FrancophonIA/ELRC3.0 huggingface dataset:
English: This enzyme plays a role in triggering the production of messenger molecules in the immune system (the body's natural defences) called cytokines, which are involved in the inflammation and other processes that cause psoriasis and psoriatic arthritis.
Danish: Dette enzym spiller en rolle ved at udløse produktion af signalmolekyler (cytokiner) fra immunsystemet (kroppens naturlige forsvar).
English: By blocking PDE4, apremilast reduces the level of these cytokines in the body, and so reduces the inflammation and other symptoms of psoriasis and psoriatic arthritis.
Danish: Ved at blokere PDE4 nedsætter apremilast indholdet af disse cytokiner i kroppen.
English: These signs include:
Danish: Symptomerne er følgende:
English: It is given into a vein in three stages, over a maximum of 48 hours: an initial injection into a vein (6.75 mg), followed by a high-dose infusion (18 mg per hour) over three hours, then a lower dose infusion (6 mg per hour) lasting up to 45 hours.
Danish: Det gives i en vene i tre omgange i løbet af højst 48 timer: først en indsprøjtning (6,75 mg) efterfulgt af en højdosisinfusion (18 mg i timen) over 3 timer og derefter en infusion med lavere dosis (6 mg i timen) i indtil 45 timer.
English: The full EPAR for Atosiban SUN can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Atosiban SUN findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Atosiban SUN on 31 July 2013.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Atosiban SUN den 31. juli 2013.
English: • regular contractions lasting at least 30 seconds at a rate of at least four every 30 minutes;
Danish: • regelmæssige veer, der varer mindst 30 sekunder og har en hyppighed på mindst 4 for hver 30 minutter
English: If contractions come back, treatment with Atosiban SUN can be repeated up to three more times during the pregnancy.
Danish: Hvis veerne vender tilbage, kan behandlingen med Atosiban SUN gentages op til tre gange mere i løbet af graviditeten.
English: This is a summary of the European public assessment report (EPAR) for Atosiban SUN.
Danish: Dette er et sammendrag af den offentlige europæiske vurderingsrapport (EPAR) for Atosiban SUN.
English: It is used to delay birth in adult women who are 24 to 33 weeks pregnant, when they show signs that they may give birth preterm (prematurely).
Danish: anvendes til at udsætte fødslen hos voksne kvinder, som er gravide i 24-33 uge, når de udviser symptomer på truende for tidlig fødsel.
English: Treatment should be started as soon as possible after diagnosis of pre-term labour.
Danish: Den skal påbegyndes snarest muligt efter, at diagnosen truende for tidlig fødsel er stillet.
English: A risk management plan has been developed to ensure that Atosiban SUN is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Atosiban SUN anvendes så sikkert som muligt.
English: Other information about Atosiban SUN
Danish: Andre oplysninger om Atosiban SUN
English: The active substance in Atosiban SUN, atosiban, is an antagonist of the natural hormone oxytocin.
Danish: Det aktive stof i Atosiban SUN, atosiban, er en antagonist til det naturlige hormon oxytocin.
English: This means that Atosiban SUN is similar to a ‘reference medicine' already authorised in the European Union (EU) called Tractocile.
Danish: Det betyder, at Atosiban SUN er identisk med et "referencelægemiddel", der allerede er godkendt i Den Europæiske Union, og som hedder Tractocile.
English: By blocking the action of oxytocin, Atosiban SUN prevents contractions and causes the womb to relax, helping to delay birth.
Danish: Ved at blokere oxytocinets virkning forhindrer Atosiban SUN veerne og får livmoderen til at slappe af, hvilket medvirker til at udsætte fødslen.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Atosiban SUN, 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 Atosiban SUN, herunder passende forholdsregler, som patienter og sundhedspersonale bør følge.
English: The CHMP concluded that, in accordance with EU requirements, Atosiban SUN has been shown to have comparable quality and to be comparable to Tractocile.
Danish: CHMP konkluderede, at det i overensstemmelse med EU's krav er blevet påvist, at Atosiban SUN er af sammenlignelig kvalitet og er bioækvivalent med Tractocile.
English: Treatment with Atosiban SUN should be carried out by a doctor who has experience in the treatment of pre-term labour.
Danish: Behandlingen med Atosiban SUN bør gives af en læge med erfaring i behandling af truende for tidlig fødsel.
English: No additional studies were needed as Atosiban SUN is a generic medicine that is given by infusion or injection and contains the same active substance as the reference medicine, Tractocile.
Danish: Der krævedes ingen supplerende undersøgelser, eftersom Atosiban SUN et generisk lægemiddel, der indgives ved infusion og indeholder det samme aktive stof som referencelægemidlet Tractocile.
English: What are the benefits and risks of Atosiban SUN?
Danish: Hvilke fordele og risici er der forbundet med Atosiban SUN?
English: Atosiban SUN is a medicine that contains the active substance atosiban.
Danish: Atosiban SUN er et lægemiddel, der indeholder det aktive stof atosiban.
English: For more information about treatment with Atosiban SUN, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Atosiban SUN, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Because Atosiban SUN is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Atosiban SUN er et generisk lægemiddel, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: For more information on generic medicines, see the question-and-answer document here.
Danish: Der kan indhentes yderligere oplysninger om generiske lægemidler i dokumentet med spørgsmål og svar.
English: This means that atosiban blocks the action of oxytocin.
Danish: Derved forstås, at atosiban blokerer virkningen af oxytocin.
English: What measures are being taken to ensure the safe and effective use of Atosiban SUN?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Atosiban SUN?
English: Therefore, the CHMP's view was that, as for Tractocile, the benefit outweighs the identified risk.
Danish: CHMP var derfor af den opfattelse, at fordelene opvejer de identificerede risici som for Tractocile.
English: What is Atosiban SUN and what is it used for?
Danish: Hvad er Atosiban SUN, og hvad anvendes det til?
English: Atosiban SUN can only be obtained with a prescription.
Danish: Atosiban SUN udleveres kun efter recept.
English: It is not intended to provide practical advice on how to use Atosiban SUN.
Danish: Det er ikke en praktisk vejledning i, hvordan Atosiban SUN bør anvendes.
English: The Committee recommended that Atosiban SUN be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Atosiban SUN.
English: Why is Atosiban SUN approved?
Danish: Hvorfor blev Atosiban SUN godkendt?
English: For practical information about using Atosiban SUN, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Atosiban SUN, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: The company provided data from the published literature on atosiban.
Danish: Virksomheden fremlagde data om Atosiban SUN fra den offentliggjorte faglitteratur.
English: Atosiban SUN is a ‘generic medicine'.
Danish: Atosiban SUN er et "generisk lægemiddel".
English: Atosiban SUN is available as a solution for injection and as a concentrate that is made up into a solution for infusion
Danish: Atosiban SUN fås som et koncentrat, der blandes til en opløsning til infusion (drop) i en vene.
English: How has Atosiban SUN been studied?
Danish: Hvordan blev Atosiban SUN undersøgt?
English: How does Atosiban SUN work?
Danish: Hvordan virker Atosiban SUN?
English: How is Atosiban SUN used?
Danish: Hvordan anvendes Atosiban SUN?
English: The medicine can be used:
Danish: Lægemidlet kan anvendes til:
English: The European Commission granted a marketing authorisation valid throughout the EU for Stronghold Plus on 9 February 2017.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Stronghold Plus den 9. februar 2017.
English: The full EPAR for Stronghold Plus can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Stronghold Plus findes på agenturets websted under: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Stronghold Plus.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Stronghold Plus.
English: The strength and number of pipettes used depends on the weight of the cat being treated.
Danish: Styrken og antallet af pipetter, der anvendes, afhænger af vægten på den behandlede kat.
English: Selamectin and sarolaner are antiparasitic medicines.
Danish: Selamectin og sarolaner er antiparasitære lægemidler.
English: People with sensitive skin or who are hypersensitive (allergic) to selamectin or sarolaner should handle Stronghold Plus with caution.
Danish: Personer med følsom hud, eller som er overfølsomme (allergiske) over for selamectin eller sarolaner, bør håndtere Stronghold Plus med forsigtighed.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Stronghold Plus's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Lægemidler til Dyr (CVMP) konkluderede, at fordelene ved Stronghold Plus opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: Stronghold Plus must only be used when there is a need to treat ticks and one or more of the above parasites.
Danish: Stronghold Plus må kun anvendes, når det er nødvendigt at behandle for flåter og en eller flere af ovennævnte parasitter.
English: Stronghold Plus must not be used in cats suffering from other diseases or in cats that are weak and underweight (for their age).
Danish: Stronghold Plus må ikke anvendes til katte, der lider af andre sygdomme, eller som er svage og undervægtige (i forhold til deres alder).
English: Stronghold Plus contains two active substances, selamectin and sarolaner.
Danish: Stronghold Plus indeholder to aktive stoffer, selamectin og sarolaner.
English: Other information about Stronghold Plus
Danish: Andre oplysninger om Stronghold Plus
English: Selamectin activates special proteins called ‘chloride channels' on the surface of nerve and muscle cells of the parasite, allowing charged chloride particles to enter nerve cells and disrupting their normal electrical activity.
Danish: Selamectin aktiverer særlige proteiner, som kaldes "kloridkanaler", på overfladen af parasittens nerve- og muskelceller, hvilket gør det muligt for ladede kloridpartikler at trænge ind i nervecellerne og afbryde deres normale elektriske aktivitet.
English: Stronghold Plus is highly flammable and should be kept away from heat, sparks, any open flame or other sources of ignition.
Danish: Stronghold Plus er meget brandfarligt og skal holdes på afstand af varme, gnister, enhver form for åben ild eller andre antændelseskilder.
English: Stronghold Plus is harmful after swallowing.
Danish: Stronghold Plus er skadeligt ved indtagelse.
English: What is Stronghold Plus and what is it used for?
Danish: Hvad er Stronghold Plus, og hvad anvendes det til?
English: Stronghold Plus is a medicine used to treat mixed infestations with both ticks and other parasites that may be found on the skin or fur of cats, such as fleas, ear mites and lice and/or worms that live inside the body.
Danish: Stronghold Plus er et lægemiddel, der anvendes til behandling af blandede angreb med både flåter og andre parasitter, som kan findes på kattes hud eller pels, såsom lopper, øremider og lus og/eller orm, der lever i kroppen.
English: Sarolaner blocks the normal movement of charged chloride particles in and out of nerve cells, especially those associated with gamma-aminobutyric acid (GABA) and glutamate, two substances that convey messages between nerves (neurotransmitters).
Danish: Sarolaner blokerer den normale transport af ladede kloridpartikler ind og ud af nervecellerne, navnlig dem, der er forbundet med gammaaminosmørsyre (GABA) og glutamat, som begge er stoffer, der overfører signaler mellem nerverne (neurotransmittere).
English: Stronghold Plus is available as a spot-on solution in three different strengths and can only be obtained with a prescription.
Danish: Stronghold Plus fås som spot-on opløsning i tre forskellige styrker og udleveres kun efter recept.
English: The most common side effects with Stronghold Plus (which may affect up to 1 in 100 cats) are mild to moderate alopecia (hair loss) at the application site, erythema (reddening of the skin) and drooling saliva.
Danish: De hyppigste bivirkninger ved Stronghold Plus (som kan optræde hos op til 1 ud af 100 dyr) er let til moderat alopeci (hårtab) på påføringsstedet, erytem (rødme i huden) og savlen.
English: A laboratory study with cats infested with biting lice showed selamectin to eliminate biting lice for 42 days after treatment compared to placebo treated cats.
Danish: En laboratorieundersøgelse med katte, der var angrebet af bidende lus, viste, at selamectin fjernede bidende lus i 42 dage efter angrebet sammenlignet med katte, der blev behandlet med placebo.
English: It is not intended to provide practical advice on how to use Stronghold Plus.
Danish: Det er ikke en praktisk vejledning i, hvordan Stronghold Plus bør anvendes.
English: Cats were treated with Stronghold Plus monthly for 3 months or another medicine, containing fipronil.
Danish: Kattene blev behandlet med Stronghold Plus én gang om måneden i tre måneder eller med et andet lægemiddel, der indeholdt fipronil.
English: The effectiveness of Stronghold Plus was investigated in a field study in cats naturally infested with fleas.
Danish: Virkningen af Stronghold Plus blev undersøgt i en feltundersøgelse hos katte, der var naturligt angrebet af lopper.
English: Why is Stronghold Plus approved?
Danish: Hvorfor er Stronghold Plus blevet godkendt?
English: Cats were treated with Stronghold Plus monthly for 3 months or another antiparasitic medicine, containing imidacloprid and moxidectin.
Danish: Kattene blev behandlet med Stronghold Plus én gang om måneden i tre måneder eller med et andet antiparasitært lægemiddel, der indeholdt imidacloprid og moxidectin.
English: What are the risks associated with Stronghold Plus?
Danish: Hvilke risici er der forbundet med Stronghold Plus?
English: Two laboratory studies with cats artificially infested with ear mites showed Stronghold Plus to reduce ear mites by more than 90% 30 days after a single treatment.
Danish: To laboratorieundersøgelser med katte, der var kunstigt angrebet af øremider, viste, at Stronghold Plus reducerede øremider med over 90 % 30 dage efter en enkelt behandling.
English: Stronghold Plus was as effective as the other medicine and reduced tick counts by more than 90%.
Danish: Stronghold Plus var lige så effektivt som det andet lægemiddel og reducerede antallet af flåter med over 90 %.
English: The contents of the pipette are squeezed onto the skin after parting the fur at the base of the cat's neck in front of the shoulder blades.
Danish: Pelsen i kattens nakke skilles foran skulderbladene, og pipettens indhold presses ud på huden.
English: Safety information has been included in the summary of product characteristics and the package leaflet for Stronghold Plus, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers.
Danish: Der er anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Stronghold Plus, herunder passende forholdsregler, som skal følges af sundhedspersoner og den, der er ejer af eller ansvarlig for dyret.
English: A laboratory study with cats artificially infected with heartworm showed Stronghold Plus to be effective for the prevention of heartworm disease.
Danish: En laboratorieundersøgelse med katte, der var kunstigt angrebet af hjerteorm, viste, at Stronghold Plus var effektivt til forebyggelse af hjerteorm.
English: Stronghold Plus was as effective as the other medicine and reduced flea counts by more than 95%.
Danish: Stronghold Plus var lige så effektivt som det andet lægemiddel og reducerede antallet af lopper med over 95 %.
English: How is Stronghold Plus used?
Danish: Hvordan anvendes Stronghold Plus?
English: Stronghold Plus kills fleas and some ticks within 24 hours and it continues to work for 5 weeks against fleas and 4 to 5 weeks against ticks (depending on the type).
Danish: Den loppedræbende virkning fortsætter i 5 uger, og den flåtdræbende virkning fortsætter i 4-5 uger (alt efter art).
English: Selamectin is effective against fleas, ear mites, biting lice, heartworms, roundworms and hookworms.
Danish: Selamectin er virksomt mod lopper, øremider, bidende lus, hjerteorm, spolorm og hageorm.
English: A second field study was conducted in cats naturally infested with ticks.
Danish: Der blev foretaget en anden feltundersøgelse hos katte, der var naturligt angrebet af flåter.
English: What benefits of Stronghold Plus have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Stronghold Plus?
English: For more information about treatment with Stronghold Plus, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Danish: Hvis du som ejer eller ansvarlig for dyret ønsker yderligere oplysninger om behandling med Stronghold Plus, kan du læse indlægssedlen eller kontakte din dyrlæge eller dit apotek.
English: For practical information about using Stronghold Plus, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Danish: Hvis du som ejer eller ansvarlig for dyret ønsker praktisk vejledning om anvendelsen af Stronghold Plus, kan du læse indlægssedlen eller kontakte din dyrlæge eller dit apotek.
English: The full EPAR for Azomyr can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Azomyr 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 Azomyr.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Azomyr.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Azomyr on 15 January 2001.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Azomyr den 15. januar 2001.
English: Other information about Azomyr
Danish: Andre oplysninger om Azomyr
English: Azomyr has also been studied in 416 patients with urticaria.
Danish: Azomyr blev også undersøgt hos 416 patienter med urticaria.
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 Azomyr.
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 Azomyr.
English: The active substance in Azomyr, desloratadine, is an antihistamine.
Danish: Det aktive stof i Azomyr, desloratadin, er et antihistamin.
English: For more information about treatment with Azomyr, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Azomyr, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: In all studies, the effectiveness of Azomyr was compared with that of placebo (a dummy treatment).
Danish: I alle undersøgelserne blev Azomyrs effekt sammenlignet med virkningen af placebo (en uvirksom behandling).
English: Azomyr is a medicine containing the active substance desloratadine.
Danish: Azomyr er et lægemiddel, der indeholder det aktive stof desloratadin.
English: In the two studies in urticaria, the decrease in symptom score after six weeks of treatment with Azomyr was 58 and 67%, compared with 40 and 33% in placebo-treated patients.
Danish: I de to undersøgelser af urticaria var faldet i symptomscoren efter seks ugers behandling med Azomyr 58 % og 67 % sammenlignet med 40 % og 33 % for patienter behandlet med placebo.
English: It is available as a 5 mg tablet, 2.5 mg and 5 mg orodispersible tablets (tablets that dissolve in the mouth), a 0.5 mg/ml syrup and a 0.5 mg/ml oral solution.
Danish: Det fås som en 5 mg tablet, 2,5 mg og 5 mg smeltetabletter (opløselig i munden), en 0,5 mg/ml sirup og en 0,5 mg/ml oral opløsning.
English: Azomyr has been studied in a total of eight studies involving about 4,800 adult and adolescent patients with allergic rhinitis (including four studies in seasonal allergic rhinitis, and two studies in patients who also had asthma).
Danish: Azomyr blev undersøgt i otte undersøgelser i alt, som omfattede 4 800 voksne og unge med allergisk rhinitis (herunder fire undersøgelser af sæsonbestemt allergisk rhinitis og to undersøgelser af patienter, som også havde astma).
English: The Committee recommended that Azomyr be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Azomyr.
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Azomyr's benefits are greater than its risks for the relief of symptoms associated with allergic rhinitis or urticaria.
Danish: Udvalget for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Azomyr opvejer risiciene ved lindring af de symptomer, der er forbundet med allergisk rhinitis eller urticaria.
English: In children less than two years of age, the most common side effects are diarrhoea (3.7%), fever (2.3%) and insomnia (difficulty sleeping; 2.3%).
Danish: Hos børn under toårsalderen var de hyppigste bivirkninger diarre (3,7 %), feber (2,3 %) og søvnløshed (2,3 %).
English: Azomyr must not be used in people who are hypersensitive (allergic) to desloratadine, loratadine or any of the other ingredients.
Danish: Azomyr må ikke anvendes til personer, som er overfølsomme (allergiske) over for desloratadin, loratadin eller et af de øvrige indholdsstoffer.
English: For the full list of all side effects reported with Azomyr, see the Package Leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Azomyr fremgår af indlægssedlen.
English: What is the risk associated with Azomyr?
Danish: Hvilken risiko er der forbundet med Azomyr?
English: The effectiveness of Azomyr was measured by looking at the change in the symptoms (nasal discharge, itching, sneezing and congestion) before and after two or four weeks of treatment.
Danish: Effekten af Azomyr blev målt ved at se på ændringen i symptomerne (næseflåd, kløe, nysen, tilstopning) før og efter to eller fire ugers behandling.