FrancophonIA/ELRC3.0 huggingface dataset:
English: The CHMP also agreed that the above-mentioned information with regards to longterm efficacy should be included in section 5.1 (Pharmacodynamic Properties) of the Summary of Product Characteristics (SPC).
Danish: Der var i CHMP ligeledes enighed om, at den ovenfor nævnte information med hensyn til langtidseffekten bør tilføjes i afsnit 5.1 (Farmakodynamiske egenskaber) i produktresumeet (SPC).
English: Box 51409 CY-3505 Limassol Cyprus
Danish: Medochemie Ltd P.O. Box 51409 CY-3505 Limassol Cyprus
English: 266 Kifissias Avenue 15232 Chalandri, Athens Greece
Danish: 15232 Chalandri, Athens Greece
English: Caution should also be exercised in those patients at risk of hyponatraemia e.g. from concomitant medications and cirrhosis.
Danish: Der bør ligeledes udvises forsigtighed hos patienter, der er disponeret for hyponatriæmi, f.eks. i forbindelse med samtidig brug af anden medicin og cirrose.
English: Increased plasma concentrations of paroxetine occur in patients with severe renal impairment (creatinine clearance less than 30 ml/min) or in those with hepatic impairment.
Danish: Øgede plasmakoncentrationer af paroxetin ses hos patienter med svært nedsat nyrefunktion (kreatininclearance under 30 ml/min.)
English: Holsten Pharma GmbH Im Bürgerstock 7
Danish: Tyskland Holsten Pharma GmbH Im Bürgerstock 7
English: As these syndromes may result in potentially lifethreatening conditions, treatment with paroxetine should be discontinued if such events (characterised by clusters of symptoms such as hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid fluctuations of vital signs, mental status changes including confusion, irritability, extreme agitation progressing to delirium and coma) occur and supportive symptomatic treatment should be initiated.
Danish: Da disse syndromer kan medføre potentielt livstruende tilstande, bør paroxetinbehandlingen seponeres ved forekomst af disse tilstande (der er kendetegnet ved en række symptomer, f.eks. hypertermi, stivhed, myoklonus, forstyrret autonom funktion eventuelt med hurtige udsving i vitale tegn, ændringer i den mentale tilstand, herunder konfusion, irritabilitet, ekstrem agitation, der udvikler sig til delirium og koma), og der bør indledes symptomatisk støttebehandling.
English: Belgium Eurogenerics N.V. Heizel Esplanade Heysel B 22 B-1020 Brussel
Danish: Heizel Esplanade Heysel B 22 B-1020 Brussel Belgium
English: Heumann Pharma GmbH Südwestpark 50
Danish: Tyskland Heumann Pharma GmbH Südwestpark 50
English: Medibial - Produtos Médicos e Farmacêuticos, S.A, Av. Da Siderurgia Nacional, 4745-457 S. Mamede do Coronado
Danish: Da Siderurgia Nacional, 4745-457 S. Mamede do Coronado
English: Pregnancy/Neonates
Danish: Graviditet/nyfødte
English: In the treatment of depressive disorders, paroxetine exhibits comparable efficacy to standard antidepressants.
Danish: Ved behandling af depressionssygdomme kan paroxetins virkning sammenlignes med standardantidepressiva.
English: Based on the assessment of data from clinical trials and from post marketing the CHMP concluded that there is a possibility of an increased risk of suicidal related behaviour associated with paroxetine in young adults (18-29 years), even though the increased risk was not statistically significant.
Danish: Baseret på vurderingen af data fra kliniske forsøg samt data, indsamlet efter markedsføringen, konkluderede CHMP, at der er mulighed for en øget risiko for selvmordsadfærd associeret med paroxetin hos unge voksne (18-29 år), selv om den øgede risiko ikke var statistisk signifikant.
English: Very rare: serotonin syndrome (symptoms may include agitation, confusion, diaphoresis, hallucinations, hyperreflexia, myoclonus, shivering, tachycardia and tremor).
Danish: Meget sjælden: Serotoninsyndrom (symptomer kan være agitation, konfusion, diaforese, hallucinationer, hyperrefleksi, myoklonus, skælven, takykardi og tremor).
English: In view of these conclusions the CHMP considered that guidance with regards to the discontinuation of paroxetine (down titration), as well as a warning and a description of the withdrawal symptoms seen on discontinuation of paroxetine should be included in the respective sections of the SPC and suitable pharmaceutical forms/strengths need to be available in order to facilitate titration.
Danish: I lyset af disse konklusioner besluttede CHMP, at der i de respektive afsnit i produktresumeet bør tilføjes en vejledning med hensyn til ophør af behandlingen med paroxetin (nedtitrering) så vel som en advarsel om og en beskrivelse af de abstinenssymptomer, der er observeret ved ophør med paroxetin, og at egnede farmaceutiske former/styrker skal være tilgængelige med henblik på at muliggøre titrering.
English: Therefore, the CHMP concluded that the previous agreed statement advising that paroxetine should not be used in children and adolescents included in section 4.4 (Special Warnings and Special Precautions for Use) of the SPC and the warning in relation to young adults should remain unchanged.
Danish: Derfor konkluderede CHMP, at den erklæring, der blev vedtaget tidligere, hvori det tilrådes at paroxetin ikke bør anvendes hos børn og unge, indeholdt i produktresuméets afsnit 4.4 (særlige advarsler og forsigtighedsregler) og advarslen i forbindelse med yngre voksne skulle forblive uændret.
English: Paroxetine should not be used in combination with thioridazine, because, as with other drugs which inhibit the hepatic enzyme CYP450 2D6, paroxetine can elevate plasma levels of thioridazine (see section 4.5 Interactions with other medicinal products and other forms of interaction).
Danish: Paroxetin bør ikke gives til patienter sammen med thioridazin, da paroxetin ligesom andre lægemidler, der hæmmer leverenzymet CYP450 2D6, kan øge plasmaniveauet af thioridazin (se 4.5 Interaktion med andre lægemidler og andre former for interaktion).
English: When paroxetine is to be co-administered with a known drug metabolising enzyme inhibitor, consideration should be given to using paroxetine doses at the lower end of the range.
Danish: Ved indgift af paroxetin sammen med en kendt lægemiddelmetaboliserende enzymhæmmer bør der anvendes doser i den lave ende af det foreslåede dosisområde.
English: Metabolite excretion is biphasic, being initially a result of first-pass metabolism and subsequently controlled by systemic elimination of paroxetine.
Danish: Udskillelsen af metabolitter sker i to faser - først som følge af first-pass-metabolisme og derefter ved systemisk eliminering af paroxetin.
English: 5.2 Pharmacokinetics
Danish: 5.2 Farmakokinetiske egenskaber
English: NSAIDs and acetylsalicylic acid, and other antiplatelet agents A pharmacodynamic interaction between paroxetine and NSAIDs/acetylsalicylic acid may occur.
Danish: NSAID og acetylsalicylsyre og andre stoffer med virkning på blodpladerne Der kan forekomme farmakodynamisk interaktion mellem paroxetin og NSAID/acetylsalicylsyre.
English: In the fixed dose studies there is a flat dose response curve, providing no suggestion of advantage in terms of efficacy for using higher than the recommended doses.
Danish: I studier med fast dosis er dosis respons kurven flad, og tyder således ikke på en fordel med hensyn til effekt, for at bruge større doser end anbefalet.
English: Social Anxiety Disorder / Social Phobia
Danish: SOCIALANGST/SOCIALFOBI
English: As with other selective 5-HT uptake inhibitors, paroxetine causes symptoms of excessive 5-HT receptor stimulation when administered to animals previously given monoamine oxidase (MAO) inhibitors or tryptophan.
Danish: Ligesom andre selektive 5-HT-optagshæmmere giver paroxetin symptomer på øget 5-HTreceptorstimulation ved indgift hos dyr, som tidligere har fået MAO-hæmmere eller tryptofan.
English: Some of the adverse drug reactions listed below may decrease in intensity and frequency with continued treatment and do not generally lead to cessation of therapy.
Danish: Intensiteten og hyppigheden af nogle af nedenstående bivirkninger kan aftage i løbet af behandlingen og fører generelt ikke til afbrydelse af behandlingen.
English: Sandoz Pharmaceuticals GmbH Carl-Zeiss-Ring 3
Danish: Tyskland Sandoz Pharmaceuticals GmbH Carl-Zeiss-Ring 3
English: Denmark GlaxoSmithKline Pharma A/S Nykær 68
Danish: Danmark GlaxoSmithKline Pharma A/S Nykær 68
English: London E16 2QJ, UK
Danish: London E16 2QJ,
English: It is therefore advised that paroxetine should be gradually tapered when discontinuing treatment over a period of several weeks or months, according to the patient's needs (see "Withdrawal Symptoms Seen on Discontinuation of Paroxetine", Section 4.2 Posology and Method of Administration).
Danish: Det anbefales derfor at seponere behandlingen gradvist ved nedtrapning af dosis over en periode på flere uger eller måneder alt efter patientens behov (se "Abstinenssymptomer ved seponering af paroxetin" i afsnit 4.2 Dosering og indgivelsesmåde).
English: Expansion of withdrawal symptoms seen on discontinuation of paroxetine treatment and inclusion of information on adverse events from paediatric clinical trials.
Danish: Udvidet beskrivelse af de abstinenssymptomer, der er set ved ophør med paroxetin-behandling, samt tilføjelse af information fra pædiatriske kliniske forsøg vedrørende utilsigtede hændelser.
English: Drug metabolising enzymes
Danish: Lægemiddelmetaboliserende enzymer:
English: Regarding safety, data from clinical trials show that paroxetine is associated with an increased risk of suicidal and hostility related behaviours in the paediatric population (7-17 years old).
Danish: Med hensyn til sikkerhed viser data fra kliniske forsøg, at paroxetin associeres med en øget risiko for selvmordsadfærd og fjendtlig adfærd i den pædiatriske population (7-17 år gamle).
English: In addition, in these trials efficacy has not been adequately demonstrated (see section 4.4 Special Warnings and Special Precautions for use and section 4.8 Undesirable Effects).
Danish: Desuden har disse undersøgelser ikke i tilstrækkeligt omfang vist effekt (se 4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen og 4.8 Bivirkninger).
English: Patients with panic disorder should be treated for a sufficient period to ensure that they are free from symptoms.
Danish: Patienter med panikangst skal behandles i en tilstrækkelig lang periode til at sikre, at de er symptomfri.
English: In studies that used a tapering regimen, symptoms reported during the taper phase or upon discontinuation of paroxetine at a frequency of at least 2% of patients and occurred at a rate at least twice that of placebo were: emotional lability (including crying, mood fluctuations, self-harm, suicidal thoughts and attempted suicide), nervousness, dizziness, nausea and abdominal pain (see section 4.4 Special Warnings and Special Precautions for use).
Danish: I undersøgelser, hvor der blev anvendt nedtrapning, blev der rapporteret følgende symptomer i nedtrapningsfasen eller efter seponering af paroxetin med en hyppighed på mindst 2% af patienterne, og hvor hyppigheden var mindst dobbelt så høj som ved placebo: emotionel labilitet (herunder gråd, humørsvingninger, selvdestruktive handlinger, selvmordstanker og selvmordsforsøg), nervøsitet, svimmelhed, kvalme og mavesmerter (se 4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen).
English: Very rare: thrombocytopenia.
Danish: Meget sjælden: Trombocytopeni.
English: Inclusion of information on the symptoms which can occur in the neonate after maternal paroxetine use in later stages of pregnancy.
Danish: Tilføjelse af information vedrørende de symptomer, der kan forekomme hos spædbørn, hvis mødre tog paroxetin i den sidste del af graviditeten.
English: Additional events that were more often seen in the paroxetine compared to placebo group were: decreased appetite, tremor, sweating, hyperkinesia, agitation, emotional lability (including crying and mood fluctuations).
Danish: Yderligere bivirkninger, der oftere blev observeret i paroxetingruppen end i placebogruppen, var nedsat appetit, tremor, svedtendens, hyperkinesi, agitation, emotionel labilitet (herunder gråd og humørsvingninger).
English: GlaxoSmithKline GmbH & Co.KG Theresienhöhe 11
Danish: Tyskland GlaxoSmithKline GmbH & Co.KG Theresienhöhe 11
English: Denmark Ratiopharm GmbH Graf-Arco-Strasse 3
Danish: Danmark Ratiopharm GmbH Graf-Arco-Strasse 3
English: In addition, the CHMP agreed that information with regards to the dose response studies should be included in section 5.1 (Pharmacodynamic Properties) of the SPC.
Danish: Desuden fastslog CHMP, at der bør tilføjes information med hensyn til dosis-respons i afsnit 5.1 (Farmakodynamiske egenskaber) i produktresumeet.
English: GlaxoSmithKline UK Limited Stockley Park West Uxbridge
Danish: Storbritannien GlaxoSmithKline UK Limited Stockley Park West
English: Increased plasma concentrations of paroxetine occur in elderly subjects, but the range of concentrations overlaps with that observed in younger subjects.
Danish: Øgede plasmakoncentrationer af paroxetin ses hos ældre brugere, men plasmakoncentrationsniveauet overlapper det observerede niveau for yngre brugere.
English: One of the three studies achieved a significant difference in the proportion of relapsers between paroxetine (38%) compared to placebo (59%).
Danish: I en af de tre undersøgelser blev der påvist en væsentlig forskel i forholdet mellem paroxetinrecidivister (38%) og placeborecidivister (59%).
English: According to the answers provided by the MAHs to CHMP, no studies were performed in children and adolescents in the other currently approved indications for adults.
Danish: Ifølge svarene til CHMP fra indehaverne af markedsføringstilladelserne er der ikke udført undersøgelser med børn og unge vedrørende de andre indikationer, der på nuværende tidspunkt er godkendt til voksne.
English: Generally these events are mild to moderate and are self-limiting, however, in some patients they may be severe and/or prolonged.
Danish: Hos de fleste patienter er disse symptomer milde til moderate og forbigående, men hos nogle patienter kan de være svære og/eller langvarige.
English: Patients should be started on 10 mg/day and the dose gradually increased in 10 mg steps according to the patient's response up to the recommended dose.
Danish: Patienten startes på 10 mg/dag og dosis øges gradvist i 10 mg trin op til anbefalet dosis, afhængigt af patientrespons.
English: It is therefore advised that when paroxetine treatment is no longer required, gradual discontinuation by dose tapering should be carried out (see section 4.2 Posology and Method of Administration and section 4.4 Special Warnings and Special Precautions for use).
Danish: Det anbefales derfor, når paroxetinbehandling ikke længere er påkrævet, at seponere medicinen gradvist ved nedtrapning af dosis (se 4.2 Dosering og indgivelsesmåde og 4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen).
English: Rue Aaint-Lambert 141
Danish: Rue Aaint-Lambert 141 B-1200 Bruxelles Belgium
English: Alpharma-ISIS GmbH & Co.KG Elisabeth-Selbert-Str. 1
Danish: Tyskland Alpharma-ISIS GmbH & Co.KG Elisabeth-Selbert-Str. 1
English: As with other SSRI's, paroxetine infrequently causes mydriasis and should be used with caution in patients with narrow angle glaucoma or history of glaucoma.
Danish: Ligesom andre SSRI forårsager paroxetin i sjældne tilfælde mydriasis og skal anvendes med forsigtighed hos patienter der har eller har haft snævervinklet glaukom.
English: In clinical trials 28% of patients treated with paroxetine reported withdrawal symptoms compared with 19% of placebo treated patients.
Danish: I kliniske forsøg rapporterede 28 % af de patienter, der blev behandlet med paroxetin, abstinenssymptomer sammenlignet med 19 % af de placebo-behandlede patienter.
English: As with other SSRIs, co-administration with serotonergic drugs (including MAOIs, L-tryptophan, triptans, tramadol, linezolid, SSRIs, lithium and St. John's Wort - Hypericum perforatumpreparations) may lead to an incidence of 5-HT associated effects (serotonin syndrome: see Section 4.3 Contraindications and Section 4.4 Special Warnings and Special Precautions for Use).
Danish: Som med andre SSRI kan samtidig indgift af paroxetin og serotonerge stoffer (f.eks. MAO-hæmmere, Ltryptofan, triptaner, tramadol, linezolid, SSRI, litium og perikumpræparater (Hypericum perforatum)) medføre 5HT-associerede virkninger (serotoninsyndrom: Se 4.3 Kontraindikationer og 4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen).
English: Inclusion of information concerning the lack of efficacy and increased risk of suicidal and hostility related behaviours in children and adolescents (7-17).
Danish: Tilføjelse af information vedrørende mangel på effekt samt øget risiko for selvmordsadfærd og fjendtlig adfærd hos børn og unge (7-17 år).
English: Post-marketing reports of hepatic events (such as hepatitis, sometimes associated with jaundice and/or liver failure) have also been received very rarely.
Danish: Der er også meget sjældent modtaget post-marketing rapporter om leverpåvirkning (hepatitis, undertiden forbundet med gulsot og/eller leversvigt).
English: Overall data from clinical trials indicate an increased risk of suicidal and hostility related behaviours in the paediatric population (7-17 years old).
Danish: De samlede data fra kliniske forsøg antyder, at der er en øget risiko for selvmordsrelateret og fjendtlig adfærd hos den pædiatriske population (7-17 år gamle).
English: Hexal Pharma Nederland B.V. Pastoorslaan 28, P.O.Box 251 2182 Bx Hillegom, The Netherlands
Danish: Pastoorslaan 28, P.O.Box 251 2182 Bx Hillegom, The Netherlands
English: Renal and urinary disorders Uncommon: urinary retention.
Danish: Lidelser i nyrer og urinveje Usædvanlig: Urinretention.
English: Abrupt discontinuation should be avoided during pregnancy (see "Withdrawal Symptoms Seen on Discontinuation of Paroxetine", section 4.2 Posology and Method of Administration).
Danish: Brat seponering bør undgås under graviditet (se ”Symptomer ved seponering af paroxetin” under 4.2 Dosering og indgivelsesmåde).
English: The most common withdrawal symptoms in children and adolescents were headaches, dizziness, nausea, nervousness and abdominal pain.
Danish: De hyppigst forekommende abstinenssymptomer hos børn og unge var hovedpine, svimmelhed, kvalme, nervøsitet samt mavepine.
English: The long-term efficacy of paroxetine in treating OCD was examined in three 24 week maintenance studies with relapse prevention design.
Danish: Langtidseffekten af paroxetin i behandlingen af OCD blev undersøgt i tre 24 ugers ”maintenance study”, med et tilbagefaldsforebyggende design.
English: Respiratory, thoracic and mediastinal disorders Common: yawning.
Danish: Respiratoriske lidelser, lidelser i thorax og mediastinum Almindelig: Gaben.
English: Medochemie Ltd, 1-10 Constantinoupoleos str. P.O.
Danish: Medochemie Ltd, 1-10 Constantinoupoleos str. P.O. Box 51407
English: From the data provided by the MAHs the CHMP concluded that efficacy has not been demonstrated in children and adolescents with major depressive disorder as included in the trials.
Danish: Ud fra de data, der blev fremlagt af indehaverne af markedsføringstilladelserne, konkluderede CHMP, at virkningen ikke er blevet påvist hos børn og unge med major depression, som inkluderet i forsøgene.
English: AbZ-Pharma GmbH Dr. Georg-Spohn-Str. 7 89143 Blaubeuren Germany
Danish: Dr. Georg-Spohn-Str. 7 89143 Blaubeuren Germany
English: Common: constipation, diarrhoea, dry mouth.
Danish: Almindelig: Forstoppelse, diarré, mundtørhed.
English: STADA Arzneimittel AG Stadastrasse 2 - 18
Danish: Tyskland STADA Arzneimittel AG Stadastrasse 2 - 18
English: Clinical trials, which have included gradual dose reduction at the end of treatment, have found that 30% of patients developed symptoms following discontinuation of treatment with paroxetine compared to 20% among those stopping placebo.
Danish: Kliniske forsøg, i hvilke der blev anvendt gradvis reduktion af dosis ved behandlingens ophør, har vist, at 30 % af patienterne udviklede symptomer efter ophør af behandlingen med paroxetin sammenlignet med 20 % af de patienter, der ophørte med at indtage placebo.
English: Norton Healthcare Limited; IVAX Quays, Albert Basin, Royal Docks,
Danish: Storbritannien Norton Healthcare Limited; IVAX Quays, Albert Basin, Royal Docks,
English: In some patients, with insufficient response to 20 mg, the dose may be increased gradually up to a maximum of 50 mg a day in 10 mg steps according to the patient's response.
Danish: For patienter med utilstrækkeligt respons på 20 mg, kan dosis øges med 10 mg gradvist op til maximalt 50 mg, afhængigt af patientrespons.
English: Approximately 95% of the paroxetine present is protein bound at therapeutic concentrations.
Danish: Paroxetins proteinbindingsgrad i terapeutiske koncentrationer er ca. 95%.
English: The same precautions observed when treating patients with major depressive disorder should therefore be observed when treating patients with other psychiatric disorders.
Danish: Der skal derfor tages de samme forholdsregler ved behandling af patienter med andre psykiatriske lidelser som ved patienter med major depression.
English: Considering the above the CHMP concluded that a warning should be included in section 4.4 (Special Warnings and Special Precautions for Use) of the SPC to reflect the risk of development of akathisia in patients treated with paroxetine.
Danish: I lyset af ovenstående konkluderede CHMP, at der bør tilføjes en advarsel i produktresumeets afsnit 4.4 (Særlige advarsler og forsigtighedsregler vedrørende brugen) om risikoen for udvikling af akatisi hos patienter, behandlet med paroxetin.
English: Caution is advised in patients taking SSRI's concomitantly with oral anticoagulants, drugs known to affect platelet function or other drugs that may increase risk of bleeding (e.g. atypical antipsychotics such as clozapine, phenothiazines, most TCA's, acetylsalicylic acid, NSAID's, COX-2 inhibitors) as well as in patients with a history of bleeding disorders or conditions which may predispose to bleeding.
Danish: Der skal udvises forsigtighed hos patienter, der tager SSRI samtidig med orale antikoagulanter, lægemidler, der vides at berøre blodpladefunktionen eller andre lægemidler, som kan øge risikoen for blødning (f.eks. atypiske antipsykotiske stoffer som clozapin, phenothiaziner, de fleste TCA, acetylsalicylsyre, NSAID, COX-2-hæmmere), samt hos patienter med tendens til blødning eller med lidelser, der gør dem prædisponeret for blødning.
English: Based on data from clinical trials and from post marketing there is a possibility of an increased risk of suicidal related behaviour associated with paroxetine in young adults (18-29 years).
Danish: Baseret på data fra kliniske forsøg samt på data, indsamlet efter markedsføringen, er der mulighed for en øget risiko for selvmordsrelateret adfærd i forbindelse med brugen af paroxetin hos unge voksne (18-29 år).
English: The indications for which paroxetine is currently approved in EU includemajor depressive disorder (MDD), panic disorder, obsessive compulsive disorder (OCD), social phobia/social anxiety disorder (SAD), generalised anxiety disorder (GAD) and post-traumatic stress disorder (PTSD).
Danish: De indikationer, til hvilke paroxetin på nuværende tidspunkt er godkendt i EU, omfatter moderat til svær depression (major depressive disorder - MDD), panikangst, obsessiv-kompulsiv tilstand (obsessive compulsive disorder - OCD), socialfobi (social phobia / social anxiety disorder - SAD), generaliseret angstsyndrom (generalised anxiety disorder - GAD) og posttraumatisk stress-syndrom (post-traumatic stress disorder - PTSD).
English: The efficacy of paroxetine in treating major depression in adults is established and supported by numerous short and long-term trials.
Danish: Virkningen af paroxetin til behandling af major depression hos voksne er etableret og understøttet af utallige kort- og langvarige forsøg.
English: 79241 Ihringen Germany
Danish: 79241 Ihringen
English: In general, improvement in patients starts after one week but may only become evident from the second week of therapy.
Danish: Normalt ses bedring hos patienten efter en uges behandling, men der kan også gå to uger.
English: Mixture
Danish: Mixtur