FrancophonIA/ELRC3.0 huggingface dataset:
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 være længerevarende (2-3 måneder eller mere).
English: Close surveillance by the physician is required.
Danish: Patienten bør overvåges nøje af lægen.
English: They normally occur within the first few days after stopping treatment.
Danish: De opstår normalt inden for de første par dage efter behandlingen er stoppet.
English: Published data concerning sertraline levels in breast milk show that small quantities of sertraline and its metabolite N-desmethylsertraline are excreted in milk.
Danish: Publicerede data vedrørende sertralinkoncentrationen i modermælk viser, at en lille mængde sertralin og dets metabolit, N-desmethylsertralin, udskilles i modermælk.
English: Efficacy and safety were not investigated with respect to long-term safety, long-term effects on endocrine parameters, on sexual, cognitive and emotional development and other maturation parameters.
Danish: Effekt og sikkerhed blev ikke undersøgt med henblik på langsigtet sikkerhed, langsigtet effekt på endokrine parametre, på seksuel, kognitiv og følelsesmæssig udvikling samt andre vækstparametre.
English: However, concerns remain about the lack of evidence with respect to relapse prevention.
Danish: Der er dog stadig betænkeligheder ved mangelen på evidens vedrørende tilbagefaldsforebyggelse.
English: In a post-hoc analysis, responders, defined as patients with a 25% or greater decrease in the CY-BOCs (the primary efficacy measure) from baseline to endpoint, were 53% of sertraline-treated patients compared to 37% of placebo-treated patients (p=0.03).
Danish: I en post-hoc analyse varrespondere, der er defineret som patienter med et 25 % eller større fald i CY-BOCs (det primære effektmål) fra baseline til endepunkt, 53 % for sertralin-behandlede patienter sammenlignet med 37 % for placebo-behandlede patienter (p=0,03).
English: Special Precautions
Danish: Særlige forsigtighedsregler
English: Animal studies showed evidence for effects on reproduction probably due to maternal toxicity caused by the pharmacodynamic action of the compound and/or direct pharmacodynamic action of the compound on the foetus (see 5.3).
Danish: Dyreforsøg har påvist virkning på reproduktionen sandsynligvis på grund af maternel toksicitet forårsaget af stoffets farmakodynamiske virkning og/eller direkte farmakodynamiske virkning på fostret (se pkt.
English: Sertraline did not produce either the stimulation and anxiety associated with d-amphetamine or the sedation and psychomotor impairment associated with alprazolam.
Danish: Sertralin fremkaldte hverken den stimulering eller angst, der er associeret med d-amfetamin eller sedation og psykomotorisk svækkelse associeret med alprazolam.
English: Panic disorder and OCD
Danish: Panikangst og OCD
English: Sertraline does not function as a positive reinforcer in rhesus monkeys trained to self administer cocaine, nor does it substitute as a discriminative stimulus for either d-amphetamine or pentobarbital in rhesus monkeys.
Danish: Sertralin fungerer ikke som en positiv forstærker i rhesusaber, der er trænet til selv at anvende kokain, ej heller som substitut for en karakteristisk stimulans for hverken d-amfetamin eller pentobarbital i rhesusaber.
English: No data is available for children under 6 years of age”.
Danish: Der er ingen tilgængelige data for børn under 6 år".
English: The CHMP agreed that overall, the safety of sertraline in the treatment of PTSD is similar to that of major depressive disorder) MDD and does not present any new issues.
Danish: CHMP var enig i, at sikkerheden af sertralin ved behandling af PTSD svarer til sikkerheden ved behandling af svær depression (MDD) og ikke giver anledning til nye problemstillinger.
English: Hypothyroidism and syndrome of inappropriate ADH secretion
Danish: Hyperprolaktinæmi, hypotyreose og syndrom med uhensigtsmæssig sekretion af ADH
English: The pattern and incidence of adverse reactions in the elderly was similar to that in younger patients.
Danish: Bivirkningernes art og hyppighed hos de ældre patienter svarede til forekomsten hos yngre patienter.
English: Two previous additional open label extension studies (that were not submitted within the context of this dossier) showed serious AEs, some of which were possibly related to study drug, including severe aggressive reactions, nervousness and paranoid reactions, two severe grand mal seizures,
Danish: To tidligere forlængede åbne undersøgelser (der ikke blev indsendt i forbindelse med dette dossier) viste alvorlige bivirkninger, hvoraf nogle muligvis var relateret til undersøgelsesmedicinen, herunder meget aggressive reaktioner, nervøsitet og paranoide reaktioner, to alvorlige grand mal-anfald, overdrevne selvmordstanker og drabstanker.
English: In accord with its selective inhibition of 5-HT uptake, sertraline does not enhance catecholaminergic activity.
Danish: I overensstemmelse med den selektive hæmning af 5-HT genoptagelse, forstærker sertralin ikke den katekolaminerge aktivitet.
English: provided the lack of long-term efficacy results is reflected in the SPC section 4.2, indicating the need for regular assessment of treatment continuation with the following wording:
Danish: under forudsætning af, at mangelen på resultater om langsigtet effekt afspejles i produktresuméets afsnit 4.2, hvor behovet for regelmæssig vurdering af fortsættelse af behandlingen skal indikeres med følgende formulering:
English: No data is available for children under 6 years of age.
Danish: Der er ingen tilgængelige data for børn under 6 år.
English: Section 4.1 - Indications: Depression (MDD)
Danish: Afsnit 4.1 - Indikationer: depression (MDD)
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. behandlingsvarighed og dosis samt hastigheden af dosisreduktion.
English: The results indicated that with respect to the primary efficacy endpoint, three of the studies demonstrated statistically significant improvement in panic disorders compared to placebo, while the fourth study did not.
Danish: Resultaterne indikerede, at hvad det primære effektendepunkt angik, påviste tre af undersøgelserne statistisk signifikante forbedringer af panikangst sammenlignet med placebo, mens den fjerde undersøgelse ikke gjorde.
English: The CHMP considered that open label studies are not appropriate to demonstrate long term efficacy for regulatory purposes, and that a single study cannot be sufficient to support a paediatric indication.
Danish: CHMP vurderede, at åbne undersøgelser ikke er egnede til at påvise langsigtet effekt i lovgivningsøjemed, og at en enkelt undersøgelse ikke kan betragtes som tilstrækkelig dokumentation for en indikation til børn.
English: In both sections, caution is advised and a lower or less frequent dose should be used in patients with hepatic impairment.
Danish: Under begge punkter anbefales det at udvise forsigtighed og bruge en lavere og mindre hyppig dosis til patienter med nedsat leverfunktion.
English: • Medicines to treat mania and depression (lithium).
Danish: • Medicin mod mani og depression (lithium).
English: Pharmacokinetics of sertraline was studied in 29 paediatric patients aged 6-12 years old, and 32 adolescent patients aged 13-17 years old.
Danish: Sertralins farmakokinetik er undersøgt hos 29 børn i alderen 6-12 år og 32 unge i alderen 13-17 år.
English: Another concern is the effect on depression and the chronicity effect, as only subgroups defined by <5 year or >5years chronicity were examined while chronic PTSD according to DSM criteria starts at >3 months.
Danish: Der er desuden betænkeligheder vedrørende effekten på depression og kronicitetseffekten, da de undersøgte undergrupper var defineret ud fra mindre eller mere end 5 års kronicitet, mens kronisk PTSD ifølge DSM's kriterier begynder ved en varighed på over 3 måneder.
English: Nevertheless, it is possible that your doctor decides to prescribe Zoloft to a patient under 18 if it is in the patient's interest.
Danish: Trods dette kan Deres læge ordinere Zoloft til patienter under 18 år, hvis han/hun beslutter, at det er i patientens bedste interesse.
English: • Do not use Zoloft together with disulfiram.
Danish: • De må ikke tage Zoloft sammen med disulfiram.
English: Prevention of relapse and recurrence was not initially requested by the MAH but proposed during the assessment by the CHMP.
Danish: Indehaveren af markedsføringstilladelsen fremsatte ikke initialt en anmodning om tilbagefaldsforebyggelse, men stillede forslag om dette under CHMP's vurdering.
English: A direct effect on PTSD while controlling for the effect on depression was not demonstrated.
Danish: Der blev ikke påvist nogen direkte effekt på PTSD, hvor der var taget højde for effekten på depression.
English: Sertraline should be discontinued in any patient entering a manic phase.
Danish: Sertralin bør seponeres hos enhver patient, der går ind i en manisk fase.
English: In vitro studies indicate that sertraline has little or no potential to inhibit CYP 1A2.
Danish: In vitro-forsøg tyder på, at sertralin i meget lille eller ingen grad hæmmer CYP1A2.
English: Therefore the CHMP considers that insufficient evidence was provided to support the duration of treatment in OCD.
Danish: CHMP vurderer derfor, at der blev givet utilstrækkelig evidens som dokumentation for varigheden af behandlingen af OCD.
English: This may be water, ginger ale, lemon/lime soda, lemonade or orange juice.
Danish: Væsken kan være vand, ginger ale, mineralvand med eller uden citrus, lemonade eller appelsinjuice.
English: • Medicines to treat epilepsy (phenytoin).
Danish: • Medicin mod epilepsi (phenytoin).
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR THE AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET PRESENTED BY THE EMEA
Danish: BILAG II FAGLIGE KONKLUSIONER OG BEGRUNDELSER FOR ÆNDRING AF PRODUKTRESUMÉERNE, ETIKETTERINGEN OG INDLÆGSSEDLEN FREMLAGT AF EMEA
English: A study was conducted which involved depressed outpatients who had responded by the end of an initial 8-week open treatment phase on sertraline 50-200 mg/day.
Danish: Et klinisk forsøg blev udført på de ambulante deprimerede patienter, der ved slutningen af en initial 8 ugers åben behandlingsfase havde responderet på sertralin 50-200 mg dagligt.
English: Accordingly, prothrombin time should be carefully monitored when sertraline therapy is initiated or stopped.
Danish: Prothrombintiden bør derfor overvåges, når sertralinbehandling initieres eller seponeres.
English: Possible Side Effects).
Danish: Bivirkninger).
English: When you later open the bottle, push down hard on the dropper while turning the dropper to the left (counter clockwise).
Danish: Når De senere skal åbne flasken, pres da pipetten hårdt ned og drej samtidigt til venstre (mod uret).
English: “Sertraline is indicated for the treatment of panic disorder, with or without agoraphobia”.
Danish: "Sertralin er indiceret til behandling af panikangst med eller uden agorafobi".
English: Comments were also made to the remaining sections of the SPC, and for all sections, the labelling and the package leaflet were revised accordingly.
Danish: Der blev også fremsat bemærkninger til de resterende punkter i produktresuméet, og etiketten og indlægssedlen blev revideret for samtlige punkter.
English: Suicide/suicidal thoughts/suicide attempts or clinical worsening Depression is associated with an increased risk of suicidal thoughts, self harm and suicide (suiciderelated events).
Danish: Selvmord/selvmordstanker/selvmordsforsøg eller klinisk forværring Depression er forbundet med en øget risiko for selvmordstanker, selvdestruktive handlinger og selvmord (selvmordsrelaterede hændelser).
English: (For symptoms, see section 4.
Danish: (Information om symptomer kan ses i afsnit 4.
English: A review of the trials included in this dossier indicated that there were two trials that included patients with a bipolar disorder and one with depression accompanied by symptoms of anxiety.
Danish: En gennemgang af undersøgelserne i dette dossier indikerede, at der var to undersøgelser af patienter med bipolar sygdom og én af patienter med depression ledsaget af symptomer på angst.
English: Hyponatraemia may occur as a result of treatment with SSRIs or SNRIs including sertraline.
Danish: Hyponatriæmi kan forekomme i forbindelse med behandling med SSRI eller SNRI, herunder sertralin.
English: The side effects depend on the dose and are often transient with continued treatment.
Danish: Bivirkningerne afhænger af dosis og er ofte forbigående ved fortsat behandling.
English: You should also tell your doctor if you are taking certain medicines for hypertension, since these medicines may also alter the sodium level in your blood.
Danish: Fortæl det til lægen, hvis De får medicin mod for højt blodtryk, da denne medicin kan ændre natriumindholdet i blodet.
English: Thoughts of suicide and worsening of your depression or anxiety disorder: If you are depressed and/or have anxiety disorders you can sometimes have thoughts of harming or killing yourself.
Danish: Selvmordstanker og forværring af Deres depression eller angst Hvis De er deprimeret og/eller lider af angst, kan De sommetider have selvmordstanker eller tanker om at gøre skade på Dem selv.
English: This has been confirmed by in-vivo interaction studies with CYP3A4 substrates (endogenous cortisol, carbamazepine, terfenadine, alprazolam), CYP2C19 substrate diazepam, and CYP2C9 substrates tolbutamide, glibenclamide and phenytoin.
Danish: Dette er bekræftet ved in vivo-interaktionsforsøg med CYP3A4-substrater (endogen cortisol, carbamazepin, terfenadin, alprazolam), CYP2C19-substratet diazepam og CYP2C9-substraterne tolbutamid, glibenclamid og phenytoin.
English: Regarding pimozide, the CHMP agreed to the MAH proposal: “Concomitant intake of pimozide is contraindicated (see section 4.5)” and regarding hepatic impairment, the CHMP considered that patients with significant hepatic impairment are not strictly contraindicated with sertraline and that appropriate warnings about the recommended use of sertraline in patients with hepatic impairment are provided in section 4.2 and section 4.4 of the proposed harmonised SPC.
Danish: Angående pimozid erklærede CHMP sig enig i forslaget fra indehaveren af markedsføringstilladelsen: "Samtidig indtagelse af pimozid er kontraindiceret (se afsnit 4.5)", og angående nedsat leverfunktion vurderede CHMP, at patienter med signifikant nedsat leverfunktion ikke er strengt kontraindicerede med sertralin, og at afsnit 4.2 og 4.4 i det foreslåede harmoniserede produktresumé indeholder passende advarsler om den anbefalede brug af sertralin til patienter med nedsat leverfunktion.
English: Sertraline is extensively metabolised by the liver.
Danish: Sertralin metaboliseres i vid udstrækning i leveren.
English: Information from clinical trials has shown an increased risk of suicidal behaviour in adults aged less than 25 years with psychiatric conditions who were treated with an antidepressant.
Danish: Information fra kliniske studier har vist, at der var en øget risiko for selvmordsadfærd hos voksne under 25 år med psykiatriske lidelser, der blev behandlet med antidepressiv medicin.
English: The study included children and adolescents aged 617.
Danish: Undersøgelsen inkluderede børn og unge på 6-17 år.
English: Endocrine disorders
Danish: Endokrine system
English: Severe adverse reactions have been reported in patients who have recently been discontinued from an MAOI and started on sertraline, or have recently had sertraline therapy discontinued prior to initiation of an MAOI.
Danish: Der er rapporteret om alvorlige reaktioner hos patienter, som for nylig har seponeret en behandling med en MAO-hæmmer og startet på sertralinbehandling, eller som har seponeret en sertralinbehandling før initiering af behandling med en MAO-hæmmer.
English: At clinical doses, sertraline blocks the uptake of serotonin into human platelets.
Danish: I kliniske doser blokerer sertralin genoptagelse af serotonin i humane blodplader.
English: Section 4.1 - Indications: Panic disorder with or without agoraphobia disorder
Danish: 4.1 - Indikationer: panikangst med eller uden agorafobi
English: The % of responders (defined as those patients that did not relapse) for sertraline and placebo arms were 83.4% and 60.8%, respectively.
Danish: Procentdelen af respondere (defineret som de patienter, der ikke fik tilbagefald) var 83,4 % for sertralin og 60,8 % for placebogruppen.
English: Depending on hepatic function, this effect may still be present for as long as two weeks after the last dose of disulfiram, although one week is the more typical duration of action with standard doses.
Danish: Afhængigt af leverfunktion kan denne effekt vedvare i op til 2 uger efter indtagelse af den sidste dosis disulfiram, selv om det normalt er 1 uge ved standarddosering.
English: The provided results also indicate that relapse rates in the sertraline/sertraline arm are significantly lower compared to the rates in sertraline/placebo and placebo/placebo arms.
Danish: De offentliggjorte resultater indikerer desuden, at tilbagefaldsraterne i sertralin/sertralingruppen er signifikant lavere end i sertralin/placeboog placebo/placebo-grupperne.
English: • If you experience agitation, confusion, diarrhoea, high temperature and blood pressure, excessive sweating and rapid heartbeat.
Danish: • Hvis De oplever rastløs uro, forvirring, diarré, høj feber og højt blodtryk, svedtendens og hurtig puls.
English: It is devoid of stimulant, sedative or anticholinergic activity or cardiotoxicity in animals.
Danish: Sertralin har ingen stimulerende, sedativ eller antikolinerg aktivitet og er ikke kardiotoksisk i dyr.
English: Due to the large volume of distribution of sertraline, forced diuresis, dialysis, haemoperfusion and exchange transfusion are unlikely to be of benefit.
Danish: Da sertralin har et stort distributionsvolumen er forceret diurese, dialyse, hæmoperfusion og udskiftningstransfusion sandsynligvis uden effekt.
English: Patients under 18 have an increased risk of undesirable effects, such as suicide attempt, suicidal thoughts and hostility (mainly aggressiveness, oppositional behaviour and anger) when they are treated with this class of medicines.
Danish: Desuden gøres opmærksom på, at patienter under 18 år har en øget risiko for bivirkninger som f.eks. selvmordsforsøg, selvmordstanker og fjendtlighed (fortrinsvis aggression, trodsig adfærd og vrede), når de behandles med denne type medicin.
English: Sertraline may act as a mild-moderate inhibitor of CYP 2D6.
Danish: Sertralin kan muligvis fungere som en mild til moderat hæmmer af CYP2D6.
English: Regarding safety, the incidence of all adverse events is within the range reported for the application of sertraline in major depression and the post-marketing experience does not indicate any adverse events which deserve special attention or concern in the application for this indication.
Danish: Hvad sikkerheden angår, ligger forekomsten af samtlige bivirkninger inden for det område, der er rapporteret for anvendelse af sertralin til svær depression, og erfaringerne efter markedsføring indikerer ingen bivirkninger, der kræver særlig opmærksomhed eller giver anledning til særlige betænkeligheder ved anvendelse til denne indikation.
English: Reproduction toxicity studies in animals showed no evidence of teratogenicity or adverse effects on male fertility.
Danish: Reproduktionstoksicitetsforsøg med dyr viste ingen tegn på teratogenicitet eller påvirkning af handyrenes fertilitet.
English: Generally neglible to undetectable levels were found in infant serum, with one exception of an infant with serum levels about 50% of the maternal level (but without a noticeable health effect in this infant).
Danish: Generelt blev der fundet ubetydelige eller umålelige sertralinkoncentrationer i spædbarns-serum, dog med en undtagelse hos et spædbarn, hvor serumkoncentrationen var omkring 50 % af moderens serumkoncentration (men uden synlig sundhedsmæssig påvirkning af barnet).
English: Chronic dosing with sertraline 50 mg daily showed moderate elevation (mean 23%-37%) of steady-state desipramine plasma levels (a marker of CYP 2D6 isozyme activity).
Danish: Længerevarende dosering med sertralin 50 mg dagligt har vist en moderat stigning (gennemsnit 23-37 %) i steady state desipraminplasmaniveauet (desipramin er en markør for CYP2D6-isoenzymaktivitet).
English: While the mechanism of this interaction is unknown, due to the narrow therapeutic index of pimozide, concomitant administration of sertraline and pimozide is contraindicated (see section 4.3).
Danish: Da mekanismen bag denne interaktion er ukendt, og på grund af pimozids snævre terapeutiske indeks, er samtidig indgift af sertralin og pimozid kontraindiceret (se pkt.
English: The MAH submitted data from a number of studies to support the proposed harmonised text for this section.
Danish: Indehaveren af markedsføringstilladelsen indsendte data fra flere undersøgelser som dokumentation for den harmoniserede tekst i dette punkt.
English: There is evidence that sertraline is excreted in human breast milk.
Danish: Der er bevis for, at sertralin udskilles i modermælk.
English: Discontinuation of sertraline should be considered in patients with symptomatic hyponatraemia and appropriate medical intervention should be instituted.
Danish: Seponering af behandling bør overvejes hos patienter med symptomatisk hyponatriæmi, og egnet medicinsk intervention bør indledes.
English: Establish and maintain an airway and ensure adequate oxygenation and ventilation, if necessary.
Danish: Luftveje bør holdes frie, og der bør gives ilt og hvis nødvendigt ventileres.
English: The two short-term placebo controlled studies were conducted in patients with social anxiety disorder.
Danish: De to kortvarige placebokontrollerede undersøgelser blev foretaget med patienter med socialangst.
English: Use the dropper provided to remove the required amount of sertraline oral concentrate and dilute with approximately 120 ml (one glass) of water, ginger ale, lemon/lime soda, lemonade or orange juice.
Danish: Brug pipetten til at afmåle den ønskede mængde koncentrat og fortynd med ca. 120 ml (1 glas) vand, ginger ale, mineralvand med brus og med eller uden citrus, lemonade eller appelsinjuice.
English: The active compound of Zoloft and associated names is sertraline, a selective serotonin reuptake inhibitor (SSRI).
Danish: Det aktive stof i Zoloft og tilknyttede navne er sertralin, en selektiv serotoningenoptagelseshæmmer (SSRI).
English: Sertraline does not act as an inhibitor of CYP 3A4, CYP 2C9, CYP 2C19, and CYP 1A2 to a clinically significant degree.
Danish: Sertralin fungerer ikke som en hæmmer af CYP3A4, CYP2C9, CYP2C19 og CYP1A2 i en klinisk signifikant grad.
English: Therefore it is considered that insufficient evidence was provided to support the duration of treatment in panic disorders.
Danish: Det vurderes derfor, at der blev givet utilstrækkelig evidens som dokumentation for varigheden af behandlingen af panikangst.
English: These may be signs of a condition known as Stevens Johnson Syndrome, or Toxic Epidermal Necrolysis (TEN).
Danish: Dette kan være tegn på Stevens-Johnsons syndrom eller toksisk epidermal nekrolyse.
English: It is characterised by feelings of intense anxiety or distress in social situations (for example: talking to strangers, speaking in front of groups of people, eating or drinking in front of others or worrying that you might behave in an embarrassing manner).
Danish: tale med fremmede, tale foran en stor forsamling, spise eller drikke foran andre personer eller være bange for, at De måske opfører Dem på en pinlig måde).
English: Consistent with the terminal elimination half-life, there is an approximately two-fold accumulation up to steady state concentrations, which are achieved after one week of once-daily dosing.
Danish: I overensstemmelse hermed er der ca. en dobbelt akkumulering op til steady state-koncentrationerne, som opnås efter en daglig dosis i en uge.