FrancophonIA/ELRC3.0 huggingface dataset:
English: How is Zirabev used?
Danish: Hvordan anvendes Zirabev?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Zirabev have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Zirabev.
English: For the full list of side effects with Zirabev, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Zirabev fremgår af indlægssedlen.
English: • cancer of the cervix (the neck of the womb) that has persisted or come back after treatment, or spread to other parts of the body.
Danish: • livmoderhalskræft, der har varet ved eller er vendt tilbage efter behandling, eller som har spredt sig til andre dele af kroppen.
English: What benefits of Zirabev have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Zirabev?
English: How does Zirabev work?
Danish: Hvordan virker Zirabev?
English: • cancer of the colon (large bowel) or the rectum (the last section of the bowel), when it has spread to other parts of the body;
Danish: • kræft i tyktarmen eller endetarmen, som har spredt sig til andre dele af kroppen
English: Strength
Danish: Administration
English: Invented name
Danish: Særnavn Navn Styrke
English: 4 ampoules
Danish: 4 ampuller
English: Ampoule (glass) 2 ml
Danish: Pedea 5 mg/ml Injektionsvæske, opløsning Intravenøs anvendelse Ampul (glas) 2 ml
English: Solution for injection Intravenous use
Danish: EU törzskönyvi szám Særnavn Styrke Lægemiddelform Indgivelsesvej
English: Invented name Strength Pharmaceutical form Route of administration Packaging Content (concentration) Package size EU/1/04/284/001 Pedea
Danish: Emballage Indhold (koncentration) Pakningsstørrelse
English: 5 mg/ml
Danish: EU/1/04/284/001
English: You may be more likely to think like this:
Danish: Du vil være mere tilbøjelig til at tænke sådan:
English: San Sebastian de los Reyes Spain
Danish: San Sebastian de los Reyes Spanien
English: • If you are a young adult.
Danish: • hvis du er et ungt menneske.
English: This risk persists until significant remission occurs.
Danish: Denne risiko varer ved, indtil der sker en signifikant remission.
English: 1150 Vienna
Danish: 1150 Wien
English: 08022 Barcelona Spain
Danish: 08022 Barcelona Spanien
English: Take Efexor at approximately the same time each day, in the morning and in the evening.
Danish: Tag Efexor på omtrent samme tidspunkt hver dag, om morgenen og om aftenen.
English: This is most likely to occur within the first few weeks of treatment.
Danish: Dette sker mest sandsynligt inden for de første uger af behandlingen.
English: Examples of these medicines include:
Danish: Eksempler på sådan medicin er bl.a.:
English: Absolute bioavailability is 40% to 45% due to presystemic metabolism.
Danish: Absolut biotilgængelighed er 40 % til 45 % på grund af præsystemisk metabolisme.
English: If you notice any signs of the following, you may need urgent medical attention:
Danish: Hvis du bemærker nogen af de følgende tegn, kan du have brug for omgående lægehjælp:
English: Cyprus, Denmark, Finland, Greece, Iceland, Ireland, Malta, Norway, United Kingdom
Danish: Cypern, Danmark, Finland, Grækenland, Irland, Island, Malta, Norge,
English: Therefore, it should be used with caution in these patients.
Danish: Det skal derfor anvendes med forsigtighed hos disse patienter.
English: Body as a Whole
Danish: Kroppen som helhed
English: The lowest effective dose should be maintained.
Danish: Den lavest effektive dosis bør anvendes.
English: 92931 Paris La Défense Cedex, France
Danish: 92931 Paris La Défense Cedex, Frankrig
English: There is a risk of an effect on the baby.
Danish: Der er en risiko for påvirkning af barnet.
English: The following Sections of the Product Information were addressed during this harmonisation procedure.
Danish: Følgende afsnit i produktresuméet er blevet behandlet under denne harmoniseringsprocedure.
English: Therefore, you should take special care in your dental hygiene.
Danish: Du skal derfor være specielt omhyggelig med din tandhygiejne.
English: This may increase the risk of caries.
Danish: Dette kan forøge risikoen for karies.
English: Administration of activated charcoal may also limit absorption of the active substance.
Danish: Administration af aktivt kul kan også begrænse absorptionen af det aktive indholdsstof.
English: You should tell your doctor if this happens to you.
Danish: Fortæl det til lægen, hvis det sker for dig.
English: Patients should be treated for a sufficient period of time, usually several months or longer.
Danish: Patienten skal behandles i en tilstrækkelig lang periode, normalt flere måneder eller længere.
English: Altered taste sensation, Tinnitus
Danish: Ændret smagsfornemmelse, tinnitus
English: Do not take more than the daily amount of Efexor that has been prescribed for you in one day.
Danish: Du må ikke tage mere end den daglige mængde Efexor, som du har fået ordineret, på én dag.
English: The cause of these deaths is unknown.
Danish: Årsagen til disse dødsfald er ikke kendt.
English: These symptoms usually begin during the first 24 hours after the baby is born.
Danish: Disse symptomer starter normalt i de første 24 timer, efter at barnet er født.
English: Despite this, your doctor may prescribe Efexor for patients under 18 because he/she decides that this is in their best interests.
Danish: Trods dette kan din læge vælge at ordinere Efexor til patienter under 18 år, fordi han/hun beslutter, at det er i deres interesse.
English: Individual dosage adjustments may be necessary.
Danish: Individuelle dosisjusteringer kan være nødvendige.
English: Therefore, your doctor may wish to do blood tests occasionally, particularly if you have been taking Efexor for a long time.
Danish: Det kan derfor ske, at din læge vil tage blodprøver fra tid til anden, især hvis du har taget Efexor i lang tid.
English: • This medicine has been prescribed for you.
Danish: • Lægen har ordineret denne medicin til dig personligt.
English: This medicinal product is authorised in the Member States of the EEA under the following names:
Danish: Dette lægemiddel er godkendt i EEA's medlemslande under følgende navne: Østrig
English: Body System Very Common
Danish: Organsystem Meget almindelig
English: • If you have previously had thoughts about killing yourself or harming yourself.
Danish: • hvis du tidligere har haft tanker om at slå dig selv ihjel eller gøre skade på dig selv
English: This has most frequently been reported in volume-depleted or dehydrated patients.
Danish: Dette er oftest forekommet hos volumendepleterede eller dehydrerede patienter.
English: Do not drive or use any tools or machines until you know how Efexor affects you.
Danish: Du må ikke køre bil eller arbejde med værktøj eller maskiner, før du ved, hvordan Efexor påvirker dig.
English: It is especially important to mention to your doctor or pharmacist if you are taking medicines containing:
Danish: Det er især vigtigt at nævne det over for din læge eller apoteket, hvis du tager medicin, der indeholder:
English: Do not use Efexor after the expiry date, which is stated on the packaging.
Danish: Brug ikke Efexor efter den udløbsdato, der står på pakningen.
English: The frequency (likelihood of occurring) of side effects is classified as follows:
Danish: Hyppigheden af bivirkningerne (sandsynligheden for at de opstår) inddeles som følger:
English: Efexor is a treatment for adults with depression.
Danish: Efexor er en behandling til voksne med depression.
English: Frequencies are defined as: 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), not known (cannot be estimated from the available data).
Danish: Frekvens defineres som: 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), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: CNS-active substances
Danish: CNS-aktive stoffer
English: If it is not treated, your condition may not go away and may become more serious and more difficult to treat.
Danish: Hvis lidelsen ikke behandles, kan det ske, at din lidelse ikke forsvinder, og at den bliver mere alvorlig og vanskeligere at behandle.
English: However, as with all CNS-active substances, patients should be advised to avoid alcohol consumption.
Danish: Som med alle CNS-aktive stoffer skal patienter dog tilrådes at undgå at indtage alkohol.
English: The no-effect dose for these findings was 1.3 times the human dose.
Danish: Dosis uden effekt i disse fund var 1,3 gange human dosis.
English: You should use Efexor only after discussing the potential benefits and the potential risks to your unborn child with your doctor.
Danish: Du må kun bruge Efexor efter at du har drøftet de mulige fordele og risici for dit ufødte barn med din læge.
English: In addition, long-term safety data in children and adolescents concerning growth, maturation and cognitive and behavioural development are lacking.
Danish: Derudover mangler der data om langtidssikkerheden hos børn og unge vedrørende vækst, modning samt kognitiv og adfærdsmæssig udvikling.
English: • If your cholesterol levels get higher.
Danish: • Hvis dit kolesteroltal stiger.
English: There were also increased reports of hostility and, especially in major depressive disorder, self-harm.
Danish: Der var også øgede indberetninger om fjendtlighed og, navnlig ved større depressiv lidelse, selvbeskadigelse.
English: Treating depression properly is important to help you get better.
Danish: Det er vigtigt at behandle depression, for at du kan få det bedre.
English: It was agreed that “No specific dose adjustments are considered necessary based on patient age alone”.
Danish: Der var enighed om: "Specifikke dosisjusteringer anses ikke for nødvendige på basis af patientens alder alene".
English: If your doctor thinks that you no longer need Efexor, he/she may ask you to reduce your dose slowly, before stopping treatment altogether.
Danish: Hvis din læge mener, at du ikke længere har brug for Efexor, kan han/hun bede dig reducere din dosis langsomt, før du helt holder op med behandlingen.
English: Venlafaxine must only be administered to pregnant women if the expected benefits outweigh any possible risk.
Danish: Venlafaxin må kun gives til gravide kvinder, hvis de forventede fordele opvejer en hvilken som helst mulig risiko.
English: They usually occur within the first few days of discontinuing treatment, but there have been very rare reports of such symptoms in patients who have inadvertently missed a dose.
Danish: De opstår normalt inden for de første få dage efter behandlingsophør, men der er i sjældne tilfælde rapporteret om sådanne symptomer hos patienter, som uforsætligt har glemt en dosis.
English: Treatment should be reassessed regularly on a case-by-case basis.
Danish: Behandlingen skal revurderes med regelmæssige intervaller, der fastsættes fra sag til sag.
English: - “prevention of recurrence of major depressive episodes”, which was adequately supported by the data provided.
Danish: - "Forebyggelse af svære depressive episoder", som støttedes fyldestgørende af de fremlagte data.
English: Measurement of serum cholesterol levels should be considered during long-term treatment.
Danish: Det skal overvejes at måle serumkolesterolniveauet under langvarig behandling.
English: In the majority of cases, these complications are observed immediately or within 24 hours after partus.
Danish: I de fleste af tilfældene blev disse komplikationer observeret umiddelbart eller inden for 24 efter fødslen.
English: Bruxism, Diarrhoea
Danish: Bruxismus, diarré
English: The following medicines may also interact with Efexor and should be used with caution.
Danish: Følgende medicin kan også indvirke på Efexor og skal bruges med forsigtighed.
English: Do not stop taking your treatment or reduce the dose without the advice of your doctor even if you feel better.
Danish: Du må ikke holde op med at tage din behandling eller reducere dosis uden lægens anvisning, heller ikke hvis du har det bedre.
English: (The “prevention of relapse of depression” indication was excluded since, based on current EU guidelines, the relapse indication is encompassed when approval for the indication of major depressive episodes is granted).
Danish: (Indikationen "forebyggelse af recidiv af depression" blev udelukket, da tilbagefaldsindikationen på basis af gældende EU-retningslinjer er omfattet, når indikationen svære depressive episoder godkendes).
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF EFEXOR AND ASSOCIATED NAMES (SEE ANNEX I)
Danish: SAMLET RESUMÉ AF DEN FAGLIGE VURDERING AF EFEXOR OG TILKNYTTEDE NAVNE (SE BILAG I)
English: You might ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behaviour.
Danish: Du kan eventuelt bede dem om at sige det til dig, hvis de synes, din depression eller angst bliver værre, eller hvis de er bekymrede over ændringer i din opførsel.
English: For prevention of recurrence of major depressive episodes.
Danish: Til forebyggelse af tilbagefald af større depressive episoder.
English: Recommended treatment
Danish: Anbefalet behandling
English: Subsequently, the physician may continue decreasing the dose, but at a more gradual rate.
Danish: Efterfølgende kan lægen fortsætte med at reducere dosis, men endnu mere gradvist.
English: Caution is advised, and a dose reduction by more than 50% should be considered.
Danish: Der bør udvises forsigtighed, og en dosisreduktion på mere end 50% bør overvejes.
English: Antidepressive medicinal products should continue for at least six months following remission.
Danish: Behandling med antidepressiv medicin fortsætte i mindst 6 måneder efter remission.
English: • Swelling of the face, throat, hands, or feet
Danish: • Hævelse af ansigt, hals, hænder eller fødder.
English: • Reproductive and sexual disorders
Danish: • Reproduktive og seksuelle forstyrrelser
English: It may harm them, even if their symptoms are the same than yours.
Danish: Det kan være skadeligt for andre, selvom de har de samme symptomer, som du har.
English: Adverse reactions are listed below by system organ class and frequency.
Danish: Bivirkningerne er anført nedenfor opdelt efter organklasse og frekvens.
English: It is general clinical experience that the risk of suicide may increase in the early stages of recovery.
Danish: De generelle kliniske erfaringer er, at risikoen for selvmord kan øges i de tidlige stadier af bedringen.
English: This may increase the risk of caries, and patients should be advised upon the importance of dental hygiene.
Danish: Dette kan forøge risikoen for karies, og patienterne skal informeres om vigtigheden af god tandhygiejne.
English: If clinically warranted due to symptom severity, dose increases can be made at more frequent intervals, but not less than 4 days.
Danish: Hvis det er klinisk berettiget på grund af symptomernes alvor, kan dosis øges med hyppigere intervaller, men ikke mindre end 4 dage.
English: A warning on the use of Efexor in the treatment of children and adolescents under the age of 18 years was also agreed upon and introduced in Section 4.4.
Danish: En advarsel om brugen af Efexor til behandling af børn og unge under 18 år blev også vedtaget og indført i afsnit 4.4.
English: All patients should be carefully screened for high blood pressure and preexisting hypertension should be controlled before initation of treatment.
Danish: Alle patienter bør omhyggeligt screenes for højt blodtryk, og eksisterende hypertension skal være kontrolleret, før behandlingen sættes i gang.
English: If your doctor has prescribed Efexor for a patient under 18, and you want to discuss this, please go back to your doctor.
Danish: Hvis din læge har ordineret Efexor til en patient under 18 år, og du gerne vil tale om dette, skal du henvende dig til din læge.
English: However, if it is time for your next dose, skip the missed dose and take only a single dose as usual.
Danish: Hvis det næsten er tid til næste dosis, skal du dog springe den glemte dosis over og kun tage en enkelt dosis som normalt.
English: • Heart problems, such as fast or irregular heart rate, increased blood pressure
Danish: • Hjerteproblemer, såsom hurtig eller uregelmæssig puls, forhøjet blodtryk.
English: Any psychoactive medicinal product may impair judgment, thinking, and motor skills.
Danish: Alle psykoaktive lægemidler kan nedsætte dømmekraften, tænkeevnen og de motoriske færdigheder.
English: These may be increased when you first start taking antidepressants, since these medicines all take time to work, usually about two weeks, but sometimes longer.
Danish: Disse tanker kan blive værre, når du begynder at tage antidepressiva, da det tager tid, før medicinen virker, sædvanligvis omkring 2 uger men nogle gange længere.
English: Side effects are known to occur when people stop using Efexor, especially when Efexor is stopped suddenly or the dose is reduced too quickly.
Danish: Det er kendt, at der er opstået bivirkninger, når personer er holdt op med at bruge Efexor, navnlig når de pludseligt er holdt op med Efexor, eller når dosis reduceres for hurtigt.
English: Like all medicines, Efexor can cause side effects, although not everybody gets them.
Danish: Efexor kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: Also, you should know that patients under 18 have an increased risk of side effects, such as suicide attempt, suicidal thoughts and hostility (predominantly aggression, oppositional behaviour and anger) when they take this class of medicines.
Danish: Du skal også vide, at patienter under 18 år har en øget risiko for at få bivirkninger, såsom selvmordsforsøg, selvmordstanker og fjendtlighed (fortrinsvis aggression, oppositionel adfærd og vrede), når de tager denne type lægemidler.
English: As improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored until such improvement occurs.
Danish: Da der muligvis ikke sker en bedring i de første uger af behandlingen, skal patienter overvåges nøje, indtil denne bedring indtræffer.
English: It is unknown whether a pharmacokinetic and/or pharmacodynamic interaction with other benzodiazepines exists.
Danish: Det er uvist, om der er en farmakokinetisk og/eller farmakodynamisk interaktion med andre benzodiazepiner.
English: Increases in heart rate can occur, particularly with higher doses.
Danish: Der kan forekomme stigninger i hjertefrekvensen, navnlig ved højere doser.
English: Dosage increases can be made at intervals of 2 weeks or more.
Danish: Dosis kan forøges med et interval på 2 uger eller mere.
English: A minority of CHMP members were of the opinion that this indication should be deleted from section 4.1, and a statement should be included in section 4.2, to indicate that longer-term treatment may also be appropriate for prevention of recurrence of major depressive episodes.
Danish: Et mindretal af CHMP-medlemmerne var af den opfattelse, at denne indikation burde slettes fra afsnit 4.1, og at der skulle medtages en erklæring i afsnit 4.2 med angivelse af, at længerevarende behandling også kan være hensigtsmæssig til forebyggelse af recidiv af svære depressive episoder.
English: • If you have a history of aggressive behaviour.
Danish: • Hvis du har eller har haft en aggressiv adfærd.
English: If, based on clinical need, a decision to treat is nevertheless taken, the patient should be carefully monitored for the appearance of suicidal symptoms.
Danish: Hvis der ikke desto mindre på grundlag af et klinisk behov træffes beslutning om behandling, skal patienten overvåges nøje for fremkomst af selvmordssymptomer.
English: Depression is associated with an increased risk of suicidal thoughts, self-harm and suicide (suiciderelated events).
Danish: Depression er forbundet med en forhøjet risiko for selvmordstanker, skade på sig selv og selvmord (selvmordsrelaterede hændelser).
English: Efexor should be taken with food.
Danish: Efexor skal tages sammen med mad.
English: With regards to cardiovascular safety, it was agreed that a contraindication was not warranted and that a revised wording for Section 4.4 was sufficient.
Danish: Med hensyn til kardiovaskulær sikkerhed var der enighed om, at en kontraindikation ikke var berettiget, og at en revideret tekst til afsnit 4.4 var tilstrækkelig.
English: Efexor may cause a sensation of restlessness or an inability to sit or stand still.
Danish: Efexor kan medføre en følelse af rastløshed eller manglende evne til at sidde eller stå stille.
English: Pharmacotherapeutic group: Other antidepressants - ATC code: NO6A X16.
Danish: Farmakoterapeutisk klassifikation: Andre antidepressiva - ATC-kode: NO6A X16
English: If you are depressed and/or have anxiety disorders, you can sometimes have thoughts of harming or killing yourself.
Danish: Hvis du har en depression og/eller lider af angst kan du nogle gange have tanker om at skade dig selv eller slå dig selv ihjel.
English: Pharmacological activity at these receptors may be related to various side effects seen with other antidepressant medicinal products, such as anticholinergic, sedative and cardiovascular side effects.
Danish: Farmakologisk aktivitet ved disse receptorer kan være relateret til forskellige bivirkninger set ved andre antidepressive lægemidler såsom antikolinerge, sedative og kardiovaskulære bivirkninger.
English: • If you are also taking or have taken any time within the last 14 days any medicines known as irreversible monoamine oxidase inhibitors (MAOIs), used to treat depression or Parkinson's disease.
Danish: • Hvis du også tager eller inden for de sidste 14 dage har taget nogen form for medicin, der kaldes irreversible monoaminoxidasehæmmere (MAO-hæmmere), som bruges til behandling af depression eller Parkinsons sygdom.
English: Medicinal products that inhibit serotonin uptake may lead to reduced platelet function.
Danish: Lægemidler, der hæmmer serotoninoptagelsen, kan føre til nedsat trombocytfunktion.
English: LIST OF EXCIPIENTS See the package leaflet for further information.
Danish: LISTE OVER HJÆLPESTOFFER Læs indlægssedlen for yderligere oplysninger.
English: They include not feeding properly and trouble with breathing.
Danish: De kan f.eks. være, at barnet ikke spiser rigtigt og har åndedrætsproblemer.
English: Other psychiatric conditions for which venlafaxine is prescribed can also be associated with an increased risk of suicide-related events.
Danish: Andre psykiatriske lidelser, som venlafaxin ordineres til, kan også være forbundet med en forhøjet risiko for selvmordsrelaterede hændelser.
English: There are no adequate data from the use of venlafaxine in pregnant women.
Danish: Graviditet Der foreligger ikke tilstrækkelige data om brugen af venlafaxin hos gravide kvinder.
English: - the Summaries of Products Characteristic, labelling, package leaflet proposed by the Marketing Authorisation Holders have been assessed based on the documentation submitted and the scientific discussion within the Committee,
Danish: - Forslaget til produktresumé, etikettering og indlægsseddel fra indehaveren af markedsføringstilladelsen blev vurderet på basis af den indsendte dokumentation og den faglige drøftelse i udvalget.
English: If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered.
Danish: Hvis der opstår uudholdelige symptomer efter en dosisreduktion eller efter ophør med behandling, kan det overvejes at genoptage den tidligere foreskrevne dosering.
English: Elderly patients, patients taking diuretics, and patients who are otherwise volume-depleted may be at greater risk for this event.
Danish: Ældre patienter, patienter som tager diuretika, og patienter, som på anden vis er volumendepleterede, kan have større risiko for sådanne tilfælde.
English: These symptoms may be due to either serotonergic effects or exposure symptoms.
Danish: Disse symptomer kan skyldes enten serotonerge virkninger eller kan være eksponeringssymptomer.