FrancophonIA/ELRC3.0 huggingface dataset:
English: If [Invented name] is taken uninterruptedly for a long time, fibrosis (accumulation of scarring in the body organs) was seen at the pleural site (membrane covering the lungs), the peritoneum (membrane covering the abdominal cavity as well as the abdominal organs) and the heart valves.
Danish: Hvis [Særnavn] tages uden afbrydelse i lang tid, er der set fibrose (dannelse af arvæv i kroppens organer) i pleura (den hinde, der dækker lungerne), peritoneum (den hinde, der dækker bughulen og bughulens organer) og hjerteklapperne.
English: The tests will include a heart ultrasound, tests on how well your lungs are functioning and an abdominal scan such as a MRI.
Danish: Disse test vil bl.a. omfatte ultralydscanning af hjertet, test af hvor godt dine lunger virker, og scanning af maven, fx en MR-scanning.
English: Section 4.1 Therapeutic indications [The wording of this section should be read as below]
Danish: Afsnit 4.1 Terapeutiske indikationer [Dette afsnit skal formuleres som angivet herunder]
English: - For prophylactic treatment of severe intractable migraine a number of other classes of treatment may be considered (e.g. beta-blockers, anticonvulsivants, calcium channel blocker or tricyclic antidepressants).
Danish: - Til profylaktisk behandling af alvorlig, intraktabel migræne kan flere andre lægemiddelklasser overvejes (fx betablokkere, antiepileptika, calciumantagonister eller tricykliske antidepressiva).
English: How to take [Invented name] [This section should be amended to reflect the following wording] You should only get your medication initiated and supervised by a doctor who specialises in the treatment of migraine and cluster headache (neurologist).
Danish: Sådan skal du tage [Særnavn] [Dette afsnit skal ændres, så det reflekterer følgende formulering] En læge, der er specialiseret i behandlingen af migræne og klyngehovedpine (en neurolog), bør påbegynde og overvåge behandlingen.
English: [The wording of this section should be read as below]
Danish: [Dette afsnit skal formuleres som angivet herunder]
English: Retro-peritoneal fibrosis (see General disorders).
Danish: Retroperitoneal fibrose (se Almene symptomer).
English: Section 4.8 Undesirable effects [This section should be amended to reflect the following wording]
Danish: Afsnit 4.8 Bivirkninger [Dette afsnit skal ændres, så det reflekterer følgende formulering]
English: For episodic cluster headaches, the duration of treatment will be adjusted according to the usual duration of the episodes but normally no longer than 2-3 months.
Danish: Ved periodevis klyngehovedpine skal behandlingens varighed tilpasses den sædvanlige varighed af episoderne, men normalt ikke være længere end 2-3 måneder.
English: Route and method of administration
Danish: Virkning og anvendelse
English: Insomnia, drowsiness, dizziness, minor psychological changes of a temporary nature (nervousness, restlessness, depression and confusion in rare cases).
Danish: Insomni, døsighed, svimmelhed, mindre psykologiske ændringer af midlertidig art (nervøsitet, rastløshed, depression og konfusion i sjældne tilfælde).
English: For episodic cluster headache, the treatment duration should be adjusted according to the usual duration of the episodes, which would normally be no longer than 2 or 3 months.
Danish: Ved episodisk klyngehovedpine skal behandlingsvarigheden tilpasses den sædvanlige varighed af episoderne, som normalt vil være højst 2 eller 3 måneder.
English: Insomnia, somnolence, dizziness, minor mood changes (nervousness, restlessness, depression and confusion in rare cases).
Danish: Søvnløshed, døsighed, svimmelhed, mindre humørændringer (nervøsitet, rastløshed, depression og forvirring i sjældne tilfælde).
English: For chronic cluster headaches, treatment duration should not exceed 6 months.
Danish: Ved kronisk klyngehovedpine bør behandlingens varighed ikke overstige 6 måneder.
English: By reporting side effects you can help provide more information on the safety of this medicine.
Danish: Du kan også indberette bivirkninger direkte via det nationale rapporteringssystem anført i Appendiks V. Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: Section 4.2 Posology and method of administration [This section should be amended to reflect the following wording]
Danish: Afsnit 4.2 Dosering og indgivelsesmåde [Dette afsnit skal ændres, så det reflekterer følgende formulering]
English: Treatment duration should not exceed 6 months.
Danish: Behandlingens varighed bør ikke overstige 6 måneder.
English: However, it should only be used after other standard treatments have failed, those treatments should have been tried for at least 4 months at the maximum dose without success before [Invented name] is started.
Danish: Disse behandlinger skal have været prøvet uden succes i mindst 4 måneder ved den maksimale dosis, før behandling med [Særnavn] påbegyndes.
English: Pleuro-pulmonary fibrosis (see General disorders), dyspnoea, pleurisy, pleural effusion.
Danish: Pleurapulmonal fibrose (se Almene symptomer), dyspnø, pleuritis, pleuraeffusion.
English: Depending on the location of the affected blood vessel, this complication may be expressed as precordial (angina) or abdominal pain, as cold, dull, and painful sensations in the extremities, with or without paresthesia, as reduced or absence of a pulse, and theoretically, through arterial hypertension.
Danish: Afhængigt af den påvirkede blodåres placering kan denne komplikation vise sig som prækordial smerte (angina) eller abdominalsmerter, som kolde, dumpe og smertefulde fornemmelser i ekstremiteterne med eller uden paræstesi, som langsommere eller manglende puls og, teorisk set, som arteriel hypertension.
English: This may be observed as heart or vascular murmurs, tachycardia, peripheral oedema, raised JVP or palpitations.
Danish: Dette kan iagttages som hjerte- eller venemumlen, takykardi, perifert ødem, forhøjet tryk i vena jugularis eller palpitationer.
English: [Invented name] is to be used only following unsuccessful treatment with other standard classes of drugs (see section 4.4) after sufficient treatment duration (at least 4 months) at the maximal tolerated dose.
Danish: 4.4) efter en tilstrækkelig behandlingsvarighed (mindst 4 måneder) ved den maksimalt tolererede dosis.
English: Depending on the location of the affected blood vessel, this complication may be expressed as chest pain or abdominal pain, as cold, dull, and painful sensations in the extremities, with or without numbness, as reduced or absence of a pulse, and theoretically, through arterial tension increase.
Danish: Afhængigt af den påvirkede blodåres placering kan denne komplikation vise sig som brystsmerter eller mavesmerter, som kolde, dumpe og smertefulde fornemmelser i ekstremiteterne med eller uden følelsesløshed, som langsommere eller manglende puls og, teoretisk set, som forhøjet blodtryk.
English: If you notice any of the following symptoms you must immediately inform your doctor: pain in your chest or abdomen, awareness of your heart beat, difficulty in breathing, dry cough, nausea, general weakness, fatigue, loss of appetite/weight loss, urinary symptoms, pain/coldness/numbness in limbs.
Danish: Hvis du oplever et af følgende symptomer, skal du straks informere din læge: Smerter i brystet eller maven, mærkbart hjerteslag, åndedrætsbesvær, tør hoste, kvalme, generel svaghed, appetitløshed/vægttab, urinvejssymptomer, smerte/kulde/følelsesløshed i arme eller ben.
English: Fibrotic symptoms of the pleura are: chest pain and shortness of breath, dry cough and weight loss.
Danish: Fibrotiske symptomer i lungehinden er: Brystsmerter og åndenød, tør hoste og vægttab.
English: Retroperitoneal Fibrosis may occur.
Danish: Der kan forekomme retroperitoneal fibrose.
English: Skin reactions (e.g. rash, urticaria)
Danish: Hudreaktioner (fx udslæt, urticaria)
English: Migraine prophylaxis
Danish: Migræneprofylakse
English: Retroperitoneal fibrosis may cause obstruction of the urinary tract with symptoms such as general asthenia, back pain, lumbar pain, dysuria, oliguria, raised blood nitrogen, nausea, anorexia, and vascular insufficiency, weak pulse and skin discolouration in the lower limbs.
Danish: Retroperitoneal fibrose kan forårsage obstruktion i urinvejene med symptomer såsom generel asteni, rygsmerter, lændesmerter, dysuri, oliguri, forhøjet kvælstof i blodet, kvalme, anoreksi og vaskulær insufficiens, svag puls og misfarvning af huden på underekstremiteterne.
English: During clinical assessment of the patient, particular attention should be paid to complaints of: abdominal, loin or chest pain, palpitations, dyspnoea, dry cough, nausea, malaise, fatigue, anorexia/weight loss, urinary symptoms, pain/coldness/numbness in limbs.
Danish: I forbindelse med den kliniske vurdering af patienten skal man være særligt opmærksom på klager over: Smerter i abdomen, lænden eller brystet, palpitationer, dyspnø, tør hoste, kvalme, utilpashed, træthed, anoreksi/vægttab, urinvejssymptomer, smerte/kulde/følelsesløshed i ekstremiteter.
English: Fibrosis of the retroperitoneum can cause symtpoms such general discomfort, back pain, waist- or rib pain, pain during urination, reduced urine production, loss of appetite and skin discolouration in the legs.
Danish: Fibrose i retroperitoneum kan forårsage symptomer som almen utilpashed, rygsmerter, smerter i talje eller ribben, smerter ved vandladning, nedsat urinproduktion, manglende appetit og misfarvning af huden på benene.
English: Patients should be examined regularly for the presence of: peripheral oedema, leg discolouration, digital clubbing, weak/irregular pulse(s), tachycardia, cardiac murmur, vascular bruits, raised jugular vein pressure, lung basal crepitations, pleural/pericardial friction rubs, abdominal/flank masses/tenderness.
Danish: Patienterne skal jævnligt undersøges for forekomst af: Perifert ødem, misfarvning af benene, trommestikfingre, svag/ujævn puls, takykardi, hjertemislyd, hjertemumlen, forhøjet tryk i vena jugularis, basal krepitation i lungerne, pleural/perikardial gnidningslyd, hævelser/ømhed i abdomen/flanken.
English: Skin disorders
Danish: Hjerte-karsygdomme
English: Check with your doctor or pharmacist if you are not sure.
Danish: Er du i tvivl, så spørg lægen eller på apoteket.
English: Before you take [Invented name] tell your doctor if:
Danish: Vær ekstra forsigtig med at tage [Særnavn] [Dette afsnit skal ændres, så det reflekterer følgende formulering] Før du tager [Særnavn], skal du fortælle lægen, hvis:
English: Pleuro-pulmonary fibrosis (see General disorders), difficulty of breath, pleura inflammation, presence of fluid in the pleura.
Danish: Pleura-pulmonal fibrose (se Almene symptomer), åndedrætsbesvær, betændelseslignende tilstand i lungehinden, væskeansamling i lungehinden.
English: Pleuro-pulmonary fibrosis presents as precordial pains, dyspnoea, pleural frictional noise, lung basal crepitations or pleural effusion, digital clubbing, dry cough, anorexia and weight loss.
Danish: Pleurapulmonal fibrose vise sig som prækordiale smerter, dyspnø, pleural gnidningslyd, basal krepitation i lungerne eller pleuraeffusion, trommestikfingre, tør hoste, appetitløshed og vægttab.
English: The duration of continuous administration should not exceed six months.
Danish: Kontinuerlig behandlingsvarighed bør ikke overstige seks måneder.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.> <Or> <[Invented name] contains lactose and sucrose.
Danish: Bør ikke anvendes til patienter med arvelig galactoseintolerans, en særlig form af hereditær lactasemangel (Lapp lactasemangel) eller glucose/galactosemalabsorption.> <Eller> <[Særnavn] indeholder lactose og saccharose.
English: Cluster headaches
Danish: Klyngehovedpine
English: Skin reactions (e.g. rash, urticaria).
Danish: Hudreaktioner (fx udslæt, nældefeber).
English: Patients with rare hereditary problems of galactose or fructose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption or sucraseisomaltase insufficiency should not take this medicine.>
Danish: Bør ikke anvendes til patienter med arvelig galactoseeller fructoseintolerans, en særlig form af hereditær lactasemangel (Lapp lactasemangel), glucose/galactosemalabsorption eller sucrase/isomaltasemangel.>
English: <Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take [Invented name].>
Danish: <[Særnavn] bør ikke anvendes til patienter, som har sjældne arvelige problemer med galactoseintolerans, en form for arvelig lactasemangel (Lapp lactasemangel) eller glucose/galactosemalabsorption.> <Eller>
English: General disorders
Danish: Almene symptomer
English: 6 August 2014
Danish: Den 6. august 2014
English: Consequently, newborns should be monitored carefully.
Danish: Nyfødte bør derfor overvåges nøje.
English: The European Commission issued a decision on 6 August 2014.
Danish: Europa-Kommissionen traf en beslutning den 6. august 2014.
English: • treatment of schizophrenia;
Danish: • behandling af skizofreni
English: Seroquel is available as tablets (25, 100, 150, 200 and 300 mg) while Seroquel XR is available as prolonged-release tablets (50, 150, 200, 300 and 400 mg).
Danish: Seroquel leveres som tabletter (25, 100, 150, 200 og 300 mg), mens Seroquel XR leveres som depottabletter (50, 150, 200, 300 og 400 mg).
English: Prolonged-release means that the active substance is released slowly from the tablet over a few hours.
Danish: Depottabletter frigiver det aktive stof langsomt fra tabletten i løbet af få timer.
English: Therefore, quetiapine should only be used during pregnancy if the benefits justify the potential risks.
Danish: Quetiapin bør derfor ikke anvendes under graviditet, medmindre fordelene opvejer de mulige risici.
English: The CHMP also harmonised other sections of the SmPC including sections 4.4 (special warnings and precautions for use) and 4.8 (undesirable effects).
Danish: CHMP harmoniserede derudover andre afsnit af produktresuméet, herunder afsnit 4.4 (særlige advarsler og forsigtighedsregler vedrørende brugen) og 4.8 (bivirkninger).
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for these medicines in the European Union (EU).
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at der er behov for harmonisering af produktinformationen for disse lægemidler i Den Europæiske Union (EU).
English: The CHMP also harmonised the dosing recommendations, particularly how to increase the dose and the recommended daily dose.
Danish: CHMP harmoniserede desuden dosisanbefalingerne, navnlig vedrørende dosisforøgelse og den anbefalede daglige dosis.
English: This has led to divergences across Member States in the way the medicines can be used, as seen in the differences in the summaries of product characteristics (SmPCs), labelling and package leaflets in the countries where the medicines are marketed.
Danish: Dette har ført til afvigelser mellem medlemsstaterne i den måde, lægemidlerne kan anvendes på, således som det fremgår af forskellene mellem produktresuméer, etikettering og indlægssedler i de lande, hvor lægemidlerne markedsføres.
English: The exact mechanism of action of quetiapine is unknown, but it attaches to several receptors on the surface of nerve cells in the brain, including the receptors for the neurotransmitters dopamine and serotonin.
Danish: Virkningsmekanismen af quetiapin kendes ikke nøjagtigt, men man ved, at det bindes til forskellige receptorer på overfladen af nervecellerne i hjernen, herunder receptorerne for neurotransmitterne dopamin og serotonin.
English: Having reviewed the data available on the use of quetiapine during pregnancy, the CHMP concluded that no definite conclusion can be drawn on the risk of malformations in the unborn child when the medicine is used during early pregnancy (first trimester).
Danish: CHMP gennemgik erfaringerne med anvendelse af quetiapin under graviditet og konkluderede, at der ikke kan drages afgørende konklusioner om risikoen for misdannelser hos det ufødte barn ved anvendelse af lægemidlet i den tidlige del af graviditeten (første trimester).
English: As neurotransmitters are chemicals that allow nerve cells to communicate with each other, this affects signals transmitted between brain cells.
Danish: Da neurotransmittere er kemiske signalstoffer, som nervecellerne anvender ved deres indbyrdes kommunikation, vil dette påvirke signalerne mellem nervecellerne.
English: Since these neurotransmitters are involved in schizophrenia, bipolar disorder and major depression, quetiapine helps to normalise the activity of the brain, reducing the symptoms of these diseases.
Danish: Da disse neurotransmittere er medvirkende ved skizofreni og ved bipolær sygdom, normaliserer quetiapin hjerneaktiviteten, så symptomerne på disse sygdomme mindskes.
English: After reviewing the available data supporting the use of the medicines, the CHMP agreed that Seroquel and Seroquel XR can continue to be used for the treatment of schizophrenia and treatment and prevention of bipolar disorder, but recommended harmonised wordings for these indications as follows:
Danish: Efter gennemgang af dokumentationen for anvendelsen af lægemidlerne fandt CHMP, at Seroquel og Seroquel XR fortsat skal kunne anvendes til behandling af skizofreni og behandling og forebyggelse af bipolær sygdom, men udvalget anbefalede følgende harmoniserede ordlyd af disse anvendelser:
English: On 12 June 2013, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Seroquel and Seroquel XR in the EU.
Danish: Den 12. juni 2013 indbragte Europa-Kommissionen sagen for CHMP med henblik på harmonisering af markedsføringstilladelserne for Seroquel og Seroquel XR i EU.
English: Questions and answers on Seroquel, Seroquel XR and associated names (quetiapine)
Danish: Spørgsmål og svar om Seroquel, Seroquel XR og relaterede navne (quetiapin)
English: Seroquel and Seroquel XR are antipsychotic medicines that contain the active substance quetiapine.
Danish: Seroquel og Seroquel XR er antipsykotiske lægemidler, der indeholder det aktive stof quetiapin.
English: • treatment of moderate to severe manic episodes in bipolar disorder and major depressive episodes in bipolar disorder;
Danish: • behandling af moderate til svære maniske episoder ved bipolær sygdom og svære depressive episoder ved bipolær sygdom
English: On 22 May 2014, the European Medicines Agency completed a review of Seroquel and Seroquel XR.
Danish: Den 22. maj 2014 afsluttede Det Europæiske Lægemiddelagentur en gennemgang af Seroquel og Seroquel XR.
English: They are also used for the prevention and treatment of bipolar disorder, a mental illness in which patients have manic episodes (periods of abnormally high mood), alternating with periods of normal mood, as well as episodes of depression.
Danish: De bruges desuden til at forebygge og behandle bipolær sygdom, hvor patienterne har perioder med abnormt højt humør (maniske episoder) vekslende med perioder med normalt humør og episoder med depression.
English: • prevention of recurrence of manic or depressed episodes in patients with bipolar disorder who previously responded to quetiapine treatment.
Danish: • forebyggelse af tilbagefald af maniske eller depressive episoder hos patienter med bipolær sygdom, hos hvem behandling med quetiapin tidligere har virket.
English: Additionally, the data available show that newborns who were exposed to antipsychotics (including quetiapine) during late pregnancy (third trimester) are at risk of side effects including agitation, somnolence, breathing and feeding problems.
Danish: Desuden viser de foreliggende oplysninger, at nyfødte, der i den sene del af graviditeten (tredje trimester) udsættes for antipsykotiske midler (herunder quetiapin), risikerer bivirkninger, herunder uro, søvnighed og problemer med vejrtrækning og fødeindtagelse.
English: Seroquel and Seroquel XR are authorised in the EU via national procedures.
Danish: Seroquel og Seroquel XR er godkendt i EU via nationale procedurer.
English: Seroquel XR can also be used as add-on treatment in major depression.
Danish: Seroquel XR kan derudover bruges som tillægsbehandling ved svær depression.
English: What are Seroquel and Seroquel XR?
Danish: Hvad er Seroquel og Seroquel XR?
English: Seroquel XR can also continue to be used as add-on to ongoing treatment for major depressive episodes in patients with major depressive disorder who have had sub-optimal response to treatment with other antidepressants.
Danish: Seroquel XR kan desuden anvendes som tillægsbehandling ved svære depressive episoder hos patienter med svær depressiv sygdom, hos hvem behandling med andre midler mod depression ikke har haft tilfredsstillende virkning.
English: They are used in patients with schizophrenia, a mental illness with a number of symptoms, including disorganised thinking and speech, hallucinations (hearing or seeing things that are not there), suspiciousness and delusions (false beliefs).
Danish: De anvendes ved skizofreni, der er en psykisk sygdom med symptomer i form af bl.a. tankeforstyrrelser og taleforstyrrelser, sansebedrag (hallucinationer), mistænksomhed og vrangforestillinger.
English: Why were Seroquel and Seroquel XR reviewed?
Danish: Hvorfor blev Seroquel og Seroquel XR vurderet igen?
English: Seroquel and Seroquel XR are also marketed under other trade names.
Danish: Seroquel og Seroquel XR markedsføres desuden under andre handelsnavne.
English: The CHMP, in the light of the data submitted and the scientific discussion within the Committee, was of the opinion that the SmPCs, labelling and package leaflets should be harmonised across the EU.
Danish: CHMP fandt, at produktresuméer, etikettering og indlægssedler bør harmoniseres i EU på grundlag af de forelagte oplysninger og den videnskabelige drøftelse i udvalget.
English: Seroquel and Seroquel XR were identified by the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) as needing harmonisation.
Danish: Koordinationsgruppen vedrørende gensidig anerkendelse og decentrale procedurer - human (CMD(h)) fandt det nødvendigt med harmonisering for Seroquel og Seroquel XR.
English: The use of Kepivance should be supervised by a doctor who has experience in anticancer therapy.
Danish: Behandling med Kepivance skal superviseres af en læge, som har erfaring med brug af anticancerbehandling.
English: Other information about Kepivance:
Danish: Oversigt over indlægssedlen:
English: Three doses are given on three consecutive days before myeloablative therapy, finishing 24 to 48 hours before the therapy.
Danish: De første tre doser bør indgives forud for den myeloablative behandling, og heraf den tredje dosis 24 til 48 timer før den myeloablative radiokemoterapi.
English: Kepivance should not be used in people who may be hypersensitive (allergic) to palifermin, proteins produced by Escherichia coli (a bacterium) or any of the other ingredients.
Danish: Det skal De vide, før De begynder at bruge Kepivance Brug ikke Kepivance: - Hvis De er allergisk over for palifermin, over for proteiner, som er produceret af Escherichia coli, eller et af de øvrige indholdsstoffer i Kepivance (angivet i punkt 6).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Kepivance on 25 October 2005.
Danish: Dato første markedsføringstilladelse: 25. oktober 2005 Dato seneste fornyelse: 23. september 2010
English: Kepivance stimulates the growth of the epithelial cells, helping to reduce the incidence, severity and duration of oral mucositis in cancer patients undergoing intensive therapy.
Danish: Kepivance benyttes til at reducere hyppigheden, varigheden og sværhedsgraden af symptomerne på oral mucositis.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
Danish: 5550 Airport Boulevard Boulder, Colorado 80301 USA