natgillin/translations-raw huggingface dataset:
For patienter med utilstrækkeligt respons på 20 mg, kan dosis øges med 10 mg gradvist op til maximalt 50 mg, afhængigt af patientrespons.
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.
CHMP/ 187488/ 2004 OBSESSIV- KOMPULSIV TILSTAND (OCD)
CHMP/ 187488/ 2004 OBSESSIVE COMPULSIVE DISORDER
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Startdosis er 20 mg daglig, og dosis kan øges gradvist med 10 mg ad gangen op til anbefalet dosis.
Patients should start on 20 mg/ day and the dose may be increased gradually in 10 mg increments to the recommended dose.
Hvis der er utilstrækkeligt respons efter nogle uger kan nogle patienter have nytte af en gradvist øget dosis op til 60 mg dagligt.
If after some weeks on the recommended dose insufficient response is seen some patients may benefit from having their dose increased gradually up to a maximum of 60 mg/ day.
Denne periode kan vare flere måneder eller endnu længere (se 5. 1 Farmakodynamiske egenskaber).
(see section 5.1 Pharmacodynamic Properties)
PANIKANGST
PANIC DISORDER
Patienten startes på 10 mg/ dag og dosis øges gradvist i 10 mg trin op til anbefalet dosis, afhængigt af patientrespons.
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.
Hvis utilstrækkeligt respons ses efter nogle ugers behandling, kan nogle patienter have nytte af en gradvist øget dosis op til højst 60 mg dagligt.
If after some weeks on the recommended dose insufficient response is seen some patients may benefit from having their dose increased gradually up to a maximum of 60 mg/ day.
Denne periode kan vare flere måneder eller endnu længere (se 5. 1 Farmakodynamiske egenskaber).
This period may be several months or even longer (see section 5.1 Pharmacodynamic Properties)
SOCIALANGST/ SOCIALFOBI
SOCIAL ANXIETY DISORDER/ SOCIAL PHOBIA
Hvis der ses utilstrækkeligt respons efter nogle ugers behandling med anbefalet dosis, kan nogle patienter have nytte af en gradvist øget dosis, i 10 mg trin, op til højst 50 mg daglig.
If after some weeks on the recommended dose insufficient response is seen some patients may benefit from having their dose increased gradually in 10 mg steps up to a maximum of 50 mg/ day.
Langtidsbrug bør evalueres med jævne mellemrum (se 5. 1 Farmakodynamiske egenskaber).
Long-term use should be regularly evaluated (see section 5.1 Pharmacodynamic Properties).
GENERALISERET ANGST
GENERALISED ANXIETY DISORDER
POSTTRAUMATISK STRESS SYNDROM (PTSD)
POST-TRAUMATIC STRESS DISORDER
Brat seponering bør undgås (se 4. 4 Særlige advarsler og forsigtighedsregler vedrørende brugen og 4. 8 Bivirkninger).
WITHDRAWAL SYMPTOMS SEEN ON DISCONTINUATION OF PAROXETINE Abrupt discontinuation should be avoided (see section 4.4 Special Warnings and Special Precautions for Use and section 4.8 Undesirable Effects).
Det nedtrapningsregime, som er blevet anvendt i kliniske forsøg, indebærer en reduktion af den daglige dosis med 10 mg/ dag med ugentlige intervaller.
The taper phase regimen used in clinical trials involved decreasing the daily dose by 10 mg at weekly intervals.
En øgning af dosis kan give nogle patienter en bedring, men den bør ikke overstige 40 mg dagligt.
Subsequently, the physician may continue decreasing the dose, but at a more gradual rate.
CHMP/ 187488/ 2004 - Børn og unge under 18 år
CHMP/ 187488/ 2004 Special Populations:
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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.
Increased plasma concentrations of paroxetine occur in elderly subjects, but the range of concentrations overlaps with that observed in younger subjects.
Desuden har disse undersøgelser ikke i tilstrækkeligt omfang vist effekt (se 4. 4 Særlige advarsler og forsigtighedsregler vedrørende brugen og 4. 8 Bivirkninger).
Increasing the dose might be useful in some patients, but the maximum dose should not exceed 40 mg daily.
- Børn under 7 år
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).
Brugen af paroxetin er ikke undersøgt hos børn under 7 år.
• Children aged below 7 years The use of paroxetine has not been studied in children less than 7 years.
Øgede plasmakoncentrationer af paroxetin ses hos patienter med svært nedsat nyrefunktion (kreatininclearance under 30 ml/ min.) og hos patienter med nedsat leverfunktion.
• Renal/ hepatic impairment 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.
Paroxetin er kontraindiceret i kombination med MAO- hæmmere.
Paroxetine is contraindicated in combination with monoamine oxidase inhibitors (MAOIs).
- to uger efter seponering af en irreversibel MAO- hæmmer eller
- two weeks after discontinuation of an irreversible MAOI, or
- mindst 24 timer efter seponering af en reversibel MAO- hæmmer (f. eks. moklobemid)
- at least 24hrs after discontinuation of a reversible MAOI (e. g. moclobemide).
Der bør gå mindst en uge mellem seponering af paroxetin og påbegyndelse af behandling med MAO - hæmmere.
At least one week should elapse between discontinuation of paroxetine and initiation of therapy with any MAOI.
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).
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).
Indgift af thioridazin alene kan medføre en forlængelse af QTc- intervallet med associeret alvorlig ventrikulær arytmi, f. eks. torsades de pointes og pludselig død.
Administration of thioridazine alone can lead to QTc interval prolongation with associated serious ventricular arrhythmia such as torsades de pointes, and sudden death.
4. 4 Særlige advarsler og forholdsregler vedrørende brugen
4.4 Special Warnings and Special Precautions for use
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.
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.
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).
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).
Børn og unge (7- 17 år)
Children and Adolescents (7-17 years)
Denne risiko varer ved, indtil der er sket en signifikant remission af sygdommen.
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.
Eftersom forbedring af depressionen ikke nødvendigvis ses før efter to eller flere ugers behandling, bør patienten følges tæt, indtil en forbedring ses.
In addition, in these trials efficacy has not been adequately demonstrated and long-term safety data in
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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.
children and adolescents concerning growth, maturation and cognitive and behavioural development are lacking (see section 4.8 Undesirable Effects).
Der er sandsynlighed for øget risiko for selvmordsadfærd hos unge i alderen 18- 29 år.
Suicide/ suicidal ideation Depression is associated with an increased risk of suicidal thoughts, self harm and suicide.
Patienter i denne aldersgruppe bør derfor følges tæt under hele behandlingen.
This risk persists until significant remission occurs.
Der er utilstrækkelig dokumentation for risikoen for selvmordsrelateret adfærd ved behandlingsnaive patienter, men nøje overvågning kan være berettiget.
As improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored until such improvement occurs.
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.
It is general clinical experience with all antidepressant therapies that the risk of suicide may increase in the early stages of recovery.
Akathisi 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.
Other psychiatric conditions for which paroxetine is prescribed can also be associated with an increased risk of suicidal behaviour.
Denne tilstand indtræffer med størst sandsynlighed inden for de første par ugers behandling.
In addition, these conditions may be co-morbid with major depressive disorder.
For patienter, der udvikler disse symptomer, er dosisøgning uhensigtsmæssig.
The same precautions observed when treating patients with major depressive disorder should therefore be observed when treating patients with other psychiatric disorders.
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.
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.
Paroxetin bør ikke bruges sammen med serotonin- precursore (f. eks.
There is a possibility of an increased risk of suicide related behaviour in young adults ages 18-29.
L- tryptofan og oxitriptan) på grund af risikoen for serotonergt syndrom (se 4. 5 Interaktion med andre lægemidler og andre former for interaktion).
Young adults should therefore be monitored carefully throughout treatment.
Paroxetin bør seponeres fra patienter i manisk fase.
There are insufficient data concerning the risk of suicide related behaviour in treatment naïve patients, but careful monitoring might be warranted.
Nedsat nyre - eller leverfunktion Der skal udvises forsigtighed ved patienter med svær nedsat nyrefunktion eller nedsat leverfunktion (se 4. 2 Dosering og indgivelsesmåde).
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.
Diabetes Behandling med SSRI kan ændre den glykæmiske kontrol hos patienter med diabetes.
This is most likely to occur within the first few weeks of treatment.
Det kan være nødvendigt at justere dosis af insulin og/ eller oral hypoglykæmisk medicin.
In patients who develop these symptoms, increasing the dose may be detrimental.
Epilepsi Ligesom andre antidepressiva skal paroxetin anvendes med forsigtighed til patienter, der lider af epilepsi.
Paroxetine should not be used in combination with serotonin-precursors (such as L-tryptophan, oxitriptan) due to the risk of serotonergic syndrome.
Kramper Forekomsten af kramper ses hos færre end 0, 1% af de patienter, der behandles med paroxetin.
Mania As with all antidepressants, paroxetine should be used with caution in patients with a history of mania.
Lægemidlet bør seponeres hos patienter, der udvikler kramper.
Paroxetine should be discontinued in any patient entering a manic phase.
Elektrochok Der er kun begrænset klinisk erfaring med indgift af paroxetin, samtidig med at der gives elektrochok.
Renal/ hepatic impairment Caution is recommended in patients with severe renal impairment or in those with hepatic impairment.
CHMP/ 187488/ 2004 Glaukom
CHMP/ 187488/ 2004 Diabetes
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Ligesom andre SSRI forårsager paroxetin i sjældne tilfælde mydriasis og skal anvendes med forsigtighed hos patienter der har eller har haft snævervinklet glaukom.
Glaucoma 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.
Hyponatriæmi Hyponatriæmi er rapporteret i sjældne tilfælde, hovedsageligt hos ældre.
Hyponatraemia Hyponatraemia has been reported rarely, predominantly in the elderly.
Der bør ligeledes udvises forsigtighed hos patienter, der er disponeret for hyponatriæmi, f. eks. i forbindelse med samtidig brug af anden medicin og cirrose.
Caution should also be exercised in those patients at risk of hyponatraemia e. g. from concomitant medications and cirrhosis.
Blødning Der er rapporteret kutan blødning, f. eks. ekkymose og purpura, i forbindelse med SSRI.
Haemorrhage There have been reports of cutaneous bleeding abnormalities such as ecchymoses and purpura with SSRIs.
Der er ligeledes rapporteret andre blødningstegn, f. eks. gastrointestinal blødning.
Other haemorrhagic manifestations e. g. gastrointestinal haemorrhage have been reported.
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.
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.
< 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]
< 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].
Symptomer ved seponering af paroxetin
Withdrawal symptoms seen on discontinuation of paroxetine treatment
Seponeringssymptomer er almindeligt forekommende ved stop af behandling, især hvis der er tale om brat seponering (se 4. 8 Bivirkninger).
Withdrawal symptoms when treatment is discontinued are common, particularly if discontinuation is abrupt (see section 4.8 Undesirable effects).
I kliniske undersøgelser er bivirkninger set ved stop af behandling hos 30% af patienterne behandlet med paroxetin og hos 20% af patienterne behandlet med placebo.
In clinical trials adverse events seen on treatment discontinuation occurred in 30% of patients treated with paroxetine compared to 20% of patients treated with placebo.
CHMP/ 187488/ 2004 Lægemiddelmetaboliserende enzymer:
CHMP/ 187488/ 2004
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Paroxetins metabolisme og farmakokinetik kan påvirkes ved induktion eller hæmning af lægemiddelmetaboliserende enzymer.
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).
Eventuel efterfølgende dosisjustering skal følge den kliniske effekt (tolerabilitet og virkning).
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).
Hvis der ses antikolinerge virkninger, skal procyclidindosis nedsættes.
4.5 Interactions with other medicinal products and other forms of interaction
Carbamazepin, fenytoin, natriumvalproat.
John's Wort – Hypericum perforatum – preparations) 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).
Samtidig indgift lader ikke til at have nogen virkning på den farmakokinetiske / - dynamiske profil hos epilepsipatienter.
Caution should be advised and a closer clinical monitoring is required when these drugs are combined with paroxetine.
Paroxetins hæmmende virkning på CYP2D6:
Drug metabolising enzymes The metabolism and pharmacokinetics of paroxetine may be affected by the induction or inhibition of drug metabolising enzymes.
Ligesom andre antidepressiva, herunder andre SSRI' er, hæmmer paroxetin det cytokrome P450 - leverenzym CYP2D6.
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.
Hæmning af CYP2D6 kan medføre øgede plasmakoncentrationer ved samtidig indgift af lægemidler, som metaboliseres af dette enzym, af f. eks. visse tricykliske antidepressiva (clomipramin, nortriptylin og desipramin), neuroleptika af fenotiazintypen (f. eks. perfenazin og thioridazin, se 4. 3 Kontraindikationer), risperidon, visse Type 1C- antiarytmika (f. eks. propafenon og flecainid) og metoprolol.
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).
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.
Any subsequent dosage adjustment should be guided by clinical effect (tolerability and efficacy).
Alkohol Som ved andre psykotrope lægemidler bør patienten informeres om at undgå alkohol under behandling med paroxetin.
If anti-cholinergic effects are seen, the dose of procyclidine should be reduced.
Orale antikoagulanter Der kan forekomme farmakodynamisk interaktion mellem paroxetin og orale antikoagulanter.
Anticonvulsants: carbamazepine, phenytoin, sodium valproate.
Samtidig indgift af paroxetin og orale antikoagulanter kan medføre øget antikoagulantaktivitet og risiko for blødning.
Concomitant administration does not seem to show any effect on pharmacokinetic/ dynamic profile in epileptic patients.
NSAID og acetylsalicylsyre og andre stoffer med virkning på blodpladerne Der kan forekomme farmakodynamisk interaktion mellem paroxetin og NSAID/ acetylsalicylsyre.
CYP2D6 inhibitory potency of paroxetine As with other antidepressants, including other SSRIs, paroxetine inhibits the hepatic cytochrome P450 enzyme CYP2D6.
Samtidig indgift af paroxetin og NSAID/ acetylsalicylsyre kan medføre øget risiko for blødning (Se 4. 4 Særlige advarsler og forholdsregler vedrørende brugen).
Inhibition of CYP2D6 may lead to increased plasma concentrations of co- administered drugs metabolised by this enzyme.
Forsigtighed bør udvises når patienter, der tager SSRI samtidig er i behandling med antikoagulantia eller lægemidler som har indvirkning på blodpladerne eller forårsager øget risiko for blødning (f. eks. atypiske antipsykotika som klozapin, fenotiaziner, de fleste tricykliske antidepressiva, acetylsalicylsyre, NSAID, COX- 2 inhibitorer).
These include certain tricyclic antidepressants (e. g. clomipramine, nortriptyline, and desipramine), phenothiazine neuroleptics (e. g. perphenazine and thioridazine, see section 4.3 Contraindications), risperidone, certain Type 1c antiarrhythmics (e. g. propafenone and flecainide) and metoprolol.
Ligeledes bør forsigtighed udvises i patienter som tidligere har haft blødninger eller som er prædisponerede for blødninger.
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.
Data vedrørende et begrænset antal eksponerede graviditeter indicerer ikke øget risiko for medfødte misdannelser hos nyfødte.
Alcohol As with other psychotropic drugs patients should be advised to avoid alcohol use while taking paroxetine.
Paroxetin bør kun anvendes under graviditet på tvingende indikation.
Oral anticoagulants A pharmacodynamic interaction between paroxetine and oral anticoagulants may occur.
Kvinder, der planlægger at blive gravide, og kvinder, der bliver gravide under behandling, skal have besked om at gå til egen læge.
Concomitant use of paroxetine and oral anticoagulants can lead to an increased anticoagulant activity and haemorrhagic risk.
Brat seponering bør undgås under graviditet (se ” Symptomer ved seponering af paroxetin ” under 4. 2 Dosering og indgivelsesmåde).
Therefore, paroxetine should be used with caution in patients who are treated with oral anticoagulants.
Nyfødte skal observeres, hvis moderen fortsætter med at bruge paroxetin til langt hen i graviditeten, særligt i sidste trimester.
(see section 4.4 Special Warnings and Special Precautions for use)
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Følgende symptomer kan forkomme hos den nyfødte efter moderens brug af paroxetin i de sene stadier af graviditeten: åndedrætsbesvær, cyanose, apnø, kramper, temperaturudsving, besvær med fødeindtagelse, opkastning, hypoglykæmi, hypotoni, hypertoni, hyperrefleksi, tremor, dirren, irritabilitet, letargi, konstant gråd, somnolens og problemer med at sove.
NSAIDs and acetylsalicylic acid, and other antiplatelet agents A pharmacodynamic interaction between paroxetine and NSAIDs/ acetylsalicylic acid may occur.
Disse symptomer kan være forårsaget af enten serotonerge effekter eller seponeringssymptomer.
Concomitant use of paroxetine and NSAIDs/ acetylsalicylic acid can lead to an increased haemorrhagic risk.
I de fleste tilfælde begynder komplikationerne umiddelbart eller hurtigt (< 24 timer) efter fødslen.
(see section 4.4 Special warnings and Special Precautions for use) Caution is advised in patients taking SSRI’ s, concomitantly with oral anticoagulants, drugs known to affect platelet function or 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.
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).
Pregnancy Data on a limited number of exposed pregnancies provide no indication of an increased risk of congenital malformations in the newborn.
Små mængder paroxetin udskilles i modermælk.
Paroxetine should only be used during pregnancy when strictly indicated.
Der blev ikke observeret lægemiddelvirkninger hos disse spædbørn.
Women planning a pregnancy and those becoming pregnant during therapy should be asked to consult their physician.