FrancophonIA/ELRC3.0 huggingface dataset:
English: In May 2003 UK reviewed data from clinical trials with paroxetine in the treatment of paediatric OCD, SAD and MDD and concluded that these data provided evidence of an association between the use of paroxetine and an increased risk of emotional lability including self-harm, hostility and suicidal behaviour in children and adolescents.
Danish: I maj 2003 gennemgik Det Forenede Kongerige data fra kliniske forsøg med paroxetin i behandlingen af pædiatrisk OCD, SAD og MDD og konkluderede, at disse data viser evidens af en sammenhæng mellem brugen af paroxetin og en øget risiko for emotionel labilitet, inklusive selvdestruktiv adfærd, fjendtlig adfærd og selvmordsadfærd hos børn og unge.
English: Paroxetine produces no clinically significant changes in blood pressure, heart rate and ECG after administration to healthy subjects.
Danish: Paroxetin producerer ingen klinisk signifikante ændringer i blodtryk, hjertefrekvens og ECG efter indgift hos raske individer.
English: Paroxetine should not be used for the treatment of children and adolescents as controlled clinical trials have found paroxetine to be associated with increased risk for suicidal behaviour and hostility.
Danish: Paroxetin bør ikke bruges til behandling af børn og unge, da kontrollerede kliniske undersøgelser har vist en sammenhæng mellem paroxetin og øget risiko for selvmordsadfærd og fjendtlighed.
English: GlaxoSmithKline d.o.o., družba za promet s farmacevtskimi izdelki, Knezov štradon 90, Ljubljana Slovenia
Danish: Slovenien GlaxoSmithKline d.o.o., družba za promet s farmacevtskimi izdelki, Knezov štradon 90, Ljubljana Slovenia
English: The incidence of possible suicide-related events and selfharm in the paroxetine group were 2-3 times that seen in the placebo group, while hostility events in the paroxetine occurred with a frequency 6 times that seen in the placebo group.
Danish: Forekomsten af mulige selvmordsrelaterede hændelser og selvdestruktiv adfærd var 2-3 gange højere i paroxetin-gruppen end i placebo-gruppen, mens hændelser med fjendtlig adfærd optrådte 6 gange hyppigere i paroxetin-gruppen end i placebogruppen.
English: Hexal AG Industriestr.
Danish: Tyskland Hexal AG Industriestr.
English: Overall the incidence of seizures is less than 0.1% in patients treated with paroxetine.
Danish: Forekomsten af kramper ses hos færre end 0,1% af de patienter, der behandles med paroxetin.
English: On the basis of the new assessed data the CHMP concluded the following: - The new evidence from the GPRD studies is more vulnerable to various biases, e.g. confounding by indication, compared to evidence coming from clinical trials.
Danish: CHMP konkluderede på baggrund af de nyligt vurderede data følgende: - Den nye dokumentation fra GPRD-undersøgelserne er mere udsat for forskellige afvigelser, f.eks. forveksling ved indikation, sammenlignet med dokumentation fra kliniske undersøgelser.
English: The metabolism and pharmacokinetics of paroxetine may be affected by the induction or inhibition of drug metabolising enzymes.
Danish: Paroxetins metabolisme og farmakokinetik kan påvirkes ved induktion eller hæmning af lægemiddelmetaboliserende enzymer.
English: Known hypersensitivity to paroxetine or any of the excipients.
Danish: Kendt hypersensitivitet over for paroxetin eller over for et eller flere af hjælpestofferne.
English: In response to these data UK contraindicated the use of paroxetine in children aged 18 years or less with major depressive disorders.
Danish: Som følge af disse data har Det Forenede Kongerige kontraindiceret brugen af paroxetin til børn med svære depressive lidelser i alderen 18 år og derunder.
English: Basics GmbH Hemmelrather Weg 201 51377 Leverkusen Germany
Danish: Tyskland Basics GmbH Hemmelrather Weg 201 51377 Leverkusen Germany
English: The use of paroxetine has been associated with the development of akathisia, which is characterized by an inner sense of restlessness and psychomotor agitation such as an inability to sit or stand still usually associated with subjective distress.
Danish: Brugen af paroxetin har været knyttet til udvikling af akathisi, som er kendetegnet ved en fornemmelse af rastløshed og psykomotorisk agitation såsom manglende evne til at sidde eller stå stille, normalt i forbindelse med indre uro.
English: As with other antidepressants, including other SSRIs, paroxetine inhibits the hepatic cytochrome P450 enzyme CYP2D6.
Danish: Ligesom andre antidepressiva, herunder andre SSRI'er, hæmmer paroxetin det cytokrome P450leverenzym CYP2D6.
English: Paroxetine is well absorbed after oral dosing and undergoes first-pass metabolism.
Danish: Paroxetin absorberes godt efter oral dosering og undergår first-pass-metabolisme.
English: Suicidal thoughts and suicide attempts were mainly observed in clinical trials of adolescents with Major Depressive Disorder.
Danish: Selvmordstanker og selvmordsforsøg blev fortrinsvis observeret ved kliniske undersøgelser af unge med major depression.
English: - The Committee considered the referral made under article 31 of Directive 2001/83/EC, as amended, for paroxetine containing medicinal products.
Danish: - Udvalget behandlede sagen, der var indbragt i henhold til artikel 31 i direktiv 2001/83/EF, med senere ændringer, vedrørende lægemidler, der indeholder stoffet paroxetin.
English: Discontinuation of paroxetine (particularly when abrupt) commonly leads to withdrawal symptoms.
Danish: Seponering af paroxetin (især brat seponering) medfører ofte symptomer.
English: In addition, in these trials efficacy has not been adequately demonstrated and long-term safety data in children and adolescents concerning growth, maturation and cognitive and behavioural development are lacking (see section 4.8 Undesirable Effects).
Danish: Desuden har disse undersøgelser ikke i tilstrækkeligt omfang vist effekt og der mangler langtidsdata vedrørende sikkerhed hos børn og unge, hvad angår vækst, modning og kognitiv og adfærdsmæssig udvikling (se 4.8 Bivirkninger).
English: On the basis of the available data the CHMP concluded that if after some weeks on the recommended dose insufficient response is seen some patients may benefit from having their dose gradually increased (in 10 mg steps) up to a maximum of 50mg/day for MDD, SAD, GAD and PTSD and up to a maximum of 60mg/day for OCD and panic disorder.
Danish: På basis af de tilgængelige data konkluderede CHMP, at nogle patienter, hvis der efter nogle uger på den anbefalede dosis observeres utilstrækkelig respons, kan have gavn af at få deres dosis gradvis forøget (i trin på 10 mg) op til maksimalt 50 mg/dag for MDD, SAD, GAD og PTSD og op til maksimalt 60 mg/dag for OCD og panikangst.
English: In patients who develop these symptoms, increasing the dose may be detrimental.
Danish: For patienter, der udvikler disse symptomer, er dosisøgning uhensigtsmæssig.
English: Rare: hyponatraemia.
Danish: Sjælden: Hyponatriæmi.
English: Denmark Copyfarm A/S Energivej 15
Danish: Danmark Copyfarm A/S Energivej 15
English: There have been reports of cutaneous bleeding abnormalities such as ecchymoses and purpura with SSRIs.
Danish: Der er rapporteret kutan blødning, f.eks. ekkymose og purpura, i forbindelse med SSRI.
English: Biomo pharma GmbH Lendersberstr.
Danish: Tyskland Biomo pharma GmbH Lendersberstr.
English: NAME OF MEDICINAL PRODUCT {INVENTED NAME} {Strength} {Pharmaceutical form} [To be completed nationally]
Danish: LÆGEMIDLETS NAVN {SÆRNAVN}{Styrke}{Lægemiddelform} [Udfyldes nationalt]
English: • Pregnancy and Lactation
Danish: • Graviditet og amning
English: Denmark United Nordic Pharma A/S Hammervej 7
Danish: Danmark United Nordic Pharma A/S Hammervej 7
English: • Undesirable effects
Danish: • Bivirkninger
English: Analysis of the available data from clinical trials and spontaneous reporting data indicate that the risk of withdrawal reactions is dependent on several factors including the duration and dose of therapy and the rate of dose reduction.
Danish: Analyse af de tilgængelige data fra kliniske forsøg samt spontant rapporterede data indikerer, at risikoen for abstinensreaktioner er afhængig af flere faktorer, inklusive behandlingens varighed og dosering, samt hvor hurtigt dosisreduktionen foregår.
English: Conditions of the Marketing Authorisations
Danish: Betingelser for markedsføringstilladelsen
English: Dosage of paroxetine should be increased gradually until an optimal response is reached (see section 4.3 Contraindications and section 4.5 Interactions with other medicinal products and other forms of interaction).
Danish: Paroxetindosis skal øges gradvist, indtil der opnås optimal respons (se 4.3 Kontraindikationer og 4.5 Interaktion med andre lægemidler og andre former for interaktion).
English: Rare: manic reactions, agitation, anxiety, depersonalisation, panic attacks, akathisia (see section 4.4 Special Warnings and Special Precautions for use).
Danish: Sjælden: Maniske reaktioner, agitation, angst, personlighedsforstyrrelser, panikanfald, akathisi (se 4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen).
English: The recommended dose is 40 mg daily.
Danish: Anbefalet dosis er 40 mg daglig.
English: Increasing the dose might be useful in some patients, but the maximum dose should not exceed 40 mg daily.
Danish: En øgning af dosis kan give nogle patienter en bedring, men den bør ikke overstige 40 mg dagligt.
English: For children and adolescents, although no completed suicides were observed, an increased risk for suicidal and self-harm behaviours was observed in patients taking SSRIs compared to those taking TCAs and in patients taking paroxetine compared to those taking other SSRIs.
Danish: Blandt børn og unge blev der, på trods af at der ikke blev konstateret tilfælde med gennemført selvmord, observeret en øget risiko for selvmorderisk og selvskadende adfærd hos patienter, der tog SSRI sammenlignet med de, der tog TCA, og hos patienter, der tog paroxetin, sammenlignet med de, der tog SSRI.
English: Serotonin Syndrome/Neuroleptic Malignant Syndrome On rare occasions development of a serotonin syndrome or neuroleptic malignant syndrome-like events may occur in association with treatment of paroxetine, particularly when given in combination with other serotonergic and/or neuroleptic drugs.
Danish: Serotoninsyndrom/malignt neuroleptisk syndrom I sjældne tilfælde kan der udvikles symptomer på serotoninsyndrom eller symptomer, der ligner symptomer på malignt neuroleptisk syndrom, i forbindelse med paroxetinbehandling, navnlig ved indgift sammen med andre serotonerge og/eller neuroleptiske midler.
English: 65439 Floersheim Germany
Danish: 65439 Floersheim
English: Esparma GmbH Lange Göhren 3
Danish: Tyskland Esparma GmbH Lange Göhren 3
English: On the basis of the available data the CHMP considered that the above information on the symptoms which can occur in the neonate after maternal paroxetine use in later stages of pregnancy, should be included in section 4.6 (Pregnancy and Lactation) of the SPC.
Danish: På basis af de tilgængelige data besluttede CHMP, at ovenstående information vedrørende de symptomer, der kan forekomme hos spædbørn, hvis mødre tog paroxetin i den sidste del af graviditeten, bør tilføjes i afsnit 4.6 (Graviditet og amning) i produktresumeet.
English: Strengthening of warnings concerning withdrawal symptoms seen on discontinuation of paroxetine and the need for down titration.
Danish: En understregning af advarslerne vedrørende de abstinenssymptomer, der ses ved ophør med paroxetin samt nødvendigheden af nedtitrering.
English: - The Committee considered that efficacy has not been demonstrated in children and adolescents with major depressive disorder.
Danish: - Udvalget var af den opfattelse, at der ikke er påvist effekt hos børn og unge med major depression.
English: ANNEX III SUMMARY OF PRODUCT CHARACTERISTICS Note: This Summary of Product Characteristics (SPC) is the one that was Annexed to the Commission Decision on this Article 31 referral for paroxetine containing medicinal products.
Danish: Bemærk: Dette er det Produktresume (SPC) , der var bilag til Europa-Kommissionens beslutning angående denne artikel 31 arbitreringssag vedrørende lægemidler indeholdende Paroxetin.
English: In clinical trials increased suicidal related behaviours (suicide attempts and suicidal thoughts) and hostility (predominantly aggression, oppositional behaviour and anger) were more frequently observed in children and adolescents treated with paroxetine compared to those treated with placebo.
Danish: Kliniske undersøgelser har vist øget selvmordsrelateret adfærd (selvmordsforsøg og selvmordstanker) og fjendtlighed (fortrinsvis aggression, opponens og vrede) hos børn og unge, der blev behandlet med paroxetin, i forhold til dem, der blev behandlet med placebo.
English: The occurrence of withdrawal symptoms is not the same as the drug being addictive or dependence producing.
Danish: Forekomsten af seponeringssymptomer betyder ikke, at lægemidlet er vanedannende eller afhængighedsskabende.
English: Patients with OCD should be treated for a sufficient period to ensure that they are free from symptoms.
Danish: Patienter med OCD skal behandles i en tilstrækkelig lang periode til at sikre, at de er symptomfri.
English: • Special Warnings and Special Precautions for Use Inclusion/reinforcement of warnings concerning the lack of efficacy and increased risk of suicidal and hostility related behaviours in children and adolescents (7-17), suicide/suicidal ideation and withdrawal symptoms.
Danish: • Særlige advarsler og forsigtighedsregler vedrørende brugen Tilføjelse og understregning af advarslerne vedrørende mangel på effekt samt øget risiko for selvmordsadfærd og fjendtlig adfærd hos børn og unge (7-17 år), selvmord/selvmordstanker og abstinenssymptomer.
English: As with other psychotropic drugs patients should be advised to avoid alcohol use while taking paroxetine.
Danish: Som ved andre psykotrope lægemidler bør patienten informeres om at undgå alkohol under behandling med paroxetin.
English: 1 A Pharma GmbH Keltenring 1+3
Danish: Tyskland 1 A Pharma GmbH Keltenring 1+3
English: Belgium Merck n.v./s.a.
Danish: Merck n.v./s.a.
English: In essence similar methods were employed in examining differences in risk of suicidal events among GP (General Practitioner) patients treated with different antidepressants.
Danish: Der blev hovedsageligt anvendt lignende metoder ved undersøgelsen af forskelle med hensyn til risiko for selvmordshændelser blandt patienter hos praktiserende læger, der behandledes med forskellige antidepressiva.
English: Paroxetine is a potent and selective inhibitor of 5-hydroxytryptamine (5-HT, serotonin) uptake and its antidepressant action and effectiveness in the treatment of OCD, Social Anxiety disorder/Social Phobia, General Anxiety Disorder, Post-traumatic Stress Disorder and Panic Disorder is thought to be related to its specific inhibition of 5-HT uptake in brain neurones.
Danish: Paroxetin er en potent og selektiv hæmmer af optagelsen af 5-hydroxitryptamin (5-HT, serotonin), og dets antidepressive virkning og effektivitet ved behandling af OCD, socialangst/socialfobi, generaliseret angst, posttraumatisk stress syndrom og panikangst anses for at være forbundet med dets specifikke hæmning af optagelsen af 5-HT i hjerneneuroner.
English: Uncommon: abnormal bleeding, predominantly of the skin and mucous membranes (mostly ecchymosis).
Danish: Usædvanlig: Unormal blødning, fortrinsvis hud- og slimhindeblødninger (oftest ekkymose).
English: Very rare: hepatic events (such as hepatitis, sometimes associated with jaundice and/or liver failure).
Danish: Meget sjælden: Leverpåvirkning (f.eks. hepatitis, undertiden forbundet med gulsot og/eller leversvigt).
English: Due to first-pass metabolism, the amount of paroxetine available to the systemic circulation is less than that absorbed from the gastrointestinal tract.
Danish: På grund af firstpass-metabolisme er paroxetinmængden til systemisk cirkulation mindre end den mængde, der absorberes fra mave-tarm-kanalen.
English: Available data from clinical trials, spontaneous reports and published literature show that withdrawal reactions in association with paroxetine are common when treatment is discontinued.
Danish: Tilgængelige data fra kliniske forsøg, spontane rapporter samt publiceret litteratur viser, at abstinensreaktioner i forbindelse med paroxetin er almindelige, når behandlingen ophører.
English: Withdrawal symptoms when treatment is discontinued are common, particularly if discontinuation is abrupt (see section 4.8 Undesirable effects).
Danish: Seponeringssymptomer er almindeligt forekommende ved stop af behandling, især hvis der er tale om brat seponering (se 4.8 Bivirkninger).
English: Paroxetine is associated with an increased risk of suicidal and hostility related behaviours in the paediatric population (7-17 years old), a possibility of an increased risk of suicidal related behaviours in young adults (18-29 years), is also associated with withdrawal reactions which can be severe in intensity and prolonged in duration and with the development of akathisia.
Danish: Paroxetin associeres med en øget risiko for selvmordsrelateret og fjendtlig adfærd hos pædiatriske patienter (7-17 år gamle), muligheden for øget risiko for selvmordsrelateret adfærd hos unge voksne (18-29 år) og er ligeledes associeret med abstinensreaktioner, som kan være kraftige og længevarende, og paroxetin associeres også med udvikling af akatisi.
English: Discontinuation of paroxetine should be considered if there is prolonged elevation of liver function test results.
Danish: Seponering af paroxetin må overvejes, hvis testresultater viser længerevarende påvirkning af leverfunktionen.
English: Efficacy in children
Danish: Virkning hos børn
English: Denmark NM Pharma A/S Lautrupvang 8
Danish: Danmark NM Pharma A/S Lautrupvang 8
English: Patients with a history of suicidal behaviour or thoughts, or those exhibiting a significant degree of suicidal ideation prior to commencement of treatment, are at a greater risk of suicidal thoughts or suicide attempts, and should receive careful monitoring during treatment.
Danish: Patienter, der tidligere har haft selvmordsadfærd eller selvmordstanker eller patienter, der udviser en signifikant grad af selvmordstanker eller selvmordsforsøg inden behandling, har større risiko for selvmordstanker eller for at forsøge at begå selvmord og bør følges tæt under behandlingen.
English: 53721 Siegburg Germany
Danish: 53721 Siegburg
English: 63741 Aschaffenburg Germany
Danish: 63741 Aschaffenburg
English: Reports of extrapyramidal disorder including oro-facial dystonia have been received in patients sometimes with underlying movement disorders or who were using neuroleptic medication.
Danish: Ekstrapyramidale lidelser, herunder oro-facial dystoni, er undertiden rapporteret hos patienter med underliggende bevægelsesforstyrrelser eller hos patienter i behandling med neuroleptika.
English: 85737 Ismaning Germany
Danish: 85737 Ismaning
English: Paroxetine should be discontinued in any patient entering a manic phase.
Danish: Paroxetin bør seponeres fra patienter i manisk fase.
English: No initial dosage adjustment is considered necessary when the drug is to be co-administered with known drug metabolising enzyme inducers (e.g. carbamazepine, rifampicin, phenobarbital, phenytoin).
Danish: Initial dosisjustering af paroxetin er ikke nødvendig, når det tages sammen med kendte lægemiddelmetaboliserende enzyminduktorer (f.eks. carbamazepin, rifampicin, fenobarbital og fenytoin).
English: Denmark Sandoz GmbH Biochemiestrasse 10
Danish: Danmark Sandoz GmbH Biochemiestrasse 10
English: Patients with depression should be treated for a sufficient period of at least 6 months to ensure that they are free from symptoms.
Danish: Patienter med depression skal behandles i mindst 6 måneder for at sikre, at de er symptomfri.
English: Cardiac disorders Uncommon: sinus tachycardia.
Danish: Hjertelidelser Usædvanlig: Sinus takykardi.
English: The drug should be discontinued in any patient who develops seizures.
Danish: Lægemidlet bør seponeres hos patienter, der udvikler kramper.
English: Suicidal related behaviours associated with paroxetine in the clinical trials were more clearly seen in the depression studies than in studies of OCD or SAD.
Danish: I kliniske forsøg blev selvmordsrelateret adfærd, associeret med paroxetin, observeret tydeligere i depressionsundersøgelser end i OCD- eller SAD-undersøgelser.
English: The recommended dose is 20 mg daily.
Danish: Anbefalet dosis er 20 mg daglig.
English: Therefore the CHMP recommended that section 4.2 (Posology and Method of Administration) of the SPC should be amended accordingly.
Danish: CHMP anbefalede derfor, at afsnit 4.2 (Dosering og indgivelsesmåde) i produktresumeet bør ændres i overensstemmelse hermed.
English: The hyponatraemia generally reverses on discontinuation of paroxetine.
Danish: Hyponatriæmi forsvinder generelt ved seponering af paroxetin.
English: The long-term efficacy of paroxetine in treating social anxiety disorder and generalised anxiety disorder and Post-traumatic Stress Disorder has not been sufficiently demonstrated.
Danish: Paroxetins langtidsvirkning ved behandling af socialangst, generaliseret angst og posttraumatisk stress syndrom er ikke påvist tilstrækkeligt.
English: The CHMP also concluded that efficacy has not been demonstrated in children and adolescents with major depressive disorder.
Danish: CHMP konkluderede ligeledes, at der ikke er påvist effekt hos børn og unge med major depression.
English: However, there is some clinical data suggesting that up-titrating the dose might be beneficial for some patients.
Danish: Der er dog nogle kliniske data, som tyder på at optitrering af dosis kan være fordelagtigt for nogle patienter.
English: Concomitant use of paroxetine and oral anticoagulants can lead to an increased anticoagulant activity and haemorrhagic risk.
Danish: Samtidig indgift af paroxetin og orale antikoagulanter kan medføre øget antikoagulantaktivitet og risiko for blødning.
English: Betapharm Arzneimittel GmbH Kobelweg 95
Danish: Tyskland Betapharm Arzneimittel GmbH Kobelweg 95
English: From the data provided the CHMP noted that in the fixed dose studies there was a flat dose response curve, providing no suggestion of advantage in terms of efficacy for using higher than the recommended doses.
Danish: Ud fra de tilgængelige data bemærkede CHMP, at der i undersøgelserne med fastsatte doser var en flad dosisrespons kurve, hvilket ikke gav nogen antydning af, at der kunne opnås nogen fordel med hensyn til virkning ved brug af højere doser end de anbefalede.
English: Experience of paroxetine in overdose has indicated that, in addition to those symptoms mentioned under section 4.8 "Undesirable Effects", vomiting, dilated pupils, fever, blood pressure changes, headache, involuntary muscle contractions, agitation, anxiety and tachycardia have been reported.
Danish: Erfaringerne ved overdosering af paroxetin har indikeret, at foruden de symptomer, som nævnes i afsnit 4.8 "Bivirkninger", er opkastning, udvidede pupiller, feber, blodtryksændringer, hovedpine, ufrivillige muskelsammentrækninger, agitation, angst og takykardi blevet rapporteret.
English: ADVERSE EVENTS FROM PAEDIATRIC CLINICAL TRIALS In short-term (up to 10-12 weeks) clinical trials in children and adolescents, the following adverse events were observed in paroxetine treated patients at a frequency of at least 2% of patients and occurred at a rate at least twice that of placebo were: increased suicidal related behaviours (including suicide attempts and suicidal thoughts), self-harm behaviours and increased hostility.
Danish: BIVIRKNINGER SET VED PÆDIATRISKE KLINISKE UNDERSØGELSER I kortvarige (10-12 uger) kliniske undersøgelser af børn og unge blev følgende bivirkninger observeret ved paroxetinbehandling med en hyppighed på mindst 2% af patienterne, og hvor hyppigheden var mindst dobbelt så høj som ved placebo: Øget selvmordsrelateret adfærd (herunder selvmordsforsøg og selvmordstanker), selvdestruktive handlinger og øget fjendtlighed.