FrancophonIA/ELRC3.0 huggingface dataset:
English: Duloxetine Lilly 30 mg Opaque white body, imprinted with ‘30 mg' and an opaque blue cap, imprinted with ‘9543'.
Danish: Mat hvid kapselbund med påskriften "30 mg" og mat blå kapseltop med påskriften "9543".
English: If your baby has any of these symptoms when it is born, or you are concerned about your baby's health, contact your doctor or midwife who will be able to advise you.
Danish: Du skal kontakte din læge eller jordemoder med henblik på råd og vejledning, hvis dit barn udviser nogle af disse symptomer efter fødslen, eller hvis du er bekymret for dit barns helbred.
English: Duloxetine Lilly must not be used in patients with liver disease resulting in hepatic impairment (see sections 4.3 and 5.2).
Danish: Duloxetin Lilly må ikke gives til patienter med nedsat leverfunktion på grund af leversygdom (se pkt.
English: Uncommon side effects (may affect up to 1 in 100 people)
Danish: Ikke almindelige bivirkninger (kan ske hos op til 1 ud af 100 patienter)
English: Do not stop taking Duloxetine Lilly, or change your dose, without talking to your doctor.
Danish: Du må kun stoppe behandlingen eller ændre dosis efter aftale med lægen.
English: Psychiatric disorders Insomnia
Danish: Psykiske forstyrrelser Søvnløshed Uro
English: Hypo-thyroidism
Danish: Hypotyreoidisme
English: Each capsule contains 30 mg of duloxetine (as hydrochloride).
Danish: Hver kapsel indeholder 30 mg duloxetin (som hydrochlorid).
English: Each capsule contains 60 mg of duloxetine (as hydrochloride).
Danish: Hver kapsel indeholder 60 mg duloxetin (som hydrochlorid).
English: Dermatitis contact Cold sweat Photo-sensitivity reactions
Danish: Nattesved Urticaria Kontaktdermatitis Koldsved Lysfølsmhedsreaktioner Øget tendens til at få blå mærker
English: See section 4.2 for information on patients with mild or moderate renal dysfunction.
Danish: For information om patienter med let til moderat nyreinsufficiens se pkt.
English: End stage renal disease (ESRD) patients receiving dialysis had 2-fold higher duloxetine Cmax and AUC values compared with healthy subjects.
Danish: Patienter med terminal nyresygdom i dialysebehandling havde et dobbelt så højt duloxetin-Cmaks.
English: Common side effects (may affect up to 1 in 10 people)
Danish: Almindelige bivirkninger (kan ske hos op til 1 ud af 10 patienter)
English: Dizziness, sensory disturbances (including paraesthesia or electric shock-like sensations, particularly in the head), sleep disturbances (including insomnia and intense dreams), fatigue, somnolence,
Danish: De almindeligste bivirkninger er svimmelhed, sensoriske forstyrrelser (inklusive paræstesier og følelsen af elektriske stød, især i hovedet), søvnforstyrrelser (inklusive søvnløshed og intense drømme), træthed, søvnighed, opstemthed eller angst, kvalme og/eller opkastning, rysten, hovedpine, myalgi, irritabilitet, diaré, hyperhidrosis og vertigo.
English: Treatment of major depressive disorder.
Danish: 4.1 Terapeutiske indikationer Behandling af major depression (moderat til svær depression).
English: • vomiting blood, or black tarry stools (faeces), gastroenteritis, burping, difficulty swallowing
Danish: • opkastning af blod eller sort, tjærefarvet afføring (på grund af blod i afføringen), mave-tarmkatar, bøvsen, synkebesvær
English: Muscle tightness Muscle twitching
Danish: Muskelstivhed Muskelsitren
English: The effect of Duloxetine Lilly 60 mg once a day in elderly depressed patients (≥65 years) was specifically examined in a study that showed a statistically significant difference in the reduction of the HAMD17 score for duloxetine-treated patients compared to placebo.
Danish: I et studie med ældre depressive patienter (≥ 65 år), som viste en statistisk signifikant forskel i reduktionen i HAMD17-scoren for duloxetinbehandlede patienter sammenlignet med placebo, blev effekten af Duloxetin Lilly 60 mg en gang daglig særligt undersøgt.
English: Dizziness Lethargy Tremor
Danish: Svimmelhed Letargi Tremor Paræstesier
English: Night sweats Urticaria
Danish: Nyrer og urinveje
English: Elevated liver enzymes (ALT, AST, alkaline phosphatase) Acute liver injury
Danish: Almindelig Ikke almindelig Sjælden Meget sjælden (ALAT, ASAT, basisk fosfatase)
English: PC:
Danish: C.
English: Very Rare
Danish: Almindelig Ikke almindelig Sjælden Meget sjælden
English: Paraesthesia
Danish: Epistaxis
English: Duloxetine Lilly 60 mg Opaque green body, imprinted with ‘60 mg' and an opaque blue cap, imprinted with ‘9542'.
Danish: Mat grøn kapselbund med påskriften "60 mg" og mat blå kapseltop med påskriften "9542".
English: Duloxetine Lilly 60 mg hard gastro-resistant capsules.
Danish: Duloxetin Lilly 60 mg hårde enterokapsler.
English: Duloxetine Lilly 30 mg hard gastro-resistant capsules.
Danish: Duloxetin Lilly 30 mg hårde enterokapsler.
English: Somnolence
Danish: Søvnforstyr
English: Duloxetine Lilly 60 mg hard gastro-resistant capsules duloxetine
Danish: LÆGEMIDLETS NAVN Duloxetin Lilly 60 mg hårde enterokapsler duloxetin
English: Infections and infestations
Danish: som bruges mod infektioner.
English: In both studies, Duloxetine Lilly 60 mg once daily and 60 mg twice daily significantly reduced pain compared with placebo.
Danish: Duloxetin Lilly blev givet i to forskellige dagsdoser: 60 mg én gang daglig og 60 mg to gange daglig.
English: Duloxetine Lilly 30 mg hard gastro-resistant capsules duloxetine
Danish: LÆGEMIDLETS NAVN Duloxetin Lilly 30 mg hårde enterokapsler duloxetin
English: Breast-feeding mothers
Danish: Ammende mødre
English: The usually recommended dose of Duloxetine Lilly is 60 mg once a day, but your doctor will prescribe the dose that is right for you.
Danish: Den sædvanlige anbefalede dosis af Duloxetin Lilly er 60 mg én gang daglig.
English: Blood potassium increased
Danish: Forhøjet kalium
English: Feeling hot Gait disturbance
Danish: Kuldegysnin-ger Føler sig syg Varmefølelse Gangforstyrrelse
English: Blood pressure increase3
Danish: Vaskulære sygdomme Forhøjet blodtryk3
English: Each capsule contains 30 or 60 mg of duloxetine (as hydrochloride).
Danish: Hver kapsel indeholder 30 eller 60 mg duloxetin som hydrochlorid - Øvrige indholdsstoffer:
English: Weight increased to match other children and adolescents of their age and sex after 6 months of treatment.
Danish: Efter 6 måneders behandling var vægten steget, så den svarede til deres jævnaldrendes af samme køn.
English: Hepatic impairment
Danish: Akut leverskade
English: In an open label long-term uncontrolled study, the pain reduction in patients responding to 8-weeks of acute treatment of Duloxetine Lilly 60 mg once daily was maintained for a further 6-months as measured by change on the Brief Pain Inventory (BPI) 24-hour average pain item.
Danish: Hos de patienter, som responderede på 8-ugers akut behandling med 60 mg Duloxetin Lilly en gang daglig i et open-label, langtids, ukontrolleret studie, holdt smertereduktionen i yderligere 6 måneder.
English: Pollakiuria
Danish: Dysuri Pollakisuri
English: Haemorrhage
Danish: Muskelspasmer
English: Duloxetine Lilly compared to placebo.
Danish: Graden af respons og bedring var også højere med Duloxetin Lilly sammenlignet med placebo.
English: 20 hard gastro-resistant capsules.
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) 20 hårde enterokapsler.
English: The other ingredients are:
Danish: Oversigt over indlægssedlen:
English: Hard gastro-resistant capsule.
Danish: Mave-tarm-kanalen Kvalme
English: Dry mouth
Danish: • sløret syn
English: − are taking or have taken within the last 14 days, another medicine known as a monoamine oxidase inhibitor (MAOI) (see ‘Other medicines and Duloxetine Lilly')
Danish: - tager, eller inden for de sidste 14 dage har været i behandling med, en MAO-hæmmer
English: Medicinal product subject to medical prescription
Danish: Lægemidlet er receptpligtigt.
English: Urinary retention Urinary hesitation Nocturia
Danish: Urinretention Forsinket vandladning Nykturi Polyuri Nedsat urinmængde
English: If you take more Duloxetine Lilly than you should
Danish: Hvis du har taget for meget Duloxetin Lilly
English: Gastrointestinal haemorrhage7 Gastroenteritis Eructation Gastritis Dysphagia
Danish: Gastrointestin-al blødning7
English: • headache, feeling sleepy • feeling sick (nausea), dry mouth
Danish: • hovedpine, søvnighed
English: INFORMATION IN BRAILLE
Danish: KLINISKE OPLYSNINGER
English: • large pupils (the dark centre of the eye), problems with eyesight
Danish: • store pupiller, synsforstyrrelser
English: Response and remission rates were also higher with
Danish: Pakningsstørrelser og yderligere oplysninger
English: Obizur has been authorised under ‘exceptional circumstances'.
Danish: Obizur er godkendt under "særlige omstændigheder".
English: Further information can be found in the summary of the risk management plan.
Danish: Yderligere oplysninger fremgår af resuméet af risikostyringsplanen
English: Obizur was not compared with any other medicine.
Danish: Obizur blev ikke sammenlignet med noget andet lægemiddel.
English: This is a summary of the European public assessment report (EPAR) for Obizur.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Obizur.
English: This is because it has not been possible to obtain complete information about Obizur due to the rarity of the disease.
Danish: Det skyldes, at det ikke har været muligt at indhente fyldestgørende oplysninger om Obizur, fordi sygdommen er sjælden.
English: The response to Obizur was considered positive if bleeding stopped or was reduced, while a negative response meant that the bleeding continued or worsened.
Danish: Responsen på Obizur blev anset for positiv, hvis blødningen standsede eller blev mindsket, hvorimod negativ respons betød, at blødningen fortsatte eller blev værre.
English: Factor VIII is one of the proteins needed for normal clotting of the blood.
Danish: Faktor VIII er et af de proteiner, der behøves til blodets normale størkning.
English: All 28 patients showed a positive response within 24 hours of starting treatment with Obizur; in 24 out of 28 patients, the bleeding stopped completely.
Danish: Alle 28 patienter udviste en positiv respons inden for 24 timer efter påbegyndelse af behandlingen med Obizur, og hos 24 patienter ud af 28 standsede blødningen fuldstændig.
English: Other information about Obizur
Danish: Andre oplysninger om Obizur
English: With regard to safety, the Committee considered that the potential for allergic reactions and the development of antibodies against the medicine is expected, and is outweighed by the beneficial effects.
Danish: Hvad angår sikkerheden fandt udvalget, at mulighederne for allergiske reaktioner og udvikling af antistoffer mod lægemidlet er forventelig, og at de opvejes af de gavnlige virkninger.
English: The full EPAR and risk management plan summary for Obizur can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR og resuméet af risikostyringsplanen for Obizur findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: A risk management plan has been developed to ensure that Obizur is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Obizur anvendes så sikkert som muligt.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that the benefits of Obizur are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Obizur opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: Hypersensitivity (allergic) reactions may occur with Obizur, and can include angioedema (swelling of tissues under the skin), burning and stinging at the injection site, chills, flushing, itchy rash, headache, hives, hypotension (low blood pressure), feeling tired or restless, nausea (feeling sick) or vomiting, tachycardia (rapid heartbeat), tightness of the chest, wheezing and tingling sensations.
Danish: Der kan forekomme overfølsomhedsreaktioner (allergi) med hævelse af vævene under huden (angioødem), brænden og stikken på injektionsstedet, kulderystelser, rødmen, kløende udslæt, hovedpine, nældefeber, for lavt blodtryk (hypotension), træthed eller rastløshed, kvalme eller opkastning, hurtig hjerterytme (takykardi), trykken for brystet, hiven efter vejret eller snurrende fornemmelser.
English: The dose, and how often it is given, as well as the length of treatment, are adjusted depending on the patient's condition and requirements, and the degree of danger posed by the bleeding.
Danish: Dosis af lægemidlet og hvor ofte det gives, justeres efter patientens tilstand og behov og efter, hvor farlig blødningen er.
English: What is Obizur and what is it used for?
Danish: Hvad er Obizur, og hvad anvendes det til?
English: Obizur contains the active substance susoctocog alfa.
Danish: Obizur indeholder det aktive stof susoctocog alfa.
English: Why is Obizur approved?
Danish: Hvorfor er Obizur blevet godkendt?
English: What measures are being taken to ensure the safe and effective use of Obizur?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Obizur?
English: Obizur must not be used in patients who have had a severe allergic reaction to susoctocog alfa, any of its other ingredients, or hamster protein.
Danish: Obizur må ikke anvendes hos patienter, der har haft en svær allergisk reaktion på susoctocog alfa, på andre af indholdsstofferne eller på hamsterprotein.
English: Since Obizur has been approved under exceptional circumstances, the company that markets the medicine will establish and maintain a patient registry to collect and analyse short- and long-term data on the effectiveness and safety of Obizur in patients with acquired haemophilia caused by antibodies against factor VIII.
Danish: Da Obizur er godkendt under særlige omstændigheder, skal den virksomhed, der markedsfører lægemidlet, oprette og føre et patientregister med indsamling og analyse af kort- og langsigtede data om virkningen og sikkerheden af Obizur hos patienter med erhvervet hæmofili forårsaget af antistoffer mod faktor VIII.
English: In some cases, reactions become severe (anaphylaxis) and may be associated with dangerously steep falls in blood pressure.
Danish: I nogle tilfælde kan reaktionerne være svære (anafylaksi) og medføre farligt pludseligt blodtryksfald.
English: It is not intended to provide practical advice on how to use Obizur.
Danish: Det er ikke en praktisk vejledning i, hvordan Obizur bør anvendes.
English: The results of the main study showed that Obizur was effective in treating serious bleeding episodes in adults with the disorder.
Danish: Hovedundersøgelsen viste, at Obizur var effektivt til at behandle alvorlige blødningsepisoder hos voksne med sygdommen.
English: What are the risks associated with Obizur?
Danish: Hvilke risici er der forbundet med Obizur?
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Obizur, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Obizur, herunder passende forholdsregler, som sundhedspersonale og patienter skal følge.
English: What information is still awaited for Obizur?
Danish: Hvilke oplysninger afventes der stadig for Obizur?
English: For the full list of all side effects and restrictions with Obizur, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger med Obizur fremgår af indlægssedlen.
English: For more information about treatment with Obizur, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Obizur, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Patients with acquired haemophilia caused by antibodies against factor VIII may develop antibodies against susoctocog alfa.
Danish: Patienter med erhvervet hæmofili forårsaget af antistoffer mod faktor VIII kan udvikle antistoffer mod susoctocog alfa.
English: susoctocog alfa, works in the body in the same way as human factor VIII, but has a slightly different shape.
Danish: Det aktive stof i Obizur, susoctocog alfa, virker på samme måde i kroppen som kroppens egen faktor XIII, men har en lidt forskellig opbygning.
English: Obizur can only be obtained with a prescription and treatment should be supervised by a doctor with experience in the treatment of haemophilia.
Danish: Lægemidlet Obizur udleveres kun efter recept, og ordination og behandling bør overvåges af en læge med erfaring i behandling af hæmofili.
English: Patients with acquired haemophilia caused by antibodies against factor VIII have blood clotting problems, such as bleeding in the joints, muscles or internal organs.
Danish: Patienter med erhvervet hæmofili som følge af antistoffer mod faktor VIII har problemer med blodets størkning, så der opstår blødning i led, muskler eller indre organer.
English: The CHMP noted the lack of specific treatments for acquired haemophilia caused by antibodies against factor VIII.
Danish: CHMP bemærkede, at der savnes specifikke behandlingsmuligheder for erhvervet hæmofili forårsaget af antistoffer mod faktor VIII.
English: As a result, it will not be as easily recognised by the antibodies and it can replace the human factor VIII that has been inactivated, thereby helping the blood to clot and controlling the bleeding.
Danish: Som følge heraf vil det ikke så let blive genkendt af antistofferne som kroppens egen faktor VIII, der er blevet inaktiveret, og det kan derfor erstatte dette.
English: Obizur has been investigated in one main study involving 28 adult patients with acquired haemophilia caused by antibodies against factor VIII who were experiencing a serious bleeding episode.
Danish: Obizur er blevet undersøgt i én hovedundersøgelse med 28 voksne patienter, som led af erhvervet hæmofili som følge af antistoffer mod faktor VIII, og som havde en alvorlig blødningsepisode.
English: Additionally, the company that markets Obizur will provide healthcare professionals who are expected to use Obizur with educational material containing information on how to calculate the dose.
Danish: Desuden skal den virksomhed, der markedsfører Obizur udlevere oplysningsmateriale til de sundhedspersoner, forventes at anvende Obizur, herunder om beregning af dosis.
English: Obizur is available as a powder and solvent that are mixed together to make a solution for injection into a vein.
Danish: Obizur leveres som et pulver med opløsningsvæske (solvens), der blandes sammen til en opløsning, som gives ved injektion i en vene.
English: Obizur is a medicine used for the treatment of bleeding episodes in adults with acquired haemophilia, a bleeding disorder caused by the spontaneous development of antibodies that inactivate factor VIII.
Danish: Obizur er et lægemiddel til behandling af blødningsepisoder hos voksne med erhvervet hæmofili, som er en blødningsforstyrrelse, der skyldes spontan udvikling af antistoffer, som inaktiverer faktor VIII.
English: For practical information about using Obizur, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Obizur, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: How is Obizur used?
Danish: Hvordan anvendes Obizur?
English: How does Obizur work?
Danish: Hvordan virker Obizur?
English: What benefits of Obizur have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Obizur?
English: --1 Recombinant Protein Q from Leishmania infantum MON-1 ≥ 36.7 ELISA Units (EU)* * Antigen content determined in an ELISA against an internal standard.
Danish: Rekombinant protein Q fra Leishmania infantum MON-1 ≥ 36,7 ELISA-enheder (EU)* * Indhold af antigen bestemt ved en ELISA mod en intern standard.
English: Lyophilisate: 1 vial; solvent:
Danish: 5 hætteglas; solvent: 5 hætteglas
English: Strength Pharmaceutical form
Danish: Særnavn Styrke LægemiddelformDyrearter, som lægemidlet er beregnet til
English: Target species
Danish: Særnavn Styrke Læemiddelform Dyrearter, som lægemidlet er beregnet til
English: 10 mg/ ml Solution for injection.
Danish: INCRELEX 10 mg/ml
English: Subcutaneous use Vial (glass)
Danish: Injektionsvæske, opløsning Til subkutant brug hætteglas (glas) 4 ml
English: 1 Vial
Danish: 1 hætteglas
English: Content
Danish: Indhold
English: INCRELEX
Danish: Styrke
English: This summary was last updated in 10-2011.
Danish: Dette sammendrag blev sidst ajourført i 10-2011.
English: Other information about Aerinaze
Danish: Andre oplysninger om Aerinaze
English: Similar results were seen in the second study.
Danish: Den anden undersøgelse gav tilsvarende resultater.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Aerinaze on 30 July 2007.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Aerinaze den 30. juli 2007.
English: This means that patients only need to take the tablet twice a day.
Danish: Det betyder, at patienten kan nøjes med at tage tabletten to gange dagligt.
English: This is a summary of the European public assessment report (EPAR) for Aerinaze.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Aerinaze.
English: The full EPAR for Aerinaze can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Aerinaze findes på agenturets websted under ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Aerinaze was more effective in reducing symptoms than either of the two active substances taken alone.
Danish: Aerinaze var mere effektivt til at mindske symptomerne end nogen af de to aktive stoffer hver for sig.
English: ‘Modified-release' means that the tablets have been made to allow one of the active substances to be released immediately and the other one released over a few hours.
Danish: "Modificeret udløsning" betyder, at tabletterne er opbygget, så det ene aktive stof frigives straks, mens det andet frigives i løbet af nogle timer.
English: Desloratadine/pseudoephedrine
Danish: Desloratadin/pseudoephedrin
English: It is available as blue and white modified-release tablets.
Danish: Det leveres som blå og hvide tabletter med modificeret udløsning.
English: The effectiveness of Aerinaze was assessed in two main studies involving a total of 1,248 adult and adolescent patients.
Danish: Der blev udført to hovedundersøgelser af virkningen af Aerinaze hos i alt 1 248 voksne og unge patienter.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Aerinaze.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Aerinaze.
English: Treatment should continue for as short a time as possible and should stop when symptoms, chiefly the congestion (blocked nose), have disappeared.
Danish: Behandlingen bør vare i kortest mulig tid og skal ophøre, når symptomerne, hovedsagelig stoppet næse, er forsvundet.
English: For more information about treatment with Aerinaze, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Aerinaze, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: What is the risk associated with Aerinaze?
Danish: Hvilken risiko er der forbundet med Aerinaze?
English: Why has Aerinaze been approved?
Danish: Hvorfor blev Aerinaze godkendt?