FrancophonIA/ELRC3.0 huggingface dataset:
English: Infections and Infestations Pharyngitis
Danish: Infektioner og parasitære sygdomme Faryngitis
English: • Medicines to treat diabetes (tolbutamide).
Danish: • Medicin mod diabetes (tolbutamid).
English: Sertraline concentrate for oral solution contains 20 mg/ml of sertraline.
Danish: Sertralin koncentrat til oral opløsning indeholder 20 mg sertralin/ml.
English: These symptoms could be due to either serotonergic effects or withdrawal symptoms.
Danish: Disse symptomer kan enten skyldes den serotonerge effekt eller seponeringssymptomer.
English: The results of the short-term studies show that 3 of the 5 placebo controlled studies demonstrated statistically significant results and that these results are supported by responders analysis that indicate a higher proportion of responders in the active arms compared to placebo.
Danish: Resultaterne af de kortvarige undersøgelser viser, at 3 af de 5 placebokontrollerede undersøgelser påviste statistisk signifikante resultater, og at disse dokumenteres af en analyse af responderende patienter, som indikerede en større andel af responderende patienter i de aktive grupper sammenlignet med placebo.
English: Hypersensitivity to the active substance or any of the excipients.
Danish: Overfølsomhed over for det aktive stof eller et eller flere af hjælpestofferne.
English: “Combined data from the 3 studies of PTSD in the general population found a lower response rate in males compared to females.
Danish: "De samlede data fra de 3 undersøgelser af PTSD i den generelle population viste en lavere responsrate hos mænd end hos kvinder.
English: Respiratory Tract Infection, Rhinitis
Danish: Øvre luftvejsinfektioner, rhinitis
English: Harmful for those suffering from alcoholism.
Danish: Sertalin er skadelig for alkoholikere.
English: • Blood thinning medicine (warfarin).
Danish: • Blodfortyndende medicin (warfarin).
English: Ethanol: The alcohol content has to be taken into consideration in patients with liver impairment, alcohol abuse, epilepsy, brain trauma or disease, pregnant women and children.
Danish: Ethanol: Der bør tages højde for alkoholindholdet, når behandling gives til patienter med nedsat leverfunktion, alkoholmisbrug, epilepsi, hjernetraume eller -sygdomgravide kvinder og børn.
English: • If you have or have previously had suicidal thoughts (see below-thoughts of suicide and worsening of your depression or anxiety disorder).
Danish: • De har eller har haft selvmordstanker (se nedenfor under ”Selvmordstanker og forværring af Deres depression eller angst”).
English: These are symptoms of Serotonin Syndrome.
Danish: Disse symptomer er tegn på serotonergt syndrom.
English: Do not take a double dose to make up for a forgotten dose.
Danish: Tag aldrig dobbeltdosis, hvis De har glemt at tage en dosis.
English: In total, 13 short term RCTs were carried out in support of the MDD indication, in addition to one randomised withdrawal study and several other long-term studies.
Danish: I alt blev der foretaget 13 kortvarige randomiserede kontrollerede undersøgelser som dokumentation for indikationen for MDD samt én randomiseret seponeringsundersøgelse og flere andre langvarige undersøgelser.
English: • Diabetes; your blood glucose levels may be altered due to Zoloft and your diabetes medicines may need to be adjusted.
Danish: Deres blodglucose kan måske ændres på grund af Zoloft, og Deres diabetes-medicin skal måske justeres.
English: Capsules, hard
Danish: Hårde kapsler
English: Sertraline has no affinity for muscarinic (cholinergic), serotonergic, dopaminergic, adrenergic, histaminergic, GABA or benzodiazepine receptors.
Danish: Sertralin har ikke affinitet til muskarine (kolinerge), serotonerge, dopaminerge, adrenerge, histaminerge, GABA eller benzodiazepinerge receptorer.
English: In some Member States, OCD is also indicated in children and adolescents (aged 6-17).
Danish: I visse medlemsstater er det også indiceret til OCD hos børn og unge (6-17 år).
English: The CHMP was of the opinion that the results of these three trials do not support the addition of “including depression accompanied by symptoms of anxiety, in patients with or without a history of mania” to the Major Depressive Episodes (MDD) indication.
Danish: CHMP var af den opfattelse, at resultaterne af disse tre undersøgelser ikke dokumenterer tilføjelsen af "inklusive depression ledsaget af symptomer på angst hos patienter med eller uden fortilfælde af mani" til indikationen for MDD.
English: In addition, co-administration of phenytoin may cause a reduction of sertraline plasma levels.
Danish: Derudover kan samtidig anvendelse af phenytoin medføre en reduktion af sertralinkoncentrationen i plasma.
English: The evidence in support of the MDD indication was considered acceptable, and the CHMP focused on the assessment of the evidence supporting the additional indication: “including depression accompanied by symptoms of anxiety, in patients with or without a history of mania”.
Danish: Evidensen til dokumentation for indikationen for MDD blev vurderet som acceptabel, og CHMP fokuserede på at vurdere evidensen til dokumentation for den tilhørende indikation "inklusive depression ledsaget af symptomer på angst hos patienter med eller uden fortilfælde af mani".
English: A statistically significantly lower relapse rate was observed for patients taking sertraline compared to those on placebo.
Danish: Der blev observeret en statistisk signifikant lavere tilbagefaldsfrekvens hos patienter, der fik sertralin sammenlignet med dem, der fik placebo.
English: Table 1 displays adverse reactions observed from postmarketing experience (frequency not known) and placebo-controlled clinical trials (comprising a total of 2542 patients on sertraline and 2145 on placebo) in depression, OCD, panic disorder, PTSD and social anxiety disorder.
Danish: Tabel 1 viser bivirkninger set efter markedsføring (frekvens ikke kendt) og placebo-kontrollerede forsøg (omfatter i alt 2.542 patienter, der fik sertralin og 2.145 patienter, der fik placebo) hos patienter med OCD, panikangst, PTSD og socialangst.
English: The data submitted to support the additional indication anxiety treatment indication proposed by the MAH consisted of various studies showing that the sertraline groups consistently had a greater reduction in the Ham-D Factor for anxiety and somatisation than the placebo group.
Danish: De data, der blev indsendt som dokumentation for den ekstra indikation til angstbehandling, indehaveren af markedsføringstilladelsen havde fremsat, bestod af forskellige undersøgelser, der viste, at sertralingrupperne konsekvent udviste en større reduktion af Ham-Dfaktoren for angst og somatisering end placebogruppen.
English: In man, following an oral once-daily dosage of 50 to 200 mg for 14 days, peak plasma concentrations of sertraline occur at 4.5 to 8.4 hours after the daily administration of the drug.
Danish: Efter 14 dages oral dosis på 50-200 mg 1 gang dagligt blev den maksimale plasmakoncentration af sertralin opnået hos mennesker 4,5-8,4 timer efter den daglige indgift.
English: In patients who develop these symptoms, increasing the dose may be detrimental.
Danish: For patienter, der udvikler disse symptomer, kan dosisøgning være uhensigtsmæssig.
English: In previous applications, the MAH had submitted data from a placebo-controlled withdrawal study (relapse prevention study) in which responders to 1 year open label treatment were randomised to treatment with sertraline or placebo for a duration of 28 weeks and the results from that study were considered.
Danish: I forbindelse med tidligere ansøgninger havde indehaveren af markedsføringstilladelsen indsendt data fra en placebokontrolleret seponeringsundersøgelse (undersøgelse af tilbagefaldsforebyggelse), hvor de responderende patienter fra en 1-årig åben behandling blev randomiseret til behandling med sertralin eller placebo i en periode på 28 uger, hvorefter resultaterne blev vurderet.
English: Dose changes should be made in steps of 50 mg at intervals of at least one week, up to a maximum of 200 mg/day.
Danish: Dosisændringer bør foretages trinvist med 50 mg ad gangen i intervaller på mindst en uge, op til en maksimal dosis på 200 mg dagligt.
English: • Other medicines to treat depression (such as amitriptyline, nortriptyline).
Danish: • Anden medicin mod depression (f.eks. amitriptylin, nortriptylin).
English: • If you have suffered from manic depressive illness (bipolar disorder) or schizophrenia.
Danish: • De har eller har haft en maniodepressiv sygdom (bipolar sygdom) eller skizofreni.
English: The MAH submitted a revised study synopsis, now including a sertraline-unexposed control group and following the evaluation of this synopsis, the study proposal was supported.
Danish: Indehaveren af markedsføringstilladelsen indsendte en revideret synopsis for undersøgelsen, nu med en kontrolgruppe, der ikke havde fået sertralin, og efter vurdering af denne synopsis blev forslaget til undersøgelsen godkendt.
English: Panic disorder, with or without agoraphobia.
Danish: Panikangst med eller uden agorafobi.
English: Food does not significantly change the bioavailability of sertraline tablets.
Danish: Samtidig indtagelse af føde ændrer ikke biotilgængeligheden af sertralin tabletter signifikant.
English: There are no clinical studies establishing the risks or benefits of the combined use of ECT and sertraline.
Danish: Der er ikke udført kliniske forsøg vedrørende risk-benefit ved samtidig anvendelse af ECT og sertralin.
English: After a one week single blind placebo lead-in, patients were randomly assigned to twelve weeks of flexible dose treatment with either sertraline or placebo.
Danish: Efter en uges indkøring med enkeltblind placebobehandling, blev patienterne randomiseret til en 12 ugers fleksibel dosering med enten sertralin eller placebo.
English: Sertraline
Danish: Sertralin
English: Just take the next dose at the right time.
Danish: De skal blot tage den næste dosis, når det er tid til næste dosis.
English: With the condition that the following text is inserted in section 5.1 of the SPC:
Danish: Dette sker under forudsætning af, at følgende tekst indsættes i produktresuméets afsnit 5.1:
English: Pfizer Hellas A.E., 243 Messoghion Ave.,
Danish: Grækenland Pfizer Hellas A.E., 243 Messoghion Ave.,
English: Regarding safety, the incidence of AEs in the PTSD dossier is within the range reported in studies for other indications and SAEs were not considered to be related to the study medication.
Danish: Hvad sikkerheden angår, ligger forekomsten af bivirkninger i PTSD-dossieret inden for det område, der er rapporteret i undersøgelser for andre indikationer, og alvorlige bivirkninger blev ikke vurderet som relateret til undersøgelsesmedicinen.
English: Reproductive System and Breast Disorders** Ejaculation
Danish: Det reproduktive system og mammae** Ejakulationssvigt
English: The most common side effects in children and adolescents were headache, insomnia, diarrhoea and feeling sick.
Danish: De mest almindelige bivirkninger hos børn og unge er hovedpine, søvnløshed, diarré og kvalme.
English: Prevention of recurrence of major depressive episodes.
Danish: Forebyggelse af tilbagevendende depressive episoder.
English: In contrast, subjects rated both alprazolam and d-amphetamine significantly greater than placebo on measures of drug liking, euphoria and abuse potential.
Danish: Forsøgspersonerne bedømte derimod både alprazolam og d-amfetamin signifikant højere end placebo, hvad angår medicinlignende eufori og potentiale for afhængighed.
English: • Sedatives (diazepam).
Danish: • Beroligende medicin (diazepam).
English: If you have liver or kidney problems, please tell your doctor and follow the doctor's instructions.
Danish: Hvis de har lever- eller nyreproblemer skal De følge lægens anvisning.
English: Sertraline concentrate for oral solution should not be used in combination with disulfiram or within 2 weeks of discontinuing treatement with disulfiram.
Danish: Sertralin koncentrat til oral opløsning bør ikke anvendes sammen med disulfiram eller inden for 2 uger efter afbrydelse af disulfiram.
English: The mean dose for completers was 70 mg/day.
Danish: Den gennemsnitlige dosis for dem, der fuldførte var 70 mg dagligt.
English: Adolescents and elderly
Danish: Unge og ældre
English: Do not use Zoloft together with pimozide.
Danish: De må ikke tage Zoloft sammen med pimozid.
English: Patients with a history of suicide-related events, or those exhibiting a significant degree of suicidal ideation prior to commencement of treatment are known to be at greater risk of suicidal thoughts or suicide attempts, and should receive careful monitoring during treatment.
Danish: Patienter, der tidligere har haft selvmordsrelaterede hændelser, eller patienter, der udviser en signifikant grad af selvmordstanker eller selvmordsforsøg inden behandling, har større risiko for selvmordstanker eller for at forsøge at begå selvmord og bør følges tæt under behandlingen.
English: • Post traumatic stress disorder (PTSD) (in adults).
Danish: • Posttraumatisk belastningsreaktion (PTSD) (hos voksne).
English: “Sertraline is indicated for the treatment of post traumatic stress disorder (PTSD)”,
Danish: "Sertralin er indiceret til behandling af posttraumatisk belastningsreaktion (PTSD)",
English: However, a substantial amount of data did not reveal evidence of induction of congenital malformations by sertraline.
Danish: En betydelig mængde data viser dog ingen tegn på, at sertralin fremkalder medførte misdannelser.
English: Sertraline should not usually be used in children and adolescents less than 18 years old, except for patients with Obsessive Compulsive Disorder.
Danish: Sertralin bør normalt ikke anvendes til børn og unge under 18 år undtagen til patienter med tvangstanker/tvangshandlinger.
English: In the two positive general population trials, the male and female sertraline vs. placebo responder rates were similar (females: 57.2% vs 34.5%; males: 53.9% vs 38.2%).
Danish: I de 2 positive almindelige populationsforsøg var responderraterne ens for mænd og kvinder, der fik sertralin sammenlignet med placebo (kvinder: 57,2 % vs. 34,5 %; mænd: 53,9 % vs. 38,2).
English: In a placebo-controlled, double-blind randomized study of the comparative abuse liability of sertraline, alprazolam and d-amphetamine in humans, sertraline did not produce positive subjective effects indicative of abuse potential.
Danish: I et placebo-kontrolleret, dobbeltblindt, randomiseret forsøg, der skulle vise den komparative tilbøjelighed for afhængighed af sertralin, alprazolam og d-amfetamin hos mennesker, fremkaldte sertralin ikke positive, subjektive virkninger, der tyder på afhængighed.
English: Zoloft capsules should be taken with food.
Danish: Zoloft kapsler bør tages sammen med mad.
English: It has only very weak effects on norepinephrine and dopamine neuronal reuptake.
Danish: Sertralin har kun meget svag effekt på den neuronale genoptagelse af noradrenalin og dopamin.
English: Seizures may occur with sertraline therapy: sertraline should be avoided in patients with unstable epilepsy and patients with controlled epilepsy should be carefully monitored.
Danish: Kramper kan opstå ved behandling med sertralin: sertralinbehandling bør undgås hos patienter med ustabil epilepsi, og bør kun gives til patienter med kontrolleret, stabil epilepsi under nøje medicinsk overvågning.
English: Concomitant treatment with irreversible monoamine oxidase inhibitors (MAOIs) is contraindicated due to the risk of serotonin syndrome with symptoms such as agitation, tremor and hyperthermia.
Danish: Samtidig behandling med irreversible monoaminooxidasehæmmere (MAO-hæmmere) er kontraindiceret på grund af risiko for udvikling af serotoninsyndrom med symptomer som f.eks. agitation, tremor og hypertermi.
English: Signs and symptoms associated with more severe and/or acute cases have included hallucination, syncope, seizure, coma, respiratory arrest, and death.
Danish: Tegn og symptomer forbundet med sværere og/eller akutte tilfælde omfatter hallucinationer, synkope, kramper, koma, respirationsstop og død.
English: Triptans
Danish: Triptaner
English: In patients with liver damage, the half life of sertraline is prolonged and AUC is increased three fold (see sections 4.2 and 4.4).
Danish: Hos patienter med leverbeskadigelse forlænges sertralins halveringstid, og AUC øges tre gange (se pkt.
English: If, based on clinical need, a decision to treat is nevertheless taken; the patient should be carefully monitored for appearance of suicidal symptoms.
Danish: Hvis det under hensyntagen til kliniske behov alligevel besluttes at behandle patienter i denne gruppe, bør disse overvåges omhyggeligt for selvmordssymptomer.
English: A multiple dose pharmacokinetic study in subjects with mild, stable cirrhosis demonstrated a prolonged elimination half life and approximately threefold greater AUC and Cmax in comparison to normal subjects.
Danish: En farmakokinetisk undersøgelse af gentagne doseringer hos patienter med mild og stabiliseret levercirrhose viste en forlænget halveringstid og ca. tre gange større AUC og Cmax sammenlignet med patienter med normal leverfunktion.
English: The four short-term placebo controlled studies were conducted in patients with PTSD and consisted of 1/2 weeks single-blind placebo run-in, followed by 12 week double-blind treatment.
Danish: De fire kortvarige placebokontrollerede undersøgelser blev foretaget på patienter med PTSD og bestod af 1/2 ugers enkeltblindet, placebokontrolleret indkøring efterfulgt af 12 ugers dobbeltblindet behandling.
English: In steady state for the 200 mg dose, the sertraline plasma levels in the 6-12 year old group were approximately 35% higher compared to the 13-17 year old group, and 21% higher compared to adult reference group.
Danish: Både 25 mg-behandlingsregimen og 50 mg-behanlingsregimen blev tolereret i lige stor grad. I steady state for 200 mg dosis var sertralins plasmakoncentration hos de 6-12 årige ca. 35 % højere sammenlignet med de 13-17 årige, og 21 % højere sammenlignet med den voksne referencegruppe.
English: • Medicines to treat excessive stomach acid and ulcers (cimetidine).
Danish: • Medicin mod for meget mavesyre og mavesår (cimetidin).
English: Sertraline exhibits dose proportional pharmacokinetics in the range of 50 to 200 mg.
Danish: Sertralins farmakokinetiske profil er proportional med dosis i området 50-200 mg.
English: Signs and symptoms of hyponatraemia include headache, difficulty concentrating, memory impairment, confusion, weakness and unsteadiness which may lead to falls.
Danish: Tegn og symptomer på hyponatriæmi omfatter hovedpine, koncentrationsbesvær, hukommelsesbesvær, konfusion, svaghed og usikkerhed, som kan føre til faldulykker.
English: In studies of patients with mild to moderate renal impairment (creatinine clearance 30-60 ml/min) or moderate to severe renal impairment (creatinine clearance 10-29 ml/min), multiple-dose pharmacokinetic parameters (AUC0-24 or Cmax) were not significantly different compared with controls.
Danish: Hos patienter med mild til moderat nedsat nyrefunktion (kreatininclearance 30-60 ml/min) eller moderat til svært nedsat nyrefunktion (kreatininclearance 1029 ml/min) var farmakokinetiske parametre (AUC og Cmax) efter gentagne doser ikke signifikant forskellige fra dem hos patienter med normal nyrefunktion.
English: Prevention of recurrence of major depressive episodes”.
Danish: Forebyggelse af tilbagevenden af svær depression".
English: Hernia, Injection Site Fibrosis, Drug Tolerance Decreased, Gait Disturbance, Unevaluable Event
Danish: Hernia, fibrose på injektionsstedet, nedsat lægemiddeltolerans, gangforstyrrelser, hændelse kan ikke vurderes
English: Physicians must monitor paediatric patients on long term treatment for abnormalities in these body systems.
Danish: Læger skal kontrollere børn for abnormiteter i kroppen, hvis de er i langtidsbehandling.
English: In general, the CHMP considered the wordings proposed by the MAH to be acceptable.
Danish: Generelt vurderede CHMP, at de foreslåede formuleringer fra indehaveren af markedsføringstilladelsen var acceptable.
English: Biotransformation Sertraline undergoes extensive first-pass hepatic metabolism.
Danish: Metabolisme Sertralin har udpræget first-pass levermetabolisme.
English: “Sertraline is indicated for the treatment of obsessive compulsive disorder (OCD) in adults”,
Danish: "Sertralin er indiceret til behandling af obsessiv-kompulsiv tilstand (OCD) hos voksne",
English: It must be diluted before use.
Danish: Koncentratet skal altid fortyndes inden brug.
English: • If you develop a severe skin rash that causes blistering (erythema multiforme), (this can affect the mouth and tongue).
Danish: • Hvis de får alvorligt blæreformet udslæt (erythema multiforme) især omkring munden og tungen.
English: • If you have suffered from bleeding disorders or have been taking medicines which thin the blood (eg acetylsalicyclic acid (aspirin), or warfarin) or may increase the risk of bleeding.
Danish: • De lider eller har lidt af blødningsforstyrrelser eller har taget blodfortyndende medicin (f.eks. acetylsalicylsyre eller warfarin), eller måske har en øget risiko for blødning.
English: Hypercholesterolaem ia, Hypoglycaemia
Danish: Hyperkolesterolæmi, hypoglykæmi
English: Therefore sertraline should be used with caution in patients with a history of mania/hypomania.
Danish: Sertralin bør derfor anvendes med forsigtighed til patienter med mani/hypomani i anamnesen.
English: Switching from Selective Serotonin Reuptake Inhibitors (SSRIs), antidepressants or antiobsessional drugs
Danish: Skift fra selektive serotonin-genoptagelseshæmmere (SSRI-præparater) eller andre antidepressiva eller antiobssessive lægemidler
English: Sertraline dosing does not have to be adjusted based on the degree of renal impairment.
Danish: Dosisjustering er ikke nødvendig baseret på graden af nedsat nyrefunktion.
English: Sertraline concentrate for oral solution
Danish: Sertralin koncentrat til oral opløsning
English: Sertraline is approved for the treatment of depression and in addition, the product is approved in some Member States for the treatment of social anxiety disorder, panic disorder (with or without agoraphobia disorder), post-traumatic stress disorder (PTSD), and obsessive-compulsive disorder (OCD).
Danish: I visse medlemsstater er produktet desuden godkendt til behandling af socialangst, panikangst (med eller uden agorafobi), posttraumatisk belastningsreaktion (PTSD) og obsessiv-kompulsiv tilstand (OCD).
English: The texts proposed by the MAH were in general accepted by the CHMP, with some occasional minor amendments.
Danish: CHMP accepterede generelt de tekster, der blev foreslået af indehaveren af markedsføringstilladelsen, med stedvise mindre ændringer.
English: The submitted results showed that the improvement on the primary outcome variable was statistically significantly greater in the sertraline versus the placebo arm.
Danish: De offentliggjorte resultater viste, at forbedringen af den primære resultatvariabel statistisk set var signifikant større i sertralingruppen end i placebogruppen.
English: This medicinal product contains butylhydroxytoluene which can cause irritation of eyes, skin and mucous membranes.
Danish: Denne medicin indeholder butylhydroxytoluen, som kan give irritation i øjne, hud og slimhinder.
English: One study recruited male military veterans, in which the primarily cause of PTSD was largely combat related and exhibiting longstanding PTSD.
Danish: Til en af undersøgelserne blev der rekrutteret mandlige soldater, hvor den primære årsag til PTSD
English: Vaginal Haemorrhage, Female Sexual Dysfunction
Danish: Vaginalblødning, seksuel dysfunktion hos kvinder,
English: If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered.
Danish: Hvis reduktion af dosis eller seponering medfører uacceptable symptomer, må det overvejes at vende tilbage til den oprindeligt ordinerede dosis.
English: In the treatment of social anxiety disorder, sexual dysfunction (ejaculation failure) in men occurred in 14% for sertraline vs 0% in placebo.
Danish: Seksuel dysfunktion hos mænd forekom i kliniske forsøg med behandling af socialangst hos 14 % for sertralin sammenlignet med 0 % for placebo.