FrancophonIA/ELRC3.0 huggingface dataset:
English: Symptoms and Signs
Danish: Tegn og symptomer
English: Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100, <1/10), uncommon (≥ 1/1,000, <1/100), rare (≥ 1/10,000, <1/1,000), very rare (<1/10,000), including isolated reports.
Danish: Hyppigheden defineres som følger: meget almindelig (≥ 1/10), almindelig (≥ 1/100, <1/10), usædvanlig (≥ 1/1.000, <1/100), sjælden (≥ 1/10.000, <1/1.000), meget sjælden (<1/10.000), herunder isolerede rapporter.
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS PRESENTED BY THE EMEA
Danish: BILAG II FAGLIGE KONKLUSIONER OG BEGRUNDELSER FOR ÆNDRING AF PRODUKTRESUMEERNE FREMLAGT AF EMEA
English: Subsequently paroxetine has been approved for the treatment of various psychiatric disorders in all EU Member States.
Danish: Efterfølgende er paroxetin blevet godkendt til behandling af forskellige psykiatriske lidelser i alle EU-medlemsstaterne.
English: The elimination half-life is variable but is generally about 1 day.
Danish: Elimineringens halveringstid varierer, men er normalt ca. 1 dag.
English: The CHMP discussed in particular whether higher doses may be necessary for some patients and can be justified by the available data.
Danish: CHMP drøftede især, hvorvidt højere doser kan være nødvendige til nogle patienter, og hvorvidt de kan retfærdiggøres af de tilgængelige data.
English: Rare: bradycardia.
Danish: Sjælden: Bradycardi.
English: Children and Adolescents (7-17 years)
Danish: Børn og unge (7-17 år)
English: New data available after the CHMP Opinion of 22 April 2004: GPRD studies
Danish: Nye oplysninger tilgængelige efter CHMP's udtalelse af 22. april 2004: GPRD-undersøgelser
English: - The Committee concluded that there are concerns in relation to the safety of paroxetine containing medicinal products.
Danish: - Udvalget konkluderede, at der er bekymringer i forbindelse med sikkerheden af lægemidler, der indeholder paroxetin.
English: Conditions set out in Annex IV of the CHMP Opinion, including the submission of 6-monthly Periodic Safety Update Reports for the next two years.
Danish: Betingelserne, gengivet i bilag IV i CHMP's udtalelse, inklusive indsendelse af periodiske sikkerhedsindberetninger hver 6. måned i de første to år.
English: Dose response
Danish: Dosis respons
English: Most withdrawal symptoms were mild or moderate.
Danish: De fleste abstinenssymptomer var milde eller moderate.
English: There was no indication of a signal of dependence of paroxetine, but long-term data are not available.
Danish: Der var ingen indikation af afhængighed af paroxetin, men langtidsdata er ikke tilgængelige.
English: Very rare: priapism.
Danish: Meget sjælden: Priapisme.
English: Nevertheless, paroxetine should not be used during lactation unless the expected benefits to the mother justify the potential risks for the infant.
Danish: Paroxetin bør alligevel ikke anvendes under amning, medmindre de forventede fordele for moderen berettiger de potentielle risici for spædbarnet.
English: Women planning a pregnancy and those becoming pregnant during therapy should be asked to consult their physician.
Danish: Kvinder, der planlægger at blive gravide, og kvinder, der bliver gravide under behandling, skal have besked om at gå til egen læge.
English: Common: somnolence, insomnia.
Danish: Almindelig: Somnolens, insomnia.
English: Data on a limited number of exposed pregnancies provide no indication of an increased risk of congenital malformations in the newborn.
Danish: Data vedrørende et begrænset antal eksponerede graviditeter indicerer ikke øget risiko for medfødte misdannelser hos nyfødte.
English: Any subsequent dosage adjustment should be guided by clinical effect (tolerability and efficacy).
Danish: Eventuel efterfølgende dosisjustering skal følge den kliniske effekt (tolerabilitet og virkning).
English: Significant and relevant results were obtained in some of these studies.
Danish: I nogle af disse undersøgelser blev der opnået signifikante og relevante resultater.
English: There are insufficient data concerning the risk of suicide related behaviour in treatment naïve patients, but careful monitoring might be warranted.
Danish: Der er utilstrækkelig dokumentation for risikoen for selvmordsrelateret adfærd ved behandlingsnaive patienter, men nøje overvågning kan være berettiget.
English: During the decision-making process for the article 31 referral on paroxetine subsequent to the CHMP opinion of 22 April 2004, UK informed the European Commission that three new studies with direct relevance to this issue had become available.
Danish: I løbet af beslutningsprocessen vedrørende indbringelsen i henhold til artikel 31 af sagen om paroxetin efterfølgende CHMP's udtalelse af 22. april 2004 meddelte Det Forenede Kongerige EuropaKommissionen, at tre nye undersøgelser med direkte relevans for dette spørgsmål var til tilgængelige.
English: Morning dosing with paroxetine does not have any detrimental effect on either the quality or duration of sleep.
Danish: Morgendosering med paroxetin har ingen skadelig virkning på søvnens kvalitet eller varighed.
English: Summary of Product Characteristics set out in Annex III of the CHMP Opinion with emphasis to the following:
Danish: Produktresumeet, gengivet i bilag III i CHMP's udtalelse med vægt på følgende:
English: Thus paroxetine is eliminated almost entirely by metabolism.
Danish: Paroxetin elimineres således næsten udelukkende via metabolisme.
English: No signs of drug effects were observed in these infants.
Danish: Der blev ikke observeret lægemiddelvirkninger hos disse spædbørn.
English: In addition, these conditions may be co-morbid with major depressive disorder.
Danish: Yderligere kan disse tilstande være co-morbide med svær depression.
English: These new data reviewed by CHMP included three studies (one published and two unpublished) based on the UK General Practice Research Database (GPRD).
Danish: De nye data, som CHMP gennemgik, omfattede tre undersøgelser (en offentliggjort og to ikkeoffentliggjorte), baseret på GPRD-data (General Practice Research Database).
English: The recommended daily dose of paroxetine is 40mg/day for OCD and panic disorder and 20mg/day for the other indications.
Danish: Den anbefalede daglige dosis af paroxetin er 40 mg/dag for OCD og panikangst og 20 mg/dag for de andre indikationer.
English: These studies did not show a statistical significant elevation of suicide related events and self harm in young adults.
Danish: Disse undersøgelser viste ikke nogen statistisk betydelig stigning af selvmordsrelaterede hændelser og selvskadende adfærd hos yngre voksne.
English: In general these events are mild to moderate, occur within the first week of cessation of treatment and resolve within two weeks.
Danish: Generelt er disse hændelser milde til moderate og opstår inden for den første uge efter ophør med behandlingen og forsvinder inden for to uger.
English: ANNEX 1 LIST OF THE INVENTED NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Danish: BILAG 1 LISTE OVER LÆGEMIDLERNES SÆRNAVNE, LÆGEMIDDELFORMER, STYRKER, INDGIVELSESVEJ OG INDEHAVERE AF MARKEDSFØRINGSTILLADELSE I MEDLEMSSTATERNE
English: It is general clinical experience with all antidepressant therapies that the risk of suicide may increase in the early stages of recovery.
Danish: Generel klinisk erfaring fra alle behandlinger med antidepressiva viser, at selvmordsrisikoen kan stige i de tidlige helbredelsesstadier.
English: Concomitant administration does not seem to show any effect on pharmacokinetic/dynamic profile in epileptic patients.
Danish: Samtidig indgift lader ikke til at have nogen virkning på den farmakokinetiske/-dynamiske profil hos epilepsipatienter.
English: The CHMP, having considered the additional data that became available after the opinion of 22 April 2004, concluded that such data do not change its previous conclusions and recommendations.
Danish: Efter at have behandlet de supplerende data, der blev tilgængelige efter udtalelsen af 22. april 2004, har CHMP konkluderet, at disse data ikke ændrer de tidligere konklusioner og henstillinger.
English: In published studies, serum concentrations in breast-fed infants were undetectable (<2 ng/ml) or very low (<4 ng/ml).
Danish: I publicerede undersøgelser kunne der ikke påvises serumkoncentrationer hos ammede spædbørn (<2 ng/ml), eller de var meget lave (<4 ng/ml).
English: Long-term efficacy
Danish: Langtidsvirkning
English: A low initial starting dose is recommended to minimise the potential worsening of panic symptomatology, which is generally recognised to occur early in the treatment of this disorder.
Danish: Lav initial dosis anbefales for at minimere risikoen for forværring af paniksymptomerne, hvilket er generelt anerkendt at forekomme tidligt i behandlingen af denne tilstand.
English: This is most likely to occur within the first few weeks of treatment.
Danish: Denne tilstand indtræffer med størst sandsynlighed inden for de første par ugers behandling.
English: The issue of suicidal behaviour among patients treated with paroxetine has been addressed in the past in literature and at national level in some Member States.
Danish: Spørgsmålet vedrørende selvmordsadfærd blandt patienter behandlet med paroxetin er tidligere blevet behandlet i litteraturen og på nationalt niveau i nogle medlemsstater.
English: Uncommon: transient increases or decreases in blood pressure.
Danish: Usædvanlig: Forbigående stigning eller fald i blodtryk.
English: The main safety issues discussed were the risk of suicide and the risk of withdrawal reactions.
Danish: De vigtigste emner vedrørende sikkerhed, der blev drøftet, var risikoen for selvmord samt risikoen for abstinensreaktioner.
English: Furthermore in one of the studies the relation between suicidality risk in relation to the indication was investigated.
Danish: En af undersøgelserne undersøgte desuden forholdet mellem selvmordsrisiko og indikation.
English: Transfer to human breast milk, and to the foetuses of laboratory animals, occurs in small amounts.
Danish: Overførsel til modermælk og til forsøgsdyrs fostre sker i små mængder.
English: There is also some evidence that paroxetine may be of therapeutic value in patients who have failed to respond to standard therapy.
Danish: Der er også visse tegn på, at paroxetin kan være af terapeutisk værdi for patienter, som ikke reagerer på standardbehandling.
English: Steady state systemic levels are attained by 7 to 14 days after starting treatment with immediate or controlled release formulations and pharmacokinetics do not appear to change during long-term therapy.
Danish: Steady state indtræder 7-14 dage efter behandlingens start med standard eller controlled release formuleringer, og de farmakokinetiske egenskaber lader ikke til at ændre sig under langtidsbehandling.
English: This period may be several months or even longer (see section 5.1 Pharmacodynamic Properties)
Danish: Denne periode kan vare flere måneder eller endnu længere (se 5.1 Farmakodynamiske egenskaber).
English: Significant and relevant results were obtained in some of the short-term studies.
Danish: Der blev opnået signifikante og relevante resultater i nogle af de kortvarige undersøgelser.
English: Uncommon: confusion, hallucinations.
Danish: Usædvanlig: Konfusion, hallucinationer.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION <Each <tablet><coated tablet><film-coated tablet> contains <10 mg><20 mg><30 mg><40 mg> paroxetine <Each ml of <oral solution><oral suspension> contains <2 mg> paroxetine [To be completed nationally]
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING <En <tablet><overtrukken tablet><filmovertrukken tablet> indeholder <10 mg><20 mg> <30 mg><40 mg> paroxetin <En ml <oral opløsning><oral suspension> indeholder <2 mg> paroxetin [Udfyldes nationalt]
English: Denmark 1A Farma A/S Herstedøstervej 27-29
Danish: Danmark 1A Farma A/S Herstedøstervej 27-29
English: The use of paroxetine has not been studied in children less than 7 years.
Danish: Brugen af paroxetin er ikke undersøgt hos børn under 7 år.
English: The CHMP also considered the available data supporting the recommended posology for each of the above indications.
Danish: CHMP vurderede ligeledes de tilgængelige data, der støttede den anbefalede dosering for hver af de ovenfor nævnte indikationer.
English: Currently paroxetine is not authorised for use in children and adolescents in any EU Member State.
Danish: På nuværende tidspunkt er paroxetin ikke godkendt til brug hos børn og unge i nogen EU-medlemsstat.
English: PHARMACEUTICAL FORM <Tablet> <Coated tablet> <Film-coated tablet> <Oral solution> <Oral suspension>
Danish: LÆGEMIDDELFORM <Tablet><Overtrukken tablet><Filmovertrukken tablet> <Oral opløsning><Oral suspension>
English: Review of the wording with regards to the possibility of increasing the recommended dose if after some weeks of treatment on the recommended dose insufficient response is seen.
Danish: Gennemgang af teksten med hensyn til muligheden for at øge den anbefalede dosis, hvis der efter nogle ugers behandling ved den anbefalede dosis opnås utilstrækkelig respons.
English: As with all antidepressant medicinal products, dosage should be reviewed and adjusted if necessary within 3 to 4 weeks of initiation of therapy and thereafter as judged clinically appropriate.
Danish: Som med al antidepressiv medicin bør dosis checkes og om nødvendigt justeres efter 3-4 ugers behandling og derefter når det er klinisk relevant.
English: It is not recommended to use paroxetine in combination with metoprolol when given in cardiac insufficiency, because of the narrow therapeutic index of metoprolol in this indication.
Danish: Det anbefales ikke at bruge paroxetin i kombination med metoprolol, når dette gives i forbindelse med hjerteinsufficiens på grund af dets snævre terapeutiske indeks i denne indikation.
English: However, in a significant proportion of individuals they may be severe in intensity and of prolonged duration (2-3 months or more).
Danish: Hos et betydeligt antal af patienterne kan de dog være kraftige i intensitet og vare længe (2-3 måneder eller mere).
English: Although the majority of the symptoms reported in the clinical trials were not serious and not described as severe, subsequently there was evidence from spontaneous reports that some patients experienced serious and severe symptoms on stopping paroxetine.
Danish: Selv om størstedelen af de symptomer, der blev rapporteret i de kliniske forsøg, ikke var alvorlige og ikke blev beskrevet som svære, har det efterfølgende vist sig fra spontane rapporter, at nogle patienter oplevede alvorlige og svære symptomer ved ophør af behandlingen med paroxetin.
English: Caution should be advised and a closer clinical monitoring is required when these drugs are combined with paroxetine.
Danish: Der bør udvises forsigtighed og tættere klinisk monitorering bør foretages når disse lægemidler kombineres med paroxetin.
English: Immune system disorders Very rare: allergic reactions (including urticaria and angioedema).
Danish: Immunsystemforstyrrelser Meget sjælden: Allergiske reaktioner (herunder urticaria og angioødem).
English: Depression is associated with an increased risk of suicidal thoughts, self harm and suicide.
Danish: Depression er forbundet med en øget risiko for selvmordstanker, selvdestruktive handlinger og selvmord.
English: Merck, Proizvodnja in prodaja farmacevtskih in kemijskih proizvodov, d.o.o., Dunajska 156, Ljubljana
Danish: Slovenien Merck, Proizvodnja in prodaja farmacevtskih in kemijskih proizvodov, d.o.o., Dunajska 156, Ljubljana
English: <The tablet should be swallowed rather than chewed.> <Shake bottle before use.>
Danish: <Tabletten bør ikke tygges, men synkes hel> <Flasken omrystes inden brug>
English: Where appropriate, the stomach should be emptied either by the induction of emesis, lavage or both.
Danish: Hvor det er hensigtsmæssigt, skal ventriklen tømmes enten ved induktion af emesis eller ved udskylning, evt. begge dele.
English: The CHMP noted that long-term safety data in children and adolescents concerning growth, maturation and cognitive and behavioural development are lacking.
Danish: CHMP bemærkede, at der mangler langtidssikkerhedsdata for børn og unge vedrørende vækst, udvikling samt kognitiv og adfærdsmæssig udvikling.
English: Phospholipidosis was not observed in primate studies of up to one-year duration at doses that were 6 times higher than the recommended range of clinical doses.
Danish: Phospholipidose er ikke observeret i primatundersøgelser af op til 1 års varighed ved doser på 6 gange det anbefalede niveau for kliniske doser.
English: - Increased suicidal related behaviours in children and adolescents was already seen in the clinical trials and post-marketing data and therefore the CHMP did not consider that the new data added new evidence on this regard.
Danish: - En stigning i selvmordsrelateret adfærd hos børn og unge var allerede set i de kliniske prøver og i data fra overvågningen efter markedsføringen, og derfor mente CHMP ikke, at de nye data tilførte ny dokumentation i denne forbindelse.
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 indtræder normalt inden for de første dage efter seponering af behandlingen, men symptomerne er i meget sjældne tilfælde rapporteret hos patienter, der uforvarende har sprunget en dosis over.
English: Genotoxicity: Genotoxicity was not observed in a battery of in vitro and in vivo tests.
Danish: Genotoksicitet: Der er ikke observeret genotoksicitet ved en række in vitro og in vivo test.
English: Patients have generally recovered without serious sequelae even when doses of up to 2000 mg have been taken alone.
Danish: Patienterne restitueredes generelt uden alvorlige følgetilstande, også i tilfælde hvor doser på op til 2000 mg er blevet taget på en gang.
English: Various analyses suggested that the risk of these outcomes was between 1.5 and 3.2 times greater with paroxetine compared to placebo.
Danish: Forskellige analyser antydede, at risikoen for disse følgevirkninger var mellem 1,5 og 3,2 gange større for paroxetin end for placebo.
English: Reproduction toxicity studies in rats have shown that paroxetine affects male and female fertility.
Danish: Reproduktionstoksicitetsundersøgelser af rotter har vist, at paroxetin påvirker den mandlige og kvindelige fertilitet.
English: Paroxetine should only be used during pregnancy when strictly indicated.
Danish: Paroxetin bør kun anvendes under graviditet på tvingende indikation.
English: Paroxetine is a phenylpiperidine derivative and is a potent and selective inhibitor of the presynaptic 5hydroxytryptamine (5-HT) reuptake.
Danish: Paroxetin er et phenylpiperidin-derivat og er en potent og selektiv inhibitor af den præsynaptiske 5hydroxytryptamin (5-HT) reabsorption.
English: 4.4 Special Warnings and Special Precautions for use
Danish: 4.4 Særlige advarsler og forholdsregler vedrørende brugen
English: Special Patient Populations
Danish: Særlige patientgrupper
English: If anti-cholinergic effects are seen, the dose of procyclidine should be reduced.
Danish: Hvis der ses antikolinerge virkninger, skal procyclidindosis nedsættes.
English: This lack of interaction with post-synaptic receptors in vitro is substantiated by in vivo studies which demonstrate lack of CNS depressant and hypotensive properties.
Danish: Denne mangel på interaktion med postsynaptiske receptorer in vitro underbygges af in vivo undersøgelser, som har vist mangel på CNS-nedsættende og hypotensive egenskaber.
English: However, the non-linearity is generally small and is confined to those subjects who achieve low plasma levels at low doses.
Danish: Afvigelse fra linearitet er dog generelt lille og begrænset til de personer, som opnår lave plasmaniveauer ved lave doser.
English: This results in disproportionate increases in plasma concentrations of paroxetine and hence pharmacokinetic parameters are not constant, resulting in non-linear kinetics.
Danish: Dette giver uforholdsmæssige stigninger i plasmakoncentrationerne af paroxetin, og de farmakokinetiske parametre er således ikke konstante, hvilket giver ikke-lineær kinetik.
English: Other psychiatric conditions for which paroxetine is prescribed can also be associated with an increased risk of suicidal behaviour.
Danish: Andre psykiatriske lidelser, for hvilke der ordineres paroxetin, kan også være forbundne med en øget risiko for selvmordsadfærd.
English: Apotex Europe Limited; Rowan House;
Danish: Storbritannien Apotex Europe Limited; Rowan House;
English: Dosing should commence at the adult starting dose.
Danish: Dosis bør begynde ved startdosis for voksne.
English: In view of the above the CHMP confirmed its previous conclusions in relation to the risk of suicidal behaviour in patients using paroxetine.
Danish: Set i lyset af ovenstående bekræftede CHMP sine tidligere konklusioner vedrørende risiko for selvmordstruende adfærd blandt patienter, der anvender paroxetin.
English: Paroxetine should not be used in the treatment of children and adolescents under the age of 18 years.
Danish: Paroxetin bør ikke bruges til behandling af børn og unge under 18 år.
English: Procyclidine: Daily administration of paroxetine increases significantly the plasma levels of procyclidine.
Danish: Procyclidin: Daglig indgift af paroxetin øger procyclidins plasmaniveau væsentligt.
English: Urinary excretion of unchanged paroxetine is generally less than 2% of dose whilst that of metabolites is about 64% of dose.
Danish: Udskillelsen af uændret paroxetin i urin er normalt under 2% af dosis, mens den for metabolitter er ca. 64% af dosis.
English: In accordance to the results, the association between suicidality risk and paroxetine appears significant only among patients with previous depression but not among patients with previous depression and anxiety or anxiety alone.
Danish: Ifølge resultaterne er sammenhængen mellem selvmordsrisiko og paroxetin kun betydelig blandt patienter med tidligere depressioner, men ikke blandt patienter med tidligere depressioner og angst eller angst alene.
English: Small amounts of paroxetine are excreted into breast milk.
Danish: Små mængder paroxetin udskilles i modermælk.
English: Very rare: gastrointestinal bleeding.
Danish: Meget sjælden: Gastrointestinal blødning.
English: From the assessed data there was no indication of a signal of dependence with paroxetine.
Danish: Ud fra de vurderede data var der ingen tegn på afhængighed af paroxetin.
English: As expected with lipophilic amines, including tricyclic antidepressants, phospholipidosis was detected in rats.
Danish: Som forventet i forbindelse med lipofile aminer, herunder tricykliske antidepressiva, er phospholipidose set hos rotter.
English: About 36% of the dose is excreted in faeces, probably via the bile, of which unchanged paroxetine represents less than 1% of the dose.
Danish: Omkring 36% af dosis udskilles i fæces, sandsynligvis via galden, hvoraf uændret paroxetin udgør under 1% af dosis.
English: Denmark Pharmascope Ltd. Unit 107
Danish: Danmark Pharmascope Ltd. Unit 107
English: • Children aged below 7 years
Danish: - Børn under 7 år
English: The overall safety profile of paroxetine containing medicinal products was reviewed by the CHMP.
Danish: Den samlede sikkerhedsprofil for lægemidler, der indeholder paroxetin, blev gennemgået af CHMP.
English: Events such as coma or ECG changes have occasionally been reported and, very rarely with a fatal outcome, but generally when paroxetine was taken in conjunction with other psychotropic drugs, with or without alcohol.
Danish: Hændelser såsom koma eller ECG-ændringer er i enkelte tilfælde blevet rapporteret og i meget sjældne tilfælde med dødelig udgang, men generelt ved indtagelse af paroxetin i forbindelse med andre psykotrope lægemidler med eller uden indtagelse af alkohol.
English: Moreover, patients are likely to experience improved sleep as they respond to paroxetine therapy.
Danish: Patienterne vil desuden sandsynligvis opleve, at de sover bedre, når de begynder at reagere på paroxetinbehandlingen.