FrancophonIA/ELRC3.0 huggingface dataset:
English: Robenacoxib is a non-steroidal anti-inflammatory drug (NSAID).
Danish: Robenacoxib er en medicintype, der er smertestillende og betændelsesdæmpende (NSAID).
English: For the treatment of pain and inflammation associated with orthopaedic or soft tissue surgery in cats.
Danish: Til behandling af smerter og inflammation forbundet med ortopæd- eller bløddelskirurgi hos katte.
English: Use in cats with impaired function of the heart, kidneys or liver or in cats that are dehydrated, have low volume of circulating blood or have low blood pressure may involve additional risks.
Danish: Hvis produktet anvendes til katte med nedsat hjerte-, nyre- eller leverfunktion eller til katte, der er dehydrerede, har en lav mængde cirkulerende blod eller har lavt blodtryk, kan det medføre yderligere risici.
English: Use in dogs with impaired function of the heart, kidneys or liver or in dogs that are dehydrated, have low volume of circulating blood or have low blood pressure may involve additional risk.
Danish: Hvis produktet anvendes til hunde med nedsat hjerte-, nyre- eller leverfunktion eller til hunde, der er dehydrerede, har en lav mængde cirkulerende blod eller har lavt blodtryk, kan det medføre yderligere risici.
English: Do not use in animals suffering from gastrointestinal ulceration.
Danish: Bør ikke anvendes til dyr, der lider af sårdannelse i mave-tarm-kanalen.
English: For pregnant women, particularly near term pregnant women, accidental injection and prolonged dermal exposure might increase the risk to the foetus.
Danish: For gravide kvinder, især de, der er tæt på terminen, øger utilsigtet injektion og forlænget hudkontakt risikoen for fostret.
English: For pregnant women, particularly near term pregnant women, prolonged dermal exposure may increase the risk to the foetus.
Danish: Hos gravide kvinder, især dem, der er tæt på terminen, øger forlænget hudkontakt risikoen for fostret.
English: The safety of the veterinary medicinal product has not been established in dogs weighing less than 2.5 kg or under 3 months of age.
Danish: Det veterinærmedicinske produkts sikkerhed er ikke fastlagt for hunde, der vejer under 2,5 kg eller er under 3 måneder gamle.
English: Round, beige to brown tablets with the imprint “NA” on one side and the following imprint on the other side:
Danish: Runde, beige til brune tabletter med mærkning NA på den ene side og følgende på den anden: 5 mg tablet: AK
English: The safety of the veterinary medicinal product has not been established in cats weighing less than 2.5 kg or under 4 months of age.
Danish: Det veterinærmedicinske produkts sikkerhed er ikke fastlagt for katte, der vejer under 2,5 kg eller er under 4 måneder gamle.
English: Use this veterinary medicinal product under strict veterinary monitoring in cats with a risk of gastrointestinal ulcers, or if the cat previously displayed intolerance to other NSAIDs.
Danish: Ved anvendelse af dette veterinærmedicinske produkt til katte med risiko for mavesår, eller til katte, der tidligere har udvist intolerance over for andre NSAID'er, er nøje tilsyn af en dyrlæge påkrævet.
English: The safety of this veterinary medicinal product has not been established in dogs weighing less than 2.5 kg or under 3 months of age.
Danish: Denne medicins sikkerhed er ikke fastlagt for hunde, der vejer under 2,5 kg eller er under 3 måneder gamle.
English: After intravenous administration robenacoxib was rapidly cleared from blood (CL of 0.44 L/kg/h in cats and 0.81 L/kg/h in dogs) with an elimination t1/2 of 1.1 h in cats and 0.8 h in dogs.
Danish: hos hunde) med en eliminationshalveringstid (t½) på 1,1 t. hos katte og 0,8 t. hos hunde.
English: MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Danish: INDEHAVER(E) AF VIRKSOMHEDSGODKENDELSE ANSVARLIG FOR BATCHFRIGIVELSE
English: Use this veterinary medicinal product under strict veterinary monitoring in animals at risk of ulceration of the digestive tract, or if the animal previously displayed intolerance to other NSAIDs.
Danish: Ved anvendelse af dette veterinærmedicinske produkt til dyr med risiko for mavesår, eller til dyr, der tidligere har udvist intolerance over for andre NSAID'er, er nøje tilsyn af en dyrlæge påkrævet.
English: EU/2/08/089/012 (7 tablets) EU/2/08/089/013 (14 tablets) EU/2/08/089/014 (28 tablets) EU/2/08/089/015 (70 tablets) EU/2/08/089/026 (30 x 1 tablets) EU/2/08/089/027 (60 x 1 tablets)
Danish: Onsior 20 mg tabletter til hunde EU/2/08/089/012 (7 tabletter) EU/2/08/089/013 (14 tabletter) EU/2/08/089/014 (28 tabletter) EU/2/08/089/015 (70 tabletter) EU/2/08/089/026 (30 x 1 tabletter) EU/2/08/089/027 (60 x 1 tabletter)
English: Use this product under strict veterinary monitoring in dogs with a risk of gastrointestinal ulcers, or if the dog previously displayed intolerance to other NSAIDs.
Danish: Ved anvendelse af dette produkt til hunde med risiko for mavesår, eller til hunde, der tidligere har udvist intolerance over for andre NSAID'er, er nøje tilsyn af en dyrlæge påkrævet.
English: EU/2/08/089/016 (7 tablets) EU/2/08/089/017 (14 tablets) EU/2/08/089/018 (28 tablets) EU/2/08/089/019 (70 tablets) EU/2/08/089/028 (30 x 1 tablets) EU/2/08/089/029 (60 x 1 tablets)
Danish: Onsior 40 mg tabletter til hunde EU/2/08/089/016 (7 tabletter) EU/2/08/089/017 (14 tabletter) EU/2/08/089/018 (28 tabletter) EU/2/08/089/019 (70 tabletter) EU/2/08/089/028 (30 x 1 tabletter) EU/2/08/089/029 (60 x 1 tabletter)
English: Do not use in pregnant and lactating animals because the safety of robenacoxib has not been established during pregnancy and lactation or in cats and dogs used for breeding.
Danish: Må ikke anvendes til drægtige og diegivende dyr, da sikkerheden af robenacoxib under drægtighed og diegivning eller hos avlskatte og -hunde ikke er fastlagt.
English: EU/2/08/089/008 (7 tablets) EU/2/08/089/009 (14 tablets) EU/2/08/089/010 (28 tablets) EU/2/08/089/011 (70 tablets) EU/2/08/089/024 (30 x 1 tablets) EU/2/08/089/025 (60 x 1 tablets)
Danish: Onsior 10 mg tabletter til hunde EU/2/08/089/008 (7 tabletter) EU/2/08/089/009 (14 tabletter) EU/2/08/089/010 (28 tabletter) EU/2/08/089/011 (70 tabletter) EU/2/08/089/024 (30 x 1 tabletter) EU/2/08/089/025 (60 x 1 tabletter)
English: Do not use in pregnant or lactating dogs because the safety of robenacoxib has not been established during pregnancy and lactation or in dogs used for breeding.
Danish: Må ikke anvendes til drægtige eller diegivende hunde, da sikkerheden ved robenacoxib under drægtighed og diegivning eller hos avlshunde ikke er fastlagt.
English: EU/2/08/089/004 (7 tablets) EU/2/08/089/005 (14 tablets) EU/2/08/089/006 (28 tablets) EU/2/08/089/007 (70 tablets) EU/2/08/089/022 (30 x 1 tablets) EU/2/08/089/023 (60 x 1 tablets)
Danish: Onsior 5 mg tabletter til hunde EU/2/08/089/004 (7 tabletter) EU/2/08/089/005 (14 tabletter) EU/2/08/089/006(28 tabletter) EU/2/08/089/007 (70 tabletter) EU/2/08/089/022 (30 x 1 tabletter) EU/2/08/089/023 (60 x 1 tabletter)
English: Do not use in pregnant and lactating animals because the safety of robenacoxib has not been established during pregnancy and lactation or in cats used for breeding.
Danish: Må ikke bruges til drægtige og diegivende dyr, da sikkerheden af robenacoxib under drægtighed og diegivning eller hos avlskatte ikke er fastlagt.
English: Imprints
Danish: Gærpulver
English: Do not use in pregnant or lactating animals because the safety of robenacoxib has not been established during pregnancy and lactation or in cats and dogs used for breeding.
Danish: Bør ikke anvendes til drægtige eller diegivende dyr, da sikkerheden af robenacoxib ikke er fastlagt under drægtighed og diegivning eller i avlskatte og -hunde.
English: Do not use in cats suffering from gastrointestinal ulceration.
Danish: Bør ikke anvendes til katte, der lider af mavesår.
English: Wash hands and exposed skin immediately after use of the product.
Danish: Særlige forsigtighedsregler for personer, som indgiver lægemidlet til dyr Vask hænder og udsat hud umiddelbart efter brug af produktet.
English: Do not use in pregnant or lactating bitches because the safety of robenacoxib has not been established during pregnancy and lactation or in dogs used for breeding.
Danish: Må ikke anvendes til drægtige eller diegivende tæver, da sikkerheden af robenacoxib ikke er fastlagt under drægtighed og diegivning eller hos avlshunde.
English: EU/2/08/089/001-003 EU/2/08/089/021
Danish: MARKEDSFØRINGSTILLADELSENS NUMRE EU/2/08/089/001-003
English: Scientific conclusions, grounds for variation to the terms of the marketing authorisations and detailed explanation of the scientific grounds for the differences from the PRAC recommendation
Danish: Videnskabelige konklusioner og begrundelse for ændring af betingelserne for markedsføringstilladelserne samt detaljeret redegørelse for den videnskabelige begrundelse for afvigelserne fra anbefalingen fra PRAC (Det Europæiske Lægemiddelagenturs Udvalg for Risikovurdering inden for
English: It is therefore very important that you (or your partner) do not become pregnant during this treatment or for a period of time after completing treatment.
Danish: Derfor er det meget vigtigt, at du (eller din partner) ikke bliver gravid i løbet af denne behandling eller i en periode efter, behandlingen er afsluttet.
English: e These are medicinal products within class where similar interactions could be predicted.
Danish: e. Dette er lægemidler inden for en klasse, hvor lignende interaktioner kunne forventes.
English: Date of first authorisation: 06 July 2016
Danish: Dato for første markedsføringstilladelse: 06 juli 2016
English: Do not give this medicine to children and adolescents under 18 years of age.
Danish: Giv ikke dette lægemiddel til børn og unge under 18 år.
English: • have liver problems other than from hepatitis C, for instance
Danish: • har andre leverproblemer end hepatitis C, for eksempel
English: Ask your doctor for effective contraception method suitable for you and your partner.
Danish: Spørg din læge om en effektiv præventionsmetode, som er egnet til dig og din partner.
English: Talk to your doctor if you:
Danish: Tal med din læge, hvis du:
English: Effects on medicinal product levels.
Danish: Virkning på lægemiddelniveau.
English: Keep the tablet bottle with you so that you can easily describe what you have taken.
Danish: Tag tabletbeholderen med, så du let kan beskrive, hvad du har taget.
English: Medicinal product by therapeutic areas/Possible Mechanism of Interaction
Danish: Lægemiddel efter behandlingsområder/mulig interaktionsmekanisme
English: Increased score (Worsening)
Danish: Øget score (forværring)
English: Study arms (Number of patients treated)
Danish: Studiearme (antal patienter behandlet)
English: Due to the bitter taste, it is recommended that the film-coated tablet is not chewed or crushed.
Danish: Grundet den bitre smag anbefales det, at den filmovertrukne tablet ikke tygges eller knuses.
English: Increased score (Worsening) No assessment
Danish: Øget score (forværring) Ingen vurdering
English: The effects of higher doses/exposures are not known.
Danish: Virkningen af højere doser/eksponeringer er ikke kendt.
English: Expected.
Danish: Forventet.
English: Recommended dose The recommended dose is one tablet once a day for 12 weeks.
Danish: Anbefalet dosis Den anbefalede dosis er én tablet én gang om dagen i 12 uger.
English: NA = Not available
Danish: IT = Ikke tilgængelig
English: • Your doctor can decide if you should take Epclusa and for how long;
Danish: • Din læge kan beslutte, om du skal tage Epclusa og hvor længe
English: The active substances in this medicine work together by blocking two different proteins that the virus needs to grow and reproduce itself, allowing the infection to be permanently eliminated from the body.
Danish: De aktive stoffer i dette lægemiddel arbejder sammen ved at blokere to forskellige proteiner, som virusset skal bruge til at vokse og formere sig, og gør det derved muligt at udrydde infektionen permanent i kroppen.
English: Observed: Rosuvastatin ↑
Danish: Observeret: Rosuvastatin ↑
English: Skin disorders Frequency not known: Stevens-Johnson syndrome
Danish: Hudlidelser Hyppighed ikke kendt: Stevens-Johnson syndrom
English: The tablet is 20 mm long and 10 mm wide.
Danish: Tabletten er 20 mm lang og 10 mm bred.
English: Swallow the tablet whole with or without food.
Danish: Slug tabletten hel med eller uden mad.
English: Clinical studies in patients with Renal Impairment - study 4062
Danish: Kliniske studier hos patienter med nedsat nyrefunktion - studie 4062
English: No assessment
Danish: Ingen vurdering
English: Observed: Atorvastatin
Danish: Observeret: Atorvastatin
English: SVR12 was achieved by 19/19 patients with cirrhosis.
Danish: SVR12 blev opnået af 19/19 patienter med cirrose.
English: Epclusa can be administered without regard to food.
Danish: Epclusa kan administreres uden hensyntagen til mad.
English: If overdose occurs the patient must be monitored for evidence of toxicity.
Danish: Hvis overdosering forekommer, skal patienten overvåges for tegn på toksicitet.
English: • Your doctor can confirm that your treatment has worked and you are free of the hepatitis C
Danish: • Din læge kan bekræfte, at behandlingen har virket, og at du ikke længere har hepatitis C-virus.
English: f Bioequivalence/Equivalence boundary 80-125%.
Danish: f. Bioækvivalens/ækvivalensgrænse 80-125 %.
English: It is very important that you also read the leaflets for the other medicines that you will be taking with Epclusa.
Danish: Det er meget vigtigt, at du også læser indlægssedlerne for de andre lægemidler, som du tager sammen med Epclusa.
English: Your doctor will test your blood before, during and after your treatment with Epclusa.
Danish: Din læge vil undersøge dit blod før, under og efter din behandling med Epclusa.
English: It is very important that you complete the full course of treatment to give the medicine the best chance to treat your hepatitis C virus infection.
Danish: Det er meget vigtigt, at du gennemfører hele behandlingsprogrammet, så lægemidlet får de bedste betingelser for at behandle din infektion med hepatitis C.
English: Pharmacokinetic data from this patient was consistent with non-adherence to treatment.
Danish: Farmakokinetiske data fra denne patient var konsistente med manglende overholdelse af behandlingen.
English: Table 3: Interactions between Epclusa and other medicinal products
Danish: Tabel 3: Interaktioner mellem Epclusa og andre lægemidler
English: No patients in the placebo group achieved SVR12.
Danish: Ingen patienter i placebogruppen opnåede SVR12.
English: If you do miss a dose, work out how long it is since you last took your Epclusa:
Danish: Hvis du glemmer en dosis, skal du regne ud, hvor lang tid der er gået, siden du sidst tog Epclusa:
English: Tell your doctor immediately if you are taking any medicines for heart problems and during treatment you experience:
Danish: Sig det straks til lægen, hvis du tager et hvilket som helst lægemiddel mod hjerteproblemer, og du under behandlingen oplever:
English:  If this applies to you, do not take Epclusa and tell your doctor immediately.
Danish: Hvis dette gælder for dig, må du ikke tage Epclusa, og du skal straks fortælle det til lægen.
English: Your liver function may change with treatment of hepatitis C and therefore may affect other medications (e.g. medicines used to suppress your immune system, etc.).
Danish: Din leverfunktion kan ændre sig under behandling for hepatitis C, og kan derfor påvirke anden medicin (f.eks. medicin brugt til at undertrykke dit immunsystem osv.).
English: These medicines can decrease the amount of velpatasvir in your blood.
Danish: Disse lægemidler kan nedsætte mængden af velpatasvir i blodet.
English: SVR12 for selected subgroups are presented in Table 13.
Danish: SVR12 for udvalgte undergrupper vises i tabel 13.
English: Virologic failure (relapse and on-treatment failure) Genotype 1a
Danish: Virologisk svigt (recidiv og svigt under behandling) Genotype 1a
English: Combinations of these variants often showed greater reductions in susceptibility to velpatasvir than single RAVs alone.
Danish: Kombinationer af disse varianter viste ofte større nedsat følsomhed for velpatasvir end de enkelte RAV'er alene.
English: The table is not all-inclusive.
Danish: Tabellen er ikke udtømmende.
English: If the starting dose is not well tolerated, the dose should be reduced as clinically indicated based on haemoglobin levels
Danish: Hvis startdosis ikke er veltolereret, bør dosis reduceres som klinisk indiceret, baseret på hæmoglobinniveauet
English: Treatment of overdose with Epclusa consists of general supportive measures including monitoring of vital signs, as well as observation of the clinical status of the patient.
Danish: Behandling af en Epclusa-overdosis består af generelt understøttende behandling, herunder overvågning af vitale tegn og observation af patientens kliniske status.
English: Protein binding of GS-331007 was minimal in human plasma.
Danish: Proteinbindingen af GS-331007 var minimal i humant plasma.
English: You must read the “Pregnancy” section in the ribavirin package leaflet very carefully.
Danish: Du skal læse punktet ”Graviditet” i indlægssedlen for ribavirin meget grundigt.
English: Patients who are identified as being at high risk of bradyarrhythmia should be continuously monitored for 48 hours in an appropriate clinical setting.
Danish: Patienter med kendt høj risiko for bradyarytmi skal monitoreres kontinuerligt i 48 timer i passende kliniske omgivelser.
English: Use only if no other alternative is available.
Danish: Bør kun anvendes, hvis der ikke er andre behandlingsmuligheder.
English: The following dosing is recommended where ribavirin is divided in two daily doses and given with food:
Danish: Følgende dosering anbefales, idet ribavirin fordeles på to daglige doser, som gives sammen med mad:
English: This change could be to Epclusa or another medicine you are taking.
Danish: Denne ændring kan vedrøre Epclusa eller andre lægemidler, du måtte tage.
English: No patient had HIV-1 rebound during the study, and CD4+ counts were stable during treatment.
Danish: Ingen patienter havde hiv 1-rebound i løbet af studiet, og CD4+-tallene var stabile under behandlingen.
English: If you are taking one of these medicines your doctor will either give you a different medicine for stomach ulcers, heartburn or acid reflux, or recommend how and when you take that medicine.
Danish: Hvis du tager et af disse lægemidler, vil din læge enten give dig et andet lægemiddel mod mavesår, halsbrand eller sure opstød, eller anbefale, hvordan og hvornår du tager lægemidlet.
English: This may make Epclusa work less well.
Danish: Dette kan få Epclusa til at virke mindre effektivt.
English: The effects of Epclusa during pregnancy are not known.
Danish: Virkningen af Epclusa under graviditet er ukendt.
English: Co-administration of Epclusa with medicinal products that are substrates of these transporters may increase the exposure of such medicinal products.
Danish: Samtidig administration af Epclusa og lægemidler, der er substrater for disse transportører, kan øge eksponeringen for sådanne lægemidler.
English: Treatment and duration
Danish: Behandling og behandlingsvarighed
English: The monohydroxylated and desmethylated velpatasvir were the metabolites identified in human plasma.
Danish: Den monohydroxylerede og desmetylerede velpatasvir var de metabolitter, der blev identificeret i humant plasma.
English: A coagulation test helps to identify patients with an increased bleeding risk due to increased dabigatran exposure.
Danish: En koagulationstest kan hjælpe med at identificere patienter med øget blødningsrisiko, der skyldes øget eksponering for dabigatran.
English: Interactions cannot be excluded with other HMG-CoA reductase inhibitors.
Danish: Interaktioner med andre HMG-CoA-reduktasehæmmere kan ikke udelukkes.
English: The human relevance of this finding is not known.
Danish: Relevansen af disse fund for mennesker er ukendt.
English: There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of sofosbuvir, velpatasvir or Epclusa in pregnant women.
Danish: Der er ingen eller utilstrækkelige data (mindre end 300 gravide forsøgspersoner) fra anvendelse af sofosbuvir, velpatasvir eller Epclusa til gravide kvinder.
English: Talk to your doctor or pharmacist before taking Epclusa if:
Danish: Kontakt lægen eller apotekspersonalet, før du tager Epclusa, hvis:
English: Observed: Digoxin
Danish: Observeret: Digoxin
English: Randomisation was stratified by the presence or absence of cirrhosis and prior treatment experience (treatment-naïve versus treatment-experienced).
Danish: Randomisering blev stratificeret efter tilstedeværelse eller fravær af cirrose og tidligere behandlingserfaring (behandlingsnaive versus behandlingserfarne).
English: • you currently take, or have taken in the last few months, the medicine amiodarone to treat irregular heartbeats (your doctor may consider alternative treatments if you have taken this medicine).
Danish: • du får eller inden for de seneste par måneder har fået lægemidlet amiodaron mod uregelmæssig hjerterytme (lægen kan overveje andre behandlinger, hvis du har taget dette lægemiddel).
English: Pharmacotherapeutic group: Direct acting antiviral, ATC code: J05AP55
Danish: Farmakoterapeutisk klassifikation: Direkte virkende antivirale midler, ATC-kode: J05AP55
English: Table 1: Recommended treatment and duration for all HCV genotypes
Danish: Tabel 1: Anbefalet behandling og behandlingsvarighed for alle HCV-genotyper
English: These data indicate that renal clearance is the major elimination pathway for GS-331007.
Danish: Disse data indikerer, at renal clearance er den primære eliminationsvej for GS-331007.
English: Epclusa should not affect your ability to drive or use any tools or machinery.
Danish: Epclusa vil ikke påvirke din evne til at føre køretøjer eller anvende værktøj eller maskiner.
English: No individual substitutions tested in genotypes 2a, 4a, or 5a conferred a > 100-fold reduction in velpatasvir susceptibility.
Danish: Ingen individuelle substitutioner testet i genotype 2a, 4a eller 5a gav en > 100 gange nedsat følsomhed for velpatasvir.
English: Variants were selected at NS5A resistance associated positions 24, 28, 30, 31, 32, 58, 92 and 93.
Danish: Varianter blev selekteret ved de NS5Aresistensforbundne positioner 24, 28, 30, 31, 32, 58, 92 og 93.
English: Clinical studies of Epclusa included 156 patients aged 65 and over (12% of total number of patients in the Phase 3 clinical studies).
Danish: Kliniske studier med Epclusa inkluderede 156 patienter i alderen 65 og derover (12 % af det samlede antal patienter i kliniske fase III-studier).
English: Rosuvastatin, at a dose that does not exceed 10 mg, may be administered with Epclusa.
Danish: Rosuvastatin kan ved en dosis, der ikke overstiger 10 mg, administreres sammen med Epclusa.
English: The response rates observed for patients ≥ 65 years of age were similar to that of patients < 65 years of age, across treatment groups.
Danish: De observerede responsrater hos patienter ≥ 65 år var sammenlignelige med raterne hos patienter < 65 år i alle behandlingsgrupper.
English: • if you have a current or previous infection with the hepatitis B virus, since your doctor may want to monitor you more closely;
Danish: • hvis du har eller har haft en infektion med hepatitis B-virus, da din læge måske vil overvåge dig tættere
English: Epclusa [Outer packaging only]
Danish: Epclusa [Kun ydre emballage]
English: Patients should be instructed not to take a double dose of Epclusa.
Danish: Patienterne skal informeres om ikke at tage en dobbelt dosis Epclusa.
English: If you need high doses of these medicines your doctor may give you a different medicine instead or adjust the dose of the medicine you are taking.
Danish: Hvis du har behov for høje doser af disse lægemidler, kan din læge give dig et andet lægemiddel i stedet eller justere dosis af det lægemiddel, du tager.
English: Close monitoring of INR is recommended with all vitamin K antagonists.
Danish: Tæt monitorering af INR anbefales ved alle vitamin Kantagonister.