FrancophonIA/ELRC3.0 huggingface dataset:
English: In view of their relative lack of pharmacological activity, it is most unlikely that they contribute to paroxetine's therapeutic effects.
Danish: På baggrund af den relative mangel på farmakologisk aktivitet er det højst usandsynligt, at metabolitterne bidrager til paroxetins terapeutiske virkning.
English: These symptoms could be due to either serotonergic effects or withdrawal symptoms.
Danish: Disse symptomer kan være forårsaget af enten serotonerge effekter eller seponeringssymptomer.
English: Rates in patients with other disorders for which paroxetine is indicated are similarly low.
Danish: Hyppigheder hos patienter med andre lidelser, til hvilke paroxetin er indiceret, er tilsvarende lave.
English: Paroxetine is extensively distributed into tissues and pharmacokinetic calculations indicate that only 1% of the paroxetine in the body resides in the plasma.
Danish: Vævsfordelingen af paroxetin er vidtgående, og farmakokinetiske beregninger viser, at kun 1% af paroxetin i kroppen findes i plasmaet.
English: Suicide/suicidal ideation
Danish: Selvmord/selvmordstanker
English: Animal studies showed reproductive toxicity, but did not indicate direct harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see Section 5.3 Preclinical Safety Data).
Danish: Dyreforsøg har vist reproduktiv toksicitet, men tyder ikke på direkte skadelige virkninger med hensyn til graviditet, fosterudvikling, fødsel eller postnatal udvikling (se 5.3 Prækliniske sikkerhedsdata).
English: Paroxetine is chemically unrelated to the tricyclic, tetracyclic and other available antidepressants.
Danish: Paroxetin er kemisk ikke relateret til tricykliske, tetracykliske og andre tilgængelige antidepressiva.
English: IIP-Institut für industrielle Pharmazie Forschungs-und Entwicklungsgesellschaft GmbH Benzstr.
Danish: Tyskland IIP-Institut für industrielle Pharmazie Forschungs-und Entwicklungsgesellschaft GmbH Benzstr.
English: Km 19 - Poligono Merck 08100 Mollet del Valles, Barcelona Spain
Danish: Km 19 - Poligono Merck 08100 Mollet del Valles, Barcelona
English: • Member States should ensure that appropriate pharmaceutical forms / strengths can be made available in order to facilitate up and down titration in accordance to the posology recommendations stated in the SPC attached to Annex III of this Opinion.
Danish: • Medlemsstaterne bør sikre, at relevante lægemiddelformer/styrker kan blive gjort tilgængelige med henblik på at muliggøre op- og nedtitrering i overensstemmelse med de anbefalinger vedrørende dosering, der angives i produktresumeet, som er vedlagt bilag III til denne udtalelse.
English: <Parabens> <Paroxetine oral suspension contains methyl and propyl hydroxybenzoate (parabens), which are known to cause urticaria; generally delayed type reactions, such as contact dermatitis, but rarely immediate reaction with bronchospasm.> [To be completed nationally].
Danish: <Parabener> <Paroxetin oral suspension indeholder methyl- og propylhydroxybenzoate (parabener), som vides at forårsage nældefeber; generelt forsinkede reaktioner, såsom kontaktdermatitis, men sjældent umiddelbar reaktion med bronkospasme.> [Udfyldes nationalt]
English: For adults, all three studies showed no significant difference in risk for suicidal behaviours among patients receiving different antidepressants or antidepressants of different classes (i.e. Tricyclic antidepressants - TCA - vs. SSRI vs. other antidepressants).
Danish: Med hensyn til voksne viste ingen af de tre undersøgelser nogen betydelig forskel med hensyn til risiko for selvmordstruende adfærd blandt patienter, der modtog forskellige antidepressiva eller antidepressiva af forskellige klasser (dvs. tricycliske antidepressiva - TCA - vs. SSRI - vs. andre antidepressiva).
English: The risk of withdrawal symptoms may be dependent on several factors including the duration and dose of therapy and the rate of dose reduction.
Danish: Risikoen for seponeringssymptomer kan afhænge af flere faktorer, f. eks. varigheden og behandlingsdosis samt hvordan dosis er blevet reduceret.
English: Animal studies indicate that paroxetine is well tolerated by the cardiovascular system.
Danish: Dyreforsøg viser, at paroxetin tolereres godt af hele hjerte-kar-systemet.
English: Hostility events were more clearly seen in the OCD studies than in the depression studies.
Danish: Hændelser med fjendtlig adfærd blev observeret tydeligere i OCD-undersøgelserne end i depressionsundersøgelserne.
English: Behavioural and EEG studies indicate that paroxetine is weakly activating at doses generally above those required to inhibit 5-HT uptake.
Danish: Adfærds- og EEG-undersøgelser viser, at paroxetin virker svagt aktiverende ved doser, der generelt ligger over det, der kræves for at hæmme 5-HT-optagelsen.
English: The activating properties are not "amphetamine-like" in nature.
Danish: Aktiveringsegenskaberne er ikke af "amfetaminlignende" art.
English: Patients, (and caregivers of patients) should be alerted about the need to monitor for the emergence of suicidal ideation/behaviour or thoughts of harming themselves and to seek medical advice immediately if these symptoms present.
Danish: Patienter (og plejepersonale) bør gøres opmærksom på behovet for overvågning med henblik på forekomst af selvmordstanker og selvmordsadfærd samt tanker om selvdestruktive handlinger og på, at de straks skal søge læge, hvis disse symptomer opstår.
English: Oral anticoagulants
Danish: Orale antikoagulanter
English: As a consequence, the CHMP has recommended the maintenance of the Marketing Authorisations for paroxetine containing medicinal products referred in Annex I as amended in accordance with the SPC set out in Annex III and under the conditions set out in Annex IV.
Danish: CHMP anbefalede derfor opretholdelse af markedsføringstilladelserne for de i bilag I nævnte lægemidler indeholdende paroxetin, som ændret i overensstemmelse med produktresumeet, der fremgår af bilag III, samt under betingelserne nævnt i bilag IV.
English: Paroxetine is associated with withdrawal reactions which can be severe in intensity and prolonged in duration.
Danish: Paroxetin associeret med abstinensreaktioner, som kan være kraftige i intensitet og være længevarende.
English: Carcinogenesis: In two-year studies conducted in mice and rats, paroxetine had no tumorigenic effect.
Danish: Carcinogenese: Undersøgelser af to års varighed på mus og rotter har ikke vist tumorigen virkning af paroxetin.
English: Suicidal behaviour, self-harm and hostility
Danish: Selvmordsadfærd, selvdestruktiv adfærd og fjendtlig adfærd Voksne
English: Significant and relevant results were obtained in the short-term studies but not in the long-term studies and therefore the CHMP concluded that the long-term efficacy has not been sufficiently demonstrated.
Danish: Der blev opnået signifikante og relevante resultater i de kortvarige undersøgelser, men ikke i de langvarige undersøgelser, og CHMP konkluderede derfor, at langtidseffekten ikke var blevet tilstrækkeligt påvist.
English: Transient increases or decreases of blood pressure have been reported following treatment with paroxetine, usually in patients with pre-existing hypertension or anxiety.
Danish: Forbigående stigning eller fald i blodtryk er rapporteret efter behandling med paroxetin, oftest hos patienter med forudgående hypertension eller angst.
English: However, as with all psychoactive drugs, patients should be cautioned about their ability to drive a car and operate machinery.
Danish: Som med alle psykoaktive lægemidler bør patienterne alligevel advares om, at deres evne til at føre motorkøretøj eller betjene maskiner kan blive forringet.
English: Pharmacotherapeutic group: Antidepressants - selective serotonin reuptake inhibitors, ATC code: N06A B05
Danish: Farmakoterapeutisk klassifikation: Antidepressiva - selektive serotonin-genoptagelseshæmmere (SSRI), ATC-kode: N06A B05.
English: MAJOR DEPRESSIVE EPISODE
Danish: Major depression
English: Following evacuation, 20 to 30 g of activated charcoal may be administered every 4 to 6 h during the first 24 h after ingestion.
Danish: Efter udtømning kan 20-30 g medicinsk kul indgives hver 4.-6. time i de første 24 timer efter indtagelse af overdosis.
English: Paroxetine use has been associated with the development of akathisia.
Danish: Brugen af paroxetin er blevet associeret med udvikling af akatisi.
English: After the Commission Decision, the Member State competent authorities will update the product information as required.
Danish: Efter Europa-Kommissionens beslutning vil denne tekst, om nødvendigt , blive opdateret af myndighederne i medlemsstaterne.
English: On 13 June 2003, UK triggered a referral to the EMEA under Article 31 of Directive 2001/83/EC, as amended, to medicinal products containing paroxetine.
Danish: Den 13. juni 2003 indbragte Det Forenede Kongerige en sag for til EMEA i henhold til artikel 31 i direktiv 2001/83/EF, med senere ændringer, vedrørende lægemidler indeholdende stoffet paroxetin.
English: Adverse drug reactions are listed below by system organ class and frequency.
Danish: Bivirkningerne er inddelt efter systemorganklasse og hyppighed.
English: Paroxetine has low affinity for muscarinic cholinergic receptors and animal studies have indicated only weak anticholinergic properties.
Danish: Paroxetin har lav affinitet til muskarine kolinerge receptorer, og dyreforsøg har kun indiceret svage antikolinerge egenskaber.
English: Denmark PharmaCoDane Aps Marielundvej 46 A
Danish: Danmark PharmaCoDane Aps Marielundvej 46 A
English: Partial saturation of the first-pass effect and reduced plasma clearance occur as the body burden increases with higher single doses or on multiple dosing.
Danish: Der forekommer delvis mætning af first-pass-virkningen og reduceret plasmaclearance, når kropsbelastningen stiger med højere enkeltdoser eller flere doser.
English: Although paroxetine does not increase the mental and motor skill impairments caused by alcohol, the concomitant use of paroxetine and alcohol is not advised.
Danish: Selvom paroxetin ikke yderligere forringer de mentale eller motoriske evner, som skyldes alkohol, frarådes samtidig brug af paroxetin og alkohol.
English: Rare: hyperprolactinaemia/galactorrhoea.
Danish: Sjælden: Hyperprolaktinæmi/galaktorré.
English: Paroxetine should not be used, as long as safety and efficacy in this age group have not been established.
Danish: Paroxetin bør ikke bruges, så længe der ikke er dokumentation for sikkerhed og virkning hos børn i denne aldersgruppe.
English: The latter effects were likely related to maternal toxicity and are not considered a direct effect on the foetus/neonate.
Danish: Sidstnævnte virkninger var sandsynligvis forbundet med svangerskabsforgiftning og anses ikke for at påvirke fostre/nyfødte unger direkte.
English: Administration of thioridazine alone can lead to QTc interval prolongation with associated serious ventricular arrhythmia such as torsades de pointes, and sudden death.
Danish: Indgift af thioridazin alene kan medføre en forlængelse af QTc-intervallet med associeret alvorlig ventrikulær arytmi, f.eks. torsades de pointes og pludselig død.
English: Studies indicate that, in contrast to antidepressants which inhibit the uptake of noradrenaline, paroxetine has a much reduced propensity to inhibit the antihypertensive effects of guanethidine.
Danish: Undersøgelser viser, at paroxetin i modsætning til antidepressiva, som hæmmer optagelsen af noradrenalin, har langt mindre tilbøjelighed til at hæmme de antihypertensive virkninger af guanethidin.
English: Metabolism does not compromise paroxetine's selective action on neuronal 5-HT uptake.
Danish: Metabolismen kompromitterer ikke paroxetins selektive virkning på optagelsen af neuronal 5-HT.
English: Neonates should be observed if maternal use of paroxetine continues into the later stages of pregnancy, particularly the third trimester.
Danish: Nyfødte skal observeres, hvis moderen fortsætter med at bruge paroxetin til langt hen i graviditeten, særligt i sidste trimester.
English: No correlation has been found between paroxetine plasma concentrations and clinical effect (adverse experiences and efficacy).
Danish: Der er ikke påvist sammenhæng mellem paroxetinplasmakoncentration og klinisk virkning (bivirkninger og effekt).
English: There has been a concern about withdrawal reactions associated with paroxetine since its licensing.
Danish: Der har været bekymring vedrørende abstinensreaktioner i forbindelse med paroxetin, siden det blev godkendt.
English: Denmark DuraScan Medical Products A/S Svendborgvej 243
Danish: Danmark DuraScan Medical Products A/S Svendborgvej 243
English: These studies investigated the risk of suicidal behaviours (including completed suicides, suicide attempts and suicidal ideation) associated with the use of various antidepressants.
Danish: Undersøgelserne så på risikoen for selvmordstruende adfærd (herunder gennemførte selvmord, selvmordsforsøg og selvmordstanker) forbundet med anvendelsen af forskellige antidepressiva.
English: Denmark Generics (UK) Limited Station Close
Danish: Danmark Generics (UK) Limited Station Close
English: Musculoskeletal disorders Rare: arthralgia, myalgia
Danish: Muskulo-skeletale lidelser Sjælden: Artalgi, myalgi
English: Endocrine disorders Very rare: syndrome of inappropriate anti-diuretic hormone secretion (SIADH).
Danish: Endokrine lidelser Meget sjælden: SIADH (Syndrome of Inappropriate Anti-Diuretic Hormone secretion).
English: Generally these symptoms are self-limiting and usually resolve within 2 weeks, though in some individuals they may be prolonged (2-3 months or more).
Danish: Symptomerne er generelt forbigående og forsvinder normalt inden for to uger, mens de hos enkelte kan vare længere (2-3 måneder eller mere).
English: Anticonvulsants: carbamazepine, phenytoin, sodium valproate.
Danish: Antikrampemidler: Carbamazepin, fenytoin, natriumvalproat.
English: Long-term use should be regularly evaluated (see section 5.1 Pharmacodynamic Properties).
Danish: Langtidsbrug bør evalueres med jævne mellemrum (se 5.1 Farmakodynamiske egenskaber).
English: The principal metabolites of paroxetine are polar and conjugated products of oxidation and methylation which are readily cleared.
Danish: Paroxetins hovedmetabolitter er polære og konjugerede oxiderings- og methyleringsprodukter, der hurtigt elimineres.
English: Clinical experience has shown that therapy with paroxetine is not associated with impairment of cognitive or psychomotor function.
Danish: Kliniske erfaringer har vist, at behandling med paroxetin ikke er forbundet med nedsat kognitiv eller psykomotorisk funktion.
English: The CHMP considered that despite some problems in the studies, mainly related to the fact that many patients suffered from co-morbid depression, there is evidence to support the efficacy in this indication, however the long-term efficacy has not been sufficiently demonstrated.
Danish: Trods nogle problemer i undersøgelserne, der hovedsagelig var relateret til det faktum, at mange patienter led af co-morbid depression, var CHMP af den opfattelse, at der er evidens til støtte for virkningen ved denne indikation; men langtidseffekten var ikke blevet tilstrækkeligt påvist.
English: Hyponatraemia has been reported rarely, predominantly in the elderly.
Danish: Hyponatriæmi er rapporteret i sjældne tilfælde, hovedsageligt hos ældre.
English: Denmark Scand Pharm Generics AB Ynglingagatan 14, 5tr
Danish: Danmark Scand Pharm Generics AB Ynglingagatan 14, 5tr
English: In accordance with this selective action, in vitro studies have indicated that, in contrast to tricyclic antidepressants, paroxetine has little affinity for alpha1, alpha2 and beta-adrenoceptors, dopamine (D2), 5-HT1 like, 5-HT2 and histamine (H1) receptors.
Danish: I overensstemmelse med denne selektive virkning har in vitro undersøgelser vist, at paroxetin i modsætning til tricykliske antidepressiva har ringe affinitet til alfa1, alfa2 og beta-adrenoceptorer, dopamin (D2), 5-HT1-lignende, 5-HT2- og histamin (H1)-receptorer.
English: Denmark Alpharma AS Harbitzalléen 3
Danish: Danmark Alpharma AS Harbitzalléen 3
English: There is a possibility of an increased risk of suicide related behaviour in young adults ages 18-29.
Danish: Der er sandsynlighed for øget risiko for selvmordsadfærd hos unge i alderen 18-29 år.
English: Gastrointestinal disorders Very common: nausea.
Danish: Gastrointestinale lidelser Meget almindelig: Kvalme.
English: 90449 Nürnberg Germany
Danish: 90449 Nürnberg
English: Increased hostility occurred particularly in children with obsessive compulsive disorder, and especially in younger children less than 12 years of age.
Danish: Øget fjendtlighed forekom især hos børn med OCD, herunder navnlig børn under 12 år.
English: A pharmacodynamic interaction between paroxetine and oral anticoagulants may occur.
Danish: Der kan forekomme farmakodynamisk interaktion mellem paroxetin og orale antikoagulanter.
English: The taper phase regimen used in clinical trials involved decreasing the daily dose by 10 mg at weekly intervals.
Danish: Det nedtrapningsregime, som er blevet anvendt i kliniske forsøg, indebærer en reduktion af den daglige dosis med 10 mg/dag med ugentlige intervaller.
English: The treatment should consist of those general measures employed in the management of overdose with any antidepressant.
Danish: Behandlingen bør omfatte de foranstaltninger, som normalt anvendes ved behandling af overdosis af ethvert andet antidepressivt middel.
English: Belgium Bexal Av J. Bordet 168, 1140 Brussels, Belgium
Danish: Av J. Bordet 168, 1140 Brussels, Belgium
English: Therefore, patients treated with higher doses, those treated for a longer duration and patients whose treatment is abruptly stopped may be at an increased risk of withdrawal symptoms upon stopping treatment with paroxetine.
Danish: Derfor kan patienter, der bliver behandlet ved højere doser, patienter, der bliver behandlet over længere tid, samt patienter, hvis behandling afbrydes pludseligt, have en øget risiko for abstinenssymptomer, når de ophører med behandlingen med paroxetin.
English: The CHMP reviewed available data from published literature and spontaneous reports in relation to withdrawal reactions in neonates whose mothers used paroxetine during pregnancy.
Danish: CHMP gennemgik tilgængelige data fra publiceret litteratur samt spontane rapporter i relation til abstinensreaktioner hos nyfødte, hvis mødre tog paroxetin under graviditeten.
English: Young adults should therefore be monitored carefully throughout treatment.
Danish: Patienter i denne aldersgruppe bør derfor følges tæt under hele behandlingen.
English: Results from observational studies indicate no increased risk of suicidality in patients who were prescribed paroxetine and likewise, post marketing reports indicate low rates of suicidal related behaviours.
Danish: Resultater fra observationsundersøgelser indikerer ikke nogen øget risiko for selvmord hos patienter, der blev ordineret paroxetin, og på lignende måde viste rapporter fra tiden efter markedsføringen lave hyppigheder af selvmordsrelateret adfærd.
English: Based on the above data concerning withdrawal reactions and suicidal behaviour, UK considered that there was Community interest to reassess the balance of risks and benefits of paroxetine and requested the CHMP to give an opinion on whether the marketing authorisations for paroxetine containing medicinal products should be maintained, varied or withdrawn.
Danish: Baseret på de ovennævnte data vedrørende abstinensreaktioner og selvmordsadfærd konkluderede Det Forenede Kongerige, at det var i Fællesskabets interesse at forholdet mellem risici og fordele ved paroxetin igen blev vurderet, og anmodede Udvalget for Farmaceutiske Specialiteter (CHMP) om at afgive en udtalelse om, hvorvidt markedsføringstilladelserne for lægemidler, der indeholder paroxetin, bør opretholdes, ændres eller trækkes tilbage.
English: Efficacy in adults
Danish: Virkning hos voksne
English: Paroxetine does not impair psychomotor function and does not potentiate the depressant effects of ethanol.
Danish: Paroxetin nedsætter ikke den psykomotoriske funktion og forstærker heller ikke ethanols depressive virkninger.
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: Eftersom forbedring af depressionen ikke nødvendigvis ses før efter to eller flere ugers behandling, bør patienten følges tæt, indtil en forbedring ses.
English: Treatment of
Danish: Behandling af
English: No studies are available in children and adolescents in the other currently approved indications for adults.
Danish: Der er ingen tilgængelige studier med børn og unge med hensyn til de andre indikationer, der på nuværende tidspunkt er godkendt til voksne.
English: Belgium Ratiopharm Belgium s.a./n.v.
Danish: Ratiopharm Belgium s.a./n.v.
English: 86156 Augsburg Germany
Danish: 86156 Augsburg
English: Therefore the CHMP considered that the benefit/risk balance of paroxetine containing medicinal products in the agreed indications is favourable and the Marketing Authorisations should be maintained in accordance with the:
Danish: CHMP vurderer derfor, at forholdet mellem fordele og risici ved brugen af lægemidler, der indeholder stoffet paroxetin i de godkendte indikationer er positivt, og at markedsføringstilladelserne bør opretholdes i overensstemmelse med:
English: Toxicology studies have been conducted in rhesus monkeys and albino rats; in both, the metabolic pathway is similar to that described for humans.
Danish: I toksikologiske undersøgelser af rhesusaber og albinorotter svarer den metaboliske pathway til den, der er beskrevet for mennesker.
English: Insulin and/or oral hypoglycaemic dosage may need to be adjusted.
Danish: Det kan være nødvendigt at justere dosis af insulin og/eller oral hypoglykæmisk medicin.
English: Reproductive system and breast disorders Very common: sexual dysfunction.
Danish: Forstyrrelser i reproduktion og lidelser i mammae Meget almindelig: Seksuel dysfunktion.
English: 4.6 Pregnancy and Lactation
Danish: 4.6 Graviditet og amning
English: Available data, including data from clinical trials, indicate an increased risk of akathisia associated with the use of paroxetine.
Danish: Tilgængelige data, inklusive data fra kliniske forsøg, indikerer, at der er en øget risiko for akatisi associeret med brugen af paroxetin.
English: Treatment with paroxetine should be initiated cautiously two weeks after terminating treatment with an irreversible MAOI or 24 hours after terminating treatment with a reversible MAO inhibitor.
Danish: Paroxetin bør introduceres med forsigtighed to uger efter afbrydelse af behandling med en irreversibel MAO-hæmmer eller 24 timer efter afbrydelse af behandling med en reversibel MAO-hæmmer.
English: Therefore, although data from the GPRD studies apparently do not confirm the findings from clinical trials with respect to increased risk in patients with anxiety disorders or in young adults, the fact that these risks were found in clinical trials justifies a warning in the SPC in relation to the risk of suicide/suicidal ideation in children and adolescents irrespective of the indication and a warning for young adults.
Danish: På trods af at oplysninger fra GPRD-undersøgelserne tilsyneladende ikke bekræfter resultaterne af de kliniske undersøgelser, hvad angår øget risiko hos patienter med angstforstyrrelser eller hos yngre voksne, så begrunder det faktum, at disse risici blev fundet i kliniske undersøgelser en advarsel i produktresuméet vedrørende risiko for selvmord/selvmordstanker hos børn og unge uanset indikation og en advarsel til yngre voksne.