FrancophonIA/ELRC3.0 huggingface dataset:
English: What is the risk associated with Clopidogrel Zentiva?
Danish: Hvilken risiko er der forbundet med Clopidogrel Zentiva?
English: Why has Clopidogrel Zentiva been approved?
Danish: Hvorfor blev Clopidogrel Zentiva godkendt?
English: In acute coronary syndrome and atrial fibrillation, Clopidogrel Zentiva is used together with aspirin, the dose of which should not be higher than 100 mg.
Danish: Ved akut koronart syndrom og atrieflimren anvendes Clopidogrel Zentiva sammen med aspirin.
English: How has Clopidogrel Zentiva been studied?
Danish: Hvordan blev Clopidogrel Zentiva undersøgt?
English: What benefit has Clopidogrel Zentiva shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Clopidogrel Zentiva?
English: What is Clopidogrel Zentiva?
Danish: Hvad er Clopidogrel Zentiva?
English: How is Clopidogrel Zentiva used?
Danish: Hvordan anvendes Clopidogrel Zentiva?
English: What is Clopidogrel Zentiva used for?
Danish: Hvad anvendes Clopidogrel Zentiva til?
English: If this happens, a more specific test can be performed.
Danish: Skulle dette ske, kan der foretages en mere specifik test.
English: {Name and Address} <{tel}> <{fax}> <{e-mail}>
Danish: {Navn og adresse} <{tlf.}> <{fax}> <{e-mail}>
English: This risk persists until significant remission occurs.
Danish: Risikoen varer ved, indtil der forekommer signifikant remission.
English: in elderly patients.
Danish: hos ældre patienter.
English: The mechanism for this increased risk is not known.
Danish: Mekanismen bag denne øgede risiko kendes ikke.
English: • Be careful how much alcohol you drink.
Danish: • Vær forsigtig med hvor meget alkohol du indtager.
English: These conditions can be caused by this type of medicine.
Danish: Disse tilstande kan skyldes denne type lægemidler.
English: You and your doctor should check your weight regularly.
Danish: Du og din læge bør regelmæssigt kontrollere din vægt.
English: Weight should be monitored regularly.
Danish: Vægten skal monitoreres regelmæssigt.
English: Individual dosage adjustments may be necessary.
Danish: Det kan være nødvendigt med individuelle dosisjusteringer.
English: The administration of activated charcoal should be considered.
Danish: Administration af aktivt kul bør overvejes.
English: About 45% of the patient population had an additional diagnosis of ADHD.
Danish: Ca. 45 % af patientpopulationen havde en yderligere diagnose af ADHD.
English: If you forget to take a dose, take it as soon as you remember.
Danish: Hvis du glemmer at tage en dosis, så tag den så snart du kommer i tanke om det.
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Danish: Produktinformationen kan efterfølgende opdateres efter behov af de relevante myndigheder i medlemsstaten i samarbejde med referencemedlemsstaten i henhold til de procedurer, der er fastsat i direktiv 2001/83/EF afsnit III kapitel 4.
English: However, some cases occurred in patients without pre-existing risk factors.
Danish: Nogle tilfælde forekom imidlertid hos patienter uden eksisterende risikofaktorer.
English: Contact your doctor or nearest hospital straight away.
Danish: Kontakt straks din læge eller nærmeste hospital.
English: • Swallow your tablets whole with a drink of water.
Danish: • Synk tabletterne hele med et glas vand.
English: Long-term implications for cognitive and behavioural development are not known.
Danish: Langsigtede konsekvenser for kognitiv og adfærdsmæssig udvikling kendes ikke.
English: The proportion of randomized patients over 75 years of age was 19%.
Danish: Andelen af randomiserede patienter over 75 år var 19 %.
English: CARTON AND LABEL FOR BOTTLE
Danish: KARTON OG ETIKET TIL FLASKE
English: The patients in these trials died from a variety of causes that were consistent with expectations for this population.
Danish: Patienterne i disse studier døde af en række forskellige årsager, som var i henhold til det forventede i denne population.
English: <[See Annex I - To be completed nationally]> [For referral procedures, as appropriate] This leaflet was last approved in {MM/YYYY}.
Danish: <[Se bilag I - Udfyldes nationalt]> [For referral procedures, as appropriate] Denne indlægsseddel blev senest revideret {MM/ÅÅÅÅ}.
English: Consequently, newborns should be monitored carefully.
Danish: Nyfødte bør som følge heraf overvåges nøje.
English: Some side effects are only seen when a blood test is taken.
Danish: Nogle bivirkninger kan kun ses, når der bliver taget en blodprøve.
English: During post-marketing experience, some cases were fatal.
Danish: Erfaringer opnået efter markedsføring viser, at nogle tilfælde var fatale.
English: • You know that you have had low levels of white blood cells in the past (which may or may not have been caused by other medicines).
Danish: • du ved, at du tidligere har haft et lavt antal hvide blodlegemer (som måske eller måske ikke har været forårsaget af andre lægemidler).
English: • Some medicines for HIV.
Danish: • Visse lægemidler mod hiv.
English: You might ask them to tell you if they think your depression is getting worse, or if they are worried about changes in your behaviour.
Danish: Du kan bede dem fortælle dig, hvis de mener, at din depression bliver værre, eller hvis de er bekymrede over en ændring i din opførsel.
English: You may be more likely to think like this if you are a young adult.
Danish: Det er sandsynligt, at du vil have lettere ved at få sådanne tanker, hvis du er en yngre voksen.
English: This belongs to a group of medicines called antipsychotics.
Danish: Dette tilhører gruppen af lægemidler, som kaldes antipsykotika.
English: Different dosing schedules exist for each indication.
Danish: Der er forskellig dosering for hver indikation.
English: Your doctor may suggest you reduce the dose gradually before stopping treatment.
Danish: Din læge kan derfor foreslå, at du mindsker dosis gradvist, før du stopper behandlingen.
English: • Inappropriate secretion of a hormone that controls urine volume.
Danish: • Uhensigtsmæssig sekretion af et hormon, der kontrollerer mængden af urin.
English: Additional information
Danish: Yderligere information
English: • You have had a stroke, especially if you are elderly.
Danish: • du har haft et slagtilfælde, specielt hvis du er ældre.
English: This Summary of Product Characteristics, labelling and package leaflet is the outcome of the referral procedure to which this Commission decision relates.
Danish: Dette produktresumé, denne etikettering og indlægsseddel er resultatet af referralproceduren, som denne afgørelse fra Kommissionen vedrører.
English: The relevance of this finding for humans is unknown.
Danish: Relevansen af disse fund for mennesker er ukendt.
English: Tardive Dyskinesia:
Danish: Tardiv dyskinesi
English: These may be increased when first starting treatment, since these medicines all take time to work, usually about two weeks but sometimes longer.
Danish: Disse tanker kan øges, når du starter med at tage din medicin, da denne type lægemidler alle tager lidt tid, før de virker, normalt omkring to uger, men nogle gange først efter lidt længere tid.
English: These thoughts may also be increased if you suddenly stop taking your medication.
Danish: Det kan også godt være, at du får flere af disse tanker, hvis du pludselig stopper med at tage din medicin.
English: • You will take your tablets once a day.
Danish: • Du skal tage tabletten én gang dagligt.
English: Your tablets may make you feel sleepy.
Danish: Dine tabletter kan gøre dig søvnig.
English: Physostigmine may be used if there are no ECG aberrations.
Danish: Physostigmin kan anvendes, hvis der ikke er nogen EKG afvigelser.
English: A second study did not demonstrate an additive effect at week 6.
Danish: Et andet studie viste ikke en additiv effekt ved uge 6.
English: Tell your doctor as soon as possible if you have:
Danish: Tal med din læge hurtigst muligt, hvis du har:
English: Close medical supervision and monitoring should be continued until the patient recovers.
Danish: Tæt medicinsk overvågning og monitorering bør fortsætte, indtil patienten kommer sig.
English: There was no apparent dose relationship.
Danish: Der var tilsyneladende ingen dosissammenhæng.
English: Constipation represents a risk factor for intestinal obstruction.
Danish: Forstoppelse udgør en risikofaktor for intestinal obstruktion.
English: This is not recommended as standard treatment, because of potential negative effect of physostigmine on cardiac conductance.
Danish: Dette anbefales ikke som standardbehandling på grund af en potentiel negativ virkning af physostigmin på hjertets ledningsevne.
English: • You have problems with your liver.
Danish: • du har problemer med leveren.
English: (16) May lead to falls.
Danish: (16) Kan medføre fald.
English: Do not drive or use any tools or machines until you know how the tablets affect you.
Danish: Du må ikke køre bil eller arbejde med maskiner, før du ved, hvordan tabletterne påvirker dig.
English: These elevations were usually reversible on continued quetiapine treatment.
Danish: Stigningerne var normalt reversible ved fortsat quetiapinbehandling.
English: (12) See text below
Danish: (12) Se tekst nedenfor.
English: • Walking, talking , eating or other activities while you are asleep.
Danish: • Går, taler, spiser eller udfører andre aktiviteter i søvne.
English: (8) Based on >7% increase in body weight from baseline.
Danish: (8) Baseret på >7 % øgning i kropsvægt fra baseline.
English: Two short-term (6 week) studies enrolled patients who had shown an inadequate response to at least one antidepressant.
Danish: To korttidsstudier (6 uger) indrullerede patienter, som havde vist utilstrækkeligt respons på mindst et antidepressivum.
English: There was no evidence of genotoxicity in a series of in vitro and in vivo genotoxicity studies.
Danish: Der sås ingen evidens for genotoksicitet i en serie af in vitro og in vivo genotoksicitetsstudier.
English: Changes in thyroid function tests have also been observed in children and adolescents.
Danish: Ændringer i thyroideafunktionstest er også blevet observeret hos børn og unge.
English: Not known (frequency cannot be estimated from the available data)
Danish: Ikke kendt (frekvens kan ikke bedømmes ud fra eksisterende data):
English: Your doctor may ask you to have blood tests from time to time.
Danish: Det kan være, at din læge tager blodprøver ind imellem.
English: In addition, these conditions may be co-morbid with major depressive episodes.
Danish: Derudover kan disse lidelser være komorbide ved depressive episoder.
English: This could increase the risk of accidental injury (fall)
Danish: Dette kan øge risikoen for ulykker (fald)
English: Doses greater than 300 mg should be initiated by physicians experienced in treating bipolar disorder.
Danish: Doser højere end 300 mg bør initieres af læger med erfaring i behandling af bipolar lidelse.
English: In some cases, a prior increase in body weight has been reported which may be a predisposing factor.
Danish: I nogle tilfælde blev der rapporteret om en forudgående øgning af legemsvægten, hvilket kan være en prædisponerende faktor.
English: • You or someone else in your family has a history of blood clots, as medicines like these have been associated with formation of blood clots.
Danish: • du eller nogen i din familie har haft blodpropper, da denne type medicin har været forbundet med dannelsen af blodpropper.
English: This pack contains:
Danish: Denne pakning indeholder:
English: Not all pack sizes may be available.
Danish: Det er ikke sikkert, at alle pakningsstørrelser er tilgængelige.
English: First trimester
Danish: Første trimester
English: Patients with intestinal obstruction/ileus should be managed with close monitoring and urgent care.
Danish: Patienter med intestinal obstruktion/ileus skal monitoreres tæt og have øjeblikkelig behandling.
English: An increased risk cannot be excluded for other antipsychotics or other patient populations.
Danish: Det kan ikke udelukkes, at der er en øget risiko for andre antipsykotika eller andre patientpopulationer.
English: Individual patients may benefit from a 600 mg dose.
Danish: Enkelte patienter kan have gavn af en dosis på 600 mg.
English: Combined pack
Danish: Kombineret pakning
English: Norquetiapine is primarily formed and eliminated via CYP3A4.
Danish: Norquetiapin er primært dannet og elimineret via CYP3A4.
English: Metabolic Risk
Danish: Metabolisk risiko
English: Formal interaction studies with commonly used cardiovascular medicinal products have not been performed.
Danish: Formelle interaktionsstudier med almindeligt anvendte kardiovaskulære lægemidler er ikke udført.
English: Approximately 73% of the radioactivity is excreted in the urine and 21% in the faeces.
Danish: Ca. 73 % af radioaktiviteten udskilles i urinen og 21 % i afføringen.
English: • Abnormal dreams and nightmares
Danish: • Abnorme drømme og mareridt.
English: You may find it helpful to tell a relative or close friend that you are depressed, and ask them to read this leaflet.
Danish: Det kan være en hjælp at fortælle en slægtning eller en god ven, at du er deprimeret, og bede dem læse denne information.
English: The safety and efficacy of doses greater than 800 mg/day have not been evaluated.
Danish: Sikkerhed og effekt af doser større end 800 mg/dag er ikke undersøgt.
English: The effects of quetiapine on human fertility have not been assessed.
Danish: Quetiapins virkninger på fertiliteten hos mennesker er ikke blevet vurderet.
English: Dyspnoea 23
Danish: Dyspnø 23
English: Note: The frequency is consistent to that observed in adults, but might be associated with different clinical implications in children and adolescents as compared to adults.
Danish: Bemærk: Hyppigheden svarer til den, der er set hos voksne, men kan være forbundet med andre kliniske konsekvenser hos børn og unge sammenlignet med voksne.
English: (25) Based upon the increased rate of vomiting in elderly patients (≥65 years of age).
Danish: (25) Baseret på en øget forekomst af opkastninger hos ældre patienter (≥65 år).
English: The following side effects have been seen more often in children and adolescents or have not been seen in adults:
Danish: Følgende bivirkninger er set oftere hos børn og unge eller er ikke set hos voksne:
English: 3-Day Starterpack (Combined pack)
Danish: 3-dages startpakke (kombineret pakke)
English: However, based on all available data, a definite conclusion cannot be drawn.
Danish: Der kan dog ikke drages nogen endelig konklusion på baggrund af de tilgængelige data.
English: It is general clinical experience that the risk of suicide may increase in the early stages of recovery.
Danish: Det er generel klinisk erfaring, at selvmordsrisikoen kan stige i restitutionens tidlige stadier.
English: Thoughts of suicide and worsening of your depression If you are depressed you may sometimes have thoughts of harming or killing yourself.
Danish: Selvmordstanker og forværring af din depression Hvis du er deprimeret, kan det være, at du ind imellem tænker på at skade dig selv eller begå selvmord.
English: Exacerbation of preexisting diabetes
Danish: Forværring af eksisterende diabetes
English: • Disturbance in speech and language.
Danish: • Tale- og sprogforstyrrelser.
English: • Menstrual disorder.
Danish: • Menstruationsforstyrrelse.
English: No data are available on maintenance of effect or recurrence prevention in this age group.
Danish: Der foreligger ingen data om vedligeholdelse af effekt eller forebyggelse af tilbagevendende sygdomsepisoder i denne aldersgruppe.
English: Hypersensitivity (including allergic skin reactions)
Danish: Overfølsomhe d (inklusive allergiske hudreaktioner)
English: • You will take your tablets once a day, at bedtime or twice a day, depending on your illness
Danish: • Du skal tage tabletten én gang dagligt ved sengetid eller to gange dagligt afhængig af din sygdom.
English: • Epilepsy medicines (like phenytoin or carbamazepine).
Danish: • Epilepsi-lægemidler (f.eks. phenytoin eller carbamazepin).
English: For these patients, the mean maximum decrease in hemoglobin at any time was -1.50 g/dL.
Danish: Hos disse patienter var den gennemsnitlige maksimale reduktion i hæmoglobin på et hvilket som helst tidspunkt -1,50 g/dl.
English: Both in mania and schizophrenia higher doses resulted in numerically lower response rates.
Danish: Både i mani og skizofreni resulterede højere doser i numerisk lavere responsrater.
English: These effects were apparent at maternal exposure levels similar or slightly above those in humans at the maximal therapeutic dose.
Danish: Disse påvirkninger var tydelige ved maternelle ekspositionsniveauer, der svarede til eller var lidt højere end niveauerne hos mennesker ved maksimal terapeutisk dosis.
English: Increases in the hormone prolactin could in rare cases lead to the following:
Danish: Stigninger i hormonet prolaktin kan i sjældne tilfælde medføre følgende:
English: In both studies, patients with known lack of response to Seroquel were excluded.
Danish: I begge studier blev patienter med kendt manglende respons på Seroquel ekskluderet.
English: The use of quetiapine has been associated with the development of akathisia, characterised by a subjectively unpleasant or distressing restlessness and need to move often accompanied by an inability to sit or stand still.
Danish: Anvendelse af quetiapin er blevet forbundet med udvikling af akatisi, som er karakteriseret ved subjektivt ubehagelig eller generende rastløshed med behov for at bevæge sig hyppigt, ledsaget af en manglende evne til at sidde eller stå stille.
English: Therefore, patients should be advised to exercise caution until they are familiar with the potential effects of the medication.
Danish: Derfor skal patienterne rådes til at udøve forsigtighed, indtil de kender medicinens potentielle virkning.
English: The data showed an additive effect at week 3.
Danish: Data viste en additiv effekt ved uge 3.
English: It must therefore be ensured that patients receive clear information on the appropriate dosage for their condition.
Danish: Det er derfor vigtigt, at patienterne får klare oplysninger om den korrekte dosis ved deres sygdom.
English: If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away.
Danish: Hvis du på noget tidspunkt tænker på at skade dig selv eller begå selvmord, skal du straks kontakte din læge eller tage på hospitalet.
English: • Worsening of pre-existing diabetes.
Danish: • Forværring af eksisterende diabetes.
English: It is important that the lowest effective dose is used for maintenance therapy.
Danish: Det er vigtigt, at der anvendes lavest effektive dosis til vedligeholdelsesbehandling.
English: In addition, for 25 mg tablets pack size of 6 tablets is registered.
Danish: Yderligere er der for 25 mg tabletterne registreret en pakningsstørrelse på 6 tabletter.
English: Do not take Seroquel :
Danish: Tag ikke Seroquel:
English: All prolonged-release tablets are capsule shaped and marked with XR and the strength.
Danish: Alle depottabletter er kapselformede og præget med XR og styrken.
English: • Schizophrenia: where you may hear or feel things that are not there, believe things that are not true or feel unusually suspicious, anxious, confused, guilty, tense or depressed.
Danish: • Skizofreni: Du kan høre eller fornemme ting, som ikke er der, tro på ting, der ikke er sande, eller føle dig usædvanligt mistroisk, nervøs, forvirret, have skyldfølelse, være anspændt eller deprimeret.
English: In patients who develop these symptoms, increasing the dose may be detrimental.
Danish: Hos patienter med disse symptomer kan en forøgelse af dosis have en ugunstig virkning.
English: Therefore, quetiapine should only be used during pregnancy if the benefits justify the potential risks.
Danish: Derfor må quetiapin kun bruges under graviditet, hvis fordelene opvejer de potentielle risici.
English: Irritability3
Danish: Irritabilitet3
English: Less than 1% of patients had an increase to a prolactin level >100 ug/L.
Danish: Mindre end 1% af patienter havde en stigning til et prolaktinniveau på >100 ug/l.
English: Do not use physostigmine in case of dysrhythmias, any degree of heart block or QRS-widening.
Danish: Brug ikke physostigmin i tilfælde af dysarytmier, alle former for hjerteblok eller QRS-udvidelser.
English: Patients (and caregivers of patients) should be alerted about the need to monitor for any clinical worsening, suicidal behaviour or thoughts and unusual changes in behaviour and to seek medical advice immediately if these symptoms present.
Danish: Patienter (eller patienternes plejere) skal underrettes om nødvendigheden af at monitorere en hvilken som helst forværring i patienternes kliniske tilstand, selvmordsadfærd eller -tanker og usædvanlige ændringer i adfærd og om straks at søge læge, hvis symptomerne optræder.
English: Occurs predominantly during the early weeks of treatment in adults.
Danish: Forekommer hovedsagelig i de første uger af behandlingen hos voksne.
English: As a consequence of this interaction, lower plasma concentrations can occur, which could affect the efficacy of quetiapine therapy.
Danish: Som en konsekvens af denne interaktion, kan lavere plasmakoncentrationer forekomme, hvilket kan påvirke effekten af quetiapin.
English: Close supervision of patients and in particular those at high risk should accompany drug therapy especially in early treatment and following dose changes.
Danish: Tæt supervision af patienterne, og især af patienter i højrisikogruppe, skal ledsage den medicinske behandling, specielt ved behandlingsstart og efter dosisjustering.
English: • Abnormal muscle movements.
Danish: • Unormale muskelbevægelser.
English: The same precautions observed when treating patients with major depressive episodes should therefore be observed when treating patients with other psychiatric disorders.
Danish: De samme forholdsregler, som der tages ved behandling af patienter med depressive episoder, bør derfor tages ved behandling af patienter med andre psykiske lidelser.
English: Other psychiatric conditions for which quetiapine is prescribed can also be associated with an increased risk of suicide related events.
Danish: Andre psykiske lidelser, for hvilke der ordineres quetiapin, er også forbundet med en øget risiko for selvmordsrelaterede hændelser.
English: The moderate amount of published data from exposed pregnancies (i.e. between 300-1000 pregnancy outcomes), including individual reports and some observational studies do not suggest an increased risk of malformations due to treatment.
Danish: De begrænsede offentliggjorte data fra anvendelse af quetiapin til gravide kvinder (mellem 300 og 1.000 graviditetsudfald), herunder individuelle rapporter og visse observationsstudier, antyder ingen øget risiko for misdannelser som følge af behandling.
English: There is an increased risk of adverse events at higher doses.
Danish: Der er øget risiko for bivirkninger ved højere doser.
English: Furthermore, the long-term safety implications of treatment with quetiapine on growth and maturation have not been studied beyond 26 weeks.
Danish: Endvidere er langsigtede sikkerhedskonsekvenser af behandlingen med quetiapin på vækst og modning ikke blevet undersøgt ud over 26 uger.
English: • Barbiturates (for difficulty sleeping).
Danish: • Barbiturater (mod søvnbesvær).
English: There was no difference in magnitude of effect between the patients who received 300 mg Seroquel IR and those who received 600 mg dose.
Danish: Der sås ingen forskel i effektens størrelse mellem de patienter, der fik Seroquel 300 mg og dem der fik 600 mg.
English: This is most likely to occur within the first few weeks of treatment.
Danish: Sandsynligheden for, at dette opstår, er størst inden for de første par uger af behandlingen.
English: Quetiapine is well absorbed following oral administration.
Danish: Quetiapin absorberes godt efter oral administration.
English: • Breakdown of muscle fibers and pain in muscles (rhabdomyolysis).
Danish: • Nedbrydning af muskelfibre og smerter i musklerne (rhabdomyolyse).