FrancophonIA/ELRC3.0 huggingface dataset:
English: Sertraline should not be used in cases of severe hepatic impairment as no clinical data are available (see section
Danish: Sertralin bør ikke anvendes i tilfælde af svært nedsat leverfunktion på grund af manglende kliniske data (se pkt.
English: Deaths have been reported involving overdoses of sertraline, primarily in combination with other drugs and/or alcohol.
Danish: Der er rapporteret om overdosering af sertralin alene i doser op til 13,5 g. Dødsfald er blevet rapporteret i forbindelse med overdosering af sertralin, primært i kombination med andre lægemidler og/eller alkohol.
English: This is most likely to occur during the first few weeks of treatment.
Danish: Dette opstår oftest i løbet af de første par uger af behandlingen.
English: Elderly patients may be at greater risk of developing hyponatraemia with SSRIs and SNRIs.
Danish: Ældre har en større risiko for udvikling af hyponatriæmi i forbindelse med behandling med SSRI eller SNRI.
English: • Allergic reaction or allergy, which may include symptoms such as an itchy skin rash, breathing problems, wheezing, swollen eyelids, face or lips.
Danish: • Allergiske reaktioner eller allergi, f.eks. kløende hududslæt, åndedrætsbesvær, hvæsende vejrtrækning, hævelse af øjenlåg, ansigt eller læber.
English: Do not mix the concentrate with anything other than the liquids listed.
Danish: Bland ikke koncentratet med andre væsker end dem, som er nævnt her.
English: Clinical pharmacology studies have shown that sertraline has no effect on psychomotor performance.
Danish: Klinisk farmakologiske forsøg har vist, at sertralin ikke påvirker den psykomotoriske adfærd.
English: Depression and OCD Sertraline treatment should be started at a dose of 50 mg/day.
Danish: Depression og obsessiv-kompulsiv sygdom (OCD) Sertralinbehandling bør startes med en dosis på 50 mg 1 gang dagligt.
English: Postnatal pup survival and body weight were decreased only during the first days after birth.
Danish: Kun i de første par dage efter fødslen faldt det postnatale afkoms overlevelse og kropsvægt.
English: When stopping treatment with sertraline the dose should be gradually reduced over a period of at least one to two weeks in order to reduce the risk of withdrawal reactions (see sections 4.4 and 4.8).
Danish: Ved ophør af behandling med sertralin bør dosis nedsættes gradvist over en periode på mindst 1-2 uger for at nedsætte risikoen for seponeringsreaktioner (se pkt.
English: Sertraline is extensively metabolised, and excretion of unchanged drug in urine is a minor route of elimination.
Danish: Da sertralin i vid udstrækning metaboliseres i leveren, er udskillelsen af uomdannet stof via urinen kun en mindre eliminationsvej.
English: Regarding the use of sertraline in Hepatic Insufficiency and in Renal Insufficiency, the CHMP agreed with the wording proposed by the MAH for harmonisation.
Danish: Angående brug af sertralin ved nedsat leverfunktion og nedsat nyrefunktion erklærede CHMP sig enig i den formulering, indehaveren af markedsføringstilladelsen havde foreslået til harmonisering.
English: Clinical relevant interactions may occur with other CYP 2D6 substrates with a narrow therapeutic index like class 1C antiarrhythmics such as propafenone and flecainide, TCAs and typical antipsychotics, especially at higher sertraline dose levels.
Danish: Især ved høje sertralindoser kan der opstå klinisk relevante interaktioner med andre CYP2D6-substrater med et snævert terapeutisk indeks, som klasse 1C-antiarrytmika, som f.eks. propafenon og flecainid, TCA og typiske antipsykotika.
English: This dosage regimen has been shown to reduce the frequency of early treatment emergent side effects characteristic of panic disorder.
Danish: Dette behandlingsregime har vist sig at reducere antallet af de nyopståede bivirkninger, der ses i begyndelsen af behandlingsperioden, og som kendetegner panikangst.
English: There is limited controlled experience regarding the optimal timing of switching from SSRIs, antidepressants or antiobsessional drugs to sertraline.
Danish: Erfaring savnes vedrørende varigheden af den optimale udvaskningsperiode ved skift fra SSRIpræparater, andre antidepressiva eller antiobsessive lægemidler til sertralin.
English: Also, the long-term safety of Zoloft in regard to growth, maturation and cognitive and behavioural development in this age group has not yet been demonstrated.
Danish: Derudover foreligger der ikke langtidsdata om sikkerhed af Zoloft med hensyn til vækst og kognitiv, modning og adfærdsmæssig udvikling i denne aldersgruppe.
English: Butylhydroxytoluene: can cause irritation of eyes, skin and mucous membranes.
Danish: Butylhydroxytoluen: Kan give irritation af øjne, hud og slimhinder.
English: Some medicines can affect the way Zoloft works, or Zoloft itself can reduce the effectiveness of other medicines taken at the same time.
Danish: Anden medicin kan påvirke Zolofts virkning, og Zoloft kan påvirke virkningen af anden medicin.
English: Nausea is the most common undesirable effect.
Danish: Kvalme er den hyppigst forekommende bivirkning.
English: Aminotransferarase Increased*, Aspartate Aminotransferase Increased*, Semen Abnormal
Danish: Forhøjelse af alaninaminotransferarase, forhøjelse af aspartataminotransferase, abnorm sæd
English: Other serotonergic drugs e.g. tryptophan, fenfluramine and 5-HT agonists Co-administration of sertraline with other drugs which enhance the effects of serotonergic neurotransmission such as tryptophan or fenfluramine or 5-HT agonists, or the herbal medicine, St John's Wort (hypericum perforatum), should be undertaken with caution and avoided whenever possible due to the potential for a pharmacodynamic interaction.
Danish: Andre serotonerge lægemidler, f.eks. tryptophan, fenfluramin og 5-HT-agonister Samtidig behandling med sertralin og andre lægemidler, der øger effekten af serotonerg neurotransmission, f.eks. tryptophan, fenfluramin, 5-HT-agonister eller naturlægemidler, som indeholder perikon (hypericum perforatum) bør gives med forsigtighed og helt undgås, så vidt det er muligt, på grund af risikoen for farmakodynamisk interaktion.
English: There have been reports of cutaneous bleeding abnormalities such as ecchymoses and purpura and other hemorrhagic events such as gastrointestinal or gynaecological bleeding, with SSRIs.
Danish: Der er rapporteret om kutane blødningsabnormiteter, så som ekkymose, purpura og andre blødningshændelser, f.eks. gastrointestinal eller gynækologisk blødning ved behandling med SSRI.
English: Abnormal bleeding/Haemorrhage
Danish: Abnorm blødning/hæmorragi
English: If concomitant treatment with sertraline and triptans is clinically warranted, appropriate observation of the patient is advised (see section 4.4).
Danish: Hvis samtidig behandling med sertralin og sumatriptan er klinisk påkrævet, tilrådes det, at patienten overvåges (se pkt.
English: The same precautions observed when treating patients with major depressive disorder should therefore be observed when treating patients with other psychiatric disorders.
Danish: Der skal derfor tages de samme forholdsregler ved behandling af patienter med andre psykiatriske lidelser som ved patienter med svær depression.
English: Section 4.1 - Indications: Post-traumatic Stress Disorder (PTSD)
Danish: Afsnit 4.1 - Indikationer: posttraumatisk belastningsreaktion (PTSD)
English: Section 4.1 - Indications: Obsessive Compulsive Disorder (OCD) (In adults)
Danish: Afsnit 4.1 - Indikationer: obsessiv-kompulsiv tilstand (OCD) (hos voksne)
English: Depression is a clinical illness with symptoms like feeling sad, unable to sleep properly or to enjoy life as you used to.
Danish: Depression er en klinisk sygdom med symptomer, som f.eks. kan være tristhed, besvær med at sove eller at nyde livet.
English: These reactions have included tremor, myoclonus, diaphoresis, nausea, vomiting, flushing, dizziness, and hyperthermia with features resembling neuroleptic malignant syndrome, seizures, and death.
Danish: Disse reaktioner omfatter tremor, myoklonus, diaforese, kvalme, opkastning, rødmen, svimmelhed samt hypertermi med karakteristika, der ligner malignt neuroleptikasyndrom, krampeanfald og død.
English: Food does not significantly change the bioavailability of sertraline concentrate for oral solution.
Danish: Samtidig indtagelse af føde ændrer ikke biotilgængeligheden af sertralin koncentrat til oral opløsning.
English: Table 1: Adverse Reactions
Danish: Tabel 1: Bivirkninger
English: Children (6-12 years old) were initially started on a 25 mg dose.
Danish: Børn (6-12 år) fik en initialdosis på 25 mg.
English: A meta-analysis of placebo-controlled clinical trials of antidepressant drugs in adult patients with psychiatric disorders showed an increased risk of suicidal behaviour with antidepressants compared to placebo in patients less than 25 years old.
Danish: En metaanalyse af placebo-kontrollerede kliniske studier af antidepressiva givet til voksne patienter med psykiatriske lidelser viste øget risiko for selvmordsadfærd hos patienter under 25 år behandlet med antidepressiva sammenlignet med placebogruppen.
English: These undesirable effects are dose dependent and are often transient in nature with continued treatment.
Danish: Bivirkningerne er dosisafhængige og ofte af forbigående natur ved fortsat behandling.
English: Zoloft tablets can be taken with or without food.
Danish: Zoloft tabletter kan tages med eller uden mad.
English: SSRIs or SNRIs including sertraline have however been associated with cases of clinically significant hyponatraemia in elderly patients, who may be at greater risk for this adverse event (see Hyponatraemia in section 4.4).
Danish: SSRI og SNRI herunder sertralin er dog forbundet med tilfælde af klinisk betydende hyponatriæmi hos ældre, som kan have en større risiko for at udvikle denne bivirkning (se hyponatriæmi under pkt.
English: [See Annex I - To be completed nationally] Sertraline
Danish: [Se bilag I - Udfyldes nationalt]sertralin
English: Caution is advised in patients taking SSRIs, particularly in concomitant use with drugs known to affect platelet function (e.g. anticoagulants, atypical antipsychotics and phenothiazines, most tricyclic antidepressants, acetylsalicylic acid and non-steroidal anti-inflammatory drugs (NSAIDs)) as well as in patients with a history of bleeding disorders (see section 4.5).
Danish: Der bør udvises forsigtighed hos patienter, der anvender SSRI, især ved samtidig anvendelse af lægemidler med kendt virkning på trombocytfunktionen (f.eks. antikoagulantia, atypiske antipsykotika og phenothiaziner, de fleste tricykliske antidepressiva, acetylsalicylsyre og non-steroide antiinflammatoriske lægemidler (NSAID)) samt hos patienter med blødningsforstyrrelser i anamnesen (se pkt.
English: Reversible, selective MAO-A inhibitor (moclobemide) Due to the risk of serotonin syndrome, the combination of sertraline with a reversible and selective MAOI, such as moclobemide, is not recommended.
Danish: Reversibel, selektiv MAO-A-hæmmer (moclobemid) På grund af risiko for serotoninsyndrom kan samtidig behandling med sertralin og en reversibel og selektiv MAO-hæmmer, som f.eks. moclobemid ikke anbefales.
English: Movement Disorders (including extrapyramidal symptoms such as hyperkinesia, hypertonia, teeth grinding or gait abnormalities), Syncope.
Danish: Bevægelsesforstyrrelser (herunder ekstrapyramidale symptomer som hyperkinesi, hypertoni, skæren tænder eller abnorm gangart), synkope.
English: A placebo-controlled trial in normal volunteers suggests that chronic administration of sertraline 200 mg/day does not produce clinically important inhibition of phenytoin metabolism.
Danish: Et placebokontrolleret forsøg med raske frivillige forsøgspersoner har vist, at længerevarende indtagelse af sertralin 200 mg dagligt ikke medførte klinisk afgørende hæmning af phenytoins metabolisering.
English: Zoloft and associated names (see Annex I) 20 mg/ml concentrate for oral solution
Danish: Zoloft og tilhørende navne (Se bilag I) 20 mg/ml koncentrat til oral opløsning
English: Coma*,
Danish: Depression*,
English: Periorbital Oedema*, Purpura*, Alopecia*, Cold Sweat, Dry skin, Urticuria*
Danish: Periorbital ødem*, purpura*, alopeci*, koldsved, tør hud, urticaria*
English: Film-Coated Tablets Oral use
Danish: Filmovertrukne tabletter Oral anvendelse
English: Generally these events are mild to moderate and are self-limiting; however, in some patients they may be severe and/or prolonged.
Danish: Hos de fleste patienter er disse symptomer milde til moderate og forbigående, men hos nogle patienter kan de være svære og/eller langvarige.
English: Hepatic Function Abnormal
Danish: Abnorm leverfunktion
English: The undesirable effects profile commonly observed in double-blind, placebo-controlled studies in patients with OCD, panic disorder, PTSD and social anxiety disorder was similar to that observed in clinical trials in patients with depression.
Danish: Bivirkningsprofilen, der ofte er observeret i dobbeltblinde, placebokontrollerede forsøg hos patienter med OCD, panikangst, PTSD og socialangst svarede til den, der er observeret i kliniske forsøg hos patienter med depression.
English: Psychiatric Disorders Insomnia
Danish: Psykiske forstyrrelser Insomni
English: In clinical trials, among patients treated with sertraline, the incidence of reported withdrawal reactions was 23% in those discontinuing sertraline compared to 12% in those who continued to receive sertraline treatment.
Danish: var hyppigheden af rapporterede seponeringssymptomer 23 % hos dem, der afbrød behandlingen sammenlignet med 12 % hos dem, der fortsatte behandlingen.
English: Zoloft can be used to treat:
Danish: De kan bruge Zoloft til behandling af
English: StevensJohnson syndrome and epidermal necrolysis, Angioedema, Face Oedema, Photosensitivity , Skin Reaction, Pruritus
Danish: Stevens-Johnson syndrom og epidermal nekrolyse, angioødem, ansigtsødem, lysfølsomhed, hudreaktion, kløe
English: Sertraline must not be used in combination with irreversible (non-selective) MAOIs such as selegiline.
Danish: Irreversible (ikke-selektive) MAO-hæmmere (selegilin) Sertralin må ikke anvendes sammen med irreversible (ikke-selektive) MAO-hæmmere, som f.eks. selegilin.
English: The MAH therefore committed to providing a long-term safety study looking at aspects of growth, sexual maturation, cognitive and emotional development and submitted a study synopsis for evaluation by the CHMP.
Danish: Indehaveren af markedsføringstilladelsen forpligtede sig derfor til at foretage en undersøgelse af langsigtet sikkerhed, der skulle se på aspekter af vækst, seksuel modning samt kognitiv og følelsesmæssig udvikling og indsendte en synopsis for undersøgelsen til vurdering hos CHMP.
English: Very common side effects (occurs in more than 1 out of 10 patients): Insomnia, dizziness, sleepiness, headache, diarrhoea, feeling sick, dry mouth, ejaculation failure, fatigue.
Danish: Meget almindelige bivirkninger (det forekommer hos flere end 1 ud af 10 patienter): Søvnløshed, svimmelhed, søvnighed, hovedpine, diarré, kvalme, mundtørhed, manglende udløsning, træthed.
English: Laryngospasm, Hyperventilation, Hypoventilation, Stridor, Dysphonia, Hiccups
Danish: Laryngospasme, hyperventilation, hypoventilation, stridor, dysfoni, hikke
English: Tell your doctor before you take Zoloft, if you suffer from or have suffered in the past from any of the following conditions:
Danish: Tal med lægen inden De tager Zoloft, hvis en af følgende tilstande gælder for Dem:
English: To be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease, or epilepsy.
Danish: De må kun tage denne medicin efter aftale med lægen, hvis De er gravid eller ammende, barn og i højrisikogruppe som patienter med leversygsdomme eller epilepsi.
English: Symptoms of overdose include serotonin-mediated side effects such as somnolence, gastrointestinal disturbances (such as nausea and vomiting), tachycardia, tremor, agitation and dizziness.
Danish: Symptomer på overdosering er bl.a. serotonin-medierede bivirkninger såsom døsighed, gastrointestinale forstyrrelser (f.eks. kvalme og opkastning), takykardi, tremor, agitation og svimmelhed.
English: Also reported were signs and symptoms associated with serotonin syndrome: In some cases associated with concomitant use of serotonergic drugs that included agitation, confusion, diaphoresis, diarrhoea, fever, hypertension, rigidity and tachycardia.
Danish: Der er rapporteret tegn og symptomer forbundet med serotonergt syndrom: Ved samtidig anvendelse af serotonerge lægemidler, er der i nogle tilfælde set agitation, konfusion, diaforese, diarré, feber, hypertension, stivhed, takykardi.
English: • Herbal medicine containing St. John's Wort (Hypericum perforatum).
Danish: • Naturmedicin, der indeholder perikon (Hypericum perforatum).
English: Glycerol: at high doses, can cause headache, abdominal pain and diarrhoea.
Danish: Glycerol: Kan ved høje doser give hovedpine, mavebesvær og diarré.
English: • Obsessive compulsive disorder (OCD) (in adults and children and adolescents aged 6-17 years old).
Danish: • Tvangstanker og tvangshandlinger (OCD) (hos voksne og børn og unge i alderen 6-17 år).
English: • Panic disorder (in adults).
Danish: • Panikangst (hos voksne).
English: Paraesthesia*, Tremor, Hypertonia, Dysgeusia, Disturbance in Attention,
Danish: Paræstesier*, tremor, hypertoni, dysgeusi, forstyrrelser i opmærksomhed
English: “Long-term efficacy data are lacking for this paediatric population, however, clinical trials for up to 64 weeks have been conducted and the safety profile is consistent with that of adults.
Danish: Der er imidlertid foretaget kliniske undersøgelser på op til 64 uger, hvor sikkerhedsprofilen svarer til profilen for voksne.
English: Anorexia, Increased Appetite*
Danish: Metabolisme og ernæring Appetitløshed, øget appetit*
English: In over 600 paediatric patients treated with sertraline, the overall profile of adverse reactions was generally similar to that seen in adult studies.
Danish: Den samlede bivirkningsprofil, der er set hos mere end 600 børn behandlet med sertralin, svarede til den, der er set i kliniske forsøg hos voksne.
English: Post traumatic stress disorder (PTSD)
Danish: Posttraumatisk belastningsreaktion (PTSD)
English: Vulvuvaginitis, Balanoposthitis, Genital Discharge, Priapism*, Galactorrhoea*
Danish: Menoragi, atrofisk vulvovaginitis, balanopostit, genital udflåd, priapisme*, galaktorré*
English: Use in renal insufficiency No dosage adjustment is necessary in patients with renal insufficiency (see section 4.4).
Danish: Nyreinsufficiens Dosisjustering er ikke nødvendig hos patienter med nyreinsufficiens (se pkt.
English: One single study was submitted in support of the paediatric indication, a 12 week randomised double blind study with a sertraline and a placebo arm.
Danish: Der blev indsendt én undersøgelse som dokumentation for indikationen til børn, en 12-ugers randomiseret dobbeltblindet undersøgelse med en sertralin- og en placebogruppe.
English: Uncommon (≥1/1000 to
Danish: Ikke almindelig (≥1/1000 til
English: “Sertraline is indicated for the treatment of obsessive compulsive disorder (OCD) in adults and paediatric patients aged 6-17 years.”
Danish: "Sertralin er indiceret til behandling af obsessiv-kompulsiv tilstand (OCD) hos voksne samt hos børn på 6-17 år."
English: Pfizer Hellas A.E., 243 Messoghion Ave., 154 51 Ν. Psychiko, Athens Greece
Danish: Pfizer Hellas A.E., 243 Messoghion Ave., 154 51 Ν. Psychiko, Athens Grækenland
English: If you experience any of these side effects, or any other side effects whilst stopping taking Zoloft, please speak to your doctor.
Danish: Tal med lægen, hvis De oplever disse eller andre bivirkninger, når De holder op med at tage Zoloft.
English: If you stop treatment with sertraline, you must wait until at least one week before you start treatment with a MAOI.
Danish: Hvis De afbryder behandlingen med sertralin, skal der gå mindst 1 uge, før De må starte i behandling med en MAO-hæmmer.
English: Leucopaenia, Thrombocytopa enia
Danish: Leukopeni, trombocytopeni
English: The use of sertraline has been associated with the development of akathisia, characterised by a subjectively unpleasant or distressing restlessness and need to move often accompanied by an inability to sit or stand still.
Danish: Brugen af sertralin har været knyttet til udvikling af akatisi, som er kendetegnet ved en fornemmelse af subjektiv ubehagelig eller forstyrrende rastløshed og et behov for psykomotorisk agitation såsom manglende evne til at sidde eller stå stille, normalt i forbindelse med indre uro.
English: This study includes a comparison group consisting of paediatric patients receiving psychotherapy alone” and also “to provide the relevant non-clinical data on juvenile animal toxicity available in the public domain, in order to justify why no further data needs to be generated in this field” were obtained from the Marketing Authorisation Holder,
Danish: Undersøgelsen inkluderer en kontrolgruppe bestående af pædiatriske patienter, der udelukkende får psykoterapi" og desuden "til at levere relevante, offentligt tilgængelige, ikke-kliniske toksicitetsdata om dyreunger for at begrunde, hvorfor der ikke behøver at blive udarbejdet yderligere data på dette område" blev indhentet fra indehaveren af markedsføringstilladelsen har CHMP anbefalet ændringen af markedsføringstilladelserne, for hvilke(n) produktresuméet, etiketteringen og indlægssedlen fremgår af bilag III for Zoloft og tilknyttede navne (se bilag I).
English: The co-administration of sertraline 200 mg daily did not potentiate the effects of alcohol, carbamazepine, haloperidol, or phenytoin on cognitive and psychomotor performance in healthy subjects; however, the concomitant use of sertraline and alcohol is not recommended.
Danish: Samtidig indtagelse af sertralin 200 mg dagligt forstærker ikke effekten af alkohol, carbamazepin, haloperidol eller phenytoin i forhold til kognitiv og psykomotorisk adfærd hos raske forsøgspersoner.
English: Sertraline is not recommended in pregnancy, unless the clinical condition of the woman is such that the benefit of the treatment is expected to outweigh the potential risk.
Danish: Sertralin må kun anvendes under graviditet, hvis kvindens kliniske tilstand er sådan, at fordelen af behandlingen forventes at veje tungere end den potentielle risiko.
English: For CY-BOCs the mean baseline and change from baseline scores for the placebo group was 22.25 ± 6.15 and -3.4 ± 0.82, respectively, while for the sertraline group, the mean baseline and change from baseline scores were 23.36 ± 4.56 and -6.8 ± 0.87, respectively.
Danish: For sertralingruppen var den gennemsnitlige baseline- og ændring fra baseline-score henholdsvis 23,36 ± 4,56 og -6,8 ± 0,87.
English: “Sertraline is indicated for the treatment of social anxiety disorder”.
Danish: "Sertralin er indiceret til behandling af socialangst".
English: Frequency of adverse reactions observed from placebo-controlled clinical trials in depression, OCD, panic disorder, PTSD and social anxiety disorder.
Danish: Frekvensen af birkninger observeret fra placebo-kontrollerede kliniske forsøg med OCD, panikangst, PTSD og socialangst.
English: Taking other medicines:
Danish: Brug af anden medicin
English: Co-administration of sertraline 200 mg daily with warfarin resulted in a small but statistically significant increase in prothrombin time, which may in some rare cases unbalance the INR value.
Danish: Samtidig behandling med sertralin 200 mg dagligt og warfarin har vist en mindre, men statistisk signifikant øgning af prothrombintid.
English: Section 4.2 - Posology and Method of Administration
Danish: Afsnit 4.2 - Dosering og indgivelsesmåde
English: Rare (≥1/10000 to
Danish: Sjælden (≥1/10.000 til ≤1/1000)
English: Drugs affecting platelet function
Danish: Lægemidler, der påvirker trombocytfunktionen
English: The maximum dosage is 200 mg daily.
Danish: Den maksimale dosis er 200 mg dagligt.
English: Peripheral Ischaemia
Danish: Perifer iskæmi
English: • Medicines to treat pain/arthritis (Non steroidal antiinflammatory drug (NSAID) such as ibuprofen, acetylsalicylic acid (aspirin).
Danish: • Medicin mod smerter/gigt (NSAID, f.eks. ibubrofen, acetylsalicylsyre).