FrancophonIA/ELRC3.0 huggingface dataset:
English: • Depression and prevention of recurrence of depression (in adults).
Danish: • Depression og forebyggelse af tilbagevendende depression (hos voksne).
English: The CHMP concluded that the safety in children and adolescents has not sufficiently been established and that a commitment to further investigate safety in paediatric patients is required.
Danish: CHMP konkluderede, at sikkerheden hos børn og unge ikke er tilstrækkeligt påvist, og at der er behov for yderligere tiltag til undersøgelse af sikkerheden for pædiatriske patienter.
English: If you are being treated for this disorder, your doctor will want to monitor you closely (see Use in children and adolescents below).
Danish: Hvis De bliver behandlet for denne lidelse, vil Deres læge kontrollere Dem regelmæssigt (se under ”Anvendelse til børn og unge under 18 år”).
English: - the Summaries of Products Characteristic, labelling and package leaflet proposed by the Marketing Authorisation Holders have been assessed based on the documentation submitted and the scientific discussion within the Committee,
Danish: - produktresuméerne, etiketteringen og indlægssedlen, som indehaveren af markedsføringstilladelsen har foreslået, er blevet vurderet på baggrund af den indsendte dokumentation og udvalgets faglige drøftelse
English: Your doctor may wish to stop your treatment.
Danish: Deres læge kan stoppe behandlingen.
English: Observed foetotoxicity was probably related to maternal toxicity.
Danish: Den observerede fototoksicitet var sandsynligvis relateret til toksicitet i moderdyret.
English: These may be increased when first starting antidepressants, since these medicines all take time to work, usually about two weeks but sometimes longer.
Danish: Disse tanker kan forstærkes, når De starter med at tage antidepressiv medicin, fordi medicinen er et stykke tid om at virke, ofte omkring 14 dage, men nogle gange længere tid.
English: If your doctor has prescribed Zoloft to a patient less than 18 years old and you want to discuss this, please contact him/her.
Danish: Hvis lægen har ordineret Zoloft til en patient under 18 år, og De ønsker at drøfte dette, skal De henvende Dem til lægen.
English: The safety profile of sertraline is acceptable and the CHMP concluded that the overall recommendation is to grant an indication for the treatment of panic disorder with the following wording:
Danish: Sikkerhedsprofilen for sertralin er acceptabel, og CHMP konkluderede, at den samlede anbefaling er at tillade en indikation for behandling af panikangst med følgende formulering:
English: You should ask your doctor if you are unsure why you have been given Zoloft.
Danish: Tal med lægen, hvis De er i tvivl om, hvorfor De har fået Zoloft.
English: In conclusion, the recurrence study is the first recurrence-prevention study in a trial with depressive patients who had experienced at least three documented episodes of major depressive disorder within the last 4 years.
Danish: Undersøgelsen af tilbagevenden er således den første undersøgelse af forebyggelse af tilbagevenden i en undersøgelse med depressive patienter, der havde oplevet mindst tre dokumenterede episoder af svær depression inden for de seneste 4 år.
English: Patients (and caregivers of patients) should be alerted about the need to monitor for any clinical worsening, suicidal behaviour or thoughts and unusual changes in behaviour and to seek medical advice immediately if these symptoms present.
Danish: Patienter (og plejepersonale) bør gøres opmærksom på behovet for overvågning med henblik på forekomst af en hvilken som helst klinisk forværring, selvmordsadfærd eller -tanker samt unormale ændringer i adfærd og på, at de straks skal søge læge, hvis disse symptomer opstår.
English: Activated charcoal, which may be used with a cathartic, may be as or more effective than lavage, and should be considered in treating overdose.
Danish: Aktivt kul, som kan anvendes sammen med et afføringsmiddel, kan være ligeså effektivt, eller mere effektiv end ventrikeltømning, og denne mulighed bør overvejes ved behandling af overdosering.
English: The CHMP was of the opinion that overall, modest short-term efficacy was demonstrated in these studies.
Danish: CHMP var af den opfattelse, at der samlet set blev påvist en moderat kortsigtet effekt i disse undersøgelser.
English: The CHMP agreed to the general aspects of the proposed study but requested the inclusion of a control group, consisting for instance of patients not treated with SSRIs or treated by psychotherapy alone.
Danish: CHMP accepterede de generelle aspekter af den foreslåede undersøgelse, men anmodede om, at der blev inddraget en kontrolgruppe, eksempelvis bestående af patienter, der ikke havde fået behandling med SSRI'er eller udelukkende havde fået behandling med psykoterapi.
English: The CHMP implemented the following text in section 4.2 of the SPC, to indicate that the need for continued treatment should be regularly evaluated:
Danish: CHMP implementerede følgende tekst i afsnit 4.2 af produktresuméet for at angive, at behovet for fortsat behandling skal vurderes regelmæssigt:
English: Nausea is the most common side effect.
Danish: Kvalme er den hyppigste bivirkning.
English: The primary endpoint was the proportion of subjects with a relapse.
Danish: Det primære endepunkt var andelen af patienter med tilbagefald.
English: Care and prudent medical judgment should be exercised when switching, particularly from long-acting agents such as fluoxetine.
Danish: Der bør derfor udvises forsigtighed og omhyggelig medicinsk vurdering, især hvis der skiftes fra langtidsvirkende stoffer, f.eks. fluoxetin.
English: Drugs Metabolized by Cytochrome P450
Danish: Lægemidler, der metaboliseres af cytokrom P450
English: The interference of depressive symptoms and their effect on PTSD is still a concern because this was not sufficiently controlled for.
Danish: Påvirkningen fra depressionssymptomer og deres effekt på PTSD giver stadig anledning til betænkeligheder, fordi der ikke er taget tilstrækkelig højde for dette.
English: In clinical trials with children and adolescents, the side effects were generally similar to adults (see above).
Danish: I kliniske forsøg hos børn og unge er der set de samme bivirkninger som hos voksne (se ovenfor).
English: If you forget to take a dose, do not take the missed dose.
Danish: Hvis De har glemt en dosis, skal De ikke tage den manglende dosis.
English: The primary efficacy variables in the different studies were the Liebowitz Social anxiety Symptom Scale (LSAS) and the Duke Brief Social Anxiety disorder Scale (BSPS).
Danish: De primære effektvariabler i de forskellige undersøgelser var LSAS (Liebowitz Social anxiety Symptom Scale) og BSPS (Duke Brief Social Anxiety disorder Scale).
English: The CHMP was of the opinion that the second relapse definition used in this study, based on only the investigators judgement rather than on objective measures of OCD, cannot be considered to be an acceptable relapse definition as it is not objective and not necessarily based on disorder specific symptoms.
Danish: CHMP var af den opfattelse, at den anden definition af tilbagefald, der blev anvendt i denne undersøgelse og som udelukkende var baseret på investigatorernes vurdering og ikke på objektive definitioner af OCD, ikke kan betragtes som en acceptabel definition af tilbagefald, eftersom den ikke er objektiv og ikke nødvendigvis er baseret på symptomer, der er specifikke for denne lidelse.
English: Therefore, the overall results of the sertraline studies are supportive of short- and long-term efficacy and, as no unexpected safety issues emerged against the known safety profile of sertraline in the treatment of depression, the CHMP considered the benefit/risk balance for the indication social anxiety disorder to be positive, and approved the following indication:
Danish: De samlede resultater af sertralinundersøgelserne dokumenterer dermed den kort- og langsigtede effekt, og da der ikke opstod uventede sikkerhedsproblemer i forhold til den kendte sikkerhedsprofil for sertralin ved behandling af depression, vurderede CHMP, at benefit/risk-forholdet for indikationen socialangst er positivt, og godkendte følgende indikation:
English: Other drug interactions, digoxin, atenolol, cimetidine Co-administration with cimetidine caused a substantial decrease in sertraline clearance.
Danish: Øvrige lægemiddelinteraktioner, digoxin, atenolol, cimetidin Samtidig behandling med cimetidin medførte et betydeligt fald i sertralin-clearance.
English: In a majority of instances the complications begin immediately or soon (<24 hours) after delivery.
Danish: I de fleste tilfælde indtræder komplikationerne straks eller inden for 24 timer efter fødslen.
English: Regarding the dosage, there are no reasons to believe that dose-response effects would be evident in children and adolescents, and subsequently disappear in adulthood and the CHMP considered that there is no evidence to support the minimum effective dose in children and in adolescents.
Danish: Hvad dosis angår, er der ikke grund til at tro, at dosisresponseffekter skulle være tydelige hos børn og unge for herefter at forsvinde hos voksne, og CHMP vurderede, at der ikke er nogen evidens som dokumentation for den mindste effektive dosis til børn og unge.
English: In conclusion, the CHMP was of the opinion that sertraline demonstrates a modest short-term effect and that the safety seems acceptable.
Danish: CHMP var således af den opfattelse, at der er påvist en moderat kortsigtet effekt af sertralin, og at sikkerheden forekommer acceptabel.
English: The CHMP considered that because anxiety is an inherent part of the depression disorder, a decrease in Hamilton anxiety can not be seen as separate due to possible interactions with improvement of depression.
Danish: CHMP vurderede, at eftersom angst er en grundlæggende del af depression, kan en mindskelse af Hamilton-angst ikke vurderes separat, da der er mulighed for interaktion med forbedring af depressionen.
English: Postnatal developmental delays found in pups from treated dams were probably due to effects on the dams and therefore not relevant for human risk.
Danish: Forsinkelse i den postnatale udvikling blev fundet i afkom fra behandlede moderdyr, og det skyldtes sandsynligvis virkningen på moderdyret, og det er derfor ikke relevant for risikoen hos mennesker.
English: As improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored until such improvement occurs.
Danish: Eftersom en forbedring af depressionen måske ikke ses før efter flere ugers behandling, bør patienten følges tæt, indtil en forbedring ses.
English: The design is largely adequate but because this trial is performed in patients with recurrent depressive episodes, the adequate wording of the SPC should mention the description of patient populations and previous episodes in section 5.1.
Danish: Undersøgelsens udformning er i det væsentlige adækvat, men fordi undersøgelsen blev udført på patienter med tilbagevendende depressive episoder, skal formuleringen i produktresuméets afsnit 5.1 inkludere en beskrivelse af patientpopulationer og foregående episoder.
English: Always take Zoloft exactly as your doctor has told you.
Danish: Tag altid Zoloft nøjagtigt efter lægens anvisning.
English: The primary efficacy variable was the CAPS-2 (Clinician-Administered PTSD scale) total severity score.
Danish: Den primære effektvariabel var den samlede sværhedsscore på CAPS-2 (Clinician-Administered PTSD Scale).
English: The CHMP considered that the lack of any evidence suggesting a difference between children and adults is not equivalent to establishing that the disorder is identical in the 2 groups.
Danish: CHMP vurderede, at mangelen på evidens som dokumentation for en forskel på børn og voksne ikke er ensbetydende med, at lidelsen er identisk i de to grupper.
English: Preclinical data does not indicate any special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenesis.
Danish: De prækliniske data viser ingen særlig risiko for mennesker vurderet ud fra konventionelle forsøg af sikkerhedsfarmakologi og toksicitet efter gentagne doser, genotoksicitet og karcinogenicitet.
English: The results submitted indicated that only 6 patients relapsed during the withdrawal phase of this study, 6% in placebo and 1% in the sertraline arm.
Danish: De offentliggjorte resultater indikerede, at kun 6 patienter fik tilbagefald i løbet af undersøgelsens seponeringsfase, 6 % fra placebogruppen og 1 % fra sertralingruppen.
English: Like all medicines, Zoloft can cause side effects, although not everybody gets them.
Danish: BIVIRKNINGER Zoloft kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: No interaction of sertraline 200 mg daily was observed with digoxin.
Danish: Der er ikke observeret interaktion mellem sertralin 200 mg dagligt og digoxin.
English: In rare cases this syndrome may occur when you are taking certain medicines at the same time as sertraline.
Danish: I sjældne tilfælde optræder dette syndrom, når De tager visse typer medicin på samme tid som sertralin.
English: Suicide-related behaviours (suicide attempt and suicidal thoughts), and hostility (predominantly aggression, oppositional behaviour and anger) were more frequently observed in clinical trials among children and adolescents treated with antidepressants compared to those treated with placebo.
Danish: Selvmordsrelateret adfærd (selvmordsforsøg og selvmordstanker) og fjendtlighed (fortrinsvis aggressioner, oppositionel adfærd og vrede) blev observeret hyppigere i kliniske forsøg blandt børn og unge behandlet med antidepressiva i forhold til gruppen behandlet med placebo.
English: • If you have low sodium level in your blood, since this can occur as a result of treatment with Zoloft.
Danish: • De har eller har haft et lavt natriumindhold i blodet, da dette kan opstå ved behandling med Zoloft.
English: Put the dropper on the bottle and tighten well.
Danish: Sæt pipetten på flasken, og skru den godt fast.
English: Sexual Dysfunction, Erectile Dysfunction
Danish: Seksuel dysfunktion, erektil dysfunktion
English: In addition, a trend toward greater improvement in the sertraline group than the placebo group was also observed on the CGI Severity scale (p=0.089).
Danish: Derudover sås en tendens til en større forbedring i sertralingruppen end i placebogruppen vurderet ud fra CGI Severity Scale (p=0,089).
English: Regarding the demonstration of the efficacy of sertraline, the CHMP considered the results of the study in war veterans (known to be a treatment resistant population) to be explained, but the reason for the negative effect in the second study unexplained, although likely to be linked to the unexpectedly high performance of the placebo group.
Danish: I forbindelse med påvisningen af sertralins effekt vurderede CHMP, at resultaterne af undersøgelsen af krigsveteraner (en behandlingsresistent population) blev forklaret, men at årsagen til den negative effekt i den anden undersøgelse ikke blev forklaret, selv om den sandsynligvis var forbundet med de uventet gode resultater i placebogruppen.
English: Co-administration with sertraline is not recommended
Danish: Samtidig administration med sertralin anbefales ikke
English: Blood and lymphatic system disorders
Danish: Blod- og lymfesystemet
English: The half-life of N-desmethylsertraline is in the range of 62 to 104 hours.
Danish: Halveringstiden for N-desmethylsertralin ligger i området 62-104 timer.
English: Mix the measured dose with 120 ml (one glass) of liquid.
Danish: Bland den afmålte dosis med 120 ml (et glas) væske.
English: The presented double-blind 12 week study in 187 children (6-17 years) supports the efficacy of sertraline but there was no justification for the dose in children and the clinical relevance of the results has not been established.
Danish: Den indsendte dobbeltblindede 12ugers undersøgelse af 187 børn (6-17 år) dokumenterer effekten af sertralin, men giver ingen begrundelse for dosis til børn.
English: “Continued treatment in panic disorder and OCD should be evaluated regularly, as relapse prevention has not been shown for these disorders”.
Danish: "Fortsat behandling af panikangst og OCD skal vurderes regelmæssigt, da der ikke er påvist tilbagefaldsforebyggelse for disse lidelser".
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Danish: BILAG I FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORMER, STYRKER, INDGIVELSESVEJE, INDEHAVERE AF MARKEDSFØRINGSTILLADELSER I MEDLEMSSTATERNE
English: Zoloft contains the active ingredient sertraline.
Danish: Zoloft indeholder det aktive stof sertralin.
English: Cardiac and other vital sign monitoring is recommended, along with general symptomatic and supportive measures.
Danish: Overvågning af hjertefunktion og andre vitale funktioner tilrådes samtidig med almindelig symptomatisk behandling og understøttende forholdsregler.
English: Major depressive episodes.
Danish: Depressive episoder.
English: The positive results that were obtained in two studies with respect to mean improvements on social anxiety scales and with respect to responders appear sufficiently robust to support short-term efficacy.
Danish: De positive resultater, der i to af undersøgelserne blev opnået, hvad angår gennemsnitlige forbedringer på skalaer for socialangst og set i forhold til responderende patienter, synes at være tilstrækkeligt pålidelige til at dokumentere den kortsigtede effekt.
English: The CHMP was of the opinion that based on the previous discussion within the committee and given the revised study synopsis submitted by the MAH, the OCD indication in paediatric patients is now also considered acceptable and therefore adopted the following indication:
Danish: CHMP var af den opfattelse, at baseret på den foregående diskussion med udvalget og under hensyntagen til den reviderede synopsis, som indehaveren af markedsføringstilladelsen havde indsendt, betragtes OCD-indikationen hos pædiatriske patienter nu også som acceptabel, og følgende indikation blev derfor vedtaget:
English: Use the dropper to measure the dose, as prescribed by the doctor.
Danish: Afmåling af dosis: Brug pipetten til at afmåle den dosis, som lægen har foreskrevet.
English: PTSD is a condition that can occur after a very emotionally traumatic experience, and has some symptoms that are similar to depression and anxiety.
Danish: PTSD er en tilstand, som kan opstå efter meget voldsomme oplevelser, og som har de samme symptomer, som depression og angst.
English: If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away.
Danish: Hvis De på noget tidspunkt får tanker om selvmord eller tanker om at gøre skade på Dem selv, skal De straks kontakte Deres læge eller hospitalet.
English: Noting that MDD is considered to be a chronic or chronic intermittent condition where treatment is aimed at amelioration and possibly interruption of the natural course of the episode, the CHMP considered it unnecessary to accept this separate indication.
Danish: CHMP noterede, at MDD betragtes som en kronisk eller kronisk tilbagevendende lidelse, hvor behandlingen sigter mod forbedring og, hvor det er muligt, afbrydelse af episodens naturlige forløb, og vurderede, at det var unødvendigt at acceptere denne separate indikation.
English: Also patients taking diuretics or who are otherwise volume-depleted may be at greater risk (see Use in elderly).
Danish: Patienter, der tager diuretika eller som på anden måde er volumendepleterede har også en større risiko (se under Ældre).
English: The assessment of the evidence for long-term efficacy and relapse prevention indicates the studies were not performed strictly according to guidelines and the long-term (24 weeks) study does suggest efficacy of long term treatment but includes exposure therapy arms which may have interfered with the interpretation of the results.
Danish: Vurderingen af evidensen for den langsigtede effekt samt tilbagefaldsforebyggelse blev ikke udført i henhold til retningslinjerne, og skønt den langvarige undersøgelse (24 uger) indikerer, at langtidsbehandling har en effekt, inddrager den også eksponeringsbehandlingsgrupper, der kan have påvirket fortolkningen af resultaterne.
English: Sertraline had no effect on the beta-adrenergic blocking ability of atenolol.
Danish: Sertralin har ikke nogen virkning på atenolols beta-adrenerge blokeringsevner.
English: The safety and efficacy of sertraline (50-200 mg/day) was examined in the treatment of non-depressed children (6-12 years old) and adolescent (13-17 years old) outpatients with obsessive compulsive disorder (OCD).
Danish: Sikkerhed og effekt af sertralin (50-200 mg dagligt) blev undersøgt ved ambulant behandling af ikkedeprimerede børn (6-12 år) og unge (13-17 år) med obsessiv-kompulsiv sygdom (OCD).
English: In patients with diabetes, treatment with an SSRI may alter glycaemic control, possibly due to improvement of depressive symptoms.
Danish: Hos patienter med diabetes kan behandling med en SSRI muligvis ændre den glykæmiske kontrol på grund af forbedring af de depressive symptomer.
English: • If you are allergic (hypersensitive) to sertraline or any of the other ingredients of Zoloft.
Danish: • hvis De er overfølsom (allergisk) over for sertralin eller et af de øvrige indholdsstoffer.
English: The CHMP concluded that short-term efficacy has been demonstrated, but that concerns remain over the lack of evidence with respect to relapse prevention.
Danish: CHMP konkluderede, at den kortsigtede effekt er påvist, men at der fortsat er betænkeligheder ved mangelen på evidens vedrørende tilbagefaldsforebyggelse.
English: You should therefore not drive or operate machinery, until you know how this medication affects your ability to perform these activities.
Danish: De bør derfor ikke føre motorkøretøj eller arbejde med maskiner, før De ved, hvordan De reagerer på behandlingen.
English: Moreover, with respect to safety, no data was submitted on endocrine parameters, effects on cognition and other maturation parameters.
Danish: Hvad angår sikkerheden, blev der endvidere ikke indsendt data om endokrine parametre, effekter på kognition og andre vækstparametre.
English: This phenomenon has also been observed with other SSRI antidepressants.
Danish: Dette fænomen er også set med andre SSRI-antidrepressiva.
English: However, longer periods are usually necessary to demonstrate therapeutic response, especially in OCD.
Danish: Terapeutisk respons er dog som regel først synlig efter en længere behandlingsperiode, især i forbindelse med OCD.
English: A low starting dose and titration steps of 25 mg are therefore recommended for children, especially with low bodyweight.
Danish: Derfor anbefales en lav startdosis og trinvis øgning af dosis med 25 mg ad gangen hos børn, især hos børn med lav legemsvægt.
English: In order to provide long-term safety evidence, the MAH proposed to augment the current Data Capture Aid (DCA) and to monitor all reported paediatric (less than 18 years of age) adverse events (AEs) in the pharmacovigilance safety database and look in more detail for AEs of interest in these cases.
Danish: For at tilvejebringe evidens for langsigtet sikkerhed foreslog indehaveren af markedsføringstilladelsen at forbedre den nuværende DCA (Data Capture Aid), overvåge alle rapporterede bivirkninger hos børn og unge (under 18 år) i lægemiddelovervågningsdatabasen og søge mere indgående efter bivirkninger af interesse i disse tilfælde.
English: • If you have previously had thoughts about killing or harming yourself.
Danish: - hvis De tidligere har haft selvmordstanker eller tanker om at gøre skade på Dem selv.
English: Anaphylactoid Reaction, Allergic Reaction, Allergy
Danish: Anafylaktoide reaktioner, allergiske reaktioner, allergi
English: Sertraline and N-desmethylsertraline are both extensively metabolized in man and the resultant metabolites excreted in faeces and urine in equal amounts.
Danish: Sertralin og Ndesmethylsertralin metaboliseres begge i vid udstrækning hos mennesker, og de fremkomne metabolitter udskilles i faeces og urin i lige store mængder.