FrancophonIA/ELRC3.0 huggingface dataset:
English: The active substance in Aranesp, darbepoetin alfa works in exactly the same way as the natural hormone to stimulate the production of red blood cells in the bone marrow.
Danish: Det aktive stof i Aranesp, darbepoetin alfa, virker fuldstændig ligesom det naturlige hormon for at stimulere dannelsen af røde blodceller i knoglemarven.
English: Haemoglobin is the protein in red blood cells that carries oxygen around the body.
Danish: Hæmoglobin er det protein i de røde blodlegemer, som transporterer ilt rundt i kroppen.
English: What are the risks associated with Aranesp?
Danish: Hvilke risici er der forbundet med Aranesp?
English: For patients with chronic renal failure, Aranesp can be injected into a vein or under the skin.
Danish: Til patienter med kronisk nyresvigt kan Aranesp gives ved indsprøjtning i en vene eller under huden.
English: It is very slightly different in its
Danish: Den er en anelse anderledes i sin struktur i forhold til det naturlige
English: Aranesp can be injected by the patient or their carer if they have been trained.
Danish: Aranesp kan indsprøjtes af patienten selv eller af omsorgsgiveren, hvis de er behørigt instrueret heri.
English: structure to the natural hormone.
Danish: hormon.
English: What benefits of Aranesp have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Aranesp?
English: Aranesp is available in a vial, a pre-filled syringe or a pre-filled pen.
Danish: Aranesp leveres i et hætteglas, en fyldt sprøjte eller en fyldt injektionspen.
English: How is Aranesp used?
Danish: Hvordan anvendes Aranesp?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Aranesp 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 Aranesp.
English: This summary was last updated on 6 January 2012.
Danish: Dette sammendrag blev sidst ajourført den 6. januar 2012.
English: These usually disappear without treatment within 24 hours.
Danish: Disse forsvinder sædvanligvis uden behandling inden for 24 timer.
English: Demodicosis was usually cured within three to six months of treatment.
Danish: Demodicosis blev sædvanligvis helbredt inden for tre til seks måneders behandling.
English: The European Commission granted a marketing authorisation valid throughout the European Union for ProMeris Duo on 19 December 2006.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for ProMeris Duo den 19. december 2006.
English: Protective gloves are recommended when handling the medicine.
Danish: Det anbefales at bære beskyttelseshandsker ved håndtering af lægemidlet.
English: This medicine is specifically developed for dogs and should not be used in any other animal species.
Danish: Lægemidlet er specielt udviklet til hunde og bør ikke anvendes til andre dyrearter.
English: ProMeris Duo metaflumizone and amitraz
Danish: ProMeris Duo metaflumizon og amitraz
English: It is recommended that the product is applied in the open air or in a well-ventilated room.
Danish: Det anbefales, at lægemidlet påføres i fri luft eller i et rum med god udluftning.
English: In very rare cases, temporary local hair loss may occur.
Danish: I meget sjældne tilfælde kan der forekomme midlertidigt lokalt hårtab.
English: The medicine killed most fleas within 24 hours, most ticks within 48 hours and most lice within a week of treatment.
Danish: Lægemidlet dræbte de fleste lopper inden for 24 timer, de fleste flåter inden for 48 timer og de fleste lus inden for en uges behandling.
English: ProMeris Duo contains components that, on very rare occasions, can irritate the airways in some people.
Danish: ProMeris Duo indeholder komponenter, som i meget sjældne tilfælde kan irritere luftvejene hos visse mennesker.
English: In rare cases, temporary irritation may occur at the site of application.
Danish: I sjældne tilfælde kan der forekomme midlertidig irritation på påføringsstedet.
English: Another study was carried out in dogs with demodicosis in veterinary practices in Italy and Albania.
Danish: Der blev gennemført en anden undersøgelse af hunde med demodicosis i dyrlægepraksisser i Italien og Albanien.
English: Data were provided on pharmaceutical quality, the safety of the medicine in dogs and its safety in humans (people who come into contact with the medicine) and in the environment.
Danish: Der blev fremlagt oplysninger om den farmaceutiske kvalitet, sikkerheden ved lægemidlet til hunde og sikkerheden for mennesker (personer, som kommer i kontakt med lægemidlet) og for miljøet.
English: There may also be a change in appearance of the fur (oily appearance and clumping or spiking of hair) at the application site.
Danish: Der kan også forekomme en ændring i pelsens udseende (olieagtigt udseende og hårklumper eller piggeagtigt hår) på påføringsstedet.
English: It is given to dogs with a pre-filled spot-on pipette, a small plastic container that is already filled with the correct amount of ProMeris Duo needed to treat one dog.
Danish: Det gives til hunde med en fyldt spot-on pipette, en lille plasticbeholder, som allerede er fyldt med den rigtige mængde ProMeris Duo, som kræves for at behandle en hund.
English: As a precautionary measure, avoid direct contact with the treated dog and do not allow children to play with the treated dog until the application site is dry.
Danish: Som forebyggende foranstaltning skal der undgås direkte kontakt med den behandlede hund, og børn må ikke få lov til at lege med den behandlede hund, før påføringsstedet er tørt.
English: Recently treated animals should not be allowed to sleep in the same bed as their owners, especially children.
Danish: Dyr, der lige er blevet behandlet, bør ikke sove i samme seng som deres ejere.
English: People taking MOAI-containing medicines, such as antidepressants, should take particular care when handling ProMeris Duo.
Danish: Personer, som er i behandling med MOAIindeholdende lægemidler såsom antidepressiva, bør udvise særlig forsigtighed ved håndtering af ProMeris Duo.
English: Amitraz is a monoamine oxidase inhibitor (MOAI).
Danish: Amitraz er en monoaminoxidasehæmmer (MOAI).
English: Other information about ProMeris Duo:
Danish: Andre oplysninger om ProMeris Duo:
English: The most common side effects in dogs are sedation (sleepiness), lethargy (a lack of energy), reduced nervous system activity, hyperglycaemia (high blood sugar levels), bradycardia (slow heart rate), and slow, shallow breathing.
Danish: De hyppigste bivirkninger hos hunde er sedation (søvnighed), apati (mangel på energi), reduceret aktivitet i nervesystemet, hyperglykæmi (forhøjet blodsukker), bradykardi (langsom hjerterytme) og langsom overfladisk respiration.
English: ProMeris Duo is available in five different sizes for various weights of dog.
Danish: ProMeris Duo findes i fem forskellige størrelser til forskellige former for hundevægt.
English: ProMeris Duo must not be used in puppies less than eight weeks old since it has not been sufficiently studied in these animals.
Danish: ProMeris Duo må ikke anvendes til hundehvalpe, som er under otte uger gamle, da midlet ikke er blevet tilstrækkeligt undersøgt hos disse dyr.
English: Wash the skin and rinse eyes with water, if accidental exposure occurs.
Danish: Vask huden og skyl øjnene med vand ved utilsigtet kontakt.
English: ProMeris Duo is an ‘ectoparasiticide'.
Danish: ProMeris Duo er et “ektoparasiticid”.
English: The effectiveness of ProMeris Duo lasted for at least six weeks against fleas and for four weeks against ticks.
Danish: Effekten af ProMeris Duo varede i mindst seks uger mod lopper og i fire uger mod flåter.
English: Avoid touching the skin with the pipette's contents.
Danish: Det skal undgås, at huden kommer i berøring med pipettens indhold.
English: This means that it will kill parasites that live on or in the skin or in the fur of animals, such as fleas, ticks, lice and Demodex mites (mites that cause demodicosis or ‘mange').
Danish: Det betyder, at det dræber parasitter, som lever på eller i huden eller pelsen på dyr såsom lopper, flåter, lus og Demodex-mider (mider, som forårsager demodicosis eller ‘skab').
English: ProMeris Duo should not enter surface water, as this may be harmful for fish and other aquatic organisms.
Danish: ProMeris Duo må ikke hældes ud i vandløb, da det kan være skadeligt for fisk og andre vandlevende organismer.
English: The effectiveness was measured looking at the clinical signs and the number of Demodex mites in skin scrapings taken every four weeks, for several weeks following monthly administration of the treatment.
Danish: Virkningen blev målt ved at se nærmere på de kliniske tegn og antallet af Demodex-mider i hudafskrab, som blev taget hver fjerde uge i flere uger efter den månedlige administration af behandlingen.
English: The Committee recommended that ProMeris Duo be given a marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for ProMeris Duo.
English: As for other products in this group, ProMeris Duo should not be used in sick dogs, dogs that have just recovered from an illness or dogs that are suffering from heat stress.
Danish: Som for andre lægemidler i denne gruppe må ProMeris Duo ikke anvendes til syge hunde, hunde, som netop er blevet raske, eller hunde, som lider under varmebelastning.
English: ProMeris Duo is a clear, yellow-to-amber solution that contains metaflumizone and amitraz as active substances.
Danish: ProMeris Duo er en klar gul til ravgul opløsning, der indeholder metaflumizon og amitraz som aktive stoffer.
English: Dogs were treated with ProMeris Duo or the combination of imidacloprid and moxidectin (another medicine authorised in the EU for this indication).
Danish: Hundene blev behandlet med ProMeris Duo eller med kombinationen af imidacloprid og moxidectin (et andet lægemiddel, som er godkendt i EU til denne indikation).
English: It can also be used as part of a treatment strategy for the control of flea allergy dermatitis, an allergic reaction to flea bites.
Danish: Det kan også indgå i behandlinger til kontrol af loppeallergidermatitis, som er en allergisk reaktion over for loppebid.
English: The effectiveness was measured by looking at the number of lice on the dogs after treatment.
Danish: Virkningen blev målt ved at se nærmere på antallet af lus på hundene efter behandling.
English: A further study compared the effectiveness of ProMeris Duo with that of fipronil (another medicine for the treatment of lice).
Danish: I en yderligere undersøgelse sammenlignede man virkningen af ProMeris Duo med virkningen af fipronil (et andet lægemiddel til behandling af lus).
English: Both active substances in ProMeris Duo, metaflumizone and amitraz, interfere with the neural activity of the parasites and consequently lead to their death.
Danish: Begge de aktive stoffer i ProMeris Duo, metaflumizon og amitraz, indvirker på parasitternes nerveaktivitet, hvilket medfører, at de dør.
English: The effectiveness of ProMeris Duo against flea, lice and tick infestations and Demodex mites has been studied in a number of studies, including one study in dogs infested with fleas or ticks carried out at veterinary practices in Germany and France.
Danish: Effekten af ProMeris Duo mod loppe-, luse- og flåtangreb og Demodex-mider er blevet undersøgt i en lang række undersøgelser, herunder en undersøgelse af hunde angrebet af lopper eller flåter, som blev udført i dyrlægepraksisser i Tyskland og Frankrig.
English: What is the risk associated with ProMeris Duo?
Danish: Hvilken risiko er der forbundet med ProMeris Duo?
English: Dogs of various breeds, ages and weights were treated with ProMeris Duo or with other medicines authorised in the European Union (EU) for flea and tick infestation.
Danish: Hunde af forskellige racer, aldre og vægte blev behandlet med ProMeris Duo eller med andre lægemidler, som er godkendt i Den Europæiske Union (EU) til loppe- og flåtangreb.
English: The contents of the pipette are squeezed onto the skin after parting the fur at the back of the head.
Danish: Pelsen i nakken holdes ud til siderne, og pipettens indhold påføres huden.
English: The effectiveness was measured looking at the number of live ticks or number of fleas on the dogs up to two months after application.
Danish: Virkningen blev målt ud fra antallet af levende flåter eller levende lopper på hundene op til to måneder efter påføringen af præparatet.
English: If a dog licks the application area, the dog might salivate considerably for a short period.
Danish: Hvis hunden kommer til at slikke på påføringsstedet, kan det give anledning til kortvarig, kraftig spytafsondring.
English: Why has ProMeris Duo been approved?
Danish: Hvorfor blev ProMeris Duo godkendt?
English: ProMeris Duo is used in dogs over eight weeks of age to treat and to prevent tick and flea infestations, and to treat demodicosis (caused by Demodex mites) and lice infestations.
Danish: ProMeris Duo anvendes til hunde, som er over otte uger gamle, til behandling og forebyggelse af flåt- og loppeangreb og til behandling af demodicosis (forårsaget af Demodex-mider) og luseangreb.
English: Do not smoke, eat or drink when applying ProMeris Duo.
Danish: Den, der påfører ProMeris Duo, må ikke ryge, spise eller drikke under påføringen.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of ProMeris Duo exceed the risks for the treatment and prevention of flea and tick infestations, and the treatment of demodicosis and lice infestation in dogs.
Danish: Udvalget for Veterinærlægemidler (CVMP) konkluderede, at fordelene ved ProMeris Duo opvejer risiciene ved behandling og forebyggelse af loppe- og flåtangreb og ved behandling af demodicosis og luseangreb hos hunde.
English: What is ProMeris Duo?
Danish: Hvad er ProMeris Duo?
English: The results of the studies showed that ProMeris Duo is effective in the treatment and prevention of flea and tick infestations, and in the treatment of demodicosis and lice infestation in dogs.
Danish: Resultaterne af undersøgelserne viste, at ProMeris Duo er effektivt til behandling og forebyggelse af loppe- og flåtangreb og til behandling af demodicosis og luseangreb på hunde.
English: How has ProMeris Duo been studied?
Danish: Hvordan blev ProMeris Duo undersøgt?
English: What is ProMeris Duo used for?
Danish: Hvad anvendes ProMeris Duo til?
English: How does ProMeris Duo work?
Danish: Hvordan virker ProMeris Duo?
English: What benefit has ProMeris Duo shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved ProMeris Duo?
English: The recommended dose is one tablet once a day.
Danish: Den anbefalede dosis er én tablet én gang om dagen.
English: It is available as brown tablets (250 mg).
Danish: Det fås som brune tabletter (250 mg).
English: Other information about Iressa:
Danish: Andre oplysninger om Iressa:
English: The European Commission granted a marketing authorisation valid throughout the European Union for Iressa to AstraZeneca AB on 24 June 2009.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Iressa til AstraZeneca AB den 24. juni 2009.
English: The main measure of effectiveness was survival (how long the patients lived).
Danish: Det primære effektmål var overlevelse (hvor længe patienterne levede).
English: Both studies included patients with and without the EGFR mutation.
Danish: Begge undersøgelser omfattede patienter med og uden EGFR-mutation.
English: The effects of Iressa were first tested in experimental models before being studied in humans.
Danish: Virkningerne af Iressa blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
English: Treatment with Iressa should be started and supervised by a doctor who has experience with anticancer treatments.
Danish: Behandling med Iressa bør indledes og overvåges af en læge, der har erfaring med kræftbehandling.
English: The Committee recommended that Iressa be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Iressa.
English: Iressa gefitinib EPAR summary for the public
Danish: Iressa gefitinib EPAR - sammendrag for offentligheden
English: The main measure of effectiveness was how long the patients lived without the disease getting worse.
Danish: Det primære effektmål var, hvor længe patienterne levede, uden at sygdommen blev værre.
English: The full EPAR for Iressa can be found here.
Danish: Den fuldstændige EPAR for Iressa findes her.
English: It is used in patients whose cancer cells have a mutation in the genes that make a protein called epidermal growth factor receptor (EGFR).
Danish: Det anvendes til patienter, hvis kræftceller har en mutation i generne, som fremstiller et protein kaldet epidermal vækstfaktorreceptor (EGFR).
English: The tablet can be dispersed in water for patients who have difficulty swallowing.
Danish: Tabletten kan opslæmmes i vand, hvis patienterne har besvær med at synke.
English: This means that it blocks specific enzymes known as tyrosine kinases.
Danish: Det betyder, at det blokerer nogle specifikke enzymer, der kaldes tyrosinkinaser.
English: Among patients with the EGFR mutation, those who took Iressa lived for an average of nine and a half months without the disease getting worse, compared with about six months for those who took the combination therapy.
Danish: Blandt de patienter, der havde en EGFR-mutation, levede de, der tog Iressa, i gennemsnit ni en halv måned, uden at sygdommen blev værre, sammenlignet med ca. seks måneder for dem, der tog kombinationsbehandlingen.
English: These enzymes can be found on the surface of cancer cells, such as EGFR on the surface of non-small cell lung cancer cells.
Danish: Disse enzymer kan findes på overfladen af kræftceller, såsom EGFR, der findes på overfladen af ikke-småcellet lungekræftceller.
English: Iressa is a medicine that contains the active substance gefitinib.
Danish: Iressa er et lægemiddel, der indeholder det aktive stof gefitinib.
English: EGFR is involved in the growth and spread of cancer cells.
Danish: EGFR har betydning for kræftcellernes vækst og spredning.
English: There is also a risk of interstitial lung disease in patients taking Iressa.
Danish: Der er ligeledes risiko for interstitiel lungesygdom hos patienter, der tager Iressa.
English: The most common side effects with Iressa (seen in more than 1 patient in 10) are loss of appetite, diarrhoea, vomiting, nausea (feeling sick), stomatitis (inflammation of the lining of the mouth), increased level of alanine aminotransferase (a liver enzyme) in the blood, skin reactions such as pustular rash, and asthenia (weakness).
Danish: De mest almindelige bivirkninger ved Iressa (som optræder hos flere end 1 ud af 10 patienter) er appetitløshed, diarré, opkastning, nausea (kvalme), stomatitis (betændelse i mundslimhinden), et forøget niveau af alaninaminotransferase (et leverenzym) i blodet, hudreaktioner såsom pustuløst udslæt samt asteni (svaghed).
English: In the first main study, Iressa was more effective at preventing the cancer from worsening than the combination.
Danish: I den første hovedundersøgelse var Iressa mere effektivt end kombinationen til at forhindre kræft i at blive værre.
English: What is the risk associated with Iressa?
Danish: Hvilken risiko er der forbundet med Iressa?
English: Iressa should not be used in people who may be hypersensitive (allergic) to gefitinib or any of the other ingredients.
Danish: Iressa bør ikke anvendes til personer, som kan være overfølsomme (allergiske) over for gefitinib eller over for et eller flere af de øvrige indholdsstoffer.
English: Iressa works only in non-small cell lung cancer cells that have a mutation in their EGFR.
Danish: Iressa virker kun på ikke-småcellet lungekræftceller, som har en mutation i deres EGFR.
English: In the second main study, patient survival among all patients who took Iressa was similar to those who took docetaxel.
Danish: I den anden hovedundersøgelse var patientoverlevelsen for alle de patienter, der tog Iressa, stort set den samme som for dem, der tog docetaxel.
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Iressa's benefits are greater than its risks for the treatment of adults with locally advanced or metastatic non-small cell lung cancer with activating mutations of EGFR.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Iressa er større end risiciene til behandling af voksne med lokal-avanceret eller metastatisk ikkesmåcellet lungekræft med aktiverede mutationer af EGFR.
English: The active substance in Iressa, gefitinib, is a protein tyrosine kinase inhibitor.
Danish: Det aktive stof i Iressa, gefitinib, er en proteintyrosinkinasehæmmer.
English: By blocking EGFR, Iressa helps to slow down the growth and spread of the cancer.
Danish: Ved at blokere EGFR er Iressa med til at hæmme kræftens vækst og spredning.
English: For the full list of all side effects reported with Iressa, see the Package Leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Iressa fremgår af indlægssedlen.
English: Why has Iressa been approved?
Danish: Hvorfor blev Iressa godkendt?
English: Iressa is used to treat adults who have non-small cell lung cancer that is locally advanced or metastatic (when cancer cells have spread from the original site to other parts of the body).
Danish: Iressa anvendes til at behandle voksne med ikke-småcellet lungekræft, som er lokal-avanceret eller metastatisk (dvs. at kræftcellerne har spredt sig fra oprindelsesstedet til andre dele af kroppen).
English: What is Iressa?
Danish: Hvad er Iressa?
English: It must not be used in mothers who are breastfeeding.
Danish: Iressa må ikke bruges til mødre, som ammer.
English: In one main study involving 1,217 adult patients with locally advanced or metastatic non-small cell lung cancer, Iressa was compared with a combination of carboplatin and paclitaxel (other anticancer medicines).
Danish: I en hovedundersøgelse, der omfattede 1.217 voksne patienter med lokal-avanceret eller metastatisk ikkesmåcellet lungekræft, blev Iressa sammenlignet med en kombination af carboplatin og paclitaxel (andre kræftlægemidler).
English: In a second main study involving 1,466 patients with locally advanced or metastatic non-small cell lung cancer, Iressa was compared with docetaxel (another anticancer medicine).
Danish: I en anden hovedundersøgelse, der omfattede 1.466 patienter med lokal-avanceret eller metastatisk ikkesmåcellet lungekræft, blev Iressa sammenlignet med docetaxel (et andet kræftlægemiddel).
English: What is Iressa used for?
Danish: Hvad anvendes Iressa til?
English: What benefit has Iressa shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Iressa?
English: How has Iressa been studied?
Danish: Hvordan blev Iressa undersøgt?
English: How is Iressa used?
Danish: Hvordan anvendes Iressa?
English: How does Iressa work?
Danish: Hvordan virker Iressa?
English: Most cases of allergic reactions occurred in patients under 12 years of age.
Danish: De fleste allergiske reaktioner optrådte hos patienter under 12 år.
English: This may lead to additional doses being given which will further worsen the patient's condition.
Danish: Dette kan føre til, at der gives yderligere doser, hvad der yderligere vil forværre patientens tilstand.
English: The review was first carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines, which made a set of recommendations.
Danish: Gennemgangen blev først foretaget af Udvalget for Risikovurdering inden for Lægemiddelvurdering (PRAC), som har ansvar for vurdering af sikkerhedsspørgsmål vedrørende lægemidler til mennesker, og som fremsatte et sæt anbefalinger.
English: The above recommendations are based on analyses of spontaneous reports of suspected adverse effects and a review of published literature.
Danish: Ovennævnte anbefalinger bygger på analyser af spontane indberetninger om formodede bivirkninger og en litteraturgennemgang.