FrancophonIA/ELRC3.0 huggingface dataset:
English: • Pigs: treatment and prevention of respiratory infections caused by Actinobacillus pleuropneumoniae susceptible to trimethoprim and sulfamethoxazole where the disease has been diagnosed in the herd.
Danish: • Svin: behandling og forebyggelse af luftvejsinfektioner forårsaget af Actinobacillus pleuropneumoniae ved følsomhed over for trimethoprim og sulfamethoxazol, når sygdommen er påvist i besætningen.
English: • Broilers: treatment and prevention of respiratory infections caused by Escherichia coli susceptible to trimethoprim and sulfamethoxazole where the disease has been diagnosed in the flock.
Danish: • Slagtekyllinger: behandling og forebyggelse af luftvejsinfektioner forårsaget af Escherichia coli ved følsomhed over for trimethoprim og sulfamethoxazol, når sygdommen er påvist i besætningen.
English: This summary was last updated in September 2017.
Danish: Dette sammendrag blev sidst ajourført i 09-2017.
English: These signs usually resolve without treatment.
Danish: Disse tegn fortager sig sædvanligvis uden behandling.
English: The European Commission granted a marketing authorisation valid throughout the EU for Simparica on 6 November 2015.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Simparica den 6. november 2015.
English: The full EPAR for Simparica can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Simparica 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 Simparica.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Simparica.
English: It contains the active substance sarolaner.
Danish: Det indeholder det aktive stof sarolaner.
English: The tablets should be kept in the original package until use in order to prevent children directly accessing the medicine.
Danish: Tabletterne bør opbevares i den originale pakning indtil brug for at undgå, at børn får direkte adgang til lægemidlet.
English: Sarolaner
Danish: Simparica sarolaner
English: Other information about Simparica
Danish: Andre oplysninger om Simparica
English: As other conditions contribute to demodectic mange, any underlying diseases should also be treated.
Danish: Idet andre forhold også bidrager til demodicose-skab, bør eventuel underliggende sygdom også behandles.
English: What is Simparica and what is it used for?
Danish: Hvad er Simparica, og hvad anvendes det til?
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Simparica'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 Simparica opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: Because fleas and ticks must start feeding on the dog in order to be killed by the medicine, the risk of transmission of diseases with which they may be infected cannot be excluded.
Danish: Da lopper og flåter skal begynde at suge næring fra hunden for at blive dræbt af lægemidlet, kan det ikke udelukkes, at de kan overføre sygdomme, de kan være inficeret med.
English: Why is Simparica approved?
Danish: Hvorfor er Simparica blevet godkendt?
English: This means that it kills parasites that live on the skin or in the fur of animals, such as fleas, ticks and mites.
Danish: Det vil sige, at det dræber parasitter, der lever på dyrets hud eller i pelsen, såsom lopper, flåter og mider.
English: It is not intended to provide practical advice on how to use Simparica.
Danish: Det er ikke en praktisk vejledning i, hvordan Simparica bør anvendes.
English: Simparica was as effective as moxidectin/imidacloprid and the percentage of Simparica-treated dogs with no live mites was 15%, 69%, 93%, 94%, 100% and 100% on days 30, 60, 90, 120, 150 and 180, respectively.
Danish: Simparica var lige så effektivt som moxidectin/imidacloprid, og andelen af Simparica-behandlede hunde uden levende mider var på 15 %, 69 %, 93 %, 94 %, 100 % og 100 % på henholdsvis dag 30, 60, 90, 120, 150 og 180.
English: Simparica is available as chewable tablets (5, 10, 20, 40, 80 and 120 mg) and can only be obtained with a prescription.
Danish: Simparica fås som tyggetabletter (5, 10, 20, 40, 80 og 120 mg) og udleveres kun efter recept.
English: It blocks the normal movement of charged chloride particles (ions) 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: Det blokerer den normale transport af ladede kloridpartikler (ioner) 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: Sarolaner kills these parasites that have ingested the dog's blood by acting on their nervous system.
Danish: Sarolaner dræber parasitter, der har indtaget hundens blod, ved at påvirke deres nervesystem.
English: For treatment of ear mite infestations a single dose should be given.
Danish: Til behandling af øremideangreb gives der en enkelt dosis.
English: What are the risks associated with Simparica?
Danish: Hvilke risici er der forbundet med Simparica?
English: The active substance in Simparica, sarolaner acts as an ‘ectoparasiticide'.
Danish: Det aktive stof i Simparica, sarolaner, virker som et "ektoparasiticid".
English: Simparica was as effective as moxidectin/imidacloprid.
Danish: Simparica var lige så effektivt som moxidectin/imidacloprid.
English: Treatment should be continued until skin scrapings are negative on at least two consecutive occasions one month apart.
Danish: Behandlingen fortsættes, indtil afskrab fra huden er negative mindst to gange i træk med en måneds mellemrum.
English: This results in uncontrolled activity of the nervous system and the paralysis and death of the parasites.
Danish: Dette medfører ukontrolleret aktivitet i parasitternes nervesystem, så de lammes og dør.
English: However, the following side effects are seen in less than 1 dog in 10,000: mild and short-lived vomiting and diarrhoea as well as tremor (shaking), ataxia (inability to coordinate body movements) or convulsions.
Danish: Følgende bivirkninger ses dog hos mindre end 1 hund ud af 10 000: mild og kortvarig opkastning og diarré samt rysten, manglende evne til at koordinere muskelbevægelser (ataksi) eller kramper.
English: For treatment of tick and flea infestations Simparica should be given once every month throughout the flea and/or tick season for optimal control.
Danish: Til behandling af flåt- og loppeangreb gives Simparica én gang om måneden i hele loppe- og/eller flåtsæsonen for at opnå bedst kontrol.
English: The appropriate strength tablet(s) should be used according to the dog's weight.
Danish: Den anvendte tabletstyrke bør svare til hundens vægt.
English: For Simparica the percentage of dogs with no live ear mites present was 91% at day 30 increasing to 99% on day 60, following two treatments.
Danish: Ved Simparica var andelen af hunde uden levende øremider på 91 % på dag 30, hvilket steg til 99 % på dag 60 efter to behandlinger.
English: In order to be exposed to the active substance, fleas and ticks must attach to the skin and commence feeding on the dog's blood.
Danish: For at lopper og flåter kan blive udsat for det aktive stof, skal de først hægte sig fast i huden og begynde at tage næring fra hundens blod.
English: Sarolaner kills fleas before they can lay eggs and so helps to reduce contamination of the dog's environment.
Danish: Sarolaner dræber lopper, før de kan lægge æg, og nedsætter derved spredning af smitte til hundens omgivelser.
English: The effectiveness of Simparica against fleas was investigated in a field study in dogs infested with at least five live fleas.
Danish: Effektiviteten af Simparica mod lopper blev undersøgt i en feltundersøgelse hos hunde med angreb af mindst fem levende lopper.
English: Another study involved dogs infested with sarcoptic mange.
Danish: En anden undersøgelse vedrørte hunde angrebet af Sarcoptes-skab.
English: Simparica is a veterinary medicine used to treat infestations with ticks and fleas, demodectic and sarcoptic mange (skin infestations caused by two different types of mites) and ear mite infestations in dogs.
Danish: Simparica er et lægemiddel til dyr, der anvendes til behandling af flåt- og loppeangreb samt demodicose- og Sarcoptes-skab (skadedyrsangreb i huden forårsaget af to forskellige typer mider) og øremideangreb hos hunde.
English: Dogs with live mites on day 30 after initial treatment received a second treatment.
Danish: Hunde med levende mider efter 30 dages behandling fik en behandling mere.
English: Safety information has been included in the summary of product characteristics and the package leaflet for Simparica, 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 Simparica, herunder passende forholdsregler, som skal følges af sundhedspersoner og den, der er ejer af eller ansvarlig for dyret.
English: Simparica was as effective as moxidectin and imidacloprid in eliminating live mites in skin scrapings.
Danish: Simparica var lige så effektivt som moxidectin og imidacloprid til at udrydde levende mider i afskrab fra huden.
English: For treatment of demodectic mange Simparica should be given once a month for at least three months.
Danish: Til behandling af demodicose-skab gives Simparica en gang om måneden i mindst tre måneder.
English: A field study was conducted in dogs infested with at least three live attached ticks.
Danish: Der blev gennemført endnu en feltundersøgelse hos hunde med angreb af mindst tre levende, fasthægtede flåter.
English: Side effects with Simparica are not common.
Danish: Almindeligvis forekommer der ikke bivirkninger ved Simparica.
English: For treatment of sarcoptic mange, Simparica is given monthly for two consecutive months.
Danish: Til behandling af Sarcoptes-skab gives Simparica en gang om måneden i to måneder i træk.
English: In a study with 98 dogs with demodectic mange, 63 dogs were treated with Simparica monthly for up to six months and 35 dogs received moxidectin/imidacloprid.
Danish: I en undersøgelse med 98 hunde med demodicose-skab blev 63 hunde behandlet med Simparica månedligt i op til seks måneder, og 35 hunde fik moxidectin/imidacloprid.
English: In a study involving dogs with ear mite infestation, 283 dogs were treated with Simparica and 131 dogs received moxidectin/imidacloprid (a spot-on mite treatment).
Danish: I en undersøgelse, der omfattede hunde med øremideangreb, blev 283 hunde behandlet med Simparica, og 131 hunde fik moxidectin/imidacloprid (en spot-on midebehandling).
English: After Simparica is given its activity against ticks and fleas lasts for at least 5 weeks.
Danish: Efter indgivelse virker Simparica mod flåter og lopper i mindst fem uger.
English: 53 dogs were treated with Simparica for two months whilst 26 dogs were given a medicine containing moxidectin and imidacloprid.
Danish: 53 hunde blev behandlet med Simparica i to måneder, mens 26 hunde fik et lægemiddel indeholdende moxidectin og imidacloprid.
English: 189 dogs were treated with Simparica for three months whilst 96 dogs were given another medicine, spinosad.
Danish: 189 hunde blev behandlet med Simparica i tre måneder, mens 96 hunde fik et andet lægemiddel, spinosad.
English: What benefits of Simparica have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Simparica?
English: Simparica was as effective as fipronil in reducing tick counts for up to 90 days after treatment.
Danish: Simparica var lige så effektivt som fipronil til at nedsætte antallet af flåter i op til 90 dage efter behandlingen.
English: Simparica can be used as part of the management of flea allergy dermatitis (an allergic reaction to flea bites).
Danish: Simparica kan anvendes som led i behandling af overfølsomhed over for loppebid (loppebetinget allergisk dermatitis).
English: How is Simparica used?
Danish: Hvordan anvendes Simparica?
English: Simparica was as effective as spinosad in reducing flea counts for up to 90 days after treatment.
Danish: Simparica var lige så effektivt som spinosad til at nedsætte antallet af lopper i op til 90 dage efter behandlingen.
English: 122 dogs were treated with Simparica for three months whilst 59 dogs were treated with another medicine, fipronil, against ticks.
Danish: 122 hunde blev behandlet med Simparica i tre måneder, mens 59 hunde blev behandlet med et andet lægemiddel, fipronil, mod flåter.
English: How does Simparica work?
Danish: Hvordan virker Simparica?
English: For more information about treatment with Simparica, 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 Simparica, kan du læse indlægssedlen eller kontakte din dyrlæge eller dit apotek.
English: For practical information about using Simparica, 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 Simparica, kan du læse indlægssedlen eller kontakte din dyrlæge eller dit apotek.
English: This summary was last updated in 08-2014.
Danish: Dette sammendrag blev senest ajourført i 08-2014.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Velphoro on 26 August 2014.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Velphoro den 26. august 2014.
English: The risk of excess iron build-up was considered limited but should be followed up after approval.
Danish: Risikoen for ophobning af jern blev anset for begrænset, men burde følges op efter godkendelsen.
English: The full EPAR and risk management plan summary for Velphoro 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 Velphoro 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 Velphoro.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Velphoro.
English: The maximum dose is 3,000 mg (6 tablets) per day.
Danish: Den maksimale dosis er 3 000 mg (6 tabletter) dagligt.
English: The tablets must be chewed and not swallowed whole.
Danish: Tabletterne skal tygges, ikke synkes hele.
English: There were no major safety concerns and although tolerability is slightly lower than with sevelamer, the overall safety profile was acceptable.
Danish: Der var ingen større sikkerhedsproblemer, og skønt Velphoro tåltes lidt dårligere end sevelamer, var den overordnede sikkerhedsprofil acceptabel.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Velphoro's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) afgjorde, at fordelene ved Velphoro overstiger risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: Other information about Velphoro
Danish: Andre oplysninger om Velphoro
English: A risk management plan has been developed to ensure that Velphoro is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Velphoro anvendes så sikkert som muligt.
English: After 3 months of treatment, blood-phosphate levels fell on average by 0.7 mmol/L with Velphoro compared with 0.8 mmol/L with sevelamer, and after 6 months of treatment 53% of patients on Velphoro had normal blood-phosphate levels (1.13 to 1.78 mmol/L) compared with 54% of patients on sevelamer.
Danish: Efter tre måneders behandling faldt blodets fosfatindhold gennemsnitligt 0,7 mmol/l med Velphoro, sammenholdt med 0,8 mmol/l med sevelamer, og efter seks måneders behandling havde 53% af patienterne på Velphoro normalt fosfatindhold i blodet (1,13-1,78 mmol/l), sammenholdt med 54% af patienterne på sevelamer.
English: After 6 months, more than half of the patients could then continue on the same treatment for up to one year, while a small group received Velphoro at a lower dose for three weeks only.
Danish: Efter seks måneder kunne over halvdelen af patienterne derefter fortsætte på samme behandling i op til et år, mens en lille gruppe fik Velphoro i lavere dosis i kun tre uger.
English: The study looked at the change in the amount of phosphate in the blood, measured in units of mmol/L.
Danish: I undersøgelsen blev ændringen i blodets fosfatmængde registreret, målt i enheden mmol/l.
English: Velphoro sucroferric oxyhydroxide
Danish: Velphoro sucroferrioxyhydroxid
English: The dose of Velphoro should be adjusted every two to four weeks, until an acceptable level of phosphate in the blood is reached, which should then be monitored regularly.
Danish: Dosis af Velphoro bør tilpasses hver 2.-4. uge, indtil fosfatindholdet i blodet er acceptabelt, hvorefter det bør overvåges regelmæssigt.
English: All patients were on dialysis and received either Velphoro or another phosphate binder, sevelamer, for 6 months.
Danish: Alle patienterne var i dialyse og fik enten Velphoro eller en anden fosfatbinder, sevelamer, i seks måneder.
English: The most common side effects with Velphoro (which may affect more than 1 in 10 people) are diarrhoea and discoloured faeces, which may become less frequent with continued treatment.
Danish: De almindeligste bivirkninger (der kan forekomme hos mere end én ud af hver 10 behandlede), er diarré og misfarvet afføring, som kan blive mindre hyppig ved fortsat behandling.
English: What measures are being taken to ensure the safe and effective use of Velphoro?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Velphoro?
English: The recommended starting dose is 1,500 mg (3 tablets) a day, taken in divided doses together with meals.
Danish: Den normale startdosis er 1 500 mg (3 tabletter) dagligt, der tages hver for sig sammen med et måltid.
English: This leads to hyperphosphataemia (high blood phosphate levels), which, in the long term, can cause complications such as heart and bone disease.
Danish: Dette medfører for højt fosfatindhold i blodet (hyperfosfatæmi), som i det lange løb kan give komplikationer i form af hjerte- og knoglesygdom.
English: Why is Velphoro approved?
Danish: Hvorfor er Velphoro blevet godkendt?
English: Velphoro was as effective as sevelamer in reducing patients' blood-phosphate levels and maintaining this effect.
Danish: Velphoro var lige så effektivt som sevelamer til at nedsætte fosfatindholdet i patienternes blod og opretholde denne virkning.
English: Velphoro has been studied in one main study involving 1,059 adults with long-term kidney disease and hyperphosphataemia.
Danish: Velphoro er blevet undersøgt i én hovedundersøgelse med 1 059 voksne med langvarig nyresygdom og hyperfosfatæmi.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Velphoro, 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 Velphoro, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: What is Velphoro and what is it used for?
Danish: Hvad er Velphoro, og hvad anvendes det til?
English: For more information about treatment with Velphoro, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Velphoro, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: In patients whose dose of Velphoro was then lowered, phosphate levels increased after 3 weeks, whereas the levels remained stable in those who continued treatment on the same dose for up to one year.
Danish: Hos patienter, hvis dosis af dette særnavn derefter blev sænket, steg fosfatindholdet efter tre uger, hvorimod det holdt sig uændret hos dem, der fortsatte behandlingen på samme dosis i op til et år.
English: Patients should keep to their prescribed low-phosphate diets.
Danish: Patienterne bør overholde den fosfatfattige diæt, de har fået ordineret.
English: The active substance in this medicine is sucroferric oxyhydroxide (also known as mixture of polynuclear iron(III)-oxyhydroxide, sucrose (sugar) and starches).
Danish: Det aktive stof i dette lægemiddel er sucroferrioxyhydroxid (en blanding af polynukleært jern(III)oxyhydroxid, saccharose (sukker) og stivelsesarter).
English: The active substance in Velphoro, sucroferric oxyhydroxide, is a phosphate binder.
Danish: Det aktive stof i Velphoro, sucroferrioxyhydroxid, er en fosfatbinder.
English: The CHMP concluded that Velphoro showed a clear beneficial effect in lowering phosphate levels.
Danish: CHMP konkluderede, at Velphoro udviste klar kliniske fordel ved at sænke fosfatindholdet.
English: For the full list of all side effects and restrictions with Velphoro, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger og begrænsninger med Velphoro fremgår af indlægssedlen.
English: Velphoro is available as chewable tablets (containing 500 mg of iron).
Danish: Velphoro leveres som tyggetabletter (med 500 mg jern).
English: It is not intended to provide practical advice on how to use Velphoro.
Danish: Det er ikke en praktisk vejledning i, hvordan Velphoro bør anvendes.
English: What are the risks associated with Velphoro?
Danish: Hvilke risici er der forbundet med Velphoro?
English: Velphoro must not be used in patients with iron accumulation disorders such as haemochromatosis.
Danish: Velphoro må ikke anvendes hos patienter med sygdomme, der medfører ophobning af jern, såsom hæmokromatose.
English: Velphoro is used with other treatments such as calcium or vitamin-D supplements which help to control bone disease linked to kidney failure and high phosphate levels.
Danish: Velphoro anvendes i kombination med andre behandlinger såsom calcium- eller vitamin D-tilskud, der medvirker til at kontrollere de knoglesygdomme, der er forbundet med nyresvigt og højt fosfatindhold.
English: Velphoro is a medicine used to control blood-phosphate levels in adults with long-term kidney disease who are undergoing haemodialysis or peritoneal dialysis to remove waste products from the blood.
Danish: Velphoro er et lægemiddel, der anvendes til at kontrollere blodets indhold af fosfat hos voksne, der har en langvarig nyresygdom og er i hæmodialyse eller peritonealdialyse for at få fjernet affaldsstoffer i blodet.
English: When taken with meals, the iron contained in Velphoro attaches to phosphate from food within the gut, preventing it from being absorbed into the body and helping to keep down the phosphate levels in the blood.
Danish: Når Velphoro tages sammen med et måltid, bindes jernindholdet i Velphoro til fosfatindholdet i føden i tarmen, så det forhindres i at blive optaget i kroppen, og blodets fosfatindhold holdes nede.
English: For practical information about using Velphoro, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Velphoro, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: How is Velphoro used?
Danish: Hvordan anvendes Velphoro?
English: What benefits of Velphoro have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Velphoro?
English: How does Velphoro work?
Danish: Hvordan virker Velphoro?