FrancophonIA/ELRC3.0 huggingface dataset:
English: • granulomatosis with polyangiitis (GPA or Wegener's granulomatosis) and microscopic polyangiitis (MPA), which are inflammatory conditions of the blood vessels.
Danish: • inflammatoriske sygdomme i blodkarrene (granulomatose med polyangiitis (GPA eller Wegeners granulomatose) og mikroskopisk polyangiitis (MPA)) Alt efter hvilken sygdom Blitzima anvendes mod, kan det gives sammen med kemoterapi (andre kræftlægemidler) eller lægemidler mod inflammatoriske sygdomme (binyrebarkhormon).
English: Medicines are not always suitable for everyone.
Danish: Medicin er ikke altid passende for enhver.
English: The other 2 studies were negative.
Danish: De øvrige 2 undersøgelser var negative.
English: Frequency not Known
Danish: Frekvens ikke kendt
English: The clinical significance of these changes is unknown.
Danish: Den kliniske betydning af disse ændringer er ukendt.
English: These increased levels were not associated with any changes in EKG.
Danish: Denne stigning er ikke forbundet med ændringer i EKG.
English: The onset of therapeutic effect may be seen within 7 days.
Danish: Terapeutisk effekt kan ses inden for 7 dage.
English: There were no significant differences between boys and girls regarding clearance.
Danish: Der var ingen signifikant forskel mellem drenge og piger med hensyn til clearance.
English: Therefore, any overdosage should be medically treated aggressively.
Danish: Enhver overdosering bør derfor behandles aggressivt.
English: Vetenskapsvägen 10 191 90 Sollentuna Sweden
Danish: Vetenskapsvägen 10 191 90 Sollentuna Sverige
English: de Europa, 20 B Parque Empresarial La Moraleja 28108 Alcobendas (Madrid) SPAIN
Danish: de Europa, 20 B Parque Empresarial La Moraleja 28108 Alcobendas (Madrid) Spanien
English: Distribution Approximately 98% of the circulating drug is bound to plasma proteins.
Danish: Fordeling Ca. 98% af det cirkulerende stof er bundet til plasmaproteiner.
English: The results of these studies indicate a positive benefit/risk balance for MDD.
Danish: Resultaterne af disse undersøgelser indikerer et positivt benefit/risk-forhold for MDD.
English: It may take several weeks before your symptoms begin to improve
Danish: Det kan tage flere uger, før Deres symptomer kan blive forbedret.
English: Over 700 elderly patients (>65 years) have participated in clinical studies.
Danish: Over 700 ældre patienter (>65 år) deltog i et klinisk forsøg.
English: Your doctor has decided that this medicine is suitable for treating your illness.
Danish: Lægen har besluttet, at denne medicin er passende til behandling af Deres sygdom.
English: <{Name of the Member State}> <{Name of the medicinal product}> <{Name of the Member State}> <{Name of the medicinal product}>
Danish: <{Medlemslandets navn}> <{Lægemidlets navn}> <{Medlemslandets navn}> <{Lægemidlets navn}>
English: Induction of emesis is not recommended.
Danish: Induktion af emesis frarådes.
English: Adolescents could be dosed like adults.
Danish: Unge kan doseres som voksne.
English: Less frequently reported was coma.
Danish: Der er mindre hyppigt rapporteret om koma.
English: <This medicinal product is authorised in the Member States of the EEA under the following names:>
Danish: Dette lægemiddel er godkendt i EEAs medlemslande under følgende navne:
English: • If you are taking or have taken disulfiram with the last 2 weeks.
Danish: • Hvis De tager eller har taget disulfiram inden for de sidste 2 uger.
English: Medicinal products containing lactose
Danish: Lægemidler, der indeholder lactose
English: In some patients they may last longer (2-3 months or more).
Danish: Hos nogle patienter kan det tage længere tid (2-3 måneder eller mere).
English: Pooled analysis and postmarketing experience (frequency not known).
Danish: Poolede analyser og efter markedsføring (frekvens ikke kendt).
English: There are no well controlled studies in pregnant women.
Danish: Der er ikke foretaget velkontrollerede forsøg med gravide kvinder.
English: The usual dose is:
Danish: Den sædvanlige dosis er
English: Never drink the concentrate undiluted.
Danish: Drik aldrig koncentratet ufortyndet.
English: Your doctor will stop your treatment in these cases.
Danish: Lægen vil stoppe behandlingen i disse tilfælde.
English: • If you start to get feelings of restlessness and not be able to sit or stand still after you start to take Zoloft.
Danish: • Hvis De begynder at blive rastløs, og ikke er i stand til at sidde eller stå stille, efter De er begyndt at tage Zoloft.
English: The results show that only two of the four studies demonstrated efficacy while the remaining two studies were negative.
Danish: Resultaterne viser, at kun to af de fire undersøgelser påviste en effekt, mens de resterende to undersøgelser var negative.
English: • If you are a child or adolescent under 18 years old.
Danish: • De er barn eller ung under 18 år.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF ZOLOFT AND ASSOCIATED NAMES (SEE ANNEX I)
Danish: SAMLET RESUMÉ AF DEN FAGLIGE VURDERING AF ZOLOFT OG TILKNYTTEDE NAVNE (SE BILAG I)
English: In addition, the MAH proposed harmonised wordings for sections 4.4, 4.5, 4.6, 4.7, 4.8 and 4.9 as well as for sections 5.1, 5.2 and 5.3.
Danish: Indehaveren af markedsføringstilladelsen foreslog desuden harmoniserede formuleringer til afsnit 4.4, 4.5, 4.6, 4.7, 4.8 og 4.9 samt afsnit 5.1, 5.2 og 5.3.
English: Do not use Zoloft after the expiry date which is stated on the pack.
Danish: Brug ikke Zoloft efter den udløbsdato, der står på pakningen.
English: CNS depressants and alcohol
Danish: CNS-depressiva og alkohol
English: The effect on anxiety is considered to be part of the antidepressant effect, and the indication can therefore not be granted.
Danish: Effekten på angst betragtes som en del af den antidepressive effekt, og indikationen kan derfor ikke tillades.
English: Take your medication once daily either in the morning or evening.
Danish: Tag medicinen 1 gang dagligt, enten morgen eller aften.
English: Your doctor will advise you on how long to take this medication for.
Danish: Lægen vil fortælle dem, hvor længe De skal tage denne medicin.
English: On the evidence available, sertraline has a wide margin of safety in overdose.
Danish: På baggrund af den tilgængelige dokumentation har sertralin en bred margin af sikkerhed ved overdosering.
English: Talk to your doctor if you are taking the following medicine:
Danish: Tal med lægen, hvis De tager følgende medicin:
English: Activation of hypomania or mania
Danish: Aktivering af hypomani eller mani
English: Generally, such symptoms are mild to moderate.
Danish: Generelt er disse symptomer milde til moderate.
English: You may be more likely to think like this:
Danish: De kan have øget risiko for sådanne tanker:
English: Long term safety and efficacy data are lacking for this paediatric population.
Danish: Længerevarende sikkerheds- og effektdata mangler for denne pædiatriske population.
English: Subsequently, the physician may continue decreasing the dose, but at a more gradual rate.
Danish: Herefter kan lægen fortsætte med at reducere dosis, men i et langsommere tempo.
English: All studies included patients with Obsessive Compulsive Disorder (OCD) according to DSM-III or III-R.
Danish: Samtlige undersøgelser inkluderede patienter med obsessiv-kompulsiv tilstand (OCD) i henhold til DSM-III eller III-R.
English: In general, such symptoms disappear on their own and wear off within 2 weeks.
Danish: Som regel forsvinder sådanne symptomer af sig selv og er væk inden for 2 uger.
English: However, the CHMP considered that the two positive studies allow to conclude on efficacy and adopted the following indication:
Danish: CHMP vurderede dog, at de to positive undersøgelser muliggjorde en konklusion om effekten og vedtog følgende indikation:
English: Patients with depression should be treated for a sufficient period of time of at least 6 months to ensure they are free from symptoms.
Danish: Patienter med depression bør behandles i en periode på mindst 6 måneder for at sikre, at de er symptomfri.
English: Symptoms of serotonergic syndrome may also occur with other products of the same class (triptans).
Danish: Symptomer på serotonergt syndrom kan også forekomme med andre produkter af samme klasse (triptaner).
English: This medicinal product contains 12 % ethanol (alcohol) and must be diluted before use.
Danish: Denne medicin indeholder 12% alkohol, og skal fortyndes før brug.
English: {Name and address} <{tel}> <{fax}> <{e-mail}>
Danish: {Navn og adresse} <{tlf}> <{fa{Navn}}> <{email}>
English: Dosage during long-term therapy should be kept at the lowest effective level, with subsequent adjustment depending on therapeutic response.
Danish: Dosering i en længerevarende behandlingsperiode bør holdes på det lavest mulige effektgivende niveau med efterfølgende justering afhængigt af terapeutisk respons.
English: • If you experience depressive symptoms with suicidal ideas.
Danish: • Hvis De får depressive symptomer med selvmordstanker.
English: There was one suicide attempt and one reported case of sertraline overdose, but no death occurred in the studies.
Danish: Der forekom ét selvmordsforsøg, og der blev rapporteret om ét tilfælde af sertralinoverdosis, men der skete ingen dødsfald i løbet af undersøgelserne.
English: Your doctor will have told you whether you have suffered from this in the past.
Danish: Lægen vil fortælle Dem, hvis De har haft dette før.
English: The pharmacokinetic profile in adolescents or elderly is not significantly different from that in adults between 18 and 65 years.
Danish: Den farmakokinetiske profil hos unge eller ældre er ikke signifikant forskellig fra den hos voksne mellem 18 og 65 år.
English: You might ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behaviour.
Danish: De kan eventuelt bede dem om at fortælle Dem, hvis De synes, at Deres depression eller angst bliver værre, eller hvis de bliver bekymrede over ændringer i Deres opførsel.
English: The following side effects were seen in clinical trials in adults.
Danish: Følgende bivirkninger er set i kliniske forsøg hos voksne.
English: Evidence was found that the early postnatal mortality was due to in-utero exposure after day 15 of pregnancy.
Danish: Der er fundet bevis for, at den tidlige, postnatale mortalitet skyldtes in-utero eksponering efter dag 15 i drægtigheden.
English: The first time you open the bottle of oral concentrate, you should put the pipette on the bottle as follows:
Danish: Første gang De åbner flasken med koncentratet, skal De sætte pipetten på flasken således:
English: The recommendation derived from the evidence regarding efficacy and safety is to grant the following indication for the treatment of OCD:
Danish: Den anbefaling, der kan afledes af evidensen vedrørende effekten og sikkerheden, er at tillade følgende indikation til behandling af OCD:
English: Taking Zoloft together with the following medicines may cause serious side effects:
Danish: Brug af Zoloft sammen med følgende medicin kan give alvorlige bivirkninger:
English: Cases of serum sodium levels lower than 110 mmol/l have been reported.
Danish: Der er rapporteret tilfælde af serum-natriumniveau under 110 mmol/l.
English: Other serotonergic drugs See section 4.4.
Danish: Andre serotonerge lægemidler Se pkt 4.4.
English: The dropper is found in the carton.
Danish: Pipetten ligger i kartonen.
English: The safety of sertraline has not fully been established in pregnant women.
Danish: Sertralins sikkerhed er ikke fuldt ud undersøgt hos gravide kvinder.
English: {Name and Address} <{tel}> <{fax}> <{e-mail}>
Danish: {Navn og adresse} <{tlf}> <{fax> <{email}>
English: Longer-term treatment may also be appropriate for prevention of recurrence of major depressive episodes (MDE).
Danish: Længerevarende behandling kan være hensigtsmæssig til forebyggelse af tilbagevendende depressive episoder (MDE).
English: In the other three short term studies, most patients were females with PTSD due to domestic abuse or sexual/physical trauma.
Danish: I de øvrige tre kortvarige undersøgelser var de fleste patienter kvinder, der led af PTSD på grund af hustruvold eller seksuelle/fysiske overgreb.
English: The primary efficacy variable was defined based on the average number of panic attacks during the last two weeks of treatment.
Danish: Den primære effektvariabel var defineret baseret på det gennemsnitlige antal panikanfald i løbet af de sidste to behandlingsuger.
English: The following adverse reactions were reported from controlled trials (n=281 patients treated with sertraline):
Danish: Følgende bivirkninger er rapporteret i kliniske kontrollerede forsøg (n=281 patienter behandlet med sertralin):
English: There were no significant differences in plasma protein binding observed between the two groups.
Danish: Der er ikke observeret nogen signifikant forskel i plasmaproteinbinding mellem grupperne.
English: In conclusion, the lack of consistent efficacy and the unknown origin of the low response in the negative study are of concern.
Danish: Fraværet af en ensartet effekt og den ukendte årsag til den lave respons i den negative undersøgelse giver således anledning til betænkeligheder.
English: “The Marketing Authorisation Holder has committed:
Danish: "Indehaveren af markedsføringstilladelsen har forpligtet sig til:
English: Put the dropper back on the bottle after use.
Danish: Sæt pipetten tilbage på flasken efter brug.
English: Therefore the CHMP considered that long-term efficacy (maintenance of effect) has not been demonstrated.
Danish: CHMP vurderede derfor, at den langsigtede effekt (vedligeholdelse af effekt) ikke er blevet påvist.
English: In addition, the improvements in anxiety presented by the MAH are far from impressive and not significant.
Danish: Desuden er de forbedringer af angst, som indehaveren af markedsføringstilladelsen har præsenteret, langt fra imponerende og ikke signifikante.
English: It is general clinical experience that the risk of suicide may increase in the early stages of recovery.
Danish: Generel klinisk erfaring viser, at selvmordsrisikoen kan stige i de tidlige helbredelsesstadier.
English: In addition, the relapse prevention study did not provide evidence with respect to the necessity to continue treatment after an acute treatment phase (of about 10-12 weeks).
Danish: Undersøgelsen af tilbagefaldsforebyggelse gav desuden ingen evidens vedrørende behovet for fortsættelse af behandlingen efter en akut behandlingsfase (på ca. 10-12 uger).
English: Tell your doctor immediately: If you experience any of the following symptoms after taking this medicine, these symptoms can be serious.
Danish: Kontakt straks lægen: Hvis De oplever en af følgende et af følgende symptomer efter at have taget denne medicin, skal De straks kontakte lægen, da disse symptomer kan være alvorlige.
English: In summary, the CHMP adopted the following harmonised wording:
Danish: CHMP vedtog således følgende harmoniserede formulering:
English: Furthermore, the CHMP was of the opinion that the effect of sertraline on PTSD is at least partly due to its effect on depression (HAMD).
Danish: Desuden mente CHMP, at sertralins effekt på PTSD til dels skyldes dets effekt på depression (HAMD).
English: Each ml of oral liquid contains 150.7 mg of alcohol.
Danish: 1 ml oral opløsning indeholder 150,7 mg alkohol.
English: Other psychiatric conditions, for which sertraline is prescribed, can also be associated with an increased risk of suicide-related events.
Danish: Andre psykiatriske lidelser, for hvilke der ordineres sertralin, kan også være forbundet med en øget risiko for selvmordsrelaterede hændelser.
English: provided the following text concerning PTSD is inserted in section 5.1:
Danish: under forudsætning af, at følgende tekst om PTSD indsættes i afsnit 5.1:
English: Neonates should be observed if maternal use of sertraline continues into the later stages of pregnancy, particularly the third trimester.
Danish: Nyfødte bør observeres, hvis maternel brug af sertralin fortsætter ind i et af de senere trin af graviditeten, især i tredje trimester.
English: Pregnancy and breast-feeding: Ask your doctor or pharmacist for advice before taking any medicine.
Danish: Graviditet og amning Spørg Deres læge eller apoteket til råds, før De tager nogen form for medicin.
English: Zoloft was included in the list of products for Summary of Products Characteristics (SPC) harmonisation, drawn up by the CMD(h), in accordance with Article 30(2) of Directive 2001/83/EC, as amended.
Danish: Zoloft stod på den liste over produkter, for hvilke produktresuméerne skulle harmoniseres, som CMD(h) havde udarbejdet i henhold til artikel 30, stk. 2, i direktiv 2001/83/EF med senere ændringer.
English: Close supervision of patients and in particular those at high risk should accompany drug therapy especially in early treatment and following dose changes.
Danish: Tæt overvågning, især af patienter i højrisikogruppen, bør ledsage den medicinske behandling særlig ved behandlingsstart og dosisændringer.
English: To date, no adverse effects on the health of infants nursed by mothers using sertraline have been reported, but a risk cannot be excluded.
Danish: Der er indtil nu ikke rapporteret om sundhedsmæssige bivirkninger hos børn, der bliver ammet af mødre, der anvender sertralin, men en risiko kan ikke udelukkes.
English: The mean half-life of sertraline is approximately 26 hours (range 22-36 hours).
Danish: Den gennemsnitlige halveringstid af sertralin er ca. 26 timer (22-36 timer).
English: Very common (≥1/10): Headache (22%), insomnia (21%), diarrhoea (11%) and nausea (15%).
Danish: Meget almindelig (≥1/10): Hovedpine (22 %), insomni (21 %), diarré (11 %) og kvalme (15 %).
English: For the randomised withdrawal study, patients were recruited from the short-term studies described above and from another 10 week study.
Danish: Til den randomiserede seponeringsundersøgelse blev der rekrutteret patienter fra de ovenfor beskrevne kortvarige undersøgelser samt fra en anden 10-ugers undersøgelse.
English: Only a small amount (<0.2%) of unchanged sertraline is excreted in the urine.
Danish: Kun en lille mængde uændret sertralin (under 0,2%) udskilles i urinen.
English: The two long-term studies were not designed to assess relapse prevention and the significant results that were obtained were with respect to subjectively defined relapse, which is not acceptable.
Danish: De to langsigtede undersøgelser var ikke udformet til at vurdere tilbagefaldsforebyggelsen, og de signifikante resultater, der blev opnået, gjaldt en subjektiv definition af tilbagefald, hvilket ikke er acceptabelt.
English: Regarding the dosing of paediatric patients with OCD, the CHMP requested the insertion of a warning in section 4.4 and adopted the following wording:
Danish: Vedrørende dosering til pædiatriske patienter med OCD krævede CHMP, at der blev indsat en advarsel i afsnit 4.4, og vedtog følgende formulering:
English: Changes in dose should not be made more frequently than once per week given the 24-hour elimination half life of sertraline.
Danish: Dosisændringer bør ikke ske hyppigere end én gang pr. uge af hensyn til sertralins halveringstid på 24 timer.
English: Initial treatment
Danish: Initialbehandling
English: Sertraline should be administered once daily, either in the morning or evening.
Danish: Sertralin bør indtages én gang dagligt enten morgen eller aften.
English: The mixture may be a little cloudy, but this is normal.
Danish: Opløsningen kan blive lidt uklar, men dette er helt normalt.
English: According to the MAH, differences in this section are related to differences in the formulations that have been approved.
Danish: Ifølge indehaveren af markedsføringstilladelsen er forskellene under dette punkt relateret til forskellene mellem de godkendte formuleringer.
English: The CHMP considered that because no placebo was used, it is difficult to put the observed adverse events into perspective.
Danish: CHMP vurderede, at eftersom der ikke blev brugt en placebogruppe, er det svært at sætte de observerede bivirkninger i perspektiv.
English: In many cases, hyponatraemia appears to be the result of a syndrome of inappropriate antidiuretic hormone secretion (SIADH).
Danish: I mange tilfælde forekommer hyponatriæmi som et resultat af uhensigtsmæssig produktion af antidiuretisk hormon (SIADH).
English: Therefore, is it still not clear if the efficacy results can be extrapolated to patients with a more recent onset, with acute PTSD (< 3months) and on patients with chronic PTSD (> 3months).
Danish: Det er derfor stadig ikke klart, om effektresultaterne kan ekstrapoleres til patienter med nyere tilfælde, akut PTSD (< 3 måneder) eller kronisk PTSD (> 3 måneder).
English: There are no specific antidotes to sertraline.
Danish: Der findes ingen specifik antidot til sertralin.
English: This will depend on the nature of your illness and how well you are responding to the treatment.
Danish: Dette vil afhænge af Deres tilstand, og hvordan De reagerer på behandlingen.
English: The low occurrence of relapse in this study suggest that relapse prevention after 1 year of treatment may not be necessary but the study did not provide information regarding the need for relapse prevention after acute treatment (12 weeks).
Danish: Den lave forekomst af tilbagefald i denne undersøgelse tyder på, at tilbagefaldsforebyggelse muligvis ikke er nødvendig efter 1 års behandling, men undersøgelsen leverede ikke oplysninger vedrørende behovet for tilbagefaldsforebyggelse efter akut behandling (12 uger).
English: In most of the cases, the recommended dose in prevention of recurrence of MDE is the same as the one used during current episode.
Danish: I de fleste tilfælde er den anbefalede dosis til forebyggelse af tilbagevendende depressive episoder, den samme som anvendes under den aktuelle episode.
English: • If you are a young adult.
Danish: - hvis De er ung.
English: Pharmacokinetics in specific patient groups
Danish: Farmakokinetik i specielle patientgrupper
English: This study includes a comparison group consisting of paediatric patients receiving psychotherapy alone.”
Danish: Undersøgelsen inkluderer en kontrolgruppe bestående af pædiatriske patienter, der udelukkende får psykoterapi."
English: Overall, the results of the two studies combined are suggestive of maintenances of effect over the long-term.
Danish: Samlet set tyder resultaterne af de to undersøgelser på, at effekten bevares på langt sigt.
English: The effects obtained in the short-term studies seem limited to women while no effect could be demonstrated in men and the CHMP considered this to be due to differences in baseline variables between males and females.
Danish: De opnåede effekter i de kortvarige undersøgelser synes begrænset til kvinder, mens der ikke kunne påvises nogen effekt hos mænd, og CHMP vurderede, at dette skyldtes forskellige baseline-variabler hos mænd og kvinder.
English: You may find it helpful to tell a relative or close friend that you are depressed or have an anxiety disorder, and ask them to read this leaflet.
Danish: Det kan måske være en hjælp at tale med en ven eller pårørende om, at De er deprimeret eller angst, og bede dem om at læse denne indlægsseddel.
English: Rare reports of severe cutaneous adverse reactions (SCAR): e.g.
Danish: Sjældne rapporter om alvorlige kutanreaktioner (SCAR): f.eks.
English: These patients (n=295) were randomized to continuation for 44 weeks on double-blind sertraline 50-200 mg/day or placebo.
Danish: Disse patienter (n=295) blev randomiseret til at fortsætte yderligere 44 uger på dobbeltblindt sertralin 50-200 mg dagligt eller placebo.
English: • Take special care if you are elderly as you may be more at risk of having low sodium level in your blood (see above).
Danish: • Hvis De er ældre, skal De være ekstra forsigtig, da De måske har risiko for at have lavt indhold af natrium i blodet (se ovenfor).
English: Schizophrenia Psychotic symptoms might become aggravated in schizophrenic patients.
Danish: Skizofreni Psykotiske symptomer kan tiltage hos skizofrene patienter.
English: Social anxiety disorder (social phobia) is an illness linked to anxiety.
Danish: Socialangst (socialfobi) er en sygdom, der er forbundet med angst.
English: Sertraline is indicated for the treatment of:
Danish: Sertralin er indiceret til behandling af: