FrancophonIA/ELRC3.0 huggingface dataset:
English: Hold on to the clear front end of the pre-filled pen and screw the needle all the way onto the clear front end of the pre-filled pen.
Danish: Hold om den klare ende på pennen og skru nålen på.
English: What Preotact contains -The active substance is parathyroid hormone.
Danish: Aktivt stof: parathyreoideahormon.
English: Preotact is a powder and solvent for solution for injection in a pre-filled pen.
Danish: Preotact består af pulver og opløsningsvæske i en fyldt pen.
English: Nervous system disorders Common
Danish: Nervesystemet Almindelig Hovedpine Svimmelhed ikke almindelig Dysgeusi Parosmi
English: Posology The recommended dose is 100 micrograms of parathyroid hormone administered once-daily
Danish: Den anbefalede dosis er 100 mikrogram parathyreoideahormon en gang daglig.
English: • Take the daily injection • Store the pre-filled pen
Danish: • Tage den daglige injektion
English: Uncommon (may affect up to 1 in 100 people):
Danish: Almindelige bivirkninger (forekommer hos mellem 1 og 10 ud af 100 behandlede)
English: • Add a needle
Danish: • Påsætte en nål
English: When you are not using it, put the pre-filled pen back into the refrigerator.
Danish: Læg pennen tilbage i køleskabet, når du ikke bruger den.
English: Cardiac disorders Common
Danish: Hjerte Almindelig Palpitationer
English: Each cartridge inside the prefilled pen contains 1.61 mg parathyroid hormone and 1.13 ml solvent (14 doses).
Danish: Cylinderampullen, der sidder i pennen, indeholder 1,61 mg parathyreoideahormon og 1,13 ml solvens (14 doser).
English: • sodium hydroxide.
Danish: • fortyndet natriumhydroxid (E 524).
English: • citric acid monohydrate,
Danish: • citronsyremonohydrat (E 330),
English: Once the cartridge is reconstituted it can be stored below 25°C for up to 7 days during the 28 day use time.
Danish: Efter blanding kan pennen opbevares uden for køleskab ved temperaturer under 25 °C i sammenlagt 7 dage ud af den samlede brugsperiode på 28 dage.
English: • headache,
Danish: • mavesmerter,
English: Preotact is supplied in a pre-filled pen containing a cartridge.
Danish: Preotact leveres i en fyldt pen indeholdende en cylinderampul med to kamre.
English: Crimp cap (containing a rubber seal): Aluminium .The rubber seal is made of bromobutyl rubber.
Danish: Gummiforseglingen er lavet af brombutylgummi.
English: Pain in extremity
Danish: Smerter i ekstremiteterne Rygsmerter
English: The dose counter
Danish: Tæller (Antal doser)
English: • increased level of calcium in the blood,
Danish: • forhøjet indhold af kalk i blodet
English: • stomach upset, vomiting,
Danish: • maveonde, opkastninger,
English: SUBSTANCE AND MANUFACTURING AUTHORISATION
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING
English: Dyspepsia
Danish: Dosistælleren
English: - This medicine has been prescribed for you only.
Danish: - Lægen har ordineret Preotact til dig personligt.
English: DO NOT SHAKE; shaking may cause denaturation of the active substance.
Danish: Omrystning kan ødelægge det virksomme lægemiddel.
English: The safety and efficacy of Preotact in patients under 18 years have not been studied.
Danish: Preotact bør ikke anvendes til børn og unge under 18 år pga. mangel på data vedrørende sikkerhed og effekt.
English: What Preotact looks like and contents of the pack
Danish: Udseende og pakningstørrelser
English: Palpitations
Danish: Parathyreoideahormon
English: Gastrointestinal disorders Very common
Danish: Mave-tarm-kanalen Meget almindelig Kvalme
English: Parosmia
Danish: ANDET
English: Elderly Dose adjustment based upon age is not required (see section 5.2).
Danish: Ældre Dosisjustering i forhold til alder er ikke nødvendig.
English: Pull the cap straight off from the front end of the pre-filled pen.
Danish: Læs brugervejledningen, der følger med din Preotact pen.
English: Measuring of the calcium levels in the blood and/or urine Your doctor will check your response to the treatment at regular intervals.
Danish: Måling af kalkindhold i blod og/eller urin
English: This overview was last updated in 09-2014.
Danish: Denne oversigt blev sidst ajourført i 09-2014.
English: Eliquis received a marketing authorisation valid throughout the EU on 18 May 2011.
Danish: Eliquis fik en markedsføringstilladelse med gyldighed i hele EU den 18. maj 2011.
English: Further information on Eliquis can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Yderligere information om Eliquis findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: It is available as tablets (2.5 mg, 5 mg).
Danish: Det fås som tabletter (2,5 mg og 5 mg).
English: For more information about using Eliquis, see the package leaflet or contact your doctor or pharmacist.
Danish: For yderligere oplysninger om brug af Eliquis, se indlægssedlen, eller kontakt din læge eller dit apotek.
English: Other information about Eliquis
Danish: Andre oplysninger om Eliquis
English: As for all medicines, data on the use of Eliquis are continuously monitored.
Danish: Som for alle lægemidler, er data vedrørende brug af Eliquis løbende overvåget.
English: Eliquis contains the active substance apixaban.
Danish: Eliquis indeholder det aktive stof apixaban.
English: The European Medicines Agency decided that Eliquis' benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur afgjorde, at fordelene ved Eliquis opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: For patients who have had a hip or knee replacement, treatment with Eliquis should be started 12 to 24 hours after the operation.
Danish: For patienter, der har fået en ny hofte eller et nyt knæ, bør behandlingen med Eliquis begynde 12 til 24 timer efter operationen.
English: What measures are being taken to ensure the safe and effective use of Eliquis?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Eliquis?
English: Side effects reported with Eliquis are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Eliquis vurderes omhyggeligt, og der foretages nødvendige forholdsregler for at beskytte patienterne.
English: Some of these side effects are not seen with all the uses of Eliquis.
Danish: Nogle af disse bivirkninger ses ikke ved alle anvendelser af Eliquis.
English: In both studies, Eliquis was compared with enoxaparin (another medicine used to prevent blood clots).
Danish: I begge studier blev Eliquis sammenlignet med enoxaparin (et andet lægemiddel, der anvendes til at forebygge blodpropper).
English: An overview of Eliquis and why it is authorised in the EU
Danish: En oversigt over Eliquis, og hvorfor det er godkendt i EU
English: Eliquis can only be obtained with a prescription.
Danish: Eliquis udleveres kun efter recept.
English: The recommended dose is one 2.5 mg tablet taken by mouth twice a day, usually for over one month (32 to 38 days) after a hip replacement or for 10 to 14 days after a knee replacement.
Danish: Den anbefalede dosis er én 2,5 mg tablet, der tages gennem munden to gange dagligt, normalt i over en måned (32 til 38 dage) efter en hofteoperation og i 10-14 dage efter en knæoperation.
English: Why is Eliquis authorised in the EU?
Danish: Hvorfor er Eliquis godkendt i EU?
English: By blocking factor Xa, it reduces the levels of thrombin in the blood, which reduces the risk of blood clots forming in the arteries and veins.
Danish: Ved at blokere faktor Xa nedsætter det blodets indhold af trombin, hvilket mindsker risikoen for dannelse af blodpropper i arterier og vener.
English: It is used in patients who have one or more risk factors, such as having had a previous stroke, having high blood pressure, diabetes, heart failure or being 75 years old or over.
Danish: Det anvendes hos patienter med en eller flere risikofaktorer, såsom tidligere slagtilfælde, højt blodtryk, sukkersyge, hjertesvigt eller alder over 75 år.
English: The most frequent side effects with Eliquis (seen in between 1 and 10 patients in 100) are anaemia (low red blood cell counts), haemorrhage (bleeding), haematoma (a collection of blood under the skin), contusion (bruising), nausea (feeling sick), low blood pressure (hypotension), epistaxis (nose bleeds), haematuria (blood in urine), low blood platelet counts (thrombocytopenia), blood tests showing alanine aminotransferase and gamma-glutamyltransferase increase and skin rash.
Danish: De hyppigste bivirkninger med Eliquis (som optræder hos 1 til 10 patienter ud af 100) er lavt antal røde blodlegemer (anæmi) blødning (hæmoragi), blodansamling under huden (hæmatom), blå mærker (kontusion), kvalme, lavt blodtryk (hypotension), næseblødning (epistaxis), blod i urinen (hæmaturi) lavt antal blodplader (trombocytopeni), blodprøver, der viser forhøjet alaninaminotransferase og gamma-glutamyltransferase, og hududslæt.
English: Thrombin is central to the process of blood clotting.
Danish: Trombin spiller en central rolle i blodets størkning.
English: Similarly, patients with atrial fibrillation are at high risk of clots forming in the heart, which can reach the brain where they can cause a stroke.
Danish: Tilsvarende har patienter med atrieflimren høj risiko for dannelse af blodpropper i hjertet, som kan føres til hjernen, hvor de kan være årsag til slagtilfælde.
English: The company that markets Eliquis will provide educational material for healthcare professionals expected to prescribe Eliquis that addresses the risk of bleeding during treatment.
Danish: Den virksomhed, der markedsfører Eliquis, skal udlevere oplysningsmateriale til de sundhedspersoner, der ventes at udskrive Eliquis, til forebyggelse af risikoen for blødning under behandlingen.
English: What is Eliquis and what is it used for?
Danish: Hvad er Eliquis, og hvad anvendes det til?
English: Eliquis was also effective at treating deep vein thrombosis and pulmonary embolism and preventing their reoccurrence in two main studies.
Danish: Eliquis var også effektivt til behandling af dyb venetrombose og lungeemboli og til forebyggelse af tilbagefald heraf i to hovedstudier.
English: Eliquis must not be used in patients who are actively bleeding, or who have liver disease which leads to problems with blood clotting and an increased risk of bleeding.
Danish: Eliquis må ikke anvendes til patienter, der bløder aktivt eller har en leversygdom, som medfører problemer med blodpropper og øget blødningsrisiko.
English: Eliquis was also shown to be effective in preventing strokes and arterial blood clots in patients with atrial fibrillation in two main studies: the first (in 18,201 patients) compared Eliquis with another medicine, warfarin, while the second (in 5,598 patients) compared Eliquis with aspirin.
Danish: Eliquis blev desuden påvist at være effektivt til at forebygge slagtilfælde og blodpropper i arterierne hos patienter med atrieflimren i to hovedstudier: Det første (med 18 201 patienter) sammenlignede Eliquis med et andet lægemiddel, warfarin, mens det andet (med 5 598 patienter) sammenlignede Eliquis med acetylsalicylsyre.
English: Patients undergoing hip or knee replacement surgery, who have had a recent trauma, or are confined to bed are at a high risk of blood clots forming in the veins, which can be dangerous and even fatal if they move to another part of the body such as the lungs.
Danish: Patienter, der får indopereret et nyt hofte- eller knæled, eller som for nylig har haft en skade eller er sengeliggende, har høj risiko for, at der i venerne dannes blodpropper, som kan være farlige eller endda dødelige, hvis de føres hen til en anden del af kroppen såsom lungerne.
English: For the full list of side effects and restrictions with Eliquis, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger med Eliquis fremgår af indlægssedlen.
English: In patients undergoing a knee replacement, the corresponding numbers were 15% (147 out of 976) for Eliquis compared with 24% (243 out of 997) for enoxaparin.
Danish: Hos patienter, der fik indsat et kunstigt knæled, var det tilsvarende antal 15 % (147 ud af 976) for Eliquis, sammenholdt med 24 % (243 ud af 997) for enoxaparin.
English: The active substance in Eliquis, apixaban, is a ‘factor Xa inhibitor'.
Danish: Det aktive stof i Eliquis, apixaban, er en faktor Xa-hæmmer.
English: What are the risks associated with Eliquis?
Danish: Hvilke risici er der forbundet med Eliquis?
English: The main measures of effectiveness were based on the number of strokes or clotting events that occurred during treatment.
Danish: Det vigtigste mål for effektiviteten var baseret på antallet af slagtilfælde eller blodprophændelser, der opstod under behandlingen.
English: 2.3% of patients treated with Eliquis had a clot or died, compared with 2.7% of patients treated with enoxaparin plus warfarin, showing that Eliquis was as effective as the comparator treatment.
Danish: 2,3 % af de patienter, der blev behandlet med Eliquis, fik en blodprop eller døde, sammenholdt med 2,7 % af dem, der blev behandlet med enoxaparin plus warfarin, hvilket beviste, at Eliquis var lige så effektivt som sammenligningslægemidlet.
English: It is also used in adults to treat deep vein thrombosis (blood clot in a deep vein, usually in the leg) and pulmonary embolism (clot in a blood vessel supplying the lungs), and to prevent their reoccurrence.
Danish: Det anvendes desuden hos voksne til behandling af dyb venetrombose (en blodprop i en dyb vene, sædvanligvis i benene) og lungeemboli (en blodprop i et kar, der forsyner lungerne), og til at forebygge, at det gentager sig.
English: For the treatment of deep vein thrombosis and pulmonary embolism, the recommended dose is 10 mg twice a day for the first week, followed by 5 mg twice a day for at least 3 months.
Danish: Til behandling af dyb venetrombose og lungeemboli er den anbefalede dosis 10 mg to gange dagligt i den første uge, efterfulgt af 5 mg to gange dagligt i mindst 3 måneder.
English: 2.3% of patients taking Eliquis (2.5 mg twice a day) experienced a clot or died, compared with 9.3% of patients taking placebo.
Danish: 2,3 % af de patienter, der fik Eliquis (2,5 mg to gange dagligt), fik en blodprop eller døde, sammenholdt med 9,3 % af dem, der fik placebo.
English: The medicine must also not be used in patients with conditions putting them at risk of major bleeding, such as an ulcer in the gut, or in patients being treated with other anticoagulant medicines except in specific circumstances (see summary of product characteristics).
Danish: Lægemidlet må heller ikke anvendes hos patienter med sygdomme, der medfører fare for større blødninger såsom mave-tarmsår, eller hos patienter, der er i behandling med andre blodfortyndende lægemidler undtagen under særlige omstændigheder (se produktresuméet).
English: For patients with atrial fibrillation at risk of stroke or blood clots, the recommended dose is 5 mg taken twice a day.
Danish: For patienter med atrieflimren, der har risiko for slagtilfælde eller blodpropper, er den anbefalede dosis 5 mg to gange dagligt.
English: Eliquis was effective at preventing blood clots in the veins following a hip or knee replacement in two main studies involving a total of 8,464 patients.
Danish: Eliquis var effektivt til at forhindre blodpropper i venerne efter indoperation af et kunstigt hofte- eller knæled i to hovedstudier med i alt 8 464 patienter.
English: In the treatment study conducted in 5,395 patients, Eliquis was compared with enoxaparin followed by warfarin; the main measure of effectiveness was based on the number of patients who either had blood clots in the veins of the legs or lungs or died because of this during the treatment period.
Danish: I behandlingsstudiet hos 5 395 patienter blev Eliquis sammenlignet med enoxaparin efterfulgt af warfarin; det vigtigste mål for effektiviteten blev baseret på det antal patienter, der enten fik blodpropper i benene eller lungerne, eller som døde på grund heraf i behandlingsperioden.
English: The yearly rates in the second study were 1.6% for patients taking Eliquis and 3.6% for patients taking aspirin.
Danish: I det andet studie var den årlige andel 1,6 % for de patienter, der fik Eliquis, og 3,6 % for dem, der fik acetylsalicylsyre.
English: Additionally, Eliquis is used to prevent stroke (caused by blood clots in the brain) and blood clots in other organs in adults with atrial fibrillation (irregular rapid contractions of the upper chambers of the heart).
Danish: Eliquis anvendes yderligere til forebyggelse af slagtilfælde (som følge af blodpropper i hjernen), og blodpropper i andre organer hos voksne med uregelmæssige hurtige sammentrækninger af hjertets forkamre (atrieflimren).
English: Eliquis is a medicine used to prevent venous thromboembolism (blood clots in the veins) in adults following a hip or knee replacement operation.
Danish: Eliquis er et lægemiddel, der anvendes til at forebygge blodpropper i venerne (venøs tromboembolisme) hos voksne efter indsætning af en ny hofte eller et nyt knæ.
English: In the study comparing Eliquis with warfarin, 1.3 % of the patients taking Eliquis had a stroke or clotting event every year compared with 1.6% of the patients taking warfarin.
Danish: I det studie, der sammenlignede Eliquis med warfarin, fik 1,3 % af de patienter, der fik Eliquis, et slagtilfælde eller en blodprophændelse om året, sammenholdt med 1,6 % af dem, der fik warfarin.
English: To prevent deep vein thrombosis and pulmonary embolism from reoccurring, the recommended dose is 2.5 mg twice a day.
Danish: Til forebyggelse af dyb venetrombose og lungeemboli er den anbefalede dosis 2,5 mg to gange dagligt.
English: The medicine's effectiveness was measured by looking at the number of patients who either had problems related to clotting in the veins or who died of any cause during the treatment period.
Danish: Lægemidlets effektivitet blev bestemt ud fra det antal patienter, der enten havde problemer med blodpropdannelse i venerne eller døde i behandlingsperioden uanset årsag.
English: In the prevention study in 2,482 patients, Eliquis was compared with placebo (a dummy treatment) and its effectiveness was measured by looking at the number of patients who either had problems related to clotting in the veins or who died of any cause during treatment.
Danish: I forebyggelsesstudiet hos 2 482 patienter blev Eliquis sammenlignet med virkningsløs behandling (placebo), og virkningen blev bedømt på det antal patienter, der enten fik problemer med blodpropper i venerne eller døde uanset årsag i løbet af behandlingsperioden.
English: What benefits of Eliquis have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Eliquis?
English: In patients undergoing a hip replacement, 1.4% of the patients who completed treatment with Eliquis (27 out of 1,949) had a clotting event or died from any cause, compared with 3.9% (74 out of 1,917) of the patients taking enoxaparin.
Danish: Hos de patienter, der fik indopereret en kunstig hofte, fik 1,4 % af dem, der gennemførte behandlingen med Eliquis (27 ud af 1 949), en blodprophændelse eller døde uanset årsag, sammenholdt med 3,9 % (74 ud af 1 917) af dem, der fik enoxaparin.
English: How is Eliquis used?
Danish: Hvordan anvendes Eliquis?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Eliquis have also been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Eliquis.
English: How does Eliquis work?
Danish: Hvordan virker Eliquis?
English: This summary was last updated in 01-2018.
Danish: Dette sammendrag blev sidst ajourført i 01-2018.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Faslodex on 10 March 2004.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Faslodex den 10. marts 2004.
English: The full EPAR for Faslodex can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Faslodex findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Faslodex.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Faslodex.
English: The recommended dose is 500 mg given once a month, with an additional 500-mg dose two weeks after the first dose.
Danish: Den anbefalede dosis er 500 mg én gang om måneden med en ekstra dosis på 500 mg to uger efter den første dosis.
English: What measures are being taken to ensure the safe and effective use of Faslodex?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Faslodex?
English: The dose is given as two injections, each given into the muscle of one buttock over one to two minutes.
Danish: Dosen gives som to injektioner, en i hver sædemuskel over ét til to minutter.
English: Other information about Faslodex
Danish: Andre oplysninger om Faslodex
English: Faslodex must not be used in women who are pregnant or breast-feeding, or in patients who have severe liver disease.
Danish: Faslodex må ikke anvendes til kvinder, der er gravide eller ammer, eller hos patienter med svær leversygdom.
English: The active substance in Faslodex, fulvestrant, is an anti-oestrogen.
Danish: Det aktive stof i Faslodex, fulvestrant, er et antiøstrogen.
English: Faslodex is an anti-oestrogen medicine used to treat advanced or metastatic breast cancer (cancer that has spread to other parts of the body) in the following patients:
Danish: Faslodex er et antiøstrogent lægemiddel til behandling af fremskreden eller metastatisk brystkræft (kræft, der har spredt sig til andre dele af kroppen) hos følgende patienter:
English: Most types of breast cancer are stimulated to grow when the hormone oestrogen attaches to targets (receptors) on cancer cells.
Danish: De fleste typer brystkræft stimuleres til at vokse, når hormonet østrogen binder sig til mål (receptorer) på kræftcellerne.
English: In women with this type of breast cancer, Faslodex is used in combination with palbociclib (another cancer medicine).
Danish: Hos kvinder med denne type brystkræft anvendes Faslodex i kombination med palbociclib (et andet kræftlægemiddel).
English: It is not intended to provide practical advice on how to use Faslodex.
Danish: Det er ikke en praktisk vejledning i, hvordan Faslodex bør anvendes.
English: Faslodex contains the active substance fulvestrant.
Danish: Faslodex indeholder det aktive stof fulvestrant.
English: It blocks the receptors for oestrogen on cells and causes the number of oestrogen receptors to fall.
Danish: Det blokerer receptorerne for østrogen på cellerne og bevirker et fald i antallet af østrogenreceptorer.
English: In addition, the medicine is effective in combination with palbociclib in patients with HR-positive, HER-2 negative breast cancer.
Danish: Desuden er lægemidlet effektivt i kombination med palbociclib hos patienter med HR-positiv, HER2-negativ brystkræft.
English: What is Faslodex and what is it used for?
Danish: Hvad er Faslodex, og hvad anvendes det til?
English: For more information about treatment with Faslodex, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker flere oplysninger om behandling med Faslodex, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Faslodex can only be obtained with a prescription.
Danish: Faslodex udleveres kun efter recept.
English: Faslodex is available as a solution for injection in prefilled syringes (250 mg).
Danish: Faslodex fås som injektionsvæske i fyldte sprøjter (250 mg).
English: • women with a type of breast cancer known as ‘HR-positive, HER-2 negative cancer' who have previously had hormonal treatment.
Danish: • kvinder med en type brystkræft kaldet "HR-positiv, HER2-negativ kræft", som tidligere har fået hormonbehandling.