dog kun begrænsede oplysninger om fastholdelse af virkningen.
English: Undesirable effects may decrease in intensity and frequency with continued treatment and do not generally lead to cessation of therapy.
Danish: Bivirkninger vil kunne formindskes i intensitet og hyppighed ved fortsat behandling og bør generelt ikke lede til et ophør med behandlingen.
English: Pharmaserve-Lilly S.A.C.I 15th KLM National Road
Danish: Grækenland Pharmaserve-Lilly S.A.C.I 15th KLM National Road
English: Steady-state plasma concentrations are achieved after dosing for several weeks.
Danish: Steady-state plasmakoncentrationer opnås først efter flere ugers behandling.
English: If your doctor has prescribed (Invented name)® for a patient under 18 and you want to discuss this, please go back to your doctor.
Danish: Hvis din læge har ordineret SÆRNAVN® til en patient under 18 år, og du gerne vil drøfte dette med lægen, bedes du henvende dig til denne.
English: They usually occur within the first few days of discontinuing treatment.
Danish: De opstår som regel inden for de første par dage efter afbrydelse af behandlingen.
English: • Tell your doctor immediately if your skin starts to turn red and then blister or peel.
Danish: • Fortæl straks din læge, hvis din hud bliver rød, danner væskefyldte vabler eller skaller.
English: Efficacy in the fluoxetine trials may depend on the inclusion of a selective patient population (one that has not spontaneously recovered within a period of 3-5 weeks and whose depression persisted in the face of considerable attention).
Danish: Fluoxetins effekt i kliniske forsøg kan muligvis afhænge af inklusion af en selektiv patientpopulation (en der ikke har haft spontan helbredelse inden for en periode på 3-5 uger, og hvis depression varede ved trods væsentlig opmærksomhed).
English: After the CD, the Member State competent authorities will update the product information as required.
Danish: Efter Kommissionens afgørelse skal medlemsstaternes kompetente myndigheder ajourføre produktoplysningerne i overensstemmelse hermed.
English: In relation to testicular toxicity, effects were observed in juvenile rats in conjunction with other clinical signs of toxicity (at a dose exceeding the maximum tolerated dose) and at an exposure level that would not be tolerated chronically in humans.
Danish: Hvad angår toksisk påvirkning af testiklerne, blev der observeret virkninger hos unge rotter sammen med andre kliniske tegn på toksicitet (ved en dosis, der overstiger den maksimale tolererede dosis) og ved et eksponeringsniveau, der ikke ville blive tolereret kronisk hos mennesker.
English: However, the product information was strengthened with appropriate warnings to inform doctors and parents about the need to monitor patients for the appearance of these events.
Danish: Produktoplysningerne er imidlertid skærpet med passende advarsler til læger og forældre om behovet for overvågning af patienterne for sådanne tegn.
English: • Swallow the capsules with a drink of water.
Danish: • Synk kapslerne med vand.
English: • Take the pack of (Invented name)® with you if you can.
Danish: • Tag SÆRNAVN® pakken med dig, hvis du kan.
English: Children and adolescents aged 8 years and above (Moderate to severe major depressive episode):
Danish: Børn og unge fra 8 år (moderat til svær depressiv episode):
English: (Invented name)® should not be used in the treatment of children under the age of 8 years.
Danish: SÆRNAVN® bør ikke bruges i behandling af børn i alderen under 8 år.
English: • Children and adolescents: The mean fluoxetine concentration in children is approximately 2fold higher than that observed in adolescents and the mean norfluoxetine concentration 1.5-fold higher.
Danish: • Børn og unge: Den gennemsnitlige koncentration af fluoxetin hos børn er ca. 2 gange større end den, der ses hos voksne, og den gennemsnitlige koncentration af norfluoxetin er 1,5 gange højere.
English: Therefore, regular monitoring for the occurrence of mania/hypomania is recommended.
Danish: Derfor anbefales regelmæssig monitorering for symptomer på mani/hypomani.
English: Most of these side effects are likely to go away with continued treatment.
Danish: De fleste af disse bivirkninger er forbigående ved vedvarende behandling.
English: The current procedure is a referral following a Mutual Recognition Procedure variation application, which concerned an extension of the indication for Prozac to include the treatment of major depressive episodes in children aged 8 to 17 years.
Danish: Den aktuelle indbringelse følger efter en ansøgning om ændring i henhold til den gensidige anerkendelsesprocedure og omfatter en udvidelse af indikationen for Prozac til behandling af svære depressive episoder hos børn i alderen 8 til 17 år.
English: • feelings of weakness, drowsiness or confusion mostly in elderly people and in (elderly) people on diuretics (water tablets);
Danish: • Følelser af svaghed, sløvhed eller forvirring mest forkommen hos ældre personer og hos (ældre) personer i behandling med diuretika (vanddrivende).