FrancophonIA/ELRC3.0 huggingface dataset:
English: These signs generally resolve without treatment and within one day.
Danish: Disse symptomer forsvinder normalt uden behandling inden for 24 timer.
English: Dogs may lack energy, show lack of muscle coordination, vomit, have a loss of appetite, diarrhoea, salivate, have blood sugar levels higher than normal, be more sensitive to stimulation, and have a slow heartbeat or slow breathing.
Danish: Hunde kan mangle energi, udvise manglende muskelkoordination, kaste op, mangle appetit, have diarré, savle, have højere blodsukker end normalt, være mere følsomme over for stimulation og have en langsom hjerterytme eller langsom vejrtrækning.
English: Certifect must not be used on rabbits and cats.
Danish: Lægemidlet må ikke anvendes til kaniner og katte.
English: Certifect is a medicine that contains three active substances, fipronil, (S)-methoprene and amitraz.
Danish: Certifect er et lægemiddel, der indeholder tre aktive stoffer, fipronil, (S)-methopren og amitraz.
English: (S)Methoprene is absorbed into flea eggs or larvae, where it stops their development.
Danish: (S)-Methopren absorberes i loppeæg eller -larver, hvor det stopper deres udvikling.
English: This means that they kill parasites that live on the skin or in the fur of animals, such as ticks, fleas and lice.
Danish: Det betyder, at de dræber de parasitter, som lever på huden eller i dyrenes pels, f.eks. flåter, lopper og lus.
English: Studies were also carried out to look at the effect of shampooing on the effectiveness of the medicine.
Danish: Der blev også udført undersøgelser for at se på effekten af vask med shampoo på lægemidlets virkning.
English: Both fipronil and amitraz kill adult parasites while (S)-methoprene kills parasites at the egg or larval stage.
Danish: Både fipronil og amitraz dræber voksne parasitter, mens (S)-methopren dræber parasitter i æg- eller larvestadiet.
English: It is available as a ‘spot-on' solution in pipettes already filled with the correct amount needed to treat one dog depending on its weight.
Danish: Det fås som en spot-on-opløsning i pipetter, som allerede er fyldt med den korrekte mængde til at behandle en hund, afhængig af dens vægt.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Certifect outweigh the risks for the approved indications and recommended that Certifect be given a marketing authorisation.
Danish: Udvalget for Veterinærlægemidler (CVMP) konkluderede, at fordelene ved Certifect er større end risiciene, når det anvendes til de godkendte indikationer, og anbefalede udstedelse af markedsføringstilladelse for Certifect.
English: What is the risk associated with Certifect?
Danish: Hvilken risiko er der forbundet med Certifect?
English: If side effects are seen, immediate medical assistance should be sought and the package leaflet or label shown to the doctor.
Danish: Hvis der opstår bivirkninger, skal der straks søges lægehjælp, og indlægssedlen eller etiketten skal vises til lægen.
English: The active substances in Certifect act as ‘ectoparasiticides'.
Danish: De aktive stoffer i Certifect fungerer som ektoparasitære midler.
English: In addition, it has been shown that ticks detach more quickly from treated dogs, which indirectly reduces the risk of transmission of certain tickborne diseases to dogs from infected ticks.
Danish: Desuden er det blevet påvist, at flåterne falder hurtigere af behandlede hunde, hvilket indirekte mindsker risikoen for overførsel af visse flåtbårne sygdomme til hunde fra smittebærende flåter.
English: This medicine can cause skin sensitisation and allergic reactions, and people with known allergy to any of the ingredients should avoid contact with the pipette contents.
Danish: Dette lægemiddel kan fremkalde hudoverfølsomhed og allergiske reaktioner, og personer med kendt allergi over for et eller flere af indholdsstofferne skal undgå kontakt med pipettens indhold.
English: The studies showed that the effect of Certifect is comparable to that of the combination of fipronil with (S)-methoprene in reducing tick and flea counts in dogs.
Danish: Undersøgelserne viste, at Certifects virkning er sammenlignelig med kombinationen af fipronil og (S)methopren til at mindske antallet af flåter og lopper hos hunde.
English: Certifect must not be used on sick (e.g. with systemic diseases such as diabetes, or with a fever) or recovering animals.
Danish: Certifect må ikke anvendes på syge dyr (med systemiske lidelser som diabetes eller med feber) eller til afkræftede dyr.
English: No studies of Certifect in the treatment of lice were presented, as field studies previously presented for the medicine containing fipronil and (S)methoprene were considered sufficient.
Danish: Der blev ikke forelagt nogen undersøgelser af Certifect til behandling af lus, da feltundersøgelser, som tidligere er fremlagt for lægemidlet med fipronil og (S)-methopren, blev anset for at være tilstrækkelige.
English: Other studies were performed to investigate if Certifect reduced the risk of transmission of certain tick-borne diseases.
Danish: Der blev udført andre undersøgelser for at undersøge, om Certifect nedsatte risikoen for overførsel af visse flåtbårne sygdomme.
English: The medicine can be used in the management of flea allergy dermatitis (an allergic reaction to flea bites).
Danish: Lægemidlet kan anvendes til at behandle loppebetinget allergisk dermatitis (en allergisk reaktion på loppebid).
English: The effectiveness of Certifect against ticks and fleas was investigated in both laboratory and field studies.
Danish: Certifects virkning mod flåter og lopper blev undersøgt med både laboratorie- og feltundersøgelser.
English: In the main field study, dogs of various breeds, age groups, gender and different weights were treated with either Certifect or a similar ‘spot-on' medicine containing fipronil and (S)-methoprene.
Danish: I hovedfeltundersøgelsen blev hunde af forskellige racer, aldersgrupper, køn og vægt behandlet med enten Certifect eller et tilsvarende spot-on-lægemiddel med fipronil og (S)-methopren.
English: Certifect should not be allowed to enter surface water, as it may be harmful for aquatic organisms.
Danish: Certifect må ikke udledes i vandløb, da det kan være farligt for fisk og andre vandlevende organismer.
English: The content of one full Certifect pipette (appropriate to the dog's weight) is applied directly to the dog's skin, after parting its fur, in two separate spots (halfway down the back of the neck, and at the base of the neck).
Danish: Indholdet af en hel Certifect-pipette (som passer til hundens vægt) påføres to forskellige steder (halvvejs nede på nakken og ved basis af nakken) direkte på hundens hud, efter at pelsen er delt.
English: Dogs may show some temporary reactions at the site of application (skin discolouration, hair loss, itching or redness).
Danish: Hunde kan udvise nogle midlertidige reaktioner på påføringsstedet (misfarvning, hårtab, kløe eller rødme).
English: What is Certifect?
Danish: Hvad er Certifect?
English: If accidental exposure to the eyes occurs, the eyes should be rinsed with water and in case of accidental exposure to the skin the skin should be washed with soap and water.
Danish: Hvis lægemidlet ved et uheld kommer i kontakt med øjnene, skylles øjnene straks med vand, og hvis lægemidlet ved et uheld kommer i kontakt med huden, vaskes huden med vand og sæbe.
English: Certifect is used in dogs to treat and prevent infestations with ticks and fleas, and to treat infestations with chewing lice.
Danish: Certifect anvendes til at behandle og forebygge angreb med flåter og lopper og til at behandle infektioner med bidende lus.
English: Amitraz stimulates the nervous system of ticks, leading to hyperactivity and death of the ticks.
Danish: Amitraz stimulerer nervesystemerne hos flåter, hvilket fører til hyperaktivitet hos flåterne, og at de dør.
English: How has Certifect been studied?
Danish: Hvordan blev Certifect undersøgt?
English: What is Certifect used for?
Danish: Hvad anvendes Certifect til?
English: Fipronil works on channels in the cells of the nervous system of ticks and fleas, blocking the transfer of ions in and out of cells,
Danish: Fipronil virker på kanalerne i cellerne i flåters og loppers nervesystem og blokerer overførslen af ioner ind og ud af cellerne, hvilket medfører ukontrolleret aktivitet i centralnervesystemet hos parasitterne, og at de dør.
English: For a full list of all side effects reported with Certifect, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Certifect fremgår af indlægssedlen.
English: What benefit has Certifect shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Certifect?
English: How does Certifect work?
Danish: Hvordan virker Certifect?
English: Influenza virus surface antigens*, inactivated: A/Vietnam/1194/2004 (H5N1) - like strain used (NIBRG-14) 7.5 micrograms** per 0.5 ml dose * propagated in eggs ** expressed in microgram haemagglutinin.
Danish: Influenzavirus-overfladeantigener*, inaktiverede: A/Vietnam/1194/2004 (H5N1) - lignende stamme anvendt (NIBRG-14) 7,5 mikrogram** pr. dosis på
English: It should be taken with food (a meal or light snack).
Danish: De skal tages sammen med mad (et måltid eller en let snack).
English: The recommended dose is four capsules three times a day (a total of 12 capsules a day).
Danish: Den anbefalede dosis er fire kapsler tre gange dagligt (i alt 12 kapsler pr. dag).
English: The full EPAR for Victrelis can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Victrelis findes på agenturets websted: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: This is a summary of the European public assessment report (EPAR) for Victrelis.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Victrelis.
English: If taken without food the medicine may not work properly.
Danish: Hvis lægemidlet tages uden mad, er det ikke sikkert, at det virker ordentligt.
English: When the enzyme is blocked, the virus does not replicate normally and this slows down the rate of replication, helping to eliminate the virus.
Danish: Når enzymet blokeres, formerer virussen sig ikke normalt, og replikationen bliver således langsommere, hvilket hjælper med at eliminere virussen.
English: In both studies Victrelis was compared with placebo (a dummy treatment).
Danish: I begge undersøgelserne blev Victrelis sammenlignet med placebo (en virkningsløs behandling).
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
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
English: These medicines can be harmful at high levels in the blood and it is important to avoid taking them when taking Victrelis.
Danish: Disse lægemidler kan være skadelige ved høje koncentrationer i blodet, og det er vigtigt at undgå at tage dem under behandlingen med Victrelis.
English: Why has Victrelis been approved?
Danish: Hvorfor blev Victrelis godkendt?
English: The effects of Victrelis were first tested in experimental models before being studied in humans.
Danish: Virkningerne af Victrelis blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
English: The company that makes Victrelis will ensure that all doctors expected to prescribe the medicine are provided with an educational pack with detailed information on the medicine, including information on the risk of anaemia and other side effects.
Danish: Den virksomhed, der fremstiller Victrelis, vil sikre, at alle læger, som forventes at ordinere lægemidlet, modtager undervisningsmateriale med detaljerede oplysninger om lægemidlet, inklusive oplysninger om risikoen for anæmi og andre bivirkninger.
English: Treatment with Victrelis should be started and monitored by a doctor experienced in managing chronic
Danish: Behandling med Victrelis skal indledes og overvåges af en læge med erfaring i behandling af kronisk
English: Victrelis can slow down the rate at which certain medicines are broken down in the liver.
Danish: Victrelis kan nedsætte den hastighed, hvormed visse lægemidler nedbrydes i leveren.
English: Victrelis was also shown to be effective in some patients whose treatment was shortened following blood tests in which the virus could no longer be detected in their blood.
Danish: Victrelis har også vist sig at være effektivt hos visse patienter, hvis behandling blev afkortet efter blodprøver, hvori der ikke længere kunne påvises virus i blodet.
English: The main measure of effectiveness was the number of patients who had no detectable virus in their blood 24 weeks after the end of the treatment and could therefore be
Danish: Det primære effektmål var antallet af patienter, som ikke havde påviseligt virus i blodet 24 uger efter afslutningen af behandlingen, og som derfor kunne anses for at være helbredt.
English: The active substance in Victrelis, boceprevir, is a protease inhibitor.
Danish: Det aktive stof i Victrelis, boceprevir, er en proteasehæmmer.
English: It must not be used in patients with autoimmune hepatitis (hepatitis caused by an immune disorder) or in pregnant women.
Danish: Det må ikke anvendes hos patienter med autoimmun hepatitis (hepatitis forårsaget af en immunsygdom) eller hos gravide kvinder.
English: The patients must first take peginterferon alfa and ribavirin for four weeks, after which they will add Victrelis to the treatment for up to 44 weeks, depending on several factors such as the patient's previous treatment and results of blood tests during treatment.
Danish: Patienterne skal først tage peginterferon alfa og ribavirin i fire uger, hvorefter de skal tilføje Victrelis til behandlingen i op til 44 uger, afhængigt af flere faktorer, såsom patientens tidligere behandling og resultaterne af blodprøver under behandlingen.
English: Victrelis is a medicine that contains the active substance boceprevir.
Danish: Victrelis er et lægemiddel, der indeholder det aktive stof boceprevir.
English: It blocks an enzyme called HCV NS3 protease, which is found on the hepatitis C virus of the type 1 genotype and is involved in the virus's replication.
Danish: Det blokerer et enzym kaldet HCV NS3protease, der findes på hepatitis C-virus af genotype 1, og som er involveret i virussens replikation.
English: In the study of previously untreated patients, 66% of patients who received Victrelis for 44 weeks (242 out 366) were cured compared with 38% of those who received placebo (137 out of 363).
Danish: I undersøgelsen af ikke tidligere behandlede patienter blev 66 % af de patienter, der fik Victrelis i 44 uger (242 ud af 366), helbredt sammenlignet med 38 % af de patienter, der fik placebo (137 ud af 363).
English: What is the risk associated with Victrelis?
Danish: Hvilken risiko er der forbundet med Victrelis?
English: The main increase in side effects seen when adding Victrelis to treatment was anaemia.
Danish: Den væsentligste forøgelse af bivirkninger, der blev set ved tilføjelse af Victrelis til behandlingen, var anæmi.
English: In a second study in patients in whom previous treatment had failed, the cure rate was 67% (107 out of 161) for patients who received Victrelis for 44 weeks compared with 21% (17 out of 80) for those
Danish: I en anden undersøgelse af patienter, hvis tidligere behandling var slået fejl, var helbredelsesraten 67 % (107 ud af 161) for patienter, der fik Victrelis i 44 uger, sammenlignet med 21 % (17 ud af 80) for
English: However, the Committee decided that the medicine's benefits outweighed its risk and recommended that it be granted marketing authorisation.
Danish: Udvalget konkluderede imidlertid, at fordelene ved lægemidlet opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse for Victrelis.
English: Victrelis is to be used in patients with compensated liver disease who have not been treated before or whose previous treatment has failed.
Danish: Victrelis skal anvendes hos patienter med kompenseret leversygdom, som ikke tidligere er behandlet, eller hvor tidligere behandling er slået fejl.
English: Two main studies involving 1,099 previously untreated and 404 previously treated patients with chronic hepatitis C genotype 1 infection and compensated liver disease were carried out.
Danish: Der blev foretaget to hovedundersøgelser, der omfattede 1 099 ikke tidligere behandlede og 404 tidligere behandlede patienter med kronisk hepatitis C genotype 1 og kompenseret leversygdom.
English: Compensated liver disease is when the liver is damaged but is
Danish: Kompenseret leversygdom er, når leveren er beskadiget, men stadig er i stand til at fungere normalt.
English: For a list of these medicines see the summary of product characteristics (also part of the EPAR).
Danish: Listen over disse lægemidler fremgår af produktresuméet (også en del af denne EPAR).
English: What measures are being taken to ensure the safe use of Victrelis?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri anvendelse af
English: For the full list of all side effects reported with Victrelis, see the
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Victrelis fremgår af
English: The other most common side effects with Victrelis are fatigue (tiredness), nausea (feeling sick), headache and dysgeusia (taste disturbances).
Danish: De hyppigste øvrige bivirkninger ved Victrelis er træthed, kvalme, hovedpine og smagsforstyrrelser (dysgeusi).
English: All patients also received peginterferon alfa and ribavirin.
Danish: Alle patienter modtog ligeledes peginterferon alfa og ribavirin.
English: The European Commission granted a marketing authorisation valid throughout the European Union for
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Victrelis den 18. juli 2011.
English: How does Victrelis work?
Danish: Hvordan virker Victrelis?
English: Victrelis must not be used in people who are hypersensitive (allergic) to boceprevir or any of the other ingredients.
Danish: Victrelis må ikke anvendes hos patienter, der er overfølsomme (allergiske) over for boceprevir eller andre af indholdsstofferne.
English: The CHMP noted that Victrelis in combination with peginterferon alfa and ribavirin significantly increases the number of patients cured of chronic hepatitis C infection.
Danish: CHMP bemærkede, at Victrelis i kombination med peginterferon alfa og ribavirin i betydelig grad øger antallet af patienter, der bliver helbredt for kronisk hepatitis C-infektion.
English: For more information on how to use Victrelis, including its combination with peginterferon alfa and ribavirin and the length of treatment, see the summary of product characteristics (also part of the EPAR).
Danish: Yderligere oplysninger om anvendelsen af Victrelis, herunder kombinationen heraf med peginterferon alfa og ribavirin og behandlingens varighed, fremgår af produktresuméet (også en del af EPAR).
English: Victrelis in combination with peginterferon alfa and ribavirin can lead to a higher rate of anaemia (low red blood cell counts) than is seen in treatment with peginterferon and ribavirin alone.
Danish: Victrelis i kombination med peginterferon alfa og ribavirin kan medføre højere forekomst af anæmi (lavt antal røde blodlegemer), end hvad der ses ved behandling med peginterferon og ribavirin alene.
English: This was an important improvement on results seen with only peginterferon alfa and ribavirin together.
Danish: Dette var en vigtig forbedring i forhold til resultaterne af behandling kun med peginterferon alfa og ribavirin sammen.
English: It is available as capsules
Danish: Det fås som kapsler (200 mg).
English: Victrelis was effective at curing patients with chronic hepatitis C genotype 1 infection who were also treated with peginterferon alfa and ribavirin.
Danish: Victrelis var effektivt til helbredelse af patienter med kronisk hepatitis C genotype 1, som også blev behandlet med peginterferon alfa og ribavirin.
English: Victrelis is used to treat adults with chronic (long-term) hepatitis C genotype 1 (a disease of the liver due to infection with the hepatitis C virus) in combination with two other medicines, peginterferon alfa
Danish: Victrelis anvendes til behandling af voksne med kronisk (langvarig) hepatitis C genotype 1 (en leversygdom forårsaget af infektion med hepatitis C-virus) i kombination med to andre lægemidler,
English: What benefit has Victrelis shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Victrelis?
English: For more information about treatment with Victrelis, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Victrelis, kan du læse indlægssedlen (også en del af denne EPAR) eller
English: The marketing authorisation holders shall complete the below conditions, within the stated timeframe, and competent authorities shall ensure that the following is fulfilled:
Danish: Indehaverne af markedsføringstilladelse skal opfylde nedenstående betingelser inden for den angivne tidsfrist, og de kompetente myndigheder skal sikre, at følgende er opfyldt:
English: The details of the visual reminder should be agreed at national level and be subject to a user test taking into account input from local patient representatives.
Danish: De nærmere detaljer for den visuelle påmindelse bør aftales på nationalt plan og bør undersøges i en brugertest, der tager hensyn til input fra lokale patientrepræsentanter.
English: With regards to the studies abovementioned, the MAHs are strongly encouraged to collaborate and perform joint studies.
Danish: Med hensyn til ovennævnte studier opfordres indehaverne af markedsføringstilladelse på det kraftigste til at samarbejde og gennemføre fælles studier.
English: These materials should ensure that prescriber are informed and the patients understand and acknowledge the risks associated with valproate in-utero exposure.
Danish: Disse materialer bør sikre, at ordinerende læger er informeret, og at patienterne forstår og anerkender risiciene ved in utero-eksponering for valproat.
English: A visual reminder on the outer package to warn patient about the harm to unborn baby and the need for effective contraception when using the medicinal product should be implemented in all medicinal products containing substances related to valproate.
Danish: En visuel påmindelse på yderemballagen som advarsel til patienterne om risikoen for skade på det ufødte barn og nødvendigheden af at anvende sikker prævention ved behandling med lægemidlet bør gennemføres for alle lægemidler, der indeholder stoffer relateret til valproat.
English: All MAHs should have in place a Risk management plan (RMP).
Danish: Alle indehavere af en markedsføringstilladelse bør have iværksat en risikostyringsplan.
English: These should be submitted to the National Competent Authorities: Within 1 month of the Commission decision.
Danish: Senest 1 måned efter Kommissionens beslutning.
English: The MAHs of medicinal products with substances related to valproate shall conduct a PASS preferably based on existing registries to further characterise the foetal anticonvulsant syndrome in children with valproate in utero exposure as compared to other anti-epileptic drugs.
Danish: Indehaverne af markedsføringstilladelse for lægemidler, der indeholder stoffer relateret til valproat, skal gennemføre et PASSstudie, helst på grundlag af eksisterende registre, for yderligere at karakterisere det føtale antiepileptikasyndrom hos børn ved in utero-eksponering for valproat i forhold til behandling med andre antiepileptika.