FrancophonIA/ELRC3.0 huggingface dataset:
English: Levetiracetam Hospira is used: on its own in adults and adolescents from 16 years of age with newly diagnosed epilepsy, to treat a certain form of epilepsy.
Danish: Levetiracetam Hospira anvendes: som monoterapi (eneste lægemiddel) til behandling af en bestemt type epilepsi hos voksne og unge over 16 år med nydiagnosticeret epilepsi.
English: (impaired coordinated movements), paraesthesia (tingling), disturbance in attention (loss of concentration);
Danish: koordinationsbesvær/ataksi(/usikre bevægelser), paræstesi (prikkende, snurrende fornemmelser eller følelsesløshed i huden), opmærksomhedsforstyrrelser (koncentrationsbesvær);
English: Duration of treatment:
Danish: Holdbarhed ved brug:
English: From 50 kg
Danish: Fra 50 kg
English: Pharmacotherapeutic group: antiepileptics, other antiepileptics, ATC code: N03AX14.
Danish: ATC -kode: N03AX14.
English: Levetiracetam Hospira 100 mg/ml concentrate for solution for infusion levetiracetam
Danish: Levetiracetam Hospira 100 mg/ml koncentrat til infusionsvæske, opløsning levetiracetam
English: What Levetiracetam Hospira is and what it is used for What you need to know before you are given Levetiracetam Hospira How Levetiracetam Hospira is given Possible side effects
Danish: Det skal du vide, før du begynder at få Levetiracetam Hospira Sådan får du Levetiracetam Hospira Bivirkninger
English: • in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with Juvenile Myoclonic Epilepsy.
Danish: • til voksne og unge over 12 år med juvenil myoklon epilepsi med myoklone anfald.
English: Moderate
Danish: Moderat nedsat
English: 5 to 15 mg/kg (0.05 to 0.15 ml/kg) twice daily
Danish: 5-15 mg/kg (0,05 til 0,15 ml/kg) to gange dagligt
English: Adverse effects not observed in clinical studies but seen in the rat and to a lesser extent in the mouse at exposure levels similar to human exposure levels and with possible relevance for clinical use were liver changes, indicating an adaptive response such as increased weight and centrilobular hypertrophy, fatty infiltration and increased liver enzymes in plasma.
Danish: Leverændringerne er af mulig klinisk relevans og tyder på et adaptivt respons såsom vægtøgning, centrilobulær hypertrofi, fedtinfiltration og forhøjede leverenzymer i plasma.
English: Each 5 ml vial contains 500 mg of levetiracetam.
Danish: Hvert 5 ml hætteglas indeholder 500 mg levetiracetam.
English: If you suffer from kidney problems, follow your doctor's instructions.
Danish: Følg lægens instruktioner.
English: Monotherapy in the treatment of partial onset seizures with or without secondary generalisation in patients from 16 years of age with newly diagnosed epilepsy.
Danish: Monoterapi behandling af patienter over 16 år med nyligt diagnosticeret partiel epilepsi med eller uden sekundær generalisering:
English: Levetiracetam Hospira is indicated as monotherapy in the treatment of partial onset seizures with or without secondary generalisation in adults and adolescents from 16 years of age with newly diagnosed epilepsy.
Danish: Indikationen for Levetiracetam Hospira er monoterapibehandling af voksne og unge over 16 år, som for nyligt har fået stillet diagnosen partiel epilepsi med eller uden sekundær generalisering.
English: Medicinal product with particulate matter or discoloration should not be used.
Danish: Præparater med uklarhed og misfarvning bør ikke anvendes.
English: 10 to 20 mg/kg (0.10 to 0.20 ml/kg) twice daily
Danish: 10-20 mg/kg (0,10 til 0,20 ml/kg) to gange dagligt
English: 500 to 1,000 mg once daily
Danish: 500 til 1.000 mg en gang dagligt
English: Levetiracetam Hospira is indicated as adjunctive therapy
Danish: Indikationen for Levetiracetam Hospira er tillægsbehandling
English: • amnesia (loss of memory), memory impairment (forgetfulness), abnormal coordination/ataxia
Danish: • amnesi (hukommelsestab), hukommelsessvækkelse (glemsomhed),
English: 250 to 750 mg twice daily
Danish: 250 til 750 mg to gange dagligt
English: How to store Levetiracetam Hospira
Danish: Sådan får du Levetiracetam Hospira
English: • in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with Idiopathic Generalised Epilepsy.
Danish: • til voksne og unge over 12 år med idiopatisk generaliseret epilepsi med primært generaliserede tonisk-kloniske anfald.
English: • delirium;
Danish: • udslæt;
English: nasopharyngitis (infection of the nose or throat); somnolence (sleepiness), headache.
Danish: • snue (infektion i næse eller hals);
English: 250 mg 2.5 ml (half 5 ml vial) 100 ml
Danish: 250 mg 2.5 ml (halvdelen af 5 ml hætteglas)
English: 1,000 mg 10 ml (two 5 ml vials) 100 ml
Danish: 1.000 mg 10 ml (to 5 ml hætteglas)
English: 10 to 30 mg/kg (0.10 to 0.30 ml/kg) twice daily
Danish: 10-30 mg/kg (0,10 til 0,30 ml/kg) to gange dagligt
English: Adjunctive therapy in the treatment of partial onset seizures with or without secondary generalization in adults, adolescents and children from 4 years of age with epilepsy.
Danish: Tillægsbehandling af voksne, unge og børn over 4 år med partiel epilepsi med eller uden sekundær generalisering.
English: 500 mg twice daily
Danish: 500 mg to gange dagligt
English: 500 mg 5 ml (one 5 ml vial)
Danish: 500 mg 5 ml (et 5 ml hætteglas)
English: 750 mg twice daily
Danish: 750 mg to gange dagligt
English: 500 to 1,500 mg twice daily
Danish: 500 til 1.500 mg to gange dagligt
English: Weight decreased, weight increase
Danish: Vægttab, vægtøgning
English: 450 mg twice daily
Danish: 450 mg to gange dagligt
English: Vial of 5 ml
Danish: 5 ml hætteglas
English: 5 to 10 mg/kg (0.05 to 0.10 ml/kg) twice daily
Danish: 5-10 mg/kg (0,05 til 0,10 ml/kg) to gange dagligt
English: 200 mg twice daily
Danish: 200 mg to gange dagligt
English: One vial contains 500 mg/5 ml levetiracetam.
Danish: Et hætteglas indeholder 500 mg levetiracetam/5 ml.
English: 250 to 500 mg twice daily
Danish: 250 til 500 mg to gange dagligt
English: Twice daily 500 mg/day
Danish: 500 mg/dag
English: Sodium acetate trihydrate Glacial acetic acid Sodium chloride Water for injections
Danish: Natriumchlorid Vand til injektionsvæsker
English: 500 to 1,000 mg twice daily
Danish: 500 til 1.000 mg to gange dagligt
English: NN:
Danish: Indgivelsesmåde:
English: 250 mg twice daily
Danish: 250 mg to gange dagligt
English: Levetiracetam efficacy was established in a double-blind, placebo-controlled study of 16 weeks duration, in patients 12 years of age and older suffering from idiopathic generalized epilepsy with myoclonic seizures in different syndromes.
Danish: Tillægsbehandling af voksne og unge over 12 år med juvenil myoklon epilepsi med myoklone anfald: Levetiracetams virkning hos patienter over 12 år med idiopatisk generaliseret epilepsi med myoklone anfald i forskellige syndromer blev påvist i et dobbeltblindt, placebokontrolleret studie med en behandlingsvarighed på 16 uger.
English: as an add-on to other antiepileptic medicines to treat: partial onset seizures with or without generalisation in adults, adolescents and children from 4 years 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.
Danish: • myoklone anfald (korte, chok-lignende ryk i en muskel eller i en gruppe af muskler) hos voksne og unge over 12 år med juvenil myoklon epilepsi
English: • convulsion, balance disorder (equilibrium disorder), dizziness (sensation of unsteadiness),
Danish: • delirium (uklarhed, forvirring og desorientering);
English: Rash
Danish: Lot
English: Following dialysis, a 5 to 10 mg/kg (0.05 to 0.10 ml/kg) supplemental dose is recommended.
Danish: (0,05 til 0,10 ml/kg) som supplerende dosis.
English: Discontinuation
Danish: Opbevaring
English: {MM/YYYY}
Danish: ---------------------------- x 1,73 Personens BSA (m
English: Twice daily 2,000 mg/day
Danish: 2.000 mg/da
English: Twice daily 1,000 mg/day
Danish: 1.000 mg/da
English: Package size l t o r
Danish: Paknings-størrelse r l
English: Put the tablet in your mouth.
Danish: Put tabletten i din mund.
English: Do not stop taking your tablets just because you feel better.
Danish: Du må ikke holde op med at tage tabletterne, fordi du har fået det bedre.
English: Date of first authorisation: 10.12.2009 Date of renewal of authorisation: 06.08.2014
Danish: Dato for første markedsføringstilladelse: 10.12.2009 Dato for seneste fornyelse: 06.08.2014
English: Consequently, newborns should be monitored carefully.
Danish: Derfor bør nyfødte overvåges nøje
English: At the time of granting the marketing authorisation, the submission of periodic safety update reports is not required for this medicinal product.
Danish: På tidspunktet for udstedelse af markedsføringstilladelsen, er fremlæggelsen af de periodiske, opdaterede sikkerhedsindberetninger ikke påkrævet for dette lægemiddel.
English: categories.
Danish: kategorier.
English: • Tell the doctor if you or someone else in your family has a history of blood clots, as medicines like these have been associated with the formation of blood clots.
Danish: • Fortæl det til lægen, hvis du eller nogen i din familie tidligere har haft blodpropper, da denne type medicin kan være forbundet med dannelse af blodpropper.
English: However, the marketing authorisation holder shall submit periodic safety update reports for this medicinal product if the product is included in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Danish: Dog skal indehaveren af markedsføringstilladelsen indsende periodiske sikkerhedsopdateringer for dette lægemiddel, hvis produktet indgår på listen over EU-referencedatoer (EURD liste) er omhandlet i artikel 107c (7), i direktiv 2001/83/EF og offentliggjort på Europa webportal om lægemidler.
English: If you are pregnant or breast-feeding, think you might may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge eller apotekspersonalet til råds, før du bruger dette lægemiddel.
English: Increased total bilirubin
Danish: Forhøjet total-bilirubin
English: Based on the results of studies in mice and rats, it was concluded that olanzapine is not carcinogenic.
Danish: På baggrund af resultater fra studier af mus og rotter blev det konkluderet, at olanzapin ikke er karcinogent.
English: Tardive dyskinesia11
Danish: Tardiv dyskinesi11
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 Dinepårørende kan også indberette bivirkninger direkte til Sundhedsstyrelsen 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: The magnitude of weight gain and the proportion of adolescent patients who had clinically significant weight gain were greater with longterm exposure (at least 24 weeks) than with short-term exposure.
Danish: Størrelsen af vægtøgning og andelen af unge patienter, som havde klinisk signifikant vægtøgning, var større ved langvarig eksponering (mindst 24 uger) end ved kortvarig eksponering.
English: In cases where dose increments of 2.5 mg are considered necessary, Olanzapine tablets should be used.
Danish: I tilfælde, hvor dosisstigninger på 2,5 mg er nødvendige, bør Olazpine tabletter anvendes.
English: Do not use this medicine after the expiry date which is stated on the carton and blister after EXP.
Danish: Brug ikke lægemidlet efter Exp den udløbsdato, der står på pakningen.
English: The frequency terms listed are 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), very rare (< 10,000), not known (cannot be estimated from the data available).
Danish: Hyppighederne er defineret som følgende: 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), meget sjælden (< 1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMA) http://www.ema.europa.eu
Danish: Detaljerede oplysninger om dette produkt forefindes på hjemmesiden for European Medicines Agency http://www.ema.europa.eu
English: • The use of Olazax Disperzi in elderly patients with dementia is not recommended as it may have serious side effects.
Danish: • Olazax Disperzi anbefales ikke til ældre, demente patienter, da det kan have alvorlige bivirkninger.
English: Alternatively, it may be dispersed in a full glass of water or other suitable beverage (orange juice, apple juice, milk or coffee) immediately before the administration.
Danish: Alternativt kan den dispergeres i et helt glas vand eller en anden passende drikkevare (appelsinjuice, æblejuice, mælk eller kaffe) umiddelbart inden indgivelsen.
English: You should not be given this medicine when breast-feeding, as small amounts of Olazax Disperzi can pass into breast milk.
Danish: Du bør ikke få denne medicin, mens du ammer, da små mængder Olazax Disperzi kan overføres til modermælken.
English: (See sections 4.5 and 5.2.)
Danish: 4.5 og 5.2).
English: It is recommended that blood pressure is measured periodically in patients over 65 years.
Danish: Det anbefales at måle blodtryket periodisk på patienter over 65 år.
English: Aluminium/aluminium blisters in cartons of 28, 56 tablets per carton.
Danish: Aluminium/aluminium blisterkort i kartoner á 28 & 56 tabletter pr. karton.
English: In patients with Parkinson's disease Olazax Disperzi may worsen the symptoms
Danish: Hos patienter med Parkinsons sygdom kan Olazax Disperzi forværre symptomerne.
English: - If you have been previously diagnosed with eye problems such as certain kinds of glaucoma (increased pressure in the eye).
Danish: • hvis du tidligere har fået at vide, at du har en bestemt slags glaukom (grøn stær) med øget tryk i øjet.
English: 1 Clinically significant weight gain was observed across all baseline Body Mass Index (BMI)
Danish: 1 Klinisk signifikant vægtøgning blev observeret på tværs af alle baseline bodymassindex (BMI)
English: The mean increase in olanzapine Cmax following fluvoxamine was 54 % in female nonsmokers and 77 % male smokers.
Danish: Den gennemsnitlige øgning af olanzapin Cmax efter fluvoxamin var 54 % hos kvindelige ikke-rygere og 77 % hos mandlige rygere.
English: Olanzapine is bound predominantly to albumin and 1-acid-glycoprotein.
Danish: Olanzapin er overvejende bundet til albumin og surt α1-glykcoprotein.
English: (≥ 5.17 mmol/l) were observed commonly.
Danish: (≥ 5,17 mmol/l) blev observeret almindeligt.
English: Electrophysiological studies demonstrated that olanzapine selectively reduced the firing of mesolimbic (A10) dopaminergic neurons, while having little effect on the striatal (A9) pathways involved in motor function.
Danish: Elektrofysiologiske studier viste, at olanzapin selektivt reducerede "firing" ved de mesolimbiske (A10) dopaminerge neuroner, hvorimod det kun havde lille påvirkning af de striatale (A9) baner for motorisk funktion.
English: Consider referral to a dietician or help with a diet plan if necessary
Danish: Henvisning til en diætist eller hjælp med at lægge en kostplan bør om nødvendigt overvejes.
English: In a study in breast-feeding, healthy women, olanzapine was excreted in breast milk.
Danish: I en studie af raske, ammende kvinder blev olanzapin udskilt i modermælken.
English: • carbamazepine (an anti-epileptic and mood stabiliser), fluvoxamine (an antidepressant) or ciprofloxacin (an antibiotic) - it may be necessary to change your Olazax Disperzi dose.
Danish: • Carbamazepin (mod epilepsi og stemningsforstyrrelser), fluvoxamin (mod depression) eller ciprofloxacin (mod infektion), da det kan blive nødvendigt at ændre din Olazax Disperzi dosis
English: Talk to your doctor or pharmacist before you take Olazax Disperzi.
Danish: Kontakt lægen eller apotekspersonalet, før du tager Olazax Disperzi.
English: Amnesia9
Danish: Amnesi9
English: Studies in patients aged 13-17 years showed various adverse reactions, including weight gain, changes in metabolic parameters and increases in prolactin levels.
Danish: Forsøg med patienter i alderen 13 - 17 år gav forskellige bivirkninger, inklusive vægtøgning, ændringer i metaboliske parametre og stigning i prolaktinværdier.
English: Investigations Elevated plasma prolactin levels 8
Danish: Undersøgelser Forhøjede plasmaprolaktinniveauer8
English: See leaflet for further information.
Danish: Se indlægssedlen for yderligere oplysninger 4.
English: Clinically significant weight gain (≥ 7 %) appears to occur more frequently in the adolescent population compared to adults with comparable exposures.
Danish: Klinisk signifikant vægtøgning (≥ 7%) synes at forekomme hyppigst i den unge population sammenlignet med ældre med sammenlignelig eksponering.
English: You should take your Olazax Disperzi tablets once a day following the advice of your doctor.
Danish: Du bør tage Olazax Disperzi orodispergible tabletter én gang dagligt efter din læges anvisning.
English: During treatment for schizophrenia, manic episode and recurrence prevention in bipolar disorder, daily dosage may subsequently be adjusted on the basis of individual clinical status within the range 5-20 mg/day.
Danish: Ved behandling af skizofreni, en manisk episode og til forebyggelse af tilbagefald i bipolær lidelse kan den daglige dosering herefter justeres på basis af den individuelle kliniske status indenfor intervallet 520 mg/dag.
English: LIST OF EXCIPIENTS Contains aspartame.
Danish: LISTE OVER HJÆLPESTOFFER Indeholder aspartam.
English: METHOD AND ROUTE(S) OF ADMINISTRATION The tablet should be dissolved in the mouth or in a drink.
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Tabletten bør opløses i munden eller i en drikkevare.
English: Olazax Disperzi contains the active substance olanzapine.
Danish: Olazax Disperzi indeholder det aktive stof olanzapin.
English: 2 Mean increases in fasting lipid values (total cholesterol, LDL cholesterol, and triglycerides) were greater in patients without evidence of lipid dysregulation at baseline.
Danish: 2 Gennemsnitlig forøgelse i fastende lipidtal (totalt kolesterol, LDL kolesterol og triglycerider) var højere hos patienter uden tegn på lipiddysregulering ved baseline.
English: It is important that you carry on taking Olazax Disperzi for as long as your doctor tells you.
Danish: Det er vigtigt, du fortsætter med at tage Olazax Disperzi, så længe lægen beder dig om det.
English: In the absence of detailed information on the pre-existing history of individual acute and tardive extrapyramidal movement disorders, it can not be concluded at present that olanzapine produces less tardive dyskinesia and/or other tardive extrapyramidal syndromes.
Danish: På grund af manglende detaljeret information om tidligere individuelle akutte og tardive ekstrapyramidale bevægelsesforstyrrelser, kan det for nuværende ikke konkluderes, at olanzapin forårsager mindre tardiv dyskinesi og/eller andre tardive ekstrapyramidale syndromer.
English: • Weight gain has been seen in patients taking Olazax Disperzi.
Danish: • Vægtøgning er set hos patienter, som tager Olazax Disperzi.
English: Animal behavioral studies with olanzapine indicated 5HT, dopamine, and cholinergic antagonism, consistent with the receptor-binding profile.
Danish: Dyreadfærdsstudier af olanzapin indikerede 5 HT, dopamin og kolinerg antagonisme i overensstemmelse med receptorbindingsprofilen.
English: If you suffer from dementia, you or your carer/relative should tell your doctor if you have ever had a stroke or “mini” stroke .
Danish: Hvis du lider af demens, bør du, din pårørende eller en anden, der hjælper dig, fortælle din læge, hvis du nogensinde har haft et slagtilfælde, også hvis du ikke har nogen følger efter det.
English: • High blood sugar and high levels of fat (triglycerides and cholesterol) have been seen in patients taking Olazax Disperzi.
Danish: • Højt sukker- og fedtindhold (triglycerider og kolesterol) i blodet er set hos patienter, som tager Olazax Disperzi.
English: Olazax Disperzi orodispersible tablets should be placed in the mouth, where it will rapidly disperse in saliva, so it can be easily swallowed.
Danish: Olazax Disperzi Orodispergible tabletter bør placeres i munden, hvor den hurtigt vil dispergere i spyttet, så den let kan synkes.
English: Blood and the lymphatic system disorders Eosinophilia
Danish: Blod og lymfesystem Eosinofili
English: Do not drink any alcohol if you have been given Olazax Disperzi as together with alcohol it may make you feel drowsy.
Danish: Drik ikke nogen form for alkohol, når du får Olazax Disperzi, da det sammen med. alkohol, kan gøre digdøsig.
English: If this happens after you have been given Olazax Disperzi tell your doctor.
Danish: Hvis dette forekommer, når du har taget Olazax Disperzi, skal du fortælle det til lægen.
English: 6 In clinical trials, the incidence of Parkinsonism and dystonia in olanzapine-treated patients was numerically higher, but not statistically significantly different from placebo.
Danish: 6 I kliniske forsøg var forekomsten af parkinsonisme og dystoni hos olanzapinbehandlede patienter numerisk højere men ikke statistisk signifikant forskellig fra placebo.
English: 16 Elevated plasma prolactin levels were reported in 47.4 % of adolescent patients.
Danish: 16 Forhøjede plasma-prolaktin blev rapporteret hos 47,4 % af de unge patienter.
English: Children and adolescents Olazax Disperzi is not for patients who are under 18 years.
Danish: Olazax Disperzi er ikke beregnet til patienter under 18 år.
English: Very rare side effects (may affect up to 1 in 10,000) include serious allergic reactions such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS).
Danish: Meget sjældne bivirkninger inkluderer alvorlige allergiske reaktioner såsom lægemiddelfremkaldt reaktion med eosinofili og systemiske symptomer (DRESS).
English: If you take more Olazax Disperzi than you should Patients who have taken more Olazax Disperzi than they should, have experienced the following symptoms: rapid beating of the heart, agitation/aggressiveness, problems with speech, unusual movements (especially of the face or tongue) and reduced level of consciousness.
Danish: Patienter, som har taget mere Olazax Disperzi end de burde, har oplevet følgende symptomer: Hurtig hjerterytme, ophidselse/aggression, problemer med at tale, usædvanlige bevægelser (især af ansigt eller tunge) eller nedsat bevidsthedsniveau (døsighed).
English: May be harmful for people with phenylketonuria.
Danish: Kan være skadelige for mennesker med fenylketonuri.
English: Orodispersible tablet
Danish: Orodispergible tablet
English: Reversible neutropenia, thrombocytopenia, or anaemia developed in a few dogs treated with 8 or 10 mg/kg/day (total olanzapine exposure [AUC] is 12- to 15-fold greater than that of a man given a 12-mg dose).
Danish: Reversibel neutropeni, trombocytopeni eller anæmi udvikledes hos enkelte hunde, som blev behandlet med 8 eller 10 mg/kg/dag (total olanzapin dosis (AUC) var 12-15 gange højere end human dosis på 12 mg).
English: This may be harmful for people with phenylketonuria.
Danish: Det kan være skadeligt for mennesker med fenylketonuri
English: A lower starting dose (5 mg/day) is not routinely indicated but should be considered for those 65 and over when clinical factors warrant (see section 4.4).
Danish: En lavere startdosis (5 mg/dag) er ikke rutinemæssigt indiceret, men bør overvejes til patienter ≥ 65 år, dersom det findes klinisk indiceret (se pkt.
English: Olazax Disperzi orodispersible tablet contains aspartame, which is a source of phenylalanine.
Danish: Olazax Disperzi Orodispergible tabletter indeholder aspartam, der er en phenylalaninkilde.